On February 26, 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 Interim Report and Half-Year Financial Results for the period ended 31 December 2024 (H1 FY25) (Press release, Starpharma, FEB 26, 2025, View Source;mc_eid=bf52dd3418 [SID1234650550]).
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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."