- Tremendous activity in recent months, including receipt of Japanese marketing approval, the fifth parallel U.S. trial approval, data from pancreatic cancer trials presented at ASCO GI Symposium, and the first brain cancer treatment -

- Multiple meaningful milestones targeted in the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART skin cancer trial, in the U.S. pilot IMPACT pancreatic cancer trial, and in the U.S. recurrent glioblastoma multiforme feasibility trial -

- $76.9 million in cash, cash equivalents & deposits provides continued balance sheet strength for clinical advancement and commercial preparation -

JERUSALEM, March 09, 2026 (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$(R)$ , reported full year 2025 financial results and provided a corporate update.

"The pace of progress at Alpha Tau today is unlike anything we've ever seen before," said Alpha Tau Chief Executive Officer Uzi Sofer. "With a slew of meaningful announcements in the past few months, culminating most recently with our receipt of marketing approval in Japan, our first outside of Israel, and with multiple meaningful milestones targeted for the coming months, we remain laser focused on execution. Clinical trial progress remains our highest priority, with an astounding five clinical trials approved in parallel in the U.S. At the same time, we continue to build out our manufacturing capabilities in New Hampshire as well as our pre-commercial preparations, while entertaining multiple tracks of strategic dialogue with partners who show increasing excitement about the ever-expanding prospects for Alpha DaRT."

Recent Corporate Highlights:

   -- Commercial-Scale U.S. Manufacturing Milestone: 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. 
 
   -- FDA Approval to Start Prostate Cancer Trial: In December, Alpha Tau 
      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 Company's Alpha DaRT 
      technology. According to the National Cancer Institute, over 300,000 new 
      cases of prostate cancer were expected to be diagnosed in 2025, and 
      clinical literature indicates that up to 15% of patients treated with 
      external beam radiation therapy can develop local recurrence within 15 
      years of treatment. The clinical trial is expected to enroll up to 12 
      U.S. patients with locally recurrent prostate cancer who have 
      demonstrated biochemical recurrence by the Phoenix definition (a rise of 
      PSA levels by 2 ng/mL from the PSA nadir). For more information, please 
      see here: https://clinicaltrials.gov/study/NCT07290998 
 
   -- First Patient Treated in U.S. Brain Cancer Trial: In December, Alpha Tau 
      treated its first patient in its pilot study for the treatment of 
      patients with recurrent glioblastoma multiforme (GBM) using the Alpha 
      DaRT technology. 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, and 
      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. For 
      more information, please see here: 
      https://clinicaltrials.gov/study/NCT06910306 
 
   -- First Module Submitted to FDA as Part of Application for Marketing 
      Authorization in Skin Cancer: In January, the Company announced the 
      submission of the first module of its pre-market approval (PMA) 
      application to the U.S. Food and Drug Administration (FDA), following the 
      FDA's previous decision to allow the Company to use the more flexible 
      modular approach. The Company submitted the module with respect to 
      non-clinical studies as part of an application for the use of Alpha DaRT 
      in treating recurrent cutaneous squamous cell carcinoma (cSCC), the 
      second most common form of skin cancer, for patients not indicated for 
      surgery or standard radiation therapy, and for whom no curative systemic 
      treatment is available. 
 
   -- New Positive Data in Pancreatic Cancer Presented at ASCO: In January, 
      investigators from the Company's first-in-human pancreatic cancer study 
      in Montreal, Canada exploring the use of Alpha DaRT in treating 
      pancreatic ductal adenocarcinoma (PDAC) were awarded two separate 
      presentations at the 2026 ASCO Gastrointestinal Cancers Symposium 
      showcasing results from the trial. The results demonstrated a 22% 
      objective response rate $(ORR)$ and an 81% disease control rate (DCR) 
      across all 32 patients treated in the study, or 23% ORR and 87% DCR when 
      excluding the first two patients, who were deliberately given low dosages 
      in order to examine feasibility and safety only. In addition, 
      investigators presented results showing the immune-preserving profile of 
      Alpha DaRT in PDAC, based on immune markers as well as inflammatory 
      indices known to be negative prognostic indicators, and which typically 
      worsen after other forms of radiation therapy. 
 
   -- Received Marketing Approval in Japan for Head and Neck Cancer: In 
      February, Alpha Tau announced the receipt of Japanese marketing approval 
      for Alpha DaRT in unresectable locally advanced or locally recurrent head 
      and neck cancer, marking the first regulatory approval of the Alpha DaRT 
      platform outside Israel. As part of the approval, Alpha Tau will need to 
      conduct a post-market surveillance (PMS) study enrolling 66 patients in 
      total at five selected leading clinical centers in Japan, and the 
      Company's immediate focus is on working closely with Japanese clinicians 
      to complete the PMS study and to generate high-quality clinical data in 
      patients with unresectable locally advanced or locally recurrent disease. 

Expected Upcoming Milestone Targets:

   -- Completion of patient recruitment in the ReSTART pivotal U.S. 
      multi-center trial in recurrent cutaneous squamous cell carcinoma at the 
      end of Q1 2026. For more information, please see here: 
      https://www.clinicaltrials.gov/study/NCT05323253 
 
   -- Completion of patient recruitment in pancreatic cancer pilot study in the 
      U.S. in Q2 2026. For more information, please see here: 
      https://www.clinicaltrials.gov/study/NCT06698458 
 
   -- Initial safety readout from the first three patients in the recurrent GBM 
      trial in Q2 2026, and completion of patient recruitment in the second 
      half of 2026. For more information, please see here: 
      https://clinicaltrials.gov/study/NCT06910306 

Financial results for year ended December 31, 2025

R&D expenses for the year ended December 31, 2025 were $32.1 million, compared to $27.0 million for the same period in 2024, due to increased employee compensation and benefits, increased costs of raw materials, and increased third-party contractor expenses (including clinical trial sites).

Marketing expenses for the year ended December 31, 2025 were $1.9 million, compared to $2.3 million for the same period in 2024, due to decreased compensation expenses and travel abroad.

G&A expenses for the year ended December 31, 2025 were $8.4 million, compared to $6.7 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation, and increased professional fees (including legal and IR expenses).

Financial expense, net, for the year ended December 31, 2025 was $0.2 million, compared to $4.3 million financial income, net, for the same period in 2024, due to a decrease in income from remeasurement of warrants and in interest from bank deposits as well as increased expense from changes in foreign exchange rates.

For the year ended December 31, 2025, the Company had a net loss of $42.6 million, or $0.53 per share, compared to a net loss of $31.8 million, or $0.45 per share, in the year ending December 31, 2024.

Balance Sheet Highlights

As of December 31, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $76.9 million, compared to $62.9 million at December 31, 2024.

Annual Report Availability

Alpha Tau's Annual Report on Form 20-F for the fiscal year ended December 31, 2025, has been filed today with the Securities and Exchange Commission. The Annual Report on Form 20-F can be accessed on the Investor Relations section of Alpha Tau's website at https://www.alphatau.com and on the SEC's website at www.sec.gov.

About Alpha DaRT(R)

Alpha DaRT(R) (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.

About Alpha Tau Medical Ltd.

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March 09, 2026 16:02 ET (20:02 GMT)