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United States securities and exchange commission logo
May 1, 2020
Lloyd M. Segal
Chief Executive Officer
Repare Therapeutics Inc.
7210 Frederick-Banting, Suite 100
St-Laurent, Qu bec, Canada H4S 2A1
Re: Repare Therapeutics
Inc.
Draft Registration
Statement on Form S-1
Submitted April 6,
2020
CIK No. 0001808158
Dear Mr. Segal:
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 submitted April 6, 2020
Prospectus Summary, page 1
1. Based on your
disclosure under "Intellectual Property" on page 124, it does not appear
that you currently have
patent protection for your leading product candidate or for any
aspect of your SNIPRx
platform. Please include a brief disclosure regarding the current
status of your
intellectual property rights in your prospectus summary and enhance the
risk factor disclosure
in the last bullet point on page 8 to more prominently disclose the
risks to your business
if you are not able to obtain such rights.
Our Clinical Program, RP-3500, page 5
2. Please revise your
statements in your prospectus that RP-3500 has the potential to be a
Lloyd M. Segal
FirstName LastNameLloyd M. Segal
Repare Therapeutics Inc.
Comapany NameRepare Therapeutics Inc.
May 1, 2020
May 1, 2020 Page 2
Page 2
FirstName LastName
"best-in-class" inhibitor. These statements could be interpreted as
implying an
expectation of regulatory approval and, if approved, favorable
comparability to
competitive products in terms of safety and efficacy, which would
appear to be premature
given the length of time and uncertainty with respect to securing
marketing approval.
Risks Associated with Our Business, page 7
3. If you believe that you will be classified as a passive foreign
investment company, or
PFIC, for the taxable year ending December 31, 2020, please revise the
summary to
briefly indicate your anticipated PFIC status and the risks to U.S.
investors, including the
adverse U.S. federal income tax consequences disclosed on page 70 such
as ineligibility
for any preferential tax rates for individuals on capital gains.
Use of Proceeds, page 79
4. Please expand your disclosure regarding the proceeds to be used for
your leading product
candidate to describe how far in the development process you estimate
the allocated
proceeds from this offering will enable you to reach.
Critical Accounting Policies and Significant Judgments and Estimates
Share-Based Compensation, page 99
5. 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 initial public offering 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.
Our Corporate History and Team, page 106
6. Please clarify, here or in the appropriate section of your filing, how
members of the
scientific advisory board are compensated.
Mechanism of Action, page 113
7. Given your disclosure that "[w]hen ATR is inhibited, cells with DNA
damage or
incomplete DNA replication can undergo cell division," please expand
your disclosure to
clarify how ATR inhibition leads to cell death as shown in your
illustration on page 114.
Preclinical Data: Monotherapy, page 117
8. We note your disclosure that you observed RP-3500 to have a favorable
safety profile in
your preclinical studies. Since this disclosure may imply that your
product
candidate is safe, and safety determinations are solely within the
authority of the U.S.
Food and Drug Administration and comparable regulatory bodies, please
revise your
disclosure to remove this implication.
Lloyd M. Segal
FirstName LastNameLloyd M. Segal
Repare Therapeutics Inc.
Comapany NameRepare Therapeutics Inc.
May 1, 2020
May 1, 2020 Page 3
Page 3
FirstName LastName
Proposed Design of Phase 1/2 Clinical Trial of RP-3500, page 121
9. Please define the term ORR which is indicated as one of your key
endpoints for your
Phase 1/2 clinical trials.
Intellectual Property, page 124
10. Please briefly explain the process for a PCT application and how that
application can
mature into a patent application in the United States. Additionally,
please discuss the
potential consequences for you if you are unable to obtain patent
protection for RP-3500,
your lead product candidate.
11. Please clarify if any of the new SL pairs that you identify would be
protectable through
intellectual property rights or otherwise. If competitors could
develop inhibitors based on
the SL pairs that you identify that would not be protected by any
intellectual property
rights that you obtain, please include appropriate risk factor
disclosure.
Research Services, License and Collaboration Agreement with Ono Pharmaceutical
Co., page
125
12. We note your reference in the third paragraph to "low double-digit"
percentages. Please
revise your disclosure to narrow the royalty range to no more than a
ten percentage point
range.
License Agreement with New York University, page 126
13. We note your disclosure in the fifth paragraph that you will be
required to pay New York
University a "specified percentage" of any future milestone payments
received under the
Ono Agreement from Ono for pre-IND development milestones, and a
"specified
percentage" of any future milestone payments received from Ono for
post-IND
development, regulatory and commercial milestones. Please revise your
disclosure to
narrow the specified percentages to no more than a ten percentage
point range.
Potential Payments and Benefits upon Termination or Change in Control, page 154
14. Please file the change in control and severance agreements described
in this section as
exhibits.
Principal Shareholders, page 168
15. Please ensure that you have identified the natural persons who have or
share beneficial
ownership of the securities held by each of the entities listed in
your table.
Description of Share Capital, page 170
16. We note your disclosure that you have an unlimited number of common
shares and
an unlimited number of preferred shares. Please include risk factor
disclosure addressing
the risks associated with your authorized capital or tell us why such
disclosure would not
Lloyd M. Segal
Repare Therapeutics Inc.
May 1, 2020
Page 4
be appropriate.
Lock-Up Agreements, page 175
17. Given your disclosure on page 165 that the second amended and restated
unanimous
shareholders' agreement will terminate upon the completion of your
offering, please
clarify how the market-standoff provisions described in the second
paragraph of this
section will apply for a period of 180 days following the date of your
prospectus.
General
18. 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.
You may contact Tracey McKoy at (202) 551-3772 or Kate Tillan at (202)
551-3604 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Tim Buchmiller at (202) 551-3635 or Celeste Murphy at (202) 551-3257
with any other
questions.
Sincerely,
FirstName LastNameLloyd M. Segal
Division of
Corporation Finance
Comapany NameRepare Therapeutics Inc.
Office of Life
Sciences
May 1, 2020 Page 4
cc: Divakar Gupta, Esq.
FirstName LastName