On June 3, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, on June 2, 2026, reported new data on ATNM-400 in prostate cancer at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting taking place in Los Angeles, California.

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Androgen receptor pathway inhibitors (ARPIs) such as enzalutamide (Xtandi, Astellas/Pfizer), apalutamide (Erleada, Johnson & Johnson), and darolutamide (Nubeqa, Bayer) are foundational to advanced prostate cancer care, but virtually all patients eventually develop resistance and progress -with up to 50,0001 patients per year exhausting ARPI therapy- creating a large and recurring unmet need. ATNM-400, Actinium’s first-in-class Actinium-225 antibody radioconjugate, targets a non-PSMA antigen linked to aggressive prostate cancer biology and delivers a high-energy alpha-particle payload that kills tumor cells through a mechanism independent of PSMA expression and androgen receptor signaling. In preclinical head-to-head studies, this PSMA-independent mechanism allowed ATNM-400 to match or exceed PSMA-targeted radioligand therapies, including 177Lu-PSMA-617 (active ingredient of Pluvicto, Novartis) and 225Ac-PSMA-617, across PSMA-high, PSMA-low, and PSMA-negative models.

The new data presented at SNMMI 2026 address three key questions: whether ATNM-400 can overcome ARPI resistance in the mCRPC setting, whether it works as both a single agent and in combination, and how its dosing and safety profile support translation to patients. The data answer each: ATNM-400 remained potent against cells and tumors resistant to all three approved ARPIs, achieved 94% tumor growth inhibition as a single agent and durable complete responses in combination, and maintained a consistent, clean safety profile across both single-bolus and repeat-dose regimens.

Prostate cancer is one of oncology’s largest commercial opportunities: androgen receptor pathway inhibitors generate more than $12 billion in annual sales in 2025 and Pluvicto (177Lu-PSMA-617) reached $2.0 billion in 2025, yet up to 50,0001 patients exhaust ARPI therapy each year and roughly 30% of mCRPC patients are ineligible for PSMA-directed therapy. Because ATNM-400 acts independently of both androgen receptor signaling and PSMA, it is positioned to serve the full mCRPC continuum, from patients who have failed ARPIs to the PSMA-low and PSMA-negative populations with no approved targeted radiotherapy today. Actinium estimates this represents a combined opportunity of more than 100,000 patients annually, addressable as a monotherapy or in combination with existing standards of care.

Sandesh Seth, Actinium’s Chairman and CEO, said, "ARPI resistance is a central problem in advanced prostate cancer as once these drugs stop working there are few good options left. The new data are compelling as ATNM-400 stayed potent in cells and tumors resistant to all three approved ARPIs, outperformed apalutamide and darolutamide on its own similar to previous data with enzalutamide, and produced durable complete responses when combined with them. Equally important for development, ATNM-400 worked across single-dose and repeat-dose regimens with a consistent, clean safety profile, giving us real flexibility as we move toward the clinic. We believe these findings position ATNM-400 as a differentiated option for patients who have run out of ARPI choices. The same resistance-targeting biology underlies the compelling activity we have reported in non-small cell lung cancer and breast cancer, positioning ATNM-400 as a potential pan-tumor backbone for large, resistance-driven patient populations, alone or in combination. We look forward to sharing additional data across these programs in the coming months as we advance ATNM-400 toward the clinic."

Highlights from the SNMMI 2026 Poster Presentation

Poster Titled: ATNM-400: A First-in-Class Non-PSMA Actinium-225 Antibody Radioconjugate Demonstrates Superior Efficacy to PSMA-617 Radioligands and ARPIs With Favorable Safety Profile in Prostate Cancer Models

New data presented at SNMMI 2026 highlight several findings central to ATNM-400’s development in prostate cancer:

In a low-PSMA, moderate-target tumor model (22Rv1), a single bolus dose of ATNM-400 (40 or 30 µCi/kg) delivered superior tumor control versus fractionated dosing, and a repeat 30 µCi/kg regimen sustained tumor control and survival through day 60 with all regimens outperforming 177Lu-PSMA-617 and showing minimal deviation from vehicle in blood, liver, and kidney safety markers. Flexible, well-tolerated dosing gives clinicians multiple ways to balance efficacy and safety and points to a wide therapeutic window.

ATNM-400 produced potent, dose-dependent killing of prostate cancer cells that are resistant to enzalutamide, apalutamide, and darolutamide, driving cell viability toward zero after each ARPI had failed, while the ARPIs alone left the resistant cells largely intact. Demonstrating activity specifically after ARPI failure addresses the most common point of progression in advanced prostate cancer and supports ATNM-400 as a treatment option for patients with few alternatives.

As monotherapy in an ARPI-resistant tumor model (22Rv1), ATNM-400 achieved 94% tumor growth inhibition versus just 32% for apalutamide and 5% for darolutamide, roughly three- to eighteen-fold greater tumor control than the ARPIs themselves. Working on its own in tumors that no longer respond to standard ARPIs positions ATNM-400 as a potential stand-alone therapy after resistance, not only an add-on.

In combination with either apalutamide or darolutamide in the same ARPI-resistant model, ATNM-400 delivered durable tumor control at 107% tumor growth inhibition, with complete responses in at least 57% of mice (4/7 and 5/7). Turning resistant tumors into complete responses by pairing ATNM-400 with the very drugs that had failed supports a combination strategy that could extend the commercial and clinical value of approved ARPIs.

In a high-PSMA, high-target tumor model (C4-2), ATNM-400 matched or exceeded both PSMA-targeted radioligands-comparable to 225Ac-PSMA-617 and superior to 177Lu-PSMA-617-while being given at roughly one-thousandth the administered radioactivity of 177Lu-PSMA-617 (40 µCi/kg versus 40 mCi/kg), with durable survival and favorable tolerability. Because ATNM-400 acts independently of PSMA, this activity carries across PSMA-high, PSMA-low, and PSMA-negative models, reaching the PSMA-variable patients that PSMA-directed radioligand therapy serve least well. Moreover as the ATNM-400 target is not expressed in the salivary glands xerostomia, a limitation of PSMA directed therapies and especially PSMA-Ac-225 based agents, is not expected.

(Press release, Actinium Pharmaceuticals, JUN 3, 2026, View Source [SID1234666411])

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])

On June 3, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, on June 2, 2026, reported new preclinical data on ATNM-400 in non-small cell lung cancer (NSCLC) at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting in Los Angeles, California.

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The new KRAS-mutant data, together with a growing body of EGFR-mutant data, demonstrate ATNM-400’s activity across the two major mutation driver classes in NSCLC and support a distinct strategic opportunity. ATNM-400 can be developed as a potential mutation-agnostic backbone for the broader NSCLC market, alone or in combination with standard-of-care therapies, rather than as another mutation-specific drug for a narrow subset.

NSCLC accounts for roughly 85% of the more than two million lung cancer cases diagnosed globally each year, a market more than twice the size of prostate cancer. It is also highly heterogeneous: no single mutation dominates, so treatments are fragmented across mutation-specific therapies such as EGFR, KRAS, BRAF, ALK and others, each marketed by different companies, each addressing only a molecular subset, and each ultimately limited by acquired resistance. ATNM-400, Actinium’s first-in-class Actinium-225 (Ac-225) antibody radioconjugate, is designed to break out of that single-mutation paradigm. Rather than blocking a specific mutant protein, it delivers a high-linear-energy-transfer alpha-particle payload that induces dense, irreversible double-strand DNA breaks and tumor-cell death independent of a tumor’s driver mutation or signaling pathway, the mechanistic basis of its mutation-agnostic activity.

ATNM-400’s target antigen, from previously published immunohistochemistry studies, is present in approximately 98% of NSCLC tumors and highly expressed in approximately 70% of those tumors. It is conserved across EGFR-, KRAS-, and other driver-defined subgroups, and further increased in tumors that have become resistant to EGFR, KRAS, and immune-checkpoint therapies. In new KRAS-mutant studies presented at SNMMI, sotorasib (active ingredient in LUMAKRAS/Amgen) and adagrasib (active ingredient in KRAZATI/BMS) increased ATNM-400’s target up to 3.5- and 3.8-fold, respectively, and adding ATNM-400 deepened tumor-cell killing beyond either inhibitor alone. These results demonstrate the same target-expression increasing, synergy-enabling biology shown previously with the EGFR inhibitor osimertinib, which produced tumor growth inhibition of 107% when combined with ATNM-400.

These combination benefits also broaden ATNM-400’s commercial opportunity. The franchises it could enhance are substantial; the KRAS inhibitor class in NSCLC is projected to exceed $5 billion in peak sales, and the EGFR-mutant segment has peak sales estimates over $15 billion, led by osimertinib (active ingredient in TAGRISSO/AZ), which generated $7.3 billion in 2025. This positions ATNM-400 to participate in these established markets by enhancing the standard of care, while also reaching the broader NSCLC population beyond any single mutation.

Sandesh Seth, Actinium’s Chairman and CEO, said, "Today’s data further strengthen our conviction that ATNM-400 represents a fundamentally different approach to treating NSCLC solid tumors. While most targeted therapies are designed for a single mutation-defined patient population, ATNM-400 combines the mutation-independent cell-killing power of Actinium-225 with a target that is broadly expressed across tumors and becomes even more abundant as resistance emerges. The consistency of activity we have now demonstrated across both EGFR- and KRAS-driven NSCLC supports our vision for ATNM-400 as a potential mutation-agnostic backbone therapy that can be used alone or in combination across large patient populations. We believe this opportunity could extend beyond lung cancer and may position ATNM-400 as a foundational therapy across multiple solid tumor indications."

Highlights from the SNMMI 2026 Poster Presentation

Poster Titled: ATNM-400: A First-in-Class Actinium-225 Antibody Radioconjugate Demonstrating Durable, Mutation-Agnostic Anti-Tumor Activity in Non-Small Cell Lung Cancer Models

New data demonstrated ATNM-400’s potential as a mutation-agnostic antibody radioconjugate therapy for NSCLC:

Across a panel of four lung cancer cell lines spanning EGFR- and KRAS-driver mutations, ATNM-400 bound and was internalized specifically by the three target-positive lines (NCI-H1975, NCI-H358 and Calu-3) but not by the target-negative line (A549), confirming that its activity is driven by target expression rather than by any particular mutation.

In a KRAS G12C model (NCI-H358), PET imaging of radiolabeled ATNM-400 showed the drug concentrating in the tumor with low uptake in healthy tissue, visually confirming that it reaches its target in a living animal and delivers its alpha payload where intended while largely sparing normal organs.

In a KRAS G13D model (Calu-3), a single dose of ATNM-400 drove tumor regression (124% and 135% inhibition at two dose levels), indicating marked antitumor potencywith full body-weight recovery. Deep responses from one dose with a clean tolerability profile point to a wide therapeutic window and dosing flexibility, favorable attributes for clinical translation.

Treatment with both approved KRAS inhibitors (sotorasib and adagrasib) raised ATNM-400’s target expression dose-dependently—up to roughly 3.5- to 3.8-fold—reaching statistical significance at every dose (p < 0.0001). The effect occurred with both agents, indicating a class-wide consequence of KRAS G12C inhibition that builds a rationale for combining ATNM-400 with these therapies.
Post both KRAS drugs ATMN400 expression increases

ATNM-400 plus sotorasib or adagrasib decreased cancer-cell viability beyond either inhibitor alone. The data demonstrate that ATNM-400 has development potential not only as a monotherapy but also in combination with these leading KRAS therapies and possibly the entire KRAS-mutant class.

In an EGFR-mutant model (NCI-H1975), ATNM-400 monotherapy achieved 75% tumor growth inhibition versus 40% for osimertinib; combined with osimertinib it reached 107% inhibition with complete cures in 100% of mice. Osimertinib raised target expression, providing a clear rationale for the combination.

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])

On June 3, 2026 Sapu Nano and Oncotelic Therapeutics (OTCQB:OTLC) reported the expansion of its Phase 1b clinical development program for Sapu003 (Everolimus for Injection) and the appointment of Global Clinical Trials (GCT) as the lead contract research organization supporting international execution of Study SP-03-B101.

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The announcement follows recent regulatory approvals supporting the study expansion and CRO transition and represents an important milestone in the evolution of the Sapu003 clinical program from its initial Australian clinical footprint toward a broader multinational clinical program.

GCT was selected following a competitive evaluation process that assessed international oncology expertise, regulatory capabilities, operational execution, clinical quality systems, and global logistics infrastructure. Following its appointment, GCT successfully completed key regulatory submissions ahead of schedule and has initiated clinical operations, regulatory coordination, site activation activities, investigational product logistics, and study management functions.

The appointment supports the expansion of the SP-03-B101 study beyond Australia into Europe and represents an important step in establishing the clinical, operational, and regulatory infrastructure necessary to support future multinational Phase 3 development. By building an international clinical network early in development, Sapu Nano aims to position Sapu003 for efficient advancement into global registrational studies following successful completion of ongoing clinical evaluation.

SP-03-B101 is an open-label Phase 1b dose-escalation study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors.

"Sapu003 has progressed from concept through formulation development, manufacturing, regulatory approval, and clinical evaluation in a remarkably short period of time," said Dr. Vuong Trieu, Chief Executive Officer. "The expansion of the program beyond Australia and the appointment of GCT provide the international infrastructure necessary to support continued clinical development. We believe these milestones position Sapu003 for broader global evaluation and future registrational studies while expanding access for patients with advanced cancers."

Sapu003 is a proprietary intravenous formulation of everolimus developed using Sapu Nano’s Deciparticle platform technology. The program is designed to address limitations associated with oral everolimus administration, including variable absorption, food effects, and first-pass metabolism, while providing more predictable systemic drug exposure through intravenous delivery.

The Company expects the expanded international footprint and integrated clinical operations platform established through GCT to support continued enrollment, future site expansion, and long-term global development objectives for the Sapu003 program.About Deciparticle

Deciparticle is Oncotelic’s proprietary nanomedicine platform designed to formulate highly water-insoluble therapeutics into ultra-small nanoparticles for intravenous administration. The platform utilizes amphiphilic polymer architectures intended to improve aqueous compatibility, stability, manufacturability, and translational flexibility across multiple therapeutic classes.

(Press release, Sapu Bioscience, JUN 3, 2026, View Source [SID1234666413])