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]

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]

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]

Financial Performance - Alpha Tau reported a net loss of $31.8 million, or $0.45 per share, for the year ended December 31, 2024, compared to a net loss of $29.2 million, or $0.42 per share, in 2023[10]. - Financial income, net, decreased to $4.3 million in 2024 from $6.5 million in 2023, attributed to lower income from warrant revaluation and bank deposits[9]. Research and Development - Research and development expenses increased to $27.0 million in 2024 from $26.4 million in 2023, driven by higher employee compensation and increased raw material costs[6]. - Alpha Tau achieved a systemic objective response rate of 75% and a complete response rate of 37.5% in a trial combining Alpha DaRT with Keytruda for head and neck cancer, significantly higher than historical rates of 19% and 5% respectively[4]. - The FDA approved an Investigational Device Exemption (IDE) for a U.S. pilot study of Alpha DaRT in combination with first-line chemotherapy for newly diagnosed pancreatic cancer, expanding the trial from 12 to 30 patients[4]. - The company is targeting the first patient enrollment in a pancreatic cancer pilot study in the U.S. in Q2 2025[13]. Operational Expenses - Marketing expenses rose to $2.3 million in 2024 from $1.9 million in 2023 due to increased marketing activities[7]. - General and administrative expenses decreased to $6.7 million in 2024 from $7.3 million in 2023, primarily due to lower professional fees[8]. Cash Position - The company had cash and cash equivalents of $62.9 million as of December 31, 2024, down from $84.9 million in 2023, with an expected runway of at least two years[11]. Facility Development - Alpha Tau's Hudson, NH facility is expected to complete its first phase of construction in the coming months, enhancing operational capabilities for Alpha DaRT production later in 2025[2].

Core Insights - Alpha Tau Medical Ltd. reported promising interim results from clinical trials of its Alpha DaRT® therapy for pancreatic cancer, showing high disease control rates and overall survival benefits [1][6] - The combination of Alpha DaRT with Keytruda demonstrated significantly higher response rates compared to historical data, indicating potential advantages in treating head and neck squamous cell carcinoma [1][6] - The company received FDA approval for multiple clinical trials, reflecting progress in its regulatory pathway and operational capabilities [5][6] Clinical Developments - Interim results from three trials for pancreatic cancer showed a high disease control rate and strong safety profile [1][6] - A combination trial of Alpha DaRT and Keytruda reported a systemic objective response rate of 75% and a complete response rate of 37.5%, significantly higher than historical benchmarks of 19% and 5% respectively [6] - FDA approved an Investigational Device Exemption (IDE) for a U.S. pilot study of Alpha DaRT with first-line chemotherapy in newly diagnosed pancreatic cancer patients, expanding the trial from 12 to 30 patients [5][6] Financial Performance - For the year ended December 31, 2024, the company reported R&D expenses of $27.0 million, up from $26.4 million in 2023, attributed to increased employee compensation and raw material costs [9] - Marketing expenses increased to $2.3 million in 2024 from $1.9 million in 2023 due to heightened marketing activities [10] - The company had a net loss of $31.8 million in 2024, compared to a net loss of $29.2 million in 2023, with a net loss per share of $0.45 [13][22] Cash Position - As of December 31, 2024, Alpha Tau had cash and cash equivalents totaling $62.9 million, down from $84.9 million in 2023, with an expected runway of at least two years [14] - The company’s total assets decreased from $107.4 million in 2023 to $86.2 million in 2024, reflecting changes in cash and short-term deposits [20] Upcoming Milestones - The company anticipates the first patient to be treated for brain cancer in Israel in H1 2025 and aims to enroll the first patient in the pancreatic cancer pilot study in the U.S. in Q2 2025 [16] - Alpha Tau is seeking FDA IDE approval in Q2 2025 for an early feasibility study in recurrent glioblastoma multiforme patients [16]

Financial Reporting and Accounting Standards - The company prepares its consolidated financial statements in accordance with U.S. GAAP, requiring estimates and judgments that affect reported amounts of assets, liabilities, and expenses [717]. - Share-based compensation is accounted for under ASC No. 718, with expenses recognized based on the probability of performance conditions being met [720]. - The fair value of public warrants is determined by the market price on Nasdaq, while private warrants are valued using a blend of market price and the Black-Scholes model [726]. Foreign Currency Exchange Risk - A 10% unfavorable movement in foreign currency exchange rates would increase operating expenses by approximately 4.5% and 4.7% for the years ended December 31, 2023 and 2024, respectively [708]. - The company does not currently hedge foreign currency exchange rate risk but may consider formal currency hedging transactions in the future [709]. Stock Options and Dividends - The expected term of options is determined using a simplified method, averaging the time-to-vesting and the contractual life of the options [727]. - The risk-free interest rate for options is based on the U.S. Treasury yield curve as of the date of grant [727]. - The company anticipates no dividends in the foreseeable future, using 0% as the expected dividend yield [727]. Company Status and Regulatory Considerations - The company remains an emerging growth company until total annual gross revenues exceed $1.235 billion or other specified conditions are met [712]. - The company is evaluating the benefits of relying on exemptions under the JOBS Act, including reduced reporting requirements [712].

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 initially 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 the intratumoral delivery of radium-224 impregnated sources [3]. - The therapy aims to destroy tumors by releasing high-energy alpha particles from the decay of radium, which primarily affects the tumor while sparing surrounding healthy tissue due to the short diffusion distance of alpha-emitting atoms [3]. Upcoming Events - CFO Raphi Levy will present at several investor conferences in March 2025, including: - Investor Summit Event on March 11, 2025, from 12:00 PM to 12:30 PM ET [1]. - Oppenheimer 35th Annual Healthcare MedTech & Services Conference on March 17, 2025, from 3:20 PM to 3:50 PM ET [1]. - Sidoti Small Cap Conference on March 19, 2025, from 11:30 AM to 12:00 PM ET [1]. - Mr. Levy will also be available for one-on-one investor meetings at these conferences [1].

Core Insights - Alpha Tau Medical Ltd. has achieved MDSAP certification for its manufacturing facility in Jerusalem, enhancing its commitment to quality and regulatory compliance while facilitating the global expansion of its alpha-radiation cancer therapy, Alpha DaRT [1][2][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 Alpha DaRT for treating solid tumors [4] - The Alpha DaRT technology was developed by professors from Tel Aviv University, aiming to deliver potent alpha-irradiation directly to solid tumors while minimizing damage to surrounding healthy tissue [5] Regulatory and Market Implications - MDSAP certification allows Alpha Tau to be audited once for compliance with ISO 13485 and the standards of five different markets, potentially speeding up the commercialization process in these regions [2] - The CEO of Alpha Tau emphasized that this milestone will help expand manufacturing capabilities and expedite marketing approvals across multiple geographies, aiming to bring a transformative product to market for solid tumor treatment [3]