Starpharma Reports $20.3M Cash, FDA Fast Track Potential for DEP® SN38

Strategic Progress and Regulatory Milestones

Starpharma (ASX: SPL) has delivered a robust quarterly update, underscoring significant strides in its clinical and commercial programs. Central to the report is the positive feedback from the US Food and Drug Administration (FDA) regarding the clinical development pathway for DEP® SN38, a dendrimer-enhanced irinotecan candidate targeting platinum-resistant ovarian cancer (PROC). The FDA's recognition of PROC as a serious unmet medical need and agreement on the suitability of the 505(b)(2) regulatory pathway could streamline Starpharma's approval process, potentially accelerating patient access.

The FDA also indicated that DEP® SN38 may qualify for Fast Track designation and accelerated approval based on interim Phase 2/3 trial data, a development that could significantly enhance the asset's commercial appeal and speed to market. This regulatory clarity bolsters Starpharma’s confidence in advancing its Investigational New Drug (IND) application and strengthens its position for partnership discussions.

Expanding Commercial Footprint in the Middle East

On the commercial front, Starpharma is poised to launch VivaGel® BV in Saudi Arabia and the United Arab Emirates during the upcoming quarter, leveraging its partnership with ITROM. This expansion into key Middle Eastern markets aligns with the company’s broader strategy to grow revenue streams from its existing product portfolio. Complementing this, Starpharma’s digital marketing initiatives have yielded a 30% increase in online sales of Viraleze™, reflecting effective brand positioning and enhanced customer engagement.

Advancing Radiopharmaceuticals and Collaborations

Beyond DEP® SN38, Starpharma continues to advance its DEP® radiopharmaceuticals program, targeting HER2-positive cancers with promising preclinical results. The company is optimizing pharmacokinetic and biodistribution profiles to develop competitive radiodiagnostic and radiotherapeutic products. Strategic collaborations remain a focus, with ongoing partnerships and active engagement with potential global collaborators to leverage the unique dendrimer platform.

Notably, Starpharma has concluded its partnership with AstraZeneca after a period of inactivity, signaling a strategic pivot to pursue more active collaborations that align with its development priorities.

Financial Position and Outlook

Starpharma closed the quarter with a healthy cash balance of $20.3 million, providing a runway of approximately 6.7 quarters at current operating cash outflows. Operating expenses included $1.2 million in R&D and $2.5 million in staffing costs, reflecting ongoing investment in innovation and talent. The company’s financial discipline and strategic focus position it well to capitalize on upcoming regulatory milestones and commercial opportunities throughout 2025.

CEO Cheryl Maley highlighted the versatility of Starpharma’s dendrimer technology and the multiple avenues for commercialisation, emphasizing the company’s readiness to convert scientific progress into shareholder value.