Quarterly Cashflow Report
Melbourne, Australia; 29 January 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today
released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December
2019.
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® irinotecan. 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.
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• 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® radiotherapeutics.
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.
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