Melbourne, Australia; 26 October 2018: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2018.

Starpharma’s cash balance as at 30 September 2018 was $49.5 million, with net operating and investing cash outflows for the quarter of $2.1 million, placing Starpharma in a strong financial position to finalise the global licensing of VivaGel^® BV and expand/accelerate the development of multiple DEP^® programs. Receipts from customers in the quarter include the upfront payment of A$2.0 million (US$1.5 million) from the European Mundipharma VivaGel^® BV licence.

Highlights for the quarter:

• The FDA confirmed its acceptance of the VivaGel^® BV NDA for filing and its progress to the next stage. The FDA also confirmed that Starpharma’s NDA is the subject of a priority review under Fast Track status, with a target review period of approximately six months from the filing acceptance.
• Licensing discussions for the US region have progressed to advanced contract negotiation with multiple parties as part of a competitive process.
• Manufacturing and supply chain activities and contracts have been implemented by Starpharma in preparation for launch in multiple markets. These activities are occurring in parallel with distribution, sales training, promotional and marketing activities by Starpharma’s partners (Aspen and Mundipharma). As launch timing of VivaGel^® BV in each region is controlled by Starpharma’s partners, optimal launch timings are being scheduled taking account of important in-market factors, such as new product/sales cycles in the relevant outlets.
• For the Mundipharma territories, first launches are being targeted for 1HCY19, including in Europe where the product is already approved, and extensive regulatory activities are underway in other regions.
• AstraZeneca’s first patent application on DEP^® Bcl2/xL conjugates was published by the World Intellectual Property Organisation. The published patent application represents the first disclosure of the compelling efficacy data on DEP^® Bcl2/xL conjugates, both alone and in combination with market-leading anti-cancer treatments including Rituximab[1], in various human leukemia models.
• DEP^® irinotecan showed impressive efficacy and safety benefits over standard irinotecan in combination with 5-FU in a human pancreatic cancer model. DEP^®irinotecan achieved complete tumour regression and 100% survival.
• The final stages of preclinical work for the DEP^® irinotecan phase 1/2 trial are nearing completion and the clinical trial is planned to commence this financial year. The trial will be open to patients with a range of cancers, including colon and pancreatic, where impressive efficacy has been shown in preclinical models.
• Recruitment activities continue to progress well for two clinical trials - for DEP^® docetaxel (phase 2) and DEP^® cabazitaxel (phase 1/2), with new sites opened in the UK in both studies to further support recruitment. No cases of neutropenia have been reported and early efficacy signals have been observed in a number of these patients.
• A range of DEP^® radiopharmaceuticals have been made and these are currently undergoing feasibility testing in a variety of models. The radiopharmaceutical area is a rapidly developing area of cancer treatment and diagnosis and has recently generated several high-value deals[2].
• Following very encouraging efficacy data for SPL7013 (the VivaGel^® active) in animal models of viral conjunctivitis, Starpharma has completed formal market research with ophthalmologists, payers and primary care physicians in the US who confirmed a high level of interest in an anti-viral therapy, like an SPL7013 ophthalmic solution. There are currently no products approved for viral conjunctivitis.

Commenting on the Company’s recent highlights and outlook, Dr Jackie Fairley, CEO of Starpharma said: “We are very pleased with the progress of regulatory and pre-launch activities for VivaGel^® BV in a range of markets. It’s great to see Mundipharma’s energy and commitment to expediting launch in multiple regions. We are delighted to have received filing acceptance and confirmation of Fast Track review from the US FDA for our VivaGel^® BV New Drug Application. This important achievement is extremely rare in the Australian context and has a clear benefit for the US licence for VivaGel^® BV”.

“With licensing negotiations well-advanced for VivaGel^® BV, we’re looking forward to expanding our exciting DEP^® portfolio - both internal and partnered. The first DEP^® patent application from our partnership with AstraZeneca demonstrates the significant commercial value that can be created using DEP^®. Data published in this patent, and recent data for DEP^® irinotecan provide further strong validation of the DEP^® platform’s broad applicability and ability to improve efficacy both alone and in combination with market leading cancer drugs”, concluded Dr Fairley.

Outlook

• VivaGel^® BV US licence
• VivaGel^® BV launch in Australia, Europe & other Mundipharma regions
• VivaGel^® BV US regulatory approval & approval in Mundipharma regions
• Revenue from VivaGel^® BV milestones, supply & sales
• Further VivaGel^® condom regulatory approvals and product launches (e.g. EU, Japan, China)
• Progress with DEP^® docetaxel & DEP^® cabazitaxel clinical trials
• DEP^® irinotecan trial commencement
• Other DEP^® program developments, including new candidate selection, DEP^® radiopharmaceuticals, Targeted DEP^® and other partnered DEP^® programs
• AstraZeneca program developments, e.g. further data published, AZD0466 advanced to the clinic & revenue from milestones; further compounds advanced/nominated

Download ASX Announcement: Quarterly Cashflow Report (pdf file, 313kb)

[1] Rituximab is a leading leukemia therapy sold under the brand names Rituxan and Mabthera. In 2017 Rituximab had sales of approximately US$7.5B and is primarily used to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia (Medtrack Database, August 2018).

[2] A radiopharmaceuticals is a drug that can be used for either diagnostic or therapeutic purposes. It is composed of a radioisotope bound to an organic molecule. Radiopharmaceuticals represent a growing area of cancer treatments, with recent deals including Novartis’ US$3.9B acquisition of Advanced Accelerator Applications and its acquisition of Endocyte for US$2.1B, and the acquisition of Australian company Sirtex for ~A$1.9B in 2018 by a consortium including CDH Genetech.