Alpha Tau Medical Announces Second Quarter 2024 Financial Results and Provides Corporate Update

Rhea-AI Summary

Alpha Tau Medical (NASDAQ: DRTS), developer of the Alpha DaRT® cancer therapy, reported Q2 2024 financial results and provided a corporate update. Key highlights include:

- First patient treated for liver metastases from colorectal cancer in May
- Publication in Cancers journal showing nearly 100% overall response rate in treated lesions
- Cash balance of $74.1 million, providing at least two years of runway
- ReSTART U.S. pivotal trial in recurrent cutaneous squamous cell carcinoma progressing
- Ongoing internal organ trials generating strong clinician interest
- New manufacturing plant in Hudson, NH approved and under renovation

Financial results for H1 2024 show R&D expenses of $13.3 million, marketing expenses of $1.1 million, and G&A expenses of $3.0 million. Net loss was $15.4 million ($0.22 per share), compared to $16.9 million ($0.24 per share) in H1 2023.

Positive

• Publication in Cancers journal showing almost 100% overall response rate in treated lesions
• Strong cash position of $74.1 million, providing at least two years of runway
• Approvals secured for new manufacturing plant in Hudson, NH
• Financial income of $2.1 million in H1 2024, compared to $0.02 million expense in H1 2023
• Reduced net loss of $15.4 million in H1 2024, compared to $16.9 million in H1 2023

Negative

• Increased R&D expenses to $13.3 million in H1 2024 from $12.3 million in H1 2023
• Increased marketing expenses to $1.1 million in H1 2024 from $0.9 million in H1 2023
• Cash and cash equivalents decreased to $74.1 million from $84.9 million at end of 2023

Insights

Medical Research Analyst

The publication in Cancers journal showcases promising results for Alpha DaRT® therapy. With an overall response rate of almost 100% in treated lesions and a complete response rate of 89%, these findings are impressive for hard-to-treat cancers. The 2-year local recurrence-free survival of 77% and absence of moderate or severe long-term toxicities are particularly encouraging. However, it's important to note that the median follow-up was only 14 months, which may limit long-term conclusions. The initiation of liver metastases treatment and planned trials for lung and brain cancers indicate a strategic expansion of Alpha DaRT's potential applications, potentially broadening its market reach if successful.

Financial Analyst

Alpha Tau's financial position appears stable with $74.1 million in cash and equivalents, providing a runway of at least two years. However, the cash balance decreased from $84.9 million at the end of 2023, indicating ongoing cash burn. R&D expenses increased slightly year-over-year, reflecting continued investment in clinical trials. The net loss narrowed to $15.4 million from $16.9 million, with a reduced loss per share of $0.22. The improvement in financial income to $2.1 million from a $0.02 million expense is notable, driven by better interest income and favorable warrant revaluations. While the company's cash position is solid, investors should monitor the burn rate and progress of clinical trials, as these will be critical for future funding needs and potential commercialization.

Market Research Analyst

Alpha Tau's progress in expanding Alpha DaRT's applications could significantly impact its market potential. The ongoing ReSTART pivotal trial for recurrent cutaneous squamous cell carcinoma, with expected completion of recruitment by year-end 2024, is a key milestone to watch. The potential pre-market approval in Japan for recurrent head and neck cancer by year-end 2024 could open up a new market. The company's preparation for future product launches, including the new manufacturing plant in New Hampshire, indicates confidence in commercialization prospects. However, investors should be aware that the path from clinical trials to market approval can be lengthy and uncertain. The "overwhelming interest" from clinicians in internal organ trials is encouraging, but concrete data from these trials, particularly in pancreatic cancer, will be important for assessing the therapy's broader market potential.

- First patient treated in May for liver metastases from colorectal cancer -

- Publication in June in Cancers journal of long-term safety and efficacy data in multiple hard-to-treat superficial cancers, with an overall response rate of almost 100% in treated lesions, no moderate or severe long-term toxicities noted, and a 2-year local recurrence-free survival was estimated at 77% -

- Cash, cash equivalents & deposits balance of $74.1 million with runway of at least two years -

JERUSALEM, Aug. 14, 2024 (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 2024 financial results and provided a corporate update.

"While we continue to advance our ReSTART U.S. multicenter pivotal trial in recurrent cutaneous squamous cell carcinoma, the overwhelming interest from clinicians and the broader community in our ongoing internal organ trials has been fantastic,” stated Alpha Tau CEO Uzi Sofer. "We are fortunate to see such strong clinician demand for participation in clinical trials, at a time when we expect meaningful data generation, in particular with continued progress in our clinical trials in pancreatic cancer outside the U.S. as well as regulatory progress on similar trials in the U.S. We also continue to prepare for potential future product launches by advancing our commercial planning activities and solidifying our supply chain, as we have secured approvals for our new manufacturing plant in Hudson, New Hampshire and commenced renovation of the facility for our needs. Alpha Tau expects to remain adequately capitalized to support all of these programs over the coming years," he concluded.

Recent Corporate Highlights:

• In June, Alpha Tau announced the publication of “Extended Follow-Up Outcomes from Pooled Prospective Studies Evaluating Efficacy of Interstitial Alpha Radionuclide Treatment for Skin and Head and Neck Cancers” in the journal Cancers. The pooled analysis included data from 4 international clinical trials spanning an array of hard-to-treat indications including skin, head & neck, and oral cavity. Initial response data demonstrated an overall response rate of almost 100% in treated lesions and a complete response rate of 89%. With follow-up as long as 51 months (median follow-up of 14 months), no moderate or severe long-term toxicities were noted, and 2-year local recurrence-free survival was estimated at 77%. For more information, please refer to https://www.mdpi.com/2072-6694/16/13/2312
• In May, the first patient with liver cancer metastases was treated in a feasibility and safety study of Alpha DaRT at McGill University Health Center in Montreal, Canada. The trial aims to recruit up to 10 patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. For more information, please refer to https://www.clinicaltrials.gov/study/NCT05829291

Upcoming Milestones

• Planning treatment of the first patient in the Israeli recurrent lung cancer safety and feasibility trial in H2 2024. The trial is currently open for recruitment; for more information please see here: https://www.clinicaltrials.gov/study/NCT05632913
• Targeting first brain cancer treatment in H2 2024.
• Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma by around year-end 2024. For more information please see here: https://www.clinicaltrials.gov/study/NCT05323253
• Anticipating response from PMDA in Japan by year-end 2024 for pre-market approval for Alpha DaRT in patients with recurrent head and neck cancer.
• Targeting announcement of safety, feasibility and efficacy data from advanced inoperable pancreatic cancer studies in Montreal and in Jerusalem by the end of Q1 2025. For more information please see here: https://www.clinicaltrials.gov/study/NCT04002479 and https://www.clinicaltrials.gov/study/NCT05657743

Financial results for quarter ended June 30, 2024

R&D expenses for the six months ended June 30, 2024 were $13.3 million, compared to $12.3 million for the same period in 2023, due to increased employee compensation and benefits, increased employee compensation and benefits, including share-based compensation, increased costs of raw materials, and increased travel expenses related to our U.S. multi-center pivotal trial, offset by lower third-party contractor expenses.

Marketing expenses for the six months ended June 30, 2024 were $1.1 million, compared to $0.9 million for the same period in 2023, due to increased employee compensation and benefits and increased marketing expenses.

G&A expenses for the six months ended June 30, 2024 were $3.0 million, compared to $3.6 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 six months ended June 30, 2024 was $2.1 million, compared to $0.02 million financial expense, net, for the same period in 2023, due to a decrease in revaluation of warrants, an increase in interest from bank deposits, and changes in foreign exchange rates, offset by interest on long-term loan.

For the six months ended June 30, 2024, the Company had a net loss of $15.4 million, or $0.22 per share, compared to a net loss of $16.9 million, or $0.24 per share, in the first half of 2023.

Balance Sheet Highlights

As of June 30, 2024, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $74.1 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 7, 2024, 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

				December 31,			June 30,
				2023			2024
		Note		Audited			Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents				$	12,657		$	2,763
Short-term deposits					69,131			68,268
Restricted deposits					3,152			3,115
Prepaid expenses and other receivables					816			1,102
Total current assets					85,756			75,248
LONG-TERM ASSETS:
Long term prepaid expenses					471			437
Property and equipment, net					12,798			12,354
Right-of-use asset		3			8,363			8,009
Total long-term assets					21,632			20,800
Total assets				$	107,388		$	96,048

INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands

				December 31,				June 30,
				2023				2024
		Note		Audited				Unaudited
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables				$	2,566			$	2,008
Other payables and accrued expenses					3,474				3,410
Current maturities of operating lease liabilities		3			1,062				1,038
Total current liabilities					7,102				6,456
LONG-TERM LIABILITIES:
Long-term loan		4			5,610				5,411
Warrants liability		5			3,597				4,055
Operating lease liabilities		3			6,604				6,109
Total long-term liabilities					15,811				15,575
Total liabilities					22,913				22,031
COMMITMENTS AND CONTINGENCIES		7
SHAREHOLDERS' EQUITY:		8
Ordinary shares of no-par value per share –
Authorized: 362,116,800 shares as of December 31, 2023 and June 30, 2024; Issued and outstanding: 69,670,612 and 69,924,154 shares as of December 31, 2023 and June 30, 2024, respectively					-				-
Additional paid-in capital					200,234				205,126
Accumulated deficit					(115,759	)			(131,109	)
Total shareholders' equity					84,475				74,017
Total liabilities and shareholders' equity				$	107,388			$	96,048

INTERIM CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)

				Six months ended June 30,
		Note		2023				2024
				Unaudited
Research and development, net				$	12,261			$	13,314
Marketing expenses					920				1,133
General and administrative					3,631				3,031
Total operating loss					16,812				17,478
Financial expenses (income), net		9			21				(2,132	)
Loss before taxes on income					16,833				15,346
Tax on income					47				4
Net loss					16,880				15,350
Net comprehensive loss				$	16,880			$	15,350
Net loss per share, basic and diluted				$	(0.24	)		$	(0.22	)
Weighted-average shares used in computing net loss per share, basic and diluted					69,262,381				69,789,717

FAQ

What were Alpha Tau Medical's (DRTS) Q2 2024 financial results?

Alpha Tau Medical reported a net loss of $15.4 million ($0.22 per share) for H1 2024, compared to $16.9 million ($0.24 per share) in H1 2023. R&D expenses were $13.3 million, marketing expenses were $1.1 million, and G&A expenses were $3.0 million.

What is the cash position of Alpha Tau Medical (DRTS) as of June 30, 2024?

As of June 30, 2024, Alpha Tau Medical had cash, cash equivalents, short-term deposits, and restricted deposits totaling $74.1 million, which is expected to fund operations for at least two years.

What clinical progress has Alpha Tau Medical (DRTS) made in Q2 2024?

In Q2 2024, Alpha Tau Medical treated the first patient with liver cancer metastases in a feasibility study, published long-term safety and efficacy data in Cancers journal showing nearly 100% overall response rate, and continued progress in their ReSTART U.S. pivotal trial for recurrent cutaneous squamous cell carcinoma.

What are Alpha Tau Medical's (DRTS) upcoming milestones for 2024-2025?

Alpha Tau Medical's upcoming milestones include treating the first patient in an Israeli recurrent lung cancer trial in H2 2024, targeting first brain cancer treatment in H2 2024, completing patient recruitment for the ReSTART trial by year-end 2024, and announcing data from pancreatic cancer studies by Q1 2025.