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United States securities and exchange commission logo
January 22, 2021
Joseph D. Vittiglio
General Counsel and Corporate Secretary
Finch Therapeutics Group, Inc.
200 Inner Belt Road, Suite 400
Somerville, Massachusetts 02143
Re: Finch Therapeutics
Group, Inc.
Draft Registration
Statement on Form S-1
Submitted December
28, 2020
CIK No. 0001733257
Dear Mr. Vittiglio:
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.
Draft Registration Statement on Form S-1, Submitted December 28, 2020
Prospectus Summary
Overview, page 1
1. Please revise
statements here and elsewhere concerning your pivotal trials to also
refer
to the phase of trial
that you are referencing.
2. We note your statement
on page 1: We believe data from our pivotal trial with CP101
validates our platform
and page 2: CP101 also demonstrated a favorable safety profile,
with no
treatment-related serious adverse events. Please revise this statement and
all
similar statements
throughout your prospectus to remove implication that your product
candidates are safe or
effective, as these determinations are solely within the authority of
Joseph D. Vittiglio
Finch Therapeutics Group, Inc.
January 22, 2021
Page 2
the FDA and comparable regulatory bodies. Please also refrain from
implying the inherent
safety of microbiome therapeutics, such as Due to this symbiotic
relationship, restoration
of this community is expected to present a favorable safety profile,
espcially given your
disclosures on page 35 concerning risks of transfer of infectious
agents such as e. coli.
3. Please revise to balance your statement on page 1 that you have a rich
clinical stage
pipeline given you only have one product candidate in clinical stage.
4. We note your statements on pages 1, 2, 4 and elsewhere that you are
the only company
with capabilities to pursue both targeted and enriched consortia,
CP101 is the first orally
administered, microbiome therapeutic candidate to meet its primary
endpoint in a pivotal
trial, and that you have the first and only late-stage, orally
administered Complete
Consortia product candidate. Please balance these statements with a
discussion of the
competitive landscape faced by the company and ensure the basis for
such statements is
apparent from the prospectus disclosure.
Key Advantages of Our Platform, page 3
5. We note your statement on page 3 that you believe FIN-211 is
positioned to be the first
microbiome therapeutic in ASD, your statements on page 4 that you
believe CP101
enables both a potential near-term commercial opportunity in recurrent
CDI and has the
ability to rapidly expand into new therapeutic areas linked to
community-level dysbiosis,
and your statement on page 5 that you designed your Human-First
Discovery platform to
rapidly scale across multiple therapeutic areas. Please revise these
and similar statements
to remove the implication that you have the ability to accelerate the
FDA approval process
required prior to commercialization, as this is outside of your
control.
Risk Factors, page 13
6. We note your statements on page 20 and 35 regarding OpenBiome s
clinical hold. Please
revise page 20 to disclose the current landscape surrounding FMT and
related products,
including with respect to SAEs reported and FDA involvement.
FirstName LastNameJoseph D. Vittiglio
7. We note your statement on page 61 that you are aware of a patent estate
that may impact
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yourNameFinch
competitiveTherapeutics
position withGroup,
respectInc.
to one of your product
candidates. Please revise to
Januarystate the product
22, 2021 Page 2candidate at issue and, if known, the territory
covered.
FirstName LastName
Joseph D. Vittiglio
FirstName LastNameJoseph D. Vittiglio
Finch Therapeutics Group, Inc.
Comapany
January 22,NameFinch
2021 Therapeutics Group, Inc.
January
Page 3 22, 2021 Page 3
FirstName LastName
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation, page 100
8. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and the
reasons for any differences between the recent valuations of your
common stock leading
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances, including stock
compensation and
beneficial conversion features. Please discuss with the staff how to
submit your response.
Our Approach, page 109
9. We note the following statement on pages 3, 105 and 109: Our
Human-First Discovery
platform is designed to significantly reduce drug development time and
risk. Please
reconcile this statement with the backdrop to the clinical hold
discussed on page 20 and
the two FDA advisories issued in 2020 concerning safety measures
related to FMT.
10. We note your reference to FIN-211 being first-in-class on page
111. This term may be
interpreted to suggest that your product candidate has been approved
by the FDA, which
is not the case. Please revise the statement to remove such
suggestion.
Our Clinical Programs, page 111
11. With respect to the p-value on page 115, please provide a brief
explanation of the
disclosed p-values and how p-values are used to measure statistical
significance.
12. Please state whether your Phase 1 trial of CP101, described on page
117, was powered for
statistical significance, and if so, provide p-values.
Our Collaborations and License Agreements, page 125
13. With respect to the Arizona State Agreement, please more specifically
describe the nature
and scope of the intellectual property that was transferred and the
product candidates it
relates to. Additionally, we note your statement that the royalty term
expires on a country-
by-country basis as to each licensed product until expiry of the last
to expire claim in such
country. Please revise to clarify when these claims are expected to
expire.
14. Please revise pages 132-133 to more specifically describe the assets
purchased under, and
the duration of, the OpenBiome Agreement entered in November of 2020.
Additionally,
please revise to describe the Asset Purchase and License Agreement
entered with
OpenBiome in 2019 and the Material Access and License Agreement,
including the
intellectual property licensed thereunder, to the extent such
agreements survive the closing
of the November 2020 OpenBiome Agreement.
Joseph D. Vittiglio
FirstName LastNameJoseph D. Vittiglio
Finch Therapeutics Group, Inc.
Comapany
January 22,NameFinch
2021 Therapeutics Group, Inc.
January
Page 4 22, 2021 Page 4
FirstName LastName
Executive Compensation, page 159
15. We note your statement on page 161 that you have entered into
employment agreements
or offer letter agreements with certain of named executive officers.
Please file such
employment agreements or offer letter agreements as exhibits pursuant
to Item 601(b)(10)
of Regulation S-K.
Principal Stockholders, page 170
16. Please revise your disclosure to identify the natural person or
persons who have voting
and/or investment control of the shares held by Symbiosis LLC on page
171. Refer to
Item 403 of Regulation S-K.
Consolidated Financial Statements
Note 6. Revenue, page F-19
17. We note that under the Takeda Pharmaceutical arrangement that you are
reimbursed for
certain research and development costs which are included under
collaboration revenue in
the consolidated statement of operations. Please explain to us the
factors you considered
in determining that such costs should be recognized as revenue and
cite the accounting
literature relied upon and how you applied it to your situation.
General
18. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications
You may contact Tara Harkins at 202-551-3639 or Kate Tillan at
202-551-3604 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Laura Crotty at 202-551-7614 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Courtney T. Thorne, Esq.