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Alpha Tau Medical Ltd. (NASDAQ: DRTS) is at the forefront of oncology therapeutics, specializing in the research, development, and potential commercialization of the Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) technology. Founded in 2016, this Israeli medical device company focuses on the innovative use of alpha radiation to treat solid tumors. The Alpha DaRT technology, initially developed at Tel Aviv University, has shown promising results in preclinical and early clinical trials for various types of cancer.
Core Business and Technology: The Alpha DaRT technology uses alpha-emitting radium-224 atoms to target and destroy cancer cells while sparing surrounding healthy tissue. This method involves inserting radioactive seeds into the tumor, which release short-lived alpha particles. These particles have high biological effectiveness and a short range, making them ideal for localized treatment of solid tumors.
The company's current clinical trials are focused on multiple cancer types, including pancreatic, liver, and recurrent cutaneous squamous cell carcinoma. These trials are being conducted in various locations, including the European Union and North America. Notably, Alpha Tau is advancing its pivotal U.S. multi-center trial, ReSTART, which aims to treat recurrent cutaneous squamous cell carcinoma, and is expected to produce significant data by 2024.
Recent Achievements: Alpha Tau has made substantial progress recently. In October 2023, the company announced a long-term lease agreement for a new manufacturing site in Hudson, New Hampshire, which will significantly boost its production capabilities. Additionally, the company reported promising interim results from its pancreatic cancer trial and treated its first patient with liver metastases in a feasibility and safety study in Montreal, Canada.
Financial Condition: As of September 30, 2023, the company reported cash, restricted cash, and deposits totaling $90.1 million, ensuring sufficient funds to support operations for at least two years. For the nine months ended September 30, 2023, R&D expenses were $18.9 million, reflecting increased investments in employee compensation, clinical trials, and pre-clinical studies.
Partnerships and Collaborations: Alpha Tau is also exploring strategic partnerships to expand its clinical and commercial footprint. Discussions with major biopharmaceutical companies are underway, particularly for the Japanese market, where the company has completed a successful clinical trial for head and neck cancers.
Forward-Looking Statements: The company remains committed to advancing its clinical programs and expanding its manufacturing capabilities. With a strong financial position and a pipeline of promising clinical trials, Alpha Tau is well-positioned to make significant strides in the fight against cancer.
For more information, visit Alpha Tau Medical Ltd.
Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) announced the acceptance of two significant pre-clinical studies in prestigious journals, showcasing the synergy of Alpha DaRT therapy with standard solid tumor treatments. The first study, published in the Red Journal, highlights the potential of Alpha DaRT combined with anti-PD1 therapy to enhance immune response in squamous cell carcinoma. The second study in Frontiers in Oncology reveals that Alpha DaRT significantly boosts the effectiveness of standard treatments for glioblastoma. Alpha Tau aims to advance clinical trials based on these promising findings.
Alpha Tau Medical Ltd. (Nasdaq: DRTS) announced the resignation of Peter Melnyk from the Board of Directors to assume the role of Chief Commercial Officer. Melnyk brings extensive experience in oncology from prior roles at Fortovia Therapeutics, Novocure, and OSI Pharmaceuticals. CEO Uzi Sofer expressed confidence that Melnyk will enhance Alpha Tau's commercialization efforts, particularly as the company seeks further marketing approvals for its Alpha DaRT cancer therapy, with a critical U.S. study on recurrent squamous cell carcinoma starting soon.
Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) announced participation in three investor conferences in September 2022. The events include Citi's 17th Annual BioPharma Conference on September 7 in Boston, MA, the Cantor Oncology, Hematology & HemeOnc Conference on September 28 in New York, NY, and the Ladenburg Thalmann Annual Healthcare Conference on September 29 in New York, NY. Each conference will feature 1:1 meetings and presentations to discuss Alpha Tau's innovative alpha-radiation cancer therapy, Alpha DaRT™, aimed at treating solid tumors.
Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) announced FDA approval for a pivotal trial of its Alpha DaRT™ therapy in recurrent cutaneous squamous cell carcinoma, expecting to treat the first patient in late 2022. The company also initiated a feasibility study in prostate cancer. Financially, R&D expenses rose to $5.4 million, while the net loss narrowed to $2.0 million or ($0.03) per share. Cash reserves increased significantly to $112.8 million, projected to sustain operations for at least two years. The company aims to expand its treatment pipeline to more invasive cancers, including pancreatic and GBM.
Alpha Tau Medical Ltd. (Nasdaq: DRTS) has announced a collaboration with MIM Software to enhance treatment planning software for its Alpha DaRT cancer therapy. This partnership aims to integrate MIM's software suite to support Alpha DaRT across multiple cancer indications and improve clinical trial integration. The collaborative effort seeks to harness MIM's advanced imaging capabilities to optimize treatment planning, enhancing patient outcomes. Notably, recent data from U.S. clinical trials showed a 100% complete response rate in skin cancer treatments at 12 and 24 weeks post-therapy.
Alpha Tau Medical Ltd. (Nasdaq: DRTS) will host a hybrid key opinion leader meeting on July 18, 2022, in New York, discussing its innovative Alpha DaRT cancer therapy. KOLs will present insights on the technology, highlighting recent clinical trials and upcoming studies, including a pivotal trial for recurrent cutaneous Squamous Cell Carcinoma. The Alpha DaRT technology employs radium-224 to target tumors with short-range alpha radiation, aiming to destroy cancer cells while sparing surrounding healthy tissue. This meeting presents a crucial opportunity for stakeholders to engage with industry experts.
Alpha Tau Medical Ltd. (Nasdaq: DRTS) announced the treatment of its first patient in a feasibility study for the Alpha DaRT™ therapy in prostate cancer at Rambam Health Care Center, Haifa, Israel. The study aims to assess the feasibility and safety of Alpha DaRT as a neoadjuvant therapy before surgery, involving up to 10 patients. Following Alpha DaRT source insertion, surgical resection is scheduled 50 days later. CEO Uzi Sofer emphasized the significance of this milestone in expanding treatment applications beyond superficial cancers.
Alpha Tau Medical Ltd. (Nasdaq: DRTS) announced the Israeli Ministry of Environmental Protection has granted an active radioactive license for Thorium-228 and Radium-224, allowing a shift to the main production floor in Jerusalem. This move will increase production capacity nearly threefold to approximately 90,000 Alpha DaRT sources annually, with future plans to apply for further increases. Additionally, the Massachusetts Department of Public Health has amended the license for Alpha Tau's subsidiary, tripling the Thorium-228 capacity from 10 milliCurie to 30 milliCurie, supporting increased production in the U.S.
Alpha Tau Medical (Nasdaq: DRTS) has announced conditional approval from the U.S. FDA for its Investigational Device Exemption (IDE) to initiate a pivotal study of its alpha-radiation therapy, Alpha DaRT™, for recurrent cutaneous Squamous Cell Carcinoma (SCC). The study will enroll up to 86 patients at 20 U.S. institutions and focus on those who have not responded to standard care. This is a significant milestone for Alpha Tau as it seeks to bring its innovative treatment to market.
On June 7, 2022, Alpha Tau Medical Ltd. (Nasdaq: DRTS) announced the resignation of board member Gary Leibler, effective immediately. His departure is cited as unrelated to the company’s performance. CEO Uzi Sofer expressed gratitude for Leibler’s significant contributions since the company's inception. Despite his resignation, Leibler remains optimistic about Alpha Tau’s prospects, especially following its successful NASDAQ public listing, which provided essential capital for advancing its innovative Alpha DaRT cancer treatment technology.
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