Appendix 4C - Quarterly Cashflow Report

28 April 2017

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)


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