Alpha Tau Announces Multiple Corporate Updates Ahead of

– Medicines and Healthcare merchandise Regulatory Agency of the United Kingdom approves scientific trial in squamous cell carcinoma of the vulva at Addenbrookes Hospital in Cambridge –

– Health Canada approves the addition of Jewish General Hospital in Montreal as a second website within the Company’s scientific trial in superior pancreatic most cancers –

– Dr. Christopher Barker of Memorial Sloan Kettering Cancer Center shall be delivering a presentation on the ASTRO 2022 Annual Meeting relating to outcomes of the Company’s U.S. pilot feasibility examine accomplished earlier in 2022 –

– Investigators at The University of Texas MD Anderson Cancer Center offered a poster on the Radiation Research Society’s 2022 Annual Meeting on tumor progress delay and immune stimulation utilizing the Alpha DaRT in treating 4T1 murine triple-negative breast most cancers tumors –

JERUSALEM, Oct. 21, 2022 (GLOBE NEWSWIRE) — Alpha Tau Medical Ltd. (“Alpha Tau”, or the “Company”)  (NASDAQ: DRTS, DRTSW), the developer of the progressive alpha-radiation most cancers remedy Alpha DaRT™, introduced at present its participation within the upcoming 2022 Annual Meeting of the American Society for Radiation Oncology (“ASTRO”), being held October 23 – 25, 2022 in San Antonio, TX, the place the Company shall be at Booth #3719. Participants focused on assembly with the Alpha Tau crew on the convention can achieve this by reserving a slot through the next hyperlink: https://calendly.com/michaelt-alpha-dart/. Ahead of the convention, the Company is happy to announce a quantity of latest developments:

• The Medicines and Healthcare merchandise Regulatory Agency (“MHRA”) of the United Kingdom has authorized the Company’s request to provoke a scientific trial for the remedy of major and recurrent Squamous Cell Carcinoma of the vulva utilizing the Alpha DaRT. The trial is predicted to be carried out with 10 sufferers, and shall be led by Dr. Li Tee Tan of Addenbrooke’s Hospital of the Cambridge University Hospitals NHS Trust. The trial seeks to measure the feasibility, security, efficacy and immunological response related to remedy with the Alpha DaRT.
• Health Canada has authorized the Company’s request to revise its Investigational Testing Authorization for the Company’s scientific trial testing the feasibility and security of the Alpha DaRT remedy in sufferers with superior pancreatic most cancers. The revision permits the Company so as to add Jewish General Hospital in Montreal, Canada as a second website to the trial, alongside Centre Hospitalier de l’Université de Montréal (CHUM).
• Dr. Christopher Barker of Memorial Sloan Kettering Cancer Center in New York will ship a presentation on the ASTRO 2022 Annual Meeting, on Wednesday, October 26, 2022 at 8:20am within the Henry B. Gonzalez Convention Center, Room 303, entitled “A Multicenter Prospective Trial of Diffusing Alpha-Emitter Radiation Therapy for Recurrent or Unresectable Cutaneous Cancers: Early Results from a Pilot Feasibility Study in the United States,” offering additional element on the outcomes of the Company’s U.S. pilot feasibility examine that was carried out in 2021, the preliminary outcomes of which have been reported earlier in 2022, together with a 100% full response charge noticed at 12 and 24 weeks after remedy with the Alpha DaRT.
• Following the Company’s announcement in January 2022 that it had signed a sponsored analysis settlement with investigators at The University of Texas MD Anderson Cancer Center, the investigators offered a poster on the Radiation Research Society’s 2022 Annual Meeting, held October 16 – 19, 2022 in Waikoloa Village, Hawaii. The poster detailed outcomes of the investigators’ pre-clinical examine utilizing the Alpha DaRT to deal with mice with 4T1 triple-negative breast most cancers tumors, demonstrating considerably smaller tumor quantity in addition to a major two-fold improve in CD8⁺ cell populations within the spleens of mice when handled with the Alpha DaRT vs. these handled with inert sources. The investigators concluded that, “[Alpha] DaRT seeds were effective in delaying tumor growth with activation of the immune system…The magnitude of increase in CD8+ populations in the irradiated spleens of mice suggests systemic activation of the immune system.”

Alpha Tau CEO Uzi Sofer commented, “Following the completion of our U.S. pilot study earlier this year, we are laser-focused on initiating our U.S. multi-center pivotal study for the treatment of recurrent cutaneous Squamous Cell Carcinoma using the Alpha DaRT, which we expect to occur before the end of the year, as we are currently progressing on the associated preparatory logistics such as IRB approvals and site initiations. At the same time, we continue to forge ahead in our strategy to broaden the application of the Alpha DaRT to other indications, and are very excited to see continued meaningful progress across three different indications: cancer of the vulva, pancreas and breast. We look forward to further advances in these and other indications, as we continue to explore ways that the Alpha DaRT can help patients around the world.”

About Alpha DaRT™

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to allow extremely potent and conformal alpha-irradiation of strong tumors by intratumoral supply of radium-224 impregnated sources. When the radium decays, its short-lived daughters are launched from the sources and disperse whereas emitting high-energy alpha particles with the objective of destroying the tumor. Since the alpha-emitting atoms diffuse solely a brief distance, Alpha DaRT goals to primarily have an effect on the tumor, and to spare the wholesome tissue round it.

About Alpha Tau Medical Ltd.

Founded in 2016, Alpha Tau is an Israeli medical system firm that focuses on analysis, growth, and potential commercialization of the Alpha DaRT for the remedy of strong tumors. The know-how was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.

Forward-Looking Statements

This press launch consists of “forward-looking statements” inside the that means of the Private Securities Litigation Reform Act of 1995. When used herein, phrases together with “anticipate,” “being,” “will,” “plan,” “may,” “continue,” and related expressions are meant to establish forward-looking statements. In addition, any statements or data that check with expectations, beliefs, plans, projections, targets, efficiency or different characterizations of future occasions or circumstances, together with any underlying assumptions, are forward-looking. All forward-looking statements are primarily based upon Alpha Tau’s present expectations and numerous assumptions. Alpha Tau believes there’s a cheap foundation for its expectations and beliefs, however they’re inherently unsure. Alpha Tau might not understand its expectations, and its beliefs might not show appropriate. Actual outcomes may differ materially from these described or implied by such forward-looking statements in consequence of numerous essential components, together with, with out limitation: (i) Alpha Tau’s potential to obtain regulatory approval for its Alpha DaRT know-how or any future merchandise or product candidates; (ii) Alpha Tau’s restricted working historical past; (iii) Alpha Tau’s incurrence of vital losses up to now; (iv) Alpha Tau’s want for extra funding and skill to lift capital when wanted; (v) Alpha Tau’s restricted expertise in medical system discovery and growth; (vi) Alpha Tau’s dependence on the success and commercialization of the Alpha DaRT know-how; (vii) the failure of preliminary knowledge from Alpha Tau’s scientific research to foretell remaining examine outcomes; (viii) failure of Alpha Tau’s early scientific research or preclinical research to foretell future scientific research; (ix) Alpha Tau’s potential to enroll sufferers in its scientific trials; (x) undesirable unintended effects attributable to Alpha Tau’s Alpha DaRT know-how or any future merchandise or product candidates; (xi) Alpha Tau’s publicity to patent infringement lawsuits; (xii) Alpha Tau’s potential to adjust to the in depth laws relevant to it; (xiii) the power to satisfy Nasdaq’s itemizing requirements; (xiv) prices associated to being a public firm; (xv) adjustments in relevant legal guidelines or laws; (xix) impacts from the COVID-19 pandemic; and the opposite essential components mentioned below the caption “Risk Factors” in Alpha Tau’s annual report filed on kind 20-F with the SEC on March 28, 2022, and different filings that Alpha Tau might make with the United States Securities and Exchange Commission. These and different essential components may trigger precise outcomes to vary materially from these indicated by the forward-looking statements made on this press launch. Any such forward-looking statements signify administration’s estimates as of the date of this press launch. While Alpha Tau might elect to replace such forward-looking statements sooner or later sooner or later, besides as required by regulation, it disclaims any obligation to take action, even when subsequent occasions trigger its views to vary. These forward-looking statements shouldn’t be relied upon as representing Alpha Tau’s views as of any date subsequent to the date of this press launch.

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