Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ:
DRTS, DRTSW), the developer of the innovative alpha-radiation
cancer therapy Alpha DaRT™, reported full year 2022 financial
results and provided a corporate update.
"We are proud of the team’s significant accomplishments in 2022,
an important year during which we announced 100% complete response
in our pilot U.S. trial in skin cancer, initiated our pivotal U.S.
trial in recurrent cutaneous squamous cell carcinoma (ReSTART), and
raised $104 million during our combination with Healthcare Capital
Corp. During this time, we meaningfully advanced our strategy to
examine the use of Alpha DaRT in treating internal organs,
including initiating our first treatment of prostate cancer and
developing multiple local delivery technologies, and we positioned
our business and manufacturing operations for future global
expansion and commercialization," stated Alpha Tau CEO Uzi
Sofer. "We also gained further meaningful visibility within the
medical and academic communities via a series of data publications
in key journals and scientific presentations. In 2023, we are
focused on conducting our ReSTART trial, clinically examining the
treatment of internal organ tumors with high unmet need, including
pancreatic and liver cancers, and on building a focused commercial
organization and beginning pre-launch activities. We remain well
capitalized to support these activities and to deliver on important
milestones later in the year and in 2024."
Recent Corporate Highlights:
- Initiated and treated first patients in the Company’s U.S.
multi-center pivotal ReSTART trial.
- Received Health Canada approval to initiate a liver cancer
feasibility trial in March 2023.
- Received an amended radioactive license approval from the
Israeli Ministry of Environmental Protection that could expand
production to up to 300,000 Alpha DaRT sources per year in the
Company’s main manufacturing facility in Jerusalem.
- Received approvals from the Israeli Ministry of Environmental
Protection and the Animal Testing Council at the Israeli Ministry
of Health to conduct pre-clinical experiments using mice and rats,
to enable the continued exploration of potential combinations
between the Alpha DaRT and systemic therapies.
Upcoming Milestones
- Targeting recruitment in the Canadian feasibility trial in
pancreatic tumors to begin in the first half of 2023.
- Planning to begin an Israeli feasibility trial in pancreatic
tumors in the first half of 2023.
- Targeting recruitment in our clinical trial at Cambridge
University Addenbrooke’s Hospital for treatment of SCC of the vulva
to begin by the second half of 2023.
- Currently compiling longer-term data from patients treated with
the Alpha DaRT for skin, superficial or head and neck tumors, which
we may submit for publication in a scientific journal by the end of
2023.
- Examining an expansion in 2023 of our ReSTART trial under the
Breakthrough Device Designation into other adjacencies, such as
immunosuppressed patients.
- Targeting completion of patient recruitment for the ReSTART
trial by Q1 2024.
Financial results for the full
year ended December 31,
2022
R&D expenses for the year ended December 31,
2022 were $20.9 million, compared to $11.4
million in 2021, due to increased employee headcount,
compensation and benefits, including share-based compensation,
increased operating costs, and increased pre-clinical study and
clinical trial expenses, particularly in preparation for our
ReSTART trial.
Marketing expenses for the year
ended December 31, 2022 were $1.0 million, compared
to $0.5 million for 2021 due to increased employee
headcount, compensation and benefits, including share-based
compensation and the hiring of our chief commercial officer.
G&A expenses for the year
ended December 31, 2022 were $10.3 million, compared
to $1.9 million for 2021, due to costs associated with
our financing transaction in the first quarter of 2022 and the
transition to a public company, increased professional fees
(including D&O insurance), and increased employee headcount,
compensation and benefits, including share-based compensation.
Financial expenses, net, for the year ended
December 31, 2022 were $1.6 million, compared to $13.5 million for
2021, due to lower expense from revaluation of warrants, an
increase in interest from bank deposits, finance income from lease
liabilities and changes in foreign exchange rates.
For the year ended December 31, 2022, the
Company had a net loss of $33.8 million, or $0.53 per share,
compared to a net loss of $27.3 million, or $0.67 per share,
in 2021.
Balance Sheet Highlights
As of December 31, 2022, the Company
had cash and cash equivalents, restricted cash and deposits in the
amount of $105.4 million, compared to $31.9 million as of December
31, 2021 and $108.5 million as of September 30, 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) Alpha Tau’s 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 on Form 20-F filed 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, |
|
|
2021 |
|
|
|
2022 |
|
ASSETS |
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash equivalents |
$ |
23,236 |
|
|
$ |
5,836 |
|
Restricted cash |
|
618 |
|
|
|
850 |
|
Short-term deposits |
|
8,080 |
|
|
|
98,694 |
|
Prepaid expenses and other receivables |
|
707 |
|
|
|
1,097 |
|
|
|
|
|
Total current assets |
|
32,641 |
|
|
|
106,477 |
|
|
|
|
|
LONG-TERM ASSETS: |
|
|
|
Long term prepaid expenses |
|
2,028 |
|
|
|
391 |
|
Property and equipment, net |
|
7,546 |
|
|
|
7,471 |
|
Right-of-use asset |
|
- |
|
|
|
5,810 |
|
|
|
|
|
Total long-term assets |
|
9,574 |
|
|
|
13,672 |
|
|
|
|
|
Total assets |
$ |
42,215 |
|
|
$ |
120,149 |
|
|
|
|
|
|
|
|
|
CONSOLIDATED BALANCE SHEETS |
|
U.S. dollars in
thousands (except share and per share data) |
|
|
|
|
December 31, |
|
|
2021 |
|
|
|
2022 |
|
LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS'
(DEFICIENCY) EQUITY |
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
Trade payables |
$ |
1,203 |
|
|
$ |
1,423 |
|
Other payables and accrued expenses |
|
3,202 |
|
|
|
2,246 |
|
Current maturities of operating lease liabilities |
|
- |
|
|
|
669 |
|
|
|
|
|
Total current liabilities |
|
4,405 |
|
|
|
4,338 |
|
|
|
|
|
LONG-TERM LIABILITIES: |
|
|
|
Warrants liability |
|
- |
|
|
|
5,630 |
|
Warrants to Convertible Preferred shares |
|
18,623 |
|
|
|
- |
|
Operating lease liabilities |
|
- |
|
|
|
4,524 |
|
|
|
|
|
Total liabilities |
|
23,028 |
|
|
|
14,492 |
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES |
|
|
|
|
|
|
|
CONVERTIBLE PREFERRED SHARES
OF NO-PAR VALUE PER SHARE – Authorized: 25,348,176 shares and 0 as
of December 31, 2021 and 2022, respectively; Issued and
outstanding: 13,739,186 and 0 shares as of December 31, 2021
and 2022, respectively |
|
53,964 |
|
|
|
- |
|
|
|
|
|
SHAREHOLDERS' (DEFICIENCY)
EQUITY: |
|
|
|
Ordinary shares of no-par value per share – |
|
|
|
|
|
|
|
Authorized: 72,423,360 and 362,116,800 shares as of
December 31, 2021 and 2022, respectively; Issued and
outstanding: 40,528,913 and 69,105,000 shares as of
December 31, 2021 and 2022, respectively |
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
18,063 |
|
|
|
192,259 |
|
Accumulated deficit |
|
(52,840 |
) |
|
|
(86,602 |
) |
|
|
|
|
Total shareholders'
(deficiency) equity |
|
(34,777 |
) |
|
|
105,657 |
|
|
|
|
|
Total liabilities, Convertible
Preferred shares and shareholders' (deficiency) equity |
$ |
42,215 |
|
|
|
120,149 |
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS |
|
U.S. dollars in
thousands (except share and per share data) |
|
|
|
|
Year ended December 31, |
|
|
2020 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development,
net |
$ |
7,544 |
|
|
$ |
11,447 |
|
|
$ |
20,890 |
|
|
|
|
|
|
|
Marketing expenses |
|
288 |
|
|
|
482 |
|
|
|
974 |
|
|
|
|
|
|
|
General and
administrative |
|
1,412 |
|
|
|
1,861 |
|
|
|
10,272 |
|
|
|
|
|
|
|
Total operating loss |
|
9,244 |
|
|
|
13,790 |
|
|
|
32,136 |
|
|
|
|
|
|
|
Financial (income) expenses,
net |
|
(520 |
) |
|
|
13,474 |
|
|
|
1,606 |
|
|
|
|
|
|
|
Loss before taxes on
income |
|
8,724 |
|
|
|
27,264 |
|
|
|
33,742 |
|
|
|
|
|
|
|
Tax on income |
|
158 |
|
|
|
7 |
|
|
|
20 |
|
|
|
|
|
|
|
Net loss |
|
8,882 |
|
|
|
27,271 |
|
|
|
33,762 |
|
|
|
|
|
|
|
Net comprehensive loss |
$ |
8,882 |
|
|
$ |
27,271 |
|
|
$ |
33,762 |
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.22 |
) |
|
$ |
(0.67 |
) |
|
$ |
(0.53 |
) |
|
|
|
|
|
|
Weighted-average shares used
in computing net loss per share, basic and diluted |
|
*) 40,274,935 |
|
|
|
40,534,697 |
|
|
|
63,534,875 |
|
|
|
|
|
|
|
|
|
|
|
*) Prior period results have been retroactively adjusted to
reflect the 1: 0.905292 stock split effected on March 7, 2022. See
also Note 10, Shareholders' Deficiency, for details.
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