- 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 commer ...

Core Insights - Alpha Tau Medical Ltd. is participating in the Jefferies Global Healthcare Conference in London on November 18-19, 2025, where CFO Raphi Levy will hold 1x1 investor meetings [1] Company Overview - Alpha Tau Medical Ltd. was founded in 2016 and is an Israeli oncology therapeutics company focused on the research, development, and potential commercialization of 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] Technology Details - 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 works by releasing short-lived daughter isotopes from radium-224, which emit high-energy alpha particles aimed at destroying tumors while minimizing damage to surrounding healthy tissue [3]

Core Insights - Alpha Tau Medical Ltd. has received a radioactive material license from the State of New Hampshire, marking a significant milestone for the commercial-scale manufacturing of its Alpha DaRT cancer therapy [1][3] - The company aims to initiate Alpha DaRT treatment manufacturing in 2026, following the completion of the first phase of its facility in Hudson, New Hampshire [1][3] Company Developments - In October 2023, Alpha Tau entered a long-term lease for a building over 14,000 rentable square feet in Hudson, New Hampshire, for the Alpha DaRT manufacturing facility, which will be constructed in multiple phases [2] - The expected nameplate capacity from the first phase is approximately 400,000 Alpha DaRT sources for local use, contingent on operational and clinical assumptions [2] Operational Milestones - CEO Uzi Sofer expressed excitement over the operational milestone and acknowledged the efforts of the operations and engineering teams, as well as the support from local authorities [3] - With the radioactive material license secured, the company can proceed with equipping the facility and aims to produce Alpha DaRT treatments during 2026 [3] Product Overview - 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 sources [6] - The therapy is currently being evaluated in multiple clinical trials for various cancers, including skin, head & neck, pancreas, lung, prostate, and brain tumors [4] Company Background - Founded in 2016, Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company focused on the research, development, and potential commercialization of Alpha DaRT for solid tumor treatment [5] - The technology was developed by professors from Tel Aviv University [5]

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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]

Company Overview - Whitehawk Therapeutics, Inc. is an oncology therapeutics company focused on applying advanced technologies to established tumor biology for improved cancer treatments [2] - The company has developed a three-asset ADC portfolio designed to address the limitations of first-generation therapies, aiming to significantly impact patients with difficult-to-treat cancers [2] Upcoming Events - The company's president and CEO, Dave Lennon, PhD, will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, at 4:50 PM ET [4] - Additionally, he will engage in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 3:30 PM ET [4] - Live webcasts of these events will be available on the Whitehawk Therapeutics IR website and can be replayed for approximately 30 days post-event [1]

Core Viewpoint - Alpha Tau Medical Ltd. is actively engaging with investors through multiple conferences in September 2025 to discuss its innovative alpha-radiation cancer therapy, Alpha DaRT, which aims to treat solid tumors while minimizing damage to surrounding healthy tissue [1][3]. 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 [5]. - The Alpha DaRT technology was developed by Professors Itzhak Kelson and Yona Keisari from Tel Aviv University [5]. Technology Insights - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes localized alpha particle radiotherapy to destroy solid tumors while sparing healthy tissue, with the potential for broad applicability in local tumor control [2][4]. - The therapy involves intratumoral delivery of radium-224 sources, which emit high-energy alpha particles that primarily affect the tumor due to their short diffusion distance [4]. Upcoming Events - The CFO, Raphi Levy, will present at several investor conferences in September 2025, including: - Citi 2025 Biopharma Back to School Summit on September 2-3, 2025, in Boston, MA [3] - H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, in New York, NY [3] - Oppenheimer's Third Annual Targeted Radiopharmaceutical Therapies in Oncology Summit on September 11, 2025, in New York, NY [3] - RTH & Co / Redburn Atlantic - Radiopharma Landscape Conference on September 26, 2025, in New York, NY [3] - Lytham Partners Fall 2025 Investor Conference on September 30, 2025, virtually [3].

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]

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 [3] - The technology behind Alpha DaRT was developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University [3] Product Information - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes intratumoral delivery of radium-224 impregnated sources to provide highly potent and conformal alpha-irradiation of solid tumors [4] - The therapy aims to destroy tumors while sparing surrounding healthy tissue, as the alpha-emitting atoms diffuse only a short distance [4] Upcoming Events - The CFO of Alpha Tau, Raphi Levy, will present at the Jefferies Global Healthcare Conference on June 5, 2025, from 1:25 to 1:55 PM ET in New York, NY [2] - Mr. Levy will also be available for one-on-one investor meetings during the conference [2]

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]