# EDGAR Filing Document

**Accession Number:** 0001583648
**File Stem:** 0001193125-25-274378
**Filing Date:** 2025-11
**Character Count:** 40809
**Document Hash:** 2b2bfd38a452e8d10c189ba83bdf50d3
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-274378.hdr.sgml**: 20251110

**ACCESSION NUMBER**: 0001193125-25-274378

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 34

**CONFORMED PERIOD OF REPORT**: 20251110

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251110

**DATE AS OF CHANGE**: 20251110

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** PALVELLA THERAPEUTICS, INC.
- **CENTRAL INDEX KEY:** 0001583648
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 300784346
- **STATE OF INCORPORATION:** NV
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37471
- **FILM NUMBER:** 251466714

**BUSINESS ADDRESS:**
- **STREET 1:** 353 W. LANCASTER AVENUE
- **STREET 2:** SUITE 200
- **CITY:** WAYNE
- **STATE:** PA
- **ZIP:** 19087
- **BUSINESS PHONE:** (484) 253-1461

**MAIL ADDRESS:**
- **STREET 1:** 353 W. LANCASTER AVENUE
- **STREET 2:** SUITE 200
- **CITY:** WAYNE
- **STATE:** PA
- **ZIP:** 19087

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Pieris Pharmaceuticals, Inc.
- **DATE OF NAME CHANGE:** 20241213

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** PIERIS PHARMACEUTICALS, INC.
- **DATE OF NAME CHANGE:** 20141218

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Marika Inc.
- **DATE OF NAME CHANGE:** 20130805

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

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**FORM** 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** November 10, 2025<br>

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Palvella Therapeutics, Inc.

**(Exact name of registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| Nevada | 001-37471 | 30-0784346 |
| **(State or other jurisdiction<br>of incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 353 W. Lancaster Ave, Suite 200 |  |  |
| Wayne**,** Pennsylvania |  | 19087 |
| **(Address of principal executive offices)** |  | **(Zip Code)** |

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**Registrant's telephone number, including area code:** (484**)** 253-1461<br>

**(Former name or former address, if changed since last report)**

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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:**

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br>**Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock, $0.001 par value per share | PVLA | The Nasdaq Capital Market |

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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. ☐

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## Item 2.02 Results of Operations and Financial Condition.
On November 11, 2025, Palvella Therapeutics, Inc. (the "<u>Company</u>") expects to issue a press release announcing its financial results for the quarter ended September 30, 2025. In light of the U.S. national holiday on November 11, 2025, the Company is furnishing a copy of such press release as Exhibit 99.1 to this Current Report on Form 8-K and such press release is incorporated herein by reference.

The information furnished pursuant to this Item 2.02, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "<u>Exchange Act</u>"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "<u>Securities Act</u>"), or the Exchange Act, except as expressly set forth by specific reference in such filing.

## Item 7.01 Regulation FD Disclosure.
On November 11, 2025, the Company expects to hold its earnings call and use a slide presentation in conjunction with the earnings call. A copy of the presentation is furnished herewith as Exhibit 99.2, and incorporated herein by reference.

The information furnished pursuant to Item 7.01, including Exhibit 99.2, shall not be deemed "filed" for purposes of Section 18 of 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 or the Exchange Act, except as expressly set forth by specific reference in such filing

## Item 9.01 Financial Statements and Exhibits.
(d) Exhibits

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [<u>Press Release of Palvella Therapeutics, Inc., dated November 11, 2025\*</u>](pvla-ex99_1.htm) |
| 99.2 | [<u>Earnings Call Presentation of Palvella Therapeutics, Inc., dated November 11, 2025\*</u>](pvla-ex99_2.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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\* Furnished herewith

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**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.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | **Palvella Therapeutics, Inc.** |
| Date: | November 10, 2025 | By:  | /s/ Matthew Korenberg |
|  |  |  | Matthew Korenberg |
|  |  |  | *Chief Financial Officer* |

---

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## Exhibit 99.1

**Exhibit 99.1**

![img6060170_0.jpg](img6060170_0.jpg)

**Palvella Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update**

*Palvella's recently expanded rare disease pipeline now comprises QTORIN™-derived product candidates advancing in four serious, rare skin diseases that currently have no FDA-approved therapies*

*Top-line results for fully enrolled Phase 2 TOIVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for cutaneous venous malformations remain on track for mid-December 2025*

*Top-line results for fully enrolled Phase 3 SELVA trial evaluating QTORIN™ rapamycin for microcystic lymphatic malformations remain on track for the first quarter of 2026*

*Expanded QTORIN™ rapamycin's development into clinically significant angiokeratomas, a rare and debilitating lymphatic disease with no FDA-approved therapies, with Phase 2 study initiation anticipated in second half of 2026*

*Announced new QTORIN™ product candidate, QTORIN™ pitavastatin, for the treatment of disseminated superficial actinic porokeratosis, a rare, chronic, and pre-cancerous genetic skin disease with no FDA-approved therapies, with Phase 2 study initiation anticipated in second half of 2026*

*Cash and cash equivalents of $63.6 million as of September 30, 2025, expected to fund operations into the second half of 2027*

*Company to host conference call at 8:30 a.m. ET on November 11, 2025*

**WAYNE, PA., November 11, 2025 (GLOBE NEWSWIRE)** -- (Nasdaq: PVLA) <u>Palvella Therapeutics, Inc.</u> (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, reported financial results for the third quarter ending September 30, 2025 and provided a corporate update.

"As we enter year-end 2025, Palvella is now advancing innovative QTORIN™-derived therapies for four serious, rare skin diseases, each lacking a single FDA-approved therapy, giving us the opportunity to potentially be first for each of these deserving rare disease communities," said Wes Kaupinen, Founder and CEO of Palvella Therapeutics. "Our lead product candidate, QTORIN™ rapamycin, continues to demonstrate its potential as a pipeline-in-a-product for mTOR-driven skin diseases, with a planned Phase 2 top-line readout in cutaneous venous malformations expected in mid-December. This will be followed by a Phase 3 topline readout in microcystic lymphatic malformations which we anticipate in the first quarter of 2026. Overall, we anticipate the next 18 months will be a catalyst-rich period highlighted by our objective to advance QTORIN™

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![img6060170_1.jpg](img6060170_1.jpg)

rapamycin toward its first potential regulatory approval, with a steady flow of clinical, pre-commercialization, regulatory, and indication expansion milestones for QTORIN™ rapamycin and our additional QTORIN™ pipeline programs expected. Achievement of these milestones will advance our vision of becoming the leading biopharmaceutical company addressing serious, rare skin diseases with no FDA-approved therapies."

**Recent Corporate Highlights**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Appointed David W. Osborne, Ph.D., as Chief Innovation Officer to provide leadership across Palvella's early-stage R&D pipeline, including maximizing the potential of the Company's proprietary QTORIN™ platform. Dr. Osborne brings extensive topical product development experience and a track record of translating science into commercially available therapies, including contributing to the development of ZORYVE® (roflumilast) cream and foam while serving as Co-Founder and Chief Technical Officer of Arcutis Biotherapeutics.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Jeffrey Martini, Ph.D., Chief Scientific Officer, presented at the Center for Dermal Research's *Innovations in Dermatological Sciences Conference* at Rutgers University, showcasing the QTORIN™ platform and its lead product candidate, QTORIN™ rapamycin, in his presentation entitled *"Unlocking the Potential of Topical Therapy in Rare Skin Diseases*."

**Recent Research and Development Highlights**

<u>QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs)</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Following FDA's review of an annual performance progress report submitted by Palvella, FDA awarded the year two proceeds from the FDA Orphan Products Grant program to support the ongoing SELVA trial, a single arm, baseline-controlled Phase 3 study of QTORIN™ rapamycin for microcystic lymphatic malformations.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Top-line results from SELVA remain on track for the first quarter of 2026.

<u>QTORIN™ rapamycin for the treatment of cutaneous venous malformations (cutaneous VMs)</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The Company completed enrollment in the Phase 2 TOIVA trial of QTORIN™ rapamycin for cutaneous VMs, meeting its recruitment target of 16 subjects enrolled at leading vascular anomaly centers.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•A peer-reviewed publication in *Lymphatic Research and Biology* highlighted 26 published studies evaluating the real-world use of off-label rapamycin in treating venous malformations, supporting rapamycin's potential as a targeted therapy for the disease. The authors also noted the continued unmet need for a topical treatment option, reinforcing the scientific rationale for the development of Palvella's QTORIN™ rapamycin for cutaneous VMs.

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![img6060170_1.jpg](img6060170_1.jpg)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•A nationally representative, retrospective, real-world, subject-blinded, physician-observational probability study published in *Orphanet Journal of Rare Diseases* estimated an annual U.S. treatment prevalence of more than 190,000 diagnosed patients with cutaneous VMs. The findings further underscored the need for the development of targeted therapies for this understudied, debilitating condition.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Top-line results from TOIVA are on track for mid-December 2025.

<u>QTORIN™ rapamycin for the treatment of clinically significant angiokeratomas</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Palvella expanded the development of QTORIN™ rapamycin into clinically significant angiokeratomas, a disease characterized by superficial vascular malformations of lymphatic origin which can cause bleeding, pain, functional impairment, and risk of infection.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Angiokeratomas were recently classified as an isolated lymphatic malformation in 2025 by the International Society for the Study of Vascular Anomalies (ISSVA).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•There are currently no FDA-approved therapies available for the estimated more than 50,000 patients in the U.S. with clinically significant angiokeratomas.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Palvella plans to meet with the FDA in the first half of 2026 to discuss the proposed design of a Phase 2 study of approximately 10-20 patients; study initiation is anticipated in the second half of 2026.

<u>QTORIN™ pitavastatin for the treatment of disseminated superficial actinic porokeratosis (DSAP)</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•The Company announced a new QTORIN™ product candidate, QTORIN™ pitavastatin, for the topical treatment of disseminated superficial actinic porokeratosis, a rare, chronic, and pre-cancerous genetic skin disease which presents as persistent, often extensive lesions that enlarge and increase in size, number, and extent over time.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Recent breakthrough discoveries on the genetics and biology of porokeratosis by Keith Choate, M.D, Ph.D., Chair of Dermatology at Yale School of Medicine, enable the development of QTORIN™ pitavastatin as the first potential pathogenesis-directed therapy for DSAP, a subtype of porokeratosis, by locally targeting the causal mevalonate pathway in the pathogenic epidermal and dermal tissue.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•There are currently no FDA-approved therapies available for the estimated more than 50,000 patients in the U.S. with DSAP.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Palvella plans to meet with the FDA in the first half of 2026 to discuss the proposed design of a Phase 2 study evaluating QTORIN™ pitavastatin in subjects with DSAP; study initiation is anticipated in the second half of 2026.

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![img6060170_1.jpg](img6060170_1.jpg)

**Third Quarter 2025 Financial Results**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Cash and cash equivalents as of September 30, 2025 were $63.6 million. Palvella expects these resources will be sufficient to fund its operations into the second half of 2027.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Research and development expenses were $6.5 million for the three months ended September 30, 2025, as compared to $3.2 million for the three months ended September 30, 2024. The increase in research and development expenses was primarily due to increased spending on the clinical development of QTORIN™ rapamycin for the treatment of microcystic LMs and cutaneous VMs, including conducting the Phase 3 SELVA and Phase 2 TOIVA trials, which were initiated in the second half of 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•General and administrative expenses were $3.6 million for the three months ended September 30, 2025, as compared to $1.9 million for the three months ended September 30, 2024. The increase in general and administrative expenses was primarily driven by increased employee compensation expense due to headcount additions, as well as increases in costs related to being a publicly-traded company.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Net loss attributable to common stockholders was $11.3 million, or $1.03 per basic and diluted share, for the three months ended September 30, 2025, as compared to net loss attributable to common stockholders of $7.0 million, or $3.94 per basic and diluted share, for the three months ended September 30, 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Shares outstanding were 13,768,036 as of November 7, 2025, including 11,836,490 shares of common stock and 1,931,546 common share equivalents assuming conversion of outstanding preferred shares and prefunded warrants.

**Conference Call Details**

Palvella will host a conference call and live audiovisual webcast to discuss the Company's third quarter 2025 financial results and provide a corporate update at 8:30 a.m. ET on November 11, 2025. To access the live webcast of the call with slides, please click <u>here</u> or visit the "Events & Presentations" section of Palvella's website. To access the call by phone, please use this <u>registration link</u>, and you will be provided with dial in details. A replay of the webcast will be available approximately 2 hours after the conclusion of the call and archived for 90 days under the "Events & Presentations" section of the Company's website at <u>www.palvellatx.com</u>.

**About Palvella Therapeutics**

<br> Founded and led by rare disease drug development veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare skin diseases, many of which are lifelong in nature. Palvella's lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and clinically

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![img6060170_1.jpg](img6060170_1.jpg)

significant angiokeratomas. Palvella's second product candidate, QTORIN™ pitavastatin, is currently being developed for the topical treatment of disseminated superficial actinic porokeratosis. For more information, please visit <u>www.palvellatx.com</u> or follow Palvella on <u>LinkedIn</u> or <u>X</u> (formerly known as Twitter).

QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and neither has been approved or cleared by the FDA or by any other regulatory agency for any indication.

**Forward-Looking Statements**

<br> This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella, as well as assumptions made by, and information currently available to, the management of Palvella. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing of the presentation of data from ongoing clinical trials, Palvella's clinical development plans and related anticipated development milestones, Palvella's cash, financial resources and expected runway, Palvella's expectations regarding its programs, including QTORIN™ rapamycin and QTORIN™ pitavastatin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella's product candidates, including QTORIN™ rapamycin and QTORIN™ pitavastatin; the outcome of early clinical trials for Palvella's product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella's limited experience in designing clinical trials and lack of experience in conducting clinical trials; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella's current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella to protect its intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; and the risks and

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![img6060170_1.jpg](img6060170_1.jpg)

uncertainties described in the filings made by Palvella with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Palvella may face. Except as required by applicable law, Palvella does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

**Contact Information**

<u>Investors</u>

Wesley H. Kaupinen<br>Founder and CEO, Palvella Therapeutics<br><u>wes.kaupinen@palvellatx.com</u> 

<u>Media</u>

Marcy Nanus

Managing Partner, Trilon Advisors LLC

<u>mnanus@trilonadvisors.com</u>

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![img6060170_2.jpg](img6060170_2.jpg)

**PALVELLA THERAPEUTICS, INC.**

**CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS**

**(in thousands, except share and per share amounts)**

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended<br>September 30,** | **Three Months Ended<br>September 30,** | **Nine Months Ended<br>September 30,** | **Nine Months Ended<br>September 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | $6528 | $3182 | $15720 | $5608 |
| &nbsp;&nbsp;&nbsp;General and administrative | 3649 | 1880 | 11578 | 4121 |
| Total operating expenses | 10177 | 5062 | 27298 | 9729 |
| Loss from operations | (10177) | (5062) | (27298) | (9729) |
| Total other income (expense), net | (1168) | (1713) | (1703) | (3754) |
| Net loss | $(11345) | $(6775) | $(29001) | $(13483) |
| Less: Cumulative Series D preferred dividends |  | (194) |  | (582) |
| Net loss attributable to common stockholders | $(11345) | $(6969) | $(29001) | $(14065) |
| Net loss per share — basic and diluted | $(1.03) | $(3.94) | $(2.63) | $(7.95) |
| Weighted-average number of common shares used in computing net loss per share — basic and diluted | 11064282 | 1770167 | 11043758 | 1770167 |

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**PALVELLA THERAPEUTICS, INC.**

**CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION**

**(in thousands)**

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| | | |
|:---|:---|:---|
|  | **September 30,** | **December 31,** |
|  | **2025** | **2024** |
| **Assets** |  |  |
| Cash and cash equivalents | $63567 | $83602 |
| Other current assets | 3370 | 4632 |
| Total current assets | 66937 | 88234 |
| Total assets | $66937 | $88234 |
| **Liabilities and Stockholders' Equity** |  |  |
| Current liabilities | $10312 | $12038 |
| Non-current liabilities | 17943 | 13589 |
| Total liabilities | 28255 | 25627 |
| Total stockholders' equity | 38682 | 62607 |
| Total liabilities and stockholders' equity | $66937 | $88234 |

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## Exhibit 99.2

![Slide 1](pvla-ex99_2s1.jpg)

First-in-disease therapies for patients with rare skin diseases Q3 2025 Financial Results & Corporate Update November 11, 2025 Exhibit 99.2

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![Slide 2](pvla-ex99_2s2.jpg)

Forward Looking Statements This presentation contains forward-looking statements of Palvella Therapeutics, Inc. (the "Company") within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "potential," "continue," "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained in this presentation include, but are not limited to, statements regarding the Company's future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters, the Company's current and prospective product candidates and any additional indications or platform candidates, the Company's planned research and development activities, the Company's planned clinical trials, including timing of receipt of data from the same, the planned regulatory framework for the Company's product candidates, the strength of the Company's intellectual property portfolio, and projections of the Company's future ﬁnancial results and other metrics. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon current estimates and assumptions of the Company and its management and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this presentation. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition, the ability of the Company to grow and manage growth, maintain relationships with suppliers and retain its management and key employees; the success, cost and timing of the Company's product development activities, studies and clinical trials; changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business or competitive factors; the Company's estimates of expenses and proﬁtability; the evolution of the markets in which the Company competes; the ability of the Company to implement its strategic initiatives and continue to innovate its existing products; and the ability of the Company to defend its intellectual property. Nothing in this Presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. Industry and Market Data The Company may from time to time provide estimates, projections and other information concerning its industry, the general business environment, and the markets for certain conditions, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information reflected in this presentation. Unless otherwise expressly stated, we obtained this industry, business information, market data, prevalence information and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources, in some cases applying our own assumptions and analysis that may, in the future, prove not to have been accurate. Trademarks This Presentation may contain trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this Presentation may be listed without the TM, SM© or® symbols, but the Company will assert, to the fullest extent under applicable law, the rights of the applicable owners, if any, to these trademarks, service marks, trade names and copyrights.

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![Slide 3](pvla-ex99_2s3.jpg)

PALVELLA (pɑlʋelːɑ, Finnish): TO SERVE Building the leading rare disease biopharma company to address serious, rare skin diseases

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![Slide 4](pvla-ex99_2s4.jpg)

Multiple High-Impact Milestones By End of Q1 2026 SEPTEMBER 2025 NOVEMBER 2025 Serious, rare, no FDA-approved therapies Commercially attractive Third Planned Indication for QTORIN™ Rapamycin: Clinically Significant Angiokeratomas 1 Phase 2 Top-line Data in Cutaneous VMs 3 16 subjects MID-DECEMBER 2025 Q1 2026 New QTORIN™ Program: QTORIN™ Pitavastatin for DSAP\* & Other Porokeratosis 2 Serious, rare, no FDA-approved therapies Clear biology Commercially attractive: >50k U.S. patients Phase 3 Top-line Data in Microcystic LMs 4 EXCEEDED ENROLLMENT TARGET 51 subjects \*DSAP = Disseminated Superficial Actinic Porokeratosis. QTORIN™ 3.9% rapamycin anhydrous gel and QTORIN™ pitavastatin are for investigational use only and neither has been approved or cleared by the FDA or by any other regulatory agency. The safety or efficacy has not been established for any use. FULLY ENROLLED ANNOUNCED ANNOUNCED

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Advancing QTORIN™ Programs for Four Serious, Rare Skin Diseases and Beyond QTORIN™ Rapamycin Microcystic Lymphatic Malformations QTORIN™ Rapamycin Cutaneous Venous Malformations QTORIN™ Rapamycin Clinically Significant Angiokeratomas QTORIN™ Pitavastatin Disseminated Superficial Actinic Porokeratosis Additional Pipeline Programs Program announced Sept. 2025 Phase 3 SELVA trial exceeded enrollment target with 51 subjects Phase 2 TOIVA trial fully enrolled with 16 subjects Program announced Nov. 2025 Key 2025 Milestones Achieved Phase 3 SELVA trial top-line data (Q1 2026) Phase 2 TOIVA trial top-line data (Mid-Dec '25) NDA submission (2H 2026) Potential FDA approval (1H 2027) Phase 3 trial initiation Phase 2 trial initiation (2H 2026) Phase 2 trial initiation (2H 2026) Planned medical / scientific presentations (ongoing) Apply for Breakthrough Therapy Designation Additional future QTORIN™ pipeline programs and indications FDA interactions and potential for regulatory designations (1H 2026) FDA interactions and potential for regulatory designations (1H 2026) IND submission Continued Strong Momentum With Steady Cadence Of Anticipated Milestones Over Next 18 Months

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QTORIN™ 3.9% RAPAMYCIN Clinical Programs

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Phase 2 TOIVA Study in cVMs: Full Enrollment Announced Sept '25 Single-arm, baseline-controlled, QD dose, age 6+, 12 weeks, n=16 No Statistical Hierarchy of Endpoints Safety Safety and tolerability Efficacy Cutaneous venous malformation – investigators' global assessment (7-point clinician change scale) Cutaneous venous malformation – multicomponent static scale Other clinician and patient-reported outcomes Top-line data anticipated Mid-December 2025 Megha Tollefson, MD Principal Investigator Enrollment closed in Sept '25 with n=16 patients

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QTORIN™ Rapamycin for Cutaneous Venous Malformations: Phase 2 TOIVA Study Objectives Safety Evaluating safety and tolerability compared to interventional and destructive approaches Efficacy Proof-of-concept study to detect one or more endpoints that could serve as the primary endpoint for Phase 3 study Dynamic change scales and static scales Evidence of clinical improvements or slowing disease progression Improvement in one or more endpoints in ~30% of patients Evidence of any time-dependent pharmacologic effect No FDA-approved therapies: Current options include laser, sclerotherapy, off-label systemic pharmacotherapies limited by toxicities Progressive disease; no spontaneous regression

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QTORIN™ Rapamycin for Microcystic Lymphatic Malformations Phase 3 Top-line Data in Microcystic LMs EXCEEDED ENROLLMENT TARGET 51 subjects Q1 2026 Potential to be first FDA-approved therapy Phase 3 SELVA trial top-line data on track for Q1 2026 Received year two of FDA Orphan Drug Grant Proceeds granted following FDA review of annual performance progress report on Phase 3 SELVA trial On track for planned 2H 2026 NDA submission Strengthened regulatory affairs leadership team Estimated >30,000 diagnosed U.S. patients support multi-billion dollar TAM Building commercial and medical affairs teams in anticipation of standalone U.S. commercialization in 2027 Breakthrough Therapy Designation Fast Track Designation Orphan Drug Designation

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Growing Commercial Opportunity for QTORIN™ Rapamycin: Pool of Addressable Patients in the U.S. Projected to Expand by >10x with Pipeline-in-a-Product Strategy 1. Lapa et al., Journal of Cutaneous Medicine and Surgery, (2025). Microcystic LMs Cutaneous VMs Clinically Significant Angiokeratomas Additional Potential Future Indications1 TODAY FUTURE Announced September 2025 Targeting announcement in 2026 and beyond = 5k 30k+ 75k+ 200k+ 50k+ Estimated timeline for potential regulatory approval 2031+ 2032+ 2027 2029

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QTORIN™ Pipeline Programs

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> 50k patients ESTIMATED DIAGNOSED IN THE U.S.1 Clinically Significant Angiokeratomas: Superficial Lymphatic Malformations Persistent and extensive: Lesions can be large and increase in size, number, and extent over time Chronically debilitating lymphatic-derived skin lesions associated with bleeding, pain, and functional impairment Recurrent bleeding: Friction can cause fragile lesions to frequently bleed Disease Biology: Increased VEGF and mTOR signaling, leading to vessel dilation and hyperkeratosis Natural history: No tendency for spontaneous regression No FDA-approved therapies Current options: laser therapy, electrosurgery, cryotherapy, and surgical excision Wang et al., Journal of Cutaneous Pathology, (2014); Trindade et al., Am J Dermopathol, (2014); Prindaville et al., Pediatric Dermatology, (2017); Singh et al, Indian Journal of Dermatology, (2023); Caraffa et al, International Journal of Infection, (2025); Molla, Clinical, Cosmetic and Investigative Dermatology, (2024). Ivy H, Julian CA. Angiokeratoma Circumscriptum. Treasure Island (FL): StatPearls Publishing; 2025 Jan; Lapa et al., Journal of Cutaneous Medicine and Surgery, (2025). 1. Clarity Pharma research (July 2025), n=643 physicians surveyed. Palvella's focus to include Fordyce, Solitary, Mibelli, and Circumscriptum subtypes

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QTORIN™ Rapamycin as a "Pipeline-in-a-Product": Advancing Program to Angiokeratoma Patients FDA meeting planned 1H 2026 Discuss proposed Phase 2 study design Longer-term, supplemental NDA (sNDA) submission planned (if approval achieved) in microcystic LMs and/or cutaneous VMs Discuss eligibility for expedited programs (Fast Track Designation) Leveraging established aspects of QTORIN™ rapamycin program QTORIN™ 3.9% rapamycin formulation Drug supply ready to deploy to clinic Open IND with FDA Division of Dermatology and Dentistry Existing intellectual property coverage Planned Phase 2 study initiating in 2H 2026 Single arm, baseline-controlled study with n=~10-20 patients Microcystic LM efficacy endpoints potentially applicable based on clinical overlap GOAL: Initiate Phase 2 clinical development in 2H 2026

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> 50k patients ESTIMATED DIAGNOSED IN THE U.S.1 Disseminated Superficial Actinic Porokeratosis (DSAP): Chronic, Pre-Cancerous, and Progressive Persistent and extensive: Clonal proliferation of abnormal keratinocytes leads to increased number and size of lesions Risk of malignant transformation: Premalignant disease with transformation to non-melanoma skin cancers2 Genetics & Disease Biology: Autosomal dominant (primary) or de novo germline mutation leads to accumulation of toxic intermediates Natural history: Spontaneous regression is extremely rare2 No FDA-approved therapies Current options: Laser, surgery, and off-label topical chemo agents & mevalonate pathway inhibitors 1. Clarity Pharma research (April 2025), n=277 physicians surveyed. 2. Williams, Grant M., et al. "Porokeratosis." StatPearls Publishing, 2024. Significant impact to quality of life: clinical signs include skin disfigurement, burning, and persistent itch

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Clear Biology: Targeting the Causal Mevalonate Pathway Target: Mevalonate Pathway Tissue: Epidermis & Dermis Site of pathogenesis-directed therapy An on-target, in-tissue approach could result in significant clinical improvement \*HMGCR = 3-hydroxy-3-methylglutaryl-coenzyme A reductase. Image sources: Milani D, Warbasse E, Chen WS. Porokeratosis. PathologyOutlines.com website. \*

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QTORIN™ Pitavastatin Clinical Pathway:Planned Initiation of Phase 2 in 2H 2026 FDA meeting planned 1H 2026 Discuss proposed Phase 2 study design Discuss eligibility for expedited programs (Fast Track Designation) QTORIN™ Pitavastatin: From Concept to Clinic QTORIN™ pitavastatin optimized for stability and drug delivery Working with FDA Division of Dermatology and Dentistry Filed intellectual property Initiation of Proposed Phase 2 study anticipated in 2H 2026 Phase 2 protocol drafted Endpoint development nearing completion with extensive input from key opinion leaders and patients GOAL: Initiate Phase 2 clinical development in 2H 2026

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Finance

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Q3 2025 Financial Highlights and 2025 Outlook $63.6 million Cash at 9/30/2025 Runway into 2H 2027 $10.2 million R&D + G&A spend in Q3 2025 ~$55 million Projected cash at year end

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Q&A Striving to be first for rare disease patients