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United States securities and exchange commission logo
June 18, 2020
Sanjiv K. Patel, M.D.
President and Chief Executive Officer
Relay Therapeutics, Inc.
399 Binney Street, 2nd Floor
Cambridge, MA 02139
Re: Relay Therapeutics,
Inc.
Draft Registration
Statement on Form S-1
Submitted May 22,
2020
CIK No. 0001812364
Dear Dr. Patel:
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
Overview, page 1
1. We note your statements
regarding your differentiated approach and how it enables you to
select product
candidates with a "potentially higher probability of clinical success." Given
the stage of your
product candidates and the length of time and uncertainty involved in
product candidate
development, please revise throughout the prospectus to remove any
implication that your
product candidates are more likely than others to receive approval
from the U.S. Food and
Drug Administration (FDA) or comparable regulators.
2. Given the status of
your development programs, please tell us the basis for your claim on
page 1 that RLY-1971
and RLY-4008 are potent and selective inhibitors of SHP2 and
FGFR2, respectively.
Sanjiv K. Patel, M.D.
FirstName LastNameSanjiv K. Patel, M.D.
Relay Therapeutics, Inc.
Comapany NameRelay Therapeutics, Inc.
June 18, 2020
Page 2
June 18, 2020 Page 2
FirstName LastName
3. Please revise to balance your Summary presentation by highlighting the
challenges you
face in advancing your novel Dynamo Platform. In this regard, we note
your dependence
on your collaboration with D.E. Shaw Research LLC, the limitations on
that collaboration
by its terms, which are discussed beginning on page 129, and the lack
of alternative to the
Anton 2 supercomputer.
4. Please revise to include a brief definition here of what you mean by
"genetically validated
target proteins."
5. The illustration provided in Figure 1 on pages 2 and 97 contains text
that is illegible.
Please revise this figure accordingly.
Our Programs, page 3
6. We refer to the program tables on pages 3, 92, and 103. Please revise
these tables to
remove the discovery-stage programs (i.e., rows 4 through 6). In this
regard, it is
premature to prominently highlight each of these programs given that
you do not identify
a specific molecule that you seek to develop and you do not discuss
IND-enabling
studies. Additionally, please include a column for each of Phase 1,
Phase 2, and Phase 3.
Please also remove the footnote indicating that a Phase 3 trial may
not be required if
Phase 2 is registrational as this statement is also premature.
7. We note your references to your product candidates as "first-in-class"
or "best-in-class" on
page 4 and throughout the registration statement. These terms suggest
that the product
candidates are effective and likely to be approved. Please delete
these references
throughout your registration statement. If your use of these terms was
intended to convey
your belief that the products are based on a novel technology or
approach and/or is further
along in the development process, you may discuss how your technology
differs from
technology used by competitors and, if applicable, that you are not
aware of competing
products that are further along in the development process. Statements
such as these
should be accompanied by cautionary language that the statements are
not intended to
give any indication that the product candidates have been proven
effective or that they
will receive regulatory approval.
Implications of Being an Emerging Growth Company and a Smaller Reporting
Company, page 7
8. Please 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.
Use of Proceeds, page 65
9. Please revise to disclose an estimate of how far in the development of
your "drug
discovery and clinical development efforts" the proceeds from this
offering will allow you
Sanjiv K. Patel, M.D.
FirstName LastNameSanjiv K. Patel, M.D.
Relay Therapeutics, Inc.
Comapany NameRelay Therapeutics, Inc.
June 18, 2020
June 18, 2020 Page 3
Page 3
FirstName LastName
to reach with respect to each product candidate. Also, please disclose
the total estimated
cost of each of the specified purposes for which the net proceeds are
intended to be used,
and, if material amounts of other funds are necessary to accomplish
the specified
purposes, provide an estimate of the amounts of such other funds and
the sources thereof.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Use of Estimates
Determination of Fair Value of Common Stock, page 89
10. 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.
Business, page 91
11. We refer to your disclosures throughout this section concerning
numerous pre-clinical
studies/models/assays. For each study that you reference, please
revise to include
information about the nature, design and results of that particular
study so that investors
have a basis to assess the applicable observation that you present,
rather than state your
conclusion, e.g., that your product candidate acts as a potent
inhibitor. Without limitation,
your discussion should identify the type of cells and methods utilized
in the referenced
study. Your disclosure also should indicate whether the results were
or were not
statistically significant and you should include all p-values.
Our solution, RLY-1971, page 105
12. We note your discussion of the experimental and computational
techniques used to
identify RLY-1971 where you conclude that simulations enabled your
medicinal chemists
the ability to design a more potent inhibitor of SHP2. Please expand
your disclosure to
briefly explain why this simulation (revealing that the loop flips
downwards, close to
where the small molecule binds) enabled a "more potent inhibitor of
SHP2."
RLY-1971 as a monotherapy, page 107
13. Please tell us how many times you tested the inhibitors in the studies
described in Figures
10, 12, and 14 on pages 107 to 110 and whether the graphs or charts
illustrate the average
or mean of the studies conducted.
Our clinical development plan, page 110
14. For RLY-1971, please disclose the current size and the anticipated
size of the clinical trial
population.
Sanjiv K. Patel, M.D.
Relay Therapeutics, Inc.
June 18, 2020
Page 4
Our solution, RLY-4008, page 113
15. We note your comparison of RLY-4008 to other inhibitors in pre-clinical
models on pages
114-118. As you have not conducted head-to-head clinical trials, please
tell us why you
believe it is appropriate to include these comparisons. Include in your
response whether
you expect to be able to rely on this data to support an application for
marketing approval
from the FDA or comparable regulatory body for commercialization of
RLY-4008.
Collaboration and License Agreement with D. E. Shaw Research, LLC, page 129
16. Please revise to clarify whether any of your product candidates are
currently co-owned
with D. E. Shaw Research. To the extent that any of your product
candidates are co-
owned, please also revise the Summary accordingly. Please also reconcile
your disclosure
on page 102 that states you retain worldwide development and
commercialization rights to
all of your programs.
Item 16. Exhibits and Financial Statement Schedules, page II-3
17. To the extent that you are redacting information pursuant to Item
601(b)(10)(iv) of
Regulation S-K, please mark the exhibit index to indicate that portions
of your exhibits
have been omitted and remove reference to "confidential treatment." See
Item
601(b)(10)(iv) of Regulation S-K.
You may contact Rolf Sundwall at 202-551-3105 or Terence O'Brien at
202-551-3355 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Christine Westbrook at 202-551-5019
with any other
questions.
Sincerely,
FirstName LastNameSanjiv K. Patel, M.D.
Division of
Corporation Finance
Comapany NameRelay Therapeutics, Inc.
Office of Life
Sciences
June 18, 2020 Page 4
cc: Gabriela Morales-Rivera, Esq.
FirstName LastName