On November 22, 2022 Alpha Tau Medical Ltd. (Nasdaq: DRTS and DRTSW), ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported third quarter 2022 financial results and provided a corporate update (Press release, Alpha Tau Medical, NOV 22, 2022, View Source [SID1234624373]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Alpha Tau remained active in the third quarter, as we continued preparations for our upcoming U.S. pivotal study in recurrent cutaneous squamous cell carcinoma and laid the groundwork for exploration of our Alpha DaRT oncology treatment platform across a broad set of applications," said Alpha Tau CEO Uzi Sofer. "At the same time, we have remained highly visible through a series of scientific publications and presentations to discuss our Alpha DaRT treatment. In anticipation of pivotal study data and a potential U.S. launch, we are actively preparing for our global commercialization efforts, having brought the highly experienced Peter Melnyk into the role of Chief Commercial Officer, while we continue to ramp up manufacturing capacity across the world. Peter will focus on prelaunch activities across the U.S. and international markets to help prepare for future reimbursement and commercialization efforts. In parallel, we continue to initiate a number of feasibility trials in internal organs and develop new delivery technologies for Alpha DaRT to expand its use in patients underserved by current treatments. With all of this activity, we remain well capitalized and focused on efficient operations as we continue to execute on our strategic plans."
Recent Corporate Highlights:
· Peter Melnyk, a former member of Alpha Tau’s Board of Directors, assumed the full-time position of Alpha Tau’s Chief Commercial Officer.
· Two landmark pre-clinical studies demonstrating significant potential synergies between the Alpha DaRT treatment and standard-of-care immunotherapy, chemotherapy and anti-angiogenic therapy were published in major peer-reviewed journals.
o Study on combination with anti-PD1 therapy published by International Journal of Radiation Oncology, Biology, Physics, known in the field as the Red Journal, the official journal of the American Society for Radiation Oncology (ASTRO).
o Study on combinations with chemotherapy and anti-angiogenic therapy in human glioblastoma multiforme xenografts published by Frontiers in Oncology, in its Radiation Oncology section.
· Medicines and Healthcare products Regulatory Agency of the United Kingdom approved clinical trial in squamous cell carcinoma of the vulva at Addenbrookes Hospital in Cambridge.
· Health Canada approved the addition of Jewish General Hospital in Montreal as a second site in the Company’s clinical trial in advanced pancreatic cancer.
· Dr. Christopher Barker of Memorial Sloan Kettering Cancer Center presented at the ASTRO 2022 Annual Meeting on results of the Company’s U.S. pilot feasibility study completed earlier in 2022.
· Investigators at The University of Texas MD Anderson Cancer Center presented a poster at the Radiation Research Society’s 2022 Annual Meeting on tumor growth delay and immune stimulation using the Alpha DaRT in treating 4T1 murine triple-negative breast cancer tumors.
Upcoming Anticipated Milestones
· Expecting first patient treated in U.S. multi-center pivotal trial in recurrent cutaneous SCC around year-end 2022.
· Targeting recruitment in the Canadian feasibility trial in pancreatic tumors to begin around year-end 2022.
· Planning to begin an Israeli feasibility trial in pancreatic tumors in the first quarter of 2023.
· Planned submission of Alpha DaRT pivotal trial results in head and neck SCC to Japan’s regulatory authority, PMDA, around year-end 2022, for marketing approval.
· Targeting Health Canada approval for initiation of liver cancer feasibility trial by the first quarter of 2023.
Financial results for the third quarter ended September 30, 2022
R&D expenses for the quarter ended September 30, 2022 were $4.8 million, compared to $3.0 million for the same period in 2021, primarily due to increased R&D headcount, costs associated with our U.S. multi-center pivotal study and other clinical studies, and increased share-based compensation costs and accrual of other compensation expenses.
Marketing expenses for the quarter ended September 30, 2022 were $0.2 million, compared to $0.1 million for the same period in 2021.
G&A expenses for the quarter ended September 30, 2022 were $2.3 million, compared to $0.5 million for the same period in 2021, primarily due to increased professional fees (including D&O insurance), share-based compensation, advisors and other expenses associated with being a public company, and accrual of other compensation expenses.
Financial income, net, for the quarter ended September 30, 2022 was $4.7 million, compared to financial expense, net of $1.2 million for the same period in 2021, primarily due to the remeasurement of warrants and interest income on cash balances.
For the quarter ended September 30, 2022, the Company had a net loss of $2.6 million, or ($0.04) per share, compared to a loss of $4.8 million, or ($0.12) per share, in the same period in 2021.
Balance Sheet Highlights
As of September 30, 2022, the Company had cash and cash equivalents, restricted cash and short-term deposits in the amount of $108.5 million, compared to $31.9 million on December 31, 2021. The Company expects that this cash balance will be sufficient to fund operations for at least two years.
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.