SecProbe.io

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;