Welcome to our dedicated page for Alpha Tau Medical SEC filings (Ticker: DRTSW), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Alpha Tau Medical Ltd.'s SEC filings document foreign private issuer reports for a clinical-stage oncology company developing Alpha DaRT for solid tumors. Recent Form 6-K reports furnish press releases and company presentations covering clinical data, trial progress, regulatory submissions, and conference-call materials for programs such as ReSTART in recurrent cutaneous squamous cell carcinoma and REGAIN in recurrent glioblastoma.
The filings also identify disclosure mechanics for furnished exhibits, incorporation by reference into registration statements, and Exchange Act treatment of company presentations and press releases. For this issuer, the filing record centers on clinical-development disclosures, FDA-related PMA and IDE context, regulatory-risk language, capital-market registration references, and public-company reporting obligations.
Alpha Tau Medical Ltd. reports that the FDA has cleared it to complete enrollment in its U.S. REGAIN trial of Alpha DaRT for recurrent glioblastoma, allowing recruitment of the final seven of up to ten patients. Two additional leading U.S. academic cancer centers have been authorized as clinical sites, broadening access and expertise for the study.
Early interim data from the first three patients treated showed 100% local disease control, a 67% complete response rate by RANO criteria, and one associated grade 3 serious adverse event that resolved, with no unanticipated toxicities and no local or distant recurrences at the cutoff date. The trial focuses on patients with recurrent glioblastoma who have very limited treatment options, and builds on prior FDA recognition of Alpha DaRT through Breakthrough Device Designation and participation in the Total Product Life Cycle Advisory Program.
Alpha Tau Medical Ltd. reports that the FDA has cleared it to complete enrollment in its U.S. REGAIN trial of Alpha DaRT for recurrent glioblastoma, allowing recruitment of the final seven of up to ten patients. Two additional leading U.S. academic cancer centers have been authorized as clinical sites, broadening access and expertise for the study.
Early interim data from the first three patients treated showed 100% local disease control, a 67% complete response rate by RANO criteria, and one associated grade 3 serious adverse event that resolved, with no unanticipated toxicities and no local or distant recurrences at the cutoff date. The trial focuses on patients with recurrent glioblastoma who have very limited treatment options, and builds on prior FDA recognition of Alpha DaRT through Breakthrough Device Designation and participation in the Total Product Life Cycle Advisory Program.
Alpha Tau Medical Ltd. Chief Financial Officer Levy Raphi sold shares in the company. On June 3, 2026, he completed two open-market sales totaling 32,500 Ordinary Shares of Alpha Tau Medical Ltd. at prices of $10.7571 and $10.9005 per share. These were reported as non-derivative transactions with direct ownership.
Alpha Tau Medical Ltd. Chief Financial Officer Levy Raphi sold shares in the company. On June 3, 2026, he completed two open-market sales totaling 32,500 Ordinary Shares of Alpha Tau Medical Ltd. at prices of $10.7571 and $10.9005 per share. These were reported as non-derivative transactions with direct ownership.
Alpha Tau Medical Ltd. filing: a Form 144 notice reports a proposed sale of 32,500 ordinary shares through Oppenheimer & Co. Inc. on NASDAQ. The excerpt also records shares issued upon RSU vesting: 21,722 shares on 03/21/2022 and 71,988 shares on 03/07/2024. The filing lists the broker-dealer and a date of 06/03/2026 alongside the share quantity.
Alpha Tau Medical Ltd. filing: a Form 144 notice reports a proposed sale of 32,500 ordinary shares through Oppenheimer & Co. Inc. on NASDAQ. The excerpt also records shares issued upon RSU vesting: 21,722 shares on 03/21/2022 and 71,988 shares on 03/07/2024. The filing lists the broker-dealer and a date of 06/03/2026 alongside the share quantity.
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 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. 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 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 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.