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SEC Comment Letters
Company Responses
Letter Text
PALVELLA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
↓
PALVELLA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2025-01-15
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2025-01-15
Generating summary...
PALVELLA THERAPEUTICS, INC.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2024-09-06
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2024-09-06
Generating summary...
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Company responded
2024-09-23
PALVELLA THERAPEUTICS, INC.
References: September 6, 2024
↓
Company responded
2024-10-15
PALVELLA THERAPEUTICS, INC.
References: October 8, 2024
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2024-10-15
Generating summary...
↓
Company responded
2024-10-29
PALVELLA THERAPEUTICS, INC.
References: October 25, 2024 | September 6, 2024
↓
Company responded
2024-11-05
PALVELLA THERAPEUTICS, INC.
References: November 4, 2024
↓
PALVELLA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-11-04
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2024-11-04
Generating summary...
PALVELLA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-10-25
PALVELLA THERAPEUTICS, INC.
References: September 6, 2024
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2024-10-25
Generating summary...
PALVELLA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
High
PALVELLA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-08-11
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2021-08-11
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Company responded
2021-08-11
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2021-08-11
Generating summary...
PALVELLA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-05-19
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2021-05-19
Generating summary...
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Company responded
2021-05-26
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2021-05-26
Generating summary...
PALVELLA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-12-09
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2019-12-09
Generating summary...
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Company responded
2019-12-11
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2019-12-11
Generating summary...
PALVELLA THERAPEUTICS, INC.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2018-08-15
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2018-08-15
Generating summary...
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Company responded
2018-08-21
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2018-08-21
Generating summary...
PALVELLA THERAPEUTICS, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-08-02
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2016-08-02
Generating summary...
PALVELLA THERAPEUTICS, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-08-02
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2016-08-02
Generating summary...
PALVELLA THERAPEUTICS, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-08-02
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2016-08-02
Generating summary...
PALVELLA THERAPEUTICS, INC.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2015-06-16
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2015-06-16
Generating summary...
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Company responded
2015-06-23
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2015-06-23
Generating summary...
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Company responded
2015-06-23
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2015-06-23
Generating summary...
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Company responded
2015-06-26
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2015-06-26
Generating summary...
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Company responded
2015-06-26
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2015-06-26
Generating summary...
PALVELLA THERAPEUTICS, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2015-03-17
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2015-03-17
Generating summary...
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Company responded
2015-05-08
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2015-05-08
Generating summary...
PALVELLA THERAPEUTICS, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2014-01-06
PALVELLA THERAPEUTICS, INC.
References: December 6, 2013
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2014-01-06
Generating summary...
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Company responded
2014-01-24
PALVELLA THERAPEUTICS, INC.
Filing - Correspondence from PALVELLA THERAPEUTICS, INC.
CORRESP · 2014-01-24
Generating summary...
PALVELLA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-12-06
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2013-12-06
Generating summary...
PALVELLA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-10-15
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2013-10-15
Generating summary...
PALVELLA THERAPEUTICS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-09-17
PALVELLA THERAPEUTICS, INC.
Filing - SEC Comment Letter to PALVELLA THERAPEUTICS, INC.
UPLOAD · 2013-09-17
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-27 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2026-01-05 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-292544 | Read Filing View |
| 2025-01-15 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2025-01-03 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-284093 | Read Filing View |
| 2024-11-07 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-11-05 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-11-04 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-281459 | Read Filing View |
| 2024-10-29 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-10-25 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-281459 | Read Filing View |
| 2024-10-15 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-10-09 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-281459 | Read Filing View |
| 2024-09-23 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-09-06 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-281459 | Read Filing View |
| 2021-08-11 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2021-08-11 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2021-05-26 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2021-05-19 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-12-11 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-12-09 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2018-08-21 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2018-08-15 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2016-08-02 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2016-08-02 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2016-08-02 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-06-26 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-06-26 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-06-23 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-06-23 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-06-16 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-05-08 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-03-17 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-01-24 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-01-06 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-12-06 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-10-15 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-09-17 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-05 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-292544 | Read Filing View |
| 2025-01-03 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-284093 | Read Filing View |
| 2024-11-04 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-281459 | Read Filing View |
| 2024-10-25 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-281459 | Read Filing View |
| 2024-10-09 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-281459 | Read Filing View |
| 2024-09-06 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | 333-281459 | Read Filing View |
| 2021-08-11 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2021-05-19 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-12-09 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2018-08-15 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-06-16 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-03-17 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-01-06 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-12-06 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-10-15 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2013-09-17 | SEC Comment Letter | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-27 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2025-01-15 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-11-07 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-11-05 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-10-29 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-10-15 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2024-09-23 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2021-08-11 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2021-05-26 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2019-12-11 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2018-08-21 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2016-08-02 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2016-08-02 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2016-08-02 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-06-26 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-06-26 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-06-23 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-06-23 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2015-05-08 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
| 2014-01-24 | Company Response | PALVELLA THERAPEUTICS, INC. | NV | N/A | Read Filing View |
2026-01-27 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Palvella Therapeutics, Inc. 353 W. Lancaster Avenue, Suite 200 Wayne, Pennsylvania 19087 January 27, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-7553 Re: Palvella Therapeutics, Inc. Registration Statement on Form S-3 Filed January 2, 2026 (File No. 333-292544) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Palvella Therapeutics, Inc. (the " Company ") hereby requests that the effective date of the Company's Registration Statement on Form S-3 (File No. 333-292544) (the " Registration Statement ") be accelerated so that the Company's Registration Statement will become effective at 4:01 PM, Eastern Time, on January 29, 2026, or as soon thereafter as is practicable. Please contact Jennifer L. Porter, Esq. of Goodwin Procter LLP, counsel to the Company, at (445) 207-7806 to provide notice of effectiveness, or if you have any questions or comments concerning this request. [ Remainder of the page intentionally left blank ] Very truly yours, PALVELLA THERAPEUTICS, INC. By: /s/ Wesley H. Kaupinen Name: Wesley H. Kaupinen Title: President and Chief Executive Officer
2026-01-05 - UPLOAD - PALVELLA THERAPEUTICS, INC. File: 333-292544
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> January 5, 2026 Wesley Kaupinen President and Chief Executive Officer Palvella Therapeutics, Inc. 353 W. Lancaster Ave., Suite 200 Wayne, PA 19087 Re: Palvella Therapeutics, Inc. Registration Statement on Form S-3 Filed January 2, 2026 File No. 333-292544 Dear Wesley Kaupinen: 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 Jason Drory at 202-551-8342 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jennifer Porter </TEXT> </DOCUMENT>
2025-01-15 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm pirs20250114_corresp.htm PALVELLA THERAPEUTICS, INC. 125 STRAFFORD AVENUE, SUITE 360 WAYNE, PA 19087 January 14, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street NE Washington, D.C. 20549 Attn: Daniel Crawford Re: Palvella Therapeutics, Inc. Registration Statement on Form S-1 Filed December 31, 2024, as amended on January 14, 2025 (File No. 333-284093) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Palvella Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333-284093) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:00 PM, Eastern Time, on January 16, 2025, or as soon thereafter as is practicable, or at such other time thereafter as our counsel, Troutman Pepper Locke LLP, may request by telephone. Please contact Joseph Walsh of Troutman Pepper Locke LLP at (212) 704-6030 to provide notice of effectiveness, or if you have any questions or comments concerning this request. [Remainder of the page intentionally left blank] Very truly yours, PALVELLA THERAPEUTICS, INC. By: /s/ Wesley Kaupinen Name: Wesley Kaupinen Title: President and Chief Executive Officer [Signature Page to Acceleration Request]
2025-01-03 - UPLOAD - PALVELLA THERAPEUTICS, INC. File: 333-284093
January 3, 2025
Wesley H. Kaupinen
President and Chief Executive Officer
Palvella Therapeutics, Inc.
125 Strafford Ave
Suite 360
Wayne, PA 19087
Re:Palvella Therapeutics, Inc.
Registration Statement on Form S-1
Filed December 31, 2024
File No. 333-284093
Dear Wesley H. Kaupinen:
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:Joseph Walsh, Esq.
2024-11-07 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm pirs20241106_corresp.htm Pieris Pharmaceuticals, Inc. 225 Franklin Street, 26th Floor Boston, MA 02110 November 7, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Real Estate & Construction 100 F Street, N.E. Washington, D.C. 20549 Attention: Gary Newberry Vanessa Robertson Lauren Hamill Laura Crotty Re: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-4, as amended File No. 333-281459 Request for Acceleration of Effectiveness Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Pieris Pharmaceuticals, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-4 (File No. 333-281459), as amended (the “Registration Statement”), so that the Registration Statement may become effective at 5:00 p.m. Eastern Time on Friday, November 8, 2024, or as soon as possible thereafter. The Registrant hereby authorizes Jeffrey D. Cohan, Esq. of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. to orally modify or withdraw this request for acceleration. The Registrant respectfully requests that it be notified of such effectiveness by a telephone call to Mr. Cohan at (212) 692-6710 and that such effectiveness also be confirmed in writing. Any questions regarding this request may be addressed to Mr. Cohan. Very truly yours, PIERIS PHARMACEUTICALS, INC. By: /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
2024-11-05 - CORRESP - PALVELLA THERAPEUTICS, INC.
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
2024-11-04 - UPLOAD - PALVELLA THERAPEUTICS, INC. File: 333-281459
November 4, 2024
Stephen Yoder
Chief Executive Officer
Pieris Pharmaceuticals, Inc.
225 Franklin Street, 26th Floor
Boston, MA 02110
Re:Pieris Pharmaceuticals, Inc.
Amendment No. 3 to Registration Statement on Form S-4
Filed October 29, 2024
File No. 333-281459
Dear Stephen Yoder:
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 a 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 letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our October 25, 2024 letter.
Amendment No. 3 to Registration Statement on Form S-4
Palvella Therapeutics, Inc., page 11
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 1.
November 4, 2024
Page 2
revise your disclosure as previously requested or provide an analysis supporting your
determination that the information is not material in your response letter.
Please contact Gary Newberry at 202-551-3761 or Vanessa Robertson at 202-551-
3649 if you have questions regarding comments on the financial statements and related
matters. Please contact Lauren Sprague Hamill at 303-844-1008 or Laura Crotty at 202-551-
7614 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joseph Walsh
2024-10-29 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm pirs20241027_corresp.htm Pieris Pharmaceuticals, Inc. 225 Franklin Street, 26th Floor Boston, MA 02110 October 29, 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. 2 to Registration Statement on Form S-4 Filed October 15, 2024 File No. 333-281459 Ladies and Gentlemen: This letter sets forth the response of Pieris Pharmaceuticals, Inc. (the “Company”) to the comments 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 October 25, 2024, with respect to the above referenced Amendment No. 2 to Registration Statement on Form S-4. Concurrently with the submission of this letter, the Company is filing Amendment No. 3 to the Registration Statement on Form S-4 (the “Third Amended Registration Statement”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed thereto in the Third Amended Registration Statement. Set forth below is the Company’s response to the Staff’s comments. For the Staff’s convenience, we have incorporated your comments into this response letter in italics. Amendment No. 2 to Registration Statement on Form S-4 The Companies Palvella Therapeutics, Inc., page 11 1. We note your response to prior comment 1. In this regard, we note seemingly inconsistent risk factor disclosure on page 69, which states: "Negative results in the development of QTORIN rapamycin for either the treatment of microcystic LM or cutaneous venous malformations may also impact [Palvella's] ability to obtain regulatory approval for other product candidates which Palvella expects to develop based on its QTORIN platform, either at all or within anticipated timeframes because, although Palvella may be targeting different indications, the underlying technology platform is the same for each product candidate and there may be commonalities in the manufacturing and development processes. Accordingly, 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 tell us how your response reconciles with this disclosure, or otherwise revise your registration statement as requested in the third bullet of prior comment 7 of our letter dated September 6, 2024. Response: The Company acknowledges the Staff’s comment with respect to the prior comment 1 and has revised the disclosure on page 12 of the Third Amended Registration Statement. Support Agreements, page 18 2. We note your response to prior comment 3. You now state on pages 18 and 179 that the Palvella stockholders that are party to a support agreement with Pieris include the "Agent Capital Fund I, LP, owning approximately 2.7% of the outstanding shares of Palvella capital stock." Please consider Securities Act Sections Compliance and Disclosure Interpretation 239.13 and explain why you believe it is appropriate to register the issuance of Pieris' shares on this Form S-4 at this time. Response: The Company acknowledges the Staff’s comment and informs the Staff that Agent Capital Fund I, LP inadvertently executed a lock-up agreement and support agreement since these agreements are limited to officers, directors and 5% or more stockholders, and Agent Capital Fund I, LP does not fall into this group. The Company has terminated the Agent Capital Fund I, LP support agreement and the lock-up agreement, Agent Capital Fund I, LP will not be delivering a written consent approving the merger, and the Company has revised the disclosure on pages 18 and 179 of the Third Amended Registration Statement accordingly. Risk Factors The articles of incorporation of the combined company will generally provide..., page 112 3. We note your response to prior comment 4. Please further revise your disclosure here and elsewhere, where appropriate, to clarify what you mean by the following: "the choice-of-forum provision does not preclude or contract the scope of exclusive federal or concurrent jurisdiction for any actions brought under the Securities Act or the Exchange Act...". Response: The Company acknowledges the Staff’s comment and respectfully advises that the language has been removed on pages 59, 112, and 314 of the Third Amended Registration Statement. Certain Unaudited Projections of Palvella, page 146 4. You now state on page 147 that Palvella provided U.S. revenue projections for QTORIN rapamycin for treatment of cutaneous venous malformations starting in 2029, and that "Pieris fully disregarded the venous malformations (VM) indication in connection with the evaluation of the Merger." In this regard: ● Please further revise to explain the reason(s) why Pieris disregarded the CVM indication when evaluating the Merger. ● In light of the foregoing, expressly state whether or not the Palvella Projections table presented on page 148 includes projections for both the microcystic LM and CVM indications during the period presented. If both, revise to disclose the date you assume Palvella will be granted regulatory approval for, and commercially launch, QTORIN rapamycin for the CVM indication. Further, with respect to line items such as total net sales, please specifically identify the material product revenue stream(s) underlying the projections. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 146 and 148 of the Third Amended Registration Statement. 5. You now disclose that Palvella arrived at the probability of regulatory approval for QTORIN rapamycin for the treatment of microcystic LM based on a joint research report published in 2021 that estimated success rates for each phase of clinical development for "other" therapeutic areas including but not limited to dermatology, and adjusting the ultimate probability of regulatory approval upwards. In this regard: ● Please revise to disclose the success rate cited in the named research report for completion of Phase 3 studies in the therapeutic area group titled "Others" that includes dermatology. ● Disclose Palvella's assumed adjusted probability of regulatory approval for QTORIN rapamycin for microcystic LM, and any other indication reflected in the Palvella Projections. ● Disclose how Palvella determined that the upward adjustment to the therapeutic area group average rate for successful completion of Phase 3 was reasonable. Explain any specific material factor(s) pertaining to Palvella's "Phase 2 clinical study results, safety profile, and FDA Breakthrough Therapy Designation" that formed the basis for Palvella's conclusion that its product candidate has a greater likelihood of regulatory approval compared to the therapeutic area group average. ● Please also revise to discuss the risk that the assumed probabilities of successful completion may be unrealistic given the unpredictability of drug development. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 147 of the Third Amended Registration Statement. Palvella's Business Phase 3 trial - PALV-09 (SELVA) and Anticipated pre-NDA Meeting, page 237 6. Please revise this section to disclose when Palvella received the FDA Orphan Drug Clinical Trial Grant to support the Phase 3 trial of QTORIN rapamycin for the treatment of microcystic LM. Please also revise to disclose the total number of grants under this program since inception and to explicitly state that the receipt of the grant does not guarantee FDA approval of QTORIN rapamycin for the treatment of microcystic LM or any other indication. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 237 of the Third Amended Registration Statement. Exhibits 7. Please revise your exhibits and exhibit index to accurately reflect the status of any redactions. In this regard: ● We note your statement at the top of the first page of Exhibits 10.18 and 10.20 stating that certain information has been redacted because it is both not material and the type of information that the company treats as private or confidential. If accurate, please revise your exhibit index to disclose that certain portions of such exhibits have been omitted pursuant to Item 601 of Regulation S-K. Refer to Item 601(b)(10)(iv) of Regulation S-K. ● We note your statement at the top of the first page of Exhibit 10.19 that certain personal information has been excluded from the exhibit pursuant to Item 601(a)(6) of Regulation S-K. As appropriate, please: (1) mark the exhibit to indicate where information has been omitted and (2) revise the exhibit index to disclose that certain portions of such exhibit have been omitted pursuant to this provision of Regulation S-K. Response: The Company acknowledges the Staff’s comment and has revised the exhibit index on pages II-4 through II-6 of the Third 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
2024-10-25 - UPLOAD - PALVELLA THERAPEUTICS, INC. File: 333-281459
October 25, 2024
Stephen Yoder
Chief Executive Officer
Pieris Pharmaceuticals, Inc.
225 Franklin Street, 26th Floor
Boston, MA 02110
Re:Pieris Pharmaceuticals, Inc.
Amendment No. 2 to Registration Statement on Form S-4
Filed October 15, 2024
File No. 333-281459
Dear Stephen Yoder:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a 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 letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our October 8, 2024 letter.
Amendment No. 2 to Registration Statement on Form S-4
The Companies
Palvella Therapeutics, Inc., page 11
We note your response to prior comment 1. In this regard, we note seemingly
inconsistent risk factor disclosure on page 69, which states: "Negative results in the
development of QTORIN rapamycin for either the treatment of microcystic LM or
cutaneous venous malformations may also impact [Palvella's] ability to obtain
regulatory approval for other product candidates which Palvella expects to develop
based on its QTORIN platform, either at all or within anticipated timeframes because,
although Palvella may be targeting different indications, the underlying technology
platform is the same for each product candidate and there may be commonalities in
the manufacturing and development processes. Accordingly, a failure in any one 1.
October 25, 2024
Page 2
QTORIN-based program may decrease trust in its technology and affect its ability to
conduct clinical programs for other QTORIN-based product candidates." Please tell us
how your response reconciles with this disclosure, or otherwise revise your
registration statement as requested in the third bullet of prior comment 7 of our letter
dated September 6, 2024.
Support Agreements, page 18
2.We note your response to prior comment 3. You now state on pages 18 and 179 that
the Palvella stockholders that are party to a support agreement with Pieris include the
"Agent Capital Fund I, LP, owning approximately 2.7% of the outstanding shares of
Palvella capital stock." Please consider Securities Act Sections Compliance and
Disclosure Interpretation 239.13 and explain why you believe it is appropriate to
register the issuance of Pieris' shares on this Form S-4 at this time.
Risk Factors
The articles of incorporation of the combined company will generally provide..., page 112
3.We note your response to prior comment 4. Please further revise your disclosure here
and elsewhere, where appropriate, to clarify what you mean by the following: "the
choice-of-forum provision does not preclude or contract the scope of exclusive federal
or concurrent jurisdiction for any actions brought under the Securities Act or the
Exchange Act...".
Certain Unaudited Projections of Palvella, page 146
4.You now state on page 147 that Palvella provided U.S. revenue projections for
QTORIN rapamycin for treatment of cutaneous venous malformations starting in
2029, and that "Pieris fully disregarded the venous malformations (VM) indication in
connection with the evaluation of the Merger." In this regard:
•Please further revise to explain the reason(s) why Pieris disregarded the
CVM indication when evaluating the Merger.
•In light of the foregoing, expressly state whether or not the Palvella Projections
table presented on page 148 includes projections for both the microcystic LM and
CVM indications during the period presented. If both, revise to disclose the date
you assume Palvella will be granted regulatory approval for, and commercially
launch, QTORIN rapamycin for the CVM indication. Further, with respect to line
items such as total net sales, please specifically identify the material product
revenue stream(s) underlying the projections.
You now disclose that Palvella arrived at the probability of regulatory approval for
QTORIN rapamycin for the treatment of microcystic LM based on a joint research
report published in 2021 that estimated success rates for each phase of clinical
development for "other" therapeutic areas including but not limited to dermatology,
and adjusting the ultimate probability of regulatory approval upwards. In this regard:
•Please revise to disclose the success rate cited in the named research report for
completion of Phase 3 studies in the therapeutic area group titled "Others" that
includes dermatology.
Disclose Palvella's assumed adjusted probability of regulatory approval for •5.
October 25, 2024
Page 3
QTORIN rapamycin for microcystic LM, and any other indication reflected in the
Palvella Projections.
•Disclose how Palvella determined that the upward adjustment to the therapeutic
area group average rate for successful completion of Phase 3 was
reasonable. Explain any specific material factor(s) pertaining to Palvella's "Phase
2 clinical study results, safety profile, and FDA Breakthrough Therapy
Designation" that formed the basis for Palvella's conclusion that its product
candidate has a greater likelihood of regulatory approval compared to the
therapeutic area group average.
•Please also revise to discuss the risk that the assumed probabilities of successful
completion may be unrealistic given the unpredictability of drug development.
Palvella's Business
Phase 3 trial - PALV-09 (SELVA) and Anticipated pre-NDA Meeting, page 237
6.Please revise this section to disclose when Palvella received the FDA Orphan Drug
Clinical Trial Grant to support the Phase 3 trial of QTORIN rapamycin for the
treatment of microcystic LM. Please also revise to disclose the total number of grants
under this program since inception and to explicitly state that the receipt of the grant
does not guarantee FDA approval of QTORIN rapamycin for the treatment of
microcystic LM or any other indication.
Exhibits
7.Please revise your exhibits and exhibit index to accurately reflect the status of
any redactions. In this regard:
•We note your statement at the top of the first page of Exhibits 10.18 and 10.20
stating that certain information has been redacted because it is both not material
and the type of information that the company treats as private or confidential. If
accurate, please revise your exhibit index to disclose that certain portions of such
exhibits have been omitted pursuant to Item 601 of Regulation S-K. Refer to Item
601(b)(10)(iv) of Regulation S-K.
•We note your statement at the top of the first page of Exhibit 10.19 that
certain personal information has been excluded from the exhibit pursuant to Item
601(a)(6) of Regulation S-K. As appropriate, please: (1) mark the exhibit to
indicate where information has been omitted and (2) revise the exhibit index to
disclose that certain portions of such exhibit have been omitted pursuant to this
provision of Regulation S-K.
October 25, 2024
Page 4
Please contact Gary Newberry at 202-551-3761 or Vanessa Robertson at 202-551-
3649 if you have questions regarding comments on the financial statements and related
matters. Please contact Lauren Sprague Hamill at 303-844-1008 or Laura Crotty at 202-551-
7614 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joseph Walsh
2024-10-15 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm pirs20241010_corresp.htm Pieris Pharmaceuticals, Inc. 225 Franklin Street, 26th Floor Boston, MA 02110 October 15, 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. 1 to Registration Statement on Form S-4 Filed August 9, 2024 File No. 333-281459 Ladies and Gentlemen: This letter sets forth the response of Pieris Pharmaceutical’s, Inc. (the “Company”) to the comments 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 October 8, 2024, with respect to the above referenced Amendment No. 1 to Registration Statement on Form S-4. Concurrently with the submission of this letter, the Company is filing Amendment No. 2 to the Registration Statement on Form S-4 (the “Second Amended Registration Statement”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed thereto in the Second Amended Registration Statement. Set forth below is the Company’s response to the Staff’s comments. For the Staff’s convenience, we have incorporated your comments into this response letter in italics. Amendment No. 1 to Registration Statement on Form S-4 Prospectus Summary The Companies Palvella Therapeutics, Inc., page 11 1. We note your response to prior comment 7, which we reissue with respect to the third and fourth bullets. Please revise both the Summary and Business sections to balance your disclosure with respect to Palvella's QTORIN platform by stating, if true, that clinical trials of QTORIN rapamycin targeting other indications (i.e., Gorlin Syndrome and pachyonychia congenita) failed to meet their respective primary endpoints, which may affect Palvella's ability to conduct clinical programs for other QTORIN-based product candidates and that the QTORIN platform may never result in the regulatory approval of any product candidate. Response: The Company acknowledges the Staff’s comment with respect to the third bullet of prior comment 7 and respectfully advises that Palvella believes that there is no connection between its previous clinical trials of QTORIN rapamycin targeting other indications (i.e., Gorlin Syndrome and pachyonychia congenita) failing to meet their respective primary endpoints and Palvella’s ability to conduct clinical programs for other QTORIN-based product candidates. Additionally, Palvella believes that such results do not create an increased likelihood or preclude regulatory approval of other QTORIN-based product candidates. Pachyonychia congenita (“PC”), Gorlin Syndrome (“GS”) and microcystic lymphatic malformations (“microcystic LM”) are unique diseases with unique genetic mutations that, in turn, have unique disease pathophysiologies. Palvella believes that its ability to conduct a Phase 3 clinical trial in microcystic LM, and its potential to receive regulatory approval, is independent of previous results in its other clinical trials. However, the Company is transparent about the results of these studies and believes these results reflect the risks that are inherent in clinical drug development, as discussed on page 65. The Company acknowledges the Staff’s comment with respect to the fourth bullet of prior comment 7 and has revised the disclosure on pages 11, 222 and 226 of the Amended Registration Statement. 2. We note your response to prior comment 8, which we reissue in part. Please further revise both the Summary and Business sections to highlight your selection of "novel endpoints or other key clinical trial design features, such as choice of control" used or to be used in your ongoing and planned clinical trials of QTORIN rapamycin for various rare disease indications. In this regard, we note your disclosure on page 62 that such clinical trial features "could delay or prevent regulatory approval for Palvella's product candidates." Your revisions should: ● Explain what you mean by "baseline-controlled" study and how such a clinical trial differs from a placebo-controlled trial; ● Explain the clinical endpoints of your ongoing and planned clinical trials; and ● Explain the novelty and/or the subjective nature of your choice of control and selected endpoints. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 12, 226, 234, 237, and 238 of the Second Amended Registration Statement. Support Agreements, page 17 3. We note your response to prior comment 12; however, we are unable to locate responsive disclosure in the registration statement. Therefore, we reissue the comment. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 18 and 179 of the Second Amended Registration Statement. Risk Factors The articles of incorporation of the combined company will generally provide..., page 58 4. We note your response to prior comment 15, which we reissue in part. Please revise your disclosure to expressly state whether the exclusive forum provision in the articles of incorporation of the combined company will apply to actions arising under the Securities Act or Exchange Act. If so, make conforming revisions in your related risk factor disclosures and disclose that risk to shareholders related to this provision may include increased costs to bring a claim. If not, please ensure that the exclusive forum provision in the governing documents states this clearly, or tell us how you will inform investors in future filings that the provision does not apply to any actions arising under the Securities Act or Exchange Act. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 59, 112, and 314 of the Second Amended Registration Statement. Certain Unaudited Financial Projections of Palvella, page 144 5. We note your response to prior comments 21 and 24 and that the summary financial projections table covers a period through 2038. Please revise this section to include the information contained in your response letter indicating that Palvella's expected patent protections were tied to the length of the period projected in the table. As appropriate, clarify any material assumptions underlying this basis for the presentation period. Additionally, to the extent material, disclose the "high-level projections" that Palvella provided to Stifel for 2039 and 2040 for purposes of conducting the discounted cash flow analysis. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 148 of the Second Amended Registration Statement. Palvella Management believes projections for 2039 and 2040 are immaterial as they are substantially more uncertain than the Palvella Projections through 2038. As a result, such projections were not included. 6. We note your response to prior comment 23, which we reissue in part. Please further revise your discussion of the material assumptions that underlie the financial projections table as follows: ● Please revise to explain how Palvella management arrived at the probability of regulatory approval for QTORIN rapamycin for each indication, as applicable. ● Clearly disclose any assumptions as to which indication(s) were assumed to have received approvals, the year(s) approval is received, and the regulatory jurisdiction(s). In this regard, we note that the bulleted list of assumptions now included on page 145 only appear to relate to QTORIN rapamycin for treatment of microcystic LM. If the probability of approval for the CVM indication was not assessed or was assessed to be 0 during the period presented, please expressly state as such, and explain the reason(s) why. ● With respect to line items such as total net sales, please specifically address the growth rates and clearly identify the material product revenue stream(s) underlying the projections. ● Revise to clarify what, if any, consideration the Pieris Board gave to the separate possibility that Palvella's product candidate may not successfully complete clinical trials in some or all indications. ● Additionally, discuss whether the projections factored in the possibility of FDA approval of new competitive products Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 146 and 147 of the Second Amended Registration Statement. 7. We note your response to prior comment 24 and reissue the first bullet thereof. With regard to the length of the projections, please disclose the basis for projections beyond year five, including whether the forecasts reflect more than simple assumptions about growth rates, or whether, for example, the forecasts reflect straight line growth assumptions. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 148 of the Second Amended Registration Statement. Pieris' Business Strategic Partnerships, page 221 8. We note your revisions in response to prior comment 28. With respect to the Pfizer Collaboration Agreements, please revise the description of the tiered royalties to disclose a royalty range within ten percentage points. Also, you disclose that the royalty term may terminate upon the last-to-expire patent on a country-by-country and product-by-product basis. Please revise to clarify when these patents are expected to expire. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 224 of the Second Amended Registration Statement. Palvella's Business QTORIN Rapamycin for the Treatment of Microcystic LM, page 228 9. We note your response to prior comment 31, which we reissue with respect to the second and third bullets. Please revise to disclose the substance of any material FDA comments or guidance received related to Palvella's NDA or bridging strategy. In this regard, we note your disclosure on page 71 that the FDA recommends that bridging to support an NDA for the treatment of microcystic LM be done in a relative bioavailability study comparing the pharmacokinetics of a topical product applied under maximal use conditions and the approved oral drug. Notwithstanding any FDA recommendation(s), explain the rationale for Palvella's plans to bridge QTORIN rapamycin and the approved oral rapamycin product based on cross-study comparison between pharmacokinetic data from the prescribing information for the approved product rather than in a relative bioavailability study. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 237 and 238 of the Second Amended Registration Statement. 10. We note your response to prior comment 32, which we reissue in part. ● In light of your disclosure on page 67 that the design of a clinical trial can determine whether its results will support approval of a product, please further revise Palvella's Business section to summarize the substance of any material comments or guidance that the FDA provided with respect to each of the following Phase 3 clinical design features: proposed patient population, choice of control, dosing, and endpoint selection. ● Notwithstanding any FDA recommendation(s), explain Palvella's rationale for designing a baseline-controlled study rather than a placebo-controlled trial. Similarly, explain Palvella's rationale for employing a dynamic assessment that uses a comparative rating scale as the primary and key secondary endpoints. ● Consistent with the disclosure on page 68, discuss any surrounding uncertainty related to Palvella's use of these approaches, explain whether, and if so why, Palvella's Phase 3 trial design may be susceptible to objection, and what additional trials or testing could be required. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 237 and 238 of the Second 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
2024-10-09 - UPLOAD - PALVELLA THERAPEUTICS, INC. File: 333-281459
October 8, 2024
Stephen Yoder
Chief Executive Officer
Pieris Pharmaceuticals, Inc.
225 Franklin Street, 26th Floor
Boston, MA 02110
Re:Pieris Pharmaceuticals, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed September 23, 2024
File No. 333-281459
Dear Stephen Yoder:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a 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 letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our September 6, 2024 letter.
Amendment No. 1 to Registration Statement on Form S-4
Prospectus Summary
The Companies
Palvella Therapeutics, Inc., page 11
We note your response to prior comment 7, which we reissue with respect to the third
and fourth bullets. Please revise both the Summary and Business sections to balance
your disclosure with respect to Palvella's QTORIN platform by stating, if true, that
clinical trials of QTORIN rapamycin targeting other indications (i.e., Gorlin
Syndrome and pachyonychia congenita) failed to meet their respective primary
endpoints, which may affect Palvella's ability to conduct clinical programs for other
QTORIN-based product candidates and that the QTORIN platform may never result
in the regulatory approval of any product candidate.1.
October 8, 2024
Page 2
2.We note your response to prior comment 8, which we reissue in part. Please further
revise both the Summary and Business sections to highlight your selection of "novel
endpoints or other key clinical trial design features, such as choice of control" used or
to be used in your ongoing and planned clinical trials of QTORIN rapamycin for
various rare disease indications. In this regard, we note your disclosure on page 62
that such clinical trial features "could delay or prevent regulatory approval for
Palvella's product candidates." Your revisions should:
•Explain what you mean by "baseline-controlled" study and how such a clinical
trial differs from a placebo-controlled trial;
•Explain the clinical endpoints of your ongoing and planned clinical trials; and
•Explain the novelty and/or the subjective nature of your choice of control and
selected endpoints.
Support Agreements, page 17
3.We note your response to prior comment 12; however, we are unable to locate
responsive disclosure in the registration statement. Therefore, we reissue the
comment.
Risk Factors
The articles of incorporation of the combined company will generally provide..., page 58
4.We note your response to prior comment 15, which we reissue in part. Please revise
your disclosure to expressly state whether the exclusive forum provision in the articles
of incorporation of the combined company will apply to actions arising under the
Securities Act or Exchange Act. If so, make conforming revisions in your related risk
factor disclosures and disclose that risk to shareholders related to this provision may
include increased costs to bring a claim. If not, please ensure that the exclusive forum
provision in the governing documents states this clearly, or tell us how you will
inform investors in future filings that the provision does not apply to any actions
arising under the Securities Act or Exchange Act.
Certain Unaudited Projections of Palvella, page 144
5.We note your response to prior comments 21 and 24 and that the summary financial
projections table covers a period through 2038. Please revise this section to include
the information contained in your response letter indicating that Palvella's expected
patent protections were tied to the length of the period projected in the table. As
appropriate, clarify any material assumptions underlying this basis for the presentation
period. Additionally, to the extent material, disclose the "high-level projections" that
Palvella provided to Stifel for 2039 and 2040 for purposes of conducting
the discounted cash flow analysis.
We note your response to prior comment 23, which we reissue in part. Please further
revise your discussion of the material assumptions that underlie the
financial projections table as follows:
Please revise to explain how Palvella management arrived at the probability of
regulatory approval for QTORIN rapamycin for each indication, as applicable. •6.
October 8, 2024
Page 3
Clearly disclose any assumptions as to which indication(s) were assumed to have
received approvals, the year(s) approval is received, and the regulatory
jurisdiction(s). In this regard, we note that the bulleted list of assumptions now
included on page 145 only appear to relate to QTORIN rapamycin for treatment
of microcystic LM. If the probability of approval for the CVM indication was not
assessed or was assessed to be 0 during the period presented, please expressly
state as such, and explain the reason(s) why.
•With respect to line items such as total net sales, please specifically address the
growth rates and clearly identify the material product revenue stream(s)
underlying the projections.
•Revise to clarify what, if any, consideration the Pieris Board gave to the separate
possibility that Palvella's product candidate may not successfully complete
clinical trials in some or all indications.
•Additionally, discuss whether the projections factored in the possibility of FDA
approval of new competitive products
7.We note your response to prior comment 24 and reissue the first bullet thereof. With
regard to the length of the projections, please disclose the basis for projections beyond
year five, including whether the forecasts reflect more than simple assumptions about
growth rates, or whether, for example, the forecasts reflect straight line growth
assumptions.
Pieris' Business
Strategic Partnerships, page 221
8.We note your revisions in response to prior comment 28. With respect to the Pfizer
Collaboration Agreements, please revise the description of the tiered royalties to
disclose a royalty range within ten percentage points. Also, you disclose that the
royalty term may terminate upon the last-to-expire patent on a country-by-country and
product-by-product basis. Please revise to clarify when these patents are expected to
expire.
QTORIN Rapamycin for the Treatment of Microcystic LM, page 228
9.We note your response to prior comment 31, which we reissue with respect to the
second and third bullets. Please revise to disclose the substance of any material FDA
comments or guidance received related to Palvella's NDA or bridging strategy. In this
regard, we note your disclosure on page 71 that the FDA recommends that bridging to
support an NDA for the treatment of microcystic LM be done in a relative
bioavailability study comparing the pharmacokinetics of a topical product applied
under maximal use conditions and the approved oral drug. Notwithstanding any FDA
recommendation(s), explain the rationale for Palvella's plans to bridge QTORIN
rapamycin and the approved oral rapamycin product based on cross-study comparison
between pharmacokinetic data from the prescribing information for the approved
product rather than in a relative bioavailability study.
We note your response to prior comment 32, which we reissue in part.10.
October 8, 2024
Page 4
•In light of your disclosure on page 67 that the design of a clinical trial can
determine whether its results will support approval of a product, please further
revise Palvella's Business section to summarize the substance of any material
comments or guidance that the FDA provided with respect to each of the
following Phase 3 clinical design features: proposed patient population, choice of
control, dosing, and endpoint selection.
•Notwithstanding any FDA recommendation(s), explain Palvella's rationale for
designing a baseline-controlled study rather than a placebo-controlled trial.
Similarly, explain Palvella's rationale for employing a dynamic assessment that
uses a comparative rating scale as the primary and key secondary endpoints.
•Consistent with the disclosure on page 68, discuss any surrounding uncertainty
related to Palvella's use of these approaches, explain whether, and if so why,
Palvella's Phase 3 trial design may be susceptible to objection, and what
additional trials or testing could be required.
Please contact Gary Newberry at 202-551-3761 or Vanessa Robertson at 202-551-
3649 if you have questions regarding comments on the financial statements and related
matters. Please contact Lauren Sprague Hamill at 303-844-1008 or Laura Crotty at 202-551-
7614 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joseph Walsh
2024-09-23 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm pirs20240913_corresp.htm Pieris Pharmaceuticals, Inc. 225 Franklin Street, 26th Floor Boston, MA 02110 September 20, 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. Registration Statement on Form S-4 Filed August 9, 2024 File No. 333-281459 Ladies and Gentlemen: This letter sets forth the response of Pieris Pharmaceutical’s, Inc. (the “Company”) to the comments 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 September 6, 2024, with respect to the above reference Registration Statement on Form S-4 (the “Registration Statement”). Concurrently with the submission of this letter, the Company is filing Amendment No. 1 to the Registration Statement on Form S-4 (the “Amended Registration Statement”). Capitalized terms used but not otherwise defined herein shall have the meanings ascribed thereto in the Amended Registration Statement. Set forth below is the Company’s response to the Staff’s comments. For the Staff’s convenience, we have incorporated your comments into this response letter in italics. Registration Statement on Form S-4 filed August 9, 2024 Questions and Answers About the Merger, page 1 1. Please revise your Q&A disclosure, where appropriate, as follows: ● Clarify the material terms of the CVR Agreement, your intentions with respect to Piers’ pre-merger assets and describe any material assets that either have been divested or may be divested by Pieris pursuant to the CVR Agreement. ● With Reference to your disclosure on pages 9 and 215, please revise the Q&A and Summary to highlight, if true, that if the merger is completed, the combined company will focus on developing Palvella’s product candidates, and it is anticipated that the combined company will not continue to develop any of Pieris’ legacy product candidates. ● Also, revise the Q&A to explain what Pieris’ stockholders will receive in the merger to provide context for your disclosure on page 8 discussing the tax treatment of the CVRs Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 5, 6, 10, 217, 295, and 300 of the Amended Registration Statement. What is the PIPE Financing?, page 2 2. We note your disclosure that the PIPE Investors have agreed to subscribe for and purchase (in cash or by cancellation of convertible notes) either shares of Pieris common stock or pre-funded warrants to purchase shares of the combined company common stock. Here and throughout where appropriate, please revise to quantify the amount of the expected $78.9 million gross PIPE proceeds to be received in cash versus the amount expected to be attributed to the conversion of outstanding Palvella convertible notes. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 2, 6, 12, 15, 114, 178, 205, 265, and 296 of the Amended Registration Statement. How many votes can be cast by all stockholders, page 4 3. Please We note your disclosure that on the record date the holder of one outstanding share of Series F Preferred Stock will be entitled to be entitled 25,000,000 votes only on Proposal No. 2 related to increasing the number of authorized shares of Pieris common stock, to be voted together with the holders of Pieris common stock as a single class. ● Consistent with your disclosure page 57 and in your 8-K dated August 8, 2024 incorporated by reference, please revise the Q&A to disclose that on August 7, 2024, Pieris entered into a Subscription and Investor Representation Agreement with James Geraghty, the chairman of the Pieris board of directors, pursuant to which he purchased one share of Pieris’ Series F Preferred Stock for $1.00 cash. ● Consistent with your disclosure on page 206, explicitly state that the issuance of the Series F Preferred Stock, with its attendant voting rights, was issued by the Company solely to affect the passage of Proposal 2, which is a condition to the completion of the Merger. Explain the reason(s) why the Board determined that such issuance was necessary in this case. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 4 of the Amended Registration Statement. 4. Please revise your disclosure to explicitly describe the impact of the outsized voting rights the holder of the Series F Preferred share will have on Proposal 2 relative to holders of common stock. In this regard: ● Please consider including an illustrative example of the effects the super voting rights of the Series F Preferred Stock will have on reaching the voting threshold necessary to approve Proposal 2. Based on the number of Pieris common shares reported outstanding in the proxy statement and assuming (1) the common shares subject to the Pieris Support Agreement and (2) the Series F Preferred share are each voted as described in the proxy statement, please clarify the number of votes that will need to be cast (i.e., the number of common shares that will need to be voted) to approve Proposal 2. ● If true, please revise to clearly explain that the mirrored voting mechanism of the Series F Preferred Stock will have a significant impact on the vote needed to pass Proposal 2. For example, assuming the minimum quorum is met with no additional shares of common stock appearing in person or by proxy, disclose whether and if so how the mirrored voting mechanism of the Series F Preferred Stock will operate with respect to the percentage of the common shares outstanding required to vote to pass Proposal 2. ● Clearly explain the consequence to holders of Pieris' common stock of not casting a vote on a common share for or against the proposal in person or by proxy. In this regard, please state the likelihood that even if a Pieris' common shareholder does not vote on the proposals, Pieris will reach or exceed the voting threshold required for approval of Proposal 2. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 4 and 5 of the Amended Registration Statement. Palvella Therapeutics, Inc., page 9 5. Please revise the Summary and throughout where appropriate to clarify the status of Palvella's ongoing and planned clinical trials. In this regard: ● Clarify if references on page 10 and elsewhere to Palvella's "planned" Phase 2 baseline-controlled trial of QTORIN Rapamycin for the treatment of CVM expected to start in Q4 2024 are separate from references to the Phase 2 baseline-controlled trial Palvella "is conducting," with top-line data expected in Q4 2025. Also revise to clarify when you submitted, or plan to submit, an IND for the planned trial for the CVM indication. ● Similarly, reconcile your disclosure on page 10 and elsewhere that "Palvella currently has one ongoing clinical trial and one clinical trial planned to start" with disclosure on page 226 that "QTORIN rapamycin is currently being evaluated in three ongoing clinical trials." ● In light of your risk factor disclosure on page 73, also disclose the location(s) of Palvella’s completed, ongoing and planned clinical trials. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 11 and 75 of the Amended Registration Statement. 6. Please revise the Summary and throughout where appropriate to eliminate any implication that Palvella's product candidates have been or will ultimately be determined safe and/or effective or have demonstrated safety and/or efficacy for purposes of approval by the FDA or comparable regulatory agency. Where you deem appropriate, you may present objective data without including your conclusions related to safety or efficacy. By way of example and not limitation, refer to the following: ● Statements that Palvella has announced "positive" or "encouraging" topline Phase 2 clinical trial results. (pages 10, 221, 229 and 264) ● Statements that "Palvella is developing the first approved therapy" for microcystic LM and CVM. (pages 226 and 233) Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 11, 223, 228, 231, 235, and 264 of the Amended Registration Statement. 7. Please revise the Summary and Palvella's Business section to provide context and balance to the discussion of Palvella's proprietary QTORIN platform. To the extent that you highlight Palvella's intention to leverage its "versatile" QTORIN platform to expand its pipeline to treat a "broad spectrum" of rare, genetic skin diseases, please include equally prominent disclosure highlighting, if true: ● that Palvella has limited experience in therapeutic discovery and development; ● Palvella's platform is novel and unproven, and that clinical evidence to support the two current clinical-stage QTORIN product candidates is preliminary and limited at this time; ● prior candidates developed using the QTORIN platform targeting different indications have failed to meet their respective primary endpoints, which may affect Palvella's ability to conduct clinical programs for other QTORIN-based product candidates; and ● the platform may never result in the regulatory approval of any product candidate. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 11, 223, 225, 226, 228, 229, 230, 231, and 234 of the Amended Registration Statement. 8. Please revise your disclosure regarding Palvella's product candidates to clarify discuss the material factors that could delay or prevent Palvella's ability to receive marketing approval. Highlight the novel and/or subjective clinical endpoints and the "baseline control" Palvella has established in connection with its Phase 3 trial design in microcystic LM, and disclose that the FDA has made comments to Palvella indicating it could request a placebo-controlled trial or additional trials to assess different clinical endpoints. In this regard, we refer to your disclosure on pages 62, 66 and 71. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 11, 64, and 68 of the Amended Registration Statement. 9. Please revise the Summary and Business sections to explicitly disclose that Palvella currently plans to pursue marketing approval for QTORIN rapamycin for microcystic LM and other indications through the FDA’s Section 505(b)(2) pathway. Briefly explain the steps necessary to achieve FDA approval using this process, and highlight those steps that still remain to be completed. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 11 and 228 of the Amended Registration Statement. Prospectus Summary, page 9 10. Please revise to disclose the remaining portion of the $7.5 million of severance costs that Pieris expects to be paid through the end of 2024. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 10 of the Amended Registration Statement. PIPE Financing, page 11 11. It appears that the shares to be sold in the PIPE Financing are included in the shares to be registered on this registration statement. You disclose in the second paragraph of this section and elsewhere that the investors in the PIPE Financing made their investment decision in a private offering; therefore, the sale must close privately. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 13, 15, 114, 178, 205, and 265 of the Amended Registration Statement. Support Agreements, page 16 12. With respect to your discussion of the support agreements on pages 17 and 175, you state that the Palvella stockholders are party to a support agreement with Pieris “include” all executive officers and directors of Palvella and “certain other stockholders owning 5% or more of the outstanding shares of Palvella capital stock.” In this regard, please show us how the percentages of securities owned by the Petrichor Opportunities Fund I LP, Petrichor Opportunities Fund I Intermediate LP, and Agent Capital Fund I, LP are reconcilable to the principal stockholder table on page 321. Otherwise confirm, if true, that only Palvella executive officers, directors, affiliates, founders and their family members, and holders of 5% or more of Palvella voting equity securities are subject to the support agreement Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 17 and 177 of the Amended Registration Statement. Pieris may be treated as a “public shell” company…, page 32 13. Please revise this risk factor to remove the qualifying phrase "may be treated" and instead disclose the risks attendant to the conclusion, disclosed on pages 20 and elsewhere throughout, that Pieris was "determined to be a shell company in that it did not meet the GAAP definition of a business, did not have more than nominal assets, and does not have more than nominal operations at the time of the merger," or otherwise advise. Similarly, revise the following sentence in risk factor disclosure on page 36: "Furthermore, if Pieris is deemed to be a shell company, the baby shelf rules, and therefore its Form S-3, would not be available to Pieris." Refer to footnote 943 of the Special Purpose Acquisition Companies, Shell Companies, and Projection adopting release (Release Nos. 33-11265; 34-99418; IC-35096), available at https://www.sec.gov/files/rules/final/2024/33-11265.pdf. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 21, 25, 34, 157, 296, and 301 of the Amended Registration Statement. Risks Related to Palvella, page 58 14. Please tell us your consideration of including risk factor disclosure concerning the clinical trial risks associated with pediatric trials. We note that based on your disclosure on page 235, Palvella intends to enroll patients aged 6 years or older in its planned Phase 2 clinical trial of QTORIN rapamycin in cutaneous venous malformations in the 4th quarter of 2024. We also note your disclosure on page 229 that toxicities have limited the use of oral rapamycin for the treatment of LM patients, particularly for pediatric and adolescent patients. Response: The Company acknowledges the Staff’s comment and respectfully advises that it did not include risk factor disclosure concerning the clinical trial risks associated with pediatric trials because Palvella’s Phase 2 clinical trial of QTORIN rapamycin in cutaneous venous malformations is a clinical trial in a pediatric population. QTORIN rapamycin is a different route of administration, with a different toxicity profile. Palvella believes there are no unique risks with pediatric patients that are not already included in other risk factor disclosure in the Amended Registration Statement. The articles of incorporation of the combined company will generally provide…, page 109 15. We note that the articles of incorporation of the combined company will identify the Eighth Judicial District Court of Clark County, Nevada as the exclusive forum for certain litigation, including any derivative action. Please disclose whether this provision will apply to actions arising under the Securities Act or Exchange Act and, if so, make conforming revisions in your related risk factor disclosure. In this regard, we note that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability cr
2024-09-06 - UPLOAD - PALVELLA THERAPEUTICS, INC. File: 333-281459
September 6, 2024
Stephen Yoder
Chief Executive Officer
Pieris Pharmaceuticals, Inc.
225 Franklin Street, 26th Floor
Boston, MA 02110
Re:Pieris Pharmaceuticals, Inc.
Registration Statement on Form S-4
Filed August 9, 2024
File No. 333-281459
Dear Stephen Yoder:
We have reviewed your registration statement and have the following comments.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a 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 letter, we may have additional comments.
Registration Statement on Form S-4
Questions and Answers About the Merger, page 1
1.Please revise your Q&A disclosure, where appropriate, as follows:
•Clarify the material terms of the CVR Agreement, your intentions with respect to
Pieris' pre-merger assets and describe any material assets that either have been
divested or may be divested by Pieris pursuant to the CVR Agreement.
•With reference to your disclosure on pages 9 and 215, please revise the Q&A and
Summary to highlight, if true, that if the merger is completed, the combined company
will focus on developing Palvella's product candidates, and it is anticipated that the
combined company will not continue to develop any of Pieris' legacy product
candidates.
•Also, revise the Q&A to explain what Pieris' stockholders will receive in the merger
to provide context for your disclosure on page 8 discussing the tax treatment of the
CVRs.
September 6, 2024
Page 2
What is the PIPE Financing?, page 2
2.We note your disclosure that the PIPE Investors have agreed to subscribe for and purchase
(in cash or by cancellation of convertible notes) either shares of Pieris common stock or
pre-funded warrants to purchase shares of the combined company common stock. Here
and throughout where appropriate, please revise to quantify the amount of the expected
$78.9 million gross PIPE proceeds to be received in cash versus the amount expected to
be attributed to the conversion of outstanding Palvella convertible notes.
How many votes can be cast by all stockholders?, page 4
3.We note your disclosure that on the record date the holder of one outstanding share of
Series F Preferred Stock will be entitled to be entitled 25,000,000 votes only on Proposal
No. 2 related to increasing the number of authorized shares of Pieris common stock, to be
voted together with the holders of Pieris common stock as a single class.
•Consistent with your disclosure page 57 and in your 8-K dated August 8, 2024
incorporated by reference, please revise the Q&A to disclose that on August 7, 2024,
Pieris entered into a Subscription and Investor Representation Agreement with James
Geraghty, the chairman of the Pieris board of directors, pursuant to which he
purchased one share of Pieris’ Series F Preferred Stock for $1.00 cash.
•Consistent with your disclosure on page 206, explicitly state that the issuance of the
Series F Preferred Stock, with its attendant voting rights, was issued by the Company
solely to affect the passage of Proposal 2, which is a condition to the completion of
the Merger. Explain the reason(s) why the Board determined that such issuance was
necessary in this case.
Please revise your disclosure to explicitly describe the impact of the outsized voting rights
the holder of the Series F Preferred share will have on Proposal 2 relative to holders of
common stock. In this regard:
•Please consider including an illustrative example of the effects the super voting rights
of the Series F Preferred Stock will have on reaching the voting threshold necessary
to approve Proposal 2. Based on the number of Pieris common shares reported
outstanding in the proxy statement and assuming (1) the common shares subject to the
Pieris Support Agreement and (2) the Series F Preferred share are each voted as
described in the proxy statement, please clarify the number of votes that will need to
be cast (i.e., the number of common shares that will need to be voted) to approve
Proposal 2.
•If true, please revise to clearly explain that the mirrored voting mechanism of the
Series F Preferred Stock will have a significant impact on the vote needed to pass
Proposal 2. For example, assuming the minimum quorum is met with no additional
shares of common stock appearing in person or by proxy, disclose whether and if so
how the mirrored voting mechanism of the Series F Preferred Stock will operate with
respect to the percentage of the common shares outstanding required to vote to pass
Proposal 2.
Clearly explain the consequence to holders of Pieris' common stock of not casting a
vote on a common share for or against the proposal in person or by proxy. In this •4.
September 6, 2024
Page 3
regard, please state the likelihood that even if a Pieris' common shareholder does not
vote on the proposals, Pieris will reach or exceed the voting threshold required for
approval of Proposal 2.
Palvella Therapeutics, Inc., page 9
5.Please revise the Summary and throughout where appropriate to clarify the status of
Palvella's ongoing and planned clinical trials. In this regard:
•Clarify if references on page 10 and elsewhere to Palvella's "planned" Phase 2
baseline-controlled trial of QTORIN Rapamycin for the treatment of CVM expected
to start in Q4 2024 are separate from references to the Phase 2 baseline-controlled
trial Palvella "is conducting," with top-line data expected in Q4 2025. Also revise to
clarify when you submitted, or plan to submit, an IND for the planned trial for the
CVM indication.
•Similarly, reconcile your disclosure on page 10 and elsewhere that "Palvella currently
has one ongoing clinical trial and one clinical trial planned to start" with disclosure on
page 226 that "QTORIN rapamycin is currently being evaluated in three ongoing
clinical trials."
•In light of your risk factor disclosure on page 73, also disclose the location(s) of
Palvellas completed, ongoing and planned clinical trials.
6.Please revise the Summary and throughout where appropriate to eliminate any implication
that Palvella's product candidates have been or will ultimately be determined safe and/or
effective or have demonstrated safety and/or efficacy for purposes of approval by the
FDA or comparable regulatory agency. Where you deem appropriate, you may present
objective data without including your conclusions related to safety or efficacy. By way of
example and not limitation, refer to the following:
•Statements that Palvella has announced "positive" or "encouraging" topline Phase 2
clinical trial results. (pages 10, 221, 229 and 264)
•Statements that "Palvella is developing the first approved therapy" for microcystic
LM and CVM. (pages 226 and 233)
7.Please revise the Summary and Palvella's Business section to provide context and balance
to the discussion of Palvella's proprietary QTORIN platform. To the extent that you
highlight Palvella's intention to leverage its "versatile" QTORIN platform to expand its
pipeline to treat a "broad spectrum" of rare, genetic skin diseases, please include equally
prominent disclosure highlighting, if true:
•that Palvella has limited experience in therapeutic discovery and development;
•Palvella's platform is novel and unproven, and that clinical evidence to support the
two current clinical-stage QTORIN product candidates is preliminary and limited at
this time;
•prior candidates developed using the QTORIN platform targeting different indications
have failed to meet their respective primary endpoints, which may affect Palvella's
ability to conduct clinical programs for other QTORIN-based product candidates; and
•the platform may never result in the regulatory approval of any product candidate.
September 6, 2024
Page 4
8.Please revise your disclosure regarding Palvella's product candidates to clarify discuss the
material factors that could delay or prevent Palvella's ability to receive marketing
approval. Highlight the novel and/or subjective clinical endpoints and the "baseline
control" Palvella has established in connection with its Phase 3 trial design in microcystic
LM, and disclose that the FDA has made comments to Palvella indicating it could request
a placebo-controlled trial or additional trials to assess different clinical endpoints. In this
regard, we refer to your disclosure on pages 62, 66 and 71.
9.Please revise the Summary and Business sections to explicitly disclose that Palvella
currently plans to pursue marketing approval for QTORIN rapamycin for microcystic LM
and other indications through the FDA’s Section 505(b)(2) pathway. Briefly explain the
steps necessary to achieve FDA approval using this process, and highlight those steps that
still remain to be completed.
Prospectus Summary
Pieris Pharmaceuticals, Inc., page 9
10.Please revise to disclose the remaining portion of the $7.5 million of severance costs that
Pieris expects to be paid through the end of 2024.
PIPE Financing, page 11
11.It appears that the shares to be sold in the PIPE Financing are included in the shares to be
registered on this registration statement. You disclose in the second paragraph of this
section and elsewhere that the investors in the PIPE Financing made their investment
decision in a private offering; therefore, the sale must close privately.
•With reference to Exhibit 107 (Filing Fee Table), please remove from this registration
statement the (1) 3,154,241 of shares of Pieris common stock and (2) up to 2,592,585
shares of Pieris common stock issuable upon the exercise of Pre-Funded Warrants to
the PIPE Investors in connection with the PIPE Financing, or otherwise advise.
•Disclosure in the penultimate sentence in the second paragraph should seemingly
refer to a resale registration statement on Form S-1 to be consistent with the
Registration Rights Agreement included in Annex L. Please review and reconcile as
appropriate.
Support Agreements, page 16
12.With respect to your discussion of the support agreements on pages 17 and 175, you state
that the Palvella stockholders that are party to a support agreement with Pieris
"include" all executive officers and directors of Palvella and "certain other stockholders
owning 5% or more of the outstanding shares of Palvella capital stock." In this regard,
please show us how the percentages of securities owned by the Petrichor Opportunities
Fund I LP, Petrichor Opportunities Fund I Intermediate LP, and Agent Capital Fund I,
LP. are reconcilable to the principal stockholder table on page 321. Otherwise confirm, if
true, that only Palvella executive officers, directors, affiliates, founders and their family
members, and holders of 5% or more of Palvella voting equity securities are subject to the
support agreement.
September 6, 2024
Page 5
Pieris may be treated as a "public shell" company..., page 32
13.Please revise this risk factor to remove the qualifying phrase "may be treated" and instead
disclose the risks attendant to the conclusion, disclosed on pages 20 and elsewhere
throughout, that Pieris was "determined to be a shell company in that it did not meet the
GAAP definition of a business, did not have more than nominal assets, and does not have
more than nominal operations at the time of the merger," or otherwise advise. Similarly,
revise the following sentence in risk factor disclosure on page 36: "Furthermore, if Pieris
is deemed to be a shell company, the baby shelf rules, and therefore its Form S-3, would
not be available to Pieris." Refer to footnote 943 of the Special Purpose Acquisition
Companies, Shell Companies, and Projection adopting release (Release Nos. 33-11265;
34-99418; IC-35096), available at https://www.sec.gov/files/rules/final/2024/33-
11265.pdf.
Risks Related to Palvella, page 58
14.Please tell us your consideration of including risk factor disclosure concerning the clinical
trial risks associated with pediatric trials. We note that based on your disclosure on page
235, Palvella intends to enroll patients aged 6 years or older in its planned Phase 2 clinical
trial of QTORIN rapamycin in cutaneous venous malformations in the 4th quarter of
2024. We also note your disclosure on page 229 that toxicities have limited the use of oral
rapamycin for the treatment of LM patients, particularly for pediatric and adolescent
patients.
The articles of incorporation of the combined company will generally provide..., page 109
15.We note that the articles of incorporation of the combined company will identify the
Eighth Judicial District Court of Clark County, Nevada as the exclusive forum for certain
litigation, including any derivative action. Please disclose whether this provision will
apply to actions arising under the Securities Act or Exchange Act and, if so, make
conforming revisions in your related risk factor disclosure. In this regard, we note that
Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits
brought to enforce any duty or liability created by the Exchange Act or the rules and
regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction
for federal and state courts over all suits brought to enforce any duty or liability created by
the Securities Act or the rules and regulations thereunder. If the provision applies to
Securities Act claims, please also revise your disclosure to state that investors cannot
waive compliance with the federal securities laws and the rules and regulations
thereunder. If this provision does not apply to actions arising under the Securities Act or
Exchange Act, please ensure that the exclusive forum provision in your bylaws states this
clearly, or tell us how you will inform investors in future filings that the provision does
not apply to any actions arising under the Securities Act or Exchange Act.
The Merger
Background of the Merger, page 119
Please revise throughout this section to disclose when and why any potential reverse
merger candidate was eliminated from consideration. By way of example only, we note
that the September 5, 2023 entry does not explain Pieris' reason(s) for reversing its prior
determination on August 24, 2024 to advance one candidate. Similarly, to the extent 16.
September 6, 2024
Page 6
known, revise throughout to disclose any material reason(s) why any potential reverse
merger candidate withdrew itself from consideration.
17.You disclose that on October 2, 2023, Pieris' Board decided to advance three candidates,
one of which was Company A, into the third and final round of diligence. You also
disclose that on October 4, 2023, one of the third-round candidates withdrew from the
process. Notwithstanding, we note that certain subsequent entries, such as those dated
October 31, 2023 and November 9, 2023, refer to "the remaining three candidates" as of
those dates. Please reconcile or advise.
18.Please revise your disclosure throughout this section to provide greater detail as to how
the material terms of the transaction structure and consideration evolved during
the negotiations between Pieris and Palvella through proposals and counter-proposals.The
disclosure should provide shareholders with an understanding of how, when, and why the
material terms of your proposed transaction evolved and why this transaction is being
recommended as opposed to any alternatives. Please specifically address :
•the acceleration of Pieris options and restricted stock units;
•contingent value rights to be issued to pre-merger Pieris stockholders;
•the valuations of the parties, including any amount ascribed by Palvella to Pieris in
excess of its ending net cash position and the reason(s) therefor;
•the equity allocations in the combined company via the contemplated exchange ratio;
•the structure of the combined company's board of directors and management;
2021-08-11 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm CORRESP PIERIS PHARMACEUTICALS, INC. 255 State Street, 9th Floor Boston, MA 02109 August 11, 2021 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards RE: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed August 5, 2021 File No. 333-258497 Acceleration Request Dear Mr. Edwards: With respect to the above-referenced Registration Statement on Form S-3 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Pieris Pharmaceuticals, Inc. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Registration Statement to Friday, August 13, 2021, at 4:00 p.m. Eastern Time, or as soon as practicable thereafter. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call Megan Gates or William Hicks of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 542-6000, with any comments or questions regarding the Registration Statement. Very truly yours, PIERIS PHARMACEUTICALS, INC. /s/ Stephen S. Yoder Stephen S. Yoder President and Chief Executive Officer cc: Ahmed Mousa, Esq., Pieris Pharmaceuticals, Inc. Megan N. Gates, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. William C. Hicks, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2021-08-11 - UPLOAD - PALVELLA THERAPEUTICS, INC.
United States securities and exchange commission logo
August 10, 2021
Ahmed S. Mousa, Esq.
General Counsel
Pieris Pharmaceuticals, Inc.
255 State Street, 9th Floor
Boston, MA 02109
Re:Pieris Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed August 5, 2021
File No. 333-258497
Dear Mr. Mousa:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan N. Gates, Esq.
2021-05-26 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm CORRESP PIERIS PHARMACEUTICALS, INC. 255 State Street, 9th Floor Boston, MA 02109 May 26, 2021 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Chris Edwards RE: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed May 17, 2021 File No. 333-256218 Acceleration Request Dear Mr. Edwards: With respect to the above-referenced Registration Statement on Form S-3 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Pieris Pharmaceuticals, Inc. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Registration Statement to Friday, May 28, 2021, at 4:00 p.m. Eastern Time, or as soon as practicable thereafter. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call Megan Gates or William Hicks of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 542-6000, with any comments or questions regarding the Registration Statement. Very truly yours, PIERIS PHARMACEUTICALS, INC. /s/ Stephen S. Yoder Stephen S. Yoder President and Chief Executive Officer cc: Ahmed Mousa, Esq., Pieris Pharmaceuticals, Inc. Megan N. Gates, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. William C. Hicks, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2021-05-19 - UPLOAD - PALVELLA THERAPEUTICS, INC.
United States securities and exchange commission logo
May 19, 2021
Ahmed S. Mousa, Esq.
General Counsel
Pieris Pharmaceuticals, Inc.
255 State Street, 9th Floor
Boston, MA 02109
Re:Pieris Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 17, 2021
File No. 333-256218
Dear Mr. Mousa:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Megan N. Gates, Esq.
2019-12-11 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm CORRESP PIERIS PHARMACEUTICALS, INC. 255 State Street, 9th Floor Boston, MA 02109 December 11, 2019 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Ms. Jacqueline Kaufman RE: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed December 4, 2019 File No. 333-235350 Acceleration Request Dear Ms. Kaufman: With respect to the above-referenced Registration Statement on Form S-3 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby requests, on behalf of Pieris Pharmaceuticals, Inc. (the “Company”), that the Securities and Exchange Commission accelerate the effective date of the Registration Statement to Thursday, December 12, 2019, at 4:00 p.m. Eastern Time, or as soon as practicable thereafter. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please contact Marc D. Mantell, Esq. of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 348-3058, with any comments or questions regarding the Registration Statement. Very truly yours, PIERIS PHARMACEUTICALS, INC. /s/ Stephen S. Yoder Stephen S. Yoder President and Chief Executive Officer cc: Ahmed Mousa, Esq., Pieris Pharmaceuticals, Inc. Marc D. Mantell, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2019-12-09 - UPLOAD - PALVELLA THERAPEUTICS, INC.
December 9, 2019
Ahmed S. Mousa
General Counsel
PIERIS PHARMACEUTICALS, INC.
255 State Street, 9th Floor
Boston, MA 02109
Re:PIERIS PHARMACEUTICALS, INC.
Registration Statement on Form S-3
Filed December 4, 2019
File No. 333-235350
Dear Mr. Mousa:
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 Jacqueline Kaufman at 202-551-3797 with any questions.
Sincerely,
Division of Corporation Finance
Office of Trade & Services
2018-08-21 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Document PIERIS PHARMACEUTICALS, INC. 255 State Street, 9th Floor Boston, MA 02109 August 21, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Mr. Jonathan Burr RE: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed August 9, 2018 File No. 333-226725 Acceleration Request Dear Mr. Burr: With respect to the above-referenced Registration Statement on Form S-3 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby requests, on behalf of Pieris Pharmaceuticals, Inc. (the “Company”), that the Securities and Exchange Commission accelerate the effective date of the Registration Statement to Friday, August 24, 2018, at 4:00 p.m. Eastern Time, or as soon as practicable thereafter. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please contact Marc D. Mantell, Esq. of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 348-3058, with any comments or questions regarding the Registration Statement. Very truly yours, PIERIS PHARMACEUTICALS, INC. /s/ Stephen S. Yoder Stephen S. Yoder President and Chief Executive Officer cc: Ahmed Mousa, Esq., Pieris Pharmaceuticals, Inc. Marc D. Mantell, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2018-08-15 - UPLOAD - PALVELLA THERAPEUTICS, INC.
August 15, 2018
Stephen S. Yoder
Chief Executive Officer
Pieris Pharmaceuticals, Inc.
255 State Street, 9th Floor
Boston, MA 02109
Re:Pieris Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed August 9, 2018
File No. 333-226725
Dear Mr. Yoder:
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 Jonathan Burr at 202-551-5833 with any questions.
Sincerely,
Division of Corporation Finance
Office of Beverages, Apparel and
Mining
cc: William C. Hicks
2016-08-02 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm CORRESP PIERIS PHARMACEUTICALS, INC. 255 State Street, 9th Floor Boston, MA 02109 August 2, 2016 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: John Reynolds, Assistant Director RE: Pieris Pharmaceuticals, Inc. Post-effective Amendment No. 1 to Form S-1 Filed April 14, 2016 Post-effective Amendment No. 2 to Form S-1 on Form S-3 Filed June 24, 2016 Post-effective Amendment No. 3 to Form S-1 on Form S-3 Filed July 28, 2016 File No. 333-202123 Acceleration Request Dear Mr. Reynolds: With respect to the above-referenced (i) Post-effective Amendment No. 1 to Form S-1, (ii) Post-effective Amendment No. 2 to Form S-1 on Form S-3 and (iii) Post-effective Amendment No. 3 to Form S-1 on Form S-3 (collectively, the “Post-effective Amendments”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Pieris Pharmaceuticals, Inc. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Post-effective Amendments to Wednesday, August 3, 2016, at 4:30 p.m. Eastern Time, or as soon as practicable thereafter. In connection with the foregoing request, the Company acknowledges the following: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call Kanasha Herbert of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 348-3015, with any comments or questions regarding the Post-effective Amendments. Very truly yours, PIERIS PHARMACEUTICALS, INC. /s/ Darlene Deptula-Hicks Darlene Deptula-Hicks Senior Vice President and Chief Financial Officer cc: Hillary Daniels, Securities and Exchange Commission Stephen S. Yoder, President and Chief Executive Officer, Pieris Pharmaceuticals, Inc. Marc D. Mantell, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2016-08-02 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm CORRESP PIERIS PHARMACEUTICALS, INC. 255 State Street, 9th Floor Boston, MA 02109 August 2, 2016 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: John Reynolds, Assistant Director RE: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-3, as amended Filed June 3, 2016 and amended on July 28, 2016 File No. 333-211844 Acceleration Request Dear Mr. Reynolds: With respect to the above-referenced Registration Statement on Form S-3, as amended (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Pieris Pharmaceuticals, Inc. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Registration Statement to Wednesday, August 3, 2016, at 4:30 p.m. Eastern Time, or as soon as practicable thereafter. In connection with the foregoing request, the Company acknowledges the following: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call Kanasha Herbert of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 348-3015, with any comments or questions regarding the Registration Statement. Very truly yours, PIERIS PHARMACEUTICALS, INC. /s/ Darlene Deptula-Hicks Darlene Deptula-Hicks Senior Vice President and Chief Financial Officer cc: Hillary Daniels, Securities and Exchange Commission Stephen S. Yoder, President and Chief Executive Officer, Pieris Pharmaceuticals, Inc. Marc D. Mantell, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2016-08-02 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm CORRESP PIERIS PHARMACEUTICALS, INC. 255 State Street, 9th Floor Boston, MA 02109 August 2, 2016 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: John Reynolds, Assistant Director RE: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-3, as amended Filed July 8, 2016 and amended on July 28, 2016 File No. 333-212439 Acceleration Request Dear Mr. Reynolds: With respect to the above-referenced Registration Statement on Form S-3, as amended (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Pieris Pharmaceuticals, Inc. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Registration Statement to Wednesday, August 3, 2016 at 4:30 p.m. Eastern Time, or as soon as practicable thereafter. In connection with the foregoing request, the Company acknowledges the following: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call Kanasha Herbert of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 348-3015, with any comments or questions regarding the Registration Statement. Very truly yours, PIERIS PHARMACEUTICALS, INC. /s/ Darlene Deptula-Hicks Darlene Deptula-Hicks Senior Vice President and Chief Financial Officer cc: Hillary Daniels, Securities and Exchange Commission Stephen S. Yoder, President and Chief Executive Officer, Pieris Pharmaceuticals, Inc. Marc D. Mantell, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2015-06-26 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Acceleration Request
June 26, 2015
U.S. Securities and Exchange Commission
Division of Corporation
Finance
101 F Street NE Mailstop 4720
Washington, D.C.
20549
Attention: Jeffrey P. Riedler
Assistant Director
Re:
Pieris Pharmaceuticals, Inc.
Registration Statement on Form S-1 (File No. 333-204833)
Ladies and Gentlemen:
In connection with the above-captioned Registration Statement, we, the representatives of the several underwriters, wish to advise you that between June 17,
2015 and June 25, 2015, approximately 1,379 copies of the Preliminary Prospectus dated June 17, 2015 were distributed as follows:
•
10 to prospective underwriters and dealers;
•
487 to institutional investors; and
•
882 to individuals.
The undersigned, as representatives of the several underwriters, have and will, and each
underwriter and dealer has advised the undersigned that it has and will, comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, we hereby join in the request of the registrant that the effectiveness of the
above-captioned Registration Statement, as amended, be accelerated to 9:00 a.m., Washington, D.C. time, on June 29, 2015 or as soon thereafter as practicable.
[Signature page follows]
Very truly yours,
OPPENHEIMER & CO. INC.
JMP SECURITIES LLC
As representatives of the
several Underwriters
OPPENHEIMER & CO. INC.
By:
/s/ Douglas Cameron
Name:
Douglas Cameron
Title:
Head of Equity Capital Markets
JMP SECURITIES LLC
By:
/s/ Stephen Ortiz
Name:
Stephen Ortiz
Title:
Managing Director
cc:
Stephen S. Yoder, Pieris Pharmaceuticals, Inc.
Darlene Deptula-Hicks, Pieris Pharmaceuticals, Inc.
William C. Hicks, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Marc Mantell, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Thomas Levato, Goodwin Procter LLP
[Signature Page to Underwriters’ Acceleration Request Letter]
2015-06-26 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Acceleration Request Pieris Pharmaceuticals, Inc. Lise-Meitner-Straße 30 D-85354 Freising Germany P: +49 (0) 8161 1411 400 F: +49 (0) 8161 1411 444 Email: deptula@pieris.com June 26, 2015 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey P. Riedler, Assistant Director Re: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed June 9, 2015, as amended on June 17, 2015, and as further amended on June 24, 2015 File No. 333-204833 Dear Mr. Riedler: With respect to the above-referenced Registration Statement on Form S-1 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Pieris Pharmaceuticals, Inc. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Registration Statement to Monday, June 29, 2015 at 9:00 a.m., or as soon as practicable thereafter. In connection with the foregoing request, the Company acknowledges the following: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call Marc D. Mantell of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 348-3058 with any comments or questions regarding the Registration Statement. Very truly yours, /s/ Darlene Deptula-Hicks Darlene Deptula-Hicks
2015-06-23 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Acceleration Request Pieris Pharmaceuticals, Inc. Lise-Meitner-Straße 30 D-85354 Freising Germany P: +49 (0) 8161 1411 400 F: +49 (0) 8161 1411 444 Email: deptula@pieris.com June 23, 2015 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey P. Riedler, Assistant Director Re: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed June 9, 2015, as amended on June 17, 2015 File No. 333-204833 Dear Mr. Riedler: With respect to the above-referenced Registration Statement on Form S-1 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Pieris Pharmaceuticals, Inc. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Registration Statement to Thursday, June 25, 2015 at 5:00 p.m., or as soon as practicable thereafter. In connection with the foregoing request, the Company acknowledges the following: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call Marc D. Mantell of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 348-3058 with any comments or questions regarding the Registration Statement. Very truly yours, /s/ Darlene Deptula-Hicks Darlene Deptula-Hicks
2015-06-23 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Acceleration Request
June 23, 2015
U.S. Securities and Exchange Commission
Division of Corporation
Finance
101 F Street NE Mailstop 4720
Washington, D.C.
20549
Attention: Jeffrey P. Riedler
Assistant Director
Re:
Pieris Pharmaceuticals, Inc.
Registration Statement on Form S-1 (File No. 333-204833)
Ladies and Gentlemen:
In connection with the above-captioned Registration Statement, we, the representatives of the several underwriters, wish to advise you that between June 17,
2015 and June 22, 2015, approximately 1,379 copies of the Preliminary Prospectus dated June 17, 2015 were distributed as follows:
•
10 to prospective underwriters and dealers;
•
487 to institutional investors; and
•
882 to individuals.
The undersigned, as representatives of the several underwriters, have and will, and each
underwriter and dealer has advised the undersigned that it has and will, comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, we hereby join in the request of the registrant that the effectiveness of the
above-captioned Registration Statement, as amended, be accelerated to 5:00 p.m., Washington, D.C. time, on June 25, 2015 or as soon thereafter as practicable.
[Signature page follows]
Very truly yours,
OPPENHEIMER & CO. INC.
JMP SECURITIES LLC
As representatives of the
several Underwriters
OPPENHEIMER & CO. INC.
By:
/s/ Douglas Cameron
Name:
Douglas Cameron
Title:
Head of Equity Capital Markets
JMP SECURITIES LLC
By:
/s/ Stephen Ortiz
Name:
Stephen Ortiz
Title:
Managing Director
cc:
Stephen S. Yoder, Pieris Pharmaceuticals, Inc.
Darlene Deptula-Hicks, Pieris Pharmaceuticals, Inc.
William C. Hicks, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Marc Mantell, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Thomas .Levato, Goodwin Procter LLP
[Signature Page to Underwriters’ Acceleration Request Letter]
2015-06-16 - UPLOAD - PALVELLA THERAPEUTICS, INC.
June 16, 2015 Via E -mail Stephen S. Yoder Chief Executive Officer Pieris Pharmaceuticals, Inc. Lise-Meitner -Strasse 30 85354 Freising -Weihenstephan, Germany Re: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed June 9 , 2015 File No. 333-204833 Dear Mr. Yoder : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under Stephen S. Yoder Pieris Pharmaceuticals, Inc. June 16 , 2015 Page 2 the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . Please contact Johnny Gharib at (202) 551 -3170 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Via E -mail Marc D. Mantell, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2015-05-08 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP 1 filename1.htm Acceleration Request Pieris Pharmaceuticals, Inc. Lise-Meitner-Straße 30 D-85354 Freising Germany P: +49 (0) 8161 1411 400 F: +49 (0) 8161 1411 444 Email: info@pieris.com May 8, 2015 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey P. Riedler, Assistant Director Re: Re: Pieris Pharmaceuticals, Inc. Registration Statement on Form S-1 Filed February 17, 2015, as amended on April 20, 2015 File No. 333-202123 Dear Mr. Riedler: With respect to the above-referenced Registration Statement on Form S-1 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Pieris Pharmaceuticals, Inc. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Registration Statement to Monday, May 11, 2015 at 5:00 p.m., or as soon as practicable thereafter. In connection with the foregoing request, the Company acknowledges the following: • should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call Marc D. Mantell of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 348-3058 with any comments or questions regarding the Registration Statement. Very truly yours, /s/ Darlene Deptula-Hicks Darlene Deptula-Hicks Acting Chief Financial Officer
2015-03-17 - UPLOAD - PALVELLA THERAPEUTICS, INC.
March 16, 2015 Via E -mail Stephen S. Yoder Chief Executive Officer and President Pieris Pharmaceuticals, Inc. Lise-Meitner -Strasse 30 85354 Freising -Weihenstaphen , Germany Re: Pieris Pharmaceuticals, Inc. Registration Statement on Form S -1 Filed February 17, 2015 File No. 333 -202123 Dear Mr. Yoder : 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 y ou provide in response to these comments, we may have additional comments. Prospectus Summary Our Company Our Business, page 2 1. Please define the following words or phrases at your first reference in the prospectus summary: Anticalin proteins; cytokines ; monovalent cMet antagonist; and receptor tyrosine kinase. Stephen S. Yoder Pieris Pharmaceuticals, Inc. March 16, 2015 Page 2 2. Please revise your disclosure to indicate where your Phase 1 trial of PRS -080 is being conducted. Risk Factors “We face significant competition from other biotechnology and pharmaceutical companies . . ., page 22 3. Please amend this risk factor to include the names of those companies who you believe will likely be your principal competitors and their products and/or product candida tes that will compete with you r products. “We could be subject to product liability lawsuits based on the use of our drug candidates in clinical testing . . .,” page 23 4. Please amend this risk factor to state the coverage limit of the product liability insurance you have obtained for your ongoing clinical trial. Risks Related to Our Intellectual Property “If we breach any of the agreements under which we license from third parties the intellectual property rights . . .,” page 27 5. Please amend this risk factor to remove the cross -references to the discussions of your license agr eement and the legal dispute arising from it, and include disclosure in their place that briefly describes the material terms of the agreement , other than the termination provisions that you have already included, and the nature of the legal dispute. Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Research and Development Expenses, pages 83 and 85 6. You indicate that since inception, you have devoted nearly al l of your efforts and resources to your research and development activities. On page 99, you disclose key research and development projects that are underway. We believe your disclosure regarding research and development expenses could be improved. Please provided disclosure regarding the composition of the total R&D expense for each period presented. This can take a variety of forms (i.e. by function) but is mainly driven by how many projects are managed and how they are reported within the organization. Business Overview, page 93 7. Please amend your disclosure to elaborate on the “strategic and business reasons” you chose to discontinue development of PRS-050. Stephen S. Yoder Pieris Pharmaceuticals, Inc. March 16, 2015 Page 3 Implementation of our A nticalin Platform Technology: Our Drug Candidates, page 99 8. Please state whether you have filed an Investigational New Drug Application (IND) relating to PRS -080 with the Food and Drug Administration and , if not , your approximate time frame for doing so. If you have not filed an IND at this time, please indicate the regulatory authority under which you are performing a clinical trial of this product candidate. Preclinical data , page 101 9. Please revise your narrative discussion accompanying the chart on page 103 to define or explain the following terms as they apply to your preclinical studies : Expected functional consequence; Hemoglobulin ; and Reticulocyte s. Please also explain the p -value s you cite with respect to hemoglobulin concentrations in reticulocytes and what such value indicate about the results of your study. Intellectual Property and Exclusivity , pag e 111 10. Please explain what “Anticalin drug class protection ” entails and specifically refers to . 11. With respect to the patent portfolio licensed from TUM , please identify the type of patent coverage obtained (e.g., method of use, c omposition of matter , etc. ) and when such patents are expected to expire. Strategic Partners hips, page 112 12. Please revise your disclosure to discuss when your agreemen ts with Allergan , Sanofi , Daiichi Sankyo , Zydus , and Stelis will expire outside of the exercise of the early - termination provisions of the agreement s. Our collaboration with Zydus, page 115 13. Please revise your disclosure with respect to your agreement with Zydus to disclose the following items : Aggregate potential milestone payments you may receive from Zydus: and Aggregate potential milestone payments you may be required to pay Zydus . Stephen S. Yoder Pieris Pharmaceuticals, Inc. March 16, 2015 Page 4 TUM license agreement, page 116 14. Please revise your disclosure with respect to your agreement with to TUM to disclose the aggregate milestone payments you may be obligated to pay TUM. Please also confirm whether you have paid the milestone payment to TUM with respect to the initiation of your Phase I clinical trial of PRS -080 and indicate the amount of such payment. Management Business Experience , page 127 15. On your sig nature page, your Chief Executive Officer is identified with the designation “M.D.” but his biogr aphy does not indicate that he has earned a medical degree or holds a license as a doctor of medicine. Please amend your disclosure as necessary to resolve this discrepancy . Unaudited Pro Forma Combined Financial Information, page F -50 16. You state that the transaction is accounted for as a recapitalization. Please tell us why it is appropriate to include a pro forma income statement. Other Comments 17. We note that some exhibits have yet to be submitted for our review. Please submit these exhibits to us as soon as practic able and be advised that we may have comments to them. 18. We further note that you have submitted an application for confidential treatment in conjunction with your draft registration statement. We will perform an independent review of this application and will forward you comments to it, if any, under separate cover. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Secur ities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made . Notwithstanding our comments, in the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursua nt to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; Stephen S. Yoder Pieris Pharmaceuticals, Inc. March 16, 2015 Page 5 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act o f 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact S asha Parikh at (202) 551 -3627 or Mary Mast at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact S cot Foley at (202) 551 -3383, Bryan Pitko at (202) 551 -3203 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: William C. Hicks, Esq. Marc D. Mantel, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. One Financial Center Boston, Massachusetts 02111
2014-01-24 - CORRESP - PALVELLA THERAPEUTICS, INC.
CORRESP
1
filename1.htm
Converted by EDGARwiz Marika Inc.
2360 Corporate Circle, Suite 400
Henderson NV 89074
Telephone: (702) 425 4332
Marikainc2013@gmail.com
January 24, 2014
BY EDGAR
Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549-7010
Re: Marika Inc.
File Number 333-190728
Gentlemen:
In accordance with Rule 461 promulgated under the Securities Act of 1933, as amended (the "Act"), Marika Inc. (the “Company”) (the “Company”) hereby requests that the Registration Statement described above (the “Registration Statement”) be accelerated so that it will become effective at 10 a.m. on Tuesday, January 28, 2014, or as soon as practicable thereafter. In connection with such request, the undersigned hereby acknowledges the following:
1.
Should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing.
2.
The action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in their filing.
3.
The Company may not assert the declaration of effectiveness or the staff’s comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Should you have any questions regarding this matter, please do not hesitate to call
Scott Olson counsel for the Company, (310) 985-1034, and email address scott@evolaw.net.
Thank you for your attention to this matter.
Very truly yours,
MARIKA INC.
By:
/s/ Aleksandrs Sviks
Name:
Aleksandrs Sviks
Title:
President, Treasurer and Secretary
(Principal Executive, Financial and Accounting Officer)
2014-01-06 - UPLOAD - PALVELLA THERAPEUTICS, INC.
January 6, 2014 Via E -mail Aleksandrs Sviks Marika Inc. Chief Executive Officer 2360 C orporate Circle , Suite 400 Henderson, NV 89074 Re: Marika Inc. Amendment No. 3 to Registration Statement on Form S -1 Filed December 11 , 2013 File No. 333 -190728 Dear Mr. Sviks: 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 that 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 a n amendment is appropriate, please tell us why in your response. Dilution, page 14 1. We note that you have updated your dilution table to utilize the September 30, 2013 financial statements. However, you do not appear to have updated the net tangible book value per common share before the offering. Please show us your calculations for all amounts in this table. Exhibit 23.2 2. We note your response to comment 2 from our letter dated December 6, 2013 and your updated auditors’ consent. We note that your au ditor consent s to the use of his opinion dated July 19, 2013 on the financial statements as of September 30, 2013 and for the period from inception May 24, 2013 to September 30, 2013 . The auditors’ opinion dated July 19, 2013 was on the financial statements as of June 30, 2013 and for the period from inception May 24, 2013 to June 30, 2013. Please revise. Aleksandrs Sviks Marika Inc. January 6, 2014 Page 2 Please contact Elizabeth Sellars , Staff Accountant , at (202) 551 -3348 or Jason Niethamer, Assistant Chief Accountant at (202) 551 -3855 if you have any questions regarding comments on the financial statements and related matters. Please contact Scott Anderegg, Staff Attorney , at (202) 551 -3342, or me at (202) 551 -3720 with any other questions. Sincerely, /s/ Mara L. Ransom Mara L. Ransom Assistant Director
2013-12-06 - UPLOAD - PALVELLA THERAPEUTICS, INC.
December 6, 2013 Via E -mail Aleksandrs Sviks Marika Inc. Chief Executive Officer 2360 C orporate Circle , Suite 400 Henderson, NV 89074 Re: Marika Inc. Amendment No. 2 to Registration Statement on Form S -1 Filed November 21, 2013 File No. 333 -190728 Dear Mr. Sviks: 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 that 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 a mendment is appropriate, please tell us why in your response. General 1. We note that you have updated your financials to provide September 30, 2013 results but you have not updated your related prospectus disclosures. For example, on page 4 you have prese nted Selected Financial Data as of June 30, 2013 instead of September 30, 2013. Please review your entire prospectus to ensure that it is update d and provide s the most current information as of the most recent date practicable. Exhibit 23.2 2. We note t hat your auditor consent s to the use of the financial statements of Marika, Inc. as of September 30, 2013 and for the period from inception May 24, 2013 to September 30, 2013, to be included in and made part of any filing to be filed with the U.S. Securities and Exchange Commission. The auditor should consent to the use of the auditor’s opinion as opposed to the financial statements. Please revise. Aleksandrs Sviks Marika Inc. December 6, 2013 Page 2 Please contact Elizabeth Sellars , Staff Accountant , at (202) 551 -3348 or Jason Niethamer, Assistan t Chief Accountant at (202) 551 -3855 if you have any questions regarding comments on the financial statements and related matters. Please contact Scott Anderegg, Staff Attorney , at (202) 551 -3342, or me at (202) 551 -3720 with any other questions. Sincere ly, /s/ Mara L. Ra nsom Mara L. Ransom Assistant Director
2013-10-15 - UPLOAD - PALVELLA THERAPEUTICS, INC.
October 15, 2013 Via E -mail Aleksandrs Sviks Marika Inc. Chief Executive Officer 2360 C orporate Circle , Suite 400 Henderson, NV 89074 Re: Marika Inc. Amendment No.1 to Registration Statement on Form S -1 Filed September 30, 2013 File No. 333 -190728 Dear Mr. Sviks: 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 that 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. Management’s Discussion and Analysis, page 14 1. We note your response to comment 7 in our letter dated September 16 , 2013 . We understand the function of the contract, however, our comment concerned why you consider the contract to be material given that there is no assurance that Superakcijas will provide you with any minimum amount of business. Please advise. Industry Overview, page 21 2. We note your response to comment 13 in our letter dated September 16 , 2013 . We reissue our comment. Please revise your description under “Our Services” to make explicit t hat you will also provide business concierge services as well and distinguish such services, as appropriate, from other concierge services. Please contact Elizabeth Sellars , Staff Accountant , at (202) 551 -3348 or Jason Niethamer, Assistant Chief Accountant at (202) 551 -3855 if you have any questions regarding comments on Aleksandrs Sviks Marika Inc. October 15, 2013 Page 2 the financial statements and related matters. Please contact Scott Anderegg, Staff Attorney , at (202) 551 -3342, or me at (202) 551 -3720 with any other questions. Sincerely, /s/ Mara L. Ransom Mara L. Ransom Assistant Director
2013-09-17 - UPLOAD - PALVELLA THERAPEUTICS, INC.
September 16, 2013 Via E -mail Aleksandrs Sviks Marika Inc. Chief Executive Officer 2360 C orporate Circle , Suite 400 Henderson, NV 89074 Re: Marika Inc. Form S -1 Filed August 20, 2013 File No. 333 -190728 Dear Mr. Sviks: 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 that 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. General 1. Please supplementally provide us with copies of all written communications, as de fined 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. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering. 2. Section (a)(2) of Rule 419 defines a blank check company as a company that is issuing penny stock that is “a development stage company that has no specific business plan or purpose or has indicated tha t its business plan is to engage in a merger or acquisition with Aleksandrs Sviks Marika Inc. September 16, 2013 Page 2 an unidentified company or companies, or other entity.” In discussing this definition in the adopting release, the Commission stated that it would “scrutinize…offerings for attempts to creat e the appearance that the registrant…has a specific business plan, in an effort to avoid the application of Rule 419.” See Security Act Release No. 33 -6932 (April 28, 1992). It appears that your business may be commensurate in scope with the uncertaint y ordinarily associated with a blank check company. Accordingly, please revise your disclosure throughout your registration statement to comply with Rule 419 of Regulation C or provide a detailed explanation as to why Rule 419 does not apply to you and th is offering. 3. Please provide us with your analysis as to whether you are a shell company, as defined in Rule 405 under the Securities Act of 1933, as amended. In this regard, we note that you appear to have no or nominal operations and assets consisting o f cash and nominal other assets. If you conclude that your company is a shell company, please revise your prospectus to disclose conspicuously that you are a shell company and further disclose the consequences of that status, such as the restrictions on y our ability to use registration statements on Form S -8, the limitations on the ability of your security holders to use Rule 144 and the potential reduced liquidity or illiquidity of your securities. Risk Factors, page 5 4. In describing your business in relationship to a risk you sometimes refer to “products” and in at least two instances you refer to translation services. In another risk factor you describe the difficulty of attracting new translators. Based on a review of your proposed business it doe s not appear that you will be selling any products nor provide any translation services. Please review all your risk factors and revise to ensure that your risk factors are tailored to the services you plan to provide. We operate in a highly competitive environment, Page 6. 5. This risk factor appears to be generic. Please revise your risk factor to discuss the specific competitive risk to your business as it appears that you will be competing against established internet listing c ompanies like eBay and Craigslist. Please also eliminate your reference to translation services. Management’s Discussion and Analysis, page 14 6. We note your statements here that Marika Inc. is an online job marketplace that connects people or companies i n need of professional translation with translators around the world, as well as your reference in the fifth paragraph on page 25 to Translation Group Inc. We note that in other places such as on page 3 and page 19 you describe your business as an errand and concierge service that will connect people in need of the performance of small tasks or errands with agents to perform those tasks. Please tell us your intended business Aleksandrs Sviks Marika Inc. September 16, 2013 Page 3 plan. Please update your document throughout, the above examples are not exhaust ive, to consistently describe your intended business. 7. This significance to you of your agreement with Superakcijas Company is unclear, even though you have filed this agreement as a material contract. Considering the contract provides no assurances that Superakcijas will provide you with any minimum amount of business, please tell us why you believe this contract is material to you. Please also disclose whether you have retained agents such that you have the ability to act upon the “run errands services” you describe here, as needed. Plan of Operation, page 15 8. In each of the headers in this section, please revise to clarify, if true, that that the amount of time needed is reflected in months following the close of your offering. Type of Errands, pag e 16 9. In the second paragraph under this heading, you refer to the profitability of your operations. Please revise to clarify that even if you have revenues after starting to sell your services, there is no guarantee that you will ever become profitable. Going Concern, page 17 10. Your disclosure in the third paragraph on page 1 8 indicates that $ 66,000 will only last you one year and yet elsewhere, such as on page 15 , you indicate that $ 25,000 will allow you to “conduct [y]our proposed operations for a minimum period of one year.” Please revise to clarify. Description of Business, page 19 How it Works, page 20 11. We note that prior to listing an agent you will perform some background checks on an agent prior to listing the agent. We also note that eBay and Craigslist have been subject to lawsuits concerning criminal and civil disputes in connection to services offered by individuals listing services on their sites. Please revise your business discussion to address this issue. Please also consider adding a risk factor addressing this risk to your business. The Competitive Advantages of Using our Services, page 20 12. Please augment you disclosure to discuss the competitive advantages of your services and website versus those of other internet listing companies that customers may access to obtain similar services like eBay and Craigslist. Aleksandrs Sviks Marika Inc. September 16, 2013 Page 4 Industry Overview , page 20 13. We note that you cite www.ibisworld.com as the source for the statement that the business concierge service industry has grown steadily over the last decade and it appears to be the source for the other industry data you provide in this section. Please prov ide us with a copy of the report(s) that support your statements appropriately marked to highlight the sections relied upon. We further note that the reference in this section is to the “business” concierge services. Your descriptions of your services ar e not limited to business concierge services. If there are different kinds of concierge services and they represent different markets and require different marketing, consider revising your business description to reflect these different markets. Compe tition, page 21 14. It appears that you are attempting to enter a market place that is dominated by established internet service listing companies like eBay and Craigslist . Please revise your disclosure to discuss the specific competiti ve nature of the market you plan to enter and eliminate your reference to translation service providers as this does appear to be related to your proposed business. Plan of Distribution, page 25 15. We note that Mr. Aleksandrs Sviks will be relying upon the safe harbor from broker - dealer registration found in Exchange Act Rule 3a -41. Please provide us with the basis for reliance upon such exemption. Offering Period and Expiration Date, page 25 16. We note that you discuss the sale of 10,000,000 shares. However, your prospe ctus is only registering the sale of 5,000,000 shares. Please revise. Procedure for Subscribing, page 26 17. Please file the subscription agreement referenced under this heading as an exhibit to your registration statement . Where you can find more informat ion, page 29 18. We note your disclosure that your fiscal year ends on October 31. From your financial statements, it appears that your fiscal year end is June 30. Please advise or revise. Exhibit 5.1 19. Counsel ’s reference to Altair International Corp. here is unclear. Please revise. Aleksandrs Sviks Marika Inc. September 16, 2013 Page 5 We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 19 33 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to its disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authorit y, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing ; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any p erson under federal securities laws of the United States . Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above regist ration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Lisa Sellars , Staff Accountant , at (202) 551 -3348 or Jason Niethamer, Assistant Chief Accountant at (202) 551 -3855 if you have any questions regarding comments on the financial statements and related matters. Please contact Scott Anderegg, Staff Attorney , at (202) 551 -3342, or me at (202) 551 -3720 with any other questions. Sincerely, /s/ Mara L. Ransom Mara L. Ransom Assistant Director
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