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
SHEETSU.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
SHEETSU.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 OPERATIONSU.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 |
|
|
|
|
|
|
|
|
Alpha Tau Medical (NASDAQ:DRTS)
Gráfica de Acción Histórica
De Jul 2024 a Ago 2024
Alpha Tau Medical (NASDAQ:DRTS)
Gráfica de Acción Histórica
De Ago 2023 a Ago 2024