Full Press Release Details
Alpha Tau Medical Announces Second Quarter
2024 Financial Results and Provides Corporate Update
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, August 14, 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 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,"
Recent Corporate Highlights:
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
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.
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:
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
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 |