Melbourne, Australia; 30 July 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2020.

Starpharma’s cash balance as at 30 June 2020 was $30.1 million. The net cash-burn for the financial year was $11.2 million (FY19: $10.1 million). Receipts for the quarter totalled $0.9 million. Receipts from customers included product sales, royalties and an approval milestone for VivaGel^® BV. Cash outflows for the quarter include expenditure on Starpharma’s clinical trials, including its three phase 2 DEP^® programs. Expenditure also included development of multiple preclinical candidates, including DEP^® lutetium and DEP^® ADC programs, as well as costs associated with VivaGel^® BV.

Starpharma continues to maintain its strong balance sheet, and is well placed to advance its three phase 2 DEP^® assets, alongside its commercial products, and to progress its development activities including the new COVID-19 nasal spray.

Key recent activities and events:

• DEP^® irinotecan phase 1 trial was successfully completed ahead of schedule and moved immediately into phase 2. In phase 1, DEP^® irinotecan was well-tolerated and patients generally experienced fewer and less severe side effects, including no cases of the problematic severe diarrhoea, which is common with the conventional form of irinotecan (and has a FDA black box warning). Encouraging efficacy signals were observed in 50% of evaluable patients. A number of patients have already been dosed in phase 2, which is actively recruiting at five sites, including The Kinghorn Cancer Centre (Sydney) and the Beatson (Glasgow), both of which recently opened for recruitment.
• Starpharma successfully developed DEP^® lutetium, a radiotherapeutic candidate that showed statistically significant and durable anticancer activity and was extremely well tolerated in a human prostate cancer model (DU-145). DEP^® lutetium is one of several promising DEP^® radiotherapeutic candidates in development.
• AstraZeneca continued to progress its phase 1 clinical trial for DEP^® AZD0466, opening the prestigious MD Anderson Cancer Center (Houston, Texas) as an additional trial site.
• Following positive results with SPL7013 against the COVID-19 SARS-CoV-2 (coronavirus), Starpharma commenced rapidly developing an SPL7013 COVID nasal spray that has the potential to prevent acquisition and transmission of SARS-CoV-2, and to complement vaccine-based prevention strategies.
  • Starpharma has patented the COVID-19 nasal spray and is expediting its development by leveraging existing regulatory approvals, clinical and nonclinical data for marketed products containing SPL7013, stocks of material, supply chains and existing relationships. Starpharma is also pursuing grant funding, and has commenced commercialisation discussions.
  • During the quarter, Starpharma confirmed with regulators the classification of the COVID-19 nasal spray, and that minimal re-development is required for the product. Starpharma’s strategy is to leverage its vast body of existing technical data for SPL7013 and existing regulatory approvals, to fast-track development and to expedite product launch.
  • Given SPL7013 has broad spectrum antiviral activity, Starpharma is also exploring the nasal spray’s application beyond COVID-19 for common respiratory viruses and as a pandemic preparedness product. 

• VivaGel^® BV was launched in the Central and Eastern European region. This launch follows launches in Germany, the UK and several other European countries. Mundipharma is continuing with activities to expand its geographic footprint of VivaGel^® Multiple additional regulatory applications were submitted for Betadine^TM BV Gel and new approvals were granted. In Australia, Aspen continued its promotional activities for Fleurstat BVgel, maintaining its #1 position by market share of topical BV treatments in Australia.
• The formal review process with the US FDA for approval of VivaGel^® BV continued and is ongoing, with the expectation that COVID-19 will continue to impact the timeline.
• Recruitment has resumed in all DEP^® clinical trials following some disruption to new patient recruitment associated with the impact of COVID-19 on UK hospitals. There are some trial sites including in London where recruitment resumption has been slower than in regional centres.
• DEP^® docetaxel – DEP^® docetaxel + gemcitabine combination study commenced at the Christie, with further sites to open in the coming weeks. This combination study will run in parallel with the ongoing phase 2 study and will further enhance the commercial potential of DEP^® The ongoing phase 2 study continues to progress following slowed recruitment due to COVID-19. Patients treated with DEP^® docetaxel in the trial have experienced impressive results including stable disease and substantial target tumour shrinkage in cancers including pancreatic, lung, prostate, gastric and oesophageal.
• DEP^® cabazitaxel – recruitment is progressing well following COVID-19 interruption, and a fifth site has been added to this trial at the Kinghorn Cancer Centre in Sydney. Impressive data continues to emerge, with demonstration of encouraging efficacy signals, including stable disease, significant target tumour shrinkage and substantial tumour marker reductions (e.g. PSA[1]), in cancers including prostate, gastro-oesophageal, breast, ovarian and cholangiocarcinoma.
• DEP^® irinotecan in combination with an immuno-oncology (IO) agent (anti PD-1 antibody) showed improvement in survival and efficacy in human colorectal cancer (CRC) models when compared to anti PD-1 antibody alone. This impressive data and results from our phase 1 DEP^® irinotecan trial have already attracted the attention of industry players and have triggered discussions regarding potential clinical combinations.
• Starpharma signed up a new DEP^® program with an existing partner in an exciting and novel area of cancer therapeutics.
• An agreement is currently being finalised for a DEP^® program in a new therapeutic area with a new commercial partner. The first DEP^® program is for an anti-infective, and the agreement will be structured to allow for expansion into other therapy areas.
• Commercial discussions are underway with two further major pharmaceutical companies for several partnered DEP^® drug delivery programs in oncology and non-oncology areas.
• Five posters featuring the DEP^® platform were presented at the AACR (American Association for Cancer Research) Annual Meeting. Three featured AstraZeneca’s DEP^® oncology product, AZD0466, which consistently outperformed venetoclax in multiple preclinical tumour models. Two posters showcased Starpharma’s three clinical-stage DEP^® products, demonstrating superior performance in a range of tumour models, both alone and in combination with other agents.
• Several preclinical programs progressed, including advancing DEP^® gemcitabine towards the clinic, and initiating new internal programs, including a DEP^® based antiviral treatment for COVID-19.

Dr Jackie Fairley, Starpharma CEO, commented: “We are pleased to have maintained good progress during this past quarter including completion of the DEP^® irinotecan trial ahead of schedule, despite the challenges presented by COVID-19. Whilst the quarter has been impacted by several one-off clinical expenses and the expansion of our internal DEP^® portfolio to three phase 2 programs, we are pleased to have been able to maintain our annual cash burn at similar levels as previous years”.

“We quickly identified an opportunity for a preventative SPL7013 COVID-19 nasal spray, confirmed an expedited regulatory pathway with regulators and have rapidly progressed its development. Specialist clinical feedback has confirmed that a preventative nasal spray would be highly valued and play an important role in reducing transmission, complementing vaccine-based prevention strategies”, added Dr Fairley.

“We continued to advance our three phase 2 DEP^® assets and to build our pipeline, adding DEP^® lutetium, which showed impressive efficacy and survival benefit. These impressive results in this rapidly expanding area further illustrate the versatility of Starpharma’s DEP^® platform,” concluded Dr Fairley. 

Receipts for the quarter of $0.9 million included product supply, royalties and milestone payments for VivaGel^® BV, as well as government grants. Operating cash outflows for the quarter reflects the investment in product R&D ($3.8 million), including one-off costs related to the completion of the DEP^® irinotecan phase 1, trial start-up cost including clinical trial supplies, and one-off regulatory costs. Staffing levels were stable with staff costs for the quarter slightly lower at $1.6 million, including directors’ fees and CEO remuneration of $232,000. The closing cash balance of $30.1 million was adversely impacted by a foreign exchange loss of $1.1 million in the quarter.

COVID-19

During the quarter, Starpharma continued to employ a broad range of measures to protect the health and safety of staff and clinical trial patients. Starpharma continues to actively monitor and review the situation, and measures are updated as appropriate.

Disruptions to the Company’s laboratory and office operations and its supply chain continue to be minimal, although, in Starpharma’s clinical trials, there was disruption to new patient recruitment associated with the impact of COVID-19 on UK hospitals. Recruitment has now resumed in all DEP^® clinical trials and as previously advised, a number of new sites have been opened.

As experienced by companies around the world, Starpharma’s partners for VivaGel^® BV have had some disruption to their sales and marketing activities, and the COVID-19 lockdowns have delayed some launches and may impact consumer demand.

Download ASX Announcement: Quarterly Cashflow and Activity Report (pdf, 219kb)

[1] PSA – Prostate Specific Antigen