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]

Core Insights - Alpha Tau Medical is pioneering a unique method for delivering alpha particle radiation directly to solid tumors, which could represent a significant advancement in oncology [1] Company Overview - Alpha Tau Medical is currently not well known in the market, but its innovative approach may lead to substantial breakthroughs in cancer treatment [1]

Summary of Alpha Tau Medical Conference Call Company Overview - **Company**: Alpha Tau Medical Ltd. (Ticker: DRTS) - **Industry**: Medical Technology, specifically focused on cancer treatment using alpha radiation Core Points and Arguments 1. **Unique Treatment Method**: Alpha Tau Medical is pioneering the use of alpha radiation directly applied to cancerous tumors, which is more efficient and effective than traditional gamma and beta radiation methods [2][4] 2. **Broad Applicability**: The treatment has shown effectiveness across approximately 20 tumor types in animal studies, with no tumors identified that do not respond [3] 3. **Immune System Activation**: The treatment not only destroys tumors but also appears to stimulate the immune system to recognize and combat tumors elsewhere in the body [3][19] 4. **FDA Engagement**: The company is in active dialogue with the FDA and is targeting large markets with a robust pipeline of upcoming milestones [4][35] 5. **Pivotal Trials**: The pivotal trial for recurrent cutaneous squamous cell carcinoma (SCC) is expected to complete patient recruitment by the end of the year, with data submission anticipated by mid-2026 [17][35] 6. **Pancreatic Cancer Program**: The company recently announced the first treatment in the U.S. for pancreatic cancer, with a focus on achieving a high disease control rate [5][29] 7. **Clinical Success**: In a pilot study for skin cancer, Alpha Tau achieved a 100% complete response rate, with no serious adverse events reported [16][17] 8. **Market Potential**: The Skin Cancer Foundation estimates 1.8 million new cutaneous SCC cases annually in the U.S., with about 64,000 cases being recurrent and difficult to treat [18] 9. **Combination with Immunotherapy**: Initial studies suggest that combining Alpha Tau's treatment with immunotherapy (e.g., Keytruda) may enhance overall response rates [21][25] 10. **Survival Benefits**: Early data indicates that patients treated with Alpha Tau's method may experience longer survival times compared to historical data for standard treatments [30][31] Additional Important Content 1. **Manufacturing Expansion**: Alpha Tau is building a commercial-scale facility in New Hampshire, aiming for a capacity of approximately 15,000 patients per year [36] 2. **Financial Health**: The company reported $83 million in cash and deposits as of Q2, with a consistent burn rate of about $5 million per quarter [37] 3. **Focus on High Unmet Need**: The company is exploring treatments for high unmet need cancers, including pancreatic cancer and glioblastoma, with ongoing trials [28][34] 4. **Regulatory Approvals**: Alpha Tau has received IDE approval from the FDA to start a U.S. study in glioblastoma, with patient recruitment expected to begin soon [34] This summary encapsulates the key points discussed during the conference call, highlighting Alpha Tau Medical's innovative approach to cancer treatment, its clinical successes, and its strategic focus on expanding its market presence and product pipeline.

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]