Synairgen plc: Preliminary results for the year ended 31 December 2019

Press release

Synairgen plc
(‘Synairgen’ or the ‘Company’)

Preliminary results for the year ended 31 December 2019

Southampton, UK – 26 May 2020: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company, today announces its preliminary statement of audited results for the year ended 31 December 2019.

Highlights (including post period-end)

Operational

• Synairgen has paused the SG015 trial of SNG001 (inhaled interferon-beta 1a) in COPD patients due to the prevalence of COVID-19 in the community, with 109 out of 120 patients recruited. The Company has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to conduct an unplanned interim analysis on the grounds that data from the 109 COPD patients with confirmed viral infection generates useful safety, biomarker and potentially efficacy data to support ongoing trials of SNG001 in COVID-19 patients. The results of this interim analysis are expected this Summer.
   
• In March 2020, Synairgen announced it had received expedited approvals from the MHRA and Health Research Authority (HRA) to conduct a trial of SNG001 in COVID-19 patients (SG016).
   
• The SG016 study has progressed well, with 98 patients out of the target of 100 now dosed in the hospital setting. Results from this part of the study are expected in July 2020.
   
• Synairgen is extending the SG016 study to patients in the home environment with confirmed COVID-19, to initiate dosing with SNG001 (or placebo) earlier in the course of the illness and before severe lower respiratory tract symptoms develop. Dosing in the home environment is expected to commence in May 2020, the details of which are included in a separate RNS announced today.

Financial

• In March 2020, Synairgen raised £14.0 million in a heavily oversubscribed equity issue to fund its COVID-19 related activities and strengthen its balance sheet.
   
• Research and development expenditure for the year amounted to £3.46 million (2018: £3.23 million) and the majority of this expenditure was focussed on running the IFN-beta Phase II clinical trial in COPD. 
   
• The loss from operations for the year ended 31 December 2019 was £4.82 million (2018: loss £4.13 million).
   
• Cash and bank deposits of £2.45 million at 31 December 2019 (31 December 2018: £5.33 million).

Board changes

      ·Paul Clegg retired from the Board as a non-executive director after the Company’s AGM in June 2019, with Iain Buchanan becoming the new Chairman of the Remuneration and Nomination Committee.

Richard Marsden, CEO of Synairgen, commented: “Over the coming months we will have three major clinical trial read-outs for SNG001, our wholly-owned, inhaled IFN-beta asset: COPD patients with regular seasonal viruses; COVID-19 hospital-treated patients; and the early treatment of COVID-19 patients in the home setting. The Company is active on many fronts from designing and managing novel trials to developing the regulatory strategy and supply chain for potential demand in the future.”

This announcement contains inside information as contained in Article 7 of the Market Abuse Regulation No. 596/2014 (‘MAR’).

For further enquiries, please contact:

Synairgen plc
Richard Marsden, Chief Executive Officer
John Ward, Finance Director
Tel: + 44 (0) 23 8051 2800

finnCap
Geoff Nash, Kate Bannatyne, Charlie Beeson (Corporate Finance)
Alice Lane, Manasa Patil (ECM)
Tel: + 44 (0) 20 7220 0500

Consilium Strategic Communications (Financial Media and Investor
Relations)
Mary-Jane Elliott, Sue Stuart, Olivia Manser
[email protected]
Tel: +44 (0) 20 3709 5700

Notes for Editors

About Synairgen

Synairgen is a respiratory drug discovery and development company founded by University of Southampton Professors Stephen Holgate, Donna Davies and Ratko Djukanovic. The business, focused primarily on lung viral defence in asthma and COPD, uses its differentiating human biology BioBank platform and world-renowned international academic KOL network to discover and develop novel therapies for respiratory disease. 

Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com

COVID-19

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.*
*Source: WHO website 20 May 2020 (https://www.who.int/health-topics/coronavirus#tab=tab_1)

*Please see PDF for the full report*

Attachment

• 200526 Synairgen prelims final