Palvella Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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| Item 7.01 | Regulation FD Disclosure. |
On December 15, 2025, Palvella Therapeutics, Inc. (the “Company”) will host a conference call with investors at 8:30 a.m. Eastern Time, to present the topline results from the Company's Phase 2 TOIVA study of QTORIN™ 3.9% rapamycin anhydrous gel for the treatment of cutaneous venous malformations. The live event and accompanying slides can be accessed by visiting https://edge.media-server.com/mmc/p/cag4c7en/. A copy of the investor presentation 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 8.01 | Other Events. |
On December 15, 2025, the Company issued a press release announcing positive topline results from the Company’s ongoing Phase 2 TOIVA study of QTORIN™ 3.9% rapamycin anhydrous gel for the treatment of cutaneous venous malformations. A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Document | |
| 99.1 | Corporate Presentation on Phase 2 TOIVA Study of QTORIN™ dated December 15, 2025* | |
| 99.2 | Press Release issued by Palvella Therapeutics, Inc. on December 15, 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: December 15, 2025 | By: | /s/ Matthew Korenberg | |
| Matthew Korenberg | |||
| Chief Financial Officer | |||