Alpha Tau Medical Ltd SEC Filings

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.

Alpha Tau Medical Ltd. reported that an abstract from its clinical trial combining its Alpha DaRT intratumoral alpha-radiation therapy with pembrolizumab in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma has been accepted for a podium presentation at the AHNS 12th International Conference on Head and Neck Cancer in Boston in July 2026.

The trial, conducted at Hadassah Medical Center in Jerusalem, evaluates Alpha DaRT as an add-on to standard-of-care immunotherapy, aiming to offer a new option for older patients who often cannot tolerate aggressive chemoradiation. Company executives and the lead investigator highlight prior monotherapy safety data and the scientific rationale for combining localized radiotherapy with systemic immunotherapy.

Alpha Tau Medical Ltd. furnished a press release describing updated results from two first-in-human trials of its Alpha DaRT intratumoral alpha-radiation therapy in pancreatic ductal adenocarcinoma. In a pooled analysis, 100% local disease control was achieved in 19 evaluable patients using modified RECIST v1.1 criteria.

Among these patients, 15 (79%) had stable disease and 4 (21%) had partial responses, despite many being heavily pre-treated or ineligible for chemotherapy. Across 26 treated subjects, only 8 device-associated adverse events occurred in 7 patients (27%), almost all resolving within two weeks, indicating a favorable safety profile. The therapy is delivered via an outpatient EUS-guided procedure designed to fit standard gastroenterology workflows.

Alpha Tau Medical Ltd. filed a Form F-3 shelf registration to offer up to $300,000,000 of securities, including ordinary shares, warrants, debt securities, subscription rights and/or units, to be sold from time to time. The base prospectus notes an at-the-market sales agreement permitting up to $100,000,000 of ordinary shares to be sold through H.C. Wainwright & Co.

The prospectus summarizes clinical-stage progress of the company’s Alpha DaRT® localized alpha-radiation therapy, regulatory milestones in Israel, the U.S. Breakthrough Device designations, and recent MHLW approval in Japan with a post-market surveillance requirement. Net proceeds are for general corporate purposes, including R&D and potential commercialization.

Alpha Tau Medical Ltd. is highlighting new pancreatic cancer research based on its Alpha DaRT® radiation therapy. An abstract combining safety and efficacy data from 58 patients across three prospective pancreatic cancer studies in Canada and Israel has been accepted for presentation at the 2026 ASCO Annual Meeting, a major global oncology conference. The pooled analysis covers endoscopic ultrasound-guided intratumoral Alpha DaRT in locally advanced or metastatic pancreatic ductal adenocarcinoma and reflects growing scientific interest in the company’s pancreatic cancer program, alongside ongoing IMPACT and ACAPELLA clinical trials.

Alpha Tau Medical Ltd. reports two key milestones in developing its Alpha DaRT alpha-radiation therapy for pancreatic cancer. In Europe, the company has successfully treated the first patient in its ACAPELLA multicenter trial in France, testing Alpha DaRT combined with capecitabine in up to 40 patients with inoperable locally advanced pancreatic ductal adenocarcinoma who have completed first-line mFOLFIRINOX chemotherapy.

In the U.S., the FDA has approved an Investigational Device Exemption supplement expanding the IMPACT pancreatic cancer pilot study from 30 to 40 patients and adding newly diagnosed patients treated with gemcitabine/nab-paclitaxel alongside Alpha DaRT. Both ACAPELLA and IMPACT focus on safety, feasibility and early efficacy signals, including tumor response, survival outcomes and conversion to surgical resection, as part of Alpha Tau’s broader global clinical strategy in high-need pancreatic cancer settings.

Alpha Tau Medical Ltd. reports two key milestones in developing its Alpha DaRT alpha-radiation therapy for pancreatic cancer. In Europe, the company has successfully treated the first patient in its ACAPELLA multicenter trial in France, testing Alpha DaRT combined with capecitabine in up to 40 patients with inoperable locally advanced pancreatic ductal adenocarcinoma who have completed first-line mFOLFIRINOX chemotherapy.

In the U.S., the FDA has approved an Investigational Device Exemption supplement expanding the IMPACT pancreatic cancer pilot study from 30 to 40 patients and adding newly diagnosed patients treated with gemcitabine/nab-paclitaxel alongside Alpha DaRT. Both ACAPELLA and IMPACT focus on safety, feasibility and early efficacy signals, including tumor response, survival outcomes and conversion to surgical resection, as part of Alpha Tau’s broader global clinical strategy in high-need pancreatic cancer settings.

Alpha Tau Medical Ltd. announced that clinical data from two Jerusalem trials of its Alpha DaRT® alpha-radiation therapy in pancreatic cancer have been accepted for a first-ever oral presentation at Digestive Disease Week (DDW) 2026.

The abstract, led by Principal Investigator Dr. Harold Jacob, will be presented on May 2, 2026 at 10:30am (Central) in the Pancreatic Cancer I: Diagnosis and Treatment session. The work underpins Alpha Tau’s broader clinical development, including its IMPACT pilot study in the U.S. and plans toward a future pivotal study.

Alpha Tau Medical Ltd. director Avruch Michael filed an initial ownership report showing substantial equity exposure to the company. He holds 1,250,941 Ordinary Shares directly and a further 321,020 Ordinary Shares held indirectly through his spouse. He also reports 4,680 Restricted Share Units, which will vest in full on the earlier of one year from March 9, 2026 or the next annual shareholders meeting, subject to continued service. In addition, he holds multiple option grants over Ordinary Shares at exercise prices ranging from $1.10 to $11.50, with expirations extending from 2027 to 2036. Some of these options are already fully vested, while others are scheduled to vest in full on the same future timeline tied to continued service.