On May 19, 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 first quarter 2025 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAY 19, 2025, View Source [SID1234653221]).
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"2025 has started off with a bang at Alpha Tau, with a flurry of important milestones as we continue to evaluate Alpha DaRT in treating internal organ tumors, expand our manufacturing capabilities, and prepare for commercial activities," said Alpha Tau Chief Executive Officer Uzi Sofer. "With four active U.S. IDEs approved by the FDA, and U.S. trials expected to begin soon in patients with newly-diagnosed pancreatic cancer and recurrent GBM, construction of the first phase of our Hudson, NH facility nearing completion, and our ambitions for the continued expansion of our clinical trial program, our recently completed financing came at the perfect time to ensure that our momentum continues to accelerate throughout the course of the year."
Recent Corporate Highlights:
● In April, Alpha Tau announced the completion of a $36.9 million registered direct financing from, and strategic marketing alliance with, an affiliate of Oramed Pharmaceuticals, Inc. (Oramed). Oramed CEO, President and Chairman Nadav Kidron has also joined the Alpha Tau Board of Directors, bringing years of public company biotech experience.
● In April, Alpha Tau announced receipt of an IDE from the FDA to conduct a U.S. pilot study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM). The clinical trial is expected to enroll up to ten U.S. patients with recurrent glioblastoma not amenable for surgical resection who have undergone a prior course of central nervous system radiation.
● In February, Alpha Tau announced achievement of Medical Device Single Audit Program (MDSAP) certification for the Company’s manufacturing facility in Jerusalem. MDSAP was established by a coalition of international medical device regulatory authorities from Australia, Brazil, Canada, Japan and the U.S., to enable medical device manufacturers to be audited once for compliance with ISO 13485 and the standards of these five different markets. MDSAP certification may also speed the timetable to commercialization within these participating geographies, as it allows for a streamlined auditing process, providing manufacturers with a comprehensive approach to meet international regulatory standards efficiently.
● 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, following a subset of the data presented by investigators at Hadassah Medical Center on a poster at the prestigious 2025 ASCO (Free ASCO Whitepaper) GI Symposium. 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 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 and 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.
Expected Upcoming Milestone Targets:
● First patient enrolled in pancreatic cancer pilot study in the U.S. in Q3 2025. For more information, please see here: View Source
● First patient treated in Israel for brain cancer in Q2 or Q3 2025.
● 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
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.
● First patient treated in U.S. GBM pilot study in H2 2025. For more information, please see here: View Source
● Response from Japan’s PMDA in H2 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.
Financial results for quarter ended March 31, 2025
R&D expenses for the three months ended March 31, 2025 were $7.2 million, compared to $6.4 million for the same period in 2024, due to increased employee compensation and benefits, increased production expenses and reduced government grants, offset by lower share-based compensation expenses.
Marketing expenses for the three months ended March 31, 2025 were $0.5 million, compared to $0.5 million for the same period in 2024.
G&A expenses for the three months ended March 31, 2025 were $1.7 million, compared to $1.4 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation, and increased professional fees (including legal expenses).
Financial income, net, for the three months ended March 31, 2025 was $0.7 million, compared to $0.4 million for the same period in 2024, due to a decrease in expense from remeasurement of warrants, offset by a decrease in interest from bank deposits.
For the three months ended March 31, 2025, the Company had a net loss of $8.7 million, or $0.12 per share, compared to a net loss of $8.0 million, or $0.11 per share, in the three months ending March 31, 2024.
Balance Sheet Highlights
As of March 31, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $54.8 million, compared to $62.9 million at December 31, 2024. In April 2025, Alpha Tau raised $36.9 million through a registered direct financing transaction.