Key Financial Results

• Half-year revenues were $2.4 million, including research revenue from Petalion Therapeutics and revenue from Viraleze™ and VivaGel® BV product sales.
• The underlying operating loss was $5.4 million, a 29% improvement on the prior corresponding period (pcp).
• Research and development expenses were $4.3 million, decreasing by $0.9 million from the pcp due to the completion of DEP® clinical programs in FY24.
• Closing cash position at 31 December 2024 was $20.3 million.

Operational Highlights

• Key regulatory milestone for DEP® SN38 with positive feedback from the FDA on the clinical pathway to commercialisation in the US, confirming that the 505(b)(2) regulatory approval pathway is appropriate for DEP® SN38 and the potential for Fast Track designation and accelerated approval.
• Continued progress in ongoing DEP® partnerships and expansion of the chemistry team to support these collaborations.
• Asset optimisation and active engagement with potential collaborators for the DEP® radiopharmaceuticals program.

Melbourne, Australia; 26 February 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, today releases its Interim Report and Half-Year Financial Results for the period ended 31 December 2024 (H1 FY25).

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

"In the first half of FY25, Starpharma has made good progress in executing our strategy, aimed at maximising the value of our DEP® assets, accelerating early asset development, and building long-term sustainability. I know our internal progress may not always be evident externally, but I can vouch for the dedication and hard work of everyone at Starpharma as we work towards achieving our strategic objectives.

“We have made important progress in advancing our DEP® clinical assets, particularly DEP® SN38, which has shown promising clinical outcomes in patients with high unmet need. A key regulatory milestone during the period was the recent meeting with the US Food and Drug Administration (FDA) regarding DEP® SN38. The FDA provided feedback on the path to market for DEP® SN38, confirming that the 505(b)(2) regulatory approval pathway is appropriate for DEP® SN38 and the potential for Fast Track designation and accelerated approval. The positive response from the US regulator increases our confidence in the potential of DEP® SN38 for treating platinum-resistant ovarian cancer. During the six months to December, our partner engagement through ongoing meetings and conference participation highlighted the importance of FDA feedback to potential partners for the commercialisation of DEP® SN38.

“We are advancing our early-stage DEP® programs, particularly in the area of radiopharmaceuticals, with the aim of initiating a first-in-patient clinical trial this calendar year. We are also expanding our research pipeline, positioning us well for future collaborations and long-term growth. Commercially, we anticipate the launch of VivaGel® BV in key markets in the Middle East and continue to support sales of Viraleze™ online through digital marketing initiatives, which have resulted in a ~30% increase in revenue from the e-commerce channels compared to the prior corresponding period.

“We have focused on building a sustainable organisation and have sufficient capital to support our medium-term objectives, with a cash balance of $20.3 million as at 31 December 2024. The completion of multiple clinical programs in FY24 has led to a reduction in our research and development expenses, extending our cash runway. Over the past 12 to 18 months, we have implemented a number of cost-saving initiatives that are positively impacting our cash balance. Notably, our Corporate and Administration costs in this half-year period have decreased by $0.5 million compared to the prior corresponding period.

“Starpharma is committed to driving revenue growth, advancing our pipeline, and managing costs effectively to deliver improved and long-term value for our shareholders. We are focused on prioritising resources for our high-impact DEP® programs, pursuing partnerships to advance our assets toward commercialisation, and increasing revenue through collaborations, licensing and product sales.”

View/download the ASX Announcement: Appendix 4D and Half Year Report 2025