Jan 29, 2021
Quarterly Cashflow and Activity Report
Melbourne, Australia; 29 January 2021: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2020.
Starpharma’s cash balance as at 31 December 2020 was $70.3 million.
Net operating cash outflows for the quarter were $0.7 million, compared to $5.4 million last quarter, with the R&D tax incentive refund of $5.7 million received in October 2020. Cash flows from financing activities include net proceeds of $47.0 million from the equity raising in the quarter.
Cash outflows for the quarter include expenditure relating to the pre-launch activities for the VIRALEZE™ antiviral nasal spray, including preparation for the manufacture of launch batches, completion of required testing and documentation requirements and commercialisation activities. Cash outflows also included expenditure on Starpharma’s three DEP® product phase 2 clinical programs.
Key recent activities and events:
- VIRALEZE™ European dossier has been completed and is undergoing final review ahead of submission shortly; VIRALEZE™ is on track to be registered in Europe and ready for market Q1 CY2021. VIRALEZE™ is an easy to use broad-spectrum antiviral nasal spray which can be stored at room temperature. Initial launch batches of VIRALEZE™ are currently being manufactured to support rapid European launch following approval. Launch preparations and commercial activities are advancing well, including discussions with pharmacy chains, B2B customers, and online platforms. Licensing discussions are continuing in parallel.
- SPL7013 demonstrated potent activity in respiratory pathogen RSV (respiratory syncytial virus) – further antiviral testing underway to expand the potential use for VIRALEZE™. Following confirmation of the activity of SPL7013 in RSV, further antiviral testing continues to be conducted at the Scripps Research Institute in other respiratory viruses to further broaden the product claims for VIRALEZE™ and expand its utility, post-approval. Based on the effectiveness of VIRALEZE™ against multiple viruses, including drug-resistant strains, the product is expected to retain activity against the coronavirus strains being reported in the UK, South Africa and elsewhere.
- Starpharma commenced a human study for VIRALEZE™ and dosing of the first cohort is complete. This study is being undertaken to support commercialisation activities for VIRALEZE™, but is not a requirement to achieve EU product registration. The study, which is being conducted in Perth, Western Australia, is expected to be completed during Q1 CY2021.
- DEP® irinotecan phase 2 trial continues to progress well. Encouraging efficacy signals have been observed for a number of tumour types, including breast, colorectal, ovarian, pancreatic, lung and oesophageal cancer. Efficacy signals include tumour shrinkage and stable disease – including 72 weeks’ stable disease in a breast cancer patient. These efficacy signals are particularly encouraging given the heavy pre-treatment in trial patients, who average ~30 dosing cycles of anti-cancer therapy and an average of four different types of treatment before entering the DEP® irinotecan trial. Preparations continue for the addition of clinical combinations with DEP® irinotecan, thereby expanding the market opportunity.
- DEP® docetaxel clinical trials continue to progress well, with encouraging efficacy signals observed, including prolonged stable disease and tumour shrinkage in patients with pancreatic, oesophageal and gastric cancer. Patients treated with DEP® docetaxel continue to experience less neutropenia than is usually associated with the standard version of docetaxel (Taxotere®) and have not required pre-treatment with cortisone.
- DEP® cabazitaxel phase 2 trial continues to progress well, with encouraging efficacy signals observed, including stable disease, significant target tumour shrinkage and substantial tumour marker reductions (e.g. PSA), in cancers including prostate, ovarian, lung, gastro-oesophageal, head and neck and other cancers. Patients treated with DEP® cabazitaxel continue to experience less neutropenia than is usually associated with the standard version of cabazitaxel (Jevtana®) and have not required pre-treatment with cortisone.
- The impact of COVID-19 in the UK, where DEP® trials are taking place, has had a variable effect on the DEP® clinical programs depending on site-specific factors including the location and type of hospital. Existing DEP® trial patients continue to receive treatment; however, new patient recruitment has slowed in some trial sites, especially those in general hospitals in large cities. Recruitment at other sites, including dedicated cancer hospitals, has been faster than usual. An Australian site has been initiated for both the DEP® irinotecan and DEP® cabazitaxel trials and recruitment there has been relatively unaffected by COVID-19 restrictions.
- AstraZeneca’s phase 1 clinical trial for DEP® AZD0466 continues to progress well, with potential expansion in the coming months.
- Further pharmacokinetic testing confirmed the enhanced benefits of DEP® remdesivir, including low injection volume (2-3 mL), and long-acting, controlled release when administered both subcutaneously and intravenously. These DEP® benefits represent a significant improvement over the large volume and repeated intravenous infusions required by current remdesivir formulation (Gilead’s Veklury®).
- Active commercial discussions in relation to several new DEP® partnered programs are advancing, including in the area of Antibody Drug Conjugates (ADCs). Starpharma also has a number of other ongoing partnered DEP® programs, which continued to make progress, including the DEP® anti-infective program with Chase Sun.
- Aspen’s Fleurstat BVgel campaign was awarded the 2020 Diamond Award for Best Launch of a Consumer Healthcare Product. VivaGel® BV continues to receive positive product reviews by BV patients. Mundipharma continued with regulatory submissions and launch activities for VivaGel® BV in multiple regions. Reduced consumer activity (e.g. social activity and workplace attendance) due to COVID-19 lockdowns have impacted consumer demand and sales activities. Formal FDA review process for the US market is ongoing.
- Progress with several internal DEP® programs being developed, including ADCs and radiopharmaceutical candidates for both therapeutic and diagnostic applications. Radiopharmaceuticals are a rapidly developing area in oncology which has recently generated several high-value deals.
- Starpharma’s laboratory and internal operations continued to operate with minimal disruption, under a COVID safe plan.
Dr Jackie Fairley, Starpharma CEO, commented: “Considering the current situation in Europe, we are pleased to see our oncology trial sites continuing to treat and recruit DEP® patients, and to see positive patient outcomes with our DEP® drugs, including a range of impressive efficacy signals and improved safety profile. We also continued to actively progress our partnered DEP® programs and we look forward to new additions in the coming months, including in the area of ADCs.”
In relation to the Company’s VIRALEZE™ nasal spray, Dr Fairley said: “We have just completed the regulatory dossier for Europe and expect to submit this shortly. We are also manufacturing the first batches of VIRALEZE™ in readiness for launch. We continue to test the active ingredient in VIRALEZE™ against further important respiratory viruses, and indeed, further strains of the coronavirus. Not surprisingly, our consumer research in Europe indicates very strong demand for VIRALEZE™, including after the roll-out of efficacious vaccines, and we are on track for the product to be launched during Q1 CY2021, which is ahead of the original schedule.”
The closing cash balance as at 31 December 2020 was $70.3 million, including the net proceeds of $47.0 million from the equity placement and share purchase plan in the quarter. Net operating cash outflows of $0.7 million for the quarter includes the receipt of $5.7 million for the R&D tax incentive refund. Investment in R&D ($4.0 million) and product manufacturing and operating expenses ($0.9 million) reflects investment in multiple phase 2 DEP® clinical programs and increased expenditure on the VIRALEZE™ nasal spray in preparation for launch. Starpharma’s VIRALEZE™ nasal spray program is also supported by a $1.0 million Australian MRFF grant, with $0.2 million received subsequent to the end of the quarter. Staffing levels remained stable with quarterly staff costs of $1.6 million, including non-executive and executive directors’ fees of $242,000.There was an unfavorable foreign exchange loss of $0.7 million in the quarter on the declining value of US dollars held.
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