22 November 2024
Appendix 4C - Quarterly Cashflow report
Melbourne, Australia: Starpharma Holdings Ltd (ASX:SPL;OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow report for the period ended 30 June 2012.
The cash balance at 30 June 2012 was $42.8 million. Total operating and investing cash outflow for the quarter was $3.8 million, resulting in an annual cash burn of $9.9 million. The increase in cash burn this year is in line with budgets and is driven primarily by the concurrent Phase 2 and two Phase 3 clinical trials underway for the VivaGel® Bacterial Vaginosis (BV) Program.
Recent progress in these programs includes:
- Full recruitment of the first of Starpharma’s two Phase 3 studies for VivaGel® as a treatment for BV. The second Phase 3 trial is now more than 70% recruited.
This study is the subject of a formal agreement with FDA under the Special Protocol Assessment (SPA) program, which confirms that the trial design, clinical endpoints and statistical analyses are acceptable for FDA approval once complete.
- Full recruitment for the Phase 2 clinical trial to investigate the ability of VivaGel® to prevent the recurrence of BV. The study is being conducted under an investigational new drug application (IND) and has enrolled 205 patients with a prior history of recurrent BV.
The two Phase 3 treatment trials and the Phase 2 trial for prevention of recurrence are all expected to complete in 2H CY2012. Following successful completion Starpharma will file an NDA and enter into one or more licensing agreements.
In addition to the active clinical trial program for VivaGel® referred to above, Starpharma has two commercial collaborations for a VivaGel® coated condom, as well as an internal drug delivery program with a focus on improvement of the blockbuster cancer drug docetaxel (Taxotere®). The drug delivery program is advancing rapidly with plans underway for clinical trials to commence in 2013.
Starpharma’s dendrimers are also being applied to enhancing the performance of important leading agrochemical agents such as Glyphosate (Roundup®).
Appendix 4C - Quarterly Cashflow Report ( pdf file, 213kb)