Alpha Tau Medical Ltd.

Alpha Tau Medical Ltd. held its Annual General Meeting of Shareholders on June 23, 2026. Shareholders approved all proposals, including the re-election of two Class II directors, re-approval of the compensation policy for executives and directors, and the re-appointment of Uzi Sofer as Chairman and his compensation package. Additionally, the extension of terms for certain director and officer options and the re-appointment of Kost Forer Gabbay & Kasierer as the independent auditor were approved.

Alpha Tau Medical announced the successful treatment of the first glioblastoma patient in Israel, and the first ever outside of the United States, using its Alpha DaRT® therapy. The procedure, performed at Hadassah University Medical Center, utilized the company's proprietary brain applicator and marks the first international clinical application of Alpha DaRT’s brain-specific delivery system. This milestone is significant for Alpha Tau's glioblastoma program, especially for patients with recurrent glioblastoma who have limited treatment options.

Alpha Tau Medical Ltd. announced FDA clearance to complete enrollment for the final seven patients in its U.S. REGAIN trial for recurrent glioblastoma and to add two new clinical sites. This follows a review of an interim safety report for the first three patients, which showed 100% local disease control and a 67% complete response rate with only one grade 3 serious adverse event. The company plans to immediately resume patient recruitment, expanding access and clinical expertise for this indication. This marks another regulatory success, building on Alpha DaRT's Breakthrough Device Designation and acceptance into the FDA's TAP Pilot program.

Alpha Tau Medical Ltd. announced that the U.S. FDA has cleared the company to immediately resume enrollment for the final seven patients in its U.S. REGAIN trial for recurrent glioblastoma (GBM). This clearance follows a positive interim safety report from the first three patients, who showed 100% local disease control and a 67% complete response rate with only one manageable serious adverse event. Additionally, two new leading U.S. academic cancer centers have been authorized to join the trial, expanding access and expertise for this critical indication.

Alpha Tau Medical Ltd. announced a strategic collaboration and supply agreement with Tolmar International Ltd., granting Tolmar exclusive U.S. commercialization rights for Alpha DaRT for prostate cancer. The agreement includes an initial $15.0 million payment for manufacturing expansion and up to $161.5 million in milestone payments. Concurrently, Alpha Tau entered a private placement with Tolmar, selling 1,668,057 ordinary shares at a 25% premium for $20.0 million in gross proceeds, intended for general corporate purposes. Tolmar also holds an option to expand into bladder cancer, subject to additional payments and a further securities purchase.

Alpha Tau Medical and Tolmar International announced a strategic collaboration to develop and commercialize Alpha DaRT for prostate cancer in the U.S. Tolmar will make an initial $20 million equity investment in Alpha Tau at a 25% premium and contribute $15 million towards a new U.S. manufacturing facility. The agreement includes up to $161.5 million in clinical, regulatory, and commercial milestones for the initial indication, with an option to expand into bladder cancer. Tolmar gains exclusive U.S. commercialization rights for prostate cancer, while Alpha Tau will manufacture the product and lead clinical development.

Alpha Tau Medical announced strong overall survival and safety results from a pooled analysis of three Phase I/II clinical studies for its Alpha DaRT® therapy in pancreatic cancer, presented at the 2026 ASCO Annual Meeting. Patients treated with Alpha DaRT after one prior line of chemotherapy showed median overall survival of 11.2 months in metastatic disease and 11.1 months in locally advanced disease, significantly exceeding historical data. The therapy demonstrated a favorable safety profile with no treatment-related deaths and all Grade ">= 3 adverse events resolving. The company is now focused on completing recruitment for its U.S. IMPACT pancreatic cancer trial.

Alpha Tau Medical announced positive overall survival and safety results from a pooled analysis of three Phase I/II clinical studies for its Alpha DaRT therapy in locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). The treatment demonstrated encouraging median overall survival (mOS) across various patient populations, including 11.2 months for metastatic patients after 1st line chemotherapy, compared to historical ~4-6 months. A favorable safety profile was observed with 36% treatment-associated adverse events and 9% Grade ≥3 events, all resolved, with no treatment-related deaths. The company is now focused on completing recruitment for its U.S. IMPACT pancreatic cancer trial.

Alpha Tau Medical Ltd. announced its Annual General Meeting of Shareholders to be held on June 23, 2026, where shareholders will consider and vote on six key proposals. These include the re-election of two Class II directors, re-approval of the compensation policy, re-appointment of Uzi Sofer as CEO and Chairman, approval of his compensation, extension of certain options, and re-appointment of the independent auditor. The Board of Directors unanimously recommends voting "FOR" each of the proposals.

Alpha Tau Medical reported groundbreaking interim results from its U.S. REGAIN trial in recurrent glioblastoma, demonstrating 100% local disease control and a 67% complete response rate. The company also completed patient enrollment in its U.S. pivotal ReSTART trial for recurrent cutaneous squamous cell carcinoma and presented positive pooled data from pancreatic cancer trials. For the first quarter of 2026, Alpha Tau reported a net loss of $22.9 million, with cash and equivalents totaling $80.2 million, providing a strong runway for continued clinical advancement.