TIDMSNG
RNS Number : 0512O
Synairgen plc
30 September 2019
Press release
Synairgen plc
('Synairgen' or the 'Company')
Interim results for the six months ended 30 June 2019
Southampton, UK - 30 September 2019: Synairgen plc (LSE: SNG),
the respiratory drug discovery and development company, today
announces its unaudited interim results for the six months ended 30
June 2019.
Highlights (including post period-end)
Operational
-- Phase II trial of inhaled interferon beta (IFN-beta) for
Chronic Obstructive Pulmonary Disease (COPD) patients progressing
well, with four new sites added in 2019
-- At 30 June 2019, 43 confirmed virus-positive patients had
been dosed. At 27 September 2019, this had increased to 55 patients
and we now have over 200 patients who have passed screening and are
in the pool waiting to develop cold/flu symptoms and provide the
remaining 65 dosed patients to meet our target of 120. The trial is
expected to complete dosing in Q1 2020, with results available in
Q2 2020
-- In July 2019, a blinded data analysis showed that respiratory
viruses were having a significant impact on the COPD patients
enrolled in the trial when they got cold/flu infections, providing
an opportunity for inhaled IFN-beta to reduce symptom severity and
show clinical benefit
-- We are also engaging with different clinical teams to
evaluate the potential of IFN-beta in many other patient types who
become severely ill with these common, and normally benign,
respiratory viral infections
-- Pharmaxis, our Australian-based partner for the antifibrotic
LOXL2 inhibitor programme, continues to pursue its strategy for the
programme
Financial
-- Research and development expenditure of GBP1.69 million (30
June 2018: GBP1.38 million) as the Company advanced its clinical
trial of inhaled interferon beta for COPD patients
-- The loss from operations for the six months ended 30 June
2019 was GBP2.21 million (30 June 2018: GBP1.86 million loss)
-- Cash and bank deposits of GBP3.52 million at 30 June 2019 (30
June 2018: GBP5.31 million). In August 2019, post period-end, the
Company received its 2018 research and development tax credit of
GBP0.84 million
Richard Marsden, CEO of Synairgen, commented: "During the first
half of the year, the Company has made good progress on its inhaled
broad-spectrum antiviral candidate IFN-beta, designed to treat
viral chest infections in patients with COPD. Such infections are a
major drain on healthcare resource and represent a significant
unmet need in terms of therapeutic treatment options. We believe
IFN-beta is a highly promising, and commercially attractive,
therapeutic that could alleviate symptoms, help manage
exacerbations and reduce healthcare costs. We look forward to
completing the trial early in 2020 with results expected in
Q2."
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, Max Bullen-Smith (Corporate Finance)
Alice Lane (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 asthma and COPD, 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 currently running a two-part Phase II trial
evaluating SNG001, the Company's wholly-owned inhaled interferon
beta (IFN-beta) therapeutic candidate. The Phase II trial, called
SG015, has been designed to assess the safety of SNG001 in COPD
patients and its clinical benefit in these patients when they have
a cold or flu infection, a major driver of COPD exacerbations.
Synairgen is quoted on AIM (LSE: SNG). For more information
about Synairgen, please see www.synairgen.com
Chairman's and Chief Executive Officer's Review
OPERATING REVIEW
Summary
During the first six months of the year, the Company has made
good progress on its wholly-owned broad spectrum antiviral product
to treat viral chest infections. At 30 June 2019 we had dosed 43
patients and at the date of this report, as we enter the 2019/2020
virus season, this has increased to 55 out of the target 120
patients. Also post period-end, as announced in July, we could see
from the data that patients were having significant changes in
their symptoms due to respiratory viruses, meaning that there is a
potential for a therapeutic to show benefit. Separately,
Synairgen's partner in the LOXL2 programme, Pharmaxis, has
continued its licensing discussions during the period, which in
time could potentially yield financial benefit to Synairgen.
Inhaled IFN-beta in COPD
2019 trial activity
The Company is focussed on completing its Phase II trial of
inhaled interferon beta (IFN-beta) to prevent or treat the major
clinical problem caused by common cold and flu viruses in patients
with COPD. The trial commenced in October 2018, and in the first
half of this year the Company has seen an uplift in number of
patients being dosed, the trigger for which is that a patient tests
positive for a respiratory virus. At the end of June, 43 out of the
targeted 120 patients had been dosed, and at the date of this
report this had increased to 55. The peak season for viruses runs
from September to March and we forecast dosing will be completed in
Q1 2020, with data becoming available in Q2 2020. A "severe" winter
virus season will accelerate the dosing completion and a "mild"
winter will delay it.
During 2019, the Company has added 4 new sites to the trial and
increased the number of patients who have passed screening and are
waiting to develop cold/flu symptoms by 50%. At the date of this
report, some 400 patients have been screened and approximately 300
have passed and became eligible for dosing when they get a cold/flu
infection. Allowing for patients who have been dosed or who have
withdrawn from the study, we currently have over 200 patients
available to dose the remaining 65 patients as we enter the cold
virus season. The pool of patients has been enlarged to mitigate
against the risk of a repeat of the last winter, where an unusually
low number of circulating viruses (reported by Public Health
England) led to fewer patients being dosed, particularly during the
2018 Autumn, than we had originally forecast.
Review of blinded trial COPD symptom data
We conduct a continuous quality control process to check the
integrity of the data as it is received. We do this in a blinded
fashion i.e. without disclosure of which patients are on placebo
and which patients are on active treatment.
Post period-end, as announced in July, a review of the blinded
patient symptom data using the Breathlessness Cough and Sputum
Score (BCSS score) for the first 40 patients showed that the
patients in the trial are being adversely affected by the viruses.
A change in the BCSS score of 1 or more is considered to be
clinically relevant.(1) As we are seeing an average increase in
BCSS score of more than 2, there is clearly an opportunity for
inhaled IFN-beta to reduce symptom severity and show clinical
benefit.
The clinical problem
Exacerbations of COPD are a major drain on healthcare resource,
and are the second most common cause of unplanned hospital
admission in England.(2) The peak for these admissions coincides
with the virus season. Viruses are implicated in 40% of
exacerbations,(3) with bacteria being the other major cause.
Patients are currently treated with oral steroids and antibiotics.
They will frequently receive antibiotics even if the cause is
suspected to be viral; this is because viral infections often
precipitate a bacterial chest infection. There is a serious gap in
the therapeutic options available to combat these severe lung
infections. A successful product would alleviate symptoms, prevent
exacerbations, reduce healthcare resource utilisation and reduce
antibiotic prescribing. The directors believe that such a product
could be very successful with annual revenues exceeding $1 billion,
just for COPD, with further potential in other patient groups where
these normally benign viruses cause serious illness.
Inhaled IFN-beta development
IFN-beta is a critical, naturally-occurring protein produced by
cells early in the infection cycle. IFN-beta orchestrates the
body's antiviral defences until the body develops antibodies to
eventually clear the virus. It can take a couple of weeks to mount
an effective antibody response. In this time, if defences are
compromised by disease, or if an organ, such as the lung in the
case of COPD, is affected by disease, then the impact of the virus
can be very severe. IFN-beta protects COPD cells from viral
infection, and in the context of a viral chest infection we believe
IFN-beta will help fight the infection and protect as yet
uninfected cells and regions of the lungs. There are hundreds of
respiratory viruses that can cause exacerbations of COPD. IFN-beta,
because it stimulates many different intra and extra cellular
antiviral pathways, has been shown to be effective in tests against
all of the cold and flu viruses that we have encountered in the
trial thus far, namely: rhinovirus; influenza; RSV; coronavirus;
and parainfluenza.
In the trial, patients wait in a 'pool' receiving daily text
messages to record symptoms. When a patient has a change in
symptoms, he or she contacts the trial site and is tested for the
presence of a respiratory virus. In past trials only half to two
thirds of patients had confirmed viral infections compromising
interpretation of the data. The novel technology being used in this
trial enables us to confirm the presence of a respiratory virus
within one hour. The obvious benefit is that the data set will not
be diluted by patients who did not have a respiratory viral
infection and who could not benefit from treatment. This is
particularly important in COPD where exacerbations can be caused by
bacterial infections. Virus-positive patients receive either
placebo or IFN-beta for two weeks. We will analyse the drug's
effects on COPD symptoms, lung function, virus load, exacerbations,
and safety. We will also assess biomarkers of inflammation and
antiviral activity with a view to identifying prognostic markers
that would help in the selection of patients for follow-on clinical
trials.
Future progression and Business Development
The current trial of inhaled IFN-beta paves the way for a Phase
IIb trial in COPD patients, and our plan is to partner to be able
to conduct this trial. We have an ongoing dialogue with several of
the largest pharmaceutical companies who, due to the magnitude of
the opportunity, are keen to review the data from this trial.
Other opportunities for an inhaled broad spectrum antiviral
Beyond COPD, we recognise that inhaled IFN-beta could help many
other different patient types who succumb to these common, and
usually benign, respiratory viral infections. Such patient groups
include:
-- Acute admissions due to respiratory viral infections.
Vulnerable groups include: diabetic patients, the elderly, and
patients with other lung conditions e.g. cystic fibrosis,
bronchiectasis;
-- Paediatric patients with severe breathing difficulties/wheeze
e.g. bronchiolitis, as well as premature infants with persistent
viral infection;
-- Some immunocompromised patient populations undergoing
oncology treatment regimens who can have difficulty clearing
respiratory viral infections; and
-- Some rarer genetic conditions where patients fail to mount an
adequate antiviral response may also derive benefit from inhaled
IFN-beta.
We are currently engaging with the different clinical teams
across the UK who focus on these different patient groups to assess
the clinical problem caused by viruses and to map a route into the
clinic. All of these indications, including the niche ones, are of
great interest to potential pharmaceutical partners.
LOXL2 Programme
Pharmaxis, our Australian-based partner for the antifibrotic
LOXL2 inhibitor programme, has updated the market (on 25 July 2019)
stating that they continue to be in licensing discussions.
Synairgen will receive circa 17% of Pharmaxis' licence
receipts/royalties, net of allowable expenses.
Board changes
In April 2019, Paul Clegg announced his intention to retire from
the Board as a non-executive director after the 2019 AGM in June.
We thank Paul for his significant contribution and advice to
Synairgen over the last 10 years and for his Chairmanship of the
Remuneration and Nomination Committee. Iain Buchanan became the new
Chairman of the Remuneration and Nomination Committee.
FINANCIAL REVIEW
With effect from 1 January 2019, the Group has adopted IFRS 16
(Leases). The adoption of this standard has had no financial impact
on either the current or comparative periods. Please refer to Note
1 for further details.
Statement of Comprehensive Income
The loss from operations for the six months ended 30 June 2019
was GBP2.21 million (six months ended 30 June 2018: GBP1.86 million
loss, year ended 31 December 2018: GBP4.13 million loss). Research
and development expenditure increased from GBP1.38 million in the
six months ended 30 June 2018 to GBP1.69 million for the six months
ended 30 June 2019 as the Group advanced the Phase II study in
COPD. Other administrative costs for the period of GBP0.52 million
were in line with the comparative period (six months ended 30 June
2018: GBP0.51 million).
The research and development tax credit increased from GBP0.33
million to GBP0.42 million. The 2019 credit of GBP0.42 million
comprises a current period credit of GBP0.37 million and a prior
period adjustment of GBP0.05 million. The increase from GBP0.33
million to GBP0.37 million is explained by the increased R&D
expenditure.
The loss after tax for the period was GBP1.77 million (six
months ended 30 June 2018: GBP1.52 million loss) and the basic loss
per share was 1.62p (six months ended 30 June 2018: loss of
1.66p).
Statement of Financial Position and cash flows
At 30 June 2019, net assets amounted to GBP4.30 million (30 June
2018: GBP5.09 million, 31 December 2018: GBP6.03 million),
including net funds (comprising cash balances and bank deposits) of
GBP3.52 million (30 June 2018: GBP5.31 million, 31 December 2018:
GBP5.33 million).
The principal elements of the GBP1.81 million decrease in net
funds over the six months ended 30 June 2019 (six months ended 30
June 2018: GBP1.54 million decrease, year ended 31 December 2018:
GBP1.51 million decrease) were:
-- Cash used in operations of GBP1.83 million (six months ended
30 June 2018: GBP1.55 million outflow; year ended 31 December 2018:
GBP3.89 million outflow);
-- Research and development tax credits received of GBPnil (six
months ended 30 June 2018: GBPnil; year ended 31 December 2018:
GBP0.07 million);
-- Capital expenditure of GBPnil (six months ended 30 June 2018:
GBP0.01 million; year ended 31 December 2018: GBP0.39 million)
-- Net proceeds from fundraising of GBPnil (six months ended 30
June 2018: GBPnil; year ended 31 December 2018: GBP2.67
million)
The Group received its 2018 research and development tax credit
of GBP0.84 million post period-end in August 2019.
Going concern
The directors have prepared detailed 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 balanced and prudent view in preparing
these forecasts, recognising the intrinsic variability in the
timing and costs of the SG015 Phase II clinical trial. This
variability is primarily a function of the inherent
unpredictability of the severity and timing of the winter
virus/cold season, which is a key factor in determining how quickly
sufficient patients will be dosed to achieve a statistically
meaningful result.
In common with many other similar biotechnology companies
Synairgen relies on equity financing at key milestone events during
the development of its programmes. Currently Synairgen does not
hold 12 months' cash resources from the date of this report to
September 2020. With our current estimate of the expected SG015
patient dosing pattern to reach 120 dosed patients, the directors
consider that the Group has adequate cash resources to complete the
clinical trial. The directors remain confident that in the event
that the trial timeline moves back or when the Group needs
additional resources to commercialise the results of the trial, it
will be able to secure such additional finance.
The directors believe that it remains appropriate to prepare the
financial statements on a going concern basis. Because, as at the
date of approval of these consolidated interim results, any
additional finance that may result from future equity funding has
neither been sought, nor committed, our ability to raise such
finance represents a material uncertainty as to the Group's ability
to continue as a going concern.
OUTLOOK
Synairgen has been preparing for a busy winter, and is well
poised to complete its Phase II clinical trial. We have increased
the number of sites in the trial and increased the number of
patients waiting to catch a cold, and commence treatment. We
anticipate that the final patients will be dosed in Q1 2020, with
data available in Q2. Potential partners for the programme await
positive data and we look forward to providing updates to the
market on our progress on all fronts.
Simon Shaw Richard Marsden
Chairman Chief Executive Officer
27 September 2019
References
1. Leidy NK et al. The breathlessness, cough and sputum scale:
the development of empirically based guidelines for interpretation.
Chest 2003 Dec; 124)6):2182-91
2. Department of Health. An Outcomes Strategy for Chronic
Obstructive Pulmonary Disease (COPD) and Asthma in England.
Published July 2011
3. Wilkinson TMA et al. A prospective, observational cohort
study of the seasonal dynamics airway pathogens in the aetiology of
exacerbations in COPD. Thorax 2017;0;1-9. Doi:
10.1136/thoraxjnl=2016-209023
Consolidated Statement of Comprehensive Income
for the six months ended 30 June 2019
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2019 2018 2018
Notes GBP000 GBP000 GBP000
Revenue - 26 105
Research and development expenditure (1,686) (1,384) (3,232)
Other administrative expenses (520) (506) (1,005)
--------------------------------------- -------- ------------ ------------ ------------
Total administrative expenses (2,206) (1,890) (4,237)
Loss from operations (2,206) (1,864) (4,132)
Finance income 17 18 36
Loss before tax (2,189) (1,846) (4,096)
Tax credit 2 417 329 795
--------------------------------------- -------- ------------ ------------ ------------
Loss and total comprehensive
loss for the period (1,772) (1,517) (3,301)
--------------------------------------- -------- ------------ ------------ ------------
Loss per ordinary share 3
Basic and diluted loss per ordinary
share (pence) (1.62)p (1.66)p (3.47)p
------------------------------------------------- ------------ ------------ ----------
Consolidated Statement of Changes in Equity (unaudited)
for the six months ended 30 June 2019
Share Share Merger Retained
capital premium reserve Deficit Total
GBP000 GBP000 GBP000 GBP000 GBP000
At 1 January 2018 914 25,771 483 (20,609) 6,559
Recognition of share-based
payments - - - 45 45
Total comprehensive
loss for the period - - - (1,517) (1,517)
At 30 June 2018 914 25,771 483 (22,081) 5,087
Issue of ordinary
shares 180 2,700 - - 2,880
Transaction costs
in respect of share
issue - (209) - - (209)
Recognition of share-based
payments - - - 53 53
Total comprehensive
loss for the period - - - (1,784) (1,784)
At 31 December 2018 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
---------------------------- --------- --------- --------- --------- --------
Consolidated Statement of Financial Position
as at 30 June 2019
Unaudited Unaudited Audited
30 30 31
June June December
2019 2018 2018
Notes GBP000 GBP000 GBP000
Assets
Non-current assets
Intangible assets 22 37 29
Property, plant and equipment 333 15 374
----------------------------------- ------ ---------- ---------- ----------
355 52 403
----------------------------------- ------ ---------- ---------- ----------
Current assets
Inventories 42 56 56
Current tax receivable 1,212 400 795
Trade and other receivables 162 199 216
Other financial assets -
bank deposits 4 - 1,250 50
Cash and cash equivalents 3,520 4,056 5,284
----------------------------------- ------ ---------- ---------- ----------
4,936 5,961 6,401
----------------------------------- ------ ---------- ---------- ----------
Total assets 5,291 6,013 6,804
----------------------------------- ------ ---------- ---------- ----------
Liabilities
Current liabilities
Trade and other payables (988) (926) (777)
----------------------------------- ------ ---------- ---------- ----------
Total liabilities (988) (926) (777)
----------------------------------- ------ ---------- ---------- ----------
Total net assets 4,303 5,087 6,027
----------------------------------- ------ ---------- ---------- ----------
Equity
Capital and reserves attributable
to equity holders of the
parent
Share capital 1,094 914 1,094
Share premium 28,262 25,771 28,262
Merger reserve 483 483 483
Retained deficit (25,536) (22,081) (23,812)
----------------------------------- ------ ---------- ---------- ----------
Total equity 4,303 5,087 6,027
----------------------------------- ------ ---------- ---------- ----------
Consolidated Statement of Cash Flows
for the six months ended 30 June 2019
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2019 2018 2018
GBP000 GBP000 GBP000
Cash flows from operating
activities
Loss before tax (2,189) (1,846) (4,096)
Adjustments for:
Finance income (17) (18) (36)
Depreciation 41 3 24
Amortisation 7 8 16
Share-based payment charge 48 45 98
Cash flows from operations
before changes in working
capital (2,110) (1,808) (3,994)
Decrease in inventories 14 - -
Decrease in trade and other
receivables 54 440 426
Increase/(Decrease) in trade
and other payables 211 (177) (326)
----------------------------------- ------------ ------------ ----------
Cash used in operations (1,831) (1,545) (3,894)
Tax credit received - - 71
----------------------------------- ------------ ------------ ----------
Net cash used in operating
activities (1,831) (1,545) (3,823)
----------------------------------- ------------ ------------ ----------
Cash flows from investing
activities
Interest received 17 12 27
Purchase of property, plant
and equipment - (6) (386)
Decrease in other financial
assets 50 750 1,950
----------------------------------- ------------ ------------ ----------
Net cash generated from investing
activities 67 756 1,591
----------------------------------- ------------ ------------ ----------
Cash flows from financing
activities
Proceeds from issuance of
ordinary shares - - 2,880
Transaction costs in respect
of share issues - - (209)
----------------------------------- ------------ ------------ ----------
Net cash generated from financing
activities - - 2,671
----------------------------------- ------------ ------------ ----------
(Decrease)/Increase in cash
and cash equivalents (1,764) (789) 439
Cash and cash equivalents
at beginning of period 5,284 4,845 4,845
----------------------------------- ------------ ------------ ----------
Cash and cash equivalents
at end of period 3,520 4,056 5,284
----------------------------------- ------------ ------------ ----------
Notes to the Interim Financial Information
for the six months ended 30 June 2019
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 2019 and in accordance with
recognition and measurement principles of International Financial
Reporting Standards (IFRSs) as endorsed by the European Union. With
the exception of the adoption of IFRS 16, further detail on which
is given below, 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
2018.
The interim financial information does not include all of the
information required for full annual financial statements and does
not comply with all the disclosures in IAS 34 'Interim Financial
Reporting'.
Adoption of new standards
IFRS 16 Leases
IFRS 16 introduces significant changes to lessee accounting by
removing the distinction between operating and finance leases,
requiring the recognition of a right-of-use asset and a lease
liability at commencement for all leases, except for short-term
leases and leases of low value assets. The Group adopted IFRS 16
Leases on 1 January 2019 by applying the modified retrospective
approach. At 1 January 2019 the Group had one lease with the
University of Southampton for property and equipment, which ended
on 31 July 2019, without an extension option. As permitted by the
practical expedients on transition to IFRS 16, the Group has made
use of the recognition exemption for short-term leases (less than
12 months of lease term from the date of initial application) and
has continued to recognise the lease costs of a straight line basis
over the remaining term of the lease.
Subsequent to the period-end, a new two year lease has been
signed effective from 1 August 2019, with annual lease commitments
of GBP168,000. In the year-end financial statements the Group will
recognise a right-of-use asset and lease liability for the present
value of these payments.
Financial information
The financial information for the year ended 31 December 2018
does not constitute the full statutory accounts for that period.
The Annual Report and Financial Statements for the year ended 31
December 2018 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 2018 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 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 balanced and prudent view in preparing
these forecasts, recognising the intrinsic variability in the
timing and costs of the SG015 Phase II clinical trial. This
variability is primarily a function of the inherent
unpredictability of the severity and timing of the winter
virus/cold season, which is a key factor in determining how quickly
sufficient patients will be dosed to achieve a statistically
meaningful result.
In common with many other similar biotechnology companies
Synairgen relies on equity financing at key milestone events during
the development of its programmes. Currently Synairgen does not
hold 12 months' cash resources from the date of this report to
September 2020. With our current estimate of the expected SG015
patient dosing pattern to reach 120 dosed patients, the directors
consider that the Group has adequate cash resources to complete the
clinical trial. The directors remain confident that in the event
that the trial timeline moves back or when the Group needs
additional resources to commercialise the results of the trial, it
will be able to secure such additional finance.
Notes to the Interim Financial Information
for the six months ended 30 June 2019 (continued)
1. Basis of preparation (continued)
The directors believe that it remains appropriate to prepare the
financial statements on a going concern basis. Because, as at the
date of approval of these consolidated interim results, any
additional finance that may result from future equity funding has
neither been sought, nor committed, our ability to raise such
finance represents a material uncertainty as to the Group's ability
to continue as a going concern.
These consolidated interim financial statements do not include
the adjustments that would arise if the Group was unable to
continue as a going concern. Should the Group be unable to obtain
funding such that the going concern basis of preparation was no
longer appropriate, adjustments would be required which would
include adjusting the balance sheet value of assets to their
recoverable amounts and to provide for further liabilities that
might arise.
Approval of financial information
The 30 June 2019 interim financial information was approved by a
duly appointed and authorised committee of the Board of Directors
on 27 September 2019.
2. Tax credit
The tax credit of GBP417,000 (six months ended 30 June 2018:
GBP329,000; year ended 31 December 2018: GBP795,000) comprises an
estimate of the research and development tax credit receivable in
respect of the current period of GBP374,000 and a prior period
adjustment of GBP43,000 in respect of 2018.
GBP838,000 was received in August 2019 in respect of the 2018
research and development tax credit.
3. Loss per ordinary share
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2019 2018 2018
Loss attributable to equity
holders of the Company (GBP000) (1,772) (1,517) (3,301)
Weighted average number of
ordinary shares in issue 109,433,442 91,399,072 95,262,984
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 2019 there were 8,737,515
options outstanding (30 June 2018: 7,281,348 options outstanding;
31 December 2018: 6,087,819 options outstanding).
4. Other financial assets
Other financial assets comprise Sterling fixed rate bank
deposits of greater than three months' maturity at the time of
deposit.
INDEPENT 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
2019 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 4.
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.
Material uncertainty related to going concern
We draw attention to Note 1 to the interim financial
information, which indicates that the Group and Parent Company are
likely to require further funding in order to meet their
obligations as they fall due across the 12 months to 30 September
2020, which is yet to be agreed. As stated in Note 1, these events
or conditions indicate that a material uncertainty exists that may
cast significant doubt on the Group and Parent Company's ability to
continue as a going concern. Our opinion is not modified in this
respect.
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 2019 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 17 August 2018 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
27 September 2019
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 or visit www.rns.com.
END
IR EAFNNAFENEAF
(END) Dow Jones Newswires
September 30, 2019 02:02 ET (06:02 GMT)
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