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United States securities and exchange commission logo
March 7, 2022
James McArthur, Ph.D.
President and Chief Executive Officer
PepGen Inc.
245 Main Street
Cambridge, MA 02142
Re: PepGen Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted February
11, 2022
CIK No. 0001835597
Dear Dr. McArthur:
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
February 11, 2022
PGN-EDO51, page 3
1. We note your response
to prior comment 5 and that you "observed the most potent exon
51 skipping based on a
cross trial comparison with publicly-available data...." If you have
not conducted
head-to-head trials, please revise your disclosure to clearly state this fact
and disclose why you
believe these comparisons are appropriate. If you provide
disclosure regarding
results from other trials, expand your disclosure to provide the other
information regarding
these trials that would help an investor make a meaningful
comparison and
understand the supporting trials and any limitations and qualifications
associated with such
trials (e.g., number of patients and whether any patients dropped out
of the trial or were
otherwise excluded and the reasons, patient population, dosage, how
James McArthur, Ph.D.
PepGen Inc.
March 7, 2022
Page 2
the baseline was measured in each study, the phase of the trial, serious
adverse events,
etc.). Please also remove your reference to "potent" and discuss the
data, rather than
drawing conclusions from the results.
Preclinical tolerability data: Generally well-tolerated at clinically-relevant
dose levels, page 141
2. We note your response to our prior comment 15, which we reissue. Please
revise to
discuss the significance of the magnesium levels and indications of
hypomagnesemia
observed for your PGN-EDO51 product candidate.
You may contact Tara Harkins at 202-551-3639 or Kevin Vaughn at
202-551-3494 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jane Park at 202-551-7439 or Jeffrey Gabor at 202-551-2544 with any
other questions.
Sincerely,
FirstName LastNameJames McArthur, Ph.D.
Division of
Corporation Finance
Comapany NamePepGen Inc.
Office of Life
Sciences
March 7, 2022 Page 2
cc: James Xu, Esq.
FirstName LastName