What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2022-03-10 compared with 2021-03-29 · 1175 added, 2315 removed, 88 unchanged (98% of the section changed)

Risk Factors.

investment in our securities involves a high degree of risk.

You should consider carefully all of the risks described below, together

with the other information contained in this annual report, before making a decision to invest in our securities.

If any of the

following events occur, our business, financial condition and operating results may be materially adversely affected.

event, the trading price of our securities could decline, and you could lose all or part of your investment.

Related to our Business

has incurred significant losses since its inception and expects to incur losses for the foreseeable future.

has no products approved for commercial sale and has not generated any revenue to date, and Gemini continues to incur significant

research and development and other expenses related to its ongoing operations.

As a result, Gemini is not profitable and has incurred

significant losses in each period since its inception in March 2015.

the years ended December 31, 2020 and December 31, 2019, Gemini reported net losses of $40.8 million and $41.4 million.

December 31, 2020, Gemini had an accumulated deficit of $112.8 million.

Gemini expects to continue to incur significant losses

for the foreseeable future, and Gemini expects these losses to increase as Gemini continues its research and development of, and

seeks regulatory approvals for, its product candidates.

Gemini anticipates that its expenses will increase substantially if, and

conducts larger

scale clinical trials for its lead product candidate, GEM103, and any other product candidates;

discovers and develops

new product candidates, and conducts nonclinical studies and clinical trials;

manufactures, or

has manufactured, clinical and commercial supplies of its product candidates;

seeks regulatory

approvals for its product candidates;

commercializes GEM103

or any other product candidates, if approved;

attempts to transition

from a company with a research focus to a company capable of supporting commercial activities, including establishing sales,

marketing and distribution infrastructure;

hires additional

clinical, scientific, and management personnel;

adds operational,

financial, and management information systems and personnel;

identifies additional

compounds or product candidates and acquires rights from third parties to those compounds or product candidates through licenses;

incurs additional

costs associated with operating as a public company.

if Gemini succeeds in commercializing GEM103 or any other product candidates, Gemini may continue to incur substantial research

and development and other expenditures to develop and market additional product candidates.

Gemini may encounter unforeseen expenses,

difficulties, complications, delays and other unknown factors that may adversely affect its business for any reason, including

as a result of the Coronavirus Disease 19, or COVID-19 pandemic.

The size of its future net losses will depend, in part, on the

rate of future growth of its expenses and its ability to generate revenue.

Its prior losses and expected future losses have had

and will continue to have an adverse effect on its stockholders’

In evaluating our company and our business, you should carefully consider the risks and uncertainties described below, together with the other information in this Annual Report on Form 10-K, including our consolidated financial statements and the related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations”.

The occurrence of one or more of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances, may have a material adverse effect on our business, reputation, revenue, financial condition, results of operations or future prospects, in which case the market price of our common stock could decline, and you could lose part or all of your investment.

Unless otherwise indicated, reference in this section and elsewhere in this Annual Report on Form 10-K to our business being adversely affected, negatively impacted or harmed will include an adverse effect on, or a negative impact or harm to, our business, reputation, financial condition, results of operations, revenue or our future prospects.

The material and other risks and uncertainties summarized above in this Annual Report on Form 10-K and described below are not intended to be exhaustive and are not the only ones we face.

Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business.

This Annual Report on Form 10-K also contains forward-looking statements that involve risks and uncertainties.

Our actual results could differ materially from those anticipated in the forward-looking statements as a result of a number of factors, including the risks described below.

See the section titled “Cautionary Note Regarding Forward-Looking Statements”.

Summary of Risk Factors

Our business is subject to numerous risks and uncertainties that you should be aware of in evaluating our business.

These risks include, but are not limited to, the following:

We may not be successful in identifying and implementing any strategic business combination or other transaction and any strategic transactions that we may consummate in the future could have negative consequences.

We may not realize any additional value in a strategic transaction.

If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks.

If a strategic transaction is not consummated, our Board may decide to pursue a dissolution and liquidation.

In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such a transaction.

Our corporate restructurings and the associated headcount reductions may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.

The impact and results of our ongoing strategic process are uncertain and may not be successful.

We may become involved in securities class action litigation that could divert management’s attention and harm the company’s business, and insurance coverage may not be sufficient to cover all costs and damages.

We have incurred significant losses since our inception and may incur losses for the foreseeable future.

We may require additional capital to finance our operations, which may not be available to us on acceptable terms, or at all.

As a result, we may not complete the development and commercialization of GEM103 or any other product candidates.

We may continue to be heavily dependent on the success of GEM103, our lead product candidate.

GEM103 and any other product candidates would need to undergo rigorous clinical trials and regulatory approvals, and success in nonclinical studies or earlier-stage clinical trials may not be indicative of results in future clinical trials.

We have been and may in the future be subject to many manufacturing risks, any of which could substantially increase our costs, delay clinical programs and limit supply of our products.

We must retain highly skilled employees in order to succeed.

If we are not able to retain our current senior management team and our scientific advisors or continue to attract and retain qualified scientific, technical and business personnel, our business will suffer.

We may rely on third parties to conduct our clinical trials and for the manufacture of our clinical drug supply.

If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates.

Our business could be adversely affected by the effects of health epidemics, including the novel coronavirus (“COVID-19”) pandemic, in regions where third parties for which we rely have significant research, development or manufacturing facilities, concentrations of clinical trial sites or other business operations, causing disruption in supplies and services.

The future sales of shares by existing stockholders and future exercise of registration rights may adversely affect the market price of our common stock.

If we are unable to obtain or protect intellectual property rights related to any of our product candidates, we may not be able to compete effectively in our market.

It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.

If we fail to comply with our obligations in our current and future intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.

Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a de-listing of our common stock.

The summary risk factors described above should be read together with the text of the full risk factors below and in the other information set forth in this Annual Report on Form 10-K, including our consolidated financial statements and the related notes, as well as in other documents that we file with the SEC.

If any such risks and uncertainties actually occur, our business, prospects, financial condition and results of operations could be materially and adversely affected.

The risks summarized above or described in full below are not the only risks that we face.

Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial may also materially adversely affect our business, prospects, financial condition and results of operations.

Risks Related to Strategic Alternative Process and Potential Strategic Transaction

In addition to our efforts, if any, to pursue clinical development of GEM103, GEM307 or any other product candidate, we also continue to evaluate all potential strategic options for the company, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transaction.

However, there can be no assurance that we will be able to successfully consummate any particular strategic transaction.

The process of continuing to evaluate these strategic options may be very costly, time-consuming and complex and we have incurred, and may in the future incur, significant costs related to this continued evaluation, such as legal and accounting fees and expenses and other related charges.

We may also incur additional unanticipated expenses in connection with this process.

A considerable portion of these costs will be incurred regardless of whether any such course of action is implemented or transaction is completed.

Any such expenses will decrease the remaining cash available for use in our business and may diminish or delay any future distributions to our stockholders.

In addition, any strategic business combination or other transactions that we may consummate in the future could have a variety of negative consequences and we may implement a course of action or consummate a transaction that yields unexpected results that adversely affects our business and decreases the remaining cash available for use in our business or the execution of our strategic plan.

There can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated, lead to increased stockholder value, or achieve the anticipated results.

Any failure of such potential transaction to achieve the anticipated results could significantly impair our ability to enter into any future strategic transactions and may significantly diminish or delay any future distributions to our stockholders.

We may not realize any additional value in a strategic transaction.

The market capitalization of our company is below the value of our cash and cash equivalents.

Potential counterparties in a strategic transaction involving our company may place minimal or no value on our assets given the limited data regarding our lead development program.

Further, the development and any potential commercialization of our product candidates will require substantial additional cash to fund the costs associated with conducting the necessary preclinical and clinical testing and obtaining regulatory approval.

Consequently, any potential counterparty in a strategic transaction involving our company may choose not to spend additional resources and continue development of our product candidates and may attribute little or no value, in such a transaction, to those product candidates.

If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks.

Although there can be no assurance that a strategic transaction will result from the process we have undertaken to identify and evaluate strategic alternatives, the negotiation and consummation of any such transaction will require significant time on the part of our management, and the diversion of management’s attention may disrupt our business.

The negotiation and consummation of any such transaction may also require more time or greater cash resources than we anticipate and expose us to other operational and financial risks, including:

increased near-term and long-term expenditures;

exposure to unknown liabilities;

higher than expected acquisition or integration costs;

incurrence of substantial debt or dilutive issuances of equity securities to fund future operations;

write-downs of assets or goodwill or incurrence of non-recurring, impairment or other charges;

increased amortization expenses;

difficulty and cost in combining the operations and personnel of any acquired business with our operations and personnel;

impairment of relationships with key suppliers or customers of any acquired business due to changes in management and ownership;

inability to retain key employees of our company or any acquired business;

possibility of future litigation.

Any of the foregoing risks could have a material adverse effect on our business, financial condition and prospects.

If a strategic transaction is not consummated, our Board may decide to pursue a dissolution and liquidation.

There can be no assurance that a strategic transaction will be completed.

If a strategic transaction is not completed, our Board may decide to pursue a dissolution and liquidation.

In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such decision and, as with the passage of time the amount of cash available for distribution will be reduced as we continue to fund our operations.

In addition, if our Board were to approve and recommend, and our stockholders were to approve, a dissolution and liquidation, we would be required under Delaware corporate law to pay our outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to our stockholders.

As a result of this requirement, a portion of our assets may need to be reserved pending the resolution of such obligations and the timing of any such resolution is uncertain.

In addition, we may be subject to litigation or other claims related to a dissolution and liquidation.

If a dissolution and liquidation were pursued, our Board, in consultation with our advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve.

Accordingly, holders of our common stock could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up.

Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction.

Our ability to consummate a strategic transaction depends upon our ability to retain our employees required to consummate such a transaction, the loss of whose services may adversely impact the ability to consummate such transaction.

In October 2021, and then again in February 2022, we undertook an organizational restructuring that significantly reduced our workforce in order to conserve our capital resources.

Our cash conservation activities may yield unintended consequences, such as attrition beyond our planned reduction in workforce and reduced employee morale, which may cause remaining employees to seek alternative employment.

Our ability to successfully complete a strategic transaction depends in large part on our ability to retain certain of our remaining personnel.

If we are unable to successfully retain our remaining personnel, we are at risk of a disruption to our exploration and consummation of a strategic alternative as well as business operations.

Our corporate restructuring and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.

In October 2021, and then again in February 2022, we undertook an organizational restructuring that significantly reduced our workforce, including the departure of our chief executive officer.

We may not realize, in full or in part, the anticipated benefits, savings and improvements in our cost structure from our restructuring efforts due to unforeseen difficulties, delays or unexpected costs.

If we are unable to realize the expected operational efficiencies and cost savings from the restructuring, our operating results and financial condition would be adversely affected.

Furthermore, our restructuring plan may be disruptive to our operations.

For example, our headcount reductions could yield unanticipated consequences, such as increased difficulties in implementing our business strategy, including retention of our remaining employees.

Employee litigation related to the headcount reduction could be costly and prevent management from fully concentrating on the business.

Any future growth would impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees.

Due to our limited resources, we may not be able to effectively manage our operations or recruit and retain qualified personnel, which may result in weaknesses in our infrastructure and operations, risks that we may not be able to comply with legal and regulatory requirements, and loss of employees and reduced productivity among remaining employees.

For example, the workforce reduction may negatively impact our clinical, regulatory, technical operations, and commercial functions, should we choose to continue to pursue them, which would have a negative impact on our ability to successfully develop, and ultimately, commercialize our product candidates.

Our future financial performance and our ability to develop our product candidates or additional assets will depend, in part, on our ability to effectively manage any future growth or restructuring, as the case may be.

The impact and results of our ongoing strategic process are uncertain and may not be successful.

Over the past several years, we have focused our strategic efforts on maximizing stockholder value through strategic transactions, such as the Business Combination.

In connection with the Business Combination, certain investors purchased an aggregate of $95.1 million of our Common Stock in a private placement of public equity (the “PIPE Financing”).

Together with FSDC’s cash resources and funding of the PIPE Financing, we received net proceeds from the Business Combination of approximately $195.9 million.

We may continue to focus our efforts on creating value from GEM103, GEM307 or other product candidates for our stockholders through a sale or other transaction involving the program and pursuing potential strategic options for our company as a whole.

Our board of directors remains dedicated to diligently deliberating upon and making informed decisions that the directors believe are in the best interests of the company and its stockholders.

There can be no assurance, however, that the company’s current strategic direction, or the board’s evaluation of strategic alternatives, will result in any initiatives, agreements, transactions or plans that will further enhance stockholder value.

In addition, given the substantial restructuring of our operations over the past several years, it may be difficult to evaluate our current business and future prospects on the basis of historical operating performance.

In the past, securities class action litigation has often followed certain significant business transactions, such as the sale of a company or announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials.

These events may also result in investigations by the SEC.

We may be exposed to such litigation or investigation even if no wrongdoing occurred.

Litigation and investigations are usually expensive and divert management’s attention and resources, which could adversely affect our business and cash resources and our ability to consummate a potential strategic transaction or the ultimate value our stockholders receive in any such transaction.

Risks Related to our Financial Position and Need for Additional Capital

We have incurred significant losses since our inception and may incur losses for the foreseeable future.

We have no products approved for commercial sale and have not generated any revenue to date, and we continue to incur significant research and development and other expenses related to our ongoing operations.

As a result, we are not profitable and have incurred significant losses in each period since our inception in March 2015.

For the years ended December 31, 2021 and 2020, we reported net losses of $71.9 million and $40.8 million, respectively.

As of December 31, 2021, we had an accumulated deficit of $184.7 million.

Depending on the outcome of our exploration of strategic alternatives, and although we revised our strategy, ceased our Phase 2 trials and announced a significant workforce restructuring, we may continue to incur significant losses for the foreseeable future, and we expect these losses would increase as we continue our research and development of, and seek regulatory approvals for, our product candidates.

We anticipate that our expenses would increase substantially if, and as, we:

conduct larger scale clinical trials for our lead product candidate, GEM103, and any other product candidates;

discover and develop new product candidates, and conduct nonclinical studies, other investigational new drug (“IND”) enabling studies and clinical trials;

manufacture, or have manufactured, preclinical, clinical and commercial supplies of our product candidates;

seek regulatory approvals for our product candidates;

commercialize GEM103 or any other product candidates, if approved;

attempt to transition from a company with a clinical development focus to a company capable of supporting commercial activities, including establishing sales, marketing and distribution infrastructure;

hire additional clinical, scientific, and management personnel;

add operational, financial, and management information systems and personnel including costs related to funding our restructuring obligations;

identify additional compounds or product candidates and acquire rights from third parties to those compounds or product candidates through licenses;

incur additional costs associated with operating as a public company.

Even if we continue to pursue product development and succeed in commercializing GEM103 or any other product candidates, we may continue to incur substantial research and development and other expenditures to develop and market additional product candidates.

We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business for any reason, including as a result of the COVID-19 pandemic.

The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue.

Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’

equity and working capital.

currently has a limited operating history, has not generated any revenue to date, and may never become profitable.

is a clinical-stage biotechnology company with a limited operating history.

Its operations to date have been limited to organizing

and staffing its company, acquiring, developing and securing its technology and product candidates, and conducting clinical trials

and preclinical studies of its product candidates.

Gemini has not yet demonstrated its ability to complete clinical trials, obtain

regulatory approval, formulate and manufacture a commercial-scale product, or conduct sales and marketing activities necessary

for successful product commercialization.

Investment in biotechnology product development is highly speculative because it entails

substantial upfront expenditures in contract research organizations, or CROs, and contract manufacturing organizations, or CMOs,

and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile,

gain regulatory approval and become commercially viable.

Consequently, any predictions you may make about its future success or

viability may not be as accurate as they could be if Gemini had a longer operating history.

GEM103 is in Phase 2a clinical development, Gemini does not expect to receive revenue from GEM103 for a number of years, if ever.

To date, Gemini has not generated any revenue and Gemini will not be able to generate product revenue unless and until GEM103,

or any other product candidate, successfully completes clinical trials, receives regulatory approval, and is commercialized.

may seek to obtain revenue from collaboration or licensing agreements with third parties.

Its ability to generate future product

revenue from GEM103 or any other product candidates also depends on a number of additional factors, including its, or its current

and future collaborators’, ability to:

successfully complete

nonclinical studies and clinical trials for GEM103 and any other product candidates;

seek and obtain

marketing approvals for any product candidates that complete clinical development;

establish and maintain

supply and manufacturing relationships with third parties, and ensure adequate and legally compliant manufacturing of bulk

drug substances and drug products to maintain that supply;

launch and commercialize

any product candidates for which Gemini obtains marketing approval, and, if launched independently, successfully establish

a sales, marketing and distribution infrastructure;

demonstrate the

necessary safety data post-approval to ensure continued regulatory approval;

obtain coverage

and adequate product reimbursement from third-party payors, including government payors;

achieve market acceptance

for any approved products;

address any competing

technological and market developments;

negotiate favorable

terms in any collaboration, licensing or other arrangements into which Gemini may enter in the future and performing its obligations

in such collaborations;

establish, maintain,

protect and enforce its intellectual property rights;

attract, hire and

retain qualified personnel.

addition, because of the numerous risks and uncertainties associated with biotechnology product development, including that its

product candidates may not advance through development or achieve the endpoints of applicable clinical trials, Gemini is unable

to predict the timing or amount of increased expenses, or if or when Gemini will achieve or maintain profitability.

its expenses could increase beyond expectations if Gemini decides, or are required by the U.S.

Food and Drug Administration, or

FDA, or applicable foreign regulatory authorities in other jurisdictions where Gemini may pursue regulatory approval, or applicable

foreign regulatory authorities, to perform nonclinical studies or clinical trials in addition to those that Gemini currently anticipates.

Even if Gemini completes the development and regulatory processes described above, Gemini anticipates incurring significant costs

associated with launching and commercializing any approved product.

Gemini does achieve profitability, Gemini may not be able to sustain or increase profitability on a quarterly or annual basis.

Its failure to become and remain profitable would decrease the value of its company and could impair its ability to raise capital,

maintain its research and development efforts, expand its business or continue its operations.

A decline in the value of its company

also could cause you to lose all or part of your investment.

will require additional capital to finance its operations, which may not be available to it on acceptable terms, or at all.

a result, Gemini may not complete the development and commercialization of GEM103 or any other product candidates.

a research and development company, Gemini’s operations have consumed substantial amounts of cash since inception.

expects its research and development expenses to increase substantially in connection with its ongoing activities, particularly

as Gemini advances GEM103 into later-stage clinical development.

of December 31, 2020, Gemini had $4.5 million of cash and cash equivalents.

Gemini believes that the net proceeds from the Business

Combination and the PIPE transaction, together with its existing cash and cash equivalents, will fund its projected operating

requirements into 2023.

Its forecast of the period of time through which its financial reserves will adequately support its operations

is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of

factors, including the factors discussed elsewhere in this “Risk factors”

Gemini has based this estimate

on assumptions that may prove to be wrong, and Gemini could utilize its available capital resources sooner than Gemini currently

Its future funding requirements, both short and long-term, will depend on many factors, including, but not limited to:

the initiation,

progress, timing, costs and results of nonclinical studies and clinical trials for GEM103 or any other product candidates

Gemini may develop, including any COVID-19-related delays or other effects on its development programs;

the outcome, timing

and cost of seeking and obtaining regulatory approvals from the FDA and applicable foreign regulatory authorities, including

the potential for such authorities to require that Gemini performs more nonclinical studies or clinical trials than those

that Gemini currently expects or change their requirements on studies that had previously been agreed to;

the cost to establish,

maintain, expand, enforce and defend the scope of its intellectual property portfolio, including the amount and timing of

any payments Gemini may be required to make, or that Gemini may receive, in connection with licensing, preparing, filing,

prosecuting, defending and enforcing any patents or other intellectual property rights;

the effect of competing

technological and market developments;

market acceptance

of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement

by third-party payors;

the cost of acquiring,

licensing or investing in additional businesses, products, product candidates and technologies;

the cost and timing

of selecting, auditing and potentially validating a manufacturing site for commercial-scale manufacturing;

the cost of establishing

sales, marketing and distribution capabilities for any product candidates for which Gemini may receive regulatory approval

and that Gemini determines to commercialize;

its need to implement

additional internal systems and infrastructure, including financial and reporting systems.

does not have any committed external source of funds or other support for its development efforts and Gemini cannot be certain

that additional funding will be available on acceptable terms, or at all.

Until Gemini can generate sufficient revenue to finance

its cash requirements, which Gemini may never do, Gemini expects to finance its future cash needs through a combination of public

or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, and other marketing

or distribution arrangements.

If Gemini raises additional funds through public or private equity offerings, the terms of these

securities may include liquidation or other preferences that adversely affect its stockholders’

Further, to the

extent that Gemini raises additional capital through the sale of common stock or securities convertible or exchangeable into common

stock, your ownership interest will be diluted.

If Gemini raises additional capital through debt financing, Gemini could be subject

to fixed payment obligations and may be subject to covenants limiting or restricting its ability to take specific actions, such

as incurring additional debt, making capital expenditures or declaring dividends.

If Gemini raises additional capital through

marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties,

Gemini may have to relinquish certain valuable rights to its product candidates, technologies, future revenue streams or research

programs or grant licenses on terms that may not be favorable to us.

Gemini also could be required to seek collaborators for one

or more of its product candidates at an earlier stage than otherwise would be desirable or relinquish its rights to product candidates

or technologies that Gemini otherwise would seek to develop or commercialize itself.

If Gemini is unable to raise additional capital

in sufficient amounts or acceptable terms, Gemini may have to significantly delay, scale back or discontinue the development or

commercialization of one or more of its product candidates or one or more of its other research and development initiatives.

of the above events could significantly harm its business, prospects, financial condition and results of operations and cause

the price of its common stock to decline.

is heavily dependent on the success of GEM103, its lead product candidate.

currently has no products that are approved for commercial sale and may never be able to develop marketable products.

Gemini expects

that a substantial portion of its efforts and expenditures over the next several years will be devoted to its lead product candidate,

Accordingly, its business currently depends heavily on the successful development, regulatory approval, and commercialization

GEM103 is currently being tested in a Phase 2a clinical trial in genetically defined patients with dry age-related

macular degeneration, or AMD and in a Phase 2a clinical trial as an add-on to anti-VEGF therapy for the treatment of wet AMD patients

at risk for progressive vision loss due to macular atrophy.

Gemini cannot be certain that GEM103 will successfully complete clinical

trials, receive regulatory approval or be successfully commercialized even if Gemini receives regulatory approval.

required to discontinue development of GEM103 or if GEM103 does not receive regulatory approval or fails to achieve significant

market acceptance, Gemini would be substantially delayed in its ability to achieve profitability, if ever.

research, testing, manufacturing, safety, efficacy, labeling, approval, sale, marketing, and distribution of GEM103 is, and will

remain, subject to comprehensive regulation by the FDA and applicable foreign regulatory authorities.

Failure to obtain regulatory

approval for GEM103 will prevent Gemini from commercializing and marketing GEM103.

its Phase 2a clinical trials of GEM103 and other future clinical trials may not be able to replicate the results from its preclinical

studies or past clinical trials of GEM103.

To the extent any of foregoing has not occurred, its expected development time and

development costs for GEM103 may be increased.

if Gemini is able to successfully obtain approval from the FDA or applicable foreign regulatory authorities for GEM103, any approval

might contain significant limitations related to use, including limitations on the stage of disease GEM103 is approved to treat,

as well as restrictions for specified age groups, warnings, precautions or contraindications.

Furthermore, even if Gemini obtains

regulatory approval for GEM103, Gemini will still need to develop a commercial infrastructure or develop relationships with collaborators

to commercialize, establish a commercially viable pricing structure and obtain coverage and adequate reimbursement from third-party

payors, including government healthcare programs otherwise.

If Gemini, or any future collaborators, are unable to successfully

commercialize GEM103, Gemini may not be able to generate sufficient revenue to continue its business.

Gemini is not successful in discovering, developing, receiving regulatory approval for and commercializing GEM103 or other product

candidates, its ability to expand its business and achieve its strategic objectives would be impaired.

Gemini plans to devote a majority of its resources to the continued preclinical and clinical testing and potential approval of

GEM103 for the treatment of patients with AMD, another key element of its strategy is to discover, develop and commercialize a

portfolio of products.

Gemini is seeking to do so through its internal discovery programs, but its resources are limited, and

those that Gemini have are geared towards preclinical and clinical testing and seeking regulatory approval of GEM103 for the treatment

of patients with AMD.

Gemini may also explore strategic collaborations for the development or acquisition of new product candidates,

but Gemini may not be successful in entering into such relationships.

GEM103 is its only product candidate in clinical stages

of development.

Research programs to identify product candidates require substantial technical, financial and human resources,

regardless of whether any product candidates are ultimately identified.

Its research programs may initially show promise in identifying

potential product candidates, yet fail to yield product candidates for clinical development for many reasons, including:

the research methodology

used may not be successful in identifying potential product candidates;

competitors may

develop alternatives that render its product candidates obsolete;

product candidates

Gemini develop may nevertheless be covered by third parties’

We currently have a limited operating history, have not generated any revenue to date and may never become profitable.

We are a clinical-stage biotechnology company with a limited operating history.

Our operations to date have been limited to organizing and staffing our company, acquiring, developing and securing our technology and product candidates, and conducting clinical trials and preclinical studies of our product candidates.

We have not yet demonstrated our ability to complete clinical trials, obtain regulatory approval, formulate and manufacture a commercial-scale product or conduct sales and marketing activities necessary for successful product commercialization.

Investment in biotechnology product development is highly speculative because it entails substantial upfront expenditures in contract research organizations (“CROs”), and contract manufacturing organizations (“CMOs”), and significant risk that any potential product candidate will fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approval and become commercially viable.

Consequently, any predictions you may make about our future success or viability may not be as accurate as they could be if we had a longer operating history.

Even if we continue to pursue approval of GEM103, we would not expect to receive revenue from GEM103 for a number of years, if ever.

To date, we have not generated any revenue, and we will not be able to generate product revenue unless and until GEM103, or any other product candidate, successfully completes clinical trials, receives regulatory approval and is commercialized.

We may seek to obtain revenue from collaboration or licensing agreements with third parties.

Our ability to generate future product revenue from GEM103 or any other product candidates also depends on a number of additional factors, including our, or our current and future collaborators’, ability to:

successfully complete nonclinical studies and clinical trials for GEM103 and any other product candidates;

seek and obtain marketing approvals for any product candidates that complete clinical development;

establish and maintain supply and manufacturing relationships with third parties, and ensure adequate and legally compliant manufacturing of bulk drug substances and drug products to maintain that supply;

launch and commercialize any product candidates for which we obtains marketing approval, and, if launched independently, successfully establish a sales, marketing and distribution infrastructure;

demonstrate the necessary safety data post-approval to ensure continued regulatory approval;

obtain coverage and adequate product reimbursement from third-party payors, including government payors;

achieve market acceptance for any approved products;

address any competing technological and market developments for our product candidates;

negotiate favorable terms in strategic alternatives including, but not limited to, any collaboration, licensing or other arrangements into which we may enter in the future and performing our obligations in such collaborations;

establish, maintain, protect and enforce our intellectual property rights;

attract, hire and retain qualified personnel.

In addition, because of the numerous risks and uncertainties associated with biotechnology product development, including that our product candidates may not advance through development or achieve the endpoints of applicable clinical trials, we are unable to predict the timing or amount of increased expenses, or if or when we would achieve or maintain profitability if we continue to pursue product development.

In addition, our expenses could increase beyond expectations if we decide, or are required by the U.S.

Food and Drug Administration (“FDA”) or applicable foreign regulatory authorities in other jurisdictions where we may pursue regulatory approval, or applicable foreign regulatory authorities, to perform nonclinical studies or clinical trials in addition to those that we currently anticipate.

Even if we complete the development and regulatory processes described above, we anticipate incurring significant costs associated with launching and commercializing any approved product.

If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.

A decline in the value of our company also could cause you to lose all or part of your investment.

If we continue to pursue product development, we will require additional capital to finance our operations, which may not be available to us on acceptable terms, or at all.

As a result, we may not complete the development and commercialization of GEM103 or any other product candidates.

As a clinical development company, our operations have consumed substantial amounts of cash since inception.

As of December 31, 2021, we had $136.6 million of cash and cash equivalents.

Subject to the outcome of our exploration of strategic alternatives, we believe that our current cash resources will enable us to fund our operating expenses and capital expenditure requirements through at least the next twelve months from the filing date of this Annual Report on Form 10-K.

Our forecast of the period of time through which our financial reserves will adequately support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed elsewhere in this “Risk factors”

We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.

Our future funding requirements, both short and long-term, will depend on many factors, including, but not limited to:

the timing and outcome of our exploration of potential strategic alternatives;

the initiation, progress, timing, costs and results of nonclinical studies and clinical trials for GEM103 or any other product candidates we may develop, including COVID-19-related delays or other effects on our development programs;

the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and applicable foreign regulatory authorities, including the potential for such authorities to require that we perform more nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously been agreed to;

the cost to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing any patents or other intellectual property rights;

the effect of competing technological and market developments;

market acceptance of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement by third-party payors;

the cost of acquiring, licensing or investing in additional businesses, products, product candidates and technologies;

the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial-scale manufacturing;

the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval and that we determine to commercialize;

our need to implement additional internal systems and infrastructure, including financial and reporting systems.

We do not have any committed external source of funds or other support for our development efforts, and we cannot be certain that additional funding will be available on acceptable terms, or at all.

To the extent we continue to pursue product development, until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, and other marketing or distribution arrangements.

If we raise additional funds through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’

Further, to the extent that we raise additional capital through the sale of common stock or securities convertible or exchangeable into common stock, your ownership interest will be diluted.

If we raise additional capital through debt financing, we could be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.

We also could be required to seek collaborators for one or more of our product candidates at an earlier stage than otherwise would be desirable or relinquish our rights to product candidates or technologies that we otherwise would seek to develop or commercialize ourselves.

If we are unable to raise additional capital in sufficient amounts or acceptable terms, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates or one or more of our other research and development initiatives.

Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline.

Risks Related to our Business

We may continue to be heavily dependent on the success of GEM103, our lead product candidate.

We currently have no products that are approved for commercial sale and may never be able to develop marketable products.

If we continue to pursue regulatory approval of our product candidates, we expect that a substantial portion of our efforts and expenditures over the next several years would be devoted to our lead product candidate, GEM103.

Accordingly, our business would depend heavily on the successful development, regulatory approval, and commercialization of GEM103.

GEM103 was tested in a Phase 2a clinical trial in genetically defined patients with dry age-related macular degeneration (“AMD”) and in a Phase 2a clinical trial as an add-on to anti-VEGF therapy for the treatment of wet AMD patients at risk for progressive vision loss due to macular atrophy.

We announced that we were ending both of these studies in January 2022.

We cannot be certain that we would successfully commence or complete any further clinical trials, receive regulatory approval or successfully commercialize GEM103 even if we were to receive regulatory approval.

If we do not perform any future clinical development of GEM103 or if GEM103 does not receive regulatory approval or fails to achieve significant market acceptance, we would be substantially delayed in our ability to achieve profitability, if ever.

The research, testing, manufacturing, safety, efficacy, labeling, approval, sale, marketing, and distribution of GEM103 is, and will remain, subject to comprehensive regulation by the FDA and applicable foreign regulatory authorities.

Failure to obtain regulatory approval for GEM103 will prevent us from commercializing and marketing GEM103.

Further, any future clinical trials of GEM103 may not be able to replicate the results from our preclinical studies or past clinical trials of GEM103.

To the extent any of the foregoing has not occurred, our expected development time and development costs for GEM103 may be increased.

Even if we are able to successfully obtain approval from the FDA or applicable foreign regulatory authorities for GEM103, any approval might contain significant limitations related to use, including limitations on the stage of disease GEM103 is approved to treat, as well as restrictions for specified age groups, warnings, precautions or contraindications.

Furthermore, even if we obtain regulatory approval for GEM103, we will still need to develop a commercial infrastructure or develop relationships with collaborators to commercialize, establish a commercially viable pricing structure and obtain coverage and adequate reimbursement from third-party payors, including government healthcare programs otherwise.

If we, or any future collaborators, are unable to successfully commercialize GEM103, we may not be able to generate sufficient revenue to continue our business.

If we are not successful in discovering, developing, receiving regulatory approval for and commercializing GEM103 or other product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.

If we continue to pursue regulatory approval of our product candidates, we would plan to devote a majority of our resources to the continued preclinical and clinical testing and potential approval of GEM103 for the treatment of patients with AMD.

However, another key element of our strategy could be to discover, develop and commercialize a portfolio of products.

We could seek to do so through our internal discovery programs, but our resources are limited.

We may also explore strategic collaborations for the development or acquisition of new product candidates, but we may not be successful in entering into such relationships.

GEM103 is our only product candidate in clinical stages of development.

Research programs to identify product candidates require substantial technical, financial and human resources, regardless of whether any product candidates are ultimately identified.

Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for many reasons, including:

the research methodology used may not be successful in identifying potential product candidates;

competitors may develop alternatives that render our product candidates obsolete;

product candidates we develop may nevertheless be covered by third parties’

patents or other exclusive rights;

a product candidate

may, on further study, be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective

or otherwise does not meet applicable regulatory criteria;

a product candidate

may not be capable of being produced in commercial quantities at an acceptable cost, or at all;

an approved product

may not be accepted as safe and effective by trial participants, the medical community or third-party payors;

intellectual property

or other proprietary rights of third parties for product candidates Gemini develop may potentially block its entry into certain

markets or make such entry economically impracticable.

Gemini fails to develop and successfully commercialize other product candidates, its business and future prospects may be harmed

and its business will be more vulnerable to any problems that Gemini encounters in developing and commercializing its product

and any other product candidates must undergo rigorous clinical trials and regulatory approvals, and success in nonclinical studies

or earlier-stage clinical trials may not be indicative of results in future clinical trials.

and any other product candidates will be subject to rigorous and extensive clinical trials and extensive regulatory approval processes

implemented by the FDA and applicable foreign regulatory authorities.

The approval process is typically lengthy and expensive,

and approval is never certain.

Gemini has limited experience in conducting the clinical trials required to obtain regulatory approval.

Gemini may not be able to conduct clinical trials at preferred sites, enlist clinical investigators, enroll sufficient numbers

of participants or begin or successfully complete clinical trials in a timely fashion, if at all.

Its planned clinical trials

may be insufficient to demonstrate that its potential products will be active, safe or effective.

Additional clinical trials may

be required if clinical trial results are negative or inconclusive, which will require us to incur additional costs and significant

in preclinical studies and earlier-stage clinical trials does not ensure that later clinical trials will generate the same results

or otherwise provide adequate data to demonstrate the effectiveness and safety of a product candidate.

In addition, the design

of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical

trial may not become apparent until the clinical trial is well advanced.

Because Gemini has limited experience designing clinical

trials, Gemini may be unable to design and execute a clinical trial to support regulatory approval.

In addition, there is a high

failure rate for drugs and biologics proceeding through clinical trials.

In fact, many companies in the pharmaceutical and biotechnology

industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in nonclinical

studies and earlier-stage clinical trials.

Similarly, the outcome of nonclinical studies may not predict the success of clinical

Moreover, data obtained from nonclinical and clinical activities are subject to varying interpretations, which may delay,

limit or prevent regulatory approval.

In addition, Gemini may experience regulatory delays or rejections as a result of many factors,

including due to changes in regulatory policy during the period of development of its product candidates.

Any such delays could

negatively impact its business, financial condition, results of operations and prospects.

time to time, Gemini may publish interim “top-line”

or preliminary data from its clinical trials.

Preliminary or interim

data from clinical trials that Gemini may complete are subject to the risk that one or more of the clinical outcomes may materially

change as patient enrollment continues and more patient data become available.

Preliminary or interim data also remain subject

to audit and verification procedures that may result in the final data being materially different from the preliminary data Gemini

previously published.

a product candidate may, on further study, be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;

a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;

an approved product may not be accepted as safe and effective by trial participants, the medical community or third-party payors;

intellectual property or other proprietary rights of third parties for product candidates we develop may potentially block our entry into certain markets or make such entry economically impracticable.

If we continue to pursue product development and we fail to develop and successfully commercialize other product candidates, our business and future prospects may be harmed, and our business will be more vulnerable to any problems that we encounter in developing and commercializing our product candidates.

To the extent we continue to pursue product development, GEM103 and any other product candidates would be subject to rigorous and extensive clinical trials and extensive regulatory approval processes implemented by the FDA and applicable foreign regulatory authorities.

The approval process is typically lengthy and expensive, and approval is never certain.

We have limited experience in conducting the clinical trials required to obtain regulatory approval.

We may not be able to conduct clinical trials at preferred sites, enlist clinical investigators, enroll sufficient numbers of participants or begin or successfully complete clinical trials in a timely fashion, if at all.

Our planned clinical trials may be insufficient to demonstrate that our potential products will be active, safe or effective.

Additional clinical trials may be required if clinical trial results are negative or inconclusive, which will require us to incur additional costs and significant delays.

Success in preclinical studies and earlier-stage clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the effectiveness and safety of a product candidate.

In addition, the design of a clinical trial can determine whether our results will support approval of a product, and flaws in the design of a

clinical trial may not become apparent until the clinical trial is well advanced.

Because we have limited experience designing clinical trials, we may be unable to design and execute a clinical trial to support regulatory approval.

In addition, there is a high failure rate for drugs and biologics proceeding through clinical trials.

In fact, many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in nonclinical studies and earlier-stage clinical trials.

Similarly, the outcome of nonclinical studies may not predict the success of clinical trials.

Moreover, data obtained from nonclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval.

For example, we provided updates from our Phase 2a studies in January 2022.

Both studies were ended early, which may limit the ability of the data to support regulatory approval.

In addition, we may experience regulatory delays or rejections as a result of many factors, including due to changes in regulatory policy during the period of development of our product candidates.

Any such delays could negatively impact our business, financial condition, results of operations and prospects.

We have published, and may from time to time in the future, publish interim “top-line”

or preliminary data from our clinical trials.

Preliminary or interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.

Preliminary or interim data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published.

As a result, interim and preliminary data should be viewed with caution until the final data are available.

Adverse differences between preliminary or interim data and final data could significantly harm its business and financial prospects.

Additionally,

several of its planned and ongoing clinical trials utilize an “open-label”

Adverse differences between preliminary or interim data and final data could significantly harm our business and financial prospects.

Additionally, several of our previous clinical trials utilized an “open-label”

trial design.

An “open-label”

clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product

candidate or either an existing approved biologic, drug, or placebo.

Most typically, open-label clinical trials test only the

investigational product candidate and sometimes may do so at different dose levels.

Open-label clinical trials are subject to

various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are

receiving treatment.

Open-label clinical trials may be subject to a “patient bias”

where patients perceive their symptoms

to have improved merely due to their awareness of receiving an experimental treatment.

In addition, open-label clinical trials

may be subject to an “investigator bias”

where those assessing and reviewing the physiological outcomes of the clinical

trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably

given this knowledge.

The results from an open-label trial may not be predictive of future clinical trial results with any of

its product candidates for which Gemini includes an open-label clinical trial when studied in a controlled environment with a

placebo or active control.

is subject to many manufacturing risks, any of which could substantially increase its costs, delay clinical programs and limit

supply of its products.

has contracted with a third party manufacturer to make new drug substance to support future clinical trials and for commercial

sale, if approved.

Its contract manufacturer may not be able to adopt, adapt or scale up the manufacturing process in a timely

manner to support its future clinical trials.

The process of manufacturing its product is complex, highly regulated and subject

to several risks, including:

the manufacturing

process is susceptible to product loss due to contamination by adventitious microorganisms, equipment failure, improper installation

or operation of equipment, vendor or operator error and improper storage conditions.

Even minor deviations from normal manufacturing

processes could result in reduced production yields and quality as well as other supply disruptions.

If microbial, viral or

other contaminations are discovered in its products or in the manufacturing facilities in which its products are made, the

manufacturing facilities may need to be closed for an extended period of time to investigate and eliminate the contamination;

the manufacturing

facilities in which its products are made could be adversely affected by equipment failures, labor and raw material shortages,

financial difficulties of its contract manufacturers, natural disasters, power failures, local political unrest and numerous

other factors;

any adverse developments

affecting manufacturing operations for its products may result in shipment delays, inventory shortages, lot failures, product

withdrawals or recalls or other interruptions in the supply of its products.

Gemini may also have to record inventory write-offs

and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts or

seek more expensive manufacturing alternatives.

manufacture of GEM103 and other product candidates require significant expertise and capital investment, including the development

of advanced manufacturing techniques and process controls.

Manufacturers of these products sometimes encounter difficulties in

production, especially during scale-up from the manufacturing process used for early clinical trials to a validated process needed

for pivotal clinical studies and commercial launch.

These problems include failure to meet target production costs and yields,

sub-par quality control testing, including stability of the product, quality assurance system failures, operator error and shortages

of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations.

Gemini cannot assure

you that any product quality issues relating to the manufacture of GEM103 or any other product candidates will not occur in the

does not have and Gemini does not currently plan to acquire or build the facilities or internal capabilities to manufacture bulk

drug substance or filled drug product for use in clinical trials or commercialization.

To a large extent, that makes us dependent

on the goodwill of its contract manufacturing partners to quickly fix deviations that will inevitably occur during the manufacturing

of its product.

Any delay or interruption in the supply of clinical trial materials could delay the completion of clinical trials,

increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to

commence new clinical trials at additional expense or terminate clinical trials altogether.

business could be adversely affected by the effects of health epidemics, including the recent COVID-19 pandemic, in regions where

third parties for which Gemini relies have significant research, development or manufacturing facilities, concentrations of clinical

trial sites or other business operations, causing disruption in supplies and services.

business could be adversely affected by health epidemics in regions where third parties for which Gemini relies, such as CROs

or CMOs, have concentrations of clinical trial sites or other business operations, and could cause significant disruption in the

operations of third-party manufacturers and CROs upon whom Gemini relies.

On January 30, 2020, the World Health Organization,

or WHO, announced a global health emergency because of SARS-CoV-2, a new strain of novel coronavirus originating in Wuhan, China,

and the risks to the international community as the virus spread globally beyond its point of origin.

In March 2020, the WHO declared

the COVID-19 outbreak a pandemic, which continues to spread throughout the world.

The spread of this pandemic has caused significant

volatility and uncertainty in U.S.

and international markets.

This could result in an economic downturn and may disrupt its business

and delay its clinical programs and timelines.

shelter-in-place and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct

of business operations could occur, related to COVID-19 pandemic or other infectious diseases, could impact personnel at third-party

manufacturing facilities in the United States and other countries, or the availability or cost of materials, which would disrupt

its supply chain.

Any manufacturing supply interruption of materials could adversely affect its ability to conduct ongoing and

future research and manufacturing activities.

addition, its clinical trials may be affected by the COVID-19 pandemic.

Clinical site initiation and patient enrollment may be

delayed due to prioritization of healthcare system resources toward the COVID-19 pandemic.

Some patients may not be able to comply

with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services.

Similarly, Gemini’s

clinical trial operations may be adversely impacted due to increased difficulty to recruit and retain patients and principal investigators

and site staff who, as healthcare providers, may have heightened exposure to COVID-19 pandemic.

spread of COVID-19 pandemic, which has caused a broad impact globally, may materially affect Gemini economically.

While the potential

economic impact brought by, and the duration of, COVID-19 pandemic may be difficult to assess or predict, a widespread pandemic

could result in significant disruption of global financial markets, reducing its ability to access capital, which could in the

future negatively affect its liquidity.

In addition, a recession or market correction resulting from the spread of COVID-19 pandemic

could materially affect its business and the value of its common stock.

global pandemic of COVID-19 continues to rapidly evolve.

The ultimate impact of the COVID-19 pandemic or a similar health epidemic

is highly uncertain and subject to change.

Gemini does not yet know the full extent of potential delays or impacts on its business,

its clinical trials, healthcare systems or the global economy as a whole.

However, these effects could have a material impact

on its operations.

may encounter difficulties in managing its growth, which could adversely affect its operations.

of the date of this annual report, Gemini had 29 full-time and part-time employees.

As Gemini continues development and pursues

the potential commercialization of its product candidates, Gemini will need to expand its financial, development, regulatory,

manufacturing, marketing and sales capabilities or contract with third parties to provide these capabilities for us.

As its operations

expand, Gemini expects that it will need to manage additional relationships with various strategic collaborators, suppliers and

other third parties.

Its future financial performance and its ability to develop and commercialize its product candidates and

to compete effectively will depend, in part, on its ability to manage any future growth effectively.

Management’s

focus and resources may be diverted from operational matters and other strategic opportunities as a result of the Business Combination.

Business Combination may place a significant burden on our management and other internal resources.

The diversion of management’s

attention and any difficulties encountered in the transition process could harm our financial condition, results of operations

and prospects.

In addition, uncertainty about the effect of the Business Combination on our systems, employees, customers, partners,

and other third parties, including regulators, may have an adverse effect on us.

These uncertainties may impair our ability to

attract, retain and motivate key personnel for a period of time after the completion of the Business Combination.

unaudited pro forma financial information included elsewhere in the proxy statement/prospectus may not be indicative of what our

actual financial position or results of operations would have been.

unaudited pro forma financial information in the proxy statement/prospectus is presented for illustrative purposes only and has

been prepared based on a number of assumptions.

Accordingly, such pro forma financial information may not be indicative of our

future operating or financial performance and our actual financial condition and results of operations may vary materially from

our pro forma results of operations and balance sheet contained elsewhere in this annual report, including as a result of such

assumptions not being accurate.

Additionally, the final acquisition accounting adjustments could differ materially from the unaudited

pro forma adjustments presented in this annual report.

The unaudited pro forma condensed combined financial information does not

give effect to any anticipated synergies, operating efficiencies or cost savings that may be associated with the Business Combination.

Gemini fails to maintain an effective system of internal control over financial reporting, Gemini may not be able to accurately

report its financial results or prevent fraud.

As a result, stockholders could lose confidence in its financial and other public

reporting, which would harm its business and the trading price of its common stock.

internal controls over financial reporting are necessary for Gemini to provide reliable financial reports and, together with adequate

disclosure controls and procedures, are designed to prevent fraud.

Any failure to implement required new or improved controls,

or difficulties encountered in their implementation could cause us to fail to meet its reporting obligations.

In addition, any

testing by Gemini conducted in connection with Section 404 of the Sarbanes-Oxley Act, or Section 404, or any subsequent testing

by its independent registered public accounting firm, may reveal deficiencies in its internal controls over financial reporting

that are deemed to be material weaknesses or that may require prospective or retroactive changes to its financial statements or

identify other areas for further attention or improvement.

Inferior internal controls could also cause investors to lose confidence

in its reported financial information, which could have a negative effect on the trading price of its stock.

will be required to disclose changes made in its internal controls and procedures on a quarterly basis and its management will

be required to assess the effectiveness of these controls annually.

However, for as long as Gemini is an emerging growth company,

or EGC, its independent registered public accounting firm will not be required to attest to the effectiveness of its internal

controls over financial reporting pursuant to Section 404.

An independent assessment of the effectiveness of its internal controls

over financial reporting could detect problems that its management’s assessment might not.

Undetected material weaknesses

in its internal controls over financial reporting could lead to restatements of its financial statements and require us to incur

the expense of remediation.

Gemini’s

disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Gemini’s

disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by it in reports

Gemini files or submits under the Securities Exchange Act of 1934, as amended, or Exchange Act, is accumulated and communicated

to management, recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.

Gemini believes that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived

and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

These inherent

limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple

error or mistake.

Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more

people or by an unauthorized override of the controls.

Accordingly, because of the inherent limitations in its control system,

misstatements or insufficient disclosures due to error or fraud may occur and not be detected.

must attract and retain highly skilled employees in order to succeed.

If Gemini is not able to retain its current senior management

team and its scientific advisors or continue to attract and retain qualified scientific, technical and business personnel, its

business will suffer.

succeed, Gemini must recruit, retain, manage and motivate qualified clinical, scientific, technical and management personnel and

Gemini faces significant competition for experienced personnel.

If Gemini does not succeed in attracting and retaining qualified

personnel, particularly at the management level, it could adversely affect its ability to execute its business plan and harm its

operating results.

Gemini is dependent on the members of its management team and its scientific advisors for its business success,

including its Chief Executive Officer, Jason Meyenburg.

Gemini does not maintain “key person”

insurance for any of

its key personnel.

An important element of its strategy is to take advantage of the research and development expertise of its

current management.

Gemini currently has employment agreements with all of its executive officers.

Its employment agreements with

its executive officers are terminable by them without notice and some provide for severance and change in control benefits.

loss of any one of its executive officers could result in a significant loss in the knowledge and experience that Gemini, as an

organization, possesses and could cause significant delays, or outright failure, in the development and further commercialization

of its product candidates.

is intense competition for qualified personnel, including management in the technical fields in which Gemini operates and Gemini

may not be able to attract and retain qualified personnel necessary for the successful research, development and commercialization

of its product candidates.

In particular, Gemini has experienced a very competitive hiring environment in Cambridge, Massachusetts,

where Gemini is headquartered.

Many of the other pharmaceutical companies that Gemini competes against for qualified personnel

has greater financial and other resources, different risk profiles and a longer history in the industry than Gemini does.

also may provide more diverse opportunities and better chances for career advancement.

Some of these characteristics may be more

appealing to high-quality candidates than what Gemini has to offer.

If Gemini is unable to continue to attract and retain high-quality

personnel, the rate and success with which Gemini can discover and develop product candidates and its business will be limited.

employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities,

including noncompliance with regulatory standards and requirements.

cannot ensure that its compliance controls, policies, and procedures will in every instance protect us from acts committed by

its employees, agents, contractors, or collaborators that would violate the law or regulation, including, without limitation,

healthcare, employment, foreign corrupt practices, environmental, competition, and patient privacy and other privacy laws and

Such improper actions could subject us to civil or criminal investigations, and monetary and injunctive penalties,

and could adversely impact its ability to conduct business, operating results, and reputation.

is exposed to the risk of employee fraud or other illegal activity by its employees, independent contractors, consultants, commercial

partners and vendors.

Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to comply

with the laws enforced by the FDA and applicable foreign regulatory authorities, fails to provide true, complete and accurate

information to the FDA and applicable foreign regulatory authorities, fails to comply with manufacturing standards Gemini has

established, fails to comply with healthcare fraud and abuse laws in the United States and similar foreign laws, or fails to report

financial information or data accurately or to disclose unauthorized activities to us.

If Gemini obtains FDA approval of any of

its product candidates and begin commercializing those products in the United States, its potential exposure under these laws

will increase significantly, and its costs associated with compliance with these laws are also likely to increase.

Additionally,

Gemini is subject to the risk that a person could allege such fraud or other misconduct, even if none occurred.

These laws may

impact, among other things, its current activities with principal investigators and research patients, as well as proposed and

future sales, marketing and education programs.

If any such actions are instituted against us, and Gemini is not successful in

defending itself or asserting its rights, those actions could have a significant impact on its business, including the imposition

of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid

and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment

of its operations, any of which could adversely affect its ability to operate its business and its results of operations.

not always possible to identify and deter employee misconduct, and the precautions Gemini takes to detect and prevent this activity

may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or

other actions or lawsuits stemming from a failure to comply with these laws or regulations.

If any such actions are instituted

against us and Gemini is not successful in defending itself or asserting its rights, those actions could result in significant

civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare

programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, and the curtailment or restructuring of

its operations.

and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered

impossible by multiple factors outside its control, significant competition for recruiting patients with AMD in clinical trials.

and qualifying patients to participate in its clinical trials is critical to its success.

Gemini may encounter delays in enrolling,

or be unable to enroll, a sufficient number of patients to complete any of its clinical trials, and even once enrolled Gemini

may be unable to retain a sufficient number of patients to complete any of its trials.

that may generally affect patient enrollment include:

the size and nature

of the patient population;

the number and location

of clinical sites where patients are to be enrolled;

competition with

other companies for clinical sites or patients;

the eligibility

and exclusion criteria for the trial;

the design of the

clinical trial;

inability to obtain

and maintain patient consents;

risk that enrolled

participants will drop out before completion;

competing clinical

trials and clinicians’

and patients’

perceptions as to the potential advantages of the product being studied in

relation to other available therapies, including any new products that may be approved for the indications Gemini is investigating.

addition, if any significant adverse events or other side effects are observed in any of its future clinical trials, it may make

it more difficult for Gemini to recruit patients to its clinical trials and patients may drop out of its trials, or Gemini may

be required to abandon the trials or its development efforts of one or more product candidates altogether.

Its inability to enroll

a sufficient number of patients for its clinical trials would result in significant delays, which would increase its costs and

have an adverse effect on Gemini.

faces substantial competition, which may result in others discovering, developing or commercializing products before or more successfully

biotechnology industry is intensely competitive and subject to rapid and significant technological change.

Its competitors include

multinational pharmaceutical companies, specialized biotechnology companies and universities and other research institutions.

An “open-label”

clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved biologic, drug, or placebo.

Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels.

Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment.

Open-label clinical trials may be subject to a “patient bias”

where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment.

In addition, open-label clinical trials may be subject to an “investigator bias”

where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge.

The results from an open-label trial may not be predictive of future clinical trial results with any of our product candidates for which we include an open-label clinical trial when studied in a controlled environment with a placebo or active control.

We have been and may in the future be subject to many manufacturing risks, any of which could substantially increase our costs, delay clinical programs and limit supply of our products.

We have historically contracted with third party manufacturers to make new drug substance to support clinical trials and for commercial sale, if approved.

Our CMOs may not be able to adopt, adapt or scale up the manufacturing process in a timely manner to support our future clinical trials.

The process of manufacturing our products is complex, highly regulated and subject to several risks, including:

the manufacturing processes are susceptible to product loss due to contamination by adventitious microorganisms, equipment failure, improper installation or operation of equipment, vendor or operator error and improper storage conditions.

Even minor deviations from normal manufacturing processes could result in reduced production yields and quality as well as other supply disruptions.

If microbial, viral or other contaminations are discovered in our products or in the manufacturing facilities in which our products are made, the manufacturing facilities may need to be closed for an extended period of time to investigate and eliminate the contamination;

the manufacturing facilities in which our products are made could be adversely affected by equipment failures, labor and raw material shortages, financial difficulties of our CMOs, natural disasters, power failures, local political unrest and numerous other factors;

any adverse developments affecting manufacturing operations for our products may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls or other interruptions in the supply of our products.

We may also have to record inventory write-offs and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts or seek more expensive manufacturing alternatives.

The manufacture of GEM103 and other product candidates requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls.

Manufacturers of these products sometimes

encounter difficulties in production, especially during scale-up from the manufacturing process used for pre-clinical and early clinical trials to a validated process needed for pivotal clinical studies and commercial launch.

These problems include failure to meet target production costs and yields, sub-par quality control testing, including stability of the product, quality assurance system failures, operator error and shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations.

We cannot assure you that any product quality issues relating to the manufacture of GEM103 or any other product candidates will not occur in the future.

We do not have and we do not currently plan to acquire or build the facilities or internal capabilities to manufacture bulk drug substance or filled drug product for use in pre-clinical studies, clinical trials or commercialization.

To a large extent, that makes us dependent on the goodwill of our contract manufacturing partners to quickly fix deviations that will inevitably occur during the manufacturing of our product.

Any delay or interruption in the supply of clinical trial materials could delay the completion of pre-clinical studies or clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to commence new pre-clinical studies or clinical trials at additional expense or terminate pre-clinical studies or clinical trials altogether.

We have no manufacturing facility.

As a result, we have been dependent on third-party manufacturers, as well as on third parties for our supply chain, and if we experience problems with any third parties, or the actual demand for our future product candidates, if any, exceed our forecasts, the manufacture of adequate supplies of our future product candidates or products could be delayed.

We do not own or operate facilities for the manufacture of our future product candidates, if any.

We currently have no plans to build our own manufacturing facilities for clinical or commercial operations.

We have in the past relied on third party manufacturers for the chemical manufacture of active pharmaceutical ingredient and for the production of final product formulation and packaging for clinical trials, and expect to rely on such third party manufacturers for any future product candidate we are able to advance into clinical development.

Although alternative third party suppliers with the necessary manufacturing and regulatory expertise and facilities exist, it could be expensive and take a significant amount of time to arrange for alternative suppliers should we commence clinical development of any future product candidate.

We may encounter technical difficulties or delays in the transfer of manufacturing on a commercial scale to third party manufacturers.

We may be unable to enter into agreements for commercial supply with third party manufacturers, or may be unable to do so on acceptable terms.

If we are unable to arrange for alternative third-party manufacturing sources, or to do so on commercially reasonable terms or in a timely manner, we may not be able to complete development of any future product candidates, or market or distribute them.

Reliance on third party manufacturers entails risks to which we would not be subject if we manufactured product candidates or products ourselves, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control, including a failure to manufacture our product candidates or any products we may eventually commercialize in accordance with our specifications, and the possibility of termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or damaging to us.

In addition, the FDA and other regulatory authorities require that our product candidates and any products that we may eventually commercialize be manufactured according to cGMP and similar foreign standards.

Any failure by our third-party manufacturers to comply with cGMP or failure to scale up manufacturing processes, including any failure to deliver sufficient quantities of product candidates in a timely manner, could lead to a delay in, or failure to obtain, regulatory approval of any of our product candidates and could cause us to incur higher costs and prevent us from commercializing our product candidates successfully.

In addition, such failure could be the basis for the FDA to issue a warning letter, withdraw approvals for product candidates previously granted to us, or take other regulatory or legal action, including recall or seizure of outside supplies of the product candidate, total or partial suspension of production, suspension of ongoing clinical trials, refusal to approve pending applications or supplemental applications, detention of products, refusal to permit the import or export of products, injunction, or imposing civil and criminal penalties.

Any significant disruption in our supplier relationships could harm our business.

Any significant delay in the supply of a product candidate or its key materials for a clinical trial could considerably delay completion of our clinical trials, product testing and potential regulatory approval of our future product candidates.

If our manufacturers or we are unable to purchase these key materials after regulatory approval has been obtained for our product candidates, the commercial launch of our product candidates would be delayed or there would be a shortage in supply, which would impair our ability to generate revenues from the sale of our product candidates.

If our third party manufacturers cannot manufacture sufficient quantity to meet the demand for our product candidates after regulatory approval, there would be a shortage in supply which would negatively impact our revenue from the sale of our product candidates.

It may take several years to establish an alternative source of supply for our product candidates and to have any such new source approved by the FDA.

Our business could continue to be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic, including in regions where third parties on which we rely have significant research, development or manufacturing facilities, concentrations of clinical trial sites or other business operations, causing disruption in supplies and services.

Our business could be adversely affected by health epidemics in regions where third parties on which we rely, such as CROs or CMOs, have concentrations of clinical trial sites or other business operations, and could cause significant disruption in the operations of third-party manufacturers and CROs upon whom we rely.

The ongoing COVID-19 pandemic and the increased prevalence of variants of the virus, and government measures taken in response, have had a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred;

supply chains have been disrupted;

facilities and production have been suspended;

and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen.

The ongoing COVID-19 pandemic and related impacts have resulted in, and will likely continue to result in, significant disruptions to the global economy and capital markets around the world.

We cannot predict the future progression or full impact of the outbreak and its effects on our business and operations.

We and our third-party CMOs, CROs and clinical sites have experienced, and may continue to experience, disruptions in supply of product candidates and/or procuring items that are essential for our research and development activities, including raw materials used in the manufacturing of our product candidates, medical and laboratory supplies used in our clinical trials or preclinical studies or animals that are used for preclinical testing, in each case, for which there may be shortages because of ongoing efforts to address the pandemic.

Additionally, we enrolled patients in our clinical trials at sites located both in the United States and internationally.

Our clinical trial sites were located in areas that were affected by COVID-19 and, as a result, our ability to enroll patients and complete our trials were impacted.

We cannot predict how long these types of delays and impacts many continue, and whether they will similarly affect any future clinical trials.

For example, even if sites are initiating and actively recruiting, we may face difficulties recruiting or retaining patients in our planned clinical trials if patients are affected by the virus or are unable to or are fearful of visiting or traveling to our clinical trial sites because of the pandemic, or if patients are unable or unwilling to be vaccinated or tested.

Prolonged delays or closure to enrollment in our planned trials or patient discontinuations could have a material adverse impact on our clinical trial plans and timelines.

In addition, our ability to collect and verify data requested of patients enrolled in our clinical trials during this pandemic was impacted to varying degrees by COVID-19, and COVID-19 could similarly impact future clinical trials.

Although clinical trial data collection continued for each of our clinical trials, data was collected at a slower pace, and with challenges and interruptions in data collection, including, in some instances, disruption of collection of complete study data.

This could have a material adverse impact on our data quality and analysis.

In addition, clinical trial sites for any potential future clinical trials may be unable or unwilling to initiate a new trial if factors relevant to the pandemic render doing so impracticable.

These COVID-19 related issues may prolong the time required to conduct any potential clinical trials and/or impact the quality of the data obtained from one or more of our completed or potential studies.

We have not incurred impairment losses in the carrying values of our assets as a result of the ongoing COVID-19 pandemic, and we are not aware of any specific related event or circumstance that would require us to revise our estimates reflected in our consolidated financial statements.

Although the COVID-19 pandemic did not have a significant impact on our financial results in 2021, the full extent to which the ongoing COVID-19 pandemic may impact our business, results of operations, financial condition and cash flows will depend on future developments that are highly uncertain, and the estimates of the impact on our business may change based on new information that may emerge concerning COVID-19, including the duration of the pandemic, any potential subsequent waves or strains of COVID-19 infection, the effectiveness, distribution and acceptance of COVID-19 vaccines and the actions to contain it or treat its impact and the economic impact on local, regional, national and international markets.

If we do not retain key employees, our ability to maintain our ongoing operations or execute a potential strategic option could be impaired.

As of February 28, 2022, we had 29 employees and we will rely heavily on the services of our existing employees to manage our ongoing operations and execute our strategic plans.

On February 28, 2022, we announced a workforce reduction by up to 24 positions, or approximately 80% of our workforce.

The loss of services from any of our existing or continuing employees could substantially disrupt our operations.

To be successful and achieve our strategic objectives, we must retain qualified personnel.

The continued review of our strategic options may create continued uncertainty for our employees and this uncertainty may adversely affect our ability to retain key employees and to hire new talent necessary to maintain our ongoing operations or to execute additional potential strategic options, which could have a material adverse effect on our business.

In addition, our current strategy and any changes to this strategy could place significant strain on our resources and our ability to maintain our ongoing operations.

We may also be required to rely more heavily on temporary or part-time employees, third party contractors and consultants to assist with managing our operations.

These consultants are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us.

We will have only limited control over the activities of these consultants and can generally expect these individuals to devote only limited time to our activities.

Failure of any of these persons to devote sufficient time and resources to our business could harm our business.

Accordingly, we may fail to maintain our ongoing operations or execute our strategic plan if we are unable to retain or hire qualified personnel or to manage our employees and consultants effectively.

We may encounter difficulties in managing any future growth, which could adversely affect our operations.

If we pursue further clinical development and the potential commercialization of our product candidates, we will need to expand our financial, development, regulatory, manufacturing, marketing and sales capabilities or contract with third parties to provide these capabilities for us.

If our operations were to expand, we would expect that we would need to manage additional relationships with various strategic collaborators, suppliers and other third parties.

Our future financial performance and our ability to develop and commercialize our product candidates and to compete effectively would depend, in part, on our ability to manage any future growth effectively.

We have undertaken restructurings in October 2021 and February 2022 with a substantial reduction in headcount, which would adversely impact our ability to meet any potential growth needs.

If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud.

As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock.

Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud.

Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations.

In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act (“Section 404”) or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement.

Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our stock.

Commencing with the end of the fiscal year to which this Annual Report on Form 10-K relates, we are required to perform system and process design evaluation and testing of the effectiveness of our internal controls over financial reporting to allow management to report on the effectiveness of our internal controls over financial reporting, as required by Section 404.

This has required that we incur substantial additional and recurring professional fees and internal costs to expand our accounting and finance functions and that we expend significant management efforts.

We will be required to disclose changes made in our internal controls and procedures on a quarterly basis.

However, for as long as we are an emerging growth company (“EGC”), our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404.

An independent assessment of the effectiveness of our internal controls over financial reporting could detect problems that our management’s assessment might not.

Undetected material weaknesses in our internal controls over financial reporting could lead to restatements of our financial statements and require us to incur the expense of remediation.

If we are not able to comply with the requirements of Section 404 in a timely manner or we are unable to maintain proper and effective internal controls over financial reporting we may not be able to produce timely and accurate financial statements.

As a result, our investors could lose confidence in our reported financial information, the market price of our stock could decline and we could be subject to sanctions or investigations by the SEC or other regulatory authorities.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Securities Exchange Act of 1934, as amended (“Exchange Act”), is accumulated and communicated to management, recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.

We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system

These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.

Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls.

Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected.

As a result of our business combination with a special purpose acquisition company, regulatory obligations may impact us

differently than other publicly traded companies.

We became a publicly traded company by completing a transaction with a special purpose acquisition company (“SPAC”).

As a result of this transaction, regulatory obligations have, and may continue, to impact us differently than other publicly traded companies.

For instance, the SEC and other regulatory agencies may issue additional guidance or apply further regulatory scrutiny to companies like us that have completed a business combination with a SPAC.

Managing this regulatory environment, which has and may continue to evolve, could divert management’s attention from the operation of our business, negatively impact our ability to raise additional capital when needed or have an adverse effect on the price of our common stock.

We must retain highly skilled employees in order to succeed.

To succeed, we must recruit, retain, manage and motivate qualified clinical, scientific, technical and management personnel and we faces significant competition for experienced personnel.

If we do not succeed in retaining qualified personnel, particularly at the management level, it could adversely affect our ability to execute our business plan and harm our operating results.

We are dependent on the members of our management team and our scientific advisors for our business success, the loss of whom could require us to identify and engage qualified replacements, and could cause our management and operations to suffer in the interim.

For example, in February 2022, Jason Meyenburg transitioned from his role as our Chief Executive Officer.

Also in February 2022, Georges Gemayel began serving as our Interim Chief Executive Officer.

Even though we are confident in the interim leadership of Dr.

Gemayel, any disruption resulting from Mr.

Meyenburg’s departure, or any further changes to our key management, commercial and scientific personnel, may be disruptive or cause uncertainty in our business and may adversely impact our results of operations and financial condition.

We do not maintain “key person”

insurance for any of our key personnel.

An important element of our strategy is to take advantage of the research and development expertise of our current management.

We currently have employment agreements with all of our executive officers.

Our employment agreements with our executive officers are terminable by them without notice and some provide for severance and change in control benefits.

The loss of any one of our executive officers could result in a significant loss in the knowledge and experience that we, as an organization, possess and could cause significant delays, or outright failure, in the development and further commercialization of our product candidates.

There is intense competition for qualified personnel, including management in the technical fields in which we operate and we may not be able to attract and retain qualified personnel necessary for the successful research, development and commercialization of our product candidates.

In particular, we have experienced a very competitive hiring environment in Cambridge, Massachusetts, where we are headquartered.

Many of the other pharmaceutical companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do.

They also may provide more diverse opportunities and better chances for career advancement.

Some of these characteristics may be more appealing to high-quality candidates than what we have to offer.

If we are unable to continue to attract and retain high-quality personnel, the rate and success with which we can discover and develop product candidates and our business will be limited.

Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We cannot ensure that our compliance controls, policies, and procedures will in every instance protect us from acts committed by our employees, agents, contractors, or collaborators that would violate the law or regulation, including, without limitation, healthcare, employment, foreign corrupt practices, environmental, competition, and patient privacy and other privacy laws and regulations.

Such improper actions could subject us to civil or criminal investigations, and monetary and injunctive penalties, and could adversely impact our ability to conduct business, operating results, and reputation.

We are exposed to the risk of employee fraud or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors.

Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to comply with the laws enforced by the FDA and applicable foreign regulatory authorities, fails to provide true, complete

and accurate information to the FDA and applicable foreign regulatory authorities, fails to comply with manufacturing standards we have established, fails to comply with healthcare fraud and abuse laws in the United States and similar foreign laws, or fails to report financial information or data accurately or to disclose unauthorized activities to us.

If we obtain FDA approval of any of our product candidates and begin commercializing those products in the United States, our potential exposure under these laws will increase significantly, and our costs associated with compliance with these laws are also likely to increase.

Additionally, we are subject to the risk that a person could allege such fraud or other misconduct, even if none occurred.

These laws may impact, among other things, our current activities with principal investigators and research patients, as well as proposed and future sales, marketing and education programs.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from government investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.

If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could result in significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, and the curtailment or restructuring of our operations.

Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, significant competition for recruiting patients with AMD in clinical trials.

Identifying and qualifying patients to participate in our clinical trials is critical to our success.

To the extent we continue to pursue product development, we may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our clinical trials, and even once enrolled we may be unable to retain a sufficient number of patients to complete any of our trials.

Factors that may generally affect patient enrollment include:

the size and nature of the patient population;

the number and location of clinical sites where patients are to be enrolled;

competition with other companies for clinical sites or patients;

the eligibility and exclusion criteria for the trial;

the design of the clinical trial;

inability to obtain and maintain patient consents;

risk that enrolled participants will drop out before completion;

competing clinical trials and clinicians’

and patients’

perceptions as to the potential advantages of the product being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating.

In addition, if any significant adverse events or other side effects are observed in any of our future clinical trials, it may make it more difficult for us to recruit patients to our clinical trials and patients may drop out of our trials, or we may be required to abandon the trials or our development efforts of one or more product candidates altogether.

Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays, which would increase our costs and have an adverse effect on us.

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us.

The biotechnology industry is intensely competitive and subject to rapid and significant technological change.

Our current competitors include multinational pharmaceutical companies, specialized biotechnology companies and universities and other research institutions.

A number of pharmaceutical companies, as well as large and small biotechnology companies such as Apellis Pharmaceuticals, Inc.

and IVERIC bio are pursuing the development or marketing of pharmaceuticals that target AMD.

It is also probable that the number

of companies seeking to develop products and therapies for the treatment of serious eye diseases, such as AMD, will increase.

Many of its competitors have substantially greater financial, technical, human and other resources than Gemini does and may be

better equipped to develop, manufacture and market technologically superior products.

In addition, many of these competitors has

significantly greater experience than Gemini has in undertaking nonclinical studies and human clinical trials of new pharmaceutical

products and in obtaining regulatory approvals of human therapeutic products.

Accordingly, its competitors may succeed in obtaining

FDA approval for superior products.

In addition, many competitors have greater name recognition and more extensive collaborative

relationships.

Smaller and earlier-stage companies may also prove to be significant competitors, particularly through collaborative

arrangements with large, established companies.

competitors may obtain regulatory approval of their products more rapidly than Gemini does or may obtain patent protection or

other intellectual property rights that limit its ability to develop or commercialize its product candidates.

Its competitors

may also develop drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile

than its products and these competitors may also be more successful than Gemini is in manufacturing and marketing their products.

If Gemini is unable to compete effectively against these companies, then Gemini may not be able to commercialize its product candidates

or achieve a competitive position in the market.

This would adversely affect its ability to generate revenue.

Its competitors

also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical

trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary

for, its programs.

Gemini’s

business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in its or related

parties’

It is also probable that the number of companies seeking to develop products and therapies for the treatment of serious eye diseases, such as AMD, will increase.

Many of our competitors have substantially greater financial, technical, human and other resources than we do and may be better equipped to develop, manufacture and market technologically superior products.

In addition, many of these competitors have significantly greater experience than we do in undertaking nonclinical studies and human clinical trials of new pharmaceutical products and in obtaining regulatory approvals of human therapeutic products.

Accordingly, our competitors may succeed in obtaining FDA approval for superior products.

In addition, to the extent we continue to pursue product development, many competitors have greater name recognition and more extensive collaborative relationships.

Smaller and earlier-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

Our competitors may obtain regulatory approval of their products more rapidly than we do or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates.

Our competitors may also develop drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile than our products and these competitors may also be more successful than us is in manufacturing and marketing their products.

If we are unable to compete effectively against these companies, then we may not be able to commercialize our product candidates or achieve a competitive position in the market.

This would adversely affect our ability to generate revenue.

Our competitors also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our or related parties’

cyber security.

its limited operating history, Gemini is still in the process of implementing its internal security measures.

Its internal computer

systems and those of current and future third parties on which Gemini rely may fail and are vulnerable to damage from computer

viruses and unauthorized access.

Its information technology and other internal infrastructure systems, including corporate firewalls,

servers, leased lines and connection to the Internet, face the risk of systemic failure that could disrupt its operations.

Gemini has not, to its knowledge, experienced any such material system failure or security breach to date, if such an event were

to occur and cause interruptions in its operations, it could result in a material disruption of its development programs and its

business operations.

For example, the loss of clinical trial data from completed or future clinical trials could result in delays

in its regulatory approval efforts and significantly increase its costs to recover or reproduce the data.

Likewise, Gemini relies

on third parties for the manufacture of its product candidates and to conduct clinical trials, and similar events relating to

their computer systems could also have a material adverse effect on its business.

To the extent that any disruption or security

breach were to result in a loss of, or damage to, its data or applications, or inappropriate disclosure of confidential or proprietary

information, Gemini could incur liability, its competitive position could be harmed and the further development and commercialization

of its product candidates could be hindered or delayed.

Comprehensive

tax reform legislation could adversely affect its business and financial condition.

“Tax Cuts and Jobs Act,”

or the Tax Act, significantly revised the Code.

The Tax Act, among other things, includes

a reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%, a limitation of the tax deduction

for net interest expense to 30% of adjusted earnings (except for certain small businesses), a limitation of the deduction for

net operating losses, or NOLs, to 80% of current year taxable income and an elimination of NOL carrybacks (though any such NOLs

may be carried forward indefinitely), and modifying or repealing many business deductions and credits (including reducing the

business tax credit for certain clinical testing expenses incurred in the testing of certain drugs for rare diseases or conditions

generally referred to as “orphan drugs”).

Additionally, on March 27, 2020, President Trump signed into law the Coronavirus

Aid, Relief, and Economic Security Act, or the CARES Act, which, among other things, suspends the 80% limitation on the deduction

for NOLs in taxable years beginning before January 1, 2021, permits a 5-year carryback of NOLs arising in taxable years beginning

after December 31, 2017 and before January 1, 2021, and generally caps the limitation on the deduction for net interest expense

at 50% of adjusted taxable income for taxable years beginning in 2019 and 2020.

Gemini continues to examine the impact this tax

reform legislation may has on its business.

Gemini urges investors to consult with their legal and tax advisers regarding the

implications of the Tax Act and the CARES Act on an investment in its common stock.

might not be able to utilize a significant portion of its U.S.

Given our limited operating history, we are still in the process of implementing our internal security measures.

Our internal computer systems and those of current and future third parties on which we rely may fail and are vulnerable to damage from computer viruses and unauthorized access.

Our information technology and other internal infrastructure systems, including corporate firewalls, servers, leased lines and connection to the Internet, face the risk of systemic failure that could disrupt our operations.

While we have not, to our knowledge, experienced any such material system failure or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations.

For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

Likewise, we rely on third parties for the manufacture of our product candidates and to conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business.

To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability, our competitive position could be harmed and the further development and commercialization of our product candidates could be hindered or delayed.

Comprehensive tax reform legislation could adversely affect our business and financial condition.

The rules dealing with United States federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service (“IRS”) and the United States Treasury Department.

Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock.

In recent years, many such changes have been made and changes are likely to continue to occur in the future.

For example, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was enacted on March 27, 2020, and, among other things, suspends the 80% limitation on the deduction for NOLs in taxable years beginning before January 1, 2021, permits a 5-year carryback of NOLs arising in taxable years beginning after December 31, 2017 and before January 1, 2021, and generally caps the limitation on the deduction for net interest expense at 50% of adjusted taxable income for taxable years beginning in 2019 and 2020.

It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be promulgated or issued under existing or new tax laws, which could result in an increase in our or our shareholders’

tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof.

We might not be able to utilize a significant portion of our U.S.

NOL carryforwards and U.S.

research and development tax credit

carryforwards.

of December 31, 2020, Gemini had U.S.

federal and state NOL carryforwards of $102.2 million and $95.1 million, respectively, and

federal and state research and development tax credit carryforwards of $3.1 million and $1.0 million, respectively.

utilized, such NOL carryforwards and research and development credits will expire at various dates beginning in 2037 (with the

exception of $94.6 million, which has no expiration date) and 2040, respectively.

Gemini does not anticipate generating revenue

from sales of products for the foreseeable future, if ever, and Gemini may never achieve profitability.

These NOL and tax credit

carryforwards could expire unused and be unavailable to offset future income tax liabilities.

Under the Tax Act, unused losses

generated in taxable years beginning after December 31, 2017 will not expire and may be carried forward indefinitely, and generally

may not be carried back to prior taxable years, except that, under the CARES Act a 5-year carryback of NOLs arising in taxable

years beginning after December 31, 2017 and before January 1, 2021 is permitted.

Additionally, for taxable years beginning after

December 31, 2020, the deductibility of such U.S.

federal NOLs is limited to 80% of its taxable income in any future taxable year.

In addition, under Section 382 of the Code, the amount of benefits from its NOL carryforwards may be impaired or limited if Gemini

incurs a cumulative ownership change of more than 50% over a three-year period.

Gemini may have experienced ownership changes

in the past and Gemini may experience ownership changes in the future as a result of the Business Combination and subsequent shifts

in its stock ownership, some of which are outside its control.

As a result, its use of U.S.

federal NOL carryforwards could be

research and development tax credit carryforwards.

As of December 31, 2021, we had federal net operating loss carryforwards of $7.6 million that are subject to expire at various dates through 2037, and net operating loss carryforwards of $156.5 million, which have no expiration date, can be carried forward indefinitely, and are limited to a deduction to 80% of annual taxable income.

We have state tax net operating loss carryforwards of $143.1 million, which may be available to offset future income tax liabilities and expire at various dates through 2041, and net operating loss carryforwards of $1.0 million, which have no expiration date, can be carried forward indefinitely.

We also have federal and state research and development tax credit carryforwards of $5.0 million and $1.2 million, respectively, which expire at various dates through 2041.

We do not anticipate generating revenue from sales of products for the foreseeable future, if ever, and we may never achieve profitability.

These NOL and tax credit carryforwards could expire unused and be unavailable to offset future income tax liabilities.

Under the Tax Act, unused losses generated in taxable years beginning after December 31, 2017 will not expire and may be carried forward indefinitely, and generally may not be carried back to prior taxable years, except that, under the CARES Act a 5-year carryback of NOLs arising in taxable years beginning after December 31, 2017 and before January 1, 2021 is permitted.

Additionally, for taxable years beginning after December 31, 2020, the deductibility of such U.S.

federal NOLs is limited to 80% of our taxable income in any future taxable year.

In addition, under Section 382 of the Code, the amount of benefits from our NOL carryforwards may be impaired or limited if we incur a cumulative ownership change of more than 50% over a three-year period.

We may have experienced ownership changes in the past and we may experience ownership changes in the future as a result of the Business Combination and subsequent shifts in our stock ownership, some of which are outside our control.

As a result, our use of U.S.

federal NOL carryforwards could be limited.

State NOL carryforwards may be similarly limited.

Any such disallowances may result in greater tax liabilities than Gemini

would incur in the absence of such a limitation and any increased liabilities could adversely affect its business, results of

operations, financial position and cash flows.

uses and generates materials that may expose it to material liability.

Gemini’s

research programs involve the use of hazardous materials and chemicals, which are currently only handled by third parties.

is subject to foreign, federal, state and local environmental and health and safety laws and regulations governing, among other

matters, the use, manufacture, handling, storage and disposal of hazardous materials and waste products.

Gemini may incur significant

costs to comply with these current or future environmental and health and safety laws and regulations.

In addition, Gemini cannot

completely eliminate the risk of contamination or injury from hazardous materials and may incur material liability as a result

of such contamination or injury.

In the event of an accident, an injured party may seek to hold us liable for any damages that

Any liability could exceed the limits or fall outside the coverage of its workers’

compensation, property and business

interruption insurance and Gemini may not be able to maintain insurance on acceptable terms, if at all.

Gemini currently carries

no insurance specifically covering environmental claims.

Related to Government Regulation

regulatory approval processes of the FDA and applicable foreign regulatory authorities are lengthy, time-consuming and inherently

unpredictable.

Its inability to obtain regulatory approval for GEM103 or any other product candidate would substantially harm

its business.

time required to obtain approval from the FDA and applicable foreign regulatory authorities is unpredictable but typically takes

many years following the commencement of nonclinical studies and clinical trials and depends upon numerous factors, including

the substantial discretion of regulatory authorities.

In addition, approval policies, regulations or the type and amount of clinical

data necessary to gain approval may change during the course of a product candidate’s development and may vary among jurisdictions.

or its other product candidates could fail to receive regulatory approval from the FDA or an applicable foreign regulatory authority

for many reasons, including:

disagreement with

the design or implementation of its clinical trials;

failure to demonstrate

that a product candidate is safe and effective for its proposed indication;

failure of clinical

trials to meet the level of statistical significance required for approval;

failure to demonstrate

that a product candidate’s clinical and other benefits outweigh its safety risks;

disagreement with

its interpretation of data from nonclinical studies or clinical trials;

the insufficiency

of data collected from clinical trials of its product candidates to obtain regulatory approval;

failure to obtain

approval of the manufacturing processes or facilities of third-party manufacturers with whom Gemini contract for clinical

and commercial supplies;

changes in the approval

policies or regulations that render its nonclinical and clinical data insufficient for approval.

FDA or an applicable foreign regulatory authority may require more information, including additional nonclinical or clinical data

to support approval, which may delay or prevent approval and its commercialization plans, or Gemini may decide to abandon the

development program for other reasons.

If Gemini were to obtain approval, regulatory authorities may approve any of its product

for fewer more limited indications than Gemini request, may require labeling or a Risk Evaluation Mitigation Strategy, or REMS,

that includes significant use or distribution restrictions or safety warnings, precautions, or contraindications, may grant approval

contingent on the performance of costly post-marketing clinical trials or may approve a product candidate with a label that does

not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.

or delays in the commencement or completion of, or ambiguous or negative results from, Gemini’s ongoing and planned clinical

trials of its product candidates could result in increased costs to us and could delay, prevent, or limit its ability to generate

revenue and continue its business.

does not know whether its current Phase 2a clinical trials or any of its planned clinical trials will be completed on schedule,

if at all, as the commencement and completion of clinical trials can be delayed or prevented for a number of reasons, including,

among others:

the FDA or applicable

foreign regulatory authorities may not authorize Gemini’s or its investigators to commence its planned clinical trials

or any other clinical trials Gemini may initiate, or may suspend its clinical trials, for example, through imposition of a

clinical hold, and may request additional data to permit allowance of its investigational new drug, or IND;

delays in filing

or receiving allowance of additional IND applications that may be required;

lack of adequate

funding to continue its clinical trials and nonclinical studies;

negative results

from its ongoing nonclinical studies;

delays in reaching

or failing to reach agreement on acceptable terms with prospective CROs and clinical study sites, the terms of which can be

subject to extensive negotiation and may vary significantly among different CROs and study sites;

the inability of

CROs to perform under these agreements, including due to impacts from the COVID-19 pandemic on their workforce;

inadequate quantity

or quality of a product candidate or other materials necessary to conduct clinical trials, for example delays in the manufacturing

of sufficient supply of finished drug product;

difficulties obtaining

ethics committee or Institutional Review Board, or IRB, approval to conduct a clinical study at a prospective site or sites;

challenges in recruiting

and enrolling subjects to participate in clinical trials, the proximity of subjects to study sites, eligibility criteria for

the clinical study, the nature of the clinical study protocol, the availability of approved effective treatments for the relevant

disease, and competition from other clinical study programs for similar indications;

severe or unexpected

drug-related side effects experienced by subjects in a clinical trial;

Gemini may decide,

or regulatory authorities may require us, to conduct additional nonclinical or clinical trials or abandon product development

delays in validating,

or inability to validate, any endpoints utilized in a clinical trial;

the FDA or applicable

foreign regulatory authorities may disagree with its clinical study design and its interpretation of data from clinical trials,

or may change the requirements for approval even after it has reviewed and commented on the design for its clinical trials;

difficulties retaining

subjects who has enrolled in a clinical trial but may be prone to withdraw due to rigors of the clinical trials, lack of efficacy,

side effects, personal issues, or loss of interest.

trials may also be delayed or terminated as a result of ambiguous or negative interim results.

In addition, a clinical study may

be suspended or terminated by us, the FDA or applicable foreign regulatory authorities, the IRBs at the sites where the IRBs are

overseeing a clinical study, a data and safety monitoring board, or DSMB, overseeing the clinical study at issue or other regulatory

authorities due to a number of factors, including, among others:

failure to conduct

the clinical study in accordance with regulatory requirements or its clinical protocols;

inspection of the

clinical study operations or study sites by the FDA or other regulatory authorities that reveals deficiencies or violations

that require us to undertake corrective action, including in response to the imposition of a clinical hold;

unforeseen safety

issues or safety signals, including any that could be identified in its ongoing nonclinical studies or clinical trials, adverse

side effects or lack of effectiveness;

changes in government

regulations or administrative actions;

problems with clinical

supply materials;

lack of adequate

funding to continue clinical trials.

inability to successfully complete nonclinical and clinical development could result in additional costs to us or impair its ability

to generate revenue.

In addition, if Gemini makes changes to a product candidate, such as changes to the formulation, Gemini may

need to conduct additional nonclinical studies or clinical trials to bridge or demonstrate the comparability of its modified product

candidate to earlier versions, which could delay its clinical development plan or marketing approval for its product candidates.

Clinical trial delays could also shorten any periods during which Gemini may have the exclusive right to commercialize its product

candidates or allow its competitors to bring products to market before Gemini does, which could impair its ability to successfully

commercialize its product candidates and may harm its business and results of operations.

has limited experience in conducting clinical trials and has never obtained approval for any product candidates and may be unable

to do so successfully.

a company, Gemini has limited experience in designing, conducting or completing clinical trials and has never progressed a product

candidate through to regulatory approval.

In part because of this lack of experience, its clinical trials may require more time

and incur greater costs than Gemini anticipates.

Gemini cannot be certain that the planned clinical trials will begin or conclude

on time, if at all.

Any such disallowances may result in greater tax liabilities than we would incur in the absence of such a limitation and any increased liabilities could adversely affect our business, results of operations, financial position and cash flows.

We use and generate materials that may expose us to material liability.

Our research programs involve the use of hazardous materials and chemicals, which are currently only handled by third parties.

We are subject to foreign, federal, state and local environmental and health and safety laws and regulations governing, among other matters, the use, manufacture, handling, storage and disposal of hazardous materials and waste products.

To the extent we continue to pursue product development, we may incur significant costs to comply with these current or future environmental and health and safety laws and regulations.

In addition, we cannot completely eliminate the risk of contamination or injury from hazardous materials and may incur material liability as a result of such contamination or injury.

In the event of an accident, an injured party may seek to hold us liable for any damages that result.

Any liability could exceed the limits or fall outside the coverage of our workers’

compensation, property and business interruption insurance and we may not be able to maintain insurance on acceptable terms, if at all.

We currently carry no insurance specifically covering environmental claims.

Risks Related to Government Regulation

The regulatory approval processes of the FDA and applicable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable.

Our inability to obtain regulatory approval for GEM103 or any other product candidate would substantially harm our business.

The time required to obtain approval from the FDA and applicable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of nonclinical studies and clinical trials and depends upon numerous factors, including the substantial discretion of regulatory authorities.

In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s development and may vary among jurisdictions.

To the extent we continue to pursue product development, GEM103 or our other product candidates could fail to receive regulatory approval from the FDA or an applicable foreign regulatory authority for many reasons, including:

disagreement with the design or implementation of our clinical trials;

failure to demonstrate that a product candidate is safe and effective for our proposed indication;

failure of clinical trials to meet the level of statistical significance required for approval;

failure to demonstrate that a product candidate’s clinical and other benefits outweigh our safety risks;

disagreement with our interpretation of data from nonclinical studies or clinical trials;

the insufficiency of data collected from clinical trials of our product candidates to obtain regulatory approval;

failure to obtain approval of the manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical and commercial supplies;

changes in the approval policies or regulations that render our nonclinical and clinical data insufficient for approval.

The FDA or an applicable foreign regulatory authority may require more information, including additional nonclinical or clinical data to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development program for other reasons.

If we were to obtain approval, regulatory authorities may approve any of our product for fewer more limited indications than we request, may require labeling or a Risk Evaluation Mitigation Strategy (“REMS”) that includes significant use or distribution restrictions or safety warnings, precautions, or contraindications, may grant approval contingent on the performance of costly post-marketing clinical trials or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.

Failures or delays in the commencement or completion of, or ambiguous or negative results from, our previous and potential clinical trials of our product candidates could result in increased costs to us and could delay, prevent, or limit our ability to generate revenue and continue our business.

We do not know whether any of our potential clinical trials will be completed on schedule, if at all, as the commencement and completion of clinical trials can be delayed or prevented for a number of reasons, including, among others:

the FDA or applicable foreign regulatory authorities may not authorize our or our investigators to commence our planned clinical trials or any other clinical trials we may initiate, or may suspend our clinical trials, for example, through imposition of a clinical hold, and may request additional data to permit allowance of our investigational new drug (“IND”);

delays in filing or receiving allowance of additional IND applications that may be required;

lack of adequate funding to continue our clinical trials, such as our previous Phase 2a studies, and nonclinical studies;

negative results from our ongoing nonclinical studies;

delays in reaching or failing to reach agreement on acceptable terms with prospective CROs and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and study sites;

the inability of CROs to perform under these agreements, including due to impacts from the COVID-19 pandemic on their workforce;

inadequate quantity or quality of a product candidate or other materials necessary to conduct clinical trials, for example delays in the manufacturing of sufficient supply of finished drug product;

difficulties obtaining ethics committee or Institutional Review Board (“IRB”) approval to conduct a clinical study at a prospective site or sites;

challenges in recruiting and enrolling subjects to participate in clinical trials, the proximity of subjects to study sites, eligibility criteria for the clinical study, the nature of the clinical study protocol, the availability of approved effective treatments for the relevant disease, and competition from other clinical study programs for similar indications;

severe or unexpected drug-related side effects experienced by subjects in a clinical trial;

We may decide, or regulatory authorities may require us, to conduct additional nonclinical or clinical trials or abandon product development programs;

delays in validating, or inability to validate, any endpoints utilized in a clinical trial;

the FDA or applicable foreign regulatory authorities may disagree with our clinical study design and our interpretation of data from clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for our clinical trials;

difficulties retaining subjects who have enrolled in a clinical trial but may be prone to withdraw due to rigors of the clinical trials, lack of efficacy, side effects, personal issues, or loss of interest.

Clinical trials may also be delayed or terminated as a result of ambiguous or negative interim results.

In addition, a clinical study may be suspended or terminated by us, the FDA or applicable foreign regulatory authorities, the IRBs at the sites where the IRBs are overseeing a clinical study, a data and safety monitoring board (“DSMB”) overseeing the clinical study at issue or other regulatory authorities due to a number of factors, including, among others:

failure to conduct the clinical study in accordance with regulatory requirements or our clinical protocols;

inspection of the clinical study operations or study sites by the FDA or other regulatory authorities that reveals deficiencies or violations that require us to undertake corrective action, including in response to the imposition of a clinical hold;

unforeseen safety issues or safety signals, including any that could be identified in our ongoing nonclinical studies or clinical trials, adverse side effects or lack of effectiveness;

changes in government regulations or administrative actions;

problems with clinical supply materials;

lack of adequate funding to continue clinical trials.

Any inability to successfully complete nonclinical and clinical development could result in additional costs to us or impair our ability to generate revenue.

For example, we announced in January 2022 that we were ending our Phase 2a studies of GEM103 early, and we currently do not have any ongoing clinical trials.

In addition, if we make changes to a product candidate, such as changes to the formulation, we may need to conduct additional nonclinical studies or clinical trials to bridge or demonstrate the comparability of our modified product candidate to earlier versions, which could delay our clinical development plan or marketing approval for our product candidates.

Clinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

We have limited experience in conducting clinical trials and have never obtained approval for any product candidates and may be unable to do so successfully.

As a company, we have limited experience in designing, conducting or completing clinical trials and have never progressed a product candidate through to regulatory approval.

In part because of this lack of experience, to the extent we continue to pursue product development, our potential clinical trials may require more time and incur greater costs than we anticipate, and we may not have sufficient resources to complete these trials.

We cannot be certain that the planned clinical trials will begin or conclude on time, if at all.

Large-scale trials will require significant additional financial and management resources.

Any performance

failure on the part of such third parties could delay the clinical development of its product candidates or delay or prevent us

from obtaining regulatory approval or commercializing its product candidates, depriving us of potential product revenue and resulting

in additional losses.

advancement of healthcare reform may negatively impact its ability to profitably sell its product candidates, if approved.

United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare

system that could prevent or delay marketing approval of its product candidates, restrict or regulate post-approval activities

and affect its ability to profitably sell any product for which Gemini obtains marketing approval.

Changes in regulations, statutes

or the interpretation of existing regulations could impact its business in the future by requiring, for example:

(i) changes to

its manufacturing arrangements;

Any performance failure on the part of such third parties could delay the clinical development of our product candidates or delay or prevent us from obtaining regulatory approval or commercializing our product candidates, depriving us of potential product revenue and resulting in additional losses.

The advancement of healthcare reform may negatively impact our ability to profitably sell our product candidates, if approved.

The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product for which we obtain marketing approval.

Changes in regulations,

statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example:

(i) changes to our manufacturing arrangements;

(ii) additions or modifications to product labeling;

(iii) the recall or discontinuation of its

(iii) the recall or discontinuation of our products;

or (iv) additional record-keeping requirements.

March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of

2010, or collectively, the Affordable Care Act, was enacted, which includes measures that has significantly changed the way health

care is financed by both governmental and private insurers.

Some of the provisions of the Affordable Care Act have yet to be implemented,

and there have been judicial, congressional, and executive branch challenges to certain aspects of the Affordable Care Act.

January 2017, President Trump has signed two Executive Orders and other directives designed to delay the implementation of certain

provisions of the Affordable Care Act or otherwise circumvent some of the requirements for health insurance mandated by the Affordable

One Executive Order directs federal agencies with authorities and responsibilities under the Affordable Care Act to

waive, defer, grant exemptions from, or delay the implementation of any provision of the Affordable Care Act that would impose

a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals

or medical devices.

The second Executive Order terminates the cost-sharing subsidies that reimburse insurers under the Affordable

Several state Attorneys General filed suit to stop the Trump administration from terminating the subsidies, but their

request for a restraining order was denied by a federal judge in California on October 25, 2017.

Further, on June 14, 2018, U.S.

Court of Appeals for the Federal Circuit ruled that the federal government was not required to pay more than $12 billion in Affordable

Care Act risk corridor payments to third-party payors who argued were owed to them.

The effects of this gap in reimbursement on

third-party payors, the viability of the Affordable Care Act marketplace, providers, and potentially its business, are not yet

has also considered legislation that would repeal or repeal and replace all or part of the Affordable Care Act.

While Congress

has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the Affordable

Care Act has been signed into law.

The Tax Act included a provision which repealed, effective January 1, 2019, the tax-based shared

responsibility payment imposed by the Affordable Care Act on certain individuals who fail to maintain qualifying health coverage

for all or part of a year that is commonly referred to as the “individual mandate.”

On January 22, 2018, President

Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain Affordable

Care Act-mandated fees, including the so-called “Cadillac”

tax on certain high cost employer-sponsored insurance plans,

the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt

medical devices.

The Bipartisan Budget Act of 2018, or the BBA, among other things, amended the Affordable Care Act, effective

January 1, 2019, to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.”

In July 2018, the Centers for Medicare and Medicaid Services, or CMS, published a final rule permitting further collections and

payments to and from certain Affordable Care Act qualified health plans and health insurance issuers under the Affordable Care

Act risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine

this risk adjustment.

Moreover, CMS issued a final rule in 2018 that will give states greater flexibility, starting in 2020, in

setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential

health benefits required under the Affordable Care Act for plans sold through such marketplaces.

On December 14, 2018, a U.S.

District Judge in the Northern District of Texas, or the Texas District Court Judge, ruled that the individual mandate is a critical

and inseverable feature of the Affordable Care Act, and therefore, because it was repealed as part of the Tax Act, the remaining

provisions of the Affordable Care Act are invalid as well.

While the Texas District Court Judge, as well as the Trump Administration

and CMS, has stated that the ruling will has no immediate effect, it is unclear how this decision, subsequent appeals and other

efforts to repeal and replace the Affordable Care Act will impact the Affordable Care Act and its business.

addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted.

In August 2011,

President Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee

on Deficit Reduction to recommend to Congress proposals in spending reductions.

The Joint Select Committee on Deficit Reduction

did not achieve a targeted deficit reduction, which triggered the legislation’s automatic reduction to several government

This includes aggregate reductions to Medicare payments to providers of, on average, 2% per fiscal year through 2025

unless Congress takes additional action.

These reductions were extended through 2027 under the BBA.

In January 2013, the American

Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals and

cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers

from three to five years.

there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices.

Specifically, there has been several recent U.S.

congressional inquiries and proposed and enacted federal and state legislation

designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare,

review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies

At the federal level, the Trump administration’s budget proposal for fiscal year 2019 contained further drug

price control measures that could be enacted during the 2019 budget process or in other future legislation, including, for example,

measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to

negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients.

Additionally, the

Trump administration released a “Blueprint”

to lower drug prices and reduce out of pocket costs of drugs that contains

additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs,

incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by

Department of Health and Human Services, or HHS, has already started the process of soliciting feedback on

some of these measures and, at the same time, is immediately implementing others under its existing authority.

For example, in

September 2018, CMS announced that it will allow Medicare Advantage Plans the option to use step therapy for Part B drugs beginning

January 1, 2019, and in October 2018, CMS proposed a new rule that would require direct-to-consumer television advertisements

of prescription drugs and biological products, for which payment is available through or under Medicare or Medicaid, to include

in the advertisement the Wholesale Acquisition Cost, or list price, of that drug or biological product.

On January 31, 2019, the

HHS Office of Inspector General, proposed modifications to the federal Anti-Kickback Statute discount safe harbor for the purpose

of reducing the cost of drug products to consumers which, among other things, if finalized, will affect discounts paid by manufacturers

to Medicare Part D plans, Medicaid managed care organizations and pharmacy benefit managers working with these organizations.

Although a number of these, and other proposed measures may require additional authorization to become effective, Congress and

the Trump administration has each indicated that it will continue to seek new legislative and/or administrative measures to control

At the state level, legislatures has increasingly passed legislation and implemented regulations designed to control

pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on

certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation

from other countries and bulk purchasing.

expects that the healthcare reform measures that has been adopted and may be adopted in the future, may result in more rigorous

coverage criteria and in additional downward pressure on the price that Gemini receives for any approved product and could seriously

harm its future revenues.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction

in payments from private third-party payors.

on May 30, 2018, the Trickett Wedler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, or the Right

to Try Act, was signed into law.

The law, among other things, provides a federal framework for certain patients to request access

to certain investigational new drug products that has completed a Phase I clinical trial and that are undergoing investigation

for FDA approval.

There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients

as a result of the Right to Try Act.

has been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed

at broadening the availability of healthcare and containing or lowering the cost of healthcare.

The implementation of cost containment

measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize

Such reforms could have an adverse effect on anticipated revenue from product candidates that Gemini may successfully

develop and for which Gemini may obtain regulatory approval and may affect its overall financial condition and ability to develop

product candidates.

Gemini’s

relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse, transparency

and other healthcare laws and regulations, which, if violated, could expose it to criminal sanctions, civil penalties, contractual

damages, reputational harm, administrative burdens and diminished profits and future earnings.

providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any product candidates

for which Gemini obtains marketing approval.

Its current and future arrangements with healthcare providers, third-party payors

and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain

the business or financial arrangements and relationships through which Gemini researches, and if approved, markets, sells and

distributes its products.

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “Affordable Care Act”), was enacted, which includes measures that has significantly changed the way health care is financed by both governmental and private insurers.

Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the Affordable Care Act .

On June 17, 2021, the U.S.

Supreme Court dismissed the most recent judicial challenge to the Affordable Care Act brought by several states without specifically ruling on the constitutionality of the Affordable Care Act .

Prior to the Supreme Court's decision, the current President of the United States issued an Executive Order to initiate a special enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the Affordable Care Act marketplace.

The Executive Order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the Affordable Care Act .

It is unclear how other healthcare reform measures of the current administrations or other efforts, if any, to challenge repeal or replace the Affordable Care Act , will impact our business.

In addition, other legislative and regulatory changes have been proposed and adopted in the United States since the Affordable Care Act was enacted:

On August 2, 2011, the U.S.

Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year.

These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022 due to the COVID-19 pandemic.

Following the temporary suspension, a 1% payment reduction will occur beginning April 1, 2022 through June 30, 2022, and the 2% payment reduction will resume on July 1, 2022.

On January 2, 2013, the U.S.

American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers.

On April 13, 2017, CMS published a final rule that gives states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the Affordable Care Act for plans sold through such marketplaces.

On May 30, 2018, the Right to Try Act, was signed into law.

The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval.

Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program.

There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.

On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020.

On December 20, 2019, the former President of the United States signed into law the Further Consolidated Appropriations Act (H.R.

1865), which repealed the Cadillac tax, the health insurance provider tax, and the medical device excise tax.

It is impossible to determine whether similar taxes could be instated in the future.

Additionally, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices.

Specifically, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S.

Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, and review the relationship between pricing and manufacturer patient programs.

At a federal level, the current President of the United States signed an Executive Order on July 9, 2021 affirming the administration’s policy to (i) support legislative reforms that would lower the prices of prescription drug and biologics, including by allowing Medicare to negotiate drug prices, by imposing inflation caps, and, by supporting the development and market entry of lower-cost generic drugs and biosimilars;

and (ii) support the enactment of a public health insurance option.

Among other things, the Executive Order also directs HHS to provide a report on actions to combat excessive pricing of prescription drugs, enhance the domestic drug supply chain, reduce the price that the Federal government pays for drugs, and address price gouging in the industry;

and directs the FDA to work with states and Indian Tribes that propose to develop section 804 Importation Programs in accordance with the

Medicare Prescription Drug, Improvement, and Modernization Act of 2003, and the FDA’s implementing regulations.

FDA released such implementing regulations on September 24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada.

On September 25, 2020, CMS stated drugs imported by states under this rule will not be eligible for federal rebates under Section 1927 of the Social Security Act and manufacturers would not report these drugs for “best price”

or Average Manufacturer Price purposes.

Since these drugs are not considered covered outpatient drugs, CMS further stated it will not publish a National Average Drug Acquisition Cost for these drugs.

If implemented, importation of drugs from Canada may materially and adversely affect the price we receive for any of our product candidates.

Further, on November 20, 2020 CMS issued an Interim Final Rule implementing the Most Favored Nation (“MFN”) Model under which Medicare Part B reimbursement rates would have been be calculated for certain drugs and biologicals based on the lowest price drug manufacturers receive in Organization for Economic Cooperation and Development countries with a similar gross domestic product per capita.

However, on December 29, 2021, CMS rescinded the Most Favored Nations rule.

Additionally, on November 30, 2020, HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.

The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers.

Pursuant to court order, the removal and addition of the aforementioned safe harbors were delayed, and recent legislation imposed a moratorium on implementation of the rule until January 1, 2026.

Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the current administration may reverse or otherwise change these measures, both the current administration and Congress have indicated that they will continue to seek new legislative measures to control drug costs.

We expect that the healthcare reform measures that has been adopted and may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product and could seriously harm our future revenues.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private third-party payors.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain drug access and marketing cost disclosure and transparency measures, and designed to encourage importation from other countries and bulk purchasing.

Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, financial condition, results of operations and prospects.

In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.

This could reduce the ultimate demand for our drugs or put pressure on our drug pricing, which could negatively affect our business, financial condition, results of operations and prospects.

There has been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare.

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product.

Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.

Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which, if violated, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing approval.

Our current and future arrangements with healthcare providers, third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we research, and if approved, markets, sells and distributes our products.

Restrictions under applicable federal and state healthcare laws and regulations, include the following:

the federal Anti-Kickback

Statute prohibits persons from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration,

directly or indirectly, in cash or in kind, to induce or reward, or in return for, the referral of an individual for the furnishing

or arranging for the furnishing, or the purchase, lease or order, or arranging for or recommending purchase, lease or order,

of any good or service for which payment may be made under a federal healthcare program, such as Medicare and Medicaid;

federal civil and

criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which can be enforced

through civil whistleblower or qui tam actions, prohibit individuals or entities from, among other things knowingly

presenting, or causing to be presented, to the federal government or a government contractor, grantee, or other recipient

of federal funds, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal

an obligation to pay money to the federal government;

the federal Health

Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal liability for knowingly and willfully executing

a scheme to defraud any healthcare benefit program, knowingly and willfully embezzling or stealing from a healthcare benefit

program, willfully obstructing a criminal investigation of a healthcare offense or knowingly and willfully making false statements

relating to healthcare matters;

HIPAA, as amended

by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their implementing regulations,

imposes obligations on certain healthcare providers, health plans and healthcare clearinghouses, known as covered entities,

as well as their business associates, which are individuals and entities that perform certain services involving the use or

disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding

the privacy, security and transmission of individually identifiable health information;

the federal Open

Payments program, created under Section 6002 of the Affordable Care Act and its implementing regulations, requires manufacturers

of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s

Health Insurance Program (with certain exceptions) to report annually to CMS information related to “payments or other

transfers of value”

made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors)

and teaching hospitals, as well as ownership and investment interests held by physicians (as defined above) and their immediate

family members;

analogous state,

local, and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing

arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including

private insurers;

state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s

voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict

payments that may be made to healthcare providers;

state and foreign laws that require drug manufacturers to report information

related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or drug

the federal Anti-Kickback Statute prohibits persons from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, the referral of an individual for the furnishing or arranging for the furnishing, or the purchase, lease or order, or arranging for or recommending purchase, lease or order, of any good or service for which payment may be made under a federal healthcare program, such as Medicare and Medicaid;

federal civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which can be enforced through civil whistleblower or qui tam actions, prohibit individuals or entities from, among other things knowingly presenting, or causing to be presented, to the federal government or a government contractor, grantee, or other recipient of federal funds, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes criminal liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense or knowingly and willfully making false statements relating to healthcare matters;

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) and their implementing regulations, imposes obligations on certain healthcare providers, health plans and healthcare clearinghouses, known as covered entities, as well as their business associates, which are individuals and entities that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs;

federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

the federal Open Payments program, created under Section 6002 of the Affordable Care Act and its implementing regulations, requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to “payments or other transfers of value”

made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians (as defined above) and their immediate family members.

Effective January 1, 2022, these reporting obligations extend to include transfers of value made to certain non-physician providers (physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified-nurse midwives);

analogous state, local, and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers;

state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or drug prices;

state and local laws that require the registration of pharmaceutical sales representatives;

and state and foreign

laws that govern the privacy and security of health information in certain circumstances, many of which differ from each other

in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

to ensure that its business arrangements with third parties comply with applicable healthcare laws and regulations will involve

substantial costs.

It is possible that governmental authorities will conclude that its business practices may not comply with

current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.

If its operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us,

Gemini may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment,

exclusion from government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations,

and the curtailment or restructuring of its operations.

If any of the physicians or other healthcare providers or entities with

whom Gemini expects to do business is found not to be in compliance with applicable laws, that person or entity may be subject

to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include

civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect its operating results and

and any potential collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws

and regulations that address privacy and data security).

In the United States, numerous federal and state laws and regulations,

including federal health information privacy laws, state data breach notification laws, state health information privacy laws,

and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act and California Consumer Privacy

Act of 2018, or CCPA), that govern the collection, use, disclosure and protection of health-related and other personal information

could apply to its operations or the operations of its collaborators.

The state of California, for example, recently adopted the

CCPA, which will come into effect beginning in January 2020.

The CCPA has been characterized as the first “GDPR-like”

privacy statute to be enacted in the United States because it mirrors a number of the key provisions of the European Union General

Data Protection Regulation, or EU GDPR.

The CCPA establishes a new privacy framework for covered businesses by creating an expanded

definition of personal information, establishing new data privacy rights for consumers in the State of California, imposing special

rules on the collection of consumer data from minors, and creating a new and potentially severe statutory damages framework for

violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data

In addition, Gemini may obtain health information from third parties (including research institutions from which Gemini

obtains clinical trial data) that are subject to privacy and security requirements under HIPAA, as amended by HITECH.

on the facts and circumstances, Gemini could be subject to civil, criminal, and administrative penalties if Gemini knowingly obtain,

use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized

or permitted by HIPAA.

and international data protection laws and regulations, including the EU GDPR and other EU data protection laws, could

require us to take on more onerous obligations in its contracts, restrict its ability to collect, use and disclose data, or in

some cases, impact its ability to operate in certain jurisdictions.

Failure to comply with these laws and regulations could result

in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or

adverse publicity and could negatively affect its operating results and business.

Moreover, clinical trial subjects, employees

and other individuals about whom Gemini or its potential collaborators obtain personal information, as well as the providers who

share this information with us, may limit its ability to collect, use and disclose the information.

Claims that Gemini has violated

individuals’

privacy rights, failed to comply with data protection laws, or breached its contractual obligations, even if

Gemini is not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm

its business.

development is uncertain and Gemini’s clinical trials for GEM103 and any other product candidates may experience delays,

which would adversely affect its ability to obtain regulatory approvals or commercialize these programs on a timely basis or at

all, which would have an adverse effect on its business.

cannot be sure that Gemini will be able to submit INDs or similar applications for its preclinical programs on the timelines Gemini

expects, if at all.

To proceed with its development plans and ultimately commercialization, Gemini may need to conduct and meet

regulatory requirements for preclinical and clinical studies.

For therapeutic applications, the FDA may require additional extensive

preclinical and other studies.

Gemini cannot be certain of the timely completion or outcomes of its preclinical testing and studies

and cannot predict if the FDA or other regulatory authorities will accept its proposed clinical programs or if the outcomes of

its preclinical testing and studies will ultimately support the further development of its programs.

As a result, there is no

assurance that Gemini will be able to submit INDs or similar applications on the timelines Gemini expects, if at all, and Gemini

cannot be sure that submission of an IND or similar applications will result in the FDA or other regulatory authorities allowing

a clinical trial design to begin.

For example, Gemini plans to use its IND for GEM103 in dry AMD to run a trial of GEM103 in wet

AMD, however, Gemini has not yet met with the FDA to discuss such plans, and the FDA may reject such plans.

if Gemini is able to obtain regulatory approvals for its product candidates, if they exhibit harmful side effects after approval,

its regulatory approvals could be revoked or otherwise negatively impacted, and Gemini could be subject to costly and damaging

product liability claims.

trials are conducted in representative samples of the potential patient population which may has significant variability.

if Gemini receives regulatory approval for GEM103 or any of its other product candidates, Gemini will have tested them in only

a small number of patients during its clinical trials.

Clinical trials are by design based on a limited number of subjects and

of limited duration for exposure to the product used to determine whether, on a potentially statistically significant basis, the

planned safety and efficacy of any product candidate can be achieved.

As with the results of any statistical sampling, Gemini

cannot be sure that all side effects of its product candidates may be uncovered, and it may be the case that only with a significantly

larger number of patients exposed to the product candidate for a longer duration, may a more complete safety profile be identified.

Further, even larger clinical trials may not identify rare serious adverse effects or the duration of such studies may not be

sufficient to identify when those events may occur.

If its applications for marketing are approved and more patients begin to

use its product, new risks and side effects associated with its products may be discovered.

There have been other products that

have been approved by the regulatory authorities but for which safety concerns has been uncovered following approval.

concerns have led to labelling changes or withdrawal of products from the market, and any of its product candidates may be subject

to similar risks.

Additionally, Gemini may be required to conduct additional nonclinical and clinical trials, require additional

warnings on the label of its products, reformulate its product or make changes, create a medication guide outlining the risks

of such side effects for distribution to patients and obtain new approvals for its and its suppliers’

manufacturing facilities

for GEM103 and any other product candidates.

Gemini might have to withdraw or recall its products from the marketplace.

may also experience a significant drop in the potential sales of its products if and when regulatory approvals for such products

are obtained, experience harm to its reputation in the marketplace or become subject to lawsuits, including class actions.

of these results could decrease or prevent any sales of its approved products or substantially increase the costs and expenses

of commercializing and marketing its products.

if its product candidates receive regulatory approval, they will remain subject to extensive regulatory scrutiny and may still

face future development and regulatory difficulties.

if Gemini obtains regulatory approval for a product candidate, regulatory authorities may still impose significant restrictions

on its product candidates, including their indicated uses or marketing, or impose ongoing requirements for potentially costly

post-approval studies.

Further, even if Gemini obtains regulatory approval for a product candidate, it would be subject to ongoing

requirements by the governing the manufacture, quality control, further development, labeling, packaging, storage, distribution,

safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other post-market information.

FDA and applicable foreign regulatory authorities will continue to closely monitor the safety profile of any product even after

If the FDA or applicable foreign regulatory authorities become aware of new safety information after approval of its

product candidates, they may require labeling changes or establishment of a REMS or similar strategy, impose significant restrictions

on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies or

post-market surveillance.

addition, manufacturers of drug and biologic products and their facilities are subject to continual review and periodic inspections

by the FDA and other regulatory authorities for compliance with current good manufacturing practice, or cGMP, regulations and

If Gemini or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated

severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions

on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or

suspension of manufacturing.

If Gemini, its product candidates or the manufacturing facilities for its product candidates fail

to comply with applicable regulatory requirements, or undesirable side effects caused by such products are identified, a regulatory

issue safety alerts,

Dear Healthcare Provider letters, press releases or other communications containing warnings about such product;

mandate modifications

to promotional materials or require us to provide corrective information to healthcare practitioners;

require that Gemini

conduct post-marketing studies;

require us to enter

into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates

for specific actions and penalties for noncompliance;

seek an injunction

or impose civil or criminal penalties or monetary fines;

suspend marketing

of, withdraw regulatory approval of or recall such product;

suspend any ongoing

clinical studies;

refuse to approve

pending applications or supplements to applications filed by us;

suspend or impose

restrictions on operations, including costly new manufacturing requirements;

seize or detain

products, refuse to permit the import or export of products or require us to initiate a product recall.

occurrence of any event or penalty described above may inhibit its ability to commercialize its products and generate revenue.

and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by the FDA, the

Department of Justice, the Department of Health and Human Services’

Office of Inspector General, state attorneys general,

members of Congress and the public.

Violations, including promotion of its products for unapproved (or off-label) uses, are subject

to enforcement letters, inquiries and investigations, and civil and criminal sanctions by the government.

Additionally, applicable

foreign regulatory authorities will heavily scrutinize advertising and promotion of any product candidate that obtains approval

outside of the United States.

the United States, engaging in the impermissible promotion of its products for off-label uses can also subject us to false claims

litigation under federal and state statutes, which can lead to civil and criminal penalties and fines and agreements that materially

restrict the manner in which a company promotes or distributes drug and biologic products.

These false claims statutes include

the federal False Claims Act, which allows any individual to bring a lawsuit against a pharmaceutical company on behalf of the

federal government alleging submission of false or fraudulent claims, or causing to present such false or fraudulent claims, for

payment by a federal program such as Medicare or Medicaid.

If the government prevails in the lawsuit, the individual will share

in any fines or settlement funds.

Since 2004, these federal False Claims Act lawsuits against pharmaceutical companies has increased

significantly in volume and breadth, leading to several substantial civil and criminal settlements regarding certain sales practices

promoting off-label product uses involving fines in excess of $1 billion.

This growth in litigation has increased the risk that

a pharmaceutical company will have to defend a false claim action, pay settlement fines or restitution, agree to comply with burdensome

reporting and compliance obligations and be excluded from Medicare, Medicaid and other federal and state healthcare programs.

If Gemini does not lawfully promote its approved products, Gemini may become subject to such litigation and, if Gemini does not

successfully defend against such actions, those actions may have a material adverse effect on its business, financial condition

and results of operations.

FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory

approval of its product candidates.

If Gemini is slow or unable to adapt to changes in existing requirements or adopt new requirements

or policies, or if Gemini is not able to maintain regulatory compliance, Gemini may lose any marketing approval that Gemini may

have obtained, which would adversely affect its business, prospects and ability to achieve or sustain profitability.

insurance coverage and reimbursement may be limited or unavailable for its product candidates, if approved, which could make it

difficult for us to sell its product candidates profitably.

success of its product candidates, if approved, depends on the availability of coverage and adequate reimbursement from third-party

payors including governmental healthcare programs, such as Medicare and Medicaid, commercial payors, and health maintenance organizations.

Gemini cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from,

its product candidates or assure that coverage and reimbursement will be available for any product that Gemini may develop.

who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs

associated with their treatment.

and state and foreign laws that govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Efforts to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs.

It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.

If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, and the curtailment or restructuring of our operations.

If any of the physicians or other healthcare providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, that person or entity may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.

We and any potential collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security).

In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act and California Consumer Privacy Act of 2018 (“CCPA”)), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators.

The state of California, for example, recently adopted the CCPA, which will come into effect beginning in January 2020.

The CCPA has been characterized as the first “GDPR-like”

privacy statute to be enacted in the United States because it mirrors a number of the key provisions of the European Union General Data Protection Regulation (“EU GDPR”).

The CCPA establishes a new privacy framework for covered businesses by creating an expanded definition of personal information, establishing new data privacy rights for consumers in the State of California, imposing special rules on the collection of consumer data from minors, and creating a new and potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches.

In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA, as amended by HITECH.

Depending on the facts and circumstances, we could be subject to civil, criminal, and administrative penalties if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

Compliance with U.S.

and international data protection laws and regulations, including the EU GDPR and other EU data protection laws, could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.

Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.

Moreover, clinical trial subjects, employees and other individuals about whom we or our potential collaborators obtain personal information, as well as the providers who share this information with us, may limit our ability to collect, use and disclose the information.

Claims that we have violated individuals’

privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.

Clinical development is uncertain, and our clinical trials for GEM103 and any other product candidates may experience delays, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, which would have an adverse effect on our business.

We cannot be sure that we will be able to submit INDs or similar applications for our preclinical programs on the timelines we expect, if at all.

To proceed with our development plans and ultimately commercialization, we may need to conduct and meet regulatory requirements for preclinical and clinical studies.

For therapeutic applications, the FDA may require additional extensive preclinical and other studies.

We cannot be certain of the timely completion or outcomes of our preclinical testing and studies and cannot predict if the FDA or other regulatory authorities will accept our proposed clinical programs or if the outcomes of our preclinical testing and studies will ultimately support the further development of our programs.

As a result, there is no assurance that we will be able to submit INDs or similar applications on the timelines we expect, if at all, and we cannot be sure that submission of an IND or similar applications will result in the FDA or other regulatory authorities allowing a clinical trial design to begin.

Even if we are able to obtain regulatory approvals for our product candidates, if they exhibit harmful side effects after approval, our regulatory approvals could be revoked or otherwise negatively impacted, and we could be subject to costly and damaging product liability claims.

Clinical trials are conducted in representative samples of the potential patient population which may has significant variability.

Even if we receive regulatory approval for GEM103 or any of our other product candidates, we will have tested them in only a small number of patients during our clinical trials.

Clinical trials are by design based on a limited number of subjects and of limited duration for exposure to the product used to determine whether, on a potentially statistically significant basis, the planned safety and efficacy of any product candidate can be achieved.

As with the results of any statistical sampling, we cannot be sure that all side effects of our product candidates may be uncovered, and it may be the case that only with a significantly larger number of patients exposed to the product candidate for a longer duration, may a more complete safety profile be

Further, even larger clinical trials may not identify rare serious adverse effects or the duration of such studies may not be sufficient to identify when those events may occur.

If our applications for marketing are approved and more patients begin to use our product, new risks and side effects associated with our products may be discovered.

There have been other products that have been approved by the regulatory authorities but for which safety concerns has been uncovered following approval.

Such safety concerns have led to labelling changes or withdrawal of products from the market, and any of our product candidates may be subject to similar risks.

Additionally, we may be required to conduct additional nonclinical and clinical trials, require additional warnings on the label of our products, reformulate our product or make changes, create a medication guide outlining the risks of such side effects for distribution to patients and obtain new approvals for our and our suppliers’

manufacturing facilities for GEM103 and any other product candidates.

We might have to withdraw or recall our products from the marketplace.

We may also experience a significant drop in the potential sales of our products if and when regulatory approvals for such products are obtained, experience harm to our reputation in the marketplace or become subject to lawsuits, including class actions.

Any of these results could decrease or prevent any sales of our approved products or substantially increase the costs and expenses of commercializing and marketing our products.

Even if our product candidates receive regulatory approval, they will remain subject to extensive regulatory scrutiny and may still face future development and regulatory difficulties.

Even if we obtain regulatory approval for a product candidate, regulatory authorities may still impose significant restrictions on our product candidates, including their indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies.

Further, even if we obtain regulatory approval for a product candidate, we would be subject to ongoing requirements by the governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, tracking and tracing, safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other post-market information.

The FDA and applicable foreign regulatory authorities will continue to closely monitor the safety profile of any product even after approval.

If the FDA or applicable foreign regulatory authorities become aware of new safety information after approval of our product candidates, they may require labeling changes or establishment of a REMS or similar strategy, impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.

In addition, manufacturers of drug and biologic products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practice (“cGMP”) regulations and standards.

If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, or undesirable side effects caused by such products are identified, a regulatory agency may:

issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about such product;

mandate modifications to promotional materials or require us to provide corrective information to healthcare practitioners;

require that we conduct post-marketing studies;

require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;

seek an injunction or impose civil or criminal penalties or monetary fines;

suspend marketing of, withdraw regulatory approval of or recall such product;

suspend any ongoing clinical studies;

refuse to approve pending applications or supplements to applications filed by us;

suspend or impose restrictions on operations, including costly new manufacturing requirements;

seize or detain products, refuse to permit the import or export of products or require us to initiate a product recall.

The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate revenue.

Advertising and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by the FDA, the Department of Justice, the Department of Health and Human Services’

Office of Inspector General, state attorneys general, members of Congress and the public.

Violations, including promotion of our products for unapproved (or off-label) uses, are subject to enforcement letters, inquiries and investigations, and civil and criminal sanctions by the government.

Additionally, applicable foreign regulatory authorities will heavily scrutinize advertising and promotion of any product candidate that obtains approval outside of the United States.

In the United States, engaging in the impermissible promotion of our products for off-label uses can also subject us to false claims litigation under federal and state statutes, which can lead to civil and criminal penalties and fines and agreements that materially restrict the manner in which a company promotes or distributes drug and biologic products.

These false claims statutes include the federal False Claims Act, which allows any individual to bring a lawsuit against a pharmaceutical company on behalf of the federal government alleging submission of false or fraudulent claims, or causing to present such false or fraudulent claims, for payment by a federal program such as Medicare or Medicaid.

If the government prevails in the lawsuit, the individual will share in any fines or settlement funds.

Since 2004, these federal False Claims Act lawsuits against pharmaceutical companies has increased significantly in volume and breadth, leading to several substantial civil and criminal settlements regarding certain sales practices promoting off-label product uses involving fines in excess of $1 billion.

This growth in litigation has increased the risk that a pharmaceutical company will have to defend a false claim action, pay settlement fines or restitution, agree to comply with burdensome reporting and compliance obligations and be excluded from Medicare, Medicaid and other federal and state healthcare programs.

If we do not lawfully promote our approved products, we may become subject to such litigation and, if we do not successfully defend against such actions, those actions may have a material adverse effect on our business, financial condition and results of operations.

The FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.

If we are slow or unable to adapt to changes in existing requirements or adopt new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.

Healthcare insurance coverage and reimbursement may be limited or unavailable for our product candidates, if approved, which could make it difficult for us to sell our product candidates profitably.

To the extent we continue to pursue product development, the success of our product candidates, if approved, depends on the availability of coverage and adequate reimbursement from third-party payors including governmental healthcare programs, such as Medicare and Medicaid, commercial payors, and health maintenance organizations.

We cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, our product candidates or assure that coverage and reimbursement will be available for any product that we may develop.

Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.

Coverage and adequate reimbursement from third-party payors is critical to new product acceptance.

payors decide which products and treatments they will cover and the amount of reimbursement.

Coverage and reimbursement by a third-party

payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

a covered benefit

under its health plan;

safe, effective

and medically necessary;

appropriate for

the specific patient;

Third-party payors decide which products and treatments they will cover and the amount of reimbursement.

Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

a covered benefit under its health plan;

safe, effective and medically necessary;

appropriate for the specific patient;

cost-effective;

neither experimental

nor investigational.

the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors.

obtaining coverage and reimbursement approval of a product from a third-party payor is a time consuming and costly process that

could require us to provide to each payor supporting scientific, clinical and cost effectiveness data for the use of its products

on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained.

There is significant uncertainty

related to the insurance coverage and reimbursement of newly approved products.

In the United States, the principal decisions

about reimbursement for new medicines are typically made by CMS, an agency within HHS, as CMS decides whether and to what extent

a new medicine will be covered and reimbursed under Medicare.

Private third-party payors tend to follow Medicare coverage and

reimbursement limitations to a substantial degree, but also has their own methods and approval process apart from Medicare determinations.

Even if Gemini obtains coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to

achieve or sustain profitability or may require co-payments that patients find unacceptably high.

failure to obtain regulatory approval in international jurisdictions would prevent Gemini from marketing its product candidates

outside the United States.

if its products are approved for marketing in the United States, in order to market and sell its products in other jurisdictions,

Gemini must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

The approval procedure

varies among countries and can involve additional testing.

The time required to obtain approval may differ substantially from

that required to obtain FDA approval.

The regulatory approval process outside the United States generally includes all of the

risks associated with obtaining FDA approval.

In addition, in many countries outside the United States, Gemini must secure product

reimbursement approvals before regulatory authorities will approve the product for sale in that country.

Obtaining applicable

foreign regulatory authorities and compliance with applicable foreign regulatory requirements could result in significant delays,

difficulties and costs for it and could delay or prevent the introduction of its products in certain countries.

Further, clinical

trials conducted in one country may not be accepted by regulatory authorities in other countries and regulatory approval in one

country does not ensure approval in any other country, while a failure or delay in obtaining regulatory approval in one country

may has a negative effect on the regulatory approval process in others.

regulatory approval for its product candidates may be withdrawn if Gemini fails to comply with regulatory requirements, if problems

occur after the product candidate reaches the market or for other reasons.

If Gemini fails to comply with the regulatory requirements

in international markets and fail to receive applicable marketing approvals, its target market will be reduced and its ability

to realize the full market potential of its product candidates will be harmed and its business will be adversely affected.

may not obtain applicable foreign regulatory approvals on a timely basis, if at all.

Approval by the FDA does not ensure approval

by regulatory authorities in other countries or jurisdictions.

Approval by one regulatory authority outside the United States

does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.

If Gemini fails to obtain

approval of its product candidates by applicable foreign regulatory authorities, Gemini will be unable to commercialize its product

in that country, and the commercial prospects of that product candidate and its business prospects could decline.

is subject to U.S.

and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money

laundering laws and regulations.

Compliance with these legal standards could impair its ability to compete in domestic and international

Gemini can face criminal liability and other serious consequences for violations, which can harm its business.

is subject to export control and import laws and regulations, including the U.S.

neither experimental nor investigational.

Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States.

Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products.

We cannot be sure that reimbursement will be available for any product candidate that we commercialize and, if reimbursement is available, the level of reimbursement.

In addition, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price (“ASP”) and best price.

Penalties may apply in some cases when such metrics are not submitted accurately and timely.

Further, these prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs.

In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors.

As a result, obtaining coverage and reimbursement approval of a product from a third-party payor is a time consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost effectiveness data for the use of our products on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained.

There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products.

In the United States, the principal decisions about reimbursement for new medicines are typically made by CMS, an agency within HHS, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare.

Private third-party payors tend to follow Medicare coverage and reimbursement limitations to a substantial degree, but also has their own methods and approval process apart from Medicare determinations.

Even if we obtains coverage for a given product, the resulting reimbursement payment rates might not be adequate for us to achieve or sustain profitability or may require co-payments that patients find unacceptably high.

In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.

The requirements governing drug pricing vary widely from country to country.

For example, the European Union provides options for its Member States to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.

To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular product candidate to currently available therapies.

A Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.

There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our product candidates.

Historically, products launched in the European Union do not follow price structures of the U.S.

and generally prices tend to be significantly lower.

Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States.

Even if our products are approved for marketing in the United States, in order to market and sell our products in other jurisdictions, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries and can involve additional testing.

The time required to obtain approval may differ substantially from that required to obtain FDA approval.

The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval.

In addition, in many countries outside the United States, we must secure product reimbursement approvals before regulatory authorities will approve the product for sale in that country.

Obtaining applicable foreign regulatory authorities and compliance with applicable foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries.

Further, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries and regulatory approval in one country does not ensure approval in any other country, while a failure or delay in obtaining regulatory approval in one country may has a negative effect on the regulatory approval process in others.

Also, regulatory approval for our product candidates may be withdrawn if we fail to comply with regulatory requirements, if problems occur after the product candidate reaches the market or for other reasons.

If we fail to comply with the regulatory

requirements in international markets and fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed and our business will be adversely affected.

We may not obtain applicable foreign regulatory approvals on a timely basis, if at all.

Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions.

Approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.

If we fail to obtain approval of our product candidates by applicable foreign regulatory authorities, we will be unable to commercialize our product in that country, and the commercial prospects of that product candidate and our business prospects could decline.

We are subject to U.S.

and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations.

Compliance with these legal standards could impair our ability to compete in domestic and international markets.

We can face criminal liability and other serious consequences for violations, which can harm our business.

We are subject to export control and import laws and regulations, including the U.S.

Export Administration Regulations, U.S.

regulations, various economic and trade sanctions regulations administered by the U.S.

Treasury Department’s Office of Foreign

Assets Controls, the U.S.

Customs regulations, various economic and trade sanctions regulations administered by the U.S.

Treasury Department’s Office of Foreign Assets Controls, the U.S.

Foreign Corrupt Practices Act of 1977, as amended, the U.S.

domestic bribery statute contained in 18

domestic bribery statute contained in 18 U.S.C.

§ 201, the U.S.

Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering

laws in the countries in which Gemini conducts activities.

Anti-corruption laws are interpreted broadly and prohibit companies

and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly

or indirectly, improper payments or anything else of value to recipients in the public or private sector.

Gemini may engage third

parties to sell its products sell its products outside the United States, to conduct clinical trials, and/or to obtain necessary

permits, licenses, patent registrations, and other regulatory approvals.

Gemini has direct or indirect interactions with officials

and employees of government agencies or government-affiliated hospitals, universities, and other organizations.

Gemini can be

held liable for the corrupt or other illegal activities of its employees, agents, contractors, and other collaborators, even if

Gemini does not explicitly authorize or has actual knowledge of such activities.

Any violations of the laws and regulations described

above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges,

debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and

other personnel, prevent new or existing product candidates from being developed or commercialized in a timely manner or otherwise

prevent those agencies from performing normal functions on which the operation of its business may rely, which could negatively

impact its business.

ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and

funding levels, ability to hire and retain key personnel and accept payment of user fees, and statutory, regulatory, and policy

Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities.

Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector.

We may engage third parties to sell our products outside the United States, to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals.

We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations.

We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we do not explicitly authorize or has actual knowledge of such activities.

Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

Changes in funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new or existing product candidates from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees, and statutory, regulatory, and policy changes.

Average review times at the agency has fluctuated in recent years as a result.

In addition, government funding of the

SEC and other government agencies on which its operations may rely, including those that fund research and development activities

is subject to the political process, which is inherently fluid and unpredictable.

at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government

agencies, which would adversely affect its business.

For example, over the last several years, including beginning on December

22, 2018, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, has had

to furlough critical FDA, SEC and other government employees and stop critical activities.

If a prolonged government shutdown

occurs, it could significantly impact the ability of the FDA to timely review and process its regulatory submissions, which could

have a material adverse effect on its business.

Further, upon completion of the Business Combination and in its operations as

a public company, future government shutdowns could impact its ability to access the public markets and obtain necessary capital

in order to properly capitalize and continue its operations.

in response to the global COVID-19 pandemic, on March 10, 2020 the FDA announced its intention to postpone most foreign inspections

of manufacturing facilities and products, and subsequently, on March 18, 2020, the FDA announced its intention to temporarily

postpone routine surveillance inspections of domestic manufacturing facilities.

On July 10, 2020, FDA announced its intention

to resume certain on-site inspections of domestic manufacturing facilities subject to a risk-based prioritization system.

FDA intends to use this risk-based assessment system to identify the categories of regulatory activity that can occur within a

given geographic area, ranging from mission critical inspections to resumption of all regulatory activities.

Regulatory authorities

outside the United States may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic.

If a prolonged

government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting

their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other

regulatory authorities to timely review and process its regulatory submissions, which could has a material adverse effect on its

For example, as of June 23, 2020, the FDA noted it is continuing to ensure timely reviews of applications for medical

products during the COVID-19 pandemic in line with its user fee performance goals;

however, FDA may not be able to continue its

current pace and review timelines could be extended.

the FDA becomes unable to continue its current level of performance, Gemini could experience delays and setbacks for its product

candidates and for any approvals Gemini may seek which could adversely affect its business.

and other product candidates for which Gemini intends to seek approval as biologic products may face competition sooner than anticipated.

is a biological product candidate.

Gemini believes that any of its product candidates approved in the United States as a biological

product under a Biologics License Application, or BLA, should qualify for the 12-year period of regulatory exclusivity.

The enactment

of the Biologics Price Competition and Innovation Act of 2009, or BPCIA, as part of the Affordable Care Act, created an abbreviated

pathway for the approval of biosimilar and interchangeable biological products.

The abbreviated regulatory pathway establishes

legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as

“interchangeable”

In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.

For example, over the last several years, including beginning on December 22, 2018, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, has had to furlough critical FDA, SEC and other government employees and stop critical activities.

If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Further, upon completion of the Business Combination and in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Separately, since March 2020 when foreign and domestic inspections of facilities were largely placed on hold due to the COVID-19 pandemic, the FDA has been working to resume routine surveillance, bioresearch monitoring and pre-approval inspections on a prioritized basis.

Since April 2021, the FDA has conducted limited inspections and employed remote interactive evaluations, using risk management methods, to meet user fee commitments and goal dates.

Ongoing travel restrictions and other uncertainties continue to impact oversight operations both domestic and abroad and it is unclear when standard operational levels will resume.

The FDA is continuing to complete mission-critical work, prioritize other higher-tiered inspectional needs (e.g., for-cause inspections), and carry out surveillance inspections using risk-based approaches for evaluating public health.

Should FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel, and the FDA does not determine a remote interactive evaluation to be adequate, the agency has stated that it generally intends to issue, depending on the circumstances, a complete response

letter or defer action on the application until an inspection can be completed.

During the COVID-19 public health emergency, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications.

Regulatory authorities outside the U.S.

may adopt similar restrictions or other policy measures in response to the ongoing COVID-19 pandemic and may experience delays in their regulatory activities.

If the FDA becomes unable to continue its current level of performance, we could experience delays and setbacks for our product candidates and for any approvals we may seek which could adversely affect our business.

GEM103 and other product candidates for which we may choose to seek approval as biologic products may face competition sooner than anticipated.

GEM103 and GEM307 are a biological product candidates.

We believe that any of our product candidates approved in the United States as a biological product under a Biologics License Application (“BLA”) should qualify for the 12-year period of regulatory exclusivity.

The enactment of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) as part of the Affordable Care Act, created an abbreviated pathway for the approval of biosimilar and interchangeable biological products.

The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable”

based on its similarity to an existing brand product.

Under the BPCIA, an application for a biosimilar

product cannot be approved by the FDA until 12 years after the original branded product was approved under a BLA.

Certain changes,

however, and supplements to an approved BLA, and subsequent applications filed by the same sponsor, manufacturer, licensor, predecessor

in interest, or other related entity do not qualify for the 12-year exclusivity period.

The law is complex and is still being

interpreted and implemented by the FDA.

Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the original branded product was approved under a BLA.

Certain changes, however, and supplements to an approved BLA, and subsequent applications filed by the same sponsor, manufacturer, licensor, predecessor in interest, or other related entity do not qualify for the 12-year exclusivity period.

The law is complex and is still being interpreted and implemented by the FDA.

As a result, its ultimate impact, implementation, and meaning are subject to uncertainty.

While it is uncertain when such processes intended to implement the BPCIA may be fully adopted by the FDA, any such processes

could have a material adverse effect on the future commercial prospects for its biological products.

However, there is also a risk that this

exclusivity could be changed in the future.

For example, this exclusivity could be shortened due to congressional action or through

other actions, including future proposed budgets, international trade agreements and other arrangements or proposals.

to which a biosimilar, once approved, will be substituted for any one of its reference products in a way that is similar to traditional

generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors

that are still developing.

It is also possible that payers will give reimbursement preference to biosimilars over reference biologics,

even absent a determination of interchangeability.

To the extent that Gemini does not receive

any anticipated periods of regulatory exclusivity for GEM103 and other product candidates or the FDA or foreign regulatory authorities

approve any biosimilar, interchangeable, or other competing products to GEM103 and other product candidates, it could has a material

adverse effect on its business, financial condition, results of operations, stock price and prospects.

While it is uncertain when such processes intended to implement the BPCIA may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for our biological products.

However, there is also a risk that this exclusivity could be changed in the future.

For example, this exclusivity could be shortened due to congressional action or through other actions, including future proposed budgets, international trade agreements and other arrangements or proposals.

The extent to which a biosimilar, once approved, will be substituted for any one of its reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

It is also possible that payers will give reimbursement preference to biosimilars over reference biologics, even absent a determination of interchangeability.

To the extent that we do not receive any anticipated periods of regulatory exclusivity for GEM103 and other product candidates or the FDA or foreign regulatory authorities approve any biosimilar, interchangeable, or other competing products to GEM103 and other product candidates, it could have a material adverse effect on our business, financial condition, results of operations, stock price and prospects.

Risks Related to Intellectual Property

Gemini’s success depends upon

its ability to obtain and maintain intellectual property protection for its products and technologies.

It is difficult and costly

to protect its proprietary rights and technology, and Gemini may not be able to ensure their protection.

Gemini’s commercial success depends

in part on its ability to obtain and maintain patent protection and trade secret protection for GEM103 and its other product candidates,

proprietary patient screening technologies and their uses as well as Gemini’s ability to operate without infringing upon

the proprietary rights of others.

Gemini generally seeks to protect its proprietary position by filing patent applications in the

United States and abroad related to its product candidates, proprietary technologies and their uses that are important to Gemini’s

Gemini also seeks to protect its proprietary position by acquiring or in-licensing relevant issued patents or pending

applications from third parties.

Finally, Gemini maintains its non-patented, but proprietary technologies, as company trade secrets.

Pending patent applications cannot be enforced

against third parties practicing the technology claimed in such applications unless, and until, patents issue from such applications,

and then only to the extent the issued claims cover the technology.

There can be no assurance that Gemini’s patent applications

or the patent applications of Gemini’s licensors will result in patents being issued or that issued patents will afford sufficient

protection against competitors with similar technology, nor can there be any assurance that the patents issued will not be infringed,

designed around or invalidated by third parties.

Even issued patents may later be found

invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices

or in courts.

The degree of future protection for Gemini and Gemini licensors’

Our success depends upon our ability to obtain and maintain intellectual property protection for our products and technologies.

It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.

Our commercial success depends in part on our ability to obtain and maintain patent protection and trade secret protection for GEM103 and our other product candidates, proprietary patient screening technologies and their uses as well as our ability to operate without infringing upon the proprietary rights of others.

We generally seek to protect our proprietary position by filing patent applications in the United States and abroad related to our product candidates, proprietary technologies and their uses that are important to our business.

We also seek to protect our proprietary position by acquiring or in-licensing relevant issued patents or pending applications from third parties.

Finally, we maintain our non-patented, but proprietary technologies, as company trade secrets.

Pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless, and until, patents issue from such applications, and then only to the extent the issued claims cover the technology.

There can be no assurance that our patent applications or the patent applications of our licensors will result in patents being issued or that issued patents will afford sufficient protection against competitors with similar technology, nor can there be any assurance that the patents issued will not be infringed, designed around or invalidated by third parties.

Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts.

The degree of future protection for our and our licensors’

proprietary rights is uncertain.

protection may be available and may not adequately protect Gemini’s rights or permit it to gain or keep any competitive advantage.

These uncertainties and/or limitations in Gemini’s ability to properly protect the intellectual property rights relating

to its product candidates could have a material adverse effect on Gemini’s financial condition and results of operations.

Gemini currently does not have any company-owned

or in-licensed patents covering GEM103.

Although Gemini is pursuing pending patent applications on GEM103, these applications may

not issue as patents and as a result Gemini may not be able to prevent biosimilars to GEM103 from entering the market when the

market exclusivity period has expired.

Gemini cannot be certain that the claims in U.S.

pending patent applications, corresponding

international patent applications and patent applications in certain foreign territories, or those of our licensors, will be considered

patentable by the United States Patent and Trademark Office (USPTO), courts in the United States or by the patent offices and courts

in foreign countries, nor can Gemini be certain that the claims in its issued patent or its licensor’s issued patents will

not be found invalid or unenforceable if challenged.

The patent application process is subject

to numerous risks and uncertainties, and there can be no assurance that Gemini or any of our potential future collaborators will

be successful in protecting its product candidates by obtaining and defending patents.

These risks and uncertainties include the

Only limited protection may be available and may not adequately protect our rights or permit us to gain or keep any competitive advantage.

These uncertainties and/or limitations in our ability to properly protect the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations.

We currently do not have any company-owned or in-licensed patents covering GEM103.

Although we are pursuing pending patent applications on GEM103, these applications may not issue as patents and as a result we may not be able to prevent biosimilars to GEM103 from entering the market when the market exclusivity period has expired.

We cannot be certain that the claims in U.S.

pending patent applications, corresponding international patent applications and patent applications in certain foreign territories, or those of our licensors, will be considered patentable by the United States Patent and Trademark Office (“USPTO”), courts in the United States or by the patent offices and courts in foreign countries, nor can we be certain that the claims in our issued patent or our licensor’s issued patents will not be found invalid or unenforceable if challenged.

The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our potential future collaborators will be successful in protecting our product candidates by obtaining and defending patents.

These risks and uncertainties include the following:

the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction;

1 unchanged sentence

patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;

Gemini’s competitors, many of whom have substantially greater resources than Gemini does and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate Gemini’s ability to make, use and sell its potential product candidates;

Our competitors, many of whom have substantially greater resources than we do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates;

there may be significant pressure on the U.S.

2 unchanged sentences

courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates.

The patent prosecution process is also

expensive and time-consuming, and Gemini or its licensors may not be able to file and prosecute all necessary or desirable patent

applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially advantageous.

It is also possible that Gemini or its licensors will fail to identify patentable aspects of our research and development output

before it is too late to obtain patent protection.

In addition, although Gemini enters into

non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development

output, such as our employees, outside scientific collaborators, CROs, third-party manufacturers, consultants, advisors and other

third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby

jeopardizing our ability to seek patent protection.

Given the amount of time required for the

development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or

shortly after such candidates are commercialized.

As a result, our intellectual property may not provide us with sufficient rights

to exclude others from commercializing products similar or identical to ours.

Gemini may be unable to obtain intellectual

property rights or technology necessary to develop and commercialize its product candidates.

Several third parties are actively researching

and seeking and obtaining patent protection in the AMD field, and there are issued third-party patents and published third-party

patent applications in these fields.

Although no third party has asserted a claim of patent infringement against us as of the date

of this annual report, a third party may hold proprietary rights that could prevent Gemini’s product candidates from being

For example, Gemini is aware of an issued European patent expiring in 2026 that claims an isolated CFH polypeptide which

could be alleged to cover GEM103.

While Gemini believes that the expiration date of this patent will be prior to European launch

of GEM103, there is a possibility that commercial manufacturing or product launch in Europe would predate the patent expiration.

If commercial manufacturing or product launch in Europe predates the patent expiration, and in the event that this patent is successfully

asserted against us, such litigation may negatively impact our ability to commercialize GEM103 in France, Germany, Ireland, Liechtenstein,

the Netherlands, Switzerland or the United Kingdom.

Gemini may not be aware of all third-party intellectual property rights potentially

relating to its product candidates and technologies.

Depending on what patent claims ultimately

issue and how courts construe the issued patent claims, as well as depending on the ultimate formulation and method of use of its

product candidates, Gemini may need to obtain a license under such patents.

There can be no assurance that such licenses will be

available on commercially reasonable terms, or at all.

If a third party does not offer us a necessary license or offers a license

only on terms that are unattractive or unacceptable to us, Gemini might be unable to develop and commercialize one or more of its

product candidates, which would have a material adverse effect on its business, financial condition and results of operations.

Moreover, even if Gemini obtains licenses to such intellectual property, but subsequently fail to meet its obligations under its

license agreements, or such license agreements are terminated for any other reasons, Gemini may lose its rights to in-licensed

technologies.

The licensing or acquisition of third-party

intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or

acquire third-party intellectual property rights that Gemini may consider attractive or necessary.

These established companies

may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization

capabilities.

The patent prosecution process is also expensive and time-consuming, and we or our licensors may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially advantageous.

It is also possible that we or our licensors will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.

In addition, although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, outside scientific collaborators, CROs, third-party manufacturers, consultants, advisors and other third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection.

Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

We may be unable to obtain intellectual property rights or technology necessary to develop and commercialize our product candidates.

Several third parties are actively researching and seeking and obtaining patent protection in the AMD field, and there are issued third-party patents and published third-party patent applications in these fields.

Although no third party has asserted a claim of

patent infringement against us as of the date of this annual report, a third party may hold proprietary rights that could prevent our product candidates from being marketed.

For example, we are aware of an issued European patent expiring in 2026 that claims an isolated CFH polypeptide which could be alleged to cover GEM103.

While we believe that the expiration date of this patent will be prior to European launch of GEM103, there is a possibility that commercial manufacturing or product launch in Europe would predate the patent expiration.

If commercial manufacturing or product launch in Europe predates the patent expiration, and in the event that this patent is successfully asserted against us, such litigation may negatively impact our ability to commercialize GEM103 in France, Germany, Ireland, Liechtenstein, the Netherlands, Switzerland or the United Kingdom.

We may not be aware of all third-party intellectual property rights potentially relating to our product candidates and technologies.

Depending on what patent claims ultimately issue and how courts construe the issued patent claims, as well as depending on the ultimate formulation and method of use of our product candidates, we may need to obtain a license under such patents.

There can be no assurance that such licenses will be available on commercially reasonable terms, or at all.

If a third party does not offer us a necessary license or offers a license only on terms that are unattractive or unacceptable to us, we might be unable to develop and commercialize one or more of our product candidates, which would have a material adverse effect on our business, financial condition and results of operations.

Moreover, even if we obtain licenses to such intellectual property, but subsequently fail to meet our obligations under our license agreements, or such license agreements are terminated for any other reasons, we may lose our rights to in-licensed technologies.

The licensing or acquisition of third-party intellectual property rights is a competitive area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary.

These established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities.

In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us.

also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate

return on its investment, or at all.

If Gemini is unable to successfully obtain rights to required third-party intellectual property

rights or maintain the existing intellectual property rights Gemini has, Gemini may have to abandon development of the relevant

program or product candidate, which could have a material adverse effect on its business, financial condition, results of operations

and prospects.

If Gemini fails to comply with its

obligations under any license, collaboration or other agreements, including the license agreement with Sanquin Blood Supply Foundation

related to anti-CFH agonistic antibodies, it may be required to pay damages and could lose intellectual property rights that are

necessary for developing and protecting its product candidates.

Gemini is dependent on patents, know-how

and proprietary technology in-licensed from Sanquin Blood Supply Foundation.

Its commercial success depends upon its ability to

develop, manufacture, market and sell its product candidates and use its and its licensor’s proprietary technologies without

infringing the proprietary rights of third parties.

Sanquin Blood Supply Foundation may have the right to terminate the license

agreement in full in the event Gemini materially breach or default in the performance of any of the obligations under the license

A termination of the license agreement with Sanquin Blood Supply Foundation could result in the loss of significant

rights and could harm its ability to commercialize its product candidates.

Disputes may also arise between Gemini

and Sanquin Blood Supply Foundation, as well as any future potential licensors, regarding intellectual property subject to a license

agreement, including:

We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment, or at all.

If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have to abandon development of the relevant program or product candidate, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

If we fail to comply with our obligations under any license, collaboration or other agreements, including the license agreement with Sanquin Blood Supply Foundation related to anti-CFH agonistic antibodies, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidates.

We are dependent on patents, know-how and proprietary technology in-licensed from Sanquin Blood Supply Foundation and other licensors.

Our commercial success depends upon our ability to develop, manufacture, market and sell our product candidates and use our and our licensor’s proprietary technologies without infringing the proprietary rights of third parties.

Sanquin Blood Supply Foundation and other licensors may have the right to terminate the license agreement in full in the event we materially breach or default in the performance of any of the obligations under the license agreement.

A termination of the license agreement with Sanquin Blood Supply Foundation or other licensors could result in the loss of significant rights and could harm our ability to commercialize our product candidates.

Disputes may also arise between us and Sanquin Blood Supply Foundation, as well as any current or future potential licensors, regarding intellectual property subject to a license agreement, including:

the scope of rights granted under the license agreement and other interpretation-related issues;

whether and the extent to which its technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

its right to sublicense patent and other rights to third parties under collaborative development relationships;

its diligence obligations with respect to the use of the licensed technology in relation to its development and commercialization of its product candidates and what activities satisfy those diligence obligations;

the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by its licensors and us and its partners;

whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

our right to sublicense patent and other rights to third parties under collaborative development relationships;

our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates and what activities satisfy those diligence obligations;

the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;

the priority of invention of patented technology.

If disputes over intellectual property

that Gemini has licensed prevent or impair its ability to maintain its current licensing arrangements on acceptable terms, Gemini

may be unable to successfully develop and commercialize the affected product candidates.

In addition, the Research Collaboration

and License Agreement under which Gemini currently licenses intellectual property is complex, and certain provisions may be susceptible

to multiple interpretations.

The resolution of any contract interpretation disagreement that may arise could narrow what Gemini

believes to be the scope of its rights to the relevant intellectual property, or increase what Gemini believes to be its financial

or other obligations under the Research Collaboration and License Agreement, either of which could has a material adverse effect

on its business, financial condition, results of operations, and prospects.

Moreover, if disputes over intellectual property that

Gemini has licensed prevent or impair its ability to maintain its current licensing arrangement on commercially acceptable terms,

Gemini may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse

effect on its business, financial conditions, results of operations, and prospects.

Gemini is generally also subject to all

of the same risks with respect to protection of intellectual property that Gemini licenses, as Gemini is for intellectual property

that Gemini owns, which are described below.

If Gemini or its licensors fail to adequately protect this intellectual property,

its ability to commercialize products could suffer.

Patent terms may be inadequate to

protect its competitive position on its product candidates for an adequate amount of time.

If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.

In addition, the Research Collaboration and License Agreement under which we currently license intellectual property is complex, and certain provisions may be susceptible to multiple interpretations.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property, or increase what we believe to be our financial or other obligations under the Research Collaboration and License Agreement, either of which could has a material adverse effect on our business, financial condition, results of operations, and prospects.

Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangement on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations, and prospects.

We are generally also subject to all of the same risks with respect to protection of intellectual property that we license, as we are for intellectual property that we own, which are described below.

If we or our licensors fail to adequately protect this intellectual property, our ability to commercialize products could suffer.

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

Patents have a limited lifespan.

United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest

In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S.

non-provisional filing date.

Various extensions may be available, but the life of a patent, and the protection it affords,

Even if patents covering its product candidates are obtained, once the patent life has expired, Gemini may be open

to competition from competitive products.

Given the amount of time required for the development, testing and regulatory review

of new product candidates, patents protecting its product candidates might expire before or shortly after Gemini or its partners

commercialize those candidates.

As a result, its owned and licensed patent portfolio may not provide us with sufficient rights

to exclude others from commercializing products similar or identical to its products.

Gemini may not be able to protect

its intellectual property rights throughout the world.

The legal protection afforded to inventors

and owners of intellectual property in countries outside of the United States may not be as protective or effective as that in

the United States and Gemini may, therefore, be unable to acquire and enforce intellectual property rights outside the United States

to the same extent as in the United States.

Whether filed in the United States or abroad, its patent applications may be challenged

or may fail to result in issued patents.

Currently, Gemini does not own or have

in-licensed issued patents covering GEM103.

Any future patents Gemini obtains may not be sufficiently broad to prevent others from

practicing its technologies or from developing or commercializing competing products.

Furthermore, others may independently develop

or commercialize similar or alternative technologies or drugs, or design around its patents.

Its patents may be challenged, invalidated,

circumvented or narrowed, or fail to provide us with any competitive advantages.

In many foreign countries, patent applications

and/or issued patents, or parts thereof, must be translated into the native language.

If its patent applications or issued patents

are translated incorrectly, they may not adequately cover its technologies;

in some countries, it may not be possible to rectify

an incorrect translation, which may result in patent protection that does not adequately cover its technologies in those countries.

Filing, prosecuting, enforcing and defending

patents on product candidates in all countries throughout the world would be prohibitively expensive, and its intellectual property

rights in some countries outside the United States are less extensive than those in the United States.

In addition, the laws of

some foreign countries do not protect intellectual property rights to the same extent as federal and certain state laws in the

United States.

Consequently, Gemini and its licensor may not be able to prevent third parties from practicing its and its licensor’s

inventions in all countries outside the United States, or from selling or importing products made using its and its licensor’s

inventions in and into the United States or other jurisdictions.

Competitors may use its and its licensor’s technologies

in jurisdictions where Gemini has not obtained patent protection to develop their own products and, further, may export otherwise

infringing products to territories where Gemini and its licensor have patent protection, but enforcement is not as strong as that

in the United States.

These products may compete with its product candidates its and its licensor’s patents or other intellectual

property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant

problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of certain countries,

particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection,

particularly those relating to biotechnology.

This could make it difficult for us and Gemini’s licensor to stop the infringement

of its and its licensor’s patents or the marketing of competing products in violation of Gemini’s and its licensor’s

proprietary rights, generally.

Proceedings to enforce Gemini’s and its licensor’s patent rights in foreign jurisdictions

could result in substantial costs and divert its and its licensor’s efforts and attention from other aspects of its business,

could put Gemini’s and its licensor’s patents at risk of being invalidated or interpreted narrowly, could place Gemini’s

and its licensor’s patent applications at risk of not issuing and could provoke third parties to assert claims against Gemini’s

or its licensor.

Gemini or its licensor may not prevail in any lawsuits that Gemini or its licensor initiates and the damages or

other remedies awarded, if any, may not be commercially meaningful.

The requirements for patentability differ

in certain countries, particularly developing countries.

For example, China has a heightened requirement for patentability and,

specifically, requires a detailed description of medical uses of a claimed drug.

In addition, India, certain countries in Europe

and certain developing countries, including Thailand, have compulsory licensing laws under which a patent owner may be compelled

to grant licenses to third parties.

In those countries, Gemini and its licensor may have limited remedies if patents are infringed

or if Gemini or its licensor are compelled to grant a license to a third party, which could materially diminish the value of those

This could limit its potential revenue opportunities.

In addition, many countries limit the enforceability of patents

against government agencies or government contractors.

In these countries, the patent owner may have limited remedies, which could

materially diminish the value of such patent.

Accordingly, Gemini and its licensor’s efforts to enforce intellectual property

rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that Gemini

owns or licenses.

Obtaining and maintaining its patent

protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental

patent agencies, and Gemini’s patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance and annuity fees on

issued United States patents and most foreign patent applications and patents must be paid to the U.S.

Patent and Trademark Office,

or USPTO, and foreign patent agencies, respectively, in order to maintain such patents and patent applications.

The USPTO and various

foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar

provisions during the patent application, examination and issuance processes.

While an inadvertent lapse can, in some cases, be

cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance

can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights

in the relevant jurisdiction.

Non-compliance events that could result in abandonment or lapse of a patent or patent application

include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize

and submit formal documents.

If Gemini or its licensor fails to maintain the patents and patent applications covering its product

candidates, its competitors might be able to enter the market with similar or identical products or technology, which would have

a material adverse effect on its business, financial condition and results of operations.

Gemini may become involved in lawsuits

or other proceedings to protect or enforce its intellectual property, which could be expensive, time-consuming and unsuccessful

and have a material adverse effect on the success of its business.

Third parties may infringe Gemini’s

or its licensor’s patents or misappropriate or otherwise violate its or its licensor’s intellectual property rights.

In the future, Gemini or its licensor may initiate legal proceedings to enforce or defend Gemini’s or its licensor’s

intellectual property rights, to protect its or its licensor’s trade secrets or to determine the validity or scope of intellectual

property rights Gemini owns or controls.

Also, third parties may initiate legal proceedings against Gemini or its licensor to challenge

the validity or scope of intellectual property rights Gemini owns, controls or to which Gemini has rights.

For example, generic

or biosimilar drug manufacturers or other competitors or third parties may challenge the scope, validity or enforceability of Gemini’s

or its licensor’s patents, requiring Gemini or its licensor to engage in complex, lengthy and costly litigation or other

These proceedings can be expensive and time-consuming and many of its or its licensor’s adversaries in these

proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than Gemini can.

Various extensions may be available, but the life of a patent, and the protection it affords, is limited.

Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive products.

Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting our product candidates might expire before or shortly after we or our partners commercialize those candidates.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to our products.

We may not be able to protect our intellectual property rights throughout the world.

The legal protection afforded to inventors and owners of intellectual property in countries outside of the United States may not be as protective or effective as that in the United States and we may, therefore, be unable to acquire and enforce intellectual property rights outside the United States to the same extent as in the United States.

Whether filed in the United States or abroad, our patent applications may be challenged or may fail to result in issued patents.

Currently, we do not own or have in-licensed issued patents covering GEM103.

Any future patents we obtain may not be sufficiently broad to prevent others from practicing our technologies or from developing or commercializing competing products.

Furthermore, others may independently develop or commercialize similar or alternative technologies or drugs, or design around our patents.

Our patents may be challenged, invalidated, circumvented or narrowed, or fail to provide us with any competitive advantages.

In many foreign countries, patent applications and/or issued patents, or parts thereof, must be translated into the native language.

If our patent applications or issued patents are translated incorrectly, they may not adequately cover our technologies;

in some countries, it may not be possible to rectify an incorrect translation, which may result in patent protection that does not adequately cover our technologies in those countries.

Filing, prosecuting, enforcing and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States are less extensive than those in the United States.

In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and certain state laws in the United States.

Consequently, we and our licensor may not be able to prevent third parties from practicing our and our licensor’s inventions in all countries outside the United States, or from selling or importing products made using our and our licensor’s inventions in and into the United States or other jurisdictions.

Competitors may use our and our licensor’s technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we and our licensor have patent protection, but enforcement is not as strong as that in the United States.

These products may compete with our product candidates our and our licensor’s patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.

The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of

patents and other intellectual property protection, particularly those relating to biotechnology.

This could make it difficult for us and our licensor to stop the infringement of our and our licensor’s patents or the marketing of competing products in violation of our and our licensor’s proprietary rights, generally.

Proceedings to enforce our and our licensor’s patent rights in foreign jurisdictions could result in substantial costs and divert our and our licensor’s efforts and attention from other aspects of our business, could put our and our licensor’s patents at risk of being invalidated or interpreted narrowly, could place our and our licensor’s patent applications at risk of not issuing and could provoke third parties to assert claims against our or our licensor.

Our or our licensor may not prevail in any lawsuits that our or our licensor initiates and the damages or other remedies awarded, if any, may not be commercially meaningful.

The requirements for patentability differ in certain countries, particularly developing countries.

For example, China has a heightened requirement for patentability and, specifically, requires a detailed description of medical uses of a claimed drug.

In addition, India, certain countries in Europe and certain developing countries, including Thailand, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.

In those countries, our and our licensor may have limited remedies if patents are infringed or if our or our licensor are compelled to grant a license to a third party, which could materially diminish the value of those patents.

This could limit our potential revenue opportunities.

In addition, many countries limit the enforceability of patents against government agencies or government contractors.

In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent.

Accordingly, our and our licensor’s efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we owns or licenses.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance and annuity fees on issued United States patents and most foreign patent applications and patents must be paid to the USPTO and foreign patent agencies, respectively, in order to maintain such patents and patent applications.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application, examination and issuance processes.

While an inadvertent lapse can, in some cases, be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

Non-compliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.

If we or our licensor fails to maintain the patents and patent applications covering our product candidates, our competitors might be able to enter the market with similar or identical products or technology, which would have a material adverse effect on our business, financial condition and results of operations.

We may become involved in lawsuits or other proceedings to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have a material adverse effect on the success of our business.

Third parties may infringe on our or our licensor’s patents or misappropriate or otherwise violate our or our licensor’s intellectual property rights.

In the future, we or our licensor may initiate legal proceedings to enforce or defend our or our licensor’s intellectual property rights, to protect our or our licensor’s trade secrets or to determine the validity or scope of intellectual property rights we own or controls.

Also, third parties may initiate legal proceedings against our or our licensor to challenge the validity or scope of intellectual property rights we own, controls or to which we have rights.

For example, generic or biosimilar drug manufacturers or other competitors or third parties may challenge the scope, validity or enforceability of our or our licensor’s patents, requiring us or our licensor to engage in complex, lengthy and costly litigation or other proceedings.

These proceedings can be expensive and time-consuming and many of our or our licensor’s adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we can.

Moreover, the outcome following legal assertions of invalidity and unenforceability is unpredictable.

Accordingly, despite Gemini’s

or its licensor’s efforts, Gemini or its licensor may not be able to prevent third parties from infringing upon or misappropriating

intellectual property rights Gemini owns, controls or has rights to, particularly in countries where the laws may not protect those

rights as fully as in the United States.

Litigation could result in substantial costs and diversion of management resources, which

could harm its business and financial results.

In addition, if Gemini or its licensor initiated legal proceedings against a third

party to enforce a patent covering a product candidate, the defendant could counterclaim that such patent is invalid or unenforceable.

Accordingly, despite our or our licensor’s efforts, we or our licensor may not be able to prevent third parties from infringing upon or misappropriating intellectual property rights we own, controls or has rights to, particularly in countries where the laws may not protect those rights as fully as in the United States.

Litigation could result in substantial costs and diversion of management resources, which could harm our business and financial results.

In addition, if we or our licensor initiated legal proceedings against a third party to enforce a patent covering a product candidate, the defendant could counterclaim that such patent is invalid or unenforceable.

In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace.

for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty,

obviousness or non-enablement.

Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution

of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution.

In an infringement

or declaratory judgment proceeding, a court may decide that a patent owned by or licensed to us is invalid or unenforceable, or

may refuse to stop the other party from using the technology at issue on the grounds that Gemini’s or its licensor’s

patents do not cover the technology in question.

An adverse result in any litigation proceeding could put one or more of Gemini’s

or its licensor’s patents at risk of being invalidated, narrowed, held unenforceable or interpreted in such a manner that

would not preclude third parties from entering the market with competing products.

Third-party pre-issuance submission of

prior art to the USPTO, or opposition, derivation, revocation reexamination, or inter partes review, or other pre-issuance

or post-grant proceedings or other patent office proceedings or litigation in the United States or other jurisdictions provoked

by third parties or brought by Gemini or its licensor, may be necessary to determine the inventorship, priority, patentability

or validity of inventions with respect to Gemini’s or its licensor’s patents or patent applications.

An unfavorable

outcome could leave its technology or product candidates without patent protection, allow third parties to commercialize its technology

or product candidates and compete directly with us, without payment to us, or could require Gemini or its licensor to obtain license

rights from the prevailing party in order to be able to manufacture or commercialize its product candidates without infringing

third-party patent rights.

Its business could be harmed if the prevailing party does not offer Gemini or its licensor a license

on commercially reasonable terms, or at all.

Even if Gemini or its licensor obtains a license, it may be non-exclusive, thereby

giving its competitors access to the same technologies licensed to Gemini or its licensor.

In addition, if the breadth or strength

of protection provided by Gemini’s or its licensor’s patents and patent applications is threatened, it could dissuade

companies from collaborating with us to license, develop or commercialize product candidates.

Even if Gemini successfully defends

such litigation or proceeding, Gemini may incur substantial costs and it may distract its management and other employees.

the uncertainties associated with litigation could have a material adverse effect on its ability to raise the funds necessary to

continue its clinical trials, continue its research programs, license necessary technology from third parties, or enter into collaborations.

Furthermore, because of the substantial

amount of discovery required in connection with intellectual property litigation, there is a risk that some of its confidential

information could be compromised by disclosure during this type of litigation.

In addition, many foreign jurisdictions have rules

of discovery that are different than those in the United States and which may make defending or enforcing its or its licensor’s

patents extremely difficult.

There could also be public announcements of the results of hearings, motions or other interim proceedings

or developments.

If securities analysts or investors perceive these results to be negative, it could have a material adverse effect

on the price of shares of our Common Stock.

Third parties may initiate legal

proceedings against Gemini alleging that Gemini infringes their intellectual property rights or Gemini may initiate legal proceedings

against third parties to challenge the validity or scope of intellectual property rights controlled by third parties, the outcome

of which would be uncertain and could have a material adverse effect on the success of its business.

Gemini’s commercial success depends

upon its ability to develop, manufacture, market and sell any product candidates that Gemini may develop and use its proprietary

technologies without infringing, misappropriating or otherwise violating the intellectual property and proprietary rights of third

The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other

intellectual property rights.

Third parties may initiate legal proceedings against Gemini or its licensor alleging that Gemini

or its licensor infringes their intellectual property rights or Gemini or its licensor may initiate legal proceedings against third

parties to challenge the validity or scope of intellectual property rights controlled by third parties, including in oppositions,

revocations, reexaminations, inter partes review or derivation proceedings before the USPTO or its counterparts in other

jurisdictions.

These proceedings can be expensive and time-consuming and many of its or its licensor’s adversaries in these

proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than Gemini or

its licensor can.

An unfavorable outcome in any such proceeding

could require Gemini or its licensor to cease using the related technology or developing or commercializing its product candidates,

or to attempt to license rights to it from the prevailing party, which may not be available on commercially reasonable terms, or

Gemini could be found liable for monetary

damages, including treble damages and attorneys’

fees, if Gemini is found to have willfully infringed a patent.

of infringement could prevent us from commercializing its product candidates or force us to cease some of its business operations,

which could materially harm its business.

Gemini performs searches of patent and

scientific databases in order to identify documents that may be of potential relevance to the freedom-to-operate and/or patentability

of its product candidates.

In general, such searches are conducted based on keywords, sequences, inventors/authors and assignees/entities

to capture U.S.

Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement.

Grounds for an unenforceability assertion could be an allegation that someone

connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution.

In an infringement or declaratory judgment proceeding, a court may decide that a patent owned by or licensed to us is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that we or our licensor’s patents do not cover the technology in question.

An adverse result in any litigation proceeding could put one or more of our or our licensor’s patents at risk of being invalidated, narrowed, held unenforceable or interpreted in such a manner that would not preclude third parties from entering the market with competing products.

Third-party pre-issuance submission of prior art to the USPTO, or opposition, derivation, revocation reexamination, or inter partes review, or other pre-issuance or post-grant proceedings or other patent office proceedings or litigation in the United States or other jurisdictions provoked by third parties or brought by us or our licensor, may be necessary to determine the inventorship, priority, patentability or validity of inventions with respect to our or our licensor’s patents or patent applications.

An unfavorable outcome could leave our technology or product candidates without patent protection, allow third parties to commercialize our technology or product candidates and compete directly with us, without payment to us, or could require us or our licensor to obtain license rights from the prevailing party in order to be able to manufacture or commercialize our product candidates without infringing third-party patent rights.

Our business could be harmed if the prevailing party does not offer us or our licensor a license on commercially reasonable terms, or at all.

Even if we or our licensor obtains a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us or our licensor.

In addition, if the breadth or strength of protection provided by our or our licensor’s patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize product candidates.

Even if we successfully defends such litigation or proceeding, we may incur substantial costs and it may distract our management and other employees.

In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue our clinical trials, continue our research programs, license necessary technology from third parties, or enter into collaborations.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

In addition, many foreign jurisdictions have rules of discovery that are different than those in the United States and which may make defending or enforcing our or our licensor’s patents extremely difficult.

There could also be public announcements of the results of hearings, motions or other interim proceedings or developments.

If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our Common Stock.

Third parties may initiate legal proceedings against us alleging that we are infringing on their intellectual property rights or we may initiate legal proceedings against third parties to challenge the validity or scope of intellectual property rights controlled by third parties, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

Our commercial success depends upon our ability to develop, manufacture, market and sell any product candidates that we may develop and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and proprietary rights of third parties.

The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights.

Third parties may initiate legal proceedings against us or our licensor alleging that we or our licensor is infringing on their intellectual property rights or we or our licensor may initiate legal proceedings against third parties to challenge the validity or scope of intellectual property rights controlled by third parties, including in oppositions, revocations, reexaminations, inter partes review or derivation proceedings before the USPTO or its counterparts in other jurisdictions.

An unfavorable outcome in any such proceeding could require us or our licensor to cease using the related technology or developing or commercializing our product candidates, or to attempt to license rights to it from the prevailing party, which may not be available on commercially reasonable terms, or at all.

We could be found liable for monetary damages, including treble damages and attorneys’

fees, if we are found to have willfully infringed a patent.

A finding of infringement could prevent us from commercializing our product candidates or force us to cease some of our business operations, which could materially harm our business.

We perform searches of patent and scientific databases in order to identify documents that may be of potential relevance to the freedom-to-operate and/or patentability of our product candidates.

In general, such searches are conducted based on keywords,

sequences, inventors/authors and assignees/entities to capture U.S.

and European patents and patent applications, PCT publications and scientific journal articles.

The patent landscape around its GEM103

product candidate is complex, and Gemini may not be aware of all third-party intellectual property rights potentially relating

to its product candidates and technologies.

Although no third party has asserted a claim of patent infringement against us as of

the date of this annual report, a third party may hold proprietary rights that could prevent Gemini’s product candidates

from being marketed.

For example, Gemini is aware of an issued European patent expiring in 2026 that claims an isolated CFH polypeptide

which could be alleged to cover GEM103.

While Gemini believes that the expiration date of this patent will be prior to European

launch of GEM103, there is a possibility that commercial manufacturing or product launch in Europe would predate the patent expiration.

If commercial manufacturing or product launch in Europe predates the patent expiration, and in the event that this patent is successfully

asserted against us, such litigation may negatively impact our ability to commercialize GEM103 in France, Germany, Ireland, Liechtenstein,

the Netherlands, Switzerland or the United Kingdom.

Moreover, it is possible that Gemini is or may become aware of patents or pending

patent applications that Gemini thinks do not relate to its product candidates or that Gemini believes are invalid or unenforceable,

but that may nevertheless be interpreted to encompass its product candidates and to be valid and enforceable.

As to pending third-party

applications, Gemini cannot predict with any certainty which claims will issue, if any, or the scope of such issued claims.

any third party intellectual property claims are asserted against us, even if Gemini believes the claims are without merit, there

is no assurance that a court would find in its favor, e.g., on questions of infringement, validity, enforceability or priority.

A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could materially

and adversely affect Gemini’s ability and the ability of its licensor to commercialize any product candidates Gemini may

develop and any other product candidates or technologies covered by the asserted third-party patents.

In order to successfully

challenge the validity of any such U.S.

patent in federal court, Gemini would need to overcome a presumption of validity.

burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S.

patent claim,

there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S.

If any such third-party

patents (including those that may issue from such applications) were successfully asserted against Gemini or its licensor or other

commercialization partners and Gemini were unable to successfully challenge the validity or enforceability of any such asserted

patents, then Gemini or its licensor and other commercialization partners may be prevented from commercializing its product candidates,

or may be required to pay significant damages, including treble damages and attorneys’

fees if Gemini is found to willfully

infringe the asserted patents, or obtain a license to such patents, which may not be available on commercially reasonable terms,

Even if Gemini were able to obtain a license, it could be non-exclusive, thereby giving its competitors and other third

parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments.

Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion

of employee resources from its business.

Furthermore, because of the substantial amount of discovery required in connection with

intellectual property litigation or administrative proceedings, there is a risk that some of its confidential information could

be compromised by disclosure.

In addition, any uncertainties resulting from the initiation and continuation of any litigation could

have a material adverse effect on its ability to raise additional funds or otherwise have a material adverse effect on its business,

results of operations, financial condition and prospects.

Any of the foregoing would have a material adverse effect on Gemini’s

business, financial condition and operating results.

Gemini may be subject to claims by

third parties asserting that its employees or Gemini has misappropriated a third party’s intellectual property, or claiming

ownership of what Gemini regards as its own intellectual property.

Many of Gemini’s employees, including

its senior management, were previously employed at other biotechnology or pharmaceutical companies, including its competitors or

potential competitors.

Some of these employees executed proprietary rights, non-disclosure and non-competition agreements in connection

with such previous employment.

Gemini may be subject to claims that Gemini or these employees have used or disclosed confidential

information or intellectual property, including trade secrets or other proprietary information, of any such employee’s former

employer, or that third parties have an interest in its patents as an inventor or co-inventor.

Litigation may be necessary to defend

against these claims.

If Gemini fails in prosecuting or defending any such claims, in addition to paying monetary damages, Gemini

may lose valuable intellectual property rights or personnel or sustain other damages.

Such intellectual property rights could be

awarded to a third party, and Gemini could be required to obtain a license from such third party to commercialize its technology

The patent landscape around our GEM103 product candidate is complex, and we may not be aware of all third-party intellectual property rights potentially relating to our product candidates and technologies.

Although no third party has asserted a claim of patent infringement against us as of the date of this annual report, a third party may hold proprietary rights that could prevent our product candidates from being marketed.

For example, we are aware of an issued European patent expiring in 2026 that claims an isolated CFH polypeptide which could be alleged to cover GEM103.

Moreover, it is possible that we may become aware of patents or pending patent applications that we think do not relate to our product candidates or that we believe are invalid or unenforceable, but that may nevertheless be interpreted to encompass our product candidates and to be valid and enforceable.

As to pending third-party applications, we cannot predict with any certainty which claims will issue, if any, or the scope of such issued claims.

If any third party intellectual property claims are asserted against us, even if we believe the claims are without merit, there is no assurance that a court would find in our favor, e.g., on questions of infringement, validity, enforceability or priority.

A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could materially and adversely affect our ability and the ability of our licensor to commercialize any product candidates we may develop and any other product candidates or technologies covered by the asserted third-party patents.

In order to successfully challenge the validity of any such U.S.

patent in federal court, we would need to overcome a presumption of validity.

As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S.

patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S.

If any such third-party patents (including those that may issue from such applications) were successfully asserted against us or our licensor or other commercialization partners and we were unable to successfully challenge the validity or enforceability of any such asserted patents, then we or our licensor and other commercialization partners may be prevented from commercializing our product candidates, or may be required to pay significant damages, including treble damages and attorneys’

fees if we are found to willfully infringe the asserted patents, or obtain a license to such patents, which may not be available on commercially reasonable terms, or at all.

Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments.

Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk that some of our confidential information could be compromised by disclosure.

In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of operations, financial condition and prospects.

Any of the foregoing would have a material adverse effect on our business, financial condition and operating results.

We may be subject to claims by third parties asserting that our employees or we have misappropriated a third party’s intellectual property, or claiming ownership of what we regards as our own intellectual property.

Many of our employees, including our senior management, were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors.

Some of these employees executed proprietary rights, non-disclosure and non-competition agreements in connection with such previous employment.

We may be subject to claims that we or these employees have used or disclosed confidential information or intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer, or that third parties have an interest in our patents as an inventor or co-inventor.

Litigation may be necessary to defend against these claims.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel or sustain other damages.

Such intellectual property rights could be awarded to a third party, and we could be required to obtain a license from such third party to commercialize our technology or products.

Such a license may not be available on commercially reasonable terms, or at all.

Even if Gemini successfully prosecutes

or defends against such claims, litigation could result in substantial costs and distract management.

In addition, while it is Gemini’s

policy to require its employees and contractors who may be involved in the conception or development of intellectual property to

execute agreements assigning such intellectual property to us, Gemini may be unsuccessful in executing such an agreement with each

party who, in fact, conceives or develops intellectual property that Gemini regards as its own.

The assignment of intellectual

property rights may not be self-executing, or the assignment agreements may be breached, and Gemini may be forced to bring claims

against third parties, or defend claims that they may bring against us, to determine the ownership of what Gemini regards as its

intellectual property.

Such claims could have a material adverse effect on its business, financial condition, results of operations

and prospects.

Gemini’s inability to protect

its confidential information and trade secrets would harm its business and competitive position.

In addition to seeking patents for some

of its technology and products, in its activities Gemini also relies substantially on trade secrets, including unpatented know-how,

technology and other proprietary materials and information, to maintain its competitive position.

Gemini seeks to protect these

trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such

as its employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and

other third parties.

Gemini also enters into confidentiality and invention or patent assignment agreements with its employees and

However, these steps may be inadequate, Gemini may fail to enter into agreements with all such parties or any of these

parties may breach the agreements and disclose its proprietary information, and there may be no adequate remedy available for such

breach of an agreement.

Gemini cannot assure you that its proprietary information will not be disclosed or that Gemini can meaningfully

protect its trade secrets.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive

and time-consuming, and the outcome is unpredictable.

In addition, some courts both within and outside the United States may be

less willing, or unwilling, to protect trade secrets.

If a competitor lawfully obtained or independently developed any of its trade

secrets, Gemini would have no right to prevent such competitor from using that technology or information to compete with us, which

could harm its competitive position.

Intellectual property rights do not

necessarily address all potential threats.

The degree of future protection afforded

by its intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect

Gemini’s business or permit Gemini to maintain our competitive advantage.

others may be able to make products that are similar to any product candidates Gemini may develop or utilize similar technology but that are not covered by the claims of the patents that Gemini licenses or may own in the future;

Gemini, or its current or future collaborators, might not have been the first to make the inventions covered by the issued patents and pending patent applications that Gemini licenses or may own in the future;

Gemini, or its current or future collaborators, might not have been the first to file patent applications covering certain of its or their inventions;

others may independently develop similar or alternative technologies or duplicate any of its technologies without infringing its owned or licensed intellectual property rights;

it is possible that Gemini’s pending patent applications or those that it may own in the future will not lead to issued patents;

issued patents that Gemini holds rights to may be held invalid or unenforceable, including as a result of legal challenges by its competitors;

its competitors might conduct research and development activities in countries where Gemini does not have patent rights and then use the information learned from such activities to develop competitive products for sale in its major commercial markets;

Gemini may not develop additional proprietary technologies that are patentable;

the patents of others may harm its business;

Gemini may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, they

could have a material adverse effect on its business, financial condition, results of operations and prospects.

Patents that ultimately issue that

cover its product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

If Gemini or its licensing partner initiate

legal proceedings against a third party to enforce a patent, if obtained, covering its product candidates, the defendant could

counterclaim that the patent covering its product candidates, as applicable, is invalid and/or unenforceable.

In patent litigation

in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous

grounds upon which a third party can assert invalidity or unenforceability of a patent.

Third parties may also raise similar claims

before administrative bodies in the United States or abroad, even outside the context of litigation.

These types of mechanisms

include inter partes review, post grant review, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).

These types of proceedings could result in revocation or amendment to its patents such that they no longer cover its product candidates.

Even if we successfully prosecutes or defends against such claims, litigation could result in substantial costs and distract management.

In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own.

The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached,

and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property.

Such claims could have a material adverse effect on our business, financial condition, results of operations and prospects.

Our inability to protect our confidential information and trade secrets would harm our business and competitive position.

In addition to seeking patents for some of our technology and products, in our activities we also rely substantially on trade secrets, including unpatented know-how, technology and other proprietary materials and information, to maintain our competitive position.

We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, CMOs, consultants, advisors and other third parties.

We also enters into confidentiality and invention or patent assignment agreements with our employees and consultants.

However, these steps may be inadequate, we may fail to enter into agreements with all such parties or any of these parties may breach the agreements and disclose our proprietary information, and there may be no adequate remedy available for such breach of an agreement.

We cannot assure you that our proprietary information will not be disclosed or that we can meaningfully protect our trade secrets.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable.

In addition, some courts both within and outside the United States may be less willing, or unwilling, to protect trade secrets.

If a competitor lawfully obtained or independently developed any of our trade secrets, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage.

others may be able to make products that are similar to any product candidates we may develop or utilize similar technology but that are not covered by the claims of the patents that we license or may own in the future;

we, or our current or future collaborators, might not have been the first to make the inventions covered by the issued patents and pending patent applications that we license or may own in the future;

we, or our current or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions;

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;

it is possible that our pending patent applications or those that we may own in the future will not lead to issued patents;

issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

we may not develop additional proprietary technologies that are patentable;

the patents of others may harm our business;

we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.

Patents that ultimately issue that cover our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

If we or our licensing partner initiate legal proceedings against a third party to enforce a patent, if obtained, covering our product candidates, the defendant could counterclaim that the patent covering our product candidates, as applicable, is invalid and/or unenforceable.

In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent.

Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.

These types of mechanisms include inter partes review, post grant review, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).

These types of proceedings could result in revocation or amendment to our patents such that they no longer cover our product candidates.

The outcome for any particular patent following legal assertions of invalidity and unenforceability is unpredictable.

to the validity question, for example, Gemini cannot be certain that there is no invalidating prior art, of which Gemini, its patent

counsel and the patent examiner were unaware during prosecution.

If a defendant were to prevail on a legal assertion of invalidity

and/or unenforceability, or if Gemini is otherwise unable to adequately protect its rights, Gemini would lose at least part, and

perhaps all, of the patent protection on its product candidates.

A loss of patent protection for its product candidates could have

a material adverse impact on its ability to commercialize or license its technology and product candidates and, resultantly, on

its business, financial condition, prospects and results of operations.

Changes in patent law could diminish

the value of patents in general, thereby impairing its ability to protect its product candidates.

As is the case with other biotechnology

and pharmaceutical companies, Gemini’s success is heavily dependent on intellectual property, particularly patents.

and enforcing patents in the biotechnology industry involves technological and legal complexity, and obtaining and enforcing biotechnology

patents is costly, time-consuming and inherently uncertain.

Supreme Court has ruled on several patent cases in recent

years, either narrowing the scope of patent protection available in certain circumstances, weakening the rights of patent owners

in certain situations or ruling that certain subject matter is not eligible for patent protection.

In addition to increasing uncertainty

with regard to its and its licensor’s ability to obtain patents in the future, this combination of events has created uncertainty

with respect to the value of patents, once obtained.

Depending on decisions by Congress, the federal courts, the USPTO and equivalent

bodies in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken

its and its licensor’s ability to obtain new patents or to enforce existing patents and patents Gemini and its licensor may

obtain in the future.

Patent reform laws, such as the Leahy-Smith

America Invents Act, or the Leahy-Smith Act, as well as changes in how patent laws are interpreted, could increase the uncertainties

and costs surrounding the prosecution of its and its licensor’s patent applications and the enforcement or defense of its

or its licensor’s issued patents.

With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel and the patent examiner were unaware during prosecution.

If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, or if we are otherwise unable to adequately protect our rights, we would lose at least part, and perhaps all, of the patent protection on our product candidates.

A loss of patent protection for our product candidates could have a material adverse impact on our ability to commercialize or license our technology and product candidates and, resultantly, on our business, financial condition, prospects and results of operations.

Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

As is the case with other biotechnology and pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.

Obtaining and enforcing patents in the biotechnology industry involves technological and legal complexity, and obtaining and enforcing biotechnology patents is costly, time-consuming and inherently uncertain.

Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances, weakening the rights of patent owners in certain situations or ruling that certain subject matter is not eligible for patent protection.

In addition to increasing uncertainty with regard to our and our licensor’s ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.

Depending on decisions by Congress, the federal courts, the USPTO and equivalent bodies in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken our and our licensor’s ability to obtain new patents or to enforce existing patents and patents we and our licensor may obtain in the future.

Patent reform laws, such as the Leahy-Smith America Invents Act (“Leahy-Smith Act”), as well as changes in how patent laws are interpreted, could increase the uncertainties and costs surrounding the prosecution of our and our licensor’s patent applications and the enforcement or defense of our or our licensor’s issued patents.

The Leahy-Smith Act includes a number of significant changes to U.S.

include provisions that affect the filing and prosecution strategies associated with patent applications, including a change from

a “first-to-invent”

to a “first-inventor-to-file”

patent system, and may also affect patent prosecution

and litigation, such as by allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures

to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes

review and derivation proceedings.

The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith

Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act and, in particular, the “first-inventor-to-file”

These include provisions that affect the filing and prosecution strategies associated with patent applications, including a change from a “first-to-invent”

to a “first-inventor-to-file”

patent system, and may also affect patent prosecution and litigation, such as by allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings.

The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act and, in particular, the “first-inventor-to-file”

provisions, became effective in 2013.

Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will has on the operation

of its business.

However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the

prosecution of its or its licensor’s patent applications and the enforcement or defense of its or its licensor’s issued

patents, all of which could has a material adverse effect on its business, financial condition and results of operations.

Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will has on the operation of our business.

However, the Leahy-Smith Act and our implementation could increase the uncertainties and costs surrounding the prosecution of our or our licensor’s patent applications and the enforcement or defense of our or our licensor’s issued patents, all of which could has a material adverse effect on our business, financial condition and results of operations.

Risks Related to Reliance on Third Parties

Gemini will rely on third parties

to conduct its clinical trials.

If these third parties do not successfully carry out their contractual duties or meet expected

deadlines or comply with regulatory requirements, Gemini may not be able to obtain regulatory approval of or commercialize any

potential product candidates.

Gemini will depend upon third parties,

including independent investigators, to conduct its clinical trials under agreements with universities, medical institutions, CROs,

strategic partners and others.

Gemini expects to have to negotiate budgets and contracts with CROs and trial sites, which may result

in delays to its development timelines and increased costs.

Gemini will rely heavily on third parties

over the course of its clinical trials, and, as a result, will have limited control over the clinical investigators and limited

visibility into their day-to-day activities, including with respect to their compliance with the approved clinical protocol.

Nevertheless,

its reliance on third parties does not relieve Gemini of its regulatory responsibilities and it will be responsible for ensuring

that each of its trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific

Gemini and these third parties are required to comply with good clinical practice, or GCP, requirements, which are regulations

and guidelines enforced by the FDA and applicable foreign regulatory authorities for product candidates in clinical development.

Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, clinical investigators and

If Gemini or any of these third parties fail to comply with applicable GCP requirements, the clinical data generated

in its clinical trials may be deemed unreliable and the FDA or applicable foreign regulatory authorities may require us to suspend

or terminate these trials or perform additional nonclinical studies or clinical trials before approving its marketing applications.

Gemini cannot be certain that, upon inspection, regulatory authorities will determine that any of its clinical trials comply with

the GCP requirements.

In addition, its clinical trials must be conducted with products produced under cGMP requirements and may

require a large number of patients.

Its failure or any failure by these third parties to comply with these applicable regulations

or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory approval

Moreover, its business may be implicated if any of these third parties violates federal or state fraud and abuse or false

claims laws and regulations or healthcare privacy and security laws.

The third parties who may conduct its future

clinical trials will not be its employees and, except for remedies that may be available to us under its agreements with those

third parties, Gemini cannot control whether or not they devote sufficient time and resources to its ongoing nonclinical and clinical

These third parties may also have relationships with other commercial entities, including Gemini’s competitors,

for whom they may also be conducting clinical trials or other product development activities, which could affect their performance

on its behalf.

If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines,

if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to

adhere to its clinical protocols or regulatory requirements or for other reasons, its clinical trials may be extended, delayed

or terminated and Gemini may not be able to complete development of, obtain regulatory approval of or successfully commercialize

its product candidates in a timely manner or at all.

As a result, its financial results and the commercial prospects for its product

candidates would be harmed, its costs could increase and its ability to generate revenue could be delayed.

If any of its relationships with these

third-party CROs or others terminate, Gemini may not be able to enter into arrangements with alternative CROs or other third parties

or to do so on commercially reasonable terms.

Switching or adding additional CROs involves additional cost and requires management

time and focus.

We may rely on third parties to conduct our clinical trials.

We continue to depend upon third parties, including independent investigators, to conduct our clinical trials under agreements with universities, medical institutions, CROs, strategic partners and others.

We continue to negotiate budgets and contracts with CROs and trial sites, which may result in delays to our development timelines and increased costs.

We continue to rely heavily on third parties over the course of our clinical trials, and, as a result, will have limited control over the clinical investigators and limited visibility into their day-to-day activities, including with respect to their compliance with the approved clinical protocol.

Nevertheless, our reliance on third parties does not relieve us of our regulatory responsibilities and we are responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards.

We and these third parties are required to comply with good clinical practice (“GCP”) requirements, which are regulations and guidelines enforced by the FDA and applicable foreign regulatory authorities for product candidates in clinical development.

Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, clinical investigators and trial sites.

If we or any of these third parties fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or applicable foreign regulatory authorities may require us to suspend or terminate these trials or perform additional nonclinical studies or clinical trials before approving our marketing applications.

We cannot be certain that, upon inspection, regulatory authorities will determine that any of our clinical trials comply with the GCP requirements.

In addition, our clinical trials must be conducted with products produced under cGMP requirements and may require a large number of patients.

Our failure or any failure by these third parties to comply with these applicable regulations or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory approval process.

Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

The third parties who may conduct our future clinical trials will not be our employees and, except for remedies that may be available to us under our agreements with those third parties, we cannot control whether or not they devote sufficient time and resources to our ongoing nonclinical and clinical programs.

These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, which could affect their performance on our behalf.

If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates in a timely manner or at all.

As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

If any of our relationships with these third-party CROs or others terminate, we may not be able to enter into arrangements with alternative CROs or other third parties or to do so on commercially reasonable terms.

Switching or adding additional CROs involves additional cost and requires management time and focus.

In addition, there is a natural transition period when a new CRO begins work.

As a result, delays may occur, which

can materially impact its ability to meet its desired clinical development timelines.

Though Gemini carefully manages its relationships

with its CROs, there can be no assurance that Gemini will not encounter similar challenges or delays in the future or that these

delays or challenges will not have a material adverse impact on its business, financial condition and prospects.

If CROs do not successfully carry out their

contractual duties or obligations or meet expected deadlines or if the quality or accuracy of the clinical data they obtain is

compromised due to the failure (including by clinical sites or investigators) to adhere to its clinical protocols, regulatory requirements

or for other reasons, its clinical trials may be extended, delayed or terminated and Gemini may not be able to obtain regulatory

approval for or successfully commercialize its product candidates.

As a result, its results of operations and the commercial prospects

for its product candidates would be harmed, its costs could increase substantially and its ability to generate revenues could be

delayed significantly.

Gemini contracts with third parties

for the manufacture of its product candidates for nonclinical testing and expects to continue to do so for clinical trials and

for commercialization.

This reliance on third parties increases the risk that Gemini will not have sufficient quantities of its

product candidates or products, if approved, or that such supply will not be available to us at an acceptable cost, which could

delay, prevent or impair its development or commercialization efforts.

Gemini does not have any manufacturing

Gemini currently relies, and expects to continue to rely, on third-party manufacturers for the manufacture of its product

candidates for nonclinical and clinical testing and for commercial supply of any of these product candidates for which Gemini obtains

marketing approval.

Reliance on third-party manufacturers may expose us to different risks than if Gemini were to manufacture product

candidates itself.

Any disruption in supply from any supplier or manufacturing location, including on account of the COVID-19 pandemic,

could lead to supply delays or interruptions which would damage its business, financial condition, results of operations and prospects.

To the extent any issues arise with its third-party manufacturers, Gemini may be unable to establish any agreements with any other

third-party manufacturers or to do so on acceptable terms.

Even if Gemini is able to establish agreements with third-party manufacturers,

reliance on third-party manufacturers entails additional risks, including:

As a result, delays may occur, which can materially impact our ability to meet our desired clinical development timelines.

Though we carefully manages our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines or if the quality or accuracy of the clinical data they obtain is compromised due to the failure (including by clinical sites or investigators) to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.

As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase substantially and our ability to generate revenues could be delayed significantly.

We contract with third parties for the manufacture of our product candidates for nonclinical testing and expects to continue to do so for clinical trials and for commercialization, if approved.

This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products, if approved, or that such supply will not be available to us at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

We do not have any manufacturing facilities.

We currently rely, and expects to continue to rely, on third-party manufacturers for the manufacture of our product candidates for nonclinical and clinical testing and for commercial supply of any of these product candidates for which we obtain marketing approval.

Reliance on third-party manufacturers may expose us to different risks than if we were to manufacture product candidates ourselves.

Any disruption in supply from any supplier or manufacturing location, including on account of the ongoing COVID-19 pandemic, could lead to supply delays or interruptions which would damage our business, financial condition, results of operations and prospects.

To the extent any issues arise with our third-party manufacturers, we may be unable to establish any agreements with any other third-party manufacturers or to do so on acceptable

Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

the possible breach of the manufacturing agreement by the third party;

1 unchanged sentence

reliance on the third party for regulatory compliance, quality assurance and safety and pharmacovigilance reporting.

Third-party manufacturers may not be able

to comply with cGMP regulations or applicable foreign regulatory requirements.

Its failure, or the failure of third-party manufacturers,

to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties,

delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or medicines, operating

restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of its product candidates

and harm its business and results of operations.

Any product candidates that Gemini may

develop may compete with other product candidates and products for access to manufacturing facilities.

There are a limited number

of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.

Any performance failure on the part of

its existing or future manufacturers could delay clinical development or marketing approval.

Gemini does not currently have arrangements

in place for redundant supply for bulk drug substances.

If any one of its current contract manufacturers cannot perform as agreed,

Gemini may be required to replace that manufacturer.

Although Gemini believes that there are several potential alternative manufacturers

who could manufacture its product candidates, Gemini may incur added costs and delays in identifying and qualifying any such replacement.

Its current and anticipated future dependence

upon others for the manufacture of its product candidates may adversely affect its future profit margins and its ability to commercialize

any product candidates that receive marketing approval on a timely and competitive basis.

The manufacture of Gemini’s

product candidates is complex and Gemini may encounter difficulties in production.

If Gemini or any of its third-party manufacturers

encounter such difficulties, or fails to meet rigorously enforced regulatory standards, its ability to provide supply of its product

candidates for clinical trials or its products for patients, if approved, could be delayed or stopped, or Gemini may be unable

to maintain a commercially viable cost structure.

The processes involved in manufacturing

its product candidates are complex, expensive, highly-regulated, and subject to multiple risks.

Further, as product candidates

are developed through nonclinical studies to late-stage clinical trials towards approval and commercialization, it is common that

various aspects of the development program, such as manufacturing methods, are altered along the way in an effort to optimize processes

Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause

its product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials.

In addition, the manufacturing process

for any products that Gemini may develop is subject to FDA and other applicable foreign regulatory authority approval processes

and continuous oversight, and Gemini will need to contract with manufacturers who can meet all applicable FDA and applicable foreign

regulatory authority requirements, including, for example, complying with cGMPs, on an ongoing basis.

If Gemini or its third-party

manufacturers are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities,

Gemini may not obtain or maintain the approvals Gemini needs to commercialize such products.

Even if Gemini obtains regulatory

approval for any of its product candidates, there is no assurance that either Gemini or its contract manufacturers will be able

to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient

quantities to meet the requirements for the potential launch of the product, or to meet potential future demand.

Any of these challenges

could delay completion of clinical trials, require bridging or comparability nonclinical or clinical trials or the repetition of

one or more clinical trials, increase clinical study costs, delay approval of its product candidates, impair commercialization

efforts, increase its cost of goods, and has an adverse effect on its business, financial condition, results of operations, and

growth prospects.

Gemini may seek to establish collaborations,

and, if Gemini is not able to establish them on commercially reasonable terms, Gemini may have to alter its development and commercialization

Gemini may pursue collaborations in order

to develop and commercialize GEM103 and other product candidates.

Gemini face significant competition in seeking appropriate collaborators.

Whether Gemini reaches a definitive agreement for a collaboration will depend, among other things, upon its assessment of the collaborator’s

resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation

of a number of factors.

Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA

or applicable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities

of manufacturing and delivering such product candidate to patients, the potential of competing products and the existence of uncertainty

with respect to its ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits

of the challenge and industry and market conditions generally.

The collaborators may also consider alternative product candidates

or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more

attractive than the one with us for its product candidates.

Collaborations are complex and time-consuming

to negotiate and document.

In addition, there have been a significant number of business combinations among large pharmaceutical

companies that have resulted in a reduced number of potential future collaborators.

Gemini may not be able to negotiate collaborations

on a timely basis, on acceptable terms, or at all.

If Gemini is unable to do so, Gemini may have to curtail the development of

the product candidate for which Gemini is seeking to collaborate, reduce or delay its development program or one or more of its

other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities or increase

its expenditures and undertake development or commercialization activities at its own expense.

If Gemini elects to increase its

expenditures to fund development or commercialization activities on its own, Gemini may need to obtain additional capital, which

may not be available to us on acceptable terms, or at all.

If Gemini does not have sufficient funds, Gemini may not be able to

further develop its product candidates or bring them to market and generate product revenue.

Third-party manufacturers may not be able to comply with cGMP regulations or applicable foreign regulatory requirements.

Our failure, or the failure of third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or medicines, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates and harm our business and results of operations.

Any product candidates that we may develop may compete with other product candidates and products for access to manufacturing facilities.

There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.

Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval.

We do not currently have arrangements in place for redundant supply for bulk drug substances.

If any one of our current CMOs cannot perform as agreed, we may be required to replace that manufacturer.

Although we believe that there are several potential alternative manufacturers who could manufacture our product candidates, we may incur added costs and delays in identifying and qualifying any such replacement.

Our current and anticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

The manufacturing of our product candidates is complex, and we may encounter difficulties in production.

If we or any of our third-party manufacturers encounter such difficulties, or fails to meet rigorously enforced regulatory standards, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.

The processes involved in manufacturing our product candidates are complex, expensive, highly-regulated, and subject to multiple risks.

Further, as product candidates are developed through nonclinical studies to late-stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way in an effort to optimize processes and results.

Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials.

In addition, the manufacturing process for any products that we may develop is subject to FDA and other applicable foreign regulatory authority approval processes and continuous oversight, and we will need to contract with manufacturers who can meet all applicable FDA and applicable foreign regulatory authority requirements, including, for example, complying with cGMPs, on an ongoing basis.

If we or our third-party manufacturers are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities, we may not obtain or maintain the approvals we need to commercialize such products.

Even if we obtain regulatory approval for any of our product candidates, there is no assurance that either we or our CMOs will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand.

Any of these challenges could delay completion of clinical trials, require bridging or comparability nonclinical or clinical trials or the repetition of one or more clinical trials, increase clinical study costs, delay approval of our product candidates, impair commercialization efforts, increase our cost of goods, and has an adverse effect on our business, financial condition, results of operations, and growth prospects.

We may seek to establish collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

We may pursue collaborations in order to develop and commercialize GEM103 and other product candidates.

We face significant competition in seeking appropriate collaborators.

Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.

Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA or applicable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products and the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally.

The collaborators may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our product candidates.

Collaborations are complex and time-consuming to negotiate and document.

In addition, there have been a significant number of business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all.

If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay our development program or one or more of our other development programs, delay our potential commercialization or reduce the scope of any sales or marketing activities or increase our expenditures and undertake development or commercialization activities at our own expense.

If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms, or at all.

If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.

Risks Related to Commercialization

Even if Gemini commercializes its

product candidates, these products may become subject to unfavorable pricing regulations, third-party reimbursement practices or

healthcare reform initiatives, which could harm its business.

The regulations that govern marketing approvals,

pricing and reimbursement for new drugs and biologics vary widely from country to country.

Current and future legislation may significantly

change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.

Some countries

require approval of the sale price of a product before it can be marketed.

In many countries, the pricing review period begins

after marketing or product licensing approval is granted.

In some foreign markets, prescription pharmaceutical pricing remains

subject to continuing governmental control even after initial approval is granted.

As a result, Gemini might obtain marketing approval

for a product in a particular country, but then be subject to price regulations that delay or limit its commercial launch of the

product, possibly for lengthy time periods, which could negatively impact the revenue Gemini generates from the sale of the product

in that particular country.

Adverse pricing limitations may hinder its ability to recoup its investment in one or more product

candidates, even if its product candidates obtain marketing approval.

Its ability to commercialize any products

successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related

treatments will be available from third-party payors such as government health administration authorities, private health insurers

and other organizations.

Even if we commercialize our product candidates, these products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which could harm our business.

The regulations that govern marketing approvals, pricing and reimbursement for new drugs and biologics vary widely from country to country.

Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.

Some countries require approval of the sale price of a product before it can be marketed.

In many countries, the pricing review period begins after marketing or product licensing approval is granted.

In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted.

As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay or limit our commercial launch of the product, possibly for lengthy time periods, which could negatively impact the revenue we generate from the sale of the product in that particular country.

Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates obtain marketing approval.

Our ability to commercialize any products successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from third-party payors such as government health administration authorities, private health insurers and other organizations.

Third-party payors determine which medications they will cover and establish reimbursement levels.

payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.

Increasingly,

third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging

the prices charged for medical products.

Gemini cannot be sure that coverage and reimbursement will be available for any product

that Gemini commercializes and, if reimbursement is available, what the level of reimbursement will be.

Coverage and reimbursement

may impact the demand for, or the price of, any product candidate for which Gemini obtains marketing approval, if any.

and reimbursement are not available or reimbursement is available only to limited levels, Gemini may not be able to successfully

commercialize any product candidate for which marketing approval is obtained, if any.

There may be significant delays in obtaining

coverage and reimbursement for newly approved drugs and biologics, and coverage may be more limited than the purposes for which

the product is approved by the FDA or applicable foreign regulatory authorities.

Moreover, eligibility for coverage and reimbursement

does not imply that a drug will be paid for in all cases or at a rate that covers its costs, including research, development, manufacture,

sale and distribution.

Interim reimbursement levels for new drugs and biologics, if applicable, may also not be sufficient to cover

its costs and may only be temporary.

Reimbursement rates may vary according to the use of the product and the clinical setting

in which it is used, may be based on reimbursement levels already set for lower cost products and may be incorporated into existing

payments for other services.

Net prices for products may be reduced by mandatory discounts or rebates required by government healthcare

programs or private payors and by any future relaxation of laws that presently restrict imports of drugs and biologics from countries

where they may be sold at lower prices than in the United States.

Its inability to promptly obtain coverage and profitable reimbursement

rates third-party payors for any approved products that Gemini develops could have a material adverse effect on its operating results,

its ability to raise capital needed to commercialize products and its overall financial condition.

If, in the future, Gemini is unable

to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates

Gemini may develop, Gemini may not be successful in commercializing those product candidates if and when they are approved.

Gemini does not currently have an infrastructure

for the sales, marketing, and distribution of pharmaceutical products.

In order to market its product candidates, if approved by

the FDA or any other regulatory body, Gemini must build its sales, marketing, managerial, and other non-technical capabilities,

or make arrangements with third parties to perform these services.

There are risks involved with both establishing its own commercial

capabilities and entering into arrangements with third parties to perform these services.

For example, recruiting and training

a sales force or reimbursement specialists is expensive and time-consuming and could delay any product launch.

If the commercial

launch of a product candidate for which Gemini recruits a sales force and establishes marketing and other commercialization capabilities

is delayed or does not occur for any reason, Gemini would have prematurely or unnecessarily incurred these commercialization expenses.

This may be costly, and its investment would be lost if Gemini cannot retain or reposition its commercialization personnel.

If Gemini enter into arrangements with

third parties to perform sales, marketing, commercial support, and distribution services, its product revenue or the profitability

of product revenue may be lower than if Gemini were to market and sell any products Gemini may develop itself.

In addition, Gemini

may not be successful in entering into arrangements with third parties to commercialize its product candidates or may be unable

to do so on terms that are favorable to us.

Gemini may have little control over such third parties, and any of them may fail to

devote the necessary resources and attention to sell and market its products effectively and they could expose its company to regulatory

enforcement and legal risk in the execution of their sales and commercialization activities.

If Gemini does not establish commercialization

capabilities successfully, either on its own or in collaboration with third parties, Gemini will not be successful in commercializing

its product candidates if approved.

If Gemini is unable to establish adequate

sales, marketing, and distribution capabilities, whether independently or with third parties, or if Gemini is unable to do so on

commercially reasonable terms, its business, results of operations, financial condition, and prospects will be materially adversely

Gemini’s product candidates

may not achieve adequate market acceptance among physicians, patients, third-party payors and others in the medical community necessary

for commercial success.

Even if Gemini’s product candidates

receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, third-party payors, pharmaceutical

companies and others in the medical community.

Demonstrating the safety and efficacy of its product candidates and obtaining regulatory

approvals will not guarantee future revenue.

Its commercial success also depends on coverage and adequate reimbursement of its

product candidates by third-party payors, including government payors and private insurers, which may be difficult or time-consuming

to obtain, may be limited in scope and may not be obtained in all jurisdictions in which Gemini may seek to market its products.

Third-party payors closely examine medical products to determine whether they should be covered by reimbursement and, if so, the

level of reimbursement that will apply.

Gemini cannot be certain that third-party payors will sufficiently reimburse sales of its

product, or enable us to sell its product at a profitable price.

Similar concerns could also limit the reimbursement amounts that

health insurers or government agencies in other countries are prepared to pay for its products.

In many regions outside the United

States where Gemini may pursue regulatory approvals and market its products, the pricing of prescription drugs is controlled by

the government or regulatory agencies.

Regulatory agencies in these countries

could determine that the pricing for its products should be based on prices of other commercially available products for the same

disease, rather than allowing Gemini to market its products at a premium as new drugs.

The degree of market acceptance of any of

its approved product candidates will depend on a number of factors, including:

Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.

Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products.

We cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be.

Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval, if any.

If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not be able to successfully commercialize any product candidate for which marketing approval is obtained, if any.

There may be significant delays in obtaining coverage and reimbursement for newly approved drugs and biologics, and coverage may be more limited than the purposes for which the product is approved by the FDA or applicable foreign regulatory

Moreover, eligibility for coverage and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution.

Interim reimbursement levels for new drugs and biologics, if applicable, may also not be sufficient to cover our costs and may only be temporary.

Reimbursement rates may vary according to the use of the product and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost products and may be incorporated into existing payments for other services.

Net prices for products may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs and biologics from countries where they may be sold at lower prices than in the United States.

Our inability to promptly obtain coverage and profitable reimbursement rates third-party payors for any approved products that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved.

We do not currently have an infrastructure for the sales, marketing, and distribution of pharmaceutical products.

In order to market our product candidates, if approved by the FDA or any other regulatory body, we must build our sales, marketing, managerial, and other non-technical capabilities, or make arrangements with third parties to perform these services.

There are risks involved with both establishing our own commercial capabilities and entering into arrangements with third parties to perform these services.

For example, recruiting and training a sales force or reimbursement specialists is expensive and time-consuming and could delay any product launch.

If the commercial launch of a product candidate for which we recruit a sales force and establishes marketing and other commercialization capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses.

This may be costly, and our investment would be lost if we cannot retain or reposition our commercialization personnel.

If we enter into arrangements with third parties to perform sales, marketing, commercial support, and distribution services, our product revenue or the profitability of product revenue may be lower than if we were to market and sell any products we may develop ourselves.

In addition, we may not be successful in entering into arrangements with third parties to commercialize our product candidates or may be unable to do so on terms that are favorable to us.

We may have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively and they could expose our company to regulatory enforcement and legal risk in the execution of their sales and commercialization activities.

If we do not establish commercialization capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates if approved.

If we are unable to establish adequate sales, marketing, and distribution capabilities, whether independently or with third parties, or if we are unable to do so on commercially reasonable terms, our business, results of operations, financial condition, and prospects will be materially adversely affected.

Our product candidates may not achieve adequate market acceptance among physicians, patients, third-party payors and others in the medical community necessary for commercial success.

Even if our product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, third-party payors, pharmaceutical companies and others in the medical community.

Demonstrating the safety and efficacy of our product candidates and obtaining regulatory approvals will not guarantee future revenue.

Our commercial success also depends on coverage and adequate reimbursement of our product candidates by third-party payors, including government payors and private insurers, which may be difficult or time-consuming to obtain, may be limited in scope and may not be obtained in all jurisdictions in which we may seek to market our products.

Third-party payors closely examine medical products to determine whether they should be covered by reimbursement and, if so, the level of reimbursement that will apply.

We cannot be certain that third-party payors will sufficiently reimburse sales of our product, or enable us to sell our product at a profitable price.

Similar concerns could also limit the reimbursement amounts that health insurers or government agencies in other countries are prepared to pay for our products.

In many regions outside the United States where we may pursue regulatory approvals and market our products, the pricing of prescription drugs is controlled by the government or regulatory agencies.

Regulatory agencies in these countries could determine that the pricing for our products should be based on prices of other commercially available products for the same disease, rather than allowing us to market our products at a premium as new

The degree of market acceptance of any of our approved product candidates will depend on a number of factors, including:

the efficacy and safety profile of the product candidate as demonstrated in clinical trials;

8 unchanged sentences

the effectiveness of sales and marketing efforts;

unfavorable publicity relating to its product candidates.

Sales of medical products also depend on

the willingness of physicians to prescribe the treatment, which is likely to be based on a determination by these physicians that

the products are safe, therapeutically effective and cost effective.

In addition, the inclusion or exclusion of products from treatment

guidelines established by various physician groups and the viewpoints of influential physicians can affect the willingness of other

physicians to prescribe the treatment.

Gemini cannot predict whether physicians, physicians’

organizations, hospitals, other

healthcare providers, government agencies or private insurers will determine that its product is safe, therapeutically effective

and cost effective as compared with competing treatments.

If any product candidate is approved but does not achieve an adequate

level of acceptance by such parties, Gemini may not generate or derive sufficient revenue from that product candidate and may not

become or remain profitable.

Product liability lawsuits against

Gemini could cause it to incur substantial liabilities and to limit commercialization of any products that Gemini may develop and

insurance coverage may not be adequate.

Gemini faces an inherent risk of product

liability exposure related to the testing of its product candidates in human clinical trials and will face an even greater risk

if Gemini commercialize any resulting products.

Product liability claims may be brought against us by subjects enrolled in its

clinical trials, patients, their family members, healthcare providers or others using, administering or selling its products.

Gemini cannot successfully defend itself against claims that its product candidates or products that Gemini may develop caused

injuries, Gemini could incur substantial liabilities.

unfavorable publicity relating to our product candidates.

Sales of medical products also depend on the willingness of physicians to prescribe the treatment, which is likely to be based on a determination by these physicians that the products are safe, therapeutically effective and cost effective.

In addition, the inclusion or exclusion of products from treatment guidelines established by various physician groups and the viewpoints of influential physicians can affect the willingness of other physicians to prescribe the treatment.

We cannot predict whether physicians, physicians’

organizations, hospitals, other healthcare providers, government agencies or private insurers will determine that our product is safe, therapeutically effective and cost effective as compared with competing treatments.

If any product candidate is approved but does not achieve an adequate level of acceptance by such parties, we may not generate or derive sufficient revenue from that product candidate and may not become or remain profitable.

Potential product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop and insurance coverage may not be adequate.

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercialize any resulting products.

Product liability claims may be brought against us by subjects enrolled in our clinical trials, patients, their family members, healthcare providers or others using, administering or selling our products.

If we cannot successfully defend ourselves against claims that our product candidates or products that we may develop caused injuries, we could incur substantial liabilities.

Regardless of merit or eventual outcome, liability claims may result in:

decreased demand for any product candidates or products that Gemini may develop;

decreased demand for any product candidates or products that we may develop;

termination of clinical trial sites or entire trial programs;

injury to its reputation and significant negative media attention;

injury to our reputation and significant negative media attention;

withdrawal of clinical trial participants;

2 unchanged sentences

loss of revenue;

diversion of management and scientific resources from its business operations;

the inability to commercialize any products that Gemini may develop;

a decline in its stock price.

Its clinical trial liability insurance

coverage may not adequately cover all liabilities that Gemini may incur.

Gemini may not be able to maintain insurance coverage

at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Its inability to obtain product liability

insurance at an acceptable cost or to otherwise protect against potential product liability claims could prevent or delay the commercialization

of any products or product candidates that Gemini develop.

Gemini intend to expand its insurance coverage for products to include

the sale of commercial products if Gemini obtains marketing approval for its product candidates in development, but Gemini may

be unable to obtain commercially reasonable product liability insurance for any products approved for marketing.

Large judgments

have been awarded in lawsuits based on drugs that had unanticipated side effects.

If Gemini is sued for any injury caused by its

products, product candidates or processes, its liability could exceed its product liability insurance coverage and its total assets.

Claims against us, regardless of their merit or potential outcome, may also generate negative publicity or hurt our ability to

obtain physician adoption of its product or expand its business.

Risks Related to Our Stock

An active trading market for our

common stock may never develop or be sustained, which may make it difficult to sell the shares of our common stock you purchase.

An active trading market for our common

stock may not develop or continue or, if developed, may not be sustained, which would make it difficult for you to sell your shares

of our common stock at an attractive price (or at all).

The market price of our common stock may decline below your purchase price,

and you may not be able to sell your shares of our common stock at or above the price you paid for such shares (or at all).

There can be no assurance that we

will be able to comply with the continued listing standards of Nasdaq.

If Nasdaq delists our shares of common

stock from trading on its exchange for failure to meet Nasdaq’s listing standards, we and our stockholders could face significant

material adverse consequences including:

diversion of management and scientific resources from our business operations;

the inability to commercialize any products that we may develop;

a decline in our stock price.

Our clinical trial liability insurance coverage may not adequately cover all liabilities that we may incur.

We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Our inability to obtain product liability insurance at an acceptable cost or to otherwise protect against potential product liability claims could prevent or delay the commercialization of any products or product candidates that we develop.

We intend to expand our insurance coverage for products to include the sale of commercial products if we obtain marketing approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability insurance for any products approved for marketing.

Large judgments have been awarded in lawsuits based on drugs that had unanticipated side effects.

If we are sued for any injury caused by our products, product candidates or processes, our liability could exceed our product liability insurance coverage and our total assets.

Claims against us, regardless of their merit or potential outcome, may also generate negative publicity or hurt our ability to obtain physician adoption of our product or expand our business.

Risks Related to Our Common Stock

There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.

If Nasdaq delists our shares of common stock from trading on its exchange for failure to meet Nasdaq’s listing standards, we and our stockholders could face significant material adverse consequences including:

a limited availability of market quotations for our securities;

reduced liquidity for our securities;

a determination that our common stock is a “penny stock”

which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;

1 unchanged sentence

a decreased ability to issue additional securities or obtain additional financing in the future.

The price of our common stock may

The price of our common stock may fluctuate

due to a variety of factors, including:

The price of our common stock has been and may continue to be volatile and the value of an investment in our common stock may decline.

Our stock price has been and is likely to continue to be highly volatile.

From February 5, 2021, the date of our Business Combination, through February 28, 2022, the trading price of our common stock ranged between a low sales price of $1.36 and a high sales price of $19.08.

The stock market in general and the market for biopharmaceutical companies in particular have experienced periods of extreme volatility that has often been unrelated to the operating performance of particular companies.

As a result of this volatility, a holder may not be able to sell our common stock at or above the price at which such holder acquired shares of our common stock.

The price of our common stock may fluctuate due to a variety of factors, including:

changes in the industries in which our and our customers operate;

variations in its operating performance and the performance of its competitors in general;

material and adverse impact of the COVID-19 pandemic on the markets and the broader global economy;

variations in our operating performance and the performance of our competitors in general;

material and adverse impact of the ongoing COVID-19 pandemic on the markets and the broader global economy;

actual or anticipated fluctuations in our quarterly or annual operating results;

publication of research reports by securities analysts about us or our competitors or our industry;

the public’s reaction to our press releases, our other public announcements and its filings with the SEC;

Our failure or the failure of its competitors to meet analysts’

the public’s reaction to our press releases, our other public announcements and our filings with the SEC;

Our failure or the failure of our competitors to meet analysts’

projections or guidance that we or our competitors may give to the market;

1 unchanged sentence

changes in laws and regulations affecting our business;

commencement of, or involvement in, litigation involving Gemini;

commencement of, or involvement in, litigation involving us;

changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;

the volume of shares of our common stock available for public sale;

general economic and political conditions such as recessions, interest rates, fuel prices, foreign currency fluctuations, international tariffs, social, political and economic risks and acts of war or terrorism.

These market and industry factors may materially

reduce the market price of our common stock regardless of our operating performance.

Reports published by analysts, including

projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common

Securities research analysts may establish

and publish their own periodic projections for Gemini.

These projections may vary widely and may not accurately predict the results

we actually achieve.

Our share price may decline if our actual results do not match the projections of these securities research

Similarly, if one or more of the analysts who write reports on us downgrades our stock or publishes inaccurate or unfavorable

research about our business, our share price could decline.

If one or more of these analysts ceases coverage of us or fails to

publish reports on us regularly, our share price or trading volume could decline.

The future sales of shares by existing

stockholders and future exercise of registration rights may adversely affect the market price of Gemini’s Common Stock.

Sales of a substantial number of shares

of Gemini’s Common Stock in the public market could occur at any time.

If Gemini’s stockholders sell, or the market

perceives that Gemini’s stockholders intend to sell, substantial amounts of Gemini’s Common Stock in the public market,

the market price of Gemini’s Common Stock could decline.

Pursuant to the Registration Rights Agreement

entered into in connection with the Business Combination, certain stockholders of FSDC and Old Gemini can each demand that Gemini

register their registrable securities under certain circumstances and each also have piggyback registration rights for these securities.

The registration of these securities permit the public sale of such securities, subject to certain contractual restrictions imposed

by the Registration Rights Agreement and the Merger Agreement.

The presence of these additional shares of Common Stock trading

in the public market may have an adverse effect on the market price of Gemini’s securities.

Our issuance of additional capital

stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.

We expect to issue additional capital stock

in the future that will result in dilution to all other stockholders.

We expect to grant equity awards to employees, directors,

and consultants under our stock incentive plans.

general economic, political and geopolitical conditions such as recessions, interest rates, fuel prices, foreign currency fluctuations, international tariffs, social, political and economic risks and acts of war or terrorism, such as the recent invasion by Russia of Ukraine.

These market and industry factors may materially reduce the market price of our common stock regardless of our operating performance.

Reports published by analysts, including projections in those reports that differ from our actual results, could adversely affect the price and trading volume of our common stock.

Securities research analysts may establish or discontinue coverage and may publish their own periodic projections for us.

These projections may vary widely and may not accurately predict the results we actually achieve.

Our share price may decline if our actual results do not match the projections of these securities research analysts.

Similarly, if one or more of the analysts who write reports on us downgrades our stock or publishes inaccurate or unfavorable research about our business, our share price could decline.

If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, our share price or trading volume could decline.

The future sales of shares by existing stockholders and future exercise of registration rights may adversely affect the market price of our Common Stock.

Sales of a substantial number of shares of our Common Stock in the public market could occur at any time.

If our stockholders sell, or the market perceives that our stockholders intend to sell, substantial amounts of our Common Stock in the public market, the market price of our Common Stock could decline.

Pursuant to the Registration Rights Agreement entered into in connection with the Business Combination, certain stockholders of FSDC and Old Gemini can each demand that we register their registrable securities under certain circumstances and each also have piggyback registration rights for these securities.

The registration of these securities permit the public sale of such securities, subject to certain contractual restrictions imposed by the Registration Rights Agreement and the Merger Agreement.

The presence of these additional shares of Common Stock trading in the public market may have an adverse effect on the market price of our securities.

Our issuance of additional capital stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.

We expect to issue additional capital stock in the future that will result in dilution to all other stockholders.

We expect to grant equity awards to employees, directors, and consultants under our stock incentive plans.

We may also raise capital through equity financings in the future.

our business strategy, we may acquire or make investments in complementary companies, products, or technologies and issue equity

securities to pay for any such acquisition or investment.

Any such issuances of additional capital stock may cause stockholders

to experience significant dilution of their ownership interests and the per share value of our common stock to decline.

Because we have no current plans

to pay cash dividends on our common stock, you may not receive any return on investment unless you sell your common stock for a

price greater than that which you paid for it.

We have no current plans to pay cash dividends

on our common stock.

The declaration, amount and payment of any future dividends will be at the sole discretion of our board of

Our board of directors may take into account general and economic conditions, our financial condition and operating

results, our available cash, current and anticipated cash needs, capital requirements, contractual, legal, tax and regulatory restrictions,

implications on the payment of dividends by us to our stockholders or by our subsidiary to us and such other factors as our board

of directors may deem relevant.

In addition, the terms of our existing financing arrangements restrict or limit our ability to

pay cash dividends.

As part of our business strategy, we may acquire or make investments in complementary companies, products, or technologies and issue equity securities to pay for any such acquisition or investment.

Any such issuances of additional capital stock may cause stockholders to experience significant dilution of their ownership interests and the per share value of our common stock to decline.

Because we have no current plans to pay cash dividends on our common stock, you may not receive any return on investment unless you sell your common stock for a price greater than that which you paid for it.

We have no current plans to pay cash dividends on our common stock.

The declaration, amount and payment of any future dividends will be at the sole discretion of our board of directors.

Our board of directors may take into account general and economic conditions, our financial condition and operating results, our available cash, current and anticipated cash needs, capital requirements, contractual, legal, tax and regulatory restrictions, implications on the payment of dividends by us to our stockholders or by our subsidiary to us and such other factors as our board of directors may deem relevant.

In addition, the terms of our existing financing arrangements restrict or limit our ability to pay cash dividends.

Accordingly, we may not pay any dividends on our common stock in the foreseeable future.

Future offerings of debt or equity

securities by us may adversely affect the market price of our common stock.

In the future, we may attempt to obtain

financing or to further increase our capital resources by issuing additional shares of our common stock or offering debt or other

equity securities, including commercial paper, medium-term notes, senior or subordinated notes, debt securities convertible into

equity or shares of preferred stock.

Future offerings of debt or equity securities by us may adversely affect the market price of our common stock.

In the future, we may attempt to obtain financing or to further increase our capital resources by issuing additional shares of our common stock or offering debt or other equity securities, including commercial paper, medium-term notes, senior or subordinated notes, debt securities convertible into equity or shares of preferred stock.

Future acquisitions could require substantial additional capital in excess of cash from operations.

We would expect to obtain the capital required for acquisitions through a combination of additional issuances of equity, corporate

indebtedness and/or cash from operations.

Issuing additional shares of our common

stock or other equity securities or securities convertible into equity may dilute the economic and voting rights of our existing

stockholders or reduce the market price of our common stock or both.

Upon liquidation, holders of such debt securities and preferred

shares, if issued, and lenders with respect to other borrowings would receive a distribution of our available assets prior to the

holders of our common stock.

Debt securities convertible into equity could be subject to adjustments in the conversion ratio pursuant

to which certain events may increase the number of equity securities issuable upon conversion.

Preferred shares, if issued, could

have a preference with respect to liquidating distributions or a preference with respect to dividend payments that could limit

our ability to pay dividends to the holders of our common stock.

Our decision to issue securities in any future offering will depend

on market conditions and other factors beyond our control, which may adversely affect the amount, timing and nature of our future

Gemini expects to incur significant

additional costs as a result of being a public company, which may adversely affect its operating results and financial condition.

Gemini expects to incur costs associated

with corporate governance requirements, including requirements under the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act,

as well as rules implemented by the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, or the Dodd-Frank Act, the

SEC and Nasdaq.

Its management and other personnel will need to devote a substantial amount of time to these compliance initiatives.

Moreover, Gemini expects these rules and regulations are expected to increase its accounting, legal and financial compliance costs

and make some activities more time-consuming and costly.

In addition, Gemini will incur additional costs associated with its public

company reporting requirements and Gemini expects those costs to increase in the future.

For example, Gemini will be required to

devote significant resources to complete the assessment and documentation of its internal control system and financial process

under Section 404, including an assessment of the design of its information systems associated with its internal controls.

To date, Gemini has not conducted a review

of its internal control for the purpose of providing the reports required by these rules.

During its review and testing, Gemini

may identify deficiencies and be unable to remediate them before Gemini must provide the required reports.

Furthermore, if Gemini

fails to remediate its existing material weakness in its internal control over financial reporting or if new material weaknesses

are identified or arise in the future, Gemini may not detect errors on a timely basis and its financial statements may be materially

Gemini or its independent registered public accounting firm may not be able to conclude on an ongoing basis that Gemini

has effective internal control over financial reporting, which could harm its operating results, cause investors to lose confidence

in its reported financial information and cause the trading price of its stock to fall.

In addition, as a public company Gemini

will be required to timely file accurate quarterly and annual reports with the SEC under the Exchange Act.

Any failure to report

its financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of its shares from Nasdaq

or other adverse consequences.

Gemini will incur significant costs to remediate any material weaknesses Gemini identifies through

these efforts.

The increased costs will increase its net loss and may require us to reduce costs in other areas of its business

or increase the prices of its products or services.

Gemini also expects these rules and regulations to make it more expensive for

us to maintain directors’

and officers’

liability insurance and Gemini may be required to accept reduced policy limits

and coverage or incur substantially higher costs to obtain the same or similar coverage.

As a result, it may be more difficult

for Gemini to attract and retain qualified persons to serve on its board of directors, its board committees, or as executive officers.

Gemini cannot predict or estimate the amount of additional costs Gemini may incur or the timing of such costs.

New laws and regulations, as well as changes

to existing laws and regulations affecting public companies, including the provisions of the Sarbanes-Oxley Act, the Dodd-Frank

Act and rules adopted by the SEC and Nasdaq, would likely result in increased costs as Gemini responds to their requirements, which

may adversely affect its operating results and financial condition.

Anti-takeover provisions contained

in the Charter and the Bylaws, as well as provisions of Delaware law, could impair a takeover attempt.

The Charter contains provisions that may

discourage unsolicited takeover proposals that stockholders may consider to be in their best interests.

Gemini is also subject

to anti-takeover provisions under Delaware law, which could discourage, delay, defer or prevent a merger, tender offer, proxy contest

or other change of control transaction that a stockholder might consider in its best interest, including those attempts that might

result in a premium over the market price for the shares of common stock held by Gemini’s stockholders.

These provisions

provide for, among other things:

We would expect to obtain the capital required for acquisitions through a combination of additional issuances of equity, corporate indebtedness and/or cash from operations.

Issuing additional shares of our common stock or other equity securities or securities convertible into equity may dilute the economic and voting rights of our existing stockholders or reduce the market price of our common stock or both.

Upon liquidation, holders of such debt securities and preferred shares, if issued, and lenders with respect to other borrowings would receive a distribution of our available assets prior to the holders of our common stock.

Debt securities convertible into equity could be subject to adjustments in the conversion ratio pursuant to which certain events may increase the number of equity securities issuable upon conversion.

Preferred shares, if issued, could have a preference with respect to liquidating distributions or a preference with respect to dividend payments that could limit our ability to pay dividends to the holders of our common stock.

Our decision to issue securities in any future offering will depend on market conditions and other factors beyond our control, which may adversely affect the amount, timing and nature of our future offerings.

We may incur significant additional costs as a result of being a public company, which may adversely affect our operating results and financial condition.

We may incur costs associated with corporate governance requirements, including requirements under the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”), as well as rules implemented by the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (“Dodd-Frank Act”), the SEC and Nasdaq.

Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives.

Moreover, we expect these rules and regulations are expected to increase our accounting, legal and financial compliance costs and make some activities more time-consuming and costly.

In addition, we will incur additional costs associated with our public company reporting requirements and we expect those costs to increase in the future.

For example, we have and will continue to devote significant resources for the continuing assessment and documentation of our internal control system and financial processes under Section 404, including an assessment of the design of our information systems associated with our internal controls.

We may identify control deficiencies and be unable to remediate them.

Furthermore, if we fail to remediate any potential material weakness in our internal control over financial reporting or if material weaknesses are identified or arise in the future, we may not detect errors on a timely basis and our financial statements may be materially misstated.

We may not be able to conclude on an ongoing basis that we have effective internal control over financial reporting, which could harm our operating results, cause investors to lose confidence in our reported financial information and cause the trading price of our stock to fall.

In addition, as a public company, we will be required to timely file accurate quarterly and annual reports with the SEC under the Exchange Act.

Any failure to report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from Nasdaq or other adverse consequences.

We will incur significant costs to remediate any potential material weaknesses that we may identify through these efforts.

The increased costs would increase our net loss and may require us to reduce costs in other areas of our business.

We also expect these rules and regulations to make it more expensive for us to maintain directors’

and officers’

liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage.

As a result, it may be more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.

We cannot predict or estimate the amount or timing of such costs.

New laws and regulations, as well as changes to existing laws and regulations affecting public companies, including the provisions of the Sarbanes-Oxley Act, the Dodd-Frank Act and rules adopted by the SEC and Nasdaq, would likely result in increased costs as we respond to their requirements, which may adversely affect our operating results and financial condition.

We may be at increased risk of securities class action litigation.

Historically, securities class action litigation has often been brought against a company following a decline in the market price of its securities.

This risk is especially relevant for us because biotechnology and pharmaceutical companies, including us, have experienced significant stock price volatility in the past.

Anti-takeover provisions contained in our charter and our by-laws, as well as provisions of Delaware law, could impair a takeover attempt.

Our charter contains provisions that may discourage unsolicited takeover proposals that stockholders may consider to be in their best interests.

We are also subject to anti-takeover provisions under Delaware law, which could discourage, delay, defer or prevent a merger, tender offer, proxy contest or other change of control transaction that a stockholder might consider in our best interest, including those attempts that might result in a premium over the market price for the shares of common stock held by our stockholders.

These provisions provide for, among other things:

a classified board with a three-year staggered term;

the ability of Gemini’s board of directors to issue one or more series of “blank check”

limit the manner in which stockholders can remove directors from the board;

the ability of our board of directors to issue one or more series of “blank check”

preferred stock;

certain limitations on convening special stockholder meetings;

advance notice for nominations of directors by stockholders and for stockholders to include matters to be considered at Gemini’s annual meetings;

amendment of certain provisions of the organizational documents only by the affirmative vote of at least two-thirds of Gemini’s then-outstanding shares of capital stock entitled to vote generally at an election of directors.

These anti-takeover provisions as well

as certain provisions of Delaware law could make it more difficult for a third party to acquire Gemini, even if the third party’s

offer may be considered beneficial by many of Gemini’s stockholders.

As a result, Gemini’s stockholders may be limited

in their ability to obtain a premium for their shares.

If prospective takeovers are not consummated for any reason, Gemini may

experience negative reactions from the financial markets, including negative impacts on the price of Gemini Common Stock.

provisions could also discourage proxy contests and make it more difficult for Gemini’s stockholders to elect directors of

their choosing and to cause Gemini to take other corporate actions that Gemini’s stockholders desire.

The Bylaws provide that the Court

of Chancery of the State of Delaware and the federal district courts of the District of Massachusetts will be the exclusive forums

for substantially all disputes between Gemini and its stockholders, which could limit Gemini’s stockholders’

to obtain a favorable judicial forum for disputes with Gemini or its directors, officers, or employees.

The By-laws provide that the Court of Chancery

of the State of Delaware is the exclusive forum for:

any derivative action or proceeding brought on its behalf;

advance notice for nominations of directors by stockholders and for stockholders to include matters to be considered at our annual meetings;

amendment of certain provisions of the organizational documents only by the affirmative vote of at least two-thirds of our then-outstanding shares of capital stock entitled to vote generally at an election of directors.

These anti-takeover provisions as well as certain provisions of Delaware law could make it more difficult for a third party to acquire us, even if the third party’s offer may be considered beneficial by many of our stockholders.

As a result, our stockholders may be limited in their ability to obtain a premium for their shares.

If prospective takeovers are not consummated for any reason, we may experience negative reactions from the financial markets, including negative impacts on the price of our Common Stock.

These provisions could also discourage proxy contests and make it more difficult for our stockholders to elect directors of their choosing and to cause us to take other corporate actions that our stockholders desire.

Our by-laws provide that the Court of Chancery of the State of Delaware and the federal district courts of the District of Massachusetts will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’

ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.

Our by-laws provide that the Court of Chancery of the State of Delaware is the exclusive forum for:

any derivative action or proceeding brought on our behalf;

any action asserting a breach of fiduciary duty;

any action asserting a claim against Gemini arising under the DGCL, the Charter, or the By-laws;

any action to interpret, apply, enforce or determine the validity of the Charter or the By-laws;

any action asserting a claim against Gemini that is governed by the internal-affairs doctrine.

This exclusive-forum provision would not

apply to suits brought to enforce a duty or liability created by the Exchange Act or the Securities Act.

Furthermore, Section 22

of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions.

both state and federal courts have jurisdiction to entertain such claims.

To prevent having to litigate claims in multiple jurisdictions

and the threat of inconsistent or contrary rulings by different courts, among other considerations, the By-laws provides that the

federal district courts of the District of Massachusetts will be the exclusive forum for resolving any complaint asserting a cause

of action arising under the Securities Act.

These exclusive-forum provisions may limit

a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with Gemini or its directors,

officers, or other employees, which may discourage lawsuits against Gemini and its directors, officers, and other employees.

a court were to find either exclusive-forum provision in the By-laws to be inapplicable or unenforceable in an action, it may incur

additional costs associated with resolving the dispute in other jurisdictions, which could harm Gemini’s business.

If the Business Combination does

not qualify as a tax-free reorganization under Section 368(a) of the Code, the holders of Old Gemini stock may incur a substantially

federal income tax liability as a result of the Business Combination.

We intend for the Business Combination

to be treated for U.S.

federal income tax purposes as a reorganization within the meaning of Section 368(a) of the Code.

we have not obtained a ruling from the Internal Revenue Service, or IRS, with respect to the tax consequences of the Business Combination

and there can be no assurance that the our position would be sustained by a court if challenged by the IRS.

Accordingly, if the

IRS or a court determines that the Business Combination does not qualify as a reorganization under Section 368(a) of the Code and

is therefore fully taxable for U.S.

federal income tax purposes, the holders of Old Gemini stock generally would recognize taxable

gain or loss on their receipt of Merger Consideration in connection with the Business Combination.

Unresolved Staff Comments.

We currently maintain

our corporate offices at 300 One Kendall Square, 3 rd Floor, Cambridge, MA 02139.

We consider our current office space

adequate for our current operations.

any action asserting a claim against us arising under the Delaware General Corporation Law (“DGCL”), our charter, or our by-laws;

any action to interpret, apply, enforce or determine the validity of our charter or our by-laws;

any action asserting a claim against us that is governed by the internal-affairs doctrine.

This exclusive-forum provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or the Securities Act.

Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions.

Accordingly, both state and federal courts have jurisdiction to entertain such claims.

To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our by-laws provides that the federal district courts of the District of Massachusetts will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act.

These exclusive-forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers, and other employees.

If a court were to find either exclusive-forum provision in the By-laws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving the dispute in other jurisdictions, which could harm our business.

Unresolv ed Staff Comments.

Our facilities consisted of office space in Cambridge, Massachusetts.

We terminated this lease on December 31, 2021 and no longer have any properties.

We believe that our current remote working arrangement is sufficient for our current needs.

Legal Proceedings.

Mine Safety Disclosures.

We are not currently subject to any material legal proceedings.

Mine Safe ty Disclosures.

Not applicable.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors