Open Annual Report 2016

Melbourne, Australia; 29 August 2016: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its annual report and financial results for the year ended 30 June 2016.

Financial Results

• Net cash burn (cash outflows before new capital) $17.5M[1]
• Cash position at end of the year $46.0M
• Net proceeds of $32.6M from equity placement and share purchase plan
• Total revenue and other income $4.6M including the first US$2M DEP™ milestone from AstraZeneca
• Reported loss $22.7M
• Receipt of $3.4M R&D tax incentive

Operational Highlights

VivaGel^®

• EU marketing approval for the VivaGel^® BV treatment and symptom relief product;
• Licensing deal with Aspen for VivaGel^® BV treatment and symptom relief product in Australia and New Zealand with pre-launch activities well advanced;
• Phase 3 clinical trials of VivaGel^® BV for the prevention of recurrent bacterial vaginosis (BV) more than 90% enrolled;
• VivaGel^® active shows potent antiviral activity against Zika virus;
• License for VivaGel^® condom in China for the Government market; and
• Significant progression of commercial and regulatory activities for the VivaGel^® condom in important markets with approvals anticipated in coming months.

Drug Delivery

• Signing of a multiproduct drug delivery license with AstraZeneca for DEP™ enhanced oncology molecule;
• Second DEP™ candidate nominated by AstraZeneca under the license;
• DEP™ docetaxel phase 1 clinical trial showing promising efficacy signals and  advancing to the final expansion phase with no neutropenia or hair loss reported;
• Extension of DEP™ programs with AstraZeneca adding a new DEP™ candidate from their portfolio;
• Impressive preclinical results for both DEP™ cabazitaxel and Targeted DEP™ candidates in human cancer models; and
• Two new Targeted DEP™ partnerships signed with world leading antibody-drug conjugate companies.

Agrochemicals

• Adama licenses Priostar^® for the US market to create novel dendrimer-enhanced versions of 2,4-D, a major global agrochemical;
• Signing of several new partnerships with leading agrochemical companies including major Japanese agrochemical business; and
• Important progress and results for Priostar^® agrochemical internal programs.

Commenting on the 2016 financial year’s achievements and the outlook, Starpharma CEO, Dr Jackie Fairley, said:

“FY16 has been a significant year in Starpharma’s development as a company, with each of our business areas reaching important commercial milestones and a number of major development and regulatory accomplishments across our VivaGel^®, drug delivery and agrochemical portfolios”.

“The year saw Starpharma sign the multiproduct DEP™ license with AstraZeneca, starting with a DEP™ enhanced oncology molecule, and rapidly expanding to a second candidate under that license. The relationship with AstraZeneca was recently further cemented when they added a completely new compound from their portfolio to the DEP™ collaborative programs. In the wider drug delivery portfolio, the phase 1 clinical trial of our internal candidate, DEP™ docetaxel, is showing promising efficacy signals and advancing into its final expansion phase with no neutropenia or hair loss reported. Also, we’ve seen impressive preclinical efficacy results for DEP™ cabazitaxel and our Targeted DEP™ candidates. The latter, generated a significant amount of industry interest and as a result we have very recently added two new partnerships with world leading antibody-drug conjugate (ADC) companies. It is great to have them working alongside Starpharma to exploit the unique benefits of the DEP™ technology for the development of the next generation of ADCs” she added.

“In the VivaGel^® portfolio we achieved a landmark for VivaGel^® BV this year - EU regulatory approval. This approval has been used to expedite regulatory processes in a number of markets as well as supporting a very active commercialisation and licensing program in preparation for product launch. The VivaGel^® BV phase 3 clinical trials for the prevention of recurrent BV are more than 90% enrolled. Thirdly, the deal with Sky and Land adds the large Chinese Government sector as a new market opportunity to the existing Ansell and Okamoto licenses for the VivaGel^® condom. We also anticipate FY17 will be another year of significant regulatory and commercial progress for the VivaGel^® condom product”.

“Finally in our agrochemical portfolio, over the period we secured an important deal with the Adama license of Priostar^® to create new enhanced versions of a major global agrochemical 2,4-D, for the US market. We have also seen important progress with further promising field trial results for Priostar^® agrochemicals in our internal programs. In addition to Adama we signed a number of external partnerships including one with a major Japanese agrochemical company” Dr Fairley stated.

Net cash outflows from operating and investing activities for the year were $17.8 million (2015: $14.3 million), with cash reserves at 30 June 2016 of $46.0 million (2015: $30.8 million).  The net loss after tax was $22.7 million (2015: $19.0 million), with the increase primarily a result of the VivaGel^® and DEP^TM docetaxel clinical programs in progress, offset by an increase in revenue. Revenue increased for the year largely as a result of the first milestone (signature fee) from AstraZeneca under the multiproduct DEP™ license.