Melbourne, Australia; 26 October 2017: 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.

Commenting on the Company’s recent highlights and outlook, Dr Jackie Fairley, Chief Executive Officer of Starpharma said: “This quarter has been an exceptionally positive period for the Company with successful clinical trial results reported in both of our VivaGel^® and DEP^® drug delivery portfolios. We’re proud to be one of very few Australian biotechs that has successfully taken a product – VivaGel^® BV – all the way from discovery to the end of phase 3, while retaining rights. We are also delighted with the positive impact these results have had on our licensing negotiations for this product.”

“Importantly, VivaGel^® BV, an Australian innovation, is expected to be available to Australian women suffering from BV in the New Year following the recent TGA approval.”

Commenting further Dr Fairley said: “The reported clinical trial data on our lead internal DEP^® candidate, DEP^® docetaxel, was also very encouraging with no reports of neutropenia and a lack of several other typical drug-related adverse events. Encouraging efficacy signals were observed in around half of the phase 1 trial patients, adding to the growing body of data which continues to validate the value of our DEP^® drug delivery platform. In addition, our partner AstraZeneca recently identified their first DEP candidate AZD0466 as a best-in-class cancer drug which is really exciting,” added Dr Fairley.

“We look forward to announcing further milestones in the coming months, including the NDA submission to the US FDA for VivaGel^® BV and commercial partnerships for the product; commencement of a phase 1 clinical trial for our next internal DEP^® candidate, DEP^® cabazitaxel; and further advancement of AstraZeneca DEP^® programs,” concluded Dr Fairley.

Further detail on Starpharma’s recent progress can be viewed in the October Shareholder Update: http://starpharma.com/news/344

Outlook

• Submission of the NDA for VivaGel^® BV to the US FDA
• Partnering deal(s) for VivaGel^® BV
• Commencement of DEP^® cabazitaxel phase 1 clinical trial
• Advancement of the AstraZeneca DEP^® programs, including AZD0466 to phase 1 and associated milestone payment
• Aspen’s launch of VivaGel^® BV for treatment of bacterial vaginosis in Australia
• Progress with DEP^® internal candidates, such as DEP^® irinotecan, and other partnered DEP^®  programs
• Further regulatory approvals and launch of VivaGel^® BV and VivaGel^® condom in other regions

Download announcement: Appendix 4C - Quarterly Cashflow Report ( pdf file, 232kb)