- Expecting very active 2026 from a clinical perspective, including significant patient accrual completions and subsequent data readouts from ReSTART pivotal skin cancer trial as well as trials in cancers of internal organs including the pancreas and brain - - Ramping U.S. manufacturing for commercial readiness - Jerusalem, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT® today issued the ...

Summary of Alpha Tau Medical FY Conference Call Company Overview - **Company**: Alpha Tau Medical (Ticker: DRTS) - **Technology**: Alpha DaRT, a novel method for delivering alpha particles directly into solid tumors, aiming for more efficient local radiation therapy compared to traditional gamma rays or beta particles [5][6] Core Points and Arguments Technology and Applications - **Alpha DaRT Mechanism**: Utilizes a small pin coated with Radium-224 to release isotopes that diffuse into tumors, allowing for a more effective radiation dose with lower activity levels [6] - **Broad Applicability**: Preclinical tests across 20 tumor types have shown positive responses, focusing on high unmet needs like pancreatic and brain tumors [7][8] Clinical Progress - **Skin Cancer Trials**: Ongoing pivotal study for recurrent squamous cell carcinoma (SCC) with near 100% response rates in previous trials. Recruitment completion targeted for Q1 2026 [10][12] - **Pancreatic Cancer Study**: Recent ASCO GI presentations reported over 80% disease control and 20% response rates in a safety and feasibility study, indicating promising results with minimal immune system impact [18][21] - **Glioblastoma (GBM) Trials**: Initial treatments have begun, with successful delivery and 95% tumor coverage in the first patient, highlighting the potential for effective treatment in a challenging cancer type [23][24] Regulatory and Manufacturing Updates - **FDA Submission Strategy**: A modular PMA application allows for rolling submissions, with preclinical data already submitted while awaiting clinical trial results [15][16] - **Manufacturing Expansion**: A new facility in New Hampshire is being developed to meet commercial production needs, with a focus on scaling up capacity for future demand [25][26] Market Strategy - **Go-to-Market Approach**: Plans to build an internal sales force for U.S. markets while exploring partnerships in Canada, Israel, and Asia for commercialization [32][34] Important but Overlooked Content - **Financial Position**: As of Q3, the company had approximately $76 million in cash, with a burn rate of $5-5.5 million per quarter, indicating a solid financial foundation for ongoing operations and trials [38] - **Immunological Effects**: Alpha DaRT appears to preserve immune function while reducing inflammatory markers, suggesting a dual benefit of tumor treatment and immune system support [21][22] Key Deliverables and Milestones for 2026 - Completion of pivotal studies in skin cancer and pancreatic cancer, with data expected later in the year [37] - Ongoing monitoring and updates from the GBM study [37] This summary encapsulates the critical insights from the Alpha Tau Medical FY Conference Call, highlighting the company's innovative approach to cancer treatment, clinical advancements, regulatory strategies, and market positioning.

Summary of Alpha Tau Medical FY Conference Call Company Overview - **Company**: Alpha Tau Medical (NasdaqCM:DRTS) - **Industry**: Healthcare, specifically focused on cancer treatment using alpha particle therapy Core Points and Arguments - **Innovative Treatment**: Alpha Tau has developed a unique treatment for local intratumoral cancer therapy using alpha particles, which is distinct from traditional gamma and beta radiation therapies [2][3] - **Clinical Trials**: The company is currently conducting five approved clinical trials in the U.S. and is expecting significant data points and potential approvals in 2026, including a pivotal trial in skin cancer and studies in pancreatic cancer and glioblastoma [4][5][36] - **Technology Mechanism**: The treatment involves injecting radium-224 into tumors, which decays and releases alpha particles that effectively target cancer cells while minimizing damage to surrounding healthy tissue [7][10][12] - **Safety Profile**: The treatment has shown a mild safety profile with minimal systemic side effects, which is a significant advantage over traditional radiation therapies [14][12] Key Data and Milestones - **Skin Cancer Study**: A pivotal study for recurrent cutaneous squamous cell carcinoma (SCC) has shown a 100% complete response rate in a small pilot study, with plans for FDA submission following data collection [15][16][17] - **Pancreatic Cancer**: Interim data indicates a median overall survival of 7.5 months for untreated patients, significantly higher than the expected 3-3.5 months [28][30] - **GBM Trials**: The first patient for recurrent glioblastoma has been treated, with plans to expand recruitment based on safety data [49][32] Market Opportunity - **Targeted Patient Population**: The company estimates around 64,000 cases of recurrent cutaneous SCC annually in the U.S. and aims to address the 3.5% of cases that recur [18][25] - **Broader Applications**: Alpha Tau is exploring treatments for various cancers, including pancreatic and glioblastoma, which have high unmet medical needs [26][31] Manufacturing and Financials - **Manufacturing Expansion**: Alpha Tau is building a commercial facility in Hudson, New Hampshire, expected to produce enough for 15,000 patients annually, with the first phase completed and licensed [34][35] - **Financial Health**: The company reported approximately $76 million in cash at the end of Q3, with a controlled cash burn rate of $5-$6 million per quarter, allowing for sustained operations through ongoing studies [37][38] Regulatory and Reimbursement Strategy - **FDA Engagement**: Alpha Tau has received breakthrough designation for several indications, facilitating faster regulatory pathways and discussions around reimbursement strategies [47][46] - **Commercial Strategy**: The company plans to establish its own sales force in the U.S. for core indications while exploring partnerships in other markets [60][61] Additional Insights - **Immune Response**: Preliminary findings suggest that the treatment may trigger systemic anti-tumor immunity, enhancing the effectiveness of immunotherapies like Keytruda [19][22] - **Patient-Centric Approach**: The treatment is designed to be minimally invasive, allowing for outpatient procedures and reducing the need for extensive radiation safety measures [12][58] Conclusion - **Transformational Year Ahead**: 2026 is positioned as a pivotal year for Alpha Tau, with multiple regulatory submissions and clinical data expected to drive growth and market presence [35][64]

Core Insights - Alpha Tau Medical Ltd. announced final results from its first-in-human pancreatic cancer study, showing an 81% disease control rate and 87% when excluding the first two patients [1][2] - The study indicates that Alpha DaRT preserves the immune system and has potential anti-inflammatory effects, differing from conventional radiation therapies [1][4] - Alpha DaRT is currently being evaluated in a U.S. multi-center pilot trial in combination with chemotherapy for newly diagnosed pancreatic cancer patients [1][3] Study Results - The trial involved 32 patients with Stage II, III, or IV pancreatic ductal adenocarcinoma (PDAC), achieving a 22% objective response rate (ORR) and an 81% disease control rate (DCR) [2] - Excluding the first two patients, the ORR improved to 23% and the DCR to 87% [2] Immune Response - The immune markers indicated that Alpha DaRT treatment preserved the immune system, with no significant changes in various inflammatory indices post-treatment [4][5] - A significant reduction in IL-6 cytokine levels was observed, suggesting a potential decrease in inflammation [4] Future Trials - The company is pursuing further studies, including the IMPACT trial, to explore Alpha DaRT's efficacy in combination with chemotherapy for patients with unresectable locally advanced or metastatic PDAC [3][6] - The CEO emphasized the importance of pancreatic cancer treatment in the company's strategy and the ongoing recruitment pace for clinical trials [6] Technology Overview - Alpha DaRT utilizes radium-224 for targeted alpha-irradiation of solid tumors, aiming to minimize damage to surrounding healthy tissue [7]

Core Insights - Several biotechnology and pharmaceutical companies experienced significant stock price increases in after-hours trading due to clinical trial updates, regulatory advancements, and investor anticipation for upcoming data releases [1] Company Updates - Alumis Inc. (ALMS) saw a surge of 17.33% to $9.75, gaining $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program for envudeucitinib in moderate-to-severe plaque psoriasis will be reported on January 6, 2026, along with a conference call to discuss the results [2] - Genelux Corp. (GNLX) climbed 10.92% to $3.86, up $0.38, following interim results from ongoing trials evaluating Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) [3] - Bright Minds Biosciences Inc. (DRUG) rose 8.42% to $86.75, gaining $6.74, and announced a conference call on January 6, 2026, to report topline results from its Phase 2 trial of BMB-101 in patients with drug-resistant Absence Seizures [4] - Context Therapeutics Inc. (CNTX) shares increased by 8.36% to $1.68, adding $0.13, despite no specific news released [4] - BioAtla, Inc. (BCAB) gained 3.95% to $0.44, up $0.017, after announcing a special purpose vehicle transaction to advance ozuriftamab vedotin in a Phase 3 study for oropharyngeal squamous cell carcinoma, receiving $5 million in initial funding [5] - Femasys Inc. (FEMY) added 7.09% to $0.6223, up $0.04, with no new updates reported [5] - Acumen Pharmaceuticals, Inc. (ABOS) jumped 11.62% to $2.21, gaining $0.23, also without new corporate updates [6] - Alpha Tau Medical Ltd. (DRTS) rose 5.36% to $5.50, up $0.28, after submitting the first module of its pre-market approval application to the FDA for Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma [7]

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]

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]