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 2023 financial
results and provided a corporate update.
"This year has already seen tremendous progress, as we advance
our ReSTART pivotal U.S. multi-center trial in recurrent cutaneous
squamous cell carcinoma, which is expected to produce data in 2024,
and continue to initiate 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. "We are looking forward to meaningful inflection points
during the rest of 2023, including interim safety and feasibility
data from our pancreatic cancer trial in Montreal, and our
forthcoming submission in Japan for pre-market approval. 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 is expected to increase our future manufacturing
capacity as well as the leasing of a second manufacturing site in
the U.S. Alpha Tau remains adequately capitalized to support all of
these programs over the coming years," he concluded.
Recent Corporate Highlights:
- In October, the Company announced that it had entered into a
long-term lease agreement for a standalone building of over 14,000
rentable square feet in Hudson, NH, with the intention of erecting
the Company’s second U.S. manufacturing site, alongside its first
site in nearby Lawrence, MA.
- In October, the Company announced that Dr. Stephen Hahn, a
former commissioner of the U.S. Food and Drug Administration (FDA)
and a distinguished expert in the field of radiation oncology and
translational clinical research, has joined its Scientific Advisory
Board.
- In September, the first patient with advanced inoperable
pancreatic cancer was treated with Alpha DaRT at Hadassah Medical
in Jerusalem, Israel, in parallel to the Company’s ongoing safety
and feasibility trial for the treatment of advanced inoperable
pancreatic cancer currently underway in Montreal, Canada.
- In August, Alpha Tau reported long-term safety and tumor
control outcomes data for patients with unresectable, recurrent, or
locally advanced head and neck or skin tumors treated with Alpha
DaRT across four prospective trials conducted at several
international institutions. In this analysis, 81 lesions were
treated in 71 patients. The median follow-up was 14 months (range:
2-51 months). A complete response (CR) was observed in 89% of
treated lesions (n=72), 10% (n=8) demonstrated a partial response,
and one patient was not evaluable. The two-year actuarial local
recurrence-free survival (LRFS) rate was 77% [95% CI: 63–87%].
Twenty percent of patients developed treatment-related acute grade
2 toxicity (such as dermatitis radiation, local pain at the
treatment site or pruritus), which subsequently resolved with
conservative treatment; there were no grade 3 or higher related
acute toxicities reported. There were no grade 2 or higher
‘late toxicities’, defined as toxicities occurring six months after
Alpha DaRT treatment or later, observed in this cohort.
Upcoming Near-Term Milestones
- Expecting to release interim safety and feasibility data in Q4
2023 from the first five patients treated in the Company’s study
examining the use of Alpha DaRT to treat patients in Montreal,
Canada with advanced inoperable pancreatic cancer. For more
information please see here:
https://www.clinicaltrials.gov/study/NCT04002479
- Expecting to submit to the PMDA in Japan in Q4 2023 for
pre-market approval for Alpha DaRT in patients with recurrent head
& neck cancer.
- Planning treatment of the first patient in the Canadian liver
metastases safety and feasibility trial in Q4 2023 or Q1 2024. The
trial is currently open for recruitment; for more information
please see here:
https://www.clinicaltrials.gov/study/NCT05829291
- Planning treatment of the first patient in the Israeli
recurrent lung cancer safety and feasibility trial in H1 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 H1 2024.
- Targeting completion of patient recruitment in the ReSTART
pivotal U.S. multi-center trial in recurrent cutaneous squamous
cell carcinoma in Q2 2024. For more information please see here:
https://www.clinicaltrials.gov/study/NCT05323253
Financial results for nine
months ended September
30, 2023
R&D expenses for the nine months ended September 30,
2023 were $18.9 million, compared to $15.5 million
for the same period in 2022, due to increased employee compensation
and benefits, including share-based compensation, increased
pre-clinical study and clinical trial expenses particularly in our
U.S. multi-center pivotal trial, and reduced government grants,
offset by lower expenses in Japan because of the completion of our
clinical study in Japan last year.
Marketing expenses for the nine months
ended September 30, 2023 were $1.5 million, compared
to $0.6 million for the same period in 2022, due to
increased employee compensation and benefits, including share-based
compensation for marketing personnel including our chief commercial
officer hired in 2022, as well as increased marketing
activities.
G&A expenses for the nine months
ended September 30, 2023 were $5.3 million, compared
to $8.1 million for the same period in 2022, due to
decreased compensation expenses as well as one-time expenses in
2022 associated with the Company’s merger with Healthcare Capital
Corp.
Financial income, net, for the nine months ended
September 30, 2023 was $4.0 million, compared to financial expense,
net of $6.2 million, for the same period in 2022, due to a decrease
in remeasurement of warrants, an increase in interest from bank
deposits, and changes in foreign exchange rates.
For the nine months ended September 30,
2023, the Company had a net loss of $21.8 million, or $0.31
per share, compared to a net loss of $30.4 million, or $0.49
per share, in the same period of 2022.
Balance Sheet Highlights
As of September 30, 2023, the Company had cash,
restricted cash, deposits and restricted deposits in the amount
of $90.1 million, compared to $105.4
million on December 31, 2022. The Company expects
that this cash balance will be sufficient to fund 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 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: IR@alphatau.com
CONSOLIDATED BALANCE
SHEETS
U.S. dollars in thousands
|
December 31, |
|
September 30, |
|
|
2022 |
|
|
|
2023 |
|
|
Audited |
|
Unaudited |
ASSETS |
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash equivalents |
$ |
5,836 |
|
|
$ |
82 |
|
Restricted cash |
|
850 |
|
|
|
- |
|
Short-term deposits |
|
98,694 |
|
|
|
87,137 |
|
Restricted deposits |
|
- |
|
|
|
2,886 |
|
Prepaid expenses and other receivables |
|
1,097 |
|
|
|
1,334 |
|
|
|
|
|
Total current assets |
|
106,477 |
|
|
|
91,439 |
|
|
|
|
|
LONG-TERM ASSETS: |
|
|
|
Long term prepaid expenses |
|
391 |
|
|
|
441 |
|
Property and equipment, net |
|
7,471 |
|
|
|
7,767 |
|
Right-of-use asset |
|
5,810 |
|
|
|
7,092 |
|
|
|
|
|
Total long-term assets |
|
13,672 |
|
|
|
15,300 |
|
|
|
|
|
Total assets |
$ |
120,149 |
|
|
$ |
106,739 |
|
|
|
|
|
The accompanying notes are an integral part of the interim
consolidated financial statements.
CONSOLIDATED BALANCE
SHEETS
U.S. dollars in thousands (except share and per
share data)
|
|
December 31, |
|
September 30, |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
Audited |
|
Unaudited |
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
Trade payables |
|
$ |
1,423 |
|
|
$ |
2,273 |
|
Other payables and accrued expenses |
|
|
2,246 |
|
|
|
3,118 |
|
Current maturities of operating lease liabilities |
|
|
669 |
|
|
|
848 |
|
|
|
|
|
|
Total current liabilities |
|
|
4,338 |
|
|
|
6,239 |
|
|
|
|
|
|
LONG-TERM LIABILITIES: |
|
|
|
|
Warrants liability |
|
|
5,630 |
|
|
|
5,443 |
|
Operating lease liabilities |
|
|
4,524 |
|
|
|
5,204 |
|
|
|
|
|
|
Total long-term liabilities |
|
|
10,154 |
|
|
|
10,647 |
|
|
|
|
|
|
Total liabilities |
|
|
14,492 |
|
|
|
16,886 |
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES |
|
|
|
|
|
|
|
|
|
SHAREHOLDERS' EQUITY: |
|
|
|
|
Ordinary shares of no-par value per share – |
|
|
|
|
|
|
|
|
Authorized: 362,116,800 shares as of December 31, 2022 and
September 30, 2023; Issued and outstanding: 69,105,000 and
69,473,825 shares as of December 31, 2022 and September 30,
2023, respectively |
|
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
|
192,259 |
|
|
|
198,247 |
|
Accumulated deficit |
|
|
(86,602 |
) |
|
|
(108,394 |
) |
|
|
|
|
|
Total shareholders' equity |
|
|
105,657 |
|
|
|
89,853 |
|
|
|
|
|
|
Total liabilities and shareholders' equity |
|
$ |
120,149 |
|
|
$ |
106,379 |
|
|
|
|
|
|
The accompanying notes are an integral part of
the interim consolidated financial statements.
CONSOLIDATED STATEMENTS OF
OPERATIONS
U.S. dollars in thousands (except share and per
share data)
|
Nine months endedSeptember
30, |
|
|
2022 |
|
|
|
2023 |
|
|
Unaudited |
|
|
|
|
Research and development,
net |
$ |
15,510 |
|
|
$ |
18,934 |
|
|
|
|
|
Marketing expenses |
|
577 |
|
|
|
1,472 |
|
|
|
|
|
General and
administrative |
|
8,064 |
|
|
|
5,331 |
|
|
|
|
|
Total operating loss |
|
24,151 |
|
|
|
25,737 |
|
|
|
|
|
Financial expenses (income),
net |
|
6,198 |
|
|
|
(3,953 |
) |
|
|
|
|
Loss before taxes on
income |
|
30,349 |
|
|
|
21,784 |
|
|
|
|
|
Income tax expense |
|
17 |
|
|
|
8 |
|
|
|
|
|
Net loss |
|
30,366 |
|
|
|
21,792 |
|
|
|
|
|
Net comprehensive loss |
$ |
30,366 |
|
|
$ |
21,792 |
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
0.49 |
|
|
$ |
0.31 |
|
|
|
|
|
Weighted-average shares used
in computing net loss per share, basic and diluted |
|
61,654,800 |
|
|
|
69,314,585 |
|
|
|
|
|
|
|
|
|
Alpha Tau Medical (NASDAQ:DRTS)
Gráfico Histórico do Ativo
De Nov 2024 até Dez 2024
Alpha Tau Medical (NASDAQ:DRTS)
Gráfico Histórico do Ativo
De Dez 2023 até Dez 2024