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

Core Insights - Palvella Therapeutics is advancing its QTORIN™-derived therapies for four serious, rare skin diseases, each lacking FDA-approved treatments, with the potential to be first in these markets [2][14] - The company reported financial results for Q3 2025, highlighting a net loss of $11.3 million, or $1.03 per share, compared to a net loss of $7.0 million, or $3.94 per share, in Q3 2024 [17] Recent Developments - The Phase 2 TOIVA trial for QTORIN™ rapamycin in cutaneous venous malformations is fully enrolled, with top-line results expected in mid-December 2025 [1][11] - The Phase 3 SELVA trial for QTORIN™ rapamycin in microcystic lymphatic malformations is on track for top-line results in Q1 2026 [1][6] - Palvella is expanding QTORIN™ rapamycin's development into clinically significant angiokeratomas, with a Phase 2 study anticipated to start in the second half of 2026 [1][11] - A new product candidate, QTORIN™ pitavastatin, is being developed for disseminated superficial actinic porokeratosis, with a Phase 2 study also expected to begin in the second half of 2026 [1][11] Financial Overview - As of September 30, 2025, the company had cash and cash equivalents of $63.6 million, expected to fund operations into the second half of 2027 [1][11] - Research and development expenses for Q3 2025 were $6.5 million, up from $3.2 million in Q3 2024, primarily due to increased spending on clinical trials [10][12] - General and administrative expenses rose to $3.6 million in Q3 2025 from $1.9 million in Q3 2024, driven by higher employee compensation and costs associated with being publicly traded [12] Leadership and Innovation - David W. Osborne, Ph.D., has been appointed as Chief Innovation Officer to lead early-stage R&D efforts, focusing on maximizing the QTORIN™ platform [5] - Jeffrey Martini, Ph.D., presented at a dermatological conference, emphasizing the potential of the QTORIN™ platform and its lead candidate [5]