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Interim results as well:
Synairgen plc
('Synairgen' or the 'Company')
Interim results for the six months ended 30 June 2020
Southampton, UK - 29 September 2020: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today announces its unaudited interim results for the six months ended 30 June 2020.
Highlights (including post period-end)
Operational
· Positive results from SG016, its double-blind placebo-controlled Phase II trial of SNG001 in hospitalised COVID-19 patients announced in July
· The Company extended the SG016 Phase II trial to include a further 120 patients with confirmed COVID-19 to be dosed in the home environment (ongoing)
· Positive results from interim analysis of SG015, its double-blind placebo-controlled Phase II trial of SNG001 in COPD patients announced in September, supporting the COVID-19 programme
· Patent applications for SNG001 in COVID-19 patients and in exacerbating COPD patients undergoing treatment with systemic corticosteroids were submitted post period-end
· Synairgen launched a Managed Access Program with Clinigen, to provide SNG001 to hospitalised COVID-19 patients - see separate announcement issued today
· The Company is currently in discussions with regulatory agencies to establish the route to approval of SNG001 as a treatment for COVID-19
· The Company is also investing in supply chain activities to ensure that drug and aerosol delivery system availability can meet potential demand, pending approval
Financial
· In March 2020, Synairgen raised £14.0 million (before expenses) in an equity issue to fund its initial COVID-19 related activities and strengthen its balance sheet
· Research and development expenditure for the six months ended 30 June 2020 was £4.47 million (30 June 2019: £1.69 million) as the Company advanced its clinical trial of SNG001 in COVID-19 patients and scale-up activities
· The loss from operations for the six months ended 30 June 2020 was £5.08 million (30 June 2019: £2.21 million loss)
· Cash balances of £10.9 million at 30 June 2020 (30 June 2019: £3.52 million)
Richard Marsden, CEO of Synairgen, said: "The first six months of this year have been the most significant in Synairgen's history. We were delighted to announce positive results from our hospital-based COVID-19 trial in July, and have been working tirelessly on the progression of SNG001 as a potential treatment for COVID-19 patients. With further positive results from our interim analysis of SNG001 in COPD announced in September 2020, we feel well-equipped to realise our strategy of progressing inhaled interferon beta for the treatment of respiratory viruses. I'd like to thank everyone involved in the Company and trials for all their hard work to date."
We finally got news and it looks great!
Synairgen and Clinigen sign Managed Access Program agreement with SNG001 for treatment of hospitalised patients with COVID-19
Southampton and Burton-on-Trent, UK - 29 September, 2020: Synairgen plc (AIM: SNG, 'Synairgen'), the respiratory drug discovery and development company and Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company, have signed an agreement to launch a Managed Access Program for Synairgen's inhaled formulation of interferon beta
(IFN-beta), SNG001, in the UK and the EU for the treatment of hospitalised COVID-19 patients.
SNG001 is an inhaled formulation of IFN-beta for direct delivery to the lungs via nebulisation. Synairgen announced positive topline data generated from 101 patients hospitalised with COVID-19 in its phase II trial, SG016, on the 20 July 2020. The trial of SNG001 in hospitalised patients produced very encouraging findings; patients who received SNG001 were more than twice as likely to recover over the course of the treatment period compared to those receiving placebo. Synairgen is currently in discussions with regulatory agencies to progress this potential COVID-19 treatment.
Richard Marsden, Chief Executive Officer of Synairgen, commented: "We are working tirelessly to progress SNG001 through the required clinical and regulatory channels to make this potentially critical treatment widely available to COVID-19 patients around the world. In the meantime, we are delighted to partner with Clinigen, whose extensive European experience and regulatory expertise will support access to treatment with SNG001 for hospitalised patients who most urgently need it."
Shaun Chilton, Clinigen Chief Executive Officer, added: "We are working with a number of companies who have products being tested against COVID-19 and are very pleased to be working with Synairgen to make this highly promising COVID-19 treatment available internationally. The early study results demonstrate that SNG001 may have a vital role in helping hospitalised patients recover more quickly from the disease."