Feb 26, 2018
Starpharma Interim Report and Half-Year Financial Results
Melbourne, Australia; 26 February 2018: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2017.
- Reported loss of $6.2M (Dec 2016: $9.0M); and
- Cash position at 31 December 2017 of $49.9M (June 2017: $61.2M) and excludes the $3.7M FY17 R&D tax incentive and US$2.4M FDA refunds subsequently received.
- VivaGel® BV phase 3 trials achieved their primary objective for VivaGel® BV, demonstrating statistically significant superiority compared to placebo in preventing recurrent bacterial vaginosis (rBV);
- VivaGel® BV NDA lodged with the US FDA under the Fast Track program, via a rolling submission;
- VivaGel® BV granted TGA marketing approval in Australia with preparations for the launch of FleurstatTM underway; and
- Significant progress in global/regional licensing negotiations for VivaGel® BV.
DEP® Drug Delivery
- DEP® docetaxel phase 1 trial successfully completed - achieving the key objective of determining a Recommended Phase 2 Dose, with no reports of protocol-defined dose limiting toxicities. No neutropenia was observed and encouraging signs of efficacy were observed in around half the patients dosed with DEP® docetaxel for multiple tumor types;
- DEP® docetaxel phase 2 trial commenced and is recruiting in major UK hospitals including Guy’s Hospital in London, and University College London Hospital Cancer Clinical Trials Unit. Two additional sites are to be added shortly;
- AstraZeneca presented its first DEP® candidate, AZD0466, a highly optimised dendrimer formulation of a novel dual Bcl2/xL inhibitor;
- DEP® cabazitaxel phase 1/2 trial commenced having achieved successful regulatory and ethics approval with two UK sites already activated for recruitment; additional sites to follow in the expansion phase;
- Significant progress on other partnered DEP® programs, including AstraZeneca’s and Targeted DEP®;
- Further preclinical studies and internal scale-up of DEP® irinotecan undertaken to expedite the path to the clinic; and
- Two DEP® research grants were awarded to Starpharma to collaborate in separate programs with Monash Institute of Pharmaceutical Sciences and the Peter MacCallum Cancer Centre.
Starpharma concluded the half-year in a strong financial position with a cash balance of $49.9 million, which does not include the $3.7M FY17 R&D tax incentive and US$2.4M FDA refund received after 31 December 2017. The net loss after tax for the half-year of $6.2 million (Dec 2016: $9.0 million) reflects investment across the VivaGel® and DEP® portfolio, including DEP® docetaxel, DEP® cabazitaxel, and DEP® irinotecan. Research expenditure for the half-year is lower than the prior corresponding period due to the completion of the VivaGel® BV phase 3 trials.
Starpharma’s CEO, Dr Jackie Fairley, commented: “We are extremely pleased with the exciting milestones accomplished during the half-year, most notably, the successful trial results within our VivaGel® and DEP® portfolios and major progress with licence negotiations and our regulatory programs in multiple regions”.
“With TGA approval now in hand for VivaGel® BV, pharmacists will soon be selling our product in Australia, and overseas we’re very close to submitting the final part of our NDA for VivaGel® BV approval in the US”, added Dr Fairley.
Commenting on the DEP® drug delivery portfolio, Dr Fairley said: “It’s been particularly gratifying to have a set of clinical results validate the benefits of our DEP® drug delivery platform, which we’d consistently seen across multiple preclinical studies. In 2018, we’ll continue to add significant value to our DEP® pipeline with clinical trials already underway for two in-house products - DEP® docetaxel and DEP® cabazitaxel - and one of our partnered DEP® products, AstraZeneca’s AZD0466, due to enter the clinic”.
Dr Fairley concluded: “Starpharma has been attracting considerable attention from investors and partners around the world, and we expect this momentum to build as more companies understand the benefits of our dendrimer platform technology and recognise the value of Starpharma’s near-term catalysts. Regulatory approvals, licensing deals, DEP® clinical trials, and the product launch for VivaGel® BV in Australia and elsewhere, are amongst the many milestones we are expecting over the next 12 months”.
Download full announcement: Starpharma Interim Report and Half-Year Financial Results (pdf 468kb)