WAYNE, Pa. — November 11, 2025 — Leads & Copy — Palvella Therapeutics, Inc., a biopharmaceutical company focused on developing treatments for rare skin diseases, has released its third-quarter financial results for 2025 and provided a corporate update.
The company’s rare disease pipeline now includes QTORIN™-derived product candidates targeting four serious, rare skin diseases without FDA-approved therapies. Top-line results from the Phase 2 TOIVA trial of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for cutaneous venous malformations are expected in mid-December 2025. Results from the Phase 3 SELVA trial of QTORIN™ rapamycin for microcystic lymphatic malformations are expected in the first quarter of 2026.
Palvella is expanding QTORIN™ rapamycin’s development into clinically significant angiokeratomas, a rare lymphatic disease. A Phase 2 study is anticipated to begin in the second half of 2026. The company also announced a new product candidate, QTORIN™ pitavastatin, for disseminated superficial actinic porokeratosis, a pre-cancerous genetic skin disease. A Phase 2 study is also planned for the second half of 2026.
As of September 30, 2025, Palvella had $63.6 million in cash and cash equivalents, which is expected to fund operations into the second half of 2027.
Wes Kaupinen, Founder and CEO of Palvella Therapeutics, said the company is advancing innovative QTORIN™-derived therapies for four serious, rare skin diseases, each lacking a single FDA-approved therapy. Kaupinen added that QTORIN™ rapamycin continues to demonstrate its potential as a pipeline-in-a-product for mTOR-driven skin diseases.
The company appointed David W. Osborne, Ph.D., as Chief Innovation Officer, to lead early-stage R&D and maximize the potential of the QTORIN™ platform. Jeffrey Martini, Ph.D., Chief Scientific Officer, presented on the QTORIN™ platform and QTORIN™ rapamycin at the Center for Dermal Research’s Innovations in Dermatological Sciences Conference at Rutgers University.
The FDA awarded the year two proceeds from the FDA Orphan Products Grant program to support the ongoing SELVA trial. Enrollment in the Phase 2 TOIVA trial was completed, with 16 subjects enrolled. A publication in Lymphatic Research and Biology highlighted studies supporting rapamycin’s potential for venous malformations.
A 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, which underscored the need for targeted therapies.
For the third quarter of 2025, research and development expenses were $6.5 million, compared to $3.2 million for the same period in 2024. General and administrative expenses were $3.6 million, compared to $1.9 million for the same period in 2024. The net loss attributable to common stockholders was $11.3 million, or $1.03 per basic and diluted share.
Palvella will host a conference call at 8:30 a.m. ET on November 11, 2025, to discuss the results and provide a corporate update.
Wesley H. Kaupinen, Founder and CEO, Palvella Therapeutics, wes.kaupinen@palvellatx.com
Marcy Nanus, Managing Partner, Trilon Advisors LLC, mnanus@trilonadvisors.com
Source: Palvella Therapeutics, Inc.
