Melbourne, Australia; 21 August 2018:Starpharma (ASX: SPL, OTCQX: SPHRY) today released its annual report and financial results for the year ended 30 June 2018. [Download the Annual Report (Pdf, 4MB)].

Financial Results

• Cash position at 30 June of $51.3M
• Net cash burn[1] of $9.9M (FY17: $18.0M excl. net proceeds from agrochemicals sale)
• Net operating cash outflows of $10.2M (FY17: $17.0M)
• Total revenue and other income of $5.0M (FY17: $3.6M)
• Loss from continuing operations of $10.3M (FY17: $15.2M)
• Reported loss of $10.3M
• Receipt of $3.7M R&D tax incentive

Operational Highlights

• VivaGel^® BV demonstrated compelling efficacy in pivotal phase 3 trials for the prevention of recurrent BV.
• VivaGel^® BV was licensed to Mundipharma for Europe, Russia, CIS, Asia, Middle East, Africa and Latin America.
• Starpharma completed and submitted a New Drug Application (NDA) for VivaGel^® BV, which was accepted for filing by the US FDA, with no issues cited. The NDA is the subject of priority Fast Track review, which provides a target review period of approximately six months from acceptance.
• VivaGel^® BV received Australian marketing approval from the TGA.
• DEP^® docetaxel achieved its key objective of determining a Recommended Phase 2 Dose (RP2D) in its phase 1 trial, with no reports of protocol-defined dose limiting toxicities, no neutropenia and encouraging efficacy signals observed.
• DEP^® docetaxel phase 2 trial commenced in leading UK hospitals in lung cancer and prostate cancer.
• DEP^® docetaxel commenced a clinical trial in combination with nintedanib (Vargatef^®) in lung cancer.
• DEP^® cabazitaxel phase 1 / 2 trial commenced in patients with advanced solid tumours.
• DEP^® irinotecan manufacture expedited via Starpharma’s scale-up facility in preparation for the phase 1 / 2 trial and final preclinical work underway.
• Multiple new development programs, including programs for targeted DEP^® and DEP^® radiopharmaceutical, and also for ophthalmology.
• AstraZeneca unveiled its first DEP^® oncology candidate, AZD0466, as a Bcl2/xL inhibitor.
• Starpharma received two separate grants for DEP^® with Monash Institute of Pharmaceutical Sciences and with Peter MacCallum Cancer Centre.

Starpharma CEO, Dr Jackie Fairley, commented: “This was an exceptionally positive year for the company with successful clinical trial results reported in both of our VivaGel^® and DEP^® drug delivery portfolios and a string of further achievements, including international licences, NDA submission to the FDA, regulatory approval and other commercial milestones. These commercial milestones and our reducing net cash burn have placed the company in a very strong financial position, with more than $50M in cash at bank”.

Commenting further on the 2018 financial year’s achievements and outlook, Dr Fairley added: “During the year we signed a multi-region licence for VivaGel^® BV with leading pharmaceutical company, Mundipharma, on very attractive deal terms. Commercial licences for VivaGel^® BV now cover most regions around the world, with the high-value US market to come. FDA’s filing acceptance of our NDA, and confirmation of its priority review, have added significant commercial value to VivaGel^® BV and we expect this to positively impact our advanced negotiations for the US region”.

“In our DEP^® portfolio, we reported exciting clinical trial results for DEP^® docetaxel, which transitioned seamlessly into phase 2, and we advanced the clinical development of two other lead products – DEP^® cabazitaxel and DEP^® irinotecan. We continue to develop and select the best possible DEP^® candidates to build significant commercial value in our DEP^® portfolio. At the same time, we continue to work closely with our DEP^® partners, advancing several programs, including AstraZeneca’s AZD0466 - a highly optimised dendrimer formulation of a dual Bcl2/xL inhibitor. We’re very pleased that our DEP^® platform is central to development of such an exciting, novel drug which has the potential to be a best-in-class, major cancer drug, and we look forward to AstraZeneca releasing further data and commencing a phase 1 trial in FY19”.

“In the year ahead, we look forward to the market launch of VivaGel^® BV in multiple regions, signing a US licence and FDA approval of VivaGel^® BV as well as multiple value-adding milestones for the DEP^® portfolio. This is a really exciting and rewarding time for Starpharma. Commercialising our VivaGel^® assets will enable us to generate recurrent revenues which will allow us to continue building on the immense commercial value around the DEP^® platform and a portfolio of life-changing drugs”, concluded Dr Fairley.

Download ASX Announcement:  Annual report and full year financial results (pdf file, 4MB)

[1] Net cash burn is considered a non-IFRS value and has not been audited in accordance with Australian Accounting Standards. Net cash burn is calculated by the movement in cash and cash equivalents from 30 June 2017 to 30 June 2018. Net cash burn for 2017 excludes the $33.3 million of net proceeds from the sale of Starpharma’s agrochemicals business.

This contains certain forward-looking statements.