Palvella Therapeutics Strengthens Leadership with Appointment of Accomplished Scientist and Biopharmaceutical Executive David W. Osborne, Ph.D.

September 03, 2025 07:30 ET | Source: Palvella Therapeutics Inc. Co-Founder and former Chief Technical Officer of Arcutis Biotherapeutics brings extensive topical product development experience, including track record of translating science into commercially available therapies Dr. Osborne to guide expansion of QTORIN™ platform, including second QTORIN™ product candidate on track to be announced by year-end 2025 WAYNE, Pa., Sept. 03, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced the appointment of David W. Osborne, Ph.D. as Chief Innovation Officer, effective immediately. Dr. Osborne, a recognized industry leader in developing novel therapies for high unmet need, debilitating skin diseases, brings over 25 years of experience advancing innovative therapies from concept to FDA approval. He has contributed to the development of three dozen topical therapies, including ZORYVE® (roflumilast) cream and foam. In his new role, Dr. Osborne will provide leadership across Palvella’s early-stage R&D pipeline, including maximizing the potential of the Company’s proprietary QTORIN™ platform, Palvella’s innovative platform for reproducibly generating novel, targeted topical therapies for serious, rare genetic skin diseases. “Having spent over 25 years working in formulation science and translational innovation, I have seen firsthand how thoughtful, patient-centered drug development can make a profound impact,” said Dr. Osborne. “Palvella and its collaborators pioneered the development of QTORIN™, a platform that enables significant technical challenges associated with topical drug formulation to be overcome, ultimately accelerating development. I see tremendous potential for addressing mTOR-driven skin diseases with QTORIN™ rapamycin, and the potential of the QTORIN™ platform extends well beyond rapamycin to additional molecules. I am inspired by Palvella’s bold vision to lead in serious, rare genetic skin diseases—an area of undeniable unmet medical need—and I am excited to help bring first-in-disease therapies to patients who currently have no options.” Dr. Osborne is an accomplished biopharmaceutical scientist and executive with over 25 years of industry-leading experience in topical drug development, translational science, and product formulation. Prior to joining Palvella, he co-founded Arcutis Biotherapeutics (Nasdaq: ARQT) and was the company’s first employee, serving as former Chief Technical Officer and playing a key role in advancing innovative topical therapies for immune-mediated skin diseases, including contributing to the development of ZORYVE® (roflumilast) cream and foam, now FDA-approved for plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. Earlier in this career, he held senior roles at Dow Pharmaceutical Sciences, Tolmar Inc., and Atrix Laboratories, where he contributed to several FDA-approved therapies, including ACZONE® 5% Gel, METROGEL® 1%, CLOBEX® Spray, DESONATE® Gel, JUBLIA® Solution and ACANYA® Gel. He began his career at The Upjohn Company and Calgon Vestal Laboratories (Merck & Co., Inc.). Dr. Osborne holds a B.S. in Chemistry from Missouri State University and a Ph.D. in Physical Chemistry from Missouri University of Science and Technology. He is also an inventor on 52 U.S. patents and over 200 issued foreign patents in drug delivery and has published extensively in peer-reviewed journals. Dr. Osborne has been recognized for his contributions to pharmaceutical sciences and dermatology, serving in leadership roles in professional organizations such as the American Association of Pharmaceutical Scientists (AAPS) Dermatopharmaceutics Focus Group and the American Chemical Society Division of Colloid and Surface Science, and acting as founding North American Editor for the journal Colloids and Surfaces. “Palvella is honored to welcome David to our senior leadership team,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella Therapeutics. “His track record of developing innovative FDA-approved medicines, combined with his deep expertise in novel topical drug formulation, will be invaluable as he guides the development of our second QTORIN™ product candidate and shapes the future expansion of the QTORIN™ platform, helping us bring meaningful therapies to patients with serious, rare genetic skin diseases.” About Palvella Therapeutics 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 genetic 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 genetic 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 evaluated in the Phase 3 SELVA clinical trial in microcystic lymphatic malformations and the Phase 2 TOIVA clinical trial in cutaneous venous malformations. For more information, please visit www.palvellatx.com or follow Palvella on LinkedIn or X (formerly known as Twitter). QTORIN™ rapamycin is for investigational use only and has not been approved or cleared by the FDA or by any other regulatory agency for any indication. Forward-Looking Statements 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 and financial resources and expected cash runway, and the potential of, and expectations regarding, Palvella’s programs, including QTORIN™ rapamycin, 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; 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 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 Investors Wesley H. Kaupinen Founder and CEO, Palvella Therapeutics wes.kaupinen@palvellatx.com Media Marcy Nanus Managing Partner, Trilon Advisors LLC mnanus@trilonadvisors.com

Palvella Therapeutics Strengthens Leadership with Appointment of Accomplished Scientist and Biopharmaceutical Executive David W. Osborne, Ph.D.

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