– First patient treatment marks successful initiation of multi-center pilot study in Alpha DaRT U.S. pancreatic cancer program – – Study explores Alpha DaRT® combined with chemotherapy in patients with newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma – – Up to 87% of newly diagnosed pancreatic cancer patients are considered inoperable at diagnosis and face a dismal prognosis, with limited benefit from existing therapies – – This pilot study is a key part of Alpha Tau’s b ...

Core Insights - Alpha Tau Medical Ltd. reported its second quarter 2025 financial results and provided a corporate update, emphasizing its focus on U.S. clinical trials and preparations for commercial scale-up [1][2] Corporate Activities - The company is actively conducting four U.S. Investigational Device Exemptions (IDEs), including pivotal trials for skin cancer and studies for pancreatic cancer and glioblastoma multiforme (GBM) [2][3] - A significant milestone includes the completion of a $36.9 million registered direct financing from Oramed Pharmaceuticals, enhancing its strategic position [3] Financial Performance - Research and Development expenses for the first half of 2025 were $14.2 million, up from $13.3 million in the same period of 2024, primarily due to increased employee compensation [5] - The company reported a net loss of $18.8 million, or $0.25 per share, compared to a net loss of $15.4 million, or $0.22 per share, in the first half of 2024 [9][18] - As of June 30, 2025, the company had cash and cash equivalents totaling $83.3 million, an increase from $62.9 million at the end of 2024, providing a runway for continued clinical advancement [10] Upcoming Milestones - The first patient is expected to be enrolled in the pancreatic cancer pilot study in Q3 2025, with treatment initiation for the GBM pilot study anticipated in H2 2025 [6] - The company expects to receive a response from Japan's PMDA regarding pre-market approval for Alpha DaRT in H2 2025 [6]

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]

Core Insights - Alpha Tau Medical Ltd. has appointed Mr. Nadav Kidron, President and CEO of Oramed Pharmaceuticals Inc., to its Board of Directors following a strategic investment between the two companies [1][2] 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 [3] - The Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) technology allows for targeted alpha-irradiation of solid tumors through the intratumoral delivery of radium-224 sources, aiming to destroy tumors while sparing surrounding healthy tissue [4]

Mr. Levy will be available for 1x1 investor meetings at both conferences. Please reach out to your H.C. Wainwright and Lytham Partners representatives to schedule. JERUSALEM, May 06, 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 CFO Raphi Levy will presentation in the following investor conferences in May 2025. Event: H.C. Wainwright 3rd Annual BioConnect ...

Core Insights - Oramed Pharmaceuticals has made a strategic investment in Alpha Tau Medical, acquiring approximately 14.1 million shares at a price of $2.612 per share, aimed at supporting Alpha Tau's innovative cancer therapy technology [1][2] - The partnership combines Oramed's oral drug delivery platform with Alpha Tau's precision radiation delivery technology, enhancing both companies' capabilities in therapeutic delivery [1][3] - Oramed will provide strategic guidance and capital markets expertise to Alpha Tau through a three-year service agreement, which includes appointing two directors to Alpha Tau's Board [2][3] Company Overview - Oramed Pharmaceuticals specializes in oral delivery solutions for drugs typically administered via injection, utilizing its proprietary Protein Oral Delivery (POD™) technology to enhance drug integrity and absorption [4] - Alpha Tau Medical, founded in 2016, focuses on the research and development of the Alpha DaRT® technology for treating solid tumors, initially developed by professors from Tel Aviv University [5] Strategic Goals - The collaboration is expected to accelerate Alpha Tau's clinical trials across four indications in the U.S., expand manufacturing capacity, and enhance commercialization efforts [1][2] - Both companies share a vision of transforming therapeutic delivery methods, with Oramed focusing on oral administration and Alpha Tau on targeted radiation therapy [3]