On February 16, 2016 Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) reported its interim report and financial results for the half-year ended 31 December 2015 (Press release, Starpharma, FEB 17, 2016, View Source [SID:1234509077]).
Financial Summary
Reported loss of $10.0M (Dec 2014: $8.5M)
Revenue of $3.7M (Dec 2014: $0.7M)
R&D tax incentives of $1.8M reported in the half-year (Dec 2014: $1.6M)
Cash position at 31 December 2015 of $54.7M (June 2015: $30.8M)
Cash inflows of $7.2M from partners and grants, includes US$2.0M from AstraZeneca and $3.4M R&D tax incentive refund
Proceeds from completion of $32.0M equity placement
Operational Highlights
Signing of a multiproduct drug delivery license with AstraZeneca with potential milestones payments of up to US$126M, plus royalties;
AstraZeneca selected second DEP candidate under the drug delivery license;
EU marketing approval granted for VivaGel BV treatment and the rapid relief of BV including symptoms;
Signing of Memorandum of Understanding to manufacture and sell the VivaGel condom in the Chinese Government sector;
Targeted DEP outperforms leading treatments in ovarian cancer model; and
Additional US patent granted for VivaGel BV with 7 year extension of term.
Starpharma concluded the half-year in a strong financial position with a cash balance of $54.7 million following the $32 million equity placement in the period, with a further $1.9 million received after the period from the closing of a share purchase plan. Cash receipts in the half-year totalled $7.2 million with $3.8 million received from partners, including AstraZeneca, and a further $3.4 million from R&D tax incentives.
The signing of the AstraZeneca DEP drug delivery licence agreement was a major highlight in the period triggering the receipt of the first US$2 million milestone under the multiproduct deal. Under the license, AstraZeneca has selected an oncology compound as the initial DEP candidate which provides for potential development, launch and sales milestones payable to Starpharma of up to US$126 million, plus royalties on net sales. In November AstraZeneca also nominated a second candidate for development, with potential milestones of up to US$93 million, plus royalties.
The net loss after tax for the half-year of $10.0 million reflects investment across the Company’s VivaGel, drug delivery and agrochemical portfolios, including the conduct of two clinical programs in parallel – the VivaGel Phase 3 clinical trials for the prevention of recurrent bacterial vaginosis and the Phase 1 DEPTM docetaxel trial.
The double-blinded, placebo controlled Phase 3 trials of VivaGel for prevention of recurrent bacterial vaginosis are actively enrolling participants across sites in the US, Canada, Mexico, Europe and Asia. Each trial will enrol around 600 women, with more than 75% of total participants enrolled to-date.
The Phase 1 clinical trial of DEP docetaxel in cancer patients, at four Australian sites continues to show very encouraging clinical data with more than 75% of patients having been recruited and administered multiple cycles of treatment. DEP docetaxel has been dosed at levels at and above the most commonly used dose for Taxotere (75mg/m2), with no bone marrow toxicities (including neutropenia) or hair loss reported. Patients treated with DEP docetaxel have also not required anti-nausea or cortisone pre-treatment.
Commenting on the Company’s achievements and outlook, Starpharma CEO Dr Jackie Fairley said:
"During the half year, we achieved several important milestones across our VivaGel, drug delivery and agrochemicals programs, and Starpharma is very well placed financially to build upon these developments in 2016. Within the VivaGel portfolio, the granting of EU marketing approval of VivaGel BV treatment for the rapid relief of bacterial vaginosis and its symptoms, and the signing of a Memorandum of Understanding for the VivaGel condom in the Chinese government sector were important regulatory and commercialisation achievements in the half-year. These achievements, combined with ongoing commercial and regulatory progress and the rollout of the VivaGel condom with existing partners in additional geographies, strengthens VivaGel’s commercial product opportunities.
"In addition to the signing of the AstraZeneca deal and the progress in the DEPTM docetaxel clinical programs, substantial progress has also been made in drug delivery, in both internal and partnered programs. Starpharma has built on its DEP pipeline of potential internal clinical candidates, with compelling pre-clinical results achieved in both DEP carbazitaxel and its novel Targeted DEPTM program, where complete tumour regression and 100% survival was achieved in an ovarian cancer model, significantly outperforming Roche’s currently marketed antibody-drug conjugate, Kadcyla."
"Finally, Starpharma’s agrochemical partnerships have been extended and expanded in scope with existing and new agrochemical companies for the development of Priostar dendrimer-improved crop protection formulations for the European, Asian and North American markets."
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