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 June 2026
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
Collaboration Agreement and Supply Agreement
On June 2, 2026, Alpha Tau Medical Ltd. (the “Company”)
together with its subsidiary, Alpha Tau Medical Inc., entered into a collaboration agreement and a supply agreement with Tolmar International
Ltd. (“Tolmar”) (together the “Tolmar Agreements”). Pursuant to the Tolmar Agreements, the Company granted Tolmar
exclusive U.S. commercialization rights for Alpha DaRT for prostate cancer. Tolmar will use commercially reasonable efforts to commercialize Alpha DaRT in accordance with a commercialization
plan and the terms of the Tolmar Agreements. Tolmar will make an initial $15.0 million payment to be used for expanding the Company’s
manufacturing capabilities for Alpha DaRT, and will make up to an aggregate of $161.5 million in clinical, regulatory and commercial milestone
payments for the first prostate cancer indication. Tolmar will pay the Company for the supply of Alpha DaRT at 60% of the net sales of
Alpha DaRT, subject to certain adjustments.
The Company granted Tolmar an option to
expand into bladder cancer, subject to additional terms and payments, including a $5.0 million payment to Alpha Tau to be used for
expanding the Company’s manufacturing capabilities for Alpha DaRT, as well as a further securities purchase as described
further below. The Company also granted Tolmar the right to negotiate commercial rights in certain geographies in Central America
and South America and to negotiate commercial rights to certain new products developed by the Company. Unless terminated earlier, the
Tolmar Agreements will expire in 20 years following the first commercial sale of Alpha DaRT for prostate cancer in the U.S., subject to the terms and conditions of the Collaboration Agreement. Both
parties may terminate the Tolmar Agreements (a) for the other party’s material breach, insolvency, or safety concerns, subject
to a customary notice and cure period or (b) if the Company is unable to secure rights to intellectual property of a third party
that is necessary for the exploitation of Alpha DaRT as contemplated under the Tolmar Agreements. Tolmar has the right to terminate
the Tolmar Agreements without cause at any time with prior written notice to the Company. The Company has the right to terminate the
Tolmar Agreements if Tolmar (a) is acquired by an entity that has certain competing products, subject to certain cure provisions,
(b) challenges the intellectual property rights licensed to Tolmar or (c) violates applicable laws.
Securities Purchase Agreement.
On June 2, 2026, concurrent with the execution
of the Tolmar Agreements, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with Tolmar
for the sale by the Company of 1,668,057 (the “Initial Shares”) of its ordinary shares, no par value per share (the “Ordinary
Shares”), in a private placement (the “Private Placement”), at a purchase price of $11.99 per Ordinary Share, a 25%
premium to the 30-trading day volume-weighted average price (“VWAP”) ending the trading day prior to the entry into the Purchase
Agreement. The Purchase Agreement also contains provisions for Tolmar, upon exercise of the option in the Tolmar Agreements to expand into bladder cancer,
to purchase an amount of Ordinary Shares equivalent to $5,000,000 (the “Additional Shares” and, together with the Initial
Shares, the “Shares”), at a price per Ordinary Share equal to a 25% premium to the then-prevailing 30-trading day VWAP.
The Company expects to receive gross proceeds of
$20.0 million from the Private Placement, before deducting the estimated offering expenses payable by the Company. The Company intends
to use the net proceeds from the Private Placement for general corporate purposes. The Purchase Agreement contains customary representations,
warranties and agreements by the parties, customary conditions to closing, indemnification obligations of the parties, termination provisions
and other obligations of the parties. Under certain circumstances the Company may be required to provide resale registration rights to
Tolmar with respect to the Ordinary Shares purchased in the Private Placement.
The offer and sale of the Shares have not been,
and will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”), or any other securities laws,
and the Shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements
of the Securities Act and any other applicable securities laws.
This Report on Form 6-K (this “Report”)
shall not constitute an offer to sell any securities or a solicitation of an offer to buy any securities, nor shall there be any sale
of any securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or jurisdiction.
On June 3, 2026, the Company issued a press release
announcing the entry into the Tolmar Agreements and the Purchase Agreement. A copy of the press release is attached hereto as Exhibit
99.1 and is incorporated by reference into this Report.
This Report and the related exhibits are incorporated
by reference into the Company’s Registration Statements on Form F-3 (File Nos. 333-274457,
333-288240 and 333-295359)
and Form S-8 (File Nos. 333-264169,
333-270406, 333-277733,
333-285745 and 333-294151).
EXHIBIT INDEX
| Exhibit No. |
|
Description |
| |
|
| 99.1 |
|
Press Release dated June 3, 2026. |
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. |
| |
|
|
| Date: June 3, 2026 |
By: |
/s/ Uzi Sofer |
| |
|
Uzi Sofer |
| |
|
Chief Executive Officer |
Exhibit 99.1
Alpha Tau and Tolmar Announce Strategic Collaboration
to Bring Alpha DaRT® Therapy to U.S. Urological Cancer Patients
- Joint partnership leverages Alpha Tau’s
highly potent, localized alpha-radiation
technology and Tolmar’s commercial leadership to transform the U.S. uro-oncology landscape
- Collaboration elevates prostate cancer as
a core strategic focus, backed by Tolmar’s initial
$15M manufacturing investment, $20M equity infusion at $11.99 per share (25%
premium to 30-day VWAP),
and up to $161.5M in clinical, regulatory and commercial milestones for the first indication
- Agreement grants Tolmar exclusive U.S. commercialization
rights for prostate cancer, with an
option to expand into bladder cancer subject to additional payments
- Alpha Tau to manufacture Alpha DaRT for Tolmar’s
commercialization, to be sold to Tolmar at
60% of the onward net sales price, subject to certain adjustments
JERUSALEM and DUBLIN, June 3, 2026 -- Alpha
Tau Medical Ltd. (Nasdaq: DRTS, DRTSW), developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, and
Tolmar International Ltd., one of the strongest commercial players in the U.S. urology, oncology, endocrinology and pediatric endocrinology
markets, today announced a strategic collaboration agreement to develop and commercialize Alpha DaRT for the treatment of prostate cancer
in the United States.
According to the American Cancer Society, prostate
cancer is the second-leading cause of cancer death in American men, behind only lung cancer, with over 330,000 new cases expected
this year and about 1 in 44 men dying from the disease. More than half of men who undergo a radical prostatectomy experience long-term
complications, including erectile dysfunction and urinary incontinence, highlighting the need for new alternatives that may potentially
avoid such surgeries.
Through the collaboration, Tolmar will hold exclusive
rights to commercialize Alpha DaRT in the United States for prostate cancer indications for a term that is expected to extend for 20 years
from first commercial sale, subject to the terms and conditions of the Collaboration Agreement. Tolmar also holds an option, exercisable
upon achievement of specified clinical criteria, to expand commercially into bladder cancer in the United States.
Alpha DaRT (Diffusing Alpha-emitters Radiation
Therapy) represents a paradigm shift in the treatment of solid tumors. While traditional radiation therapies face limitations of efficacy
and focused targeted delivery, Alpha DaRT is designed to deliver highly potent and conformal therapy directly inside the tumor, by means
of recoiling radioisotopes that release alpha particles with high energy and short diffusion. Alpha DaRT therefore has the potential to
destroy cancer cells with precision and spare the surrounding healthy tissue, offering patients a new and highly localized treatment modality
to maximize their quality of life.
Alpha Tau Chief Executive Officer, Uzi
Sofer, remarked, “Our clinical exploration of prostate cancer is already well underway, having treated patients in Israel and
secured an IDE from the FDA for a U.S. trial. Working alongside Tolmar, a top commercial leader with a keen understanding of this
market, unlocks a vital channel with the potential to reach tens of thousands of patients per year in this first urological
indication alone. Alongside our core clinical programs to date in glioblastoma, pancreatic cancer, and squamous cell carcinoma,
expanding into prostate cancer allows us to extend the reach of our platform technology exponentially and builds upon our deep
commitment to advancing innovative therapies across multiple oncology settings. This partnership will also spur additional expansion
of our U.S. manufacturing capacity, advancing our commitment to deliver this groundbreaking science to patients as quickly as
possible.”
“Alpha DaRT represents
a meaningful advancement in oncology, with the potential to make a significant difference for patients facing prostate cancer," said
Anil D’Souza, Chief Executive Officer of Tolmar. "By combining innovative science with Tolmar’s proven capabilities and
deep experience supporting providers, we are focused on expanding access to new treatment options for patients and the clinicians who
care for them. Throughout our extensive due diligence of Alpha Tau, we were consistently impressed with Uzi and the talent of the Alpha
Tau leadership team, thinking strategically through all aspects of this unique therapy, from manufacturing to supply chain, and into clinical
settings, as we were increasingly convinced of the promise of the technology, the market opportunity, and the commercial prospects. Together,
we are mobilized to work to accelerate its development and bring this therapy to patients across the United States as efficiently as possible.”
Tolmar Chief Medical Officer, Anjan Chatterjee,
MD, MPH, MBA, added, “From a clinical perspective, Alpha DaRT’s localized mechanism of action is incredibly promising for
urological oncology. For clinicians treating prostate cancer, the ability to deliver potent alpha-radiation precisely to the tumor while
minimizing radiation-induced damage to nearby healthy tissue (off-target activity) can address a profound unmet medical need. We are eager
to collaborate with Alpha Tau's medical team to advance the U.S. clinical development program and bring this solution to patients and
their physicians in the oncology community.”
Alpha Tau Chief Financial Officer, Raphi Levy,
commented, “We are very excited about the potential for this collaboration. We have long identified the prostate cancer market as
compelling, and with our concentration also on other cancers, we stand to benefit greatly from Tolmar’s focus and deep industry
expertise in this sector, and we will be excellently positioned towards introducing a much-needed therapy in a seamless and integrated
fashion. It has been a pleasure working with Tolmar to get to this moment, though we know the work is only just beginning.”
Key Terms of the Collaboration
Tolmar will hold exclusive rights to commercialize
Alpha DaRT in the United States for prostate cancer indications for a term that is expected to extend for 20 years from first commercial
sale, subject to the terms and conditions of the Collaboration Agreement. Tolmar also holds an option to expand the agreement to include
bladder cancer commercialization in the U.S., exercisable upon achievement of specified clinical criteria.
Alpha Tau will lead clinical development of the
Alpha DaRT for these indications, working in close collaboration with Tolmar and subject to joint governance under the collaboration agreement.
Alpha Tau will be responsible for manufacturing and supply of the product, while Tolmar will have full responsibility and control over
commercialization, including pricing, customer engagement, and sales execution in the United States. The supply price to Tolmar is based
on a percentage of net sales (set at 60%, subject to certain adjustments as defined in the Supply Agreement).
At closing, Tolmar will make a $20M equity investment
in Alpha Tau at $11.99 a share, a 25% premium to the 30-trading day volume-weighted average price (VWAP) prior to signature, and will
pay $15M towards the construction of a new Alpha DaRT production facility in the U.S. Certain payments have also been agreed for future
clinical development and U.S. regulatory approval work, which total up to $96.5M in development and regulatory milestone payments for
the initial indication, and up to $65M in commercial milestone payments, subject to achievement of specified milestones.
Should Tolmar exercise the U.S. bladder cancer
option, Tolmar will invest another $5M at a 25% premium to the then-prevailing 30-trading day VWAP and pay an additional $5M for expanded
manufacturing capacity, as well as similar payments of up to $96.5M for future clinical development and U.S. regulatory approval work
for the first bladder cancer indication to be pursued jointly by the parties.
Under the terms of the agreement, Tolmar receives
a right of first negotiation on new Alpha Tau products for U.S. urological cancers covered by the agreement, as well as a right of first
negotiation for certain additional products and geographic opportunities, as specified in the Collaboration Agreement. Alpha Tau retains
all rights to Alpha DaRT outside of the prostate and bladder markets in the U.S., as well as all global rights outside the U.S.
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.
About Tolmar
Founded in 2007, Tolmar is a specialty pharmaceutical
company focused on developing and commercializing products that address unmet needs in urology, oncology, endocrinology and pediatric
endocrinology. Driven by a passion for advancing patient care and improving outcomes, Tolmar is committed to supporting healthcare providers
with the education, tools, and therapies needed to deliver high-quality, evidence-based care. Guided by core values rooted in accountability,
ethical conduct, continuous improvement, and a deep commitment to people, Tolmar operates with a proactive and agile approach to innovation
and partnership. To date, the company has produced 22 marketed products supported by five New Drug Applications (NDAs) and 17 Abbreviated
New Drug Applications (ANDAs) across its key therapeutic areas.
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,”
“will,” “plan,” “may,” “continue,” and similar expressions are intended to identify forward-looking
statements. In addition, any statements or information that refer to the Alpha DaRT treatment, including feasibility and go to market
process, and other expectations, beliefs, plans, including with respect to clinical trials, regulatory approvals and market entry, 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, 2026, 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.
Alpha Tau Investor Relations Contact:
IR@alphatau.com
Tolmar Media Relations Contact:
media@tolmar.com
or
Glenn Silver
glenn.silver@finnpartners.com
(973) 818-8198
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