UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO SECTION 13A-16 OR 15D-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2024
Commission File Number: 001-41316
Alpha Tau Medical Ltd.
(Exact Name of Registrant as Specified in Its
Charter)
Kiryat HaMada St. 5
Jerusalem, Israel 9777605
+972 (3) 577-4115
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form
40-F ☐
CONTENTS
On August 14, 2024, Alpha Tau Medical Ltd. (the “Company”)
issued a press release titled “Alpha Tau Medical Announces Second Quarter 2024 Financial Results and Provides Corporate Update.”
A copy of this press release is attached to this Form 6-K as Exhibit 99.1.
The financial information included in the consolidated balance sheets
and consolidated statements of operations contained in the press release attached as Exhibit 99.1 to this report on Form 6-K is hereby
incorporated by reference into the registrant’s Registration Statements on Form F-3 (File Nos. 333-271073, 333-264306 and 333-274457)
and Form S-8 (File Nos. 333-264169, 333-270406 and 333-277733).
EXHIBIT INDEX
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Alpha Tau Medical Ltd. |
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Date: August 14, 2024 |
By: |
/s/ Uzi Sofer |
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Uzi Sofer |
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Chief Executive Officer |
3
Exhibit 99.1
Alpha Tau Medical Announces Second Quarter
2024 Financial Results and Provides Corporate Update
-
First patient treated in May for liver metastases from colorectal cancer -
-
Publication in June in Cancers journal of long-term safety and efficacy data in multiple hard-to-treat superficial cancers, with
an overall response rate of almost 100% in treated lesions, no moderate or severe long-term toxicities noted, and a 2-year local recurrence-free
survival was estimated at 77% -
- Cash, cash equivalents & deposits balance
of $74.1 million with runway of at least two years -
JERUSALEM, August 14, 2024 -- 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 SHEETS
U.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 SHEETS
U.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 OPERATIONS
U.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 | |
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