On August 25, 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 second quarter 2022 financial results and provided a corporate update (Press release, Alpha Tau Medical, AUG 25, 2022, View Source [SID1234618700]).

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"We have made significant progress by gaining conditional FDA approval, whose conditions have since been satisfied, for our pivotal trial IDE in SCC as well as treating our first patient in a prostate cancer feasibility trial. We’ve seen overwhelming interest from leading clinical sites across the U.S. in participating in our upcoming pivotal trial in SCC, and look forward to initiating that trial shortly. While making clinical progress, we are thoughtfully expanding our pipeline from superficial cancers that only require a temporary Alpha DaRT implant, to more invasive internal tumors like liver and prostate, and then finally to ones such as pancreatic cancer and GBM with the greatest unmet need. We’ve made great strides in GBM in large animal studies, on the back of receipt of Breakthrough Device Designation for recurrent GBM from the FDA," said Alpha Tau CEO Uzi Sofer. "In tandem, we have been preparing for global commercialization efforts by expanding our manufacturing capabilities alongside our expanded radioactive licenses in Israel and in the U.S., as well as educating the medical community on our technology via hands-on experience in our trials."

Recent Corporate Highlights:

Approval by the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) application to initiate our multi-center pivotal study for the treatment of recurrent cutaneous Squamous Cell Carcinoma (SCC) using the Alpha DaRT. The clinical study has been approved to enroll up to 86 patients at up to 20 institutions in the U.S., in addition to any sites that may be added outside the U.S., and will focus on patients with recurrent cutaneous SCC who have failed at least first line standard of care therapy and are not indicated for another curative standard of care therapy.

First patient treated in a feasibility study evaluating the Alpha DaRT as a neoadjuvant therapy in patients with prostate cancer. This is the Company’s first patient treated with Alpha DaRT in an internal organ.

Alpha Tau was granted 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 by the Israeli Ministry of Environmental Protection. This license should enable the Company to achieve a nearly 3x increase in production capacity, to yield approximately 90,000 Alpha DaRT sources per year.

First patients treated with Alpha DaRT in a French multicenter trial for skin cancer, which is currently being conducted at six cancer centers in France, on patients with malignant cutaneous lesions (including SCC, BCC, lentigo maligna melanoma, and carcinosarcoma), and is evaluating two cohorts: (1) newly diagnosed patients (up to 49 subjects), and (2) patients with locally recurrent disease (36 subjects). The primary effectiveness endpoint is the assessment of the overall response rate using RECIST criteria, 9 to 11 weeks after Alpha DaRT source insertion. Dr. Pascal Pommier is the principal investigator of this study.

Held an investor KOL event featuring Professor Michael Zelefsky and Dr. Mark D’Andrea to review clinical data and user experience with Alpha DaRT and to preview potential new indications for the technology. The event was held in New York on July 18, 2022 and a replay is available here and on the Alpha Tau website in the Investors section.
Upcoming Anticipated 2022 Milestones

Expecting first patient treated in U.S. multi-center pivotal trial in recurrent cutaneous SCC in the second half of 2022.
Targeting recruitment in the Canadian feasibility trial in pancreatic tumors to begin in the fourth quarter of 2022.
Planned submission of Alpha DaRT pivotal trial results in head and neck SCC to Japan’s regulatory authority, PMDA, in the coming months for marketing approval.
Targeting Health Canada approval for initiation of liver cancer feasibility trial by the end of 2022.
Financial results for the second quarter ended June 30, 2022

R&D expenses for the quarter ended June 30, 2022 were $5.4 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.

Marketing expenses for the quarter ended June 30, 2022 were $0.1 million, compared to $0.1 million for the same period in 2021.

G&A expenses for the quarter ended June 30, 2022 were $2.4 million, compared to $0.4 million for the same period in 2021, primarily due to increased professional fees (including D&O insurance), share-based compensation, and costs (including bonuses) associated with our financing transaction in the first quarter of 2022.

Financial income, net, for the quarter ended June 30, 2022 was $6.0 million, compared to financial expense, net of $3.5 million for the same period in 2021, primarily due to the remeasurement of warrants.

For the quarter ended June 30, 2022, the Company had a net loss of $2.0 million, or ($0.03) per share, compared to a loss of $7.0 million, or ($0.17) per share, in the same period in 2021.

Balance Sheet Highlights

As of June 30, 2022, the Company had cash and cash equivalents, restricted cash and short term deposits in the amount of $112.8 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.