REG - Synairgen plc - 2022 Full Year Results
27/04/2023 07:00
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RNS Number : 6172X Synairgen plc 27 April 2023
Synairgen plc
('Synairgen' or the 'Company')
Results for the year ended 31 December 2022
Southampton, UK - 27 April 2023: 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 preliminary statement of audited results for the year ended 31
December 2022.
Highlights (including post period-end)
Operational
· Completed further analysis of data accumulated from the more than 750
patients dosed to date with SNG001. Findings included:
o Development of stratification criteria to target specific populations in
future trials;
o SNG001 reduced the risk of several recognised Long COVID symptoms;
o Evidence of accelerated viral clearance of rhinovirus from the lung in
COPD patients; and
o Further demonstration of the well-tolerated safety profile of SNG001.
· Announced data from the US NIH-led ACTIV-2 Phase 2 trial for SNG001
in COVID-19 which showed an encouraging reduction in hospitalisation with
SNG001 versus placebo in home-based patients.
· Published data from the Phase 3 SPRINTER trial for SNG001 in
hospitalised COVID-19 in the European Respiratory Journal Open Research in
December 2022. Data from the trial, which did not meet primary or key
secondary endpoints, included the observation of an encouraging signal in the
reduction in progression to severe disease or death for patients treated with
SNG001.
· Gained a deeper understanding of the extent of the mechanism of
action of SNG001 as a host directed, variant-agnostic antiviral agent:
o Potent antiviral activity was shown in vitro against SARS-CoV-2 Alpha,
Beta, Delta, Gamma and Omicron Variants of Concern, adding to our existing in
vitro studies which showed potent antiviral activity against a wide variety of
seasonal respiratory and pandemic viruses including RSV, rhinovirus, various
influenza strains including H5N1, and MERS-CoV.
· Undertook a thorough evaluation of clinical development options to
map out a route to conducting a Phase 3 registrational programme required for
a regulatory submission.
o Identified a clinical development plan for SNG001 designed to address the
unmet need in targeted, high-risk patient populations that appear to be most
responsive to SNG001 in previous clinical trials, for example elderly patients
and those with certain co-morbidities.
o In addition, we plan to assess SNG001 in immunocompromised patients who
are particularly vulnerable to respiratory viral infections, ventilated
patients with confirmed viral pneumonia, and also those who appear unable to
clear virus and become long term "shedders" and mutation hosts.
o Plan will start with a series of focused,
investigator-led/Synairgen-sponsored studies, using existing resources, which
are intended to lead towards a Phase 3 registrational programme. Preparation
is underway for these focused trials to initiate in H2 2023.
Financial
· Loss from operations for the year ended 31 December 2022 of
£20.3 million (2021: £57.9 million), with R&D expenditure decreasing to
£14.9 million (2021: £52.9 million).
· Cash and deposit balances of £19.7 million at 31 December 2022
(31 December 2021: £33.8 million).
Richard Marsden, CEO of Synairgen, said: "2022 was an insightful year for
Synairgen, pointing us towards a clear clinical development plan following
analysis of the Phase 3 SPRINTER data and other important data.
"We confirmed with our clinical collaborators the significant unmet need for
broad-spectrum antivirals to help address both the ongoing need to treat viral
lung infections, and in preparation for future pandemics. We believe that
SNG001 has the potential to help fill this important gap in respiratory
treatments for high-risk patient groups and we look forward to initiating the
first trials in the second half of this year."
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)
Freddie Barnfield, Duncan Monteith, Euan Brown
Tel: + 44 (0) 20 7260 1000
Consilium Strategic Communications (Financial Media and Investor Relations)
Mary-Jane Elliott, Namrata Taak
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. The Company's primary focus is developing
SNG001 (inhaled interferon beta) for the treatment 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) .
CHAIRMAN'S STATEMENT
2022 started with high hopes for the success of our Phase 3 clinical trial of
SNG001 for the treatment of COVID-19 in hospitalised patients. Unfortunately,
the trial did not meet its primary endpoints, which was most likely due to
improvements in standards of care and is further discussed in this report.
However, the data did provide significant insights into the patient groups
that appeared to benefit most from SNG001. This has enabled Synairgen to
refocus on SNG001's potential both in the hospital and the home environment as
a broad-spectrum antiviral for those most at risk of severe respiratory
problems. This obviously includes COVID-19, however the Group's work in 2022
has shown that there is a significant unmet need in the broader respiratory
antiviral area, in addition to the need to find potential treatment solutions
for future viral pandemics. Respiratory virus infections remain a leading
cause of death globally.
Working closely with our partners, including academic institutions, diagnostic
and medical device companies, advisors, and our strong team of researchers,
scientists and regulatory experts, and building on the substantial body of
trial evidence we have for SNG001, the team spent much of the year
advancing the clinical development plans to pursue this goal. These are in
the process of being discussed with potential trial sites and investigators
with a view to commencing later this year.
I would like to take this opportunity to thank the Board of Directors for
their unwavering support during this challenging time. Their guidance and
expertise have been invaluable in helping us navigate both the challenges and
analysis of the opportunities. I would also like to note the retirement of
Theo Harold and Iain Buchanan, both of whom have made significant
contributions to Synairgen. At the same time, we are pleased to welcome Amanda
Radford and Flic Gabbay to our Board of Directors. Their experience and
insight will be instrumental in helping us achieve our goals.
I am proud of the dedication and hard work of our entire team in a
particularly challenging year, and I am excited for our future progress in
developing this novel treatment for a wide range of viral respiratory
diseases.
Simon Shaw
Chairman
OPERATIONAL REVIEW
Overview
2022 was an important year for Synairgen, providing the Group with insights
and data that have helped refine and clarify the potential for SNG001.
In the first quarter of 2022 the Group received the disappointing news that
the Phase 3 SPRINTER trial of SNG001 in hospitalised patients with COVID-19
did not meet the trial's primary endpoints. Following the announcement of the
topline results, post hoc analyses subsequently showed positive trends in
subsets of higher risk patient groups within the trial. Through this work and
months of investigation, both in-house and with clinical collaborators on both
sides of the Atlantic, we have established a number of ways forward for the
SNG001 development programme. We are embarking on these with renewed vigour in
2023.
From a clinical perspective, alongside the safety data accumulated to date
from the more than 750 patients dosed with SNG001, we gained important new
insights about the specific patient populations to target in future clinical
trials, particularly in relation to the potential for reducing the risk of
disease progression - whether in the hospital setting or the home environment.
We can also see from the SPRINTER trial that SNG001 may have a positive effect
in reducing the risk of several recognised Long COVID symptoms. Finally, a
further analysis during the year of the SG015 Phase 2 trial in patients with
COPD showed accelerated viral clearance of human rhinovirus in patients
receiving SNG001 compared to placebo.
On the non-clinical side, we learned more about the mechanism of action of
SNG001 as a host directed, variant-agnostic antiviral agent. Adding to our
existing in vitro studies which showed potent antiviral activity against a
wide variety of seasonal respiratory and pandemic viruses including RSV,
rhinovirus, various influenza strains including H5N1 and MERS-CoV, we showed
potent antiviral activity in further in vitro studies against SARS-CoV-2
Alpha, Beta, Gamma, Delta and Omicron Variants of Concern.(( 1 (#_ftn1) ))
The market context is clear: there are no approved antiviral therapies for
the majority of hospitalised adult patients due to respiratory viral lung
infections, and the pandemic has highlighted the significant issues for health
systems and patients as a result. In the US alone, approximately three million
people are hospitalised every year due to viral lung infections such as
rhinovirus, Respiratory Syncytial Virus (RSV), COVID-19, influenza and
others.(( 2 (#_ftn2) ))
Our work in 2022 has shown that there is a significant unmet need in this
broader antiviral area, in addition to the need to find potential treatment
solutions for future viral pandemics. Our clinical work over many trials to
date indicates that SNG001 has potential utility against a wide spectrum of
respiratory viruses in certain high-risk patient groups.
Development Plan
This accumulated non-clinical and clinical data, together with third party
research and feedback from the clinical community, has strengthened our
conviction that SNG001 has potential as a broad-spectrum antiviral which could
be directed towards certain types of patients infected with a wide range of
respiratory viruses. The Synairgen team, and our collaborators and advisors,
have assessed many different options for an optimal clinical development
programme, and have mapped out a series of focused clinical trials to confirm
the signals we have seen and investigate SNG001 against this wide spectrum of
respiratory viruses in specific high-risk patient groups.
Mindful of the insights gained in 2022 and the challenges outlined, Synairgen
continues to explore the potential of SNG001 in three settings:
· For use as a broad-spectrum antiviral in people hospitalised with
severe viral lung infections, particularly those in high-risk groups;
· To prevent progression of disease/hospitalisation in high-risk
patient groups with a range of respiratory viruses in the home setting; and
· As a possible future pandemic preparedness option for government
agencies.
We are now progressing protocols specific to three main opportunities for the
next stage of the development programme, namely in the patient populations
identified: in the elderly (who were most at risk during the pandemic);
immunocompromised (such as patients taking chemotherapy for whom even a common
cold can delay effective treatment of their underlying disease); and other
patients who may benefit most from the use of SNG001 (including ventilated
patients with confirmed viral pneumonia and those who appear unable to clear
virus and become long term "shedders" and mutation hosts). Both individually
and collectively, these are significant unaddressed market opportunities.
Clinical Development Outlook
The Group and its clinical advisors believe that based on the safety data and
body of pre-clinical and clinical data for SNG001 it has the potential to be
the first inhaled broad-spectrum antiviral for the patients who are at high
risk of disease progression.
The development of a broad-spectrum antiviral treatment has been a significant
challenge in the field of antiviral research. The search for a broad-spectrum
antiviral treatment can be traced back several decades, with a growing
recognition of the need for a treatment that can effectively target a wide
range of different viral infections.
In recent years, there has been increased recognition in the importance of
developing broad-spectrum antivirals that target the host cell rather than the
virus itself. However, despite this growing interest, there is currently no
precedent for a broad-spectrum antiviral clinical development programme.
Many of the platform trials that emerged during the COVID-19 pandemic have
completed or wound down in part due to lower rates of severe illness or
changes in funding. Synairgen has been and remains in contact with the
relevant platform trial investigators and will continue to evaluate options
should they arise; however, in parallel, wanting to move forward at pace, we
believe that implementing our own current clinical development plan as quickly
as possible will provide promising opportunities to collect appropriate and
meaningful data to support an eventual regulatory submission.
Over the past year, the Group has undertaken a thorough evaluation of clinical
development options with the aim of conducting a Phase 3 registrational
programme required for a regulatory submission. As there is no precedent for
a broad-spectrum antiviral clinical development programme, designing and
determining a clinical pathway is complex as there are multiple viruses being
targeted for different high-risk patient groups. It has been determined that
to achieve this aim, a multi-staged clinical development plan is required.
The Group is now advancing a clinical development plan for SNG001 designed to
address the unmet need in targeted patient populations that appear to be most
responsive to SNG001 in previous clinical trials, as well as in
immunocompromised patients who are particularly vulnerable to respiratory
viral infections, and also ventilated patients with confirmed viral pneumonia.
This plan will start with a series of focused,
investigator-led/Synairgen-sponsored studies that build a pathway towards a
Phase 3 registrational programme. Preparation is underway for these focused
trials to initiate in H2 2023.
Clinical Need
Severe viral lung infections can be caused by a variety of viruses, including
influenza, coronaviruses, RSV, rhinovirus, and adenovirus, among others. These
infections can lead to serious complications, including pneumonia, acute
respiratory distress syndrome (ARDS), and death, particularly in vulnerable
populations such as elderly individuals, those with COPD and asthma, and
people with weakened immune systems.
In the US, severe viral lung infections are responsible for upwards of three
million hospitalisations annually, at a cost of $50 billion.(( 3 (#_ftn3) ))
Current antiviral treatments are limited in their efficacy, as they are
typically specific to a single virus. For example, while certain antivirals
are effective against influenza, they are not effective against other viruses
that can cause severe lung infections, such as coronaviruses or RSV.
This highlights the need for a broad-spectrum antiviral that can effectively
treat a range of different viral lung infections, regardless of the specific
virus causing the infection. A broad-spectrum antiviral would be a valuable
addition to the healthcare arsenal, as it would improve outcomes for patients
and reduce the spread of viral infections in healthcare settings.
Additionally, a broad-spectrum antiviral would be useful in the event of a
pandemic caused by a novel virus, as it would provide a treatment option even
if the aetiology of the specific virus is not yet known.
In summary, the need for a broad-spectrum antiviral to treat severe viral lung
infections is driven by the high incidence of severe lung infections caused by
a variety of different viruses, the limited number and efficacy of current
antivirals, and the potential to improve outcomes for patients and reduce the
spread of viral infections.
The annual cost of hospitalisations for severe lung infections illustrates the
substantial market opportunity for an effective broad-spectrum antiviral to
treat such infections.
Rationale for SNG001 as a broad-spectrum antiviral
There is a strong scientific rationale underpinning SNG001 for use in treating
patients infected with a broad range of respiratory viruses, combined with its
safety profile and a growing body of encouraging clinical and non-clinical
data which has helped us better understand the potential role SNG001 might
play in treating patients at risk of developing severe illness due to these
respiratory viruses.
The Group has conducted in vitro testing of SNG001 against a broad range of
respiratory viruses ranging from seasonal cold and flu viruses like RSV and
rhinovirus; highly pathogenic viruses such as H5N1, a form of 'bird flu',
MERS-CoV, SARS-CoV-2 variants of concern including Alpha, Beta, Gamma, Delta
and Omicron.(( 4 (#_ftn4) )) In vitro tests have shown potent antiviral
activity at concentrations that are readily achievable following inhaled
delivery of interferon beta. We believe these concentrations could not be
accomplished at the lining of the lungs via the injected route, and indeed
recent studies have shown systemic use of IFN-B through injection is
ineffective in fighting COVID-19 in the lungs.(( 5 (#_ftn5) ))
2022 Clinical Summary and Progress
SPRINTER - Investigating SNG001 in the hospitalised environment
SPRINTER (SG018; NCT04732949) was a global, randomised, placebo-controlled,
double-blind clinical trial assessing the efficacy and safety of inhaled
SNG001 for the treatment of adults hospitalised due to COVID-19 who required
treatment with supplemental oxygen. The trial recruited a total of 623
patients who were randomised to receive SNG001 (n=309) or placebo (n=314) on
top of standard of care.
Synairgen announced in February 2022 that the Phase 3 SPRINTER trial did not
meet the primary endpoints of discharge from hospital and recovery. There was,
however, an encouraging signal in the key secondary endpoint of reduction in
the relative risk (RRR) of progression to severe disease or death within 35
days including a 25.7% reduction in the Intention-to-Treat population and
36.3% reduction in the Per Protocol population (though neither was
statistically significant).
To assess the strength of this signal and identify specific patient
populations that might benefit most from treatment, post hoc analyses were
performed on groups of patients recognised to be at greater risk of developing
severe disease in hospital. These analyses included patients ≥65 years old,
those with co-morbidities associated with worse COVID-19 outcomes and those
who, at baseline, despite receiving low flow oxygen, had clinical signs of
compromised respiratory function (defined as oxygen saturation of ≤ 92% or
respiratory rate ≥ 21 breaths/min).
These analyses showed stronger treatment effects with SNG001 in high-risk
patient subgroups, 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 or death
compared to placebo by 70% in the Per Protocol population (Odds Ratio (95%
Confidence Interval) 0.23 (0.06, 0.98); p=0.046).
The data from this pivotal trial was presented at the Clinical Trials
Symposium of the American Thoracic Society 2022 (ATS 2022) International
Conference in San Francisco, California in May 2022 and appeared in the
peer-reviewed European Respiratory Journal Open Research (ERJOR) in December
2022.
In addition to this, Long COVID symptoms and patient reported outcome measures
were assessed as a secondary endpoint of the SPRINTER trial at follow-up
visits via telephone/video call on Day 60 and 90. Patients on SNG001 saw the
relative risk of fatigue/malaise reduced RRR=35.4% , one of the most common
symptoms of Long COVID.
ACTIV-2 - Investigating antiviral treatments in the home environment
In October 2022, Synairgen received the positive topline results for outcomes
through 28 days of follow-up from the Phase 2 evaluation of SNG001 from the US
National Institute of Allergy and Infectious Diseases (NIAID) ACTIV-2 trial
(Protocol ACTIV-2/A5401: "Adaptive Platform Treatment Trial for Outpatients
with COVID-19 [Adapt out COVID]"; Appendix B). This trial was established to
investigate potential therapies in adults experiencing mild to moderate
COVID-19 outside of the hospital setting. Based on the study results, the
Independent Data Safety Monitoring Board for ACTIV-2 recommended SNG001
advance from Phase 2 into Phase 3 but in March 2022, the NIH decided to halt
all participant recruitment in the trial due to the significant shift in the
nature of the pandemic. At that point, the Phase 3 component, including
SNG001, was halted.
Overall SNG001 was well-tolerated and there was no statistically significant
difference between SNG001 and placebo with respect to the primary safety
outcome measure, and there were no statistically significant differences in
the other primary outcomes namely time to symptom improvement or viral
clearance. It is notable that one patient was hospitalised in the SNG001
treatment group compared with seven in the Placebo group (1/110 SNG001 versus
7/110 placebo, representing an 86% relative risk reduction p=0.07). While the
Phase 2 stage of the trial was not powered to prove this, the promising
decrease in hospitalisations in patients that received SNG001 may be
important, especially combined with a good safety profile.
The data from the ACTIV-2 trial was presented at the Conference on
Retroviruses and Opportunistic Infections Conference (CROI) in February 2023
by Dr William Fischer from the University of North Carolina at Chapel Hill and
have been submitted for publication in a peer-reviewed journal.
To build on the results of the ACTIV-2 trial, one of the clinical
opportunities we are investigating for SNG001 is its use in the home
environment to help prevent hospitalisation in high-risk patients with a wide
range of viral lung infections.
SG015 COPD trial virology
In early 2020, due to the emergence of SARS-CoV-2, Synairgen's SG015
(NCT03570359) 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 a significant improvement in the lung
function of exacerbating patients.
In September 2022, Synairgen reported positive data from post hoc assessments
of lung sputum samples from SG015 which showed that SNG001 accelerated
clearance of rhinovirus (which approximately half of the trial participants
had) from the lungs. This builds on existing data supporting SNG001's
mechanism of action.
Manufacturing
As we look ahead to delivering the clinical development programme, we have
made the strategic decision to focus our manufacturing efforts on the supply
of additional pre-filled syringe drug product and placebo for clinical trials.
While we remain committed to exploring new packaging options, such as
blow-filled sealed delivery, we believe that at this time it is important to
prioritise the production of SNG001 to fulfil current requirements, using
current proven process and materials.
FINANCIAL REVIEW
Consolidated Statement of Comprehensive Income
The loss from operations for the year ended 31 December 2022 was £20.3
million (2021: £57.9 million loss) with research and development expenditure
amounting to £14.9 million (2021: £52.9 million) and other administrative
expenses of £5.4 million (2021: £5.0 million).
Research and development expenditure continued to be focussed on clinical
trials and manufacturing activities.
Clinical trial expenditure on SPRINTER, SG015 and SG016 reduced markedly
compared to 2021. Additional preparatory costs for the ACTIV-2 Phase 3 study
were incurred in 2022 prior to the trial being halted.
Manufacturing activities (including procurement of long lead time items) also
reduced significantly in 2022 with the main area of expenditure being on
outsourced activities, including blow fill seal drug product development,
release testing, stability testing and comparison testing, with all costs
being expensed to the income statement.
Other administrative expenses, which comprises all expenses which are not
research and development expenditure, of £5.4 million in 2022 remained
broadly in line with the total expenditure of £5.0 million in 2021. There was
greater expenditure on medical affairs and corporate communications in 2022
compared to 2021 when there was a greater expenditure on pre-commercialisation
activities.
Interest receivable increased from £nil to £0.2 million as deposit interest
rates increased during the second half of 2022.
The research and development tax credit decreased from £9.2 million to £2.4
million in line with reduced qualifying research and development expenditure.
The credit equates to 16% of our 2022 research and development expenditure
(2021: 17%).
The loss after tax for 2022 was £17.6 million (2021: £48.7 million) and the
basic loss per share was 8.76p (2021: basic loss per share of 24.28p).
Consolidated Statement of Financial Position and Cash Flows
At 31 December 2022, net assets amounted to £20.3 million (2021: £37.0
million), including cash and deposit balances of £19.7 million, comprising
cash and cash equivalents of £15.9 million and other financial assets - bank
deposits of £3.8 million, (2021: £33.8 million cash and cash equivalents).
The principal elements of the £14.1 million decrease during the year ended 31
December 2022 (2021: £41.2 million decrease) in cash and deposit balances
were:
· Cash outflows from operations before changes in working capital:
£19.3 million (2021: £57.2 million), with the reduction being attributable
to the lower research and development expenditure as explained above;
· Changes in working capital: £4.1 million outflow (2021: £12.2
million inflow), on account of the reduction in trade and other payables as
discussed below. In 2021 there was a reduction in trade and other receivables
of some £7.8 million and an increase in trade and other payables of £4.4
million;
· Interest received £0.1 million (2021: £nil); and
· Research and development tax credits received: £9.1 million (2021:
£3.9 million) on account of receipt of the 2021 tax credit.
The other significant changes in the Statement of Financial Position were:
· Current tax receivable decreased from £9.1 million to £2.4 million
on account of the lower research and development tax credit receivable; and
· Trade and other payables decreased from £7.6 million to £3.3
million as trade payables reduced from £4.2 million to £0.5 million in line
with the reduction in the level of operating expenditure.
OUTLOOK
Underpinned by the encouraging data accumulated to date for SNG001 and that
respiratory virus infections remain a leading cause of death globally, we
remain excited by its potential to be the first inhaled broad-spectrum
antiviral for patients at high risk of disease progression, in both the
hospital and home environment.
Based on the significant clinical need and the insights gained from our
clinical and pre-clinical data, the Group will advance its clinical
development plan for SNG001 with a series of focused,
investigator-led/Synairgen-sponsored studies, commencing in H2 2023 utilising
existing cash resources, to build a pathway towards a Phase 3 registrational
programme.
We continue to gather valuable insights from studies conducted and look
forward to presenting our latest analysis of the Phase 3 SPRINTER trial data
at ISIRV and ATS in May and updating all our shareholders on our progress in
due course.
Consolidated Statement of Comprehensive Income
for the year ended 31 December 2022
Year Year
ended 31 December ended 31 December
2022 2021
Notes £000 £000
Research and development expenditure (14,936) (52,857)
Other administrative expenses (5,364) (5,009)
Total administrative expenses and Loss from operations (20,300) (57,866)
Finance income 207 11
Finance expense - (2)
Loss before tax (20,093) (57,857)
Tax 2,448 9,194
2
Loss and total comprehensive loss for the period attributable to equity (17,645) (48,663)
holders of the parent
Loss per ordinary share 3
Basic and diluted loss per share (pence) (8.76)p (24.28)p
Consolidated Statement of Changes in Equity
for the year ended 31 December 2022
Share capital Share premium Merger reserve Retained Total
deficit
£000 £000 £000 £000 £000
At 1 January 2021 1,999 125,245 483 (42,586) 85,141
Loss and total comprehensive loss for the year - - - (48,663) (48,663)
Transactions with equity holders of the Group
Issue of ordinary shares 14 - - - 14
Recognition of share-based payments - - - 508 508
14 - - 508 522
At 31 December 2021 2,013 125,245 483 (90,741) 37,000
Loss and total comprehensive loss for the year - - - (17,645) (17,645)
Transactions with equity holders of the Group
Issue of ordinary shares 1 - - - 1
Recognition of share-based payments - - - 919 919
1 - - 919 920
At 31 December 2022 2,014 125,245 483 (107,467) 20,275
Consolidated Statement of Financial Position
as at 31 December 2022
31 31
December December
2022 2021
£000 £000
Assets
Non-current assets
Intangible assets 44 53
Property, plant and equipment 86 173
Right-of-use assets - -
130 226
Current assets
Current tax receivable 2,415 9,055
Trade and other receivables 1,308 1,530
Other financial assets - bank deposits 3,750 -
Cash and cash equivalents 15,926 33,827
23,399 44,412
Total assets 23,529 44,638
Liabilities
Current liabilities
Trade and other payables (3,254) (7,638)
Total liabilities (3,254) (7,638)
Total net assets 20,275 37,000
Equity
Capital and reserves attributable to equity holders of the parent
Share capital 2,014 2,013
Share premium 125,245 125,245
Merger reserve 483 483
Retained deficit (107,467) (90,741)
Total equity 20,275 37,000)
Consolidated Statement of Cash Flows
for the year ended 31 December 2022
Year Year
ended 31 ended 31
December December
2022 2021
£000 £000
Cash flows from operating activities
Loss before tax (20,093) (57,857)
Adjustments for:
Finance income (207) (11)
Finance expense - 2
Lease adjustment - (4)
Depreciation of property, plant and equipment 93 92
Depreciation of right-of-use assets - 94
Amortisation of intangible fixed assets 9 9
Share-based payment charge 919 508
Cash flows from operations before changes in working capital (19,279) (57,167)
Decrease in inventories - 41
Decrease in trade and other receivables 289 7,841
(Decrease)/Increase in trade and other payables (4,384) 4,359
Cash used in operations (23,374) (44,926)
Tax credit received 9,088 3,910
Net cash used in operating activities (14,286) (41,016)
Cash flows from investing activities
Interest received 140 12
Purchase of intangible assets - (18)
Purchase of property, plant and equipment (6) (15)
Increase in other financial assets (3,750) -
Net cash used in investing activities (3,616) (21)
Cash flows from financing activities
Proceeds from issue of ordinary shares 1 14
Principal paid on lease liabilities - (124)
Interest paid on lease liabilities - (2)
Net cash generated from/(used in) financing activities 1 (112)
Decrease in cash and cash equivalents (17,901) (41,149)
Cash and cash equivalents at beginning of the year 33,827 74,976
Cash and cash equivalents at end of the year 15,926 33,827
Notes
1. Basis of preparation
The financial information of the Group set out above does not constitute
"statutory accounts" for the purposes of Section 435 of the Companies Act
2006. The financial information for the year ended 31 December 2022 has been
extracted from the Group's audited financial statements which were approved by
the Board of directors on 26 April 2023 and will be delivered to the Registrar
of Companies for England and Wales in due course. The financial information
for the year ended 31 December 2021 has been extracted from the Group's
audited financial statements for that period which have been delivered to the
Registrar of Companies for England and Wales. The reports of the auditors on
both these financial statements were unqualified, did not include any
references to any matters to which the auditors drew attention by way of
emphasis without qualifying their report and did not contain a statement under
Section 498(2) or Section 498(3) of the Companies Act 2006. While the
financial information included in this preliminary announcement has been
prepared in accordance with the recognition and measurement criteria of UK
adopted International Financial Reporting Standards ('IFRSs'), this
announcement does not itself contain sufficient information to comply with
those IFRSs. This financial information has been prepared in accordance with
the accounting policies set out in the December 2022 report and financial
statements.
2. Tax
The tax credit of £2,448,000 (2021: £9,194,000) relates to research and
development tax credits in respect of the year ended 31 December 2022
(£2,415,000) and an adjustment in respect of prior periods (£33,000).
3. Loss per ordinary share
Basic loss per share is calculated by dividing the loss attributable to
ordinary equity holders of the parent company by the weighted average number
of ordinary shares in issue during the year.
The loss attributable to ordinary shareholders and weighted average number of
ordinary shares for the purpose of calculating the diluted earnings 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 under the terms of IAS
33.
1 (#_ftnref1) Synairgen on file.
2 (#_ftnref2) IQVIA market research Q4 2022; Sources: US CDC, HCUP, IQVIA
Claims Data, PubMed; data on file.
3 (#_ftnref3) Hartnett J. Influenza Other Respir Viruses. 2022;16:906-915;
Pastula ST et.al.,OFID, 2017, ofw270; Zhou JA et.al., CID, 2020, 70(5):
773-779; Disease Burden of Flu | CDC; Preliminary Medicare COVID-19 Data
Snapshot (Dec 2021); ICER Report: Special Assessment of Outpatient Treatments
for COVID-19 (Feb 2022).
4 (#_ftnref4) Synairgen on file.
5 (#_ftnref5) WHO Solidarity Trial Consortium. Repurposed Antiviral Drugs
for Covid-19 - Interim WHO Solidarity Trial Results. N Engl J Med.
2021;384:497-511.
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