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Alpha Tau Medical Announces Third Quarter 2024 Financial Results and Provides Corporate Update - Alpha DaRT accepted into the prestigious Total Product Life Cycle Advisory Program (TAP) of the FDA, to accelerate market a

Key Takeaway: Alpha Tau Medical Ltd. reported its third quarter 2024 financial results, demonstrating significant advancements in its Alpha DaRT technology. The FDA has accepted Alpha DaRT into its Total Product Life Cycle Advisory Program to enhance market access for patients with recurrent glioblastoma multiforme. Additionally, Alpha Tau has treated the first patient in a lung cancer study and received FDA approval to initiate a study for treating recurrent cutaneous squamous cell carcinoma in immunocompromised patients. Despite recording a net loss, the company's CEO expressed optimism regarding the ongoing trials and future data releases.

Market Sentiment Analysis

POSITIVE FACTORS

  • Alpha DaRT accepted into the FDA's Total Product Life Cycle Advisory Program.
  • First patient treated in a lung cancer study in Israel, showing progress in clinical trials.
  • Sufficient cash balance expected to fund operations for at least two years.

CONCERNS & RISKS

  • Net loss increased slightly from $21.8 million to $22.3 million compared to the previous year.
  • Continued reliance on funding and capital raises indicated as a potential risk.

Full Press Release Details

Tau Medical Announces Third Quarter 2024 Financial Results and Provides Corporate Update
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) -
- First patient treated in Recurrent Lung Cancer
study in Israel, which will assess the safety and feasibility of delivering Alpha DaRT sources into the lung using an
endobronchial ultrasound procedure -
- FDA approval of an Investigational Device
Exemption (IDE) application to initiate a multi-center study for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC) in
immunocompromised patients using the Alpha DaRT -
- Cash, cash equivalents & deposits balance
of $68.4 million, with runway of at least two years -
JERUSALEM, November 19, 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 third quarter 2024 financial results
and provided a corporate update.
"Alpha Tau has continued to make great progress during 2024, with a number of important trials moving ahead and continued generation
of data across superficial tumors and cancers of internal organs," said Alpha Tau Chief Executive Officer Uzi Sofer. "Our
decision to use the ReSTART pivotal trial to explore our implementation of the Alpha DaRT treatment with community clinicians
such as Mohs surgeons continues to bear fruit. We look forward to releasing important data in internal organ cancers in the coming months
and giving our stakeholders a deeper look at the future we envision for the Alpha DaRT ," stated Alpha Tau CEO Uzi
Recent Corporate Highlights:
Upcoming Milestones:
Financial results for quarter ended September 30, 2024
R&D expenses for the nine months ended September 30, 2024 were $19.5 million, compared to $18.9 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 nine months ended September
30, 2024 were $1.7 million, compared to $1.5 million for the same period in 2023, due to increased employee compensation and benefits.
G&A expenses for the nine months ended September 30, 2024 were $4.6 million, compared to $5.3 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 nine months ended September 30, 2024 was $3.5 million, compared to $4.0 million for the same period in
2023, due to changes in foreign exchange rates, a decrease in interest from bank deposits, and an increase in interest on long-term loan.
For the nine months ended September 30, 2024, the Company had a net loss of $22.3 million, or $0.32 per share, compared to a net loss
of $21.8 million, or $0.31 per share, in the nine months of 2023.
Balance Sheet Highlights
As of September 30, 2024, the Company had cash
and cash equivalents, short-term deposits and restricted deposits in the amount of $68.4 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
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, September 30,
2023 2024
Audited Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 12,657 $ 5,526
Short-term deposits 69,131 59,696
Restricted deposits 3,152 3,202
Prepaid expenses and other receivables 816 1,361
Total current assets 85,756 69,785
LONG-TERM ASSETS:
Long-term prepaid expenses 471 438
Property and equipment, net 12,798 12,704
Operating lease right-of-use assets 8,363 7,800
Total long-term assets 21,632 20,942
Total assets $ 107,388 $ 90,727
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
December 31, September 30,
2023 2024
Audited Unaudited
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables $ 2,566 $ 2,507
Other payables and accrued expenses 3,474 2,817
Current maturities of operating lease liabilities 1,062 1,025
Total current liabilities 7,102 6,349
LONG-TERM LIABILITIES:
Long-term loan 5,610 5,482
Warrants liability 3,597 3,440
Operating lease liabilities 6,604 6,058
Total long-term liabilities 15,811 14,980
Total liabilities 22,913 21,329
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Ordinary shares of no-par value per share - Authorized: 362,116,800 shares as of December 31, 2023 and September 30, 2024; Issued and outstanding: 69,670,612 and 70,051,583 shares as of December 31, 2023 and September 30, 2024, respectively - -
Additional paid-in capital 200,234 207,431
Accumulated deficit (115,759 ) (138,033 )
Total shareholders' equity 84,475 69,398
Total liabilities and shareholders' equity $ 107,388 $ 90,727
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Nine months ended September 30,
2023 2024
Unaudited
Research and development, net $ 18,934 $ 19,487
Marketing expenses 1,472 1,662
General and administrative 5,331 4,619
Total operating loss 25,737 25,768
Financial (income), net (3,953 ) (3,498 )
Loss before taxes on income 21,784 22,270
Income tax expense 8 4
Net loss 21,792 22,274
Net comprehensive loss $ 21,792 $ 22,274
Net loss per share, basic and diluted $ 0.31 $ 0.32
Weighted-average shares used in computing net loss per share, basic and diluted 69,314,585 69,857,700

Frequently Asked Questions

What recent FDA acceptance has Alpha DaRT received?

Alpha DaRT was accepted into the FDA's Total Product Life Cycle Advisory Program.

How much cash does Alpha Tau have as of September 2024?

As of September 30, 2024, Alpha Tau reported cash and equivalents of $68.4 million.

What is the primary goal of Alpha DaRT therapy?

Alpha DaRT aims to deliver targeted alpha-irradiation to solid tumors, minimizing damage to healthy tissue.

What was Alpha Tau's net loss for the first nine months of 2024?

For the nine months ended September 30, 2024, Alpha Tau reported a net loss of $22.3 million.

What type of cancers is Alpha DaRT being studied for?

Alpha DaRT is being studied for recurrent glioblastoma, lung cancer, and cutaneous squamous cell carcinoma.

Last updated: Nov 19, 2024