PRESS RELEASE
30 September 2024
Genflow Biosciences
Plc
("Genflow" or "the Company")
HALF YEAR
RESULTS
Genflow (LSE: GENF) is pleased to
announce its half year results for the six-month period ended 30
June 2024.
Chairman's
Statement
It is with pleasure that I take this
opportunity to update shareholders of Genflow Biosciences Plc
("Genflow" or the "Company") on the Company's performance during
the first six months of 2024.
Over the six months to 30 June 2024,
the Company has made strides in its principal longevity programs:
MASH (Metabolic Dysfunction-Associated Steatohepatitis) and Werner
Syndrome.
In June, we updated shareholders on
the momentum created with respect to our pre-clinical programs in
MASH, and the guidance expected to be received from the FDA in the
future. This guidance, which we anticipate receiving in the future,
is expected to come through the FDA's Initial Targeted Engagement
for Regulatory Advice on CBER Products (INTERACT), as a result of
the Company submitting a comprehensive briefing package conducted
with our lead drug candidate, GF-1002, for the treatment of MASH.
In the meantime, the FDA has encouraged Genflow to proceed with its
plans to identify appropriate animal models through pilot
proof-of-concept ("POC") studies. Specifically, we have established
a functional 3-D organoids of liver using cells from Werner
patients. This organoid testing helps reduce the need for
animal models in our scientific research. Organoids are miniature,
lab-grown versions of human organs or tissues that mimic the
structure and function of their real counterparts. By using these
organoids, we can model human Werner Syndrome and better test
response of our SIRT6 based gene therapy in a more human-relevant
environment, rather than relying on unreliable animal
models.
Additionally, we have initiated a
feasibility study with a Contract Development Manufacturing
Organization (CDMO), Exothera S.A, to assess the ability to produce
its future MASH clinical lot in accordance with Good Manufacturing
Practices (GMP). We are also in the process of selecting Contract
Research Organizations (CROs) to conduct our upcoming dog clinical
trial, aimed at studying our simplified Nake DNA version of our
Centenarian SIRT6 drug candidate, GF-1004. We will provide updates
in relation to our veterinary study in due course.
Over the period, we have also been
working on two exciting collaborations supported by non-diluting
and non-reimbursable research grants from the Government of
Wallonia in Belgium, as follows;
· Sarcopenia
research program
with Revatis SA - focusing on the development of muscle
progenitor cells which will be loaded with Genflow's proprietary
SIRT6 for the prevention and treatment of sarcopenia, the
age-related loss of muscle mass and function. Genflow aims to
counteract the detrimental effects of aging on muscle tissue with
our sarcopenia program, which holds potential for significantly
improving the quality of life for older adults affected by muscle
loss and weakness.
· Exosome-mRNA project with EXO
Biologics - which aims to deliver a
therapeutic product composed of exosomes encapsulating an AAV or
mRNA encoding SIRT6. The exosome therapy will be designed to target
liver fibrosis (MASH) and Werner Syndrome, potentially leading to
groundbreaking treatments for both diseases.
During the period, the Company has
received grant funding of totalling €777,281 in respect of these
projects, with further financial support committed in the first
half of 2025.
In addition, Genflow Biosciences
SRL, received €350,000 in April 2024, from the regional government
of Wallonia - Belgium Service Public de Wallonie, representing the
second tranche of this awarded grant recognised in the previous
year, 2023.
Further strengthening the Company's
financial position and increasing its institutional investor base,
the Company completed a placing and subscription to which raised
£715,000 (before expenses) during the period. We were privileged to
have Premier Miton, a well-known UK institution, participate in
this fundraise.
Financial
Overview
As of 30 June 2024, the Group had
cash reserves of £1,139,859 (31 December 2023: £683,974) which has
been derived from equity fundraising of £663,600 (net of expenses)
and the receipt of research and development grants of £664,219
(€777,281) and £299,145 (€350,000) The Company remains debt
free.
Administration expenses for 30 June
2024 totalled £1,316,368 (30 June 2023: £815,477), which primarily
consisted of research and development costs of £938,109 (30 June
2023: £415,157), legal and professional fees totalling £90,654 (30
June 2023: £103,366) and Directors' fees of £178,656 (30 June 2023:
£178,783).
The significant jump in research and
development costs for 2024 is in relation to the advancement of
testing, which has transitioned to the in vivo stage, which is inherently
more costly.
Other Comprehensive Income was
charged with a translation gain of £8,652 upon converting the
Subsidiary's results for the period to GBP.
Future
On behalf of the Board, I thank you
for your continued support. Our commitment to pioneering
therapeutic solutions for longevity has been strengthened by the
support of our collaborative partners and promising feedback from
the FDA during the six-months to 30 June 2024. This encouragement
reinforces our commitment to developing effective therapeutic
solutions for age-related diseases. We remain focused on our
mission to improve healthspan, and I look forward to providing you
with further updates as we progress through our work programs,
including clinical dog trials.
Tamara Joseph
Chairman
CONSOLIDATED STATEMENT OF FINANCIAL
POSITION
AS AT 30 June 2024
|
Note
|
Unaudited
6 Months
ended
30 June
2024
|
Audited
12 Months
ended
31
December 2023
|
Unaudited
6 Months
ended
30 June
2023
|
|
|
|
|
|
Non-current assets
|
|
|
|
|
Property, plant &
equipment
|
|
3,456
|
3,394
|
3,991
|
Total non-current assets
|
|
3,456
|
3,394
|
3,991
|
|
|
|
|
|
Current assets
|
|
|
|
|
Trade and other
receivables
|
6
|
207,791
|
384,285
|
400,891
|
Cash and cash equivalents
|
|
1,139,859
|
683,974
|
1,507,437
|
Total current assets
|
|
1,347,650
|
1,068,259
|
1,908,328
|
Total assets
|
|
1,351,106
|
1,071,653
|
1,912,319
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
Trade and other payables
|
7
|
492,761
|
345,738
|
194,134
|
Total current liabilities
|
|
492,761
|
345,738
|
194,134
|
|
|
|
|
|
Total liabilities
|
|
492,761
|
345,738
|
194,134
|
Net
Assets
|
|
858,345
|
725,915
|
1,718,185
|
|
|
|
|
|
Equity
|
|
|
|
|
Share capital
|
8
|
104,912
|
87,752
|
87,752
|
Share premium
|
8
|
4,837,340
|
4,190,900
|
4,190,900
|
Other reserves
|
9
|
212,577
|
219,488
|
204,592
|
Retained earnings
|
|
(4,296,484)
|
(3,772,225)
|
(2,765,059)
|
Total equity
|
|
858,345
|
725,915
|
1,718,185
|
CONSOLIDATED STATEMENT OF COMPREHENSIVE
INCOME
FOR
THE SIX MONTHS ENDED 30 JUNE 2024
|
|
|
|
|
|
|
|
|
Notes
|
Unaudited
6 Months
ended
30 June
2024
|
|
Audited
12 Months
ended
31
December 2023
|
|
Unaudited
6 Months
ended
30 June
2023
|
Other operating income
|
|
792,109
|
|
169,854
|
|
194,068
|
Administrative expenses
|
4
|
(1,316,368)
|
|
(1,798,559)
|
|
(815,477)
|
Operating loss
|
|
(524,259)
|
|
(1,628,705)
|
|
(621,409)
|
|
|
|
|
|
|
|
Finance costs
|
|
-
|
|
-
|
|
(130)
|
|
|
|
|
|
|
|
Loss
before tax
|
|
(524,259)
|
|
(1,628,705)
|
|
(621,539)
|
|
|
|
|
|
|
|
Tax
expense
|
|
-
|
|
-
|
|
-
|
Loss
for the period / year attributable to owners of the
parent
|
|
(524,259)
|
|
(1,628,705)
|
|
(621,539)
|
|
|
|
|
|
|
|
Other Comprehensive loss:
|
|
|
|
|
|
|
Items that could be reclassified to profit or
loss
|
|
|
|
|
|
|
Exchange differences on translation
of foreign operations
|
|
(8,652)
|
|
(11,853)
|
|
(26,749)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss for the period / year attributable to
owners of the parent
|
|
(532,911)
|
|
(1,640,558)
|
|
(648,288)
|
|
|
|
|
|
|
|
Loss per share (pence) from
continuing operations attributable to owners of the Parent - Basic
& Diluted
|
5
|
(0.165)
|
|
(0.557)
|
|
(0.210)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Unaudited
6 Months
ended
30 June
2024
|
Audited
12 Months
ended
31
December 2023
|
Unaudited
6 months
ended
30 June
2023
|
Cash flows used in operating activities:
|
|
|
|
Loss after taxation
|
(524,259)
|
(1,628,705)
|
(621,539)
|
Adjustments for:
|
|
|
|
Depreciation &
amortisation
|
605
|
1,034
|
413
|
Share based payments
|
1,741
|
-
|
-
|
Decrease/(increase) in trade and
other receivables
|
168,964
|
(131,014)
|
(142,229)
|
Increase/(decrease) in trade and
other payables
|
154,185
|
103,228
|
(107,585)
|
Foreign exchange
|
-
|
-
|
26,749
|
Net
cash outflow from operating activities
|
(198,764)
|
(1,655,457)
|
(844,191)
|
|
|
|
|
|
|
|
|
Cash
flow used in investing activities:
|
|
|
|
Purchase of property, plant &
equipment
|
(743)
|
(2,439)
|
(4,528)
|
Net
cash used in investing activities
|
(743)
|
(2,439)
|
(4,528)
|
|
|
|
|
Cash
flow from financing activities:
|
|
|
|
Proceeds from issue of
shares
|
715,000
|
-
|
-
|
Cost of share issue
|
(51,400)
|
-
|
-
|
Net
cash generated from financing activities
|
663,600
|
-
|
-
|
|
|
|
|
Net
increase/(decrease) in cash and cash equivalents
|
464,093
|
(1,657,896)
|
(848,719)
|
Cash and cash equivalents at
beginning of period / year
|
683,974
|
2,356,225
|
2,356,225
|
FX on cash
|
(8,208)
|
(14,355)
|
(69)
|
Cash
and cash equivalents at end of period
|
1,139,859
|
683,974
|
1,507,437
|
|
|
|
|
|
|
|
|
|
|
| |
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR
THE SIX MONTHS ENDED 30 JUNE 2024
|
Share
capital
|
Share
premium
|
Other
reserves
|
Retained
earnings/loss
|
Total
|
Unaudited- 30 June 2024
|
|
|
|
|
|
At 1
January 2024
|
87,752
|
4,190,900
|
219,488
|
(3,772,225)
|
725,915
|
Loss of the period
|
-
|
-
|
-
|
(524,259)
|
(524,259)
|
Exchange differences on translation
of foreign operations
|
-
|
-
|
(8,652)
|
-
|
(8,652)
|
Total comprehensive loss for the period
|
-
|
-
|
(8,652)
|
(524,259)
|
(532,911)
|
Transactions with owners
|
|
|
|
|
|
Issue of share capital
|
17,160
|
697,840
|
-
|
-
|
715,000
|
Costs of issue
|
-
|
(51,400)
|
-
|
-
|
(51,400)
|
Share based payments
|
-
|
-
|
1,741
|
-
|
1,741
|
Total Transactions with owners
|
17,160
|
646,440
|
1,741
|
-
|
665,341
|
At
30 June 2024 (unaudited)
|
104,912
|
4,837,340
|
212,577
|
(4,296,484)
|
858,345
|
|
|
|
|
Unaudited- 30 June 2023
|
|
|
|
|
|
At 1
January 2023
|
87,752
|
4,190,900
|
231,341
|
(2,143,520)
|
2,366,473
|
Loss of the period
|
-
|
-
|
-
|
(621,539)
|
(621,539)
|
Exchange differences on translation
of foreign operations
|
-
|
-
|
(26,749)
|
-
|
(26,749)
|
Total comprehensive loss for the period
|
-
|
-
|
(26,749)
|
(621,539)
|
(648,288)
|
Total Transactions with owners
|
-
|
-
|
-
|
-
|
-
|
At
30 June 2023 (unaudited)
|
87,752
|
4,190,900
|
204,592
|
(2,765,059)
|
1,718,185
|
|
|
|
|
|
|
|
|
|
|
|
|
Audited- 31 December 2023
|
|
|
|
|
|
At 1
January 2023
|
87,752
|
4,190,900
|
231,341
|
(2,143,520)
|
2,366,473
|
Loss for the year
|
-
|
-
|
-
|
(1,628,705)
|
(1,628,705)
|
Exchange differences on translation
of foreign operations
|
-
|
-
|
(11,853)
|
-
|
(11,853)
|
Total comprehensive loss for the period
|
-
|
-
|
(11,853)
|
(1,628,705)
|
(1,640,558)
|
Total Transactions with owners
|
-
|
-
|
-
|
-
|
-
|
At
31 December 2023 (audited)
|
87,752
|
4,190,900
|
219,488
|
(3,772,225)
|
725,915
|
1.
Reporting Entity
Genflow Biosciences Plc (the "Company") is a
company domiciled in the United Kingdom. The consolidated interim
financial information as at, and for the six months ended, 30 June
2024 comprise the results of the Company and its subsidiaries
(together referred to as the "Group").
The consolidated financial statements of the
Group as at, and for the year ended, 31 December 2023 are available
upon request from the Company's registered office at 6 Heddon
Street, London, W1B 4BT or at genflowbio.com.
2.
BASIS OF
PREPARATION
The financial information of the Group for the
6 months ended 30 June 2024 was approved and authorised for issue
by the Board of the Company on 30 September 2024. The interim
results have not been audited. This financial information has been
prepared in accordance with the accounting policies that are
expected to be applied in the Report and Accounts of the Company
for the year ended 31 December 2023 and are consistent with the
recognition and measurement requirements of IFRS as adopted by the
United Kingdom. The comparative information for the full year ended
31 December 2023 is not the Group's full annual accounts for that
period but has been derived from the annual financial statements
for that period.
The consolidated financial
information incorporates the results of the Group as at 30 June
2024. The corresponding amounts are for the year ended 31 December
2023 and for the 6 month period ended 30 June 2023.
The Group financial information is
presented in Pound Sterling and values are rounded to the nearest
pound.
The same accounting policies,
presentation and methods of computation are followed in the interim
consolidated financial information as were applied in the Group's
latest annual audited financial statements except for those that
relate to new standards and interpretations effective for the first
time for periods beginning on (or after) 1 January 2024 and will be
adopted in the 2024 annual financial statements.
A number of new standards and
amendments became effective on 1 January
2024 and have been adopted by the Group. None of these standards
have materially affected the Group.
3.
GOING
CONCERN
As the Group's assets are not
generating revenue, an operating loss has been reported and an
operating loss is expected in the 12 months to 30 June 2025.
However, the Directors believe that the Group will have sufficient
funds to meet its immediate working capital requirements and
undertake its targeted operating activities over the next 12 months
from the date of approval of these financial statements.
As at 30 June 2024, the Group has
cash resources of £1,139,859. The Group received funding during the
period to support working capital requirements and to support its
scientific research and development work streams. In April 2024,
the Company completed a placing and subscription which raised
£715,000 (before expenses); and received the second tranche of the
grant from the Wallonia Region, totalling €350,000. In May 2024,
the Group secured further grant funding of €1.55m, of which
€777,273 has been received and the remainder will be received in
2025.
Management plan to use these funds,
and future grant funding, to meet the working capital requirements
of the Group and to further its research and development
activities. In early 2024, management prepared a forecast covering
18-months and believe that current cash reserves plus the receipt
of committed grant funding in 2025 will adequately cover the
working capital requirements of the Group. Notably, all research
and development costs are discretionary and therefore, can be
reduced if necessary. However, the Group will need to seek further
funding to progress the Group's research workstreams and to
progress to the clinical trial phase.
As such, the Directors have a
reasonable expectation that the Group has, and will have, future
access to adequate resources to continue in operational existence
for the foreseeable future and, therefore, continue to adopt the
going concern basis in preparing the interim financial
statements.
4.
EXPENSES BY
NATURE
|
Unaudited
6 Months
ended
30 June
2024
£
|
Audited
12 Months
ended
31
December 2023
£
|
Unaudited
6 Months
ended
30 June
2023
£
|
|
|
|
|
Directors' fees
|
178,656
|
362,312
|
178,783
|
Directors' pensions
|
713
|
1,093
|
381
|
Directors' social security
contributions
|
5,069
|
14,945
|
8,245
|
Fees payable to the Company's
auditors for the audit of the Parent Company and group financial
statements
|
5,000
|
53,285
|
-
|
Professional, legal and consulting
fees
|
90,654
|
215,971
|
103,366
|
PR and marketing
|
48,535
|
106,819
|
63,903
|
Accounting related
services
|
3,780
|
7,839
|
8,638
|
Insurance
|
19,595
|
22,476
|
19,563
|
Office and administrative
expenses
|
10,777
|
18,897
|
5,092
|
IT and software services
|
7,377
|
5,828
|
1,492
|
Travel and entertainment
|
927
|
23,830
|
13,255
|
Research and development
costs
|
938,109
|
960,314
|
415,157
|
Share based payments
|
1,741
|
-
|
-
|
Depreciation
|
610
|
1,034
|
-
|
Other expenses
|
4,825
|
3,196
|
(2,398)
|
Total administrative expenses
|
1,316,368
|
1,798,559
|
815,477
|
5.
LOSS PER
SHARE
|
Unaudited
6 Months
ended
30 June
2024
£
|
Audited
12 Months
ended
31
December 2023
£
|
Unaudited
6 Months
ended
30 June
2023
£
|
|
|
|
|
Net loss for the year
from continued operations attributable to equity
shareholders
|
524,259
|
1,628,705
|
621,539
|
|
|
|
|
Weighted average
number of shares for the period/year
|
318,085,714
|
292,506,618
|
292,506,618
|
|
|
|
|
Basic loss per share for continued operations (expressed in
pence)
|
(0.165)
|
(0.557)
|
(0.210)
|
6.
TRADE AND OTHER DEBTORS
Trade and other debtors
|
Unaudited
6 Months
ended
30 June
2024
£
|
Audited
12 Months
ended
31
December 2023
£
|
Unaudited
6 Months
ended
30 June
2023
£
|
VAT receivable
|
46,011
|
36,278
|
48,205
|
Prepayments
|
158,748
|
41,041
|
22,854
|
Other
receivables
|
3,032
|
306,966
|
329,832
|
|
207,791
|
384,285
|
400,891
|
Trade and other receivables are all
due within one year. The fair value of all receivables is the same
as their carrying values stated above. These assets, excluding
prepayments, are the only form of financial asset within the Group,
together with cash and cash equivalents. There are no trade
receivables therefore an aging analysis has not been
provided.
7.
TRADE AND OTHER PAYABLES
|
Unaudited
6 Months
ended
30 June
2024
£
|
Audited
12 Months
ended
31
December 2023
£
|
Unaudited
6 Months
ended
30 June
2023
£
|
Trade payables
|
442,221
|
254,695
|
143,654
|
Accruals
|
32,841
|
60,014
|
34,012
|
Other payables
|
17,699
|
31,029
|
16,468
|
|
492,761
|
345,738
|
194,134
|
All trade and other payables are due
for payment within twelve months. Trade payables are settled within
normal commercial terms, usually between 30-60 days.
8.
Share capital
Company
|
Number of
shares
|
Ordinary
shares
£
|
Share
premium
£
|
Total
£
|
Issued and fully paid
|
|
|
|
|
At 1 January 2023
|
292,506,618
|
87,752
|
4,190,900
|
4,278,652
|
At
30 December 2023
|
292,506,618
|
87,752
|
4,190,900
|
4,278,652
|
Issue of Ordinary Shares
|
57,200,000
|
17,160
|
697,840
|
715,000
|
Deduction of cost of
capital
|
-
|
-
|
(51,400)
|
(51,400)
|
At
30 June 2024
|
349,706,618
|
104,912
|
4,837,340
|
4,942,252
|
On 9 Aril 2024, the Company issued
and allotted 57,200,000 new Ordinary Shares at a price of 0.0125
pence per share for gross proceeds of £715,000 (excluding
expenses).
9.
Share WARRANT reserve
The balance held in the share
options reserve relates to the fair value of the share warrants
that have been charged to the profit or loss since adoption of IFRS
2 'Share-based payment'.
Warrants:
At 30 June 2024, 2,860,000 warrants
over shares were exercisable (31 December 2023: No warrants were
exercisable).
2,860,000 warrants were granted
during the year (31 December 2023: No warrants granted) pursuant to
the terms of a placing of shares.
During the period ended 30 June
2024, no warrants were exercised (year ended 31 December 2023: No
warrants were exercised) and no warrants expired in the period
(year ended 31 December 2023: No warrants expired).
£1,741 was charge to loss for the
year in respect of outstanding warrants (2023: Nil).
10.
COMMITMENTS
The commitments stated in the
Group's Annual Financial Statements for the year ended 31 December
2023 remain in place.
11.
EVENTS AFTER THE REPORTING DATE
There were no events after the
reporting period.
Market Abuse Regulation (MAR) Disclosure
The information contained within
this announcement is deemed to constitute inside information as
stipulated under the Market Abuse Regulation ("MAR") (EU) No.
596/2014, as incorporated into UK law by the European Union
(Withdrawal) Act 2018. Upon the publication of this announcement,
this inside information is now considered to be in the public
domain.
Contacts
Genflow Biosciences
|
Harbor Access
|
Dr Eric Leire, CEO
|
Jonathan Paterson, Investor
Relations
|
+32-477-495-881
|
+1 475 477 9401
|
|
Jonathan.Paterson@Harbor-access.com
|
|
|
Corporate Brokers
|
|
Capital Plus Partners Ltd
|
|
Keith Swann, +44 0203 821
6169
|
|
Jon Critchley, +44 0203 821
6168
|
|
|
About Genflow Biosciences
Founded in 2020, Genflow Biosciences
Plc. (LSE:GENF) (OTCQB:GENFF), a biotechnology company
headquartered in the UK with R&D facilities in Belgium, is
pioneering gene therapies to decelerate the aging process, with the
goal of promoting longer and healthier lives while mitigating the
financial, emotional, and social impacts of a fast-growing aging
global population. Genflow's lead compound, GF-1002, works through
the delivery of a centenarian variant of the SIRT6 gene which has
yielded promising preclinical results. Scheduled to begin in 2025,
Genflow's clinical trial aims to explore the potential benefits of
GF-1002 in treating MASH (Metabolic Dysfunction-Associated
Steatohepatitis), the most prevalent chronic liver disease for
which there is no effective treatments. Please
visit www.genflowbio.com
and follow the Company on LinkedIn and Twitter/X.
DISCLAIMER
The contents of this announcement
have been prepared by, and are the sole responsibility of, the
Company.
This announcement may contain
forward-looking statements. The forward-looking statements
include, but are not limited to, statements regarding the Company's
or the Directors' expectations, hopes, beliefs, intentions or
strategies regarding the future. In addition, any statement that
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forward-looking statements, but the absence of these words does not
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Forward-looking statements include
all matters that are not historical facts. Forward-looking
statements are based on the current expectations and assumptions
regarding the Company, the business, the economy and other future
conditions. Because forward-looking statements relate to the
future, by their nature, they are subject to inherent
uncertainties, risks and changes in circumstances that are
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of future performance and the Company's actual financial condition,
actual results of operations and financial performance, and the
development of the industries in which it operates or will operate,
may differ materially from those made in or suggested by the
forward-looking statements contained in this announcement. In
addition, even if the Company's financial condition, results of
operations and the development of the industries in which it
operates or will operate, are consistent with the forward-looking
statements contained in this announcement, those results or
developments may not be indicative of financial condition, results
of operations or developments in subsequent periods. Important
factors that could cause actual results to differ materially from
those in the forward-looking statements include regional, national
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Any forward-looking statement
contained in this announcement applies only as of the date of this
announcement and is expressly qualified in its entirety by these
cautionary statements. Factors or events that could cause the
Company's actual plans or results to differ may emerge from time to
time, and it is not possible for the Company to predict all of
them. The Company expressly disclaims any obligation or undertaking
to release publicly any updates or revisions to any forward-looking
statements contained in this announcement to reflect any change in
its expectations or any change in events, conditions or
circumstances on which any forward-looking statement contained in
this announcement is based, unless required to do so by applicable
law, the Prospectus Regulation Rules, the Listing Rules, the
Disclosure Guidance and Transparency Rules of the FCA or the UK
Market Abuse Regulation.