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United States securities and exchange commission logo
December 6, 2021
Paul Berns
Chief Executive Officer
Neumora Therapeutics, Inc.
65 Grove Street
Watertown, Massachusetts 02472
Re: Neumora
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted November
8, 2021
CIK No. 0001885522
Dear Mr. Berns:
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 November 8, 2021
Summary, page 1
1. Please clarify the
meaning of scientific or technical terms the first time they are used in
order to ensure that
lay readers will understand the disclosure. For example, please briefly
explain what you mean
by polysomnographic measures and allosteric modulators.
2. Please expand your
disclosure in the Summary to clarify that you have licensed certain
product candidates and
from whom the product was licensed. For example, we refer to
your disclosure on page
F-19 and elsewhere that your NMRA-140 and NMRA-511
product candidates are
licensed from The Scripps Research Institute in connection with
your acquisition of
BlackThorn Therapeutics, Inc.
Paul Berns
Neumora Therapeutics, Inc.
December 6, 2021
Page 2
Summary
Our Precision Neuroscience Pipeline, page 3
3. We note the inclusion of five discovery stage programs in your
pipeline table. Given the
early stage of development of these programs, please explain why these
programs are
sufficiently material to your business to warrant inclusion in your
Summary pipeline
table. If they are material, please expand your disclosure in the
Business section to
provide a more fulsome discussion of these programs, including a
description of
preclinical studies or other development activities conducted.
Alternatively, please
remove any programs that are not currently material from your pipeline
table.
4. Please enlarge your pipeline table on pages 3, 117, and 129 to ensure
all text is legible.
We contract with third parties for the manufacture of our product
candidates..., page 50
5. You disclose on page 50 that you rely on certain single-source
suppliers for the raw
materials for your product candidates. Please expand your disclosure
under an appropriate
heading in the Business section to identify the suppliers on which you
rely and the
material terms of your agreements with such parties. Refer to Item
101(h)(4)(v) of
Regulation S-K.
Industry and Market Data, page 85
6. We note your statement cautioning investors not to give undue weight
to assumptions and
estimates in your prospectus and that such information is inherently
imprecise. These
statements may imply an inappropriate disclaimer of responsibility
with respect to third
party information; therefore, please either remove the potential
disclaiming language or
clearly state in this section that you are liable for such
information.
Use of Proceeds, page 86
7. We note the paragraph at the bottom of page 86 regarding the uncertainty
surrounding
your potential use of proceeds and the "significant discretion and
flexibility" management
will have in applying the proceeds from the offering. In relation to the
first bullet point
listed in the intended uses, please either confirm in your response that
the company is
unable to provide more granular detail regarding the allocation of
proceeds to the product
FirstName LastNamePaul Berns
candidates listed in its pipeline table, or revise this section to
provide such specific
Comapany NameNeumora Therapeutics, Inc.
information.
December 6, 2021 Page 2
FirstName LastName
Paul Berns
FirstName LastNamePaul Berns
Neumora Therapeutics, Inc.
Comapany6,
December NameNeumora
2021 Therapeutics, Inc.
December
Page 3 6, 2021 Page 3
FirstName LastName
Business, page 115
8. Please clarify the meaning of scientific or technical terms the first
time they are used in
the Business section in order to ensure that all investors will
understand the disclosure.
For example, please briefly explain what you mean by alpha, beta and
theta bands,
anxiolysis, galvanic skin response, pharmaco-fMRI, monoamine signaling
molecule,
phosphorylation, nanomolar, inflammasome, microglia, and
alpha-synuclein.
9. For each of the preclinical trials and rat and human studies discussed
in this section for
your product candidates starting on page 130, including those
conducted by third parties,
please expand your disclosure to clarify the scope, size, design and
whether the studies
were powered to show statistical significance.
NMRA-140 (KOR), page 129
10. Please expand on the significance of the SAD and MAD portions of the
Phase 1 trial for
NMRA-140 and briefly discuss the meaning of the food effect
assessed in the SAD
portion of the Phase 1 trial.
NMRA-511, page 133
11. We note your disclosure on page 133 relating to the limitations of
existing first-line
anxiety treatments and second-line treatments such as benzodiazepines.
Please clarify
whether your NMRA-511 as an investigational small molecule antagonist
is also intended
to be a first- or second-line treatment for the treatment of
neuropsychiatric disorders.
NMRA-094, page 135
12. We note your reference to Graph (A) and Graph (B) on page 136. Please
clearly label the
graphics accordingly and ensure all text is legible.
Patent Portfolio, page 142
13. We refer to your disclosure relating to the NMRA-140 patent families
in your molecule
patent portfolio. Please clarify your disclosure of the patents and
patent applications that
comprise the patent family you co-own with TSRI. Please also disclose
the applicable
jurisdictions of the issued foreign patents and foreign pending patent
applications related
to the NMRA-140, NMRA-511 and NMRA-094 product candidates.
14. You disclose on page 143 that your precision neuroscience platform
patent portfolio is
comprised of eight issued U.S. patents, three issued foreign patents
and additional pending
U.S. and foreign pending applications. Please revise to clarify the
number of patents and
patent applications related to each of the multimodal processes and
Syllable portfolio and
the applicable jurisdictions of the issued foreign patents and foreign
pending patent
applications.
Paul Berns
FirstName LastNamePaul Berns
Neumora Therapeutics, Inc.
Comapany6,
December NameNeumora
2021 Therapeutics, Inc.
December
Page 4 6, 2021 Page 4
FirstName LastName
15. We note your disclosure on page 143 relating to your biomarker patent
portfolio. Please
revise to specify the number of patents or patent applications in this
patent portfolio,
whether they are owned or licensed, the expiration dates and
identification of applicable
jurisdictions of foreign patents and pending applications, as
applicable.
In-Licensing and Collaboration Agreements, page 144
16. We note your disclosure on pages 97 and F-22 that you acquired
Propellex Bio, Inc.
(Propellex) to gain access to the rights granted to Propellex under an
exclusive license
with TSRI (2020 TSRI License Agreement) related to preclinical
molecules for the
treatment of Parkinson s disease and other neurogenerative diseases.
You also disclose on
pages F-23 and F-28 that while you have terminated all efforts related
to the Propellex
IPR&D program as of April 2021, the 2020 TSRI License Agreement has
not been
terminated. Please discuss the 2020 TSRI License Agreement in this
section, including
the material terms of the agreement and the extent to which the
licensed rights under the
agreement relate to your NMRA-NLRP3 and NMRA-GCase programs for the
treatment
of Parkinson s disease. Please file the 2021 TSRI License Agreement
and the Harvard
License Agreement as exhibits to the registration statement or explain
to us why you
believe you are not required to do so. Refer to Item 601(b)(10) of
Regulation S-K.
17. We refer to your disclosure relating to the exclusive CK1 License and
GCase License
Agreement with Amgen. Please disclose when the last-to-expire licensed
patent is
scheduled to expire and the aggregate amounts paid or received to date
(including the
payment of any up-front, execution fees or annual license fees) under
the CK1 License
and GCase License Agreement with Amgen, the 2015 TSRI License
Agreement, and the
Harvard License Agreement.
18. Please revise your disclosure relating to the research collaboration
agreement with Amgen
to discuss the scope of the intellectual property, such as the product
candidates the
collaboration agreement relates to, as well as the aggregate amounts
paid or received to
date (including the payment of any up-front or execution fees).
Principal Stockholders, page 184
19. In footnote 4 to the table, please identify the natural persons who
are the beneficial owners
of the shares held by SVF II AIV (DE) LLC.
General
20. Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance
on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain,
copies of those
communications.
Paul Berns
FirstName LastNamePaul Berns
Neumora Therapeutics, Inc.
Comapany6,
December NameNeumora
2021 Therapeutics, Inc.
December
Page 5 6, 2021 Page 5
FirstName LastName
You may contact Eric Atallah at 202-551-3663 or Al Pavot at 202-551-3738
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Jane Park at 202-551-7439 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Phillip Stoup, Esq.