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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