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.