TIDMSNG
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
GBP14.0 million (30 June 2021: GBP38.9 million loss).
- Research and development expenditure for the six months ended
30 June 2022 was GBP11.1 million (30 June 2021: GBP36.9 million) as
expenditure on the Phase 3 SPRINTER trial and manufacturing
activities reduced.
- Administrative expenses for the six months ended 30 June 2022
were GBP2.9 million (30 June 2021: GBP2.0 million) on account of
pre-commercialisation activities.
-- Research and development tax credit decreased from GBP6.0
million in H1 2021 to GBP1.6 million in H1 2022 with reduced
qualifying expenditure.
-- Cash balances of GBP18.0 million at 30 June 2022 (30 June
2021: GBP46.2 million, 31 December 2021: GBP33.8 million).
-- Post period-end receipt of FY 2021 research and development tax credit of GBP9.1 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
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
Tel: +44 (0) 20 3709 5700
MKC STRATEGIES, LLC (US Media Relations)
Mary Conway
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 .
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]) In the US, seasonal
influenza alone contributes an estimated economic burden of
approximately $ 11 billion a year. ([2]) 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])
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]) Annual influenza epidemics alone
(which represent only about 1/5 of all respiratory virus
hospitalisations ([5]) ) 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])
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])
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]) 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]) 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])
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]) 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]) , 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 GBP14.0 million (six months ended 30 June 2021 (H1
2021): GBP38.9 million loss; year ended 31 December 2021 (FY 2021):
GBP57.9 million loss) with research and development expenditure
amounting to GBP11.1 million (H1 2021: GBP36.9 million; FY 2021:
GBP52.9 million) and other administrative expenses GBP2.9 million
(H1 2021: GBP2.0 million; FY 2021: GBP5.0 million).
The reduction in research and development expenditure from
GBP36.9 million to GBP11.1 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 GBP2.0
million in H1 2021 to GBP2.9 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 GBP6.0
million in H1 2021 to GBP1.6 million in H1 2022 on account of the
reduced qualifying expenditure.
The loss after tax for H1 2022 was GBP12.4 million (H1 2021:
GBP32.9 million; FY 2021: GBP48.7 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 GBP24.9 million (30 June
2021: GBP52.4 million, 31 December 2021: GBP37.0 million),
including cash balances of GBP18.0 million (30 June 2021: GBP46.2
million, 31 December 2021: GBP33.8 million). Post period-end, in
August 2022, the tax credit of GBP9.1 million in respect of FY 2021
was received.
The principal elements for the GBP15.8 million reduction in cash
balances during H1 2022 (H1 2021: GBP28.8 million reduction, FY
2021: GBP41.1 million reduction) were:
-- Cash used in operations GBP15.8 million (H1 2021: GBP28.7
million outflow, FY 2021: GBP44.9 million outflow); and,
-- Research and development tax credits received of GBPnil (H1
2021: GBPnil, FY 2021: GBP3.9 million).
The other significant changes in the statement of financial
position were:
-- Current tax receivable: 30 June 2022: GBP10.6 million, 30
June 2021 GBP9.7 million, 31 December 2021: GBP9.1 million. As
noted above, the 2021 tax credit was received in August 2022.
-- Trade and other receivables: 30 June 2022: GBP0.7 million, 30
June 2021: GBP1.1 million, 31 December 2021: GBP1.5 million.
-- Trade and other payables: 30 June 2022: GBP4.6 million, 30
June 2021: GBP4.9 million, 31 December 2021: GBP7.6 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 GBP000 GBP000 GBP000
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
capital premium reserve deficit Total
GBP000 GBP000 GBP000 GBP000 GBP000
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
GBP000 GBP000 GBP000
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
GBP000 GBP000 GBP000
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 GBP1,579,000 (six months ended 30 June 2021:
GBP5,971,000; year ended 31 December 2021: GBP9,194,000) 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
Loss attributable to
equity holders of the
Company (GBP000) (12,406) (32,919) (48,663)
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).
INDEPENT 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] 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] Economic burden of seasonal influenza in the United States;
Putri, WCWS, et al. Vaccine, 2018-06-22, Vol.36 (27),
p.3960-3966
[3] 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]
https://www.hsj.co.uk/coronavirus/the-importance-of-prevention-in-managing-winter-respiratory-viruses/7031473.article
[5]
https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003550#::text=Data%20from%2063%20sources%20showed,
significant%20differences%20by%20age%20group.
[6]
https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)
[7] 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] Synairgen data on file.
[9] https://pubmed.ncbi.nlm.nih.gov/24937476/
[10] WHO Solidarity Trial Consortium. Repurposed Antiviral Drugs
for Covid-19 - Interim WHO Solidarity Trial Results. N Engl J Med.
2021;384:497-511.
[11] 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] Synairgen data on file
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