Alpha Tau Medical Ltd. (Nasdaq: DRTS and DRTSW), ("Alpha Tau" or
the “Company”), the developer of the innovative alpha-radiation
cancer therapy Alpha DaRT™, reported third quarter 2022 financial
results and provided a corporate update.
"Alpha Tau remained active in the third quarter, as we continued
preparations for our upcoming U.S. pivotal study in recurrent
cutaneous squamous cell carcinoma and laid the groundwork for
exploration of our Alpha DaRT oncology treatment platform across a
broad set of applications," said Alpha Tau CEO Uzi Sofer. "At
the same time, we have remained highly visible through a series of
scientific publications and presentations to discuss our Alpha DaRT
treatment. In anticipation of pivotal study data and a potential
U.S. launch, we are actively preparing for our global
commercialization efforts, having brought the highly experienced
Peter Melnyk into the role of Chief Commercial Officer, while we
continue to ramp up manufacturing capacity across the world. Peter
will focus on prelaunch activities across the U.S. and
international markets to help prepare for future reimbursement and
commercialization efforts. In parallel, we continue to initiate a
number of feasibility trials in internal organs and develop new
delivery technologies for Alpha DaRT to expand its use in patients
underserved by current treatments. With all of this activity, we
remain well capitalized and focused on efficient operations as we
continue to execute on our strategic plans."
Recent Corporate
Highlights:
- Peter Melnyk, a former member of Alpha Tau’s Board of
Directors, assumed the full-time position of Alpha Tau’s Chief
Commercial Officer.
- Two landmark pre-clinical studies
demonstrating significant potential synergies between the Alpha
DaRT treatment and standard-of-care immunotherapy, chemotherapy and
anti-angiogenic therapy were published in major peer-reviewed
journals.
- Study on combination with anti-PD1 therapy published by
International Journal of Radiation Oncology, Biology, Physics,
known in the field as the Red Journal, the official journal of the
American Society for Radiation Oncology (ASTRO).
- Study on combinations with chemotherapy and anti-angiogenic
therapy in human glioblastoma multiforme xenografts published by
Frontiers in Oncology, in its Radiation Oncology section.
- Medicines and Healthcare products Regulatory Agency of the
United Kingdom approved clinical trial in squamous cell carcinoma
of the vulva at Addenbrookes Hospital in Cambridge.
- Health Canada approved the addition of Jewish General Hospital
in Montreal as a second site in the Company’s clinical trial in
advanced pancreatic cancer.
- Dr. Christopher Barker of Memorial Sloan Kettering Cancer
Center presented at the ASTRO 2022 Annual Meeting on results of the
Company’s U.S. pilot feasibility study completed earlier in
2022.
- Investigators at The University of Texas MD Anderson Cancer
Center presented a poster at the Radiation Research Society’s 2022
Annual Meeting on tumor growth delay and immune stimulation using
the Alpha DaRT in treating 4T1 murine triple-negative breast cancer
tumors.
Upcoming Anticipated
Milestones
- Expecting first patient treated in U.S. multi-center pivotal
trial in recurrent cutaneous SCC around year-end 2022.
- Targeting recruitment in the Canadian feasibility trial in
pancreatic tumors to begin around year-end 2022.
- Planning to begin an Israeli feasibility trial in pancreatic
tumors in the first quarter of 2023.
- Planned submission of Alpha DaRT pivotal trial results in head
and neck SCC to Japan’s regulatory authority, PMDA, around year-end
2022, for marketing approval.
- Targeting Health Canada approval for initiation of liver cancer
feasibility trial by the first quarter of 2023.
Financial results
for the third
quarter ended September
30, 2022
R&D expenses for the quarter ended September 30, 2022
were $4.8 million, compared to $3.0 million for the
same period in 2021, primarily due to increased R&D headcount,
costs associated with our U.S. multi-center pivotal study and other
clinical studies, and increased share-based compensation costs and
accrual of other compensation expenses.
Marketing expenses for the quarter ended
September 30, 2022 were $0.2 million, compared to $0.1
million for the same period in 2021.
G&A expenses for the quarter ended September
30, 2022 were $2.3 million, compared to $0.5
million for the same period in 2021, primarily due to
increased professional fees (including D&O insurance),
share-based compensation, advisors and other expenses associated
with being a public company, and accrual of other compensation
expenses.
Financial income, net, for the quarter ended
September 30, 2022 was $4.7 million, compared to financial expense,
net of $1.2 million for the same period in 2021, primarily due to
the remeasurement of warrants and interest income on cash
balances.
For the quarter ended September 30, 2022,
the Company had a net loss of $2.6 million, or ($0.04) per
share, compared to a loss of $4.8 million, or ($0.12) per
share, in the same period in 2021.
Balance Sheet Highlights
As of September 30, 2022, the Company
had cash and cash equivalents, restricted cash and short-term
deposits in the amount of $108.5 million, compared
to $31.9 million on December 31, 2021. 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; (xix)
impacts from the COVID-19 pandemic; 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 28, 2022, 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
SHEETSU.S. dollars in thousands
|
|
September 30, |
|
December 31, |
|
|
2022 |
|
2021 |
|
|
Unaudited |
|
Audited |
ASSETS |
|
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
Cash and cash equivalents |
|
$ |
5,930 |
|
$ |
23,236 |
Restricted cash |
|
|
792 |
|
|
618 |
Short-term deposits |
|
|
101,735 |
|
|
8,080 |
Prepaid expenses and other receivables |
|
|
2,869 |
|
|
707 |
|
|
|
|
|
Total current assets |
|
|
111,326 |
|
|
32,641 |
|
|
|
|
|
LONG-TERM ASSETS: |
|
|
|
|
Long term prepaid expenses |
|
|
393 |
|
|
2,028 |
Property and equipment, net |
|
|
7,647 |
|
|
7,546 |
|
|
|
|
|
Total long-term assets |
|
|
8,040 |
|
|
9,574 |
|
|
|
|
|
Total assets |
|
$ |
119,366 |
|
$ |
42,215 |
CONSOLIDATED BALANCE
SHEETSU.S. dollars in thousands (except share
and per share data)
|
|
September 30, |
|
December 31, |
|
|
2022 |
|
2021 |
|
|
Unaudited |
|
Audited |
LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS'
DEFICIENCY |
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
Trade payables |
|
$ |
1,310 |
|
|
$ |
1,203 |
|
Other payables and accrued expenses |
|
|
2,043 |
|
|
|
3,202 |
|
|
|
|
|
|
Total current liabilities |
|
|
3,353 |
|
|
|
4,405 |
|
|
|
|
|
|
LONG-TERM LIABILITIES: |
|
|
|
|
Warrants liability |
|
|
8,757 |
|
|
|
- |
|
Warrants to Convertible Preferred shares |
|
|
- |
|
|
|
18,623 |
|
|
|
|
|
|
Total liabilities |
|
|
12,110 |
|
|
|
23,028 |
|
|
|
|
|
|
Convertible preferred shares
of no-par value per share – Authorized: 0 and 25,348,176 shares as
of September 30, 2022 and December 31, 2021, respectively; Issued
and outstanding: 0 and 13,739,186 shares as of September 30, 2022
and December 31, 2021, respectively |
|
|
- |
|
|
|
53,964 |
|
|
|
|
|
|
SHAREHOLDERS' DEFICIENCY: |
|
|
|
|
Ordinary shares of no-par
value per share – Authorized: 362,116,800 and 72,423,360 shares as
of September 30, 2022 and December 31, 2021, respectively; Issued
and outstanding: 69,011,550 and 40,528,913 shares as of September
30, 2022 and December 31, 2021, respectively |
|
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
|
190,462 |
|
|
|
18,063 |
|
Accumulated deficit |
|
|
(83,206 |
) |
|
|
(52,840 |
) |
|
|
|
|
|
Total shareholders' equity
(deficiency) |
|
|
107,256 |
|
|
|
(34,777 |
) |
|
|
|
|
|
Total liabilities, Convertible
Preferred shares and shareholders' equity (deficiency) |
|
$ |
119,366 |
|
|
$ |
42,215 |
|
CONSOLIDATED STATEMENTS OF
OPERATIONSU.S. dollars in thousands (except
share and per share data)
|
|
Three months endedSeptember
30, |
|
Nine months endedSeptember
30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
Research and development,
net |
|
$ |
4,827 |
|
|
$ |
3,032 |
|
|
$ |
15,510 |
|
$ |
8,218 |
|
|
|
|
|
|
|
|
|
Marketing expenses |
|
|
248 |
|
|
|
102 |
|
|
|
577 |
|
|
356 |
|
|
|
|
|
|
|
|
|
General and
administrative |
|
|
2,283 |
|
|
|
500 |
|
|
|
8,064 |
|
|
1,273 |
|
|
|
|
|
|
|
|
|
Total operating loss |
|
|
7,358 |
|
|
|
3,634 |
|
|
|
24,151 |
|
|
9,847 |
|
|
|
|
|
|
|
|
|
Financial (income) expenses,
net |
|
|
(4,744 |
) |
|
|
1,168 |
|
|
|
6,198 |
|
|
13,622 |
|
|
|
|
|
|
|
|
|
Loss before taxes on
income |
|
|
2,614 |
|
|
|
4,802 |
|
|
|
30,349 |
|
|
23,469 |
|
|
|
|
|
|
|
|
|
Income tax expense
(benefit) |
|
|
9 |
|
|
|
(5 |
) |
|
|
17 |
|
|
21 |
|
|
|
|
|
|
|
|
|
Net loss |
|
|
2,623 |
|
|
|
4,797 |
|
|
|
30,366 |
|
|
23,490 |
|
|
|
|
|
|
|
|
|
Net comprehensive loss |
|
$ |
2,623 |
|
|
$ |
4,797 |
|
|
$ |
30,366 |
|
$ |
23,490 |
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to Ordinary shareholders, basic and diluted |
|
$ |
0.04 |
|
|
$ |
0.12 |
|
|
$ |
0.49 |
|
$ |
0.58 |
|
|
|
|
|
|
|
|
|
Weighted-average shares used
in computing net loss per share attributable to Ordinary
shareholders, basic and diluted |
|
|
68,798,251 |
|
|
|
40,515,336 |
|
|
|
61,654,800 |
|
|
40,513,766 |
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