DRTS

- Groundbreaking interim results from U.S. REGAIN trial in recurrent glioblastoma demonstrate 100% local disease control, 67% complete response rate, and favorable safety profile - - Completion of patient enrollment in the U.S. pivotal ReSTART trial in recurrent cutaneous squamous cell carcinoma, the Company’s first U.S. pivotal study - - Pooled data from two pancreatic cancer trials presented at Digestive Disease Week (DDW) 2026 demonstrated 100% local disease control and favorable safety, the first oral presentation of Alpha DaRT® pancreatic data at a premier international gastroenterology conference - - Abstracts accepted for presentation at the 2026 ASCO Annual Meeting and at the AHNS 12th International Conference on Head and Neck Cancer, reflecting growing scientific recognition across multiple solid tumor indications - - FDA approval of an IDE supplement to expand the IMPACT pancreatic cancer trial to patients receiving gemcitabine with Abraxane® (nab-paclitaxel) and recruit additional patients - - First patient successfully treated for pancreatic cancer in Europe at CHU Grenoble Alpes under the multicenter ACAPELLA trial in France, and first patient successfully treated in Italy at the University of Verona’s Pancreas Institute - - Cash, cash equivalents, short-term deposits and restricted deposits balance of $80.2 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, May 18, 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®, reported first quarter 2026 financial results and provided a corporate update. “The first quarter of 2026 has been a truly defining period for Alpha Tau, reflecting the convergence of two powerful dynamics that have been years in the making: the maturation of clinical data from our most advanced programs, and the global initiation of novel trials addressing some of the most pressing unmet needs in oncology,” said Alpha Tau CEO Uzi Sofer. “The groundbreaking interim results from our U.S. REGAIN trial in recurrent glioblastoma, with 100% local disease control and a 67% complete response rate as of May 3, represent powerful potential clinical benefit in patients facing a devastating disease with virtually no curative options. Our pancreatic cancer program has also...

- Interim results from the first three brain cancer patients treated; two of whom demonstrated complete response, with total disappearance of all enhancing tumor lesions, per multiple MRI scans since treatment - - One associated grade 3 serious adverse event (SAE) was observed, since resolved - - 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 - - Conference call with principal investigator to be held today, Monday, May 11, 2026, at 8:30am ET - JERUSALEM, May 11, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT® today announced groundbreaking interim data from its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma (GBM), also known as the REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial. In accordance with the FDA’s request for an interim safety analysis, results were analyzed after three patients were treated in the trial, with one patient treated in each of December 2025, February 2026 and March 2026. No unanticipated associated SAEs have been observed as of the cutoff date of May 3, 2026, and only one associated grade 3 SAE was observed: seizure with temporary paralysis, which resolved with the administration of steroids. In addition, as measured via regular MRI scans and defined by Response Assessment in Neuro-Oncology (RANO) criteria, the first two patients demonstrated a continued complete response, signifying the total disappearance of all enhancing tumor lesions, and the third patient demonstrated stable disease with a 30% decrease in tumor dimension. As of the cutoff date, no patients have any local or distant recurrence, or any residual symptoms from the procedure, and the patient has recovered from the associated SAE. The first three patients were treated at The Ohio State University Comprehensive Cancer Center (OSUCCC) in Columbus, Ohio, by a multidisciplinary team led by Principal Investigator and Radiation Oncologist Joshua D. Palmer, MD, Medical Physicist Michael Degnan, MS, DABR and Neurosurgeon J. Bradley Elder, MD, using a novel delivery approach designed specifically by Alpha Tau for intracranial use. "Today is a very important day for Alpha T...

JERUSALEM, May 08, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT® today announced that it will host a conference call and webcast on Monday, May 11, 2026 at 8:30am ET to discuss interim clinical data from the first three patients treated in its U.S. trial of Alpha DaRT for patients with recurrent glioblastoma (GBM), also known as the REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial. Conference Call and Webcast Details Date: Monday, May 11, 2026 Time: 8:30am ET Web Access: https://alpha-tau-interim-results-conference-call.open-exchange.net/ An archived webcast will be available following the event. About the REGAIN Study The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. The primary objective of the study is to evaluate the feasibility and safety of the treatment, following the Company’s promising results from pre-clinical studies. Additional information about the trial can be found at https://www.clinicaltrials.gov/study/NCT06910306 About Alpha Tau Medical Ltd. Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University. About Alpha DaRT® Alpha DaRT (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. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including “anticipate,” “will,” “plan,” “may,” “continue,” and similar expressions are inte...

- Abstract from trial evaluating Alpha DaRT® in combination with pembrolizumab in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma selected for podium presentation - - The AHNS International Conference on Head and Neck Cancer is widely recognized as one of the premier global forums dedicated to advancing head and neck oncology - - Clinical trial builds on Alpha DaRT monotherapy data generated across clinical studies in the United States, Europe, Israel, and Japan, and marks a key milestone in the Company’s combination therapy strategy - - Head and neck cancer is the sixth most common malignancy worldwide, with elderly patients facing particularly limited treatment options and poor outcomes - JERUSALEM, May 05, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) (“Alpha Tau”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that an abstract entitled “Management of Locally Advanced and Metastatic Head and Neck Squamous Cell Carcinoma in Elderly Patients Using Diffusing Alpha-Emitter Radiation Therapy in Combination with Pembrolizumab” has been accepted for podium presentation at the American Head and Neck Society (“AHNS”) 12th International Conference on Head and Neck Cancer, taking place July 18-22, 2026, in Boston, Massachusetts. The presentation is scheduled to occur during the Proffered Papers session on Radiation and Adjuvant Therapies on Tuesday, July 21, 2026, 10:30 AM - 12:00 PM. The AHNS International Conference on Head and Neck Cancer is one of the world’s premier forums dedicated to advancing multidisciplinary head and neck oncology, bringing together leading surgeons, oncologists, and researchers from across the globe. Selection for a podium presentation represents one of the highest distinctions at the conference, reserved for abstracts of particular scientific merit and clinical significance. Head and neck squamous cell carcinoma (HNSCC) is the sixth most common malignancy worldwide, with approximately 25-40% of patients diagnosed at age 70 or older. Elderly patients with locally advanced or metastatic disease face a particularly significant unmet medical need, as they are often ineligible for or unable to tolerate aggressive multimodal therapies, and available treatment options for this vulnerable population are associated with suboptimal sur...

- Abstract accepted at the American Society of Clinical Oncology (ASCO) Annual Meeting - the world’s largest and most prestigious medical oncology conference - - Pooled analysis combines safety and efficacy data from 58 patients across three prospective clinical studies conducted at centers in Canada and Israel - - Acceptance of abstract comes in the same year as presentations at the ASCO Gastrointestinal Cancers Symposium and at Digestive Disease Week (DDW), reflecting growing interest within the expert scientific community in Alpha DaRT pancreatic cancer clinical data - - Abstract to be published on ASCO conference website on May 21, 2026, at 5:00 PM ET - JERUSALEM, April 27, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) (“Alpha Tau”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that an abstract entitled “Combined Safety and Efficacy Results from Three Clinical Studies Evaluating Alpha Radiotherapy for Advanced Pancreatic Cancer” has been accepted at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 - June 2, 2026. The abstract is expected to be published on May 21, 2026, at 5:00 PM ET on the ASCO conference website at https://www.asco.org/annual-meeting. The ASCO Annual Meeting is widely regarded as the largest and most prestigious medical oncology conference in the world, attracting tens of thousands of leading oncologists, researchers, and healthcare professionals from across the globe. Abstract acceptance at ASCO is determined through a rigorous, peer-review process and represents recognition of the scientific merit and clinical relevance of the submitted research. The abstract presents a pooled analysis of safety and efficacy data from three prospective clinical studies evaluating endoscopic ultrasound (EUS)-guided intratumoral Alpha DaRT treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). The studies were conducted at the Jewish General Hospital and Centre Hospitalier de l'Université de Montréal (CHUM) in Montreal, Canada, and at the Hadassah Medical Center in Jerusalem, Israel, enrolling a combined total of 58 patients. Acceptance of the abstract at the ASCO Annual Meeting, together with abstract presentation at ASCO GI and Digestive Disease Week (DDW) this year, underscores the growing scient...

- 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®, 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 Canc...

- Final results from first pancreatic cancer study in Montreal demonstrate 81% disease control rate, or 87% excluding the first two patients - - Immune markers demonstrate immune system preservation not typical of conventional radiation therapy treatments, as well as potential anti-inflammatory effect - - Alpha DaRT currently being studied together with first-line chemotherapy in U.S. multi-center pilot trial for newly diagnosed pancreatic cancer - JERUSALEM, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT® today announced the release of final results from its first-in-human pancreatic cancer study in Montreal, Canada exploring the use of Alpha DaRT in treating pancreatic ductal adenocarcinoma (PDAC). The results have been published as two abstracts and will be presented at the upcoming 2026 ASCO Gastrointestinal Cancers Symposium in San Francisco, January 8 – 10, 2026. Study Principal Investigator Corey Miller, MD, MSc, Director of Therapeutic Endoscopy of the Division of Gastroenterology of the JGH, Assistant Professor of Medicine at McGill University, Associate Researcher at the Lady Davis Institute, will lead a presentation entitled “Feasibility, Safety and Efficacy of Endoscopic Ultrasound-Guided Alpha Radiotherapy for Advanced Pancreatic Cancer: A Pilot Study” with final clinical results of the Company’s trial. In the trial, 32 patients with Stage II, III or IV PDAC were treated, many of whom had one or more prior rounds of chemotherapy. The results demonstrate 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. The Company is further exploring the use of Alpha DaRT in treating PDAC in its U.S. multi-center pancreatic cancer pilot study, known as IMPACT (Intratumoral Pancreatic Alpha Combination Trial), evaluating the safety, feasibility, and efficacy of Alpha DaRT in combination with chemotherapy for patients with newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma, as well as in other clinical studies in Europe. Additional information about the IMPACT trial can be found at https://clin...

- Alpha DaRT pancreatic cancer patient treatments underway in U.S. multi-center pilot study - - Newly received radioactive material license for New Hampshire facility positions the Company for continued advancement towards commercial readiness - - Multiple meaningful milestones targeted in the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART trial - - Cash, cash equivalents & deposits balance of $75.9 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, Nov. 20, 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®, reported third quarter 2025 financial results and provided a corporate update. "The third quarter has seen a fantastic continuation of our accelerating momentum at Alpha Tau, as the pace of patient treatments continues to rise, and we draw increased interest from our peers in the industry" said Alpha Tau Chief Executive Officer Uzi Sofer. “Receiving the radioactive license approval in New Hampshire was a significant milestone in our push for operational commercial readiness, and we are continuing to develop that facility for use in treating patients in the U.S., Canada, and elsewhere, having invested almost $2 million into the facility in Q3. We are very happy with the rate of recruitment in our U.S. multi-center pilot study in pancreatic cancer, and look forward to some potential targeted near-term milestones, including a forthcoming response from the PMDA to our request for marketing authorization in Japan in treating recurrent head & neck cancer, and treating our first patients with glioblastoma multiforme (GBM) shortly. With four IDEs currently active for trials in the U.S., we are continuing to explore with the FDA other potential U.S. trial initiations, potentially in prostate cancer or head & neck cancers.” Recent Corporate Highlights: In September, Alpha Tau announced the treatment of the first patient in its U.S. multi-center pancreatic cancer clinical trial. The trial is expected to enroll up to 30 patients with newly diagnosed pancreatic cancer, in two cohorts: 15 patients with locally advanced disease, and 15 patients with metastatic disease. Patients will receive mFOLFIRINOX chemotherapy together with the Alpha DaRT treatment. Up...

- FDA approval of IDE to conduct a U.S. pilot study exploring the use of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer - - Multiple U.S. clinical trials, including pancreatic cancer and GBM pilot studies, positioned for imminent patient treatment initiation during the remainder of 2025 - - Secured $36.9 million through a strategic equity offering at market price from Oramed, while concurrently entering into a strategic IR/PR alliance - - Cash, cash equivalents & deposits balance of $83.3 million provides runway for continued clinical advancement and commercial preparation - JERUSALEM, Aug. 11, 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®, reported second quarter 2025 financial results and provided a corporate update. "The Company's focus activities continue to coalesce, with an increasing emphasis on U.S. clinical trials, priority indications in internal organs, and preparations for commercial scale-up," said Alpha Tau Chief Executive Officer Uzi Sofer. "All four U.S. IDEs are active: Our pivotal skin cancer ReSTART (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) trial continues to recruit patients actively and is nearing completion; we expect to commence treatment shortly in our trial in immunocompromised patients as well as the pilot IMPACT (Intratumoral Pancreatic Alpha Combination Trial) study; and the GBM study should initiate later in 2025. In parallel we are also deepening our focus on pancreatic cancer, with studies expected to launch shortly in France and Italy. And our push towards commercialization continues: a PMDA response is expected imminently, potentially opening up new commercial opportunities for the Company, and we expect to complete our first phase of construction shortly in our commercial-scale facility in Hudson, New Hampshire, which should be ready to manufacture Alpha DaRT treatments in early 2026." Recent Corporate Highlights: ·In April, Alpha Tau announced receipt of an IDE from the FDA to conduct a U.S. pilot study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer with an estimated average survival rate of only 8 months. The clinical trial is expected to enroll up to ten U.S. pati...

- Interim Jan-2025 results from three trials of Alpha DaRT® in treating pancreatic cancer shared at prestigious 2025 ASCO GI Symposium and R&D Update Day, showing >90% disease control rate, impressive overall survival in sub-group analyses, and positive safety profile - - 75% systemic objective response rate (ORR) and 37.5% complete response rate meaningfully higher thus far than historical Keytruda® monotherapy data in Jan-2025 interim read out of a combination trial of Alpha DaRT and Keytruda in head and neck squamous cell carcinoma (HNSCC) - - FDA approval of Investigational Device Exemption (IDE) and IDE supplement to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy in patients with newly diagnosed locally advanced or metastatic pancreatic cancer -- MDSAP certification of the Company’s Jerusalem facility meets the standards of the U.S., Australia, Brazil, Canada, and Japan, and completes audit for compliance with ISO 13485 - - FDA approval of IDE to conduct a U.S. pilot study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer -- Completion of $36.9 million financing after balance sheet date bolsters the Company’s capital position during ongoing acceleration of activities - JERUSALEM, May 19, 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®, reported first quarter 2025 financial results and provided a corporate update.“2025 has started off with a bang at Alpha Tau, with a flurry of important milestones as we continue to evaluate Alpha DaRT in treating internal organ tumors, expand our manufacturing capabilities, and prepare for commercial activities,” said Alpha Tau Chief Executive Officer Uzi Sofer. “With four active U.S. IDEs approved by the FDA, and U.S. trials expected to begin soon in patients with newly-diagnosed pancreatic cancer and recurrent GBM, construction of the first phase of our Hudson, NH facility nearing completion, and our ambitions for the continued expansion of our clinical trial program, our recently completed financing came at the perfect time to ensure that our momentum continues to accelerate throughout the course of the year.” Recent Corporate Highlights: In April, Alpha Tau announced the completion of a $36.9 million reg...

- Interim results from three trials exploring the use of Alpha DaRT® in treating pancreatic cancer showing high disease control rate, impressive overall survival in sub-group analyses, and positive safety profile - - Systemic ORR and complete response rates meaningfully higher thus far than historical Keytruda® monotherapy data in interim read out of a combination trial of Alpha DaRT and Keytruda in treating recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) - - Interim data from pancreatic cancer trials presented at the prestigious 2025 ASCO GI Symposium - - FDA approval of Investigational Device Exemption (IDE) and IDE supplement to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy in patients with newly diagnosed locally advanced or metastatic pancreatic cancer - - Alpha DaRT accepted into the prestigious Total Product Life Cycle Advisory Program (TAP) of the FDA, to accelerate market access to the Alpha DaRT for patients with recurrent glioblastoma multiforme (GBM) - - Cash, cash equivalents & deposits balance of $62.9 million, with runway of at least two years - JERUSALEM, March 12, 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®, reported full year 2024 financial results and provided a corporate update. “Alpha Tau has been incredibly busy and very successful throughout 2024. With fantastic clinical results observed across a number of difficult cancers, we are now able to demonstrate the broader Alpha Tau vision of expanding our focus on treating internal organ tumors of high unmet need, as well as helping metastatic patients by harnessing the potential systemic immune benefits of Alpha DaRT”, said Alpha Tau Chief Executive Officer Uzi Sofer. “FDA approval of our forthcoming U.S. trials in patients with newly diagnosed pancreatic cancer and our investigator-initiated trial in immunocompromised patients with recurrent cSCC, not only aligns with our broader vision but also reflects continued progress in our regulatory pathway to approval for Alpha DaRT. In parallel, we remain focused on expanding our operational capabilities, with our Hudson, NH facility expected to complete its first phase of construction in the coming months and come online for production of Alpha D...