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 24, 2023, Alpha Tau Medical Ltd. (the “Company”) issued a press release titled “Former U.S. Commissioner of
Food and Drug Administration Stephen M. Hahn, M.D. Appointed to Alpha Tau Advisory Board” 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.
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Alpha Tau Medical Ltd. |
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Date: October 24, 2023 |
By: |
/s/
Uzi Sofer |
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Uzi Sofer |
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Chief Executive Officer |
3
Exhibit 99.1
Former U.S. Commissioner of Food and Drug Administration Stephen
M. Hahn, M.D.
Appointed to Alpha Tau Advisory Board
JERUSALEM, October 24, 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 Stephen M. Hahn, M.D., former commissioner of the U.S. Food and Drug Administration (“FDA”), has joined
its Scientific Advisory Board. A distinguished expert in the field of radiation oncology and translational/clinical research, and a renowned
physician, Dr. Hahn brings a wealth of regulatory and scientific experience to the Company as it advances its Alpha DaRT technology towards
FDA clearance.
“I am pleased to welcome Dr. Hahn to the Alpha Tau Scientific
Advisory Board at an ideal time in the Company’s growth trajectory,” said Company CEO Uzi Sofer. “As we continue to
focus on executing our clinical strategy, including with our ongoing multicenter ReSTART pivotal trial for recurrent Squamous Cell Carcinoma
of the skin, and on broadening the Alpha DaRT treatment to other indications such as pancreatic, head and neck, and prostate cancers and
glioblastoma, which the Company is already exploring in clinical trials in earnest, Dr. Hahn’s vast expertise and insight will be
of tremendous value. We are very excited by what this wonderful partnership can potentially offer cancer patients worldwide.”
Dr. Hahn is currently CEO-Partner of Flagship Pioneering and CEO of
Harbinger Health, where he specializes in innovating in the field of preventive health care and global health strategy. He previously
served as FDA Commissioner from 2019 to 2021, overseeing regulatory affairs, including therapeutics and vaccine development, devices,
diagnostics, and clinical trials. Prior to his FDA appointment, Dr. Hahn served as chief medical executive, deputy president, and chief
operating officer at the world renowned MD Anderson Cancer Center in Houston, Texas. Prior to his executive leadership roles at MD Anderson,
Dr. Hahn was at the helm of radiation oncology at the University of Pennsylvania’s Perelman School of Medicine.
“I have been watching Alpha Tau’s development with excitement
for quite some time,” said Dr. Hahn. “I am delighted to be joining the Company and to help contribute towards introducing
a new modality for the treatment of cancer which will hopefully break new ground in the field of radiation oncology, and which has very
promising potential as a combination with immunotherapy for advanced metastatic patients.”
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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