TIDMCIZ
RNS Number : 9139N
Cizzle Biotechnology Holdings PLC
28 September 2023
28 September 2023
Cizzle Biotechnology Holdings Plc
("Cizzle", the "Company" or the "Group")
Interim results for the six months ended 30 June 2023
Cizzle Biotechnology Holdings PLC (LSE: CIZ), the UK based
diagnostics developer, is pleased to announce its interim results
for the six months ended 30 June 2023.
Highlights
-- On 24 April 2023 the Group announced a new 12 month agreement
with the University of York running until 25 September 2024, which
builds on successful outcomes of the current research programme,
including meeting key milestones for monoclonal antibody
characterisation and assay platform optimization. This agreement
also extended access to state of the art facilities and world
leading scientists to support new solutions for early cancer
diagnostics and therapeutic tools.
-- On 12 June 2023 the Group announced that it had raised gross
proceeds of GBP350,000 at an issue price of 2.1p per share. A
variation to the Company's GBP500,000 loan facility agreement was
announced whereby repayment of any drawdown on this facility now
being satisfied by the issue of new ordinary shares in the Company
at a fixed price of 2.1p per share. This facility was extended
until 8 December 2024.
Post Period Highlights
-- The Company has a put option to sell its 5% economic interest
and royalty sharing agreement in the AZD 1656 asset to treat
inflammatory pulmonary and cardiovascular disease ("Option") to
Conduit Pharmaceuticals ("Conduit"), to be satisfied through the
issuance of new shares in Conduit (the "Option"). Conduit became a
publicly traded company on NASDAQ in the USA on 25 September 2023.
Cizzle exercised its Option on 26 September 2023 and once this has
been settled, the Company is expected to hold 395,460 shares in the
NASDAQ listed business with no restrictions.
-- On 10 August 2023 the Group announced an expansion of its
current research programme with the University of York to develop
its CIZ1B biomarker technology for early stage cancer diagnosis,
and other potential applications in cancer therapy. This follows
significant progress in isolating additional new and specific
monoclonal antibodies to the CIZ1B biomarker and incorporating
these into a new high-throughput clinical diagnostic immunoassay
platform. The recent developments meet key milestones to begin
commercial clinical trials. The Company is now engaged in clinical
trials design to support the validation and accreditation of the
CIZ1B test prior to commercial launch.
-- On 19 September 2023 the Group and Bio-Techne Corporation, a
NASDAQ Tech listed company, announced progress evaluating specific
monoclonal antibodies for Cizzle's CIZ1B cancer biomarker. Cizzle
has successfully completed an evaluation programme aimed at
assessing the feasibility of using the Simple Western platform from
ProteinSimple (a Bio-Techne brand) for high throughput detection of
the CIZ1B cancer biomarker which may be useful in the detection of
early-stage lung cancer.
Commenting Allan Syms, Chairman of Cizzle Biotechnology, said
:
"The Group continued to make excellent progress during the first
half of 2023 as key milestones were met in the development of our
proprietary assay for the CIZ1B biomarker which is highly
associated with early stage lung cancer. About 5,000 people die of
lung cancer every day which in part is due to the lack of simple
tests that can detect cancer early and as a result lead to
diagnosis when the disease is more advanced and survival rates are
poor.
"We have now expanded our range of specific monoclonal
antibodies for CIZ1B and as recently reported we are now deploying
these on a high throughput laboratory platform provided by
Bio-Techne, a $12 billion market capitalised life science and
biomedical research group. Bio-Techne have worked closely with Prof
Coverley's research team at the University of York and, having
completed a successful evaluation programme, we are now able us to
accelerate our clinical trials programme, initially in the USA.
" Our goal remains to develop simple, inexpensive, blood tests
for early cancer detection that can help save lives. The priority
will be to complete clinical trials and achieve LDT (Laboratory
Developed Test) accreditation and then to expand the use of our
CIZ1B antibodies for use in a lateral flow format, such as that now
commonly used for COVID antigen detection which will provide a
familiar test format with an established global distribution
infrastructure."
"We have also previously reported on our ambitions to expand our
target customer base in the pharmaceutical industry through
building a portfolio of early cancer detection tests, companion
diagnostics and royalty bearing stakes in significant drug assets.
We were therefore, pleased to report in the past few weeks the
positive development arising from the merger of our partners
Conduit Pharmaceuticals with Murphy Canyon Acquisition Corp.
resulting in Conduit becoming a NASDAQ listed company. The
Company's put option to sell its 5% economic interest and royalty
sharing agreement in Conduit's AZD 1656 asset to treat inflammatory
pulmonary and cardiovascular disease to Conduit for a total
consideration of GBP3.25 million, would be satisfied through the
issuance of new shares in the NASDAQ listed merged business."
Executive Chairman's Statement
Operational and strategic overview
The Group has focussed on realising and commercialising, through
systematic development, Cizzle's technology for the early detection
of cancer.
Research and Development Progress
Cizzle is developing a blood test for the early detection of
lung cancer. Its technology is based on the ability to detect a
stable plasma biomarker, a variant of CIZ1 known as CIZ1B. CIZ1 is
a naturally occurring cell nuclear protein involved in DNA
replication, and the targeted CIZ1B variant is highly correlated
with early-stage lung cancer.
On 24 April 2023 the Group announced a new 12 month agreement
with the University of York, running until 25 September 2024, that
builds on successful outcomes from the current research programme
and meeting key milestones for monoclonal antibody characterisation
and assay platform optimization. This agreement extended access to
state of the art facilities and world leading scientists to support
new solutions for early cancer diagnostics and therapeutic
tools.
On 10 August 2023 the Group announced an expansion of its
research programme with the University of York to . This followed
significant further progress in isolating additional new and
specific monoclonal antibodies to the CIZ1B biomarker and
incorporating these into a new high-throughput clinical diagnostic
immunoassay platform. The recent developments meet key milestones
to begin commercial clinical trials. The Company is now engaged in
clinical trials design to support the validation and accreditation
of the CIZ1B test prior to commercial launch.
On 19 September 2023 the Group and Bio-Techne Corporation, a
NASDAQ Tech listed company, announced progress evaluating specific
monoclonal antibodies for Cizzle's CIZ1B cancer biomarker. Cizzle
has successfully completed an evaluation programme aimed at
assessing the feasibility of using the Simple Western platform from
ProteinSimple (a Bio-Techne brand) for high throughput detection of
the CIZ1B cancer biomarker which may be useful in the detection of
early-stage lung cancer.
Funding
In June 2023 the Company completed a fund raising providing
gross proceeds of GBP350,000 by way of a subscription for its
shares. The funds will be used to provide working capital for the
Company and to continue development of a laboratory-developed test
("LDT") accredited service for the early detection of lung cancer
and taking the Company's proprietary CIZ1B biomarker blood test
through to UKCA, CE marking and/or FDA 510(k) clearance.
On 21 Sept 2023 the Group announced an update on its Option with
Conduit and noted shareholder approval for Conduit-Murphy merger
and NASDAQ listing. The Company has a put option to sell its 5%
economic interest and royalty sharing agreement in the AZD 1656
asset to treat inflammatory pulmonary and cardiovascular disease to
Conduit, to be satisfied through the issuance of new shares in
Conduit (the "Option"). The merger completed and Conduit became a
publicly traded company on NASDAQ in the USA on 25 September 2023.
Cizzle exercised its Option on 26 September 2023 and once this has
been settled, the Company is expected to hold 395,460 shares in the
NASDAQ listed business with no restrictions.
Financial overview
During the six months ended 30 June 2023, the Company continued
its focus on being a healthcare diagnostics developer. The Group
consists of Cizzle Biotechnology Holdings PLC as the parent company
with wholly owned subsidiaries, Cizzle Biotechnology Ltd ("CBL")
and Cizzle Biotech Ltd (formerly Enfis Ltd). The current Group
structure was formed when the Company completed the acquisition of
CBL on 14 May 2021 and was admitted to trading on the standard list
of the Main Market of the London Stock Exchange.
The financial results for the six months to 30 June 2023 are
summarised as follows:
-- Corporate expenses, before exceptional items: GBP342,000 (H1 2022: GBP345,000).
-- Non-cash corporate expenses relating to a share option
charge: GBP115,000 (H1 2022: GBP70,000)
-- Taxation credit: GBP26,000 (H1 2022: GBP25,000)
-- Total comprehensive loss of GBP431,000 (H1 2022, Loss GBP390,000).
-- Loss per share 0.12p, (H1 2022, Loss of 1.43p).
-- Cash balances as at 30 June 2023: GBP451,000 (30 June 2022: GBP444,000).
Responsibility Statement
We confirm that to the best of our knowledge:
-- the interim financial statements have been prepared in
accordance with International Accounting Standards 34, Interim
Financial Reporting;
-- give a true and fair view of the assets, liabilities,
financial position and loss of the Company;
-- the Interim report includes a fair review of the information
required by DTR 4.2.7R of the Disclosure and Transparency Rules,
being an indication of important events that have occurred during
the first six months of the financial year and their impact on the
set of interim financial statements; and a description of the
principal risks and uncertainties for the remaining six months of
the year; and
-- the Interim report includes a fair review of the information
required by DTR 4.2.8R of the Disclosure and Transparency Rules,
being the information required on related party transactions.
The interim report was approved by the Board of Directors and
the above responsibility statement was signed on its behalf by
Allan Syms on 27 September 2023.
Enquiries:
Cizzle Biotechnology Holdings Via IFC Advisory
plc
Allan Syms (Executive Chairman)
Allenby Capital Limited +44(0) 20 33285656
John Depasquale
George Payne
Novum Securities Limited +44(0) 20 7399 9400
Colin Rowbury
Jon Bellis
IFC Advisory Limited +44(0) 20 3934 6630
Tim Metcalfe
Florence Chandler
About Cizzle Biotechnology
Cizzle Biotechnology is developing a blood test for the early
detection of lung cancer. Cizzle Biotechnology is a spin- out from
the University of York, founded in 2006 around the work of
Professor Coverley and colleagues . Its proof-of-concept prototype
test is based on the ability to detect a stable plasma biomarker, a
variant of CIZ1 known as CIZ1B. CIZ1 is a naturally occurring cell
nuclear protein involved in DNA replication, and the targeted CIZ1B
variant is highly correlated with early-stage lung cancer.
For more information please see
https://cizzlebiotechnology.com
You can also follow the Company through its twitter account
@CizzlePlc and on LinkedIn.
Consolidated Statement of Comprehensive Income
For the six months ended 30 June 2023
Group Group Group
Six months Six months Year ended
ended ended
30 June 2023 30 June 2022 31 December
2022
Unaudited Unaudited Audited
Notes GBP'000 GBP'000 GBP'000
Revenue - - -
Cost of Sales - - -
Gross Profit - - -
Administrative Expenses
-on going administrative expenses (342) (345) (823)
-share option charge (115) (70) (140)
Total administrative expenses
including exceptional items (457) (415) (963)
---------------------------- ---------------------------- -------------
Operating Loss and loss before
income tax (457) (415) (963)
Income tax 3 26 25 51
---------------------------- ---------------------------- -------------
Loss and total comprehensive
income for the period
attributable
to the equity shareholders
of the parent (431) (390) (912)
---------------------------- ---------------------------- -------------
Earnings per share Loss-
basic and diluted - pence 4 (0.12)p (1.43)p (0.3)p
Consolidated Statement of Financial Position
as at 30 June 2023
Group Group Group
30 June 30 June 31 Dec
2023 2022 2022
Unaudited Unaudited Audited
GBP'000 GBP'000 GBP'000
Non-Current Assets
Intangible asset 2,080 2,080 2,080
Total Non-Current Assets 2,080 2,080 2,080
------------ ---------- ---------
Current Assets
Trade and other receivables 223 87 227
Cash and cash equivalents 451 444 478
------------ ---------- ---------
Total Current Assets 674 531 705
------------ ---------- ---------
Total Assets 2,754 2,611 2,785
------------ ---------- ---------
Equity
Ordinary shares 3,504 3,495 3,502
Share premium 35,330 33,564 34,917
Share capital reduction reserve 10,081 10,081 10,081
Share option reserve 314 405 199
Shares to be issued - 880 115
Reverse acquisition reserve (40,021) (40,021) (40,021)
Retained losses (6,584) (5,907) (6,153)
Total equity 2,624 2,497 2,640
------------ ---------- ---------
Liabilities
Current liabilities
Trade and other payables 130 114 145
Total current liabilities 130 114 145
------------ ---------- ---------
Total equity and liabilities 2,754 2,611 2,785
------------ ---------- ---------
Consolidated Statement of Cash Flows
For the six months ended 30 June 2023
Group Group Group
6 Months 6 Months 6 Months
ended ended ended
30 June 30 June 31 Dec
2023 2022 2022
Unaudited Unaudited Unaudited
GBP'000 GBP'000 GBP'000
Cash flow from operating activities
Operating loss before tax (457) (415) (963)
Adjustment for:
Share option charge 115 70 140
Share based payment to former director - - 8
------------ ------------ -------------------------
Operating cash flow before working
capital movements (342) (345) (815)
Decrease in trade and other receivable 30 18 16
Decrease in trade and other payables (15) (104) (73)
------------ ------------ -------------------------
Net cash used in operating activities (327) (431) (872)
------------ ------------ -------------------------
Cash flow from investing activities
Purchase of Put Option - - (120)
------------ ------------ -------------------------
Net cash inflow outflow from investing
activities - - (120)
------------ ------------ -------------------------
Cash flow from financing activities
Proceeds from the issue of ordinary
shares (net of issue costs) 300 - 480
Proceeds from shares to be issued - - 115
Net cash inflow from financing activities 300 - 595
------------ ------------ -------------------------
Net decrease in cash and cash equivalents (27) (431) (397)
Cash and cash equivalents at the
start of the period 478 875 875
------------ ------------ -------------------------
Cash and cash equivalents at the
end of the period 451 444 478
------------ ------------ -------------------------
Consolidated Statement of Changes in Equity
For the six months ended 30 June 2023 (unaudited)
Ordinary Capital Share Shares Reverse
Share Share Redemption Option to be Acquisition Retained
Group Capital Premium Reserve Reserve issued Reserve Losses Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 January 2023 3,502 34,917 10,081 199 115 (40,021) (6,153) 2,640
-------- -------- ------------ -------- --------- --------------------------- --------- --------
Issue of shares for
cash 2 465 - - (115) - - 352
Share issue costs - (52) - - - - - (52)
Share option charge - - - 115 - - - 115
-------- -------- ------------ -------- --------- --------------------------- --------- --------
Total transactions with
owners 2 413 - 115 (115) - - 415
Comprehensive Loss for
the Period - - - - - - (431) (431)
At 30 June 2023 3,504 35,330 10,081 314 - (40,021) (6,584) 2,624
-------- -------- ------------ -------- --------- --------------------------- --------- --------
For the six months ended 30 June 2022
Capital Deferred
Ordinary Redemption Share consideration Reverse
Share Share Reserve Option - shares Acquisition Retained
Group Capital Premium Reserve to be issued Reserve Losses Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 January 2022 3,493 32,566 10,081 335 - (40,021) (5,517) 937
---------- ----------- --------------- ---------- ----------------- ----------------------------- ----------- ----------
Issue of shares for
the acquisition of
intangible asset 2 998 - - - - - 1,000
Deferred consideration
arising on the
acquisition
of an intangible asset - - - - 880 - - 880
Share option charge - - - 70 - - - 70
Total transactions
with owners 2 998 - 70 880 - - 1,950
Comprehensive Loss
for the Period - - - - - - (390) (390)
---------- ----------- --------------- ---------- ----------------- ----------------------------- ----------- ----------
At 30 June 2022 3,495 33,564 10,081 405 880 (40,021) (5,907) 2,497
---------- ----------- --------------- ---------- ----------------- ----------------------------- ----------- ----------
Consolidated Statement of Changes in Equity (continued)
For the year ended 31 December 2022 (Audited)
Capital
Shares Redemption
Ordinary to Reserve Share Reverse
Share Share be Option Acquisition Retained
Capital Premium issued Reserve Reserve Losses Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
At 1 January 2022 3,493 32,566 - 10,081 335 (40,021) (5,517) 937
---------- -------- --------- ------------ -------- --------------------------- --------- --------
Issue of shares
for
acquisition of
AZD 1656
intangible
asset 5 1,875 - - - - - 1,880
Issue of shares
for
cash 4 500 - - - - - 504
Cost of share
issue - (80) - - - - - (80)
Share options
exercised - 56 - - (276) - 276 56
Shares to be
issued - - 115 - - - - 115
Share option
charge - - - - 140 - - 140
---------- -------- --------- ------------ -------- --------------------------- --------- --------
Total transactions
with owners 9 2,351 115 - (136) - 276 2,615
Comprehensive Loss
for the year - - - - - - (912) (912)
At 31 December
2022 3,502 34,917 115 10,081 199 (40,021) (6,153) 2,640
---------- -------- --------- ------------ -------- --------------------------- --------- --------
Notes to the financial statements
For the six months ended 30 June 2023 (unaudited)
1. Basis of preparation
These condensed interim financial statements have been prepared
in accordance with IAS 34 - Interim Financial Reporting using the
recognition and measurement principles of UK-adopted International
Accounting Standards and should be read in conjunction with the
audited consolidated financial statements of the Group for the year
ended 31 December 2022.
The principal accounting policies used in preparing these
condensed interim financial statements are those expected to apply
to the Group's Consolidated Financial Statements for the year
ending 31 December 2023.
The results for the six-months ended 30 June 2023 are the Group
results.
The financial information for the six months ended 30 June 2023
is unaudited and does not constitute statutory financial statements
for those periods. The financial information for the year ended 31
December 2022 has been extracted from the audited financial
statements for this period. The financial information has been
prepared in accordance with accounting policies consistent with
those set out in the Group financial statements for the year ended
31 December 2022.
2. Continuing and discontinued operations
The Group is considered to have one class of business which is
focused on the early detection of lung cancer via the development
of an immunoassay test for the CIZ1B biomarker.
3. Income Tax
The Income tax credit of GBP26,000 for the six months ended 30
June 2023 relates to accrued income for the recovery of tax on
qualifying research and development expenditure. For the six months
ended 30 June 2022 there was income tax credit of GBP25,000 and a
credit of GBP51,000 for the year ended 31 December 2022.
4. Earnings per share
Group Group Group
6 months 6 months Year
ended ended ended
31 December
30 June 2022 30 June 2022 2022
Basic loss per share:
Total comprehensive loss
- GBP'000 (431) (390) (912)
Weighted number of Ordinary
Shares - '000 347,765 271,956 291,323
Loss per share - operations
- pence (0.12p) (1.43p) (0.3p)
As the Group result for the six months ended 30 June 2023, 30
June 2022 and year ended 31 December 2022 is a loss, any exercise
of share options or warrants would have an anti-dilutive effect on
earnings per share. Consequently earnings per share and diluted
earnings per share are the same, as potentially dilutive share
options have been excluded from the calculation.
5. Copies of Interim Report
Copies of this interim report are available upon request to
members of the public from the Company Secretary, SGH Company
Secretaries Limited, 6(th) Floor, 60 Gracechurch Street, London,
EC3V 0HR. This interim report can also be viewed on the Group's
website: https://cizzlebiotechnology.com .
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END
IR DGGDCGUDDGXR
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Cizzle Biotechnology (LSE:CIZ)
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