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Alpha Tau Medical Announces Second Quarter 2023 Financial Results and Provides Corporate Update -Treated the first patient with advanced inoperable pancreatic cancer in a safety and feasibility trial in Canada in April-

Key Takeaway: Alpha Tau Medical reported second quarter 2023 financial results and corporate updates, highlighting the treatment of its first patient with advanced inoperable pancreatic cancer in a trial in Canada. The company noted a strong 89% complete response rate in earlier trials for skin and neck cancers, along with a 77% local recurrence-free survival rate over two years. Alpha Tau has a cash position of $94.4 million, projected to fund operations for at least two more years. The company also announced a land grant in Jerusalem for expanded manufacturing capacity, although it incurred a net loss of $16.9 million for the period.

Market Sentiment Analysis

POSITIVE FACTORS

  • Successful treatment of the first patient with advanced pancreatic cancer in Canada.
  • Reported an impressive 89% complete response rate in recent trials.
  • The company has sufficient cash reserves to fund operations for at least two years.
  • Valuable land grant received for expanding manufacturing capacity.

CONCERNS & RISKS

  • Net loss of $16.9 million reported for the first half of 2023.
  • Increased R&D and marketing expenses indicate rising operational costs.
  • Dependence on regulatory approvals for future product candidates could pose risks.
  • There may be challenges in patient enrollment for clinical trials.

Full Press Release Details

Tau Medical Announces Second Quarter 2023
Financial Results and Provides Corporate Update
-Treated the first patient with advanced inoperable
pancreatic cancer in a safety and feasibility trial in Canada in April-
-89% CR, two-year local recurrence-free survival
of 77%, and no treatment-related grade 2 or higher late-onset toxicity reported from an analysis of four feasibility trials in 71 patients
with unresectable skin and head and neck cancers -
- Valuable land grant received in Jerusalem
to enable a standalone company headquarters and future increased manufacturing capacity -
- Cash, restricted cash, & deposits
balance of $94.4 million with runway for at least two years-
JERUSALEM, August 28, 2023 (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 2023 financial results and provided a corporate update
"This year we are advancing
our ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma, which is expected to produce data in 2024,
and initiating a series of feasibility trials in difficult-to-treat internal organ tumors with high unmet need, such as pancreatic and
liver cancers," stated Alpha Tau CEO Uzi Sofer. "Read-outs from the pivotal trial and these smaller feasibility programs
should represent meaningful inflection points for our growth story and could pave the way for larger studies in more indications
that may support other potential U.S. marketing authorizations. We were especially pleased to report
a strong 89% Complete Response rate and 77% two-year local recurrence-free survival rate from a recent analysis of 81 treated lesions
in skin or head and neck cancers, as well as the absence of major late-onset toxicities. In parallel, we are preparing for future product
launches by advancing our commercial planning activities and solidifying our supply chain, which was recently bolstered by a valuable
land grant in Jerusalem that may increase our future manufacturing capacity, alongside other large-scale expansions across the world,
including another site being planned in the U.S. Alpha Tau remains adequately capitalized to support all of these programs over the coming
years," he concluded.
Recent Corporate Highlights:
Upcoming 2023 Milestones
Financial results for six months ended June
R&D expenses for the six months ended June
30, 2023 were $12.3 million, compared to $10.7 million for the same period in 2022, due to increased employee compensation
and benefits, including share-based compensation, increased operating costs, and increased pre-clinical study and clinical trial expenses
particularly in our U.S. multi-center pivotal trial, offset by lower expenses in Japan because of the completion of our clinical study
Marketing expenses for
the six months ended June 30, 2023 were $0.9 million, compared to $0.3 million for the same period in 2022, due
to increased employee compensation and benefits, including share-based compensation and the hiring of our chief commercial officer.
the six months ended June 30, 2023 were $3.6 million, compared to $5.8 million for the same period in 2022, due
to decreased professional fees (including D&O insurance), and one-time costs and bonuses associated with our financing transaction
in the first quarter of 2022.
Financial expense, net,
for the six months ended June 30, 2023 was $0.0 million, compared to $10.9 million, for the same period in 2022, due to a decrease in
revaluation of warrants, an increase in interest from bank deposits, and changes in foreign exchange rates.
For the six months ended June
30, 2023, the Company had a net loss of $16.9 million, or $0.24 per share, compared to a net loss of $27.7 million, or $0.48
per share, in the same period of 2022.
Balance Sheet Highlights
As of June 30, 2023, the
Company had cash, restricted cash and deposits in the amount of $94.4 million, compared to $105.4 million at December
31, 2022. The Company expects that this cash balance will be sufficient to fund 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 9, 2023, 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,
2022 2023
Audited Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 5,836 $ 855
Restricted cash 850 834
Short-term deposits 98,694 92,672
Prepaid expenses and other receivables 1,097 1,698
Total current assets 106,477 96,059
LONG-TERM ASSETS:
Long term prepaid expenses 391 441
Property and equipment, net 7,471 7,549
Right-of-use asset 5,810 7,157
Total long-term assets 13,672 15,147
Total assets $ 120,149 $ 111,206
INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
December 31, June 30,
2022 2023
Audited Unaudited
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables 1,423 1,789
Other payables and accrued expenses 2,246 2,781
Current maturities of operating lease liabilities 669 846
Total current liabilities 4,338 5,416
LONG-TERM LIABILITIES:
Warrants liability 5,630 7,794
Operating lease liabilities 4,524 5,433
Total long-term liabilities 10,154 13,227
Total liabilities 14,492 18,643
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Ordinary shares of no-par value per share - Authorized: 362,116,800 shares as of December 31, 2022 and June 30, 2023; Issued and outstanding: 69,105,000 and 69,373,135 shares as of December 31, 2022 and June 30, 2023, respectively - -
Additional paid-in capital 192,259 196,045
Accumulated deficit (86,602 ) (103,482 )
Total shareholders' equity 105,657 92,563
Total liabilities and shareholders' equity $ 120,149 $ 111,206
INTERIM CONSOLIDATED STATEMENTS
U.S. dollars in thousands (except share and per share data)
Six months ended June 30,
2022 2023
Unaudited
Research and development, net $ 10,683 $ 12,261
Marketing expenses 329 920
General and administrative 5,781 3,631
Total operating loss 16,793 16,812
Financial expenses, net 10,942 21
Loss before taxes on income 27,735 16,833
Tax on income 8 47
Net loss 27,743 16,880
Net comprehensive loss $ 27,743 $ 16,880
Net loss per share, basic and diluted $ (0.48 ) $ (0.24 )
Weighted-average shares used in computing net loss per share, basic and diluted 58,023,875 69,262,381

Frequently Asked Questions

What were Alpha Tau's second quarter financial results?

Alpha Tau reported a net loss of $16.9 million for Q2 2023, improving from $27.7 million in 2022.

What is Alpha DaRT?

Alpha DaRT is a radiation therapy designed to target solid tumors using alpha-emitting radium-224.

How successful were recent clinical trials?

Recent trials showed an 89% Complete Response rate and a 77% local recurrence-free survival rate.

What is Alpha Tau's financial position?

As of June 30, 2023, Alpha Tau had $94.4 million in cash, sufficient for at least two years.

What is Alpha Tau's future focus?

The company aims to advance pivotal trials and expand into new cancer treatment areas.

Last updated: Aug 28, 2023