Palvella Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - The Phase 3 SELVA trial for QTORIN™ rapamycin has exceeded its enrollment target of 40 patients, with enrollment expected to close in June 2025 and top-line results anticipated in Q1 2026 [1][4] - The Phase 2 TOIVA trial for QTORIN™ rapamycin is on track to report top-line results in Q4 2025 [1] - QTORIN™ rapamycin has the potential to become the first approved therapy for microcystic lymphatic malformations and cutaneous venous malformations in the U.S. [1][4] Clinical Trials - The SELVA trial has expanded to include patients aged 3 to 5 years old, with a total of over 40 patients aged six and older enrolled [7] - A recent epidemiology study supports a significant market opportunity for QTORIN™ rapamycin if approved, as it targets a serious, rare genetic disease with no current FDA-approved therapies [4][7] Financial Overview - As of March 31, 2025, the company reported cash and cash equivalents of $75.6 million, expected to fund operations into the second half of 2027 [1][12] - Research and development expenses for Q1 2025 were $4.1 million, up from $1.0 million in Q1 2024, primarily due to increased spending on clinical trials [12] - General and administrative expenses rose to $3.8 million in Q1 2025 from $0.8 million in Q1 2024, driven by employee compensation and public company operational costs [12] Market Potential - An estimated 44,553 high probability lymphatic malformation patients with cutaneous involvement have been identified in the U.S., indicating a substantial market for QTORIN™ rapamycin [7] - The company has received a patent for QTORIN™ rapamycin for the treatment of microcystic LMs, extending its patent life into 2038 [7]