Palvella Therapeutics (Nasdaq: PVLA) reports positive Phase 2 QTORIN data

Rhea-AI Filing Summary

Palvella Therapeutics, Inc. reported a key clinical update for its dermatology program. On December 15, 2025, the company scheduled an investor conference call to present topline results from its Phase 2 TOIVA study of QTORIN 3.9% rapamycin anhydrous gel for treating cutaneous venous malformations, a vascular skin condition. The call is accompanied by an online slide presentation, provided as Exhibit 99.1.

Palvella also issued a press release, filed as Exhibit 99.2, announcing positive topline results from this ongoing Phase 2 study. Together, the call, slides, and press release highlight progress in the clinical development of QTORIN for this indication, giving investors more detail on how the program is advancing.

Positive

• Palvella reports positive topline results from its ongoing Phase 2 TOIVA study of QTORIN 3.9% rapamycin gel in cutaneous venous malformations, marking a significant clinical milestone.

Negative

• None.

Insights

Biotech clinical-development analyst

Positive Phase 2 topline results for QTORIN mark a meaningful clinical milestone for Palvella.

Palvella Therapeutics disclosed that it has obtained positive topline results from its ongoing Phase 2 TOIVA study of QTORIN 3.9% rapamycin anhydrous gel in cutaneous venous malformations. A dedicated investor call on December 15, 2025, with accompanying slides and a detailed corporate presentation, underlines the importance of this dataset for the company’s development strategy.

Positive Phase 2 topline data can be a critical de‑risking step in the drug-development path, especially for a focused indication like cutaneous venous malformations. However, the excerpt does not include specific efficacy or safety metrics, so external assessment still depends on the detailed presentation and press release in Exhibits 99.1 and 99.2.

The company’s decision to feature the results via an investor call and press release signals that this study is a central asset in its pipeline narrative. Subsequent disclosures in these exhibits and future filings will frame how these results translate into later-stage trial design and the overall outlook for QTORIN in this indication.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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): December 15, 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

(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 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

FAQ

What did Palvella Therapeutics (PVLA) announce in this 8-K?

Palvella Therapeutics announced that it has obtained positive topline results from its ongoing Phase 2 TOIVA study of QTORIN 3.9% rapamycin anhydrous gel for treating cutaneous venous malformations.

What is QTORIN 3.9% rapamycin gel being studied for at Palvella Therapeutics (PVLA)?

QTORIN 3.9% rapamycin anhydrous gel is being studied in the Phase 2 TOIVA trial for the treatment of cutaneous venous malformations, a vascular skin condition.

How is Palvella Therapeutics (PVLA) sharing its Phase 2 TOIVA results with investors?

On December 15, 2025, Palvella is hosting an investor conference call with a live webcast and slide presentation, and it has furnished a detailed corporate presentation as Exhibit 99.1.

Which exhibits in the Palvella Therapeutics (PVLA) filing relate to the QTORIN Phase 2 study?

Exhibit 99.1 is the corporate presentation on the Phase 2 TOIVA study of QTORIN, and Exhibit 99.2 is the press release announcing positive topline results.

Is the Palvella Therapeutics (PVLA) investor presentation considered filed with the SEC?

The investor presentation furnished under Item 7.01, including Exhibit 99.1, is explicitly stated as not deemed “filed” for purposes of Section 18 of the Exchange Act.

When did Palvella Therapeutics (PVLA) hold the call on its Phase 2 TOIVA results?

The company scheduled the investor conference call for December 15, 2025 at 8:30 a.m. Eastern Time to present the Phase 2 TOIVA topline results.