View:
United States securities and exchange commission logo
August 18, 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.
Amendment No. 1 to
Draft Registration
Statement on Form S-1
Submitted August 3,
2020
CIK 0001699382
Dear Dr. Mack:
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. 1 to Draft Registration Statement on Form S-1 Submitted on
August 3, 2020
Prospectus Summary , page 1
1. We note your response
to prior comment 2 and your revised disclosure on page 1 that you
believe "[you] have
designed [y]our lead product candidate, PC14586, to potently and
selectively correct p53
misfolding caused by a specific p53 mutation, Y220C, while
sparing wild-type p53."
As previously noted, please balance your disclosure with equally
prominent explanations
that your product candidate remains in the early development
stages and your novel
approach is unproven.
David H. Mack, Ph.D.
FirstName LastNameDavid
PMV Pharmaceuticals, Inc. H. Mack, Ph.D.
Comapany
August 18, NamePMV
2020 Pharmaceuticals, Inc.
August
Page 2 18, 2020 Page 2
FirstName LastName
2. We note your response to prior comment 4 and your revised disclosure
on page 1 that you
"cannot guarantee that the U.S. Food and Drug Administration, or FDA,
will agree with
this strategy of utilizing the Phase 1/2 clinical trial as a pivotal
study . . . " As you further
explain on page 133, please also clarify here that you intend to
pursue the accelerated
approval pathway if the data from your Phase 1/2 trail supports the
path, and that even if
you obtain accelerated approval, you anticipate that the FDA will
require post-approval
trials to confirm clinical benefit.
Risks Related to Our Business, page 6
3. Please expand your last bullet to also state that the companion
diagnostics will need to be
separately approved by the FDA as medical devices. We refer to prior
comment 6.
Business, page 116
4. Please expand your disclosure in the Business section to include that
you expect to
initially seek approval of your product candidates, "in most instances
at least as a second
line therapy," as you state on page 27.
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.