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PepGen Inc.
Response Received
1 company response(s)
Medium - date proximity
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PepGen Inc.
Response Received
1 company response(s)
High - file number match
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PepGen Inc.
Response Received
1 company response(s)
High - file number match
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PepGen Inc.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2022-04-22
PepGen Inc.
Filing - SEC Comment Letter to PepGen Inc.
UPLOAD · 2022-04-22
Generating summary...
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Company responded
2022-04-22
PepGen Inc.
References: October 28, 2021
Filing - Correspondence from PepGen Inc.
CORRESP · 2022-04-22
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Company responded
2022-05-02
PepGen Inc.
References: April 22, 2022
Filing - Correspondence from PepGen Inc.
CORRESP · 2022-05-02
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Company responded
2022-05-03
PepGen Inc.
Filing - Correspondence from PepGen Inc.
CORRESP · 2022-05-03
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Company responded
2022-05-03
PepGen Inc.
Filing - Correspondence from PepGen Inc.
CORRESP · 2022-05-03
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Company responded
2022-05-04
PepGen Inc.
References: May 3, 2022
Filing - Correspondence from PepGen Inc.
CORRESP · 2022-05-04
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PepGen Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-05-03
PepGen Inc.
Filing - SEC Comment Letter to PepGen Inc.
UPLOAD · 2022-05-03
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PepGen Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2022-03-07
PepGen Inc.
Filing - SEC Comment Letter to PepGen Inc.
UPLOAD · 2022-03-07
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PepGen Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2021-10-28
PepGen Inc.
Filing - SEC Comment Letter to PepGen Inc.
UPLOAD · 2021-10-28
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-19 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2026-04-17 | SEC Comment Letter | PepGen Inc. | DE | 377-09262 | Read Filing View |
| 2024-07-03 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2024-07-02 | SEC Comment Letter | PepGen Inc. | DE | 333-280570 | Read Filing View |
| 2023-06-14 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2023-06-09 | SEC Comment Letter | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-05-04 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-05-03 | SEC Comment Letter | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-05-03 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-05-03 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-05-02 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-04-22 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-04-22 | SEC Comment Letter | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-03-07 | SEC Comment Letter | PepGen Inc. | DE | N/A | Read Filing View |
| 2021-10-28 | SEC Comment Letter | PepGen Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-17 | SEC Comment Letter | PepGen Inc. | DE | 377-09262 | Read Filing View |
| 2024-07-02 | SEC Comment Letter | PepGen Inc. | DE | 333-280570 | Read Filing View |
| 2023-06-09 | SEC Comment Letter | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-05-03 | SEC Comment Letter | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-04-22 | SEC Comment Letter | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-03-07 | SEC Comment Letter | PepGen Inc. | DE | N/A | Read Filing View |
| 2021-10-28 | SEC Comment Letter | PepGen Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-19 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2024-07-03 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2023-06-14 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-05-04 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-05-03 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-05-03 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-05-02 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
| 2022-04-22 | Company Response | PepGen Inc. | DE | N/A | Read Filing View |
2026-05-19 - CORRESP - PepGen Inc.
CORRESP 1 filename1.htm CORRESP PepGen Inc. 321 Harrison Avenue, 8th Floor Boston, Massachusetts 02118 May 19, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Daniel Crawford Re: PepGen Inc. Registration Statement on Form S-3 (File No. 333-296016) Request for Acceleration of Effective Date To whom it may concern: Pursuant to Rule 461 under the Securities Act of 1933, as amended, PepGen Inc. (the “ Company ”) hereby respectfully requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-296016), be accelerated by the Securities and Exchange Commission to 4:00 p.m. Eastern time, on May 21, 2026, or as soon thereafter as possible. We request that we be notified of such effectiveness by a telephone call to Jonathan Burr of Goodwin Procter LLP at 202-346-4198 and that such effectiveness also be confirmed in writing. Very truly yours, PepGen Inc. By: /s/ Joseph Vittiglio, Esq. Name: Joseph Vittiglio, Esq. Title: Chief Business and Legal Officer cc: Edwin O’Connor, Goodwin Procter LLP Finnbarr Murphy, Goodwin Procter LLP Jonathan Burr, Goodwin Procter LLP
2026-04-17 - UPLOAD - PepGen Inc. File: 377-09262
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 17, 2026 James McArthur, Ph.D. President and Chief Executive Officer PepGen Inc. 321 Harrison Avenue, 8th Floor Boston, MA 02118 Re: PepGen Inc. Draft Registration Statement on Form S-3 Submitted April 15, 2026 CIK No. 0001835597 Dear James McArthur Ph.D.: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement and non-public draft submission on EDGAR at least two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jonathan Burr, Esq. </TEXT> </DOCUMENT>
2024-07-03 - CORRESP - PepGen Inc.
CORRESP 1 filename1.htm CORRESP PepGen Inc. 321 Harrison Avenue, 8th Floor Boston, Massachusetts 02118 July 3, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Chris Edwards Re: PepGen Inc. Registration Statement on Form S-3 (File No. 333-280570) Request for Acceleration of Effective Date To whom it may concern: Pursuant to Rule 461 under the Securities Act of 1933, as amended, PepGen Inc. (the “Company”) hereby respectfully requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-280570), be accelerated by the Securities and Exchange Commission to 4:00 p.m. Eastern time, on July 8, 2024, or as soon thereafter as possible. We request that we be notified of such effectiveness by a telephone call to Alicia M. Tschirhart of Goodwin Procter LLP at (415) 733 6156 and that such effectiveness also be confirmed in writing. Very truly yours, PepGen Inc. By: /s/ James McArthur, Ph.D. Name: James McArthur, Ph.D. Title: Chief Executive Officer cc: Finnbarr Murphy, Goodwin Procter LLP Alicia M. Tschirhart, Goodwin Procter LLP
2024-07-02 - UPLOAD - PepGen Inc. File: 333-280570
July 2, 2024
James McArthur, Ph.D.
President and Chief Executive Officer
PepGen Inc.
321 Harrison Avenue, 8th Floor
Boston, Massachusetts 02118
Re:PepGen Inc.
Registration Statement on Form S-3
Filed June 28, 2024
File No. 333-280570
Dear James McArthur Ph.D.:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Alicia Tschirhart, Esq.
2023-06-14 - CORRESP - PepGen Inc.
CORRESP 1 filename1.htm CORRESP PepGen Inc. 321 Harrison Avenue, 8th Floor Boston, Massachusetts 02118 June 14, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Alan Campbell Re: PepGen Inc. Registration Statement on Form S-3 (File No. 333-272378) Request for Acceleration of Effective Date To whom it may concern: Pursuant to Rule 461 under the Securities Act of 1933, as amended, PepGen Inc. (the “Company”) hereby respectfully requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-272378), be accelerated by the Securities and Exchange Commission to 4:00 p.m. Eastern time, on June 16, 2023, or as soon thereafter as possible. We request that we be notified of such effectiveness by a telephone call to Alicia M. Tschirhart of Goodwin Procter LLP at (415) 733 6156 and that such effectiveness also be confirmed in writing. Very truly yours, PepGen Inc. By: /s/ James McArthur, Ph.D. Name: James McArthur, Ph.D. Title: Chief Executive Officer cc: James Xu, Goodwin Procter LLP Alicia M. Tschirhart, Goodwin Procter LLP
2023-06-09 - UPLOAD - PepGen Inc.
United States securities and exchange commission logo
June 9, 2023
James McArthur, Ph.D.
President and Chief Executive Officer
PepGen Inc.
321 Harrison Avenue, 8th Floor
Boston, Massachusetts 02118
Re:PepGen Inc.
Registration Statement on Form S-3
Filed June 2, 2023
File No. 333-272378
Dear James McArthur:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: James Xu, Esq.
2022-05-04 - CORRESP - PepGen Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 May 4, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street NE Washington, DC 20549 Attention: Tara Harkins Kevin Vaughn Jane Park Jeffrey Gabor Re: PepGen Inc. Amendment No 1 to Registration Statement on Form S-1 Filed May 2, 2022 File No. 333-264335 Ladies and Gentlemen: This letter is confidentially submitted on behalf of PepGen Inc. (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Amendment No. 1 to Registration Statement on Form S-1, filed on May 2, 2022 (the “Registration Statement”), as set forth in the Staff’s letter dated May 3, 2022 addressed to James McArthur, Ph.D., the Company’s President and Chief Executive Officer (the “Comment Letter”). The Company is concurrently filing Amendment No. 2 to the Registration Statement (the “Amendment No. 2”), which includes changes to reflect responses to the Staff’s comments and other updates. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comments refer to the Registration Statement, and page references in the responses refer to Amendment No. 2. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in Amendment No. 2. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. U.S. Securities and Exchange Commission May 4, 2022 Page 2 Amendment No. 1 to Registration Statement on Form S-1 filed May 2, 2022 PGN-EDO51, page 3 1. We note your response to prior comment 1. Given that you did not conduct head-to-head trials with EXONDYS 51 and DYNE-251, please remove these comparisons. Please also disclose more information about R6G-PMO so that investors can make a meaningful comparison. Please also expand your disclosure to discuss the meaning of PGN-EDO51 having “greater activity” than R6G-PMO. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 2, 3, 4, 119, 120 and 128 to remove references to non-head-to-head comparisons of its PGN-EDO51 candidate to EXONDYS 51 and DYNE-251. In addition, the Company advises the Staff that it has revised its disclosure on pages 3, 4 and 120 to provide more information about R6G-PMO, its structure and the Company’s use of the compound in its head-to-head preclinical studies of PGN-EDO51. The Company has also revised its disclosure to clarify that its reference to “greater activity” is intended to convey observations of more exon skipping activity of PGN-EDO51 seen in its head-to-head preclinical studies. *** If you should have any questions regarding the enclosed matters, please contact me at (650) 752 3355. Sincerely, /s/ James Xu, Esq. James Xu, Esq. Enclosures cc: James McArthur, Ph.D., President and Chief Executive Officer, PepGen, Inc.
2022-05-03 - UPLOAD - PepGen Inc.
United States securities and exchange commission logo
May 3, 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 Registration Statement on Form S-1
Filed May 3, 2022
File No. 333-264335
Dear Dr. McArthur:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Amendment No. 1 to Registration Statement on Form S-1 filed May 2, 2022
PGN-EDO51, page 3
1.We note your response to prior comment 1. Given that you did not conduct head-to-head
trials with EXONDYS 51 and DYNE-251, please remove these comparisons. Please also
disclose more information about R6G-PMO so that investors can make a meaningful
comparison. Please also expand your disclosure to discuss the meaning of PGN-EDO51
having "greater activity" than R6G-PMO.
FirstName LastNameJames McArthur, Ph.D.
Comapany NamePepGen Inc.
May 3, 2022 Page 2
FirstName LastName
James McArthur, Ph.D.
PepGen Inc.
May 3, 2022
Page 2
You may contact Tara Harkins at 202-551-3639 or Kevin Kuhar at 202-551-3662 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.
2022-05-03 - CORRESP - PepGen Inc.
CORRESP 1 filename1.htm CORRESP PepGen Inc. 245 Main Street Cambridge, Massachusetts 02142 May 3, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Tara Harkins Kevin Vaughn Jane Park Jeffrey Gabor Re: PepGen Inc. Registration Statement on Form S-1, as amended (File No. 333-264335) Request for Acceleration of Effective Date To whom it may concern: Pursuant to Rule 461(a) under the Securities Act of 1933, as amended, PepGen Inc. (the “Company”) hereby respectfully requests that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333-264335), as amended, be accelerated by the Securities and Exchange Commission to 4:00 p.m. Eastern time, on May 5, 2022, or as soon thereafter as possible. We request that we be notified of such effectiveness by a telephone call to James Xu of Goodwin Procter LLP at (650) 752 3355 and that such effectiveness also be confirmed in writing. Very truly yours, PepGen Inc. By: /s/ James McArthur, Ph.D. Name: James McArthur, Ph.D. Title: Chief Executive Officer cc: James Xu, Goodwin Procter LLP
2022-05-03 - CORRESP - PepGen Inc.
CORRESP 1 filename1.htm CORRESP May 3, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attn: Tara Harkins Kevin Vaughn Jane Park Jeffrey Gabor Re: PepGen Inc. Registration Statement on Form S-1, as amended (File No. 333-264335) Request for Acceleration of Effective Date Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), BofA Securities, Inc., SVB Securities LLC and Stifel, Nicolaus & Company, Incorporated, as representatives of the several underwriters, hereby join PepGen Inc. (the “Company”) in requesting that the Securities and Exchange Commission take appropriate action to cause the Registration Statement on Form S-1 (File No. 333-264335) (the “Registration Statement”) to become effective as of 4:00 p.m. Eastern time, on May 5, 2022, or as soon thereafter as possible. Pursuant to Rule 460 of the General Rules and Regulations of the Securities and Exchange Commission under the Securities Act of 1933, as amended, please be advised that there has been distributed or will be distributed to each underwriter or dealer who is reasonably anticipated to participate in the distribution of the security as many copies of the Company’s preliminary prospectus dated May 2, 2022 as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We advise that we have complied and will continue to comply, and that we have been informed by the participating underwriters that they have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, to the extent applicable. [Signature Page Follows] Very truly yours, By: BOFA SECURITIES, INC. By: /s/ Michael Liloia Name: Michael Liloia Title: Director By: SVB SECURITIES LLC By: /s/ Dan Dubin Name: Dan Dubin Title: Vice Chairman, Global Co-Head of Investment Banking By: STIFEL, NICOLAUS & COMPANY, INCORPORATED By: /s/ Michael Chien Name: Michael Chien Title: General Counsel [Signature Page to Acceleration Request]
2022-05-02 - CORRESP - PepGen Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 May 2, 2022 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street NE Washington, DC 20549 Attention: Tara Harkins Kevin Vaughn Jane Park Jeffrey Gabor Re: PepGen Inc. Draft Registration Statement on Form S-1 (File No. 333-264335) Filed April 15, 2022 CIK No. 0001835597 Ladies and Gentlemen: This letter is confidentially submitted on behalf of PepGen Inc. (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-1, filed on April 15, 2022 (the “Registration Statement”), as set forth in the Staff’s letter dated April 22, 2022 addressed to James McArthur, Ph.D., the Company’s President and Chief Executive Officer (the “Comment Letter”). The Company is concurrently filing Amendment No. 1 to the Registration Statement (the “Amendment No. 1”), which includes changes to reflect responses to the Staff’s comments and other updates. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comments refer to the Registration Statement, and page references in the responses refer to Amendment No. 1. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in Amendment No. 1. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. U.S. Securities and Exchange Commission May 2, 2022 Page 2 Registration Statement on Form S-1 filed April 15, 2022 PGN-EDO51, page 3 1. We note your response to our prior comment 1, which we reissue in part. Please remove the reference to “potent” on pages 3, 120 and 127. Given the prominent disclosure of the cross-trial comparisons conducted with data published by Sarepta Therapeutics and Dyne Therapeutics in your Summary, please advise whether you relied on such cross-trial comparisons in your CTA submission for PGN-EDO51. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on pages 3, 120 and 127 to remove references to “potent”. The Company supplementally advises the Staff its preclinical data package for PGN-EDO51, including preliminary safety and efficacy data, was submitted as part of its CTA for the product candidate. Comparative data for Sarepta Therapeutics and Dyne Therapeutics were published by those respective companies and are publicly available. The Company further advises the Staff that the purpose of the CTA was to seek clearance from the regulatory agency to begin clinical testing in humans for the Company’s Phase 1 program for PGN-EDO51. The Company believes that while preliminary efficacy data on PGN-EDO51 provided additional information for the regulatory agency to consider, for purposes of the CTA, the Company’s primary objective was to communicate sufficient safety data for the agency to permit dosing humans with PGN-EDO51. Preclinical tolerability data: Generally well-tolerated…page 143 2. We acknowledge your revised disclosure in response to our prior comment 2. Please revise to include the meaning of “hypomagnesemia.” Revise to clarify that hypomagnesemia is a side effect observed in your non-GLP repeat-dose study of PGNEDO51 and identify the number of NHPs that experienced hypomagnesemia in your study. RESPONSE: The Company respectfully advises the Staff that it has revised its disclosure on page 143 to provide a definition of hypomagnesemia, to clarify that it was a side effect observed in its non-GLP repeat-dose study, and to identify the number NHPs that experienced hypomagnesemia in the study. Research and Development, page F-12 3. We note your disclosure relating to the receipt of government grants and refundable research and development tax credits. Please provide a brief description of the material terms of your government grants, including but not limited to, the aggregate amounts, conditions and term, and file any agreements as exhibits to the registration statement or tell us why it is not material. U.S. Securities and Exchange Commission May 2, 2022 Page 3 RESPONSE: The Company respectfully advises the Staff that a brief description of the material terms of the government grants referenced in the Staff’s comment is contained in note 6, “Material Agreements” of the consolidated financial statements on page F-17. With respect to the discussion on page F-12 regarding reductions of research and development expenses recorded in the Company’s consolidated statements of operations, the Company supplementally advises the Staff that the amounts presented in this discussion includes research and development tax credits. The amount of government grants received for the applicable periods are discussed in note 6 on page F-17. The Company further advises the Staff that it does not believe any of its government grants are material agreements within the meaning of Item 601 of Regulation S-K. As described in the Registration Statement, the Company’s business includes advancing and developing product candidates, and companies in its industry routinely receive government grants in the ordinary course of business. The Company supplementally advises the Staff that its business is not substantially dependent on these grants. The Company further advises that the amounts provided by these grants, totaling $1.4 million and $0.2 million for the years ended December 31, 2020 and 2021, respectively, represent a small proportion of the Company’s expenditures, the total amount that the Company is eligible to receive is $2.1 million, and the Company will not receive any further funding from this government grant. For the foregoing reasons, the Company believes that these government grants do not rise to the level of a material agreement under Item 601 of Regulation S-K and do not need to be filed as an exhibit to the Registration Statement. *** If you should have any questions regarding the enclosed matters, please contact me at (617) 570 1483. Sincerely, /s/ James Xu, Esq. James Xu, Esq. Enclosures cc: James McArthur, Ph.D., President and Chief Executive Officer, PepGen, Inc.
2022-04-22 - CORRESP - PepGen Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 CONFIDENTIAL TREATMENT REQUESTED BY PEPGEN INC. CERTAIN PORTIONS OF THIS LETTER AS FILED VIA EDGAR HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. OMITTED INFORMATION HAS BEEN REPLACED IN THIS LETTER AS FILED VIA EDGAR WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].” April 22, 2022 VIA EDGAR AND FEDERAL EXPRESS U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Tara Harkins, Kevin Vaughn, Jane Park and Jeffrey Gabor Re: PepGen Inc. – Anticipated Price Range Registration Statement on Form S-1 File No. 333-264335 CIK No. 0001835597 Ladies and Gentlemen: On behalf of PepGen Inc. (the “Company”), in response to comments from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) received by letter dated October 28, 2021 (the “Original Comment Letter”) relating to the Company’s Draft Registration Statement on Form S-1, originally confidentially submitted to the Commission on October 1, 2021, and subsequently publicly filed by the Company with the Commission on April 15, 2022 (File No. 333-264335) (the “Registration Statement”), we submit this supplemental letter to further address comment 12 of the Original Comment Letter. Because of the commercially sensitive nature of information contained herein, this submission is accompanied by the Company’s request for confidential treatment for selected portions of this letter. The Company has concurrently filed a separate letter with the Office of Freedom of Information and Privacy Act Operations in connection with the confidential treatment request, pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83. For the Staff’s reference, we have enclosed a copy of the Company’s letter to the Office of Freedom of Information and Privacy Act Operations. 1 Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 We confirm on behalf of the Company that, prior to circulating copies of the preliminary prospectus in connection with the offering, the Company will file a pre-effective amendment to the Registration Statement that will include all information other than information that may be excluded in reliance upon Rule 430A of Regulation C, and the actual price range to be included in such amendment which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range and will be subject to then-current market conditions, as well as further business and market developments affecting the Company. The Company expects to reflect the Stock Split (as defined below) in a pre-effective amendment to the Registration Statement that includes the actual price range shortly preceding the commencement of the Company’s public marketing process. However, all historical dollar amounts and per share amounts in this letter are pre-Stock Split, and therefore, consistent with the current filed Registration Statement. The Company respectfully requests that the bracketed information contained in this letter be treated as confidential information pursuant to Rule 83 promulgated by the Commission, 17 C.F.R. §200.8, and that the Commission provide timely notice to James McArthur, Ph.D., President and Chief Executive Officer, PepGen Inc., 245 Main Street, Cambridge, MA 02142, before it permits any disclosure of the bracketed information in this letter. For the convenience of the Staff, we have recited the prior comment from the Staff in the Original Comment Letter in italicized type and have followed the comment with the Company’s response. 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. Preliminary IPO Price Range The Company advises the Staff that it estimates a preliminary price range of approximately $[***] to $[***] per share (the “Preliminary Price Range”) for its initial public offering (“IPO”), before giving effect to an anticipated [***]-to-1 reverse stock split that the Company plans to implement prior to effectiveness of the Registration Statement (the “Stock Split”) resulting in a midpoint of the Preliminary Price Range of $[***] per share (the “Midpoint Price”). The actual price range to be included in a subsequent amendment to the Registration Statement (which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range) has not yet been determined and remains subject to adjustment based on factors outside of the Company’s control. However, the Company believes that the foregoing Preliminary Price Range will not be subject to significant change. 2 Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 Determining the Fair Value of Common Stock Prior to the IPO As there has been no public market for the Company’s common stock to date, the estimated fair value of its common stock has been determined by the Company’s board of directors (the “Board”) as of the date of each option grant, with input from management, considering the Company’s most recent third-party valuations of its common stock and the Board’s assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent third-party valuation through the date of the grant. The third-party valuations of the Company’s common stock used to support its recent stock option grants were as follows: Date of Third-party Valuation Date of Board Approval of the Third-party Valuation Fair Value Per Share of Common Stock as of Grant Date January 31, 2021 March 22, 2021 $ 2.66 June 30, 2021 August 30, 2021 $ 8.80 September 13, 2021 September 27, 2021 $ 11.56 November 1, 2021 November 11, 2021 $ 10.68 December 31, 2021 February 28, 2022 $ 11.03 The following table, reproduced from the Registration Statement, summarizes by grant date the number of shares subject to options granted between March 22, 2021, the first date the Company granted options, and March 7, 2022, the per share exercise price of the options and the fair value of common stock underlying the options on each grant date: Grant Date Number of Shares Subject to Options Granted Per Share Exercise Price of Options Fair Value Per Share of Common Stock as of Grant Date Estimated Per Share Fair Value of Options(1) March 22, 2021 86,772 $ 0.00 $ 2.66 $ 2.66 March 22, 2021 7,330 $ 4.87 $ 2.66 $ 1.28 March 22, 2021 459,774 $ 2.66 $ 2.66 $ 1.63 March 30, 2021 21,760 $ 2.66 $ 2.66 $ 1.63 April 21, 2021 49,328 $ 2.66 $ 2.66 $ 1.69 August 30, 2021 122,035 $ 8.80 $ 8.80 $ 5.99 September 3, 2021 158,537 $ 8.80 $ 8.80 $ 5.99 September 6, 2021 483,704 $ 8.80 $ 8.80 $ 5.99 September 27, 2021 34,658 $ 11.56 $ 11.56 $ 7.77 November 11, 2021 457,325 $ 10.68 $ 10.68 $ 7.39 December 17, 2021 134,700 $ 10.68 $ 10.68 $ 7.38 February 28, 2022 117,600 $ 11.03 $ 11.03 (2 ) March 4, 2022 15,000 $ 11.03 $ 11.03 (2 ) March 7, 2022 47,500 $ 11.03 $ 11.03 (2 ) 3 Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 (1) The per share estimated fair value of options reflects the fair value of options as estimated at the date of grant using the Black-Scholes option-pricing model. (2) The Company intends to determine the compensation expense related to the February and March 2022 awards in connection with the preparation of its interim consolidated financial statements for the period ending March 31, 2022. Once determined, the estimate of the grant date fair value of these stock-based awards will be reflected in the financial statements relating to such period. The Company’s determinations of the fair value of the common stock were performed using methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Guide”). The equity value of the Company was estimated by the market approach. The market approaches applied were the backsolve method, the market adjusted equity value method, and the guideline IPO transactions method. The backsolve method approach estimates the value of the Company’s business by reference to the closest round of equity financing preceding the date of the valuation. The market adjusted equity value method calculates the equity value starting with the equity valuation from the prior valuation date and updates the valuation for changes in market indexes or peer group, and progress in the Company’s research and development activities. The guideline IPO transactions method estimates the value of the Company’s business based on review of peer guideline IPO transactions. In accordance with the Practice Guide, the Company considered the following methods for allocating the enterprise value across its classes and series of shares to determine the estimated fair value of its incentive shares at each valuation date. • Option Pricing Method (“OPM”). The OPM estimates the value of the common stock of the Company by treating the rights of the holders of common stock as equivalent to that of call options on any value of the enterprise above certain break points of value based upon the liquidation preferences of the holders of the Company’s convertible preferred stock, as well as their rights to participation. Thus, the value of the common stock can be determined by estimating the value of its portion of each of these call option rights. Consequently, the common stock has value only if the funds available for distribution to stockholders exceed the value of the liquidation preference at the time of a liquidity event. • Probability-Weighted Expected Return Method (“PWERM”). The PWERM is a scenario-based analysis that estimates the value per share based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes considered by the Company, as well as the economic and control rights of each share class. • Hybrid Method. The Hybrid Method is a hybrid between the PWERM and OPM, estimating the probability-weighted value across multiple scenarios, but using the OPM to estimate the allocation of value within one or more of those scenarios. Weighting allocations are assigned to the OPM and PWERM methods factoring possible future liquidity events. Additionally, as the Company’s shares represent a non-marketable interest in a private enterprise, an adjustment to the preliminary fair value estimates must be made to account for the lack of liquidity that a holder may experience. This adjustment is commonly referred to as a discount for lack of marketability (“DLOM”). 4 Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 January 31, 2021 Valuation The Board relied, in part, on the results of the January 31, 2021 valuation in its determination of the fair value of common stock of $2.66 per share for its option grants of an aggregate of 624,964 shares on March 22, 2021, March 30, 2021 and April 21, 2021. The valuation analysis was performed using the Hybrid Method, estimating the probability-weighted value across two scenarios: (i) an OPM backsolve scenario based on the Company’s Series A-2 convertible preferred stock financing (recent transaction method) being weighted at 90%; and (ii) an IPO scenario (guideline IPO transactions method) being weighted at 10%. OPM Backsolve Scenario In the OPM backsolve scenario, the Company’s total equity value was derived using the OPM backsolve method relative to the Company’s $8.0 million Series A-2 convertible preferred stock financing at $11.42 per share in November 2020. The Series A-2 convertible preferred stock financing included an initial issuance of shares of Series A-2 convertible preferred stock and the right to purchase additional shares of Series A-2 convertible preferred stock in two additional tranche closings, whereby the Company was subject to achieving two subsequent scientific- and regulatory-based milestones. As a result, the OPM backsolve considered the initial Series A-2 convertible preferred stock plus the option to purchase shares of Series A-2 stock in two additional tranches to derive the bundle purchase price of the Series A-2 convertible preferred stock equal to $11.42 per share. The total fair value of equity in the OPM backsolve scenario was then allocated to the different classes of equity using the OPM allocation framework. Under the OPM allocation framework, the valuation specialist estimated the breakpoints for the different classes of equity and applied the OPM to arrive at the fair value of each class of equity security, including the common stock. The OPM allocation utilized a probability-weighted term of 2.5 years based on an analysis of potential transactions, which considered the Company’s funding status and time to a potential liquidity event. A volatility factor of 71.5% was selected based on an analysis of guideline public companies. The DLOM was concluded to be 30.0%. The fair value per share of common stock in the OPM backsolve scenario on a minority, non-marketable basis was determined to be $[***]. IPO Scenario For the IPO scenario, the future enterprise value at an expected IPO date was discounted to present value and allocated to issued and outstanding shares, which assumed that all shares of preferred stock would convert into shares of common stock. The enterprise value was based upon the backsolve method into the recent completed Series A-2 convertible preferred stock financing and the guideline IPO transactions. The selected future enterprise value was between the low and 25th percentile of the guideline IPO transactions identified. The valuation in the IPO scenario estimated the time to a potential liquidity event at 0.75 years based on the Company’s plans and progress in pursuing an initial public offering. A discount rate of 25% was applied. The DLOM in this scenario was concluded to be 17.9%. The fair value per share of common stock in the IPO scenario on a minority, non-marketable basis was determined to be $[***]. 5 Goodwin Procter LLP 100 Northern Avenue Boston, MA 02210 goodwinlaw.com +1 617 570 1000 Key assumptions used by the Company in the January 31, 2021 valuation were as follows: Scenario Value of Common Stock Per Share (minority, marketable basis) DLOM Value of Common Stock Per Share (minority, minority, non-marketable basis) Probability Probability-Weighted Common Stock Value Per Share IPO $ [***] 17.9 % $ [***] 10 % $ [***] Trade Sale $ [***] 30.0 % $ [***] 90 % $ [***] In May 2021, the Company completed a repeat-dose study in non-human primates and a duration of effect study in a mouse model of disease, thus achieving the milestones associated with the second tranche closing of the Series A-2 convertible preferred stock financing. Following and in connection with this close, 1,400,558 shares of Series A-2 convertible preferred stock were sold at $11.42 per share for aggregate gross proce
2022-04-22 - UPLOAD - PepGen Inc.
United States securities and exchange commission logo
April 22, 2022
James McArthur, Ph.D.
President and Chief Executive Officer
PepGen Inc.
245 Main Street
Cambridge, MA 02142
Re:PepGen Inc.
Registration Statement on Form S-1
Filed April 15, 2022
File No. 333-264335
Dear Dr. McArthur:
We have reviewed your 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 amending your registration statement and providing the
requested information. 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 any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our February 11, 2022 letter.
Registration Statement on Form S-1 filed April 15, 2022
PGN-EDO51, page 3
1.We note your response to our prior comment 1, which we reissue in part. Please remove
the reference to "potent" on pages 3, 120 and 127. Given the prominent disclosure of the
cross-trial comparisons conducted with data published by Sarepta Therapeutics and Dyne
Therapeutics in your Summary, please advise whether you relied on such cross-trial
comparisons in your CTA submission for PGN-EDO51.
Preclinical tolerability data: Generally well-tolerated..., page 143
2.We acknowledge your revised disclosure in response to our prior comment 2. Please
revise to include the meaning of "hypomagnesemia." Revise to clarify that
FirstName LastNameJames McArthur, Ph.D.
Comapany NamePepGen Inc.
April 22, 2022 Page 2
FirstName LastName
James McArthur, Ph.D.
PepGen Inc.
April 22, 2022
Page 2
hypomagnesemia is a side effect observed in your non-GLP repeat-dose study of PGN-
EDO51 and identify the number of NHPs that experienced hypomagnesemia in your
study.
Research and Development, page F-12
3.We note your disclosure relating to the receipt of government grants and refundable
research and development tax credits. Please provide a brief description of the material
terms of your government grants, including but not limited to, the aggregate amounts,
conditions and term, and file any agreements as exhibits to the registration statement or
tell us why it is not material.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
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.
2022-03-07 - UPLOAD - PepGen Inc.
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
FirstName LastNameJames McArthur, Ph.D.
Comapany NamePepGen Inc.
March 7, 2022 Page 2
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: James Xu, Esq.
2021-10-28 - UPLOAD - PepGen Inc.
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.
FirstName LastNameJames McArthur, Ph.D.
Comapany NamePepGen Inc.
October 28, 2021 Page 2
FirstName LastName
James McArthur, Ph.D.
PepGen Inc.
October 28, 2021
Page 2
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.
FirstName LastNameJames McArthur, Ph.D.
Comapany NamePepGen Inc.
October 28, 2021 Page 3
FirstName LastName
James McArthur, Ph.D.
PepGen Inc.
October 28, 2021
Page 3
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.”
FirstName LastNameJames McArthur, Ph.D.
Comapany NamePepGen Inc.
October 28, 2021 Page 4
FirstName LastName
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,
have presented or expect to present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain, copies of those
communications.
FirstName LastNameJames McArthur, Ph.D.
Comapany NamePepGen Inc.
October 28, 2021 Page 5
FirstName LastName
James McArthur, Ph.D.
PepGen Inc.
October 28, 2021
Page 5
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.
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