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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