Actinium Presents Data Supporting Paradigm Changing Potential of ATNM-400 in Prostate Cancer Demonstrating Its Superior Efficacy and Improved Survival in Treatment Resistant Tumor Models versus Pluvicto and ARPI Therapy, and Also Enhanced Efficacy in Combination with ARPI Therapy at the 4th Annual Targeted Radiopharmaceuticals Summit

On July 31, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported additional preclinical data supporting its ATNM-400 radiotherapy prostate cancer candidate at the 4th Annual Targeted Radiopharmaceuticals Summit (TRP) being held July 29 – 31, 2025 in San Diego, CA (Press release, Actinium Pharmaceuticals, JUL 31, 2025, View Source [SID1234654691]). ATNM-400 is a novel, first-in-class targeted radiotherapy designed to deliver potent Actinium-225 (Ac-225), an alpha-emitter radioisotope, to prostate cancer cells by targeting a non-Prostate Specific Membrane Antigen (PSMA), disease-driving protein overexpressed in advanced and treatment-resistant disease. Unlike PSMA-targeted agents that primarily serve as imaging and targeting tools, the ATNM-400 target is directly implicated in tumor progression, survival signaling, and resistance to androgen receptor (AR) pathway inhibitor (ARPI) therapy. The presentation titled, "Building a Transformative Ac-225 Portfolio for Next-Generation Precision Oncology" on Wednesday, July 30, 2025, highlighted new PET imaging data showing tumor-specific uptake of ATNM-400, robust tumor control and improved survival outcomes in preclinical studies.

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ATNM-400 Demonstrated Sustained Tumor-Specific Uptake

PET imaging confirmed tumor-specific uptake of the ATNM-400 antibody

The ATNM-400 antibody showed sustained tumor uptake up to 216 hours with rapid clearance from normal tissues
ATNM-400 Produced Robust Tumor Control, Improved Survival and Superior Efficacy After Pluvicto Resistance

ATNM-400 is more efficacious than Pluvicto (Lu-177-PSMA-617) with potent tumor control

ATNM-400 significantly improved survival compared to Pluvicto with continued follow-up ongoing

ATNM-400 is highly effective in prostate cancer tumors with acquired Pluvicto resistance, halting tumor growth and producing potent tumor cell killing after Pluvicto stops working, highlighting its potential in advanced disease settings that are resistant to standard treatments
Enhanced Efficacy of ATNM-400 with Enzalutamide Supports Potential for Novel Combinations

ATNM-400 demonstrated significant in vitro tumor cell killing when used in combination with AR-targeting agents, such as enzalutamide (Xtandi)

The ATNM-400 enzalutamide combination produced superior anti-tumor efficacy and durable tumor control compared to enzalutamide alone with 40% of prostate cancer tumor-bearing animals having complete cures

Actinium previously highlighted that ATNM-400 inhibited tumor growth of enzalutamide resistant tumors whereas re-treatment with Pluvicto or additional enzalutamide did not

Actinium highlighted that follow-up continues to further evaluate the durability of ATNM-400’s anti-tumor efficacy in prostate cancer with additional data expected in the second half of 2025. Actinium’s TRP presentation can be accessed via the Investor Relations page of Actinium’s website HERE.

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are highly encouraged by the growing body of data supporting the therapeutic potential of ATNM-400 and the significance of its target being directly implicated in tumor progression, survival signaling, and resistance to ARPI therapy. The new data presented at TRP highlight the utility of the differentiated mechanism of action of ATNM-400 via the Ac-225 alpha-emitter payload evidenced by durable tumor control, improved survival rates compared to Pluvicto, and efficacy in enzalutamide and Pluvicto resistant models. We believe ATNM-400 has the potential to redefine the treatment paradigm in the high-value, advanced disease, and metastatic castrate-resistant prostate cancer settings, which impact tens of thousands of patients annually. We look forward to presenting additional data in the second half of this year and further highlighting ATNM-400’s differentiated potential in treatment settings with high unmet needs."

About ATNM-400

ATNM-400 is a highly innovative, first-in-class, non-PSMA targeting Actinium-225 (Ac-225) radiotherapy candidate for prostate cancer. In comparison to Pluvicto (Lu-177-PSMA-617) and the majority of radiotherapies in development for prostate cancer, which target prostate specific membrane antigen (PSMA) and are either non-differentiated or barely differentiated, ATNM-400 targets a distinct non-PSMA disease-driving protein overexpressed in advanced and treatment-resistant disease. The receptor specifically targeted by ATNM-400 is highly expressed in metastatic castration-resistant prostate cancer (mCRPC), contributes directly to disease progression, poorer survival outcomes, and continues to be expressed at a high level even after androgen receptor inhibitor (ARPI) and Pluvicto treatment. ATNM-400 leverages the alpha-particle emitter Ac-225, which can cause lethal irreversible double-stranded DNA breaks and is more potent compared to the beta-particle emitter Lutetium-177 (Lu-177) used by Pluvicto, as well as a shorter path length that could result in fewer off-target effects.

Prostate cancer is the most commonly diagnosed cancer in men, with ~1.5 million new cases globally and over 313,000 expected in the U.S. in 2025. While early-stage disease is typically managed with surgery, radiation, and ARPI therapy, up to 20% of cases progress to mCRPC – a lethal stage with limited treatment options. Targeted radiotherapy is a growing field in prostate cancer, dominated by PSMA-targeting agents like Pluvicto, which had sales of over $1.3 billion in 2024, yet many patients either lack PSMA expression or develop resistance to Pluvicto. In the U.S., 40,000–60,000 mCRPC patients annually progress after ARPIs such as Xtandi, which had sales of over $5.9 billion in 2024, highlighting a significant unmet need.

Summary of Consolidated Financial Results for the First Quarter of the Year Ending March 31, 2026

On July 31, 2025 Sumitomo Dainippon Pharma reported Summary of Consolidated Financial Results for the First Quarter of the Year Ending March 31, 2026.

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(Filing, 3 mnth, JUN 30, Sumitomo Dainippon Pharma, 2025, JUL 31, 2025, View Source [SID1234661680])

Quarterly Activities Report & Appendix 4C

On July 31, 2025 Starpharma (ASX: SPL, US OTC: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, reported its Quarterly Activities Report and Appendix 4C for the quarter ended 30 June 2025 (Q4 FY25) (Press release, Starpharma, JUL 31, 2025, View Source;mc_eid=bf52dd3418 [SID1234654648]).

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Starpharma’s Chief Executive Officer, Cheryl Maley, commented:

"Over the past year, we have made meaningful progress across our strategic initiatives, aimed at maximising DEP asset value, accelerating early asset development, and building long-term sustainability. Our primary focus has been on out-licensing Starpharma’s clinical-stage DEP assets, establishing new research partnerships to leverage Starpharma’s dendrimer platform technology, increasing revenue from our marketed products, and enhancing the depth our intellectual property portfolio.

"We are pleased to report a $3.1 million increase in underlying customer receipts this financial year, driven by sales of the Viraleze and VivaGel BV products and Petalion research revenue. We have made notable strides with our research partners and expanded our collaborative model through the strategic Star Navigator program. Our radiotheranostics program is also advancing, and we are diligently making important decisions to shape the future of this program effectively.

"This year has not been without its challenges, particularly given the complex geopolitical environment we are navigating. We have actively sought feedback and technical expertise from global conferences, FDA engagement, key opinion leaders, and extensive interactions with investors and international companies. These efforts and learnings are continuously being integrated with our core strategy.

"Looking ahead to FY26, our approach is rigorous and focused on strategic execution, aiming to develop assets with unparalleled commercial potential. We are dedicated to achieving tangible outcomes and delivering value for our shareholders by realising the full potential of Starpharma’s dendrimer platform in collaboration with partners, and through our internal drug discovery and development efforts. Restoring value for our investors remains a top priority. Starpharma’s platform technology presents multiple opportunities for value creation, and we are confident that the progress made in FY25 has laid the groundwork for a successful year ahead."

Maximising DEP Asset Value

In FY25, our top priority was the out-licensing of Starpharma’s clinical-stage assets, DEP SN38 and DEP cabazitaxel, and throughout the year we have committed extensive internal and external resources to achieving this. We have engaged considerably with small to large-size companies, which have shown interest in the DEP assets. The licensing process has taken longer than anticipated, which we attribute to a range of factors including the evolving oncology landscape shifting towards targeted treatment options and the current geo-political environment, which has impacted the biotechnology industry at large. We remain confident in the potential of these assets and the benefits of the DEP technology highlighted by the available clinical data, and are committed to securing partnerships, employing both internal and external resources.

Starpharma engaged with global biotechnology and pharmaceutical stakeholders at the 2025 BIO International Convention in Boston in June. Starpharma’s business development team actively promoted the company’s innovative DEP platform, highlighting the technology’s potential to provide therapeutic and commercial value in oncology and next-generation therapeutics. During the conference, Starpharma initiated and advanced discussions for potential collaborations and licensing opportunities for Starpharma’s clinical-stage assets, as well as for its commercial products VivaGel BV and Viraleze. With over 20,000 attendees focused on business development and strategic alliances, Starpharma’s presence at this high-profile event provided a valuable platform to showcase its leadership and technical capabilities in dendrimer-based drug delivery and platform innovation. The company also gained important insights into evolving industry needs and emerging healthcare opportunities, all of which help shape Starpharma’s business development strategy and R&D priorities.

Accelerating Early Asset Development

Starpharma is strategically intensifying its focus on enhancing its internal pipeline with novel assets that offer innovation, high commercial potential and a strong competitive advantage. Advancing our radiotheranostics program towards the clinic and exploring other emerging therapeutic areas with potential for significant commercial opportunity are integral to our plans for FY26. By doing so, we aim to better position ourselves for successful partnerships, delivering significant value to our shareholders and advancing our mission to improve patient outcomes through our platform dendrimer technology.

DEP radiotheranostics program

Starpharma is continuing to develop and optimise its DEP radiotheranostics assets through preclinical studies to guide important decisions that will shape the clinical program, which is planned for 2026. Alongside the preclinical program, Starpharma is continuing to identify and engage with potential clinical trial sites, and key opinion leaders in the radiopharmaceuticals field, while connecting with and gathering input and insights into radiotheranostic delivery challenges and needs from potential partners.

During the quarter, Starpharma’s business development team participated in the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in the US. SNMMI is one of the industry’s most influential conferences related to radiopharmaceuticals. Participation in this event enabled Starpharma to connect with global stakeholders and gather valuable insights in the rapidly evolving field of radiopharmaceuticals. These interactions help inform and shape our DEP radiopharmaceuticals program, ensuring that our development pathway aligns with clinical needs and commercial opportunities.

Research collaborations

Alongside advancing existing partnerships this quarter, Starpharma established preliminary research programs with two new potential collaborators through its Star Navigator program. These strategic initiatives aim to explore the potential applications of Starpharma’s proprietary dendrimer technology in emerging therapeutic areas. Should these collaborations prove successful, they may evolve into formal research partnerships, potentially adding significant value to the company’s portfolio.

By providing streamlined and efficient pathways for collaboration, Star Navigator enables a broader spectrum of partners, ranging from early-stage researchers to global pharmaceutical companies, to leverage the unique capabilities of Starpharma’s dendrimer technology. This program provides access to the DEP platform, as well as Starpharma’s technical expertise and collaborative frameworks, designed to accelerate and de-risk the process from discovery to development. Expanding Starpharma’s partnership models with the Star Navigator program is a strategic move to unlock new collaboration opportunities and co-develop novel assets, positioning Starpharma for future platform licensing.

Building Long-Term Sustainability

For FY25, underlying customer receipts grew to $4.9 million, a 165% increase on the prior year, excluding the one-time FY24 receipt related to the VivaGel BV exit from Mundipharma. This result highlights our strategic focus on building sustainable revenue growth.

This quarter, Starpharma received payment for the first delivery of Viraleze to Etqan & Nazahah LLC (E&N), kickstarting the product’s expansion into the Saudi Arabian market. E&N’s phased distribution plan, already in motion, will target a wide array of channels, including chain and hospital pharmacies, e-pharmacies, and major retailers.

During the quarter, Starpharma signed a distribution agreement with Synmosa, a Taiwan-based pharmaceutical company, for VivaGel BV distribution in the Philippines, Malaysia, and Singapore. Synmosa’s established presence in women’s health will position VivaGel BV well in these markets. Starpharma is now working with Synmosa to transfer the product registrations for these territories to Synmosa.

Q4 FY25 Financial Summary

Starpharma’s cash balance at 30 June 2025 was $15.4 million. Customer receipts reached $2.0 million this quarter, a 51% increase from the prior quarter (Q3 FY25), driven by sales of the Viraleze and VivaGel BV products.

Net operating cash outflows for the quarter were $2.0 million, including research and development (R&D) costs of $1.8 million and staffing costs of $2.0 million. The company is anticipating an inflow of ~$3.5 million under the Australian Government’s R&D Tax Incentive scheme in H1FY26.

For the full FY25, customer receipts were $4.9 million, up 165% on an underlying basis compared to FY24. Cash operating payments for FY25 of $18.2 million were lower than FY24 payments of $24.2 million due to the completion of the DEP clinical programs and cost reduction initiatives for administration and corporate costs. These financial results reflect Starpharma’s focus on resource management and its ongoing commitment to sustainable business operations.

Staffing costs for the quarter included payments to non-executive and executive directors of $269,000. Other related party payments included service fees of $1,000 to CBE Pure Solutions Pty Ltd, where Starpharma non-executive director Dr Jeff Davies is also a director and shareholder.

Based on Starpharma’s 4C, which is appended, the company’s cash balance of $15.4 million at 30 June 2025 represents 7.7 quarters of funding. Starpharma remains sharply focused on increasing revenue through product sales and licencing agreements, and optimising resource management to improve shareholder value and deliver on our long-term sustainability goals. Through disciplined cost management and a clear strategy to monetise Starpharma’s portfolio and dendrimer platform technology, the company is well-positioned to deliver on its strategy in the year ahead.

AIM ImmunoTech Announces Closing of $8.0 Million Public Offering

On July 31, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) (the "Company"), reported the closing of its previously announced public offering of an aggregate of 2,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants (Press release, AIM ImmunoTech, JUL 31, 2025, View Source [SID1234654666]). The warrants have an exercise price of $4.00 per share, and were exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8.0 million.

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Maxim Group LLC acted as sole placement agent in connection with this offering.

The securities described above were being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-284443) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 28, 2025. Copies of the final prospectus relating to this offering have been filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745.

Conference on Q1 FY2025 (April 1, 2025 to June) Financial results

On July 31, 2025 Sumitomo Dainippon Pharma reported first quarter financial results.

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(Presentation, Sumitomo Dainippon Pharma, JUL 31, 2025, View Source [SID1234661682])