[8-K] PALVELLA THERAPEUTICS, INC. Reports Material Event

Rhea-AI Filing Summary

Palvella Therapeutics disclosed on September 24, 2025 that it is expanding the development program for QTORIN™ 3.9% rapamycin anhydrous gel into Clinically Significant Angiokeratomas. The filing notes a press release describing this expansion has been furnished as Exhibit 99.1 and is being made under Regulation FD disclosure standards.

The notice is procedural in form: it confirms the program expansion but does not provide clinical data, trial design, timelines, or cost information. The filing is signed by the company’s Chief Financial Officer, indicating formal corporate disclosure rather than new regulatory approvals or completed clinical results.

Positive

• Program expansion into Clinically Significant Angiokeratomas for QTORIN™ 3.9%
• Formal disclosure furnished as Exhibit 99.1 under Regulation FD, ensuring information is public
• Corporate sign-off by the Chief Financial Officer, indicating official company communication

Negative

• No clinical details provided: no trial design, endpoints, or patient population described
• No timeline or milestones were disclosed for studies, regulatory submissions, or readouts
• No financial impact information: costs, funding source, or budgetary implications are absent

Insights

Clinical Development Strategist

Expanding a topical rapamycin program into angiokeratomas signals a targeted clinical development push.

The change shows the company is applying QTORIN™ 3.9% to a new dermatologic indication, Clinically Significant Angiokeratomas, which may require dedicated safety and efficacy studies. The filing itself confirms intent but contains no trial design, endpoints, or enrollment timelines.

Key dependencies include upcoming study protocols, regulatory interactions, and clinical readouts; expect protocol publication or trial initiation dates to appear before data readouts.

Investor Relations Analyst

The 8-K is a formal Regulation FD disclosure that alerts investors but provides limited operational detail.

The document furnishes a press release as Exhibit 99.1 and is signed by the CFO, which meets public-disclosure requirements without adding financial guidance. There is no mention of expected costs, milestones, or timelines that would move near-term valuation.

Investors should look for follow-up communications such as a press release with program details, a clinicaltrials.gov listing, or subsequent filings that specify milestones and dates.

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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

FAQ

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

Palvella announced the expansion of QTORIN™ 3.9% rapamycin anhydrous gel development into Clinically Significant Angiokeratomas and furnished a press release as Exhibit 99.1.

Does the filing provide clinical trial details for QTORIN in angiokeratomas?

No. The filing confirms program expansion but does not include trial design, endpoints, enrollment, or timeline information.

When was this disclosure made public?

The disclosure is dated September 24, 2025 and was filed on an 8-K as a Regulation FD disclosure.

Did Palvella report a regulatory approval for QTORIN in this filing?

No. The filing reports an expansion of the development program; it does not state any regulatory approvals or clearances.

Where can investors find the press release referenced in the 8-K?

The press release is furnished as Exhibit 99.1 to the 8-K; investors should review that exhibit for additional text that may contain further details.