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 October 2023
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
October 30, 2023, Alpha Tau Medical Ltd. (the “Company”) issued a press release titled “Alpha Tau Enters Into Long-Term
Lease of Site in New Hampshire for Second U.S. Manufacturing Facility.” A copy of this press release is attached to this Form 6-K
as Exhibit 99.1.
The
information in this Report on Form 6-K, including in Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed”
for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject
to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities
Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference
in such a filing.
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.
|
Alpha Tau Medical Ltd. |
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|
|
Date: October 30, 2023 |
By: |
/s/
Uzi Sofer |
|
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Uzi Sofer |
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Chief Executive Officer |
3
Exhibit
99.1
Alpha
Tau Enters Into Long-Term Lease of Site in New Hampshire for Second U.S. Manufacturing Facility
JERUSALEM,
October 30, 2023 -- Alpha Tau Medical Ltd. (“Alpha Tau”, or the “Company”) (NASDAQ: DRTS, DRTSW), the developer
of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today that its U.S. subsidiary, Alpha Tau Medical Inc.,
has entered into a long-term lease agreement for a standalone building of over 14,000 rentable square feet in Hudson, New Hampshire,
with the intention of erecting the Company’s second U.S. manufacturing site, alongside its first site in nearby Lawrence, Massachusetts.
“I
am pleased that our planned expansion of global manufacturing capacity continues apace, as we push forward towards our first targeted
U.S. FDA clearance, as we see rapidly growing clinician interest in Alpha DaRT around the world, and as we get ready for future commercialization,”
said Alpha Tau CEO Uzi Sofer. “The Hudson site promises to be larger than our existing Lawrence site, and is expected to support
our goals of materially scaling up capacity as well as achieving manufacturing redundancy. In parallel, we are also progressing with
our expansion plan in Israel, with the addition of a second site at our future standalone headquarters in Jerusalem.”
Alpha
Tau COO Amnon Gat added, “The Hudson site will be an important component of our future manufacturing footprint in the U.S. We anticipate
initiating manufacturing of Alpha DaRT treatments at this facility within two years, if not sooner, and being able to manufacture nearly
1.8 million Alpha DaRT sources per year when it is up to full capacity. We would look to install this capacity in two or three phases,
each phase only costing in the low single-digit millions to build out.”
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.
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.
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
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