Palvella Therapeutics Strengthens Executive Leadership Team with Appointment of Rare Disease Commercial Veteran Ashley Kline as Chief Commercial Officer

Rhea-AI Summary

Palvella Therapeutics (NASDAQ: PVLA) has appointed Ashley Kline as Chief Commercial Officer to lead the commercial launch of QTORIN™ rapamycin for microcystic lymphatic malformations. The appointment is significant given Kline's impressive track record at Dompé Pharmaceuticals, where she led Oxervate® to achieve over $500 million in annual U.S. sales. QTORIN™ aims to be the first FDA-approved therapy for microcystic lymphatic malformations, a rare genetic disease affecting over 30,000 patients in the U.S. Kline's expertise in rare disease commercialization, particularly her success with Oxervate's capital-efficient launch strategy, positions her well to build Palvella's commercial organization.

Positive

• Appointment of proven commercial executive with successful track record in rare disease commercialization
• New CCO previously led Oxervate to achieve $500M+ in annual U.S. sales with early profitability
• Targeting large market opportunity with 30,000+ patients for microcystic lymphatic malformations
• Potential to be first FDA-approved therapy in their target indication

Negative

• Product still pending FDA approval
• Commercial infrastructure yet to be built

Ms. Kline to lead Palvella’s commercial buildout for planned standalone U.S. launch of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations, a serious, rare, and lifelong genetic disease affecting an estimated more than 30,0000 patients in the U.S., if approved

Under Kline’s leadership at Dompé, Oxervate®, a first-in-disease topical therapy for rare disease neurotrophic keratitis, scaled to over $500 million in annual U.S. sales while achieving early profitability

WAYNE, Pa., May 27, 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 Ashley Kline as Chief Commercial Officer, effective immediately.

Ms. Kline brings a proven track record in commercialization of novel therapies for serious, rare diseases. Prior to joining Palvella as Chief Commercial Officer, she served as Global Biotech Head and U.S. General Manager at Dompé Pharmaceuticals. There, she led the successful launch of Oxervate®, a first-in-disease topical therapy approved in 2018 for neurotrophic keratitis (NK), a rare, serious, and progressive eye disease that previously had no FDA-approved therapies. Under her leadership, Oxervate surpassed $500 million in annual U.S. sales by 2023 and achieved early profitability through an innovative, capital-efficient, and high-touch launch strategy that emphasized high-impact physician outreach and education—establishing it as one of the top-performing non-oncology orphan drugs of the past decade.

"Ashley is a proven commercial executive in rare diseases and we are thrilled to welcome her to the Palvella team," said Wes Kaupinen, Founder and Chief Executive Officer. "Ashley brings a dynamic, results-driven approach and deep knowledge of the key factors for achieving success in launching the first FDA-approved therapy for a serious, rare disease. Her leadership was instrumental to Oxervate’s success which is widely regarded as one of the top rare disease launches over the last decade. Ashley’s strong patient-orientation, her ability to build and lead high performing teams, and her analytically driven approach will contribute to Palvella achieving our vision of building the leading rare disease biopharmaceutical company focused on serious, rare genetic skin diseases.”

Earlier in her career, Ms. Kline was a member of the commercial team at Genentech and a consultant for Bain and Company. She also held commercial roles at Santen Pharmaceuticals and Adverum Biotech. Ms. Kline earned her M.B.A. from the Kellogg School of Management at Northwestern University with majors in Finance, Decision Science, and Analytical Consulting and a B.A., with distinction, from the University of North Carolina at Chapel Hill.

"This is an exciting time to join Palvella as the Company has the potential to market the first and only therapeutic option for patients suffering from microcystic lymphatic malformations and cutaneous venous malformations, both rare and debilitating genetic diseases that significantly impact quality of life," said Ms. Kline. "I look forward to building out Palvella's commercial organization and working alongside a team that shares my passion and sense of responsibility to reduce the burden of illness, especially in areas of high unmet medical need."

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

FAQ

Who is Ashley Kline and what is her role at Palvella Therapeutics (PVLA)?

Ashley Kline is the newly appointed Chief Commercial Officer at Palvella Therapeutics, responsible for leading the commercial buildout for QTORIN rapamycin's U.S. launch. She previously served as Global Biotech Head at Dompé Pharmaceuticals where she led Oxervate to $500M+ in annual sales.

What is QTORIN rapamycin and what condition does it treat?

QTORIN 3.9% rapamycin anhydrous gel is a therapeutic candidate for treating microcystic lymphatic malformations, a serious rare genetic disease affecting over 30,000 patients in the U.S. It aims to be the first FDA-approved therapy for this condition.

What was Ashley Kline's major achievement at Dompé Pharmaceuticals?

At Dompé, Kline led the successful launch of Oxervate, achieving over $500 million in annual U.S. sales by 2023 and early profitability through an innovative, capital-efficient launch strategy for this rare disease treatment.

How many patients could potentially benefit from PVLA's QTORIN treatment?

According to the press release, more than 30,000 patients in the U.S. are affected by microcystic lymphatic malformations, representing the potential market for QTORIN rapamycin.

What is Palvella Therapeutics' (PVLA) main focus as a company?

Palvella Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for patients with serious, rare genetic skin diseases that currently have no FDA-approved treatments.