Core Insights - Alpha Tau Medical Ltd. has initiated a multi-center pilot study in the U.S. for its Alpha DaRT® therapy targeting pancreatic cancer, marking a significant step in addressing the urgent need for innovative treatments in this area [1][4][10] Industry Overview - Pancreatic cancer is the third leading cause of cancer-related deaths in the U.S., with approximately 66,000 new cases diagnosed annually, and up to 87% of these patients are considered inoperable at diagnosis [3][4] - The prognosis for these patients is poor, with limited benefits from existing therapies, highlighting the critical need for new treatment options [3][4] Company Strategy - The pilot study, known as IMPACT, aims to evaluate the safety, feasibility, and efficacy of Alpha DaRT in combination with chemotherapy for patients with newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma [1][6] - This study is part of Alpha Tau's broader strategy to provide Alpha DaRT to cancer patients with significant unmet needs [1][4] Study Details - The IMPACT study plans to enroll up to 30 patients, with 15 having inoperable locally advanced disease and 15 with metastatic disease, across multiple centers in the U.S., Canada, and Israel [6][7] - Eligible patients must have newly diagnosed, histologically confirmed pancreatic adenocarcinoma and must be inoperable, non-irradiated, and either chemotherapy-naïve or within the first four cycles of their initial chemotherapy regimen [7] Treatment Methodology - Patients will continue receiving standard-of-care chemotherapy (mFOLFIRINOX) while Alpha DaRT sources will be implanted into the primary tumor using ultrasound-guided endoscopy [8][9] - The primary objectives of the study include assessing the feasibility of Alpha DaRT source implantation and evaluating its safety and tolerability, with secondary objectives focusing on local tumor response and overall survival [9]

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]

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 [2] - The technology behind Alpha DaRT was developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University [2] Product Information - 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 aims to destroy tumors while sparing surrounding healthy tissue, as the alpha-emitting atoms diffuse only a short distance [3] Investor Engagement - CFO Raphi Levy will present at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, in New York, NY [1] - Additionally, Mr. Levy will participate in 1x1 meetings at the Lytham Partners Spring 2025 Investor Conference on May 29, 2025, which will be held virtually [1]

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]