On January 29, 2020 Starpharma (ASX: SPL, OTCQX: SPHRY) reported its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2019 (Press release, Starpharma, JAN 29, 2020, View Source [SID1234553660]).

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Starpharma’s cash balance as at 31 December 2019 was $35.9 million, with net operating cash outflows for the quarter of $0.5 million, compared to $4.6 million last quarter. Receipts for the quarter included the $4.9 million R&D tax incentive refund received in December 2019. Product supply and royalty receipts for VivaGel BV totalled $0.9 million for the quarter.

The cash balance does not include the anticipated US$3 million milestone payment from AstraZeneca which is expected to be received during the March quarter.

Cash outflows for the quarter include the manufacture of VivaGel BV product to support the roll-out in multiple regions, including the UK, Eastern Europe and Asia. Cash outflows also included expenditure on Starpharma’s three DEP clinical programs, including several new sites across the DEP studies. Outflows also included expenditure on the dual strategy to achieve FDA approval through the formal review process, as well as preparation, including start-up activities, for a possible VivaGel BV treatment clinical trial.

Key recent events:

AstraZeneca commenced the phase 1 clinical trial of its first DEP product, AZD0466. The successful dosing of the first patient in this trial triggered a US$3 million milestone payment, which is expected to be received in the coming weeks.
DEP cabazitaxel trial progressed from phase 1 to phase 2 on positive results. The trial met its objective of evaluating safety, tolerability and preliminary efficacy data, and identifying a recommended phase 2 dose. The trial transitioned seamlessly into phase 2, with two new sites initiated and recruitment underway.
Patients continue to be recruited into the phase 2 trial for DEP docetaxel, with efficacy signals observed in a variety of tumour types including non-small cell lung cancer, prostate cancer, and several hard to treat tumours. Six sites in the UK are currently recruiting patients, including two new sites – the Christie and the Beatson (Glasgow).
Patients continue to be recruited into the dose escalation phase of the phase 1/2 trial for DEP The three leading cancer sites actively recruiting for this trial are the Christie, the Royal Marsden and Newcastle Freeman Hospital.
VivaGel BV was launched in the UK under the brand Betafem BV Gel.
Starpharma supplied product to Mundipharma to support the roll-out of VivaGel BV in Europe, including countries in Central and Eastern Europe, where launches are expected in the coming months.
Further regulatory approvals were granted in Asia. Advanced marketing activities are underway, and product has been delivered by Starpharma in preparation for launch.
Aspen continued to advance their marketing and promotional activities for Fleurstat BVgel in Australia, and preparations have progressed for the New Zealand launch, including product supply by Starpharma and training of sales representatives.
Starpharma progressed its dual strategy regarding FDA approval of VivaGel BV with ongoing support from a team of expert FDA consultants (regulatory, statistical, clinical, legal; several ex-FDA). This includes seeking formal review of some of the FDA’s initial conclusions, as well as preparation for a possible BV treatment trial.
VivaGel condom was granted marketing approval in Europe. LifeStyles has commenced marketing preparations ahead of the launch of the VivaGel condom under the brand name Absolute DUAL PROTECTION.
New DEP candidate, DEP gemcitabine, was advanced for development upon demonstrating significantly enhanced anti-tumour activity compared with Gemzar (gemcitabine), both alone and in combination with Nab‑paclitaxel (Abraxane), in a human pancreatic cancer model.
Several new DEP patents were filed covering DEP in combination with marketed anticancer agents and novel DEP
Dr Jackie Fairley, Starpharma CEO, commented: "It was a key milestone for Starpharma to see AstraZeneca treat its first patient with our partnered DEP product, AZD0466. AstraZeneca describes AZD0466 as having the potential to be a ‘best-in-class’ agent in this field due to its ability to target both Bcl2 and Bcl/xL. We will follow the progress of the AZD0466 trial, which is currently being conducted in multiple sites in the US, with interest. In our internal portfolio, we progressed DEP cabazitaxel into phase 2 on positive phase 1 results and we delivered excellent data on our new candidate, DEP gemcitabine. With four DEP products now in the clinic, and a pipeline of high-potential candidates, the DEP platform is generating a deep portfolio of valuable products".

"We also achieved key milestones for VivaGel BV, with the launch into the UK market. We continue to work closely with our partners to support the roll-out in Europe and Asia, as well as the New Zealand launch. In the last few months, several submissions have also been prepared and submitted for countries in other regions. During the next quarter we are focussed on accelerating our clinical trials, wherever possible, and working towards further regulatory approvals and launches for VivaGel BV," concluded Dr Fairley.