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United States securities and exchange commission logo
May 24, 2023
Paul Berns
Chief Executive Officer
Neumora Therapeutics, Inc.
65 Grove Street
Watertown, Massachusetts 02472
Re: Neumora
Therapeutics, Inc.
Amendment No. 7 to
Draft Registration Statement on Form S-1
Submitted May 2,
2023
CIK No. 0001885522
Dear Paul Berns:
We have reviewed your amended 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.
Amendment No. 7 to Draft Registration Statement on Form S-1 submitted
May 2, 2023
Cover Page
1. Please disclose whether
your offering is contingent upon final approval of your NASDAQ
listing on your cover
page. Please also ensure the disclosure is consistent with your
underwriting agreement.
Prospectus Summary
Overview, page 1
2. We note your revised
disclosure here and throughout the Prospectus that in a Phase 2
clinical trial,
NMRA-140 monotherapy treatment demonstrated clinically meaningful and
statistically
significant improvements in symptoms of depression, anhedonia and anxiety
Paul Berns
FirstName LastNamePaul Berns
Neumora Therapeutics, Inc.
Comapany
May NameNeumora Therapeutics, Inc.
24, 2023
May 24,
Page 2 2023 Page 2
FirstName LastName
in patients with moderate to severe MDD and demonstrated a favorable
safety profile,
which we believe has the potential to provide significant advantages
relative to the
standard of care, if approved. Please revise this disclosure as
follows:
replace the phrase "clinically meaningful" with a description of
the objective data
observed in the trial;
define the phrase "statistically significant" where first used,
describing the trial's
endpoints;
remove statements regarding the "favorable safety profile" of the
treatment, as
conclusions regarding safety are determinations that are solely
within the purview of
the FDA and similar foreign regulatory bodies; and
where you describe the data and results of the trial also clearly
disclose the clinical
trial failed to reach its primary endpoint.
3. We note your statements here and throughout the prospectus that drug
candidates
employing patient selection biomarkers were more likely to be
successful than those
without patient selection biomarkers. Namely, we note the following:
"From 2011 to
2020, clinical development success rates for new drug candidates that
employed patient
selection biomarkers were approximately 16% compared to approximately
8% for those
without patient selection biomarkers." Please revise your disclosure
to provide a source
for the cited statement and to clarify that employing a patient
biomarker does not
necessarily mean that your product candidates will be approved and
commercialized, and
that no final determinations regarding your candidates have been made
by the FDA at this
time. Please also note that clinical development success rates are
based on a variety of
factors that may not be consistent across drug candidates, only one
input of which may be
the use of patient biomarkers. Alternatively, please remove these
statements.
4. We note your newly added statement on page 2 and elsewhere that you
believe your
Precision Toolbox "will enable [you] to execute potential strategies
to help identify
biomarkers that can be used to maximize clinical trial efficiency and
outcomes, and
expand life cycle management opportunities, resulting in a greater
likelihood of matching
the right drug for the right patient." Please revise this statement in
each place that it
appears to remove the implication that you may progress through the
clinical trial process
at a faster rate, as this is unknown and not entirely within your
control, and to remove the
implication that your product candidates will necessarily be approved
for use in patients
and reach commercialization.
Our Pipeline, page 2
5. We note you now depict the clinical progress of four different studies
for NMRA-140 s
major depressive disorder indication in your pipeline table. Please
revise to remove the
individual study progress rows and revert to a single row depicting
the overall current
phase of development for the program.
6. Please revise your pipeline table to remove the NMRA-140 for
neuropsychiatric disorders
program given your disclosure on page 3 and elsewhere stating that you
intend to explore
Paul Berns
Neumora Therapeutics, Inc.
May 24, 2023
Page 3
and evaluate its potential, implying that you are not currently
developing NMRA-140 in
this indication.
7. We note you removed the description of your NMRA-GCASE program here and
reduced
its discussion in the Business section. We also note the NMRA-NMDA
program s limited
discussion in the prospectus. Please revise to remove these programs
from your pipeline
tables as the programs do not appear material based on your disclosure.
Alternatively,
provide an analysis supporting your determination that the programs are
material
and revise your disclosure accordingly.
Our Strategy, page 4
8. We note your reference to your "differentiated IP position" both here
and page 119. Please
revise to explain why your IP position is different from your
competitors, as it is not
apparent from your disclosure, or remove the term.
Intellectual Property, page 131
9. We note your revised disclosure providing the expected expiration date
of the last issued
patent from the patent families licensed to you from TSRI for your
NMRA-140 program.
Please revise to disclose the expiration of all material patents for
your NMRA-140
program.
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
Daniel Crawford at 202-551-7767 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
FirstName LastNamePaul Berns
Division of
Corporation Finance
Comapany NameNeumora Therapeutics, Inc.
Office of Life
Sciences
May 24, 2023 Page 3
cc: Phillip Stoup, Esq.
FirstName LastName