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Alpha Tau Announces Second Quarter 2025 Financial Results and Provides Corporate Update

1. FDA approved IDE for U.S. GBM pilot study initiation. 2. Alpha Tau secured $36.9 million for clinical advancements. 3. Upcoming clinical trials for pancreatic and skin cancer underway. 4. Strong cash reserve ensures ongoing clinical and commercial efforts. 5. Hudson facility ready for production of Alpha DaRT in 2026.

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$3.5608/11 04:08 PM EDTEvent Start
$3.2508/12 10:43 PM EDTLatest Updated
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FAQ

Why Bullish?

The FDA approval and funding boost are significant positive catalysts, driving investor confidence as seen historically in similar biotech scenarios where FDA approvals led to stock price surges.

How important is it?

The article's focus on FDA approvals and funding indicates a strong forward momentum for DRTS, aligning well with investor interests in the biotech market, boosting the stock's outlook.

Why Short Term?

Immediate clinical trial initiations and capital influx are expected to influence investor sentiment and stock dynamics in the near future, akin to events around pivotal trial announcements in biotech.

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ORMP
August 11, 2025 16:02 ET  | Source: Alpha Tau Medical Ltd. - 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 $36.9 million through a strategic equity offering at market price from Oramed, while concurrently entering into a strategic IR/PR alliance - - Cash, cash equivalents & deposits balance of $83.3 million provides runway for continued clinical advancement and commercial preparation - 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/NCT06698458First patient treated in U.S. GBM pilot study in H2 2025. For more information, please see here: https://www.clinicaltrials.gov/study/NCT06910306Completion 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/NCT05323253Response 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 $14.2 million, compared to $13.3 million for the same period in 2024, primarily due to an increase in employee compensation and benefits and third-party contractor expenses, reflecting increased clinical activities, as well as decreased government grants, offset by lower costs of raw materials, share-based compensation expenses and travel expenses. Marketing expenses for the six months ended June 30, 2025 were $0.9 million, compared to $1.1 million for the same period in 2024, due to decreased employee compensation and benefits and decreased marketing conference activities. General and Administrative expenses for the six months ended June 30, 2025 were $3.9 million, compared to $3.0 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation and professional fees (including legal, financing and IR expenses), offset by a decrease in travel expenses and D&O insurance costs. Financial income, net, for the six months ended June 30, 2025 was $0.3 million, compared to $2.1 million for the same period in 2024, primarily due to a decrease in interest from bank deposits, and changes in foreign exchange rates. For the six months ended June 30, 2025, the Company had a net loss of $18.8 million, or $0.25 per share, compared to a net loss of $15.4 million, or $0.22 per share, in the six months ended June 30, 2024. Balance Sheet Highlights As of June 30, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $83.3 million, compared to $62.9 million at December 31, 2024. 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 SHEETSU.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 OPERATIONSU.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        

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