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]

JERUSALEM, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ:DRTS, DRTSW)), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today an approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) supplement to the IDE previously announced on Jan 27, 2025, which had approved a clinical study examining the combination of Alpha DaRT and first-line chemotherapy in 12 patients with newly d ...

- High disease control rate and strong interim safety results observed in pancreatic cancer patients across three trials exploring the use of Alpha DaRT® - - Ad-hoc analyses of pancreatic cancer population subgroups suggest meaningful improvement in median overall survival (OS) for patients treated with Alpha DaRT after prior therapy, compared to previously published studies of alternative monotherapies, across all analyzed subgroups – - Investigational Device Exemption (IDE) received from the FDA to conduc ...

- High disease control rate and strong interim safety results observed in pancreatic cancer patients across three trials exploring the use of Alpha DaRT® - - Ad-hoc analyses of pancreatic cancer population subgroups suggest meaningful improvement in median overall survival (OS) for patients treated with Alpha DaRT after prior therapy, compared to previously published studies of alternative monotherapies, across all analyzed subgroups – - Investigational Device Exemption (IDE) received from the FDA to conduc ...

JERUSALEM, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ:DRTS, DRTSW)), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today that an abstract entitled "Interim analysis of feasibility, safety, and tumor control in two first-in-human trials of a novel alpha-emitting radionuclide for pancreatic adenocarcinoma," submitted by principal investigators involved in the Company's Israeli pancreatic cancer trial, has been accept ...

JERUSALEM, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today that an abstract entitled “Interim analysis of feasibility, safety, and tumor control in two first-in-human trials of a novel alpha-emitting radionuclide for pancreatic adenocarcinoma,” submitted by principal investigators involved in the Company’s Israeli pancreatic cancer trial, has been accept ...