Melbourne, Australia; 28 October 2016: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2016.

The cash balance as at 30 September 2016 was $37.6 million, compared with a cash balance of $46.0 million at 30 June 2016. Starpharma’s strong cash position supports the continued development and commercialisation of its late-stage VivaGel^® portfolio, DEP™ drug delivery and agrochemical programs.

Highlights:

• 100% enrolment achieved in the pivotal phase 3 trials for VivaGel^® BV for the prevention of recurrent BV;
• Favourable revision to FDA guidance for BV treatment opening up a significant new commercial opportunity for VivaGel^® BV;
• Regulatory approval granted for marketing of the VivaGel^® condom in Canada;
• Signing of an exclusive license and supply agreement for the manufacture and sale of VivaGel^® condoms to the Government segment of the Chinese condom market;
• Signing and initiation of an important new DEP™ drug delivery program with AstraZeneca for a product in their portfolio, in addition to the existing multiproduct license;
• Initiation of a large UK site in the DEP™ docetaxel trial to accelerate trial completion, to enrich the patient cohort with specific cancer types, and to facilitate transition to phase 2;
• Signing of two new Targeted DEP™ partnerships with world leading antibody-drug conjugate companies; and
• Significant progress in commercial negotiations and launch preparations for VivaGel^® BV for the treatment and rapid relief of BV.

The larger than usual net operating cash outflows for this quarter includes a number of one-off milestone payments associated with advanced patient enrolment and completion, as well as clinical investigator payments and other trial costs, of the phase 3 clinical trials for VivaGel^® BV prevention of recurrence. Whilst the cost of running these pivotal clinical trials to support marketing approval increases the cash outflows above the Company’s traditional cash burn run-rate, the achievement of full patient enrolment is a commercially important milestone with trial completion expected in the first quarter of 2017.

The quarter also includes costs across Starpharma’s portfolio of programs, including the initiation of a large UK site to accelerate trial completion in the DEP™ docetaxel trial, the product manufacture of phase 2 DEP™ docetaxel clinical material, and expenditure associated with other internal DEP™ programs.

The 2017 financial year will be a transitional year for VivaGel^® BV - for both the prevention of recurrence and treatment products. Key upcoming milestones include the reporting of the phase 3 clinical results, additional licensing deals in a number of territories, further regulatory approvals and product launches, and leveraging the recent revised US FDA guidance for BV treatment products.

Also during the quarter, Starpharma announced a series of milestones for the VivaGel^® condom, including the signing of an exclusive license and supply agreement with Shenyang Sky and Land Latex Co. for the large Chinese Government market, and regulatory approval permitting Ansell to launch the VivaGel^® condom in Canada. Shenyang Sky and Land is a major provider of condoms to the Chinese Government, having an estimated total requirement of ~3 billion condoms per year. The deal opens up this new market opportunity for the VivaGel^® condom, alongside the existing Ansell and Okamoto licenses.

In the DEP™ drug delivery portfolio, Starpharma signed and initiated two new partnered programs for Targeted-DEP™ with two global leaders in the antibody-drug conjugate (ADC) market. Starpharma also further expanded its AstraZeneca partnership, with the initiation of a new DEP™ program applying the platform to a product from AstraZeneca’s portfolio. This new program is in addition to the current programs and outside the scope of the existing license signed in September 2015. Meanwhile, patient recruitment continues in the final phase of the DEP™ docetaxel clinical trial, with the recently added UK site now actively enrolling patients.

“The achievements and positive regulatory developments this quarter are important commercially and position the Company strongly for licence negotiations for VivaGel^® BV and further commercial exploitation of the DEP™ platform,” said Chief Executive Officer Dr Jackie Fairley.

“In the near term, we look forward to product launches of VivaGel^® BV, and the VivaGel^® condom in Canada and to advancing the market opportunities for these products and the DEP™ platform more broadly.”

“As we, and our partners, prepare for the launch of the VivaGel^® BV product for treatment and rapid relief of BV in coming months, Starpharma is well placed financially to advance the development and commercialisation of its diverse portfolio.” 

Download ASX Announcement: Appendix 4C - Quarterly Cashflow Report (pdf file, 296kb)