On August 2016 Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) reported its annual report and financial results for the year ended 30 June 2016 (Press release, Starpharma, AUG 30, 2016, View Source [SID:1234514814]).
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 DEPTM 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.
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