Alpha Tau Announces First Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - Alpha Tau Medical Ltd. has reported significant interim results from trials of its Alpha DaRT® therapy for pancreatic cancer, achieving over 90% disease control rate and a 75% systemic objective response rate in combination with Keytruda® [1][3][13] - The company has received FDA approvals for multiple Investigational Device Exemptions (IDE) to conduct clinical studies in pancreatic cancer and recurrent glioblastoma multiforme (GBM) [5][6][13] - Alpha Tau completed a $36.9 million financing round to support its ongoing clinical and manufacturing activities [6][11] Company Developments - The CEO of Alpha Tau highlighted the company's progress in expanding manufacturing capabilities and preparing for commercial activities, with four active U.S. IDEs approved by the FDA [3] - The company achieved MDSAP certification for its Jerusalem facility, which may expedite the commercialization process in multiple international markets [5][6] - Alpha Tau is set to begin U.S. trials for newly diagnosed pancreatic cancer and recurrent GBM patients soon [3][5] Financial Performance - For Q1 2025, Alpha Tau reported R&D expenses of $7.2 million, an increase from $6.4 million in Q1 2024, primarily due to higher employee compensation and production costs [8] - The company recorded a net loss of $8.7 million, or $0.12 per share, compared to a net loss of $8.0 million, or $0.11 per share, in the same period last year [10][22] - As of March 31, 2025, Alpha Tau had cash and cash equivalents totaling $54.8 million, down from $62.9 million at the end of 2024 [11] Clinical Trial Updates - Interim results from trials showed a 37.5% complete response rate in a combination trial of Alpha DaRT with Keytruda for head and neck squamous cell carcinoma, significantly higher than historical benchmarks [1][13] - The company announced the initiation of a U.S. pilot study for Alpha DaRT in combination with first-line chemotherapy for newly diagnosed pancreatic cancer, expanding the trial from 12 to 30 patients [13] - Alpha Tau is also preparing for a multicenter clinical trial in France for locally advanced pancreatic cancer [13]