Melbourne, Australia; 27 August 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its annual report and financial results for the year ended 30 June 2020.

Financial Results

• Cash position at 30 June 2020 of $30.1M
• Net cash burn[1] of $11.2M (FY19: $10.1M)
• Total revenue and other income of $7.1M (FY19: $2.7M), an increase of 162% compared to the prior year
• Reported loss of $14.7M (FY19: $14.3M)
• Receipt of $4.9M R&D tax incentive

Key activities

• AstraZeneca commenced phase 1 trial for its first DEP^® product, AZD0466, and triggered a US$3 million milestone payment to Starpharma;
• DEP^® irinotecan phase 1 trial commenced and was completed successfully with encouraging efficacy signals observed, and progressed to a phase 2 trial;
• DEP^® cabazitaxel phase 1 trial was completed successfully with encouraging efficacy signals observed, and progressed to a phase 2 trial;
• Starpharma’s internal clinical DEP^® trials for DEP^® docetaxel, DEP^® cabazitaxel and  DEP^® irinotecan progressed well with all three assets now in phase 2 trials; encouraging efficacy signals were observed in each trial and multiple new sites opened;
• DEP^® docetaxel + gemcitabine clinical combination study commenced following ethics committee and regulatory approvals;
• VivaGel^® BV was launched in the UK and in Central and Eastern European countries, by Mundipharma under the Betadine brand; First Asian regulatory approvals were granted and VivaGel^® BV was launched in South East Asia; VivaGel^® BV achieved product sales and royalties of $1.5 million;
• VivaGel^® BV achieved #1 ranking in topical BV treatment in Australia, and product roll-out continued in Australia under the brand name Fleurstat BVgel, and Aspen launched the product in New Zealand;
• SPL7013 was tested and found to have significant activity against SARS-CoV-2, the coronavirus that causes COVID-19. Significant progress was made with product development for a nasal spray;
• Development of a DEP^® radiotherapy product, DEP^® lutetium, opening up a new opportunity for the application of the DEP^® platform;
• Signed a new DEP^® partnership with leading Chinese Pharmaceutical company Tianjin Chase Sun Pharmaceutical Co., Ltd, in a new therapeutic area (anti-infectives), with potential for additional programs in other therapeutic areas;
• DEP^® irinotecan in combination with immuno-oncology (IO) showed superior anti-tumour activity and significant survival benefit compared to IO alone in two human colorectal cancer models;
• Impressive data were reported for DEP^® irinotecan, alone and in combination with Lynparza^®, in a refractory human colon cancer model;
• DEP^® gemcitabine demonstrated significantly enhanced anti-tumour activity compared with Gemzar^® (gemcitabine) in a human pancreatic cancer model;
• A novel DEP^® HER-2 Targeted ADC (Antibody Drug Conjugate) conjugate demonstrated significant tumour regression and 100% survival in a preclinical human ovarian cancer model;
• Continued to actively pursue US FDA approval of VivaGel^® BV including progressing a detailed administrative review process with the agency;
• Expansion of Okamoto’s licence for the VivaGel^® condom in 11 further Asian countries (in addition to Japan);
• Achieved EU approval for the VivaGel^® condom, and Lifestyles commenced marketing preparations for launch in Europe;
• Advanced arrangements with potential partners of new Targeted (ADC) and non-ADC DEP^® programs;
• Signed a new DEP^® partnered program with an existing partner in a novel area of cancer therapeutics, and progressed DEP^® program discussions with two further major pharmaceutical companies;
• AACR (American Association for Cancer Research) Annual Meeting 2020 featured five posters based on Starpharma’s DEP^® products; and
• TGA licence granted to Starpharma to manufacture DEP^® active pharmaceutical ingredient in-house for clinical trial purposes.

Starpharma concluded the year in a strong financial position with a cash balance of $30.1 million. Revenues for the year totalled $6.6 million including a US$3 million AstraZeneca milestone payment and $1.5 million for VivaGel^® product sales and royalties. The net loss after tax for the year was $14.7 million, 3% higher than the previous year due to increased development expenses associated with the company’s expanding clinical product portfolio, which now includes three phase 2 assets.

Starpharma CEO, Dr Jackie Fairley, commented: “The past year has been an extraordinary period for all of us. While COVID-19 has impacted companies around the world, Starpharma was able to achieve a number of important milestones during the year, including: significant progress with our internal clinical-stage DEP^® assets with three products now in phase 2; advancing multiple new development programs, including in antivirals and radiotherapy; in addition to several product launches of VivaGel^® BV in the UK, Europe and Asia”.

Dr Fairley added: “As the pandemic emerged we also identified an opportunity for a preventative SPL7013 COVID-19 nasal spray. We already knew SPL7013 has broad spectrum antiviral activity, and undertook further testing which established it has significant activity against SARS-CoV-2. In a short period of time we have been able to develop nasal formulations, select a manufacturer and appropriate device components, and have undertaken pilot manufacture. We have also held discussions with regulators and confirmed a rapid development pathway. Feedback from key opinion leaders confirms that a SPL7013 antiviral nasal spray could be an important addition in preventing the transmission of COVID-19 and complementing vaccine-based strategies”.

“One of several DEP^® milestones for the year included  the commencement of AstraZeneca’s phase 1 trial for its first DEP^® product, AZD0466. In our internal DEP^® portfolio, we continued to advance our three clinical-stage DEP^® assets, including initiating a new combination study for DEP^® docetaxel; moving DEP^® cabazitaxel to phase 2; and successfully completing phase 1 for DEP^® irinotecan, ahead of schedule. We also made some important additions to our preclinical DEP^® pipeline with our first radiopharmaceutical, DEP^® lutetium, DEP^® gemcitabine and a novel HER-2 Targeted DEP^® (ADC).”

“In the year ahead, we will continue to advance our clinical DEP^® assets and expand our portfolio by moving up our preclinical programs and explore value-adding combinations to increase the market opportunities. Starpharma is well positioned for further growth as we achieve further approvals and launches in our VivaGel^® portfolio, as well as accelerating the development of our COVID-19 nasal spray.”, concluded Dr Fairley.

Starpharma has published a standalone ESG (Environment, Social & Governance) Report which is available at https://starpharma.com/responsibility.

Download ASX Announcement: Starpharma annual report and full year financial results (PDF, 6MB)

[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 from 30 June 2019 to 30 June 2020.