Alpha Tau Announces Full Year 2024 Financial Results and Provides Corporate Update

Core Insights - Alpha Tau Medical Ltd. reported promising interim results from clinical trials of its Alpha DaRT® therapy for pancreatic cancer, showing high disease control rates and overall survival benefits [1][6] - The combination of Alpha DaRT with Keytruda demonstrated significantly higher response rates compared to historical data, indicating potential advantages in treating head and neck squamous cell carcinoma [1][6] - The company received FDA approval for multiple clinical trials, reflecting progress in its regulatory pathway and operational capabilities [5][6] Clinical Developments - Interim results from three trials for pancreatic cancer showed a high disease control rate and strong safety profile [1][6] - A combination trial of Alpha DaRT and Keytruda reported a systemic objective response rate of 75% and a complete response rate of 37.5%, significantly higher than historical benchmarks of 19% and 5% respectively [6] - FDA approved an Investigational Device Exemption (IDE) for a U.S. pilot study of Alpha DaRT with first-line chemotherapy in newly diagnosed pancreatic cancer patients, expanding the trial from 12 to 30 patients [5][6] Financial Performance - For the year ended December 31, 2024, the company reported R&D expenses of $27.0 million, up from $26.4 million in 2023, attributed to increased employee compensation and raw material costs [9] - Marketing expenses increased to $2.3 million in 2024 from $1.9 million in 2023 due to heightened marketing activities [10] - The company had a net loss of $31.8 million in 2024, compared to a net loss of $29.2 million in 2023, with a net loss per share of $0.45 [13][22] Cash Position - As of December 31, 2024, Alpha Tau had cash and cash equivalents totaling $62.9 million, down from $84.9 million in 2023, with an expected runway of at least two years [14] - The company’s total assets decreased from $107.4 million in 2023 to $86.2 million in 2024, reflecting changes in cash and short-term deposits [20] Upcoming Milestones - The company anticipates the first patient to be treated for brain cancer in Israel in H1 2025 and aims to enroll the first patient in the pancreatic cancer pilot study in the U.S. in Q2 2025 [16] - Alpha Tau is seeking FDA IDE approval in Q2 2025 for an early feasibility study in recurrent glioblastoma multiforme patients [16]