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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): September 24, 2025
PALVELLA
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
| Nevada |
001-37471 |
30-0784346 |
(State or other jurisdiction of
incorporation) |
(Commission
File Number) |
(IRS Employer
Identification No.) |
| 353 W. Lancaster Avenue, Suite 200 |
|
| Wayne, Pennsylvania |
19087 |
| (Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including
area code: (484) 253-1461
125 Strafford Ave, Suite
360
Wayne, Pennsylvania 19087
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each
exchange on which registered |
| Common stock, $0.001 par value per share |
|
PVLA |
|
The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ¨
| Item 7.01 |
Regulation FD Disclosure. |
On September 24, 2025, Palvella Therapeutics, Inc. (the “Company”)
issued a press release announcing the expansion of the Company’s QTORIN™ 3.9% rapamycin anhydrous gel development program
into Clinically Significant Angiokeratomas. A copy of the press release is furnished herewith as Exhibit 99.1, and incorporated herein
by reference.
The information furnished pursuant to Item 7.01, including Exhibit
99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such
filing.
| Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
|
Document |
| 99.1 |
|
Press Release issued by Palvella Therapeutics, Inc. on September 24, 2025* |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
*Furnished herewith
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
| |
PALVELLA THERAPEUTICS, INC. |
| |
|
|
| Date: September 24, 2025 |
By: |
/s/ Matthew Korenberg |
| |
|
Matthew Korenberg |
| |
|
Chief Financial Officer |
