Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2018.

Starpharma’s cash balance as at 31 March 2018 was $54.1 million, with net operating and investing cash inflows for the quarter of $3.7 million, placing Starpharma in a strong cash position to commercialise its VivaGel^® products and accelerate the development of multiple DEP^® programs. The cash inflows for the quarter included the R&D tax incentive of $3.7 million and US$2.4 million received from the FDA after granting Starpharma a Small Business Waiver for its NDA fee.

Recent operational highlights include:

• VivaGel^® BV NDA completed, with FDA review being conducted under Fast Track status. The NDA submission for VivaGel^® BV for two indications, treatment and prevention of BV, has been completed and will be submitted to the FDA on Monday 30 April 2018, US time. Fast Track status for VivaGel^® BV provides for priority regulatory review by the FDA, which is expected to take approximately 6-8 months.
• Licensing negotiations for commercial rights to VivaGel^® BV are well-advanced across multiple regions, including the US. Licences are currently under negotiation with parties for all regions, including major global and regional companies as well as companies specialising in women's health. Starpharma expects to make announcements in relation to licence rights to VivaGel^® BV in the near future.
• Fleurstat BV gel Australian launch preparations proceeding smoothly with final marketing preparations and manufacturing activities underway. Starpharma is undertaking product manufacture and product labelling via its qualified vendors. Key launch activities, including distribution preparations, marketing and promotion preparations are well-advanced by Starpharma’s partner, Aspen Pharmacare.
• Phase 2 DEP^® docetaxel trial is enrolling patients at Guy’s Hospital London and two further UK sites have been initiated – Freeman Hospital Newcastle upon Tyne and University College London Hospital. Several patients have received multiple cycles of DEP^® docetaxel in the phase 2 study, and a number of patients have also been dosed in the combination phase of the study.
• Phase 1/2 DEP^® cabazitaxel trial has commenced following regulatory and ethics approvals, and multiple sites initiated. Guy’s Hospital London and University College London Hospital have been initiated for participation in this study with recruitment underway. The key objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP^® cabazitaxel, to define a recommended phase 2 dose and to explore anti-tumour efficacy of the product.
• The collaboration between AstraZeneca and Starpharma, which comprises several DEP^® candidates under a multiproduct licence and an additional DEP^® program, continue to progress smoothly. The use of Starpharma’s in-house DEP^® scale-up facilities has enabled partnered DEP^® programs to be rapidly advanced with materials manufactured for both internal and partnered DEP^® programs.
• Preclinical work on several internal DEP^® products including DEP^® irinotecan continues to progress well with a view to Starpharma advancing further DEP^® candidates to the clinic.

Commenting on the Company’s recent highlights and outlook, Dr Jackie Fairley, CEO of Starpharma said: “We are delighted to have completed the submission of our US NDA for VivaGel^® BV, and we anticipate the FDA will finalise its review by the end of the year. The NDA has been an extensive undertaking, with more than 110,000 pages of data and reports submitted. At the same time, we’ve been very focussed on licensing negotiations for VivaGel^® BV and we are currently finalising a number of deals and look forward to making announcements in the near future.”

Commenting further, Dr Fairley said: “It’s also an exciting time for our DEP^® portfolio. During the quarter we initiated several new sites for our DEP^® docetaxel phase 2 trial and the DEP^® cabazitaxel phase 1/2 trial. We’ve continued to strengthen ties with our partners, including AstraZeneca, and we were delighted to have recently hosted several guests from AstraZeneca, including Global CEO, Dr. Pascal Soriot. We look forward to our first partnered DEP^® program entering the clinic - AstraZeneca’s AZD0466, and to building on this already strong corporate relationship,” concluded Dr Fairley.

Outlook

• Aspen’s launch of VivaGel^® BV as Fleurstat  BV gel in Australia
• Execution of multiple licences for VivaGel^® BV (multiple territories/licences)
• FDA approval of NDA for VivaGel^® BV
• Further regulatory approvals and launch of VivaGel^® BV in other regions
• Advancement of the AstraZeneca DEP^® programs, including AZD0466 and associated milestone payments
• Progress with the phase 2 DEP^® docetaxel clinical trial and phase 1/2 DEP^® cabazitaxel clinical trial, and further site(s) commencing recruitment
• Progress with other DEP^® internal candidates, including DEP^® irinotecan, and other partnered DEP^® programs
• Other partnered DEP^® deals anticipated
• Further regulatory approvals and launch of the VivaGel^® condom in other regions

Download ASX Announcement: Quarterly Cashflow Report (pdf, 240kb)