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United States securities and exchange commission logo
July 23, 2020
David H. Mack, Ph.D.
President and Chief Executive Officer
PMV Pharmaceuticals, Inc.
8 Clarke Drive, Suite 3
Cranbury, NJ 08512
Re: PMV
Pharmaceuticals, Inc.
Draft Registration
Statement on Form S-1
Submitted June 26,
2020
CIK 0001699382
Dear Dr. Mack:
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 on June 26, 2020
Market and Industry Data, page ii
1. We note your statement
on pg. ii that, "Industry publications and other reports [you] have
obtained from
independent parties generally state that the data contained in these
publications or other
reports have been obtained in good faith or from sources considered
to be reliable, but
they do not guarantee the accuracy or completeness of such data." The
statement implies a
disclaimer of responsibility for this information in the registration
statement. Please
either delete this statement or specifically state that you are liable for the
information related to
the market and industry data.
David H. Mack, Ph.D.
FirstName LastNameDavid
PMV Pharmaceuticals, Inc. H. Mack, Ph.D.
Comapany
July NamePMV Pharmaceuticals, Inc.
23, 2020
July 23,
Page 2 2020 Page 2
FirstName LastName
Prospectus Summary, page 1
2. Please revise to limit the discussion of your pre-clinical results in
the Summary section to
a high-level discussion of your observations, as the more detailed
discussion of specific
results with graphics is more appropriate for the Business section.
Additionally, as the
FDA or other similar regulatory authorities will need to make efficacy
determinations
regarding any drug product, please balance disclosures relating to the
desired purpose of
your product candidates (such as PC14586 being designed to "potently
and selectively
correct p53 misfolding") with equally prominent explanations that any
conclusions
regarding desired effects are premature as your product candidate
remains pre-clinical,
and as you state on pages 20 and 23, the scientific evidence is
"preliminary and limited,"
and your novel approach "unproven."
3. As the FDA will need to make efficacy determinations regarding any
drug product, please
balance disclosures relating to the desired purpose of your product
candidate or your
platform (such as PC14586 being designed to "potently and selectively
correct p53
misfolding") with equally prominent explanations that any conclusions
regarding desired
effects are premature as your product candidate remains pre-clinical,
and as you state on
pages 20 and 23, the scientific evidence is "preliminary and limited,"
and your novel
approach "unproven." Please also clarify, if true, that your program's
approach
assumes that a specific p53 mutation is the only genetic mutation
resulting in a patient s
cancer.
4. We refer to your statement on page 1 that your strategy is to seek
approval under an
accelerated pathway and that you believe your Phase 1/2 trial can
serve as a pivotal study.
Please revise to provide balancing disclosure that you have not yet
submitted an IND for
the trial to the FDA, and that there can be no assurance that the FDA
will permit you to
utilize an expedited approval process or agree with your
tumor-agnostic approach, and
provide similar disclosure in the summary risk factor section. Please
also provide the basis
for your belief that phases 1 and 2 can be combined in the same trial.
5. Please revise your pipleline table here and in the Business section to
state in the last
column that you need to submit a required IND to the FDA before
initiating your Phase 1
trial. Additionally, we note you have included a row for "other p53
hotspot mutation",
which is in the discovery phase. Given the early-stage development of
the program and
your limited disclosure on pages 132-133 concerning the program,
please explain why this
program is sufficiently material to your business to warrant inclusion
in your pipeline
table. Please also remove the box graphic at the bottom of the table
as this information is
already conveyed elsewhere in the Summary and does not appear
appropriate to highlight
in a pipeline table.
David H. Mack, Ph.D.
FirstName LastNameDavid
PMV Pharmaceuticals, Inc. H. Mack, Ph.D.
Comapany
July NamePMV Pharmaceuticals, Inc.
23, 2020
July 23,
Page 3 2020 Page 3
FirstName LastName
Risks Related to Our Business, page 9
6. Please expand on your last bullet to explain, if true, that you
currently do not have any
patent protection for your product candidate. Also add a bullet
explaining that PC14586
will require the development of companion diagnostics with third party
collaborators, and
that they will need to be separately approved by the FDA as medical
devices, as you
explain on page 21.
Implications of being an emerging growth company, page 10
7. 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.
Risk Factors
Our principal stockholders and management own a significant percentage. . .,
page 84
8. Please expand this risk factor to disclose the connections between
certain of your directors
and your principal stockholders.
Use of Proceeds, page 95
9. Please revise to clarify whether you will be able to complete the
Phase 1/2 trial with the
allocated net proceeds from the offering. If any material amounts of
other funds are
necessary, please disclose the amount of funds needed to complete the
Phase 1/2 clinical
trial. Refer to Instruction 3 to Item 504 of Regulation S-K.
Management s Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations, page 107
10. While we note your disclosure on page 106 that you do not allocate
costs to specific
product candidates, please expand your disclosures to disaggregate
research and
development expenses by nature or type of expense for each period
presented.
Critical Accounting Policies and Significant Judgments and Estimates
Stock Based Compensation, page 111
11. 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.
David H. Mack, Ph.D.
PMV Pharmaceuticals, Inc.
July 23, 2020
Page 4
Common Stock Valuations, page 112
12. Please expand your disclosures for the determination of the fair value
of common stock to
provide additional details regarding your use of the hybrid approach
including the nature
of the material assumptions involved. To the extent 3rd party
valuations were performed,
please provide the results of such valuations and whether such
valuations corroborated
any internal valuations performed. Finally, please provide additional
detail regarding the
extent to which recent sales of redeemable convertible preferred stock
and/or common
stock in arms-length transactions represented significant inputs to
provide investors with
context of the extent to which your estimates were complex and
subjective.
Business
Overview, page 115
13. We note your disclosure on page 30 that you "expect to initially seek
approval of [y]our
product candidates in most instances at least as a second therapy."
Please expand your
disclosure here to clarify whether you expect to initially seek
approval of PC14586 as a
second line therapy.
Our Strategy, page 117
14. We refer to your statement in the last paragraph on page 117 that your
strategy of using
assays will "enable a rapid determination of efficacy." Please revise
the statement as it
could be interpreted as implying an expectation of rapid regulatory
approval.
Mechanism of Action, page 125
15. Please further expand your disclosure to explain how PC14586
selectively binds to the
crevice created by the Y220C mutation. Additionally, expand your
narrative discussion of
the graphic on page 126 to numerically explain how mutant p53 was
induced to convert to
wild-type in a dose-dependent manner, and provide the basis for your
statement that you
demonstrated that PC14586 "rapidly converts" mutant p53 to wild-type.
16. We refer to the figures at the top of page 127, and note that you
state that PC14586
upregulated p21 and MDM2 in a dose-dependent manner. However, please
explain why
the curve shown in the figures do not correspond to the the levels of
expression of p21 and
MDM2 with respect to wild-type p53.
Preclinical In Vivo Data , page 127
17. Please revise this section to ensure your narrative disclosure includes,
where applicable,
FirstName LastNameDavid H. Mack, Ph.D.
an explanation of how TGI and tumor regression are measured, whether a
vehicle was
Comapany
used,NamePMV Pharmaceuticals,
and if so, provide Inc. of it, dosing information,
the number of mice used
an explanation
July 23,in2020
eachPage
study,4 the duration of the study, and whether graphs show mean
or average results.
FirstName LastName
David H. Mack, Ph.D.
FirstName LastNameDavid
PMV Pharmaceuticals, Inc. H. Mack, Ph.D.
Comapany
July NamePMV Pharmaceuticals, Inc.
23, 2020
July 23,
Page 5 2020 Page 5
FirstName LastName
18. We refer to your statement on page 127 that oral daily dosing of
PC14586 up to the
specified dose was "well tolerated" in the mice being observed, as
evidenced by the lack
of body weight loss. Please revise to discuss any other clinical signs
or toxicity measures
that were evaluated, and if there were no other evaluation measures,
please clarify this
fact.
19. Please expand your discussion of the results shown in the graphical
illustrations on page
128 to more clearly explain how PC14586 adminstration resulted in
conversion of mutant
p53 protein to a wild-type p53 structure and how it induced the
expression of the p53
downstream target MIC-1. Please also clarify whether the figures
reflect information from
the same study, and clearly label the information portrayed in the
horizontal axes of the
three figures.
20. Please explain the basis for your statement on page 128 that "[you]
believe this syngeneic
mouse model better represents the patient population that we expect to
see in the clinic, as
compared to mouse xenograft models that incorporate human tumors in
mice with no
immune system" given your statement in the risk factors on page 33
that "[your] product
candidates will be used in patients that have weakened immune systems
.. . ."
21. Please expand your disclosure regarding your results from a
pre-clinical study combining
PC14586 with an anti-PD-1 therapy to explain the anti-PD-1 therapy and
the rationale for
using such combination therapy. Additionally, please revise the graphs
on pages 129 and
130 to label the various lines.
Intellectual Property, page 135
22. We note your statement in the first sentence of the second paragraph
in this section that
you "intend to pursue patent protection," and your statement on page
15 that your limited
operating history includes filing patent applications. Please revise
to clarify whether you
have filed any patent applications relevant to PC14586, and if yes,
please revise to provide
additional information, including the type of protection to which they
relate, the
jurisdictions in which applications were filed, and relevant
expiration dates.
Exhibits
23. We note that you have entered into different severance participation
agreements with each
of Dr. Mack, Mr. Kung and Dr. Jalota. Please file such agreements in
accordance with
Item 601(b)(10) of Regulation S-K.
David H. Mack, Ph.D.
FirstName LastNameDavid
PMV Pharmaceuticals, Inc. H. Mack, Ph.D.
Comapany
July NamePMV Pharmaceuticals, Inc.
23, 2020
July 23,
Page 6 2020 Page 6
FirstName LastName
You may contact Ameen Hamady at 202-551-3891 or Kevin Kuhar at
202-551-3662 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Deanna Virginio at 202-551-4530 or Dorrie Yale at 202-551-8776 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Megan J. Baier, Esq.