REG - Synairgen plc - 2023 Full Year Results
27/06/2024 07:00
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RNS Number : 0538U Synairgen plc 27 June 2024
Synairgen plc
('Synairgen' or the 'Company')
Results for the year ended 31 December 2023
Southampton, UK - 27 June 2024: 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 2023.
Highlights (including post period-end)
Operational
· Completed a full assessment of the underpinning science, clinical
trial data, clinical need and commercial opportunity to determine next steps
for SNG001
· Commenced preparatory work in 2023 to deliver a trial focusing on
mechanically ventilated patients who we believe are the most attractive
near-term patient group with respect to the extent of the unmet need, the
commercial potential in a clearly identifiable population and the clinical
development route for SNG001
· Recognised that opportunities for potential future assessment of
SNG001 in platform trials and/or academic trials may materialise in the event
of an emerging virus threat
· Continued collaboration with the University of Southampton's
UNIVERSAL trial aimed at better characterising patients hospitalised with
respiratory viral infections with over 500 patients recruited to date
Financial
1. Prudent cost control applied across all operations
2. Loss from operations for the year ended 31 December 2023 was £10.3
million (2022: £20.3 million loss)
3. Cash and cash equivalents, and bank deposits of £12.0 million at 31
December 2023 (31 December 2022: £19.7 million)
Richard Marsden, CEO of Synairgen, said: "We are pleased to have selected an
exciting path forward for SNG001, which is to conduct a Phase 2 trial in
mechanically ventilated patients where there is a substantial unmet medical
need with 25% to 45% mortality and few antiviral therapeutic options.
Alongside this, we have continued our work as part of the UK-wide UNIVERSAL
trial and remain open to other collaborations and platform trials in the
future. We will keep all stakeholders up to date on developments, including
financing, as we prepare to start the trial this winter."
Annual Report and AGM update
Synairgen has published its Annual Report and Accounts for the year ended 31
December 2023 on its website, www.synairgen.com (http://www.synairgen.com) .
The date of the upcoming AGM will be published in due course, with the Annual
Report and Accounts and AGM notice posted to shareholders ahead of this.
The information contained within this announcement is deemed to constitute
inside information as stipulated under the retained EU law version of the
Market Abuse Regulation (EU) No. 596/2014 (the "UK MAR") which is part of UK
law by virtue of the European Union (Withdrawal) Act 2018. The information is
disclosed in accordance with the Company's obligations under Article 17 of the
UK MAR. Upon the publication of this announcement, this inside information is
now considered to be in the public domain.
For further enquiries, please contact:
Synairgen plc
Media@synairgen.com (mailto:Media@synairgen.com)
Tel: + 44 (0) 23 8051 2800
Cavendish Capital Markets Limited (NOMAD and Joint Broker)
Geoff Nash, Charlie Beeson (Corporate Finance)
Sunila de Silva (ECM)
Tel: + 44 (0) 20 7220 0500
Deutsche Numis (Joint Broker)
Freddie Barnfield, Duncan Monteith, Euan Brown
Tel: + 44 (0) 20 7260 1000
ICR Consilium (Financial Media and Investor Relations)
Mary-Jane Elliott, Namrata Taak, Lucy Featherstone
Synairgen@consilium-comms.com (mailto:Synairgen@consilium-comms.com)
Tel: +44 (0) 20 3709 5700
Notes for Editors
About Synairgen
Synairgen is a UK-based respiratory company focused on drug discovery and the
development of SNG001 (inhaled interferon beta) as potentially the first
host-targeted, broad-spectrum antiviral treatment delivered directly into the
lungs for severe viral lung infections.
Millions of people globally are hospitalised every year due to viral lung
infections and there are currently no approved antiviral therapies for the
majority of these patients. Synairgen is developing SNG001 to address this
need.
Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen,
please see www.synairgen.com (http://www.synairgen.com)
CHAIRMAN'S STATEMENT
There remains a significant unmet medical need for new treatments for
respiratory viral infections which are caused by a wide range of viruses
(influenza, RSV, SARS-CoV-2, rhinovirus, metapneumovirus and others).
Antiviral therapeutic options are limited for the majority of hospitalised
adult patients with severe viral lung infections, which remain a leading cause
of death globally. Approximately 2.5 million people in the US are hospitalised
each year due these respiratory viruses.
Synairgen's relentless focus in the year has been on applying the insights
gained from 2020/21 to determine the best path forward for clinical
development of its investigational drug, SNG001, for severe viral lung
infections. This was conducted amidst the backdrop of a challenging year for
the biotech sector; we have regained momentum and stand on the verge of
embarking on a Phase 2 trial in patients who are mechanically ventilated as a
result of a respiratory viral infection, subject to finalising the trial
financing plan. We have selected this population because it has a high unmet
need, represents a significant commercial opportunity, patients are readily
identifiable, and the clinical path is clear. We look forward to communicating
the trial design and associated financing plan.
Since the results of SPRINTER and ACTIV-2 trials were announced, our team has
focussed on using the findings from these studies, the literature and clinical
experts to determine which patients stand to potentially benefit most from
SNG001 and developing the clinical network and trial protocol which carries an
appropriate level of risk and reward for Synairgen shareholders. The
considerable research work that was required to critically evaluate all
potential options has ultimately led us to eliminate a number of potentially
promising avenues for further clinical development. We have made a strategic
decision to focus on mechanically ventilated patients in the hospital setting
enabling clinical development with smaller, easier to deliver clinical trials
in an area of high unmet medical and pharmacoeconomic need. We have determined
that it is inappropriate at this stage for the Company to conduct clinical
trials in the non-hospitalised setting, although we believe that SNG001
continues to be an attractive asset in this setting, and we are open for
inclusion of SNG001 in platform trials and/or collaborations as and when viral
threats emerge.
I would like to take this opportunity to thank the entire team for their
unwavering commitment to finding a path forward for SNG001 and express my
appreciation to our shareholders for their continued support. I look forward
to updating the market with greater detail on our development plans.
Simon Shaw
Chairman
OPERATIONAL REVIEW
Overview
During the past year the Group thoroughly assessed a wide range of options to
identify the best route forward for its broad-spectrum host-directed antiviral
drug, SNG001 (inhaled interferon beta), for the treatment of severe viral lung
infections. Respiratory viral infections are the most common cause of
infectious disease and when they affect the lungs, they can cause significant
morbidity and mortality. Interferon beta is a naturally occurring protein,
produced in response to viral infections, that drives the body's antiviral
responses. People who make less interferon beta, for example due to their
genetic profile, age or disease, are at greater risk of developing severe
viral lung infections. Respiratory viruses themselves also supress interferon
beta production to evade host antiviral responses. Together these factors
provide the rationale to deliver SNG001 directly into the lungs as an aerosol
to boost/restore the lungs' antiviral responses to clear the virus. During the
year, Synairgen completed a review of potential development opportunities for
SNG001 through careful assessment of the underpinning science, strength of
clinical data, trial feasibility, clinical need and commercial opportunity.
This included options in both hospitalised and non-hospitalised patients, and
those with critical illness due to any respiratory virus.
As a result of this analysis, it has become clear that the hospitalised
patient setting provides the greatest opportunity for SNG001 to provide
assessable benefit in a group of patients in whom there is considerable unmet
clinical need. Synairgen has focused its efforts on projects designed to
enable identification of hospitalised patients at the highest risk of poor
outcomes, which would make clinical trials more targeted whilst maximising the
chance of success clinically and commercially.
The Company has developed a new trial plan focussed on mechanically ventilated
patients that takes into account a range of important factors including
learnings from trials of SNG001 in hospitalised patients, the high unmet need,
and the clear commercial strategy for this group of very expensive to treat
patients. It is intended to commence the trial this winter and will be
supported by data from various projects, including the UNIVERSAL trial, a
UK-wide observational trial in patients hospitalised with respiratory viral
infections, led by Prof. Tom Wilkinson and colleagues from the University of
Southampton, in conjunction with pharmaceutical industry partners. Recruitment
has continued at pace into UNIVERSAL and the important insights will help the
Company develop criteria to select populations most likely to respond to
SNG001 for inclusion in future clinical trials.
Our strategy and plans
Mechanically ventilated patients
Respiratory viral infections are a significant burden on the global healthcare
system, and are associated with high morbidity and mortality. Approximately
2.5 million(12) people in the US continue to be hospitalised each year due to
respiratory symptoms associated with a respiratory virus. Prior to the
pandemic, influenza was often singled out as the main driver of the winter
virus season accounting for ~0.5m(1) hospitalisations each year, however it is
estimated that the so called 'common cold viruses' such as rhinovirus,
coronavirus, RSV, parainfluenza, HMPV and adenovirus collectively account for
an additional 2 million hospitalisations(2), and SARS-CoV-2 persists as a
problematic pathogen.
Patients on ventilators with viral pneumonia have a 25-45%(34) chance of
dying. There are few approved antiviral options for these patients and, for
most respiratory viruses, no specific antiviral treatments. The literature
also indicates that patients who develop severe viral lung disease have higher
viral loads and shed virus for longer pointing to a compromised
immune/antiviral response.
Analyses of several trials conducted by Synairgen to date reveal that, across
different patient populations and care settings, those with more severe
disease at the start of treatment responded best to treatment with SNG001.
This includes prevention of hospitalisation in patients treated in the
community as well as progression to severe disease or death in patients
hospitalised due to their viral infection. These observations underpin our
strategy of targeting patients at the highest risk of poor outcomes.
As a broad-spectrum antiviral drug, SNG001 has shown in vitro effects against
multiple respiratory viruses and in vivo has uncovered its potential to treat
and/or prevent severe viral lung infection. Preparatory work for a trial
commenced in 2023 and has continued into 2024. The company is currently
finalising potential trial structures and a potential financing plan to enable
it to pursue an enhanced trial structure. If this comes about, details will be
communicated in due course.
UNIVERSAL trial
During the year the Group has continued its work with Prof. Tom Wilkinson from
the University of Southampton to progress UNIVERSAL, a multi-centre
observational study in patients recently hospitalised due to respiratory
viruses. UNIVERSAL is supported by Synairgen, AstraZeneca, and Janssen. A key
objective is to develop methods to identify patients at higher risk of poor
outcomes due to respiratory viruses.
UNIVERSAL is progressing well with more than 500 patients recruited to date.
Data and samples are being analysed as they are collected, and will continue
through 2024. Results from UNIVERSAL will provide more insight for the Company
to help inform the design of future trials with SNG001, allowing Synairgen to
identify patients at the highest risk of disease progression whilst avoiding
patients who are more likely to recover rapidly without the need for an
antiviral intervention.
Key learnings from other patient populations
Non-hospitalised: During the pandemic the Company generated encouraging data
in non-hospitalised patients from both its own 'SG016 home trial' and through
collaboration with the US Government's ACTIV-2 trial team, which was
ultimately halted due to declining rates of infection. This COVID-19 data
sits well alongside earlier data from trials in asthma and COPD.
Neither the SG016 home nor ACTIV-2 studies were powered to demonstrate
statistical significance on hospital admission as an endpoint, however pooling
the data from all 330 COVID-19 patients from the two studies showed that 1 out
of 165 patients on SNG001 (<1%) were hospitalised compared to 10 out of 165
(6%) placebo patients(56). This represents a ~90% relative risk reduction, a
comparable reduction to that seen with Paxlovid in Phase 3 trials. The
encouraging signals coincided with the less pathogenic Omicron becoming the
dominant circulating variant. As a result, hospitalisation rates with COVID-19
significantly dropped, meaning that clinical trial sizes needed to confirm the
efficacy of SNG001 in the outpatient setting would exceed thousands of
patients and therefore became commercially unfeasible for a Company of
Synairgen's size.
Despite this, Synairgen believes that SNG001 continues to be an attractive
asset for inclusion in platform trials, a position the Company was not in
prior to the pandemic.
Long term viral shedders: Beyond pandemic preparedness, Synairgen has explored
various non-hospitalised patient groups who are particularly vulnerable to
viral lung infections, with a particular focus on patients who struggle to
clear the virus and become long term shedders of virus, many of whom are
immunocompromised patients (e.g. through undertaking cancer treatments). After
careful consideration, the Company elected not to fund its own trials in these
very high-risk patients at this point in time. This decision was primarily
based on the large size of trial required to demonstrate a reduction in the
rate that patients are hospitalised, and the logistical complexity of patient
identification. The Company will, however, continue to be open to trial
collaborations in this area.
Summary
After conducting a rigorous evaluation of the clinical need, supporting
scientific literature, trial feasibility, and commercial viability,
Synairgen's strategic decision is to determine an appropriately sized trial in
mechanically ventilated patients who it believes are most likely to benefit
from SNG001 as a result of infection from a wide range of respiratory viruses
causing appreciable morbidity, mortality and a strain on health care
infrastructure.
The Company continues to be extremely excited by the potential for SNG001 to
be the first inhaled broad-spectrum antiviral targeting the lungs. The
Synairgen team is ever grateful for the support of its loyal investors,
partners and staff in a crucial year where it has researched the rationale
for, and is gearing up to execute on, the most appropriate strategy for the
development of SNG001. The Company is currently finalising its assessment of
the best combination of trial structure/locations and associated financing
requirement and aim to communicate the outcome of this soon with a view to
commencing the next Phase II trial this winter.
FINANCIAL REVIEW
Consolidated Statement of Comprehensive Income
The loss from operations for the year ended 31 December 2023 was £10.3
million (2022: £20.3 million loss) with research and development expenditure
amounting to £6.5 million (2022: £14.9 million) and other administrative
expenses of £3.8 million (2022: £5.4 million).
Expenditure on research and development activity decreased in 2023, continuing
the trend from the prior year, as the Group focussed on refining plans for
future clinical trials.
Clinical trial expenditure was limited to the cost of closing out the
SPRINTER, SG015 and SG016 trials, in conjunction with preparatory work to
design future clinical trial activity, such as participation in the UNIVERSAL
trial.
Manufacturing activities also reduced significantly in the year, with spend
focussed on the manufacture of a new batch of drug product and placebo
(pre-filled syringes), and third-party laboratory testing (incorporating
stability, comparison and release testing of drug product, qualification of
new reference standards). All manufacturing costs were expensed to the
income statement.
Expenditure on science (R&D) and quality departments remain flat on the
prior year, with regulatory costs reducing in-line with diminished trial
activity.
Other administrative expenses totalled £3.8 million in 2023, which comprise
all expenses which are not research and development expenditure, and
predominantly reflect staff costs and professional fees. This represents a
decrease of £1.6 million on the prior year (2022: £5.4 million), due to cost
saving initiatives implemented within commercial, medical affairs, business
development, and corporate communications.
Interest receivable increased from £0.2 million to £0.6 million, as deposit
interest rates increased during 2023.
The research and development tax credit (including R&D expenditure credit
- "RDEC") decreased from £2.4 million to £1.3 million in line with reduced
qualifying research and development expenditure. The credit equates to 20% of
our 2023 research and development expenditure (2022: 16%).
The loss after tax for 2023 was £8.4 million (2022: £17.6 million) and the
basic loss per share was 4.18p (2022: basic loss per share of 8.76p).
Consolidated Statement of Financial Position and Cash Flows
At 31 December 2023, net assets amounted to £12.7 million (2022: £20.3
million), including cash and deposit balances of £12.0 million, comprising
cash and cash equivalents of £10.5 million and other financial assets - bank
deposits of £1.5 million (2022: £19.7 million cash and bank deposit
balances).
The principal elements of the £7.7 million decrease during the year ended 31
December 2023 (2022: £14.1 million decrease) in cash and bank deposit
balances were:
· Cash outflows from operations before changes in working capital:
£9.4 million (2022: £19.3 million), with the reduction being attributable to
the lower research and development administrative expenditure and as explained
above;
· Changes in working capital: £1.2 million outflow (2022: £4.1
million outflow), due to a reduction in trade and other payables of £1.7
million, and a £0.5 million decrease in trade and other receivables;
· Interest received £0.6 million (2022: £0.2 million); and
· Research and development tax credits received: £2.4 million
(2022: £9.1 million) on account of receipt of the 2022 tax credit.
The other significant changes in the Statement of Financial Position
were:
· Current tax receivable decreased from £2.4 million to £1.3
million on account of the lower research and development tax credit (including
RDEC) receivable;
· Trade and other receivables decreased by £0.5 million to £0.8
million (2022: £1.3 million), due predominantly to a reduction in prepayments
due to the reduction in the level of operating expenditure; and
· Trade and other payables decreased by £1.7 million to £1.6
million (2022: £3.3 million), in line with the reduction in the level of
operating expenditure.
Consolidated Statement of Comprehensive Income
for the year ended 31 December 2023
Year Year
ended ended
31 December 31 December
2023 2022
Notes £000 £000
Research and development expenditure (6,531) (14,936)
Other administrative expenses (3,761) (5,364)
Total administrative expenses and loss from operations (10,292) (20,300)
Finance income 635 207
Loss before tax (9,657) (20,093)
Tax 5 1,249 2,448
Loss and total comprehensive loss for the period attributable to equity (8,408) (17,645)
holders of the parent
Loss per ordinary share
Basic and diluted loss per share (pence) 6 (4.18)p (8.76)p
Consolidated Statement of Changes in Equity
for the year ended 31 December 2023
Share capital Share Merger reserve Retained Total
premium deficit
£000 £000 £000 £000 £000
At 1 January 2022 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
At 31 December 2022 2,014 125,245 483 (107,467) 20,275
Loss and total comprehensive loss for the year (8,408) (8,408)
Transactions with equity holders of the Group
Recognition of share-based payments - - - 790 790
At 31 December 2023 2,014 125,245 483 (115,085) 12,657
Consolidated Statement of Financial Position
as at 31 December 2023
31 December 31 December
2023 2022
£000 £000
Assets
Non-current assets
Intangible assets 102 44
Property, plant and equipment 26 86
128 130
Current assets
Current tax receivable 1,249 2,415
Trade and other receivables 828 1,308
Other financial assets - bank deposits 1,500 3,750
Cash and cash equivalents 10,516 15,926
14,093 23,399
Total assets 14,221 23,529
Liabilities
Current liabilities
Trade and other payables (1,564) (3,254)
Total liabilities (1,564) (3,254)
Total net assets 12,657 20,275
Equity
Capital and reserves attributable to equity holders of the parent
Share capital 2,014 2,014
Share premium 125,245 125,245
Merger reserve 483 483
Retained deficit (115,085) (107,467)
Total equity 12,657 20,275
Consolidated Statement of Cash Flows
for the year ended 31 December 2023
Year Year
ended ended
31 December 31 December
2023 2022
£000 £000
Cash flows from operating activities
Loss before tax (9,657) (20,093)
Adjustments for:
Finance income (635) (207)
Depreciation of property, plant and equipment 73 93
Amortisation of intangible fixed assets 11 9
Share-based payment charge 790 919
Cash flows from operations before changes in working capital (9,418) (19,279)
Decrease in trade and other receivables 473) 289)
(Decrease) in trade and other payables (1,690) (4,384)
Cash used in operations (10,635) (23,374)
Tax credit received 2,415 9,088
Net cash used in operating activities (8,220) (14,286)
Cash flows from investing activities
Interest received 642 140
Purchase of intangible assets (69) -
Purchase of property, plant and equipment (13) (6)
Receipt of bank deposits 3,750 -
Cash paid for deposits (1,500) (3,750)
Net cash generated from/(used in) investing activities 2,810 (3,616)
Cash flows from financing activities
Proceeds from issue of ordinary shares - 1
Net cash generated from/(used in) financing activities - 1
Decrease in cash and cash equivalents (5,410) (17,901)
Cash and cash equivalents at beginning of the year 15,926 33,827
Cash and cash equivalents at end of the year 10,516 15,926)
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 2023 has been
extracted from the Group's audited financial statements which were approved by
the Board of directors on 26 June 2024 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 2022 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 2023 report and financial
statements.
2. New standards, interpretations and amendments adopted from 1
January 2023
With effect from 1 January 2023, the Group adopted the amendments to existing
standards set out below that are effective for an annual period that begins on
or after 1 January 2023:
· Amendments to IAS 1 and IFRS Practice Statement 2 - Disclosure of
Accounting Policies
· Amendments to IAS 8 - Definition of Accounting Estimates
The adoption of these amendments has not had a material impact on the
disclosures or on the amounts reported in the Group's financial statements.
3. New standards, interpretations and amendments not yet
effective
At the date of approval of these Group financial statements, the Group had not
yet applied the following new and revised accounting standards, amendments and
interpretations that have been issued by the IASB and have been adopted by the
UK Endorsement Board (UKEB):
Effective 1 January 2024:
· Amendments to IFRS 16 - Lease Liability in a Sale and Leaseback
· Amendments to IAS 1 - Classification of Liabilities as Current or
Non-current
The Group does not expect the adoption of these IFRS amendments will have a
material impact on the Group in the current period or will have material
impact on future reporting periods and on foreseeable future transactions.
The Group financial statements are presented in Sterling.
4. Going concern
The directors have prepared financial forecasts to estimate the likely cash
requirements of the Group over the period to 31 December 2025, 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 consider that they have taken a prudent view in preparing these
forecasts.
The directors have identified that the Group will need to raise further funds
during 2024 in order to conduct the planned Phase 2 clinical trial in
mechanically ventilated patients. The ability of the Group to secure a fund
raise in 2024 cannot be guaranteed, therefore the directors have prepared an
alternative forecast which maintains a budget for further pre-clinical
preparatory work that would produce data to undertake a fund raise in 2025,
whilst significantly reducing research and development, and administrative
spend. Should this alternative forecast be required, the directors are
confident of achieving savings in expenditure within their control, resulting
in the Group having sufficient resources until Q1 2026 without the need for a
further fund raise, whilst maintaining the principal activity of the Group.
In addition, the directors have considered the sensitivity of the financial
forecasts to changes in key assumptions, including, among others, potential
cost overruns within anticipated spend.
After due consideration of these forecasts and current cash resources,
including the sensitivity of key inputs, 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 12 months from the date of this
report) and, for this reason, the financial statements have been prepared on a
going concern basis.
5. Tax
The tax credit of £1.3 million (2022: £2.4 million) relates to research and
development tax credits (including R&D expenditure credit - "RDEC") in
respect of the year ended 31 December 2023.
6. 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.
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. END FR BQLLLZQLEBBERecent news on Synairgen
See all newsREG - Synairgen plc - Interim Results
AnnouncementREG - Synairgen plc - Appointment of New Chairman and Notice of AGM
AnnouncementREG - Synairgen plc - Board Change
AnnouncementREG - Synairgen plc - 2023 Full Year Results
AnnouncementREG - Synairgen plc - Grant of Options
Announcement