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

Core Insights - The Phase 3 SELVA trial for QTORIN™ rapamycin has completed enrollment, exceeding its target by over 25%, with top-line results expected in Q1 2026 [1][5] - The Phase 2 TOIVA trial for QTORIN™ rapamycin is on track for results in Q4 2025 [1][9] - QTORIN™ rapamycin aims to be the first approved therapy for microcystic lymphatic malformations and cutaneous venous malformations in the U.S. [1][3] - The company plans to announce a third clinical indication for QTORIN™ rapamycin and a second candidate from the QTORIN™ platform by the end of 2025 [1][9] Research and Development Highlights - Enrollment in the Phase 3 SELVA trial included 51 subjects, surpassing the original target of 40 [5] - The company received initial proceeds from an FDA Orphan Products Grant, potentially totaling $2.6 million, to support the SELVA trial [5] - Key presentations at scientific meetings included an oral presentation on the SELVA trial design and Phase 2 results [5] - The USPTO issued patent No. 12,268,673 for QTORIN™ rapamycin, with a patent life extending into 2038 [5] Financial Overview - As of June 30, 2025, the company reported cash and cash equivalents of $70.4 million, expected to fund operations into the second half of 2027 [1][9] - Research and development expenses for Q2 2025 were $5.1 million, up from $1.4 million in Q2 2024, primarily due to increased clinical development spending [9][17] - General and administrative expenses rose to $4.1 million in Q2 2025 from $1.5 million in Q2 2024, driven by increased employee compensation and public company operating costs [9][17] - The net loss attributable to common stockholders for Q2 2025 was $9.5 million, or $0.86 per share, compared to a net loss of $4.4 million, or $2.47 per share, in Q2 2024 [9][17] Corporate Developments - The company is expanding its rare disease pipeline with plans for two new development programs in 2025 [3][9] - The appointment of Ashley Kline as Chief Commercial Officer strengthens the executive leadership team [9] - The company was added to the Russell 3000® and Russell 2000® indexes on June 27, 2025 [9]