Appendix 4C - Quarterly Cashflow Report

19 July 2017

Melbourne, Australia; 19 July 2017: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2017.

 

The cash balance as at 30 June 2017 was $61.8 million, with operating and investing cash inflows for the full year of $15.7 million, placing Starpharma in a strong cash position to commercialise its VivaGel® products and accelerate the development of multiple DEP® programs. The 30 June balance includes the net proceeds from the recent sale of Starpharma’s Agrochemicals business and the milestone payment received from AstraZeneca.

 

Recent highlights:

  • Agrochemicals: Starpharma sold its agrochemicals business to Agrium Inc, one of the largest agribusinesses in the world, for $35 million – greater than four times the book value of the assets and with no impact to the IP of the VivaGel® and DEP® portfolios.
  • Partnered DEP®: Received $2.6 million milestone payment from AstraZeneca for their first oncology compound under Starpharma’s multiproduct DEP® license, triggered by the final preclinical milestone prior to commencing clinical trials. DEP® partnered programs continued to generate impressive results, consistent with the performance of DEP® more broadly.
  • DEP® docetaxel: Continues to show promising efficacy signals, with no neutropenia among patients in the final expansion stage of the phase 1 trial. Preparations are well-advanced to use an adaptive trial design to facilitate rapid transition into phase 2 following completion of the final few patients in the phase 1 cohort. Phase 2 product manufacture and CRO selection are already complete. 
  • DEP® cabazitaxel: Final preclinical studies complete. Product manufacture, documentation, site and CRO selection are well-advanced ahead of the phase 1 trial start later this year. Starpharma used its new in-house scale-up facilities to manufacture DEP® cabazitaxel for the upcoming trial, resulting in a faster turnaround time and cost savings. 
  • DEP® irinotecan:  Demonstrated significantly improved anti-tumour activity and increased survival compared with irinotecan in a variety of human colon cancer models, including irinotecan resistant HT-29 model. Activities are underway to expedite the development and scaling up of DEP® irinotecan for further preclinical studies prior to clinical trials.  
  • VivaGel® rBV phase 3 trials: Data collation and routine quality control review are complete, with the statistical analysis plan and bio-statistical programming in the process of being finalised, prior to unblinding the data. Trial results are expected to be released in late July/early August.
  • FDA New Drug Application: Compilation of the first NDA for VivaGel® BV (for BV treatment) is well-advanced and expected to be submitted as early as possible in the second half of 2017, with rBV to follow. Starpharma is leveraging its QIDP designation and Fast Track status to support the NDA process.
  • Appointed global healthcare investment bank: Licensing discussions in US, Europe, and global negotiations continue to progress positively following the coveted Fast Track and QIDP FDA designations granted earlier this year. Starpharma has appointed a leading global healthcare investment bank to facilitate the competitive process amongst several potential partners.
  • VivaGel® condom: Ansell launched the VivaGel® condom in North America. Good regulatory progress has also been achieved in other key regions.  

 

The net operating cash outflows of $1.3 million for the quarter reflect the expenditure on the final stages of the phase 3 clinical trials for VivaGel® rBV, the DEP® docetaxel clinical programs, as well as preparations for the DEP® cabazitaxel clinical trial and other internal DEP® programs. Net cash inflows from investing activities of $33.0 million include cash consideration from the successful sale of the agrochemicals business in June 2017.

 

Commenting on the Company’s recent highlights and outlook, Dr Jackie Fairley, Chief Executive Officer of Starpharma said: “The past quarter has been a transformative period for the Company. The recent sale of our agrochemicals business and the AstraZeneca milestone payment demonstrate the value and optionality of our dendrimer products, where the value has been recognised and rewarded in significant commercial terms. Having successfully monetised our Priostar® IP, Starpharma is now in a particularly strong position to expedite and expand the development of internal DEP® candidates and broaden our pipeline to run more DEP® clinical trials in parallel, while continuing to commercialise the VivaGel® portfolio.”

 

“The remainder of 2017 represents a particularly exciting period for Starpharma with several significant milestones expected, including the near-term reporting of VivaGel® rBV phase 3 results and regulatory activities for both VivaGel® BV indications; topline results for the phase 1 DEP® docetaxel trial/transition to phase 2; and commencement of our first clinical trial for DEP® cabazitaxel”, added Dr Fairley.

 

Outlook

  • Results from the pivotal VivaGel® rBV phase 3 trials.
  • NDA for VivaGel® BV expected as early as possible in 2H CY2017 for treatment, with the prevention of rBV indication to follow.
  • Results from the phase 1 DEP® docetaxel trial and transition to phase 2.
  • Commencement of DEP® cabazitaxel phase 1 clinical trial.
  • Aspen’s launch of VivaGel® BV for treatment of bacterial vaginosis upon TGA approval.
  • Partnering deal(s) for VivaGel® BV.
  • Further regulatory approvals and launch of VivaGel® condom in other regions.
  • DEP® milestone payments and additional DEP® licenses.
  • Progress and further data on DEP® internal candidates, such as DEP® irinotecan.

Download announcement: Appendix 4C - Quarterly Cashflow Repor( pdf file, 170kb)


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