Oct 30, 2020
Quarterly Cashflow and Activities Report
Melbourne, Australia; 30 October 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2020.
Starpharma’s cash balance as at 30 September 2020 was $24.9 million, with net operating cash outflows for the quarter of $4.7 million. The cash balance does not include $48.9 million from the capital raising or $5.7 million of R&D Tax Incentive Refund, which occurred after the end of the quarter. With both the R&D Tax Incentive Refund and the proceeds from the financing, Starpharma is in an extremely strong financial position with more than $70 million cash on hand.
The oversubscribed share placement saw a high level of demand from local, US and global institutions, and included significant investments by a number of new institutional investors. This financing has further strengthened Starpharma’s financial position and will enable the Company to continue accelerated development and commercialisation activities for the launch of the SPL7013 COVID-19 nasal spray. Starpharma will also expedite the pipeline development of new DEP® candidates. In addition, the Company will add important clinical combinations for its clinical DEP® assets, to further expand the commercial opportunity for these products, including DEP® irinotecan.
Key recent activities and events:
- Key development activities were completed for SPL7013 COVID-19 nasal spray, including reformulation, pilot product manufacture, selection of device components, packaging, artwork creation and branding, and selection of manufacturer. Regulatory documentation is also being compiled in preparation for submission. The Company continues commercial discussions and preparations across a range of distribution channels and customer groups (e.g. B2B, online platforms), with the product expected to be ready for market in 1H CY2021.
- Antiviral testing of SPL7013 at Scripps Research Institute confirmed SPL7013 is virucidal, inactivating more than 99.99% of SARS-CoV-2, the virus that causes COVID‑19. Potent antiviral activity of SPL7013 against SARS-CoV-2 was evident when used either before or after exposure of cells to the virus meaning that the nasal spray could potentially be used before or after exposure to the virus.
- DEP® irinotecan phase 2 trial is rapidly recruiting patients, with 27 patients already dosed and a high level of interest in the study. Encouraging efficacy signals have been observed for a number of tumour types, including colorectal, ovarian, pancreatic and oesophageal cancer. The trial continues to recruit patients with a focus on those with colorectal as well as breast and pancreatic. Starpharma has commenced preparations for the addition of clinical combinations with DEP® irinotecan, based on investigator interest and preclinical studies, including in the area of immunotherapy.
- Starpharma developed and patented DEP® remdesivir, an improved version of Gilead’s remdesivir, an antiviral drug recently approved by the FDA for the treatment of COVID-19 patients with severe disease. DEP® remdesivir has the potential to expand the application of remdesivir, by creating a long-acting version which could be given as a small subcutaneous injection rather than an intravenous infusion in hospital. Following the announcement of the successful and rapid development of DEP® remdesivir, Starpharma has received an increase in the number of enquiries about the DEP® platform from pharmaceutical companies.
- DEP® docetaxel phase 2 trial continues to progress well, with further observations of encouraging efficacy signals, including prolonged stable disease and tumour shrinkage in patients with pancreatic, oesophageal and gastric cancer. For example, a 72 year old female trial participant with extensive intrahepatic cholangiocarcinoma achieved >16 weeks stable disease following 4 cycles of DEP® This result was achieved despite the patient having been heavily pre-treated for this rare but aggressive form of cancer.
- DEP® docetaxel + gemcitabine combination study has commenced based on compelling DEP® preclinical data and investigator interest. This combination study will recruit an initial cohort of approximately 10-12 patients and will run in parallel with the phase 2 DEP® docetaxel trial.
- DEP® cabazitaxel phase 2 trial continues to progress well, with encouraging efficacy signals, including stable disease, significant target tumour shrinkage and substantial tumour marker reductions (e.g. PSA), in cancers including prostate, ovarian, lung, gastro-oesophageal and others. For example, 65-year old male trial participant with late‑stage (metastatic) gastro-oesophageal cancer achieved a 50% reduction in target tumours, and was maintained for >27 weeks following six cycles of DEP® This result was achieved despite the patient having been heavily pre-treated with >15 cycles of three different kinds of anti-cancer treatment.
- AstraZeneca continued to progress its phase 1 clinical trial program for DEP® AZD0466, and further sites were opened during the quarter in the US.
- VivaGel® BV achieved TGA approval for an expansion of the marketing authorisation for VivaGel® BV (Fleurstat BVgel) to include the indication of prevention of recurrent bacterial vaginosis – bringing the approved indications for VivaGel® BV (Fleurstat BVgel) in line with those in Europe and Asia.
- VivaGel® BV was launched in the Nordic region, new regulatory approvals were also received for countries in Africa and the Middle East, and further submissions are underway. The formal FDA review is ongoing, and COVID-19 has had an impact on timing.
- Signed and commenced a new DEP® partnership with leading Chinese company Chase Sun to develop several DEP® nanoparticle formulations for an anti-infective drug with the view of enhancing its performance and expanding its therapeutic utility.
- Starpharma is progressing multiple DEP® partnered programs and further commercial discussions with new pharmaceutical companies, including Antibody Drug Conjugates (ADCs), and other therapeutic areas. ADCs continue to generate significant industry interest and have been the subject of recent deals, including Gilead’s acquisition of Immunomedics for US$21 billion (Sep 2020).
- Progress with several internal DEP® programs being developed, including radiopharmaceutical candidates, both therapeutic and diagnostic.
- Medical Research Future Fund awarded Starpharma $1 million in matched grant funding for the SPL7013 COVID-19 nasal spray following consideration of more than 100 applications by an international industry panel.
- Starpharma’s laboratory and internal operations have continued to operate under a COVID safe plan, with minimal disruption. Recruitment continued in all DEP® clinical trials during the quarter and Starpharma’s partners for VivaGel® BV have experienced some disruption to sales and marketing activities.
Dr Jackie Fairley, Starpharma CEO, commented: “The past quarter has been a period of significant achievements for the Company, with the expedited development of the SPL7013 COVID-19 nasal spray, which is expected to be ready for market in H1CY2021. The recent impressive virucidal results, inactivating >99.99% of coronavirus, provide a powerful rationale for the product to complement vaccines and other PPE. The expedited development of the nasal spray means this product may be available ahead of vaccine rollout.”
“It was particularly pleasing to see rapid recruitment into a number of our DEP® programs following the interruption by COVID-19. DEP® irinotecan continues to attract significant interest from patients, investigators and partners. We look forward to initiating important, value-adding combinations to further expand the commercial opportunity for our clinical assets. We were also delighted to sign and commence a new DEP® partnership with Chase Sun, to apply DEP® to an anti-infective drug.”
“The power of the DEP® platform was further illustrated by our ability to rapidly develop a long-acting DEP® version of Gilead’s antiviral drug, remdesivir, which could be administered subcutaneously. This program demonstrates Starpharma’s capacity to rapidly turnaround new candidates, as well as the broad applicability of the DEP® platform.”
“We also continue to add greater depth to our partnered DEP® programs with major pharmaceutical companies, including in the area of ADCs which have recently been the subject of significant commercial deals, such as those struck between Gilead + Immunomedics (US$21 billion), and Merck + Seattle Genetics (~US$2.6 billion),” added Dr Fairley.
Net operating cash outflows of $4.7 million for the quarter reflects the investment in product R&D ($2.6 million), namely multiple DEP® clinical programs, including the DEP® docetaxel + gemcitabine phase 1. Receipts from customers and Government grants totalled $547,000, with customer receipts during this quarter reflecting the timing of supply of VivaGel® BV batches, which vary according to launch timing. Staffing levels remained stable with quarterly staff costs of $1.6 million, including non-executive and executive directors’ fees of $275,000. The closing cash balance as at 30 September 2020 of $24.9 million, excludes the subsequent capital raising and R&D Tax Incentive Refund which bring cash on hand to more than $70 million.
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