United States securities and exchange commission logo
November 27, 2020
Dennis Ryan
Chief Financial Officer
FS Development Corp.
600 Montgomery Street, Suite 4500
San Francisco, California 94111
Re: FS Development
Corp.
Draft Registration
Statement on Form S-4
Submitted November
2, 2020
CIK No. 0001816736
Dear Mr. Ryan:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
Please respond to this letter by providing the requested
information and either submitting
an amended draft registration statement or publicly filing your
registration statement on
EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
Registration Statement on Form S-4
Market and Industry Data, page 2
1. We note your statement
that this filing contains information from third-party sources
believed to be reliable
but you make no representation as to the adequacy, fairness,
accuracy or
completeness of any information obtained from third-party sources. As the
latter part of this
statement appears to disclaim your responsibility for information in the
registration statement,
please revise to remove this disclaimer.
Gemini Therapeutics, Inc., page 17
2. Please revise your
pipeline table here and on page 148 to include a column for Phase 3.
Given the early-stage
development of your four programs other than GEM103, please
Dennis Ryan
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FS Development Corp.
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explain to us why each program is sufficiently material to your
business to warrant
inclusion in your pipeline table or revise your table as appropriate.
Please also explain
what you mean by IND enabled and IND ready and what the difference is
between the
two, if any.
Board s Reasons for the Business Combination, page 18
3. We note your statements that the Board believes "Gemini is well
positioned for the
ongoing Phase 2a trial to demonstrate multiple dose safety and
tolerability" and that
exploratory endpoints may provide "initial evidence of a clinical
benefit." Efficacy and
safety are determinations that are solely within the authority of the
FDA or similar foreign
regulators. Please revise these statements as they appear to be
speculative. We also note
your statements that "the Board believes GEM103 has a lower risk than
non-endogenous
proteins of failing to show efficacy" and "has a lower risk of rare
unexpected safety issues
due to the endogenous nature of CFH" as well as "the Board believes
Gemini s lead
program has seen some de-risking ahead of receipt of GEM103 Phase 2a
trial
data." Please revise these statements and any other statements that
imply that you will be
successful in mitigating the risk associated with drug development.
Risk Factors, page 32
4. We note your statement in the introductory paragraph to the risk
factors that the "risk
factors are not exhaustive and investors are encouraged to perform
their own investigation
with respect to the business, prospects, financial condition and
operating results of Gemini
and [y]our business, prospects, financial condition and operating
results following the
completion of the Business Combination." It appears inappropriate to
suggest
that investors perform their own investigation if that is meant
as a substitute for a
comprehensive Risk Factors section. Please revise accordingly.
If we fail to comply with our obligations under any license, collaboration or
other agreements,
including the license agreement with Sanquin, page 55
5. With respect to your research collaboration and license agreement with
Sanquin, in an
appropriate location in your prospectus, please disclose the material
terms of this
agreement including the nature and scope of the intellectual property
transferred, each
parties' rights and obligations, the duration of the agreement and the
royalty term, the
termination provisions, any up-front or execution payments, the
aggregate future potential
milestone payments, and the royalty rate. Please also file the
agreement as an exhibit or
tell us why you do not believe it is required.
FS Development s Sponsor, directors and officers have interests in the
Business Combination...,
page 68
6. Please expand your discussion to disclose the officers' and directors'
aggregate average
investment per share. In addition, clarify that in addition to FS
Development's officers and
Dennis Ryan
FS Development Corp.
November 27, 2020
Page 3
directors being at risk to lose their entire investment if the
transaction is not approved,
their significantly lower investment per share in their FS Development
shares results in a
difference between a transaction that increases the value of the
officers' and directors'
investment and a transaction that increases the value of the public
shareholders'
investment.
Risks Related to FS Development and the Business Combination, page 68
7. Please include a separate risk factor addressing the potential
consequences resulting from
the potential waiver of conditions to the merger.
Background of the Business Combination, page 98
8. We note your disclosure that you delivered non-binding indications of
interest to five
potential target businesses. Please expand the discussion to describe
how the consideration
of these target businesses progressed and disclose the reasons why
these alternative targets
were not ultimately pursued. We also note your disclosure that FS
Development ceased
contact with other potential target businesses in the biotechnology
industry when the
mutual exclusivity agreement with Gemini was executed. Please disclose
how many other
potential target businesses in the biotechnology industry FS
Development was in contact
with at that time, what stage of negotiation they were in, why the
Board decided to pursue
a transaction with Gemini over the alternatives that existed at the
time and what factors
the Board considered to make that decision.
9. We note your disclosure that Gemini indicated it would be willing to
consider a business
combination at an enterprise value of at least $200 million and the
non-binding indication
of interest set forth a proposed enterprise value of Gemini of $215
million and other
material terms of a potential business combination. Please revise to
discuss how the $215
million proposed enterprise value was arrived at and disclose what the
other material
terms were. Please further revise to discuss the negotiations
regarding the enterprise value
and the other material terms from the non-binding indication of
interest until execution of
the merger agreement.
Representations and Warranties, page 102
10. Please expand your discussion to describe the representations and
warranties. For
example, what has Gemini represented or warranted with respect to
financial information,
licenses and permits, material contracts, etc.?
FirstName LastNameDennis Ryan
Conditions to Closing, page 103
Comapany NameFS Development Corp.
11. Please
November 27,identify the 3closing conditions that are subject to waiver.
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Satisfaction of 80% Test, page 108
12. Please disclose how the Board determined that the business combination
had a fair market
value of 80% of the balance of the funds in the trust account at the
time of execution of
the merger agreement, including the material details of the specific
analyses used, what
sources of information were used to make the determination, any
quantitative or
qualitative factors considered such as previous offers received by
Gemini.
Information About Gemini
Our Strategy, page 148
13. We note your disclosure here that your strategy is to "rapidly
advance" your lead program
through clinical development. Please revise this disclosure to remove
any implication that
you will be successful in commercializing your product candidates in a
rapid or
accelerated manner as such statements are speculative.
Intellectual Property, page 153
14. Please revise this section to specifically identify all material
foreign jurisdictions where
patents are granted or patent applications are pending, the patent
expiration dates and
expected expiration dates for pending patent applications for each
material foreign
jurisdiction, the specific products, product groups and technologies
to which such patents
relate, identify which patent families are owned or licensed, and the
type of patent
protection you have.
15. We note your disclosure elsewhere in the prospectus regarding an
issued European patent
expiring in 2026 that claims an isolated CFH polypeptide which could
be alleged to cover
GEM103 and that there is a possibility that commercial manufacturing
or product launch
for GEM103 in Europe would predate the patent expiration. Please
revise to disclose if
you expect this patent to have any impact on your development plans
for GEM103, your
patent portfolio and your business.
Security Ownership of Certain Beneficial Owners and Management, page 207
16. Please revise your disclosure to identify the natural person or
persons who have voting
and investment control of the shares held by each of Adage Capital
Management LP,
Blackrock Financial Management, R.A. Capital Management LLC, Redmile
Group,
Wellington Management Co LLP, Orbimed Private Investments VI, LP, and
the entities
affiliated with Atlas and Lighthouse Ventures. Refer to Item 403 of
Regulation S-K and
Exchange Act Rule 13d-3.
Policies and Procedures for Related Party Transactions, page 214
17. Please disclose the standards that will be applied in determining
whether to approve any
of the transactions described in this section. Refer to Item
404(b)(1)(ii) of Regulation S-
K.
Dennis Ryan
FS Development Corp.
November 27, 2020
Page 5
FS Development Corp. Financial Statements
Note 4 - Related Party Transactions, page F-11
18. We note the disclosure on page F-12 that the Sponsor "has indicated an
interest to
purchase $25.0 million of the Company s Class A Common Stock in a
private placement
that would occur concurrently with the consummation of the initial
Business
Combination." We also note the related disclosure on page 211 that "the
Sponsor has
entered into a subscription agreement to purchase" the $25.0 million in
common
stock. Please clarify whether this agreement has actually been entered
into and revise your
disclosure as necessary. Because the funds of the private placement would
be used as part
of the consideration to the sellers in the merger, address the need to
include the private
placement as a pro forma adjustment within the pro forma financial
information beginning
on page 87.
You may contact Jenn Do at 202-551-3743 or Lynn Dicker at 202-551-3616
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Ada Sarmento at 202-551-3798 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
FirstName LastNameDennis Ryan
Division of
Corporation Finance
Comapany NameFS Development Corp.
Office of Life
Sciences
November 27, 2020 Page 5
cc: Joel L. Rubinstein, Esq.
FirstName LastName