What changed in this filing

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Item 1A. Risk Factors

2023-03-31 compared with 2022-03-21 · 199 added, 218 removed, 1684 unchanged (20% of the section changed)

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and potentially obtaining regulatory approvals and manufacturing products, as well as marketing and selling products approved for sale,

The total cost to complete an interim analysis

and file a BLA application for drug approval in the U.S.

total cost to complete an interim analysis and file a BLA application for drug approval in the U.S.

could exceed $30 million;

however, we believe that we have budget flexibility

with respect to the design of the Phase III clinical trial.

We believe that we may be able to alter the cost of our Phase III clinical

trial by adjusting the enrollment rate, the number of patients, and/or the number of immunological assays.

While our budget for such

Phase III trial may be flexible, our ability to reduce or modify costs may be adversely effected by, among other things, unexpected or

higher costs associated with the trial, time required to complete the trial and other factors that may be beyond our control.

and future capital requirements depend on many factors, including:

we believe that we have budget flexibility with respect to the design of the Phase III clinical trial.

We believe that we may be able

to alter the cost of our Phase III clinical trial by adjusting the enrollment rate, the number of patients, and/or the number of immunological

While our budget for such Phase III trial may be flexible, our ability to reduce or modify costs may be adversely effected by,

among other things, unexpected or higher costs associated with the trial, time required to complete the trial and other factors that

may be beyond our control.

Our budgets and future capital requirements depend on many factors, including:

scope, progress, results and costs of our ongoing and planned development programs for our product candidate, as well as any additional

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of December 31, 2022, we had federal net operating loss, or NOLs, carryforwards of approximately $14.9 million.

Our NOLs generated

in tax years ending on or prior to December 31, 2017 are only permitted to be carried forward for 20 years under applicable U.S.

laws, and will begin to expire, if not utilized, beginning in 2027.

These NOL carryforwards could expire unused and be unavailable to

offset future income tax liabilities.

Under the Tax Act, federal NOLs incurred in tax years ending after December 31, 2017 may be carried

forward indefinitely, but the deductibility of such federal NOLs is limited.

It is uncertain if and to what extent various states will

conform to the Tax Act, or whether any further regulatory changes may be adopted in the future that could minimize its applicability.

In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions of state law, if

a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in the

ownership of its equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change

tax attributes to offset its post-change income may be limited.

Our NOLs generated in

tax years ending on or prior to December 31, 2017 are only permitted to be carried forward for 20 years under applicable U.S.

and will begin to expire, if not utilized, beginning in 2027.

These NOL carryforwards could expire unused and be unavailable to offset

future income tax liabilities.

Under the Tax Act, federal NOLs incurred in tax years ending after December 31, 2017 may be carried forward

indefinitely, but the deductibility of such federal NOLs is limited.

It is uncertain if and to what extent various states will conform

to the Tax Act, or whether any further regulatory changes may be adopted in the future that could minimize its applicability.

under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions of state law, if a corporation

undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in the ownership of its

equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes

to offset its post-change income may be limited.

Related to the Development and Regulatory Approval of Our Product Candidate

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of other trials underway in the same patient population;

ability of clinical sites to staff sufficiently for

the start-up and conduct of our clinical trial;

of clinical sites to staff sufficiently for the start-up and conduct of our clinical trial;

of physicians to participate in our planned clinical trials;

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regulatory authorities may not agree and may require that we conduct additional clinical trials.

drug development involves a lengthy and expensive process with an uncertain outcome, including the risk of a clinical trial being

placed on clinical hold.

drug development involves a lengthy and expensive process with an uncertain outcome, including the risk of a clinical trial being placed

on clinical hold.

testing is expensive and can take many years to complete, with the outcome inherently uncertain.

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not subject to initial and continuing IRB review and approval.

may experience delays in our ongoing or future clinical trials, and we do not know whether planned clinical trials will begin or enroll

patients on time, will need to be redesigned or will be completed on schedule, if at all.

There can be no assurance that the FDA

will not put clinical trials of our product candidate on clinical hold in the future.

Clinical trials may be delayed, suspended

or prematurely terminated for a variety of reasons, such as:

or failure in reaching agreement with the FDA or a comparable foreign regulatory authority on a clinical trial design and protocols

that we are able to execute;

or failure in reaching agreement with the FDA, including with respect to our ongoing discussions regarding our planned Phase III

clinical trial, or a comparable foreign regulatory authority on (i) interim analysis and statistical design, (ii) a drug candidate

manufacturing plan for clinical trials or commercial use, (iii) protocol amendments, (iv) adaptive modifications to clinical trial

design upfront or after additional trial data is analyzed, (v) choice of hazard ratio, (vi) use of alpha spend (alpha-spending makes

it possible to perform sequential testing while maintaining the overall error probability of the statistical analysis of clinical

trial endpoints), (vii) statistical power assumptions, (viii) disease free survival assumptions for treated versus placebo arms of a clinical trial, (ix) number of patients or sizing of a clinical trial, including inclusion of patients

from outside of the US who may be treated with different standard of care than in the US, (x) duration of treatment and follow-up

required to demonstrate safety and efficacy of our product candidate, (xi) use of intent to treat or other patient populations as a

basis for primary and secondary endpoints, (xii) determinants of clinical meaningfulness and relevance, (xiii) subgroup analysis

whether prospectively designed or not, and (xiv) and the impact on any of the above on the timing and financeability of clinical

trials for our product candidate;

previously disclosed in our Quarterly Report on Form 10-Q for the three months ended March 31, 2022, the FDA placed our evaluation of

GLSI-100 in certain HER2 /neu positive patients and Flamingo-01 on clinical hold prohibiting us from commencing Flamingo-01 until

we provided such manufacturing information.

On July 11, 2022, we received a letter from the FDA stating that we have satisfactorily addressed

all clinical hold issues identified and that the clinical hold has been removed and we may proceed with the clinical trial.

be no assurance that the FDA will not place future clinical trials of our product candidate on additional clinical holds in the future.

Clinical trials may be delayed, suspended or prematurely terminated for a variety of reasons, such as:

or failure in reaching agreement with the FDA or a comparable foreign regulatory authority on a clinical trial design that we are

able to execute;

or failure in obtaining authorization to commence a trial or inability to comply with conditions imposed by a regulatory authority

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or failure in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject

to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

to extensive negotiation and may vary significantly among different CROs and trial sites;

or failure in obtaining IRB approval or the approval of other reviewing entities, including comparable foreign regulatory authorities,

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or failure in patients completing a clinical trial or returning for post-treatment follow-up;

sites and investigators deviating from clinical trial protocol, failing to conduct the clinical trial in accordance

with regulatory requirements, or dropping out of a clinical trial;

to identify and maintain a sufficient number of clinical trial sites, many of which may already be engaged in other clinical

trial programs, including some that may be for the same indication;

sites and investigators deviating from clinical trial protocol, failing to conduct the clinical trial in accordance with regulatory

requirements, or dropping out of a clinical trial;

to identify and maintain a sufficient number of clinical trial sites, many of which may already be engaged in other clinical trial

programs, including some that may be for the same indication;

of our third-party clinical trial managers, CROs, clinical trial sites, contracted laboratories or other third-party vendors to satisfy

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and clinical trials, that might require modification to the protocol for a clinical trial;

decision by the FDA, the IRB, a comparable foreign regulatory authority, or us to suspend or terminate clinical trials at any time for

safety issues or for any other reason;

decision by the FDA, the IRB, a comparable foreign regulatory authority, or us to suspend or terminate clinical trials at any time

for safety issues or for any other reason;

risk-benefit profile, unforeseen safety issues or adverse side effects;

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may conduct future clinical trials in countries outside of the U.S.

Consequently, we may be subject to risks related to operating

in foreign countries.

Consequently, we may be subject to risks related to operating in

foreign countries.

Risks associated with conducting operations in foreign countries include:

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monitors biomedical research to protect the rights and welfare of human patients.

As a result of safety or toxicity issues that

we may experience in our clinical trials, or negative or inconclusive results from the clinical trials of others for drug candidates

similar to our own, we may not receive approval to market our current product candidate or any product candidates we may pursue, which

could prevent us from ever generating revenues or achieving profitability.

As a result of safety or toxicity issues that we may

experience in our clinical trials, or negative or inconclusive results from the clinical trials of others for drug candidates similar

to our own, we may not receive approval to market our current product candidate or any product candidates we may pursue, which could

prevent us from ever generating revenues or achieving profitability.

Results of our trials could reveal an unacceptably high severity

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all targeted indications.

The drug-related side effects could also affect patient recruitment or the ability of enrolled patients

to complete the trial or result in potential product liability claims.

Any of these occurrences may have a material adverse effect

on our business, results of operations, financial condition, cash flows and future prospects.

The drug-related side effects could also affect patient recruitment or the ability of enrolled patients to

complete the trial or result in potential product liability claims.

Any of these occurrences may have a material adverse effect on our

business, results of operations, financial condition, cash flows and future prospects.

Additionally,

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product development program may not uncover all possible adverse events that patients who take our product candidate may experience.

The number of patients exposed to our product candidate and the average exposure time in the clinical development program may

be inadequate to detect rare adverse events or chance findings that may only be detected once the product is administered to more patients

and for greater periods of time.

The number of patients exposed to our product candidate and the average exposure time in the clinical development program may be inadequate

to detect rare adverse events or chance findings that may only be detected once the product is administered to more patients and for

greater periods of time.

trials by their nature utilize a sample of the potential patient population.

However, with a limited number of patients and limited

duration of exposure, we cannot be fully assured that rare and severe side effects of our product candidate will be uncovered.

and severe side effects may only be uncovered with a significantly larger number of patients exposed to our product candidate.

safety problems occur or are identified after our product candidate reaches the market, the FDA may require that we amend the labeling

of the product or recall the product, or may even withdraw approval for the product.

However, with a limited number of patients and limited duration

of exposure, we cannot be fully assured that rare and severe side effects of our product candidate will be uncovered.

Such rare and severe

side effects may only be uncovered with a significantly larger number of patients exposed to our product candidate.

If such safety problems

occur or are identified after our product candidate reaches the market, the FDA may require that we amend the labeling of the product

or recall the product, or may even withdraw approval for the product.

to successfully validate and develop a companion diagnostic for our product candidate could harm our drug development strategy and operational

has informed us that we will need a companion diagnostic for HLA typing of patients.

We do not have any third-party collaborators at

this time with an approved companion diagnostic for HLA typing.

Our product development program is dependent on the validation and

development of an in vitro companion diagnostic by us or by third-party collaborators for HLA typing.

Companion diagnostics are developed in

conjunction with clinical programs for the associated product and are subject to regulation as medical devices.

The approval of a

companion diagnostic as part of the product labeling may limit the use of the product candidate to only those patients who express

the specific genetic alteration it was developed to detect.

product development program is dependent on the validation and development of an in vitro companion diagnostic by us or by third-party

collaborators.

Companion diagnostics are developed in conjunction with clinical programs for the associated product and are subject to

regulation as medical devices.

The approval of a companion diagnostic as part of the product labeling may limit the use of the product

candidate to only those patients who express the specific genetic alteration it was developed to detect.

diagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities as medical devices and require separate

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or may be subject to burdensome post-approval clinical trial or risk management requirements.

Also, any regulatory approval of

our current product candidate or any future product candidates we may pursue, once obtained, may be withdrawn.

Also, any regulatory approval of our current

product candidate or any future product candidates we may pursue, once obtained, may be withdrawn.

current product candidate and future product candidates could fail to receive regulatory approval from the FDA.

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FDA or a comparable foreign regulatory authority may require more information, including additional preclinical or clinical data to support

approval or additional clinical trials, which may delay or prevent approval and our commercialization plans, or we may decide

to abandon the development program.

If we were to obtain approval, regulatory authorities may approve our current product candidate and

any future product candidates we may pursue for fewer or more limited indications than we request (including failing to approve the most

commercially promising indications), 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.

approval or additional clinical trials, which may delay or prevent approval and our commercialization plans, or we may decide to abandon

the development program.

If we were to obtain approval, regulatory authorities may approve our current product candidate and any future

product candidates we may pursue for fewer or more limited indications than we request (including failing to approve the most commercially

promising indications), 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.

we are unable to obtain regulatory approval for our product candidate in one or more jurisdictions, or any approval contains significant

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they may require labeling changes or establishment of a risk evaluation and mitigation strategy, impose significant restrictions on such

product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval clinical trials

or post-market surveillance.

product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval clinical trials or post-market

surveillance.

addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and

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active pharmaceutical ingredient for our product candidate is currently sourced from Polypeptide Laboratories located in San Diego, California.

We believe this single source is currently capable of supplying all anticipated needs of our proposed clinical trials, as well

as initial commercial introduction.

We believe this single source is currently capable of supplying all anticipated needs of our proposed clinical trials, as well as initial

commercial introduction.

We will be developing a source or sources for drug product manufacturing.

If we are able to commercialize

our product in the future, there is no assurance that our manufacturers will be able to meet commercialized scale production requirements

If we are able to commercialize our

product in the future, there is no assurance that our manufacturers will be able to meet commercialized scale production requirements

in a timely manner or in accordance with applicable standards or cGMP.

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plan to rely on CROs and other third-party vendors for all currently contemplated clinical trials.

We rely on these parties for

the execution of our preclinical studies and clinical trials, including the proper and timely conduct of our clinical trials, and we

control only some aspects of their activities.

Outsourcing these functions involves risk that third parties may not perform to our standards,

may not produce results or data in a timely manner or may fail to perform at all.

We rely on these parties for the execution

of our preclinical studies and clinical trials, including the proper and timely conduct of our clinical trials, and we control only some

aspects of their activities.

Outsourcing these functions involves risk that third parties may not perform to our standards, may not produce

results or data in a timely manner or may fail to perform at all.

we may have agreements governing the commitments of our third-party vendor services, we will have limited influence over their actual

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uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval.

product candidate for which we seek regulatory approval and reimbursement will need to meet or surpass our target product profile to be deemed a viable alternative to currently approved therapies.

product candidate for which we seek regulatory approval and reimbursement will need to meet or surpass our target product profile to

be deemed a viable alternative to currently approved therapies.

payors decide which drugs and treatments they will cover and the amount of reimbursement.

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require us to provide the payor with supporting scientific, clinical and cost-effectiveness data for the use of our products, if licensed.

In the U.S., the principal decisions about reimbursement for new drug products are typically made by the Centers for Medicare

and Medicaid Services, or CMS, an agency within the U.S.

In the U.S., the principal decisions about reimbursement for new drug products are typically made by the Centers for Medicare and Medicaid

Services, or CMS, an agency within the U.S.

Department of Health and Human Services, or HHS.

CMS decides whether and to

what extent a new drug product will be covered and reimbursed under Medicare, and private payors tend to follow CMS to a substantial

However, no uniform policy of coverage and reimbursement for drug products exists among third-party payors and coverage and reimbursement

levels for drug products can differ significantly from payor to payor.

Further, one payor’s determination to provide coverage for

a product does not assure that other payors will also provide coverage for the product.

Adequate third-party reimbursement may not be

available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

CMS decides whether and to what extent a

new drug product will be covered and reimbursed under Medicare, and private payors tend to follow CMS to a substantial degree.

no uniform policy of coverage and reimbursement for drug products exists among third-party payors and coverage and reimbursement levels

for drug products can differ significantly from payor to payor.

Further, one payor’s determination to provide coverage for a product

does not assure that other payors will also provide coverage for the product.

Adequate third-party reimbursement may not be available

to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.

if we obtain coverage for a given product, if the resulting reimbursement rates are insufficient, hospitals may not approve our product

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believe that any of the product candidates we develop that is licensed in the U.S.

as a biological product under a BLA should

qualify for the 12-year period of exclusivity.

However, there is a risk that this exclusivity could be shortened due to congressional

action or otherwise, or that the FDA will not consider the subject product candidates to be reference products for competing products,

potentially creating the opportunity for generic competition sooner than anticipated.

Moreover, the extent to which a biosimilar, once

licensed, will be substituted for any one of the 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.

as a biological product under a BLA should qualify

for the 12-year period of exclusivity.

However, there is a risk that this exclusivity could be shortened due to congressional action

or otherwise, or that the FDA will not consider the subject product candidates to be reference products for competing products, potentially

creating the opportunity for generic competition sooner than anticipated.

Moreover, the extent to which a biosimilar, once licensed,

will be substituted for any one of the 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.

Related to Healthcare Compliance Regulations

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Product liability

claims may be brought against us by patients enrolled in our clinical trials, patients, healthcare providers or others using,

administering or selling our product.

If we cannot successfully defend ourselves against claims that our product candidate or product

caused injuries, we could incur substantial liabilities.

claims may be brought against us by patients enrolled in our clinical trials, patients, healthcare providers or others using, administering

or selling our product.

If we cannot successfully defend ourselves against claims that our product candidate or product caused injuries,

we could incur substantial liabilities.

Regardless of merit or eventual outcome, liability claims may result in:

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and require us to develop and implement costly compliance programs.

we expand our operations outside of the U.S., we must dedicate additional resources to comply with numerous laws and regulations

in each jurisdiction in which we plan to operate.

we expand our operations outside of the U.S., we must dedicate additional resources to comply with numerous laws and regulations in each

jurisdiction in which we plan to operate.

The Foreign Corrupt Practices Act, or FCPA, prohibits any U.S.

individual or business

from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political

party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business

in obtaining or retaining business.

individual or business from

paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party

or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in

obtaining or retaining business.

The FCPA also obligates companies whose securities are listed in the U.S.

to comply with

certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions

of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls

for international operations.

to comply with certain accounting

provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation,

including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international

with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem.

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trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

laws, regulations and Executive Orders also restrict the use and dissemination outside of the U.S., or the sharing with certain

nationals, of information classified for national security purposes, as well as certain products and technical data relating

to those products.

If we expand our presence outside of the U.S., it will require us to dedicate additional resources to comply

with these laws, and these laws may preclude us from developing, manufacturing, marketing or selling certain products and product candidates

outside of the U.S., which could limit our growth potential and increase our development costs.

laws, regulations and Executive Orders also restrict the use and dissemination outside of the U.S., or the sharing with certain non-U.S.

nationals, of information classified for national security purposes, as well as certain products and technical data relating to those

If we expand our presence outside of the U.S., it will require us to dedicate additional resources to comply with these laws,

and these laws may preclude us from developing, manufacturing, marketing or selling certain products and product candidates outside of

the U.S., which could limit our growth potential and increase our development costs.

failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension

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For example, quarantines or other travel limitations (whether voluntary or required) may impede participant

movement, affect sponsor access to clinical trial sites, or interrupt healthcare services, and we may be unable to conduct our

clinical trials.

Further, if the spread of the coronavirus pandemic continues and our operations are adversely impacted, we risk a delay,

default and/or nonperformance under existing agreements which may increase our costs.

These cost increases may not be fully recoverable

or adequately covered by insurance.

movement, affect sponsor access to clinical trial sites, or interrupt healthcare services, and we may be unable to conduct our clinical

Further, if the spread of the coronavirus pandemic continues and our operations are adversely impacted, we risk a delay, default

and/or nonperformance under existing agreements which may increase our costs.

These cost increases may not be fully recoverable or adequately

covered by insurance.

and deaths related to the pandemic may disrupt the healthcare and healthcare regulatory systems in the U.S..

Such disruptions could

divert healthcare resources away from, or materially delay FDA review and/or approval with respect to, our clinical trials.

It is unknown

how long these disruptions could continue, were they to occur.

Any elongation or de-prioritization of our clinical trials or delay in

regulatory review resulting from such disruptions could materially affect the development and study of our product candidates.

Such disruptions could divert

healthcare resources away from, or materially delay FDA review and/or approval with respect to, our clinical trials.

It is unknown how

long these disruptions could continue, were they to occur.

Any elongation or de-prioritization of our clinical trials or delay in regulatory

review resulting from such disruptions could materially affect the development and study of our product candidates.

currently utilize third parties to, among other things, manufacture raw materials.

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situation closely.

Data collection

is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information.

collection is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information.

are subject to stringent privacy and data protection requirements and these requirements may become more complex as we grow our business

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imposes strict rules on the transfer of personal data out of the European Union to the U.S.

and other jurisdictions that have

not been deemed to offer “adequate” privacy protections.

and other jurisdictions that have not been

deemed to offer “adequate” privacy protections.

addition to the requirement of the GDPR, European Union Member States may make their own further laws and regulations in relation to

the processing of genetic, biometric or health data, which could result in differences between Member States, limit our ability to

use and share personal data or could cause our costs to increase, and harm our business and financial condition.

Should we commence

clinical trial activity within the member states of the European Union, such activity will be regulated by the GDPR as well as

applicable member state laws.

In addition, we are subject to evolving and strict rules on the transfer of personal data out of the

European Union to the U.S..

For example, evolution of laws governing the cross-border transfer of data, such as the

invalidation of the EU–U.S.

Privacy Shield, creates additional uncertainty around the legality and mechanics of such

Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business or

require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and

penalties, litigation, and reputational harm in connection with any future European activities.

We could be adversely affected if we

fail to comply fully with all of these requirements.

Failure to comply with European Union data protection laws may result in fines

(for example, of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year

(whichever is higher) under the GDPR) and other administrative penalties, which may be onerous and adversely affect our business,

financial condition, results of operations and prospects.

the processing of genetic, biometric or health data, which could result in differences between Member States, limit our ability to use

and share personal data or could cause our costs to increase, and harm our business and financial condition.

Should we commence clinical

trial activity within the member states of the European Union, such activity will be regulated by the GDPR as well as applicable member

In addition, we are subject to evolving and strict rules on the transfer of personal data out of the European Union to the

For example, evolution of laws governing the cross-border transfer of data, such as the invalidation of the EU–U.S.

Shield, creates additional uncertainty around the legality and mechanics of such transfers.

Compliance with the GDPR will be a rigorous

and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those

efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with any future

European activities.

We could be adversely affected if we fail to comply fully with all of these requirements.

Failure to comply with

European Union data protection laws may result in fines (for example, of up to €20,000,000 or up to 4% of the total worldwide annual

turnover of the preceding financial year (whichever is higher) under the GDPR) and other administrative penalties, which may be onerous

and adversely affect our business, financial condition, results of operations and prospects.

addition, further to the United Kingdom’s (UK) exit from the EU on January 31, 2020, the GDPR ceased to apply in the UK at the

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the U.S., there has been a flurry of activity at the state level.

In California, the California Consumer Privacy Act, or CCPA,

was enacted in June 2018, became effective on January 1, 2020, and became subject to enforcement by the California Attorney General’s

office on July 1, 2020.

The CCPA broadly defines personal information, and creates new individual privacy rights and protections for

California consumers (as defined in the law), places increased privacy and security obligations on entities handling personal data of

consumers or households, and provides for civil penalties for violations and a private right of action for data breaches.

The CCPA requires

covered companies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected

California residents with ways to opt-out of certain sales or transfers of personal information.

While there is an exception for protected

health information that is subject to HIPAA and clinical trial regulations, the CCPA may impact our business activities if we become

a “Business” regulated by the scope of the CCPA.

In California, the California Consumer Privacy Act, or CCPA, was enacted

in June 2018, became effective on January 1, 2020, and became subject to enforcement by the California Attorney General’s office

on July 1, 2020.

The CCPA broadly defines personal information, and creates new individual privacy rights and protections for California

consumers (as defined in the law), places increased privacy and security obligations on entities handling personal data of consumers

or households, and provides for civil penalties for violations and a private right of action for data breaches.

The CCPA requires covered

companies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected California

residents with ways to opt-out of certain sales or transfers of personal information.

While there is an exception for protected health

information that is subject to HIPAA and clinical trial regulations, the CCPA may impact our business activities if we become a “Business”

regulated by the scope of the CCPA.

addition to the CCPA, new privacy and data security laws have been proposed in more than half of the states in the U.S.

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will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.

of March 21, 2022, we had 3 full-time employee and 3 part-time employees.

We will need to grow the size of our organization

in order to support our continued development and potential commercialization of our product candidate.

As our development and commercialization

plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales, marketing, financial

and other resources may increase.

Our management, personnel and systems currently in place may not be adequate to support this future

Future growth would impose significant added responsibilities on members of management, including:

of March 15, 2023, we had 3 full-time employees and 3 part-time employees.

We will need to grow the size of our organization in

order to support our continued development and potential commercialization of our product candidate.

As our development and

commercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales,

marketing, financial and other resources may increase.

Our management, personnel and systems currently in place may not be adequate

to support this future growth.

Future growth would impose significant added responsibilities on members of management,

our clinical trials effectively;

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requiring stockholder approval.

of March 21, 2022, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially

own approximately 70% of our outstanding shares of common stock.

As a result, these stockholders, acting together, have the ability

to control the outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation

or sale of all or substantially all of our assets.

In addition, these stockholders, acting together, have the ability to control the

management and affairs of our company.

Accordingly, this concentration of ownership might harm the market price of our common stock by:

of March 15, 2023, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially own

approximately 52% of our outstanding shares of common stock.

As a result, these stockholders, acting together, have the ability to

control the outcome of matters submitted to our stockholders for approval, including the election of directors and any merger,

consolidation or sale of all or substantially all of our assets.

In addition, these stockholders, acting together, have the ability

to control the management and affairs of our company.

Accordingly, this concentration of ownership might harm the market price of

our common stock by:

deferring or preventing a change in corporate control;

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provision which provides that unless we consent in writing to the selection of an alternative forum, the U.S.

federal district

courts will be the exclusive forum for the resolution of any complaint asserting a cause of action arising

under the Securities Act.

Any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock are deemed

to have notice of and consented to this provision.

federal district courts

will be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.

or entity purchasing or otherwise acquiring any interest in shares of our capital stock are deemed to have notice of and consented to

this provision.

choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes

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controls and procedures.

We are required to furnish a report by management on, among other things, the effectiveness of internal control

over financial reporting.

This assessment will include disclosure of any material weaknesses identified by management in our internal

We are required to furnish a report by management on, among other things, the effectiveness of internal

control over financial reporting.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial

reporting that results in more than a reasonable possibility that a material misstatement of annual or interim financial statements will

not be prevented or detected on a timely basis.

Section 404 of the Sarbanes-Oxley Act also generally requires an attestation from an

issuer’s independent registered public accounting firm on the effectiveness of its internal control over financial reporting.

for as long as we remain an emerging growth company under the JOBS Act, we may take advantage of the exemption permitting us not to comply

with the independent registered public accounting firm attestation requirement.

This assessment will include disclosure of any material weaknesses identified by management in our

internal control over financial reporting.

A material weakness is a deficiency, or combination of deficiencies, in internal control

over financial reporting that results in more than a reasonable possibility that a material misstatement of annual or interim

financial statements will not be prevented or detected on a timely basis.

Section 404 of the Sarbanes-Oxley Act also generally

requires an attestation from an issuer’s independent registered public accounting firm on the effectiveness of its internal

control over financial reporting.

However, for as long as we remain an emerging growth company under the JOBS Act, we may take

advantage of the exemption permitting us not to comply with the independent registered public accounting firm attestation

compliance with Section 404 of the Sarbanes-Oxley Act may require that we incur substantial accounting expense and expend significant

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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