Correspondence 0001437749-24-033378 from PALVELLA THERAPEUTICS, INC. (PVLA) (CIK 0001583648) (PVLA)
PALVELLA THERAPEUTICS, INC. (PVLA) (CIK 0001583648)
Date: Nov. 5, 2024 · CIK: 0001583648 · Accession: 0001437749-24-033378
AI Filing Summary & Sentiment
File numbers found in text: 333-281459
Referenced dates: November 4, 2024
Letter
pirs20241104_corresp.htm
Pieris Pharmaceuticals, Inc.
225 Franklin Street, 26th Floor
Boston, MA 02110
November 5, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Real Estate & Construction
100 F Street, NE
Washington, D.C. 20549
Attention:
Gary Newberry
Vanessa Robertson
Lauren Hamill
Laura Crotty
Re:
Pieris Pharmaceuticals, Inc.
Amendment No. 3 to Registration Statement on Form S-4
Filed October 29, 2024
File No. 333-281459
Ladies and Gentlemen:
This letter sets forth the response of Pieris Pharmaceuticals, Inc. (the “Company”) to the comment of the staff of the Division of Corporate Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in your letter dated November 4, 2024, with respect to the above referenced Amendment No. 3 to Registration Statement on Form S-4.
Concurrently with the submission of this letter, the Company is filing Amendment No. 4 to the Registration Statement on Form S-4 (the “Fourth Amended Registration Statement”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed thereto in the Fourth Amended Registration Statement.
Set forth below is the Company’s response to the Staff’s comment. For the Staff’s convenience, we have incorporated your comment into this response letter in italics.
Amendment No. 3 to Registration Statement on Form S-4
Palvella Therapeutics, Inc., page 11
1.
We acknowledge your response to prior comment 1, which we reissue. We continue to believe that the failure of QTORIN-rapamycin to meet primary clinical trial endpoints in two prior trials targeting Gorlin Syndrome and pachyonychia congenita may be considered material information and should be disclosed in the Summary and Palvella's Business Section. In this regard, we note: (1) Palvella's current and past product candidates utilize or utilized QTORIN, Palvella's proprietary anhydrous topical gel platform, as a mechanism to deliver rapamycin for the treatment of various targeted diseases; and (2) your disclosure on page 70 that "a failure in any one QTORIN-based program may decrease trust in its technology and affect its ability to conduct clinical programs for other QTORIN-based product candidates." Please either revise your disclosure as previously requested or provide an analysis supporting your determination that the information is not material in your response letter.
Response: The Company acknowledges the Staff’s comment with respect to the prior comment 1 and has revised the disclosure on pages 12 and 229 of the Fourth Amended Registration Statement.
*****
Sincerely,
PIERIS PHARMACEUTICALS, INC.
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CORRESP 1 filename1.htm pirs20241104_corresp.htm Pieris Pharmaceuticals, Inc. 225 Franklin Street, 26th Floor Boston, MA 02110 November 5, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Real Estate & Construction 100 F Street, NE Washington, D.C. 20549 Attention: Gary Newberry Vanessa Robertson Lauren Hamill Laura Crotty Re: Pieris Pharmaceuticals, Inc. Amendment No. 3 to Registration Statement on Form S-4 Filed October 29, 2024 File No. 333-281459 Ladies and Gentlemen: This letter sets forth the response of Pieris Pharmaceuticals, Inc. (the “Company”) to the comment of the staff of the Division of Corporate Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in your letter dated November 4, 2024, with respect to the above referenced Amendment No. 3 to Registration Statement on Form S-4. Concurrently with the submission of this letter, the Company is filing Amendment No. 4 to the Registration Statement on Form S-4 (the “Fourth Amended Registration Statement”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed thereto in the Fourth Amended Registration Statement. Set forth below is the Company’s response to the Staff’s comment. For the Staff’s convenience, we have incorporated your comment into this response letter in italics. Amendment No. 3 to Registration Statement on Form S-4 Palvella Therapeutics, Inc., page 11 1. We acknowledge your response to prior comment 1, which we reissue. We continue to believe that the failure of QTORIN-rapamycin to meet primary clinical trial endpoints in two prior trials targeting Gorlin Syndrome and pachyonychia congenita may be considered material information and should be disclosed in the Summary and Palvella's Business Section. In this regard, we note: (1) Palvella's current and past product candidates utilize or utilized QTORIN, Palvella's proprietary anhydrous topical gel platform, as a mechanism to deliver rapamycin for the treatment of various targeted diseases; and (2) your disclosure on page 70 that "a failure in any one QTORIN-based program may decrease trust in its technology and affect its ability to conduct clinical programs for other QTORIN-based product candidates." Please either revise your disclosure as previously requested or provide an analysis supporting your determination that the information is not material in your response letter. Response: The Company acknowledges the Staff’s comment with respect to the prior comment 1 and has revised the disclosure on pages 12 and 229 of the Fourth Amended Registration Statement. ***** Sincerely, PIERIS PHARMACEUTICALS, INC. /s/ Stephen Yoder Name: Stephen Yoder Title: Chief Executive Officer Cc: William C. Hicks, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Marc D. Mantell, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Jeffrey D. Cohan, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Christopher Miller, Esq., Troutman Pepper Hamilton Sanders LLP Joseph Walsh, Esq., Troutman Pepper Hamilton Sanders LLP