Melbourne, Australia; 16 July 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2019.

Starpharma’s cash balance as at 30 June 2019 was $41.3 million. The net cash-burn for the financial year was $10.1 million (FY18: $9.9 million). The net operating and investing cash outflows for the quarter was $3.5 million. Cash outflows for the quarter include the manufacture of VivaGel^® BV to support launches in Australia and Europe and expenditure on Starpharma’s three DEP^® clinical programs, including final preparations and initiation of multiple sites for the DEP^® irinotecan trial. Receipts for the quarter included supply receipts for VivaGel^® BV and first receipts for the VivaGel^® condom in Japan.

The cash balance does not include the $0.7 million (US$0.5 million) milestone payment from Mundipharma for the launch of VivaGel^® BV in Europe, which was received in July 2019.

Key recent events:

• First global launches for VivaGel^® BV: VivaGel^® BV was launched in several European countries, including Germany, under the brand name Betadine™ BV, generating a milestone payment of US$0.5M to Starpharma. VivaGel^® BV was also launched in Australia by Aspen as Fleurstat BVgel.
• Starpharma signed a Development and Option Agreement with AstraZeneca to progress development of a DEP^® version of one of AstraZeneca’s major marketed oncology medicines. This new commercial deal is separate to the existing multi-product licence with AstraZeneca, under which AZD0466 is being developed.
• AZD0466 (AstraZeneca’s DEP^® Bcl2/xL oncology product): AstraZeneca’s Senior Vice President and Head of Oncology, IMED Biotech Unit, Dr Susan Galbraith, presented AZD0466 to clinicians at ASCO as part of their oncology development update. US FDA investigational new drug application (IND) for AZD0466 is planned in the near future with the product expected to enter the clinic later this year.
• A US patent was granted for AstraZeneca’s Bcl2/xL DEP^® conjugates (including AZD0466), which provides US exclusivity until 2038, and the potential for up to 5 years’ extension.
• Starpharma received formal feedback from the US FDA regarding approval of VivaGel^® The FDA feedback highlighted several potential options and Starpharma is currently working through these with the FDA and its expert consultants.
• Mundipharma has submitted regulatory applications for VivaGel^® BV in multiple countries under their agreement, and Starpharma and Mundipharma have also compiled a number of other regulatory applications for submission in the coming months.
• VivaGel^® BV commercial discussions continued in the remaining countries not licensed, including India, Canada and Israel.
• Okamoto launched the VivaGel^® condom in Japan under its leading ‘003’ brand and Starpharma received first receipts from Okamoto in April. Regulatory activities for the VivaGel^® condom have progressed in other regions.
• Final preparations are being completed ahead of commencement of the DEP^® irinotecan clinical trial in the near future. Initial UK sites include Guy’s Hospital London, The Christie and The Royal Marsden, with other sites to be added in the expansion phase of the trial.
• DEP^® docetaxel: Monotherapy and combination arms of the trial continue to show encouraging efficacy signals and a notable lack of bone marrow toxicity (e.g. neutropenia) and other common side effects including hair-loss, anaphylaxis and oedema.
• DEP^® cabazitaxel: Patient recruitment continuing following multiple dose escalations and a number of patients being treated with more than 10 cycles of DEP^® Encouraging efficacy signals continue to be observed in multiple patients in prostate cancer, for which cabazitaxel is approved, as well as other tumour types where efficacy would not necessarily be expected for the marketed form of cabazitaxel. These other tumour types include pancreatic cancer and ovarian cancer.
• Promising combination data were reported for DEP^® irinotecan showing significant efficacy and safety benefits over leading colorectal cancer drugs, irinotecan (Camptosar^®) and cetuximab (Erbitux^®), in the irinotecan-refractory HT‑29 human colon cancer nonclinical model.
• Other internal DEP^® preclinical and partnered DEP^® programs progressed well during the quarter.

Starpharma’s strong balance sheet and expected revenue from VivaGel^® products and partnered DEP^® milestones places the Company in a strong position to support ongoing commercial roll-out and regulatory milestones for the VivaGel^® portfolio, while continuing to expand and build value in the DEP^® portfolio, including progressing clinical trials for its three internal DEP^® products.

Dr Jackie Fairley, Starpharma CEO, commented: “We are delighted to now have our VivaGel^® BV products on the market in multiple regions, with the recent launches in Europe and Australia. We look forward to the further roll-out of VivaGel^® BV internationally in the coming months.”

“The next quarter will also be an exciting period for DEP^® with the commencement of our clinical trial for DEP^® irinotecan, our third DEP^® product to enter the clinic. Our strategy is to build a valuable portfolio of clinical-stage assets for licensing. In our partnered DEP^® area, we were delighted to sign a second commercial deal with AstraZeneca for one of their major oncology products and we also look forward to the near-term IND filing for AZD0466 and its clinical trial commencement later this year,” concluded Dr Fairley. 

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