Alpha Tau Announces Receipt of Radioactive License to Allow Production in Main Manufacturing Floor at its Jerusalem Site, Amended Radioactive License with Increased Capacity at L

16 Jun, 2022

JERUSALEMJune 16, 2022 /PRNewswire/ — Alpha Tau Medical Ltd. (Nasdaq: DRTS) (“Alpha Tau” or the “Company”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, today announced that the Israeli Ministry of Environmental Protection has granted the Company an active radioactive license for use and possession of Thorium-228 and Radium-224, radioactive materials which are utilized in the production of the Alpha DaRT sources, in the main manufacturing floor of the Company’s production facility in Jerusalem. This license will enable the Company to shift production from a smaller, ancillary installation at the site, to the main manufacturing floor, thereby achieving a nearly 3x increase in production capacity, to yield approximately 90,000 Alpha DaRT sources per year. As the Jerusalem site has been designed to support production of up to 400,000 sources per year, the Company anticipates applying in the future for additional increases to the radioactive license, in order to further expand its production capacity and fully utilize the Jerusalem facility.

In addition, the Company is also pleased to announce that the Radiation Control Program of the Department of Public Health of the Commonwealth of Massachusetts has amended the license previously issued to Alpha Tau’s subsidiary, Alpha Tau Medical Inc., tripling the amount of Thorium-228 for use and possession at the Lawrence, MA site, from 10 milliCurie to 30 milliCurie.

“These are important milestones in the continued planned development of our global manufacturing capabilities,” said Uzi Sofer, CEO of Alpha Tau. “While our site in Lawrence, MA continues to serve our global needs for the production of Thorium-228 generators, the receipt of a larger license will allow us to expand our production capacity as intended and work toward local manufacturing of Alpha DaRT sources on the ground in the U.S. The increase of the Israeli production capacity arrives at a perfect time, as we wrap up our first U.S. clinical trial and look towards our upcoming U.S. multi-center pivotal trial, alongside a broader set of activities around the world.”

Alpha Tau COO Amnon Gat added, “The continued expansion of our manufacturing capacity is critical to ensure sufficient and timely supply of our Alpha DaRT treatment to patients worldwide. Moreover, our ability to bring Alpha DaRT production into the U.S. will allow us to increase our redundancy across multiple plants and to support a steady supply of Alpha DaRT treatments for our patients in our various clinical trials.”

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 it.