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Pharvaris N.V.
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Pharvaris N.V.
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SEC wrote to company
2023-08-14
Pharvaris N.V.
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Pharvaris N.V.
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SEC wrote to company
2022-03-03
Pharvaris N.V.
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Pharvaris N.V.
Response Received
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SEC wrote to company
2021-01-28
Pharvaris N.V.
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Company responded
2021-02-01
Pharvaris N.V.
References: December 9, 2020
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Pharvaris N.V.
Response Received
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SEC wrote to company
2021-01-15
Pharvaris N.V.
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Company responded
2021-01-22
Pharvaris N.V.
References: December 9, 2020
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Pharvaris N.V.
Awaiting Response
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2021-01-04
Pharvaris N.V.
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Pharvaris N.V.
Awaiting Response
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SEC wrote to company
2020-12-10
Pharvaris N.V.
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-11 | SEC Comment Letter | Pharvaris N.V. | Netherlands | 001-40010 | Read Filing View |
| 2025-08-06 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2025-07-24 | SEC Comment Letter | Pharvaris N.V. | Netherlands | 001-40010 | Read Filing View |
| 2023-08-15 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2023-08-14 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2022-03-08 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2022-03-03 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-02-02 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-02-02 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-02-01 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-01-28 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-01-22 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-01-22 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-01-15 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-01-04 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2020-12-10 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-11 | SEC Comment Letter | Pharvaris N.V. | Netherlands | 001-40010 | Read Filing View |
| 2025-07-24 | SEC Comment Letter | Pharvaris N.V. | Netherlands | 001-40010 | Read Filing View |
| 2023-08-14 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2022-03-03 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-01-28 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-01-15 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-01-04 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2020-12-10 | SEC Comment Letter | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-06 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2023-08-15 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2022-03-08 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-02-02 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-02-02 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-02-01 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-01-22 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
| 2021-01-22 | Company Response | Pharvaris N.V. | Netherlands | N/A | Read Filing View |
2025-08-11 - UPLOAD - Pharvaris N.V. File: 001-40010
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 11, 2025 Berndt Modig Chief Executive Officer Pharvaris N.V. Emmy Noetherweg 2 2333 BK Leiden The Netherlands Re: Pharvaris N.V. Form 20-F for Fiscal Year Ended December 31, 2024 File No. 001-40010 Dear Berndt Modig: We have completed our review of your filing. 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. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-08-06 - CORRESP - Pharvaris N.V.
CORRESP 1 filename1.htm CORRESP Pharvaris N.V. Emmy Noetherweg 2 2333 BK Leiden The Netherlands August 6, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Eric Atallah and Kevin Kuhar Re: Pharvaris N.V. Form 20-F for Fiscal Year Ended December 31, 2024 File No. 001-40010 Dear Mr. Atallah and Mr. Kuhar: This letter sets forth the response of Pharvaris N.V. (the “ Company ”) to the comment letter dated July 24, 2025 from the staff of the Division of Corporate Finance (the “ Staff ”) of the U.S. Securities and Exchange Commission regarding the Company’s annual report for fiscal year ended December 31, 2024 on Form 20-F, filed on April 7, 2025 (File No. 001-40010) (“ Form 20-F ”), transmitted to Berndt Modig, Chief Executive Officer of the Company. For your convenience, set forth below is the text of the Staff’s comment and the Company’s response thereto. Form 20-F for Fiscal Year Ended December 31, 2024 Item 4. Information on the Company B. Business Overview, page 44 Staff’s comment : We note your inclusion of a molecule named “PHAXXX” for an undisclosed indication in your pipeline table on page 47. In future filings, please clarify if this refers to a specific molecule you are currently developing or if it is a placeholder for future programs in early development. If it does refer to a specific molecule, please revise future filings to provide more fulsome disclosure related to this molecule, including the intended indication and any development steps you have undertaken. To the extent it is a placeholder, tell us why it is sufficiently material to your business to warrant inclusion in your pipeline table. Alternatively, remove any programs that are not currently material to your business from your pipeline table in future filings. Response : The Company respectfully acknowledges the Staff’s comment. PHAXXX is in early-stage development for a confidential indication. In response to the Staff’s comment, the Company will remove the inclusion of PHAXXX from the pipeline table in future filings, because the program is currently not material to our business. Item 5. Operating and Financial Review and Prospects Research and development expenses, page 87 Staff’s comment : We note that during 2024 both of your product candidates IR and XR began Phase 3 clinical trials. Please tell us and revise future filings to disclose the costs incurred during each period presented for each of your key research and development product candidates. If you do not track your research and development costs by project, disclose that fact and explain why you do not maintain and evaluate research and development costs by project in future filings. Response : The Company respectfully acknowledges the Staff’s comment. Below is the draft research and development (“ R&D ”) expenses table the Company intends to include in its future filings, beginning with the quarterly financials on Form 6-K for the third quarter of 2025. In addition to such quantitative disclosure, if the Company has any qualitative period-to-period insights of management related to the R&D expenses of its key product candidates on a disaggregated basis, then it intends provide additional narrative disclosure. [Current Period] [Prior Period] Change (in €) Project Specific Expenses IR XR Unallocated Expenses Personnel expenses Other expenses Total We hope that the foregoing has been responsive to the Staff’s comment. If you have any questions, please contact Sophia Hudson, P.C. at (212) 446-4750 or Jennifer L. Lee, P.C. at (212) 909-3021, each of Kirkland & Ellis LLP, counsel to the Company. Sincerely, Pharvaris N.V. By: /s/ Berndt Modig Name: Berndt Modig Title: Chief Executive Officer cc: Sophia Hudson, P.C. Jennifer L. Lee, P.C. Kirkland & Ellis LLP 2
2025-07-24 - UPLOAD - Pharvaris N.V. File: 001-40010
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 24, 2025 Berndt Modig Chief Executive Officer Pharvaris N.V. Emmy Noetherweg 2 2333 BK Leiden The Netherlands Re: Pharvaris N.V. Form 20-F for Fiscal Year Ended December 31, 2024 File No. 001-40010 Dear Berndt Modig: We have reviewed your filing and have the following comments. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 20-F for Fiscal Year Ended December 31, 2024 Item 4. Information on the Company B. Business Overview, page 44 1. We note your inclusion of a molecule named "PHAXXX" for an undisclosed indication in your pipeline table on page 47. In future filings, please clarify if this refers to a specific molecule you are currently developing or if it is a placeholder for future programs in early development. If it does refer to a specific molecule, please revise future filings to provide more fulsome disclosure related to this molecule, including the intended indication and any development steps you have undertaken. To the extent it is a placeholder, tell us why it is sufficiently material to your business to warrant inclusion in your pipeline table. Alternatively, remove any programs that are not currently material to your business from your pipeline table in future filings. July 24, 2025 Page 2 Item 5. Operating and Financial Review and Prospects Research and development expenses, page 87 2. We note that during 2024 both of your product candidates IR and XR began Phase 3 clinical trials. Please tell us and revise future filings to disclose the costs incurred during each period presented for each of your key research and development product candidates. If you do not track your research and development costs by project, disclose that fact and explain why you do not maintain and evaluate research and development costs by project in future filings. 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 Eric Atallah at 202-551-3663 or Kevin Kuhar at 202-551-3662 if you have questions regarding comments on the financial statements and related matters. Please contact Tyler Howes at 202-551-3370 or Joshua Gorsky at 202-551-7836 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2023-08-15 - CORRESP - Pharvaris N.V.
CORRESP 1 filename1.htm CORRESP Pharvaris N.V. Emmy Noetherweg 2 2333 BK Leiden The Netherlands August 15, 2023 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Pharvaris N.V. Registration Statement on Form F-3 Filing Date August 7, 2023 File No. 333-273757 REQUEST FOR ACCELERATION OF EFFECTIVENESS Pursuant to Rule 461 under the Securities Act of 1933, as amended, Pharvaris N.V. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form F-3 (the “Registration Statement”), File No. 333-273757, to 4:30 p.m., Eastern Time, on August 16, 2023, or as soon thereafter as practicable. Please contact Sophia Hudson of Kirkland & Ellis LLP, special counsel to the Company, at (212) 446-4750 as soon as the Registration Statement has been declared effective, or if you have any other questions or concerns regarding this matter. Sincerely, /s/ Berndt Modig Berndt Modig Chief Executive Officer
2023-08-14 - UPLOAD - Pharvaris N.V.
United States securities and exchange commission logo
August 14, 2023
Berndt Modig
Chief Executive Officer
Pharvaris N.V.
Emmy Noetherweg 2
2333 BK Leiden
Re:Pharvaris N.V.
Registration Statement on Form F-3
Filed August 7, 2023
File No. 333-273757
Dear Berndt Modig:
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 Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer Lee, Esq.
2022-03-08 - CORRESP - Pharvaris N.V.
CORRESP 1 filename1.htm Acceleration Request Pharvaris N.V. J.H. Oortweg 21 2333 CH Leiden, The Netherlands March 8, 2022 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Pharvaris N.V. Registration Statement on Form F-3 Filing Date March 1, 2022 File No. 333-263198 REQUEST FOR ACCELERATION OF EFFECTIVENESS Pursuant to Rule 461 under the Securities Act of 1933, as amended, Pharvaris N.V. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form F-3 (the “Registration Statement”), File No. 333-263198, to 4:30 p.m., Eastern Time, on March 10, 2022, or as soon thereafter as practicable. Please contact Sophia Hudson of Kirkland & Ellis LLP, counsel to the Company, at (212) 446-4750 as soon as the Registration Statement has been declared effective, or if you have any other questions or concerns regarding this matter. Sincerely, /s/ Berndt Modig Berndt Modig Chief Executive Officer
2022-03-03 - UPLOAD - Pharvaris N.V.
United States securities and exchange commission logo
March 3, 2022
Berndt Modig
Chief Executive Officer
Pharvaris N.V.
J.H. Oortweg 21
2333 CH Leiden
The Netherlands
Re:Pharvaris N.V.
Registration Statement on Form F-3
Filed on March 2, 2022
File No. 333-263198
Dear Mr. Modig:
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 Jessica Ansart at (202) 551-4511 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Sophia Hudson
2021-02-02 - CORRESP - Pharvaris N.V.
CORRESP 1 filename1.htm CORRESP February 2, 2021 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Julie Sherman Kate Tillan Jason L. Drory Chris Edwards Re: Pharvaris B.V. Registration Statement on Form F-1 (File No. 333-252157) Request for Acceleration of Effective Date Dear Ladies and Gentlemen: In connection with the proposed offering of the securities under the above-captioned Registration Statement on Form F-1 (the “Registration Statement”), we wish to advise you that we, as representatives of the underwriters, hereby join with Pharvaris B.V.’s request that the effective date of the Registration Statement be accelerated so that the same will become effective on February 4, 2021 at 2:00 p.m. E.S.T., or as soon as practicable thereafter. Pursuant to Rule 460 under the Securities Act of 1933, please be advised that, as representatives of the underwriters, we have distributed approximately 2,449 copies of the preliminary prospectus, dated February 1, 2021, through the date hereof. We, the undersigned, as representatives of the several underwriters, will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. [Signature Page Follows] Sincerely, MORGAN STANLEY & CO. LLC BOFA SECURITIES, INC. SVB LEERINK LLC As representatives of the Underwriters MORGAN STANLEY & CO. LLC By: /s/ Kalli Dircks Name: Kalli Dircks Title: Managing Director BOFA SECURITIES, INC. By: /s/ Michael Liloia Name: Michael Liloia Title: Director SVB LEERINK LLC By: /s/ Gabriel Cavazos Name: Gabriel Cavazos Title: Managing Director [Signature Page to UW Acceleration Request]
2021-02-02 - CORRESP - Pharvaris N.V.
CORRESP 1 filename1.htm CORRESP Pharvaris B.V. J.H. Oortweg 21 2333 CH Leiden The Netherlands February 2, 2021 Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-3628 Attn: Ms. Julie Sherman Ms. Kate Tillan Mr. Jason L. Drory Mr. Chris Edwards Re: Pharvaris B.V. Registration Statement on Form F-1 Registration No. 333-252157 Dear Ms. Sherman, Ms. Tillan, Mr. Drory and Mr. Edwards: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant hereby requests that the effective date for the Registration Statement referred to above be accelerated so that it will be declared effective at 2:00 p.m. Eastern Standard Time on February 4, 2021 or as soon thereafter as is practicable. By separate letter, the underwriters of the issuance of the securities being registered join in this request for acceleration. Please do not hesitate to contact Sophia Hudson of Kirkland & Ellis LLP at (212) 446-4750 with any questions or comments with respect to this letter. Sincerely, PHARVARIS B.V. By: /s/ Berndt Modig Name: Berndt Modig Title: Chief Executive Officer Via EDGAR cc: Sophia Hudson, Kirkland & Ellis LLP
2021-02-01 - CORRESP - Pharvaris N.V.
CORRESP 1 filename1.htm CORRESP Sophia Hudson, P.C. 601 Lexington Avenue New York, NY 10022 United States To Call Writer Directly: Facsimile: +1 212 446 4750 +1 212 446 4800 +1 212 446 4900 sophia.hudson@kirkland.com www.kirkland.com February 1, 2021 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attention: Julie Sherman Kate Tillan Jason L. Drory Chris Edwards Re: Pharvaris B.V. Amendment No. 1 to Registration Statement on Form F-1 Filed January 22, 2021 CIK No. 0001830487 Dear Ms. Sherman, Ms. Tillan, Mr. Drory and Mr. Edwards: On behalf of our client, Pharvaris B.V. (the “Company”), we set forth below the Company’s responses to the letter, dated January 28, 2021, containing comments of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the above referenced Amendment No. 1 to Registration Statement on Form F-1 publicly filed with Commission by the Company on January 22, 2021 (the “Registration Statement”). The Company also hereby further responds to an earlier comment contained in the Staff’s letter dated December 9, 2020, on the Company’s Draft Registration Statement on Form F-1 confidentially submitted on November 12, 2020. In order to facilitate your review of our responses, we have restated each of the Staff’s comments in these letters, and we have numbered the paragraphs below to correspond to the numbers in the Staff’s letters. For your convenience, we have also set forth the Company’s response to each of the Staff’s comments immediately below the corresponding numbered comment. Beijing Boston Chicago Dallas Hong Kong Houston London Los Angeles Munich Palo Alto Paris San Francisco Shanghai Washington, D.C. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences February 1, 2021 Page 2 In addition, the Company has revised the Registration Statement in response to the Staff’s comments and is publicly filing an amendment to the Registration Statement (the “Amendment”) concurrently with this letter, which reflects these revisions and clarifies certain other information. Page numbers in the text of the Company’s responses correspond to page numbers in the Amendment. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in the Amendment. Amendment No. 1 to Registration Statement on Form F-1 publicly filed on January 22, 2021 Material United States and Dutch Income Tax Considerations, page 177 1. Staff’s comment: We note your revised disclosure and your response to comment 5. It appears that you do not intend to file a tax opinion relating to the U.S. tax consequences of this transaction. Please tell us why you have determined that such a tax opinion is not required for this transaction considering, for example, the uncertainty relating to your PFIC status. Alternatively, please file an opinion that addresses U.S. tax matters. Refer to Item 601 of Regulation S-K and Section III.A of Staff Legal Bulletin No. 19. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 181 of the Amendment. Draft Registration Statement on Form F-1 submitted November 12, 2020 Use of Proceeds, page 67 11. Staff’s comment: We note your disclosure that you intend to use a portion of the net proceeds to fund the clinical development of PHVS416 and PHVS719. Please revise to specify how far in the clinical development of the associated product candidates you expect to reach with the net proceeds. In this regard, we note that you have a number of clinical trials planned for the associated product candidates. Also, to the extent material amounts of other funds are necessary to accomplish your specified purposes, state the amounts of such other funds and the sources thereof. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 71 of the Amendment. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences February 1, 2021 Page 3 We hope that the foregoing has been responsive to the Staff’s comments. If you have any questions regarding this matter, please contact the undersigned at (212) 446-4750 or by e-mail at sophia.hudson@kirkland.com. Sincerely, /s/ Sophia Hudson, P.C. Sophia Hudson, P.C. VIA E-MAIL cc: Berndt Modig Morgan Conn, Ph.D. Anna Nijdam, MSc RA Pharvaris B.V. Jennifer Lee, Esq. Kirkland & Ellis LLP Frank F. Rahmani, Esq. Samir A. Gandhi, Esq. Sidley Austin LLP Paul van der Bijl NautaDutilh N.V.
2021-01-28 - UPLOAD - Pharvaris N.V.
United States securities and exchange commission logo
January 28, 2021
Berndt Modig
Chief Executive Officer
Pharvaris, B.V.
J.H. Oortweg 21
2333 CH Leiden, The Netherlands
Re:Pharvaris, B.V.
Amendment No. 1 to Registration Statement on Form F-1
Filed January 22, 2021
File No. 333-252157
Dear Mr. Modig:
We have reviewed your amended registration statement and have the following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 this comment, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our January 15, 2021 letter.
Amendment No. 1 to Registration Statement on Form F-1
Material United States and Dutch Income Tax Considerations, page 177
1.We note your revised disclosure and your response to comment 5. It appears that you do
not intend to file a tax opinion relating to the U.S. tax consequences of this transaction.
Please tell us why you have determined that such a tax opinion is not required for this
transaction considering, for example, the uncertainty relating to your PFIC status.
Alternatively, please file an opinion that addresses U.S. tax matters. Refer to Item 601 of
Regulation S-K and Section III.A of Staff Legal Bulletin No. 19.
FirstName LastNameBerndt Modig
Comapany NamePharvaris, B.V.
January 28, 2021 Page 2
FirstName LastName
Berndt Modig
Pharvaris, B.V.
January 28, 2021
Page 2
You may contact Julie Sherman at 202-551-3640 or Kate Tillan at 202-551-3604 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jason L. Drory at 202-551-8342 or Chris Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Sophia Hudson, Esq.
2021-01-22 - CORRESP - Pharvaris N.V.
CORRESP 1 filename1.htm CORRESP Sophia Hudson, P.C. To Call Writer Directly: +1 212 446 4750 sophia.hudson@kirkland.com 601 Lexington Avenue New York, NY 10022 United States +1 212 446 4800 www.kirkland.com Facsimile: +1 212 446 4900 January 22, 2021 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attention: Julie Sherman Kate Tillan Jason L. Drory Chris Edwards Re: Pharvaris B.V. Amendment No. 2 to Draft Registration Statement on Form F-1 Submitted January 11, 2021 CIK No. 0001830487 Dear Ms. Sherman, Ms. Tillan, Mr. Drory and Mr. Edwards: On behalf of our client, Pharvaris B.V. (the “Company”), we set forth below the Company’s responses to the letter, dated January 15, 2021, containing the comments of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) with respect to the above referenced Amendment No. 2 to Draft Registration Statement on Form F-1 confidentially submitted by the Company on January 11, 2021 (the “Draft Registration Statement”). In order to facilitate your review of our responses, we have restated each of the Staff’s comments in this letter, and we have numbered the paragraphs below to correspond to the numbers in the Staff’s letter. For your convenience, we have also set forth the Company’s response to each of the Staff’s comments immediately below the corresponding numbered comment. Beijing Boston Chicago Dallas Hong Kong Houston London Los Angeles Munich Palo Alto Paris San Francisco Shanghai Washington, D.C. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 22, 2021 Page 2 In addition, in response to the Staff’s comments, the Company has revised the Registration Statement on form F-1 which it publicly filed on January 15, 2021 (the “Registration Statement”) and is publicly filing an amendment to the Registration Statement (the “Amendment”) concurrently with this letter, which reflects these revisions and clarifies certain other information. Page numbers in the text of the Company’s responses correspond to page numbers in the Amendment. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in the Amendment. Amendment No. 2 to Draft Registration Statement on Form F-1 submitted January 11, 2021 Prospectus Summary, page 1 1. Staff’s comment: We note your revised disclosure in response to prior comments 1 and 2 and your disclosures that “[p]otency as used in this prospectus refers to the amount of drug required to produce a pharmacological effect of given intensity and is not a measure of therapeutic efficacy” and that you, “have not conducted a head-to-head comparison of icatibant or any other drug candidate to PHA121 in a clinical trial.” Please include clarifying language on page 3 when you state your belief that PHVS416 is “More potent inhibitor than icatibant” and “Longer half-life than icatibant.” Specifically, include disclosure that your beliefs are not based on head-to-head studies but on your models and that potency is not a measure of efficacy. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 3 and 97 of the Amendment. Our Pipeline, page 4 2. Staff’s comment: We note your response to our prior comment 3 and reissue in part. The pipeline table should clearly depict your material product candidates and their current stage of development. For example, text that reflects upcoming milestones should not be included in the “Phase 1” and “Phase 2” columns, but should be in the “Upcoming Milestone” column. In addition, please include narrative disclosure here and elsewhere you include the pipeline table to make clear that the sole active pharmaceutical ingredient in PHA121 is the same active pharmaceutical ingredients in PHVS416 and PHVS719 and discuss how you plan to rely on trial data from PHA121 to advance PHVS416 and PHVS719. Also, we note your disclosure on page 1, where you state you “are developing PHA121 for the on-demand setting as PHVS416, which is delivered in a soft capsule designed to rapidly treat symptoms with a single dose.” However, your pipeline table indicates that you are developing PHVS416 for both the on-demand and prophylactic treatments of HAE. Please revise your pipeline table or otherwise advise. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 22, 2021 Page 3 Response: In response to the Staff’s comment, the Company has revised the pipeline table and has included the requested narrative disclosure on pages 1, 4, 5, 81, 95 and 98 of the Amendment. PHA121, page 101 3. Staff’s comment: We note your revised statement on page 101 where you state, “PHA121 combines the preclinical effectiveness and selectivity of bradykinin-B2-receptor antagonism with oral bioavailability and extended exposure upon a single dose.” Please revise this statement and any similar statements throughout your prospectus that state or imply that your product candidates are safe or effective as these determinations are solely within the authority of the FDA and comparable regulatory bodies. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 104 of the Amendment. License Agreement, page 113 4. Staff’s comment: We note your response to our prior comment 4, including your updated disclosure on page 113. Please expand your disclosure to (i) identify your product candidates that are dependent on the license agreement; (ii) disclose when the latest to expire patents is scheduled to expire; (iii) aggregate amounts paid to date under the license agreement; and (iv) aggregate potential milestone payments outstanding. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 114 of the Amendment. Material United States and Dutch Income Tax Considerations, page 176 5. Staff’s comment: We note that the tax opinions filed as Exhibit 8.2 and Exhibit 8.1 are short-form tax opinions. Please revise the tax disclosure in your tax section to clearly identify and articulate the opinion being rendered and state clearly that it is the opinion of the named counsel. Please also revise opinion itself to state, if true, that the statements made in the prospectus constitute counsel’s opinion, as opposed to summaries. For guidance, refer to Section III.B of Staff Legal Bulletin No. 19. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 182 of the Amendment and NautaDutilh N.V. has revised the form of its opinion and the Company has filed such revised opinion as Exhibit 8.1 to the Amendment. In addition, the Company has removed the opinion of Kirkland & Ellis LLP submitted with the Draft Registration Statement. In consideration of the disclosure regarding U.S. taxation included in the Registration Statement, the Company does not believe a U.S. tax opinion is required to be filed pursuant to Item 601(b)(8) of Regulation S-K. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 22, 2021 Page 4 We hope that the foregoing has been responsive to the Staff’s comments. If you have any questions regarding this matter, please contact the undersigned at (212) 446-4750 or by e-mail at sophia.hudson@kirkland.com. Sincerely, /s/ Sophia Hudson, P.C. Sophia Hudson, P.C. VIA E-MAIL cc: Berndt Modig Morgan Conn, Ph.D. Anna Nijdam, MSc RA Pharvaris B.V. Jennifer Lee, Esq. Kirkland & Ellis LLP Frank F. Rahmani, Esq. Samir A. Gandhi, Esq. Sidley Austin LLP Paul van der Bijl NautaDutilh N.V.
2021-01-22 - CORRESP - Pharvaris N.V.
CORRESP 1 filename1.htm CORRESP Sophia Hudson, P.C. To Call Writer Directly: +1 212 446 4750 sophia.hudson@kirkland.com 601 Lexington Avenue New York, NY 10022 United States +1 212 446 4800 www.kirkland.com Facsimile: +1 212 446 4900 CONFIDENTIAL TREATMENT REQUESTED BY PHARVARIS B.V. FOIA Confidential Treatment Requested Pursuant to 17 C.F.R. §200.83 The entity requesting confidential treatment is: Pharvaris B.V. J.H. Oortweg 21, 2333 CH Leiden, The Netherlands CERTAIN PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION FILED VIA EDGAR. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[*].” January 22, 2021 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attention: Julie Sherman Kate Tillan Jason L. Drory Christine Westbrook Re: Pharvaris B.V. Draft Registration Statement on Form F-1 Submitted November 12, 2020 CIK No. 0001830487 Dear Ms. Sherman, Ms. Tillan, Mr. Drory and Ms. Westbrook: On behalf of our client, Pharvaris B.V. (the “Company”), we have set forth below the Company’s response to Comment 12 of the comments received from the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter, dated December 9, 2020, with respect to the above referenced Draft Registration Statement on Form F-1 confidentially submitted by the Company initially on November 12, 2020 (the “Draft Registration Statement”). Beijing Boston Chicago Dallas Hong Kong Houston London Los Angeles Munich Palo Alto Paris San Francisco Shanghai Washington, D.C. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 22, 2021 Page 2 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 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, as well as a copy of this correspondence, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. For the convenience of the Staff, we have recited the prior comment from the Staff in italicized type and have followed the comment with the Company’s response. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Estimates and Judgments Share-Based Payments, page 85 12. Staff’s comment: 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 IPO and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances including stock compensation and beneficial conversion features. Price Range To assist the Staff in its evaluation of stock-based compensation disclosures and certain other matters, the Company advises the Staff that the Company currently anticipates an approximate price range of $[*] to $[*] per share (the “Price Range”) for an initial public offering (the “IPO”) of the Company’s ordinary shares, with a midpoint of the anticipated Price Range of approximately $[*] per share (the “Midpoint Price”). The Price Range has been determined based on a number of factors, including the progress of the Company’s preclinical studies and clinical trials, other developments in the Company’s business, input received from the Company’s “testing the waters meetings,” current market conditions and input received from Morgan Stanley & Co. LLC, BofA Securities, Inc. and SVB Leerink LLC (collectively, the “Underwriters”), including discussions that took place on January 21, 2021 among representatives of the Company and representatives of the Underwriters. The Price Range does not consider any discount for the current lack of liquidity for the Company’s ordinary shares and assumes a successful IPO with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company or being sold in an acquisition transaction. As is typical for initial public offerings, the Price Range was not derived using a formal determination of fair value, but was determined as a result of discussions among representatives of the Company and of the Underwriters. During these discussions, the parties considered quantitative factors, as well as non-quantitative factors, such as the valuation of the Company in its recent Series C convertible preferred stock financing consummated in November 2020; the valuations of recently completed public offerings of biotech companies and those issuers’ respective stages of development as compared to the Company; current market conditions; recent strategic and collaboration transactions in the life sciences/biotechnology industry; and the current valuations of public companies at a similar stage of clinical development as the Company. Prior to January 21, 2021, the Underwriters had not provided the Company with a specific estimated price range. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 22, 2021 Page 3 The actual bona fide price range to be included in the publicly filed registration statement (the “Registration Statement”) has not yet been determined and remains subject to adjustment based on further discussions between the Company and the Underwriters, developments in the Company’s business, market conditions and other factors that are outside of the Company’s control. However, the Company believes the actual bona fide price range will be within the Price Range. In addition, the actual bona fide price range to be included in the Registration Statement will be reflected in an amendment to the Registration Statement that will be filed before the commencement of the road show and will comply with the Staff’s interpretation regarding the parameters of a bona fide price range. Equity Grants and Ordinary Shares Valuation As stated in the Draft Registration Statement, the Company has granted stock-based awards, consisting of stock options and restricted stock units (“RSUs”), to certain of its employees, directors and consultants for employee or similar services. The Company accounts for stock-based compensation by measuring and recognizing compensation expense based on estimated grant-date fair value and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the applicable award. Generally, the Company issues stock options with only service-based vesting conditions. The RSUs issued by the Company vest based upon the satisfaction of service-based and performance-based vesting conditions. The Company determines the total amount to be expensed for these awards by reference to the grant date fair value of the equity instruments granted, including the impact of any non-vesting conditions. The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. If the length of the vesting period varies depending on when a non-market performance condition is satisfied, the total expense is recognized over the expected vesting period. The Draft Registration Statement describes the Company’s use of the Black-Scholes option-pricing model (“Black-Scholes”) for the purpose of calculating the estimated grant date fair value of the stock options. Since the Company is a private company and the equity instruments are not marketable, an Option Pricing Model (“OPM”) with estimated probabilities of two different exit scenarios (IPO and trade sale) was applied to back-solve the Company’s total equity value such that the value per Series A preferred share, Series B preferred share and Series C preferred share is equal to the respective investment price per share paid in each investment round. The estimated total equity value was used as input to the OPM when determining the fair value of the Company’s ordinary shares at the applicable measurement dates. The Company’s board of directors (the “Board”), with input from management, determined the estimated fair value per share of the Company’s ordinary shares for financial reporting purposes to be as follows: Valuation Date Date of Underlying Valuation Estimated Fair Value Per Ordinary Share Valuation Method January 1, 2020 December 31, 2019 € 2.38 OPM February 3, 2020 December 31, 2019 € 2.38 OPM December 17, 2020 November 5, 2020 € 7.25 OPM January 1, 2021 November 5, 2020 € 7.25 OPM Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 22, 2021 Page 4 These estimated fair values per ordinary share were determined after considering valuation reports from an independent third-party valuation firm as well as other objective and subjective factors as appropriate, including the progress of the Company’s preclinical studies and clinical trials; the Company’s stage of development and programs; the Company’s cash burn and cash balances; the issuance of preferred stock and the rights, preferences and privileges of preferred stock as compared to ordinary shares; the need for additional private financings and the potential availability of and pricing thereof; the likelihood of achieving a liquidity event, including an initial public offering; and the other factors described below. A discussion of each valuation and equity grant since January 1, 2020, along with a comparison of the estimated fair value of the Company’s ordinary shares to the Midpoint Price is set forth below. The following table sets forth all equity awards made by the Company from January 1, 2020 to the present: Grant date Type of award Number of shares Exercise price of options per share Estimated fair value per ordinary share on grant date (utilized for IFRS 2 calculation)* January 1, 2020 Options 600,000 € 2.38 € 2.38 February 3, 2020 Options 440,000 € 2.38 € 2.38 December 17, 2020 Options 32,445 € 7.25 € 7.25 December 17, 2020 RSUs 129,650 — € 9.67 January 1, 2021 Options 107,000 € 7.25 € 7.25 * A discount for lack of marketability of 25.0% was applied for the options (excluding the RSUs). Analysis of January 1, 2020 Grants The Board considered the results of the December 31, 2019 third-party valuation in its determination of the fair value of ordinary shares of €2.38 per share as of January 1, 2020, when it granted options for the purchase of an aggregate of 600,000 ordinary shares to members of the Company’s senior management. The principal factors contributing to the change in the fair value of ordinary shares from the previous third-party valuation to the December 31, 2019 valuation was the approval of the Company’s Phase 1 clinical trial achievement in June 2019. In addition, the Company completed a $66 million Series B financing in August 2019. The Board determined that the fair value of the Company’s common stock remained €2.38 per share from December 31, 2019 to January 1, 2020, since there were no significant developments in the business. Analysis of February 3, 2020 Grants The Board considered the results of the December 31, 2019 third-party valuation in its determination of the fair value of ordinary shares of €2.38 per share as of February 3, 2020, when it granted options for the purchase of 440,000 ordinary shares to a member of the Company’s senior management. This included 308,000 options with service-based vesting conditions and 132,000 performance-based options. The Board determined that the fair value of the Company’s ordinary shares remained €2.38 per share from January 1, 2020 to February 3, 2020, since there were no significant developments in the business. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences January 22, 2021 Page 5 When preparing the Company’s financial statements as of and for the period ending September 30, 2020, in compliance with International Financial Reporting Standards (IFRS) 2, the Company reassessed the fair value of (i) one-third of the February 3, 2020 grant performance-based options as of July 13, 2020, the date the performance goals for 2020 were determined, and (ii) the remaining February 3, 2020 grant performance-based options as of September 30, 2020, related to the performance periods 2021 and 2022. The Board considered the results of the November 5, 2020 third-party valuation, including the principal factors contributing to the increase in fair value of the ordinary share at the time of such valuation, in its reassessment of the fair value of such performance based-options. See “Analysis of December 17, 2020 Grants” below for a description of the November 5, 2020 valuation. At the time of the reassessment, the Company’s management and the Board applied a weighted probability of an initial public offering scenario versus a trade sale scenario of (i) 50% versus 50% as of July 13, 2020 and (ii) 75% versus 25% as of September 30, 2020 (the increase, in part, due to the receipt of the Series C financing term sheet described below). As a result, the Board determined that the fair value of the Company’s ordinary share increased to €5.82 from February 3, 2020 to July 13, 2020, and further increased to €7.25 from July 13, 2020 to September 30, 2020. Analysis of December 17, 2020 Grants The Board considered the results of the November 5, 2020 third-party valuation in its determination of the fair value of ordinary shares of €7.25 per share as of December 17, 2020, when it granted options for the purchase of 32,445 ordinary shares to employees and 129,650 RSUs. The principal factors contributing to the increase in fair value of ordinary shares from the February 3, 2020 valuation to the December 17, 2020 valuation were the following: • In June 2020, the data of the Bradykinin challenge was presented. The data was of high quality, increasing the value of the Company. • In July 2020, positive data of non-clinical studies as preparation for Phase 2 were presented, enabling the Company to continue with their Phase 2 studies. • In July 2020, the Board approved to start with preparations for, and launch of, a Series C cross-over financing round and to start with preparations to get the Company ready for an initial public offering in 2021. • In July 2020, the Company started its first investor meetings. • In September 2020, a term sheet was received from one of the lead investors for Series C. • In November 2020, the Company completed a $80 million Series C equity financing. • Management and the Board increased the expected equity volatility from 80% in February 2020, to 90% in November 2020, which was based on observed historical volatility of daily share price returns for comparable companies measured for a period equal to the expected time to liquidity. • Management and the Board decreased the timing to an expected liquidity event to seven months from February 2020 to November 5, 2020, based on expected timing of a liquidity event. Securities and Exchange Commission Division of C
2021-01-15 - UPLOAD - Pharvaris N.V.
United States securities and exchange commission logo
January 15, 2021
Berndt Modig
Chief Executive Officer
Pharvaris, B.V.
J.H. Oortweg 21
2333 CH Leiden, The Netherlands
Re:Pharvaris, B.V.
Amendment No. 2 to
Draft Registration Statement on Form F-1
Submitted January 11, 2021
CIK No. 0001830487
Dear Mr. Modig:
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.
Draft Registration Statement on Form F-1 submitted January 11, 2021
Prospectus Summary, page 1
1.We note your revised disclosure in response to prior comments 1 and 2 and your
disclosures that "[p]otency as used in this prospectus refers to the amount of drug required
to produce a pharmacological effect of given intensity and is not a measure of therapeutic
efficacy" and that you, "have not conducted a head-to-head comparison of icatibant or any
other drug candidate to PHA121 in a clinical trial." Please include clarifying language on
page 3 when you state your belief that PHVS416 is "More potent inhibitor than icatibant"
and "Longer half-life than icatibant." Specifically, include disclosure that your beliefs are
not based on head-to-head studies but on your models and that potency is not a measure of
FirstName LastNameBerndt Modig
Comapany NamePharvaris, B.V.
January 15, 2021 Page 2
FirstName LastNameBerndt Modig
Pharvaris, B.V.
January 15, 2021
Page 2
efficacy.
Our Pipeline, page 4
2.We note your response to our prior comment 3 and reissue in part. The pipeline table
should clearly depict your material product candidates and their current stage of
development. For example, text that reflects upcoming milestones should not be included
in the "Phase 1" and "Phase 2" columns, but should be in the "Upcoming Milestone"
column. In addition, please include narrative disclosure here and elsewhere you include
the pipeline table to make clear that the sole active pharmaceutical ingredient in PHA121
is the same active pharmaceutical ingredients in PHVS416 and PHVS719 and discuss how
you plan to rely on trial data from PHA121 to advance PHVS416 and PHVS719. Also, we
note your disclosure on page 1, where you state you "are developing PHA121 for the on-
demand setting as PHVS416, which is delivered in a soft capsule designed to rapidly treat
symptoms with a single dose." However, your pipeline table indicates that you are
developing PHVS416 for both the on-demand and prophylactic treatments of HAE. Please
revise your pipeline table or otherwise advise.
PHA121, page 101
3.We note your revised statement on page 101 where you state, "PHA121 combines the
preclinical effectiveness and selectivity of bradykinin-B2-receptor antagonism with oral
bioavailability and extended exposure upon a single dose." Please revise this
statement and any similar statements throughout your prospectus that state or imply that
your product candidates are safe or effective as these determinations are solely within the
authority of the FDA and comparable regulatory bodies.
License Agreement, page 113
4.We note your response to our prior comment 4, including your updated disclosure on page
113. Please expand your disclosure to (i) identify your product candidates that are
dependent on the license agreement; (ii) disclose when the latest to expire patents is
scheduled to expire; (iii) aggregate amounts paid to date under the license agreement; and
(iv) aggregate potential milestone payments outstanding.
Material United States and Dutch Income Tax Considerations, page 176
5.We note that the tax opinions filed as Exhibit 8.2 and Exhibit 8.1 are short-form tax
opinions. Please revise the tax disclosure in your tax section to clearly identify and
articulate the opinion being rendered and state clearly that it is the opinion of the named
counsel. Please also revise opinion itself to state, if true, that the statements made in the
prospectus constitute counsel's opinion, as opposed to summaries. For guidance, refer to
Section III.B of Staff Legal Bulletin No. 19.
You may contact Julie Sherman at 202-551-3640 or Kate Tillan at 202-551-3604 if you
have questions regarding comments on the financial statements and related matters. Please
FirstName LastNameBerndt Modig
Comapany NamePharvaris, B.V.
January 15, 2021 Page 3
FirstName LastName
Berndt Modig
Pharvaris, B.V.
January 15, 2021
Page 3
contact Jason L. Drory at 202-551-8342 or Chris Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Sophia Hudson, Esq.
2021-01-04 - UPLOAD - Pharvaris N.V.
United States securities and exchange commission logo
January 4, 2021
Berndt Modig
Chief Executive Officer
Pharvaris, B.V.
J.H. Oortweg 21
2333 CH Leiden, The Netherlands
Re:Pharvaris, B.V.
Amendment No. 1 to
Draft Registration Statement on Form F-1
Submitted December 18, 2020
CIK No. 0001830487
Dear Mr. Modig:
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 F-1 submitted December 18, 2020
Prospectus Summary
Overview, page 1
1.We note your revised disclosure in response to prior comment 2. You continue to describe
your potential product candidates as "potent," a "potent inhibitor," "potent antagonist" or
"a potent and selective treatment for acute" HAE" on pages 1, 3, 94, 95 and
elsewhere. Your disclosure continues to inappropriately indicate your conclusions
regarding the efficacy of your product candidate by stating that your product candidate
was observed to be potent. Please delete such references here and throughout your
registration statement.
FirstName LastNameBerndt Modig
Comapany NamePharvaris, B.V.
January 4, 2021 Page 2
FirstName LastName
Berndt Modig
Pharvaris, B.V.
January 4, 2021
Page 2
2.We note your response to our prior comments 3, 15 and 17. Despite your revised
disclosure, we continue to believe that it is not appropriate for you to compare PHA121
with icatibant where the trials were not head-to-head. In addition, statements that your
early-stage product candidate is "more potent" than an FDA approved drug, such as your
statement, "[PHA121 is] more potent inhibitor than icatibant" and "PHA121 was shown to
be consistently 25-fold more potent at inhibiting the effects of administered bradykinin
than icatibant on a molar basis," are inappropriate. Please revise your disclosure
throughout your prospectus accordingly to remove such comparisons. You can discuss
your Bradykinin Challenge Study as well as the fact that you believe it establishes a proof
of concept; however, you should not make comparison statements that imply that your
product candidate is more effective or more potent than an approved product candidate
unless the results were derived from a head-to-head study.
Pipeline, page 4
3.We note your response to our prior comment 7 and disagree with your reasons for
continuing to show that you have completed Phase 1 for PHVS416 in your pipeline table
given your disclosure elsewhere that you have ongoing Phase 1 studies. The table should
depict your material product candidates and their current stage of development. You may
include a narrative discussion regarding the fact that you anticipate beginning a Phase 2
study prior to the completion of your ongoing Phase 1 studies.
Business, page 88
4.We note your MD&A disclosure that "[i]n 2019, a milestone payment of €300,000 was
paid to a third-party upon commencement of Phase 1 development." In your Business
section please disclose the material terms of your material agreements, such as the name
of the third party, potential aggregate milestone payments, expiration term and termination
provisions related to this agreement. In addition, please file the agreement as an exhibit or
tell us why you believe such agreement is not required to be filed. See Item 601(b)(10) of
Regulation S-K.
PHA121
Overview, page 100
5.We note your revised graphic on page 101 as well as the inclusion of a legend. However,
please include narrative disclosure to explain the graphic on page 101.
FirstName LastNameBerndt Modig
Comapany NamePharvaris, B.V.
January 4, 2021 Page 3
FirstName LastName
Berndt Modig
Pharvaris, B.V.
January 4, 2021
Page 3
You may contact Julie Sherman at 202-551-3640 or Kate Tillan at 202-551-3604 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jason L. Drory at 202-551-8342 or Chris Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Sophia Hudson, Esq.
2020-12-10 - UPLOAD - Pharvaris N.V.
United States securities and exchange commission logo
December 9, 2020
Berndt Modig
Chief Executive Officer
Pharvaris, B.V.
J.H. Oortweg 21
2333 CH Leiden, The Netherlands
Re:Pharvaris, B.V.
Draft Registration Statement on Form F-1
Submitted November 12, 2020
CIK No. 0001830487
Dear Mr. Modig:
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 submitted November 12, 2020
Market and Industry Data, page ii
1.Your statement that you have not independently verified third-party market and industry
information may imply an inappropriate disclaimer of responsibility with respect to the
third party information. Please either delete the statement or specifically state that you are
liable for such information.
Prospectus Summary
Overview, page 1
2.Here and elsewhere throughout your prospectus you refer to your product candidate,
PHA121, as being "highly potent," "a potent antagonist" and a "potent and selective
FirstName LastNameBerndt Modig
Comapany NamePharvaris, B.V.
December 9, 2020 Page 2
FirstName LastNameBerndt Modig
Pharvaris, B.V.
December 9, 2020
Page 2
treatment for acute HAE." Given the stage of your product development, it appears
premature to describe your product candidates as potent, which implies they are effective.
Similarly, we note your reference to your product candidates' "anticipated therapeutic
profile." Please revise your disclosure to remove such statements throughout your
prospectus.
3.We refer to the comparisons here and elsewhere in your prospectus where you state
that: "PHA121 was shown to be consistently 25-fold more potent than icatibant on a molar
basis," "more potent than icatibant," "observed greater potency for PHA121 compared to
icatibant," and "observed that PHA121 was more potent in blocking the effects of BK in
humans than icatibant, when comparing the PHA121 results of the trial to published data
on icatibant." Please remove these comparisons as they do not appear to be based on
a head-to-head studies or tell us why you believe such comparisons are appropriate.
4.We note your disclosure in this section and in the Business section that you plan to initiate
a "pivotal" trial in the on-demand setting following your planned RAPIDe-1 trial. Please
revise the disclosure in these sections to make it clear that even if you receive positive
data from RAPIDe-1 trial, the U.S. Food and Drug Administration (FDA) or other
regulators may require you to conduct additional trials.
5.Please place your discussion of the bradykinin challenge in appropriate context with
reference to your limited trial data to date and indicate that you have not yet conducted a
Phase 2 study. Additionally, we note your disclosure on page 3 that you expect your
planned trials of PHVS416 and PHVS719 will support a regulatory application for
PHVS719 in prophylaxis for HAE. Please remove this disclosure as it is premature and
speculative given the current stage of development.
Differentiation of PHA121, page 3
6.We note your statements here and throughout your document that your product candidates
are designed or have the potential to be "best-in-class." This term suggests that the product
candidate is effective and likely to be approved. Please delete these references throughout
your registration statement. If your use of this term was intended to convey your belief
that the product is based on a novel technology or approach and/or is further along in the
development process, you may discuss how your technology differs from technology used
by competitors and, if applicable, that you are not aware of competing products that are
further along in the development process. Statements such as these should be
accompanied by cautionary language that the statements are not intended to give any
indication that the product candidate has been proven effective or that it will receive
regulatory approval.
Our Pipeline, page 4
7.Please revise the pipeline table on page 4, which also appears on page 91, so that it
reflects the current status of your product candidates. For example, we note your
disclosure on page 97 that you still have ongoing and planned Phase 1 studies for your
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Comapany NamePharvaris, B.V.
December 9, 2020 Page 3
FirstName LastNameBerndt Modig
Pharvaris, B.V.
December 9, 2020
Page 3
product candidate, such that it does not appear that you have completed your Phase 1
studies. In addition, we note your disclosure on page 103 that you plan to conduct a Phase
1 bridging study in 2021 for PHVS719 and that you only have a "prototype formulation
for extended release." Accordingly, please remove the dashed box from your pipeline
chart for PHVS719.
Recent Developments
COVID-19, page 6
8.We note your disclosure that the COVID-19 pandemic caused you to experience a delay
in enrollment in your Phase 1 study of PHA121. Please revise to discuss in greater detail
the extent of the delay and also disclose if any of your other clinical trials have been
affected. Please also revise any associated risk factors to specifically discuss the impact
COVID-19 has actually had on your clinical trials to date given the amount of time that
has passed since the initial outbreak.
Implications of Being an “Emerging Growth Company” and a Foreign Private Issuer, page 9
9.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.
Risk Factors, page 14
10.Please update your risk factor disclosure by relocating risks that could apply generally to
any company or offering of securities to the end of the risk factor section under the
caption “General Risk Factors.” Refer to Item 105 of Regulation S-K and
SEC Release Nos. 33-10825; 34-89670.
Use of Proceeds, page 67
11.We note your disclosure that you intend to use a portion of the net proceeds to fund the
clinical development of PHVS416 and PHVS719. Please revise to specify how far in the
clinical development of the associated product candidates you expect to reach with the net
proceeds. In this regard, we note that you have a number of clinical trials planned for the
associated product candidates. Also, to the extent material amounts of other funds are
necessary to accomplish your specified purposes, state the amounts of such other funds
and the sources thereof.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Estimates and Judgments
Share-Based Payments, page 85
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
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Comapany NamePharvaris, B.V.
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December 9, 2020
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reasons for any differences between the recent valuations of your common stock leading
up to the IPO and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances including stock compensation and
beneficial conversion features.
Business
Current Treatments and Their Limitations, page 94
13.We note your disclosure that "four other angioedema-specific oral medications for acute,
as well as prophylactic, use are in clinical development." Please provide additional
disclosure about these potential competitors, including the stage of development.
PHA121
Overview, page 95
14.We note your statement here that "PHA121 showed efficacy and clear dose-dependent
activity." You also state on page 97 that, "PHA121 was safe and well tolerated when
administered orally up to single doses of 22 mg." Please revise these and all similar
statements throughout your prospectus that state or imply that your product candidates are
safe or effective as these determinations are solely within the authority of the FDA and
comparable regulatory bodies.
15.We note your disclosure that "PHA121 demonstrated longer duration and faster onset of
activity than injected icatibant in the same study." Please expand your disclosure to
describe the icatibant study, including who completed the study, how the 0.6 mg/kg dose
of icatibant compares to the doses depicted in PHA121, and discuss the vehicle in the
icatibant study. To the extent the icatibant study is not a head-to-head study please remove
this disclosure or tell us why you believe your comparison is appropriate.
16.The graphic provided on the bottom of page 95 contains text that is illegible. Please revise
this figure accordingly. In addition, the graphic contains abbreviations such as "HMWK"
that are not defined. Please define abbreviations in all graphics here and
elsewhere. Additionally, all graphics throughout the prospectus should be accompanied
by narrative disclosure that clearly explains the context for the graphic.
Bradykinin Challenge Study, page 98
17.We note your comparison of the results of PHA121 observed in your Bradykinin
Challenge Study to published reports of clinical trial data for icatibant as well as your
related predictions on page 2. As these comparisons are not based on head-to-head studies,
please tell us why you believe it is appropriate to include them. Address in your response
whether you expect to be able to rely on such comparisons to support an application for
marketing approval.
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PHA121-C002 (SAD extension), page 100
18.We note your disclosure regarding the occurrence of treatment-related adverse events
related to PHA121. Please expand your disclosure to provide the number of patients who
experienced each such treatment-related adverse event.
Intellectual Property, page 104
19.Please expand your disclosure to clarify the patent term for your sole granted U.S. patent
for PHA121. In addition, please identify the material jurisdictions that are included in
your "27 pending non-U.S. applications."
Corporate Structure, page 127
20.In order to provide appropriate context for your disclosure, please revise to include an
organizational chart that identifies the significant subsidiaries of the Company. Refer
to Item 4(a) of Form F-1 and Item 4.C of Form 20-F.
Employees, page 127
21.Please provide a breakdown of each main category of activity and geographic location for
each of your employees. Refer to Item 4(a) of Form F-1 and Item 6.D of Form 20-F.
Related Party Transactions, page 140
22.We note your disclosure that you issued shares of Series C preferred stock in November
2020. Please identify the related parties and describe the related party interest.
Financial Statements
Note 21. Events After the Reporting Period, page F-26
23.We see from your disclosure herein that you granted 600,000 share options on January 1,
2020. Please reconcile this disclosure with that on page II-2 that indicates that 600,000
share options were granted on December 13, 2019.
General
24.At first use, please define abbreviations. For example only, we note that "DDI," "SAD"
and "GLP" on page 97 and "DBP" on page 99 are not defined at first use.
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FirstName LastName
Berndt Modig
Pharvaris, B.V.
December 9, 2020
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You may contact Julie Sherman at 202-551-3640 or Kate Tillan at 202-551-3604 if you
have questions regarding comments on the financial statements and related matters. Please
contact Jason L. Drory at 202-551-8342 or Christine Westbrook at 202-551-5019 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Sophia Hudson, Esq.