REG - Cizzle Biotechnology - Interim Results
28/09/2023 07:00
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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 £350,000 at an issue price of 2.1p per share. A variation to the Company's
£500,000 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 £3.25 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
£350,000 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: £342,000 (H1 2022:
£345,000).
· Non-cash corporate expenses relating to a share option charge:
£115,000 (H1 2022: £70,000)
· Taxation credit: £26,000 (H1 2022: £25,000)
· Total comprehensive loss of £431,000 (H1 2022, Loss £390,000).
· Loss per share 0.12p, (H1 2022, Loss of 1.43p).
· Cash balances as at 30 June 2023: £451,000 (30 June 2022:
£444,000).
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 plc Via IFC Advisory
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
(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 ended Six months ended Year ended
30 June 2023 30 June 2022 31 December 2022
Unaudited Unaudited Audited
Notes £'000 £'000 £'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
£'000 £'000 £'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
£'000 £'000 £'000
Cash flow from operating activities
(457) (415) (963)
Operating loss before tax
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)
Group Ordinary Share Share Reverse Retained Total
Share Premium Capital Option Shares to be issued Acquisition Losses
Capital Redemption Reserve Reserve
Reserve
£'000 £'000 £'000 £'000 £'000 £'000 £'000
£'000
At 1 January 2023 3,502 34,917 199 (40,021) (6,153) 2,640
10,081 115
Issue of shares for cash 2 465 - - - 352
- (115)
Share issue costs - (52) - - - (52)
- -
Share option charge - - - 115 - - 115
-
Total transactions with owners 2 413 115 - - 415
- (115)
Comprehensive Loss for the Period - - - - (431) (431)
- -
At 30 June 2023 3,504 35,330 314 (40,021) (6,584) 2,624
10,081 -
For the six months ended 30 June
2022
Group Ordinary Share Share Reverse Retained Total
Share Premium Capital Option Deferred consideration - shares to be issued Acquisition Losses
Capital Redemption Reserve Reserve
Reserve
£'000 £'000 £'000 £'000 £'000 £'000 £'000
£'000
At 1 January 2022 3,493 32,566 335 (40,021) (5,517) 937
10,081 -
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 - - 1,950
- 880
Comprehensive Loss for the Period - - - - (390) (390)
- -
At 30 June 2022 3,495 33,564 405 (40,021) (5,907) 2,497
10,081 880
Consolidated Statement of Changes in Equity (continued)
For the year ended 31 December 2022 (Audited)
Ordinary Share Share Reverse Retained Total
Share Premium Capital Option Acquisition Losses
Capital Shares to Redemption Reserve Reserve
be issued Reserve
£'000 £'000 £'000 £'000 £'000 £'000 £'000
£'000
At 1 January 2022 3,493 32,566 335 (40,021) (5,517) 937
- 10,081
Issue of shares for acquisition of 5 1,875 - - - 1,880
AZD 1656 intangible asset - -
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 (136) - 276 2,615
115 -
Comprehensive Loss for the year - - - - (912) (912)
- -
At 31 December 2022 3,502 34,917 199 (40,021) (6,153) 2,640
115 10,081
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 £26,000 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 £25,000 and a credit of £51,000 for the year ended 31
December 2022.
4. Earnings per share
Group Group Group
6 months 6 months Year
ended ended ended
30 June 2022 30 June 2022 31 December 2022
Basic loss per share:
Total comprehensive loss - £'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
(https://cizzlebiotechnology.com) .
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