Melbourne Australia; Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today released its interim report and financial results for the half-year ended 31 December 2012.

Financial Highlights

• Reported loss $1.8M (Dec 2011: $4.7 million)
• R&D tax incentives of $6.8M reported in the half-year
• Cash position at 31 December 2012 $33.2M
• R&D tax incentive receivables at 31 December 2012 $8.1M

Operational Highlights

• Completion of Phase 2 and Phase 3 Trials of VivaGel^®
• Crop protection agreement signed with Nufarm
• Cancer drug agreement signed with AstraZeneca
• Starpharma's docetaxel demonstrates targeted tumour delivery
• Starpharma's docetaxel superior to Taxotere^® across multiple cancer types
• Starpharma's new formulations demonstrate further improvement in crop protection
• Awarded Janssen 2012 Company of the Year
• Successful application to recoup $6 million cash for overseas R&D

Commenting on the results, Starpharma CEO Dr Jackie Fairley said:

“In 2012 the Company achieved a number of significant advances across its portfolio and whilst gross R&D expenditure has increased compared to last year, a significant proportion of this expenditure is non-recurrent and will be re-couped under the R&D Tax Incentive Program. Starpharma is in a strong cash position as we continue to expand and advance our portfolio into a range of large global markets.”

The net loss after tax of $1.8 million (Dec 2011: $4.7 million) includes the expenses of the VivaGel^® clinical program, together with development expenses in drug delivery and agrochemical programs.  In the half-year, R&D tax incentives of $6.8 million (Dec 2011: Nil) were reported as a contra expense, of which $4.1 million related to FY2012 expenditure.

The cash balance at 31 December 2012 was $33.2 million, compared with $42.8 million at 30 June 2012. This balance excludes the anticipated $8.1 million receivable under the R&D Tax Incentive Program - $5.3 million to be received this financial year.  Net cash outflows from operations were $10.2 million, largely relating to the two bacterial vaginosis (BV) clinical programs for VivaGel^® (treatment and prevention of recurrence).  A significant proportion (>50%) of the Company’s YTD cash flow is attributable to the non-recurrent costs for these two clinical programs.

In the half-year, Starpharma secured a number of important new commercial relationships and its proprietary dendrimer-docetaxel formulation was shown to be superior to Taxotere^® in a range of models, in addition to demonstrating significant tumour targeting.  The Company’s agrochemical programs, both partnered and internal, continue to advance well.

The Company completed a Phase 2 clinical trial assessing VivaGel^® performance as therapy to prevent Bacterial Vaginosis (BV) recurrence and these results are on track to report before the end of Q1 2013.  Starpharma’s Phase 3 clinical trials of VivaGel^® for the treatment of BV announced in the half-year, whilst not meeting the primary FDA endpoint, did demonstrate statistically significant Clinical Cure at the end of treatment (EOT), effectiveness in treating patient symptoms, and an excellent safety profile.  Accordingly, the Company is currently undertaking further analysis of the trial data as well as exploring alternative claim strategies and jurisdictions.

Download ASX Announcement:  Interim Report and Half-year Financial Results ( pdf file, 1MB)