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RNS Number : 6863M
Synairgen plc
25 May 2022
Synairgen plc
('Synairgen' or the 'Company')
Results for the year ended 31 December 2021
Southampton, UK - 25 May 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 preliminary statement
of audited results for the year ended 31 December 2021.
Highlights (including post period-end)
Operational
-- Recruited 623 patients into the Company's Phase 3 SPRINTER
trial, a double-blind, placebo-controlled trial conducted in 17
countries, to investigate the efficacy and safety of SNG001 in
people hospitalised with COVID-19.
o The trial did not meet the primary endpoints, as previously
announced. There was, however, an encouraging signal in reduction
in the relative risk (RRR) of progression to severe disease or
death within 35 days (26% reduction in the Intention-to-Treat (ITT)
population and 36% reduction in the Per Protocol population).
o Further follow-on analyses indicated stronger treatment
effects in high-risk patient sub-groups, with the strongest effect
observed in patients with compromised respiratory function despite
being on supplemental oxygen (44% reduction in the ITT population
and 70% reduction in the Per Protocol population), who comprised
approximately one-third of the overall trial population.
o The data has further validated the favourable safety profile
of SNG001.
-- Recruitment started and completed in the US Government's
Phase 2 ACTIV-2 trial conducted in the US to investigate SNG001 in
people with COVID-19 at home, prior to hospitalisation.
o The Data Safety Monitoring Board graduated SNG001 from Phase 2
to Phase 3 in the ACTIV-2 trial, sponsored by the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health, and led by the NIAID-funded AIDS
Clinical Trials Group (ACTG). The NIAID subsequently decided to
cease the Phase 3 ACTIV-2 study.
-- In vitro studies confirmed potency against multiple variants
of the SARS-CoV-2 virus including Alpha, Beta and Gamma, followed
early in 2022 by Delta and Omicron.
-- Significant development and scale-up of manufacturing capability.
-- Strengthened its Board of Directors and senior leadership team.
Financial
-- Loss from operations for the year ended 31 December 2021 of
GBP57.9 million (2020: GBP17.7 million), with R&D expenditure
increasing from GBP15.5 million to GBP52.9 million (2020: GBP15.5
million) on account of Phase 3 trial and manufacturing
activities.
-- The research and development tax credit increased from GBP3.8
million to GBP9.2 million, resulting in a loss after tax of GBP48.7
million (2020: GBP13.9 million loss).
-- Cash balances of GBP33.8 million at 31 December 2021 (31 December 2020: GBP75.0 million).
Richard Marsden, CEO of Synairgen, said : "Since the completion
and reporting of the Phase 3 SPRINTER data and subsequent analyses
of different high-risk patient groups within the trial, we remain
encouraged that SNG001 has the potential to show clinically
important benefits in preventing disease progression and death in
patients with severe viral lung infections.
"We are now working in haste on discussions with platform trial
organisers and investigators, as well as regulatory authorities,
the pharmaceutical and biotech industry and government bodies to
identify and establish the optimal method of conducting further
trials to confirm these findings and move forward, not just for
COVID-19, but also as a potential treatment for patients
hospitalised due to a range of viruses including influenza, RSV,
adenovirus, para-influenza and rhinoviruses."
Results webcast details
A webcast will be hosted by Synairgen's management team at 12:00
BST today, followed by a Q&A for analysts.
The webcast link can be accessed here: Synairgen Preliminary
Results webcast
To access details for the analyst Q&A, please contact:
cscsynairgen@consilium-comms.com
For further enquiries, please contact:
Synairgen plc
Brooke Clarke, Head of Communications
Media@syairgen.com
Tel: + 44 (0) 23 8051 2800
finnCap (NOMAD and Joint Broker)
Geoff Nash, Kate Bannatyne, 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, Jessica Hodgson, Namrata Taak
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. 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 .
CHAIRMAN'S STATEMENT
This year has marked significant progress for Synairgen and the
development of our investigational candidate SNG001, inhaled
interferon beta, for potential use in treating people with
COVID-19. Built on a 15-year scientific foundation and strong
rationale for use in COVID-19 and for other viruses that cause
severe viral lung infections, the Synairgen team and our
consultants, partners and advisers have been unwavering in their
efforts to bring SNG001 to those patients who may benefit.
Our business has many challenges. We operate in an environment
of political and market volatility against the ever-changing
backdrop of COVID-19. Despite these challenges, we started and
completed enrolment in SPRINTER, our first-ever Phase 3,
double-blind, placebo-controlled clinical trial, conducted in 17
countries with more than 620 participants. It was obviously
disappointing that the primary endpoints of the SPRINTER trial were
not met, however we saw what we believe is an important signal in a
key secondary endpoint towards a relative reduction in the risk of
disease progression and death (36% in the Per Protocol population)
compared with placebo, on top of current standard of care
treatment. Subsequent post hoc analyses of subgroups recognised to
be at higher risk of disease progression (such as the elderly,
those with co-morbidities associated with worse COVID-19 outcomes,
and those who showed signs of respiratory compromise despite use of
oxygen) suggest further investigation is warranted. Full details
are contained in the Operating Review. These findings post hoc
indicate which patients are most likely to benefit from SNG001 and,
coupled with its favourable safety profile, have enabled Synairgen
to refine the strategy for the SNG001 development programme.
Outside the clinic, our in vitro studies of SNG001 have shown it
to be potent against all SARS-CoV-2 variants tested to date,
including Alpha, Beta, Gamma, Delta and Omicron. [1]
There have been substantial and rapid improvements in the
standard of care in the treatment and prevention of severe illness
caused by SARS-CoV-2 which means that the majority of patients are
discharged from hospital without the need for higher levels of care
such as high flow oxygen or ventilation. However, there remains a
need to further improve standard of care for COVID-19 patients at
high risk of progressing to more severe disease or death. In 2021,
despite new therapies and successful vaccination programmes, deaths
from COVID-19 still surpassed those of 2020. [2] As such, Synairgen
is actively seeking inclusion of SNG001 in a platform trial or
other trials for hospitalised patients so that the encouraging
signal seen in reducing the relative risk of disease progression
and death in SPRINTER can be confirmed.
During the year, the Board played an important role in working
with the Company's management team to make strategic and
operational decisions. In September, I was delighted to welcome
Theodora Harold to the Board as a non-executive director and chair
of the Audit Committee. I thank all of our Board Members for their
sound judgement, challenge and advice throughout the year.
On behalf of the Board, I would like to thank our shareholders
for their continued support, and Synairgen employees and partners
for staying committed and focused through a year of challenge and
change.
As we look ahead and continue to learn more about this virus
which has affected the world so significantly, our priority, using
carefully managed resources and in collaboration with experts, is
clear: to rapidly confirm the important signal we've found from the
SPRINTER trial in COVID-19 and to investigate SNG001 in patients
hospitalised with a range of seasonal viruses such as influenza,
Respiratory Syncytial Virus (RSV) and para-influenza.
SIMON SHAW
CHAIRMAN
OPERATING REVIEW
Introduction
There remains an urgent need for additional treatment options,
with distinct mechanisms of action, for high-risk patients
hospitalised due to COVID-19 and other viruses, particularly to
prevent progression to severe disease or death. Vaccines,
antibodies and antivirals have done much to reduce the risks
associated with COVID-19, however there is growing evidence that
protection from the virus afforded by vaccines is not comprehensive
and may wane over time. Furthermore, there are limitations to many
direct-acting COVID-19 therapeutics, particularly in respect of
continuing efficacy against new variants as they emerge. Additional
market research conducted by Synairgen also indicates that current
therapies do not fully meet the current medical need. [3]
2021 achievements
2021 was a significant year in which Synairgen made important
progress investigating SNG001 for the possible treatment of
COVID-19 in both the hospital and home settings.
1. Started and completed recruitment into the Company's Phase 3 SPRINTER trial, a double-blind, placebo-controlled trial conducted in 17 countries to investigate the efficacy of SNG001 in 623 patients hospitalised with COVID-19.
2. Recruitment was started and completed in the US Government's
ACTIV-2 Phase 2 trial conducted in the US to investigate SNG001 in
people with COVID-19 at home, prior to hospitalisation.
3. In vitro studies confirmed potency against multiple variants
of the SARS-CoV-2 virus including Alpha, Beta and Gamma (followed
early in 2022 by Delta and Omicron).
In addition, the Company focused on the regulatory, commercial
and manufacturing activities that would be required to support use
of SNG001 in hospitals following potential regulatory approval
including expedited routes.
Topline SPRINTER data
The topline data from the SPRINTER trial, announced in late
February 2022, 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,
the use of antivirals and anti-inflammatories, and changes in
hospital practices since the beginning of the pandemic. The Company
did observe an encouraging signal with respect to a reduction in
the relative risk of patients progressing to severe disease or
death (36% in the Per Protocol population [4] ). Further post hoc
analysis of this endpoint suggested that SNG001 prevented disease
progression in patient groups with recognised risk factors, such as
older age, the existence of certain co-morbidities and compromised
respiratory function. The strongest effects were observed in
patients with compromised respiratory function (high respiratory
rate and low oxygen saturations) despite being on supplemental
oxygen, who represented approximately one-third of the patients in
the trial, where SNG001 significantly 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.
Summary
Given the evolution of COVID-19, emergence of variants and the
changing treatment landscape, and on the advice of our independent
clinical and scientific advisers, we are actively seeking to have
SNG001 included in further COVID-19 trials which would provide
adequate statistical power to evaluate the encouraging effects we
observed in SPRINTER, as well as further investigation of SNG001 in
patients hospitalised with a range of seasonal viruses such as
influenza, RSV and para-influenza.
Despite the challenging environment outlined above, Synairgen
continues to explore the potential of SNG001 in three settings:
1. In people hospitalised with COVID-19, including in high-risk
sub-populations such as those with compromised respiratory
function, despite use of supplemental oxygen;
2. For possible use as a broad-spectrum antiviral for people
hospitalised with other severe viral lung infections caused by a
range of 'regular' seasonal viruses; and,
3. As a possible future pandemic preparedness option for government agencies.
Rationale for SNG001 in COVID-19
There is a strong scientific rationale underpinning SNG001 for
use in treating COVID-19, combined with a good safety profile and a
growing body of encouraging clinical data which will help us better
understand the role SNG001 can play in helping patients at risk of
developing severe illness due to respiratory viruses.
Interferon beta ('IFN-beta') is a naturally-occurring protein,
orchestrating 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 pH neutral, and is free of mannitol,
arginine and human serum albumin (which may be pharmacologically
active in the airways), making SNG001 suitable for inhaled delivery
direct to the site of infection.
There is strong evidence that deficiency in IFN-beta production
by the lung could explain the enhanced susceptibility in
higher-risk patient groups to developing severe lower respiratory
tract (lung) disease during respiratory viral infections, including
COVID-19. [5]
Viruses, including coronaviruses such as SARS-CoV-2, have
evolved mechanisms to suppress IFN-beta production, helping the
virus 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. [6] The Company has
conducted in vitro testing against SARS-CoV-2 variants of concern
(VOC) including Alpha, Beta, Gamma, Delta and Omicron and shown
potent antiviral activity at concentrations that are readily
achievable following inhaled delivery of interferon beta.
Delivery via the inhaled route results in a high local
concentration in the lungs, the site of the infection. 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-beta through injection is ineffective in
fighting COVID-19 in the lungs. [7]
2021 clinical progress in COVID-19
Synairgen conducted a Phase 2 trial of SNG001 in people with
COVID-19 in 2020, consisting of both a Hospital and a Home Cohort.
The Hospital Cohort generated positive results with patients
treated with SNG001 being twice as likely to recover over the
treatment period compared to those receiving placebo. This was a
clear signal that patients on drug recovered faster than those on
placebo. There were also trends towards prevention of progression
to severe disease or death and faster hospital discharge. This was
a robust, double-blind, placebo-controlled trial conducted at nine
specialist hospital sites in the UK in the first few months of the
pandemic, at a time when hospital practices for COVID-19 were not
yet established, and when patients were unvaccinated and were not
treated with antiviral and anti-inflammatory treatments available
in 2021. The data from the Hospital Cohort were peer reviewed and
published in the Lancet Respiratory Medicine in November 2020.
Building on the positive results seen in the Hospital Cohort of
the Phase 2 trial, the Company worked with regulatory authorities
to design a larger Phase 3 trial (SPRINTER) to evaluate SNG001 in
people hospitalised due to COVID-19 who required supplemental
oxygen.
Synairgen began recruitment into the SPRINTER trial in January
2021 and concluded recruitment in November 2021. The SPRINTER trial
was a global Phase 3, randomised, placebo-controlled, double-blind,
multi-site clinical trial assessing the efficacy and safety of
inhaled SNG001 on top of standard of care for the treatment of
adults hospitalised due to COVID-19 requiring treatment with
supplemental oxygen by mask or nasal prongs. Patients requiring
high-flow nasal oxygen therapy, non-invasive ventilation, or
endotracheal intubation (invasive ventilation) and patients that
were vaccinated at randomisation were excluded (exclusion of
vaccinated patients was later removed via protocol amendment).
COVID-19 was confirmed using a validated molecular test for the
presence of the SARS-CoV-2 virus. The trial enrolled 623 patients,
randomised (1:1) to treatment with inhaled SNG001 or placebo at
more than 100 sites across the following 17 countries: Argentina,
Belgium, Brazil, Colombia, France, Germany, India, Israel, Italy,
Mexico, Netherlands, Portugal, Romania, Serbia, Spain, the United
Kingdom and the United States.
There was no difference between SNG001 and placebo in the
hospital discharge or recovery primary endpoints in the trial, with
the majority of patients discharged from hospital within the
treatment period. We believe this is due to the improvements in
standard of care driven by vaccines, the use of antivirals and
anti-inflammatories, and changes in hospital practices. For further
context, when the Phase 2 trial was conducted in March 2020,
systemic corticosteroids and antivirals for COVID-19 were not
routinely being used. Accordingly, no patients in the Phase 2 trial
received any of these treatments for COVID-19. When the Phase 3
SPRINTER trial was conducted in 2021, there was considerably higher
routine use of dexamethasone and remdesivir, meaning that almost
90% of SPRINTER patients were also being treated with systemic
corticosteroids, around 20% were taking remdesivir, and around 30%
of patients were vaccinated to some degree.
Nevertheless, a 36% reduction in the risk of disease progression
or death (a key secondary endpoint) was observed in the Per
Protocol population, which trended towards statistical significance
(p=0.119), which we believe is an important signal.
The potential importance of this signal triggered a more
comprehensive, post hoc analysis of the SPRINTER data to 'stress
test' the robustness of this encouraging observation. The analyses
focused on the disease progression endpoint in high-risk groups and
showed a consistent trend in favour of SNG001 with respect to a
reduction in the risk of progression to develop severe disease or
death. The strongest treatment effect was in patients who, despite
being on supplemental oxygen, had compromised respiratory function
at baseline (low oxygen saturation or a high breathing rate). This
group represented around one third of the overall trial
population.
-- Participants in the Per Protocol population with compromised
respiratory function (oxygen saturation of <= 92% or respiratory
rate >= 21 breaths/min at baseline) treated with SNG001 had a
70% reduction in the risk of progression to severe disease or death
compared to placebo (Odds Ratio (95% Confidence Interval) 0.23
(0.06, 0.98); p=0.046).
SNG001 was well tolerated in the SPRINTER trial with a
favourable safety profile consistent with previous studies:
-- The proportion of patients with any treatment-emergent
adverse events (TEAE) related to study treatment was 22.6% for
SNG001 vs. 25.4% for placebo,
-- The proportion of patients with any serious TEAE was 12.6% for SNG001 vs. 18.2% for placebo,
-- The proportion of patients with a serious respiratory TEAE
was 4.7% for SNG001 vs. 9.9% for placebo.
These findings are consistent with an effect on disease
progression.
This trend seen with respect to prevention of progression to
severe disease or death, supported by the post hoc analysis,
provides a strong rationale to investigate SNG001 in a further
targeted COVID-19 trial, and more widely in patients hospitalised
with a range of seasonal viruses such as influenza, RSV and
para-influenza, which can lead to severe viral lung infections
requiring hospitalisation. The stronger treatment effect observed
in patients with compromised lung function at baseline in the post
hoc analyses suggests that these patients should be targeted in
future trials.
Home use of SNG001 in the US Government's ACTIV-2 trial
SNG001 was also investigated during 2021 as part of the US
National Institute of Health's ACTIV programme to accelerate the
development of the most promising COVID-19 treatments with the
ultimate aim of identifying treatments which reduce
hospitalisations. The ACTIV-2 study, sponsored by the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health, and led by the NIAID-funded AIDS
Clinical Trials Group (ACTG), tested a number of treatments in
adults in an outpatient setting who had documented positive
SARS-CoV-2 infection.
The Phase 2 evaluation of SNG001 saw the recruitment of
approximately 220 participants across US sites, in a home-based
setting, split between SNG001 and placebo. If an investigational
agent showed promise by demonstrating safety and efficacy signals
through 28 days following administration, it moved from Phase 2 to
Phase 3, which was planned to include significantly more
patients.
In October 2021, the Data Safety Monitoring Board recommended
graduation of SNG001, based on data from the Phase 2 trial, to
Phase 3. As the Company and the ACTIV-2 team were preparing to
initiate recruitment for Phase 3, the Omicron variant became the
dominant variant in the US, causing a significant shift in the
nature of the pandemic. In March 2022, due to the need to modify
the study design in light of the emergence of the Omicron variant
of SARS-CoV-2, the US National Institutes of Health (NIH) ACTIV-2
trial team asked Synairgen to temporarily pause preparation
activities for ACTIV-2 Phase 3 until the timeline for the
activation of SNG001 in the trial could be clarified. Several weeks
later, the National Institutes of Health (NIH) halted all patient
recruitment in ACTIV-2 and discontinued all arms of the trial,
including the one to evaluate SNG001.
As a result, discussions with NIH, NIAIDS and the ACTIV teams
are ongoing to try to identify an appropriate clinical trial to
continue the evaluation of SNG001 in the home environment.
Adding to our finding from the Home Cohort of the Company's
Phase 2 trial in 2020, the ACTIV-2 trial also demonstrated that
patients can successfully initiate treatment "remotely",
self-administering SNG001 at home with the support of a YouTube
video. Importantly, patients can be initiated on SNG001 without the
need for a face-to-face meeting with a healthcare professional,
reducing the burden on hospital facilities and minimising the risk
of onward infection.
We now anticipate receiving the Phase 2 data from the ACTIV-2
team in the summer of 2022, which will be factored into the SNG001
clinical development plan to further build the case that SNG001 may
have an important role in combatting COVID-19 and future emerging
virus threats.
Building Readiness for the Future
Over the course of 2021, in readiness for the possibility that
our Phase 3 SPRINTER data would have been sufficient for regulatory
submissions (which would require a high level of immediate activity
to support use of SNG001 under expedited approval pathways), the
Company began building its capabilities and capacity in the areas
of regulatory, commercial, manufacturing, communications, quality
and finance. This included strengthening its senior leadership team
as well as establishing commercial and distribution partnerships
and preparing the foundations for a US commercial organisation.
With the SPRINTER data now analysed, the Company is carefully
managing its team and cost base in order to progress the path for
SNG001 as rapidly as possible using the various avenues as
described.
Leadership team
The Company senior management team was strengthened with newly
created roles including:
-- Richard Hennings: Richard joined in March 2021 as Chief
Commercial Officer, having previously held commercial leadership
roles at Verona Pharma, Gilead Sciences, Novartis and
AstraZeneca.
-- Richard Francis: Richard joined in September 2021 as Senior
Vice President for CMC, bringing more than 35 years' experience in
the development, regulatory approval and commercialisation of many
biopharmaceutical products including Cablivi(R), Orthoclone
OKT3(R), Remicade(R), and ReoPro(R).
-- Brooke Clarke: Brooke joined in September 2021 as Senior Vice
President, Head of Communications, with more than 30 years'
strategic communications and corporate affairs experience,
including most recently leadership roles at Shire plc and Hikma
plc.
-- Gareth Walters: Gareth joined in October 2021 as Chief
Regulatory Officer and brings a wide range of experience from
pre-clinical to commercialisation. He previously held senior
regulatory and commercial roles at Chugai Pharmaceuticals and
Roche.
-- Helen Gearing: Helen joined in December 2021 as Senior Vice
President for Finance. Prior to joining Synairgen, Helen was
responsible for leading, building and scaling the finance function
of Seqirus, a global leader in influenza vaccines, and prior to
that was with GSK.
Regulatory
In preparation for regulatory submissions in the US, Europe and
the UK, Synairgen's regulatory team continued engagement with the
US Food and Drug Administration (FDA), the EMA and the MHRA on
requirements and content for regulatory submissions.
With SNG001 having been granted Fast Track status from the FDA,
the US was the priority focus of preparatory activities for a
potential regulatory Emergency Use Authorisation submission and
launch.
With the SPRINTER data now analysed, we are exploring all
avenues in order to expedite the development of SNG001.
Manufacturing & distribution
Manufacturing pharmaceutical products has been very challenging
due to COVID-19, with shortages in key ingredients, components,
equipment and manufacturing slots. Despite these challenges,
Synairgen made good progress in commercial scale manufacturing
processes for drug substance and drug product, and continued to
build inventory, distribution, pre-commercialisation and
commercialisation capabilities:
-- Process Performance Qualification commercial scale
manufacturing batches of the drug substance (the raw ingredient
IFN-beta) with our partner Akron Biotechnology;
-- Drug product in pre-filled glass syringes (the finished
format, ready-to-use) in partnership with Catalent at commercial
supportive scale following completion of Process Performance
Qualification;
-- Completed a commercial scale manufacturing batch and testing
using polyethylene blow-fill-seal container technology to mitigate
against the global supply chain shortages of medical grade glass
and the reduction of available syringe filling manufacturing slots
caused by the number of vaccines and therapeutics in development
for COVID-19;
-- Long-term stability studies for both drug substance and drug
product initiated to support regulatory submissions; and,
-- Built inventory of certain specific long-lead time items
needed to administer the drug to patients.
The progress made in manufacturing during the year means the
Company is in a good position to support further potential clinical
trials in COVID-19 and for other viruses that cause
hospitalisations.
In readiness for a possible regulatory authorisation in the US,
the Company also made good progress in identifying potential
COVID-19-experienced partners for in-market support activity such
as pharmacovigilance and medical affairs to support healthcare
professionals and patient support programmes. Synairgen also
identified the required structure and roles for a US commercial
organisation and these can be mobilised in the future as required
but due to cost conservation currently there is no requirement to
deploy such US personnel.
FINANCIAL REVIEW
Statement of Comprehensive Income
The loss from operations for the year ended 31 December 2021 was
GBP57.9 million (2020: GBP17.7 million) with research and
development expenditure amounting to GBP52.9 million (2020: GBP15.5
million) and other administrative expenses of GBP5.0 million (2020:
GBP2.2 million).
Clinical trial expenditure increased significantly during 2021
as the Phase 3 SPRINTER trial commenced patient recruitment in
January 2021. Other clinical trial expenditure included the
completion of the SG016 Home trial and the ACTIV-2 trial, including
some preparatory costs for the Phase 3 element of the trial.
Alongside the clinical trial activity, regulatory activities were
increased in preparation for potential regulatory submissions in
2022.
The remainder of the research and development expenditure has
been focussed on upscaling SNG001 manufacturing development
activities and procuring long lead time components. A number of
drug substance commercial scale batches were completed during 2021,
including three Process Performance Qualification (PPQ) batches.
Two different drug product activities were advanced during the
year, with PPQ batches of both pre-filled glass syringes and
polyethylene blow-fill-seal containers being manufactured. The
Company has also invested in the development of release assays at a
US-based supplier. The internal Chemistry Manufacturing and
Controls (CMC) team has been strengthened during the year with a
number of new senior hires.
Other administrative expenses increased from GBP2.2 million to
GBP5.0 million. The increase was attributable firstly to the
establishment of a commercial team and preparatory activities for a
potential launch in 2022, and secondly, to the increase in
administrative and financial personnel and professional costs to
accommodate the increase in scale of the business.
The research and development tax credit increased from GBP3.8
million to GBP9.2 million on account of the increased qualifying
project expenditure, primarily on the SPRINTER trial and
manufacturing development activities. The credit equates to 17% of
our 2021 research and development expenditure (2020: 25%).
The loss after tax for 2021 was GBP48.7 million (2020: GBP13.9
million) and the basic loss per share was 24.28p (2020: basic loss
per share of 9.46p).
Statement of Financial Position and Cash Flows
At 31 December 2021, net assets amounted to GBP37.0 million
(2020: GBP85.1 million), including cash balances of GBP33.8 million
(2020: GBP75.0 million).
The principal elements of the GBP41.2 million decrease during
the year ended 31 December 2021 (2020: GBP72.5 million increase) in
cash balances were:
-- Cash outflows from operations before changes in working
capital: GBP57.2 million (2020: GBP17.3 million), with the increase
being attributable to the higher operating loss as discussed
above;
-- Changes in working capital: GBP12.2 million inflow (2020:
GBP7.5 million outflow) on account of the reduction in trade and
other receivables and the increase in trade and other payables as
detailed below;
-- Research and development tax credits received: GBP3.9 million
(2020: GBP0.9 million) on account of the increased 2020 tax
credit;
-- Share issue proceeds (net of costs): GBPnil (2020: GBP97.9 million); and,
-- Net settlement of options GBPnil (2020: GBP1.3 million outflow).
The other significant changes in the statement of financial
position were:
-- Current tax receivable increased from GBP3.8 million to
GBP9.1 million on account of the higher research and development
tax credit receivable;
-- Trade and other receivables decreased from GBP9.4 million to
GBP1.5 million on account of a reduction in manufacturing and
clinical trial prepayments; and,
-- Trade and other payables increased from GBP3.3 million to
GBP7.6 million, reflecting the increased level of activity.
OUTLOOK
On the back of the data from the Phase 3 SPRINTER trial and
subsequent analyses of different high-risk patient groups within
the trial, we are encouraged that SNG001 has the potential to show
clinically important benefits in preventing disease progression and
death. This data was well received at the recent ATS International
Conference in San Francisco in mid-May 2022. We are now, working in
haste, fully focussed on discussions with platform trial organisers
and investigators, as well as regulatory authorities, the
pharmaceutical and biotech industry and government bodies to
identify and establish the optimal method of conducting further
trials to confirm these findings and provide the Company with the
evidence required for a regulatory submission. In addition,
building on our existing body of evidence, we are actively
exploring the opportunity to collaborate and trial the product as a
broad-spectrum, virus-agnostic treatment in patients hospitalised
with a range of seasonal viruses such as influenza, RSV and
para-influenza.
Consolidated Statement of Comprehensive Income
for the year ended 31 December 2021
Year Year
ended 31 ended 31
December December
2021 2020
Notes GBP000 GBP000
Research and development expenditure (52,857) (15,495)
Other administrative expenses (5,009) (2,246)
Total administrative expenses
and Loss from operations (57,866) (17,741)
Finance income 11 19
Finance expense (2) (10)
Loss before tax (57,857) (17,732)
Tax 2 9,194 3,816
Loss and total comprehensive
loss for the period attributable
to equity holders of the parent (48,663) (13,916)
Loss per ordinary share 3
Basic and diluted loss per share
(pence) (24.28)p (9.46)p
Consolidated Statement of Changes in Equity
for the year ended 31 December 2021
Merger Retained
Share capital Share premium reserve deficit Total
GBP000 GBP000 GBP000 GBP000 GBP000
At 1 January 2020 1,094 28,262 483 (27,586) 2,253
Issue of ordinary shares 905 100,170 - - 101,075
Transaction costs in
respect of share issues - (3,187) - - (3,187)
Recognition of share-based
payments - - - 207 207
Net settlement of share
options - - - (1,291) (1,291)
Loss and total comprehensive
loss for the year - - - (13,916) (13,916)
At 31 December 2020 1,999 125,245 483 (42,586) 85,141
Issue of ordinary shares 14 - - - 14
Recognition of share-based
payments - - - 508 508
Loss and total comprehensive
loss for the year - - - (48,663) (48,663)
At 31 December 2021 2,013 125,245 483 (90,741) 37,000
Consolidated Statement of Financial Position
as at 31 December 2021
31 ) 31 )
December ) December )
2021 ) 2020 )
GBP000 ) GBP000 )
Assets
Non-current assets
Intangible assets 53 ) 44 )
Property, plant and equipment 173 ) 250 )
Right-of-use assets - ) 94 )
226 ) 388 )
Current assets
Inventories - ) 41 )
Current tax receivable 9,055 ) 3,771 )
Trade and other receivables 1,530 ) 9,372 )
Cash and cash equivalents 33,827 ) 74,976 )
44,412 ) 88,160 )
Total assets 44,638 ) 88,548 )
Liabilities
Current liabilities
Trade and other payables (7,638) (3,279)
Lease liabilities - ) (128)
Total liabilities (7,638) (3,407)
Total net assets 37,000 ) 85,141 )
Equity
Capital and reserves attributable
to equity holders of the parent
Share capital 2,013 ) 1,999 )
Share premium 125,245 ) 125,245 )
Merger reserve 483 ) 483 )
Retained deficit (90,741) (42,586)
Total equity 37,000 ) 85,141 )
Consolidated Statement of Cash Flows
for the year ended 31 December 2021
Year Year
ended 31 ended 31
December December
2021 2020
GBP000 GBP000
Cash flows from operating activities
Loss before tax (57,857) (17,732)
Adjustments for:
Finance income (11) (19)
Finance expense 2 ) 10 )
Lease adjustment (4) - )
Depreciation of property, plant and equipment 92 ) 90 )
Depreciation of right-of-use assets 94 ) 161 )
Amortisation of intangible fixed assets 9 ) 9 )
Share-based payment charge 508 ) 207 )
Cash flows from operations before changes
in working capital (57,167) (17,274)
Decrease in inventories 41 ) - )
Decrease/(Increase) in trade and other
receivables 7,841 ) (9,244)
Increase in trade and other payables 4,359 ) 1,789 )
Cash used in operations (44,926) (24,729)
Tax credit received 3,910 ) 910 )
Net cash used in operating activities (41,016) (23,819)
Cash flows from investing activities
Interest received 12 ) 31 )
Purchase of intangible assets (18) (37)
Purchase of property, plant and equipment (15) (39)
Net cash used in investing activities (21) (45)
Cash flows from financing activities
101,075
Proceeds from issue of ordinary shares 14 ) )
Transaction costs in respect of share
issues - ) (3,187)
Net settlement of share options - ) (1,291)
Principal paid on lease liabilities (124) (196)
Interest paid on lease liabilities (2) (15)
Net cash (used in)/generated from financing
activities (112) 96,386 )
(Decrease)/Increase in cash and cash
equivalents (41,149) 72,522 )
Cash and cash equivalents at beginning
of the year 74,976 ) 2,454 )
Cash and cash equivalents at end of the
year 33,827 ) 74,976 )
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 2021 has been extracted from the Group's audited
financial statements which were approved by the Board of directors
on 24 May 2022 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 2020 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. Whilst 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 2021 report and financial statements.
2. Tax
The tax credit of GBP9,194,000 (2020: GBP3,816,000) relates to
research and development tax credits in respect of the year ended
31 December 2021 (GBP9,055,000) and an adjustment in respect of
prior periods (GBP139,000).
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] Synairgen. SNG001 inhibits SARS-CoV-2 variant infection in
cell based assays. 2021-2
[2] CBS News, November 23, 2021
[3] IQVIA market research, December 2021. On file.
[4] 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.
[5] 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.
[6] Synairgen data on file.
[7] 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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FR AIMBTMTJTTIT
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May 25, 2022 03:30 ET (07:30 GMT)
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