Apr 29, 2019
Quarterly Cashflow Report
Melbourne, Australia; 29 April 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2019.
Starpharma’s cash balance as at 31 March 2019 was $44.7 million, with a positive net operating and investing cash inflow for the quarter of $0.3 million. The cash inflows for the quarter included the $4.0 million R&D tax incentive, with outflows including costs related to Starpharma’s DEP® clinical programs and the manufacture of product for the VivaGel® BV launch.
Starpharma’s strong cash balance and upcoming expected receipts associated with the international roll-out of VivaGel® products enables the Company to support the ongoing regulatory activities for VivaGel® BV while continuing to build its high‑value DEP® portfolio.
Key events during the quarter:
- VivaGel® BV launch activities (Australia): VivaGel® BV has been officially launched in Australia by Aspen as Fleurstat BVgel. The product has undergone distribution across Australia and is available from pharmacies.
- VivaGel® BV launch activities (Europe): Mundipharma’s preparations are well advanced for the launch of VivaGel® BV in Europe before the end of FY19, and product for launch has been manufactured.
- VivaGel® BV regulatory activities: a meeting was held with the US FDA as part of the process to clarify and address FDA’s request for confirmatory data prior to the approval of VivaGel® BV in the US. Further information is expected once formal outcomes of the meeting and the subsequent follow up has been confirmed in writing by the FDA, which is expected within several weeks. In addition, regulatory activities have advanced in multiple countries within Mundipharma’s territory.
- VivaGel® BV commercial discussions continue in the remaining countries not licensed, including India, Canada and Israel.
- VivaGel® condom: Starpharma obtained first receipts from Okamoto in April and Okamoto are progressing well with their launch plans for the VivaGel® condom in Japan which is expected mid-year; regulatory activities in other regions have continued.
- DEP® docetaxel: More than 70% of the initial cohort in the monotherapy arm have been enrolled and encouraging efficacy signals have been observed (stable disease and tumour shrinkage) together with a notable lack of bone marrow toxicity. Patients in the combination arm also continue to show encouraging efficacy signals and recruitment continues to progress well.
- DEP® cabazitaxel: Dose escalation continues. Several patients have now been dosed with multiple cycles, and no dose-limiting toxicities or other significant toxicities associated with DEP® cabazitaxel have been observed. Efficacy signals have been observed in prostate and other tumour types and at doses several fold lower than usually prescribed for cabazitaxel (due to the trial being in the escalation phase).
- Commencement of the DEP® irinotecan trial is expected mid-year; the Clinical Research Organisation (CRO) has been appointed, sites have been selected and the ethics and regulatory submissions are well advanced. Starpharma and the CRO are currently finalising trial documents ahead of trial start.
- Partnered programs progressed well during the quarter, including preparations for clinical trial commencement of AstraZeneca’s AZD0466, which is expected this year. Additional partnering discussions have advanced for new DEP®
- Recent patent grants include: an additional US patent granted for DEP® docetaxel, bringing the total US patents for the product to six, with an expiry date of 2032.
Dr Jackie Fairley, Starpharma CEO, commented: “We were extremely excited to see the launch of Fleurstat BVgel in Australia – it’s fitting that the first launch in the world of VivaGel® BV is in the very country it was developed. During this time, we’ve also been working closely with Mundipharma to finalise preparations for the launch of VivaGel® BV in Europe, as well as progressing registrations for multiple other territories”.
“Our internal DEP® products - DEP® docetaxel and DEP® cabazitaxel both continue to generate positive clinical results, including the observation of efficacy signals in a range of tumour types. It’s also really pleasing to see the enthusiasm from clinicians and potential partners regarding DEP® irinotecan entering the clinic. In parallel, we are engaged in discussions for a number of high-value commercial partnering opportunities for our DEP® platform and look forward to reporting on these,” concluded Dr Fairley.
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