- Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission framework granted to Alpha Tau by the FDA allows for streamlined review and feedback from the FDA as each module is submitted - - Module submitted in parallel to execution of ReSTART pivotal study (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), which is expected to complete recruiting patients in Q1 2026 - JERUSALEM, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd ...

- The overview presentation will review some of the Company’s recent achievements as well as the outlook for upcoming data milestones -JERUSALEM, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that CEO Uzi Sofer and CFO Raphi Levy will present a corporate overview and update at the J.P. Morgan 2026 Healthcare Conference on Thursday, January 15, 2026 at ...

- First patient in the world treated with Alpha DaRT® in the brain – - According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months – - This 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 - JERUSALEM, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the ...

Core Insights - Alpha Tau Medical Ltd. is advancing its innovative alpha-radiation cancer therapy, Alpha DaRT, with a multi-center clinical trial for pancreatic cancer in the U.S. expected to complete patient recruitment by the end of Q1 2026 [1][2] - The company will present two abstracts at the 2026 ASCO Gastrointestinal Cancers Symposium, showcasing data from its recently completed pilot trial in Montreal [1][2] Company Overview - Alpha Tau Medical Ltd. was founded in 2016 and focuses on the research, development, and potential commercialization of Alpha DaRT for treating solid tumors [4] - The technology was developed by professors from Tel Aviv University, emphasizing its academic foundation [4] Clinical Trial Details - The U.S. multi-center pancreatic cancer clinical trial began patient treatment in September 2025 and aims to enroll up to 30 patients with newly diagnosed pancreatic cancer [2] - Approximately 87% of newly diagnosed pancreatic cancer patients are deemed inoperable, highlighting the significant unmet medical need [2] Technology Description - Alpha DaRT utilizes radium-224 for intratumoral delivery, allowing for targeted alpha-irradiation of solid tumors while minimizing damage to surrounding healthy tissue [3]

- FDA approval marks Alpha Tau’s fifth simultaneous active U.S. IDE as the Company expands Alpha DaRT’s reach into recurrent prostate cancer -JERUSALEM, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with locally recurrent prostate cancer using the Co ...

Core Insights - Alpha Tau Medical Ltd. is participating in the Jefferies Global Healthcare Conference in London on November 18-19, 2025, where CFO Raphi Levy will hold 1x1 investor meetings [1] Company Overview - Alpha Tau Medical Ltd. was founded in 2016 and is an Israeli oncology therapeutics company focused on the research, development, and potential commercialization of Alpha DaRT for treating solid tumors [2] - The technology behind Alpha DaRT was developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University [2] Technology Details - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed for highly potent and conformal alpha-irradiation of solid tumors through intratumoral delivery of radium-224 impregnated sources [3] - The therapy works by releasing short-lived daughter isotopes from radium-224, which emit high-energy alpha particles aimed at destroying tumors while minimizing damage to surrounding healthy tissue [3]

Core Insights - Alpha Tau Medical Ltd. has received a radioactive material license from the State of New Hampshire, marking a significant milestone for the commercial-scale manufacturing of its Alpha DaRT cancer therapy [1][3] - The company aims to initiate Alpha DaRT treatment manufacturing in 2026, following the completion of the first phase of its facility in Hudson, New Hampshire [1][3] Company Developments - In October 2023, Alpha Tau entered a long-term lease for a building over 14,000 rentable square feet in Hudson, New Hampshire, for the Alpha DaRT manufacturing facility, which will be constructed in multiple phases [2] - The expected nameplate capacity from the first phase is approximately 400,000 Alpha DaRT sources for local use, contingent on operational and clinical assumptions [2] Operational Milestones - CEO Uzi Sofer expressed excitement over the operational milestone and acknowledged the efforts of the operations and engineering teams, as well as the support from local authorities [3] - With the radioactive material license secured, the company can proceed with equipping the facility and aims to produce Alpha DaRT treatments during 2026 [3] Product Overview - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed for highly potent and conformal alpha-irradiation of solid tumors through intratumoral delivery of radium-224 sources [6] - The therapy is currently being evaluated in multiple clinical trials for various cancers, including skin, head & neck, pancreas, lung, prostate, and brain tumors [4] Company Background - Founded in 2016, Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company focused on the research, development, and potential commercialization of Alpha DaRT for solid tumor treatment [5] - The technology was developed by professors from Tel Aviv University [5]

Core Viewpoint - Alpha Tau Medical Ltd. is actively engaging with investors through multiple conferences in September 2025 to discuss its innovative alpha-radiation cancer therapy, Alpha DaRT, which aims to treat solid tumors while minimizing damage to surrounding healthy tissue [1][3]. Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and potential commercialization of the Alpha DaRT technology for treating solid tumors [5]. - The Alpha DaRT technology was developed by Professors Itzhak Kelson and Yona Keisari from Tel Aviv University [5]. Technology Insights - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes localized alpha particle radiotherapy to destroy solid tumors while sparing healthy tissue, with the potential for broad applicability in local tumor control [2][4]. - The therapy involves intratumoral delivery of radium-224 sources, which emit high-energy alpha particles that primarily affect the tumor due to their short diffusion distance [4]. Upcoming Events - The CFO, Raphi Levy, will present at several investor conferences in September 2025, including: - Citi 2025 Biopharma Back to School Summit on September 2-3, 2025, in Boston, MA [3] - H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, in New York, NY [3] - Oppenheimer's Third Annual Targeted Radiopharmaceutical Therapies in Oncology Summit on September 11, 2025, in New York, NY [3] - RTH & Co / Redburn Atlantic - Radiopharma Landscape Conference on September 26, 2025, in New York, NY [3] - Lytham Partners Fall 2025 Investor Conference on September 30, 2025, virtually [3].

Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and potential commercialization of the Alpha DaRT for treating solid tumors [3] - The technology behind Alpha DaRT was developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University [3] Product Information - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes intratumoral delivery of radium-224 impregnated sources to provide highly potent and conformal alpha-irradiation of solid tumors [4] - The therapy aims to destroy tumors while sparing surrounding healthy tissue, as the alpha-emitting atoms diffuse only a short distance [4] Upcoming Events - The CFO of Alpha Tau, Raphi Levy, will present at the Jefferies Global Healthcare Conference on June 5, 2025, from 1:25 to 1:55 PM ET in New York, NY [2] - Mr. Levy will also be available for one-on-one investor meetings during the conference [2]

Core Insights - Alpha Tau Medical Ltd. has reported significant interim results from trials of its Alpha DaRT® therapy for pancreatic cancer, achieving over 90% disease control rate and a 75% systemic objective response rate in combination with Keytruda® [1][3][13] - The company has received FDA approvals for multiple Investigational Device Exemptions (IDE) to conduct clinical studies in pancreatic cancer and recurrent glioblastoma multiforme (GBM) [5][6][13] - Alpha Tau completed a $36.9 million financing round to support its ongoing clinical and manufacturing activities [6][11] Company Developments - The CEO of Alpha Tau highlighted the company's progress in expanding manufacturing capabilities and preparing for commercial activities, with four active U.S. IDEs approved by the FDA [3] - The company achieved MDSAP certification for its Jerusalem facility, which may expedite the commercialization process in multiple international markets [5][6] - Alpha Tau is set to begin U.S. trials for newly diagnosed pancreatic cancer and recurrent GBM patients soon [3][5] Financial Performance - For Q1 2025, Alpha Tau reported R&D expenses of $7.2 million, an increase from $6.4 million in Q1 2024, primarily due to higher employee compensation and production costs [8] - The company recorded a net loss of $8.7 million, or $0.12 per share, compared to a net loss of $8.0 million, or $0.11 per share, in the same period last year [10][22] - As of March 31, 2025, Alpha Tau had cash and cash equivalents totaling $54.8 million, down from $62.9 million at the end of 2024 [11] Clinical Trial Updates - Interim results from trials showed a 37.5% complete response rate in a combination trial of Alpha DaRT with Keytruda for head and neck squamous cell carcinoma, significantly higher than historical benchmarks [1][13] - The company announced the initiation of a U.S. pilot study for Alpha DaRT in combination with first-line chemotherapy for newly diagnosed pancreatic cancer, expanding the trial from 12 to 30 patients [13] - Alpha Tau is also preparing for a multicenter clinical trial in France for locally advanced pancreatic cancer [13]