Starpharma Holdings (ASX:SPL) has delivered a year of strategic focus and scientific progress, sharpening its efforts to extract long-term value from its proprietary dendrimer technology platform while strengthening its commercial foundations across oncology, women’s health and antiviral products.
At the heart of the company’s activities is its DEP (Dendrimer Enhanced Product) platform, designed to address some of the most challenging issues in drug delivery by enhancing solubility, biodistribution, and tolerability.
More than 350 patients have already been treated with DEP products in clinical trials, validating both the platform’s versatility and its scalability. One of the highlights of the past year was the positive feedback received from the US FDA for DEP SN38, which is being developed for platinum-resistant ovarian cancer.
Starpharma said the agency indicated the program could be eligible for Fast Track designation and potentially accelerated approval, recognising the significant unmet need for more effective treatments.
In August, results from DEP SN38’s clinical program were published in the Journal of Clinical Oncology, reinforcing the credibility of the company’s data and further strengthening the commercial case for out-licensing.
Alongside SN38, the company continued to progress DEP cabazitaxel, with both assets central to ongoing discussions with potential partners. While the company acknowledged that the licensing process has taken longer than anticipated, reflecting a shift in oncology development priorities toward targeted therapies, as well as broader financial market conditions, Starpharma has reported continuing interest from a wide range of pharmaceutical companies. Management remains confident that the quality of its clinical data and regulatory pathway will deliver value through future partnerships.
The company also invested significantly in its radiotheranostics program, particularly HER2-targeted candidates, where extensive preclinical work has positioned Starpharma to initiate a first-in-human study in 2026.
While late-stage programs remain the flagship of the business, Starpharma has also pushed ahead with early-stage innovation. Its 'Star Navigator' initiative, launched in June 2025, is designed to streamline collaborations by providing partners with access to the DEP platform for research and development. Early projects are already underway with two new collaborators, showcasing the breadth of potential therapeutic applications. The company also continued to progress joint ventures and alliances, including with Petalion Therapeutics, which has delivered strong synergies in its first year. Collaborations with Genentech and MSD remain ongoing, while the long-standing AstraZeneca partnership formally concluded in 2024, allowing resources to shift to more active opportunities.
Commercial products are playing an increasingly important role in Starpharma’s business model. VivaGel BV, a novel non-antibiotic treatment for bacterial vaginosis, is now registered in over 40 countries. In the past year, it was launched in Saudi Arabia and the UAE through ITROM Pharmaceutical, and a new licensing deal was signed with Synmosa Biopharma to cover the Philippines, Malaysia and Singapore. Aspen continues to market the product successfully in Australia under the Fleurstat brand. Viraleze, a broad-spectrum antiviral nasal spray, is registered in 35 jurisdictions and grew online sales by 40 per cent in the financial year 2025, supported by new digital campaigns and a London Underground billboard campaign. Preparations are also underway for its launch in Saudi Arabia later in 2025 with distribution partner Etqan and Nazahah.
For the year ended 30 June 2025, Starpharma reported revenue and other income of $5.9 million, down from $9.8 million in the prior year, which had included a one-off settlement payment of $6.6 million. The net loss after tax was $10 million, compared with an $8.2 million loss in 2024. Research and development expenditure totalled $8.4 million, focused on advancing DEP radiotheranostics and other pipeline programs. Cash reserves at year-end stood at $15.4 million, down from $23.4 million twelve months earlier, with net operating cash outflows of $ 8.0 million.
Chairman Rob Thomas said the company had remained disciplined in directing resources to the areas of most significant impact, guided by three principles: maximising DEP asset value, accelerating early-stage development and building long-term sustainability. Chief executive officer Cheryl Maley described the past year as one of recalibration and renewed focus, emphasising that deliberate decisions to concentrate on the most critical opportunities have created a more resilient organisation.
Starpharma also continued to strengthen its governance and culture, highlighting its third consecutive year of Great Place to Work certification alongside broader initiatives in environmental stewardship and workplace inclusion.
“Our mission remains to deliver better outcomes for patients through our unique dendrimer technology,” Maley said. “The progress made in FY25 gives us confidence in our ability to create enduring value for both patients and shareholders.”