REG - Synairgen plc - Interim results for six months ended 30 June 2020
29/09/2020 07:00
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20200929:nRSc3710Aa
RNS Number : 3710A Synairgen plc 29 September 2020
Press release
Synairgen plc
('Synairgen' or the 'Company')
Interim results for the six months ended 30 June 2020
Southampton, UK - 29 September 2020: Synairgen plc (LSE: SNG), the respiratory
drug discovery and development company, today announces its unaudited interim
results for the six months ended 30 June 2020.
Highlights (including post period-end)
Operational
· Positive results from SG016, its double-blind placebo-controlled
Phase II trial of SNG001 in hospitalised COVID-19 patients announced in July
· The Company extended the SG016 Phase II trial to include a
further 120 patients with confirmed COVID-19 to be dosed in the home
environment (ongoing)
· Positive results from interim analysis of SG015, its double-blind
placebo-controlled Phase II trial of SNG001 in COPD patients announced in
September, supporting the COVID-19 programme
· Patent applications for SNG001 in COVID-19 patients and in
exacerbating COPD patients undergoing treatment with systemic corticosteroids
were submitted post period-end
· Synairgen launched a Managed Access Program with Clinigen, to
provide SNG001 to hospitalised COVID-19 patients - see separate announcement
issued today
· The Company is currently in discussions with regulatory agencies
to establish the route to approval of SNG001 as a treatment for COVID-19
· The Company is also investing in supply chain activities to
ensure that drug and aerosol delivery system availability can meet potential
demand, pending approval
Financial
· In March 2020, Synairgen raised £14.0 million (before expenses)
in an equity issue to fund its initial COVID-19 related activities and
strengthen its balance sheet
· Research and development expenditure for the six months ended 30
June 2020 was £4.47 million (30 June 2019: £1.69 million) as the Company
advanced its clinical trial of SNG001 in COVID-19 patients and scale-up
activities
· The loss from operations for the six months ended 30 June 2020
was £5.08 million (30 June 2019: £2.21 million loss)
· Cash balances of £10.9 million at 30 June 2020 (30 June 2019:
£3.52 million)
Richard Marsden, CEO of Synairgen, said: "The first six months of this year
have been the most significant in Synairgen's history. We were delighted to
announce positive results from our hospital-based COVID-19 trial in July, and
have been working tirelessly on the progression of SNG001 as a potential
treatment for COVID-19 patients. With further positive results from our
interim analysis of SNG001 in COPD announced in September 2020, we feel
well-equipped to realise our strategy of progressing inhaled interferon beta
for the treatment of respiratory viruses. I'd like to thank everyone involved
in the Company and trials for all their hard work to date."
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, Finance Director
Tel: + 44 (0) 23 8051 2800
finnCap
Geoff Nash, Kate Bannatyne, Charlie Beeson (Corporate Finance)
Alice Lane, Manasa Patil (ECM)
Tel: + 44 (0) 20 7220 0500
Consilium Strategic Communications (Financial Media and Investor
Relations)
Mary-Jane Elliott, Sue Stuart, Olivia Manser
synairgen@consilium-comms.com
Tel: +44 (0) 20 3709 5700
Notes for Editors
About Synairgen
Synairgen is a respiratory drug discovery and development company founded by
University of Southampton Professors Stephen Holgate, Donna Davies and Ratko
Djukanovic. The business, focused primarily on lung viral defence in asthma,
COPD, and COVID-19, uses its differentiating human biology BioBank platform
and world-renowned international academic KOL network to discover and develop
novel therapies for respiratory disease. Synairgen is quoted on AIM (LSE:
SNG). For more information about Synairgen, please see
https://www.synairgen.com (https://www.synairgen.com)
Operating Review
Summary
During the first half of the year, Synairgen made significant clinical
progress with its inhaled formulation of interferon beta, SNG001. Most
importantly, Synairgen's results from its Phase II trial of SNG001 in 101
hospitalised COVID-19 patients indicated that its inhaled interferon beta
could provide a valuable treatment option in the face of the global pandemic.
With further safety, efficacy and other supporting data for SNG001 provided
from the interim analysis of Synairgen's Phase II COPD trial in September
2020, the Company is currently wholly focused on working with governments,
regulators and other key stakeholders to progress SNG001 as a treatment for
COVID-19.
COVID-19
COVID-19, caused by the SARS-CoV-2 virus, is a global threat and there is an
urgent need to assess new treatments to prevent and effectively treat the
severe lower respiratory tract illness that can occur with this disease. Older
people and those with co-morbidities such as heart and lung complications or
diabetes are at greatest risk of developing severe or fatal disease.
Interferon beta applicability to COVID-19
Interferon beta ('IFN-beta') is a naturally-occurring protein, orchestrating
the body's antiviral responses. There is growing evidence that deficiency in
IFN-beta production by the lung could explain the enhanced susceptibility in
'at-risk' patient groups to developing severe lower respiratory tract (lung)
disease during respiratory viral infections. Furthermore, viruses, including
coronaviruses such as SARS-CoV-2, have evolved mechanisms which suppress
endogenous IFN-beta production, helping the virus to evade the innate immune
system. The addition of exogenous IFN-beta before or during viral infection of
lung cells in vitro either prevents or greatly reduces viral replication.
Synairgen's SNG001 is a formulation of IFN-beta-1a for direct delivery to the
lungs via nebulisation. It is pH neutral, and is free of mannitol, arginine
and human serum albumin, making it suitable for inhaled delivery direct to the
site of action.
The COVID-19 trial - SG016
Synairgen's clinical trial in COVID-19 patients, SG016, is a double-blind,
placebo-controlled trial. The two-part 221 patient trial comprises 101
patients initiated in the hospital setting (results announced 20 July 2020,
see below), and a further 120 patients in the home setting (currently
ongoing).
Hospital trial
Synairgen's Phase II trial of SNG001 in hospitalised COVID-19 patients was
conducted across nine NHS trusts in the UK and was adopted by the NIHR
Respiratory Translational Research Collaboration, who gave it Urgent Public
Health status. These sites are leading centres in respiratory medicine in the
UK, whose internationally recognised experts are working together to
accelerate development and discovery of treatments for COVID-19.
Results of SG016 trial in hospital patients
On 20 July 2020, the Company announced positive top-line results from the
trial.
The design of this trial, which began dosing patients in March 2020, was based
on the recommendations contained within the World Health Organization (WHO)
R&D Blueprint Novel Coronavirus COVID-19 Therapeutic Trial Synopsis issued
in February 2020.
The primary endpoint was the change in condition assessed using the WHO
Ordinal Scale for Clinical Improvement (OSCI; see table below) during the
dosing period in the Intention-to-Treat population (ITT).
WHO Ordinal Scale for Clinical Improvement (Feb 2020)
OSCI
Patient State Descriptor Score
Uninfected No clinical or virological evidence of infection 0
Ambulatory No limitation of activities 1
Limitation of activities 2
Hospitalised Hospitalised, no oxygen therapy 3
- Mild disease
Oxygen by mask or nasal prongs 4
Hospitalised Non-invasive ventilation or high-flow oxygen 5
- Severe disease
Intubation and mechanical ventilation 6
Ventilation + additional organ support 7
Dead Death 8
As no clinical data had been collected using the OSCI in the study population
at the time, multiple pre-specified analyses were conducted at fixed time
points and over the whole dosing period, with the aim of learning about SNG001
as a potential treatment for COVID-19 patients, and to inform future trial
design. There was no hierarchy within the analyses or adjustments made for
multiplicity. Top-line data was presented on 20 July.
101 patients were randomised; 48 received SNG001 and 50 received placebo (ITT
population; patients who took at least one dose of study medication). Of these
86, 43 in each arm, met the criteria for the per-protocol population (PP
population; positive PCR test, had taken at least two out of their first three
scheduled doses and had no protocol deviations impacting on efficacy).
Results of primary endpoint analyses are shown in the tables below (where an
Odds Ratio (OR) or Hazard Ratio (HR) of 1 would indicate no difference between
SNG001 and placebo):
A ratio above 1 signifies a greater likelihood of (for HR), or odds of (for
OR), the effect occurring on SNG001 compared to placebo
ITT population PP population
(n = 98) (n = 86)
Ratio p-value Ratio p-value
Analysis (95% CI) (95% CI)
Odds of improvement across the OSCI (any improvement at day 15/16 compared to
baseline)
OR 2·32 (1·07, 5·04) OR 2.80 (1.21, 6.52)
0·033 0·017
Time to Recovery(a) (time from first dose to no limitation of activities
without subsequent relapse)
HR 2·19 (1·03, 4·69) HR 2.29 (1.07, 4.91)
0·043 0.033
Odds of Recovery (no limitation of activities recorded at day 15/16 without
subsequent relapse)
OR 3·19 (1·24, 8·24) OR 3.18 (1.21, 8.39)
0·017 0.019
Time to Hospital Discharge(b) (time from first dose to hospital discharge with
no subsequent hospital re-admission)
HR 1·37 (0·85, 2·20) HR 1.53 (0.96, 2.42)
0·196 0.072
Odds of Hospital Discharge (discharged from hospital at day 15/16 without
subsequent hospital re-admission)
OR 1·63 (0·61, 4·35) OR 2.14 (0.64, 7.12)
0·330 0.215
(a )Recovery was defined as a post baseline OSCI score of 0 or 1 which does
not rise above 1 at any subsequent visits.
(b )Hospital Discharge was defined as a post baseline OSCI score of 2 or less
which does not rise above 2 at any subsequent visits.
A ratio below 1 signifies a lower likelihood of (for HR), or odds of (for OR),
the effect occurring on SNG001 compared to placebo
ITT population PP population
(n = 98) (n = 86)
Ratio p-value Ratio p-value
Analysis (95% CI) (95% CI)
Time to severe disease or death (time from first dose until first incidence of HR 0·50 (0.18, 1.38) 0·179 Not calculated as not part of statistical analysis plan
OSCI≥5)
Odds of severe disease or death (OSCI≥5 at any time in the first 16 days OR 0·28 (0·07, 1·08)
after first dose)
OR 0.18 (0.04, 0.93) 0.041(b)
0·064(a)
Time to intubation or death (time from first dose until first incidence of Not calculated as not part of statistical analysis plan
OSCI≥6)
HR 0·38 (0·09, 1·65) 0·198
Odds of intubation or death (OSCI≥6 at any time in the first 16 days after
first dose)
OR 0·42 (0·09, 1·83) 0·246(b) OR 0.31 (0.05, 1.79) 0.189(b)
( a) Using the pre-specified logistic regression analysis, SNG001 reduced the
odds of developing severe disease or dying in the ITT population by 79% (OR
0·21; 95% CI: 0·04, 0·97; p=0·046). As quasi-complete separation of data
occurred in some model covariates, an additional post-hoc, Firth logistic
regression analysis was conducted. This showed there was a trend towards
reduced odds of progression to severe disease or death in the ITT population
(72% reduction; OR 0·28; 95% CI: 0·07, 1·08; p=0·064) that became
significant in the per protocol population (82% reduction; OR 0.18; 95% CI:
0.04, 0.93; p=0.041).
(b) Post hoc analysis using the Firth logistic regression analysis.
Key findings
· SNG001 treatment, when compared to placebo, was associated with
greater odds of improvement across the WHO OSCI and with more rapid recovery
to a point where patients were no longer limited in their activity, with a
greater proportion of patients recovering during the study period. There was a
strong trend towards reduced odds of progression to severe disease or death in
the ITT population that became significant in the per-protocol population.
· Over the treatment period, patient-reported Breathlessness Cough
and Sputum Scale (BCSS) and in particular breathlessness scores, were markedly
reduced in patients who received SNG001 compared to those receiving placebo
(p=0.026 and p=0.007, respectively).
Other findings
· The median duration of COVID-19 symptoms at the point dosing
commenced was 10 days, suggesting that there is a wide window for effective
treatment.
· Odds ratios for improvement, recovery and hospital discharge were
in favour of SNG001 at day 28 suggesting that the treatment effect extends
beyond the end of the dosing period. A treatment that accelerates full
recovery may be especially relevant to the 1 in 20 patients with COVID-19 who
experience wide-ranging long term symptoms for at least a month and sometimes
longer (known as long, long-haul or long-tail COVID).
· Three patients died during the study; all deaths occurred in
patients randomised to placebo, therefore, no modelling analysis was
undertaken.
· SNG001 was well tolerated.
Home Trial
In April 2020, Synairgen received approvals to extend the SG016 trial into the
home environment, with the objective of initiating dosing earlier in the
infection cycle of COVID-19, and before severe lower respiratory tract
symptoms have developed. The trial is ongoing, recruiting patients who are
either aged 65 or over, or are aged 50 or over with a high-risk comorbidity.
Patients must have had symptoms for less than seven (originally two) days. The
home trial involves SNG001 (or placebo) being delivered to eligible
participants while observing social distancing measures as implemented by the
UK Government. In order to minimise risks to patients and healthcare workers
in this setting, all visits are conducted by video link.
Patients interact with the trial team using Skype/Teams/Zoom or their
preferred choice of video conferencing as soon as COVID-19 symptoms develop,
and are informed about the trial and provide online consent. Patients will
self-swab under video supervision. Within a few hours of the swab been taken,
the virus test results are known. If positive for SARS-CoV-2, the drug
(placebo or SNG001), aerosol delivery device, and other trial equipment are
despatched to the patient. Each dose is taken under video supervision.
Endpoints will also be assessed during the video calls.
This is the first trial of its type to be conducted "remotely" in this way
and, if successful, may point towards a potential domiciliary care protocol
for this and future viral outbreaks. The trial has however struggled to
recruit patients during the summer months due to effective social distancing
in the 'shielded' patient group. The trial completion will depend on both a
second wave in the UK, and governmental support with patient recruitment to
succeed.
Managed Access Program
Synairgen and Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global
pharmaceutical and services company, signed an agreement to launch a Managed
Access Program for SNG001 in the UK and the EU for the treatment of
hospitalised COVID-19 patients - see separate announcement issued today.
Manufacturing Scale Up
In preparation for gaining approvals for SNG001, the Company has made good
progress with discussions with a variety of international suppliers to scale
up production of SNG001 rapidly, with the aim of being able to produce
approximately 100,000 treatments per month in 2021.
Regulatory Next Steps
Synairgen is currently in discussions with regulatory agencies to establish
the regulatory route to approval of SNG001 as a treatment for COVID-19.
Chronic Obstructive Pulmonary Disease (COPD)
COPD is a progressive lung disease, punctuated by periods of exacerbation
characterised by acute worsening of symptoms which require treatment with oral
corticosteroids and/or antibiotics, which have major implications for both the
patient and the healthcare system. COPD exacerbations are the second most
common cause of unplanned hospitalisation in England.
Interferon beta (IFN-beta) applicability to COPD
COPD patients are approximately five times more likely to become severely ill
(exacerbate) due to respiratory viruses than asthmatic patients, and have
always been recognised as a larger potential market for a broad-spectrum
antiviral product which could prevent exacerbations or accelerate recovery
from exacerbation. However, half of infectious COPD exacerbations are caused
by bacteria, with no virus present. This meant use of SNG001 in the context of
COPD would be very challenging without a point-of-care to confirm viral
infection. The bioMérieux BioFire FilmArray and other technologies which have
subsequently become available, have ensured the selection and treatment of
solely those patients where the presence of a virus is confirmed.
The COPD trial - SG015
In 2018 Synairgen commenced a two-part COPD trial (SG015) to assess the safety
and lung antiviral biomarker and efficacy responses to SNG001 in the absence
of viral infection. In the first part of the trial, SNG001 was well tolerated
in patients with moderate to severe COPD. We also observed a strong antiviral
biomarker signal, which was comparable to the response previously observed in
asthma. This paved the way to proceed into the second part of the trial, which
was designed to dose 120 patients with confirmed naturally-occurring
respiratory virus infections to look in addition at lung function. Recruitment
into the trial commenced in earnest in January 2019 and was progressing well
until the emergence of COVID-19.
Impact of COVID-19 on SG015 programme
The emergence of COVID-19 made it difficult to test for viral activity in COPD
patients and to dose them without potentially exposing vulnerable patients and
research staff to SARS-CoV-2. Hence in March 2020 the trial was paused, with
109 out of the targeted 120 patients recruited. MHRA approval was then
received to run an interim analysis on the grounds that the data from COPD
patients with confirmed viral infection could generate useful safety,
biomarker and efficacy data to support ongoing trials of SNG001 in COVID-19
patients.
Results of interim analysis of SNG015 trial in COPD patients
On 8 September 2020, Synairgen announced a positive interim analysis of SNG001
in COPD patients. Key findings included:
· SNG001 was well tolerated during the treatment period in a study
population that was elderly (mean age 66 years) and suffering from reduced
respiratory function, as measured by forced expiratory volume in one second
(FEV1) (59% of predicted value).
· The percentage of on-treatment adverse events was similar in the
placebo and SNG001 treatment groups (48.1% versus 45.6%, respectively), with
treatment-related adverse events being more frequent in the placebo group
(25%) compared to the SNG001 group (15.8%).
· Over the treatment period, lung antiviral responses to viral
infection were significantly enhanced in patients receiving SNG001 compared to
those on placebo, as assessed by measuring increases in the gene expression of
interferon beta-dependent antiviral biomarkers MX1 (p=<0.001) and OAS1
(p=<0.001) in lung (sputum) cells.
· The impact of viral infection on COPD patients in the trial was
most evident on peak expiratory flow rate (PEFR), a measure of lung function,
and patient-reported symptoms assessed using the Breathlessness Cough and
Sputum Score (BCSS), and was particularly apparent in exacerbating patients
(i.e. patients already requiring treatment with oral corticosteroids and/or
antibiotics at the time of randomisation, who represented one third of
patients enrolled).
· Exacerbating patients who received SNG001 had significantly
better lung function during the treatment period (difference in change from
baseline morning PEFR between patients receiving SNG001 and placebo over days
2-15 was 25.5L/min; p=0.041).
· Although there was no significant difference in total BCSS in
this group over the treatment period, there was a trend for the breathlessness
component of the score, in exacerbating patients suggesting that patients may
have recovered more rapidly if they received SNG001 rather than placebo.
· Viral infections had less impact on non-exacerbating patients and
there were no significant treatment effects.
Activities paused to focus on COVID-19
Synairgen's immediate priority is to progress SNG001 as a therapeutic for
COVID-19 and as such the COPD programme will remain paused.
LOXL2
Pharmaxis, the Company's Australian-based partner for the antifibrotic LOXL2
inhibitor programme, updated the market on 31 July 2020 stating that it is
currently pursuing a number of different partnering options to enable the drug
to enter the clinic in Phase 2 trials and will provide more information when
the process concludes. Synairgen is entitled to receive circa 17% of
Pharmaxis' licence receipts/royalties, net of allowable expenses.
Intellectual Property
Patent filings
Adding to the Company's IP portfolio, patent applications were submitted
following (i) the results from the study for the use of inhaled IFN-beta in
COVID-19 patients and (ii) the interim analysis of the data from the trial
that used inhaled IFN-beta to treat virus-induced exacerbations in COPD
patients undergoing treatment with systemic corticosteroids.
FINANCIAL REVIEW
Statement of Comprehensive Income
The loss from operations for the six months ended 30 June 2020 was £5.08
million (six months ended 30 June 2019: £2.21 million loss; year ended 31
December 2019: £4.82 million loss). Research and development expenditure
increased from £1.69 million in the six months ended 30 June 2019 to £4.47
million for the six months ended 30 June 2020 as the Company commenced its
COVID-19 activities (clinical trials and manufacturing scale-up) and advanced
the Phase II study in COPD. Other administrative costs for the period
increased to £0.60 million from £0.52 million for the six months ended 30
June 2019 on account of greater public company costs.
The research and development tax credit increased from £0.42 million to
£1.11 million on account of the higher research and development activities,
equating to 25% of R&D expenditure in both periods.
The loss after tax for the period was £3.96 million (six months ended 30 June
2019: £1.77 million loss) and the basic loss per share was 3.11p (six months
ended 30 June 2019: loss of 1.62p).
Fundraising
£14 million (before expenses) was raised in March 2020 by the issue of 40
million ordinary shares at a price of 35p per share to fund the following
activities:
· COVID-19 initial clinical trial activity (£7 million);
· Manufacture of SNG001 drug product and other supply chain
considerations (£4 million); and
· Strengthened balance sheet for potential partnering discussions,
working capital and fees (£3 million).
Statement of Financial Position and cash flows
At 30 June 2020, net assets amounted to £11.58 million (30 June 2019: £4.30
million, 31 December 2019: £2.25 million), including cash balances of £10.88
million (30 June 2019: £3.52 million, 31 December 2019: £2.45 million).
Trade and other payables amounted to £1.98 million (30 June 2019: £0.99
million, 31 December 2019: £1.49 million) with the increase from the 30 June
2019 and 31 December 2019 balances being attributable to the COVID-19 research
and development activities.
The principal elements of the £8.43 million increase in cash balances over
the six months ended 30 June 2020 (six months ended 30 June 2019: £1.76
million decrease, year ended 31 December 2019: £2.88 million decrease) were:
· Cash used in operations of £4.63 million (six months ended 30
June 2019: £1.83 million outflow; year ended 31 December 2019: £3.73 million
outflow);
· Research and development tax credits received of £nil (six
months ended 30 June 2019: £nil; year ended 31 December 2019: £0.84
million);
· Payments of lease liabilities £0.13 million (six months ended 30
June 2019: £nil; year ended 31 December 2019: £nil); and
· Net proceeds from fundraising of £13.22 million (six months
ended 30 June 2019: £nil; year ended 31 December 2019: £nil).
Going concern
The directors have prepared detailed financial forecasts to estimate the
likely cash requirements of the Company 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 balanced and prudent view in preparing
these forecasts.
In common with many other similar biotechnology companies Synairgen relies on
equity financing at key milestone events during the development of its
programmes. Events are moving very quickly for the Company as it plans the
next phases of development and approval of SNG001 as a therapy for COVID-19
over the shortest possible timescale to meet regulatory requirements and
global healthcare demands. The Company and Group currently have enough
existing financial resources to meet their currently contracted commitments,
as at the date of signing this report, for the next 12 months. On this basis,
the Directors have concluded that the going concern basis of accounting is
appropriate and that there are no material uncertainties arising within the
next 12 months.
Over the next 6-12 months the Company intends to pursue the development of
SNG001 as a therapy for COVID-19 through further clinical trial activity and
upscaling of manufacturing and supply arrangements. To the extent that such
activities are in addition to the Company's current commitments they will
require financing. The Directors will investigate all potential sources of
finance, including but not limited to, new equity, and remain confident that
funding will be available prior to entering into further commitments.
OUTLOOK
The major developments during the first six months of the year have leveraged
the significant experience that surrounds Synairgen and we are grateful to our
entire team that has worked tirelessly. We are continuing our strategy of
progressing inhaled IFN-beta for the treatment of severe viral lung
infections. SNG001 shows great promise as a treatment for COVID-19 patients,
and we were delighted to announce positive results from the hospital-based
trial and to have supplemented that data set with a positive interim analysis
of SNG001 in COPD patients in September. The Company is now fully focused on
expediting the next steps with SNG001 in COVID-19, including discussions with
regulatory agencies to set out a route to approval, and separately working
with our manufacturing partners to achieve meaningful scale up.
Our goal is to deliver an effective treatment for COVID-19 and continue to
work in the interests of patients and our shareholders.
Consolidated Statement of Comprehensive Income
for the six months ended 30 June 2020
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2020 2019 2019
Notes £000 £000 £000
Research and development expenditure (4,474) (1,686) (3,460)
Other administrative expenses (602) (520) (1,357)
Total administrative expenses (5,076) (2,206) (4,817)
Loss from operations (5,076) (2,206) (4,817)
Finance income 9 17 30
Finance expense (6) - (6)
Loss before tax (5,073) (2,189) (4,793)
Tax credit 2 1,111 417 908
Loss and total comprehensive loss for the period (3,962) (1,772) (3,885)
Loss per ordinary share 3
Basic and diluted loss per ordinary share (pence) (3.11)p (1.62)p (3.55)p
Consolidated Statement of Changes in Equity (unaudited)
for the six months ended 30 June 2020
Share Share Merger Retained Total
capital premium reserve Deficit
£000 £000 £000 £000 £000
At 1 January 2019 1,094 28,262 483 (23,812) 6,027
Recognition of share-based payments - - - 48 48
Total comprehensive loss for the period - - - (1,772) (1,772)
At 30 June 2019 1,094 28,262 483 (25,536) 4,303
Recognition of share-based payments - - - 63 63
Total comprehensive loss for the period - - - (2,113) (2,113)
At 31 December 2019 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
Consolidated Statement of Financial Position
as at 30 June 2020
Unaudited Unaudited Audited
30 30 31
June June December
2020 2019 2019
Notes £000 £000 £000
Assets
Non-current assets
Intangible assets 11 22 16
Property, plant and equipment 292 333 301
Right-of-use assets 175 - 255
478 355 572
Current assets
Inventories 41 42 41
Current tax receivable 1,976 1,212 865
Trade and other receivables 383 162 139
Cash and cash equivalents 10,884 3,520 2,454
13,284 4,936 3,499
Total assets 13,762 5,291 4,071
Liabilities
Non-current liabilities
Lease liabilities (43) - (127)
Current liabilities
Trade and other payables (1,978) (988) (1,490)
Lease liabilities (165) - (201)
(2,143) (988) (1,691)
Total liabilities (2,186) (988) (1,818)
Total net assets 11,576 4,303 2,253
Equity
Capital and reserves attributable to equity holders of the parent
Share capital 1,494 1,094 1,094
Share premium 41,080 28,262 28,262
Merger reserve 483 483 483
Retained deficit (31,481) (25,536) (27,586)
Total equity 11,576 4,303 2,253
Consolidated Statement of Cash Flows
for the six months ended 30 June 2020
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2020 2019 2019
£000 £000 £000
Cash flows from operating activities
Loss before tax (5,073) (2,189) (4,793)
Adjustments for:
Finance income (9) (17) (30)
Finance expense 6 - 6
Depreciation of property, plant & equipment
45 41 83
Depreciation of right-of-use assets 81 - 67
Amortisation 5 7 13
Share-based payment charge 67 48 111
Cash flows from operations before changes in working capital (4,878) (2,110) (4,543)
Decrease in inventories - 14 15
(Increase)/Decrease in trade and other receivables (243) 54 81
Increase in trade and other payables 488 211 713
Cash used in operations (4,633) (1,831) (3,734)
Tax credit received - - 838
Net cash used in operating activities (4,633) (1,831) (2,896)
Cash flows from investing activities
Interest received 7 17 26
Purchase of property, plant and equipment (36) - (10)
Decrease in other financial assets - 50 50
Net cash (used in)/generated from investing activities (29) 67 66
Cash flows from financing activities
Proceeds from issuance of ordinary shares, gross 14,000 - -
Transaction costs in respect of share issues (782) - -
Principal paid on lease liabilities (123)
Interest paid on lease liabilities (3) - -
Net cash generated from financing activities 13,092 - -
Increase/(Decrease) in cash and cash equivalents 8,430 (1,764) (2,830)
Cash and cash equivalents at beginning of period 2,454 5,284 5,284
Cash and cash equivalents at end of period 10,884 3,520 2,454
Notes to the Interim Financial Information
for the six months ended 30 June 2020
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 2020 and in accordance with recognition and measurement
principles of International Financial Reporting Standards (IFRSs) as endorsed
by the European Union. 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 2019.
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 2019 does not
constitute the full statutory accounts for that period. The Annual Report and
Financial Statements for the year ended 31 December 2019 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 2019 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.
Going Concern
The directors have prepared detailed financial forecasts to estimate the
likely cash requirements of the Company 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 balanced and prudent view in preparing
these forecasts.
In common with many other similar biotechnology companies Synairgen relies on
equity financing at key milestone events during the development of its
programmes. Events are moving very quickly for the Company as it plans the
next phases of development and approval of SNG001 as a therapy for COVID-19
over the shortest possible timescale to meet regulatory requirements and
global healthcare demands. The Company and Group currently have enough
existing financial resources to meet their currently contracted commitments,
as at the date of signing this report, for the next 12 months. On this basis,
the Directors have concluded that the going concern basis of accounting is
appropriate and that there are no material uncertainties arising within the
next 12 months.
Over the next 6-12 months the Company intends to pursue the development of
SNG001 as a therapy for COVID-19 through further clinical trial activity and
upscaling of manufacturing and supply arrangements. To the extent that such
activities are in addition to the Company's current commitments they will
require financing. The Directors will investigate all potential sources of
finance, including but not limited to, new equity, and remain confident that
funding will be available prior to entering into further commitments.
Approval of financial information
The 30 June 2020 interim financial information was approved by the Board of
Directors on 28 September 2020.
2. Tax credit
The tax credit of £1,111,000 (six months ended 30 June 2019: £417,000; year
ended 31 December 2019: £908,000) comprises an estimate of the research and
development tax credit receivable in respect of the current period.
Notes to the Interim Financial Information
for the six months ended 30 June 2020 (continued)
3. Loss per ordinary share
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2020 2019 2019
Loss attributable to equity holders of the Company (£000) (3,962) (1,772) (3,885)
Weighted average number of ordinary shares in issue 127,318,567 109,433,442 109,433,422
The loss attributable to shareholders and the weighted average number of
ordinary shares for the purposes of calculating the diluted loss per ordinary
share are identical to those used for basic loss per share. This is because
the exercise of share options would have the effect of reducing the loss per
ordinary share and is therefore antidilutive. At 30 June 2020 there were
10,042,735 options outstanding (30 June 2019: 8,737,515 options outstanding;
31 December 2019: 8,487,515 options outstanding).
The movements on share capital and share premium were as follows:
Ordinary shares of 1p each
£000 Share premium £000
Number of shares Total £000
At 1 January 2019 and 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
INDEPENDENT REVIEW REPORT TO SYNAIRGEN PLC
Introduction
We have been engaged by the Company to review the financial information in the
interim results for the six months ended 30 June 2020 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 interim results and
considered whether it contains any apparent misstatements or material
inconsistencies with the information in the financial information.
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 interim results 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 financial
information in the interim results 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 interim results
for the six months ended 30 June 2020 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
dated 23 January 2020 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
United Kingdom
28 September 2020
BDO LLP is a limited liability partnership registered in England and Wales
(with registered number OC305127).
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END IR KKFBDBBKBOCBRecent news on Synairgen
See all newsRCS - Synairgen PLC - Board and Executive Leadership Changes
AnnouncementRCS - Synairgen PLC - Shares Admitted to Trading on Asset Match
AnnouncementREG - AIM Synairgen plc - Cancellation - Synairgen plc
AnnouncementREG - Synairgen plc - Update on trading post cancellation
AnnouncementREG - Synairgen plc - Result of General Meeting
Announcement