TIDMSNG
RNS Number : 4655N
Synairgen plc
30 September 2021
Synairgen plc
('Synairgen' or the 'Company')
Interim results for the six months ended 30 June 2021
Scaling up and preparing for Phase III COVID-19 trial data
read-out
Webcast today at 13:00 BST
Southampton, UK - 30 September 2021 : Synairgen plc (LSE: SNG),
the drug discovery, development and commercialisation company,
today announces its unaudited interim results for the six months
ended 30 June 2021.
Richard Marsden, CEO of Synairgen, said: "The need for an
effective, broad-spectrum antiviral to treat patients hospitalised
due to COVID-19 remains urgent. While vaccines have played an
important role in reducing many of the risks associated with the
SARS-CoV-2 virus, thousands of patients continue to require
hospital treatment in the US and Europe every day with acute
symptoms from COVID-19. This, coupled with the potential of waning
immunity and the emergence of new SARS-CoV-2 variants, highlights
the urgent need for additional effective antiviral therapies.
"The Phase III SPRINTER trial of SNG001 is progressing well,
with the last patient expected to be enrolled during November.
SNG001 is an inhaled, broad-spectrum antiviral interferon beta
(IFN-beta) formulation, which is delivered directly to the lower
respiratory tract, stimulating the lungs' immune defences, and has
an established safety profile. Positive data from this trial would
represent a major breakthrough in the battle against COVID-19. To
ensure we can get this treatment to patients as quickly as
possible, we are preparing to engage the US FDA on a potential
application for Emergency Use Authorisation (EUA) and have aligned
with partners with COVID-19 expertise for distribution and
in-market support."
Operational highlights (including post period end)
Synairgen's wholly-owned lead programme SNG001 has potential
value in three settings:
-- COVID-19 patients hospitalised due to severe lower respiratory tract (LRT) symptoms;
-- Government stockpiling for future pandemic preparedness; and
-- Severe viral lung infections caused by regular common cold and flu viruses that lead to h ospitalisation.
Earlier work establishing safety, dosing regimen, and patient
selection, has been instrumental in paving the way for rapid and
significant progress during this pandemic.
Phase III trial progress and preparation for regulatory
submissions
-- Good progress with the global Phase III SPRINTER study of
Synairgen's interferon beta (IFN-beta) formulation, SNG001, being
developed for hospitalised (non-ventilated) patients suffering from
COVID-19 infection, with approaching 80% of trial participants
enrolled to date. Due to the sporadic nature of the pandemic in
different regions, we now expect the last patient to be enrolled
during November, with top line results expected in early 2022
-- Progression of commercial scale manufacturing processes for drug substance and drug product
-- Continued engagement with the US FDA on requirements and content for regulatory submissions
-- Continues to build distribution, pre-commercialisation and commercialisation capabilities
-- Experienced, commercially-focused senior leadership team
appointed in manufacturing, communications and corporate affairs,
and commercial positions. Use of third party COVID-19-experienced
contractors for distribution and in-market support
Other operating highlights
-- Positive results from in vitro studies showing antiviral
activity of IFN-beta against key COVID-19 variants announced in May
2021, with further testing underway
-- Combined data from the hospital and home cohorts of
Synairgen's Phase II study showed that the more breathless patients
are significantly more likely (>3 fold) to recover on SNG001
than placebo
-- Phase II recruitment completed for study of SNG001 in the
ongoing US government funded ACTIV-2 trial evaluating patients with
mild to moderate COVID-19 symptoms in the home setting. Results are
being assessed to determine whether SNG001 will be progressed into
the Phase III part of this Phase II/III trial
Financial highlights
-- Loss before tax for the six months ended 30 June 2021 was
GBP38.89 million (30 June 2020: GBP5.07 million loss)
- Research and development expenditure for the six months ended
30 June 2021 was GBP36.91 million (30 June 2020: GBP4.47 million)
as the Company advanced its Phase III clinical trial and scaled up
its manufacturing activities
- Administrative expenses for the six months ended 30 June 2021
were GBP1.99 million (30 June 2020: GBP0.60 million) as the Company
built up its management infrastructure and invested in
pre-commercialisation activities
-- Research and Development tax credit increased from GBP1.11
million to GBP5.97 million with scale up of qualifying
activities
-- Cash balances of GBP46.21 million at 30 June 2021 (GBP10.88 million at 30 June 2020)
Results webcast details
A webcast will be hosted by Synairgen's management team at 13:00
BST, followed by a Q&A for analysts.
The webcast link can be accessed here:
https://www.lsegissuerservices.com/spark/Synairgen/events/28f37f03-c7dd-4071-b047-66b191931742
To access details for the analyst Q&A, please contact:
synairgen@consilium-comms.com
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No. 596/2014 ('MAR').
For further enquiries, please contact:
Synairgen plc
Richard Marsden, Chief Executive Officer
John Ward, Chief Financial Officer
Brooke Clarke, Head of Communications
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, Lucy Featherstone
synairgen@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 COVID-19 as potentially the first host-targeted
broad-spectrum antiviral treatment delivered directly into the
lungs. Granted Fast Track status from the US Food and Drug
Administration (FDA) and deemed an Urgent Public Health study by
the UK's National Institute for Health Research (NIHR), Synairgen's
Phase III clinical programme is currently evaluating nebulised
SNG001 in patients across 17 countries. In a Phase II trial in
hospitalised COVID-19 patients, SNG001 demonstrated a greater than
twofold chance of recovery to 'no limitation of activities' versus
placebo.
Founded by University of Southampton Professors Sir Stephen
Holgate, Donna Davies and Ratko Djukanovic in 2003, Synairgen is
quoted on AIM (LSE: SNG). For more information about Synairgen,
please see www.synairgen.com .
OPERATING REVIEW
Summary
For many years, Synairgen has been developing SNG001, an
inhaled, broad-spectrum antiviral interferon beta (IFN-beta)
formulation, which is delivered directly to the lower respiratory
tract, stimulating the lungs' immune defences. The Company
continues to develop SNG001 for (i) COVID-19; (ii) future pandemic
preparedness; and (iii) patients hospitalised with severe viral
lung infections. Earlier work, establishing safety, dosing regimen,
and patient selection has been instrumental in allowing Synairgen
to make rapid progress during this pandemic.
During the first half of the year, Synairgen has focused on
progressing the 610-patient global Phase III SPRINTER trial of
SNG001 for the treatment of patients hospitalised with COVID-19. In
parallel, the Company is building the infrastructure necessary to
enable access to SNG001 in the US under a potential EUA for
patients requiring hospitalisation due to COVID-19, followed by a
Biologics Licence Application (BLA) and Marketing Authorisation
Application (MAA) elsewhere. Positive data from this trial would
represent a major breakthrough in the battle against COVID-19.
The clinical need for SNG001 in COVID-19
Despite the vaccination programme in the US, the number of
patients being admitted to hospital remains significant. There are
currently around 10,000 new patients hospitalised with COVID-19
each day, contributing to a shortage of available hospital capacity
and poor outcomes for patients with other conditions.(1)
While vaccines have done much to reduce the risks associated
with COVID-19, there is growing evidence that protection from the
virus afforded by vaccines is not comprehensive and may decline
over time. Variant strains of SARS-CoV-2 also appear to pose
varying degrees of risk to the efficacy of the currently approved
vaccines. As evidence grows that vaccine efficacy may decline over
time, the protocol of the SG018 trial was amended to include
vaccinated individuals. Currently, where this amendment is
approved, 25-30% of patients entering the trial are vaccinated.
Accordingly, the need for effective antiviral treatments for
COVID-19 is clear.
There is an accumulating body of academic literature
demonstrating the benefits of IFN-beta. Viruses, including
coronaviruses such as SARS-CoV-2, have evolved mechanisms that
evade the immune system. One of these mechanisms is the suppression
of IFN-beta production by cells, IFN-beta being an essential driver
of multiple antiviral defences. Suppression of IFN-beta in an organ
such as the lungs gives an advantage to the virus, allowing it to
replicate unhindered and spread through the lungs causing cell
death and inflammation.
It has been shown in in vitro experiments that adding IFN-beta
can upregulate antiviral responses in cells and protect against
infection with a broad range of respiratory viruses, including
SARS-CoV-2. Furthermore, individuals who produce less IFN-beta due
to their genetic makeup or naturally-occurring antibodies against
other interferons have been associated with a greater risk of
developing severe viral lung illness. By administering IFN-beta
protein directly into the airways via a nebuliser, the aim is to
restore IFN-beta levels and to 'switch on' antiviral defences to
clear the virus.
The challenge with IFN-beta has been delivering it in the right
formulation, at the right dose, in the right patient, at the right
time. Over the last 15 years Synairgen has:
-- Developed a formulation containing IFN-beta protein delivered
locally to the lungs through inhalation;
-- Conducted multiple Phase I/II clinical trials in asthma,
COPD, and COVID-19, totalling 339 patients who were treated with
SNG001; and
-- Demonstrated successful activation of antiviral activity in
the lungs by observing biomarkers, efficacy signals in patients
with lower respiratory illness, and a good tolerability
profile.
When the COVID-19 pandemic started, a Phase II trial of SNG001
in hospitalised COVID-19 patients was initiated by the Company in
March 2020. The data from this Phase II placebo-controlled study of
101 randomised COVID-19 hospitalised patients showed that SNG001
given for 14 days was associated with greater odds of improvement
versus placebo on the WHO Ordinal Scale for Clinical Improvement
(OSCI) and more rapid recovery to the point where patients were no
longer limited in their activity, with a greater proportion of
patients recovering during the 28-day study period.
Phase III SRINTER trial progress
The clinical trial team, working alongside Parexel, has gained
trial approvals in 17 countries for SG018, and initiated over 100
trial sites. This activity, especially movement of trial supplies
across borders, has been very challenging due to COVID-19-related
restrictions. Despite this, the Company's strategy of setting up
trial sites in various countries has been successful. The first
patients were recruited in January 2021 in the UK, and the trial is
approaching 80% enrolment of patients out of the targeted 610. The
Company anticipates the last patients will be entered into the
trial during November 2021, and top line results are expected in
early 2022.
Regulatory, distribution and in-market support (conditional on
successful Phase III readout)
The Company is expediting preparations to file an Emergency Use
Authorisation (EUA) in the US for patients requiring
hospitalisation due to COVID-19, followed by a Biologics Licence
Application (BLA) to enable commercial launch.
Synairgen has been awarded Fast Track status by the US FDA and
is preparing for pre-submission meetings in the US and EU to
confirm the contents of the marketing applications and plans to
request expedited reviews.
Preparations are underway for distribution and in-market support
activity such as pharmacovigilance, medical affairs to support
health care professionals, and patient support programmes. The
Company is negotiating with several organisations, all of whom have
relevant experience dealing with COVID-19 and can provide these and
other services to enable a successful launch.
Manufacturing
Manufacturing pharmaceutical products has been very challenging
due to COVID-19, with shortages in key ingredients, components,
equipment and manufacturing slots. Despite these challenges, during
2021, Synairgen has undertaken the following activities:
-- Process qualification commercial scale manufacturing batches
of the drug substance (the raw ingredient IFN-beta) have been made
with our partner Akron Biotechnology;
-- Drug product in pre-filled glass syringes (the finished
format, ready-to-use) has been made in partnership with Catalent at
commercial supportive scale;
-- Completed a drug product manufacturing commercial scale batch
(currently under testing) using polyethylener 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 ongoing for both drug substance
and drug product to support regulatory submissions; and
-- Built inventory of certain specific long-lead time items
needed to administer the drug to patients.
As a result, the Company expects to have tens of thousands of
treatment courses available to the market should an EUA be granted.
With government support, the Company has the potential to increase
capacity to approximately 100,000 treatment courses per month.
Other in vitro and clinical progress - COVID-19
In vitro studies
SNG001 potently reduced virus to undetectable levels in cells
infected with the 'Wuhan-like' Germany/BavPat1/2020 strain, and
Alpha and Beta SARS-CoV-2 variants. Concentrations of IFN-beta,
readily achievable in the lungs following inhaled delivery, that
gave 99% inhibition (IC(99) ) were 9.5, 24.7 and 14.8 IU/mL
respectively. Further research is underway to assess SNG001 against
other variants.
SG016: Combined data from hospital and home cohorts
In April 2021, Synairgen published data from the home cohort of
its SG016 Phase II trial of inhaled interferon beta in 120 COVID-19
patients.
Most of the home-initiated patients exhibited only mild disease
which Synairgen believes compromised the possibility of showing
treatment effects in this patient population. It was decided
therefore to analyse the subset of patients with the most severe
symptoms in a post-hoc a nalysis, including an analysis of the
combined data from the home and hospital cohorts of the Phase II
study. The analysis showed that the more breathless patients are
significantly more likely (>3 fold) to recover on SNG001 than
placebo , reinforcing our confidence in the design of the ongoing
Phase III trial in hospitalised patients.
ACTIV-2 progress
This US National Institute of Health (NIH) Phase II/III ACTIV-2
study is led by the NIAID-funded AIDS Clinical Trials Group (ACTG)
. The trial is an adaptive, randomised, blinded, placebo-controlled
trial which involved treating 110 patients with SNG001 in a
home-based setting. Phase II is now completed, and a review is
underway to determine whether SNG001 should be advanced into the
Phase III part of the trial.
Potential indications for the use of SNG001, beyond COVID-19
In addition to addressing the most pressing need for COVID-19
therapeutics, Synairgen believes there are two additional potential
markets for SNG001: future pandemic preparedness and severe viral
lung infections requiring hospitalisation.
Pandemic Preparedness
A positive result in the Phase III trial in COVID-19 patients
would give strong support for the use of SNG001 as a broad-spectrum
antiviral for future respiratory virus outbreaks or pandemics. With
these characteristics, interested governments may consider SNG001
as a suitable option for stockpiling, providing enough treatment
courses to protect a certain percentage of their population.
Severe viral lung infections requiring hospitalisation
Beyond COVID-19, there remains a significant need for a
broad-spectrum antiviral to treat patients hospitalised due to
chest infections caused by regular respiratory viruses such as
influenza, adenovirus, parainfluenza virus, coronavirus, and
rhinovirus (common cold). Indeed, collectively, these viruses are
associated with approximately half of all 'chest infection'
hospitalisations. Influenza is the most common cause, followed by
RSV (one of the common cold viruses) in children.
In in vitro experiments, IFN-beta has demonstrated activity
against all these viruses. Following a positive outcome from the
Phase III trial in hospitalised COVID-19 patients, the Company will
initiate a programme aimed at securing a marketing authorisation
for SNG001 to be used as a broad-spectrum antiviral for patients
admitted to hospital with severe viral lung infections.
Strengthening leadership team for the future
During 2021, the Company has made key hires in commercial,
manufacturing, corporate affairs, and regulatory, and bolstered
teams in the areas of clinical and quality, in advance of results
from the ongoing Phase III trial.
This is part of our broader capability enhancement which,
combined with significant support from a wider network of
third-party providers, will provide a strong basis from which to
apply for an EUA and subsequent BLA and MAAs, with a view to
launching as soon possible if approvals are granted.
Recent hires joining the management team include:
-- Richard Hennings: Richard joined as Chief Commercial Officer
in March 2021, having previously held commercial leadership roles
at Gilead Sciences, Novartis and AstraZeneca.
-- Richard Francis: Richard joined in September 2021 as Head of
CMC, bringing more than 35 years' experience in the development,
regulatory approval and commercialization of many biopharmaceutical
products including Cablivi(R), Orthoclone OKT3(R), Remicade(R), and
ReoPro(R).
-- Brooke Clarke: With more than 30 years of strategic
communications and corporate affairs experience, including most
recently leadership roles at Shire plc and Hikma plc, Brooke joined
in September 2021 as Head of Communications.
FINANCIAL REVIEW
Statement of Comprehensive Income
The loss from operations for the six months ended 30 June 2021
(H1 2021) was GBP38.90 million (six months ended 30 June 2020 (H1
2020): GBP5.08 million loss; year ended 31 December 2020 (FY 2020):
GBP17.74 million loss) with research and development expenditure
amounting to GBP36.91 million (H1 2020: GBP4.47 million; FY 2020:
GBP15.50 million) and other administrative expenses GBP1.99 million
(H1 2020: GBP0.60 million; FY 2020: GBP2.25 million).
Research and development expenditure of GBP4.47 million in H1
2020 was focused on the Phase II SG016 hospital trial, increasing
stocks of active and placebo syringes for future clinical trials
and completing the SG015 COPD study. On the back of the successful
results from the SG016 hospital study a fundraising was undertaken
in October 2020 to enable progression into Phase III and scale up
of manufacturing activities.
The most significant clinical expenditure in H1 2021 has been on
the Phase III SPRINTER study, as discussed earlier in the report,
with recruitment commencing in January 2021. The other items of
clinical expenditure related to the SG016 home study, which
completed during the period, and the ACTIV-2 trial.
The remainder of the research and development expenditure has
been focussed on upscaling SNG001 manufacturing activities and
procuring long lead time components. Drug substance manufacturing
(with Akron Biotechnology) has completed Process Performance
Qualification (PPQ) and a number of drug substance batches have
been manufactured. Some of this drug substance has been shipped to
Catalent for fill/finishing into glass syringes and PPQ batches
have been manufactured. PPQ preparatory work has been undertaken by
Woodstock Sterile Solutions for polyethylene blow-fill-seal
containers. Investment has also been made into release assay
development at a US-based supplier.
Other administrative expenditure has increased from GBP0.60
million in H1 2020 to GBP1.99 million in H1 2021 on account of (i)
the establishment of a commercial team, which is preparing for
SNG001 launch; (ii) the increase in finance and administration
headcount to handle the higher volumes of activity; and (iii)
higher investor relations activity costs.
The research and development tax credit increased from GBP1.11
million in H1 2020 to GBP5.97 million in H1 2021 on account of the
increased qualifying expenditure.
The loss after tax for H1 2021 was GBP32.92 million (H1 2020:
GBP3.96 million; FY 2020: GBP13.92 million) and the basic loss per
share was 16.47p (H1 2020: 3.11p loss; FY 2020: 9.46p loss).
Statement of Financial Position and Cash Flows
At 30 June 2021, net assets amounted to GBP52.37 million (30
June 2020: GBP11.58 million, 31 December 2020: GBP85.14 million),
including cash balances of GBP46.21 million (30 June 2020: GBP10.88
million, 31 December 2020: GBP74.98 million).
The principal elements for the GBP28.76 million decrease in cash
balances during H1 2021 (H1 2020: GBP8.43 million increase, year
ended 31 December 2020 (FY 2020): GBP72.52 million increase)
were:
-- Cash used in operations GBP28.67 million (H1 2020: GBP4.63
million outflow, FY 2020: GBP24.73 million outflow);
-- Research and development tax credits received of GBPnil (H1
2020: GBPnil, FY 2020: GBP0.91 million);
-- Share issue proceeds (net of costs) GBPnil (H1 2020: GBP13.22
million, FY 2020: GBP97.89 million); and
-- Net settlement of options GBPnil (H1 2020: GBPnil, FY 2020: GBP1.29 million).
The other significant changes in the statement of financial
position were:
-- Current tax receivable: 30 June 2021: GBP9.74 million, 30
June 2020 GBP1.98 million, 31 December 2020: GBP3.77 million,
reflecting the higher research and development tax credits due;
-- Trade and other receivables: 30 June 2021: GBP1.14 million,
30 June 2020: GBP0.38 million, 31 December 2020: GBP9.37 million.
The 31 December 2020 balance included a number of manufacturing
prepayments relating to drug substance manufacture, for which
product was received during H1 2021; and
-- Trade and other payables: 30 June 2021: GBP4.95 million, 30
June 2020: GBP1.98 million, 31 December 2020: GBP3.28 million,
reflecting the increase in operating activities.
SUMMARY AND OUTLOOK
The SARS-CoV-2 virus remains a significant global threat. The
potential for waning vaccine efficacy and the emergence of new
SARS-CoV-2 variants highlights the urgent need for additional
effective antiviral therapies. Most immediately, there is a
significant need for a drug for the hospitalised patient at the
time of admission that lowers the risk of further deterioration,
reduces the duration of hospital stay, and enhances the chance of
recovery following discharge.
Synairgen is focused on completing its 610 patient Phase III
SPRINTER trial with top line data expected in early 2022. Positive
results from this would mark a major breakthrough in the treatment
of COVID-19, and a transitional milestone for Synairgen.
In the meantime, Synairgen is building capabilities in the areas
of regulatory, manufacturing, supply chain, and in-market
support.
Synairgen has been progressing SNG001 as a broad-spectrum
antiviral for many years. The Company's earlier work, establishing
safety, dosing regimen, and patient selection has been instrumental
in allowing it to make rapid progress during this pandemic and,
whilst Synairgen waits for the results of the SPRINTER trial with
confidence, it remains grateful to everyone who has continued to
work tirelessly to advance the programme.
REFERENCES
1. Centers for Disease Control and Prevention. COVID Data
Tracker Weekly Review. Accessed Sept 27, 2021.
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html
Consolidated Statement of Comprehensive Income
for the six months ended 30 June 2021
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2021 2020 2020
Notes GBP000 GBP000 GBP000
Research and development
expenditure (36,906) (4,474) (15,495)
Other administrative expenses (1,991) (602) (2,246)
------------------------------- ------ ------------ ------------ ----------
Total administrative expenses
and loss from operations (38,897) (5,076) (17,741)
Finance income 9 9 19
Finance expense (2) (6) (10)
------------------------------- ------ ------------ ------------ ----------
Loss before tax (38,890) (5,073) (17,732)
Tax credit 2 5,971 1,111 3,816
------------------------------- ------ ------------ ------------ ----------
Loss and total comprehensive
loss for the period (32,919) (3,962) (13,916)
------------------------------- ------ ------------ ------------ ----------
Loss per ordinary share 3
Basic and diluted loss per ordinary
share (pence) (16.47)p (3.11)p (9.46)p
--------------------------------------- ------------ ------------ ----------
Consolidated Statement of Changes in Equity (unaudited)
for the six months ended 30 June 2021
Share Share Merger Retained
capital 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 400 13,600 - - 14,000
Transaction costs
in respect of share
issue - (782) - - (782)
Recognition of share-based
payments - - - 67 67
Total comprehensive
loss for the period - - - (3,962) (3,962)
At 30 June 2020 1,494 41,080 483 (31,481) 11,576
Issue of ordinary
shares 505 86,570 - - 87,075
Transaction costs
in respect of share
issue - (2,405) - - (2,405)
Recognition of share-based
payments - - - 140 140
Net settlement of
share options - - - (1,291) (1,291)
Total comprehensive
loss for the period - - - (9,954) (9,954)
At 31 December 2020 1,999 125,245 483 (42,586) 85,141
Recognition of share-based
payments - - - 148 148
Total comprehensive
loss for the period - - - (32,919) (32,919)
At 30 June 2021 1,999 125,245 483 (75,357) 52,370
---------------------------- --------- --------- --------- --------- ---------
Consolidated Statement of Financial Position
as at 30 June 2021
Unaudited Unaudited Audited
30 30 31
June June December
2021 2020 2020
Notes GBP000 GBP000 GBP000
Assets
Non-current assets
Intangible assets 46 11 44
Property, plant and equipment 212 292 250
Right-of-use assets 13 175 94
-------------------------------------------- ---------- ---------- ----------
271 478 388
------------------------------------------- ---------- ---------- ----------
Current assets
Inventories - 41 41
Current tax receivable 9,742 1,976 3,771
Trade and other receivables 1,137 383 9,372
Cash and cash equivalents 46,214 10,884 74,976
-------------------------------------------- ---------- ---------- ----------
57,093 13,284 88,160
------------------------------------------- ---------- ---------- ----------
Total assets 57,364 13,762 88,548
-------------------------------------------- ---------- ---------- ----------
Liabilities
Non-current liabilities
Lease liabilities - (43) -
----------------------------------- ------- ---------- ---------- ----------
Current liabilities
Trade and other payables (4,948) (1,978) (3,279)
Lease liabilities (46) (165) (128)
-------------------------------------------- ---------- ---------- ----------
(4,994) (2,143) (3,407)
------------------------------------------- ---------- ---------- ----------
Total liabilities (4,994) (2,186) (3,407)
-------------------------------------------- ---------- ---------- ----------
Total net assets 52,370 11,576 85,141
-------------------------------------------- ---------- ---------- ----------
Equity
Capital and reserves attributable
to equity holders of the
parent
Share capital 1,999 1,494 1,999
Share premium 125,245 41,080 125,245
Merger reserve 483 483 483
Retained deficit (75,357) (31,481) (42,586)
-------------------------------------------- ---------- ---------- ----------
Total equity 52,370 11,576 85,141
-------------------------------------------- ---------- ---------- ----------
Consolidated Statement of Cash Flows
for the six months ended 30 June 2021
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2021 2020 2020
GBP000 GBP000 GBP000
Cash flows from operating
activities
Loss before tax (38,890) (5,073) (17,732)
Adjustments for:
Finance income (9) (9) (19)
Finance expense 2 6 10
Depreciation of property,
plant & equipment 45 45 90
Depreciation of right-of-use
assets 81 81 161
Amortisation 5 5 9
Share-based payment charge 148 67 207
Cash flows from operations
before changes in working
capital (38,618) (4,878) (17,274)
Decrease in inventories 41 - -
Decrease/(Increase) in trade
and other receivables 8,235 (243) (9,244)
Increase in trade and other
payables 1,669 488 1,789
------------------------------------- ------------ ------------ ----------
Cash used in operations (28,673) (4,633) (24,729)
Tax credit received - - 910
------------------------------------- ------------ ------------ ----------
Net cash used in operating
activities (28,673) (4,633) (23,819)
------------------------------------- ------------ ------------ ----------
Cash flows from investing
activities
Interest received 10 7 31
Purchase of intangible assets (7) - (37)
Purchase of property, plant
and equipment (7) (36) (39)
Net cash used in investing
activities (4) (29) (45)
------------------------------------- ------------ ------------ ----------
Cash flows from financing
activities
Proceeds from issuance of
ordinary shares, gross - 14,000 101,075
Transaction costs in respect
of share issues - (782) (3,187)
Net settlement of share options - - (1,291)
Principal paid on lease liabilities (83) (123) (196)
Interest paid on lease liabilities (2) (3) (15)
------------------------------------- ------------ ------------ ----------
Net cash (used in)/generated
from financing activities (85) 13,092 96,386
------------------------------------- ------------ ------------ ----------
(Decrease)/Increase in cash
and cash equivalents (28,762) 8,430 72,522
Cash and cash equivalents
at beginning of period 74,976 2,454 2,454
------------------------------------- ------------ ------------ ----------
Cash and cash equivalents
at end of period 46,214 10,884 74,976
------------------------------------- ------------ ------------ ----------
Notes to the Interim Financial Information
for the six months ended 30 June 2021
1. Basis of preparation
Basis of accounting
The interim financial information, which is unaudited, has been
prepared on the basis of the accounting policies expected to apply
for the financial year to 31 December 2021 and in accordance with
international accounting standards in conformity with the
requirements of the Companies Act 2006. The accounting policies
applied in the preparation of this interim financial information
are consistent with those used in the financial statements for the
year ended 31 December 2020.
The interim financial information does not include all of the
information required for full annual financial statements and does
not comply with all the disclosure requirements in IAS 34 'Interim
Financial Reporting'.
Financial information
The financial information for the year ended 31 December 2020
does not constitute the full statutory accounts for that period.
The Annual Report and Financial Statements for the year ended 31
December 2020 have been filed with the Registrar of Companies. The
Independent Auditor's Report on the Annual Report and Financial
Statements for the year ended 31 December 2020 was unqualified, did
not draw attention to any matters by way of emphasis, and did not
contain a statement under 498(2) or 498(3) of the Companies Act
2006.
Financial information is published on the Company's website in
accordance with legislation in the United Kingdom governing the
preparation and dissemination of financial information, which may
vary from legislation in other jurisdictions. The maintenance and
integrity of the Company's website is the responsibility of the
directors. The directors' responsibility also extends to the
ongoing integrity of the financial information contained
therein.
Going Concern
The directors have prepared financial forecasts to estimate the
likely cash requirements of the Group over the next twelve months,
given its stage of development and lack of recurring revenues. In
preparing these financial forecasts, the directors have made
certain assumptions with regards to the timing and amount of future
expenditure over which they have control. The directors have
attempted to take a prudent view in preparing these forecasts,
recognising the inherent variability in costs of the ongoing Phase
III clinical trial of SNG001 in COVID-19 patients , the
manufacturing scale up and the commercialisation preparation
activities .
The directors' plans reflect their expected ability to complete
the Phase III clinical trial, and certain manufacturing scale-up
and commercialisation preparation activities utilising existing
cash resources at the date of this report - should the Phase III
clinical trial outcome be successful, the directors would seek to
raise the further funding required to complete submissions of
marketing authorisation applications and full commercialisation
activities.
The current cash resources are sufficient to cover the above
plans up to and including the read-out of the Phase III results and
existing committed costs for the next twelve months to September
2022, regardless of the outcome of the currently ongoing Phase III
trial.
After due consideration of these forecasts and current cash
resources, the directors consider that the Group has adequate
financial resources to continue in operational existence for the
foreseeable future (being a period of at least twelve months from
the date of this report) and, for this reason, the financial
statements have been prepared on a going concern basis.
Approval of financial information
The 30 June 2021 interim financial information was approved by
the Board of Directors on 29 September 2021.
Notes to the Interim Financial Information
for the six months ended 30 June 2021 (continued)
2. Tax credit
The tax credit of GBP5,971,000 (six months ended 30 June 2020:
GBP1,111,000; year ended 31 December 2020: GBP3,816,000) comprises
an estimate of the research and development tax credit receivable
in respect of the current period.
3. Loss per ordinary share
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2020 2020 2020
Loss attributable to equity
holders of the Company (GBP000) (32,919) (3,962) (13,916)
Weighted average number of
ordinary shares in issue 199,914,402 127,318,567 147,120,120
The loss attributable to shareholders and the weighted average
number of ordinary shares for the purposes of calculating the
diluted loss per ordinary share are identical to those used for
basic loss per share. This is because the exercise of share options
would have the effect of reducing the loss per ordinary share and
is therefore antidilutive. On 4 June 2021, 831,725 options were
granted to employees. At 30 June 2021 there were 9,503,004 options
outstanding (30 June 2020: 10,042,735 options outstanding; 31
December 2020: 8,671,279 options outstanding).
The movements on share capital and share premium were as
follows:
Ordinary
shares of Share premiumGBP000
Number of 1p each Total
shares GBP000 GBP000
At 1 January 2020 109,433,442 1,094 28,262 29,356
Issue of ordinary
shares 40,000,000 400 13,600 14,000
Costs of issue of
shares - - (782) (782)
-------------- ----------- ---------------------- ----------
At 30 June 2020 149,433,442 1,494 41,080 42,574
Issue of ordinary
shares 50,480,960 505 86,570 87,075
Costs of issue of
shares - - (2,405) (2,405)
-------------- ----------- ---------------------- ----------
At 31 December 2020
and 30 June 2021 199,914,402 1,999 125,245 127,244
-------------- ----------- ---------------------- ----------
INDEPENDENT REVIEW REPORT TO SYNAIRGEN PLC
Introduction
We have been engaged by the Company to review the condensed set
of financial statements in the half-yearly financial report for the
six months ended 30 June 2021 which comprises the Consolidated
Statement of Comprehensive Income, the Consolidated Statement of
Changes in Equity, the Consolidated Statement of Financial
Position, the Consolidated Statement of Cash Flows and the related
notes 1 to 3.
We have read the other information contained in the half-yearly
financial report and considered whether it contains any apparent
misstatements or material inconsistencies with the information in
the condensed set of financial statements.
Directors' responsibilities
The interim report, including the financial information
contained therein, is the responsibility of and has been approved
by the directors. The directors are responsible for preparing the
interim report in accordance with the rules of the London Stock
Exchange for companies trading securities on AIM which require that
the half-yearly report be presented and prepared in a form
consistent with that which will be adopted in the Company's annual
accounts having regard to the accounting standards applicable to
such annual accounts.
Our responsibility
Our responsibility is to express to the Company a conclusion on
the condensed set of financial statements in the half-yearly
financial report based on our review.
Scope of review
We conducted our review in accordance with International
Standard on Review Engagements (UK and Ireland) 2410, "Review of
Interim Financial Information Performed by the Independent Auditor
of the Entity", issued by the Financial Reporting Council for use
in the United Kingdom. A review of interim financial information
consists of making enquiries, primarily of persons responsible for
financial and accounting matters, and applying analytical and other
review procedures. A review is substantially less in scope than an
audit conducted in accordance with International Standards on
Auditing (UK) and consequently does not enable us to obtain
assurance that we would become aware of all significant matters
that might be identified in an audit. Accordingly, we do not
express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that
causes us to believe that the condensed set of financial statements
in the half-yearly financial report for the six months ended 30
June 2021 is not prepared, in all material respects, in accordance
with the rules of the London Stock Exchange for companies trading
securities on AIM.
Use of our report
Our report has been prepared in accordance with the terms of our
engagement to assist the Company in meeting the requirements of the
rules of the London Stock Exchange for companies trading securities
on AIM and for no other purpose. No person is entitled to rely on
this report unless such a person is a person entitled to rely upon
this report by virtue of and for the purpose of our terms of
engagement or has been expressly authorised to do so by our prior
written consent. Save as above, we do not accept responsibility for
this report to any other person or for any other purpose and we
hereby expressly disclaim any and all such liability.
BDO LLP
Chartered Accountants
Reading
Date: 29 September 2021
BDO LLP is a limited liability partnership registered in England
and Wales (with registered number OC305127).
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END
IR EAFNNASNFEAA
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September 30, 2021 02:00 ET (06:00 GMT)
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