On November 19, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported third quarter 2024 financial results and provided a corporate update (Press release, Alpha Tau Medical, NOV 19, 2024, View Source [SID1234648496]).
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"Alpha Tau has continued to make great progress during 2024, with a number of important trials moving ahead and continued generation of data across superficial tumors and cancers of internal organs," said Alpha Tau Chief Executive Officer Uzi Sofer. "Our decision to use the ReSTART pivotal trial to explore our implementation of the Alpha DaRT treatment with community clinicians such as Mohs surgeons continues to bear fruit. We look forward to releasing important data in internal organ cancers in the coming months and giving our stakeholders a deeper look at the future we envision for the Alpha DaRT," stated Alpha Tau CEO Uzi Sofer.
Recent Corporate Highlights:
● In October, Alpha Tau announced its acceptance into FDA’s Total Product Life Cycle Advisory Program (TAP) to accelerate market access to Alpha DaRT for patients with recurrent glioblastoma multiforme (GBM). TAP’s primary goal is to expedite and enable patient access to innovative and highly promising medical devices which are not currently on the market by providing frequent, and strategic communications with the FDA, and by facilitating engagement with other key parties for developers of devices of public health importance, working toward reducing the time, cost and uncertainty of patient access through reimbursement and commercial adoption following FDA authorization.
● In October, the first patient with recurrent lung cancer was treated in a clinical trial at Hadassah Medical Center in Jerusalem, Israel. The study will assess safety and feasilibity of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure, including the rate of successful source placement and any treatment-related adverse events. For more information, please see here: View Source
● In September, the FDA approved and Investigational Device Exemption (IDE) application to initiate a multi-center study for the treatment of recurrent cutaneous Squamous Cell Carcinoma (cSCC) in immunocompromised patients using the Alpha DaRT. The clinical study, which is an investigator-initiated study led by the Winship Cancer Institute of Emory University in Atlanta, has been approved to enroll up to 28 U.S. patients at up to 8 institutions in the U.S., and will focus on patients with recurrent cSCC who have a weakened immune system due to any primary or secondary immunodeficiencies, excluding diabetes. For more information, please see here: View Source
Upcoming Milestones:
● Anticipating response from PMDA in Japan in Q1 2025 for pre-market approval for Alpha DaRT in patients with recurrent head and neck cancer.
● Planned release of data from pancreatic cancer trials in Canada and Israel in Q1 2025.
● Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in H1 2025. For more information, please see here: View Source
● Targeting release of data from combination trial of Alpha DaRT with pembrolizumab (Keytruda) in H1 2025. For more information, please see here: View Source
● Targeting first brain cancer treatment in H1 2025.
Financial results for quarter ended September 30, 2024
R&D expenses for the nine months ended September 30, 2024 were $19.5 million, compared to $18.9 million for the same period in 2023, due to increased employee compensation and benefits, including share-based compensation, increased costs of raw materials, reduced government grants, and increased travel expenses related to our U.S. multi-center pivotal trial, offset by lower third-party contractor expenses.
Marketing expenses for the nine months ended September 30, 2024 were $1.7 million, compared to $1.5 million for the same period in 2023, due to increased employee compensation and benefits.
G&A expenses for the nine months ended September 30, 2024 were $4.6 million, compared to $5.3 million for the same period in 2023, primarily due to decreased professional fees (including D&O insurance and legal expenses), offset by increased travel expenses and increased employee compensation and benefits, including share-based compensation.
Financial income, net, for the nine months ended September 30, 2024 was $3.5 million, compared to $4.0 million for the same period in 2023, due to changes in foreign exchange rates, a decrease in interest from bank deposits, and an increase in interest on long-term loan.
For the nine months ended September 30, 2024, the Company had a net loss of $22.3 million, or $0.32 per share, compared to a net loss of $21.8 million, or $0.31 per share, in the nine months of 2023.
Balance Sheet Highlights
As of September 30, 2024, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $68.4 million, compared to $84.9 million at December 31, 2023. The Company expects that this cash balance will be sufficient to fund anticipated 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.