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 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].

Financial Performance - The company reported a net loss of $18,805,000 for the six months ended June 30, 2025, compared to a net loss of $15,350,000 for the same period in 2024, representing a 16% increase in losses[8][18]. - The net loss for the six months ended June 30, 2025, was $18,805,000, resulting in a net loss per Ordinary share of $0.25[65]. - Segment net loss increased from $15,350 in 2024 to $18,805 in 2025, representing a 15.9% increase[67]. - Financial income, net for the six months ended June 30, 2025, was $(315,000), a decrease from $(2,132,000) in the same period of 2024[64]. - Tax on income increased significantly from $4 in 2024 to $164 in 2025[67]. Assets and Equity - As of June 30, 2025, the total assets of Alpha Tau Medical Ltd. amounted to $110,954,000, an increase from $86,204,000 as of December 31, 2024[4][6]. - The total shareholders' equity increased to $86,623,000 as of June 30, 2025, from $62,666,000 as of January 1, 2025, reflecting a significant capital raise[6][11]. - The accumulated deficit increased to $166,314,000 as of June 30, 2025, from $147,509,000 at the beginning of the year[6][18]. Cash Flow and Financing - Cash and cash equivalents at the end of the period were $11,703,000, a decrease from $13,724,000 at the beginning of the period[13][18]. - The company had negative cash flows from operating activities of $14,612,000 for the six months ended June 30, 2025, compared to $12,803,000 for the same period in 2024[13][18]. - Alpha Tau Medical Ltd. issued 14,336,323 ordinary shares during the first half of 2025, raising $37,431,000 in additional paid-in capital[11]. - The Company entered into a long-term loan of approximately $5,248,000 in October 2023, maturing in October 2026[33]. Research and Development - Research and development expenses for the six months ended June 30, 2025, were $14,182,000, up from $13,314,000 in the same period of 2024, indicating a 6.5% increase[8]. - The company expects to continue incurring substantial losses during its clinical development phase, necessitating further financing and regulatory approvals[15][18]. - Alpha Tau Medical Ltd. is focused on the development of Alpha DaRT technology for treating solid tumors, with ongoing efforts to secure additional funding and regulatory approvals[15][17]. Warrants and Liabilities - As of June 30, 2025, the Company has 13,605,561 Public Warrants and 2,142,000 Private Warrants outstanding, classified as liabilities[24]. - The fair value of Public Warrants increased from $2,857,000 on December 31, 2024, to $3,267,000 on June 30, 2025[45]. - The fair value of Private Warrants was $481,000 as of December 31, 2024, and increased to $514,000 as of June 30, 2025[45]. - The fair value of Level 3 Private Warrants liability decreased from $977,000 at the beginning of the period to $481,000 at the end of the period, reflecting a change in fair value of $(496,000) for the six months ended June 30, 2025[48]. - The Company's contingent liability to the IIA totaled $7,478,000 as of June 30, 2025, which includes $474,000 of royalty-bearing grants assumed from Althera[50]. - The Company received IIA participation payments amounting to $5,533,000 through June 30, 2025, and is committed to pay royalties at a rate of 3% of future revenue from funded research programs[51]. Expenses - The total share-based compensation expense for the six months ended June 30, 2025, was $5,331,000, compared to $4,867,000 for the same period in 2024[60]. - Salaries and related benefits rose from $10,642 in 2024 to $11,596 in 2025, an increase of 9%[67]. - Clinical trials, subcontractors, and materials expenses increased from $2,732 in 2024 to $3,431 in 2025, a rise of 25.6%[67]. - Professional, legal, and marketing expenses grew from $1,557 in 2024 to $1,678 in 2025, an increase of 7.8%[67]. - Financial expenses improved from a net loss of $2,132 in 2024 to a net loss of $315 in 2025, a reduction of 85.2%[67]. Other Information - The Company is currently evaluating the impact of adopting ASU 2023-09, effective for fiscal years beginning after December 15, 2025[29]. - The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025, which may impact the company's consolidated financial statements[68]. - The weighted average remaining lease term decreased from 10.07 years as of December 31, 2024, to 9.50 years as of June 30, 2025[32]. - Total undiscounted lease payments as of June 30, 2025, amount to $9,761,000, with a present value of lease liabilities of $7,281,000[32]. - The estimated fair values of financial instruments approximate their carrying value due to short-term maturities[28]. - The Company has recorded a total of $151,000 in interest expenses and $196,000 in currency exchange income for the six-month period ended June 30, 2024[35]. - As of June 30, 2025, the Company had 16,709,831 options outstanding with a weighted average exercise price of $4.38, and 11,103,202 of these options were exercisable[59]. - The Company has unrecognized compensation costs of $15,435,000 expected to be recognized over a weighted average period of approximately 2.08 years as of June 30, 2025[60]. - The Company entered into a collaboration agreement with MIM Software, Inc. to develop treatment planning software for clinical sites using the Alpha DaRT therapy, which includes future commercial sales[54].

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 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 - Alpha Tau Medical Ltd. has successfully closed a registered direct offering, raising approximately $36.9 million through the sale of 14,110,121 ordinary shares at a price of $2.612 per share [1][2] - The investment comes at a crucial time for Alpha Tau, which is experiencing significant growth with four active U.S. trial approvals and expansion into multiple internal organ applications [1][4] - Alpha Tau plans to utilize the net proceeds for general corporate purposes, including research and development, manufacturing expansion, and potential commercialization of its product candidates [2] Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and commercialization of the Alpha DaRT technology for treating solid tumors [6] - The Alpha DaRT technology involves intratumoral delivery of radium-224 to enable targeted alpha-irradiation of tumors, aiming to destroy cancer cells while sparing healthy tissue [7] Strategic Partnership - An affiliate of Oramed Pharmaceuticals has entered into an agreement to provide Alpha Tau with strategic services, including investor and public relations, over the next three years [3] - Both companies express strong confidence in the partnership, with expectations for significant advancements in clinical and commercial efforts [4]

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]