Oct 30, 2019
Quarterly Cashflow Report
Melbourne, Australia; 30 October 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2019.
Starpharma’s cash balance as at 30 September 2019 was $36.8 million, with net operating cash outflows for the quarter of $4.6 million. The cash balance does not include the anticipated $4.9 million R&D tax incentive which is expected to be received during the December quarter.
Receipts from customers for the quarter totalled $1.1 million, which includes launch/regulatory milestones, product supply and royalty receipts from partners for VivaGel® BV. Cash outflows for the quarter include the manufacture of VivaGel® BV product following launches in Australia and Europe as well as expenditure on Starpharma’s three DEP® clinical programs, including trial commencement and site setup costs for DEP® irinotecan in the quarter.
Key recent events:
- FDA authorised the IND for a phase 1 clinical trial of AstraZeneca’s first DEP® product, AZD0466. The AZD0466 clinical program is expected to commence later this year following site set-up and ethics committee/IRB approvals.
- Starpharma commenced its phase 1/2 clinical trial for DEP® The trial will be conducted at multiple sites, with initial sites already opened including leading UK cancer centres The Christie, The Royal Marsden and Newcastle Freeman Hospital.
- The first Asian regulatory approvals were received for VivaGel® BV and these approvals will facilitate and accelerate further registrations in Asia. The launch of BetadineTM BV Gel in Asia is expected in the coming months and further regulatory submissions have been made in countries across Asia and other Mundipharma regions.
- Marketing and promotional activities for VivaGel® BV continued following the launch of Betadine BVTM in Europe (June) and Fleurstat BVgel in Australia, where the product is currently for sale. In Australia, Fleurstat BVgel is available in major pharmacy chains (Chemist Warehouse, Terry White, Amcal, Priceline, etc).
- Starpharma continues to progress with a dual strategy to achieve US approval for VivaGel® BV with input from its team of expert FDA consultants, statisticians and legal advisors. In parallel with seeking further review of some of the FDA’s initial conclusions, Starpharma has also undertaken significant preparations for a possible BV treatment trial, if required.
- Promising efficacy signals were observed in the DEP® cabazitaxel and DEP® docetaxel trials, as well as a notable lack of bone marrow toxicity and other common side effects. The dose escalation phase for DEP® cabazitaxel is approaching completion with multiple patients displaying efficacy signals, including stable disease of more than 47 weeks and significant reductions in specific tumour biomarkers, such as prostate specific antigen (PSA).
- Impressive data were reported for DEP® irinotecan, alone and in combination with Merck and AstraZeneca’s Lynparza®, in a refractory human colon cancer model. DEP® irinotecan showed significant anti-tumour efficacy and synergy compared with standard irinotecan (Camptosar®) and Lynparza® (olaparib). These data have been shared with a number of interested partners and will also inform the conduct of the DEP® irinotecan clinical program.
- A novel HER-2 Targeted DEP® conjugate (ADC) from Starpharma’s internal Targeted DEP® program demonstrated significant tumour regression and 100% survival in a preclinical human ovarian cancer model. Starpharma’s novel HER-2 Targeted DEP® drug conjugate significantly outperformed leading products Kadcyla®, a HER-2 targeted antibody-drug conjugate (ADC), and Herceptin®
- Two new DEP® patents were filed covering new DEP® candidates currently in preclinical development.
Dr Jackie Fairley, Starpharma CEO, commented: “We are delighted to see our first AstraZeneca partnered DEP® product, AZD0466, cleared by the FDA to enter human clinical trials. This is an important milestone for the Company and provides further industry validation for the utility of the DEP® platform. This candidate will be the fourth DEP® product to enter the clinic following the commencement of Starpharma’s DEP® irinotecan during the quarter”.
“We were also pleased to see the roll-out of VivaGel® BV into Europe as well as Australia, and to receive the first regulatory approvals in Asia where the product is expected to be launched later this calendar year. The next quarter will be an exciting period for Starpharma with the anticipated commencement of a phase 1 trial for AZD0466, and further progress with our three internal DEP® clinical trials, further regulatory approvals and launches for VivaGel® BV,” concluded Dr Fairley.
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