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

Starpharma’s cash balance as at 30 June 2018 was $51.3 million. The net cash-burn for the financial year was $9.9 million which is just over half of last year’s net cash-burn (excluding net proceeds from the agribusiness sale) of $18.1 million.

Receipts from customers in the quarter include the upfront payment of A$1.3 million (US$1.0 million) from the first Mundipharma license (May 2018) but does not include a further A$2.0 million (US$1.5 million) upfront payment from the second Mundipharma licence which expanded their territory to include Europe. This second upfront payment was received in early July 2018.

Starpharma’s strong balance sheet and anticipated near-term revenues place the company in an excellent position to build further value in its DEP^® portfolio, through advancement and expansion of its programs, in parallel with the launch of VivaGel^® BV in partnered territories. This is a transformative period for Starpharma as it progresses from a largely development stage company to revenue generation based on a deep portfolio of both commercial and development opportunities.

VivaGel^® BV highlights in the quarter include:

• VivaGel^® BV licensed to Mundipharma for Asia (including China, Japan and Korea), the Middle East, Africa and parts of Latin America for an attractive revenue share, in addition to milestones of up to A$12.4M (US$9.2M).
• A further licence agreement for VivaGel^® BV was signed with Mundipharma for Europe, Russia, CIS and the balance of Latin America for an attractive revenue share, and additional milestones of up to A$20.8M (US$15.5M). The combination of territories under licence with Mundipharma means Starpharma is eligible to receive total signing, regulatory and commercial milestones of up to A$33.2M (US$24.7M), in addition to receiving a revenue share from Mundipharma sales.  
• Completed the VivaGel^® BV NDA, which was subsequently advanced to the next stage of the US FDA review, following acceptance for filing with no issues identified. The FDA also confirmed that the VivaGel^® BV NDA will be the subject of a priority review, which has a target review period of approximately 6 months from acceptance. This is expected to positively impact on licensing discussions for the US which are at an advanced stage.
• Extensive preparations continue for the launch of VivaGel^® BV in a number of regions, including in Australia, Europe, Asia and elsewhere. This included marketing and sales planning, as well as market research by partners to support launches. Mundipharma plans to expedite the product launch under the Betadine^® brand through their extensive marketing network and has commenced regulatory activities for its regions other than the EU where the product is already approved.
• Significant supply activities for VivaGel^® BV including packaging development and supply chain development have been undertaken in conjunction with Starpharma’s contract manufacturing organisations in preparation for multi-region launches.

In the DEP^® portfolio, the phase 2 DEP^® docetaxel trial recruitment is progressing well with three sites recruiting and a fourth to commence shortly. Starpharma has completed recruitment in the first cohort of patients with lung cancer in the combination study, which is trialing the combined use of DEP^® docetaxel and nintedanib (Vargatef^®). Based on positive feedback from oncologists involved in the study, Starpharma is now exploring the potential to expand recruitment in this combination arm of the study. No cases of neutropenia have been reported in either the Phase 2 or the combination (DEP^® docetaxel and nintedanib) arms of the study.

In the phase 1/2 DEP^® cabazitaxel trial, recruitment is underway at Guy’s Hospital London and University College London Hospital. Final preclinical work is being completed ahead of commencing the phase 1/2 DEP^® irinotecan trial. Manufacture of DEP^® irinotecan trial material has already been completed at Starpharma’s scale-up facility and is currently being formulated in preparation for trial commencement. Partnered DEP^® programs continue to progress well and Starpharma has manufactured a number of partnered DEP^® candidates at progressively larger scales, during the year. The Company has also advanced a number of new DEP^® candidates into preclinical development during the quarter.

Commenting on the Company’s recent highlights and outlook, Dr Jackie Fairley, CEO of Starpharma said: “We are delighted to have executed licences for VivaGel^® BV in the majority of regions around the world with our newly announced partner, Mundipharma. We’re impressed by Mundipharma’s commitment to the feminine care category and their plans to expedite the product launch of VivaGel^® BV, particularly in Europe and Asia. FDA’s recent filing acceptance of our NDA and confirmation of its priority review both add significant commercial value and is expected to positively impact our advanced US negotiations. These important achievements place Starpharma in a very strong position as we move into a pivotal year ahead.”  

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 in multiple regions (e.g. Japan, China, EU)
• Progress with DEP^® docetaxel & DEP^® cabazitaxel clinical trials
• DEP^® irinotecan to advance to the clinic
• New DEP^® candidates selected for further development
• AstraZeneca program developments, e.g. AZD0466 advanced to the clinic & revenue from milestones; further compounds advanced
• Other partnered DEP^® deals and program developments, including for Targeted DEP^®

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