SecProbe.io

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