REG - Synairgen plc - Interim Results
29/09/2022 07:00
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RNS Number : 0807B Synairgen plc 29 September 2022
Synairgen plc
('Synairgen' or the 'Company')
Interim results for the six months ended 30 June 2022
Southampton, UK - 29 September 2022: Synairgen plc (LSE: SNG), the respiratory
company developing SNG001, an investigational formulation for inhalation
containing the broad-spectrum antiviral protein interferon beta, today
announces its unaudited interim results for the six months ended 30 June 2022.
Highlights (including post period-end)
Synairgen continues to explore the potential of SNG001 in three settings:
1. For use as a broad-spectrum antiviral for people hospitalised with
severe viral lung infections caused by a range of common seasonal viruses;
2. In people hospitalised with COVID-19, including in high-risk
sub-populations such as those with compromised respiratory function; and,
3. As a possible future pandemic preparedness option for government
agencies.
Operational
· Released results from the Phase 3 SPRINTER trial in hospitalised
COVID-19 patients. The trial did not meet the primary or key secondary
endpoints, however, there was an encouraging signal in reduction in the
relative risk (RRR) of progression from requiring low flow oxygen to more
severe disease or death within 35 days (26% reduction in the
Intention-to-Treat (ITT) population and 36% reduction in the Per Protocol (PP)
population).
· Conducted a post hoc analysis of the Phase 3 SPRINTER trial which
showed stronger treatment effects with SNG001 in high-risk patient sub-groups,
with the strongest effect observed in those who had clinical signs of
compromised respiratory function. In these patients, who represented
approximately one-third of the SPRINTER trial population, SNG001 significantly
reduced the risk of progression to severe disease and death compared to
placebo by 70% in the PP population (Odds Ratio (95% Confidence Interval) 0.23
(0.06, 0.98); p=0.046).
· Presented results from the Phase 3 SPRINTER trial at two major
respiratory congresses: the American Thoracic Society (ATS) International
Conference in May and the European Respiratory Society (ERS) International
Congress in September.
· Released positive findings from the 60- and 90-day follow-up visits
in the SPRINTER trial showing reductions in the relative risk of recognised
Long COVID symptoms, with an abstract accepted for presentation at IDWeek to
be held in Washington, DC in October.
· Presented an overview of positive accelerated viral clearance data
from patients in COPD (SG015) study at the Disease Prevention and Control
Summit in September in National Harbor, Maryland, USA.
· Entered into a collaboration on the UNIVERSAL study, an observational
study being led by the Clinical Trials Unit of the University of Southampton,
UK and funded by Janssen, a Johnson & Johnson company.
· Reported potent antiviral activity of SNG001 in in vitro studies
against SARS-CoV-2 Delta and Omicron variants.
· Presented positive results of a sub-group analysis from the Phase 2
SG016 trial at the 32(nd) European Congress of Clinical Microbiology &
Infectious Diseases held in April.
· Announced that patient recruitment halted in the US Government's
Phase 2/3 ACTIV-2 trial in people with COVID-19 at home, prior to
hospitalisation. Synairgen continues to await data from the ACTIV-2 team.
Financial
· Loss before tax for the six months ended 30 June 2022 was £14.0
million (30 June 2021: £38.9 million loss).
- Research and development expenditure for the six months ended 30
June 2022 was £11.1 million (30 June 2021: £36.9 million) as expenditure on
the Phase 3 SPRINTER trial and manufacturing activities reduced.
- Administrative expenses for the six months ended 30 June 2022 were
£2.9 million (30 June 2021: £2.0 million) on account of
pre-commercialisation activities.
· Research and development tax credit decreased from £6.0 million in
H1 2021 to £1.6 million in H1 2022 with reduced qualifying expenditure.
· Cash balances of £18.0 million at 30 June 2022 (30 June 2021: £46.2
million, 31 December 2021: £33.8 million).
· Post period-end receipt of FY 2021 research and development tax
credit of £9.1 million.
Richard Marsden, CEO of Synairgen, said: "Over the course of the pandemic we
generated a significant amount of clinical and non-clinical data which
supports the development of SNG001 as a broad-spectrum antiviral to treat or
prevent a wide range of severe lung infections. We have been scrutinising the
requirements, feasibility and timing of several clinical development options,
including company-sponsored studies focussing on certain high need
populations, government-funded trials, as well as investigator-led studies.
We continue to be excited about the potential of SNG001."
For further enquiries, please contact:
Synairgen plc
Brooke Clarke, Head of Communications
Media@synairgen.com (mailto:Media@synairgen.com)
Tel: + 44 (0) 23 8051 2800
finnCap (NOMAD and Joint Broker)
Geoff Nash, Charlie Beeson (Corporate Finance)
Alice Lane, Sunil de Silva (ECM)
Tel: + 44 (0) 20 7220 0500
Numis Securities Limited (Joint Broker)
James Black, Freddie Barnfield, Duncan Monteith
Tel: + 44 (0) 20 7260 1000
Consilium Strategic Communications (Financial Media and Investor Relations)
Mary-Jane Elliott, Namrata Taak, Lucy Featherstone
cscsynairgen@consilium-comms.com (mailto:cscsynairgen@consilium-comms.com)
Tel: +44 (0) 20 3709 5700
MKC STRATEGIES, LLC (US Media Relations)
Mary Conway
MConway@MKCStrategies.com (mailto:MConway@MKCStrategies.com)
Tel: +1 516-606-6545
Notes for Editors
About Synairgen
Synairgen is a UK-based respiratory company focused on drug discovery,
development and commercialisation. Synairgen's primary focus is developing
SNG001 (inhaled interferon beta) for the treatment and prevention of severe
viral lung infections, including COVID-19, as potentially the first
host-targeted, broad-spectrum antiviral treatment delivered directly into the
lungs. SNG001 has been granted Fast Track status from the US Food and Drug
Administration (FDA). Founded by University of Southampton Professors Sir
Stephen Holgate, Donna Davies and Ratko Djukanovic in 2003, Synairgen is
quoted on AIM (LSE: SNG). For more information about Synairgen, please see
www.synairgen.com (http://www.synairgen.com) .
OPERATING REVIEW
Summary
Respiratory viral infections, including COVID-19, continue to pose a
significant threat to global public health and are a major cause of mortality
worldwide. Prior to the COVID-19 pandemic, annual deaths from viral
respiratory infections were estimated to be around 2.7 million worldwide.(( 1
(#_ftn1) )) In the US, seasonal influenza alone contributes an estimated
economic burden of approximately $11 billion a year.(( 2 (#_ftn2) )) The
recent pandemic has highlighted the urgent need for broad-spectrum antivirals
for severe viral lung infections caused by seasonal viruses and other emerging
respiratory viral threats.(( 3 (#_ftn3) ))
Following the Phase 3 SPRINTER trial result, Synairgen has been consulting
with experts and has, as a result, brought the clinical opportunity and
Synairgen's priority into clear focus: to unlock the full potential of SNG001
to the benefit of patients by further investigating its efficacy in patients
hospitalised due to a range of viruses including SARS-CoV-2, influenza,
respiratory syncytial virus (RSV), adenovirus, parainfluenza and
rhinoviruses.
The clinical need for broad-spectrum antivirals to treat respiratory viral
infections
Respiratory viral infections, particularly in the winter months, have a
significant impact on the public, healthcare systems and the economy,
particularly for those with COPD, asthma and the immunocompromised. With
COVID-19 now also included within the seasonal illnesses being treated, the
winter of 2022 could be even more challenging than usual.(( 4 (#_ftn4) ))
Annual influenza epidemics alone (which represent only about 1/5 of all
respiratory virus hospitalisations(( 5 (#_ftn5) ))) are estimated to result
in about 3 to 5 million cases of severe illness and about 290,000 to 650,000
respiratory deaths worldwide according to the World Health Organisation.(( 6
(#_ftn6) ))
Our consultations with scientists, academics and clinicians have reinforced
the significant clinical opportunity for SNG001 as a potential treatment for a
broad range of respiratory viruses, including SARS-CoV-2, influenza, RSV,
adenovirus, parainfluenza and rhinoviruses. The scientific rationale of
delivering IFN-beta directly to the lungs to restore antiviral defences,
paired with our growing body of clinical, non-clinical and safety data, also
support the further investigation of SNG001 as a broad-spectrum antiviral for
severe lung infections.
Inhaled IFN-beta/SNG001
Interferon beta ('IFN-beta') is a naturally occurring protein with a novel
mechanism of action that boosts the body's antiviral responses. Synairgen's
SNG001 is a formulation containing the fully glycosylated form of IFN-beta
(IFN-beta-1a) for direct delivery to the lungs via specific nebulisers. It is
near to neutral pH, and is free of mannitol, arginine and human serum albumin
(which may be pharmacologically active in the airways).
There is strong evidence that a deficiency in IFN-beta production in the lung
could explain the enhanced susceptibility in higher-risk patient groups to
developing severe lower respiratory tract (lung) disease during respiratory
viral infections.(( 7 (#_ftn7) ))
Compounding this, viruses have evolved mechanisms to suppress IFN-beta
production, helping them to evade the innate immune system. The addition of
IFN-beta before or during viral infection of lung cells in vitro either
prevents or greatly reduces viral replication.(( 8 (#_ftn8) )) Synairgen has
conducted in vitro testing against multiple viruses including RSV, rhinovirus,
various influenza strains including H5N1, MERS-CoV and SARS-CoV-2 including
Alpha, Beta, Gamma, Delta and Omicron variants of concern (VOC), and shown
potent antiviral activity at concentrations that are readily achievable
following inhaled delivery of SNG001.
Delivery via the inhaled route results in a high local concentration in the
lungs, the site of the infection. We have shown that antiviral pathways are
activated up to 24 hours after administration of SNG001.(( 9 (#_ftn9) )) We
believe these concentrations could not be accomplished at the lining of the
lungs via the injected route, and indeed systemic use of IFN-beta through
injection did not reduce mortality, initiation of ventilation or
hospitalisation duration in hospitalised patients with COVID-19 in the WHO
Solidarity Trial conducted early in the pandemic.(( 10 (#_ftn10) ))
SNG001 clinical data
Phase 3 SPRINTER (NCT04732949)
The topline data from the Phase 3 SPRINTER trial, announced in February and
presented at the ATS International Conference in May and at the ERS
International Congress in September showed that the primary endpoints of
earlier hospital discharge and recovery were not met, likely due to
improvements in standard of care such as vaccination programmes, new
therapeutic options such as dexamethasone and remdesivir, and changes in
hospital practices since the beginning of the pandemic. Synairgen did observe
an encouraging signal with respect to a reduction in the relative risk of
patients on low flow oxygen progressing to more severe disease or death.(( 11
(#_ftn11) )) A post hoc analysis of this endpoint suggested that SNG001 may
have larger effects in preventing disease progression in patient groups with
recognised risk factors, such as older age, the existence of certain
co-morbidities and compromised respiratory function. For example, in patients
with compromised respiratory function (high respiratory rate and low oxygen
saturations) despite being on supplemental oxygen, SNG001, reduced the risk of
progression compared to placebo (44% in the Intention-to-Treat population and
70% in the Per Protocol population) in this post hoc analysis. This group
represented approximately one-third of the patients in the trial. The data
further confirmed the favourable safety profile of SNG001.
60- and 90-day analysis/Long COVID
Analysis of 60- and 90-day data from the SPRINTER trial showed SNG001 reduced
the relative risk of recognised symptoms of Long COVID at day 60 and/or day
90. The full analysis of the Day 60 and Day 90 data, including several
patient-reported outcome (PRO) measures is ongoing, and will be presented in
October at IDWeek 2022 in Washington and submitted for publication in a
peer-reviewed journal.
Phase 2 SG015 (NCT03570359)
In early 2020, due to the emergence of SARS-CoV-2, Synairgen's SG015 trial in
COPD patients was paused with 109 out of the targeted 120 patients recruited.
An interim analysis of the data was reported in September 2020 which
demonstrated that SNG001 boosted lung antiviral responses as assessed using
sputum biomarkers and led to a significant difference in the lung function
recovery in exacerbating COPD patients.
In September 2022, Synairgen announced additional findings from this Phase 2
COPD study suggesting, in a post hoc analysis, that SNG001 had accelerated
viral clearance from the lung (significantly lower proportion of patients on
SNG001 had detectable virus on Day 7; p=0.014), building on existing data
supporting SNG001's mechanism of action.
UNIVERSAL study
The COVID-19 pandemic highlighted the important link between research and
clinical care, and its impact on the timely development of much-needed
broad-spectrum antivirals for severe lung viral infections caused by seasonal
viruses and emerging respiratory viral threats. In September 2022, Synairgen
announced a collaboration with the Clinical Trials Unit of the University of
Southampton, UK, and Janssen, a Johnson & Johnson company, on the
UNIVERSAL study, an observational study designed to provide a better
understanding of what drives clinical outcomes in patients hospitalised due to
an infection with any one of a range of respiratory viruses. Results from the
trial will help to further inform the development programme of SNG001.
Other in vitro and clinical progress - COVID-19
In vitro studies
In vitro studies conducted at Viroclinics-DDL in the Netherlands in Spring
2022 showed that SNG001 has potent antiviral activity against SARS-CoV-2 Delta
and Omicron variants at concentrations that are achievable following inhaled
delivery of interferon beta(( 12 (#_ftn12) )), building upon previous in
vitro studies demonstrating antiviral activity against RSV, rhinovirus,
various influenza strains including H5N1, MERS-CoV and SARS-CoV-2 including
Alpha, Beta, Gamma, Delta and Omicron variants of concern (VOC).
ACTIV-2
We continue to await the Phase 2 data from the ACTIV-2 team, which when
received, will be assessed and used as appropriate to inform the SNG001
clinical development plan as Synairgen builds the case that SNG001 may have an
important role in combatting COVID-19 and future emerging virus threats.
Platform Trials Update
Over the course of 2022, as the burden on hospitals from COVID-19 has receded,
large platform trials likewise have wound down due to low infection rates and
changes in funding or have evolved to focus on more specific aspects of
COVID-19. We have engaged and continue to engage with many of these platform
trial sponsors in the US, Europe and the UK, and remain ready to participate
in suitable platform trials. While we explore multiple options, our approach
is to build upon the SPRINTER results and determine the quickest and most
effective pathway to explore efficacy of SNG001 across a broad range of
respiratory viruses for those hospitalised with severe lung infections.
FINANCIAL REVIEW
Statement of Comprehensive Income
The loss from operations for the six months ended 30 June 2022 (H1 2022) was
£14.0 million (six months ended 30 June 2021 (H1 2021): £38.9 million loss;
year ended 31 December 2021 (FY 2021): £57.9 million loss) with research and
development expenditure amounting to £11.1 million (H1 2021: £36.9 million;
FY 2021: £52.9 million) and other administrative expenses £2.9 million (H1
2021: £2.0 million; FY 2021: £5.0 million).
The reduction in research and development expenditure from £36.9 million to
£11.1 million is attributable to the lower expenditure on (i) manufacturing
activities (including procurement of long lead time items) and (ii) the Phase
3 SPRINTER trial.
Other administrative expenditure has increased from £2.0 million in H1 2021
to £2.9 million in H1 2022 on account of pre-commercialisation activities,
including the establishment of a corporate communications function.
The research and development tax credit decreased from £6.0 million in H1
2021 to £1.6 million in H1 2022 on account of the reduced qualifying
expenditure.
The loss after tax for H1 2022 was £12.4 million (H1 2021: £32.9 million; FY
2021: £48.7 million) and the basic loss per share was 6.16p (H1 2021: 16.47p
loss; FY 2021: 24.28p loss).
Statement of Financial Position and Cash Flows
At 30 June 2022, net assets amounted to £24.9 million (30 June 2021: £52.4
million, 31 December 2021: £37.0 million), including cash balances of £18.0
million (30 June 2021: £46.2 million, 31 December 2021: £33.8 million). Post
period-end, in August 2022, the tax credit of £9.1 million in respect of FY
2021 was received.
The principal elements for the £15.8 million reduction in cash balances
during H1 2022 (H1 2021: £28.8 million reduction, FY 2021: £41.1 million
reduction) were:
· Cash used in operations £15.8 million (H1 2021: £28.7 million
outflow, FY 2021: £44.9 million outflow); and,
· Research and development tax credits received of £nil (H1 2021:
£nil, FY 2021: £3.9 million).
The other significant changes in the statement of financial position were:
· Current tax receivable: 30 June 2022: £10.6 million, 30 June 2021
£9.7 million, 31 December 2021: £9.1 million. As noted above, the 2021 tax
credit was received in August 2022.
· Trade and other receivables: 30 June 2022: £0.7 million, 30 June
2021: £1.1 million, 31 December 2021: £1.5 million.
· Trade and other payables: 30 June 2022: £4.6 million, 30 June 2021:
£4.9 million, 31 December 2021: £7.6 million.
With the ongoing reduction in our committed research and development cash
burn, Synairgen has adequate cash resources, reaching into Q4 2023, to enable
it to determine and pursue its strategic pathway for SNG001, including if
necessary the exploration of all options to provide the necessary funds to
allow it to continue its clinical development programme.
OUTLOOK
Data from our trials and subsequent analyses continues to support the
potential of SNG001 to provide clinically important benefits in the treatment
of severe viral lung infections. Synairgen now has data from its Phase 3
SPRINTER trial in patients hospitalised with COVID-19, subsequent analyses of
different high-risk patient groups within the trial, the 60- and 90-day
follow-up Long COVID data, as well as the data from the COPD trial conducted
before the pandemic. The SPRINTER data were well-received at two major
respiratory congresses: the ATS International Conference in San Francisco in
May 2022 and the ERS International Congress in September 2022 and have been
accepted for presentation at IDWeek in October 2022 in Washington, DC.
With input from clinical advisers, a review of data across our clinical
development programmes further supports our approach to investigate SNG001 as
a broad-spectrum antiviral for a range of respiratory viral infections.
While prudently managing costs, we are actively pursuing and refining multiple
clinical approaches including company- and investigator-sponsored studies and
possibly platform studies (as and when appropriate), to confirm the most
expeditious clinical development path for SNG001 in patients hospitalised due
to a severe viral lung infection including SARS-CoV-2, influenza, RSV,
adenovirus, parainfluenza and rhinoviruses.
Consolidated Statement of Comprehensive Income
for the 6 months ended 30 June 2022
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2022 2021 2021
Notes £000 £000 £000
Research and development expenditure (11,106) (36,906) (52,857)
Other administrative expenses (2,903) (1,991) (5,009)
Total administrative expenses and loss from operations (14,009) (38,897) (57,866)
Finance income 24 9 11
Finance expense - (2) (2)
Loss before tax (13,985) (38,890) (57,857)
Tax credit 2 1,579 5,971 9,194
Loss and total comprehensive loss for the period (12,406) (32,919) (48,663)
Loss per ordinary share 3
Basic and diluted loss per ordinary share (pence) (6.16)p (16.47)p (24.28)p
Consolidated Statement of Changes in Equity
for the 6 months ended 30 June 2022
Share Share Merger Retained Total
capital premium reserve deficit
£000 £000 £000 £000 £000
At 1 January 2021 1,999 125,245 483 (42,586) 85,141
Recognition of share-based payments - - - 148 148
Total comprehensive loss for the period - - - (32,919) (32,919)
At 30 June 2021 1,999 125,245 483 (75,357) 52,370
Issue of ordinary shares 14 - - - 14
Recognition of share-based payments - - - 360 360
Total comprehensive loss for the period - - - (15,744) (15,744)
At 31 December 2021 2,013 125,245 483 (90,741) 37,000
Issue of ordinary shares 1 - - - 1
Recognition of share-based payments - - - 323 323
Total comprehensive loss for the period - - - (12,406) (12,406)
At 30 June 2022 2,014 125,245 483 (102,824) 24,918
Consolidated Statement of Financial Position
as at 30 June 2022
Unaudited Unaudited Audited
30 30 31
June June December
2022 2021 2021
£000 £000 £000
Assets
Non-current assets
Intangible assets 48 46 53
Property, plant and equipment 130 212 173
Right-of-use assets - 13 -
178 271 226
Current assets
Current tax receivable 10,634 9,742 9,055
Trade and other receivables 710 1,137 1,530
Cash and cash equivalents 18,022 46,214 33,827
29,366 57,093 44,412
Total assets 29,544 57,364 44,638
Liabilities
Current liabilities
Trade and other payables (4,626) (4,948) (7,638)
Lease liabilities - (46) -
Total liabilities (4,626) (4,994) (7,638)
Total net assets 24,918 52,370 37,000
Equity
Capital and reserves attributable to equity holders of the parent
Share capital 2,014 1,999 2,013
Share premium 125,245 125,245 125,245
Merger reserve 483 483 483
Retained deficit (102,824) (75,357) (90,741)
Total equity 24,918 52,370 37,000
Consolidated Statement of Cash Flows
for the 6 months ended 30 June 2022
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2022 2021 2021
£000 £000 £000
Cash flows from operating activities
Loss before tax (13,985) (38,890) (57,857)
Adjustments for:
Finance income (24) (9) (11)
Finance expense - 2 2
Lease adjustment - - (4)
Depreciation of property, plant & equipment 47 45 92
Depreciation of right-of-use assets - 81 94
Amortisation 5 5 9
Share-based payment charge 323 148 508
Cash flows from operations before changes in working capital (13,634) (38,618) (57,167)
Decrease in inventories - 41 41
Decrease in trade and other receivables 825 8,235 7,841
(Decrease)/Increase in trade and other payables (3,012) 1,669 4,359
Cash used in operations (15,821) (28,673) (44,926)
Tax credit received - - 3,910
Net cash used in operating activities (15,821) (28,673) (41,016)
Cash flows from investing activities
Interest received 19 10 12
Purchase of intangible assets - (7) (18)
Purchase of property, plant and equipment (4) (7) (15)
Net cash generated from/(used in) investing activities 15 (4) (21)
Cash flows from financing activities
Proceeds from issuance of ordinary shares 1 - 14
Principal paid on lease liabilities - (83) (124)
Interest paid on lease liabilities - (2) (2)
Net cash generated from/(used in) financing activities 1 (85) (112)
Decrease in cash and cash equivalents (15,805) (28,762) (41,149)
Cash and cash equivalents at beginning of period 33,827 74,976 74,976
Cash and cash equivalents at end of period 18,022 46,214 33,827
Notes to the Interim Financial Information
for the six months ended 30 June 2022
1. Basis of preparation
Basis of accounting
The interim financial information, which is unaudited, has been prepared on
the basis of the accounting policies expected to apply for the financial year
to 31 December 2022 and in accordance with UK adopted international accounting
standards in conformity with the requirements of the Companies Act 2006. The
accounting policies applied in the preparation of this interim financial
information are consistent with those used in the financial statements for the
year ended 31 December 2021.
The interim financial information does not include all of the information
required for full annual financial statements and does not comply with all the
disclosure requirements in IAS 34 'Interim Financial Reporting'.
Financial information
The financial information for the year ended 31 December 2021 does not
constitute the full statutory accounts for that period. The Annual Report and
Financial Statements for the year ended 31 December 2021 have been filed with
the Registrar of Companies. The Independent Auditor's Report on the Annual
Report and Financial Statements for the year ended 31 December 2021 was
unqualified, did not draw attention to any matters by way of emphasis, and did
not contain a statement under 498(2) or 498(3) of the Companies Act 2006.
Financial information is published on the Company's website in accordance with
legislation in the United Kingdom governing the preparation and dissemination
of financial information, which may vary from legislation in other
jurisdictions. The maintenance and integrity of the Company's website is the
responsibility of the directors. The directors' responsibility also extends to
the ongoing integrity of the financial information contained therein.
Going Concern
The directors have prepared financial forecasts to estimate the likely cash
requirements of the Group over the period to 30 September 2023, given its
stage of development and lack of recurring revenues. In preparing these
financial forecasts, the directors have made certain assumptions with regards
to the timing and amount of future expenditure over which they have control.
The directors have taken a prudent view in preparing these forecasts and will
not commit to expenditure which the Group can't meet out of existing
resources.
The Group's available resources at the date of this report are sufficient to
cover the Group's committed activities of interacting with platform and other
investigator-led studies, designing a broad-spectrum antiviral clinical
trial, engaging with pharmaceutical companies regarding
collaboration/licensing opportunities for that broad indication and, if
required, engaging with providers of any other type of funding (details of
these activities, current operating expense levels to 30 June 2022 and working
capital at 30 June 2022 can be found in the Operating and Financial Reviews).
Regardless of the outcome of these activities, which are uncertain, the
Group's available resources are sufficient to cover existing committed costs
and the costs of these activities until at least 30 September 2023.
After due consideration of these forecasts and current cash resources, the
directors consider that the Group has adequate financial resources to continue
in operational existence for the foreseeable future (being a period of at
least twelve months from the date of this report) and, for this reason, the
financial statements have been prepared on a going concern basis.
Notes to the Interim Financial Information
for the six months ended 30 June 2022 (continued)
1. Basis of preparation (continued)
Approval of financial information
The 30 June 2022 interim financial information was approved by a committee of
the Board of Directors on 28 September 2022.
2. Tax credit
The tax credit of £1,579,000 (six months ended 30 June 2021: £5,971,000;
year ended 31 December 2021: £9,194,000) comprises an estimate of the
research and development tax credit receivable in respect of the current
period.
3. Loss per ordinary share
Unaudited Unaudited Audited
Six months Six months Year
ended ended ended
30 30 31
June June December
2022 2021 2021
(12,406) (32,919) (48,663)
Loss attributable to equity holders of the Company (£000)
Weighted average number of ordinary shares in issue 000s 201,345 199,914 200,442
The loss attributable to shareholders and the weighted average number of
ordinary shares for the purposes of calculating the diluted loss per ordinary
share are identical to those used for basic loss per share. This is because
the exercise of share options would have the effect of reducing the loss per
ordinary share and is therefore antidilutive. At 30 June 2022 there were
8,477,640 options outstanding (30 June 2021: 9,503,004 options outstanding; 31
December 2021: 8,517,282 options outstanding).
INDEPENDENT REVIEW REPORT TO SYNAIRGEN PLC
Conclusion
Based on our review, nothing has come to our attention that causes us to
believe that the condensed set of financial statements in the half-yearly
financial report for the six months ended 30 June 2022 is not prepared, in all
material respects, in accordance with the London Stock Exchange AIM Rules for
Companies.
We have been engaged by the company to review the condensed set of financial
statements in the half-yearly financial report for the six months ended 30
June 2022 which comprises the Consolidated Statement of Comprehensive Income,
the Consolidated Statement of Changes in Equity, the Consolidated Statement of
Financial Position, the Consolidated Statement of Cash Flows and the related
notes 1 to 3.
Basis for conclusion
We conducted our review in accordance with International Standard on Review
Engagements (UK) 2410, "Review of Interim Financial Information Performed by
the Independent Auditor of the Entity" ("ISRE (UK) 2410"). A review of interim
financial information consists of making enquiries, primarily of persons
responsible for financial and accounting matters, and applying analytical and
other review procedures. A review is substantially less in scope than an audit
conducted in accordance with International Standards on Auditing (UK) and
consequently does not enable us to obtain assurance that we would become aware
of all significant matters that might be identified in an audit. Accordingly,
we do not express an audit opinion.
As disclosed in note 1, the annual financial statements of the group are
prepared in accordance with UK adopted international accounting standards. The
condensed set of financial statements included in this half-yearly financial
report is not prepared in accordance with UK adopted International Accounting
Standard 34, "Interim Financial Reporting".
Conclusions relating to going concern
Based on our review procedures, which are less extensive than those performed
in an audit as described in the Basis for conclusion section of this report,
nothing has come to our attention to suggest that the directors have
inappropriately adopted the going concern basis of accounting or that the
directors have identified material uncertainties relating to going concern
that are not appropriately disclosed.
This conclusion is based on the review procedures performed in accordance with
ISRE (UK) 2410, however future events or conditions may cause the group to
cease to continue as a going concern.
Responsibilities of directors
The directors are responsible for preparing the half-yearly financial report
in accordance with
the London Stock Exchange AIM Rules for Companies which require that the
half-yearly report be presented and prepared in a form consistent with that
which will be adopted in the Company's annual accounts having regard to the
accounting standards applicable to such annual accounts.
In preparing the half-yearly financial report, the directors are responsible
for assessing the company's ability to continue as a going concern,
disclosing, as applicable, matters related to going concern and using the
going concern basis of accounting unless the directors either intend to
liquidate the company or to cease operations, or have no realistic alternative
but to do so.
Auditor's responsibilities for the review of the financial information
In reviewing the half-yearly report, we are responsible for expressing to the
Company a conclusion on the condensed set of financial statement in the
half-yearly financial report. Our conclusion, including our Conclusions
Relating to Going Concern, are based on procedures that are less extensive
than audit procedures, as described in the Basis for Conclusion paragraph of
this report.
Use of our report
Our report has been prepared in accordance with the terms of our engagement to
assist the Company in meeting the requirements of the rules of the London
Stock Exchange AIM Rules for Companies and for no other purpose. No person
is entitled to rely on this report unless such a person is a person entitled
to rely upon this report by virtue of and for the purpose of our terms of
engagement or has been expressly authorised to do so by our prior written
consent. Save as above, we do not accept responsibility for this report to
any other person or for any other purpose and we hereby expressly disclaim any
and all such liability.
BDO LLP
Chartered Accountants
Reading, UK
Date: 28 September 2022
BDO LLP is a limited liability partnership registered in England and Wales
(with registered number OC305127).
1 (#_ftnref1) GBD 2015 LRI Collaborators Estimates of the global, regional,
and national morbidity, mortality, and aetiologies of lower respiratory tract
infections in 195 countries: a systematic analysis for the Global Burden of
Disease Study 2015. Lancet Infect Dis. 2017;17:1133-1161
2 (#_ftnref2) Economic burden of seasonal influenza in the United States;
Putri, WCWS, et al. Vaccine, 2018-06-22, Vol.36 (27), p.3960-3966
3 (#_ftnref3) Chitalia, V.C., Munawar, A.H. A painful lesson from the
COVID-19 pandemic: the need for broad-spectrum, host-directed antivirals. J
Transl Med 18, 390 (2020). https://doi.org/10.1186/s12967-020-02476-9
4 (#_ftnref4)
https://www.hsj.co.uk/coronavirus/the-importance-of-prevention-in-managing-winter-respiratory-viruses/7031473.article
5 (#_ftnref5)
https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003550#:~:text=Data%20from%2063%20sources%20showed,significant%20differences%20by%20age%20group.
6 (#_ftnref6)
https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)
7 (#_ftnref7) Zheng Y, Zhuang MW, Han L, et al. Severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) membrane (M) protein inhibits type I and
III interferon production by targeting RIG-I/MDA-5 signaling. Signal Transduct
Target Ther. 2020;5:299.
8 (#_ftnref8) Synairgen data on file.
9 (#_ftnref9) https://pubmed.ncbi.nlm.nih.gov/24937476/
10 (#_ftnref10) WHO Solidarity Trial Consortium. Repurposed Antiviral Drugs
for Covid-19 - Interim WHO Solidarity Trial Results. N Engl J Med.
2021;384:497-511.
11 (#_ftnref11) The main reason patients were excluded from the Per Protocol
population was failure to receive two full doses in the first three days of
treatment.
12 (#_ftnref12) Synairgen data on file
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