REG - Cizzle Biotechnology - Interim Results
30/09/2024 07:00
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RNS Number : 1266G Cizzle Biotechnology Holdings PLC 30 September 2024
30 September 2024
Cizzle Biotechnology Holdings Plc
("Cizzle", the "Company" or together with its subsidiaries the "Group")
Interim results for the six months ended 30 June 2024
Cizzle Biotechnology Holdings PLC (LSE: CIZ), the UK based healthcare
diagnostics developer, is pleased to announce its unaudited interim results
for the six months ended 30 June 2024.
Highlights
· March 2024 Fundraising: The Company successfully raised
approximately £0.62 million through an equity placing. These funds will be
used by the Group to finalise its first commercial test for detecting CIZ1B,
to strengthen its intellectual property, advance its research with the
University of York, and support general corporate activities.
· North America Partnership: On 2 April 2024, the Group entered
into a Strategic Licencing and Partnership Memorandum of Understanding for
North America with Cizzle Bio Inc. ("BIO"). Its proprietary CIZ1B biomarker
test has subsequently been selected for a major study at a leading US cancer
centre. Cizzle received an up-front payment of US$100,000 as a non-refundable
fee to grant BIO an exclusive negotiating period from the signing of a
memorandum of understanding on 1 April 2024 ("MoU").
· Research Agreement Extension: The Group's research agreement with
the University of York was extended until July 2025.
· Financial results: Loss for the period of £1,411,000 (H1 2023:
Loss £457,000), includes a £1,081,000 (H1 2023: £Nil) fair value loss on a
financial asset. This being a non-cash item, the Group's net cash used in
operating activities (which excludes proceeds from the issue of ordinary
shares) was £238,000 (H1 2023: £327,000).
Post Period Highlights
· Partnership with BBI Solutions: In July 2024 the Group announced
a strategic agreement with BBI Solutions, the world's largest independent
producer of immunodiagnostic reagents, for the supply of monoclonal
antibodies. This partnership is a significant step toward commercialising
Cizzle's cost-effective biomarker test for early-stage lung cancer detection.
· Update on Strategic Licensing Partnership in North America: On 25
July 2024, Cizzle agreed a 60-day extension with BIO for the completion of the
binding legal agreement as envisaged under the MoU, to enable BIO to complete
on additional strategic investment.
· Moffitt Cancer Center Collaboration: On 9 September 2024, the
Group was selected by Moffitt Cancer Center ("Moffitt"), Florida's leading
cancer hospital, to test patients with suspicious lung nodules in a clinical
evaluation using the Group's proprietary CIZ1B biomarker assay. This will be
the first time that suspected lung cancer patients will be tested for the
CIZ1B Biomarker as part of a major clinical evaluation.
Commenting Allan Syms, Chairman of Cizzle Biotechnology, said:
"Throughout 2024, the Group has made significant progress in developing its
blood test to help in the early detection of lung cancer through (i) the
manufacturing of its core antibodies with BBI Solutions in their ISO
13485-certified facilities; (ii) the industrial collaboration with an industry
leading laboratory instrumentation partner; and (iii) being selected by the
number one cancer centre in Florida to conduct a clinical evaluation of our
biomarker for their patients presenting with suspicious lung nodules.
Furthermore, the establishment of a partnership with BIO has now moved the
business into the commercial phase of bringing our non-invasive, cost
effective CIZ1B biomarker lung cancer blood test to market. Not only does this
mark the achievement of our planned major milestones targeting full product
launch in April 2025, but also makes our goal of helping detect lung cancer
early and thereby proving a valuable new means for early intervention and
ultimately helping save lives. The partnership with BIO is expected to be
completed shortly giving us the potential for a significant guaranteed royalty
deal in North America."
Executive Chairman's Statement
Operational and strategic overview
Cizzle has focussed on the systematic development and commercialisation of
novel and proprietary clinical diagnostic tests for the early detection of
cancer particularly where there is an unmet clinical need. It is widely
considered that to beat cancer, early detection and
diagnosis is arguably the single most important and impactful objective
we can have. Patients diagnosed early have the best chance of curative
treatment and long-term survival reducing patient stress and improving
healthcare economic performance.
The Group's platform 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. Since the
Group's admission to the London Stock Exchange in 2021, it has invested in the
development of its technology to now enable its full commercialisation through
a global licensing and partnership strategy.
With the commercial manufacture of CIZ1B monoclonal antibodies underway,
optimisation of the laboratory platform for the test, collaboration with a
major US cancer hospital and entering shortly into a guaranteed royalty
bearing partnership in the USA, the Group anticipates its proprietary
technology will be available for sale in April 2025.
Research and Development Progress
Based on the original published research by Professor Coverley and her team at
the University of York, it has been shown that CIZ1B can be measured with high
sensitivity that should allow for non-intrusive, cost effective testing in a
high-throughput, hospital-friendly format and in the future a rapid point of
care test for use in doctors' offices and pharmacies. During the period,
Cizzle continued to support its research agreement and collaboration with the
University of York which has been extended to July 2025, and to work with
external expert partners and suppliers to develop and supply of proprietary
key monoclonal antibodies and other detector proteins for its assay platform.
Following the successful generation of new proprietary monoclonal antibodies
which are the central component of the tests to detect the presence of the
CIZ1B biomarker, the Company announced on 18 July 2024 that it had ordered its
first batch of antibodies from BBI Solutions ("BBI"), the world's largest
independent producer of immunodiagnostic reagents. The initial order is being
manufactured at BBI's ISO 13485-certified facilities and are expected to
support up to 5,000 assays, including the Moffat Cancer Centre programme,
marking a significant inflection point for the Company as it moves from
research and development into commercial manufacture and commencement of the
use of Cizzle's technology for testing patients in cancer clinics.
Licensing Strategy and Commercial Progress
The Company operates a global licensing and partnership strategy because the
directors believe this is the fastest and most cost-effective means to bring
its technology to market. For product solutions, this aims to leverage
partners expertise and pre-existing high throughput platforms to accelerate
deployment and installation of laboratory testing. Expansion into different
geographies aims to maximise speed and scale of market entry through
specialist licensing partners that provide expert clinical and commercial
teams based in territory that fund all clinical and commercial activities
thereby preserving shareholder funds to focus on next generation products such
as point of care tests and the detection of a wider range of cancers. Wherever
possible we seek up-front fees, guaranteed royalty income and other benefits
where appropriate.
On 19 Sep 2023 the Company announced it had successfully completed an
evaluation programme aimed at assessing the feasibility of using the Simple
Western platform from ProteinSimple for high throughput detection of the CIZ1B
cancer biomarker. ProteinSimple is part of Bio-Techne Corporation, a NASDAQ
Tech listed company. The Company has continued to optimise that platform to
make it suitable for use in laboratories accredited by the College of American
Pathology Pathologists (CAP) with Clinical Laboratory Improvement Amendments
(CLIA) certification.
With commercial antibodies in production and continuing the programme with
BioTechne, the Company was pleased to announce on 2 April 2024 that it had
signed a Memorandum of Understanding ("MoU") with a new business, funded by
high-net worth individuals as an exclusive licensing partner for the USA and
Canada. To align the interests of the two businesses, the US entity was named
Cizzle Bio. The Company received a non-refundable upfront fee of US$100,000
and following the completion of the binding legal agreement, an initial up
front royalty of US$300,000 is payable to Cizzle. Thereafter a royalty of 10%
will be paid on revenues using the Company's technology, guaranteed by
sequential minimum US$ 1 million payments on the 15(th) and 30(th) month
anniversaries. The Company will also benefit in a 10% equity stake for no cash
consideration.
BIO expects to register its first US CLIA accredited lab with the FDA (US Food
and Drug Administration) for the CIZ1B Laboratory Developed Test (LDT) shortly
after completing the licensing agreement and then plans to achieve CLIA
Certification for the LDT test in November 2024, with insurer reimbursement
code achievement and full product launch April 2025.
Since signing the MOU, BIO has been making significant progress in promoting
the CIZ1B biomarker test and building relationships with clinicians and
hospitals across the USA. The extensive network being generated by BIO and
following scientific review, the Group announced on 9 September 2024 that it
had been selected by Moffitt, to test patients with suspicious lung nodules in
a clinical evaluation using the Group's proprietary CIZ1B biomarker assay.
This is a significant development given the project will be carried out in the
real-world setting of a busy comprehensive cancer centre with a large lung
cancer practice and a high volume, well-organized clinical thoracic research
program.
As part of Moffitt's Phase 2 programme, "Using Biomarkers for Diagnosis, Risk
Stratification of Post-treatment Recurrence and Long Term Survival of Lung
Cancer" ("the programme"), the Company will for the first time be analysing
patient blood samples to determine biomarker accuracy in predicting whether or
not a nodule is likely to be cancer. The programme is a large observational
prospective study in patients with suspicious indeterminant (undiagnosed) lung
nodules seen in the Lung Cancer Early Detection (LEAD) Center Lung Nodule
Clinic, led by its Director Dr. Lary Robinson. The study follows US
recommended guidelines and will be using the first batch of the Company's new
commercial monoclonal antibody, to provide new sensitivity and specificity
data of the CIZ1B biomarker blood test in the diagnosis of early-stage lung
cancer in people with indeterminant lung nodules. The blood sample tests for
CIZ1B will be conducted in Professor Dawn Coverley's laboratory at the
University of York.
Moffitt note that of the low number of lung cancer patients surviving long
term, most are early-stage patients who had surgical resection.
Unfortunately, with current screening using low dose chest CT scans ("LDCT"),
only 17% are found with localized, potentially curable disease. And although
LDCT is an effective tool in high-risk populations, only 3.9% of eligible
people obtain a scan. Developing a high sensitivity (>90%) and high
specificity (>90%) blood-based biomarker would greatly facilitate the
evaluation of the 1.6 million new lung nodules found yearly on CT scans in the
U.S., differentiating malignant from benign nodules. The study also recognises
that a highly sensitive and specific biomarker potentially could be employed
for initial lung cancer screening with just a blood test at the primary care
physicians' office .
BIO expect to announce further clinical evaluations with additional major US
cancer centres and clinics this year, to be conducted in their growing network
of CAP and CLIA laboratories.
The Group already has a further licensing deal in China which is being
progressed as the supply of the Company's commercial antibodies increases. The
programme will commence after the first laboratory in the US has achieved CLIA
accreditation.
Funding
In April 2024 the Company successfully raised approximately £0.62 million
through an equity placing, as announced on 26 March 2024. The funds will be
utilised towards completing the Company's first proposed commercial test to
detect CIZ1B which will be used in the US through our partnership with BIO and
planned for full release in April 2025, to further protect the Company's
Intellectual Property, progress the Company's research with the University of
York and for general corporate purposes. The Company also terminated the
£500,000 loan facility agreement with E3 Fund SP that was entered into in
2022 and had not been drawn down. In May 2024 the Company received £78,000 in
respect of a non-refundable fee to grant Cizzle Bio an exclusivity period to
negotiate a licensing deal to Cizzle Bio throughout the USA and Canada.
Financial overview
During the six months ended 30 June 2024, the Company continued its focus on
being a healthcare diagnostics developer.
The financial results for the six months to 30 June 2024 are summarised as
follows:
· Other income and interest receivable: £79,000 (H1: £Nil)
· Corporate expenses, before exceptional items: £299,000 (H1 2023:
£342,000).
· Non-cash administrative expenses relating to:
o Share option charge: £120,000 (H1 2023: £115,000)
o Net fair value loss on financial asset: £1,081,000 (H1 2023: £Nil)
· Taxation credit: £10,000 (H1 2023: £26,000)
· Total comprehensive loss of £1,411,000 (H1 2023, Loss £431,000).
· Loss per share 0.37p, (H1 2023, Loss of 0.12p).
· Cash balances as at 30 June 2024: £484,000 (30 June 2023:
£451,000).
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 29
September 2024.
*https://www.cancerresearchuk.org/funding-for-researchers/research-opportunities-in-early-detection-and-diagnosis/early-detection-and-diagnosis-roadmap
Enquiries:
Cizzle Biotechnology Holdings plc Via IFC Advisory
Allan Syms (Executive Chairman)
Allenby Capital Limited +44(0) 20 33285656
John Depasquale/George Payne (Corporate Finance)
Stefano Aquilino/Amrit Nahal (Sales and Corporate Broking)
IFC Advisory Limited +44(0) 20 3934 6630
Tim Metcalfe
Florence Chandler
About Cizzle Biotechnology
Cizzle is developing a blood test to help in the early detection of lung
cancer. Based on the pioneering work of Professor Coverley and colleagues, at
the University of York, on a naturally occurring cell nuclear protein
involved in DNA replication called CIZ1, they discovered that a variant
called CIZ1B is highly associated with the presence of early-stage cancer. The
Company has now entered into commercial royalty bearing licensing agreements
and collaborations with leading centres of excellence in cancer for the use of
its proprietary technology as part of its strategy to bring its non-intrusive,
cost effective blood test to market. Cizzle was admitted to the Standard List
of the main market of the London Stock Exchange in May 2021.
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.
Condensed Consolidated Statement of Comprehensive Income
For the six months ended 30 June 2024
Group Group Group
Six months ended Six months ended Year ended
30 June 2024 30 June 2023 31 December 2023
Unaudited Unaudited Audited
Notes £'000 £'000 £'000
Revenue - - -
Cost of Sales - - -
Gross Profit - - -
Other income 78 - -
Interest receivable 1 - -
Administrative Expenses
-on-going administrative expenses (299) (342) (669)
-cost associated with put option - - (120)
-share option charge (120) (115) (307)
-gain on transfer of intangible asset - - 44
-net fair value loss on financial asset measured at fair value through profit (1,081) - (711)
or loss
Total administrative expenses including exceptional items (1,500) (457) (1,763)
Operating Loss and loss before income tax (1,421) (457) (1,763)
Income tax 3 10 26 46
Loss and total comprehensive income for the period attributable to the equity
shareholders of the parent
(1,411) (431) (1,717)
Earnings per share Loss- basic and diluted - pence 4 (0.37)p (0.12)p (0.5)p
Condensed Consolidated Statement of Financial Position
as at 30 June 2024
Group Group Group
30 June 30 June 31 Dec
2024 2023 2023
Unaudited Unaudited Audited
Notes £'000 £'000 £'000
Non-Current Assets
Intangible asset - 2,080 -
Total Non-Current Assets - 2,080 -
Current Assets
Investment held at fair value through profit or loss 5 332 - 1,413
Trade and other receivables 107 223 136
Cash and cash equivalents 484 451 144
Total Current Assets 923 674 1,693
Total Assets 923 2,754 1,693
Equity
Ordinary shares 3,507 3,504 3,504
Share premium 35,910 35,330 35,335
Share capital reduction reserve 10,081 10,081 10,081
Share option reserve 598 314 478
Reverse acquisition reserve (40,021) (40,021) (40,021)
Retained losses (9,281) (6,584) (7,870)
Total equity
794 2,624 1,507
Liabilities
Current liabilities
Trade and other payables 129 130 186
Total current liabilities 129 130 186
Total equity and liabilities 923 2,754 1,693
Condensed Consolidated Statement of Cash Flows
For the six months ended 30 June 2024
Group Group Group
6 Months 6 Months 12 Months
ended ended ended
30 June 30 June 31 Dec
2024 2023 2023
Unaudited Unaudited Unaudited
£'000 £'000 £'000
Cash flow from operating activities
(1,421) (457) (1,763)
Operating loss before tax
Adjustment for:
Movement on put option - - 120
Gain on transfer of intangible asset - - (44)
Net fair value loss on financial assets measured at fair value through profit 1,081 - 711
or loss
Share option charge 120 115 307
Operating cash flow before working capital movements (220) (342) (669)
(Increase) / Decrease in trade and other receivable (9) 30 (24)
Increase / (Decrease) in trade and other payables (55) (15) 13
Cash used in operations (284) (327) (680)
Tax received 46 - 41
Net cash used in operating activities (238) (327) (639)
Cash flow from financing activities
Proceeds from the issue of ordinary shares (net of issue costs) 578 300 305
Net cash inflow from financing activities 578 300 305
Net increase / (decrease) in cash and cash equivalents 340 (27) (334)
Cash and cash equivalents at the start of the period 144 478 478
Cash and cash equivalents at the end of the period 484 451 144
Condensed Consolidated Statement of Changes in Equity
For the six months ended 30 June 2024 (unaudited)
Group Ordinary Share Share Reverse Retained Total
Share Premium Capital Option Acquisition Losses
Capital Redemption Reserve Reserve
Reserve
£'000 £'000 £'000 £'000 £'000 £'000 £'000
At 1 January 2024 3,504 35,335 478 (40,021) (7,870) 1,507
10,081
Issue of shares for cash 3 648 - - - 651
-
Share issue costs - (73) - - - (73)
-
Share option charge - - - 120 - - 120
Total transactions with owners 3 575 120 - - 698
-
Comprehensive Loss for the Period - - - - (1,411) (1,411)
-
At 30 June 2024 3,507 35,910 598 (40,021) (9,281) 794
10,081
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 -
Condensed Consolidated Statement of Changes in Equity (continued)
For the year ended 31 December 2023 (Audited)
Group Ordinary Share Share Reverse Retained Total
Share Premium Option Acquisition Losses
Capital Reserve Reserve
Shares to be issued Capital
Redemption
Reserve
£'000 £'000 £'000 £'000 £'000 £'000 £'000
£'000
At 1 January 2023 3,502 34,917 199 (40,021) (6,153) 2,640
115 10,081
Registration of shares to be issued - 115 - - - -
(115) -
2 348 - - - 350
Issue of shares for cash
- -
Costs of share issue - (45) - - - (45)
- -
Share option charge - - 279 - - 279
- -
Total transactions with owners 2 418 279 - - 584
(115) -
Comprehensive Loss for the year - - - - (1,717) (1,717)
- -
At 31 December 2023 3,504 35,335 478 (40,021) (7,870) 1,507
- 10,081
Notes to the financial statements
For the six months ended 30 June 2024 (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 2023. The interim
report does not include all of the notes of the type normally included in an
annual financial report. Accordingly, this report is to be read in conjunction
with the annual report for the year ended 31 December 2023, which has been
prepared in accordance with UK-adopted international accounting standards and
the requirements of the Companies Act 2006, and any public announcements made
by the Company during the interim reporting period.
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 2024. The results for the
six-months ended 30 June 2024 are the Group results. The financial information
for the six months ended 30 June 2024 is unaudited and does not constitute
statutory financial statements for those periods. The financial information
for the year ended 31 December 2023 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 2023.
1.1. Going concern
The interims financial statements have been prepared on a going concern basis
which the directors consider to be appropriate as the directors are confident
that the Group and Company will have sufficient funds to continue to meet its
liabilities as they fall due for at least 12 months from the date of approval
of these financial statements.
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 £10,000 for the six months ended 30 June 2024
relates to accrued income for the recovery of tax on qualifying research and
development expenditure. For the six months ended 30 June 2023 there was
income tax credit of £26,000 and a credit of £46,000 for the year ended 31
December 2023.
4. Earnings per share
Group Group Group
6 months 6 months Year
ended ended ended
30 June 2024 30 June 2023 31 December 2023
Basic loss per share:
Total comprehensive loss - £'000 (1,411) (431) (1,717)
Weighted number of Ordinary Shares - '000 378,328 347,765 355,861
Loss per share - operations - pence (0.37p) (0.12p) (0.5p)
As the Group result for the six months ended 30 June 2024, 30 June 2023 and
year ended 31 December 2023 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. Current assets
Included within current assets is an investment held at value through profit
or loss that had a market value at 30 June 2024 of £332,000 (30 June 2023:
£nil). At 31 December 2023 the market value of this investment was
£1,413,000 and during the 6 months to 30 June 2024 there has been a decrease
in the value of £1,081,000 which has been accounted for within the
Consolidated Statement of Comprehensive Income. As noted in the group
accounts to 31 December 2023 the Company exercised, in September 2023. a Put
Option to acquire £3,250,000 payable in shares in Conduit Pharmaceuticals
Inc, a company that was subsequently listed on NASDAQ during December 2023.
The Put Option arose in December 2022 when the Company agreed to sell its:
i) 5% economic interest in the commercialisation of
the AZD 1656 asset to treat inflammatory pulmonary and cardiovascular disease;
and
ii) Its royalty sharing agreement with St George Street
Capital, a UK-based biomedical charity
to Conduit Pharmaceuticals Limited.
6. 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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