Alpha Tau and Tolmar Announce Strategic Collaboration to Bring Alpha DaRT® Therapy to U.S. Urological Cancer Patients

On 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, reported a strategic collaboration agreement to develop and commercialize Alpha DaRT for the treatment of prostate cancer in the United States.

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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.

(Press release, Alpha Tau Medical, JUN 3, 2026, View Source [SID1234666429])

MAIA Biotechnology Receives FDA Clearance to Open U.S. Enrollment in Ongoing Phase 2 THIO-101 Trial Expansion

On June 3, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared an amendment to update its investigational new drug (IND) application which enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial of its lead candidate, ateganosine, as a treatment for advanced non-small cell lung cancer (NSCLC). Ateganosine is a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. Ateganosine sequenced with a monoclonal antibody checkpoint inhibitor is being evaluated as a therapy for patients in ongoing Phase 2 and Phase 3 clinical trials.

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MAIA obtained FDA clearance of its updated IND highlighting MAIA’s improved efficiencies to its manufacturing capabilities, including new manufacturers, formulation and storage conditions for ateganosine, and MAIA is now cleared to enroll patients in the U.S. for the expansion of the Phase 2 THIO-101 study of patients receiving advanced third-line (3L) NSCLC treatment. In addition to the U.S., the THIO-101 study is ongoing at 44 clinical sites in six countries. MAIA recently activated its first U.S. clinical site at Summit Medical Group in New Jersey.

In July 2025, the FDA granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. The additional data from the expansion studies may further support a filing for FDA Accelerated Approval.

"Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks," said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. "To date, data has shown overall survival (OS) beyond two years for eight patients treated with ateganosine in Parts A and B of THIO-101. We believe this bodes well for Parts C and D evaluations which are specific to third-line treatment care only, where the unmet need for improved clinical outcomes is most urgent."

K. Robinson Lewis, Senior Vice President and Head of Regulatory and Quality for MAIA, commented, "We are excited about the prospects for our U.S. trials following FDA clearance of our amended IND. The unmet need for effective third-line NSCLC treatments is widespread in the U.S. Based on strong clinical data documented so far, we are confident in the potential of our therapy to address this significant and substantially underserved patient population."

In parallel with THIO-101, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial, THIO-104, designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 third-line NSCLC patients.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

(Press release, MAIA Biotechnology, JUN 3, 2026, View Source [SID1234666428])

OSE Immunotherapeutics Reports Full Year 2025 Audited Consolidated Financial Results and Announces the Filing of its 2025 Universal Registration Document

On June 3, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (the "Company"), reported its full year 2025 audited consolidated financial results, as approved by the Board of Directors on June 3, 2026. These audited financial statements are unchanged compared to the unaudited financial statements previously reported on April 30, 2026, with only the IRIS Financing announced on May 28, 2026, added as a subsequent event. Audit procedures by the Company’s statutory auditors on the Company’s 2025 consolidated financial statements were completed. Final certification will take place after the completion of procedures required before the Universal Registration Document is filed with the French market authority (Autorité des Marchés Financiers or AMF).

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Full Year 2025 Consolidated Financial Results (IFRS, audited)


In million euros 2024 2025
Revenues 69.9 2.6
Other income 13.6 0.1
Operating income 83.4 2.7
Research and development expenses (30.4) (33.9)
General and administrative expenses (6.5) (8.8)
Share-based payments non-cash expenses (2.7) (1.9)
Other operating items - 4.4
Operating profit (loss) 43.7 (37.5)
Financial income (loss) (3.9) 0.1
Net income (loss) 37.4 (37.7)
EPS (in € per share) 1.71 (1.69)
Net cash flows from operating activities 48.4 (34.0)
Net cash flows from investment activities (46.9) 41.4
Net cash flows from financing activities (3.5) (6.5)
Net cash flows (1.9) 0.8
Cash and cash equivalents at closing 16.7 17.6
Total Cash Position at closing (incl. long-term deposits) 64.2 22.7
Full Year 2025 Consolidated Financial Results are further detailed in the Company’s press release reporting unaudited financials on April 30, 2026.

Cash Runway and Financing Strategy

To date, the Company does not have sufficient net working capital to meet its obligations over the next 12 months.

The Company’s cash and cash equivalents totaled €17.0 million as of March 31, 2026.

After the completion of the IRIS Financing and assuming related gross proceeds of €19.3 million over a 24-month period, and based on its current plans, the Company estimates that its cash and cash equivalents will be sufficient to fund its operations until the end of December 2026. This cash runway does not include any potential future milestone payments from existing partnerships.

The IRIS Financing is the first step of a global financing strategy aiming at securing OSE’s 3-year Strategic Plan and the Company is actively engaging with institutional investors in the United States and in Europe.

To further extend its runway beyond 2026, the Company continues to evaluate several complementary options, including a potential new strategic partnership involving one of its proprietary assets, equity offering to institutional investors, restructuring of its existing debt, and potential milestone payments from current partnerships.

Although the Company is confident in its ability to meet its short-term financing objectives, there is no guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions to finance all of its activities on a 12-month horizon.

2025 Financial Statements have been approved on a going concern basis, although this situation constitutes a significant uncertainty that may cast significant doubt on the Company’s ability to continue as a going concern beyond the currently estimated cash runway. Auditors’ certification report will include a going concern qualification.

2025 Universal Registration Document

The 2025 Universal Registration Document was filed today with the AMF.

The Universal Registration Document includes in particular:

The 2025 annual financial report;
The management report;
The report on corporate governance; and
The description of the share buyback program.
The Universal Registration Document may be consulted on the Company’s website (www.ose-immuno.com), "Investors" section, and on the AMF’s website (www.amf-france.org).

(Press release, OSE Immunotherapeutics, JUN 3, 2026, View Source [SID1234666427])

Iovance’s Amtagvi® (lifileucel) Granted Approval for the Treatment of Advanced Melanoma in Australia

On June 3, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that the Therapeutic Goods Administration (TGA) of Australia granted approval with conditions of Amtagvi (lifileucel), a tumor-derived autologous T cell immunotherapy, for previously treated advanced (metastatic or unresectable) melanoma. Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

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"This approval in Australia is our third marketing authorization for Amtagvi and marks a significant step forward for Iovance in the country with the highest rate of melanoma globally," said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. "We are in the process of authorizing our first Australian treatment center as we advance our expansion strategy for Amtagvi in additional markets with a high prevalence of advanced melanoma."

Australia has the highest rate of melanoma globally, with an estimated 17,000 new cases diagnosed each year and more than 1,500 deaths annually.1,2 Similar to the U.S. and other global markets, there is a significant need for new therapies for patients with advanced melanoma.

TGA granted approval based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, if applicable.

About the C-144-01 Clinical Trial
C-144-01 is a global, multicenter Phase 2 study in which patients received lifileucel monotherapy. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and, if BRAF V600 mutation positive, a BRAF inhibitor or a BRAF inhibitor with a MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR) and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The detailed results of C-144-01 were published in the Journal for ImmunoTherapy of Cancer in 2022. A five-year analysis of C-144-01 was published in the Journal of Clinical Oncology in 2025.

Iovance is investigating Amtagvi in frontline advanced melanoma in the Phase 3 trial, TILVANCE-301 (NCT05727904), as well as in additional solid tumor types.

(Press release, Iovance Biotherapeutics, JUN 3, 2026, View Source [SID1234666426])

Mission Bio’s Tapestri Enables Single-Cell Profiling of Residual Disease, Identifying AML Patients Likely to Benefit from Motixafortide in the Multicenter BLAST Trial

On June 3, 2026 Mission Bio, a leader in single-cell multiomics, jointly announces with Heidelberg University Hospital, Martin Luther University Halle-Wittenberg, the East German Study Group for Hematology and Oncology (OSHO), and the Study Alliance Leukemia (SAL) findings from a retrospective single-cell analysis of the randomized, double-blind, placebo-controlled phase II BLAST clinical trial in acute myeloid leukemia (AML). The investigator-initiated trial was sponsored by Martin Luther University Halle-Wittenberg, scientifically coordinated and led by Heidelberg University Hospital, and conducted at 29 academic centers in Germany with the active support of OSHO and SAL.

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The initial clinical trial tested whether adding the CXCR4 inhibitor Motixafortide to high-dose cytarabine consolidation could reduce the risk of relapse in 128 AML patients in first complete remission. Across the overall cohort, the clinical trial did not meet its primary endpoint, demonstrating a median relapse-free survival (RFS) of 10.3 months with Motixafortide and 11.5 months with placebo (log-rank p = 0.98). A prespecified retrospective analysis of bone marrow samples using single-cell DNA and protein profiling on the Mission Bio Tapestri platform examined whether a clinically defined subgroup might nevertheless benefit.

Among patients treated with Motixafortide, high CXCR4 expression on residual leukemic cells was associated with a significantly reduced risk of relapse (p = 0.047). In the placebo arm, the same marker was associated with significantly elevated relapse risk (p = 0.02), consistent with the established role of the CXCR4-CXCL12 axis in bone-marrow-mediated chemoresistance. A multivariable Cox model confirmed a significant treatment-by-CXCR4 interaction (p = 0.0015).

In the post-consolidation setting, residual leukemic cells are rare and embedded in a largely normal bone marrow background. Standard-of-care analysis methods cannot reliably attribute CXCR4 signal to residual leukemic cells from the normal hematopoietic cells. By linking CXCR4 protein expression to genetically defined leukemic clones at single-cell resolution, the Tapestri platform made it possible to detect this subgroup. In individual patients, genetically distinct subclones showed divergent CXCR4 dynamics over the course of treatment, illustrating the clonal heterogeneity that standard-of-care analysis methods cannot resolve.

The results suggest that CXCR4 expression, when assessed specifically on residual leukemic cells and in the context of their clonal identity, may serve as a predictive biomarker for Motixafortide therapy in AML. The team emphasized that the analysis is retrospective and hypothesis-generating, and that the findings need to be confirmed in a prospective, biomarker-stratified clinical trial before they can guide treatment decisions in routine practice. This study supports integrating functional, clonally resolved single-cell measurable residual disease (MRD) profiling, as enabled by the Tapestri platform, into the design of future AML clinical trials.

"Our analysis suggests that the same biological marker can carry very different meanings depending on the treatment context. Patients with high CXCR4 expression on residual leukemic cells are at particularly high risk of relapse, but they also appear to benefit most from CXCR4 inhibition. Reliably identifying these patients requires measuring CXCR4 directly on residual leukemic cells and linking it to their clonal architecture, which is what single-cell MRD profiling enables," said Enise Ceran, MD, first author of the study, Medical Department V, Heidelberg University Hospital.

"These results demonstrate the need for single-cell MRD approaches to functionally characterize the molecular and phenotypic landscape of residual disease, enabling the identification of biomarker-driven therapy selection to treat AML," said Carsten Müller-Tidow, MD, corresponding author and Professor of Medicine, Hematology, Oncology and Rheumatology at Heidelberg University Hospital.

"AML is not a single disease. It is a dynamic, evolving ecosystem of clones, and this analysis proves that the right drug, matched to the right patient, works. Motixafortide works powerfully in CXCR4-high patients. Tapestri is what makes that match possible," said Zivjena Vucetic, MD, PhD, Chief Medical Officer of Mission Bio.

Mission Bio added that AML’s clonal complexity means that population-level assays can obscure the biology driving relapse. The company is actively working with clinical partners to incorporate Tapestri-based biomarker screening into prospective trial protocols.

The findings will be presented as a proffered abstract at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2026 in Stockholm, June 11–14, 2026. The full results have been published in Blood: Ceran E, Jaramillo S, Merbach AK, et al. Inhibition of high CXCR4 with Motixafortide and absence of single-cell MRD predict outcome after AML consolidation. Blood. 2026. doi:10.1182/blood.2025032033

(Press release, Mission Bio, JUN 3, 2026, View Source [SID1234666425])