Newsletter - Issue no. 1

The Jewish New Year has now begun, providing us with a great opportunity to kick-off our quarterly Alpha Tau newsletter. This last year has seen fantastic progress. The significant operational, regulatory and clinical advancement was summarised by additional funding of $29 million that was recently raised from private and VC investors. Thank you to all our investors and partners – we cannot do this without you. We look forward to working together to realize the therapeutic potential of Alpha DaRT and develop a cancer treatment that can help save the lives of millions of patients around the world. I am delighted to share with you our latest news, developments and recent activities. Enjoy the read. Uzi Sofer, CEO and Chairman, Alpha Tau Medical

The Birth of Alpha Tau Medical

How did it all start? Read our very own Co-Founder and Chief Biomedical Officer, Professor Yona Keisari’s blog, sharing his memories and clinical insights describing what sparked the birth of the Alpha Tau technology to fight cancer. Read more.

Company Update

Alpha Tau Raises $29 Million from Private Financing We are delighted to have raised $29 million in private financing. The funding will be invaluable to accelerate the expansion of our global clinical research program and establish new production facilities to meet the growing demand for Alpha DaRT. I would like to thank all the investors that participated in this round; Shavit Capital,, Medison Ventures and private investors including,

Sir Ronald Cohen and Alan Patricof. Read the full PR.

FDA Has Granted IDE Approval to Commence U.S. Clinical Studies We are pleased to share that the FDA granted Investigational Device Exemption (IDE) approval, enabling Alpha Tau to commence clinical safety and effectiveness studies in the U.S. This is another significant achievement and we look forward to launching our first clinical trial with the leading cancer research institution, Memorial Sloan Kettering Cancer Center.

Alpha Tau Receives Radioactive-Safety Approval in the USA We are happy to announce that the Massachusetts Radiation Control Program (RCP), under agreement with the U.S. Nuclear Regulatory Commission (NRC), approved the treatment of Alpha DaRT, as a Sealed Source and Device (SSD). The new approval enables the initiation of clinical trials in leading cancer centers across the U.S. which are interested in investigating the Alpha DaRT as a treatment for various types of solid tumors. Read the full PR.

Expanding Presence in the USA We have now started the build of our new production facility in Lawrence, MA in the United States, following the signing of a long-term rental contract that includes options for growth and extension. Amnon Gat, Alpha Tau’s highly experienced Chief Operations Officer, has relocated from the company’s Israel headquarters to head the U.S. operations. The complicated project of building the production facility and getting all the necessary approval is expected to take several months.

We will keep you updated on our progress.

The Pathway to CE Clearance is Getting Closer We are at the final stages of applying for European CE mark. We have passed the final audit by our Notified Body, BSI, and are submitting the technical file, including our clinical data. The approval itself, enabling commercialization of the Alpha DaRT treatment in Europe, is expected in the first half of 2019." ​

Two New Clinical Trials Start in Rome, Italy with Leading Cancer Centers, La Sapienza and IFO We are delighted to announce we have initiated two new clinical trial protocols evaluating the efficacy of the Alpha DaRT in two leading medical centers in Rome, Italy. Following approval from the Institutional Review Board (IRB) earlier this month, La Sapienza is commencing Alpha Tau’s third clinical trial protocol for Squamous Cell Carcinoma (SCC) of the skin and oral cavity, and IFO is initiating our first study into Cutaneous and Mucosal malignant Neoplasia (CMN).

Opening Japan to the World’s First Alpha Radiation Radiotherapy for Solid Tumors We have formed a new partnership with HekaBio K.K to establish the world’s first alpha radiation brachytherapy in Japan. HekaBio K.K. is a leading developer, manufacturer and distributor of pharmaceutical products that address unmet medical needs in Japan. The new subsidiary will optimize local distribution and manufacturing of the Alpha DaRT cancer treatment in Japan.

Thank you for visiting us at ASTRO!