Alpha Tau Announces Full Year 2024 Financial Results and Provides Corporate Update

Rhea-AI Summary

Alpha Tau Medical (NASDAQ: DRTS) reported its full year 2024 financial results and corporate updates. The company's innovative Alpha DaRT cancer therapy showed promising interim results across multiple trials:

Key clinical highlights include high disease control rates in pancreatic cancer trials, and impressive response rates in combination with Keytruda for head and neck cancer treatment. The company received FDA approval for a U.S. pilot study combining Alpha DaRT with first-line chemotherapy for pancreatic cancer patients.

Financial results show:

• R&D expenses: $27.0M (vs $26.4M in 2023)
• Net loss: $31.8M or $0.45 per share (vs $29.2M in 2023)
• Cash position: $62.9M (vs $84.9M in 2023)

The company expects its current cash balance to fund operations for at least two years.

Positive

• Strong clinical results with 100% disease control rate in pancreatic cancer trials
• 75% response rate in combination therapy with Keytruda, significantly above historical benchmarks
• FDA approval for U.S. pilot study in pancreatic cancer
• Solid cash position of $62.9M providing two-year runway
• Acceptance into FDA's TAP program for accelerated market access

Negative

• Increased net loss to $31.8M in 2024 from $29.2M in 2023
• Cash position decreased to $62.9M from $84.9M year-over-year
• R&D expenses increased to $27.0M from $26.4M
• Marketing expenses rose to $2.3M from $1.9M

Insights

Biotech and Oncology Clinical Expert

Alpha Tau's 2024 results showcase remarkable clinical progress against a backdrop of financial discipline. The interim data from pancreatic cancer trials demonstrates a 100% disease control rate and strong safety profile—truly exceptional results in one of oncology's most challenging indications. Even more compelling is the 75% systemic objective response rate and 37.5% complete response rate in the combination study with Keytruda for HNSCC, far exceeding historical benchmarks of 19% and 5% respectively.

The FDA's approval of an expanded IDE for treating newly diagnosed pancreatic cancer patients (30 patients across two cohorts) signals regulatory confidence in Alpha DaRT's potential. The acceptance into FDA's prestigious TAP program for glioblastoma additionally accelerates the regulatory pathway for this deadly indication.

Alpha Tau's technological differentiation lies in its alpha radiation approach, which delivers precise, potent radiation with minimal collateral damage. These latest results suggest potential systemic immune effects beyond local tumor control—a holy grail in radiation oncology that could meaningfully expand Alpha DaRT's applications to metastatic disease.

The $62.9 million cash position providing a two-year runway offers sufficient capital to advance multiple clinical programs through critical milestones, including completion of the pivotal ReSTART trial in Q3 2025.

Financial Analyst

Alpha Tau's full-year results reveal a carefully managed financial position despite advancing an ambitious clinical program. The $31.8 million net loss ($0.45 per share) represents a modest 8.9% increase from 2023's $29.2 million loss, demonstrating controlled spend despite expanded clinical activities.

R&D expenses increased marginally by 2.3% to $27.0 million, reflecting disciplined resource allocation while still progressing multiple clinical trials. The $62.9 million cash position provides approximately two years of runway at current burn rates—a important buffer for a clinical-stage biotech navigating multiple regulatory pathways.

The company's strategic focus on high-unmet-need cancers like pancreatic, glioblastoma, and recurrent head and neck cancers positions Alpha DaRT in markets with significant commercial potential and competition. The manufacturing facility in Hudson, NH represents a strategic investment that will enhance production capabilities and potentially reduce COGS when commercialization begins.

While financial income decreased year-over-year, the strong interim clinical data enhances Alpha Tau's partnership potential and could accelerate non-dilutive funding opportunities. The upcoming regulatory milestones—particularly the PMDA response expected in Q3 2025 and potential completion of patient recruitment in the pivotal ReSTART trial—represent significant near-term catalysts that could materially impact Alpha Tau's valuation and strategic optionality.

Alpha Tau's 2024 results reveal substantial clinical progress across multiple hard-to-treat cancers while maintaining solid financial discipline. The interim data from pancreatic cancer trials showing 100% disease control rate is particularly noteworthy—this represents an exceptional signal in one of oncology's most treatment-resistant cancers where even modest responses typically make headlines.

The combination therapy results with Alpha DaRT and Keytruda in recurrent HNSCC are potentially game-changing, with systemic response rates of 75% and complete response rates of 37.5%—far exceeding Keytruda's historical benchmarks of 19% and 5%. Complete responses in recurrent head and neck cancer are exceedingly rare, suggesting Alpha DaRT may be potentiating immunotherapy effects through its unique alpha radiation mechanism.

Alpha Tau secured critical regulatory advancements, including FDA approval to expand their pancreatic cancer study to 30 patients and acceptance into the prestigious TAP program for glioblastoma treatment. The TAP designation is particularly significant as it provides intensive, tailored FDA guidance throughout development, potentially accelerating approval timelines.

Financially, the $62.9 million cash balance provides approximately two years of runway despite advancing multiple clinical programs. This should comfortably fund the company through several value-inflecting milestones, including completion of patient recruitment in their pivotal ReSTART trial expected in Q3 2025 and the anticipated PMDA response regarding Japanese approval for head and neck cancer applications.

The presentation of interim data at the 2025 ASCO GI Symposium adds scientific credibility and visibility to Alpha Tau's pancreatic cancer program, potentially facilitating investigator interest and patient recruitment for upcoming trials.

- Interim results from three trials exploring the use of Alpha DaRT^® in treating pancreatic cancer showing high disease control rate, impressive overall survival in sub-group analyses, and positive safety profile -

- Systemic ORR and complete response rates meaningfully higher thus far than historical Keytruda^® monotherapy data in interim read out of a combination trial of Alpha DaRT and Keytruda in treating recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) -

- Interim data from pancreatic cancer trials presented at the prestigious 2025 ASCO GI Symposium -

- 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 -

- Alpha DaRT accepted into the prestigious Total Product Life Cycle Advisory Program (TAP) of the FDA, to accelerate market access to the Alpha DaRT for patients with recurrent glioblastoma multiforme (GBM) -

- Cash, cash equivalents & deposits balance of $62.9 million, with runway of at least two years -

JERUSALEM, March 12, 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 full year 2024 financial results and provided a corporate update.

“Alpha Tau has been incredibly busy and very successful throughout 2024. With fantastic clinical results observed across a number of difficult cancers, we are now able to demonstrate the broader Alpha Tau vision of expanding our focus on treating internal organ tumors of high unmet need, as well as helping metastatic patients by harnessing the potential systemic immune benefits of Alpha DaRT”, said Alpha Tau Chief Executive Officer Uzi Sofer. “FDA approval of our forthcoming U.S. trials in patients with newly diagnosed pancreatic cancer and our investigator-initiated trial in immunocompromised patients with recurrent cSCC, not only aligns with our broader vision but also reflects continued progress in our regulatory pathway to approval for Alpha DaRT. In parallel, we remain focused on expanding our operational capabilities, with our Hudson, NH facility expected to complete its first phase of construction in the coming months and come online for production of Alpha DaRT later in 2025.”

Recent Corporate Highlights:

• 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. 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:
  
  • Investigational Device Exemption (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, but 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.
  • 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.
    
• In January, researchers from Hadassah Medical Center presented a poster entitled “Interim analysis of feasibility, safety, and tumor control in two first-in-human trials of a novel alpha-emitting radionuclide for pancreatic adenocarcinoma” at the prestigious 2025 ASCO GI Symposium, with interim data demonstrating 100% disease control rate and a strong safety profile. They also reported on a patient with pancreatic adenocarcinoma with metastases in the liver, who was seeing inadequate response from second-line chemotherapy but then saw full resolution of all tumors on PET scan after adding in Alpha DaRT treatment.
  
• In December, Alpha Tau announced the appointment of Maya Netser to its Board of Directors, bringing a wealth of experience and a keen understanding of the industry from her many years of corporate leadership and advisory, following the completion of Meir Jakobsohn’s term as a director.

Upcoming Milestones:

• Targeting first patient treated in Israel for brain cancer in H1 2025.
• Anticipating response from Japan’s PMDA in Q3 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.
• Targeting first patient enrolled in pancreatic cancer pilot study in the U.S. in Q2 2025.
• Seeking FDA IDE approval in Q2 2025 to conduct early feasibility study in recurrent glioblastoma multiforme (GBM) patients.    
• Targeting 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: https://www.clinicaltrials.gov/study/NCT05323253

Financial results for year ended December 31, 2024

R&D expenses for the year ended December 31, 2024 were $27.0 million, compared to $26.4 million for the same period in 2023, due to increased employee compensation and benefits, including share-based compensation, increased costs of raw materials, reduced government grants, and increased travel expenses related to our U.S. multi-center pivotal trial, offset by lower third-party contractor expenses.

Marketing expenses for the year ended December 31, 2024 were $2.3 million, compared to $1.9 million for the same period in 2023, due to increased marketing activities and travel abroad.

G&A expenses for the year ended December 31, 2024 were $6.7 million, compared to $7.3 million for the same period in 2023, primarily due to decreased professional fees (including D&O insurance and legal expenses), offset by increased travel expenses and increased employee compensation and benefits, including share-based compensation.

Financial income, net, for the year ended December 31, 2024 was $4.3 million, compared to $6.5 million for the same period in 2023, due to a decrease in income from revaluation of warrants and in interest from bank deposits and an increase in interest on long-term loan, offset by changes in foreign exchange rates.

For the year ended December 31, 2024, the Company had a net loss of $31.8 million, or $0.45 per share, compared to a net loss of $29.2 million, or $0.42 per share, in the year ending December 31, 2023.

Balance Sheet Highlights

As of December 31, 2024, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $62.9 million, compared to $84.9 million at December 31, 2023. The Company expects that this cash balance will be sufficient to fund anticipated operations for at least two years.

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, 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:
IR@alphatau.com

CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
	December 31,
	2023				2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	12,657			$	13,724
Short-term deposits		69,131				45,876
Restricted deposits		3,152				3,255
Prepaid expenses and other receivables		816				1,374
Total current assets		85,756				64,229
LONG-TERM ASSETS:
Long term prepaid expenses		471				432
Property and equipment, net		12,798				13,934
Operating lease right-of-use assets		8,363				7,609
Total long-term assets		21,632				21,975
Total assets	$	107,388			$	86,204

CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
	December 31,
		2023				2024
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables	$	2,566			$	3,531
Other payables and accrued expenses		3,474				4,133
Current maturities of operating lease liabilities		1,062				1,011
Total current liabilities		7,102				8,675
LONG-TERM LIABILITIES:
Long-term loan		5,610				5,561
Warrants liability		3,597				3,338
Operating lease liabilities		6,604				5,964
Total long-term liabilities		15,811				14,863
Total liabilities		22,913				23,538
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Ordinary shares of no-par value per share – Authorized: 362,116,800 shares as of December 31, 2023 and 2024; Issued and outstanding: 69,670,612 and 70,380,570 shares as of December 31, 2023 and 2024, respectively		-				-
Additional paid-in capital		200,234				210,175
Accumulated deficit		(115,759	)			(147,509	)
Total shareholders' equity		84,475				62,666
Total liabilities and shareholders' equity	$	107,388			$	86,204

CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
	Year ended December 31,
		2022				2023				2024
Research and development, net	$	20,890			$	26,424			$	27,020
Marketing expenses		974				1,924				2,349
General and administrative		10,272				7,332				6,673
Total operating loss		32,136				35,680				36,042
Financial expenses (income), net		1,606				(6,539	)			(4,298	)
Loss before taxes on income		33,742				29,141				31,744
Tax on income		20				16				6
Net loss		33,762				29,157				31,750
Net comprehensive loss	$	33,762			$	29,157			$	31,750
Net loss per share, basic and diluted	$	(0.53	)		$	(0.42	)		$	(0.45	)
Weighted-average shares used in computing net loss per share, basic and diluted		63,534,875				69,377,922				69,927,566

FAQ

What were the key clinical results for DRTS's Alpha DaRT therapy in pancreatic cancer trials?

The trials showed 100% disease control rate, strong safety profile, and full tumor resolution in a patient with pancreatic adenocarcinoma and liver metastases who previously had inadequate response to second-line chemotherapy.

How did DRTS's Alpha DaRT perform in combination with Keytruda for head and neck cancer?

The combination showed 75% systemic objective response rate and 37.5% complete response rate, significantly higher than Keytruda's historical benchmarks of 19% and 5% respectively.

What is DRTS's current cash position and expected runway?

As of December 31, 2024, DRTS had $62.9 million in cash and deposits, with an expected runway of at least two years.

What are the major upcoming milestones for DRTS in 2025?

Key milestones include first brain cancer patient treatment in H1, PMDA response in Q3, first pancreatic cancer patient enrollment in Q2, and completion of ReSTART trial recruitment in Q3 2025.