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United States securities and exchange commission logo
October 28, 2021
James McArthur, Ph.D.
President and Chief Executive Officer
PepGen Inc.
245 Main Street
Cambridge, MA 02142
Re: PepGen Inc.
Draft Registration
Statement on Form S-1
Submitted October
1, 2021
CIK No. 0001835597
Dear Dr. McArthur:
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 on October 1, 2021
Overview, page 1
1. Please revise the
opening paragraph to provide context and balance to your disclosure that
you are an
early-stage biopharmaceutical company and to highlight that your operations
are preclinical in
nature and your reliance on patents in-licensed from OUI and MRC.
2. Please clarify the
meaning and significance 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 the meaning of exon, dystrophin, CUG trinucleotide and
HSALR.
James McArthur, Ph.D.
FirstName
PepGen Inc.LastNameJames McArthur, Ph.D.
Comapany
October 28,NamePepGen
2021 Inc.
October
Page 2 28, 2021 Page 2
FirstName LastName
Our Portfolio, page 2
3. We note the inclusion of your PGN-EDO44 and PGN-EDO45 discovery
programs in your
pipeline table on pages 2 and 117. We also refer to the inclusion of
PGN-EDONMD for
an undisclosed indication in the last row of your pipeline table.
Given the status of
development, no specified target indication for PGN-EDONMD and limited
disclosure
regarding these discovery programs, it seems premature to highlight
these products
prominently in the pipeline table. Please explain why these programs
are sufficiently
material to your business to warrant inclusion in your pipeline table.
If they are material,
please expand your disclosure in your Business section to provide a
more fulsome
discussion of these programs or alternatively, remove any programs
that are not currently
material from the pipeline table.
4. We refer to your disclosure on page 2 of your pipeline of
oligonucleotide therapeutics
candidates that are engineered to safely and effectively target
the root cause of serious
diseases, such as Duchenne muscular dystrophy. Please note that
determinations of safety
and efficacy are solely within the authority of the FDA; therefore,
please revise the
prospectus to remove all references and/or implications of safety and
efficacy, including
that cited above.
PGN-EDO51, page 3
5. We refer to your disclosure on page 3 relating to your conclusion that
you observed the
most potent exon skipping compared to any approved therapeutic or
known
developmental candidate across target issues. Please revise your
Summary to provide
more balanced disclosure by clarifying whether any head-to-head
comparisons were
conducted.
Our Team and Investors, page 5
6. We note that you identify certain entities as investors in your
company on page 5;
however, some do not appear to be among your principal stockholders as
disclosed on
page 183. If material, please expand your disclosure to describe the
nature of each named
entity s investment in you and explain to us why including this
information is
appropriate. Please also explain in your response your plans to update
investor about
changes these entities make with respect to their investments in the
company.
Special Note Regarding Forward-Looking Statements, page 91
7. You state on page 92 that investors are cautioned not to place
undue reliance on
statements that reflect your intentions and expectations disclosed in
forward-looking
statements. Please note that you are responsible for the disclosure
contained in your
registration statement and you may not use language that could be
interpreted as a
disclaimer of information contained in your filing. Please revise.
James McArthur, Ph.D.
FirstName
PepGen Inc.LastNameJames McArthur, Ph.D.
Comapany
October 28,NamePepGen
2021 Inc.
October
Page 3 28, 2021 Page 3
FirstName LastName
Use of Proceeds, page 93
8. To the extent known, please revise your disclosure to include each of
the programs listed
in your Summary pipeline table and the approximate amount of proceeds
you intend to
allocate toward each of the programs identified, as well as how far
the proceeds from the
offering will allow you to proceed with the continued development of
each of your
programs. Refer to Instruction 3 to Item 504 of Regulation S-K.
Capitalization, page 96
9. You disclose that you have 1,051,720 shares of Class A common stock
outstanding as of
June 30, 2021. However, on page F-25 you disclose that you have
910,160 shares of Class
A common stock outstanding as of the same date. Please reconcile these
amounts and
revise accordingly. Please note that this discrepancy also impacts
your historical net
tangible book value per share calculation of your common stock on page
98.
10. We note on pages F-19 and F-37 that all of your outstanding preferred
shares will convert
automatically into common stock in the closing of the sale of shares
of your common
stock to the public at a price of at least $57.12 per share (subject
to adjustment) in an
underwritten public offering. Explain to us why you believe these pro
forma adjustments
related to the conversion of your preferred shares upon the initial
public offering
are factually supportable by confirming to us that you presently
expect the offering to
meet such conditions. If management subsequently concludes the
conditions may not be
satisfied, please revise the filing accordingly.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development, page 103
11. Please revise to also include disaggregated disclosures by nature of
expenses incurred for
each reporting period presented.
Critical Accounting Polices and Estimates
Stock-Based Compensation, page 111
12. 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 initial public offering and the estimated offering price.
This information will help
facilitate our review of your accounting for equity issuances
including stock
compensation. Please discuss with the staff how to submit your
response.
Business, page 116
13. Please revise the graphic on page 136 to ensure that the labels and
units on both axes are
legible. Please also revise the graphics on page 142 and 143 to
clarify the meaning of the
abbreviations, such as PPMO dose and WT.
James McArthur, Ph.D.
PepGen Inc.
October 28, 2021
Page 4
Comparison with Other Oligonucleotide Delivery Technologies in Development,
page 126
14. We note your disclosure on page 126 of the in vivo studies comparing
your EDO
technology with other CPP-PMO approaches in a number of animal models.
We also
refer to your disclosure on page 134 relating to the repeat dose
administration of PGN-
EDO51. Please expand your disclosure to address the related
statistical significance
and/or p-values and the design and scope of your studies, including
the number of subjects
and whether any adverse events were observed (if any).
Safety data: Generally well-tolerated a clinically-relevant dose levels, page
135
15. We refer to your disclosure of levels of hypomagnesemia observed in
patients on page
135. Please expand your disclosure to discuss the significance of the
magnesium levels
observed and how the results support your conclusion that PGN-EDO51
has a potential
therapeutic index.
License of Technology Agreement with Oxford University Innovation Limited...,
page 149
16. Please revise to disclose when the last-to-expire licensed patent is
set to expire under the
OUI/MRC License. Please also disclose the upfront or execution
payments, the aggregate
of milestone payments to be paid or received and the aggregate amounts
paid or received
under the OUI/MRC License, as applicable.
Intellectual Property, page 151
17. We note your disclosure on page 153 relating to the issued patent and
patent applications
that you exclusive license under the OUI/MRC License with respect to
the EDO platform.
Please expand your disclosure to specify the specific technology to
which such patent
relates, as well as the type of patent protection and the applicable
jurisdiction of the one
issued patent.
General
18. 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,
FirstName LastNameJames McArthur, Ph.D.
have presented or expect to present to potential investors in reliance
on Section 5(d) of the
Comapany NamePepGen
Securities Inc. or not you retained, or intend to retain, copies
of those
Act, whether
Octobercommunications.
28, 2021 Page 4
FirstName LastName
James McArthur, Ph.D.
FirstName
PepGen Inc.LastNameJames McArthur, Ph.D.
Comapany
October 28,NamePepGen
2021 Inc.
October
Page 5 28, 2021 Page 5
FirstName LastName
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,
Division of
Corporation Finance
Office of Life
Sciences
cc: James Xu, Esq.