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Alpha Tau Medical Announces First Quarter 2024 Financial Results and Provides Corporate Update - Presented preclinical data demonstrating abscopal immune effect in pancreatic murine tumor models at ESTRO 2024 Congress in

Key Takeaway: Alpha Tau Medical announced its first-quarter financial results for 2024, including a net loss of $8.0 million. The company showcased preclinical data indicating an abscopal immune effect in pancreatic cancer models at ESTRO 2024 and treated its first patient in a liver metastases study. They are actively recruiting for trials in the U.S., Canada, and Israel, capitalizing on ongoing developments in their alpha-radiation therapy, Alpha DaRT. With a solid cash reserve of $80.7 million, Alpha Tau aims to continue advancing its projects and is preparing for future product launches.

Market Sentiment Analysis

POSITIVE FACTORS

  • Presented promising preclinical data on immune effects in tumor models.
  • Successfully treated first patient in a safety study in Canada.
  • Solid financial position with $80.7 million in cash and a runway of at least two years.
  • Ongoing patient recruitment for pivotal trials indicates long-term project viability.

CONCERNS & RISKS

  • Reported net loss of $8 million in Q1 2024, though slightly improved from Q1 2023.
  • Increased clinical trial expenses, which could impact financial stability if not managed.
  • Potential risks associated with regulatory approvals for new therapies.

Full Press Release Details

Tau Medical Announces First
Quarter 2024 Financial Results and
Provides Corporate Update
- Presented preclinical data demonstrating
abscopal immune effect in pancreatic murine tumor models at ESTRO 2024 Congress in Glasgow -
- First patient with liver metastases treated
in a feasibility and safety study of Alpha DaRT at the McGill University Health Center in Montreal, Canada -
- Patient recruitment for ReSTART U.S. multi-center
pivotal trial and for pancreatic cancer feasibility and safety studies in Canada and Israel currently ongoing -
- Cash, cash equivalents, deposits & restricted
deposits balance of $80.7 million with runway of at least two years -
JERUSALEM, May 20, 2024 -- 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 2024 financial results and provided a corporate update.
"This year we remain focused on advancing
our ReSTART U.S. multi-center pivotal trial in recurrent cutaneous squamous cell carcinoma, but in parallel we have seen very encouraging
initial results from our internal organ trials over the past quarter, which remind us of the broader opportunity set ahead of us,"
stated Alpha Tau CEO Uzi Sofer. "Alongside our focus on completing our pivotal trial and feasibility programs, we also continue
to make good progress in preparing for potential future product launches by advancing our commercial planning activities and solidifying
our supply chain, with a focus on building out our new planned manufacturing facility in Hudson, New Hampshire. Alpha Tau anticipates
remaining adequately capitalized to support all of these programs over the coming years," he concluded.
Recent Corporate Highlights:
Upcoming 2024 Milestones
Financial results for quarter ended March 31, 2024
for the quarter ended March 31, 2024 were $6.4 million, compared to $6.3 million for the same period in 2023, due to increased employee
compensation and benefits, including share-based compensation, and increased preclinical study and clinical trial expenses, particularly
as related to its ReSTART U.S. multi-center pivotal trial, offset by increased government grants.
Marketing expenses for the quarter ended March
31, 2024 were $0.5 million, compared to $0.4 million for the same period in 2023, due to increased employee compensation and benefits
and increased marketing expenses.
G&A expenses for the quarter ended March
31, 2024 were $1.4 million, compared to $1.9 million for the same period in 2023, due primarily to a reduction in D&O insurance costs.
Financial income, net, for the quarter ended March 31, 2024 was $0.4 million, compared to $0.4 million for the same period in 2023, as
an increase in interest from bank deposits was offset by a higher expense from remeasurement of warrants.
For the quarter ended March 31, 2024, the Company had a net loss of $8.0 million, or $0.11 per share, compared to a net loss of $8.2 million,
or $0.12 per share, in the first quarter of 2023.
Balance Sheet Highlights
As of March 31, 2024, the Company had cash and
cash equivalents, deposits and restricted deposits in the amount of $80.7 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.
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 medical
device 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:
CONSOLIDATED BALANCE SHEET
U.S. dollars in thousands
December 31, 2023 March 31, 2024
Audited Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 12,657 $ 7,296
Short-term deposits 69,131 70,257
Restricted deposits 3,152 3,124
Prepaid expenses and other receivables 816 527
Total current assets 85,756 81,204
LONG-TERM ASSETS:
Long term prepaid expenses 471 465
Property and equipment, net 12,798 12,592
Right-of-use asset 8,363 8,183
Total long-term assets 21,632 21,240
Total assets $ 107,388 $ 102,444
CONSOLIDATED BALANCE SHEET
U.S. dollars in thousands
December 31, 2023 March 31, 2024
Audited Unaudited
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade Payables $ 2,566 $ 2,459
Other payables and accrued expenses 3,474 3,491
Current maturities of operating lease liabilities 1,062 1,050
Total current liabilities 7,102 7,000
LONG-TERM LIABILITIES:
Long-term loan 5,610 5,526
Warrants liability 3,597 4,486
Operating lease liabilities 6,604 6,366
Total long-term liabilities 15,811 16,378
Total liabilities 22,913 23,378
SHAREHOLDERS' EQUITY:
Share capital
Ordinary shares of no-par value per share - Authorized: 362,116,800 shares as of December 31, 2023 and March 31, 2024; Issued and outstanding: 69,670,612 and 69,796,755 shares as of December 31, 2023 and March 31, 2024, respectively - -
Additional paid-in capital 200,234 202,806
Accumulated deficit (115,759 ) (123,740 )
Total shareholders' equity 84,475 79,066
Total liabilities and shareholders' equity $ 107,388 $ 102,444
CONSOLIDATED STATEMENT OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Three months ended
March 31,
2023 2024
Unaudited
Research and development, net $ 6,306 $ 6,448
Marketing expenses 400 533
General and administrative expenses 1,938 1,443
Total operating loss 8,644 8,424
Financial income, net (478 ) (444 )
Loss before taxes on income 8,166 7,980
Tax on income 21 1
Net loss 8,187 7,981
Net comprehensive loss 8,187 7,981
Net loss per share, basic and diluted $ (0.12 ) $ (0.11 )
Weighted-average shares used in computing net loss per share, basic and diluted 69,205,654 69,714,250

Frequently Asked Questions

What recent clinical trial milestone did Alpha Tau achieve?

Alpha Tau treated its first patient with liver metastases in a feasibility study.

How much cash does Alpha Tau have as of March 31, 2024?

Alpha Tau reported cash and equivalents of $80.7 million as of March 31, 2024.

What is Alpha DaRT designed for?

Alpha DaRT is designed for targeted alpha-radiation therapy to treat solid tumors.

What are Alpha Tau's financial results for Q1 2024?

In Q1 2024, Alpha Tau reported a net loss of $8.0 million, up slightly from last year.

Where is Alpha Tau's planned manufacturing facility located?

The new manufacturing facility is planned to be built in Hudson, New Hampshire.

Last updated: May 20, 2024