Appendix 4C - Quarterly Cashflow Report
31 January 2017
Melbourne, Australia; Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2016.
The cash balance as at 31 December 2016 was $36.3 million, compared with a cash balance of $37.6 million at 30 September 2016 placing Starpharma in a strong cash position with a number of important milestones upcoming in 2017.
- VivaGel® BV granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US FDA for both treatment of bacterial vaginosis (BV) and prevention of recurrent BV;
- Progress with compiling a US marketing application for submission to the FDA for treatment of BV, with the prevention indication to follow;
- Enrolment completed for the pivotal phase 3 trials for VivaGel® BV for the prevention of recurrent BV; Trial completion expected Q1 CY2017, with top line results expected Q2 CY2017;
- Advanced commercial negotiations for VivaGel® BV in Europe and other territories; US negotiations accelerated by recent FDA designations;
- Preparations underway for Ansell’s imminent launch of the VivaGel® condom in Canada;
- DEP® docetaxel phase 1 clinical trial progressing well in the final expansion phase including enrolment of several new patients at Guy’s and St Thomas’ Hospital, London with specific tumour types of interest;
- Preparations for phase 2 trials for DEP® docetaxel continue to advance with product manufacture complete; site and CRO selection well advanced;
- Partnered DEP® programs continue to perform extremely well, including the most recent AstraZeneca program and Targeted DEP® partnerships;
- DEP® cabazitaxel preclinical program now in its final stages ahead of the planned phase 1 clinical trial in CY2017;
- DEP® irinotecan showed near complete tumour regression in multiple human tumour models; preclinical results reproduced in two different cell lines of human colon cancer;
- Expand in-house DEP® scale-up facilities to facilitate rapid development of internal candidates and expedite partnered programs;
- Signed a license and supply agreement for a VivaGel® condom with one of Iran’s fastest growing pharmaceutical companies, Koushan Pharmed;
- Additional positive Priostar® glyphosate field-trial results and a further patent allowed in the US; and
- Receipt of $3.5M from R&D tax incentive refund.
The net operating cash outflows of $1.9 million for the quarter reflect the expenditure on the final stages of phase 3 clinical trials for VivaGel® BV, the DEP® docetaxel clinical trial program and other programs across Starpharma’s portfolio, offset by the receipt of the R&D tax incentive related to expenditure from the prior financial year.
“We anticipate a significant year in 2017 with numerous milestones to be reported as we approach the conclusion of our VivaGel® BV phase 3 trials, complete the DEP® docetaxel phase 1, gear up for phase 2 DEP® docetaxel and the phase 1 DEP® cabazitaxel program, in parallel with the development of our other internal and partnered DEP® programs” said Dr Jackie Fairley, Chief Executive Officer of Starpharma.
“The recent QIDP and Fast Track designations for VivaGel® BV, coupled with favourable changes to the FDA’s guidance on BV treatment, open up a significant new market opportunity for Starpharma. We look forward to the upcoming launch of our VivaGel® BV treatment product in Australia, while we continue to negotiate deals abroad and progress regulatory filings in other territories.”
“Our partnered and internal programs continue to validate the reproducible benefits of the DEP® platform including reduced toxicities, formulation enhancement and improved efficacy. The response to our DEP® platform and VivaGel® BV portfolio from existing and potential new partners has been extremely positive, with successful meetings held throughout the US and Europe following the recent JP Morgan Conference,” Dr Fairley concluded.
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