Melbourne, Australia; 14 July 2016: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2016.

The cash balance as at 30 June 2016 was $46.0 million, with operating and investing cash outflows for the full year of $17.8 million. The cash outflows for the year include expenditure related to the phase 3 clinical trials of VivaGel^® for prevention of recurrent bacterial vaginosis (BV) and the phase 1 clinical trial of DEP™ docetaxel, as well as the wider drug delivery and agrochemical programs.

Highlights for the quarter include:

• Achieving more than 90% recruitment in the phase 3 clinical trials of VivaGel^® for prevention of recurrent BV;
• DEP™ docetaxel phase 1 clinical trial advancing to the final expansion phase with no neutropenia or hair loss reported, whilst showing promising efficacy signals;
• Significant progression of commercial and regulatory activities for the VivaGel^® condom in important markets;
• Extensive launch preparations and progress on commercial negotiations for VivaGel^® BV;
• Expansion of the AstraZeneca DEP™  partnered program to evaluate new therapeutic applications outside the existing license agreement;
• Demonstration of potent antiviral activity of the VivaGel^® active against the Zika virus in laboratory studies; and
• Demonstration of significantly improved efficacy and elimination of neutropenia with DEP™ cabazitaxel compared to Jevtana^® (standard cabazitaxel) in preclinical studies.

The phase 3 clinical trials of VivaGel^® for the prevention of recurrent BV are nearing the important milestone of full enrolment, with over 90% of required patients now recruited.

The DEP™ docetaxel phase 1 clinical trial is advancing into the final expansion phase with a large European site recently added to facilitate completion of phase 1 and in preparation for phase 2. Importantly, no cases of neutropenia or alopecia (hair loss) have been reported to date, and due to the formulation being polysorbate-80 free, patients have not required steroid pre-treatment or experienced any hypersensitivity reactions. There have been promising efficacy signals at a broad range of dose levels, including at levels lower than the usual Taxotere^® clinical doses, in patients that have undergone many prior treatments, including with taxanes, and in a number of cancer types that are typically not sensitive to docetaxel, such as pancreatic, brain, and oesophageal cancers.

Significant progress has been made on the regulatory and commercialisation activities for the VivaGel^® portfolio of products, both for VivaGel^® BV for the topical treatment and rapid relief of BV and the VivaGel^® condom. Starpharma looks forward to concluding some of these activities in the near future.

With the demonstration of potent antiviral activity against the Zika virus, Starpharma is now investigating the potential to include Zika in the list of viruses inactivated for the VivaGel^® condoms – further improving the value-add of the product opportunity.

Further highlights in the quarter occurred in the drug delivery portfolio, where the partnered program with AstraZeneca is progressing well and now expanding to include additional DEP™ programs beyond the existing multi-product license agreement signed in September 2015. In addition, very promising preclinical results were achieved for Starpharma’s internal development candidate, DEP™ cabazitaxel.

“There has been significant progress across the portfolio in the recent quarter, and we look forward to announcing some of these in the near future. The clinical, regulatory and commercial progress in the quarter has been extensive, positioning the Company well to execute on the global commercialisation strategy for VivaGel^®. Meanwhile, we continue to advance the core drug delivery and agrochemicals development programs, with significant progress and generation of encouraging data. The strong cash balance means Starpharma is well positioned to support the development and commercialisation of our deep and broad portfolio,” said Dr Jackie Fairley, Chief Executive Officer of Starpharma.

Download ASX Announcement: Appendix 4C - Quarterly Cashflow Report (pdf file, 123kb)