Latest news with #IDE
Yahoo
12-06-2025
- Business
- Yahoo
Presidio Medical™ Receives IDE Approval for Ultra Low Frequency (ULF™) Neuromodulation Clinical Study and Appoints Dimas Jiménez as Chief Financial Officer
FDA Investigational Device Exemption (IDE) Approval enables Presidio's ULF platform technology to be tested in a pivotal clinical trial in the United States, representing a significant step in bringing this transformational technology to patients who suffer from chronic nociceptive low back pain. SAN MATEO, Calif., June 12, 2025--(BUSINESS WIRE)--Presidio Medical, Inc., a global clinical-stage medical device company developing a transformational Ultra Low Frequency (ULF™) neuromodulation platform, received IDE approval from the FDA, enabling the company to commence a global, pivotal, randomized controlled trial, the FULFILL Study, in the United States and Australia. ULF Neuromodulation will be delivered via leads implanted in the epidural space, also known as Spinal Cord Stimulation (SCS). Presidio is a patient-centric medical technology company developing a novel approach to treating chronic nociceptive low back pain with the goal of providing durable relief to an underserved patient population. The ULF neuromodulation platform is designed to target localized pain by reducing neuronal responses; suppression of these signals may reduce suffering for patients who have chronic nociceptive low back pain. There are currently no approved SCS treatment options for nociceptive back pain, which presents a $20B market opportunity. "IDE approval from the FDA represents a significant milestone for Presidio and enables the study of ultra low frequency modulation of the nervous system. The results from our first-in-human clinical trial in Australia, which were presented by Dr. Marc Russo at NANS earlier this year, were very encouraging. We are excited to now begin a more robust trial, which we believe will demonstrate the safety and efficacy of our ULF platform," said Michael Onuscheck, Presidio Medical's Chief Executive Officer. In addition, the company is pleased to announce Dimas Jiménez has joined as Chief Financial Officer (CFO). Mr. Jiménez brings over four decades of finance experience, spanning roles from Wall Street to both large and start-up life science organizations. He will be responsible for continuing to build the financial infrastructure of Presidio, supporting the commercialization efforts of our ULF neuromodulation system and expanding relationships with current and future investors. "We are extremely pleased to welcome Dimas to the Presidio team. The breadth and depth of his experience within the life science industry and his expertise in working with pre-commercialization start-up organizations is invaluable as we continue to grow and evolve as a company," said Onuscheck. "Presidio's ULF platform has the potential to greatly improve the lives of patients who suffer from debilitating chronic back pain. I've spent a significant amount of my career working with companies whose goal is to disrupt the status quo. I couldn't be more excited to be a part of this mission-driven and patient-centric organization," said Jiménez. Mr. Jiménez most recently served as the CFO of Spire Health and has held prior positions as CFO at StemoniX and Orphagen Pharmaceuticals. He has managed four company exits and has helped raise $670 million in capital for life science organizations. Mr. Jiménez received a Bachelor of Arts degree from Dartmouth College, a Master of Business Administration from Stanford University and is a Chartered Financial Analyst (CFA). About Presidio Medical Presidio Medical was founded in 2017 and is headquartered in San Mateo, CA. This clinical stage privately held medical device company is developing a transformational neuromodulation platform to treat diseases of undesired neural activity, with a first indication in the treatment of chronic pain. Presidio's investors include Deerfield Management, Invus Opportunities, Action Potential Venture Capital, and ShangBay Capital. For more information, visit: View source version on Contacts Media Contact Maureen ShayPresidio Medical, 650-502-1071 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
11-06-2025
- Business
- Business Wire
Anaconda Biomed Appoints Dr. Charles Carignan as New Chairman of the Board of Directors
BARCELONA, Spain & MARIN, Calif.--(BUSINESS WIRE)-- Anaconda Biomed S.L., a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, announced today the appointment of long-time medtech executive Charles (Chuck) Carignan, M.D., as chairman of the board. Dr. Carignan is joining the company at a critical time as enrollment progresses in the global investigational device exemption (IDE) ATHENA clinical trial, and additional work continues on building the company's pipeline of products. Dr. Carignan brings extensive clinical, product development, commercialization, and leadership expertise to the role. He has served on committees of the U.S. Food and Drug Administration, Centers for Medicare & Medicaid Services, the World Health Organization, the United Nations, and the U.S. Agency for International Development. Additionally, he has led multiple successful corporations, including being the founding president and CEO of NinePoint Medical, president and CEO of BionX Medical, and CEO of SoniVie Inc. Additional prior roles include executive vice president and chief medical officer at Novasys Medical, chief medical officer of Endosurgery at Boston Scientific, and vice president of clinical research and medical affairs at Conceptus, Inc. He currently serves as the executive chairman of Cairdac, chairman of SamanTree Medical, and a director of Biothea and Prothea. 'It is a privilege to welcome Chuck to Anaconda Biomed,' said Trent Reutiman, chief executive officer. 'With his leadership experience at Boston Scientific, numerous private venture-backed start-ups, and international government health agencies, Chuck brings a proven track record of developing and overseeing global healthcare companies. His operational and clinical insights will be invaluable as we continue to grow.' Dr. Carignan is joining the company at a critical time as enrollment progresses in the global investigational device exemption (IDE) ATHENA clinical trial, and additional work continues on building the company's pipeline of products. Dr. Carignan added, 'Beginning with the unique ANA Funnel Catheter technology, Anaconda has the opportunity to literally change the shape of the mechanical thrombectomy field. I am honored to join the board to actively contribute to the next phase of the company's successes by working closely with Trent and the rest of the board.' About ANA Funnel Catheter ANA5 Advanced Neurovascular Access™ (ANA Funnel Catheter) is designed as an expandable and collapsable funnel catheter for interventional neurovascular procedures, requiring the retrieval of clot, and benefiting from limiting flow and/or flow reversal towards that goal. The device consists of a radiopaque nitinol braid funnel, covered with a polymeric coating enabling local flow arrest. The catheter is currently an investigational device and is not available for sale in the United States or the European Union. About Anaconda Biomed Anaconda Biomed is an innovative medical technology company dedicated to developing next-generation thrombectomy systems for the treatment of ischemic stroke. At the heart of its product portfolio is the ANA Funnel Catheter. Anaconda Biomed has received funding from prominent life science investment firms, including Ysios Capital, Omega Funds, Innogest, Asabys Partners, Banco Sabadell, and private investors. Additionally, through public grants, the company has received significant public support from ENISA, CDTI (Innvierte and NEOTEC), the Ministry of Science & Innovation (Emplea and Retos), EIB, and EIT Health. For more information, please visit and follow the company on LinkedIn.
Yahoo
11-06-2025
- Business
- Yahoo
Anaconda Biomed Appoints Dr. Charles Carignan as New Chairman of the Board of Directors
BARCELONA, Spain & MARIN, Calif., June 11, 2025--(BUSINESS WIRE)--Anaconda Biomed S.L., a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, announced today the appointment of long-time medtech executive Charles (Chuck) Carignan, M.D., as chairman of the board. Dr. Carignan brings extensive clinical, product development, commercialization, and leadership expertise to the role. He has served on committees of the U.S. Food and Drug Administration, Centers for Medicare & Medicaid Services, the World Health Organization, the United Nations, and the U.S. Agency for International Development. Additionally, he has led multiple successful corporations, including being the founding president and CEO of NinePoint Medical, president and CEO of BionX Medical, and CEO of SoniVie Inc. Additional prior roles include executive vice president and chief medical officer at Novasys Medical, chief medical officer of Endosurgery at Boston Scientific, and vice president of clinical research and medical affairs at Conceptus, Inc. He currently serves as the executive chairman of Cairdac, chairman of SamanTree Medical, and a director of Biothea and Prothea. "It is a privilege to welcome Chuck to Anaconda Biomed," said Trent Reutiman, chief executive officer. "With his leadership experience at Boston Scientific, numerous private venture-backed start-ups, and international government health agencies, Chuck brings a proven track record of developing and overseeing global healthcare companies. His operational and clinical insights will be invaluable as we continue to grow." Dr. Carignan is joining the company at a critical time as enrollment progresses in the global investigational device exemption (IDE) ATHENA clinical trial, and additional work continues on building the company's pipeline of products. Dr. Carignan added, "Beginning with the unique ANA Funnel Catheter technology, Anaconda has the opportunity to literally change the shape of the mechanical thrombectomy field. I am honored to join the board to actively contribute to the next phase of the company's successes by working closely with Trent and the rest of the board." About ANA Funnel Catheter ANA5 Advanced Neurovascular Access™ (ANA Funnel Catheter) is designed as an expandable and collapsable funnel catheter for interventional neurovascular procedures, requiring the retrieval of clot, and benefiting from limiting flow and/or flow reversal towards that goal. The device consists of a radiopaque nitinol braid funnel, covered with a polymeric coating enabling local flow arrest. The catheter is currently an investigational device and is not available for sale in the United States or the European Union. About Anaconda Biomed Anaconda Biomed is an innovative medical technology company dedicated to developing next-generation thrombectomy systems for the treatment of ischemic stroke. At the heart of its product portfolio is the ANA Funnel Catheter. Anaconda Biomed has received funding from prominent life science investment firms, including Ysios Capital, Omega Funds, Innogest, Asabys Partners, Banco Sabadell, and private investors. Additionally, through public grants, the company has received significant public support from ENISA, CDTI (Innvierte and NEOTEC), the Ministry of Science & Innovation (Emplea and Retos), EIB, and EIT Health. For more information, please visit and follow the company on LinkedIn. View source version on Contacts MEDIA CONTACT: Joe DuraesPazanga Health Communications jduraes@ 917-687-6419
Geeky Gadgets
02-06-2025
- Business
- Geeky Gadgets
Trae AI: The Free AI Coding Tool That's Smarter Than Your IDE
What if your coding environment could think, adapt, and evolve alongside your projects—without costing you a dime? Enter Trae AI, a free alternative to traditional coding IDEs that's redefining the way developers approach their work. Unlike its well-known competitors like Visual Studio Code, Trae AI doesn't just stop at being functional; it's designed to be fantastic. With features like customizable coding agents and seamless integration of innovative AI models, this platform promises to streamline workflows, boost productivity, and empower developers to tackle even the most complex challenges. Whether you're debugging intricate code or experimenting with AI-driven applications, Trae AI offers a modern solution that's as versatile as it is powerful. In this breakdown, Prompt Engineering explore how Trae AI sets itself apart from the crowd. From its innovative Multi-Contextual Prompt Systems (MCPS) to its robust privacy measures, this IDE is packed with tools that cater to both the creative and technical needs of developers. You'll discover how Trae AI's AI model compatibility can push the boundaries of your projects and why its thoughtful design makes it accessible for developers of all skill levels. But is it truly the free, all-in-one solution it claims to be? Let's unpack its features, benefits, and potential limitations to see if Trae AI lives up to its bold promise of being the ultimate coding companion. Overview of Trae AI IDE TL;DR Key Takeaways : Trae AI is a free, modern IDE designed to rival platforms like Visual Studio Code, offering advanced customization, seamless AI integration, and robust privacy measures. Customizable coding agents with Multi-Contextual Prompt Systems (MCPS) streamline workflows, improve precision, and adapt to specific project needs. Supports integration with advanced AI models like Gemini 2.5 Pro, GPT-4.1, and Cloud 3.5 Sonnet, along with custom AI models via API keys for innovation and experimentation. Features include a clean user interface, real-time code execution previews, integrated web search, and tools for diverse projects like text-to-image generation and REST API integration. Emphasizes data privacy and security with local data storage, encrypted transmissions, and regional compliance options, making sure a secure development environment. Customizable Coding Agents for Enhanced Productivity A standout feature of Trae AI is its customizable coding agents, which are designed to streamline workflows and improve precision. These agents use Multi-Contextual Prompt Systems (MCPS) to handle complex, multi-layered instructions, allowing you to adapt tools and workflows to specific tasks. This level of customization ensures that your coding environment evolves alongside your projects, whether you're debugging intricate code, scripting automation processes, or developing APIs. By tailoring these agents to your unique requirements, you can significantly boost both productivity and accuracy, making Trae AI a powerful tool for developers seeking efficiency. Seamless AI Model Integration for Advanced Development Trae AI supports a wide range of advanced AI models, including Gemini 2.5 Pro, GPT-4.1, and Cloud 3.5 Sonnet. This compatibility allows you to select the model that best aligns with your project goals, making sure optimal performance and precision. Additionally, the platform offers the flexibility to integrate custom AI models via API keys, allowing experimentation and innovation. This feature is particularly beneficial for developers working on AI-driven applications, machine learning projects, or other innovative technologies. By providing seamless integration with these models, Trae AI enables you to push the boundaries of what is possible in software development. Free Cursor Alternative Trae AI Coding Assistant Gain further expertise in AI Coding IDE by checking out these recommendations. Features That Simplify and Enhance Your Workflow Trae AI is equipped with a robust set of features designed to simplify coding tasks and enhance overall productivity. Key highlights include: A clean and intuitive user interface that assists easy navigation and efficient project management. that assists easy navigation and efficient project management. Integrated web search capabilities , allowing you to access relevant information without leaving the IDE. , allowing you to access relevant information without leaving the IDE. Preconfigured MCPS options for quick access to documentation, examples, and templates . . Real-time code execution and output previews, allowing you to test and refine your code efficiently. These features work cohesively to create a seamless development experience, saving you time and effort while making sure high-quality results. Whether you're a beginner or an experienced developer, Trae AI's thoughtful design makes it accessible and practical for a wide range of users. Versatility Across Diverse Projects Trae AI's versatility makes it an ideal choice for a broad spectrum of applications. For example, the platform supports the development of text-to-image generators by integrating APIs such as Google's Gemini API. With built-in tools for image generation, regeneration, and downloading, Trae AI caters to both creative and technical projects. Additionally, its support for REST APIs simplifies the integration of external services, allowing you to expand the scope of your projects. Whether you're building innovative applications or managing routine tasks, Trae AI provides the tools and flexibility needed to bring your ideas to life. Privacy and Security: A Foundational Priority Trae AI places a strong emphasis on data privacy and security, making sure that your work remains protected at all times. The platform stores data locally and uses temporary uploads only for processing tasks, minimizing the risk of unauthorized access. All transmissions are encrypted, and strict access controls are implemented to safeguard your files. Furthermore, regional data deployment options allow you to comply with local regulations, making Trae AI a reliable choice for developers handling sensitive or confidential information. This commitment to security ensures peace of mind, allowing you to focus on your projects without concerns about data breaches or compliance issues. Optimized Usability for Developers of All Levels Designed with both simplicity and functionality in mind, Trae AI is particularly well-suited for small to medium-sized projects. Features such as code diffs and inline editing make it easy to track changes and refine your work, while the platform's extensive customization options allow you to tailor the environment to your specific needs. Although some AI models may have rate limits, Trae AI's comprehensive feature set ensures that it remains a strong alternative to traditional IDEs. Best of all, the platform is completely free, making it accessible to developers of all experience levels, from beginners to seasoned professionals. A Modern IDE Built for Today's Developers Trae AI stands out as a robust and secure coding IDE that prioritizes customization, functionality, and user experience. By integrating advanced AI models, customizable coding agents, and strong privacy measures, it offers a comprehensive solution for developers seeking a modern and efficient coding environment. Whether you're working on innovative AI applications, creative projects, or routine programming tasks, Trae AI equips you with the tools and flexibility to succeed. With its free access and versatile features, Trae AI is a valuable resource for developers looking to enhance their workflows and achieve their goals. Media Credit: Prompt Engineering Latest Geeky Gadgets Deals Some of our articles include affiliate links. If you buy something through one of these links, Geeky Gadgets may earn an affiliate commission. Learn about our Disclosure Policy
Yahoo
20-05-2025
- Business
- Yahoo
Alpha Tau Announces First Quarter 2025 Financial Results and Provides Corporate Update
- Interim Jan-2025 results from three trials of Alpha DaRT® in treating pancreatic cancer shared at prestigious 2025 ASCO GI Symposium and R&D Update Day, showing >90% disease control rate, impressive overall survival in sub-group analyses, and positive safety profile - - 75% systemic objective response rate (ORR) and 37.5% complete response rate meaningfully higher thus far than historical Keytruda® monotherapy data in Jan-2025 interim read out of a combination trial of Alpha DaRT and Keytruda in head and neck squamous cell carcinoma (HNSCC) - - FDA approval of Investigational Device Exemption (IDE) and IDE supplement to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy in patients with newly diagnosed locally advanced or metastatic pancreatic cancer -- MDSAP certification of the Company's Jerusalem facility meets the standards of the U.S., Australia, Brazil, Canada, and Japan, and completes audit for compliance with ISO 13485 - - FDA approval of IDE to conduct a U.S. pilot study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer -- Completion of $36.9 million financing after balance sheet date bolsters the Company's capital position during ongoing acceleration of activities - JERUSALEM, May 19, 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®, reported first quarter 2025 financial results and provided a corporate update.'2025 has started off with a bang at Alpha Tau, with a flurry of important milestones as we continue to evaluate Alpha DaRT in treating internal organ tumors, expand our manufacturing capabilities, and prepare for commercial activities,' said Alpha Tau Chief Executive Officer Uzi Sofer. 'With four active U.S. IDEs approved by the FDA, and U.S. trials expected to begin soon in patients with newly-diagnosed pancreatic cancer and recurrent GBM, construction of the first phase of our Hudson, NH facility nearing completion, and our ambitions for the continued expansion of our clinical trial program, our recently completed financing came at the perfect time to ensure that our momentum continues to accelerate throughout the course of the year.' Recent Corporate Highlights: In April, Alpha Tau announced the completion of a $36.9 million registered direct financing from, and strategic marketing alliance with, an affiliate of Oramed Pharmaceuticals, Inc. (Oramed). Oramed CEO, President and Chairman Nadav Kidron has also joined the Alpha Tau Board of Directors, bringing years of public company biotech experience. In April, Alpha Tau announced receipt of an IDE from the FDA to conduct a U.S. pilot study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM). The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation. In February, Alpha Tau announced achievement of Medical Device Single Audit Program (MDSAP) certification for the Company's manufacturing facility in Jerusalem. MDSAP was established by a coalition of international medical device regulatory authorities from Australia, Brazil, Canada, Japan and the U.S., to enable medical device manufacturers to be audited once for compliance with ISO 13485 and the standards of these five different markets. MDSAP certification may also speed the timetable to commercialization within these participating geographies, as it allows for a streamlined auditing process, providing manufacturers with a comprehensive approach to meet international regulatory standards efficiently. In January, Alpha Tau hosted a virtual R&D Update Day to present interim results from multiple trials as well as more information regarding the expected regulatory path forward in internal organs. Principal investigators presented data showing high disease control rate and strong interim safety results observed across three trials exploring the use of Alpha DaRT in pancreatic cancer patients, following a subset of the data presented by investigators at Hadassah Medical Center on a poster at the prestigious 2025 ASCO GI Symposium. Principal investigators also reported strong interim results in median survival of patients treated with Alpha DaRT after prior therapy as compared to previously published studies of alternative monotherapies, across all analyzed subgroups. At the R&D Update Day, positive interim results were also reported for the first eight patients recruited in a combination trial of Alpha DaRT with pembrolizumab (Keytruda), a checkpoint inhibitor, in treating patients with recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC). A reported systemic objective response rate of 75% and complete response rate of 37.5% were observed, compared to historical benchmarks of 19% and 5%, respectively, for pembrolizumab on its own in the KEYNOTE-048 trial. Approvals for two forthcoming clinical trials exploring the use of Alpha DaRT in treating pancreatic cancer were also announced during the R&D Update Day: IDE received from the FDA to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy in patients with newly diagnosed pancreatic cancer, the first step toward regulatory approval in the U.S. The trial was initially approved for 12 patients with metastatic cancer and was then expanded to 30 patients in two cohorts of 15 patients each, one cohort of patients with newly diagnosed locally advanced cancer and the other of patients with newly diagnosed metastatic cancer. Approval from France's Ministry of Health to commence a French multicenter clinical trial of Alpha DaRT alongside capecitabine for patients with locally advanced pancreatic cancer, as well as a second study at a single center in France examining the use of Alpha DaRT delivered via Fine Needle System, or FNS, in the treatment of locally advanced pancreatic cancer. Expected Upcoming Milestone Targets: First patient enrolled in pancreatic cancer pilot study in the U.S. in Q3 2025. For more information, please see here: First patient treated in Israel for brain cancer in Q2 or Q3 2025. Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q3 2025. For more information, please see here: First patient treated in U.S. GBM pilot study in H2 2025. For more information, please see here: Response from Japan's PMDA in H2 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer. Financial results for quarter ended March 31, 2025 R&D expenses for the three months ended March 31, 2025 were $7.2 million, compared to $6.4 million for the same period in 2024, due to increased employee compensation and benefits, increased production expenses and reduced government grants, offset by lower share-based compensation expenses. Marketing expenses for the three months ended March 31, 2025 were $0.5 million, compared to $0.5 million for the same period in 2024. G&A expenses for the three months ended March 31, 2025 were $1.7 million, compared to $1.4 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation, and increased professional fees (including legal expenses).Financial income, net, for the three months ended March 31, 2025 was $0.7 million, compared to $0.4 million for the same period in 2024, due to a decrease in expense from remeasurement of warrants, offset by a decrease in interest from bank the three months ended March 31, 2025, the Company had 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 three months ending March 31, 2024. Balance Sheet Highlights As of March 31, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $54.8 million, compared to $62.9 million at December 31, 2024. In April 2025, Alpha Tau raised $36.9 million through a registered direct financing transaction. About Alpha DaRT®Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around Alpha Tau Medical Ltd. Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv Statements This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on March 12, 2025, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release. Investor Relations Contact: IR@ BALANCE SHEET U.S. dollars in thousands December 31,2024 March 31,2025 Audited Unaudited ASSETS CURRENT ASSETS: Cash and cash equivalents $ 13,724 $ 5,019 Short-term deposits 45,876 46,617 Restricted deposits 3,255 3,212 Prepaid expenses and other receivables 1,374 1,938 Total current assets 64,229 56,786 LONG-TERM ASSETS: Long term prepaid expenses 432 439 Property and equipment, net 13,934 16,191 Operating lease right-of-use assets 7,609 7,512 Total long-term assets 21,975 24,142 Total assets $ 86,204 $ 80,928 CONSOLIDATED BALANCE SHEET U.S. dollars in thousands December 31,2024 March 31, 2025 Audited Unaudited LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Trade Payables $ 3,531 $ 2,577 Other payables and accrued expenses 4,133 6,188 Current maturities of operating lease liabilities 1,011 1,001 Total current liabilities 8,675 9,766 LONG-TERM LIABILITIES: Long-term loan 5,561 5,472 Warrants liability 3,338 3,545 Operating lease liabilities 5,964 5,820 Total long-term liabilities 14,863 14,837 Total liabilities 23,538 24,603 SHAREHOLDERS' EQUITY: Share capital Ordinary shares of no-par value per share – Authorized: 362,116,800 shares as of December 31, 2024 and March 31, 2025; Issued and outstanding: 70,380,570 and 70,511,475 shares as of December 31, 2024 and March 31, 2025, respectively - - Additional paid-in capital 210,175 212,525 Accumulated deficit (147,509 ) (156,200 ) Total shareholders' equity 62,666 56,325 Total liabilities and shareholders' equity $ 86,204 $ 80,928 CONSOLIDATED STATEMENT OF OPERATIONS U.S. dollars in thousands (except share and per share data) Three months ended March 31, 2024 2025 Unaudited Research and development, net $ 6,448 $ 7,170 Marketing expenses 533 459 General and administrative expenses 1,443 1,679 Total operating loss 8,424 9,308 Financial income, net (444 ) (716 ) Loss before taxes on income 7,980 8,592 Tax on income 1 99 Net loss 7,981 8,691 Net comprehensive loss 7,981 8,691 Net loss per share, basic and diluted $ (0.11 ) $ (0.12 ) Weighted-average shares used in computing net loss per share, basic and diluted 69,714,250 70,450,897 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
