Core Insights - Alpha Tau Medical Ltd. has submitted the first module of its pre-market approval (PMA) application to the FDA for its Alpha DaRT therapy aimed at treating recurrent cutaneous squamous cell carcinoma (cSCC) [1][2] - The FDA has granted Alpha Tau a flexible modular submission framework, allowing for streamlined review and feedback as each module is submitted [1][2] - The ReSTART pivotal study, which is currently ongoing, is expected to complete patient recruitment by Q1 2026 [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 Alpha DaRT for solid tumors [3] - The Alpha DaRT technology was developed by professors from Tel Aviv University and is designed for targeted alpha-irradiation of tumors [4] Technology Details - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes radium-224 sources for intratumoral delivery, 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 [3] - The technology behind Alpha DaRT was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University [3] 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 [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 - Alpha Tau will present a corporate overview and update at the J.P. Morgan 2026 Healthcare Conference on January 15, 2026, at 11:15 AM PT / 2:15 PM ET in San Francisco, CA [1] - The presentation will include a review of recent achievements and the outlook for upcoming data milestones [1] - Institutional investor meetings will also be hosted at the event, and a webcast link will be available on the company's Investor Relations page [2]

Summary of Alpha Tau Medical Conference Call Company Overview - **Company**: Alpha Tau Medical (NasdaqCM:DRTS) - **Industry**: Medical Technology, specifically focused on cancer treatment using alpha particle radiation therapy Core Points and Arguments 1. **Unique Treatment Approach**: Alpha Tau Medical is pioneering the use of alpha particles for localized cancer treatment, allowing direct injection into tumors, which is a significant advancement over traditional gamma and beta radiation methods [2][3][4] 2. **Efficiency of Alpha Particles**: The company claims that alpha particles are more efficient in killing tumor cells, allowing for much lower doses of radiation, which can be administered in standard medical settings without the need for specialized nuclear facilities [4][5] 3. **Broad Applicability**: Alpha Tau is exploring treatment across various tumor types, having seen positive responses in over 20 different types in preclinical studies [5][6] 4. **Clinical Trials and Milestones**: The company is actively conducting pivotal studies for recurrent skin cancer and has recently treated its first patient with recurrent glioblastoma, achieving over 95% tumor coverage [6][7][38] 5. **Regulatory Approvals**: Alpha Tau has received approval for its treatment in Israel and is awaiting responses for submissions in Japan and the U.S. for various cancer indications [16][49][50] 6. **Market Potential**: The company targets difficult-to-treat cancer cases, estimating around 64,000 stubborn skin cancer cases annually in the U.S. that could benefit from their treatment [20] 7. **Combination Therapies**: Alpha Tau is investigating the potential of combining its treatment with checkpoint inhibitors like Merck's Keytruda, showing promising early results in enhancing systemic anti-tumor immunity [22][24][27] 8. **Financial Health**: As of Q3, Alpha Tau reported approximately $76 million in cash, with a burn rate of about $5 million per quarter, indicating a strong financial position to support ongoing trials and operations [40][41][47] Additional Important Information 1. **Manufacturing Expansion**: The company is expanding its manufacturing capabilities, having completed the first phase of a commercial-scale facility in New Hampshire, which is crucial for future production [40] 2. **Patient-Centric Focus**: Alpha Tau emphasizes the importance of minimizing side effects and improving patient quality of life, particularly in treating painful conditions like pancreatic cancer [35][36] 3. **Upcoming Data Releases**: The company anticipates significant data releases in the second half of the year, which could influence future approvals and market strategies [39][50][55] 4. **Investor Interest**: The stock has seen a 50% increase over the past six months, indicating growing investor interest and confidence in the company's potential [52] This summary encapsulates the key points discussed during the conference call, highlighting Alpha Tau Medical's innovative approach to cancer treatment, ongoing clinical trials, regulatory efforts, and financial stability.

Group 1: Market Movements - Biotech stocks experienced significant fluctuations in after-hours trading, with several companies rebounding after substantial losses during regular sessions, driven by fresh clinical data, FDA designations, and financing announcements [1] - Stoke Therapeutics, Inc. (STOK) saw its stock rise to $33.95 (+11.42%) in post-market hours after closing at $30.47 (-7.67%), following positive data presentations with Biogen regarding zorevunersen for Dravet syndrome [2] - Alpha Tau Medical Ltd. (DRTS) experienced a notable increase in share price, climbing to $5.30 (+25.26%) after closing at $4.23 (+8.74%), following the treatment of the first patient in its pilot study for recurrent glioblastoma multiforme [3] Group 2: Company Announcements - Absci Corp. (ABSI) rose to $3.65 (+3.69%) after hours, building on a close of $3.52 (+2.03%), with no new announcements but previously reported first volunteer dosing in its Phase 1/2a HEADLINE study of ABS-201 [4] - Senti Biosciences, Inc. (SNTI) surged to $1.60 (+3.92%) after hours, despite a sharp decline to $1.54 (-35.56%) during regular trading, driven by the FDA granting RMAT designation to its investigational CAR-NK cell therapy for AML and other hematologic malignancies [5] - TuHURA Biosciences, Inc. (HURA) edged up to $1.18 (+0.85%) after hours, following a significant decline to $1.17 (-40.91%) at the close, announcing a registered direct offering of 9.4 million shares priced at $1.65 per share [6]

Core Viewpoint - Alpha Tau Medical Ltd. has successfully treated the first patient in the world with its Alpha DaRT technology for recurrent glioblastoma multiforme (GBM), marking a significant milestone in cancer treatment [3][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 Alpha DaRT for solid tumors [9]. - The Alpha DaRT technology was initially developed by professors from Tel Aviv University [9]. Technology Details - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes intratumoral delivery of radium-224 sources to emit high-energy alpha particles, aiming to destroy tumors while sparing surrounding healthy tissue [10]. - The technology is designed to provide highly potent and conformal alpha-irradiation specifically targeting solid tumors [10]. Clinical Study Insights - The pilot study aims to enroll up to ten U.S. patients with recurrent glioblastoma who are not suitable for surgical resection and have previously undergone central nervous system radiation [8]. - The primary objective of the study is to evaluate the feasibility and safety of the Alpha DaRT treatment, following promising preclinical results [8]. Treatment Significance - The treatment of GBM patients with Alpha DaRT addresses a critical need for new local therapies, given the high recurrence rate of GBM, typically within 6-9 months [4][6]. - The procedure demonstrated excellent feasibility, achieving over 95% coverage of the tumor volume with a novel delivery device that integrates seamlessly into standard neurosurgical workflows [7].

Core Insights - Alpha Tau Medical Ltd. is advancing its innovative alpha-radiation cancer therapy, Alpha DaRT, with a multi-center clinical trial for pancreatic cancer in the U.S. expected to complete patient recruitment by the end of Q1 2026 [1][2] - The company will present two abstracts at the 2026 ASCO Gastrointestinal Cancers Symposium, showcasing data from its recently completed pilot trial in Montreal [1][2] Company Overview - Alpha Tau Medical Ltd. was founded in 2016 and focuses on the research, development, and potential commercialization of Alpha DaRT for treating solid tumors [4] - The technology was developed by professors from Tel Aviv University, emphasizing its academic foundation [4] Clinical Trial Details - The U.S. multi-center pancreatic cancer clinical trial began patient treatment in September 2025 and aims to enroll up to 30 patients with newly diagnosed pancreatic cancer [2] - Approximately 87% of newly diagnosed pancreatic cancer patients are deemed inoperable, highlighting the significant unmet medical need [2] Technology Description - Alpha DaRT utilizes radium-224 for intratumoral delivery, allowing for targeted alpha-irradiation of solid tumors while minimizing damage to surrounding healthy tissue [3]

Core Viewpoint - Alpha Tau Medical Ltd. has received FDA approval for a pilot study using its Alpha DaRT technology to treat locally recurrent prostate cancer, marking its fifth active Investigational Device Exemption (IDE) in the U.S. [1][3] Group 1: Company Developments - The FDA's approval allows Alpha Tau to expand its Alpha DaRT technology into the U.S. market for prostate cancer treatment [1] - The clinical trial will enroll up to 12 patients with locally recurrent prostate cancer, focusing on safety and efficacy evaluations [2] - Alpha Tau aims to provide a new local salvage therapy option for patients facing limited alternatives [3] Group 2: Technology Overview - Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) utilizes radium-224 to deliver targeted alpha-radiation to solid tumors, minimizing damage to surrounding healthy tissue [4] - The technology was developed by researchers from Tel Aviv University and is focused on treating solid tumors [5]

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) is designed for highly potent and conformal alpha-irradiation of solid tumors through the intratumoral delivery of radium-224 impregnated sources [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 - CFO Raphi Levy will present at the 37th Annual Piper Sandler Healthcare Conference on December 3, 2025, from 1:00 to 1:25 PM ET in New York, NY [2] - Mr. Levy will also present at Sidoti's Year End Virtual Investor Conference on December 10, 2025, from 11:30 AM to 12:00 PM ET [2] - Mr. Levy will be available for one-on-one investor meetings at both conferences [2]

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. 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]