Synairgen plc (SNG.L) Full Year Results/Significant progress continues towards a treatment for COVID-19

Preliminary results for the year ended 31 December 2020

Southampton, UK – 12 May 2021: Synairgen plc (LSE: SNG), the respiratory company developing inhaled interferon beta (IFN-beta) for the treatment of severe viral lung infections, today announces its preliminary statement of audited results for the year ended 31 December 2020.

Highlights (including post period-end)

Operational

· Positive results from Synairgen’s Phase II trial (SG016) of inhaled interferon beta-1a (SNG001) in 101 hospitalised COVID-19 patients reported in July 2020

– Further analyses announced in September 2020 and trial data published in The Lancet Respiratory Medicine in November 2020

· SG016 trial expanded to include a further 120 COVID-19 patients in the home environment

– Analysis of combined data from Hospital and Home Cohorts in April 2021 showed that patients with significant breathlessness are three times more likely to recover to “no limitation of activities” on the OSCI scale when receiving SNG001 compared to placebo (p=0.004)

· SNG001 awarded Fast Track designation with IND cleared by the US FDA in December

· International Phase III trial (SG018) of SNG001 in hospitalised COVID-19 patients initiated in December 2020

– First patient dosed in January 2021, initial trial results expected in H2 2021

· SNG001 included in US NIH government-funded ACTIV-2 Phase II/III trial in COVID-19 outpatients in January 2021 and commenced patient dosing in February 2021

– Phase II evaluation will see the recruitment of up to 220 participants

· Investment in supply chain activities for SNG001 and the Aerogen aerosol delivery system have been made in preparation for launch

· Agreements signed with Akron Biotechnology for drug substance manufacture and Catalent Biologics for fill/finish

· Positive data from interim analysis of SNG001 trial in COPD patients supporting future progression of SNG001 for exacerbating COPD patients

· Patent applications made for use of inhaled interferon beta-1a to treat:

– COVID-19 patients

– Virus-induced exacerbations of COPD patients undergoing treatment with systemic corticosteroids

Financial

· In October 2020, Synairgen raised £87.1 million (before expenses) in an equity issue to fund SG018 Phase III trial, SNG001 manufacturing, regulatory activities, and to strengthen balance sheet

· In March 2020, Synairgen raised £14.0 million (before expenses) in an equity issue to fund initial COVID-19 clinical trial activity

· The loss from operations for the year ended 31 December 2020 was £17.7 million (2019: £4.8 million), with research and development expenditure amounting to £15.5 million (2019: £3.5 million)

– £12.0 million year-on-year increase on research and development expenditure attributable to COVID-19 activities

· Cash balances of £75.0 million at 31 December 2020 (31 December 2019: £2.5 million)

Richard Marsden, CEO of Synairgen, said: “Synairgen has made exceptional progress over 2020, with our broad-spectrum antiviral taking centre stage as a possible treatment for COVID-19, supported by a growing body of clinical evidence. Our inhaled interferon beta candidate, SNG001, has now demonstrated in a number of robust placebo-controlled clinical trials that it has the potential to prevent patient deterioration and accelerate recovery. Alongside vaccines, access to treatments that are both virus and strain agnostic is critical. Our efforts are focused on making such treatments available to the public as swiftly as possible by advancing our late-stage clinical trials, seeking marketing authorisations and ensuring the manufacturing and commercial capabilities can be rapidly up-scaled to meet potential demand.”

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No. 596/2014 (‘MAR’).

For further enquiries, please contact:

Synairgen plc

Richard Marsden, Chief Executive Officer

John Ward, Chief Financial Officer

Tel: + 44 (0) 23 8051 2800

 

Notes for Editors

About Synairgen

Synairgen is a clinical-stage respiratory drug discovery and development company founded by University of Southampton Professors Sir Stephen Holgate, Donna Davies and Ratko Djukanovic.

Synairgen is currently focused on developing its product candidate, SNG001 (inhaled interferon beta) for the treatment of COVID-19. SNG001 is potentially the first host-targeted broad-spectrum antiviral treatment delivered directly into the lungs. The Company is evaluating nebulised SNG001 in its Phase III clinical programme, which has been deemed an Urgent Public Health study by the UK’s National Institute for Health Research (NIHR). SNG001 has also been granted Fast Track status from the US Food and Drug Administration (FDA). In a Phase II trial, COVID-19 patients with marked/severe breathlessness demonstrated a threefold greater chance of recovery when treated with SNG001 versus placebo.

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

COVID-19

COVID-19, caused by the SARS-CoV-2 virus, is an ongoing global pandemic and there is widespread recognition of the urgent need for antiviral therapies, alongside vaccination programs, both for this and future pandemics. Such therapies could be used to prevent and effectively treat the severe lower respiratory tract illness that can occur with these types of diseases.

SNG001 (inhaled Interferon beta) applicability to COVID-19

Interferon beta (‘IFN-beta’) is a naturally-occurring protein, which orchestrates the body’s antiviral responses. It is used widely in the treatment of multiple sclerosis and is a safe and well tolerated drug. There is growing evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility in ‘at-risk’ patient groups to developing severe lower respiratory tract (lung) disease during respiratory viral infections.

Viruses, including coronaviruses such as SARS-CoV-2, have evolved mechanisms which suppress endogenous IFN-beta production, helping the virus to evade the innate immune system. The addition of exogenous IFN-beta before or during viral infection of lung cells in vitro either prevents or greatly reduces viral replication, potentially reducing the severity of infection and accelerating recovery.

Synairgen’s SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation. It is near to pH neutral, and is free of mannitol, arginine and human serum albumin, making it suitable for inhaled delivery direct to the site of action. Phase I and II trial data have shown that SNG001 activates lung antiviral defences as measured in sputum cells, and that SNG001 has been well tolerated in approximately 280 asthma/COPD/COVID-19 patients to-date. SNG001 has the potential to address the urgent need for antiviral therapies for COVID-19 and for future pandemic respiratory infections, alongside vaccination programmes.

In July 2020, Synairgen announced the results of its Phase II double-blind, placebo-controlled study of 101 randomised COVID-19 hospitalised patients, which showed that SNG001 given for 14 days was associated with greater odds of improvement versus placebo on the WHO Ordinal Scale for Clinical Improvement (OSCI) and more rapid recovery to the point where patients were no longer limited in their activity, with a greater proportion of patients recovering during the 28-day study period.

The results were published in The Lancet Respiratory Medicine: “Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial”. Monk, P D PhD, et al., 12 November 2020, accessible here.

The Company’s global Phase III trial (SG018) evaluating SNG001 for the treatment of hospitalised COVID-19 patients is ongoing. The trial is deemed an Urgent Public Health study by the UK’s National Institute for Health Research (NIHR). In the US, SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA). The Company is seeking further equivalent prioritisations and support from governments in participating countries.

CHAIRMAN’S STATEMENT

Synairgen has made significant progress during 2020, from being one of the first movers in the UK to begin clinical trials to combat COVID-19, to ending the year with compelling clinical data and late-stage clinical trials underway both in the UK and internationally to investigate our inhaled interferon beta candidate (SNG001) in patients with COVID-19. The year has been unprecedented globally for all sectors, and the healthcare industry, and in particular biotechnology, has played a central role. Synairgen’s expanded team and speed to action has enabled the Company to make significant strides in the fight against COVID-19. Synairgen has a potential role to play in the provision of a life-saving treatment against COVID-19 and other viruses, and in situations where the various vaccines may not prove effective or suitable.

In July 2020, we received landmark positive results in the Phase II study SG016 in hospitalised COVID-19 patients. This paved the way for our follow-on trial in the home setting and, ultimately, our larger multinational Phase III study SG018, which has been approved to commence by regulators in 12 countries. The importance of progress being made in trials of COVID-19 treatments cannot be understated. While vaccination efforts are crucial to defeating the pandemic, we also need therapeutics to save lives and to help those who become infected despite vaccination. Based on the compelling data published in November 2020 in the Lancet Respiratory Medicine journal supported by evidence from the recently announced home-based trial results, we believe Synairgen’s inhaled interferon beta candidate could play a critical role in addressing the impact of COVID-19 and similar viruses by reducing the severity of the disease and accelerating patient recovery.

The inclusion of SNG001 in the US government-funded ACTIV-2 trial is a further indication of international interest in our inhaled interferon beta treatment. Unlike many other treatments, inhaled interferon beta, as a drug taken through a nebuliser, can be self-administered at home under virtual supervision, making it a key part of reducing strain on healthcare systems, both through preventing severe disease and through lowering the number of necessary hospital visits for patients suffering respiratory symptoms.

These successes reflect the scientific research supporting the role of interferons in orchestrating antiviral responses undertaken by our scientific founders, Prof Donna Davies, Prof Ratko Djukanovic, and Prof Sir Stephen Holgate, who continue to play an active role in Synairgen. 2021 is set to be an even more impactful year for Synairgen pending the clinical results from our late-stage trials evaluating SNG001. We are optimistic about the potential for inhaled interferon beta as a potentially effective treatment for COVID-19 and future viral outbreaks.

It has been a very challenging year for Synairgen’s staff, combining the significant additional workload of our COVID-19 programmes and an escalation of our manufacturing and commercialisation strategies with the logistical limitations of lockdown and travel restrictions. On behalf of the Board, I wholeheartedly thank our staff and outsourced contractors for their hard work, perseverance and resilience.

Thanks to the support of our shareholders, Synairgen is in a robust financial position following two oversubscribed fundraises during the year. We continue to scale up operations and prepare for commercialisation of the product and look forward to reporting further progress in the coming months.

SIMON SHAW

CHAIRMAN


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