Melbourne, Australia; Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2014.

Financial Summary

• Reported loss of $8.5M (Dec 2013: $5.6M)
• Cash position at 31 December 2014 of $39.3M
• R&D tax incentives of $1.6M reported in the half-year (Dec 2013: $2.6M)
• Receipt of $4.2M R&D tax incentive refund
• $20.5M net proceeds from equity placement and share purchase plan

Operational Highlights:

• Launch of the VivaGel^® condom in Australia by Starpharma’s marketing partner, Ansell, under its LifeStyles^® Dual Protect™ brand: product now on sale in Woolworths stores nationally
• Grant of FDA Special Protocol Assessment (SPA) for VivaGel^® phase 3 trials
• Commencement of VivaGel^® phase 3 trials for prevention of recurrent bacterial vaginosis
• DEP™ docetaxel phase 1 trial approaching 50% recruitment with encouraging initial results
• Marketing clearance for the VivaGel^® condom achieved in New Zealand
• Starpharma’s Priostar^® glyphosate patent allowed in China

The net loss after tax of $8.5 million (Dec 2013: $5.6 million) includes expenses for the VivaGel^® clinical program, together with development expenses in the drug delivery and agrochemical programs.  The company has two clinical programs underway; a phase 1 study of DEP™ docetaxel recruiting 25-30 patients in Australian hospitals, and two phase 3 studies for VivaGel^® for the prevention of recurrent bacterial vaginosis, each recruiting around 600 patients across North America, Europe and Asia.

Commenting on the Company’s achievements and outlook, Starpharma CEO Dr Jackie Fairley said:

“During the half year, we saw the launch of the VivaGel^® condom in Australia, and the commencement of pivotal clinical trials for recurrent bacterial vaginosis (BV), which are progressing well after receiving the SPA from the US FDA. We have also had particularly exciting developments across our drug delivery programs including in the DEP™ docetaxel trial where we have seen some important improvements in pharmacokinetics, good tolerability and a lack so far of dose limiting side effects of docetaxel, including neutropenia. Apart from the relevance to DEP™ docetaxel, these data from human studies of the DEP™ drug delivery dendrimer platform are proving important in highlighting the value of the portfolio more broadly, including with partners and potential licensees.”

“Starpharma is well placed financially and operationally to capitalise on upcoming important milestones in 2015 with substantial progress across our three portfolio areas, VivaGel^®, drug delivery and agrochemicals.”

Financial results

The cash balance at 31 December 2014 was $39.3 million, compared with $24.0 million at 30 June 2014. The cash balance includes the net proceeds from the completion of an equity placement and share purchase plan in the half year, raising $20.5M of net proceeds after transaction costs. 

Clinical trial costs for both VivaGel^® and DEP™ docetaxel programs contributed to the net cash outflows from operations of $5.1 million (Dec 2013: $6.0 million). These programs include the phase 1 clinical trial of DEP™ docetaxel and the VivaGel^® phase 3 trials for prevention of recurrent BV.

Phase 1 DEP™ docetaxel clinical trial

The phase 1 trial of DEP™ docetaxel is progressing well and preliminary findings to-date have shown the drug is well tolerated with no neutropenia nor hair loss observed. Significant improvements in the pharmacokinetic profile of docetaxel have also been shown, and these improvements align with the predicted benefits of the DEP™ drug delivery technology and results in preclinical studies.

Patients are being enrolled at two sites in Melbourne and one in Brisbane – The Alfred Hospital, Austin Hospital/Olivia Newton John Cancer Centre and Royal Brisbane & Women’s Hospital, with a Sydney site opening shortly.  The clinical trial is open label and its objectives are to determine the maximum tolerated dose (MTD), dose limiting toxicities (DLTs) and assess the safety and tolerability of DEP™ docetaxel in patients with various solid tumours. Patients are currently being enrolled in a dose escalation phase of the trial, with some now having received as many as 5 cycles of treatment. Despite several dose escalations, the MTD has not yet been reached. The trial is approaching 50% of anticipated recruitment.

Phase 3 clinical trials of VivaGel^® for prevention of recurrent bacterial vaginosis

The phase 3 trials of VivaGel^® to prevent recurrent BV are progressing well.  Up to 600 women will be recruited into each trial across North America, Europe and Asia.

The two phase 3, double blind, randomised, placebo-controlled trials are identical in design and are comparing the rate of recurrent BV in women using VivaGel^® to the rate of recurrent BV in women using a placebo gel during a 16-week treatment period. The primary endpoint of the trials is prevention of recurrent BV at or by the 16-week visit.

VivaGel^® condom

In late October 2014, sales commenced for the VivaGel^® condom by Starpharma’s marketing partner, Ansell, under its LifeStyles^® Dual Protect™ brand, with the product available in Woolworths’ stores across Australia.

The VivaGel^® condom is a world-first product based on Australian innovation. It is the only condom available that incorporates an antiviral agent, VivaGel^®, which has been shown in laboratory studies to achieve viral inactivation rates of up to 99.9%.

Marketing clearance for the VivaGel^® condom was also achieved in New Zealand in November. Launch of the VivaGel^® condom in Japan was delayed last year by a classification review by the Japanese Ministry of Health following changes to device regulations. Starpharma and Okamoto are working closely with the authorities to expedite this process. Regulatory processes are ongoing in a number of other markets and these are unaffected by the Japanese classification review.

The availability of the VivaGel^® condom in Australia represents the first of three women’s health and sexual wellness products incorporating VivaGel^® that are in various advanced stages of development and commercialisation. The focus over the December quarter was to rollout the product to Woolworths stores nationally, with distribution via other retail channels to commence during 2015. The agreement with Ansell includes the typical commercial terms, including the receipt of royalties based on sales occurring in arrears. Given the timing of the launch in late October, there was no receipt of royalties in the current half year period. 

Agrochemical Program

In agrochemicals, internal and partnered programs continue to progress and Starpharma’s Priostar^® glyphosate patent was allowed in China, further strengthening and expanding the Company’s patent portfolio for the use of its proprietary dendrimers in agrochemical products.

Download ASX Announcement: Interim Report and Half-Year Financial Results (pdf file, 416kb)