Melbourne, Australia; 25 January 2018: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2017.

Starpharma’s cash balance as at 31 December 2017 was $49.9 million, with net operating and investing cash outflows for the quarter of $7.2 million. The cash outflows for the quarter included $3.2 million (US$2.4 million) paid to the FDA on the submission of the New Drug Application (NDA) for VivaGel^® BV in November. Subsequent to the NDA submission, Starpharma received a Small Business Waiver from the FDA for the NDA submission fee and the full amount was refunded in January.

Starpharma anticipates the cash burn for the second half of the financial year to be significantly lower with material cash inflows, including from the R&D tax incentive of $3.7 million and revenue from its pharmaceutical products, including VivaGel^® BV and DEP^® milestones. In light of the current licence negotiations and commercialisation activities, cash inflows are envisaged to continue to build in the subsequent year.

Starpharma’s cash balance places the Company in a very strong position to continue to accelerate its multiple DEP^® candidates, such as DEP^® docetaxel and DEP^® cabazitaxel through clinical development, advance partnered programs and secure valuable commercial licences for VivaGel^® BV ahead of launch in a number of key markets.

Recent operational highlights include:

• VivaGel^® BV NDA lodged with the US FDA under the Fast-Track program for both treatment and prevention of BV. In late December, Starpharma filed the clinical treatment data under its rolling submission, adding to the three modules already submitted in November. The remainder of the NDA is anticipated to be filed in the coming weeks. Licence negotiations in multiple territories are occurring in parallel and continue to progress well.
• VivaGel^® BV received approval from the TGA and launch preparations are advancing well. Aspen Pharmacare Australia will market and sell the product in Australia as Fleurstat™ BV gel.  
• Phase 2 DEP^® docetaxel trial commenced in major UK hospitals including Guy’s and St Thomas’ Hospital London where a number of patients have already received multiple cycles of DEP^® docetaxel.
• University College London Hospital (UCLH) Cancer Clinical Trials Unit has been initiated in the phase 2 DEP^® docetaxel trial and is expected to commence recruitment shortly. Two further sites in the UK are also in the process of being initiated.
• Majority of the preparations for the DEP^® cabazitaxel phase 1 / 2 human clinical trial are now complete with trial commencement expected imminently at Guy’s and St Thomas’ Hospital and UCLH. The key outcomes of the trial will be to evaluate the safety, tolerability and pharmacokinetics of DEP^® cabazitaxel, to define a recommended phase 2 dose and to explore anti-tumour efficacy of the product.

Commenting on the Company’s recent highlights and outlook, Dr Jackie Fairley, CEO of Starpharma said: “We are extremely pleased with the progress of our multiple DEP^® programs and will continue to accelerate development wherever possible, through our in-house scale up facilities and by initiating further trial sites shortly. It’s great to once again see the benefits of DEP^® with patients experiencing no neutropenia following DEP^® docetaxel treatment in phase 2, consistent with earlier findings. We are pursuing a number of high-value commercial opportunities from Starpharma’s DEP^® platform with partners and look forward to reporting on these throughout the year. In particular we look forward to AstraZeneca’s first DEP product AZD0466 entering the clinic. This is a really exciting oncology agent which has the potential to be best in class and have a major impact in both blood and solid tissue cancers”.

Commenting further, Dr Fairley said: “In addition to these activities with our DEP^® programs, we have been focussed on finalising our NDA submission for VivaGel^® BV, licensing negotiations and launch preparations of the product in Australia. Our licence negotiations for VivaGel^® BV outside Australia/NZ are progressing well, and we look forward to announcing further details in the coming months,” concluded Dr Fairley.

Outlook

• Clinical module for the prevention of recurrent BV indication, and the final module of the NDA for VivaGel^® BV to be submitted to the FDA
• Partnering deal(s) finalised and announced for VivaGel^® BV
• Aspen’s launch of VivaGel^® BV as Fleurstat^TM BV gel in Australia
• Advancement of the AstraZeneca DEP^® programs, including AZD0466 to phase 1 and associated milestone payment
• Progress with and further sites commencing for the phase 2 DEP^® docetaxel and phase 1/2 DEP^® cabazitaxel
• Progress with other DEP^® internal candidates, such as DEP^® irinotecan, and other partnered DEP^®  programs
• Further regulatory approvals and launch of VivaGel^® BV and VivaGel^® condom in other regions
• Receipt of $3.7 million FY17 R&D tax incentive refund

Download announcement: Appendix 4C - Quarterly Cashflow Report ( pdf file, 691kb)