Interim Report and Half-Yearly Financial Results
27 February 2017
Melbourne, Australia; 27 February 2017: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2016.
- Reported loss of $9.0M (Dec 2015: $10.0M)
- R&D tax incentives of $1.7M reported in the half-year (Dec 2015: $1.8M)
- Cash position at 31 December 2016 of $36.3M (June 2016: $46.0M)
- Receipt of $3.5M R&D tax incentive refund from FY16
- VivaGel® BV granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for both treatment of Bacterial Vaginosis (BV) and prevention of recurrent BV by US FDA;
- Favourable revision to FDA regulatory guidance for BV treatment opens up significant new commercial opportunities for VivaGel® BV;
- Enrolment completed for pivotal phase 3 trials: VivaGel® BV - prevention of recurrent BV;
- Significant progress in commercial negotiations and launch preparations for VivaGel® BV for the treatment and rapid relief of BV;
- Progress with compiling a US marketing application for submission to the FDA for treatment of BV, with the prevention indication to follow;
- License and supply agreements for the VivaGel® condom in China and Iran; and
- Canadian regulatory approval for marketing of the VivaGel® condom, enabling Ansell to launch in early 2017.
DEP® Drug Delivery
- AstraZeneca initiated a new (additional) DEP® drug delivery program with DEP® performing extremely well across the multiple programs underway;
- Two new Targeted DEP® partnerships with world-leading antibody-drug conjugate companies producing promising data;
- DEP® docetaxel phase 1 clinical trial in its final expansion phase continues to show promising efficacy signals with no neutropenia or hair loss reported;
- Guy’s and St Thomas’ Hospital in London added to the DEP® docetaxel trial to accelerate trial completion, to enrich the patient cohort with specific cancer types, and facilitate rapid transition to phase 2;
- Preparations well advanced for DEP® docetaxel phase 2 trial including product manufacture, site and CRO selection;
- Reproduced excellent preclinical results for DEP® cabazitaxel with planned phase 1 clinical trial in CY2017;
- DEP® irinotecan showed near complete tumour regression in multiple human colon cancer mouse xenograft models; and
- An expansion of in-house DEP® scale-up facilities to facilitate rapid development of internal candidates and expedite partnered programs.
- New partnerships with leading agrochemical companies;
- Additional positive Priostar® glyphosate field-trial results; and
- US patent granted for a Priostar® glyphosate formulation.
Starpharma concluded the half-year in a strong financial position with a cash balance of $36.3 million. The net loss after tax for the half-year of $9.0 million (Dec 2015: $10.0 million) reflects investment across the VivaGel®, DEP® drug delivery and agrochemical portfolios, including the conduct of two separate clinical programs – the VivaGel® BV phase 3 clinical trials for the prevention of recurrent BV and the phase 1 DEP® docetaxel trial. Revenue for the half-year is lower than the prior corresponding period (pcp), with the AstraZeneca upfront license milestone occurring in the pcp.
Commenting on the half-year’s highlights and outlook, Starpharma CEO, Dr Jackie Fairley, said: “We are particularly pleased with the important commercial, regulatory and clinical milestones achieved in the half-year. It was most gratifying to be granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for both indications for VivaGel® BV by the FDA and to have achieved 100% enrolment in the phase 3 program for the prevention of recurrent BV. During this time, we are focussed on preparing our US FDA marketing application - in the first instance for treatment, and subsequently for the prevention indication and are pleased our application will be expedited and given priority review, a benefit of the QIDP status granted earlier this year.”
“In drug delivery, we entered into several new DEP® partnerships, including with two world-leading antibody-drug conjugate companies and also a new and important program with AstraZeneca. Our DEP® platform continues to spark intense interest from global partners, based on the outstanding safety and efficacy benefits being reproduced in our internal and external programs. In the condom category, we announced deals for the large Chinese and Iranian markets. Meanwhile, Ansell is planning to launch the VivaGel® condom in Canada in the very near future following regulatory approval late last year.”
“We expect the positive momentum from the half-year to keep building with catalysts throughout 2017, namely: the VivaGel® BV trial results, planned NDA filing for VivaGel® BV, commencement of a phase 2 DEP® docetaxel program, and further commercial deals and corporate developments to be announced across Starpharma’s portfolio,” said Dr Fairley.
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