Full Press Release Details
Financial Results and Provides Corporate Update
results from three trials of Alpha DaRT in treating pancreatic cancer shared at prestigious 2025 ASCO GI Symposium and
R&D Update Day, showing >90% disease control rate, impressive overall survival in sub-group analyses, and positive safety profile
objective response rate (ORR) and 37.5% complete response rate meaningfully higher thus far than historical Keytruda monotherapy
data in Jan-2025 interim read out of a combination trial of Alpha DaRT and Keytruda in head and neck squamous cell carcinoma (HNSCC) -
FDA approval of Investigational Device Exemption (IDE) and IDE supplement to conduct a U.S. pilot study of Alpha DaRT together with first-line
chemotherapy in patients with newly diagnosed locally advanced or metastatic pancreatic cancer -
- MDSAP certification
of the Company's Jerusalem facility meets the standards of the U.S., Australia, Brazil, Canada, and Japan, and completes audit
for compliance with ISO 13485 -
- FDA approval of IDE to conduct a U.S. pilot
study of Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive brain cancer -
- Completion of $36.9 million financing
after balance sheet date bolsters the Company's capital position during ongoing acceleration of activities -
JERUSALEM, 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.
"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:
Expected Upcoming Milestone Targets:
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
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.
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.
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, projections,
objectives, performance 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:
CONSOLIDATED BALANCE SHEET
U.S. dollars in thousands
| December 31, 2024 | March 31, 2025 | |||||||
| Audited | Unaudited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 13,724 | $ | 5,019 | ||||
| Short-term deposits | 45,876 | 46,617 | ||||||
| Restricted deposits | 3,255 | 3,212 | ||||||
| Prepaid expenses and other receivables | 1,374 | 1,938 | ||||||
| Total current assets | 64,229 | 56,786 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Long term prepaid expenses | 432 | 439 | ||||||
| Property and equipment, net | 13,934 | 16,191 | ||||||
| Operating lease right-of-use assets | 7,609 | 7,512 | ||||||
| Total long-term assets | 21,975 | 24,142 | ||||||
| Total assets | $ | 86,204 | $ | 80,928 |
CONSOLIDATED BALANCE SHEET
U.S. dollars in thousands
| December 31, 2024 | March 31, 2025 | |||||||
| Audited | Unaudited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade Payables | $ | 3,531 | $ | 2,577 | ||||
| Other payables and accrued expenses | 4,133 | 6,188 | ||||||
| Current maturities of operating lease liabilities | 1,011 | 1,001 | ||||||
| Total current liabilities | 8,675 | 9,766 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term loan | 5,561 | 5,472 | ||||||
| Warrants liability | 3,338 | 3,545 | ||||||
| Operating lease liabilities | 5,964 | 5,820 | ||||||
| Total long-term liabilities | 14,863 | 14,837 | ||||||
| Total liabilities | 23,538 | 24,603 | ||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Share capital | ||||||||
| Ordinary shares of no-par value per share - Authorized: 362,116,800 shares as of December 31, 2024 and March 31, 2025; Issued and outstanding: 70,380,570 and 70,511,475 shares as of December 31, 2024 and March 31, 2025, respectively | - | - | ||||||
| Additional paid-in capital | 210,175 | 212,525 | ||||||
| Accumulated deficit | (147,509 | ) | (156,200 | ) | ||||
| Total shareholders' equity | 62,666 | 56,325 | ||||||
| Total liabilities and shareholders' equity | $ | 86,204 | $ | 80,928 |
STATEMENT OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
| Three months ended March 31, | ||||||||
| 2024 | 2025 | |||||||
| Unaudited | ||||||||
| Research and development, net | $ | 6,448 | $ | 7,170 | ||||
| Marketing expenses | 533 | 459 | ||||||
| General and administrative expenses | 1,443 | 1,679 | ||||||
| Total operating loss | 8,424 | 9,308 | ||||||
| Financial income, net | (444 | ) | (716 | ) | ||||
| Loss before taxes on income | 7,980 | 8,592 | ||||||
| Tax on income | 1 | 99 | ||||||
| Net loss | 7,981 | 8,691 | ||||||
| Net comprehensive loss | 7,981 | 8,691 | ||||||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.12 | ) | ||
| Weighted-average shares used in computing net loss per share, basic and diluted | 69,714,250 | 70,450,897 |