Melbourne, Australia; 24 February 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2019.

Financial Result

• Cash position at 31 December 2019 $35.9M (June 2019 $41.3M)
• Net cash burn¹ of $5.4M for the half year, down 22% on prior corresponding period (pcp)
• Total revenue and other income of $5.7M (pcp: $0.7M), including US$3M AstraZeneca milestone payment and more than $1.0M for VivaGel^® product sales and royalties
• Reported loss for half-year of $5.9M (pcp: $7.3M), down by 19%
• Net operating cash outflows of $5.2M
• Receipt of $4.9M R&D tax incentive received in December
• In February, Starpharma received US$3.0M milestone payment from AstraZeneca

VivaGel^®

• VivaGel^® BV was launched in the UK under the brand Betafem^® BV Gel. Starpharma supplied product 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.
• VivaGel^® BV was recently launched in Asia under the brand Betadine^TM BV Gel, following the receipt of first Asian regulatory approvals and the supply of product during the half-year. Advanced marketing activities have been undertaken ahead of further launches in the Southeast Asian region.
• Aspen continued to advance their marketing and promotional activities for Fleurstat BVgel in Australia, and progressed with launch preparations for New Zealand. Starpharma has supplied product for the launch and conducted detailed sales representative training.
• 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.

DEP^® Drug Delivery

• Recruitment progressed, and promising efficacy signals were observed in the DEP^® docetaxel phase 2 trial in a variety of tumour types including non-small cell lung cancer, prostate cancer, and several hard to treat tumours. Two new sites, the Christie and the Beatson (Glasgow), were initiated and recruitment is continuing. Preparations advanced for the commencement of a DEP^® docetaxel + gemcitabine (Gemzar^®) combination arm with particular interest in pancreatic cancer.
• 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 progressing well.
• Commenced phase 1/2 clinical trial for DEP^® irinotecan, with recruitment continuing at three leading cancer sites, including the Christie, the Royal Marsden and Newcastle Freeman Hospital.
• AstraZeneca commenced the phase 1 clinical trial of its first DEP^® product, AZD0466, after the US FDA authorised the IND. The successful dosing of the first patient in this trial triggered a US$3 million milestone to Starpharma.
• Impressive data were reported for DEP^® irinotecan, alone and in combination with Merck and AstraZeneca’s Lynparza^®, in a refractory human colon cancer model.
• New DEP^® candidate, DEP^® gemcitabine, was advanced for development after 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.
• A novel HER-2 Targeted DEP^® conjugate (ADC) from Starpharma’s internal Targeted DEP^® program demonstrated significant tumour regression and 100% survival in a preclinical human ovarian cancer model.
• A range of DEP^® radiopharmaceutical and other DEP^® candidates have been made and are undergoing testing in a variety of models.
• Several new DEP^® patents were filed covering new DEP^® candidates and DEP^® in combination with marketed anticancer agents and novel DEP^®

Starpharma concluded the half-year in a strong financial position with a cash balance of $35.9 million, which does not include the US$3.0 million milestone payment from AstraZeneca for the first successful dosing of AZD0466, which was subsequently received in February 2020.

Revenues for the half-year totalled $5.9 million including a US$3 million AstraZeneca milestone payment and more than $1.0 million for VivaGel^® product sales and royalties. The net loss after tax for the half-year was $5.9 million (Dec 2018: $7.3 million), which is lower than the prior period primarily due to the aforementioned increase in revenue from DEP^® milestones and VivaGel^® products. The increase in expenditure in the half-year was predominantly driven by higher research and product development expenses including expenditure on the Company’s internal DEP^® clinical programs and preparations for a possible VivaGel^® BV treatment clinical trial. With the commencement of the DEP^® irinotecan clinical trial in the half-year, the Company has three DEP^® internal clinical trials underway, including DEP^® docetaxel and DEP^® cabazitaxel.

The increase in commercial and regulatory operating expense reflects internal and external costs related to US regulatory activities, commercial licences and the launch of VivaGel^® BV in multiple markets. The increase in corporate, administration and finance expense over the prior corresponding period predominately reflects a lower foreign currency gain in the current period.

Starpharma’s CEO, Dr Jackie Fairley, commented: “We achieved several significant milestones in the recent period, notably the launch of VivaGel^® BV in Asia and the UK, regulatory approvals in Asia, and we supplied product to multiple regions for future launches of the product in 2020. In our DEP^® portfolio, we announced positive interim results and advancement in our internal clinical trials, and AstraZeneca commenced a phase 1 trial for DEP^® AZD0466 in the US. This was our first partnered DEP^® product to enter the clinic, alongside our three internal clinical-stage DEP^® products, DEP^® docetaxel, DEP^® cabazitaxel and DEP^® irinotecan. AZD0466 is a great illustration of the benefits that can be created for novel agents using Starpharma’s DEP^® platform.”

Dr Fairley concluded: “We expect to announce further milestones throughout the next period, including the launch of VivaGel^® BV in New Zealand and additional countries in Central and Eastern Europe, as well as further regulatory approvals. We will continue to focus on advancing high potential DEP^® candidates through development, accelerating our clinical trials, wherever possible, and pursuing partnerships to leverage our proprietary DEP^® technology,” concluded Dr Fairley.

Download ASX Announcement: Interim Report and Half-Year Financial Results (pdf file, 555kb)

[1] Net cash burn is considered a non-IFRS value and has not been audited in accordance with Australian Accounting Standards. Net cash burn is calculated by the movement in cash and cash equivalents between reporting periods.