10-K
1
f10k2020_geminitherape.htm
ANNUAL REPORT
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31, 2020
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
File Number 001-39438
GEMINI
THERAPEUTICS, INC.
(Exact
name of Registrant as specified in its Charter)
Delaware
85-1612845
(State
or other jurisdiction of
incorporation or organization)
(I.R.S.
Employer
Identification No.)
300
One Kendall Square, 3 rd Floor
Cambridge,
MA
02139
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code: (617) 401-4400
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange
on which registered
Common
stock, par value $0.0001 per share
GMTX
The
Nasdaq Global Market
Securities
registered pursuant to Section 12(g) of the Act:
None
Indicate
by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate
by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
Indicate
by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit such files). Yes ☒ No ☐
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405) is not contained herein,
and will not be contained, to the best of Registrant’s knowledge, in definitive proxy or information statements incorporated
by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☐
Smaller reporting company
☒
Emerging growth company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of March 15, 2021, the Registrant had 42,998,664 shares of its common stock, $0.0001 par value per share outstanding.
Documents
Incorporated by Reference: None.
Table
of Contents
Page
PART I
1
Item
1.
Business
1
Item
1A.
Risk
Factors
3
Item
1B.
Unresolved
Staff Comments
42
Item
2.
Properties
42
Item
3.
Legal
Proceedings
42
Item
4.
Mine
Safety Disclosures
42
PART II
43
Item
5.
Market
for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities
43
Item
6.
Selected
Financial Data
43
Item
7.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
44
Item
7A.
Quantitative
and Qualitative Disclosures About Market Risk
50
Item
8.
Consolidated
Financial Statements and Supplementary Data
50
Item
9.
Changes
in and Disagreements With Accountants on Accounting and Financial Disclosure
50
Item
9A.
Controls
and Procedures
50
Item
9B.
Other
Information
50
PART III
51
Item
10.
Directors,
Executive Officers and Corporate Governance
51
Item
11.
Executive
Compensation
57
Item
12.
Security
Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters
57
Item
13.
Certain
Relationships and Related Transactions, and Director Independence
60
Item
14.
Principal
Accounting Fees and Services
62
PART IV
63
Item
15.
Exhibits,
Consolidated Financial Statement Schedules
63
i
SUMMARY
OF MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS
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:
● Gemini
has incurred significant losses since its inception and expects to incur losses for the
foreseeable future.
● Gemini
will require additional capital to finance its operations, which may not be available
to it on acceptable terms, or at all. As a result, Gemini may not complete the development
and commercialization of GEM103 or any other product candidates.
● Gemini
is heavily dependent on the success of GEM103, its lead product candidate.
● GEM103
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.
● Gemini
is subject to many manufacturing risks, any of which could substantially increase its
costs, delay clinical programs and limit supply of its products.
● Gemini
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.
● 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
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.
● Its
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.
● 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.
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.
ii
EXPLANATORY
NOTE
On
February 5, 2021 (the “Closing Date”), subsequent to the end of the fiscal year ended December 31, 2020, the fiscal
year to which this Annual Report on Form 10-K relates, FS Development Corporation, a Delaware corporation (“ FSDC ”),
consummated the previously announced business combination (the “ Business Combination ”) pursuant to the terms
of the Agreement and Plan of Merger, dated as of October 15, 2020 (as amended, supplemented or otherwise modified from time to
time, the “ Merger Agreement ”), by and among Gemini Therapeutics, Inc., a Delaware corporation (“ Old
Gemini ”), Shareholder Representative Services LLC, a Colorado limited liability company solely in its capacity as the
representative, agent and attorney-in-fact of the Company Securityholders (the “ Stockholders’ Representative ”),
FSDC and FSG Merger Sub Inc., a Delaware corporation (“ Merger Sub ”).
On
the day prior to the Closing Date, Old Gemini changed its name to “Gemini Therapeutics Sub, Inc.” Pursuant to the
Merger Agreement, on the Closing Date, (i) FSDC changed its name to “Gemini Therapeutics, Inc.” (together with its
consolidated subsidiaries, “ Gemini ”), and (ii) Old Gemini merged with and into Merger Sub (the “ Merger ”),
with Old Gemini as the surviving company in the Merger and, after giving effect to such Merger, Old Gemini becoming a wholly-owned
subsidiary of Gemini.
In
accordance with the terms and subject to the conditions of the Merger Agreement, at the effective time of the Merger (the “ Effective
Time ”), (i) all shares of Old Gemini’s Series B Preferred Stock (including shares of Series B Preferred Stock
issued upon conversion of outstanding convertible promissory notes), Series A Preferred Stock and Common Stock (collectively,
“ Old Gemini Stock ”) issued and outstanding immediately prior to the Effective Time, whether vested or unvested,
was converted into the right to receive their pro rata portion of the 17,942,274 shares of FSDC Class A Common Stock (the “ Common
Stock ”) issued as Merger consideration (the “ Merger Consideration ”), provided that 2,150,000 shares
of Common Stock are being held in escrow for a period of 12 months to satisfy any indemnification obligations of Old Gemini under
the Merger Agreement; (ii) each option exercisable for Old Gemini Stock that was outstanding immediately prior to the Effective
Time was assumed and continues in full force and effect on the same terms and conditions as were previously applicable to such
options, subject to adjustments to exercise price and number of shares Common Stock issuable upon exercise based on the final
conversion ratio calculated in accordance with the Merger Agreement, and (iii) 4,264,341 shares of Common Stock were reserved
for issuance under the newly adopted 2021 Stock Option and Incentive Plan (the “ 2021 Plan ”).
All
references herein to the “Closing” refer to the closing of the transactions contemplated by the Merger Agreement (the
“ Transactions ”), including the Merger and the transactions contemplated by the subscription agreements entered
into by FSDC and certain investors (the “ PIPE Investors ”) pursuant to which the PIPE Investors collectively
committed to subscribe for, and did subscribe for, an aggregate of 9,506,000 shares of Common Stock for an aggregate purchase
price of $95,060,000 (the “ PIPE Investment ”).
By
operation of Rule 12g-3(a) under the Exchange Act, Gemini is the successor issuer to FSDC and has succeeded to the attributes
of FSDC as the registrant, including FSDC’s U.S. Securities and Exchange Commission file number 001-39438 and CIK Code 0001816736.
Except
as otherwise expressly provided herein, the information in this Annual Report on Form 10-K does not reflect the consummation of
the business combination which, as discussed above, occurred subsequent to the period covered hereunder.
iii
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
We
make forward-looking statements in this report. These forward-looking statements relate to expectations for future financial performance,
business strategies or expectations for our business. Specifically, forward-looking statements may include statements relating
to:
● the
benefits of the Business Combination;
● the
future financial performance of the post-combination company following the Business Combination;
● Success
in retaining or recruiting, or changes required in, our officers, key employees or directors following the Business Combination;
● Public
securities’ potential liquidity and trading;
● from
the outcome of any known and unknown litigation; and
● other statements preceded by, followed by or that
include the words “may,” “can,” “should,” “will,” “estimate,” “plan,”
“project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,”
“seek,” “target” or similar expressions.
These
forward-looking statements are based on information available as of the date of this report and our management’s current
expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking
statements should not be relied upon as representing our views as of any subsequent date. We do not undertake any obligation to
update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new
information, future events or otherwise, except as may be required under applicable securities laws.
Forward-looking
statements in this report relating to Gemini following the Closing include, but are not limited to, statements about:
● the
ability of Gemini’s clinical trials to demonstrate acceptable safety and efficacy of Gemini’s product candidates,
including GEM103, Gemini’s lead product candidate, and other positive results;
● the
timing, progress and results of clinical trials for GEM103 and Gemini’s other product candidates, including statements regarding
the timing of initiation and completion of studies or trials and related preparatory work,
● the
period during which the results of the trials will become available, and Gemini’s research and development programs;
● the
timing, scope and likelihood of regulatory filings;
● Gemini’s
ability to obtain marketing approvals of its product candidates and to meet existing or future regulatory standards or comply
with post-approval requirements;
● Gemini’s
expectations regarding the potential market size and the size of the patient populations for its product candidates, if approved
for commercial use;
● Gemini’s
commercialization, marketing and manufacturing capabilities and strategy;
● Gemini’s
intellectual property position and expectations regarding its ability to obtain and maintain intellectual property protection;
● Gemini’s
ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent
with its commercial objectives;
● the
impact of government laws and regulations;
● Gemini’s
competitive position and expectations regarding developments and projections relating to its competitors and any competing therapies
that are or become available; and
● developments
and expectations regarding developments and projections relating to Gemini’s competitors and industry.
As
a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different
from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include:
●
the risk that the
Business Combination disrupts current plans and operations;
●
the ability to recognize
the anticipated benefits of the Business Combination, which may be affected by, among other things, competition and the ability
of the combined business to grow and manage growth profitably;
●
costs related to
the Business Combination;
●
changes in applicable
laws or regulations;
●
the possibility
that we may be adversely affected by other economic, business, and/or competitive factors; and
●
other risks and
uncertainties described under the section of this Annual Report on Form 10-K entitled “Risk Factors” and our other
filings with the Securities and Exchange Commission (the “SEC”).
iv
PART
I
References
in this report to “FSDC” refer to FS Development Corporation, the reporting company prior to the business combination.
References to “Gemini,” the “Company,” “we,” “us” and “our” refer
to Gemini Therapeutics, Inc., a Delaware corporation, the post-combination company and the successor entity to FSDC. References
to our “Board” refer to our officers and directors, and references to the “Sponsor” refer to FS Development
Holdings, LLC, a Delaware limited liability company.
Item
1. Business.
Introduction
FSDC
was formed as a blank check company incorporated on June 25, 2020 in Delaware, formed for the purpose of effecting a merger, share
exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses (the “business
combination”). Until the consummation of the business combination, FSDC did not engage in any operations nor generate any
revenue.
On
August 14, 2020, FSDC consummated its initial public offering (the “Initial Public Offering”) of 12,075,000 shares
of Class A Common Stock, generating total gross proceeds of $120,750,000. Substantially concurrent with the consummation
of the Initial Public Offering, the Sponsor purchased 441,500 shares of Class A Common Stock (the “Private Placement
Shares”) for an aggregate purchase price of $4,415,000, or $10.00 per share. A total of $120,750,000, comprised of the proceeds
from the Initial Public Offering and the sale of the Private Placement Shares, were placed in a U.S.-based trust account at JP
Morgan Chase Bank, N.A., maintained by Continental Stock Transfer & Trust Company, acting as trustee. Except with respect
to interest earned on the funds held in the trust account that may be released to FS Development to pay its taxes, the proceeds
from the Initial Public Offering will not be released from the trust account until the earliest to occur of: (i) the completion
of FSDC’s initial business combination, (ii) the redemption of the Public Shares if FSDC has not completed its initial
business combination by August 14, 2022, subject to applicable law, and (iii) the redemption of the Public Shares properly
tendered in connection with a stockholder vote to amend the current charter to modify the substance or timing of its obligation
to redeem 100% of its Public Shares if FSDC does not complete its initial business combination by August 14, 2022 or with respect
to any other provisions relating to stockholders’ rights or pre-initial business combination activity.
On
February 5, 2021, FSDC consummated the previously announced Business Combination. In accordance with the terms and subject to
the conditions of the Merger Agreement, at the Effective Time of the Merger (i) all shares of Old Gemini Stock issued and outstanding
immediately prior to the Effective Time, whether vested or unvested, was converted into the right to receive their pro rata portion
of the 17,942,274 shares of Common Stock issued as Merger Consideration, provided that 2,150,000 shares of Common Stock are being
held in escrow for a period of 12 months to satisfy any indemnification obligations of Old Gemini under the Merger Agreement;
(ii) each option exercisable for Old Gemini Stock that was outstanding immediately prior to the Effective Time was assumed and
continues in full force and effect on the same terms and conditions as were previously applicable to such options, subject to
adjustments to exercise price and number of shares Common Stock issuable upon exercise based on the final conversion ratio calculated
in accordance with the Merger Agreement, and (iii) 4,264,341 shares of Common Stock were reserved for issuance under the newly
adopted 2021 Plan.
In
connection with the Closing, the PIPE Investors subscribed for an aggregate of 9,506,000 shares of Common Stock for an aggregate
purchase price of $95,060,000.
In
connection with the Business Combination, 100 shares of Class A common Stock of FSDC were redeemed at a per share purchase price
of approximately $10.00. Upon the Closing, Gemini had 42,998,664 shares of Common Stock outstanding.
1
As
a result of the Business Combination, FSDC was renamed Gemini Therapeutics, Inc., and Old Gemini became a wholly-owned subsidiary
of Gemini.
Except
as otherwise expressly provided below, this report does not reflect the consummation of the business combination which, as discussed
above, occurred subsequent to the period covered hereunder.
Employees
As
of December 31, 2020 and prior to the business combination, we had three executive officers. These individuals were not obligated
to devote any specific number of hours to our matters but they intended to devote as much of their time as they deemed necessary
to our affairs until we completed an initial business combination. The amount of time they devoted in any time period varied based
on the stage of the business combination process we were in. We had no full-time employees prior to the completion of the business
combination.
Available
Information
We
are required to file Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q with the U.S. Securities and Exchange Commission
(the “SEC”) on a regular basis, and are required to disclose certain material events in a Current Report on Form 8-K.
The public may read and copy any materials we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE,
Washington, DC 20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.
The SEC also maintains an Internet website that contains reports, proxy and information statements and other information regarding
issuers that file electronically with the SEC. The SEC’s Internet website is located at http://www.sec.gov.
2
Item
1A. Risk Factors.
RISK
FACTORS
An
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. In that
event, the trading price of our securities could decline, and you could lose all or part of your investment.
Risks
Related to our Business
Gemini
has incurred significant losses since its inception and expects to incur losses for the foreseeable future.
Gemini
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.
For
the years ended December 31, 2020 and December 31, 2019, Gemini reported net losses of $40.8 million and $41.4 million. As of
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
as, Gemini:
●
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;
and
●
incurs additional
costs associated with operating as a public company.
Even
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’ equity and working capital.
3
Gemini
currently has a limited operating history, has not generated any revenue to date, and may never become profitable.
Gemini
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.
Though
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. Gemini
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; and
●
attract, hire and
retain qualified personnel.
4
In
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. In addition,
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.
If
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.
Gemini
will require additional capital to finance its operations, which may not be available to it on acceptable terms, or at all. As
a result, Gemini may not complete the development and commercialization of GEM103 or any other product candidates.
As
a research and development company, Gemini’s operations have consumed substantial amounts of cash since inception. Gemini
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.
As
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” section. 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
expects. 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; and
●
its need to implement
additional internal systems and infrastructure, including financial and reporting systems.
5
Gemini
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’ rights. 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. Any
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.
Gemini
is heavily dependent on the success of GEM103, its lead product candidate.
Gemini
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,
GEM103. Accordingly, its business currently depends heavily on the successful development, regulatory approval, and commercialization
of GEM103. 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. If Gemini is
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.
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 Gemini from commercializing and marketing GEM103.
Further,
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.
Even
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.
6
If
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.
Although
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’ 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; and
●
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.
If
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
candidates.
GEM103
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.
GEM103
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
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 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
trials. 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.
7
From
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. 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” 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.
Gemini
is subject to many manufacturing risks, any of which could substantially increase its costs, delay clinical programs and limit
supply of its products.
Gemini
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; and
●
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.
The
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
future.
Gemini
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.
8
Its
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.
Its
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.
Quarantines,
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.
In
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.
The
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.
The
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.
Gemini
may encounter difficulties in managing its growth, which could adversely affect its operations.
As
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.
The
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.
The
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.
The
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.
9
If
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.
Effective
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.
Gemini
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.
Gemini
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.
To
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. The
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.
There
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. 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 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.
Its
employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities,
including noncompliance with regulatory standards and requirements.
Gemini
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
regulations. 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.
10
Gemini
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. It is
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.
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 its control, significant competition for recruiting patients with AMD in clinical trials.
Identifying
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.
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; and
●
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.
In
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.
11
Gemini
faces 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. Its 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.
Its
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’ cyber security.
Given
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. While
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.
The
“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.
12
Gemini
might not be able to utilize a significant portion of its U.S. NOL carryforwards and U.S. research and development tax credit
carryforwards.
As
of December 31, 2020, Gemini had U.S. federal and state NOL carryforwards of $102.2 million and $95.1 million, respectively, and
U.S. federal and state research and development tax credit carryforwards of $3.1 million and $1.0 million, respectively. If not
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
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.
Gemini
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. Gemini
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
result. 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.
Risks
Related to Government Regulation
The
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.
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.
GEM103
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;
13
●
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; or
●
changes in the approval
policies or regulations that render its 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 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.
Failures
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.
Gemini
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;
14
●
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
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 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;
and
●
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.
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, 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; and
●
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 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.
15
Gemini
has limited experience in conducting clinical trials and has never obtained approval for any product candidates and may be unable
to do so successfully.
As
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. 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.
The
advancement of healthcare reform may negatively impact its ability to profitably sell its 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 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; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of its
products; or (iv) additional record-keeping requirements.
In
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. Since
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
Care Act. 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
Care Act. 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
known.
Congress
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.
16
In
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
programs. 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.
Recently,
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
for drugs. 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
consumers. The U.S. 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
drug costs. 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.
Gemini
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.
Further,
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.
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
its product. 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.
17
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.
Healthcare
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. 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; and
●
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.
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.
18
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 its operating results and
business.
Gemini
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
breaches. 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. Depending
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.
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 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.
Clinical
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.
Gemini
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.
Even
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.
Clinical
trials are conducted in representative samples of the potential patient population which may has significant variability. Even
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. Such safety
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. Gemini
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. Any
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.
19
Even
if its product candidates receive regulatory approval, they will remain subject to extensive regulatory scrutiny and may still
face future development and regulatory difficulties.
Even
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.
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 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.
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, or cGMP, regulations and
standards. 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
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 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; or
●
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 its ability to commercialize its 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 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.
In
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.
20
The
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.
Healthcare
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.
The
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.
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.
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;
and
●
neither experimental
nor investigational.
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 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.
Its
failure to obtain regulatory approval in international jurisdictions would prevent Gemini from marketing its product candidates
outside the United States.
Even
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.
Also,
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. Gemini
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.
21
Gemini
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
markets. Gemini can face criminal liability and other serious consequences for violations, which can harm its business.
Gemini
is subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, 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
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.
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 its business may rely, which could negatively
impact its 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.
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 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.
Separately,
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. The
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
business. 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.
If
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.
22
GEM103
and other product candidates for which Gemini intends to seek approval as biologic products may face competition sooner than anticipated.
GEM103
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” 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. 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. 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 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.
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
business. 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’ proprietary rights is uncertain. Only limited
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.
23
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
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;
●
patent applications may not result in any patents being issued;
●
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;
●
there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and
●
countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. 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
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. Gemini may not be aware of all third-party intellectual property rights potentially
relating to its product candidates and technologies.
24
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. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Gemini
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
agreement. 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:
●
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; and
●
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.
25
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.
Patents have a limited lifespan. 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,
is limited. 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.
26
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
patents. 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
proceedings. 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.
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.
In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. 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 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.
27
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. In addition,
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
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 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.
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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
at all.
Gemini could be found liable for monetary
damages, including treble damages and attorneys’ fees, if Gemini is found to have willfully infringed a patent. A finding
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. 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. If
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. 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. patent. 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,
or at all. 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.
29
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
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
consultants. 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. For example:
●
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;
30
●
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; and
●
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.
The outcome for any particular patent following legal assertions of invalidity and unenforceability is unpredictable. With respect
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. 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. The U.S. 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.
31
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. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. 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.
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
standards. 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
trial sites. 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
process. 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
programs. 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.
32
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. 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
facilities. 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:
●
the possible breach of the manufacturing agreement by the third party;
●
the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us; and
●
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.
33
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
and results. 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
plans.
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.
34
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.
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. Third-party payors determine which medications they will cover and establish reimbursement levels. 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. 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. If coverage
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.
35
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
affected.
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:
●
the efficacy and safety profile of the product candidate as demonstrated in clinical trials;
●
the timing of market introduction of the product candidate as well as competitive products;
●
the clinical indications for which the product candidate is approved;
●
acceptance of the product candidate as a safe and effective treatment by clinics and patients;
●
the potential and perceived advantages of the product candidate over alternative treatments, including any similar generic treatments;
●
the cost of treatment in relation to alternative treatments;
●
the availability of coverage and adequate reimbursement and pricing by third-party payors;
36
●
the relative convenience and ease of administration;
●
the frequency and severity of adverse events;
●
the effectiveness of sales and marketing efforts; and
●
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. If
Gemini cannot successfully defend itself against claims that its product candidates or products that Gemini may develop caused
injuries, Gemini 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;
●
termination of clinical trial sites or entire trial programs;
●
injury to its reputation and significant negative media attention;
●
withdrawal of clinical trial participants;
●
significant costs to defend the related litigation;
●
substantial monetary awards to trial subjects or patients;
●
loss of revenue;
●
diversion of management and scientific resources from its business operations;
●
the inability to commercialize any products that Gemini may develop; and
●
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.
37
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:
●
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;
●
a limited amount of news and analyst coverage; and
●
a decreased ability to issue additional securities or obtain additional financing in the future.
The price of our common stock may
be volatile.
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;
●
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’ projections or guidance that we or our competitors may give to the market;
●
additions and departures of key personnel;
●
changes in laws and regulations affecting our business;
●
commencement of, or involvement in, litigation involving Gemini;
●
changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;
38
●
the volume of shares of our common stock available for public sale; and
●
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
stock.
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
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 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. We may also raise capital through equity financings in the future. 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.
39
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
offerings.
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
misstated. 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.
40
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:
●
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” 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; and
●
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. These
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’ ability
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;
●
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; and
●
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. 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, 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.
41
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. If
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
greater U.S. 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. However,
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.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
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.
Item 3. Legal Proceedings.
None.
Item 4. Mine Safety Disclosures.
None.
42
PART II
Item 5. Market for Registrant’s
Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities.
Market Information
Our common stock trades
on Nasdaq under the symbol “GMTX”. FSDC’s Class A ordinary shares were traded on Nasdaq under the symbol “FSDC”
prior to the consummation of the business combination.
Holders
As of March 15, 2021,
there were 42,998,664 holders of record of our common stock.
Dividends
We have not paid any
cash dividends on our common stock to date and FSDC did not pay cash dividends prior to the consummation of the business combination.
The payment of cash dividends in the future will be dependent upon our revenues and earnings, if any, capital requirements and
general financial condition. The payment of any cash dividends will be within the discretion of our board of directors. In addition,
our board of directors is not currently contemplating and does not anticipate declaring stock dividends in the foreseeable future.
Securities Authorized for Issuance Under
Equity Compensation Plans
As of December 31,
2020, FSDC did not have any equity compensation plans.
Recent Sales of Unregistered Securities; Use of Proceeds
from Registered Offerings
Except as previously disclosed in our Quarterly Reports on
Form 10-Q during 2020, we did not sell any securities that were not registered under the Securities Act during the period covered
by this Annual Report on Form 10-K.
Item 6. Selected Financial Data
Not applicable.
43
ITEM 7. MANAGEMENT’S DISCUSSION
AND ANALYSIS
References to “we”, “us”,
“our” or the “Company” are to FS Development Corp., except where the context requires otherwise. The following
discussion should be read in conjunction with our financial statements and related notes thereto included elsewhere in this Annual
Report on Form 10-K.
Cautionary Note Regarding Forward-Looking
Statements
This Annual Report on Form 10-K includes forward-looking statements
within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. We have based these forward-looking
statements on our current expectations and projections about future events. These forward-looking statements are subject to known
and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of activity, performance or
achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied
by such forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,”
“should,” “could,” “would,” “expect,” “plan,” “anticipate,”
“believe,” “estimate,” “continue,” or the negative of such terms or other similar expressions.
Factors that might cause or contribute to such a discrepancy include, but are not limited to, those described in our other U.S.
Securities and Exchange Commission (“SEC”) filings.
Overview
We are a blank
check company incorporated in Delaware on June 25, 2020 for the purpose of effecting a merger, capital stock exchange, asset acquisition,
share purchase, reorganization or similar business combination with one or more businesses (the “business combination”).
Our sponsor is FS Development Holdings, LLC, a Delaware limited liability company (our “Sponsor”).
Our registration statement for our Initial
Public Offering (the “Initial Public Offering”) became effective on August 11, 2020. On August 14, 2020, we consummated
the Initial Public Offering of 12,075,000 shares of Class A common stock, including the issuance of 1,575,000 shares
of Class A Common Stock as a result of the underwriter’s exercise in full of its over-allotment option, (each, a “Public
Share” and collectively, the “Public Shares”) at $10.00 per share, generating gross proceeds of approximately
$120.8 million, and incurring offering costs of approximately $7.1 million, inclusive of approximately $4.2 million in
deferred underwriting commissions.
Simultaneously with the closing of the
Initial Public Offering, we consummated the private placement (“Private Placement”) of 441,500 shares of Class
A common stock (each, a “Private Placement Share” and collectively, the “Private Placement Shares”), at
a price of $10.00 per Private Placement Share to our Sponsor, generating proceeds of approximately $4.4 million.
Upon the closing of the Initial Public
Offering, the Private Placement, and the over-allotment option on August 14, 2020, approximately $120.8 million ($10.00
per share) of the net proceeds of the sale of the shares in the Initial Public Offering and the Private Placement were placed in
a trust account (“Trust Account”), located in the United States at J.P. Morgan Chase Bank, N.A. with Continental Stock
Transfer & Trust Company acting as trustee, and invested only in U.S. “government securities” within the meaning
of Section 2(a)(16) of the Investment Company Act having a maturity of 185 days or less or in money market funds meeting
certain conditions under Rule 2a-7 promulgated under the Investment Company Act which invest only in direct U.S. government
treasury obligations, until the earlier of: (i) the completion of a Business Combination and (ii) the distribution of
the assets held in the Trust Account as described below.
44
Our certificate of incorporation provides
that, other than the withdrawal of interest to pay franchise and income taxes (less up to $100,000 to pay dissolution expenses),
none of the funds held in the Trust Account will be released until the earliest of: (i) the completion of the initial business
combination; (ii) the redemption of any Public Shares sold in the Initial Public Offering that have been properly tendered
in connection with a stockholder vote to amend our certificate of incorporation to affect the substance or timing of our obligation
to redeem 100% of such Public Shares if we have not consummated an initial business combination within 24 months from the
closing of the Initial Public Offering, or August 14, 2022 (the “Combination Period”); or (iii) the redemption
of 100% of the Public Shares if we are unable to complete an initial business combination within the Combination Period. The proceeds
deposited in the Trust Account could become subject to the claims of our creditors, if any, which could have priority over the
claims of our public stockholders.
Business Combination
On February 5, 2021, we consummated the
previously announced Business Combination. In accordance with the terms and subject to the conditions of the Merger Agreement,
at the Effective Time of the Merger (i) all shares of Old Gemini Stock issued and outstanding immediately prior to the Effective
Time, whether vested or unvested, was converted into the right to receive their pro rata portion of the 17,942,274 shares of Common
Stock issued as Merger Consideration, provided that 2,150,000 shares of Common Stock are being held in escrow for a period of 12
months to satisfy any indemnification obligations of Old Gemini under the Merger Agreement; (ii) each option exercisable for Old
Gemini Stock that was outstanding immediately prior to the Effective Time was assumed and continues in full force and effect on
the same terms and conditions as were previously applicable to such options, subject to adjustments to exercise price and number
of shares Common Stock issuable upon exercise based on the final conversion ratio calculated in accordance with the Merger Agreement,
and (iii) 4,264,341 shares of Common Stock were reserved for issuance under the newly adopted 2021 Plan.
In connection with the Closing, the PIPE
Investors subscribed for an aggregate of 9,506,000 shares of Common Stock for an aggregate purchase price of $95,060,000.
In connection with the Business Combination,
100 shares of Class A common Stock of FSDC were redeemed at a per share purchase price of approximately $10.00. Upon the Closing,
Gemini had 42,998,664 shares of Common Stock outstanding.
As a result of the Business Combination,
FSDC was renamed Gemini Therapeutics, Inc., and Old Gemini became a wholly-owned subsidiary of Gemini.
Liquidity and Capital Resources
As of December
31, 2020, we had approximately $1.2 million in our operating bank account, approximately $5,000 of interest income available
in the Trust Account to pay the Company’s franchise and income tax obligations and working capital of approximately $740,000.
Further, we have incurred and expect to continue to incur significant costs in pursuit of our acquisition plans.
45
Our liquidity
needs to date have been satisfied through the $25,000 capital contribution to purchase founder shares by our Sponsor, the loan
proceeds under a promissory note of $200,000 from the Sponsor to cover the Company’s offering costs in connection with the
Initial Public Offering, and the net proceeds from the consummation of the Private Placement not held in the Trust Account. The
balance of the promissory note was fully repaid on August 14, 2020. In addition, in order to finance transaction costs in connection
with a business combination, the Sponsor or an affiliate of the Sponsor, or certain of our officers and directors may, but are
not obligated to, provide us working capital loans (“Working Capital Loans”). As of December 31, 2020, there were no
amounts outstanding under any Working Capital Loans.
Based on the foregoing, management believes
that we will have sufficient working capital and borrowing capacity from the Sponsor or an affiliate of the Sponsor, or certain
of our officers and directors to meet our needs through the earlier of the consummation of a business combination or one year from
this filing. Over this time period, we will be using these funds for paying existing accounts payable, identifying and evaluating
prospective initial business combination candidates, performing due diligence on prospective target businesses, paying for travel
expenditures, selecting the target business to merge with or acquire, and structuring, negotiating and consummating the business
combination.
Management continues to evaluate the impact
of the COVID-19 pandemic and has concluded that the specific impact is not readily determinable as of the date of the balance sheet.
The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Results of Operations
Our entire activity
since inception through December 31, 2020 related to our formation, the preparation for the Initial Public Offering, and
since the closing of the Initial Public Offering , the search for a prospective
initial business combination . We have neither engaged in any operations nor generated any revenues to date. We will not
generate any operating revenues until after completion of our initial business combination. We will generate non-operating income
in the form of interest earned on cash equivalents held in Trust Account. We expect to incur increased expenses as a result
of being a public company (for legal, financial reporting, accounting and auditing compliance), as well as for due diligence expenses.
For the period
from June 25, 2020 (inception) through December 31, 2020, we had a net loss of approximately $812,000, which consisted of approximately
$717,000 in general and administrative expenses and approximately $100,000 of franchise tax expense, which was partially offset
by approximately $5,000 of interest earned on cash equivalents held in the Trust Account.
Related Party Transactions
Founder Shares and Private Placement
Shares
On June 30, 2020, our Sponsor purchased
2,875,000 shares of the Company’s Class B common stock, par value $0.0001 per share, (the “Founder Shares”) for
an aggregate price of $25,000. On July 24, 2020, our Sponsor transferred 30,000 Founder Shares to each of its independent
director nominees at their original per-share purchase price, for an aggregate of 90,000 Founder Shares transferred. On August
11, 2020, we effected a 1:1.05 stock split of the Class B common stock, resulting in our Sponsor holding an aggregate of 2,928,750
Founder Shares and there being an aggregate of 3,018,750 Founder Shares outstanding. All shares and the associated amounts
have been retroactively restated to reflect the aforementioned stock split. Our Sponsor agreed to forfeit up to 393,750 Founder
Shares to the extent that the over-allotment option is not exercised in full by the underwriter, so that the Founder Shares would
represent 20.0% of our issued and outstanding shares of common stock after the Initial Public Offering (excluding the Private Placement
Shares). On August 14, 2020, the underwriter exercised the over-allotment option; thus, these Founder Shares were no longer subject
to forfeiture.
Simultaneously with the closing of the
Initial Public Offering, we consummated the Private Placement of 441,500 Private Placement Shares, at a price of $10.00 per
Private Placement Share to the Sponsor, generating proceeds of approximately $4.4 million.
46
The Sponsor and FSDC’s officers and
directors (the “Initial Stockholders”) agreed, subject to limited exceptions, not to transfer, assign or sell any of
the Founder Shares or Private Placement Shares until the earlier to occur of: (i) one year after the completion of the initial
Business Combination and (ii) the date on which we complete a liquidation, merger, capital stock exchange or other similar transaction
after the initial Business Combination that results in all of our stockholders having the right to exchange their Class A common
stock for cash, securities or other property; except to certain permitted transferees and under certain circumstances. Any permitted
transferees will be subject to the same restrictions and other agreements of the Initial Stockholders with respect to any Founder
Shares or Private Placement Shares. Notwithstanding the foregoing, if (1) the closing price of the Class A common stock equals
or exceeds $12.00 per share (as adjusted for stock splits, stock capitalizations, reorganizations, recapitalizations and the like)
for any 20 trading days within any 30-trading day period commencing at least 150 days after the initial business combination
or (2) if the Company consummates a transaction after the initial business combination which results in the Company’s stockholders
having the right to exchange their shares for cash, securities or other property, the Founder Shares and Private Placement Shares
will be released from the lock-up.
Related Party Loans
On June 30, 2020, our Sponsor agreed to
loan the Company an aggregate of up to $200,000 to cover expenses related to the Initial Public Offering pursuant to a promissory
note. This promissory note is non-interest bearing and payable upon the completion of the Initial Public Offering. The Company
borrowed $200,000 under the promissory, and fully repaid it on August 14, 2020.
In addition, in order to finance transaction
costs in connection with an initial business combination, our Sponsor or an affiliate of our Sponsor, or certain of our officers
and directors may, but are not obligated to, loan us funds as may be required as Working Capital Loans. If we complete an initial
business combination, we will repay the Working Capital Loans out of the proceeds of the Trust Account released to us. Otherwise,
the Working Capital Loans would be repaid only out of funds held outside the Trust Account. In the event that an initial business
combination does not close, we may use a portion of proceeds held outside the Trust Account to repay the Working Capital Loans
but no proceeds held in the Trust Account would be used to repay the Working Capital Loans. Except for the foregoing, the terms
of such Working Capital Loans, if any, have not been determined and no written agreements exist with respect to such loans. The
Working Capital Loans would either be repaid upon consummation of an initial business combination or, at the lender’s discretion,
up to $1.5 million of such Working Capital Loans may be convertible into warrants of the post initial business combination
entity at a price of $1.00 per warrant. To date, we have no borrowings under the Working Capital Loans.
Forward Purchase
Agreement
In connection with the execution of the
Merger Agreement, an affiliate of the Sponsor entered into a subscription agreement to purchase 1,500,000 shares of Class A Common
Stock at a purchase price of $10 per share in a private placement that would occur concurrently with the closing of the Merger
(the “Closing”). The affiliate of the Sponsor has assigned to the Sponsor its obligation to purchase its shares under
the subscription agreement so that the Sponsor will purchase 1,500,000 of such shares at the Closing. At the time of the Initial
Public Offering, the Sponsor had originally indicated an interest to purchase up to $25.0 million of shares in connection with
the initial business combination. This purchase of 1,500,000 shares represents the Sponsor’s allocation of shares in the
PIPE Investment. In addition, the Initial Stockholders entered into the Parent Support Agreement in which they agreed to vote,
at any meeting of the stockholders of the Company, and in any action by written consent of the stockholders of the Company, all
of such holders’ Class A common stock and Class B common stock (i) in favor of the Merger Agreement, each of the Parent Proposals
(as defined in the Merger Agreement) and the transactions contemplated by the Merger Agreement and the Parent Support Agreement,
and (ii) in favor of any other matter reasonably necessary to the consummation of the transactions contemplated by the Merger Agreement
and the approval of the Parent Proposals. Also, in connection with the Closing, the Sponsor and certain other stockholders will
enter into a Voting Agreement with us, and the Initial Stockholders and certain other stockholders will enter into a Registration
Rights Agreement with us that will replace the existing registration rights agreement in its entirety. For a description of the
Voting Agreement and the Registration Rights Agreement see Item 13 “Certain Relationships and Related Transactions and Director
Independence” in this report.
47
Administrative Services Agreement
We have entered into an agreement that
provides that, commencing on the date that the Company’s securities are first listed on Nasdaq and continuing until the earlier
of the consummation of a Business Combination and our liquidation, we will pay our Sponsor a total of $10,000 per month for office
space, secretarial and administrative services provided to members of the Company’s management team. Additionally, our Sponsor,
and our officers and directors, or any of their respective affiliates will be reimbursed for any out-of-pocket expenses incurred
in connection with activities on our behalf such as identifying potential target businesses and performing due diligence on suitable
Business Combinations. Our audit committee will review on a quarterly basis all payments that were made to our Sponsor, our officers
or directors, or their affiliates.
Contractual Obligations
Registration Rights
The Initial Stockholders are entitled to
registration rights pursuant to a registration rights agreement. The Initial Stockholders will be entitled to make up to three
demands, excluding short form registration demands, that we register such securities for sale under the Securities Act. In addition,
these holders will have “piggy-back” registration rights to include their securities in other registration statements
filed by us. We will bear the expenses incurred in connection with the filing of any such registration statements. In connection
with the Closing, the Initial Stockholders and certain other stockholders will enter into a Registration Rights Agreement with
us that will replace the existing registration rights agreement in its entirety. See the description of the Registration Rights
Agreement elsewhere in this report.
Underwriting Agreement
The underwriter was entitled to an underwriting
discount of $0.20 per share, or approximately $2.4 million in the aggregate, paid upon the closing of the Initial Public Offering.
In addition, $0.35 per share, or approximately $4.2 million in the aggregate will be payable to the underwriter for deferred underwriting
commissions. The deferred fee will become payable to the underwriter from the amounts held in the Trust Account solely in the event
that we complete a Business Combination, subject to the terms of the underwriting agreement.
Critical Accounting Policies and Estimates
Investments Held in the Trust Account
Our portfolio of investments held in the
Trust Account is comprised of U.S. government securities, within the meaning set forth in Section 2(a)(16) of the Investment Company
Act, with a maturity of 185 days or less, or investments in money market funds that invest in U.S. government securities, or a
combination thereof. Our investments held in the Trust Account are classified as trading securities. Trading securities are presented
on the balance sheet at fair value at the end of each reporting period. Gains and losses resulting from the change in fair value
of these investments are included in interest earned from investments held in Trust Account in the statement of operations. The
estimated fair values of investments held in the Trust Account are determined using available market information, other than for
investments in open-ended money market funds with published daily net asset values (“NAV”), in which case the Company
uses NAV as a practical expedient to fair value. The NAV on these investments is typically held constant at $1.00 per unit.
48
Class A Common Stock Subject
to Possible Redemption
We account for our Class A common
stock subject to possible redemption in accordance with the guidance in ASC Topic 480 “Distinguishing Liabilities from Equity.”
Shares of Class A common stock subject to mandatory redemption (if any) are classified as liability instruments and are measured
at fair value. Shares of conditionally redeemable Class A common stock (including Class A common stock that feature redemption
rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely
within our control) are classified as temporary equity. At all other times, shares of Class A common stock are classified
as stockholders’ equity. Our Class A common stock features certain redemption rights that are considered to be outside
of our control and subject to the occurrence of uncertain future events. Accordingly, as of December 31, 2020, 11,226,874 shares
of Class A common stock subject to possible redemption are presented as temporary equity, outside of the stockholders’
equity section of our balance sheet.
Net Loss Per Common Share
We comply with
accounting and disclosure requirements of FASB ASC Topic 260, “Earnings Per Share.” Net income per share is computed
by dividing net income (loss) applicable to common stockholders by the weighted average number of common shares of common stock
outstanding for the period.
Our statement of operations includes a
presentation of income per share for common stock subject to redemption in a manner similar to the two-class method of
income per share. Net income per common share, basic and diluted for Class A common stock subject to redemption is calculated
by dividing the interest earned from cash equivalents held in the Trust Account of approximately $4,500, net of applicable franchise
taxes of approximately $4,500 for the period from June 25, 2020 (inception) through December 31, 2020, by the weighted average
number of shares of Class A common stock subject to redemption that is outstanding for the period. Net loss per common share,
basic and diluted for Class B common stock and non-redeemable Class A common stock for the period from June 25, 2020 (inception)
through December 31, 2020 is calculated by dividing the general and administration expenses of approximately $717,000 and franchise
taxes of approximately $95,000, resulting in a net loss of approximately $812,000, by the weighted average number of Class B common
stock and non-redeemable Class A common stock outstanding for the period.
Off-Balance Sheet Arrangements and Contractual Obligations
As of December 31, 2020, we did not
have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii)
of Regulation S-K and did not have any commitments or contractual obligations.
JOBS Act
The Jumpstart
Our Business Startups Act of 2012 (the “JOBS Act”) contains provisions that, among other things, relax certain reporting
requirements for qualifying public companies. We qualify as an “emerging growth company” and under the JOBS Act are
allowed to comply with new or revised accounting pronouncements based on the effective date for private (not publicly traded) companies.
We are electing to delay the adoption of new or revised accounting standards, and as a result, we may not comply with new or revised
accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies. As
a result, the financial statements may not be comparable to companies that comply with new or revised accounting pronouncements
as of public company effective dates.
Additionally,
we are in the process of evaluating the benefits of relying on the other reduced reporting requirements provided by the JOBS Act.
Subject to certain conditions set forth in the JOBS Act, if, as an “emerging growth company,” we choose to rely on
such exemptions we may not be required to, among other things, (i) provide an auditor’s attestation report on our system
of internal controls over financial reporting pursuant to Section 404, (ii) provide all of the compensation disclosure that may
be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii)
comply with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the financial statements (auditor discussion and analysis) and (iv)
disclose certain executive compensation related items such as the correlation between executive compensation and performance and
comparisons of the CEO’s compensation to median employee compensation. These exemptions will apply for a period of five years
following the completion of our Initial Public Offering or until we are no longer an “emerging growth company,” whichever
is earlier.
Recent Accounting
Pronouncements
Our management
does not believe there are any other recently issued, but not yet effective, accounting pronouncements, if currently adopted, that
would have a material effect on our financial statements.
49
ITEM 7A. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company as defined
by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
Please see our Financial Statements beginning on page F-1 of
this Annual Report.
ITEM 9. CHANGES IN AND DISAGREEMENTS
WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
None.
ITEM 9A. CONTROLS AND PROCEDURES.
Evaluation of Disclosure
Controls and Procedures
Disclosure controls
and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our
reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified
in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed
to ensure that information required to be disclosed in company reports filed or submitted under the Exchange Act is accumulated
and communicated to management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding
required disclosure.
As required by Rules
13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer and Chief Financial Officer carried out an evaluation of
the effectiveness of the design and operation of our disclosure controls and procedures as of December 5, 2020. Based upon their
evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures (as
defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were effective.
Management’s Report on Internal
Control Over Financial Reporting
Management is responsible
for establishing and maintaining adequate internal control over financial reporting for the Company. Management assessed the effectiveness
of our internal control over financial reporting as of December 31, 2020. Based on its assessment, management concluded that our
internal control over financial reporting was effective as of December 31, 2020.
Changes in Internal Control Over Financial
Reporting
During the most recently
completed fiscal quarter, there has been no change in our internal control over financial reporting that has materially affected,
or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION.
None.
50
PART III
Item 10. Directors, Executive Officers
and Corporate Governance.
The following sets forth certain information,
as of the date of this report, concerning the directors and officers of Gemini.
Name
Age
Position
Jason Meyenburg
44
President, Chief Executive Officer and Director
Brian Piekos
46
Chief Financial Officer
Scott Lauder, Ph.D.
57
Chief Technology Officer
Marc Uknis, M.D.
56
Chief Medical Officer
Jean George (1)
62
Director
Carl Gordon, Ph.D., CFA
55
Director
David Lubner (1)
56
Director
Tuyen Ong, M.D., MRCOphth (1)
45
Director
Jason Rhodes (1)
51
Director
Jim Tananbaum (2)
57
Director
(1)
Gemini Designee
(2)
Sponsor Designee
Jason Meyenburg has served as our
Chief Executive Officer since September 2019. Previously, from March 2018 to September 2019, Mr. Meyenburg served as Chief Commercial
Officer of Orchard Therapeutics plc, a publicly-traded biotechnology company. Before that, Mr. Meyenburg served as the Chief Commercial
Officer of Sucampo Pharmaceuticals, Inc. from April 2017 to March 2018. Prior to that, Mr. Meyenburg served as the Chief Commercial
Officer of Vtesse, Inc., which became a wholly-owned subsidiary of Sucampo in April 2017, from December 2016 to April 2017. Additionally,
from January 2003 to February 2016, Mr. Meyenburg held roles of increasing responsibility at Alexion Pharmaceuticals, Inc., a publicly-traded
biotechnology company, including most recently as the Senior Vice President of Commercial Operations for the Americas. Mr. Meyenburg
holds an M.B.A. from Duke University and a B.S. in Biochemistry from University of Maryland. We believe that Mr. Meyenburg is qualified
to serve as a member of our board of directors because of his commercial experience in the life sciences industry.
Brian Piekos has served as our Chief Financial Officer
since February 2021. Prior to joining us, Mr. Piekos was most recently Executive Vice President, Chief Financial Officer and Treasurer
of AMAG Pharmaceuticals, Inc., from September 2015 to November 2020. Prior to joining AMAG, he held leadership roles in Corporate
Finance, Tax and Treasury at Cubist Pharmaceuticals, Inc. from August 2010 to February 2015. Mr. Piekos began his career as a healthcare
investment banker at Needham & Company and Leerink Partners, now SVB Leerink. Mr. Piekos earned his MBA from the Simon
Business School at the University of Rochester. He obtained an M.S. in molecular biology from the University of Massachusetts Medical
School and a B.A. in biochemistry from Ithaca College.
Scott Lauder, Ph.D. has served as
our Chief Technology Officer since November 2017. Previously, from October 2016 to October 2017, Dr. Lauder served as our Senior
Vice President of Process Development and Manufacturing. Prior to that, from July 2013 to October 2016, Dr. Lauder served as the
Vice President of Process Sciences and Clinical Manufacturing for Merrimack Pharmaceuticals, Inc., a publicly-traded pharmaceutical
company. Dr. Lauder holds a Ph.D. in Biochemistry from Northwestern University and a B.Sc. in Microbiology from the University
of Manitoba.
Marc Uknis, M.D. has served as our
Chief Medical Officer since March 2020. Previously, in 2020, Dr. Uknis served as Vice President and Head of Clinical Development,
Safety and Pharmacoviligance/Risk Management at Alexion Pharmaceuticals, Inc., a publicly-traded biotechnology company. Prior to
that, Dr. Uknis served as Vice President and Head of Clinical Development, Safety and Pharmacoviligance/Risk Management at Achillion
Pharmaceuticals, Inc., a publicly-traded biotechnology company, from June 2018 until its acquisition by Alexion Pharmaceuticals,
Inc. in January 2020. Prior to that, Dr. Uknis served as Senior Director, Therapeutic Area Lead, Solid Organ and Cellular Transplant
Research and Development at CSL Behring from October 2015 to June 2018. Prior to that, Dr. Uknis served as Director, Clinical Development:
Global Lead, Transplant Medicine R&D at ViroPharma Incorporated from October 2007 to October 2015. Dr. Uknis holds a M.D. from
Temple University and a B.A. in Biology from Temple University.
51
Jean George has served as a member
of our Board since April 2016. Since February 2002, she has been a Managing Director at Advanced Technology Ventures, a venture
capital fund, where she currently serves as the East Coast lead partner for healthcare investments. Since March 2012, Ms. George
has served as Managing Director at Lightstone Ventures, a venture capital firm. Ms. George currently serves as a member of the
board of directors of the public company, Calithera Biosciences. During the past five years, Ms. George served as a member of the
board of directors of Zeltiq Aesthetics from 2005 to 2015, Catabasis Pharma from 2010 to 2018 and Acceleron Pharma from 2005 to
2020. Ms. George holds an M.B.A. from Simmons College Graduate School of Management and a B.S. in biology from the University of
Maine. We believe that Ms. George is qualified to serve on our board of directors due to her extensive investment and financial
experience.
Carl L. Gordon, Ph.D., CFA has served
as a member of our board of directors since April 2016. Dr. Gordon is a founding member, Managing Partner, and Co-Head of Global
Private Equity at OrbiMed Advisors LLC, an investment firm. Dr. Gordon currently serves on the boards of directors of Adicet Bio,
Inc., Keros Therapeutics Inc., ORIC Pharmaceuticals Inc., Turning Point Therapeutics, Inc., and Prevail Therapeutics, Inc., as
well as several private companies. Dr. Gordon previously served on the boards of directors of several biopharmaceutical companies,
including Alector Inc., Arsanis, Inc. (which merged with X4 Pharmaceuticals, Inc.), Acceleron Pharma Inc., ARMO Biosciences, Inc.,
Intellia Therapeutics, Inc., Passage Bio Inc., Selecta Biosciences, Inc., and SpringWorks Therapeutics Inc. Dr. Gordon received
a B.A. in chemistry from Harvard College, a Ph.D. in molecular biology from the Massachusetts Institute of Technology, and he was
a Fellow at The Rockefeller University. We believe that Dr. Gordon is qualified to serve on our board of directors due to his scientific
expertise, extensive business experience, and experience in venture capital and the life science industry.
David C. Lubner has been a member
of our Board since April 2020. From January 2016, until its acquisition by UCB S.A. in April 2020, Mr. Lubner served as the Executive
Vice President and Chief Financial Officer of Ra Pharmaceuticals, Inc., a publicly-traded biotechnology company. Before that, Mr.
Lubner served as a member of the senior management team of Tetraphase Pharmaceuticals, Inc, from 2006 through 2015. From 2010 to
2015, Mr. Lubner served as Senior Vice President and the Chief Financial Officer of Tetraphase, where he led financial operations
and was responsible for corporate finance activities. From 1999 to 2005, he served as the Chief Financial Officer of PharMetrics
Inc., a pharmacy and medical claims data informatics company, which was acquired by IMS Health in 2015. Prior to joining PharMetrics,
Mr. Lubner served as Vice President and Chief Financial Officer of ProScript, Inc. where Velcade® (bortezomib), a therapy widely
used for treatment of the blood cancer, multiple myeloma, was discovered, from 1996 to 1999. Mr. Lubner is also a member of the
board of directors of Dyne Therapeutics, Inc., a biotechnology company, Therapeutics Acquisition Corporation (d/b/a as Research
Alliance Corp. I.), a blank check company focused on the healthcare industry. Mr. Lubner also serves on the boards of directors
of several private companies and was previously a member of the board of directors of Nightstar Therapeutics plc, (formerly Nasdaq:
NITE), focused on the development of one-time retinal gene therapies for patients suffering from rare inherited retinal diseases,
acquired by Biogen in June 2019. Mr. Lubner is a member of the American Institute of CPAs and a Certified Public Accountant in
the Commonwealth of Massachusetts. Mr. Lubner received his B.S. in business administration from Northeastern University and M.S.
in taxation from Bentley University. We believe that Mr. Lubner is qualified to serve on our board of directors based on his extensive
senior executive experience and his biotechnology company board experience.
Tuyen Ong, M.D., MRCOphth ., has
served as a member of our Board since August 2020. Dr. Ong is a board-certified ophthalmologist and biotechnology/pharmaceutical
industry management executive. He currently serves as Senior Vice President and Head of Biogen Ophthalmology Franchise at Biogen.
Dr. Ong served as Chief Development Officer at Nightstar Therapeutics up until its acquisition by Biogen in June 2019. During which
time he was involved with the company’s public listing on the Nasdaq, corporate and gene therapy strategy, investor and M&A
activities. Dr. Ong brings over 20 years of clinical and drug development experience from both large pharma and biotech, working
in the fields of ophthalmology, genetic and rare disease at PTC Therapeutics Inc., Bausch and Lomb Inc. (acquired by Valeant Pharmaceuticals
International, Inc.), and Pfizer. Dr. Ong holds an M.D. from the University College London and an M.B.A. from New York University
Stern School of Business. He is a member of the Royal College of Ophthalmologists and a Churchill Fellow.
52
Jason Rhodes has been a member of
our Board since April 2016 and a partner at Atlas Ventures since 2014. Mr. Rhodes also served as the founding President and Chief
Executive Officer of Dyne Therapeutics, Inc. from December 2017 to November 2018. From 2010 to 2014, Mr. Rhodes was employed at
Epizyme, Inc., a biotechnology company, where he most recently served as President and Chief Financial Officer. Mr. Rhodes serves
as a member of the board of directors of Dyne Therapeutics, Inc., Replimune Group, Inc., Generation Bio Co. and several private
companies, and previously served as a director at Bicycle Therapeutics, Inc. from 2016 to 2020. Mr. Rhodes earned a B.A. in history
from Yale University and an M.B.A. from the Wharton School of the University of Pennsylvania. We believe that Mr. Rhodes is qualified
to serve on our board of directors based on his extensive leadership experience, his biotechnology company board experience and
his experience investing in life science companies.
Jim Tananbaum has been a director
since June 2020. Prior to the Closing, Dr. Tananbaum also served as the President and Chief Executive Officer of FSDC since June
2020. Dr. Tananbaum is also the chief executive officer of Foresite Capital, a U.S.-focused healthcare investment firm, which he
founded in 2011. Prior to founding Foresite Capital, Dr. Tananbaum served as Co-Founder and Managing Director of Prospect Venture
Partners L.P. II and III, healthcare venture partnerships, from 2000 to 2010. Dr. Tananbaum was also the Founder of GelTex, Inc.
in 1991, an intestinal medicine pharmaceutical company acquired by Sanofi-Genzyme, and Theravance, Inc. in 1997 (now Theravance
Biopharma, Inc., a diversified biopharmaceutical company focused on organ-selective medicines, and Innoviva, Inc., a respiratory-focused
healthcare asset management company partnered with Glaxo Group Limited). Dr. Tananbaum received a B.S. and a B.S.E.E. from Yale
University in Applied Math and Computer Science, and an M.D. and an M.B.A. from Harvard University. Dr. Tananbaum’s qualifications
to serve on our board of directors include his scientific, financial and strategic business development expertise gained as a physician,
founder of two life science companies and venture capital investor focused on life science companies.
Number and Terms of Office of Officers
and Directors
Gemini’s board of directors consists
of seven members following the Closing of the Business Combination. In accordance with the filed Charter, immediately after the
Closing, the board of directors was divided into three classes. At each annual general meeting of stockholders, the successors
to directors whose terms then expire will be elected to serve from the time of election and qualification until the third annual
meeting following the election. The directors are divided among the three classes as follows:
●
the Class I directors will be Jean George and Dr. Carl Gordon their terms will expire at the annual meeting of stockholders to be held in 2021;
●
the Class II directors will be David Lubner, Dr. Tuyen Ong, and Jason Rhodes, and their terms will expire at the annual meeting of stockholders to be held in 2022; and
●
the Class III directors will be Jason Meyenburg and Dr. Jim Tananbaum, and their terms will expire at the annual meeting of stockholders to be held in 2023.
Gemini expects that
any additional directorships resulting from an increase in the number of directors will be distributed among the three classes
so that, as nearly as possible, each class will consist of one-third of the directors. The division of the board of directors into
three classes with staggered three-year terms may delay or prevent a change of our management or a change in control.
Committees of the Board of Directors
Effective upon completion
of the business combination, Gemini’s board of directors established the following committees: an audit committee, a compensation
committee, and a nominating and corporate governance committee. Members will serve on these committees until their resignation
or until otherwise determined by Gemini’s board of directors.
Audit Committee
Gemini’s audit
committee consists of Dr. Carl Gordon, David Lubner and Jason Rhodes. The Board has determined each member of the audit committee
is independent under the listing standards of the Nasdaq Stock Market, or the Listing Standards, and Rule 10A-3(b)(1) of the Exchange
Act. The chairperson of the audit committee is David Lubner. The Board has determined that David Lubner is an “audit committee
financial expert” within the meaning of SEC regulations. The Board has also determined that each member of the audit committee
has the requisite financial expertise required under the applicable requirements of the Nasdaq Stock Market. In arriving at this
determination, the board of directors has examined each audit committee member’s scope of experience and the nature of their
employment in the corporate finance sector.
53
The primary purpose
of the audit committee is to discharge the responsibilities of the board of directors with respect to our accounting, financial,
and other reporting and internal control practices and to oversee our independent registered accounting firm. Specific responsibilities
of our audit committee include:
●
selecting a qualified firm to serve as the independent registered public accounting firm to audit Gemini’s financial statements;
●
helping to ensure the independence and performance of the independent registered public accounting firm;
●
discussing the scope and results of the audit with the independent registered public accounting firm, and reviewing, with management and the independent accountants, our interim and year-end operating results;
●
developing procedures for employees to submit concerns anonymously about questionable accounting or audit matters;
●
reviewing policies on risk assessment and risk management;
●
reviewing related party transactions;
●
obtaining and reviewing a report by the independent registered public accounting firm at least annually, that describes Gemini’s internal quality-control procedures, any material issues with such procedures, and any steps taken to deal with such issues when required by applicable law; and
●
approving (or, as permitted, pre-approving) all audit and all permissible non-audit service to be performed by the independent registered public accounting firm.
Compensation Committee
The compensation committee consists of
Jean George, Dr. Tuyen Ong, and Dr. Jim Tananbaum. The Board has determined each member is a “non-employee director”
as defined in Rule 16b-3 promulgated under the Exchange Act and an “outside director” as that term is defined in Section
162(m) of the Internal Revenue Code of 1986, as amended, or the Code. The Board has determined each member of the compensation
committee, other than Dr. Jim Tananbaum, is independent under the Listing Standards. The Listing Standards provide that, under
limited and exceptional circumstances, a director who is not a current officer or employee (or a family member of an officer or
employee) of our company, but who does not otherwise meet the independence criteria, (i) may serve as a member of compensation
committee if such membership is in the best interests of our company and our shareholders and (ii) such member does not serve longer
than two years. The Board has elected to rely on this limited exception in appointing Dr. Jim Tananbaum as a member of the compensation
committee. In making this election, the Board considered Dr. Tananbaum’s extensive experience in the life sciences industry
and the marketplace for life science executives in making this decision. The chairperson of the compensation committee is Dr. Tuyen
Ong. The primary purpose of the compensation committee is to discharge the responsibilities of the board of directors to oversee
its compensation policies, plans and programs and to review and determine the compensation to be paid to its executive officers,
directors and other senior management, as appropriate.
Specific responsibilities of the compensation
committee will include:
●
reviewing and approving, or recommending that our board of directors approve, the compensation of our executive officers;
●
reviewing and recommending to our board of directors the compensation of our directors;
●
reviewing and approving, or recommending that our board of directors approve, the terms of compensatory arrangements with our executive officers;
●
administering our stock and equity incentive plans;
●
selecting independent compensation consultants and assessing whether there are any conflicts of interest with any of the committee’s compensation advisors;
●
reviewing and approving, or recommending that our board of directors approve, incentive compensation and equity plans, severance agreements, change-of-control protections and any other compensatory arrangements for our executive officers and other senior management, as appropriate;
54
●
reviewing and establishing general policies relating to compensation and benefits of our employees; and
●
reviewing our overall compensation philosophy.
Nominating and Corporate Governance Committee
The nominating and
corporate governance committee consists of Jean George, Jason Rhodes and Dr. Jim Tananbaum. The Board has determined each member
of the nominating and corporate governance committee, other than Dr. Jim Tananbaum, is independent under the Listing Standards.
The Listing Standards provide that, under limited and exceptional circumstances, a director who is not a current officer or employee
(or a family member of an officer or employee) of our company, but who does not otherwise meet the independence criteria, (i) may
serve as a member of nominating and corporate governance committee if such membership is in the best interests of our company and
our shareholders and (ii) such member does not serve longer than two years. The Board has elected to rely on this limited exception
in appointing Dr. Jim Tananbaum as a member of the nominating and corporate governance committee. In making this election, the
Board considered Dr. Tananbaum’s extensive experience in the life sciences industry and in serving on the board of directors
of numerous organizations. The chairperson of our nominating and corporate governance committee is Jean George.
Specific responsibilities of our nominating
and corporate governance committee include:
●
identifying, evaluating and selecting, or recommending that our board of directors approve, nominees for election to our board of directors;
●
evaluating the performance of our board of directors and of individual directors;
●
reviewing developments in corporate governance practices;
●
evaluating the adequacy of our corporate governance practices and reporting;
●
reviewing management succession plans; and
●
developing and making recommendations to our board of directors regarding corporate governance guidelines and matters.
Director Nominations
Gemini’s board
of directors will consider director candidates recommended for nomination by Gemini’s shareholders during such times as they
are seeking proposed nominees to stand for election at the next annual meeting of shareholders (or, if applicable, a special meeting
of shareholders). Gemini’s shareholders that wish to nominate a director for election to Gemini’s board of directors
followed the procedures set forth in Gemini’s bylaws.
Gemini has not formally
established any specific, minimum qualifications that must be met or skills that are necessary for directors to possess. In general,
in identifying and evaluating nominees for director, the board of directors will consider educational background, diversity of
professional experience, knowledge of Gemini’s business, integrity, professional reputation, independence, wisdom, and the
ability to represent the best interests of Gemini’s stockholders.
Compensation Committee Interlocks and Insider Participation
The compensation committee consists of
Jean George, Dr. Tuyen Ong, and Dr. Jim Tananbaum. The Board has determined each member is a “non-employee director”
as defined in Rule 16b-3 promulgated under the Exchange Act and an “outside director” as that term is defined in Section
162(m) of the Internal Revenue Code of 1986, as amended, or the Code. The Board has determined each member of the compensation
committee, other than Dr. Jim Tananbaum, is independent under the Listing Standards. The Listing Standards provide that, under
limited and exceptional circumstances, a director who is not a current officer or employee (or a family member of an officer or
employee) of our company, but who does not otherwise meet the independence criteria, (i) may serve as a member of compensation
committee if such membership is in the best interests of our company and our shareholders and (ii) such member does not serve longer
than two years. The Board has elected to rely on this limited exception in appointing Dr. Jim Tananbaum as a member of the compensation
committee. In making this election, the Board considered Dr. Tananbaum’s extensive experience in the life sciences industry
and the marketplace for life science executives in making this decision. The chairperson of the compensation committee is Dr. Tuyen
Ong. The primary purpose of the compensation committee is to discharge the responsibilities of the board of directors to oversee
its compensation policies, plans and programs and to review and determine the compensation to be paid to its executive officers,
directors and other senior management, as appropriate.
55
Specific responsibilities of the compensation
committee will include:
●
reviewing and approving, or recommending that our board of directors approve, the compensation of our executive officers;
●
reviewing and recommending to our board of directors the compensation of our directors;
●
reviewing and approving, or recommending that our board of directors approve, the terms of compensatory arrangements with our executive officers;
●
administering our stock and equity incentive plans;
●
selecting independent compensation consultants and assessing whether there are any conflicts of interest with any of the committee’s compensation advisors;
●
reviewing and approving, or recommending that our board of directors approve, incentive compensation and equity plans, severance agreements, change-of-control protections and any other compensatory arrangements for our executive officers and other senior management, as appropriate;
●
reviewing and establishing general policies relating to compensation and benefits of our employees; and
●
reviewing our overall compensation philosophy.
Delinquent Section 16(a) Reports
Section 16(a) of the
Securities Exchange Act of 1934, as amended, requires our officers, directors and persons who beneficially own more than ten percent
of our ordinary shares to file reports of ownership and changes in ownership with the SEC. These reporting persons are also required
to furnish us with copies of all Section 16(a) forms they file.
The Company is not
aware of any late or delinquent filings required under Section 16(a) of the Exchange Act in respect of the Company’s equity
securities other than the following reports filed late due to administrative error: a Form 3 which inadvertently omitted Foresite
Capital Fund V, L.P and Foresite Capital Management V LLC as beneficial owners of 3,018,750 shares of Class B Common Stock of FSDC;
a Form 3 for James Tananbaum, which inadvertently omitted 3,018,750 shares of Class B Common Stock of FSDC; and a Form 4 of the
Sponsor, Foresite Capital Fund V, L.P, Foresite Capital Management V LLC and James Tananbaum which inadvertently omitted 441,500
shares of Class A Common Stock of FSDC.
Code of Ethics and Committee Charters
We have adopted a
Code of Ethics that applies to all of our directors, executive officers and employees that complies with the rules and regulations
of the Nasdaq. Copies of our code of ethics and our board committee charters are available on our website ( https://geminitherapeutics.com ).
You may review these documents by accessing our public filings at the SEC’s web site at www.sec.gov. In addition, a copy
of the code of ethics will be provided without charge upon request to us in writing at 300 One Kendall Square, 3 rd Floor
Cambridge, MA or by telephone at 617-401-4400. If we make any amendments to our Code of Ethics other than technical, administrative
or other non-substantive amendments, or grant any waiver, including any implicit waiver, from a provision of the Code of Ethics
applicable to our principal executive officer, principal financial officer principal accounting officer or controller or persons
performing similar functions requiring disclosure under applicable SEC or Nasdaq rules, we will disclose the nature of such amendment
or waiver on our website. The information included on our website, or any of the websites of entities that we are affiliated with,
is not incorporated by reference into this Annual Report on Form 10-K or in any other report or document we file with the SEC,
and any references to our website are intended to be inactive textual references only.
56
Limitations on Liability and Indemnification
of Officers and Directors
The Certificate of
Incorporation limits the liability of the directors of Gemini to the fullest extent permitted by the DGCL, and the Bylaws provide
that we will indemnify them to the fullest extent permitted by such law. We have entered and expect to continue to enter into agreements
to indemnify our directors, executive officers and other employees as determined by our board of directors. Under the terms of
such indemnification agreements, we are required to indemnify each of our directors and officers, to the fullest extent permitted
by the laws of the state of Delaware, if the basis of the indemnitee’s involvement was by reason of the fact that the indemnitee
is or was a director or officer of Gemini or any of its subsidiaries or was serving at Gemini’s request in an official capacity
for another entity. We must indemnify our officers and directors against all reasonable fees, expenses, charges and other costs
of any type or nature whatsoever, including any and all expenses and obligations paid or incurred in connection with investigating,
defending, being a witness in, participating in (including on appeal), or preparing to defend, be a witness or participate in any
completed, actual, pending or threatened action, suit, claim or proceeding, whether civil, criminal, administrative or investigative,
or establishing or enforcing a right to indemnification under the indemnification agreement. The indemnification agreements also
require us, if so requested, to advance within 10 days of such request all reasonable fees, expenses, charges and other costs that
such director or officer incurred, provided that such person will return any such advance if it is ultimately determined that such
person is not entitled to indemnification by us. Any claims for indemnification by our directors and officers may reduce our available
funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
Item 11. Executive Compensation.
Prior to the consummation of the business
combination, none of FSDC’s executive officers or directors received any cash compensation for services rendered to FSDC.
In July 2020, the Sponsor transferred 30,000 Founders Shares to each of Mr. Carey, Dr. Dubin and Dr. Pakianathan.
None of FSDC’s executive officers or directors have received any cash compensation for services rendered to us. Commencing
August 11, 2020 through February 5, 2021, we paid the Sponsor $10,000 per month for office space, secretarial and administrative
services provided to members of our management team. In addition, the Sponsor, executive officers and directors, or any of their
respective affiliates were reimbursed for any out-of-pocket expenses incurred in connection with activities on our behalf such
as identifying potential target businesses and performing due diligence on suitable business combinations. Our audit committee
reviewed on a quarterly basis all payments that were made to the Sponsor, executive officers or directors, or our or their affiliates.
Any such payments prior to an initial business combination were made from funds held outside the trust account. Other than quarterly
audit committee review of such reimbursements, there were no additional controls in place governing our reimbursement payments
to our directors and executive officers for their out-of-pocket expenses incurred in connection with our activities on our behalf
in connection with identifying and consummating an initial business combination. Other than these payments and reimbursements,
no compensation of any kind, including finder’s and consulting fees, were paid by FSDC to the Sponsor, executive officers
and directors, or any of their respective affiliates, prior to completion of our initial business combination.
Item 12. Security Ownership of Certain
Beneficial Owners and Management and Related Shareholder Matters.
The following table sets forth information
regarding the beneficial ownership of the Common Stock as of March 15, 2021
●
each person who is known to be the beneficial owner of more than 5% of Gemini’s outstanding Common Stock immediately following the consummation of the Transactions;
●
each of Gemini’s current executive officers and directors;
●
all executive officers and directors of Gemini as a group following the consummation of the Transaction.
57
Beneficial ownership is determined according
to the rules of the SEC, which generally provide that a person has beneficial ownership of a security if he, she or it possesses
sole or shared voting or investment power over that security, including options and warrants (as applicable) that are currently
exercisable or exercisable within 60 days. Unless otherwise indicated, Gemini believes that all persons named in the table have
sole voting and investment power with respect to all Common Stock beneficially owned by them. Unless otherwise noted, the business
address of each of the executive officers and directors of Gemini is 300 One Kendall Square, 3 rd Floor, Cambridge, MA
02139. The percentage of shares beneficially owned if based on 42,998,664 shares of Common Stock outstanding after giving effect
to the Transactions.
Name and Address of Beneficial Owner
Number of Shares
%
Directors and Officers:
Jason Meyenburg (1)
270,020
*
Brian Piekos
-
Scott Lauder (2)
169,230
*
Marc Uknis (3)
64,589
*
Jean George
-
Carl Gordon
-
David Lubner (4)
13,635
Tuyen Ong
-
Jason Rhodes
-
Jim Tananbaum (5)
4,870,250
11.3
All Directors and Executive Officers as a group (10 individuals)
5,376,806
12.5
Five Percent Holders:
FS Development Holdings, LLC (5)
4,870,250
11.3
Orbimed Private Investments VI, LP (6)
5,826,224
13.5
Entities affiliated with Atlas Ventures (7)
5,254,365
12.2
Entities affiliated with Lightstone Ventures (8)
4,836,106
11.2
Entities affiliated with Fidelity (9)
2,500,000
5.8
*
Less than one percent.
(1)
Represents shares of Common Stock that are exercisable as of March 15, 2021 or will become exercisable within 60 days of such date.
(2)
Represents shares issued as Merger consideration
and shares of Common Stock that are exercisable as of March 15, 2021 or will become exercisable within 60 days of such date.
(3)
Represents shares of Common Stock that
are exercisable as of March 15, 2021 or will become exercisable within 60 days of such date.
(4)
Represents shares of Common Stock that
are exercisable as of March 15, 2021 or will become exercisable within 60 days of such date.
(5)
FS Development Holdings, LLC is the record
holder of 4,870,250 shares reported herein, including 1,500,000 shares issued in the PIPE Investment. Foresite Capital Management
V, LLC (“FCM V”), is the general partner of Foresite Capital Fund V LP (“FCM V LP”) and Foresite Capital
Opportunity Management V, LLC (“FCOM V”) is the general partner of Foresite Capital Opportunity Fund V, L.P. (“FCOM
LP”), with FCM LP and FCOM LP being the sole members of FS Development Holdings, LLC. FCM V and FCOM V, as general managers
of the sole members, have voting and investment discretion with respect to the common stock held of record by FS Development Holdings,
LLC. Dr. Tananbaum, in his capacity as managing member of FCM V and FCOM V, may be deemed to have voting and investment discretion
over these shares. Each of FCM V LP, FCOM LP, FCM V, FCOM V and Dr. Tananbaum disclaim beneficial ownership of these shares except
to the extent of any pecuniary interest therein.
(6)
Represents 5,316,224 shares issued as Merger Consideration to OrbiMed Private Investments VI, LP pursuant to the Agreement and Plan of Merger, dated as of October 15, 2020, by and among Gemini Therapeutics, Inc., FS Development Corp., FSG Merger Sub Inc. and Shareholder Representative Services LLC. Also represents 510,000 shares issued in the private placement of public securities (“PIPE”) investment. OrbiMed Capital GP VI LLC, or GP VI, is the general partner of OrbiMed Private Investments VI, LP, or OPI VI. OrbiMed Advisors LLC, or OrbiMed Advisors, is the managing member of GP VI. By virtue of such relationships, OrbiMed Advisors and GP VI may be deemed to have voting and investment power with respect to the shares held by OPI VI and as a result may be deemed to have beneficial ownership of these shares. OrbiMed Advisors exercises investment and voting power through a management committee comprised of Carl Gordon, Sven H. Borho, and Jonathan T. Silverstein, each of whom disclaims beneficial ownership of the shares held by OPI VI.
58
(7)
Represents 4,744,365 shares issued as Merger consideration (4,015,045 shares to Atlas Venture Fund X, L.P. (“Atlas Fund X”) and 729,320 shares to Atlas Venture Opportunity Fund I, L.P. (“Atlas Fund I”)) pursuant to the Agreement and Plan of Merger, dated as of October 15, 2020, by and among Gemini Therapeutics, Inc., FS Development Corp., FSG Merger Sub Inc. and Shareholder Representative Services LLC. Atlas Venture Associates X, L.P. is the general partner of Atlas Fund X, and Atlas Venture Associates X, LLC is the general partner of Atlas Venture Associates X, L.P. Each of Atlas Fund X, Atlas Venture Associates X, L.P., and Atlas Venture Associates X, LLC may be deemed to beneficially own the shares held by Atlas Fund X. Each of Atlas Venture Associates X, L.P. and Atlas Venture Associates X, LLC disclaim Section 16 beneficial ownership of the securities owned by Atlas Fund X, except to the extent of its pecuniary interest therein, if any. Atlas Venture Associates Opportunity I, L.P. is the general partner of Atlas Fund I, and Atlas Venture Associates Opportunity I, LLC, or AVAO, LLC, is the general partner of Atlas Venture Associates Opportunity I, L.P. Each of Atlas Fund I, Atlas Venture Associates Opportunity I, L.P. and AVAO, LLC may be deemed to beneficially own the shares held by Atlas Fund I. Each of Atlas Venture Associates Opportunity I, L.P. and AVAO LLC disclaim Section 16 beneficial ownership of the securities owned by Atlas Fund I, except to the extent of its pecuniary interest therein, if any. Also represents 510,000 shares issued in the private placement of public securities (“PIPE”) on February 5, 2021 to Atlas Venture Fund XII, L.P. (“Atlas Fund XII”). The general partner of Atlas Fund XII is Atlas Venture Associates XII, L.P. (“AVA XII LP”). Atlas Venture Associates XII, LLC (“AVA XII LLC”) is the general partner of AVA XII LP. Each of Atlas Fund XII, AVA XII LP, and AVA XII LLC may be deemed to beneficially own the shares held by Atlas Fund XII. Each of AVA XII LP and AVA XII LLC disclaim Section 16 beneficial ownership of the securities owned by Atlas Fund XII, except to the extent of its pecuniary interest therein, if any.
(8)
Represents 4,436,106 shares issued as Merger Consideration (1,308,198 shares to Lightstone Singapore, L.P. (“LV Singapore”), 375,040 shares to Lightstone Ventures (A), L.P. (“LV(A) LP”) and 2,752,868 shares to Lightstone Ventures, L.P. (“LV LP”)) pursuant to the Agreement and Plan of Merger, dated as of October 15, 2020, by and among Gemini Therapeutics, Inc., FS Development Corp., FSG Merger Sub Inc. and Shareholder Representative Services LLC. LSV Associates, LLC (LSV Associates) is the General Partner of LV Singapore, LV LP and LV(A) LP. As the individual general partners of LSV Associates, Michael A. Carusi, Jean M. George and Henry A. Plain Jr. share voting and dispositive power with respect to the shares held of record by LV Singapore, LV LP and LV(A) LP. Also represents 400,000 shares issued in the private placement of public securities (“PIPE”) on February 5, 2021. LSV Associates is the General Partner of LV Singapore, LV LP and LV(A) LP. As the individual general partners of LSV Associates, Michael A. Carusi, Jean M. George and Henry A. Plain Jr. share voting and dispositive power with respect to the shares held of record by LV Singapore, LV LP and LV(A) LP.
(9)
Represents shares issued in the PIPE Investment. Fidelity Management & Research Company, or Fidelity, 82 Devonshire Street, Boston, Massachusetts 02109, a wholly owned subsidiary of FMR LLC and an investment adviser registered under Section 203 of the Investment Advisers Act of 1940, is the beneficial owner of such shares of common stock as a result of acting as investment adviser to various investment companies registered under Section 8 of the Investment Company Act of 1940. Abigail P. Johnson is a Director, the Chairman, the Chief Executive Officer and the President of FMR LLC. Members of the Johnson family, including Abigail P. Johnson, are the predominant owners, directly or through trusts, of Series B voting common shares of FMR LLC, representing 49% of the voting power of FMR LLC. The Johnson family group and all other Series B shareholders have entered into a shareholders’ voting agreement under which all Series B voting common shares will be voted in accordance with the majority vote of Series B voting common shares. Accordingly, through their ownership of voting common shares and the execution of the shareholders’ voting agreement, members of the Johnson family may be deemed, under the Investment Company Act of 1940, to form a controlling group with respect to FMR LLC. Neither FMR LLC nor Abigail P. Johnson has the sole power to vote or direct the voting of the shares owned directly by the various investment companies registered under the Investment Company Act (“Fidelity Funds”) advised by Fidelity, which power resides with the Fidelity Funds’ Boards of Trustees. Fidelity carries out the voting of the shares under written guidelines established by the Fidelity Funds’ Boards of Trustees.
59
Item 13. Certain Relationships and Related Transactions,
and Director Independence.
On June 30, 2020 the Sponsor purchased
an aggregate of 2,875,000 Founders Shares for a total purchase price of $25,000, or approximately $0.009 per share. In July 2020,
the Sponsor transferred 30,000 Founders Shares to each of Mr. Carey, Dr. Dubin and Dr. Pakianathan. On August 11, 2020,
we effected a 1:1.05 stock split of our Class B Common Stock, resulting in the Sponsor holding 2,928,750 Founders Shares and
there being an aggregate of 3,018,750 Founders Shares outstanding. The number of Founders Shares outstanding was determined based
on the expectation that the total size of the Initial Public Offering would be a maximum of 12,075,000 Class A shares if the
underwriters’ over-allotment option is exercised in full, and therefore that such Founders Shares would represent 20% of
the issued and outstanding shares of common stock (excluding the Private Placement Shares) after such offering.
The Sponsor purchased 441,500 Private Placement
Shares at a price of $10.00 per share, or $4,415,000 in the aggregate, in a private placement that closed simultaneously with the
FS Development IPO. The Private Placement Shares may not, subject to certain limited exceptions, be transferred, assigned or sold
until 30 days after the completion of our initial business combination.
Until the completion of our initial business
combination we utilized office space at 600 Montgomery Street, Suite 4500, San Francisco, California 94111 from the Sponsor. Following
the closing of the Initial Public Offering, we paid the Sponsor $10,000 per month for office space, secretarial and administrative
services provided to members of our management team pursuant to the terms of an administrative services agreement between us and
the Sponsor. Upon completion of our initial business combination, we ceased paying these monthly fees.
No compensation of any kind, including
finder’s and consulting fees, were paid by the Company to the Sponsor, executive officers and directors, or any of their
respective affiliates, for services rendered prior to or in connection with the completion of an initial business combination.
However, these individuals were reimbursed for any out-of-pocket expenses incurred in connection with activities on our behalf
such as identifying potential target businesses and performing due diligence on suitable business combinations. Our audit committee
reviewed on a quarterly basis all payments that were made to the Sponsor, officers, directors or our or their affiliates.
The Sponsor loaned us $200,000 to be used
for a portion of the expenses of the Initial Public Offering. These loans were non-interest bearing, unsecured and were due at
the earlier of December 31, 2020 or the closing of the Initial Public Offering. These loans were fully repaid on August 14, 2020.
In addition, in order to finance transaction
costs in connection with an intended initial business combination, the Sponsor or an affiliate of the Sponsor or certain of our
officers and directors may, but are not obligated to, loan us funds as may be required on a non-interest basis. If we complete
an initial business combination, we would repay such loaned amounts. In the event that the initial business combination does not
close, we may use a portion of the working capital held outside the trust account to repay such loaned amounts but no proceeds
from our trust account would be used for such repayment. Up to $1,500,000 of such loans may be convertible into private placement
shares of the post business combination entity at a price of $10.00 per shares at the option of the lender. Except as set forth
above, the terms of such loans, if any, have not been determined and no written agreements exist with respect to such loans. As
of December 31, 2020, there are no loans outstanding.
Any of the foregoing payments to the Sponsor,
repayments of loans from the Sponsor or repayments of working capital loans prior to our initial business combination will be made
using funds held outside the trust account.
After our initial business combination,
members of our management team who remain with us may be paid consulting, management or other fees from the combined company. The
directors of the post-combination business will determine executive and director compensation.
In connection with the Business Combination,
as part of the PIPE Investment, an affiliate of our Sponsor entered into a subscription agreement to purchase 1,500,000 shares
of our Class A Common Stock at a purchase price of $10 per share in a private placement that occurred concurrently with the
consummation of our initial business combination. The affiliate of our Sponsor assigned to the Sponsor its obligation to purchase
its shares under the subscription agreement so that on the Closing the Sponsor purchased such shares. At the time of the FS Development
IPO, the Sponsor had originally indicated an interest to purchase up to $25 million of shares in connection with FSDC’s initial
business combination. This purchase of 1,500,000 shares represents the Sponsor’s allocation of shares in the PIPE Investment.
The funds from such private placement were used as part of the consideration to the sellers in our initial business combination,
and any excess funds from such private placement would be used for working capital in the post-transaction company.
60
We have entered into a registration rights
agreement (the “existing registration rights agreement”) with respect to the Founders Shares and Private Placement
Shares. Pursuant to such agreement, we will be obligated to register up to 3,520,250 shares of Class A Common Stock. The number
of shares of Class A Common Stock includes (i) 2,928,750 shares of Class A Common Stock to be issued upon conversion
of the Founders Shares, (ii) 441,500 Private Placement Shares and (iii) 150,000 shares of Class A Common Stock issued upon
conversion of working capital loans. The holders of these securities are entitled to make up to three demands, excluding short
form demands, that we register such securities. In addition, the holders have certain “piggy-back” registration rights
with respect to registration statements filed subsequent to our completion of our initial business combination. We will bear the
expenses incurred in connection with the filing of any such registration statements. As part of the registration rights agreement,
certain holders of registrable securities agreed to a lock-up period of one year from the Closing of the Business Combination.
In connection with the Closing of the Business
Combination, the Initial Stockholders and certain other stockholders entered into the Registration Rights Agreement with FSDC and
Old Gemini that replaced the existing registration rights agreement. Pursuant to such agreement, certain stockholders of FSDC and
Old Gemini can each demand that the Gemini register their registrable securities under certain circumstances and will each also
have piggyback registration rights for these securities. In addition, following the Closing, Gemini is required to file and maintain
an effective registration statement under the Securities Act covering such securities and certain other securities of Gemini. The
registration of these securities will permit the public sale of such securities, subject to certain contractual restrictions imposed
by such agreement and the Merger Agreement.
In connection with the execution of the
Merger Agreement, the Initial Stockholders entered into support agreements with FSDC, Old Gemini and Sponsor. Under such support
agreements, each such stockholder agreed to vote, at any meeting of the stockholders of the Company, and in any action by written
consent of the stockholders of the Company, all of such stockholder’s Class B Common Stock of FSDC (i) in favor
of (A) the Merger Agreement, (B) certain proposals requiring approval by the stockholders of the Company in connection
with Business Combination, and (C) the transactions contemplated by the Merger Agreement and the Company Support Agreement,
and (ii) in favor of any other matter reasonably necessary to the consummation of the transactions contemplated by the Merger
Agreement and the approval of such stockholder proposals. In addition, such support agreements prohibit each such stockholder from,
among other things, selling, assigning or transferring any Class B Common Stock of FSDC held by such stockholder or taking
any action that would prevent or disable such stockholder from performing its obligations under the support agreement.
On the Closing Date, Gemini, the Sponsor
and the Major Gemini Investors (collectively, the “ Voting Parties ”) entered into a Voting Agreement, pursuant
to which each Voting Party agrees to vote all voting securities of Gemini that it owns from time to time and that it may vote in
an election of the Company’s directors (collectively, “ Voting Shares ”) in accordance with the provisions
of the Voting Agreement, whether at a regular or special meeting of stockholders.
Pursuant to the Voting Agreement, the post-Closing
Board shall be comprised of seven directors, which must include Jason Meyenburg, Dr. Jim Tananbaum and Dr. Carl Gordon, divided
into three classes, designated Class I, II and III, with Class I consisting of two directors, Class II consisting of three directors
and Class III consisting of two Directors. Jean George and Dr. Carl Gordon shall constitute the initial members of Class I and
shall be nominated in Class I, the members of which shall have an initial term that expires at the annual meeting of stockholders
of Gemini held in 2021; David Lubner, Dr. Tuyen Ong and Jason Rhodes shall constitute the initial members of Class II and shall
be nominated in Class II, the members of which shall have an initial term that expires at the annual meeting of stockholders of
Gemini held in 2022; and Jason Meyenburg and Dr. Jim Tananbaum shall constitute the initial members of Class III and shall be nominated
in Class III, the members of which shall have an initial term that expires at the annual meeting of stockholders of Gemini held
in 2023.
Pursuant to the Voting Agreement, until
the earlier of (i) fifth anniversary of the Closing Date or (ii) the date on which Sponsor owns less than 1,217,563 shares of Common
Stock, at each annual or special meeting of stockholders of Gemini, Sponsor shall have the right to designate for election as a
member of the Board, and the Board (including any committee thereof) shall nominate (and recommend for election and include such
recommendation in a timely manner in any proxy statement or other applicable announcement to Gemini’s stockholders), one
individual to serve as a Class III Director. If Sponsor ceases to be entitled to nominate any directors, then such directors shall
be nominated by the Board and approved by the holders of the outstanding shares of Common Stock.
61
Pursuant to the Voting Agreement, Old Gemini
shall have the authority to appoint four directors to the Board, with such procedures as are determined by Old Gemini’s Board.
All directors elected pursuant to the terms
of the Voting Agreement shall be removed from the Board only upon the vote or written consent of the Voting Party that is entitled
to nominate, appoint or elect such director. Upon any decrease in the rights of any such Voting Party to nominate, appoint or elect
any director, the applicable Voting Party shall promptly cause the removal or resignation of an applicable directors if requested
by the Board. Upon any individual elected to serve as a director pursuant to the Voting Agreement ceasing to be a member of the
Board, whether by death, resignation or removal or otherwise, only the Voting Party that was entitled to nominate, appoint or elect
such individual shall have the right to fill any resulting vacancy in the Board; provided that such Voting Party still has the
right to nominate, appoint or elect the applicable director.
Director Independence
The rules of the Nasdaq
require that a majority of the our Board be independent. An “independent director” is defined generally as a person
other than an executive officer or employee of us or any other individual having a relationship which, in the opinion of the issuer’s
board of directors, would interfere with the exercise of independent judgement in carrying out the responsibilities of a director.
The Board has determined that each individual who serves on the Board, other than Mr. Meyenburg and Dr. Tananbaum, qualifies as
an independent director under Nasdaq listing standards.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND
SERVICES
The following is a summary of fees paid
to WithumSmith+Brown, PC, for services rendered.
Audit Fees . Audit fees consist of
fees billed for professional services rendered for the audit of our year-end financial statements, reviews of our quarterly financial
statements and services that are normally provided by our independent registered public accounting firm in connection with statutory
and regulatory filings. The aggregate fees billed by WithumSmith+Brown, PC for audit fees, inclusive of required filings with the
SEC for the period from June 25, 2020 (inception) through December 31, 2020, and of services rendered in connection with our initial
public offering, totaled $122,365.
Audit-Related Fees . Audit-related
fees consist of fees billed for assurance and related services that are reasonably related to performance of the audit or review
of our year-end financial statements and are not reported under “Audit Fees.” These services include attest services
that are not required by statute or regulation and consultation concerning financial accounting and reporting standards. We did
not pay WithumSmith+Brown, PC any audit-related fees during the period from June 25, 2020 (inception) through December 31, 2020.
Tax Fees . Tax fees consist of fees
billed for professional services relating to tax compliance, tax planning and tax advice. We did not pay WithumSmith+Brown, PC
any tax fees during the period from June 25, 2020 (inception) through December 31, 2020.
All Other Fees . All other fees consist
of fees billed for all other services. We did not pay WithumSmith+Brown, PC any other fees during the period from June 25, 2020
(inception) through December 31, 2020.
62
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT
SCHEDULES.
(a)
The following documents are filed as part of this report:
(1)
Financial Statements
Reference is made to the Index to Financial Statements
of the Company under Item 8 of Part II above.
(2)
Financial Statement Schedule
All financial statement schedules are omitted because
they are not applicable or the amounts are immaterial, not required, or the required information is presented in the financial
statements and notes thereto in Item 8 of Part II above.
(3)
Exhibits
We hereby file as part of this
report the exhibits listed in the attached Exhibit Index.
Exhibit Index
Exhibit No.
Description
2.1†
Merger Agreement, dated as of October 15, 2020, by and among Gemini Therapeutics, Inc., Shareholder Representative Services LLC, FS Development Corp., and FSG Merger Sub Inc. (incorporated by reference to Annex A to the Proxy Statement/Prospectus).
3.1
Amended and Restated Articles of Incorporation of Gemini Therapeutics, Inc. (incorporated by reference to Annex B to the Proxy Statement/Prospectus).
3.2
Amended and Restated By-laws of Gemini Therapeutics, Inc. (incorporated by reference to Annex C to the Proxy Statement/Prospectus).
4.1
Form of Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to Form S-4/A filed on January 19, 2021).
10.1
Registration
Rights Agreement, dated February 5, 2021, by and among Gemini Therapeutics, Inc. and the stockholders party thereto (incorporated
by reference to Exhibit 10.1 on Form 8-A12B/A filed on February 5, 2021.)
10.2
Voting Agreement, dated February 5, 2021, by and among Gemini Therapeutics, Inc. and the other parties thereto. (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on February 11, 2021).
10.3
Lockup Agreement, dated February 5, 2021, by and among Gemini Therapeutics, Inc. and the other parties thereto (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed on February 11, 2021).
10.4
Gemini 2021 Stock Option and Incentive Plan (incorporated by reference to Annex D to the Proxy Statement/Prospectus).
10.5
Forms of Award Agreements under the Gemini 2021 Stock Option and Incentive Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s Current Report on Form 8-K filed on February 11, 2021).
10.6
Form of Indemnification Agreement for Directors of Gemini Therapeutics, Inc. (incorporated by reference to Exhibit 10.6 to the Registrant’s Current Report on Form 8-K filed on February 11, 2021).
10.7
Form of Indemnification Agreement for Executive Officers of Gemini Therapeutics, Inc. (incorporated by reference to Exhibit 10.7 to the Registrant’s Current Report on Form 8-K filed on February 11, 2021).
10.8
Escrow Agreement (Shareholder Representative), dated as of February 5, 2021, by and among FS Development Holdings, LLC, FS Development Corp., Shareholder Representative Services LLC and Continental Stock Transfer & Trust Company (incorporated by reference to Exhibit 10.2 on Form 8-A12B/A filed on February 5, 2021).
10.9
Form of Subscription Agreement (incorporated by reference to Annex E to the Proxy Statement/Prospectus).
10.10
Employment Agreement, dated January 21, 2021, by and between Gemini Therapeutics, Inc. and Jason Meyenburg (incorporated by reference to Exhibit 10.9 to the Registrant’s Current Report on Form 8-K filed on February 11, 2021) .
63
10.11
Employment Agreement, dated December 24, 2020, by and between Gemini Therapeutics, Inc. and Dr. Marc Uknis (incorporated by reference to Exhibit 10.10 to the Registrant’s Current Report on Form 8-K filed on February 11, 2021).
10.12
Employment Agreement, dated January 22, 2021, by and between Gemini Therapeutics, Inc. and Dr. Scott Lauder (incorporated by reference to Exhibit 10.11 to the Registrant’s Current Report on Form 8-K filed on February 11, 2021).
16.1
Withum’s Letter to the Securities and Exchange Commission, dated February 11, 2021 (incorporated by reference to Exhibit 16.1 to the Registrant’s Current Report on Form 8-K filed on February 11, 2021).
21.1
List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Registrant’s Current Report on Form 8-K filed on February 11, 2021).
24*
Power of Attorney (included on signature page of this report).
31.1*
Certification of the Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of the Chief Financial Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 .
32.1*+
Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 .
32.2*+
Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 .
101.INS*
XBRL Instance Document
101.SCH*
XBRL Taxonomy Extension Schema Document
101.CAL*
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
XBRL Taxonomy Extension Label Linkbase Document
101.LAB*
XBRL Taxonomy Extension Label Linkbase Document
†
Certain of the exhibits and schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Registrant agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request.
*
Filed herewith.
+
The certifications furnished in Exhibit 32.1 and Exhibit 32.2 hereto are deemed to accompany this Annual Report on Form 10-K and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the registrant specifically incorporates it by reference.
64
FS
DEVELOPMENT CORP.
INDEX
TO FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm
F-2
Financial
Statements
Balance Sheet as of December 31, 2020
F-3
Statement of Operations for the period from June 25, 2020 (inception) through December 31, 2020
F-4
Statement
of Changes in Stockholders’ Equity for the period from June 25, 2020 (inception) through December 31, 2020
F-5
Statement
of Cash Flows for the period from June 25, 2020 (inception) through Years Ended December 31, 2020
F-6
Notes
to Financial Statements
F-7
F- 1
Report
of Independent Registered Public Accounting Firm
To
the Stockholders and the Board of Directors of
FS
Development Corp.
Opinion
on the Financial Statements
We
have audited the accompanying balance sheet of FS Development Corp. (the “Company”) as of December 31, 2020, the related
statements of operations, changes in stockholders’ equity and cash flows for the period from June 25, 2020 (inception) through
December 31, 2020, and the related notes (collectively referred to as the “financial statements”). In our opinion,
the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2020,
and the results of its operations and its cash flows for the period from June 25, 2020 (inception) through December 31, 2020,
in conformity with accounting principles generally accepted in the United States of America.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on
the Company’s financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting
Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance
with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the
PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error
or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
reporting. As part of our audit we are required to obtain an understanding of internal control over financial reporting but not
for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly,
we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the financial statement, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
We believe that our audit provides a reasonable basis for our opinion.
/s/
WithumSmith+Brown, PC
We
have served as the Company’s auditor since 2020.
New
York, New York
March
29, 2021
F- 2
FS
DEVELOPMENT CORP.
BALANCE
SHEET
December
31, 2020
Assets:
Current assets:
Cash
$ 1,212,084
Prepaid expenses
125,948
Total current assets
1,338,032
Cash equivalents held in Trust Account
120,754,533
Total Assets
$ 122,092,565
Liabilities and Stockholders’ Equity:
Current liabilities:
Accounts payable
$ 4,653
Accrued expenses
492,588
Franchise tax payable
100,324
Total current liabilities
597,565
Deferred underwriting commissions
4,226,250
Total liabilities
4,823,815
Commitments and Contingencies
Class A common stock, $0.0001 par value; 11,226,874 shares subject to possible redemption at $10.00 per share
112,268,740
Stockholders’ Equity:
Preferred stock, $0.0001 par value; 1,000,000 shares authorized; none issued and outstanding
-
Class A common stock, $0.0001 par value; 100,000,000 shares authorized; 1,289,626 shares issued and outstanding (excluding 11,226,874 shares subject to possible redemption)
129
Class B common stock, $0.0001 par value; 10,000,000 shares authorized; 3,018,750 shares issued and outstanding
302
Additional paid-in capital
5,812,074
Accumulated deficit
(812,495 )
Total stockholders’ equity
5,000,010
Total Liabilities and Stockholders’ Equity
$ 122,092,565
The
accompanying notes are an integral part of these financial statements.
F- 3
FS
DEVELOPMENT CORP.
STATEMENT
OF OPERATIONS
For
the Period from June 25, 2020 (inception) through December 31, 2020
General and administrative expenses
$ 716,705
Franchise tax expense
100,323
Operating Expenses
(817,028 )
Interest earned on cash equivalents held in Trust Account
4,533
Loss before income tax expense
(812,495 )
Income tax benefit
-
Net Loss
(812,495 )
Weighted average shares outstanding of Class A common stock subject to redemption
12,075,000
Basic and diluted net income per share, Class A common stock subject to redemption
$ 0.00
Weighted average shares outstanding of Class B common stock and non-redeemable Class A common stock
3,257,081
Basic and diluted net loss per share, Class B common stock and non-redeemable Class A common stock
$ (0.25 )
The
accompanying notes are an integral part of these financial statements.
F- 4
FS
DEVELOPMENT CORP.
STATEMENT
OF CHANGES IN STOCKHOLDERS’ EQUITY
For
the Period from June 25, 2020 (inception) through December 31, 2020
Common Stock
Additional
Total
Class A
Class B
Paid-In
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance - June 25, 2020 (inception)
-
$ -
-
$ -
$ -
$ -
$ -
Issuance of Class B common stock to initial stockholders
-
-
3,018,750
302
24,698
-
25,000
Sale of units in initial public offering, gross
12,075,000
1,208
-
-
120,748,792
-
120,750,000
Offering costs
-
-
-
-
(7,108,755 )
-
(7,108,755 )
Sale of private placement warrants to Sponsor in private placement
441,500
44
-
-
4,414,956
-
4,415,000
Common stock subject to possible redemption
(11,226,874 )
(1,123 )
-
-
(112,267,617 )
-
(112,268,740 )
Net loss
-
-
-
-
-
(812,495 )
(812,495 )
Balance - December 31, 2020
1,289,626
$ 129
3,018,750
$ 302
$ 5,812,074
$ (812,495 )
$ 5,000,010
The
accompanying notes are an integral part of these financial statements.
F- 5
FS
DEVELOPMENT CORP.
STATEMENT
OF CASH FLOWS
For
the Period from June 25, 2020 (inception) through December 31, 2020
Cash Flows from Operating Activities:
Net loss
$ (812,495 )
Interest earned on cash equivalents held in Trust Account
(4,533 )
Changes in operating assets and liabilities:
Prepaid expenses
(125,948 )
Accounts payable
3,653
Franchise tax payable
100,324
Accrued expenses
422,588
Net cash used in operating activities
(416,411 )
Cash Flows from Investing Activities
Cash deposited in Trust Account
(120,750,000 )
Net cash used in investing activities
(120,750,000 )
Cash Flows from Financing Activities:
Proceeds from issuance of Class B common stock to Sponsor
25,000
Proceeds from note payable to related party
200,000
Repayment of note payable to related party
(200,000 )
Proceeds received from initial public offering, gross
120,750,000
Proceeds received from private placement
4,415,000
Offering costs paid
(2,811,505 )
Net cash provided by financing activities
122,378,495
Net increase in cash
1,212,084
Cash - beginning of the period
-
Cash - end of the period
$ 1,212,084
Supplemental disclosure of noncash activities:
Offering costs included in accounts payable
$ 1,000
Offering costs included in accrued expenses
$ 70,000
Deferred underwriting commissions in connection with the initial public offering
$ 4,226,250
Initial value of Class A common stock subject to possible redemption
$ 113,053,770
Change in value of Class A common stock subject to possible redemption
$ (785,030 )
The
accompanying notes are an integral part of these financial statements.
F- 6
FS DEVELOPMENT CORP.
NOTES TO THE FINANCIAL STATEMENTS
Note 1—Description
of Organization, Business Operations and Basis of Presentation
FS
Development Corp. (the “Company”) is a blank check company incorporated in Delaware on June 25, 2020. The Company
was formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or
similar business combination with one or more businesses (the “Business Combination”). The Company is an emerging
growth company and, as such, the Company is subject to all of the risks associated with emerging growth companies.
As
of December 31, 2020, the Company had not commenced any operations. All activity for the period from June 25, 2020 (inception)
through December 31, 2020 relates to the Company’s formation and the initial public offering (“Initial Public Offering”)
and since the closing of the Initial Public Offering, the search for a prospective initial Business Combination. The Company will
not generate any operating revenues until after the completion of its initial Business Combination, at the earliest. The Company
will generate non-operating income in the form of interest income on cash and cash equivalents from the proceeds derived
from the Initial Public Offering. The Company has selected December 31 as its fiscal year end.
The
Company’s sponsor is FS Development Holdings, LLC, a Delaware limited liability company (the “Sponsor”). The
registration statement for the Company’s Initial Public Offering became effective on August 11, 2020. On August 14, 2020,
the Company consummated its Initial Public Offering of 12,075,000 shares of Class A common stock, including the issuance
of 1,575,000 shares of Class A Common Stock as a result of the underwriter’s exercise in full of its over-allotment option,
(each, a “Public Share” and collectively, the “Public Shares”) at $10.00 per share, generating gross proceeds
of approximately $120.8 million, and incurring offering costs of approximately $7.1 million, inclusive of approximately
$4.2 million in deferred underwriting commissions (Note 5).
Simultaneously
with the closing of the Initial Public Offering, the Company consummated the private placement (“Private Placement”)
of 441,500 shares of Class A common stock (each, a “Private Placement Share” and collectively, the “Private
Placement Shares”), at a price of $10.00 per Private Placement Share to the Sponsor, generating proceeds of approximately
$4.4 million (Note 4).
Upon
the closing of the Initial Public Offering and the Private Placement , approximately
$120.8 million ($10.00 per share) of the net proceeds of the sale of the Public
Shares in the Initial Public Offering and of the Private Placement Shares in the Private Placement were placed in a trust
account (“Trust Account”) located in the United States at JP Morgan Chase Bank, N.A. with Continental Stock Transfer & Trust Company acting as trustee, and are invested only in U.S. “government securities” within the meaning of
Section 2(a)(16) of the Investment Company Act having a maturity of 185 days or less or in money market funds meeting certain
conditions under Rule 2a-7 promulgated under the Investment Company Act which invest only in direct U.S. government treasury
obligations, as determined by the Company, until the earlier of: (i) the completion of a Business Combination and (ii) the distribution
of the Trust Account as described below.
The
Company’s management has broad discretion with respect to the specific application of the net proceeds of the Initial Public
Offering and the sale of Private Placement Shares, although substantially all of the net proceeds are intended to be applied generally
toward consummating a Business Combination. There is no assurance that the Company will be able to complete a Business Combination
successfully. The Company must complete one or more initial Business Combinations having an aggregate fair market value of at
least 80% of the net assets held in the Trust Account (as defined below) (net of amounts disbursed to management for working capital
purposes and excluding the amount of any deferred underwriting discount held in trust) at the time of the agreement to enter into
the initial Business Combination. However, the Company will only complete a Business Combination if the post-transaction company
owns or acquires 50% or more of the voting securities of the target or otherwise acquires a controlling interest in the target
sufficient for it not to be required to register as an investment company under the Investment Company Act of 1940, as amended
(the “Investment Company Act”).
F- 7
The Company will provide the holders of the Company’s
outstanding Public Shares (the “Public Stockholders”) with the opportunity to redeem all or a portion of their Public
Shares upon the completion of a Business Combination either (i) in connection with a stockholder meeting called to approve the
Business Combination or (ii) by means of a tender offer. The decision as to whether the Company will seek stockholder approval
of a Business Combination or conduct a tender offer will be made by the Company, solely in its discretion. The Public Stockholders
will be entitled to redeem their Public Shares for a pro rata portion of the amount then held in the Trust Account (initially anticipated
to be $10.00 per Public Share). The per-share amount to be distributed to Public Stockholders who redeem their Public Shares
will not be reduced by the deferred underwriting commissions the Company will pay to the underwriters (as discussed in Note 5).
These Public Shares will be recorded at a redemption value and classified as temporary equity upon the completion of the Initial
Public Offering in accordance with the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification
(“ASC”) Topic 480 “Distinguishing Liabilities from Equity.” The Company will proceed with a Business Combination
if a majority of the shares voted are voted in favor of the Business Combination. The Company will not redeem the Public Shares
in an amount that would cause its net tangible assets to be less than $5,000,001. If a stockholder vote is not required by law
and the Company does not decide to hold a stockholder vote for business or other legal reasons, the Company will, pursuant to its
Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”), conduct the redemptions pursuant
to the tender offer rules of the U.S. Securities and Exchange Commission (“SEC”) and file tender offer documents with
the SEC prior to completing a Business Combination. If, however, stockholder approval of the transaction is required by law, or
the Company decides to obtain stockholder approval for business or legal reasons, the Company will offer to redeem shares in conjunction
with a proxy solicitation pursuant to the proxy rules and not pursuant to the tender offer rules. Additionally, each public stockholder
may elect to redeem their Public Shares irrespective of whether they vote for or against the proposed transaction. If the Company
seeks stockholder approval in connection with a Business Combination, the Initial Stockholders (as defined below) have agreed to
vote their Founder Shares (as defined below in Note 4) and any Public Shares purchased during or after the Initial Public Offering
in favor of a Business Combination. In addition, the Initial Stockholders have agreed to waive their redemption rights with respect
to their Founder Shares and Public Shares in connection with the completion of a Business Combination.
The
Certificate of Incorporation provides that a Public Stockholder, together with any affiliate of such stockholder or any other
person with whom such stockholder is acting in concert or as a “group” (as defined under Section 13 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”)), will be restricted from redeeming its shares with respect
to more than an aggregate of 20% or more of the Public Shares, without the prior consent of the Company.
The
Sponsor and the Company’s officers and directors (the “Initial Stockholders”) have agreed not to propose an
amendment to the Certificate of Incorporation to modify the substance or timing of the Company’s obligation to redeem 100%
of the Public Shares if the Company does not complete a Business Combination within the Combination Period (as defined below)
or with respect to any other material provisions relating to stockholders’ rights or pre-initial Business Combination
activity, unless the Company provides the Public Stockholders with the opportunity to redeem their Public Shares in conjunction
with any such amendment.
If
the Company is unable to complete a Business Combination within 24 months from the closing of the Initial Public Offering,
or August 14, 2022 (the “Combination Period”), the Company will (i) cease all operations except for the purpose of
winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem the Public Shares,
at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account, including interest
earned on the funds held in the Trust Account and not previously released to the Company to pay its taxes (less up to $100,000
of interest to pay dissolution expenses), divided by the number of then outstanding Public Shares, which redemption will completely
extinguish Public Stockholders’ rights as stockholders (including the right to receive further liquidating distributions,
if any), and (iii) as promptly as reasonably possible following such redemption, subject to the approval of the remaining stockholders
and the board of directors, liquidate and dissolve, subject in each case to the Company’s obligations under Delaware law
to provide for claims of creditors and the requirements of other applicable law.
The
Initial Stockholders have agreed to waive their rights to liquidating distributions from the Trust Account with respect to the
Founder Shares and Private Placement Shares if the Company fails to complete a Business Combination within the Combination Period.
However, if the Initial Stockholders acquire Public Shares on or after the Initial Public Offering, they will be entitled to liquidating
distributions from the Trust Account with respect to such Public Shares if the Company fails to complete a Business Combination
within the Combination Period. The underwriters have agreed to waive their rights to the deferred underwriting commission (see
Note 5) held in the Trust Account in the event the Company does not complete a Business Combination within the Combination Period
and, in such event, such amounts will be included with the other funds held in the Trust Account that will be available to fund
the redemption of the Public Shares. In the event of such distribution, it is possible that the per share value of the residual
assets remaining available for distribution (including Trust Account assets) will be only $10.00. In order to protect the amounts
held in the Trust Account, the Sponsor has agreed to be liable to the Company if and to the extent any claims by a third party
(except for the Company’s independent registered public accounting firm) for services rendered or products sold to the Company,
or a prospective target business with which the Company has entered into a letter of intent, confidentiality or other similar
agreement or business combination agreement (a “Target”), reduce the amount of funds in the Trust Account to below
the lesser of (i) $10.00 per Public Share and (ii) the actual amount per Public Share held in the Trust Account as of the date
of the liquidation of the Trust Account, if less than $10.00 per Public Share due to reductions in the value of the trust assets,
less taxes payable, provided that such liability will not apply to any claims by a third party or Target that executed a waiver
of any and all rights to the monies held in the Trust Account (whether or not such waiver is enforceable) nor will it apply to
any claims under the Company’s indemnity of the underwriters of the Initial Public Offering against certain liabilities,
including liabilities under the Securities Act of 1933, as amended (the “Securities Act”). The Company will seek to
reduce the possibility that the Sponsor will have to indemnify the Trust Account due to claims of creditors by endeavoring to
have all vendors, service providers, prospective target businesses or other entities with which the Company does business, execute
agreements with the Company waiving any right, title, interest or claim of any kind in or to monies held in the Trust Account.
F- 8
Business Combination
On February 5, 2021 (the “Closing
Date”), subsequent to the end of the fiscal year ended December 31, 2020, the Company consummated the previously announced
business combination (the “ Business Combination ”) pursuant to the terms of the Agreement and Plan of Merger,
dated as of October 15, 2020 (as amended, supplemented or otherwise modified from time to time, the “ Merger Agreement ”),
by and among Gemini Therapeutics, Inc., a Delaware corporation (“ Old Gemini ”), Shareholder Representative Services
LLC, a Colorado limited liability company solely in its capacity as the representative, agent and attorney-in-fact of the Company
Securityholders (the “ Stockholders’ Representative ”), the Company and FSG Merger Sub Inc., a Delaware
corporation (“ Merger Sub ”).
On the day prior to the Closing Date, Old
Gemini changed its name to “Gemini Therapeutics Sub, Inc.” Pursuant to the Merger Agreement, on the Closing Date, (i)
FSDC changed its name to “Gemini Therapeutics, Inc.” (together with its consolidated subsidiaries, “ Gemini ”),
and (ii) Old Gemini merged with and into Merger Sub (the “ Merger ”), with Old Gemini as the surviving company
in the Merger and, after giving effect to such Merger, Old Gemini becoming a wholly-owned subsidiary of Gemini.
In accordance with the terms and subject
to the conditions of the Merger Agreement, at the effective time of the Merger (the “ Effective Time ”), (i) all
shares of Old Gemini’s Series B Preferred Stock (including shares of Series B Preferred Stock issued upon conversion of outstanding
convertible promissory notes), Series A Preferred Stock and Common Stock (collectively, “ Old Gemini Stock ”)
issued and outstanding immediately prior to the Effective Time, whether vested or unvested, was converted into the right to receive
their pro rata portion of the 17,942,274 shares of FSDC Class A Common Stock (the “ Common Stock ”) issued as
Merger consideration (the “ Merger Consideration ”), provided that 2,150,000 shares of Common Stock are being
held in escrow for a period of 12 months to satisfy any indemnification obligations of Old Gemini under the Merger Agreement; (ii)
each option exercisable for Old Gemini Stock that was outstanding immediately prior to the Effective Time was assumed and continues
in full force and effect on the same terms and conditions as were previously applicable to such options, subject to adjustments
to exercise price and number of shares Common Stock issuable upon exercise based on the final conversion ratio calculated in accordance
with the Merger Agreement, and (iii) 4,264,341 shares of Common Stock were reserved for issuance under the newly adopted 2021 Stock
Option and Incentive Plan (the “ 2021 Plan ”).
All references herein to the “Closing”
refer to the closing of the transactions contemplated by the Merger Agreement (the “ Transactions ”), including
the Merger and the transactions contemplated by the subscription agreements entered into by the Company and certain investors (the
“ PIPE Investors ”) pursuant to which the PIPE Investors collectively committed to subscribe for, and did subscribe
for, an aggregate of 9,506,000 shares of Common Stock for an aggregate purchase price of $95,060,000 (the “ PIPE Investment ”).
Basis
of Presentation
The
accompanying financial statements are presented in U.S. dollars, in conformity with accounting principles generally accepted in
the United States of America (“GAAP”) for financial information and pursuant to the rules and regulations of the Securities
and Exchange Commission (“SEC”).
F- 9
Emerging
Growth Company
The
Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act, as modified by
the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and it may take advantage of certain exemptions
from various reporting requirements that are applicable to other public companies that are not emerging growth companies including,
but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley
Act of 2002, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any
golden parachute payments not previously approved.
Further,
Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised
financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement
declared effective or do not have a class of securities registered under the Exchange Act) are required to comply with the new
or revised financial accounting standards. The JOBS Act provides that an emerging growth company can elect to opt out of the extended
transition period and comply with the requirements that apply to non-emerging growth companies but
any such an election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period, which
means that when a standard is issued or revised and it has different application dates for public or private companies, the Company,
as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard.
This
may make comparison of the Company’s financial statements with another public company that is neither an emerging growth
company nor an emerging growth company that has opted out of using the extended transition period difficult or impossible because
of the potential differences in accounting standards used.
Liquidity
and Capital Resources
The
accompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates,
among other things, the realization of assets and satisfaction of liabilities in the normal course of business. As of December
31, 2020, the Company had approximately $1.2 million in its operating bank account, approximately $5,000 of interest income
available in the Trust Account to pay the Company’s franchise and income tax obligations and working capital of approximately
$740,000. Further, the Company has incurred significant costs in pursuit of its acquisition plans.
The
Company’s liquidity needs to date have been satisfied through the $25,000 capital contribution to purchase Founder Shares
(as defined below) by the Sponsor, the loan proceeds under a promissory note of $200,000 from the Sponsor to cover the Company’s
offering costs in connection with the Initial Public Offering, and the net proceeds from the consummation of the Private Placement
not held in the Trust Account. The balance of the promissory note was fully repaid on August 14, 2020. In addition, in order to
finance transaction costs in connection with a Business Combination, the Sponsor or an affiliate of the Sponsor, or certain of
the Company’s officers and directors may, but are not obligated to, provide the Company Working Capital Loans (see Note
4). As of December 31, 2020, there were no amounts outstanding under any Working Capital Loans.
Based
on the foregoing, management believes that the Company will have sufficient working capital and borrowing capacity from the Sponsor
or an affiliate of the Sponsor, or certain of the Company’s officers and directors to meet its needs through the earlier
of the consummation of a Business Combination or one year from this filing. Over this time period, the Company will be using these
funds for paying existing accounts payable, identifying and evaluating prospective initial Business Combination candidates, performing
due diligence on prospective target businesses, paying for travel expenditures, selecting the target business to merge with or
acquire, and structuring, negotiating and consummating the Business Combination.
Management
continues to evaluate the impact of the COVID-19 pandemic and has concluded that the specific impact is not readily determinable
as of the date of the balance sheet. The financial statements do not include any adjustments that might result from the outcome
of this uncertainty.
F- 10
Note 2—Basis
of Presentation and Summary of Significant Accounting Policies
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Making estimates requires management
to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation
or set of circumstances that existed at the date of the financial statements, which management considered in formulating its estimate,
could change in the near term due to one or more future confirming events. Actual results could differ from those estimates.
Cash
and Cash Equivalents
The
Company considers all short-term investments with an original maturity of three months or less when purchased to be cash equivalents. The
Company had $120,754,533 in cash equivalents held in the Trust Account as of December 31, 2020.
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentration of credit risk consist of cash accounts in a financial institution
which, at times, may exceed the Federal depository insurance coverage of $250,000, and investments held in Trust Account. The
Company has not experienced losses on these accounts and management believes the Company is not exposed to significant risks on
such accounts.
Investments
Held in the Trust Account
The
Company’s portfolio of investments held in the Trust Account is comprised of U.S. government securities, within the meaning
set forth in Section 2(a)(16) of the Investment Company Act, with a maturity of 185 days or less, or investments in money market
funds that invest in U.S. government securities, or a combination thereof. The Company’s investments held in the Trust Account
are classified as trading securities. Trading securities are presented on the balance sheet at fair value at the end of each reporting
period. Gains and losses resulting from the change in fair value of these investments are included in net gain from investments
held in Trust Account in the accompanying statement of operations. The estimated fair values of investments held in the Trust
Account are determined using available market information, other than for investments in open-ended money market funds with published
daily net asset values (“NAV”), in which case the Company uses NAV as a practical expedient to fair value. The NAV
on these investments is typically held constant at $1.00 per unit.
Fair
Value of Financial Instruments
Fair
value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction
between market participants at the measurement date. GAAP establishes a three-tier fair value hierarchy, which prioritizes the
inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for
identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements).
These tiers include:
● Level
1, defined as observable inputs such as quoted prices (unadjusted) for identical instruments in active markets;
● Level
2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted
prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not
active; and
F- 11
● Level
3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are
unobservable.
In
some circumstances, the inputs used to measure fair value might be categorized within different levels of the fair value hierarchy.
In those instances, the fair value measurement is categorized in its entirety in the fair value hierarchy based on the lowest
level input that is significant to the fair value measurement.
As
of December 31, 2020, the carrying values of cash, accounts payable, accrued expenses and franchise tax payable approximate their
fair values due to the short-term nature of the instruments.
Offering
Costs Associated with the Initial Public Offering
The
Company complies with the requirements of the FASB ASC Topic 340-10-S99-1 and SEC Staff Accounting Bulletin Topic 5A – “Expenses
of Offering.” Offering costs consist of costs incurred in connection with the formation and preparation for the Initial
Public Offering. These costs, together with the underwriting discount, were charged to additional paid-in capital upon the completion
of the Initial Public Offering.
Class A
Common Stock Subject to Possible Redemption
The
Company accounts for its Class A common stock subject to possible redemption in accordance with the guidance in FASB ASC
Topic 480 “Distinguishing Liabilities from Equity.” Shares of Class A common stock subject to mandatory redemption
(if any) are classified as liability instruments and are measured at fair value. Shares of conditionally redeemable Class A
common stock (including Class A common stock that feature redemption rights that are either within the control of the holder
or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified
as temporary equity. At all other times, shares of Class A common stock are classified as stockholders’ equity. The
Company’s Class A common stock features certain redemption rights that are considered to be outside of the Company’s
control and subject to the occurrence of uncertain future events. Accordingly, as of December 31, 2020, 11,226,874 shares of Class A
common stock subject to possible redemption are presented as temporary equity, outside of the stockholders’ equity section
of the Company’s balance sheet.
Net
Loss Per Common Share
Net loss per common share of common stock
is computed by dividing net loss applicable to stockholders by the weighted average number of shares of common stock outstanding
during the periods. The Company’s statement of operations includes a presentation of income per share for common stock subject
to redemption in a manner similar to the two-class method of income per share. Net income per common share,
basic and diluted for Class A common stock subject to redemption is calculated by dividing the net gain from investments held
in the Trust Account of approximately $4,500, net of applicable franchise taxes of approximately $4,500 for the period from June
25, 2020 (inception) through December 31, 2020, by the weighted average number of shares of Class A common stock subjection
to redemption that is outstanding for the period. Net loss per common share, basic and diluted for Class B common stock and
non-redeemable Class A common stock for the period from June 25, 2020 (inception) through December 31, 2020 is calculated by dividing
the general and administration expenses of approximately $717,000 and franchise taxes of approximately $95,000, resulting in a
net loss of approximately $812,000, by the weighted average number of Class B common stock and non-redeemable Class A common stock
outstanding for the period.
Income
Taxes
The
Company complies with the accounting and reporting requirements of FASB ASC Topic 740, “Income Taxes,” which requires
an asset and liability approach to financial accounting and reporting for income taxes. Deferred tax assets and liabilities are
recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts
of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted
tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or
settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that
included the enactment date. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount
expected to be realized.
F- 12
FASB
ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement
of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to
be sustained upon examination by taxing authorities. The Company recognizes accrued interest and penalties related to unrecognized
tax benefits as income tax expense.
Recent
Accounting Pronouncements
Management
does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have
an effect on the Company’s financial statements.
Note 3—Initial
Public Offering
On
August 14, 2020, the Company consummated its Initial Public Offering of 12,075,000 Public Shares, including the issuance of 1,575,000
Public Shares as a result of the underwriter’s exercise in full of its over-allotment option, at $10.00 per share, generating
gross proceeds of approximately $120.8 million, and incurring offering costs of approximately $7.1 million, inclusive of approximately
$4.2 million in deferred underwriting commissions.
Note
4—Related Party Transactions
Founder
Shares and Private Placement Shares
On
June 30, 2020, the Sponsor purchased 2,875,000 shares of the Company’s Class B common stock, par value $0.0001 per share,
(the “Founder Shares”) for an aggregate price of $25,000. On July 24, 2020, the Sponsor transferred 30,000 Founder
Shares to each of its independent director nominees at their original per-share purchase price, for an aggregate of 90,000 Founder
Shares transferred. On August 11, 2020, the Company effected a 1:1.05 stock split of the Class B common stock, resulting in the
Sponsor holding an aggregate of 2,928,750 Founder Shares and there being an aggregate of 3,018,750 Founder Shares outstanding. All
shares and the associated amounts have been retroactively restated to reflect the aforementioned stock split. The Sponsor
agreed to forfeit up to 393,750 Founder Shares to the extent that the over-allotment option is not exercised in full
by the underwriter, so that the Founder Shares would represent 20.0% of the Company’s issued and outstanding shares of common
stock after the Initial Public Offering (excluding the Private Placement Shares). On August 14, 2020, the underwriter exercised
the over-allotment option; thus, these Founder Shares were no longer subject to forfeiture.
Simultaneously
with the closing of the Initial Public Offering, the Company consummated the Private Placement of 441,500 Private Placement
Shares, at a price of $10.00 per Private Placement Share to the Sponsor, generating proceeds of approximately $4.4 million.
The
Initial Stockholders agreed, subject to limited exceptions, not to transfer, assign or sell any of the Founder Shares or Private
Placement Shares until the earlier to occur of: (i) one year after the completion of the initial Business Combination and (ii)
the date on which the Company completes a liquidation, merger, capital stock exchange or other similar transaction after the initial
Business Combination that results in all of the Company’s stockholders having the right to exchange their Class A common
stock for cash, securities or other property; except to certain permitted transferees and under certain circumstances. Any permitted
transferees will be subject to the same restrictions and other agreements of the Initial Stockholders with respect to any Founder
Shares or Private Placement Shares. Notwithstanding the foregoing, if (1) the closing price of the Class A common stock equals
or exceeds $12.00 per share (as adjusted for stock splits, stock capitalizations, reorganizations, recapitalizations and the like)
for any 20 trading days within any 30-trading day period commencing at least 150 days after the initial Business Combination
or (2) if the Company consummates a transaction after the initial Business Combination which results in the Company’s stockholders
having the right to exchange their shares for cash, securities or other property, the Founder Shares and Private Placement Shares
will be released from the lock-up.
F- 13
Related
Party Loans
On
June 30, 2020, the Sponsor agreed to loan the Company an aggregate of up to $200,000 to cover expenses related to the Initial
Public Offering pursuant to a promissory note (the “Note”). This loan is non-interest bearing and payable upon
the completion of the Initial Public Offering. The Company borrowed $200,000 under the Note, and fully repaid it on August 14,
2020.
In
addition, in order to finance transaction costs in connection with a Business Combination, the Sponsor or an affiliate of the
Sponsor, or certain of the Company’s officers and directors may, but are not obligated to, loan the Company funds as may
be required (“Working Capital Loans”). If the Company completes a Business Combination, the Company would repay the
Working Capital Loans out of the proceeds of the Trust Account released to the Company. Otherwise, the Working Capital Loans would
be repaid only out of funds held outside the Trust Account. In the event that a Business Combination does not close, the Company
may use a portion of proceeds held outside the Trust Account to repay the Working Capital Loans but no proceeds held in the Trust
Account would be used to repay the Working Capital Loans. The Working Capital Loans would either be repaid upon consummation of
a Business Combination or, at the lender’s discretion, up to $1.5 million of such Working Capital Loans may be convertible
into shares of Class A Common Stock of the post Business Combination entity at a price of $10.00 per share. Except for the foregoing,
the terms of such Working Capital Loans, if any, have not been determined and no written agreements exist with respect to such
loans. To date, the Company had no borrowings under the Working Capital Loans.
Forward
Purchase Agreement
In
connection with the execution of the Merger Agreement, an affiliate of the Sponsor entered into a subscription agreement to
purchase 1,500,000 shares of Class A Common Stock at a purchase price of $10 per share in a private placement that would
occur concurrently with the closing of the Merger (the “Closing”). In addition, the Initial Stockholders entered
into the Parent Support Agreement in which they agreed to vote, the affiliate of the Sponsor has assigned to the Sponsor its
obligation to purchase its shares under the subscription agreement so that the Sponsor will purchase 1,500,000 of such shares
at the Closing. At the time of the Initial Public Offering, the Sponsor had originally indicated an interest to purchase up
to $25.0 million of shares in connection with the initial business combination. This purchase of 1,500,000 shares represents
the Sponsor’s allocation of shares in the PIPE Investment at any meeting of the stockholders of the Company, and in any
action by written consent of the stockholders of the Company, all of such holders’ Class A common stock and Class B
common stock (i) in favor of the Merger Agreement, each of the Parent Proposals (as defined in the Merger Agreement) and the
transactions contemplated by the Merger Agreement and the Parent Support Agreement, and (ii) in favor of any other matter
reasonably necessary to the consummation of the transactions contemplated by the Merger Agreement and the approval of the
Parent Proposals. Also, in connection with the Closing, the Sponsor and certain other stockholders will enter into a Voting
Agreement with the Company and the Initial Stockholders and certain other stockholders will enter into a Registration Rights
Agreement with the Company that will replace the existing registration rights agreement in its entirety. See Note 8 for a
discussion of certain agreements entered into, or to be entered into, in connection with the execution of the Merger
Agreement.
F- 14
Administrative Services Agreement
The
Company has entered into an agreement that provides that, commencing on the date that the Company’s securities are first
listed on Nasdaq and continuing until the earlier of the Company’s consummation of a Business Combination and the Company’s
liquidation, the Company will pay the Sponsor a total of $10,000 per month for office space, secretarial and administrative services
provided to members of the Company’s management team. The Company incurred approximately $50,000 in administrative expenses
under the agreement, which is recognized in the accompanying statement of operations for the period from June 25, 2020 (inception)
through December 31, 2020 within general and administrative expense.
The
Sponsor, officers and directors, or any of their respective affiliates will be reimbursed for any out-of-pocket expenses
incurred in connection with activities on the Company’s behalf such as identifying potential target businesses and performing
due diligence on suitable Business Combinations. The Company’s audit committee will review on a quarterly basis all payments
that were made to the Sponsor, officers or directors, or their affiliates.
Note
5—Commitments and Contingencies
Registration
Rights
The
holders of Founder Shares and Private Placement Shares that may be issued upon conversion of Working Capital Loans, if any, will
be entitled to registration rights pursuant to a registration rights agreement. The holders of these securities are entitled to
make up to three demands, excluding short form demands, that the Company register such securities. In addition, the holders have
certain “piggy-back” registration rights with respect to registration statements filed subsequent to the completion
of the initial Business Combination. The Company will bear the expenses incurred in connection with the filing of any such registration
statements. In connection with the Closing, the Initial Stockholders and certain other stockholders will enter into a Registration
Rights Agreement with us that will replace the existing registration rights agreement in its entirety. See Note 8.
Underwriting
Agreement
The
underwriter was entitled to an underwriting discount of $0.20 per share, or approximately $2.4 million in the aggregate, paid
upon the closing of the Initial Public Offering. In addition, $0.35 per share, or approximately $4.2 million in the aggregate
will be payable to the underwriter for deferred underwriting commissions. The deferred fee will become payable to the underwriter
from the amounts held in the Trust Account solely in the event that the Company completes a Business Combination, subject to the
terms of the underwriting agreement.
Note
6—Stockholders’ Equity
Class
A Common Stock — The Company is authorized to issue 100,000,000 shares of Class A common stock with
a par value of $0.0001 per share. As of December 31, 2020, there were 12,516,500 Class A common stock outstanding, including 11,226,874
Class A common stock subject to possible conversion were classified as temporary equity in the accompanying balance sheet.
Class
B Common Stock — The Company is authorized to issue 10,000,000 shares of Class B common stock with
a par value of $0.0001 per share. On June 30, 2020, the Company issued 2,875,000 shares of Class B common stock. On
August 11, 2020, the Company effected a 1:1.05 stock split of the Class B common stock, resulting in an aggregate of
3,018,750 shares of Class B common stock outstanding, including an aggregate of up to 393,750 shares of Class B
common stock that were subject to forfeiture by the Sponsor, to the Company by the Initial Stockholders for no consideration
to the extent that the underwriters’ over-allotment option was not exercised in full or in part, so that the
Initial Stockholders would collectively own 20% of the Company’s issued and outstanding common stock (excluding the
Private Placement Shares) after the Initial Public Offering (excluding the Private Placement Shares). All shares and the
associated amounts have been retroactively restated to reflect the aforementioned stock split. On August 14, 2020, the
underwriter exercised the over-allotment option; thus, these Founder Shares were no longer subject to forfeiture.
Holders
of record of Class A common stock and Class B common stock will vote together as a single class on all matters submitted to a
vote of our stockholders, with each share of common stock entitling the holder to one vote except as required by law.
F- 15
The
Class B common stock will automatically convert into Class A common stock concurrently with or immediately following the consummation
of the initial Business Combination on a one-for-one basis, subject to adjustment for stock splits, stock dividends, reorganizations,
recapitalizations and the like, and subject to further adjustment as provided herein. In the case that additional shares of Class
A common stock or equity-linked securities are issued or deemed issued in connection with the initial Business Combination,
the number of shares of Class A common stock issuable upon conversion of all Founder Shares will equal, in the aggregate, on an
as-converted basis, 20% of the total number of shares of Class A common stock issued and outstanding (excluding the Private
Placement Shares) after such conversion (after giving effect to any redemptions of shares of Class A common stock by Public Stockholders),
including the total number of shares of Class A common stock issued, or deemed issued or issuable upon conversion or exercise
of any equity-linked securities or rights issued or deemed issued, by the Company in connection with or in relation to the
consummation of the initial Business Combination, excluding any shares of Class A common stock or equity-linked securities
or rights exercisable for or convertible into shares of Class A common stock issued, or to be issued, to any seller in the initial
Business Combination and any private placement shares issued upon conversion of Working Capital Loans, provided that such conversion
of Founder Shares will never occur on a less than one-for-one basis.
Preferred
Stock — The Company is authorized to issue 1,000,000 shares of preferred stock, par value $0.0001 per
share, with such designations, voting and other rights and preferences as may be determined from time to time by the Company’s
board of directors. As of December 31, 2020, there were no shares of preferred stock issued or outstanding.
Note
7—Income Taxes
The
Company’s taxable income primarily consists of interest income on the Trust Account. The Company’s general and administrative
expenses are generally considered start-up costs and are not currently deductible. There was no income tax expense for the period
from June 25, 2020 (inception) through December 31, 2020.
The
income tax provision (benefit) consists of the following for the period from June 25, 2020 (inception) through December 31, 2020:
Current
Federal
$ -
State
-
Deferred
Federal
(170,624 )
State
-
Valuation allowance
170,624
Income tax provision
$ -
The
Company’s net deferred tax assets are as follows as of December 31, 2020:
Deferred tax assets:
Start-up/Organization costs
$ 150,508
Net operating loss carryforwards
20,116
Total deferred tax assets
170,624
Valuation allowance
(170,624 )
Deferred tax asset, net of allowance
$ -
In
assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or
all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation
of future taxable income during the periods in which temporary differences representing net future deductible amounts become deductible.
Management considers the scheduled reversal of deferred tax assets, projected future taxable income and tax planning strategies
in making this assessment. After consideration of all of the information available, management believes that significant uncertainty
exists with respect to future realization of the deferred tax assets and has therefore established a full valuation allowance.
F- 16
There
were no unrecognized tax benefits as of December 31, 2020. No amounts were accrued for the payment of interest and penalties at
December 31, 2020. The Company is currently not aware of any issues under review that could result in significant payments, accruals
or material deviation from its position. The Company is subject to income tax examinations by major taxing authorities since inception.
A
reconciliation of the statutory federal income tax rate (benefit) to the Company’s effective tax rate (benefit) is as follows
for the period from June 25, 2020 (inception) through December 31, 2020:
Statutory Federal income tax rate
21.0 %
Change in Valuation Allowance
(21.0 )%
Income Taxes Benefit
0.0 %
Note 8—Subsequent
Events
The Company evaluated subsequent events
and transactions that occurred after the balance sheet date up to the date that the financial statements were available to be issued.
Based on this evaluation, the Company identified the following subsequent event for disclosure.
The
transaction contemplated by the Merger Agreement, dated October 15, 2020, closed on February 5, 2021 (the “Closing Date”)
pursuant to the terms of the Merger Agreement. On the day prior to the Closing Date, Old Gemini changed its name to “Gemini
Therapeutics Sub, Inc.” Pursuant to the Merger Agreement, on the Closing Date, (i) FSDC changed its name to “Gemini
Therapeutics, Inc.” (together with its consolidated subsidiaries, “ New Gemini ”), and (ii) Old Gemini
merged with and into Merger Sub (the “ Merger ”), with Old Gemini as the surviving company in the Merger and,
after giving effect to such Merger, Old Gemini becoming a wholly-owned subsidiary of New Gemini.
In
accordance with the terms and subject to the conditions of the Merger Agreement, at the effective time of the Merger (the “ Effective
Time ”), (i) all shares of Old Gemini’s Series B Preferred Stock (including shares of Series B Preferred Stock
issued upon conversion of outstanding convertible promissory notes), Series A Preferred Stock and Common Stock (collectively,
“ Old Gemini Stock ”) issued and outstanding immediately prior to the Effective Time, whether vested or unvested,
was converted into the right to receive their pro rata portion of the 17,942,274 shares of FSDC Class A Common Stock (the “ Common
Stock ”) issued as Merger consideration (the “ Merger Consideration ”), provided that 2,150,000 shares
of Common Stock are being held in escrow for a period of 12 months to satisfy any indemnification obligations of Old Gemini under
the Merger Agreement; (ii) each option exercisable for Old Gemini Stock that was outstanding immediately prior to the Effective
Time was assumed and continues in full force and effect on the same terms and conditions as were previously applicable to such
options, subject to adjustments to exercise price and number of shares Common Stock issuable upon exercise based on the final
conversion ratio calculated in accordance with the Merger Agreement, and (iii) 4,264,341 shares of Common Stock were reserved
for issuance under the newly adopted 2021 Stock Option and Incentive Plan.
On
the Closing Date, pursuant to the subscription agreements entered into by the Company and the PIPE Investors (including the
Sponsor) , the PIPE Investors subscribed for an aggregate of 9,506,000 shares of Common Stock for an aggregate purchase price
of $95,060,000.
In
connection with the closing of the Business Combination, the Initial Stockholders and certain other stockholders entered into
the Registration Rights Agreement with the Company and Old Gemini that replaced the existing registration rights agreement. Pursuant
to such agreement, certain stockholders of FSDC and Old Gemini can each demand that the Company register their registrable securities
under certain circumstances and will each also have piggyback registration rights for these securities. In addition, following
the Closing, the Company is required to file and maintain an effective registration statement under the Securities Act covering
such securities and certain other securities of the Company. The registration of these securities will permit the public sale
of such securities, subject to certain contractual restrictions imposed by such agreement and the Merger Agreement.
Refer
to the Company’s Current Report on Form 8-K, filed with the SEC on February 11, 2021 for additional information.
F- 17
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused
this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
GEMINI
THERAPEUTICS, INC.
Date: March
29, 2021
By:
/s/
Jason Meyenburg
Jason Meyenburg
Chief
Executive Officer
POWER
OF ATTORNEY
KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Jason Meyenburg, his or
her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him or her and in his
or her name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and
to file the same, with all exhibits thereto, and other documents in connection therewith, with the United States Securities and
Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform
each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes
as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of
them, or their or his substitutes or substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report on Form 10-K has been signed below
by the following persons on behalf of the Registrant in the capacities and on the dates indicated.
Name
Title
Date
/s/
Jason Meyenburg
Chief
Executive Officer and Director (Principal
Executive Officer)
March
29, 2021
Jason
Meyenburg
/s/
Brian Piekos
Principal
Financial and Principal Accounting Officer
March
29, 2021
Brian
Piekos
/s/
Jim Tananbaum
Director
March
29, 2021
Dr.
Jim Tananbaum
/s/
Carl Gordon
Director
March
29, 2021
Dr.
Carl Gordon
/s/
Jean George
Director
March
29, 2021
Jean
George
/s/
David Lubner
Director
March
29, 2021
David
Lubner
/s/
Tuyen Ong
Director
March
29, 2021
Dr.
Tuyen Ong
/s/ Jason Rhodes
Director
March 29, 2021
Jason Rhodes
65
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.