Melbourne, Australia; 17 February 2016: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2015.
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.”
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a world leader in the development of dendrimer products for pharmaceutical, life science and other applications.
Starpharma’s underlying technology is built around dendrimers – a type of synthetic nanoscale polymer that is highly regular in size and structure and well suited to pharmaceutical and medical uses. Starpharma has three core development programs: VivaGel® portfolio, DEP™ drug delivery, and agrochemicals with the Company developing a number of products internally and others via commercial partnerships.
Starpharma’s lead products are based on VivaGel® (SPL7013, astodrimer sodium), a proprietary dendrimer which has antimicrobial properties. VivaGel® formulated as a water based gel and delivered vaginally now has EU regulatory approval for topical treatment and rapid relief of bacterial vaginosis (BV) and is under clinical development for the prevention of recurrent BV. Starpharma has also signed separate licence agreements with Ansell Limited (ASX:ANN) and Okamoto Industries. Inc., (TSE: JP3192800005) to market a value-added, VivaGel® condom. The VivaGel® condom is available for purchase in Australia under Ansell’s Lifestyles® Dual ProtectTM brand. Ansell manufactures and sells leading condom brands worldwide, including LifeStyles®, ZERO® and SKYN®. Okamoto is the market leader for condoms sold in Japan, which is the world’s second largest condom market.
In the wider pharmaceutical field, Starpharma has both partnered and internal programs in Drug Delivery. A number of dendrimer-enhanced, or DEP® versions of existing drugs are under development. The most advanced of these is DEP® docetaxel, a dendrimer-enhanced version of docetaxel (Taxotere®), which is in clinical development in patients with solid tumours. In preclinical studies DEP® docetaxel has shown significant tumour-targeting and superior anti-cancer effects across a range of important cancer types including breast, prostate, lung and ovarian tumour, when compared to Taxotere® (docetaxel). AstraZeneca has signed a licensing agreement with Starpharma for the use of its DEP® drug delivery platform in the development and commercialisation of an AstraZeneca oncology compound, with potential for follow on compounds directed at a defined family of targets.
In agrochemicals Starpharma has a series of partnerships with leading industry players including global leader Adama (formerly Makhteshim Agan) as well as internal programs including an enhanced version of glyphosate (the active ingredient in Roundup®).
For more information please visit: www.starpharma.com
Media:
Buchan Consulting
Rebecca Wilson
Mob: +61 417 382 391
rwilson@buchanwe.com.au
Gabriella Hold
+61 3 9866 4722
ghold@buchanwe.com.au
Starpharma:
Dr Jackie Fairley, Chief Executive Officer
Nigel Baade, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com
www.starpharma.com
