Full Press Release Details
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
"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.
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,"