Alpha Tau Medical Ltd SEC Filings

Alpha Tau Medical entered a long-term collaboration and supply agreement with Tolmar, granting Tolmar exclusive U.S. commercialization rights for Alpha DaRT in prostate cancer, with an option to expand into bladder cancer. Tolmar will pay an initial $15.0 million to expand Alpha Tau’s manufacturing, up to $161.5 million in clinical, regulatory and commercial milestone payments for the first prostate indication, and 60% of net sales for product supply. Concurrently, Tolmar agreed to a private placement of 1,668,057 ordinary shares at $11.99 per share, providing expected gross proceeds of $20.0 million to Alpha Tau for general corporate purposes, with the potential for an additional $5.0 million equity investment if it exercises the bladder cancer option.

Alpha Tau Medical Ltd. reported new clinical data on its Alpha DaRT® alpha-radiation therapy for pancreatic ductal adenocarcinoma, based on a pooled analysis of three prospective Phase I/II studies.

Patients treated with Alpha DaRT after first-line chemotherapy reached median overall survival of 11.2 months in metastatic disease and 11.1 months in locally advanced disease from trial enrollment, compared with about 4–6 months and about 9 months, respectively, for second-line chemotherapy in published historical data. The safety profile appeared favorable, with treatment-associated adverse events in 36% of subjects and Grade ≥3 events in 9%, no treatment-related deaths, no chronic toxicity, and all Grade ≥3 events resolving.

The company notes these results support the potential feasibility and safety of Alpha DaRT as a one-time, minimally invasive intratumoral treatment and points to the next step of completing recruitment in the multicenter U.S. IMPACT pancreatic cancer trial.

Alpha Tau Medical Ltd. is calling a June 23, 2026 annual shareholder meeting to vote on six governance and compensation proposals. Shareholders will consider re-electing two Class II directors, re-approving the compensation policy, and allowing CEO Uzi Sofer to continue also serving as board chairman with a new compensation package.

Investors are also asked to authorize the board to extend option terms for directors and officers and to re-appoint Kost Forer Gabbay & Kasierer (Ernst & Young Global) as independent auditors for 2026. The record date is May 12, 2026, when 90,325,876 ordinary shares were outstanding, each with one vote.

Alpha Tau Medical Ltd. is calling a June 23, 2026 annual shareholder meeting to vote on six governance and compensation proposals. Shareholders will consider re-electing two Class II directors, re-approving the compensation policy, and allowing CEO Uzi Sofer to continue also serving as board chairman with a new compensation package.

Investors are also asked to authorize the board to extend option terms for directors and officers and to re-appoint Kost Forer Gabbay & Kasierer (Ernst & Young Global) as independent auditors for 2026. The record date is May 12, 2026, when 90,325,876 ordinary shares were outstanding, each with one vote.

Alpha Tau Medical reported a first quarter 2026 net loss of $22.9 million, or $0.26 per share, widening from a $8.7 million loss a year earlier, mainly due to higher research and development spending and a large non-cash warrants remeasurement expense.

R&D expenses rose to $11.0 million from $7.2 million as clinical trial activity expanded. Despite the loss, cash, cash equivalents, short-term deposits and restricted deposits were $80.2 million as of March 31, 2026, slightly above $76.9 million at year-end 2025.

Clinically, interim data from the U.S. REGAIN trial in recurrent glioblastoma showed 100% local disease control and a 67% complete response rate, and the pivotal ReSTART trial in recurrent cutaneous squamous cell carcinoma completed enrollment with 88 patients, while the company continues commercialization efforts in Japan following prior PMDA marketing approval for Alpha DaRT.

Alpha Tau Medical reported a first quarter 2026 net loss of $22.9 million, or $0.26 per share, widening from a $8.7 million loss a year earlier, mainly due to higher research and development spending and a large non-cash warrants remeasurement expense.

R&D expenses rose to $11.0 million from $7.2 million as clinical trial activity expanded. Despite the loss, cash, cash equivalents, short-term deposits and restricted deposits were $80.2 million as of March 31, 2026, slightly above $76.9 million at year-end 2025.

Clinically, interim data from the U.S. REGAIN trial in recurrent glioblastoma showed 100% local disease control and a 67% complete response rate, and the pivotal ReSTART trial in recurrent cutaneous squamous cell carcinoma completed enrollment with 88 patients, while the company continues commercialization efforts in Japan following prior PMDA marketing approval for Alpha DaRT.

Alpha Tau Medical Ltd. furnished a presentation on interim clinical data from its U.S. REGAIN trial of Alpha DaRT in patients with recurrent glioblastoma. The pilot study plans to enroll 10 patients, with feasibility and safety as primary endpoints.

Three patients have been treated so far. All showed tumor responses: two achieved complete responses with no discernable lesion on MRI, and one had stable disease with a 30% tumor size reduction at one month. One patient is reported as having no evidence of disease.

Adverse events included grade 2–3 seizures in two patients, managed with steroids and brief hospitalization, with all returning to neurologic baseline. No unanticipated side effects or dose-limiting toxicities were observed in this interim analysis, and further enrollment is planned pending FDA review of the initial safety data.

Alpha Tau Medical reported highly encouraging interim results from its U.S. REGAIN trial of Alpha DaRT for recurrent glioblastoma, an aggressive brain cancer. The first three treated patients showed 100% local disease control, with two achieving complete response and the third showing stable disease with a 30% tumor reduction per RANO criteria. As of May 3, 2026, no local or distant recurrence or residual procedure-related symptoms were seen, and only one associated grade 3 serious adverse event, a seizure with temporary paralysis, occurred and resolved with steroids. The trial is designed to enroll up to ten U.S. patients to further evaluate feasibility and safety of this investigational therapy.

Alpha Tau Medical Ltd. is hosting a conference call and webcast on May 11, 2026 at 8:30am ET to discuss interim clinical data from the first three patients treated in its U.S. REGAIN trial for recurrent glioblastoma. The REGAIN study is a feasibility and safety trial expected to enroll up to ten U.S. patients with recurrent glioblastoma that cannot be surgically removed and have previously received central nervous system radiation. Alpha Tau develops Alpha DaRT, which delivers radium‑224 directly into solid tumors so its short‑lived decay products emit high‑energy alpha particles aimed at destroying tumor tissue while sparing nearby healthy tissue.

Alpha Tau Medical Ltd. is hosting a conference call and webcast on May 11, 2026 at 8:30am ET to discuss interim clinical data from the first three patients treated in its U.S. REGAIN trial for recurrent glioblastoma. The REGAIN study is a feasibility and safety trial expected to enroll up to ten U.S. patients with recurrent glioblastoma that cannot be surgically removed and have previously received central nervous system radiation. Alpha Tau develops Alpha DaRT, which delivers radium‑224 directly into solid tumors so its short‑lived decay products emit high‑energy alpha particles aimed at destroying tumor tissue while sparing nearby healthy tissue.

Alpha Tau Medical Ltd. has completed enrollment of 88 patients in its ReSTART pivotal trial, a multicenter U.S.-led study of Alpha DaRT for recurrent cutaneous squamous cell carcinoma. This first U.S. pivotal study to fully enroll supports Alpha Tau’s modular FDA pre-market approval application, following Breakthrough Device Designation for Alpha DaRT in this indication.

Alpha Tau Medical Ltd. has completed enrollment of 88 patients in its ReSTART pivotal trial, a multicenter U.S.-led study of Alpha DaRT for recurrent cutaneous squamous cell carcinoma. This first U.S. pivotal study to fully enroll supports Alpha Tau’s modular FDA pre-market approval application, following Breakthrough Device Designation for Alpha DaRT in this indication.

Alpha Tau Medical Ltd. reported a clinical milestone as it successfully treated the first pancreatic cancer patient in Italy with its Alpha DaRT® therapy at the University of Verona’s Pancreas Institute. The procedure is part of a feasibility and safety study (CTP-PANC-03) for locally advanced, unresectable pancreatic cancer.

The single-center trial in Verona plans to enroll up to 15 patients who have confirmed locally advanced pancreatic cancer, tumors of ≤ 5 cm, and have either received at least one line of chemotherapy or are medically unfit for systemic treatment. Alpha DaRT sources can be delivered via endoscopic ultrasound or a percutaneous approach, with a safety interim analysis after the first 5 patients.

The study’s primary objective is to evaluate feasibility and safety of Alpha DaRT source placement, while secondary objectives include local tumor control per RECIST v1.1, changes in CA 19-9 biomarker levels, tumor coverage, and adverse events. Exploratory objectives focus on immune biomarkers, and the company emphasizes this as its first protocol to incorporate the percutaneous delivery route for pancreatic cancer.