TIDMSNG
RNS Number : 1345N
Synairgen plc
21 September 2023
Synairgen plc
('Synairgen' or the 'Company')
Interim results for the six months ended 30 June 2023
Southampton, UK - 21 September 2023: Synairgen plc (LSE: SNG),
the respiratory company developing SNG001, an investigational
formulation for inhalation containing the immunomodulatory
broad-spectrum antiviral protein interferon beta, today announces
its unaudited interim results for the six months ended 30 June
2023.
Highlights (including post period-end)
Operational
-- Progressing the Company's patient identification strategy
through biomarker and existing clinical data analysis. This will
enable the Company to identify patients at higher risk of disease
progression, including those with deficient innate immune response
and/or high viral load, who might therefore be more likely to
respond to SNG001 in future clinical studies.
-- Conducting non-interventional preparatory work to expand
hospitalised patient populations for potential treatment with
SNG001, which are likely to include: ventilated patients with
confirmed viral pneumonia; and patients who are unable to clear
virus and become persistent viral "shedders", a majority of whom
are immunocompromised. Subject to this preparatory work and
regulatory approval timelines, trials are anticipated to start in
H1 2024.
-- Insights from non-interventional studies and the substantial
body of evidence gathered to date from previous clinical trials
will inform a robust clinical programme for the development of
SNG001.
Financial
-- Cash and deposit balances of GBP14.6 million at 30 June 2023
(30 June 2022: GBP18.0 million; 31 December 2022: GBP19.7 million).
Post period-end receipt of FY 2022 research and development tax
credit of GBP2.4 million.
-- Loss before tax for the six months ended 30 June 2023 was
GBP5.2 million (30 June 2022: GBP14.0 million loss).
o Research and development expenditure for the six months ended
30 June 2023 was GBP3.5 million (30 June 2022: GBP11.1 million) as
expenditure on the Phase 3 SPRINTER trial, substantially completed
in 2022, decreased and manufacturing activities reduced.
o Administrative expenses for the six months ended 30 June 2023
were GBP2.1 million (30 June 2022: GBP2.9 million), with the
reduction being attributable to the pre-commercialisation
activities incurred in 2022.
Richard Marsden, CEO of Synairgen, said: "We are focused on
progressing our method of identifying those individuals most likely
to respond to SNG001 treatment using the large body of data already
gathered through previous trials and new non-interventional
research, which is currently underway. We hope to maximise the
benefits of treatment with SNG001 by targeting patients most likely
to respond to treatment by applying both existing and new
technologies for patient selection in our next trials of SNG001.
This will enable us to focus on the most appropriate patients which
will ultimately lead to trials of SNG001 in more targeted, but
still large, patient populations at high risk of severe
outcomes."
The information contained within this announcement is deemed to
constitute inside information as stipulated under the retained EU
law version of the Market Abuse Regulation (EU) No. 596/2014 (the
"UK MAR") which is part of UK law by virtue of the European Union
(Withdrawal) Act 2018. The information is disclosed in accordance
with the Company's obligations under Article 17 of the UK MAR. Upon
the publication of this announcement, this inside information is
now considered to be in the public domain.
For further enquiries, please contact:
Synairgen plc
Media@synairgen.com
Tel: + 44 (0) 23 8051 2800
Cavendish Capital Markets Limited (NOMAD and Joint Broker)
Geoff Nash, Charlie Beeson (Corporate Finance)
Sunila de Silva (ECM)
Tel: + 44 (0) 20 7220 0500
Numis Securities Limited (Joint Broker)
Freddie Barnfield, Duncan Monteith, Euan Brown
Tel: + 44 (0) 20 7260 1000
ICR Consilium (Financial Media and Investor Relations)
Mary-Jane Elliott, Namrata Taak, Lucy Featherstone
Synairgen@consilium-comms.com
Tel: +44 (0) 20 3709 5700
Notes for Editors
Synairgen is a UK-based respiratory company focused on drug
discovery and the development of SNG001 (inhaled interferon beta)
as potentially the first host-targeted, broad-spectrum antiviral
treatment delivered directly into the lungs for severe viral lung
infections.
Millions of people globally are hospitalised every year due to
viral lung infections and there are currently no approved antiviral
therapies for the majority of these patients. Synairgen is
developing SNG001 to address this need.
Synairgen is quoted on AIM (LSE: SNG). For more information
about Synairgen, please see www.synairgen.com .
OPERATIONAL REVIEW
Synairgen is progressing with vital foundational work in
readiness to commence further clinical trials of SNG001 as a broad
spectrum antiviral treatment. This work is based on key learnings
from the COVID-19 pandemic, which have accelerated the development
of new approaches including the broader application of key virus
testing in hospitals for symptomatic patients and the advancement
of technologies that increase understanding of how respiratory
viruses impact the individual, particularly immune system function,
using blood and airway fluid samples.
Before commencing further trials of SNG001, and taking into
account our helpful learnings from previous studies, Synairgen is
developing a patient identification strategy applying existing and
new technologies and biomarkers to identify patients whose disease
is being actively driven by virus (high virus load) and/or who are
struggling to mount an effective antiviral response (deficient
innate immune response). The Company believes that these patients
are most likely to demonstrate a response to SNG001, with potential
benefits in respect of future trial size, duration and costings. By
using Synairgen's proposed targeted approach to patient
identification the Company is able to better design studies with
fewer subjects and thus reduce cost and timings for its drug
development.
A study led by the Universities of Southampton and Leicester,
involving over 300 adults hospitalised with viral acute respiratory
illness, reported that higher viral loads were associated with a
prolonged length of stay in the hospital. This suggests that viral
load measured at the point of hospital admission could be used in
clinical trials, and potentially in clinical practice, to predict
those at risk of extended hospitalisation.(1) Building upon this,
Synairgen is exploring the relationship between virus load and
other risk factors which predict poor outcome in hospitalised
patients to inform the development of SNG001 in the hospital
setting.
In addition, the Company is expanding the populations of
interest to include mechanically ventilated patients in ICU with
confirmed viral pneumonia and patients unable to clear virus and
become persistent virus shedders, the majority of whom are
immunocompromised.
The overall patient identification approach should lead to
trials of SNG001 in more targeted, but still large, patient
populations at high risk of deterioration/progression to severe
outcomes.
In the first half of 2023, Synairgen continued this foundational
work to determine the most relevant trials to support its goals.
With respiratory viral infections being responsible for upwards of
three million hospitalisations in the US each year(2) the Company
remains committed to address this significant unmet need. Despite
the great need, there are few therapeutics available to treat the
range of viruses that cause these hospitalisations.
Additionally, Synairgen continued to share findings from its
trials of SNG001 in COVID-19 patients, including at the American
Thoracic Society 2023 conference in May and, post-period end, at
the European Respiratory Society 2023 congress in September. These
conferences are an extremely valuable way to build the Company's
network and showcase the need for a broad-spectrum antiviral.
In summary, Synairgen is continuing to work at pace, partnering
with high quality researchers and collaborators, to ensure it has
the right trial designs, equipped with the right diagnostic tools,
to be able to identify trial participants potentially most likely
to benefit from a broad-spectrum antiviral and SNG001. This work
(including biomarker assessments), together with the substantial
body of evidence gathered from clinical trials with SNG001 to date,
will inform a robust clinical development programme for SNG001. It
is the Company's goal to commence trials as soon as possible,
subject to approval timelines, and within H1 2024.
FINANCIAL REVIEW
Statement of Comprehensive Income
The loss from operations for the six months ended 30 June 2023
(H1 2023) was GBP5.5 million (six months ended 30 June 2022 (H1
2022): GBP14.0 million loss; year ended 31 December 2022 (FY 2022):
GBP20.3 million loss) with research and development expenditure
amounting to GBP3.5 million (H1 2022: GBP11.1 million; FY 2022:
GBP14.9 million) and other administrative expenses GBP2.1 million
(H1 2022: GBP2.9 million; FY 2022: GBP5.4 million).
The reduction in research and development expenditure from
GBP11.1 million to GBP3.5 million is attributable to the lower
expenditure on the Phase 3 SPRINTER trial, which was substantially
completed in 2022, and reduced manufacturing activities.
Other administrative expenditure decreased from GBP2.9 million
in H1 2022 to GBP2.1 million in H1 2023 on account of
pre-commercialisation activities incurred in 2022.
The research and development tax credit decreased from GBP1.6
million in H1 2022 to GBP0.5 million in H1 2023 on account of the
reduced qualifying expenditure and the reduction in the small or
medium enterprises (SME) R&D scheme rates effective as of 1
April 2023.
The loss after tax for H1 2023 was GBP4.7 million (H1 2022:
GBP12.4 million; FY 2022: GBP17.6 million) and the basic loss per
share was 2.36p (H1 2022: 6.16p loss; FY 2022: 8.76p loss).
Statement of Financial Position and Cash Flows
At 30 June 2023, net assets amounted to GBP16.0 million (30 June
2022: GBP24.9 million; 31 December 2022: GBP20.3 million),
including cash and deposit balances of GBP14.6 million (30 June
2022: GBP18.0 million; 31 December 2022: GBP19.7 million). Post
period-end, in August 2023, the tax credit of GBP2.4 million in
respect of FY 2022 was received.
The principal elements of the GBP5.1 million reduction in cash
and deposit balances during H1 2023 (H1 2022: GBP15.8 million
reduction; FY 2022: GBP14.2 million reduction) were:
-- Cash used in operations GBP5.3 million (H1 2022: GBP15.8
million outflow; FY 2022: GBP23.4 million outflow);
-- Research and development tax credits received of GBPnil (H1
2022: GBPnil; FY 2022: GBP9.1 million); and
-- Interest received GBP0.3 million (H1 2022: GBPnil; FY 2022: GBP0.1 million).
The other significant changes in the statement of financial
position were:
-- Current tax receivable: 30 June 2023: GBP2.9 million; 30 June
2022: GBP10.6 million; 31 December 2022: GBP2.4 million on account
of the lower research and development tax credit receivable. As
noted above, the 2022 tax credit of GBP2.4 million was received in
August 2023.
-- Trade and other payables: 30 June 2023: GBP2.7 million; 30
June 2022: GBP4.6 million; 31 December 2022: GBP3.3 million, in
line with the reduction in the level of operating expenditure.
The Company's cash resources are sufficient to cover its plans
to design and establish data from an observational study and two
investigator-led/Synairgen-sponsored Phase 2 clinical trials,
including manufacture of active and placebo for use in these
trials. Regardless of the outcome of these activities, which are
uncertain, the Company's available resources are sufficient to
cover existing committed costs and the estimated costs of these
activities until at least 30 September 2024, 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.
Change of Name of Nominated Adviser and Joint Broker
The Company also announces that its Nominated Adviser and Joint
Broker has changed its name to Cavendish Capital Markets Limited
following completion of its own corporate merger.
References
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7112535/
2 IQVIA market research Q4 2022; Sources. US CDC, HCUP, IQVIA
Claims Data, PubMed; data on file
Consolidated Statement of Comprehensive Income
for the 6 months ended 30 June 2023
Unaudited Unaudited Audited
Six months Six months
ended 30 ended 30 Year
June June ended 31
2023 2022 December
2022
Notes GBP000 GBP000 GBP000
Research and development expenditure (3,463) (11,106) (14,936)
Other administrative expenses (2,051) (2,903) (5,364)
Total administrative expenses
and loss from operations (5,514) (14,009) (20,300)
Finance income 300 24 207
Loss before tax (5,214) (13,985) (20,093)
Tax credit 2 466 1,579 2,448
Loss and total comprehensive
loss for the period (4,748) (12,406) (17,645)
-------------------------------------- ---------- ------------ ------------ ----------
Loss per ordinary share 3
Basic and diluted loss per ordinary
share (pence) (2.36)p (6.16)p (8.76)p
-------------------------------------------------- ------------ ------------ ----------
Consolidated Statement of Changes in Equity
for the 6 months ended 30 June 2023
Share Share Merger Retained
Capital premium reserve deficit Total
GBP000 GBP000 GBP000 GBP000 GBP000
At 1 January 2022 2,013 125,245 483 (90,741) 37,000
------------------------------ --------- --------- --------- ---------- ---------
Loss and total comprehensive
loss for the period - - - (12,406) (12,406)
------------------------------ --------- --------- --------- ---------- ---------
Transactions with
equity holders of
the Group
Issue of ordinary
shares 1 - - - 1
Recognition of share-based
payments - - - 323 323
------------------------------ --------- --------- --------- ---------- ---------
1 - - 323 324
------------------------------ --------- --------- --------- ---------- ---------
At 30 June 2022 2,014 125,245 483 (102,824) 24,918
------------------------------ --------- --------- --------- ---------- ---------
Loss and total comprehensive
loss for the period - - - (5,239) (5,239)
Transactions with
equity holders of
the Group
Recognition of share-based
payments - - - 596 596
At 31 December 2022 2,014 125,245 483 (107,467) 20,275
------------------------------ --------- --------- --------- ---------- ---------
Loss and total comprehensive
loss for the period - - - (4,748) (4,748)
Transactions with
equity holders of
the Group
Recognition of share-based
payments - - - 437 437
At 30 June 2023 2,014 125,245 483 (111,778) 15,964
------------------------------ --------- --------- --------- ---------- ---------
Consolidated Statement of Financial Position
as at 30 June 2023
Unaudited Unaudited Audited
30 30 31
June June December
2023 2022 2022
GBP000 GBP000 GBP000
Assets
Non-current assets
Intangible assets 92 48 44
Property, plant and equipment 42 130 86
134 178 130
------ --------------- ------------ ----------
Current assets
Current tax receivable 2,881 10,634 2,415
Trade and other receivables 1,060 710 1,308
Other financial assets -
bank deposits 4,000 - 3,750
Cash and cash equivalents 10,631 18,022 15,926
------------------------------------------ --------------- ------------ ----------
18,572 29,366 23,399
------ --------------- ------------ ----------
Total assets 18,706 29,544 23,529
------------------------------------------ --------------- ------------ ----------
Liabilities
Current liabilities
Trade and other payables (2,742) (4,626) (3,254)
Total liabilities (2,742) (4,626) (3,254)
------------------------------------------ --------------- ------------ ----------
Total net assets 15,964 24,918 20,275
------------------------------------------ --------------- ------------ ----------
Equity
Capital and reserves attributable
to equity holders of the
parent
Share capital 2,014 2,014 2,014
Share premium 125,245 125,245 125,245
Merger reserve 483 483 483
Retained deficit (111,778) (102,824) (107,467)
------------------------------------------ --------------- ------------ ----------
Total equity 15,964 24,918 20,275
------------------------------------------ --------------- ------------ ----------
Consolidated Statement of Cash Flows
for the 6 months ended 30 June 2023
Unaudited Unaudited Audited
Six months Six months Year
ended 30 ended 30 ended 31
June June December
2023 2022 2022
GBP000 GBP000 GBP000
Cash flows from operating
activities
Loss before tax (5,214) (13,985) (20,093)
Adjustments for:
Finance income (300) (24) (207)
Depreciation of property, plant
& equipment 45 47 93
Amortisation 5 5 9
Share-based payment charge 437 323 919
Cash flows from operations before
changes in working capital (5,027) (13,634) (19,279)
Decrease in trade and other receivables 242 825 289
Decrease in trade and other payables (512) (3,012) (4,384)
----------------------------------------------- -------------- -------------- ------------
Cash used in operations (5,297) (15,821) (23,374)
Tax credit received - - 9,088
----------------------------------------------- -------------- -------------- ------------
Net cash used in operating activities (5,297) (15,821) (14,286)
----------------------------------------------- -------------- -------------- ------------
Cash flows from investing activities
Interest received 307 19 140
Purchase of intangible assets (54) - -
Purchase of property, plant and
equipment (1) (4) (6)
Other financial assets - bank deposits
New deposits (4,000) - (3,750)
Deposit maturities 3,750 - -
Net cash generated from/(used
in) investing activities 2 15 (3,616)
----------------------------------------------- -------------- -------------- ------------
Cash flows from financing activities
Proceeds from issuance of ordinary
shares - 1 1
Net cash generated from financing
activities - 1 1
----------------------------------------------- -------------- -------------- ------------
Decrease in cash and cash equivalents (5,295) (15,805) (17,901)
Cash and cash equivalents at beginning
of period 15,926 33,827 33,827
----------------------------------------------- -------------- -------------- ------------
Cash and cash equivalents at end
of period 10,631 18,022 15,926
----------------------------------------------- -------------- -------------- ------------
Notes to the Interim Financial Information
for the six months ended 30 June 2023
1. Basis of preparation
Basis of accounting
The condensed financial statements have been prepared using
accounting policies consistent with international accounting
standards. While the financial figures included in this half-yearly
report have been computed in accordance with international
accounting standards applicable to interim periods, this
half-yearly report does not contain sufficient information to
constitute an interim financial report as that term is defined in
IAS 34. They do not include all disclosures that would otherwise be
required in a complete set of financial statements and should be
read in conjunction with the 31 December 2022 Annual Report. The
financial information for the half years ended 30 June 2023 and 30
June 2022 does not constitute full financial statements and both
periods are unaudited.
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 2022 and those
expected to apply for the financial year to 31 December 2023. The
Group has not early adopted any standard, interpretation or
amendment that has been issued but is not yet effective.
Financial information
The financial information for the year ended 31 December 2022
does not constitute the full statutory accounts for that period.
The Annual Report and Financial Statements for the year ended 31
December 2022 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 2022 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 Company over the period to 30
September 2024, 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 taken a prudent view in preparing these
forecasts.
The Company's available resources at the date of this report are
sufficient to cover the Company's plans to design and establish
data from an observational study and two
investigator-led/Synairgen-sponsored Phase 2 clinical trials,
including manufacture of active and placebo for use in these
trials. Regardless of the outcome of these activities, which are
uncertain, the Company's available resources are sufficient to
cover existing committed costs and the estimated costs of these
activities until at least 30 September 2024.
Notes to the Interim Financial Information
for the six months ended 30 June 2023 (continued)
1. Basis of preparation (continued)
Going concern (continued)
After due consideration of these forecasts and current cash
resources, the directors consider that the Company 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 2023 interim financial information was approved by a
committee of the Board of Directors on 20 September 2023.
2. Tax credit
The tax credit of GBP466,000 (six months ended 30 June 2022:
GBP1,579,000; year ended 31 December 2022: GBP2,448,000) comprises
an estimate of the research and development tax credit receivable
in respect of the current period.
The deferred tax assets have not been recognised as there is
uncertainty regarding when suitable future pro ts against which to
offset the accumulated tax losses will arise. There is no
expiration date for the accumulated tax losses.
3. Loss per ordinary share
Unaudited Unaudited Audited
Six months Six months Year
ended ended ended
30 30 31
June June December
2023 2022 2022
Loss attributable to
equity holders of the
Company (GBP000) (4,748) (12,406) (17,645)
Weighted average number
of ordinary shares in
issue (000) 201,345 201,345 201,360
Basic and diluted loss
per share (pence) (2.36) (6.16) (8.76)
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 2023 there were 18,119,156
options outstanding (30 June 2022: 8,477,640 options outstanding;
31 December 2022: 14,450,882 options outstanding).
INDEPENT REVIEW REPORT TO SYNAIRGEN PLC
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 2023 is not prepared, in all material respects, in accordance
with the London Stock Exchange AIM Rules for Companies.
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 2023 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.
Basis for conclusion
We conducted our review in accordance with International
Standard on Review Engagements (UK) 2410, "Review of Interim
Financial Information Performed by the Independent Auditor of the
Entity" ("ISRE (UK) 2410"). 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.
As disclosed in note 1, the annual financial statements of the
Company are prepared in accordance with UK adopted international
accounting standards. The condensed set of financial statements
included in this half-yearly financial report is not in accordance
with UK adopted International Accounting Standard 34, "Interim
Financial Reporting".
Conclusions relating to going concern
Based on our review procedures, which are less extensive than
those performed in an audit as described in the Basis for
conclusion section of this report, nothing has come to our
attention to suggest that the directors have inappropriately
adopted the going concern basis of accounting or that the directors
have identified material uncertainties relating to going concern
that are not appropriately disclosed.
This conclusion is based on the review procedures performed in
accordance with ISRE (UK) 2410, however future events or conditions
may cause the Company to cease to continue as a going concern.
Responsibilities of directors
The directors are responsible for preparing the half-yearly
financial report in accordance with the London Stock Exchange AIM
Rules for Companies 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.
In preparing the half-yearly financial report, the directors are
responsible for assessing the company's ability to continue as a
going concern, disclosing, as applicable, matters related to going
concern and using the going concern basis of accounting unless the
directors either intend to liquidate the company or to cease
operations, or have no realistic alternative but to do so.
Auditor's responsibilities for the review of the financial
information
In reviewing the half-yearly report, we are responsible for
expressing to the Company a conclusion on the condensed set of
financial statement in the half-yearly financial report. Our
conclusion, including our Conclusions Relating to Going Concern,
are based on procedures that are less extensive than audit
procedures, as described in the Basis for Conclusion paragraph of
this report.
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 AIM Rules for Companies 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
Southampton , UK
Date: 20 September 2023
BDO LLP is a limited liability partnership registered in England
and Wales (with registered number OC305127).
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