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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
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
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.
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
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