Melbourne, Australia; Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2017.

The cash balance as at 31 March 2017 was $29.7 million placing Starpharma in a strong cash position to continue with the commercialisation of its products across the VivaGel^®, DEP^® drug delivery and agrochemicals portfolios.

The March balance does not include the recently announced AstraZeneca milestone payment of US$2 million that is due to be received in the June quarter.

Recent operational highlights:

• AstraZeneca triggered a US$2 million (~AUD$2.7 million) milestone payment for their first oncology compound under Starpharma’s multiproduct DEP^® license following achievement of the final preclinical milestone prior to commencing clinical development.
• Completion of the pivotal phase 3 clinical trials evaluating VivaGel^® BV for the prevention of recurrent bacterial vaginosis (rBV); top-line results available in Q2 CY2017.
• US FDA granted QIDP designation and Fast Track status for VivaGel^® BV, each carrying significant benefits for regulatory approval and commercialisation.
• US marketing submission for VivaGel^® BV treatment well advanced with submission expected in the near future, with the rBV indication to follow.
• Advanced commercial negotiations for VivaGel^® BV in multiple regions, including Europe; Global/US commercial negotiations positively impacted by Fast Track, QIDP and the favourable revision to FDA’s guidance on BV.
• VivaGel^® condom now available in North America, following the Canadian launch by Ansell under the LifeStyles^® Dual Protect^™ brand; Starpharma will receive royalties based on sales.
• DEP^® docetaxel continues to show promising efficacy signals with no neutropenia or hair loss reported in the final expansion phase of its phase 1 clinical trial; patients with specific cancer types recruited at Guy’s and St Thomas’ Hospital, in London to accelerate trial completion, and facilitate rapid transition to phase 2.
• Key preparation such as product manufacture, site and CRO selection well advanced for the DEP^® docetaxel phase 2 trial.
• Expansion of Starpharma’s in-house DEP^® scale-up facilities and capabilities to accelerate the development of internal candidates (e.g. DEP^® cabazitaxel) and partnered DEP^® programs.
• Final preclinical DEP^® cabazitaxel activities including manufacture of clinical trial material underway ahead of planned Phase 1 trial in CY2017.
• Other DEP^® partnered programs, including with world-leading antibody drug conjugate companies, progressing extremely well.

The net operating cash outflows of $5.8 million for the quarter reflect the expenditure on the closing stages of phase 3 clinical trials for VivaGel^® rBV, the DEP^® docetaxel clinical programs, as well as DEP^® cabazitaxel, capital expenditure for in‑house scale up facility and other programs across Starpharma’s portfolio.

Commenting on the operational highlights, Dr Jackie Fairley, Chief Executive Officer of Starpharma said: “Starpharma has recently reported several important achievements including a further milestone triggered for AstraZeneca’s first DEP^® candidate, QIDP and Fast Track designations for VivaGel^® BV, as well as completion of the phase 3 VivaGel^® BV (rBV) trials. These are important and commercially relevant achievements for the company.”

Outlook

• Results from the pivotal VivaGel^® BV phase 3 trials (rBV).
• Aspen’s launch of VivaGel^® BV for treatment of bacterial vaginosis upon TGA approval.
• US marketing submission for VivaGel^® BV expected in the near future for the treatment, with the prevention of rBV indication to follow.
• Partnering deal(s) for VivaGel^® BV.
• Results from the phase 1 DEP^® docetaxel trial and initiation of phase 2.
• Commencement of DEP^® cabazitaxel phase 1 clinical trial.
• Further regulatory approvals and launch of VivaGel^® condom in other regions.
• Further Priostar^® licenses and other commercial deal structures for Priostar^® in Agrochemicals.

Download announcement: Appendix 4C - Quarterly Cashflow Report ( pdf file, 120kb)