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MOLECULAR PARTNERS AG
Response Received
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MOLECULAR PARTNERS AG
Response Received
1 company response(s)
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SEC wrote to company
2022-07-07
MOLECULAR PARTNERS AG
Summary
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Company responded
2022-07-08
MOLECULAR PARTNERS AG
Summary
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MOLECULAR PARTNERS AG
Response Received
4 company response(s)
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SEC wrote to company
2021-05-06
MOLECULAR PARTNERS AG
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Company responded
2021-05-12
MOLECULAR PARTNERS AG
References: May 6, 2021
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Company responded
2021-06-10
MOLECULAR PARTNERS AG
References: June 9, 2021
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Company responded
2021-06-11
MOLECULAR PARTNERS AG
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Company responded
2021-06-11
MOLECULAR PARTNERS AG
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MOLECULAR PARTNERS AG
Awaiting Response
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SEC wrote to company
2021-06-09
MOLECULAR PARTNERS AG
Summary
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MOLECULAR PARTNERS AG
Response Received
1 company response(s)
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SEC wrote to company
2021-04-12
MOLECULAR PARTNERS AG
Summary
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Company responded
2021-04-22
MOLECULAR PARTNERS AG
References: April 11, 2021
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-22 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2025-04-21 | SEC Comment Letter | MOLECULAR PARTNERS AG | Switzerland | 333-286488 | Read Filing View |
| 2022-07-08 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2022-07-07 | SEC Comment Letter | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-06-11 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-06-11 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-06-10 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-06-09 | SEC Comment Letter | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-05-12 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-05-06 | SEC Comment Letter | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-04-22 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-04-12 | SEC Comment Letter | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-21 | SEC Comment Letter | MOLECULAR PARTNERS AG | Switzerland | 333-286488 | Read Filing View |
| 2022-07-07 | SEC Comment Letter | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-06-09 | SEC Comment Letter | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-05-06 | SEC Comment Letter | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-04-12 | SEC Comment Letter | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-22 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2022-07-08 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-06-11 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-06-11 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-06-10 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-05-12 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
| 2021-04-22 | Company Response | MOLECULAR PARTNERS AG | Switzerland | N/A | Read Filing View |
2025-04-22 - CORRESP - MOLECULAR PARTNERS AG
CORRESP 1 filename1.htm Document April 22, 2025 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Daniel Crawford Re: Molecular Partners AG Registration Statement on Form F-3 Filed April 11, 2025 File No. 333-286488 Acceleration Request Requested Date: April 24, 2025 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “ Registrant ”) hereby requests that the Securities and Exchange Commission (the “ Commission ”) take appropriate action to cause the above-referenced Registration Statement on Form F-3 (File No. 333-286488) (the “ Registration Statement ”), to become effective on April 24, 2025, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the Commission’s staff. The Registrant hereby authorizes Brandon Fenn of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Brandon Fenn of Cooley LLP at (212) 479-6626. [Signature page follows] Very truly yours, Molecular Partners AG By: /s/ Robert Hendriks Robert Hendriks SVP, Finance cc: Patrick Amstutz, Molecular Partners AG Michael Pitzner, Molecular Partners AG Ryan Sansom, Cooley LLP Brandon Fenn, Cooley LLP Minkyu Park, Cooley LLP Dieter Gericke, Homburger AG Karin Mattle, Homburger AG
2025-04-21 - UPLOAD - MOLECULAR PARTNERS AG File: 333-286488
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 21, 2025 Patrick Amstutz Chief Executive Officer and Director Molecular Partners AG Wagistrasse 14 8952 Z rich-Schlieren Switzerland Re: Molecular Partners AG Registration Statement on Form F-3 Filed April 11, 2025 File No. 333-286488 Dear Patrick Amstutz: 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 Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Brandon Fenn, Esq. </TEXT> </DOCUMENT>
2022-07-08 - CORRESP - MOLECULAR PARTNERS AG
CORRESP
1
filename1.htm
Document
July 8, 2022
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Dillon Hagius
Re: Molecular Partners AG
Registration Statement on Form F-3
Filed July 1, 2022
File No. 333-265960
Acceleration Request
Requested Date: July 12, 2022
Requested Time: 4:00 p.m. Eastern Time
Ladies and Gentlemen:
In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form F-3 (File No. 333-265960) (the “Registration Statement”), to become effective on July 12, 2022, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the Commission’s staff. The Registrant hereby authorizes Brandon Fenn of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Brandon Fenn of Cooley LLP at (212) 479-6626.
[Signature page follows]
Very truly yours,
Molecular Partners AG
By: /s/ Andreas Emmenegger
Andreas Emmenegger
Chief Financial Officer
cc: Patrick Amstutz, Molecular Partners AG
Julien Gander, Molecular Partners AG
Ryan Sansom, Cooley LLP
Brandon Fenn, Cooley LLP
Jonathan Robertson, Cooley LLP
Dieter Gericke, Homburger AG
Lorenzo Togni, Homburger AG
2022-07-07 - UPLOAD - MOLECULAR PARTNERS AG
United States securities and exchange commission logo
July 7, 2022
Patrick Amstutz
Chief Executive Officer
Molecular Partners Inc.
245 Main Street
Cambridge, Massachusetts 02142
Re:Molecular Partners Inc.
Registration Statement on Form F-3
Filed July 1, 2022
File No. 333-265960
Dear Mr. Amstutz:
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 Dillon Hagius at 202-551-7967 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ryan Sansom
2021-06-11 - CORRESP - MOLECULAR PARTNERS AG
CORRESP 1 filename1.htm Document Wagistrasse 14 8952 Zürich-Schlieren Switzerland VIA EDGAR June 11, 2021 U.S Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Christie Wong Mr. Terence O'Brien Ms. Ada Sarmento Mr. Tim Buchmiller Re: Molecular Partners AG Registration Statement on Form F-1 File No. 333-255447 Acceleration Request Requested Date: June 15, 2021 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form F-1 to become effective on June 15, 2021, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, or at such later time as its counsel may orally request via telephone call to the staff. The Registrant hereby authorizes each of Divakar Gupta, Ryan Sansom and Brandon Fenn of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Divakar Gupta of Cooley LLP at +1 212 479 6474, Ryan Sansom at + 1 617 937 2335 or Brandon Fenn at +1 212 479 6626. Thank you for your assistance with this matter. [Signature Page Follows] Sincerely, Brandon Fenn By: /s/ Patrick Amstutz Name: Patrick Amstutz Title: Chief Executive Officer cc: Andreas Emmenegger, Chief Financial Officer, Molecular Partners AG Divakar Gupta, Cooley LLP Ryan Sansom, Cooley LLP Brandon Fenn, Cooley LLP
2021-06-11 - CORRESP - MOLECULAR PARTNERS AG
CORRESP 1 filename1.htm Document J.P. Morgan Securities LLC 383 Madison Avenue New York, New York 10179 SVB Leerink LLC One Federal Street, 37th Floor Boston, MA 02110 Cowen and Company, LLC 599 Lexington Avenue New York, New York 10022 June 11, 2021 VIA EDGAR U.S Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Christie Wong Mr. Terence O'Brien Ms. Ada Sarmento Mr. Tim Buchmiller Re: Molecular Partners AG Registration Statement on Form F-1 (File No. 333-255447) Request for Acceleration on Effective Date Acceleration Request Requested Date: June 15, 2021 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, hereby join in the request of Molecular Partners AG (the “Company”) for acceleration of the effective date of the above-named Registration Statement so that it becomes effective at 4:00 PM, Eastern Time, on June 15, 2021, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Cooley LLP, request by telephone that such Registration Statement be declared effective. Pursuant to Rule 460 under the Act, we, as representatives of the several underwriters, wish to advise you that there will be distributed to each Underwriter or dealer, who is reasonably anticipated to participate in the distribution of the securities, as many copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus. We, the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, Acting severally on behalf of themselves and the several underwriters J.P. MORGAN SECURITIES LLC By: /s/ David Ke Name: David Ke Title: Managing Director SVB LEERINK LLC By: /s/ Jon. A. Civitarese Name: Jon A. Civitarese Title: Managing Director COWEN AND COMPANY, LLC By: /s/ Bill Follis Name: Bill Follis Title: Managing Director [Signature Page to Underwriters’ Acceleration Request]
2021-06-10 - CORRESP - MOLECULAR PARTNERS AG
CORRESP 1 filename1.htm Document Ryan Sansom + 1 617 937 2335 rsansom@cooley.com Via EDGAR June 10, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Christie Wong Mr. Terence O’Brien Ms. Ada Sarmento Mr. Tim Buchmiller Re: Molecular Partners AG Amendment No. 3 to Registration Statement on Form F-1 Filed on June 9, 2021 File No. 333-255447 Ladies and Gentlemen: On behalf of our client, Molecular Partners AG (the “Company”), we are responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated June 9, 2021 (the “Comment Letter”), relating to the above referenced Amendment No. 3 to the Registration Statement on Form F-1, filed on June 9, 2021. We are also concurrently filing a fourth amendment to the Registration Statement on Form F-1 (the “Amendment No. 4”), which reflects changes in response to the Staff’s comments, as well as other updates. The numbering of the paragraphs below corresponds to the numbering of the comments in the Comment Letter. For the Staff’s convenience we have incorporated your comments into this response letter in italics. Page references in the text of this response letter correspond to the page numbers of the Amendment No. 3. Capitalized terms used in this response letter but otherwise not defined herein shall have the meanings ascribed to such terms in the Amendment No. 4. Amendment No. 3 to Registration Statement on Form F-1 Use of Proceeds, page 83 1.We note your disclosure that you intend to advance the development of your infectious disease program including the expansion of your research and development activities for COVID-19 antiviral therapeutic product candidates using the proceeds of this offering. Please revise to disclose an estimate of how far in the development of your infectious disease program the proceeds from this Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com June 10, 2021 Page 2 offering will allow you to reach, including the development of a certain number of additional products, specific phases of clinical trials or preclinical testing. Response to Comment 1: In response to the Staff’s comment, the Company has revised the disclosure on pages 10 and 83 of the Amendment No. 4. Tax Implications for U.S. Holders, page 234 2.We note that the tax opinion filed as Exhibit 8.1 appears to be a short-form tax opinion. Please revise this section in your filing to clearly identify that the "Swiss Tax Implications for U.S. Holders" disclosure is the opinion of the counsel or accountant. Please revise the opinion to also include a similar statement. Counsel or the accountant must opine on the tax consequences of the offering, not the manner in which those consequences are described in the prospectus. For guidance, refer to Sections III.B.2 and III.C.2 of Staff Legal Bulletin No. 19. Response to Comment 2: In response to the Staff’s comment, the Company has revised the disclosure on page 234 of the Amendment No. 4 and has filed a revised Exhibit 8.1 with the Amendment No. 4. * * * * Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com June 10, 2021 Page 3 Please direct any questions or comments concerning the Form F-1 or this response letter to either the undersigned at +1 617 937 2335 or Brandon Fenn at +1 212 479 6626. Very truly yours, /s/ Ryan Sansom Ryan Sansom cc: Patrick Amstutz, Molecular Partners AG Julien Gander, Molecular Partners AG Divakar Gupta, Cooley LLP Brandon Fenn, Cooley LLP Deanna Kirkpatrick, Davis Polk & Wardwell LLP Yasin Keshvargar, Davis Polk & Wardwell LLP Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com
2021-06-09 - UPLOAD - MOLECULAR PARTNERS AG
United States securities and exchange commission logo
June 9, 2021
Julien Gander, LL.M.
General Counsel
Molecular Partners AG
Wagistrasse 14
8952 Zürich-Schlieren
Switzerland
Re:Molecular Partners AG
Amendment No. 3 to Registration Statement on Form F-1
Filed June 9, 2021
File No. 333-255447
Dear Mr. Gander:
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. 3 to Registration Statement on Form F-1
Use of Proceeds, page 83
1.We note your disclosure that you intend to advance the development of your infectious
disease program including the expansion of your research and development activities for
COVID-19 antiviral therapeutic product candidates using the proceeds of this offering.
Please revise to disclose an estimate of how far in the development of your infectious
disease program the proceeds from this offering will allow you to reach, including
the development of a certain number of additional products, specific phases of clinical
trials or preclinical testing.
FirstName LastNameJulien Gander, LL.M.
Comapany NameMolecular Partners AG
June 9, 2021 Page 2
FirstName LastName
Julien Gander, LL.M.
Molecular Partners AG
June 9, 2021
Page 2
Swiss Tax Implications for U.S. Holders, page 234
2.We note that the tax opinion filed as Exhibit 8.1 appears to be a short-form tax opinion.
Please revise this section in your filing to clearly identify that the "Swiss Tax Implications
for U.S. Holders" disclosure is the opinion of the counsel or accountant. Please revise the
opinion to also include a similar statement. Counsel or the accountant must opine on the
tax consequences of the offering, not the manner in which those consequences are
described in the prospectus. For guidance, refer to Sections III.B.2 and III.C.2 of Staff
Legal Bulletin No. 19.
You may contact Christie Wong at 202-551-3684 or Terence O'Brien at 202-551-3355 if
you have questions regarding comments on the financial statements and related matters. Please
contact Ada D. Sarmento at 202-551-3798 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ryan Sansom, Esq.
2021-05-12 - CORRESP - MOLECULAR PARTNERS AG
CORRESP 1 filename1.htm Document Ryan Sansom + 1 617 937 2335 rsansom@cooley.com Via EDGAR May 12, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Christie Wong Mr. Terence O’Brien Ms. Ada Sarmento Mr. Tim Buchmiller Re: Molecular Partners AG Registration Statement on Form F-1 Filed on April 22, 2021 File No. 333-255447 Ladies and Gentlemen: On behalf of our client, Molecular Partners AG (the “Company”), we are responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated May 6, 2021 (the “Comment Letter”), relating to the above referenced Registration Statement on Form F-1 filed with the Commission on April 22, 2021 (File No. 333-255447) (the “Registration Statement”), as amended by an Amendment No. 1 to the Registration Statement filed with the Commission on May 4, 2021. We are also concurrently filing an Amendment No. 2 to the Registration Statement (the “Amended Registration Statement”), which reflects changes in response to the Staff’s comments, as well as other updates. The numbering of the paragraphs below corresponds to the numbering of the comments in the Comment Letter. For the Staff’s convenience we have incorporated your comments into this response letter in italics. Page references in the text of this response letter correspond to the page numbers of the Amended Registration Statement. Capitalized terms used in this response letter but otherwise not defined herein shall have the meanings ascribed to such terms in the Amended Registration Statement. Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com May 12, 2021 Page 2 Registration Statement on Form F-1 Prospectus Summary, page 1 1.We note your revisions in response to prior comment 1. Please remove references to the "encouraging" activity and/or tolerability of your programs on pages 6, 110 and 140. Please also revise to describe what you mean by "clinical benefit" on page 113. Response to Comment 1: In response to the Staff’s comment, the Company has revised the disclosure on pages 5, 112 and 145 of the Amended Registration Statement. Our Pipeline, page 2 2.We note your response to our prior comment 3. Please remove the two discovery programs from your pipeline table. We will not object to a discussion of the programs below the table. Response to Comment 2: In response to the Staff’s comment, the Company has revised its Pipeline on pages 2, 109 and 120 of the Amended Registration Statement. Our Strategy, page 6 3.We note your revisions in response to prior comment 5. We also note statements that partnering with Novartis will allow you to more rapidly develop your product candidate and that your strategy is to rapidly advance the clinical development of your COVID-19 antiviral therapeutic product candidates. Please revise this disclosure to remove any implication that you will be successful in commercializing your product candidates in a rapid or accelerated manner as such statements are speculative. Response to Comment 3: In response to the Staff’s comment, the Company has revised the disclosure on pages 3, 6, 110, 114 and 115 of the Amended Registration Statement. Principal Shareholders, page 179 4.We note your revisions in response to prior comment 17 and reissue in part. Please revise your disclosure to identify the natural person or persons who have voting and investment control of the shares held by Suvretta Capital Management, LLC and Essex Woodlands Health Ventures VIII, LLC. It appears that UBS Fund Management (Switzerland) AG may be a wholly-owned subsidiary of UBS Group AG. If this is correct, please revise footnote 8 to the table accordingly. Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com May 12, 2021 Page 3 Response to Comment 4: The Company respectfully acknowledges the Staff’s comment and in response has revised its disclosure on page 184 of the Amended Registration Statement. * * * * Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com May 12, 2021 Page 4 Please direct any questions or comments concerning the Form F-1 or this response letter to either the undersigned at +1 617 937 2335 or Brandon Fenn at +1 212 479 6626. Very truly yours, /s/ Ryan Sansom Ryan Sansom cc: Patrick Amstutz, Molecular Partners AG Julien Gander, Molecular Partners AG Divakar Gupta, Cooley LLP Brandon Fenn, Cooley LLP Deanna Kirkpatrick, Davis Polk & Wardwell LLP Yasin Keshvargar, Davis Polk & Wardwell LLP Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com
2021-05-06 - UPLOAD - MOLECULAR PARTNERS AG
United States securities and exchange commission logo
May 6, 2021
Julien Gander, LL.M.
General Counsel
Molecular Partners AG
Wagistrasse 14
8952 Zürich-Schlieren
Switzerland
Re:Molecular Partners AG
Registration Statement on Form F-1
Filed April 22, 2021
File No. 333-255447
Dear Mr. Gander:
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.
Registration Statement on Form F-1
Prospectus Summary, page 1
1.We note your revisions in response to prior comment 1. Please remove references to the
"encouraging" activity and/or tolerability of your programs on pages 6, 110 and 140.
Please also revise to describe what you mean by "clinical benefit" on page 113.
Our Pipeline, page 2
2.We note your response to our prior comment 3. Please remove the two discovery
programs from your pipeline table. We will not object to a discussion of the programs
below the table.
FirstName LastNameJulien Gander, LL.M.
Comapany NameMolecular Partners AG
May 6, 2021 Page 2
FirstName LastName
Julien Gander, LL.M.
Molecular Partners AG
May 6, 2021
Page 2
Our Strategy, page 6
3.We note your revisions in response to prior comment 5. We also note statements that
partnering with Novartis will allow you to more rapidly develop your product candidate
and that your strategy is to rapidly advance the clinical development of your COVID-19
antiviral therapeutic product candidates. Please revise this disclosure to remove any
implication that you will be successful in commercializing your product candidates in a
rapid or accelerated manner as such statements are speculative.
Principal Shareholders, page 179
4.We note your revisions in response to prior comment 17 and reissue in part. Please revise
your disclosure to identify the natural person or persons who have voting and investment
control of the shares held by Suvretta Capital Management, LLC and Essex Woodlands
Health Ventures VIII, LLC. It appears that UBS Fund Management (Switzerland) AG
may be a wholly-owned subsidiary of UBS Group AG. If this is correct, please revise
footnote 8 to the table accordingly.
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 Christie Wong at (202) 551-3648 or Terence O’Brien at (202) 551-3355
if you have questions regarding comments on the financial statements and related matters. Please
contact Ada Sarmento at (202) 551-3798 or Tim Buchmiller at (202) 551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ryan Sansom, Esq.
2021-04-22 - CORRESP - MOLECULAR PARTNERS AG
CORRESP 1 filename1.htm Document Ryan Sansom + 1 617 937 2335 rsansom@cooley.com Via EDGAR April 22, 2021 U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Christie Wong Mr. Terence O’Brien Ms. Ada Sarmento Mr. Tim Buchmiller Re: Molecular Partners AG Draft Registration Statement on Form F-1 Submitted on March 15, 2021 CIK No. 0001745114 Ladies and Gentlemen: On behalf of our client, Molecular Partners AG (the “Company”), we are responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in its letter dated April 11, 2021 (the “Comment Letter”), relating to the above referenced Confidential Draft Registration Statement on Form F-1 as confidentially submitted to the Commission on March 15, 2021. We are also filing the Registration Statement on Form F-1 (the “Form F-1), which reflects changes in response to the Staff’s comments, as well as other updates. The numbering of the paragraphs below corresponds to the numbering of the comments in the Comment Letter. For the Staff’s convenience we have incorporated your comments into this response letter in italics. Page references in the text of this response letter correspond to the page numbers of the Form F-1. Capitalized terms used in this response letter but otherwise not defined herein shall have the meanings ascribed to such terms in the Form F-1. Draft Registration Statement on Form F-1 submitted March 15, 2021 Prospectus Summary, page 1 1.We note certain statements in this section and in the Business section discussing "positive" progress on your first COVID-19 antiviral therapeutic product candidates, "positive" preclinical data from your existing COVID-19 antiviral therapeutic product candidates, the "encouraging" activity and tolerability of certain of your product candidates, the success of abicipar in two positive Phase 3 trials in nAMD, that you are encouraged by anecdotal signs of clinical efficacy in AMG506, that DARPin based TCEs showed equivalent efficacy and that conditionally activated CD3-PDD shows similar efficacy but none of the toxicity of the active TCE. Efficacy Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com April 22, 2021 Page 2 and safety are determinations that are solely within the authority of the FDA or similar foreign regulators. You may present clinical trial end points and objective data resulting from trials without concluding efficacy, and you may state that your product candidates are well tolerated if true. Please revise these statements, and any other statements regarding safety or efficacy, as appropriate. Response to Comment 1: In response to the Staff’s comment, the Company has revised the disclosure throughout the Form F-1 to remove any inference regarding efficacy or safety of its product candidates. In addition, the Company has revised the disclosure on pages 1, 6, 8 and 21 of the Form F-1 to further advise potential investors of the early-stage nature of its product candidates, to highlight the risks related to reliance on the Company’s early results and to reaffirm that any conclusions regarding the safety and efficacy of the Company’s product candidates are solely within the purview of the FDA and other regulatory agencies. Our Pipeline, page 2 2.Please revise the pipeline to indicate the current status of development of each of your product candidates. For example, we note your disclosure on page 5 that following the submission of a BLA for abicipar, your partner Abbvie is considering next steps because the FDA determined that the ocular inflammation profile seen in the two Phase 2 clinical trials did not provide an adequate risk reward benefit as submitted, and additional work would be required to show the ocular inflammation profile of abicipar would be similar to those products already approved for the treatment of nAMD. We also note your disclosure on page 17 that your Phase 1 trial of ensovibep has been delayed due to an inability to dose healthy volunteers due to government restrictions in the UK since the end of 2020 in response to the pandemic. Response to Comment 2: In response to the Staff’s comment, the Company has revised its Pipeline on pages 2, 107 and 118 of the Form F-1. 3.We note that you have included two programs in the discovery phase in your pipeline table. Given the early-stage development of these programs, please explain why each program is sufficiently material to your business to warrant inclusion in your pipeline table. Response to Comment 3: In response to the Staff’s comment, the Company has revised its pipeline on pages 2, 107 and 118 of the Form F-1 to further clarify that the aforementioned programs are in the discovery phase. Additionally, the Company respectfully advises the Staff that, as a platform therapeutics company, the Company believes that its investment in and potential value derived from these discovery areas is a material component of the Company’s business, as evidenced by the Company’s plans to use a portion of the proceeds from the offering for the development of these programs and any related potential product candidates that are derived from these programs. For example, the Company respectfully advises the Staff that these Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com April 22, 2021 Page 3 discovery programs led to the development of its AML, ensovibep and MP0423 product candidates, and the descriptions included in the Form F-1 on these programs on pages 119 and 133 further describe the significance of these programs to the Company. Our Strategy, page 6 4.Please provide the basis for your statement that you are the world leaders in DARPin engineering and research. Response to Comment 4: The Company respectfully acknowledges the Staff’s comment and in response has revised its disclosure on pages 6 and 112 of the Form F-1. The Company respectfully advises that the Company was founded by the inventors of the DARPin technology and has held a worldwide exclusive license from the University of Zurich since 2004 on patents relating to the fundamentals of DARPin technology. From this time forward, the Company has been the only company contractually permitted to use, make, develop, sell or offer to sell the claimed DARPin technology and DARPin molecules generated therewith, with certain research exemptions for academic institutions and research organizations. Furthermore, since the time of invention and licensure, the Company has developed and patented over 25 families of patents spanning 150 granted and over 100 additional pending U.S. and foreign patent applications which to date enable us to be the global leaders in DARPin engineering and research. 5.We note that part of your strategy is to rapidly advance the clinical development of your COVID-19 antiviral therapeutic product candidates in your infectious disease program in collaboration with Novartis and you discuss that it took you less than eight weeks to go from concept to candidate identification on page 119. Please balance this disclosure and similar disclosure throughout the prospectus to clarify that the process of clinical development is inherently uncertain and that there can be no guarantee that you will achieve similar development timelines with your future product candidates. Response to Comment 5: In response to the Staff’s comment, the Company has revised the disclosure throughout the Form F-1 to balance the disclosure throughout to clarify that the process of clinical development is inherently uncertain and that there can be no guarantee that we will achieve similar development timelines with our future product candidates, remove any inference regarding regulatory approval or the safety, tolerability and efficacy of our product candidates. In addition, the Company has revised the disclosure on pages 8, 21 and 128 to further advise potential investors of the early-stage nature of its product candidates, to highlight the risks related to reliance on the Company’s early results and to reaffirm that any conclusions regarding the safety and efficacy of the Company’s product candidates are solely within the purview of the FDA and other regulatory agencies. Risk Factors, page 14 Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com April 22, 2021 Page 4 6.Given the length of your risk factor section, please revise to comply with Regulation S-K Item 105 by relocating risks that could generically apply to any registrant or offering to the end of the section under the caption "General Risk Factors." Response to Comment 6: In response to the Staff’s comment, the Company has revised its disclosure on pages 77 and 78 of the Form F-1 accordingly. Use of Proceeds, page 83 7.Please revise to disclose if you intend to complete your planned Phase 1 clinical trial for MP0317 and your ongoing Phase 1 clinical trial for MP0420 with the proceeds of the offering. Please also revise to disclose whether you intend to initiate or complete a Phase 1 trial for MP0423 using the proceeds of the offering and how far you expect the proceeds from the offering to allow you to proceed in the development of your AML CD3 product candidate. Response to Comment 7: In response to the Staff’s comment, the Company has revised its disclosure on page 83 of the Form F-1 to include estimations of how far in development the Company believes the proceeds from this offering will allow it to reach. Business COVID-19 Product Candidates: Ensovibep (MP0420) and MP0423, page 118 8.We note your disclosure on page 120 that Part A of the EMPATHY trial is "ongoing" yet your disclosure on page 119 indicates that the EMPATHY trial has not yet commenced. Please revise or advise. Response to Comment 8: In response to the Staff’s comment, the Company has revised its disclosure on page 121 of the Form F-1. B. Our Oncology Program, page 124 9.Please balance the disclosure in this section by noting that AMG 506 (MP0310) and MP0317 both utilize novel mechanisms of action which may result in greater research and development expenses, regulatory issues that could delay or prevent approval, or the discovery of unknown or unanticipated adverse effects. Response to Comment 9: In response to the Staff’s comment, the Company has revised its disclosure on page 125 of the Form F-1 accordingly. Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com April 22, 2021 Page 5 Beyond Bi-specifics: Our Next Generation DARPin-based TCE Platform, page 131 10.Please explain what you mean by "IND-ready" in this section. Response to Comment 10: In response to the Staff’s comment, the Company has revised its disclosure on page 133 of the Form F-1. Intellectual Property, page 138 11.Please revise to disclose the material foreign jurisdictions where you own or license patents or pending patent applications. Response to Comment 11: In response to the Staff’s comment, the Company has revised its disclosure on page 141 of the Form F-1 accordingly. 12.We note your disclosure that certain patents that you licensed from the University of Zurich pertaining to your DARPin platform to generate your DARPin product candidates will expire in 2021 and one patent will expire in 2023. Please revise to disclose what effect you expect the expiration of these patent to have on your patent portfolio and your business and if you intend to take any action to mitigate such effect. Please also disclose whether the inability to enter into a non-exclusive license with the University of Zurich for the remaining U.S. patent that will expire in 2023 would have a material impact on your business and, if so, if you intend to take any action to mitigate such impact. Response to Comment 12: In response to the Staff’s comment, the Company has revised its disclosure on pages 142 and 147 of the Form F-1. License and Collaboration Agreements, page 141 13.If you would be unable to enforce royalty obligations under any of your license and collaboration agreements after the licensed patent rights have expired, please revise to clarify this in this section as appropriate. Response to Comment 13: In response to the Staff’s comment, the Company has revised its disclosure on pages 145, 146, 147 and 148 of the Form F-1 accordingly. Option and Equity Rights Agreement with Novartis, page 141 Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com April 22, 2021 Page 6 14.Please revise to disclose when the royalty term will end under this agreement or how it is. Response to Comment 14: In response to the Staff’s comment, the Company has revised its disclosure on page 145 of the Form F-1 accordingly. Discovery Alliance Agreement with Allergan, an AbbVie Company, page 143 15.Please revise to clarify whether the royalty term is the same as the term of the agreement. Response to Comment 15: In response to the Staff’s comment, the Company has revised its disclosure on page 147 of the Form F-1 accordingly. License Agreement with the University of Zurich, page 144 16.Please revise to disclose the term of the agreement, the termination provisions, the royalty term, and any other payment terms such as aggregate future potential milestone payments, upfront or execution payments made or aggregate amounts paid under the agreement to date. Response to Comment 16: In response to the Staff’s comment, the Company has revised its disclosure on pages 9, 147 and 148 of the Form F-1 accordingly. Principal Shareholders, page 174 17.Please revise your disclosure to identify the natural person or persons who have voting and investment control of the shares held by each entity in the table. Response to Comment 17: In response to the Staff’s comment, the Company has revised its disclosure on pages 179 of the Form F-1. Certain Important Provisions of our Articles of Association, Organizational Rules and Swiss Law, page 179 18.We note that you refer shareholders to, in part, Swiss law. It is not appropriate to qualify your disclosure by reference to information that is not included in the filing or filed as an exhibit. Please revise accordingly. Response to Comment 18: Cooley LLP 500 Boylston Street 14th Floor Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com April 22, 2021 Page 7 In response to the Staff’s comment, the Company has revised its disclosure on page 183 of the Form F-1. General 19.Please supplementally 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. Response to Comment 19: The Company respectfully acknowledges the Staff’s comment and will supplementally provide to the Staff, under separate cover, copies of the written communications, as defined in Rule 405 under the Securities Act of 1933, as amended (the “Securities Act”), that have been used in meetings with potential investors in reliance on Section 5(d) of the Securities Act. These materials were only made available for viewing by potential investors during the Company’s presentations, and no copies were retained by any potential investor. Pursuant to Rule 418 under the Securities Act, the copies supplementally provided shall not be deemed to be filed with, or a part of, or included in, the Form F-1. To the extent the Company conducts additional meetings, it expects to use the same or similar materials, and th
2021-04-12 - UPLOAD - MOLECULAR PARTNERS AG
United States securities and exchange commission logo
April 11, 2021
Julien Gander, LL.M.
General Counsel
Molecular Partners AG
Wagistrasse 14
8952 Zürich-Schlieren
Switzerland
Re:Molecular Partners AG
Draft Registration Statement on Form F-1
Submitted March 15, 2021
CIK No. 0001745114
Dear Mr. Gander:
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 F-1
Prospectus Summary, page 1
1.We note certain statements in this section and in the Business section discussing
"positive" progress on your first COVID-19 antiviral therapeutic product
candidates, "positive" preclinical data from your existing COVID-19 antiviral therapeutic
product candidates, the "encouraging" activity and tolerability of certain of your product
candidates, the success of abicipar in two positive Phase 3 trials in nAMD, that you are
encouraged by anecdotal signs of clinical efficacy in AMG506, that DARPin based TCEs
showed equivalent efficacy and that conditionally activated CD3-PDD shows similar
efficacy but none of the toxicity of the active TCE. Efficacy and safety are determinations
FirstName LastNameJulien Gander, LL.M.
Comapany NameMolecular Partners AG
April 11, 2021 Page 2
FirstName LastNameJulien Gander, LL.M.
Molecular Partners AG
April 11, 2021
Page 2
that are solely within the authority of the FDA or similar foreign regulators. You may
present clinical trial end points and objective data resulting from trials without concluding
efficacy, and you may state that your product candidates are well tolerated if true. Please
revise these statements, and any other statements regarding safety or efficacy, as
appropriate.
Our Pipeline, page 2
2.Please revise the pipeline to indicate the current status of development of each of your
product candidates. For example, we note your disclosure on page 5 that following the
submission of a BLA for abicipar, your partner Abbvie is considering next steps because
the FDA determined that the ocular inflammation profile seen in the two Phase 2 clinical
trials did not provide an adequate risk reward benefit as submitted, and additional work
would be required to show the ocular inflammation profile of abicipar would be similar to
those products already approved for the treatment of nAMD. We also note your disclosure
on page 17 that your Phase 1 trial of ensovibep has been delayed due to an inability to
dose healthy volunteers due to government restrictions in the UK since the end of 2020 in
response to the pandemic.
3.We note that you have included two programs in the discovery phase in your pipeline
table. Given the early-stage development of these programs, please explain why each
program is sufficiently material to your business to warrant inclusion in your pipeline
table.
Our Strategy, page 6
4.Please provide the basis for your statement that you are the world leaders in DARPin
engineering and research.
5.We note that part of your strategy is to rapidly advance the clinical development of your
COVID-19 antiviral therapeutic product candidates in your infectious disease program in
collaboration with Novartis and you discuss that it took you less than eight weeks to go
from concept to candidate identification on page 119. Please balance this disclosure and
similar disclosure throughout the prospectus to clarify that the process of clinical
development is inherently uncertain and that there can be no guarantee that you will
achieve similar development timelines with your future product candidates.
Risk Factors, page 14
6.Given the length of your risk factor section, please revise to comply with Regulation S-K
Item 105 by relocating risks that could generically apply to any registrant or offering to
the end of the section under the caption "General Risk Factors."
Use of Proceeds, page 83
7.Please revise to disclose if you intend to complete your planned Phase 1 clinical trial for
FirstName LastNameJulien Gander, LL.M.
Comapany NameMolecular Partners AG
April 11, 2021 Page 3
FirstName LastNameJulien Gander, LL.M.
Molecular Partners AG
April 11, 2021
Page 3
MP0317 and your ongoing Phase 1 clinical trial for MP0420 with the proceeds of the
offering. Please also revise to disclose whether you intend to initiate or complete a Phase
1 trial for MP0423 using the proceeds of the offering and how far you expect the proceeds
from the offering to allow you to proceed in the development of your AML CD3 product
candidate.
Business
COVID-19 Product Candidates: Ensovibep (MP0420) and MP0423, page 118
8.We note your disclosure on page 120 that Part A of the EMPATHY trial is "ongoing" yet
your disclosure on page 119 indicates that the EMPATHY trial has not yet
commenced. Please revise or advise.
B. Our Oncology Program, page 124
9.Please balance the disclosure in this section by noting that AMG 506 (MP0310) and
MP0317 both utilize novel mechanisms of action which may result in greater research and
development expenses, regulatory issues that could delay or prevent approval, or the
discovery of unknown or unanticipated adverse effects.
Beyond Bi-specifics: Our Next Generation DARPin-based TCE Platform, page 131
10.Please explain what you mean by "IND-ready" in this section.
Intellectual Property, page 138
11.Please revise to disclose the material foreign jurisdictions where you own or license
patents or pending patent applications.
12.We note your disclosure that certain patents that you licensed from the University of
Zurich pertaining to your DARPin platform to generate your DARPin product
candidates will expire in 2021 and one patent will expire in 2023. Please revise to disclose
what effect you expect the expiration of these patent to have on your patent portfolio and
your business and if you intend to take any action to mitigate such effect. Please also
disclose whether the inability to enter into a non-exclusive license with the University of
Zurich for the remaining U.S. patent that will expire in 2023 would have a material impact
on your business and, if so, if you intend to take any action to mitigate such impact.
License and Collaboration Agreements, page 141
13.If you would be unable to enforce royalty obligations under any of your license and
collaboration agreements after the licensed patent rights have expired, please revise to
clarify this in this section as appropriate.
Option and Equity Rights Agreement with Novartis, page 141
14.Please revise to disclose when the royalty term will end under this agreement or how it is
FirstName LastNameJulien Gander, LL.M.
Comapany NameMolecular Partners AG
April 11, 2021 Page 4
FirstName LastName
Julien Gander, LL.M.
Molecular Partners AG
April 11, 2021
Page 4
determined.
Discovery Alliance Agreement with Allergan, an AbbVie Company, page 143
15.Please revise to clarify whether the royalty term is the same as the term of the agreement.
License Agreement with the University of Zurich, page 144
16.Please revise to disclose the term of the agreement, the termination provisions, the royalty
term, and any other payment terms such as aggregate future potential milestone payments,
upfront or execution payments made or aggregate amounts paid under the agreement to
date.
Principal Shareholders, page 174
17.Please revise your disclosure to identify the natural person or persons who have voting
and investment control of the shares held by each entity in the table.
Certain Important Provisions of our Articles of Association, Organizational Rules and Swiss
Law, page 179
18.We note that you refer shareholders to, in part, Swiss law. It is not appropriate to qualify
your disclosure by reference to information that is not included in the filing or filed as an
exhibit. Please revise accordingly.
General
19.Please supplementally 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.
You may contact Christie Wong at (202) 551-3648 or Terence O’Brien at (202) 551-3355
if you have questions regarding comments on the financial statements and related matters.
Please contact Ada Sarmento at (202) 551-3798 or Tim Buchmiller at (202) 551-3635 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Ryan Sansom, Esq.