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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 (NASDAQ: DRTS), developer of the Alpha DaRT® cancer therapy, announced two significant upcoming events. First, an abstract on pancreatic adenocarcinoma trials will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium (January 23-25, 2025) in San Francisco. The presentation will occur during Poster Session B on January 24.
Additionally, the company will host an R&D Update Day on January 27, 2025, where they will discuss new data from both Israeli and Canadian pancreatic cancer trials, including feasibility, safety, tumor response, and survival metrics. The update will also cover findings from trials combining Alpha DaRT with pembrolizumab for head and neck cancer treatment.
Alpha Tau Medical (Nasdaq: DRTS) announced changes to its Board of Directors, with Maya Netser joining and Meir Jakobsohn stepping down but continuing as an advisor. Netser brings over 25 years of experience as a C-level technology leader, board member, and investor. She is the founder of Quantum Leap VC and previously served as CEO of Cabaret Biotech, where she led the company to a successful acquisition by Kite Pharma and Gilead Sciences.
Netser's appointment comes at a strategic time as Alpha Tau expands into internal organ treatments with its Alpha DaRT® cancer therapy. She holds an LL.B and MBA from Tel Aviv University and is a member of the Israeli National Team of Directors.
Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® alpha-radiation cancer therapy, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. CEO Uzi Sofer and CFO Raphi Levy will deliver a corporate overview and update on January 16, 2025, from 9:45 AM to 10:25 AM PT at the Westin St. Francis in San Francisco. The presentation will highlight recent company achievements and upcoming data milestones. Institutional investors can schedule one-on-one meetings with the executives through their J.P. Morgan representatives. A webcast of the presentation will be available on the company's website in the Investor Relations section.
Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® alpha-radiation cancer therapy, has announced its participation in the upcoming Ladenburg Oncology Innovators & Investors Symposium.
CFO Raphi Levy will represent the company at this virtual event, scheduled for December 12, 2024, from 11:00 AM to 11:25 AM EST. The format will include both a presentation and one-on-one meetings, which can be arranged through Ladenburg representatives.
Alpha Tau Medical (NASDAQ: DRTS) reported Q3 2024 financial results and corporate updates. Key developments include acceptance into FDA's Total Product Life Cycle Advisory Program (TAP) for Alpha DaRT® treatment of recurrent glioblastoma, first patient treatment in a recurrent lung cancer study in Israel, and FDA approval for a multi-center study treating recurrent cutaneous squamous cell carcinoma. The company reported a net loss of $22.3 million ($0.32 per share) for the nine months ended September 30, 2024. Cash position stands at $68.4 million, providing runway for at least two years.
Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® alpha-radiation cancer therapy, announces CFO Raphi Levy's participation in two major healthcare conferences. Levy will attend the Citi 2024 Global Healthcare Conference on December 3rd in Miami, FL, participating in one-on-one meetings from 8:30 AM to 4:30 PM EST. Additionally, he will join the Piper Sandler 36th Annual Healthcare Conference on December 5th in New York, NY, featuring a fireside chat from 10:00-10:25 AM EST along with one-on-one meetings.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) has been accepted into the FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to accelerate market access for Alpha DaRT® in treating recurrent glioblastoma multiforme (GBM). This follows the company's previous Breakthrough Device Designation for this indication. TAP aims to expedite patient access to innovative medical devices by providing early, frequent, and strategic communications with the FDA and facilitating engagement with key stakeholders.
The program offers tailored assistance from FDA TAP advisors to advance devices to market, focusing on product lifecycle regulation, payer coverage policies, and integration of patient insights. With an estimated 14,000 new GBM diagnoses per year in the U.S. and low five-year survival rates, Alpha Tau sees this as a important step in their strategy to treat internal organs with high unmet medical needs.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) has treated its first patient with recurrent lung cancer using the Alpha DaRT® therapy at Hadassah Medical Center in Jerusalem, Israel. The clinical trial aims to treat up to ten patients with recurrent tumors in the mediastinum area, allowing concurrent use of other therapies if indicated. The study will assess the safety and feasibility of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure, as well as evaluate the efficacy of Alpha DaRT for this indication.
Lung cancer is the leading cause of cancer-related deaths worldwide, with almost 2.5 million new cases detected annually. In the U.S., it's the third most common cancer, with an estimated 210,000 new cases per year. The Alpha DaRT treatment offers a potential new approach for patients with treatment options, especially those who have already undergone conventional radiation therapy.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) announced FDA approval of an Investigational Device Exemption (IDE) for a multi-center study using Alpha DaRT® to treat recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients. The study, led by Winship Cancer Institute of Emory University, will enroll up to 28 U.S. patients across 8 institutions.
The trial's primary efficacy objective is the objective response rate (ORR), with secondary objectives including progression-free survival, overall survival, and local control. Immunocompromised patients face a significantly higher risk of cSCC, with organ transplant recipients having a 65-100 fold greater incidence compared to the general population.
This study addresses clinician requests to treat immunocompromised patients, who are ineligible for Alpha Tau's ongoing ReSTART pivotal trial for recurrent cSCC. The company aims to provide a new potential treatment alternative for this vulnerable population.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW), developer of the Alpha DaRT® alpha-radiation cancer therapy, has announced its participation in four upcoming investor conferences. CFO Raphi Levy will present at the following events:
1. H.C. Wainwright 26th Annual Global Investment Conference on September 10, 2024, in New York, NY
2. Sidoti Small-Cap Virtual Investor Conference on September 19, 2024 (virtual)
3. Redburn Atlantic and Rothschild & Co 2024 Radiopharma Conference on September 26, 2024, in New York, NY
4. Lytham Partners Fall 2024 Investor Conference on October 1, 2024 (virtual)
Mr. Levy will be available for one-on-one investor meetings at all conferences. Interested parties should contact their respective conference representatives to schedule meetings.
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