Core Insights - Alpha Tau Medical Ltd. is advancing its innovative alpha-radiation cancer therapy, Alpha DaRT, with ongoing patient treatments in a U.S. multi-center pilot study for pancreatic cancer [2][5] - The company has received a radioactive material license for its New Hampshire facility, which is a significant step towards commercial readiness [2][5] - Alpha Tau has a strong financial position with a cash balance of $75.9 million, allowing for continued clinical advancement and commercial preparation [2][11] Recent Corporate Highlights - The company reported a significant increase in patient treatment rates and interest from industry peers during the third quarter of 2025 [2] - Alpha Tau has invested nearly $2 million into its New Hampshire facility in Q3 2025 to prepare for operational readiness [2] - The first patient was treated in the U.S. multi-center pancreatic cancer clinical trial, which aims to enroll up to 30 patients [5] Expected Upcoming Milestone Targets - Completion of patient recruitment in the U.S. pivotal ReSTART trial for recurrent cutaneous squamous cell carcinoma is expected by Q1 2026 [5] - The company anticipates a response from Japan's PMDA regarding marketing authorization for Alpha DaRT in treating recurrent head and neck cancer by the end of 2025 [5] - The first patient in the U.S. GBM pilot study is expected to be treated in Q4 2025 [5] Financial Results - Research and Development expenses for the nine months ended September 30, 2025, were $22.5 million, an increase from $19.5 million in the same period in 2024 [6] - Marketing expenses decreased to $1.4 million in 2025 from $1.7 million in 2024 [7] - General and Administrative expenses rose to $5.8 million in 2025 from $4.6 million in 2024 [8] - The company reported a net loss of $30.5 million, or $0.39 per share, for the nine months ended September 30, 2025, compared to a net loss of $22.3 million, or $0.32 per share, in the same period in 2024 [10][20] Balance Sheet Highlights - As of September 30, 2025, the company had cash and cash equivalents totaling $75.9 million, an increase from $62.9 million at the end of 2024 [11] - Total assets were reported at $86.2 million as of September 30, 2025, compared to $104.7 million at the end of 2024 [16][18]

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]