Quarterly Cashflow report

26 October 2017

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2017.

The cash balance as at 30 September 2017 was $56.9 million, with net operating and investing cash outflows for the quarter of $4.3 million. Combined with achieving a number of very positive milestones during the quarter, Starpharma’s strong cash balance places it in an excellent position to commercialise its VivaGel® products and accelerate the development of multiple DEP® drug delivery programs.

Recent operational highlights include:

  • Successful VivaGel® BV phase 3 trials achieved their primary objective for VivaGel® BV, demonstrating statistically significant superiority compared to placebo in preventing recurrent bacterial vaginosis (rBV).
  • VivaGel® BV results strongly support a FDA New Drug Application (NDA). The NDA preparation is well-advanced for both indications – BV treatment and prevention of rBV. Starpharma will soon commence submission of the NDA (which runs to more than 45,000 pages) leveraging its QIDP designation and Fast Track status to speed up the regulatory process and secure early market access.
  • DEP® docetaxel successfully completed phase 1 trial and achieved the key objective of determining a Recommended Phase 2 Dose (RP2D), with no reports of protocol-defined dose limiting toxicities. No neutropenia was observed and no reports of several other common adverse events.
  • AstraZeneca presented its first DEP® candidate, AZD0466, a highly optimised dendrimer formulation of a novel dual Bcl2/xL inhibitor, which has the potential to be a best-in-class cancer drug with a broad combination opportunity in solid and haematological tumours.
  • DEP® docetaxel phase 2 trial commenced, with recruitment and patient screening activities underway. The phase 2 study is an open-label, two-stage design, with the objective of establishing anti-tumour activity (efficacy) and safety of DEP®docetaxel at the RP2D.
  • VivaGel® BV granted marketing approval in Australia from the TGA for treatment of BV. Launch plans are well advanced with Aspen Pharmacare Australia and the product is expected to be available over-the-counter in pharmacies in the New Year. The product will be marketed as Fleurstat™ BV gel, and will carry the VivaGel® brand. 
  • DEP® research grants were awarded to Starpharma to collaborate in separate programs with Monash Institute of Pharmaceutical Sciences and the Peter MacCallum Cancer Centre.

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© Starpharma Holdings Limited 2017