Alpha Tau Announces Second Quarter 2025 Financial Results and Provides Corporate Update
Rhea-AI Summary
Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® cancer therapy, reported Q2 2025 financial results and corporate updates. The company received FDA approval for an IDE to conduct a U.S. pilot study for recurrent glioblastoma multiforme (GBM) treatment. Alpha Tau secured $36.9 million through strategic equity offering from Oramed and maintains a strong cash position of $83.3 million.
The company is advancing multiple U.S. clinical trials, including studies in pancreatic cancer and GBM, with patient treatments expected to begin in 2025. Their ReSTART pivotal skin cancer trial is nearing completion. The company's first phase of their Hudson, NH commercial facility is expected to be operational by early 2026. For H1 2025, Alpha Tau reported a net loss of $18.8 million ($0.25 per share), compared to $15.4 million ($0.22 per share) in H1 2024.
Positive
- FDA approval received for GBM pilot study IDE, expanding therapeutic applications
- Strategic $36.9 million equity financing secured at market price
- Strong cash position of $83.3 million, up from $62.9 million in December 2024
- Multiple clinical trials advancing with imminent patient treatment initiation
- Commercial-scale facility in Hudson, NH nearing completion
Negative
- Increased net loss to $18.8 million in H1 2025 from $15.4 million in H1 2024
- R&D expenses increased to $14.2 million from $13.3 million year-over-year
- Financial income decreased significantly to $0.3 million from $2.1 million in prior year
Insights
Alpha Tau secures FDA IDE approval for GBM study, raises $36.9M, and advances clinical trials while maintaining strong $83.3M cash position.
Alpha Tau's Q2 2025 results reveal a strong operational momentum across multiple fronts despite widening losses. The FDA approval of their Investigational Device Exemption (IDE) for recurrent glioblastoma multiforme (GBM) represents a significant clinical expansion beyond their initial skin cancer focus. GBM is an aggressive brain cancer with dismal survival rates, offering substantial market potential if Alpha DaRT demonstrates efficacy.
The company has strategically secured
Alpha Tau's strategic focus on internal organ indications like pancreatic cancer and GBM demonstrates a pivot toward higher-value therapeutic areas with significant unmet needs. The pending commercial facility in New Hampshire positions them for potential FDA approval in their lead indication. Their net loss widened to
The company's four active U.S. IDEs across multiple cancer types showcase a diversified clinical pipeline, reducing single-indication risk. The anticipated PMDA response (Japan's regulatory authority) could potentially open their first commercial market, providing validation for their alpha radiation technology and early revenue opportunities. With near-term clinical milestones in pancreatic cancer, GBM, and skin cancer, the company has multiple catalysts that could drive valuation in the coming quarters.
Alpha Tau's expanding clinical program for Alpha DaRT in aggressive cancers represents meaningful progress in targeted radiation therapy development.
The FDA's approval of Alpha Tau's IDE for recurrent glioblastoma multiforme is scientifically significant. GBM represents one of oncology's most challenging indications with extremely limited treatment options and dismal outcomes - the 8-month average survival mentioned in the release accurately reflects the dire prognosis. Alpha DaRT's targeted alpha radiation approach could theoretically overcome several limitations of conventional radiation in brain tumors, particularly radiation-induced cognitive decline and tissue damage.
Alpha Tau's expansion beyond superficial tumors (skin cancers) into internal organs represents a critical technical evolution for their alpha-particle technology. Internal organ applications present substantially different challenges for radiation delivery, requiring sophisticated implantation techniques and precision targeting. The simultaneous development across multiple difficult-to-treat cancers - GBM, pancreatic cancer, and immunocompromised patients - suggests the platform's versatility.
The company's Breakthrough Device Designation for GBM indicates the FDA recognizes the potential significance of this approach. Alpha radiation's high linear energy transfer creates dense ionization tracks that can potentially overcome the radioresistance often observed in GBM. However, the pilot study size (up to 10 patients) is appropriately conservative for initial safety assessment in this delicate neurological indication.
The parallel development in pancreatic cancer through the IMPACT study (Intratumoral Pancreatic Alpha Combination Trial) addresses another area of profound unmet need. Pancreatic tumors are notoriously difficult to treat with conventional radiation due to surrounding critical structures and intrinsic radioresistance. Alpha DaRT's short-range radiation profile could theoretically provide therapeutic doses while sparing adjacent tissues.
The company's progress toward commercial-scale manufacturing capability in New Hampshire by early 2026 aligns well with their clinical development timeline, suggesting coordinated advancement of both therapeutic development and production capacity for potential commercial launch.
- FDA approval of IDE to conduct a U.S. pilot study exploring the use of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer -
- Multiple U.S. clinical trials, including pancreatic cancer and GBM pilot studies, positioned for imminent patient treatment initiation during the remainder of 2025 -
- Secured
- Cash, cash equivalents & deposits balance of
JERUSALEM, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, reported second quarter 2025 financial results and provided a corporate update.
"The Company's focus activities continue to coalesce, with an increasing emphasis on U.S. clinical trials, priority indications in internal organs, and preparations for commercial scale-up," said Alpha Tau Chief Executive Officer Uzi Sofer. "All four U.S. IDEs are active: Our pivotal skin cancer ReSTART (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) trial continues to recruit patients actively and is nearing completion; we expect to commence treatment shortly in our trial in immunocompromised patients as well as the pilot IMPACT (Intratumoral Pancreatic Alpha Combination Trial) study; and the GBM study should initiate later in 2025. In parallel we are also deepening our focus on pancreatic cancer, with studies expected to launch shortly in France and Italy. And our push towards commercialization continues: a PMDA response is expected imminently, potentially opening up new commercial opportunities for the Company, and we expect to complete our first phase of construction shortly in our commercial-scale facility in Hudson, New Hampshire, which should be ready to manufacture Alpha DaRT treatments in early 2026."
Recent Corporate Highlights:
·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), a highly aggressive brain cancer with an estimated average survival rate of only 8 months. 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, building on the Breakthrough Device Designation received from the FDA for this indication.
- In April, Alpha Tau announced the completion of a
$36.9 million registered direct financing from, and strategic public 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.
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: https://www.clinicaltrials.gov/study/NCT06698458
- First patient treated in U.S. GBM pilot study in H2 2025. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06910306
- Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in H2 2025. For more information, please see here: https://www.clinicaltrials.gov/study/NCT05323253
- Response from Japan's PMDA in H2 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.
- First phase of Hudson, NH facility becomes operational in early 2026.
Financial Results for Six Months Ended June 30, 2025
Research and Development expenses for the six months ended June 30, 2025 were
Marketing expenses for the six months ended June 30, 2025 were
General and Administrative expenses for the six months ended June 30, 2025 were
Financial income, net, for the six months ended June 30, 2025 was
For the six months ended June 30, 2025, the Company had a net loss of
Balance Sheet Highlights
As of June 30, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of
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.
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, including with respect to clinical trials, regulatory approvals and studies, the construction of our NH facility, projections, objectives, performance, our ability to commercialize, applications with regulatory bodies or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on March 12, 2025, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release.
Investor Relations Contact:
IR@alphatau.com
| INTERIM CONSOLIDATED BALANCE SHEETS | ||||||||||
| U.S. dollars in thousands | ||||||||||
| June 30, | ||||||||||
| December 31, | 2025 | |||||||||
| 2024 | (unaudited) | |||||||||
| ASSETS | ||||||||||
| CURRENT ASSETS: | ||||||||||
| Cash and cash equivalents | $ | 13,724 | $ | 11,703 | ||||||
| Short-term deposits | 45,876 | 67,996 | ||||||||
| Restricted deposits | 3,255 | 3,554 | ||||||||
| Prepaid expenses and other receivables | 1,374 | 2,525 | ||||||||
| Total current assets | 64,229 | 85,778 | ||||||||
| LONG-TERM ASSETS: | ||||||||||
| Long-term prepaid expenses | 432 | 463 | ||||||||
| Property and equipment, net | 13,934 | 17,285 | ||||||||
| Operating lease right-of-use assets | 7,609 | 7,428 | ||||||||
| Total long-term assets | 21,975 | 25,176 | ||||||||
| Total assets | $ | 86,204 | $ | 110,954 | ||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||
| CURRENT LIABILITIES: | ||||||||||
| Trade payables | $ | 3,531 | $ | 2,397 | ||||||
| Other payables and accrued expenses | 4,133 | 4,679 | ||||||||
| Current maturities of operating lease liabilities | 1,011 | 1,080 | ||||||||
| Total current liabilities | 8,675 | 8,156 | ||||||||
| LONG-TERM LIABILITIES: | ||||||||||
| Long-term loan | 5,561 | 6,033 | ||||||||
| Warrants liability | 3,338 | 3,781 | ||||||||
| Operating lease liabilities | 5,964 | 6,201 | ||||||||
| Deferred tax liability | - | 160 | ||||||||
| Total long-term liabilities | 14,863 | 16,175 | ||||||||
| Total liabilities | 23,538 | 24,331 | ||||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||||
| SHAREHOLDERS' EQUITY: | ||||||||||
| Ordinary shares of no-par value per share – Authorized: 362,116,800 shares as of December 31, 2024 and June 30, 2025; Issued and outstanding: 70,380,570 and 85,043,199 shares as of December 31, 2024 and June 30, 2025, respectively | - | - | ||||||||
| Additional paid-in capital | 210,175 | 252,937 | ||||||||
| Accumulated deficit | (147,509 | ) | (166,314 | ) | ||||||
| Total shareholders' equity | 62,666 | 86,623 | ||||||||
| Total liabilities and shareholders' equity | $ | 86,204 | $ | 110,954 | ||||||
| INTERIM CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
| U.S. dollars in thousands (except share and per share data) | ||||||||||
| Six months ended June 30, | ||||||||||
| 2024 | 2025 | |||||||||
| Unaudited | ||||||||||
| Research and development, net | $ | 13,314 | $ | 14,182 | ||||||
| Marketing expenses | 1,133 | 918 | ||||||||
| General and administrative | 3,031 | 3,856 | ||||||||
| Total operating loss | 17,478 | 18,956 | ||||||||
| Financial income, net | (2,132 | ) | (315 | ) | ||||||
| Loss before taxes on income | 15,346 | 18,641 | ||||||||
| Tax on income | 4 | 164 | ||||||||
| Net loss | 15,350 | 18,805 | ||||||||
| Net comprehensive loss | $ | 15,350 | $ | 18,805 | ||||||
| Net loss per share, basic and diluted | $ | (0.22 | ) | $ | (0.25 | ) | ||||
| Weighted-average shares used in computing net loss per share, basic and diluted | 69,789,717 | 75,452,040 | ||||||||
FAQ
What is the current cash position of Alpha Tau Medical (DRTS) as of Q2 2025?
What was Alpha Tau's (DRTS) net loss per share in H1 2025?
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When will Alpha Tau's (DRTS) Hudson, NH facility become operational?
