Jul 30, 2021

Quarterly Cashflow and Activities Report (ASX Announcement)

Quarterly Cashflow and Activities Report (ASX Announcement)

Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2021.

Starpharma’s cash balance as at 30 June 2021 was $60.5 million. The net cash-burn for the financial year was $16.5 million (FY20: $11.2 million) excluding the $46.9 million of equity raising proceeds.

Receipts for the quarter from customers and grants totalled $2.4 million. Receipts from customers for the quarter of $1.9 million included VIRALEZE™ and VivaGel® BV product sales as well as royalties for VivaGel® BV. Government grants of $0.5 million in the quarter included the Australian Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) program grant for VIRALEZE™. Cash outflows for the quarter include expenditure related to VIRALEZE™ launch activities including product manufacture, and also clinical costs and antiviral testing for VIRALEZE™. Expenditure also included trial costs for Starpharma’s three phase 2 DEP® clinical programs, as well as further development of multiple preclinical DEP® candidates, such as DEP® radiopharmaceuticals and DEP® ADCs.

Key recent activities and events:

  • VIRALEZE™ was registered for sale in India and Starpharma is in advanced discussions for local distribution arrangements in India with potential commercial partners into both the private (consumer) and Government markets. In the interim, consumers in India can purchase VIRALEZE™ online.
  • VIRALEZE™ was launched in Europe in May 2021 through a dedicated webstore, which followed the product launch in LloydsPharmacy and online in the UK earlier in the year.
  • VIRALEZE™ sales in the UK via LloydsPharmacy are temporarily paused while Starpharma and its distribution partner address correspondence from the MHRA in relation to promotional claims. In parallel, Starpharma is undertaking contingencies in relation to packaging in the event changes are required.
  • Starpharma is negotiating distribution and marketing arrangements for VIRALEZE™ in a number of countries in addition to India, including various European countries and other international regions. In parallel, Starpharma continued to progress regulatory activities for VIRALEZE™ for a number of other markets, including in Australia where a submission has been made to the TGA.[1]
  • Impressive data established that SPL7013, the antiviral agent in VIRALEZE™ nasal spray, has potent virucidal activity (>99.99%) against the globally significant Delta variant of SARS-CoV-2. Antiviral testing at Scripps Research Institute has now confirmed that SPL7013 has >99% virucidal activity against all four of the WHO-designated SARS‑CoV‑2 variants of concern[2] (Alpha, Beta, Gamma, Delta) in laboratory studies, as well as the closely related Kappa variant.
  • Extensive antiviral data for SPL7013 (the antiviral agent in VIRALEZE™) was published in the prestigious international scientific journal, Antiviral Research[3].
  • Starpharma secured a partnership between VIRALEZE™ and 2021 English Premiership rugby union champions, Harlequins.
  • VIRALEZE™ clinical trial: Starpharma completed a double-blinded, placebo-controlled safety study to support marketing of VIRALEZE™. The study involved 40 healthy volunteers, using the product 4 times a day for 14 consecutive days. All participants have completed the study. VIRALEZE™ was extremely well tolerated by all participants and study results will be released following final analysis of all blood samples and trial data.
  • During the quarter, AstraZeneca commenced recruitment into a multi-region combined phase 1/2 trial in advanced haematological malignancies as part of its expedited clinical development program for DEP® The new phase 1/2 trial design is aimed at seamless transition to phase 2, to facilitate marketing approval. Data was also recently published showing the potent anti-cancer effects of AZD0466 in a malignant mesothelioma model.[4]
  • DEP® irinotecan phase 2 trial continues to progress well, with 53 patients now recruited. Encouraging efficacy signals observed include significant tumour shrinkage maintained for up to 26 weeks, prolonged stable disease for up to 71 weeks in breast cancer, impressive tumour shrinkage and reductions in tumour marker levels for a number of tumour types, including breast, colorectal, ovarian, pancreatic, lung and oesophageal cancer. A patient with heavily pre-treated metastatic ovarian cancer also experienced a 98% reduction of tumour marker (CA-125) following 5 cycles of DEP® irinotecan and follow up scans showed a complete disappearance of her target tumour.
  • DEP® docetaxel clinical trials continue to progress well, with 49 patients now recruited and encouraging efficacy signals observed, including prolonged stable disease and significant tumour shrinkage including in patients with hard-to-treat tumours such as pancreatic, oesophageal, cholangiocarcinoma, and gastric cancer. These impressive tumour responses in heavily pre-treated include stable disease for up to 40 weeks and significant tumour shrinkage in an oesophageal cancer patients, maintained for more than 28 weeks.
  • DEP® cabazitaxel phase 2 trial continues to progress well, with 42 patients now recruited and multiple efficacy signals observed, including radiological responses, significant reductions in prostate-specific antigen (PSA) and lack of new bone metastases, seen in multiple prostate cancer patients. These observations have been reported for patients who have been previously heavily treated with chemotherapy and radiation. Responses included patients previously treated with conventional cabazitaxel or conventional docetaxel (taxanes). One patient who had previously received multiple cycles of conventional docetaxel and several other anticancer agents achieved three responses - significant tumour shrinkage, a PSA response and a reduction in the number of bone metastases. Other notable efficacy signals in heavily pre-treated patients include longstanding significant shrinkage in two different types of gastro-oesophageal cancers, as well as ovarian, cholangiocarcinoma, lung, thymic and head and neck cancers.
  • Starpharma was invited to present its DEP® technology at the prestigious, international Controlled Release Society (CRS) Virtual Annual Meeting, during a session called ‘Success Stories from Bench to Trials to Market’. There was also a presentation on new data on AZD0466 generated under a research collaboration between AstraZeneca, Starpharma, and Monash Institute of Pharmaceuticals Sciences.
  • Further DEP® candidates continue to be progressed toward the clinic, including progress with DEP® Additional development was undertaken for multiple DEP® candidates in the area of radiopharmaceuticals and antibody drug conjugates (ADCs).
  • Starpharma has initiated a number of new radiopharmaceutical and ADC commercial discussions, and continued to progress its disclosed/undisclosed partnered programs, including with AstraZeneca, Merck Sharpe & Dohme (MSD) and Chase Sun.
  • For VivaGel® BV, Starpharma and Mundipharma teams continued to progress regulatory activities in a range of countries, as well as marketing activities with key opinion leaders in Europe. VivaGel® BV is currently registered in more than 45 countries.
  • LifeStyles launched the VivaGel® condom in countries in Europe during the quarter, marketed under LifeStyles’ Manix and Akuel brands of condoms as the Absolute™ Dual Protection condom.

Dr Jackie Fairley, Starpharma CEO, commented: “During the quarter Starpharma achieved a further product registration for VIRALEZE™, in India, launched the product in Europe and also confirmed impressive antiviral activity of SPL7013 against the problematic Delta variant. Recent testing at Scripps Research Institute confirmed virucidal activity >99.99% for SPL7013 (VIRALEZE™ antiviral agent) against all four SARS-CoV-2 variants of concern including the Delta variant. Given its potent and broad spectrum of activity, VIRALEZE™ could prove to be particularly beneficial as an additional protective measure against these variants. We are rapidly progressing other registrations and distribution arrangements in further countries and regions.”  

Dr Fairley added, “In addition, Starpharma continued to progress our partnered DEP® programs, including with MSD in the exciting area of ADCs, and the expansion of AstraZeneca’s clinical program for DEP® AZD0466. We also progressed our three clinical stage DEP® assets which continued to recruit well and report impressive tumour responses in heavily pre-treated patients who otherwise would have limited options.”

The closing cash balance as at 30 June 2021 was $60.5 million. Net operating cash outflows of $3.6 million for the quarter includes significant investment in R&D ($2.6 million) and product manufacturing and operating expenses ($1.7 million), this reflects investment in multiple phase 2 DEP® clinical programs and launch, promotion and manufacture of VIRALEZE™. Receipts from customers and grants in the quarter totalled $2.4 million. Staffing costs remained stable with quarterly staff costs of $1.6 million, including non-executive and executive directors’ fees of $233,000.

Download ASX Announcement: Quarterly Cashflow and Activity Report (pdf, 459kb)

[1] VIRALEZE™ is not registered for sale or supply in Australia.

[2] The Delta, Alpha, Beta and Gamma variants of SARS-CoV-2 are all classified ‘Variants of Concern’ by global health authorities due to their increased transmissibility, increased disease severity (COVID-19), and/or reduced effectiveness of current treatments or vaccines.

[3] Paull, J.R.A. et al. Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro (2021). Antiviral Research. https://doi.org/10.1016/j.antiviral.2021.105089 

[4] Research paper on AZD0466 published: “A novel BH3-mimetic, AZD0466, targeting BCL-XL and BCL-2 is effective in a pre-clinical model of malignant pleural mesothelioma”.

 This contains certain forward-looking statements.