SEC Comment Letter 0000000000-24-008475 to Maze Therapeutics, Inc. (MAZE) (CIK 0001842295) (MAZE)
Maze Therapeutics, Inc. (MAZE) (CIK 0001842295)
Date: July 25, 2024 · CIK: 0001842295 · Accession: 0000000000-24-008475
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July 25, 2024
Jason Coloma, Ph.D.
Chief Executive Officer
Maze Therapeutics, Inc.
171 Oyster Point Blvd.
Suite 300
South San Francisco, CA 94080
Re:Maze Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted on June 21, 2024
CIK 0001842295
Dear Jason Coloma Ph.D.:
We have reviewed your draft registration statement and have the following comments.
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 a comment applies 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 this letter and your amended
draft registration statement or filed registration statement, we may have additional comments.
Draft Registration Statement on Form S-1
Cover Page
1.Please disclose on the prospectus cover page whether your offering is contingent upon
final approval of your Nasdaq listing. Please ensure the disclosure is consistent with your
underwriting agreement.
Prospectus Summary
Overview, page 1
2.We note your disclosures here, and elsewhere, regarding MZE782 potentially being “first-
in-class.” This term suggests that your product candidate is effective, more advanced than
other products being developed, and likely to be approved. Please revise to delete such
references throughout your registration statement.
Please provide the basis for your belief that you are the first company to implement a 3.
July 25, 2024
Page 2
platform that supports end-to-end variant identification, functional capabilities and
advanced research tools and methodologies at scale.
Our Pipeline, page 2
4.We note your inclusion of two rows for “multiple targets” in the “Wholly-owned
Portfolio” section, and two rows for unidentified partners in the “Company Creation
& Partners” section. Please explain why such programs are sufficiently material to your
business to warrant inclusion in your pipeline table. If they are material, please revise the
table to identify the multple targets and identify the companies you have partnered with to
develop ALS candidate(s). Additionally, expand your disclosure in the Business section to
provide a more fulsome discussion of these programs, including a description of the
development activities to date, and the material terms of the corresponding exclusive
license agreements. Alternatively, please remove any programs that are not currently
material from your pipeline table.
5.Please revise the summary discussion of Broadwing Bio to clarify that you are not the
sole owner of Broadwing Bio and specify your ownership percentage.
6.Please remove the “Compass Platform” row from the pipeline table. The platform itself is
not a product candidate. Therefore, it is not appropriate to incude it in the pipeline table.
7.We note you have not yet applied for an IND for MZE782, yet your pipeline table
indicates “Phase 1 initiation” in the arrow. Given that your IND has not been filed, it is
not clear why you believe Phase 1 has begun and it is not more appropriate to indicate that
your preclincial trials have been completed. Please explain.
8.Please refrain from stating or implying efficacy for your product candidates.
Determinations related to efficacy are solely within the authority of the FDA. Given that
your discussion is based on preclincial trials, your discussion should focus on a potential
mechanism of action and not on efficacy or improvements over currently available
products.
Our approach to precision medicine: Compass platform, page 3
9.We note your belief that the Compass platform has the potential to “improve the overall
likelihood” of regulatory and commercial success for your precision medicine candidates.
Please provide balancing disclosure with your statement on page 22 that you cannot
provide any assurance that the application of your Compass platform will result in the
ultimate regulatory approval of any of your therapeutic candidates.
10.Please describe your platform’s multiple contributions to the scientific community over
the past five years.
11.Please ensure the text and logos are legible in the graphic.
Our Team and Investors, page 4
We note your disclosure on page 5 that you have raised approximately $424 million from
“leading life science investors,” including Third Rock Ventures, ARCH Venture Partners,
Matrix Capital Management and Google Ventures. Please provide balancing disclosure, as
you do on page 110, that prospective investors should not rely on such investors’
investment decisions, that these investors may have different risk tolerances and that the 12.
July 25, 2024
Page 3
shares purchased in the referenced financings may have been conducted at a significant
discount to the IPO price, if true.
We have entered, and may in the future enter, into strategic collaborations, transactions and
licensing partnerships..., page 26
13.Please put the risk in context by revising this risk factor to clarify that the FTC's authority
was based on concerns that that Genzyme's license would eliminate a competitor
challenging Sanofi's monopoly in the Pompe disease market.
We rely on third parties to manufacture our clinical product supplies..., page 29
14.We note your disclosure on page 30 that you "rely on third parties located in China for
some of [y]our contract manufacturing” and that "[you] are exposed to the possibility of
product supply disruption and increased costs in the event of changes in the policies of the
United States or Chinese governments[.]" Please tell us whether any Chinese companies
you do business with have been named as "companies of concern" in the amended version
of the U.S. House of Representatives' draft of the BIOSECURE Act approved on May 15,
2024, or are a subsidiary or affiliate of a named company of concern. In addition, please
revise your disclosure to include an updated discussion of the pending BIOSECURE
legislation that would result in trade restrictions, sanctions, or other regulatory
requirements by the U.S. government, which could restrict or even prohibit your ability to
work with your contractual counterparties.
Exclusive License Agreement, page 92
15.Describe the material terms of your partnership agreements related to the development of
product candidates for the treatment of ALS. File these agreements or provide an analysis
supporting your conclusion that they are not required to be filed.
Exclusive license agreement with Shionogi, page 92
16.With respect to your agreement with Shionogi, please quantify all payments made to date,
clarify when the valid claims covering the applicable Licensed Product will expire,
explain how reversion royalties work and disclose the applicable rate and when the
reversion royalties expire.
Management's discussion and analysis of financial condition and results of operations
Exclusive license agreement with Shionogi, page 92
17.In your notes to financial statements and other areas in this filing deemed necessary,
please provide your accounting policy with respect to recognizing revenue related to your
license agreements such as up-front fees, milestones payments and royalties as well as the
accounting literature you relied upon in your accounting treatment.
Results of operations
Comparisons of the years ended December 31, 2022 and 2023, page 95
With regards to your general and administrative expenses, please revise to provide a table
that breaks out your G&A expense by its components as you note on page 94, similar to
that provided for your research and development expenses. In addition, provide a robust
explanation for the changes in the underlying components for the periods presented. As 18.
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Page 4
part of your response, clearly explain the nature of the legal costs referenced as being
higher in 2023 on page 96, including the extent to which such elevated costs are expected
to continue in future periods.
Critical accounting policies, significant judgements and use of estimates
Common stock valuations, page 103
19.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. Please discuss with the staff how to submit your response. Revise your
MD&A to provide a table presenting the number of units granted, the exercise price, the
fair value used for the underlying shares, and compensation expense to be recognized for
all compensatory issuances during 2023 and the subsequent period through the date of the
registration statement.
Discovery of MZE829, page 118
20.We note your disclosure on page 119 relating to comparisons with inaxaplin, or VX-147.
Please explain what inaxaplin is.
MZE829 clinical trials, page 120
21.Please disclose the number of volunteers enrolled in the Phase 1 study.
22.If participants in the Phase 1 trial experienced any serious adverse events, please describe
the events and the number of each type of event.
MZE782 clinical development plans, page 125
23.Please revise to clearly describe the current status of your clinical development plans with
respect to MZE782. In this regard, we note that you have not yet submitted an IND for
MZE829 yet reference Phase 1 clinical trials from which you “expect” to demonstrate
clinical proof of mechanism, as well as your plan for Phase 2 “based on supporting data
from Phase 1.” To the extent known, please disclose the material terms for the planned
Phase 1 trial, including the number of expected participants, trial design, endpoints and
any protocols.
MZE001 for Pompe disease, page 126
24.Please provide the number of volunteers that enrolled in your Phase 1 trial for MZE001,
describe any primary and secondary endpoints and whether they were achieved. Explain
how the trial demonstrated proof of mechanism without indicating that the candidate is
effective. To the extent that any participants experienced any serious adverse events,
please describe them and quantify the number of each type of event.
Intellectual Property, page 131
Please describe the type of patents (composition of matter, use, or process) for your issued
patents, the expiration dates and type of patents for your material US and foreign patent 25.
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applications, and the jurisdictions for your material foreign patent applications. With
respect to the patent portfolios you out-licensed, please provide the product candidate(s)
and/or technology to which such patents or patent applications relate, the type of patents
or patent applications, the jurisdictions, and expiration dates. In this regard, it may be
useful to provide tabular disclosure.
Employment Agreements, page 159
26.We note your disclosure that you intend to enter into new employment agreements with
certain senior management personnel in connection with this offering. We also note your
disclosure on page 50 that you entered into employment agreements with your executive
officers. Please reconcile or otherwise advise.
General
27.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.
Please contact Sasha Parikh at 202-551-3627 or Kevin Vaughn at 202-551-3494 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jimmy (CF) McNamara at 202-551-7349 or Suzanne Hayes at 202-551-3675 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences