On November 20, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported third quarter 2025 financial results and provided a corporate update.

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"The third quarter has seen a fantastic continuation of our accelerating momentum at Alpha Tau, as the pace of patient treatments continues to rise, and we draw increased interest from our peers in the industry" said Alpha Tau Chief Executive Officer Uzi Sofer. "Receiving the radioactive license approval in New Hampshire was a significant milestone in our push for operational commercial readiness, and we are continuing to develop that facility for use in treating patients in the U.S., Canada, and elsewhere, having invested almost $2 million into the facility in Q3. We are very happy with the rate of recruitment in our U.S. multi-center pilot study in pancreatic cancer, and look forward to some potential targeted near-term milestones, including a forthcoming response from the PMDA to our request for marketing authorization in Japan in treating recurrent head & neck cancer, and treating our first patients with glioblastoma multiforme (GBM) shortly. With four IDEs currently active for trials in the U.S., we are continuing to explore with the FDA other potential U.S. trial initiations, potentially in prostate cancer or head & neck cancers."

Recent Corporate Highlights:

● In September, Alpha Tau announced the treatment of the first patient in its U.S. multi-center pancreatic cancer clinical trial. The trial is expected to enroll up to 30 patients with newly diagnosed pancreatic cancer, in two cohorts: 15 patients with locally advanced disease, and 15 patients with metastatic disease. Patients will receive mFOLFIRINOX chemotherapy together with the Alpha DaRT treatment. Up to 87% of newly diagnosed pancreatic cancer patients are considered inoperable at diagnosis and face a dismal prognosis, with limited benefit from existing therapies, and the pilot study is a key part of Alpha Tau’s broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs. For more information, please see here: View Source

● In October, Alpha Tau announced the receipt of a radioactive material license for its New Hampshire manufacturing facility, its first commercial-scale facility. The license paves the way for the introduction of radioactive material and continued positive momentum toward initiating Alpha DaRT treatment manufacturing onsite in 2026. Total expected nameplate capacity from the first phase of construction is approximately 400,000 Alpha DaRT sources for local use, subject to a number of operational and clinical assumptions.

Expected Upcoming Milestone Targets:

● First patient treated in U.S. GBM pilot study in Q4 2025. For more information, please see here: View Source

● Response from Japan’s PMDA around year end 2025 to the application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.

● Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q1 2026. For more information, please see here: View Source

● Completion of patient recruitment in pancreatic cancer pilot study in the U.S. by the end of Q1 2026. For more information, please see here: View Source

Financial Results for Nine Months Ended September 30, 2025

Research and Development expenses for the nine months ended September 30, 2025 were $22.5 million, compared to $19.5 million for the same period in 2024, primarily due to an increase in employee compensation and benefits, costs of raw materials and third-party contractor expenses, reflecting increased clinical activities, as well as decreased government grants, offset by lower share-based compensation expenses and travel expenses.

Marketing expenses for the nine months ended September 30, 2025 were $1.4 million, compared to $1.7 million for the same period in 2024, due to decreased employee compensation and benefits and decreased marketing conference activities and travel expenses.

General and Administrative expenses for the nine months ended September 30, 2025 were $5.8 million, compared to $4.6 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation and professional fees (including legal and IR expenses), offset by a decrease in travel expenses and D&O insurance costs.

Financial expense, net, for the nine months ended September 30, 2025 was $0.6 million, compared to financial income, net, of $3.5 million for the same period in 2024, primarily due to an increase in the remeasurement of warrants, a decrease in interest from bank deposits, and changes in foreign exchange rates.

For the nine months ended September 30, 2025, the Company had a net loss of $30.5 million, or $0.39 per share, compared to a net loss of $22.3 million, or $0.32 per share, in the nine months ended September 30, 2024.

Balance Sheet Highlights

As of September 30, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $75.9 million, compared to $62.9 million at December 31, 2024.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, NOV 20, 2025, View Source [SID1234660838])