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 2024
financial results and provided a corporate update.
“Alpha Tau has continued to make great progress
during 2024, with a number of important trials moving ahead and
continued generation of data across superficial tumors and cancers
of internal organs,” said Alpha Tau Chief Executive Officer Uzi
Sofer. “Our decision to use the ReSTART pivotal trial to explore
our implementation of the Alpha DaRT® treatment with community
clinicians such as Mohs surgeons continues to bear fruit. We look
forward to releasing important data in internal organ cancers in
the coming months and giving our stakeholders a deeper look at the
future we envision for the Alpha DaRT®,” stated Alpha Tau CEO Uzi
Sofer.
Recent Corporate Highlights:
- In October, Alpha Tau announced its acceptance into FDA’s Total
Product Life Cycle Advisory Program (TAP) to accelerate market
access to Alpha DaRT® for patients with recurrent glioblastoma
multiforme (GBM). TAP’s primary goal is to expedite and enable
patient access to innovative and highly promising medical devices
which are not currently on the market by providing frequent, and
strategic communications with the FDA, and by facilitating
engagement with other key parties for developers of devices of
public health importance, working toward reducing the time, cost
and uncertainty of patient access through reimbursement and
commercial adoption following FDA authorization.
- In October, the first patient with recurrent lung cancer was
treated in a clinical trial at Hadassah Medical Center in
Jerusalem, Israel. The study will assess safety and
feasibility of delivering Alpha DaRT® sources into the lung
using an endobronchial ultrasound (EBUS) procedure, including the
rate of successful source placement and any treatment-related
adverse events. For more information, please see here:
https://www.clinicaltrials.gov/study/NCT05632913
- In September, the FDA approved and Investigational Device
Exemption (IDE) application to initiate a multi-center study for
the treatment of recurrent cutaneous Squamous Cell Carcinoma (cSCC)
in immunocompromised patients using the Alpha DaRT®. The clinical
study, which is an investigator-initiated study led by the Winship
Cancer Institute of Emory University in Atlanta, has been approved
to enroll up to 28 U.S. patients at up to 8 institutions in the
U.S., and will focus on patients with recurrent cSCC who have a
weakened immune system due to any primary or secondary
immunodeficiencies, excluding diabetes. For more information,
please see here:
https://www.clinicaltrials.gov/study/NCT06615635
Upcoming Milestones:
- Anticipating response from PMDA in Japan in Q1 2025 for
pre-market approval for Alpha DaRT in patients with recurrent head
and neck cancer.
- Planned release of data from pancreatic cancer trials in Canada
and Israel in Q1 2025.
- Targeting completion of patient recruitment in the ReSTART
pivotal U.S. multi-center trial in recurrent cutaneous squamous
cell carcinoma in H1 2025. For more information, please see here:
https://www.clinicaltrials.gov/study/NCT05323253
- Targeting release of data from combination trial of Alpha DaRT
with pembrolizumab (Keytruda®) in H1 2025. For more information,
please see here:
https://www.clinicaltrials.gov/study/NCT05047094
- Targeting first brain cancer treatment in H1 2025.
Financial results for quarter ended September 30,
2024 R&D expenses for the nine months ended September
30, 2024 were $19.5 million, compared to $18.9 million for the same
period in 2023, due to increased employee compensation and
benefits, including share-based compensation, increased costs of
raw materials, reduced government grants, and increased travel
expenses related to our U.S. multi-center pivotal trial, offset by
lower third-party contractor expenses.
Marketing expenses for the nine months ended
September 30, 2024 were $1.7 million, compared to $1.5 million for
the same period in 2023, due to increased employee compensation and
benefits.
G&A expenses for the nine months ended
September 30, 2024 were $4.6 million, compared to $5.3 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 nine months ended
September 30, 2024 was $3.5 million, compared to $4.0 million for
the same period in 2023, due to changes in foreign exchange rates,
a decrease in interest from bank deposits, and an increase in
interest on long-term loan.
For the nine months ended September 30, 2024,
the Company had a net loss of $22.3 million, or $0.32 per share,
compared to a net loss of $21.8 million, or $0.31 per share, in the
nine months of 2023.
Balance Sheet Highlights
As of September 30, 2024, the Company had cash
and cash equivalents, short-term deposits and restricted deposits
in the amount of $68.4 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, |
|
September 30, |
|
|
2023 |
|
|
|
2024 |
|
|
Audited |
|
Unaudited |
ASSETS |
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash equivalents |
$ |
12,657 |
|
|
$ |
5,526 |
|
Short-term deposits |
|
69,131 |
|
|
|
59,696 |
|
Restricted deposits |
|
3,152 |
|
|
|
3,202 |
|
Prepaid expenses and other receivables |
|
816 |
|
|
|
1,361 |
|
|
|
|
|
Total current assets |
|
85,756 |
|
|
|
69,785 |
|
|
|
|
|
LONG-TERM ASSETS: |
|
|
|
Long-term prepaid expenses |
|
471 |
|
|
|
438 |
|
Property and equipment, net |
|
12,798 |
|
|
|
12,704 |
|
Operating lease right-of-use assets |
|
8,363 |
|
|
|
7,800 |
|
|
|
|
|
Total long-term assets |
|
21,632 |
|
|
|
20,942 |
|
|
|
|
|
Total assets |
$ |
107,388 |
|
|
$ |
90,727 |
|
CONSOLIDATED BALANCE
SHEETSU.S. dollars in thousands (except share
and per share data)
|
December 31, |
|
September 30, |
|
|
2023 |
|
|
|
2024 |
|
|
Audited |
|
Unaudited |
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
Trade payables |
$ |
2,566 |
|
|
$ |
2,507 |
|
Other payables and accrued expenses |
|
3,474 |
|
|
|
2,817 |
|
Current maturities of operating lease liabilities |
|
1,062 |
|
|
|
1,025 |
|
|
|
|
|
Total current liabilities |
|
7,102 |
|
|
|
6,349 |
|
|
|
|
|
LONG-TERM LIABILITIES: |
|
|
|
Long-term loan |
|
5,610 |
|
|
|
5,482 |
|
Warrants liability |
|
3,597 |
|
|
|
3,440 |
|
Operating lease liabilities |
|
6,604 |
|
|
|
6,058 |
|
|
|
|
|
Total long-term liabilities |
|
15,811 |
|
|
|
14,980 |
|
|
|
|
|
Total liabilities |
|
22,913 |
|
|
|
21,329 |
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES |
|
|
|
|
|
|
|
SHAREHOLDERS' EQUITY: |
|
|
|
Ordinary shares of no-par value per share – |
|
|
|
|
|
|
|
Authorized: 362,116,800 shares as of December 31, 2023 and
September 30, 2024; Issued and outstanding: 69,670,612 and
70,051,583 shares as of December 31, 2023 and September 30,
2024, respectively |
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
200,234 |
|
|
|
207,431 |
|
Accumulated deficit |
|
(115,759 |
) |
|
|
(138,033 |
) |
|
|
|
|
Total shareholders'
equity |
|
84,475 |
|
|
|
69,398 |
|
|
|
|
|
Total liabilities and
shareholders' equity |
$ |
107,388 |
|
|
$ |
90,727 |
|
CONSOLIDATED STATEMENTS OF
OPERATIONSU.S. dollars in thousands (except
share and per share data)
|
|
Nine months ended September 30, |
|
|
2023 |
|
|
|
2024 |
|
|
Unaudited |
|
|
|
|
Research and development,
net |
$ |
18,934 |
|
|
$ |
19,487 |
|
|
|
|
|
Marketing expenses |
|
1,472 |
|
|
|
1,662 |
|
|
|
|
|
General and
administrative |
|
5,331 |
|
|
|
4,619 |
|
|
|
|
|
Total operating loss |
|
25,737 |
|
|
|
25,768 |
|
|
|
|
|
Financial (income), net |
|
(3,953 |
) |
|
|
(3,498 |
) |
|
|
|
|
Loss before taxes on
income |
|
21,784 |
|
|
|
22,270 |
|
|
|
|
|
Income tax expense |
|
8 |
|
|
|
4 |
|
|
|
|
|
Net loss |
|
21,792 |
|
|
|
22,274 |
|
|
|
|
|
Net comprehensive loss |
$ |
21,792 |
|
|
$ |
22,274 |
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
0.31 |
|
|
$ |
0.32 |
|
|
|
|
|
Weighted-average shares used
in computing net loss per share, basic and diluted |
|
69,314,585 |
|
|
|
69,857,700 |
|
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