On March 12, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported full year 2024 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAR 12, 2025, View Source [SID1234651093]).

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"Alpha Tau has been incredibly busy and very successful throughout 2024. With fantastic clinical results observed across a number of difficult cancers, we are now able to demonstrate the broader Alpha Tau vision of expanding our focus on treating internal organ tumors of high unmet need, as well as helping metastatic patients by harnessing the potential systemic immune benefits of Alpha DaRT", said Alpha Tau Chief Executive Officer Uzi Sofer. "FDA approval of our forthcoming U.S. trials in patients with newly diagnosed pancreatic cancer and our investigator-initiated trial in immunocompromised patients with recurrent cSCC, not only aligns with our broader vision but also reflects continued progress in our regulatory pathway to approval for Alpha DaRT. In parallel, we remain focused on expanding our operational capabilities, with our Hudson, NH facility expected to complete its first phase of construction in the coming months and come online for production of Alpha DaRT later in 2025."

Recent Corporate Highlights:

● In January, Alpha Tau hosted a virtual R&D Update Day to present interim results from multiple trials as well as more information regarding the expected regulatory path forward in internal organs. Principal investigators presented data showing high disease control rate and strong interim safety results observed across three trials exploring the use of Alpha DaRT in pancreatic cancer patients. Principal investigators also reported strong interim results in median survival of patients treated with Alpha DaRT after prior therapy as compared to previously published studies of alternative monotherapies, across all analyzed subgroups.

● At the R&D Update Day, positive interim results were also reported for the first eight patients recruited in a combination trial of Alpha DaRT with pembrolizumab (Keytruda), a checkpoint inhibitor, in treating patients with recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC). A reported systemic objective response rate of 75% and complete response rate of 37.5% were observed, compared to historical benchmarks of 19% and 5%, respectively, for pembrolizumab on its own in the KEYNOTE-048 trial.

● Approvals for two forthcoming clinical trials exploring the use of Alpha DaRT in treating pancreatic cancer were also announced during the R&D Update Day:

o Investigational Device Exemption (IDE) received from the FDA to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy in patients with newly diagnosed pancreatic cancer, the first step toward regulatory approval in the U.S. The trial was initially approved for 12 patients with metastatic cancer, but was then expanded to 30 patients in two cohorts of 15 patients each, one cohort of patients with newly diagnosed locally advanced cancer and the other of patients with newly diagnosed metastatic cancer.

o Approval from France’s Ministry of Health to commence a French multicenter clinical trial of Alpha DaRT alongside capecitabine for patients with locally advanced pancreatic cancer, as well as a second study at a single center in France examining the use of Alpha DaRT delivered via Fine Needle System, or FNS, in the treatment of locally advanced pancreatic cancer.

● In January, researchers from Hadassah Medical Center presented a poster entitled "Interim analysis of feasibility, safety, and tumor control in two first-in-human trials of a novel alpha-emitting radionuclide for pancreatic adenocarcinoma" at the prestigious 2025 ASCO (Free ASCO Whitepaper) GI Symposium, with interim data demonstrating 100% disease control rate and a strong safety profile. They also reported on a patient with pancreatic adenocarcinoma with metastases in the liver, who was seeing inadequate response from second-line chemotherapy but then saw full resolution of all tumors on PET scan after adding in Alpha DaRT treatment.

● In December, Alpha Tau announced the appointment of Maya Netser to its Board of Directors, bringing a wealth of experience and a keen understanding of the industry from her many years of corporate leadership and advisory, following the completion of Meir Jakobsohn’s term as a director.

Upcoming Milestones:

● Targeting first patient treated in Israel for brain cancer in H1 2025.

● Anticipating response from Japan’s PMDA in Q3 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.

● Targeting first patient enrolled in pancreatic cancer pilot study in the U.S. in Q2 2025.

● Seeking FDA IDE approval in Q2 2025 to conduct early feasibility study in recurrent glioblastoma multiforme (GBM) patients.

● Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q3 2025. For more information, please see here: View Source

Financial results for year ended December 31, 2024

R&D expenses for the year ended December 31, 2024 were $27.0 million, compared to $26.4 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 year ended December 31, 2024 were $2.3 million, compared to $1.9 million for the same period in 2023, due to increased marketing activities and travel abroad.

G&A expenses for the year ended December 31, 2024 were $6.7 million, compared to $7.3 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 year ended December 31, 2024 was $4.3 million, compared to $6.5 million for the same period in 2023, due to a decrease in income from revaluation of warrants and in interest from bank deposits and an increase in interest on long-term loan, offset by changes in foreign exchange rates .

For the year ended December 31, 2024, the Company had a net loss of $31.8 million, or $0.45 per share, compared to a net loss of $29.2 million, or $0.42 per share, in the year ending December 31, 2023.

Balance Sheet Highlights

As of December 31, 2024, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $62.9 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.