1 September 2024
Annual Report and full year financial results
Melbourne, Australia; Starpharma Holdings Ltd (ASX:SPL; OTCQX:SPHRY) today released its annual report and financial results for the year ended 30 June 2015.
Financial Results
- Net cash burn (cash outflows before new capital) $13.7M
- Cash position at end of the year $30.8M
- Net proceeds of $20.5M from equity placement and share purchase plan
- Total revenue and other income $1.7M
- Reported loss $18.95M
Operational Highlights
VivaGel®
- Phase 3 clinical trials of VivaGel® for the prevention of recurrent bacterial vaginosis (BV) commenced following the granting of a Special Protocol Assessment (SPA) from the US FDA.
- Regulatory submissions for marketing approval were made and commercial discussions are underway for the VivaGel® BV symptomatic relief product.
- The VivaGel® condom was launched in Australia by Starpharma’s marketing partner, Ansell, under its LifeStyles® Dual Protect™ brand.
- Marketing clearance achieved for the VivaGel® condom in New Zealand, and under regulatory review in other markets.
Drug Delivery
- Dose level of DEP™ docetaxel in the phase 1 trial exceeds the most commonly used dose for Taxotere® of 75mg/m2, with no reports of neutropenia or hair loss.
- Extension of collaboration agreement with AstraZeneca to scale-up a DEP™ enhanced oncology molecule for further development by AstraZeneca.
- Significant progress has been made in both internal and partnered drug delivery programs.
Agrochemicals
- Further field studies show dendrimer-enhanced formulation of glyphosate is more effective on hard-to-control weeds than glyphosate alone.
- Priostar® glyphosate patent granted in China, the largest glyphosate producer in the world.
Corporate
- Strong institutional demand for capital raising.
- Receipt of $4.2M R&D tax incentive.
- Relocation to established laboratories and office space in Abbotsford.
Commenting on the 2015 financial year, Starpharma CEO Dr Jackie Fairley said: “Significant progress continues across Starpharma’s three portfolios. The granting by the US FDA of an SPA, and subsequent commencement of the phase 3 clinical trials of VivaGel® for the prevention of recurrent BV marked an important start to the year.”
“The launch in Australia of the VivaGel® condom, under the Dual Protect™ brand was an important milestone. It is pleasing that Ansell has recently rolled out the Dual Protect™ condom into pharmacies, following the initial launch in Woolworths’ stores. Starpharma looks forward to further regulatory approvals to expand the condom’s market and geographic reach over the coming year.”
“We are also excited by the recent progress in our drug delivery portfolio, with the DEP™ docetaxel phase 1 clinical trial now approximately two thirds recruited. Patients in the trial are receiving doses exceeding the most commonly used dose for Taxotere® with no neutropenia or hair loss observed or reported. More broadly, significant progress has also been made in internal and partnered drug delivery programs, notably the extension of the highly successful AstraZeneca collaboration.”
Net cash outflows from operating and investing activities for the year were $14.3 million (2014: $10.1 million), with cash reserves at 30 June 2015 of $30.8 million (2014: $24.0 million). The net loss after tax was $18.95 million (2014: $14.6 million), with the increase primarily a result of clinical programs in progress in the 2015 financial year.
Net cash burn is considered a non-IFRS value and has not been audited in accordance with Australian Accounting Standards. Net cash burn is calculated by the movement in cash and cash equivalents from 30 June 2014 to 30 June 2015 adjusted for the net proceeds on the issue of equity of $20.5M.