Full Press Release Details
Tau Announces Third Quarter 2025 Financial Results and Provides Corporate Update
- Alpha DaRT pancreatic cancer patient treatments
underway in U.S. multi-center pilot study -
- Newly received radioactive material
license for New Hampshire facility positions the Company for continued advancement towards commercial readiness -
- Multiple meaningful milestones targeted in
the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART trial -
- Cash, cash equivalents & deposits balance
of $75.9 million provides runway for continued clinical advancement and commercial preparation -
JERUSALEM, November 20, 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 third quarter 2025 financial results and provided a corporate update.
"The third quarter has seen a
fantastic continuation of our accelerating momentum at Alpha Tau, as the pace of patient treatments continues to rise, and we draw
increased interest from our peers in the industry" said Alpha Tau Chief Executive Officer Uzi Sofer. "Receiving the
radioactive license approval in New Hampshire was a significant milestone in our push for operational commercial readiness, and we
are continuing to develop that facility for use in treating patients in the U.S., Canada, and elsewhere, having invested almost $2
million into the facility in Q3. We are very happy with the rate of recruitment in our U.S. multi-center pilot study in pancreatic
cancer, and look forward to some potential targeted near-term milestones, including a forthcoming response from the PMDA to our
request for marketing authorization in Japan in treating recurrent head & neck cancer, and treating our first patients with
glioblastoma multiforme (GBM) shortly. With four IDEs currently active for trials in the U.S., we are continuing to explore with the
FDA other potential U.S. trial initiations, potentially in prostate cancer or head & neck cancers."
Recent Corporate Highlights:
Expected Upcoming Milestone Targets:
Financial Results for Nine Months Ended September 30, 2025
Research and Development expenses for the nine months ended September
30, 2025 were $22.5 million, compared to $19.5 million for the same period in 2024, primarily due to an increase in employee compensation
and benefits, costs of raw materials and third-party contractor expenses, reflecting increased clinical activities, as well as decreased
government grants, offset by lower share-based compensation expenses and travel expenses.
Marketing expenses for the nine months ended September 30, 2025 were
$1.4 million, compared to $1.7 million for the same period in 2024, due to decreased employee compensation and benefits and decreased
marketing conference activities and travel expenses.
General and Administrative expenses for the nine months ended September
30, 2025 were $5.8 million, compared to $4.6 million for the same period in 2024, primarily due to increased employee compensation and
benefits, including share-based compensation and professional fees (including legal and IR expenses), offset by a decrease
in travel expenses and D&O insurance costs.
Financial expense, net, for the nine months ended September 30, 2025
was $0.6 million, compared to financial income, net, of $3.5 million for the same period in 2024, primarily due to an increase in the
remeasurement of warrants, a decrease in interest from bank deposits, and changes in foreign exchange rates.
For the nine months ended September 30, 2025, the Company had a net
loss of $30.5 million, or $0.39 per share, compared to a net loss of $22.3 million, or $0.32 per share, in the nine months ended September
Balance Sheet Highlights
As of September 30, 2025, the Company had cash and cash equivalents,
short-term deposits and restricted deposits of $75.9 million, compared to $62.9 million at December 31, 2024.
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,"
"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 and planned treatments, regulatory approvals and expected responses, studies, the construction of our NH facility and expected
production capacity, patient recruitment, 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:
INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| December 31, | September 30, | |||||||
| 2024 | 2025 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 13,724 | $ | 3,329 | ||||
| Short-term deposits | 45,876 | 68,882 | ||||||
| Restricted deposits | 3,255 | 3,669 | ||||||
| Prepaid expenses and other receivables | 1,374 | 1,220 | ||||||
| Total current assets | 64,229 | 77,100 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Long-term prepaid expenses | 432 | 472 | ||||||
| Property and equipment, net | 13,934 | 19,742 | ||||||
| Operating lease right-of-use assets | 7,609 | 7,380 | ||||||
| Total long-term assets | 21,975 | 27,594 | ||||||
| Total assets | $ | 86,204 | $ | 104,694 |
INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
| December 31, | September 30, | |||||||
| 2024 | 2025 | |||||||
| Unaudited | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 3,531 | $ | 3,055 | ||||
| Other payables and accrued expenses | 4,133 | 4,969 | ||||||
| Current maturities of operating lease liabilities | 1,011 | 1,119 | ||||||
| Total current liabilities | 8,675 | 9,143 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term loan | 5,561 | 6,153 | ||||||
| Warrants liability | 3,338 | 5,433 | ||||||
| Operating lease liabilities | 5,964 | 6,230 | ||||||
| Deferred tax liability | - | 151 | ||||||
| Total long-term liabilities | 14,863 | 17,967 | ||||||
| Total liabilities | 23,538 | 27,110 | ||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares of no-par value per share - Authorized: 362,116,800 shares as of December 31, 2024 and September 30, 2025; Issued and outstanding: 70,380,570 and 85,264,146 shares as of December 31, 2024 and September 30, 2025, respectively | - | - | ||||||
| Additional paid-in capital | 210,175 | 255,584 | ||||||
| Accumulated deficit | (147,509 | ) | (178,000 | ) | ||||
| Total shareholders' equity | 62,666 | 77,584 | ||||||
| Total liabilities and shareholders' equity | $ | 86,204 | $ | 104,694 |
INTERIM CONSOLIDATED STATEMENTS
U.S. dollars in thousands (except share and per share data)
| Nine months ended September 30, | ||||||||
| 2024 | 2025 | |||||||
| Unaudited | ||||||||
| Research and development, net | $ | 19,487 | $ | 22,489 | ||||
| Marketing expenses | 1,662 | 1,408 | ||||||
| General and administrative | 4,619 | 5,789 | ||||||
| Total operating loss | 25,768 | 29,686 | ||||||
| Financial expenses (income), net | (3,498 | ) | 649 | |||||
| Loss before taxes on income | 22,270 | 30,335 | ||||||
| Income tax expense | 4 | 156 | ||||||
| Net loss | 22,274 | 30,491 | ||||||
| Net comprehensive loss | $ | 22,274 | $ | 30,491 | ||||
| Net loss per share, basic and diluted | $ | 0.32 | $ | 0.39 | ||||
| Weighted-average shares used in computing net loss per share, basic and diluted | 69,857,700 | 78,721,389 |