CHAIRMAN'S STATEMENT

I am pleased to report Roquefort Therapeutics' audited financial statements and strategic progress to shareholders for the year ended 31 December 2023. During the period the Company continued to progress its corporate strategy, which is to identify the next generation of medicines for the most difficult to treat cancers with a high mortality rate, develop medicines in-house and with academic partners through the pre-clinical phase to clinical trial readiness and IND filing stage before licensing or sale to big pharma.

 

Diagnostic Licencing Agreement

2023 started with significant momentum, with the Group's Midkine antibody program, targeting metastatic breast cancer and metastatic lung cancer, successfully demonstrating in vivo safety in pre-clinical development programs carried out by leading cancer research groups. Notably in February, Roquefort Therapeutics validated Midkine as a target by signing a Licence and Royalty Agreement with Randox Laboratories ("Randox") in relation to the Group's Midkine antibody portfolio. In FY23 the Company received an upfront non-refundable payment of £200,000, with further milestone payments expected in 2024 and royalty payments expected to commence in 2025. Randox is developing a diagnostic to identify patients with cancers that overexpress Midkine which is highly synergistic with Roquefort Therapeutics' development of first-in-class cancer medicines. Roquefort Therapeutics and Randox are also collaborating in research programs to identify new diagnostics for Midkine overexpressed cancers that may be treatable with the Company's Midkine therapeutics.

 

To help drive drug development programs forward, in March 2023, the Company formed a Scientific Advisory Board, working closely with Chief Scientific Officer Professor Sir Martin Evans. The Scientific Advisory Board is comprised of experienced Professors Jo Martin, Trevor Jones and Armand Keating, who together are a team of researchers, biopharmaceutical innovators and clinicians with an emphasis on linking pre-clinical research, clinical trials, production of medicines and the care of patients. The Company is utilising their drug development expertise to complete pre-clinical development to reach key milestones and realise the value of the IP retained within the Company's portfolio, either via licensing transactions or a clinical program sale.

 

Pre-clinical Development

The Roquefort Therapeutics portfolio consists of novel patent protected pre-clinical anti-cancer medicines, consisting of five best in class medicines:

·     Midkine antibodies with significant in vivo efficacy and toxicology studies, and orphan drug indication;

·     Midkine RNA oligonucleotide therapeutics with novel anti-cancer gene editing action;

·     Midkine mRNA therapeutics targeting solid tumours;

·     STAT-6 siRNA therapeutics targeting solid tumours with significant in vivo efficacy; and

·     MK cell therapy with direct and Natural Killer cell-mediated anti-cancer action.

 

The Company continued the encouraging pre-clinical development seen in 2022 throughout 2023. In June we completed with our research partners, the Olivia Newton John Cancer Research Institute and Hawkins Laboratory at La Trobe University, Melbourne, the first in vivo efficacy results for our anti-Midkine patented antibodies CAB-101 (ROQA2) and CAB-102 (ROQA1). The in vivo efficacy study tested the anti-cancer killing ability of CAB-101 and CAB-102 in a validated experimental model of osteosarcoma, a third indication. Treatment with CAB-101 was found to produce a statistically significant reduction in lung metastasis, and CAB-102 was found to reduce proliferation of the primary tumour. Osteosarcoma is our third indication in the anti-Midkine antibody program and our first orphan drug indication.

 

Osteosarcoma is the Company's first orphan drug indication and reflects the strategic decision to target cancer niches in which there remains a high unmet clinical need, an accelerated development pathway and the potential to offer a best-in-class treatment in a significant market niche. There are commercial benefits to an orphan drug indication such as market exclusivity for 7 years in the USA and up to 10 years in the UK and EU, tax credits for the clinical drug testing cost and fee reductions.

 

In March 2023 we announced that Roquefort Therapeutics had enhanced the portfolio with the creation of a new novel family of mRNA Therapeutics. This new platform of mRNA therapeutics was developed within budget internally and consists of four mRNA pre-clinical therapeutics targeting Roquefort Therapeutics' novel Midkine target. In June we achieved positive in vivo results in our anti-cancer mRNA therapeutic in breast and liver cancer, where the studies demonstrated a statistically significant reduction in both cancer growth and migration. We further consolidated our leadership position in the Midkine field by updating our filed patents to protect the mRNA compositions and methods. The Company is particularly excited about this program because the mRNA cancer market is a highly attractive new field of medicine (~$31 billion, 7.8% CAGR) and is led by Pfizer, Moderna and BioNTech. Roquefort Therapeutics is well positioned in this field, with four mRNA sequences that uniquely target Midkine. The Company completed in vivo studies in March 2024 with positive results (refer Post Period End section for further details).

 

In June 2023, our anti-cancer Midkine RNA oligonucleotide program targeting Midkine expressing cancers showed further pre-clinical progress having produced >90% in vitro efficacy in human liver and neuroblastoma cancer cells. The studies were conducted with the Company's strategic research partnerships at the Faculty of Medicine and Health at the University of Sydney and the Immune Oncology Laboratory at the School of Biomedical Sciences, University of New South Wales. The Company believes liver cancer to be an attractive market niche with the global liver cancer drug market estimated at US$2.4 billion in 2022 and is projected to reach US$9.3 billion by 2030, at a CAGR of 18.6% according to the market research firm Research And Markets in February 2023.

 

The achievements of 2023 have enabled Roquefort Therapeutics to develop a highly synergistic approach to the target, Midkine. Our proprietary combination of RNA oligonucleotides attacks a different Midkine region versus our antibodies and mRNA, and this diversity of targeting regions may be helpful in developing mono or combination therapies going forward, which has potential commercial appeal.

 

Following the acquisition of Oncogeni in September 2022, which pivoted Roquefort Therapeutics into a material oncology group, the Company acquired two families of innovative cell and RNA oncology medicines, both in pre-clinical development, Mesodermal Killer ("MK") cells and small interfering RNA ("siRNA") therapeutics. Both programs saw progress during 2023.

 

In August 2023, Roquefort Therapeutics announced the development of new novel siRNA therapeutics and strengthened the IP position with a new patent filing for the novel anti-cancer siRNA therapeutics. Professor Graham Robertson, Vice President of Drug Discovery developed four additional siRNA sequences to complement the existing siRNA portfolio. These sequences are being developed in combination with nano-particle delivery systems to target the hard-to-treat, high mortality solid cancers including colon and breast cancer. In March 2024 we announced that in validated in vitro models of colon cancer, results demonstrated efficacy in four new siRNA sequences in reducing STAT-6 expression by 40-50% (refer Post Period End section). The Company is encouraged by the commercial potential of its siRNA targets STAT-6 and SH2, following Sanofi's (NASDAQ: SNY) licencing transaction with Recludix which included a US$125 million upfront payment, and total deal of up to US$ 1.2 billion for a pre-clinical program targeting STAT-6 and SH2. Roquefort Therapeutics is particularly encouraged by this as our siRNA programs are also in pre-clinical development and target STAT-6 and the SH2 domain and have shown significant in vitro anti-cancer activity.

 

The Company announced in November 2023 that its proprietary novel MK cell program reached a significant preclinical milestone during the period. MK cells were tested in combination with Natural Killer cells ("NK cells"). The activation of NK cells produced up to a two-fold increase in cytotoxicity over NK cells alone in three difficult to treat cancers: ovarian cancer, acute myeloid leukaemia and multiple myeloma. The Company believes this demonstration of the activation of NK cells in multiple cancers is a significant milestone because the NK cell activation is a highly attractive modality for large pharmaceutical companies. Recent transactions in this promising market include the $1.4 billion partnership between Sanofi and Innate Pharma announced in December 2022 and >$300 million Gilead and Dragonfly Therapeutics transaction in May 2022 for Dragonfly's proprietary activators of NK cells. The Company's MK cells progressed into further in vivo studies in validated models of NK cell activation and cancer cytotoxicity with positive results announced in February 2024 (refer Post Period End section for further details).

 

Out-Licencing Discussions (Therapeutics)

In line with our strategy, the Company commenced confidential out-licencing discussions with potential partners in 2023, including large pharmaceuticals companies and a specialist private equity fund. The programs and jurisdictions being negotiated include the Midkine antibodies and STAT-6 siRNA programs, and relate to licences for the US, Europe and Japan markets.

 

Post Period End

During the first quarter of 2024 the Company made further progress across its pre-clinical drug development program with positive results reported for the MK cell therapy program (February 2024) and the Midkine mRNA and STAT-6 siRNA programs (March 2024):

 

·     MK Cell Therapy: the Company continued studies in validated models of NK cell activation and cytotoxicity and demonstrated an anti-cancer effect in leukaemia. This efficacy was superior to NK cells alone confirming that the MK cells activate NK cells. NK cell activation is a new field with high commercial potential in which large pharmaceutical partners completed significant deals in 2022 and 2023;

·     Midkine mRNA: the latest experiments combined the mRNA with a LNP delivery system in a validated in vivo model of liver cancer and demonstrated the safety and efficacy in reducing functional Midkine of the novel mRNA LNP combination. This represents a significant milestone in both the discovery of a novel mRNA therapeutic and in the safe combination with an LNP to allow for the delivery of the mRNA as an anti-cancer medicine; and

·     STAT-6 siRNA: the Company continued the development of its novel STAT-6 medicines in validated in vitro models of colon cancer with the results demonstrating efficacy of the four new siRNA sequences in reducing STAT-6 expression by 40-50%.

 

The Company continued to engage in confidential out-licencing discussions with potential partners and the Company will make an announcement should a binding agreement be reached with one or more partners.

 

Strategy & Outlook

Through the material strategic progress delivered over the course of FY2023, Roquefort Therapeutics is looking to build on its successful pre-clinical development of its five pre-clinical programs to deliver at least one out-licencing transaction during 2024. We believe that during 2023 we have delivered on our strategy to select and acquire novel medicines and to develop them to reach significant milestones, and to a level that attracts interest from potential licencing partners.

 

Roquefort Therapeutics is well positioned in this market to create shareholder value by securing a licencing deal, with newly validated targets (like STAT-6 and Midkine) novel modalities (like siRNA, mRNA and cell therapy) garnering high deal values because they offer the potential to create first-in-class medicines which have a greater likelihood of generating blockbuster (multi-billion dollar) revenues. Our strategy fits this paradigm, whereby we create significant value by discovering these first-in-class medicines before the market recognises them and enhance their value with targeted R&D to optimise the appeal to Big Pharma. Our portfolio has interest from Big Pharma and private equity, and in line with our strategy, we remain in discussions with these potential partners.

 

The Chairman's Statement should be read as part of the Strategic Report.

 

Stephen West, Executive Chairman

25 April 2024

 

DIRECTORS' REPORT

The Directors present their report with the audited financial statements of Roquefort Therapeutics plc ("the Company") and its subsidiaries Lyramid Pty Limited ("Lyramid"), Oncogeni Ltd ("Oncogeni") and Tumorkine Pty Limited ("Tumorkine") (together "the Group") for the year ended 31 December 2023. A commentary on the business for the year is included in the Chairman's Statement. A review of the business is also included in the Strategic Report.

 

The Company's Ordinary Shares are listed on the London Stock Exchange, on the Official List pursuant to Chapter 14 of the Listing Rules, which sets out the requirements for Standard Listings.

 

Directors

The Directors of the Company during the year and their beneficial interest in the Ordinary shares of the Company at 31 December 2023 were as follows:

Director	Position	Appointed	Ordinary shares	Warrants
Stephen West1	Executive Chairman	17/08/2020	5,616,501	7,000,000
Ajan Reginald	Chief Executive Officer	16/09/2022	11,663,051	-
Sir Martin Evans	Chief Scientific Officer	16/09/2022	-	-
Dr Michael Stein	Non-Executive Director	22/03/2021	-	2,000,000
Ms Jean Duvall	Non-Executive Director	05/04/2022	-	300,000
Dr Simon Sinclair2	Non-Executive Director	20/04/2022	96,336	300,000
Dr Darrin Disley	Non-Executive Director	16/09/2022	1,495,901	-

¹4,628,485 Ordinary shares and 7,000,000 warrants held by Cresthaven Investments Pty Ltd ATF The Bellini Trust (a Company related to Stephen West)

² 300,000 warrants held by Livingstone Investment Holdings Ltd; and 60,415 Ordinary shares were held by Simon Sinclair direct

 

Qualifying Third Party Indemnity Provision

At the date of this report, the Company has a third-party indemnity policy in place for all Directors.

 

Substantial shareholders

As at 31 December 2023, the total number of issued Ordinary Shares with voting rights in the Company was 129,149,998. Details of the Company's capital structure and voting rights are set out in note 19 to the financial statements.

 

The Company has been notified of the following interests of 3 per cent or more in its issued share capital as at the date of approval of this report.

Party Name	Number of Ordinary Shares	% of Share Capital
Ajan Reginald	11,663,051	9.00%
Abdelatif Lachab	7,750,000	6.00%
Jane Whiddon1	7,300,000	5.65%
M Sheikh	5,744,870	4.45%
Stephen West2	5,616,501	4.35%
Provelmare Holding Ltd	5,000,000	3.87%
Z Sheikh	4,018,910	3.11%
M Rollins	4,000,000	3.10%
K Fallon	3,905,215	3.02%

 

 

¹ 2,500,000 shares held by MIMO Strategies Pty Ltd (ATF the MIMO Trust); 4,100,000 shares held by 6466 Investments Pty Ltd; 700,000 shares held by Nautical Holdings WA Pty Ltd - all of which are entities controlled by J Whiddon

² 4,628,485 shares held by Cresthaven Investments Pty Ltd ATF the Bellini Trust (a Company related to Stephen West)

 

Financial instruments

Details of the Company's financial risk management objectives and policies as well as exposure to financial risk are contained in the accounting policies and note 22 of the financial statements.

 

Greenhouse Gas (GHG) Emissions

The Group is aware that it needs to measure its operational carbon footprint in order to limit and control its environmental impact. However, due to its operational footprint being limited to a laboratory leased from September 2022 to 31 December 2023, consuming less than 40,000 kWh of energy, the Group is currently exempt from GHG reporting requirements.

 

In the future, the Group will only measure the impact of its direct activities, as the full impact of the entire supply chain of its suppliers cannot be measured practically.

 

TCFD Disclosure

The Group operated a leased lab facility from October 2022 until the agreement expired in December 2023. From this point the Group outsourced laboratory work and does not intend to lease another facility in 2024. The Group will therefore begin to consider its impact on the environment and the risks it faces from climate change, for the first time during 2024 and expects to develop its sustainability plans over a 5 year period, commensurate with the size of its operations. Climate change was not considered a principal risk or uncertainty for the year ended 31 December 2023.

 

In line with the requirements of the Financial Conduct Authority's Listing Rule 14.3.27R, and for the above reasons, we note that we have not made the disclosures, in respect of the financial year ended 31 December 2023, in line with the recommendations and recommended disclosures of the TCFD.

 

Dividends

The Directors do not propose a dividend in respect of the year ended 31 December 2023.

 

Research and development, Future developments and events subsequent to the year end

Further details of the Company's research and development, future developments and events subsequent to the year-end are set out in the Strategic Report. Research and development costs incurred for the year ended 31 December 2023 were £620,159 (2022: £319,315).

 

Corporate Governance

The Governance Report forms part of the Director's Report.

 

Going Concern

The Directors have prepared financial forecasts to estimate the likely cash requirements of the Group over the period to 30 June 2025, given its stage of development and lack of recurring revenues. In preparing these financial forecasts, the Directors have made certain assumptions with regards to the timing and amount of future expenditure over which they have control. The Directors have considered the sensitivity of the financial forecasts to changes in key assumptions, including, among others, potential cost overruns within committed spend, ability to raise new funding and changes in exchange rates.

 

The Group's available resources are sufficient to cover the Group's plans to complete existing pre-clinical development activities during 2024, however, they are not sufficient to cover existing committed costs and the costs of planned activities for at least 12 months from the date of signing these consolidated and company financial statements.

 

The Directors plan to raise further funds during 2024 (either through licencing deals and/or other financing arrangements) and have reasonable expectations that sufficient cash will be raised (either through licencing deals and/or other financing arrangements) to fund the planned operations of the Group for a period of at least 12 months from the date of approval of these financial statements. The funding requirement indicates that a material uncertainty exists which may cast significant doubt over the Group's and Company's ability to continue as a going concern, and therefore its ability to realise its assets and discharge its liabilities in the normal course of business.

 

After due consideration of these forecasts, current cash resources, including the sensitivity of key inputs and success in raising new funding the Directors consider that the Group will have adequate financial resources to continue in operational existence for the foreseeable future (being a period of at least 12 months from the date of this report) and, for this reason, the financial statements have been prepared on a going concern basis. The financial statements do not include the adjustments that would be required should the going concern basis of preparation no longer be appropriate.

 

Principal Activities

The Company's principal activity in the reporting period was the pre-clinical development of next generation medicines focused on hard-to treat cancers.

 

Auditors

On 23 November 2023, BDO LLP resigned as the Group's auditors and confirmed that there were no circumstances connected with their resignation which they considered should be brought to the attention of the Company's members or creditors in accordance with Section 519 of the Companies Act 2006.

 

On 23 November 2023 it was announced that the Company had appointed RPG Crouch Chapman LLP as its auditors with immediate effect. The appointment of RPG Crouch Chapman LLP will be subject to approval by shareholders at the next Annual General Meeting of the Company.

 

Statement of Directors' responsibilities

The Directors are responsible for preparing the Annual Report alongside the financial statements in accordance with applicable law and regulations.

 

Company law requires the Directors to prepare financial statements for each financial year. Under that law the Directors have prepared the financial statements in accordance with UK adopted International Accounting Standards.

 

Under company law the Directors must not approve the financial statements unless they are satisfied that they give a true and fair view of the state of affairs of the Company and of the profit or loss of the Company for that year. The Directors are also required to prepare financial statements in accordance with the rules of the London Stock Exchange for companies with a Standard Listing.

 

In preparing these financial statements, the Directors are required to:

·     Select suitable accounting policies and then apply them consistently;

·     Make judgements and accounting estimates that are reasonable and prudent;

·     State whether applicable UK adopted International Accounting Standards have been followed, subject to any material departures disclosed and explained in the financial statements; and

·     Prepare the financial statements on the going concern basis unless it is inappropriate to presume that the Company will continue in business.

 

The Directors are responsible for keeping adequate accounting records that are sufficient to show and explain the Company's transactions and disclose with reasonable accuracy at any time the financial position of the Company and enable them to ensure that the financial statements and the Remuneration Committee Report comply with the Companies Act 2006. They are also responsible for safeguarding the assets of the Company and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities. They are also responsible to make a statement that they consider that the annual report and accounts, taken as a whole, is fair, balanced, and understandable and provides the information necessary for the shareholders to assess the Company's position and performance, business model and strategy.

 

The Directors are responsible for the maintenance and integrity of the corporate and financial information included on the Company's website. Legislation in the United Kingdom governing the preparation and dissemination of the financial statements may differ from legislation in other jurisdictions.

 

Statement of Directors' responsibilities pursuant to Disclosure and Transparency Rules

Each of the Directors confirm that, to the best of their knowledge and belief:

·     the financial statements prepared in accordance with UK adopted International Accounting Standards, give a true and fair view of the assets, liabilities, financial position and loss of the Group and Company; and

·     the Annual Report and financial statements, including the Strategic Report, includes a fair review of the development and performance of the business and the position of the Group and Company, together with a description of the principal risks and uncertainties that they face.

 

Disclosure of Information to Auditors

So far as the Directors are aware, there is no relevant audit information of which the Company's auditors are unaware, and each Director has taken all the steps that they ought to have taken as a Director in order to make themselves aware of any relevant audit information and to establish that the Company's auditors are aware of that information.

 

This directors' report was approved by the Board of Directors on 25 April 2024 and is signed on its behalf by Stephen West, Executive Chairman

 

STRATEGIC REPORT

The Directors present the Strategic Report of the Company and the Group for the year ended 31 December 2023.

 

Section 172(1) Statement - Promotion of the Company for the benefit of the members as a whole

The Directors believe they have acted in the way most likely to promote the success of the Company for the benefit of its members as a whole, as required by s172 of the Companies Act 2006.

 

The requirements of s172 are for the Directors to:

·     Consider the likely consequences of any decision in the long term;

·     Act fairly between the members of the Company;

·     Maintain a reputation for high standards of business conduct;

·     Consider the interests of the Company's employees;

·     Foster the Company's relationships with suppliers, customers and others; and

·     Consider the impact of the Company's operations on the community and the environment.

 

We aim to work responsibly with our stakeholders, including suppliers. The key Board decisions made in the year and post year end are set out below:

 

Significant events / decisions	Key s172 matter(s) affected	Actions and Consequences
Entering into a licence	Shareholders and Business	The Group entered into a
agreement with Randox	Relationships	material sales contract with Randox to licence out its technology for diagnostics. The agreement is intended to generate another revenue stream from diagnostics for the Group.
Portfolio optimisation	Shareholders and Business Relationships	The Group constantly monitors the commercial viability of its programmes to ensure that the optimum mix is carried forward.

 

Interests of Employees

The Company's Governance Report sets out (under board responsibilities) the processes in place to safeguard the interests of employees.

 

Foster business relationships with suppliers, joint venture partners and others

Potential suppliers and joint venture partners are considered in the light of their suitability to comply with the Company's policies.

 

Impact of operations on the community and environment

The Company will continue to monitor the future impact of any new potential research facilities on the community and environment.

 

Maintain a reputation for high standards of business conduct

The Governance Report sets out the Board and Committee structures and Board and Committee meetings held during the year, together with the experience of executive management and the Board and the Company's policies and procedures.

 

Act fairly between members of the Company

The Board takes feedback from a wide range of shareholders (large and small) and endeavours at every opportunity to pro-actively engage with all shareholders (via regulatory news reporting-RNS) and engage with any specific shareholders in response to particular queries they may have from time to time. The Board considers that its key decisions during the year have impacted equally on all members of the Company.

 

Review of Business in the Year

Operational Review

The Company's principal activity is set out in the Directors' Report.

 

During the year, the Company continued to progress its novel patent protected pre-clinical anti-cancer medicines through a combination of partnerships with leading academic cancer research centres and at the Company's state of the art laboratory in Stratford-upon-Avon.

 

In February 2023, Roquefort Therapeutics validated Midkine as a target by signing a Licence and Royalty Agreement with Randox Laboratories ("Randox") in relation to the Group's Midkine antibody portfolio. In FY23 the Company received an upfront payment of £200,000, with further milestone payments expected in 2024 and royalty payments expected to commence in 2025. Randox is developing a diagnostic to identify patients with cancers that overexpress Midkine which is highly synergistic with Roquefort Therapeutics' development of first-in-class cancer medicines.

 

During 2023, the Group completed pre-clinical development programs with the following leading academic cancer research centres:

·     Olivia Newton-John Cancer Research Institute, La Trobe University, Melbourne

o Breast cancer metastasis antibody programs: in vivo safety was successfully demonstrated in January 2023.

·     Lowy Cancer Research Centre, University of New South Wales

o Liver and Colorectal cancer Midkine RNA and STAT-6 siRNA programs: the in vitro Midkine RNA oligonucleotide study confirmed in June 2023 that the Company's novel anti-sense oligonucleotides produced a novel non-functional Midkine protein that has been shown to produce >90% in vitro efficacy (at the mRNA level) in human liver cancer and neuroblastoma cancer cells.

·     Hawkins Laboratory Biochemistry and Genetics, La Trobe University, Melbourne

o Lung cancer metastasis antibody programs: in vivo safety was successfully demonstrated in January 2023, and in vivo efficacy results were released in June 2023 which showed a statistically significant reduction in lung metastasis, and a reduced proliferation (growth rate) of the primary tumour. The efficacy study was carried out in a validated experimental model of osteosarcoma.

·     School of Medical Sciences, University of Sydney

o Midkine RNA programs: in June 2023 a proprietary combination of the Company's Midkine RNA oligonucleotides demonstrated in vitro efficacy in hepatocellular carcinoma (HCC) liver cancer cells producing a significant reduction in full length Midkine and generated a novel non-functional Midkine.

 

In March 2023 the Company announced the successful development of a new novel platform of anti-cancer mRNA therapeutics, being the Company's fifth program and the third in its Midkine family. In June 2023 the Company successfully completed in vitro studies for the anti-cancer mRNA therapeutic in breast and liver cancer. The studies demonstrated a statistically significant reduction in both proliferation (cancer growth) and migration.

 

In August 2023 the Company announced the successful development of new siRNA sequences and new patent filing for its family of novel anti-cancer siRNA therapeutics. The new siRNA sequences expanded the Company's portfolio of siRNA medicines that attack the targets STAT-6 (Signal Transducer and Activator of Transcription) and its SH2 (Src-homology-2) domain.

 

During the year the Company tested its MK cells in combination with natural killer ("NK") cells with positive results, announced in November 2023, showing: (1) the activation of NK cells; and (2) that this activation produced up to a two-fold increase in cytotoxicity over NK cells alone in three different difficult to treat cancers, which was statistically significant.

 

Events since the year end

There have been no significant events subsequent to 31 December 2023.

 

Financial review

Results for the year to 31 December 2023

The Consolidated Statement of Comprehensive Income for the year shows a loss of £1,744,540 (2022: loss of £1,615,417) and the Consolidated Statement of Financial Position at 31 December 2023 shows net equity of £5,499,543 (2022: £7,206,636) for the Group.

 

The total comprehensive loss for the year of £1,717,495 (2022: loss of £1,630,406) occurred as a result of on-going research and development costs and administrative expenses required to operate the Company.

 

The Group generated £200,000 (2022: £0) in revenue from an exclusive licence and royalty agreement, for its technology to be used in medical diagnostics. The revenue was recorded under IFRS 15 in which Group recognised milestone revenue upon the completion of certain milestones. The initial amount represents the £200,000 non-refundable deposit with the remainder of the revenue to be received subject to certain commercial and technical milestones.

 

Administrative expenses increased to £1,499,193 (2022: £1,306,561) mainly due to Directors' and employee costs increasing to £1,087,947 (2022: £573,538), consulting and professional fees increasing to £217,876 (2022: £209,768) reflecting an increase in staff and operational activities during the year. Research and development expenditure increased to £620,159 (2022: £319,315) as the Group carried out external studies with the University of Western Sydney for the Midkine RNA oligonucleotide pre-clinical program in the first half of the year and commenced internal and external studies on the other programs later in the year.

 

Cash flow

Net cash outflow for the Group for 2023 was £1,786,164 (2022: £1,421,258 inflow).

 

Net cash used in investing activities for 2023 decreased to £52,573 (2022: £103,478). In 2023 this activity was for the purchase of fixed assets, whereas the 2022 figure relates to the acquisition of Oncogeni Ltd. There were no business acquisitions in the current year.

 

Net cash used in financing activities for 2023 was £58 (2022: £3,121,202 inflow). The 2022 figure reflects the receipt of proceeds from an equity placement undertaken in December 2022 for the acquisition of Oncogeni Ltd. There were no fundraising events in the current year.

 

Closing cash

As at 31 December 2023, the Group held £537,322 (2022: £2,322,974) of cash.

 

Key Performance Indicators

The Company's non-financial KPIs are positive R&D results within the existing pre-clinical portfolio, the development of new novel anti-cancer therapeutics, the registration of new patents to protect the clinical advancements in anti-cancer therapeutics being achieved during the pre-clinical stages of drug discovery and entering into licencing deals with other companies.

 

The Company's financial KPIs are the Company's cash runway and budgeted R&D spend compared to actuals.

 

Position of Company's Business

At the year end

At the year end the Company's Statement of Financial Position shows net assets totalling £5,981,627 (2022: £7,481,379). It is likely the Company will need to raise further funds (either through licencing deals and/or other financing arrangements) to cover its plans to complete existing pre-clinical development activities and complete licencing negotiations. As at reporting date the Directors are confident in their ability to raise further funds either through licencing deals and/or other financing arrangements.

 

Environmental matters

The Board contains personnel with a good history of running businesses that have been compliant with all relevant laws and regulations and there have been no instances of non-compliance in respect of environmental matters.

 

Employee information

As at the date of this report, the Company has an Executive Chairman, two Executive Directors and four Non-Executive Directors. The Company is committed to gender equality and, as future roles are identified, a wide-ranging search would be completed with the most appropriate individual being appointed irrespective of gender.

 

A split of our employees and directors by gender at the date of this report, is shown below:

 

	Male	Female
Directors	6	1
Employees	1	1
Total employees (including directors)	7	2

 

Social/Community/Human rights matters

The Company ensures that employment practices take into account the necessary diversity requirements and compliance with all employment laws. The Board has experience in dealing with such issues and sufficient training and qualifications to ensure they meet all requirements.

 

Anti-corruption and anti-bribery policy

The government of the United Kingdom has issued guidelines setting out appropriate procedures for companies to follow to ensure that they are compliant with the UK Bribery Act 2010. The Company has conducted a review into its operational procedures to consider the impact of the Bribery Act 2010 and the Board has adopted an anti- corruption and anti-bribery policy.

 

Principal Risks and Uncertainties

The Group operates in an uncertain environment and is subject to a number of risk factors. The Directors consider the following risk factors are of particular relevance to the Group's activities although it should be noted that this list is not exhaustive and that other risk factors not presently known or currently deemed immaterial may apply.

 

Issue	Risk/Uncertainty	Mitigation
The Group is not breakeven and there is no guarantee that it will generate significant profits in the near future	The generation of revenues is difficult to predict and there is no guarantee that the Group will generate significant revenues in the foreseeable future. The Group will face risks frequently encountered by pre-revenue businesses looking to bring new products to the market. There is also no guarantee that the intellectual property held will ultimately result in a commercially viable product. It is also possible that technical and/or regulatory hurdles could lengthen the time required for the delivery of such a product. The Group's future growth will also depend on its ability to secure commercialisation partnerships on appropriate terms, to manage growth and to expand and improve operational, financial and management information, quality control systems and its commercialisation function on a timely basis, whilst at the same time maintaining effective cost controls.	The CEO actively manages the commercial activities of the Group as it develops. The CEO and the Directors oversee the progress of the development of the Group's research programs and associated technologies and ensure funding is in place to support the necessary trials and further development steps as these come on stream.
Research and development risks carry technical risks, including the programs undertaken by the Group and there is no guarantee that these technical risks can be effectively overcome, and a successful, approved product can be developed	All therapeutic research and development programs carry technical risks, including the programs undertaken by the Group. These risks include: those associated with delays in development of effective and potent drugs; failure of delivery by third party suppliers of research services or materials essential to the programs; and outcomes of clinical testing. There is no guarantee that these technical risks can be effectively overcome, and a successful, approved product can be developed. Furthermore, the Group is pursuing relatively new drug classes. Whilst several examples of approved drugs now exist in these classes, as yet no such drug has been developed for the Group's targets. There is a risk that these novel classes of drugs may not be an effective way of modulating the target's expression to exert appropriate clinical benefit in the target conditions.	The Directors engage in continuous dialogue with the CEO and senior scientific staff to critically review the technical risks. The Board has established a Scientific Advisory Board to support them in this review process.
Biotechnology programs are subject to the most stringent                regulatory oversight by various government agencies and ethics committees and there is no guarantee that the proposed development work will result in an efficacious treatment, or even if it does, that the drug will be approved by regulatory authorities	Key regulatory focus areas are safety and efficacy, and future clinical trials conducted by the Group may be suspended or abandoned entirely in the event that regulatory agencies consider that continuation of these trials could expose participants to undue risks. Before obtaining regulatory approval of a product for a target indication, substantial evidence must be gathered in controlled clinical trials that the product candidate is safe and effective for use for that clinical setting. Similar approvals must be obtained from the relevant regulatory authorities in each country in which the product may be made available, including Australia, US and the EU.	The Scientific Advisory Board will be critical in supporting the Board in understanding and mitigating these risks. Even so, a sudden unforeseen change in the regulations could have a material adverse impact on the development program. The Group cannot guarantee that the proposed development work will result in an efficacious treatment, or even if it does, that the drug will be approved by regulatory authorities.
Even where the Group is successful in terms of technical and regulatory approvals, there is no guarantee it will be successful in securing an appropriate licensing deal or in achieving alternative means of commercialising its drugs	There may be other companies developing effective treatments for the same conditions as the Group, which could make commercialising any drug more difficult. The research and development programs planned are expected to take several years before any drug might be ready and the market for such drugs may contract significantly or become too competitive for an economically viable drug launch. In addition, even post regulatory approval, any drug may need to be withdrawn from the market, as well as expose the Group to claims for compensation as a result of serious adverse events associated with the treatment. Historically, very few drugs make it from discovery to regulatory approval and commercialisation.	The CEO and certain Board members have extensive experience in developing products to pre-IND and completing licencing deals. The Board is in continuous dialogue with the CEO regarding ongoing licencing discussions.
Existing patents and licences are subject to the terms and conditions of the relevant licence agreement which could be terminated for non-compliance with the terms of such licence agreement	The Group's subsidiary Lyramid Pty Ltd operates its Midkine antibody research and development programs under a worldwide, licence agreement with Anagenics Ltd, the owner of the Midkine patents. Similarly, the Group's subsidiary Oncogeni Ltd operates its MK Cell and siRNA programs under worldwide licencing agreements with Cell Therapy Limited and Sirna Limited respectively. Whilst the Group is currently compliant, there is a risk that the rights to these patents, as defined by the relevant licence agreement, will be forfeited by virtue of either party failing to meet licence conditions.	The CEO has a good understanding of the details of the licence agreements and the Group's obligations under them. Should any areas of concern arise, legal counsel will be sought before further steps are taken.
The Group's ability to compete will depend in part, upon the successful protection of its intellectual property, in particular its patents and know-how	Filing, prosecuting and defending patents in all countries throughout the world would be prohibitively expensive. It is possible that competitors will use the technologies in jurisdictions where the Group has not registered patents.	The Group seeks to protect its intellectual property through the filing of patent applications, as well as robust confidentiality obligations on its employees. The Board intends to defend the Group's intellectual property vigorously, where necessary through litigation and other means.
The successful operation of the Group will depend partly upon the performance and expertise of its current and future management and employeesz	The loss of the services of certain of these members of the Group's key management, including Ajan Reginald, the CEO, or the inability to identify, attract and retain a sufficient number of suitably skilled and qualified employees may have a material adverse effect on the Group. Any future expansion of the Group may require considerable management time which may in turn inhibit management's ability to conduct the day to day business of the Group.	The CEO and Executive Chairman hold shares in the Company representing 9% and 4.3% respectively of the issued capital. In addition, the Group offers incentives to Directors and employees through share warrants, which makes them linked to the long-term success of the business.
The further operations of the Group will depend on its ability to raise further funds through either equity markets or licence revenue deals	Pre-revenue companies are dependent on their ability to raise additional funds or generate profits in the future to continue operations.	The CEO and Chairman have extensive experience in both the capital markets and Bio-technology sector and are confident in their abilities to raise additional fundings or revenue.

 

Composition of the Board

A full analysis of the Board, its function, composition and policies, is included in the Governance Report.

 

Capital Structure

The Company's capital consists of ordinary shares which rank pari passu in all respects which are traded on the Standard segment of the Main Market of the London Stock Exchange. There are no restrictions on the transfer of securities in the Company or restrictions on voting rights and none of the Company's shares are owned or controlled by employee share schemes. There are no arrangements in place between shareholders that are known to the Company that may restrict voting rights, restrict the transfer of securities, result in the appointment or replacement of Directors, amend the Company's Articles of Association or restrict the powers of the Company's Directors, including in relation to the issuing or buying back by the Company of its shares or any significant agreements to which the Company is a party that take effect after or terminate upon, a change of control of the Company following a takeover bid or arrangements between the Company and its Directors or employees providing for compensation for loss of office or employment (whether through resignation, purported redundancy or otherwise) that may occur because of a takeover bid.

 

Approved by the Board on 25 April 2024

Stephen West, Executive Chairman

 

Consolidated Statement of Comprehensive Income

		Year ended 31 December 2023	Year ended 31 December 2022
	Note	£	£
Revenue	7	200,000	-
Other income		-	-
Administrative expenses	9	(1,499,193)	(1,306,561)
Share based payments - directors and senior managers	9	(10,402)	(8,427)
Research and development expenditure	9	(620,159)	(319,315)
Operating loss & loss before, interest, taxation & depreciation		(1,929,754)	(1,634,303)
Interest receivable		1,469	-
Interest payable		(58)	-
Depreciation	14	(3,890)	-
Loss for the year before taxation		(1,932,233)	(1,634,303)
Taxation	10	187,693	18,886
Loss for the year		(1,744,540)	(1,615,417)
Other comprehensive income (loss)	8	27,045	(14,989)
Total comprehensive loss for the period attributable to equity holders of the parent		(1,717,495)	(1,630,406)
Loss per share (basic and diluted) attributable to the equity holders (pence)	8	(1.35)	(1.56)

 

The notes to the financial statements form an integral part of these financial statements.

 

Consolidated Statement of Financial Position

	Note	As at 31 December 2023 £	As at 31 December 2022 £
Assets
Non-current assets
Property, Plant & Equipment	14	50,152	-
Intangible assets	12	5,343,505	5,343,505
Total non-current assets		5,393,657	5,343,505
Current assets
Trade and other receivables	15	157,589	101,738
Cash and cash equivalents	16	537,322	2,322,974
Total current assets		694,911	2,424,712
Total assets		6,088,568	7,768,217
Equity and liabilities
Equity attributable to shareholders
Share capital	19	1,291,500	1,291,500
Share premium	19	4,403,094	4,403,094
Share based payments reserve	20	385,537	375,135
Merger relief reserve	21	3,700,000	3,700,000
Retained deficit		(4,293,268)	(2,548,728)
Currency translation reserve	8	12,680	(14,365)
Total equity		5,499,543	7,206,636
Liabilities
Non-Current liabilities
Deferred tax liabilities	18	281,911	281,911
Current liabilities
Trade and other payables	17	307,114	279,670
Total liabilities		589,025	561,581
Total equity and liabilities		6,088,568	7,768,217

 

The notes to the financial statements form an integral part of these financial statements.

 

COMPANY Statement of Financial Position

	Note	As at 31 December 2023 £	As at 31 December  2022 £
Assets
Non-current assets
Property, Plant & Equipment	14	50,152	-
Investments	13	4,874,774	4,874,774
Intercompany receivables		812,951	451,622
Total non-current assets		5,737,877	5,326,396
Current assets
Trade and other receivables	15	124,988	64,309
Cash and cash equivalents	16	301,674	2,274,478
Total current assets		426,662	2,338,787
Total assets		6,164,539	7,665,183
Equity and liabilities
Equity attributable to shareholders
Share capital	19	1,291,500	1,291,500
Share premium	19	4,403,094	4,403,094
Share based payments reserve	20	385,537	375,135
Merger relief reserve 1	21	3,700,000	3,700,000
Retained deficit		(3,798,504)	(2,288,350)
Total equity		5,981,627	7,481,379
Liabilities
Current liabilities
Trade and other payables	17	182,912	183,804
Total liabilities		182,912	183,804
Total equity and liabilities		6,164,539	7,665,183

 

The notes to the financial statements form an integral part of these financial statements.

 

The Company has taken advantage of section 408 of the Companies Act 2006 and consequently a profit and loss account has not been presented for the Company. The Company's loss for the financial period was £1,510,524 (2022: loss of £1,287,740).

 

Consolidated Statement of Changes in Equity

	Ordinary Share capital	Share Premium	Share Based Payment Reserve	Merger Relief reserve	Retained earnings	Translation Reserve	Total equity
	£	£	£	£	£	£	£
As at 31 December 2021	719,000	3,460,595	366,708	450,000	(914,321)	624	4,082,606
Loss for the year	-	-	-	-	(1,615,417)	-	(1,615,417)
Exchange differences	-	-	-	-	-	(14,989)	(14,989)
Total comprehensive loss for the year	-	-	-	-	(1,615,417)	(14,989)	(1,630,406)
Transactions with owners Ordinary shares issued	572,500	942,499	-	3,250,000	-	-	4,764,999
Stamp duty on share issue					(18,990)		(18,990)
Warrants charge	-	-	8,427	-	-	-	8,427
Total transactions with owners	572,500	942,499	8,427	3,250,000	(18,990)	-	4,754,436
As at 31 December 2022	1,291,500	4,403,094	375,135	3,700,000	(2,548,728)	(14,365)	7,206,636
Loss for the year	-	-	-	-	(1,744,540)	-	(1,744,540)
Exchange differences	-	-	-	-	-	27,045	27,045
Total comprehensive income / (loss) for the year	-	-	-	-	(1,744,540)	27,045	(1,717,495)
Transactions with owners Ordinary shares issued	-	-	-	-	-	-	-
Warrants charge	-	-	10,402	-	-	-	10,402
Total transactions with owners	-	-	10,402	-	-	-	10,402
As at 31 December 2023	1,291,500	4,403,094	385,537	3,700,000	(4,293,268)	12,680	5,499,543

 

The notes to the financial statements form an integral part of these financial statements.

 

COMPANY Statement of Changes in Equity

	Ordinary Share capital	Share Premium	Merger relief reserve	Share Based Payment Reserve	Retained earnings	Total equity
	£	£	£	£	£	£
As at 31 December 2021	719,000	3,460,595	450,000	366,708	(981,620)	4,014,683
Loss for the year	-	-	-	-	(1,287,740)	(1,287,740)
Total loss for the year	-	-	-	-	(1,287,740)	(1,287,740)
Transactions with owners Ordinary Shares issued	572,500	942,499	3,250,000	-	-	4,764,999
Stamp duty on share issue					(18,990)	(18,990)
Warrants issued	-	-	-	8,427	-	8,427
Total transactions with owners	572,500	942,499	3,250,000	8,427	(18,990)	4,754,436
As at 31 December 2022	1,291,500	4,403,094	3,700,000	375,135	(2,288,350)	7,481,379
Loss for the year	-	-	-	-	(1,510,154)	(1,510,154)
Total loss for the year	-	-	-	-	(1,510,154)	(1,510,154)
Transactions with owners Ordinary Shares issued	-	-	-	-	-	-
Share-based payments	-	-	-	10,402	-	10,402
Total transactions with owners	-	-	-	10,402	-	10,402
As at 31 December 2023	1,291,500	4,403,094	3,700,000	385,537	(3,798,504)	5,981,627

 

The notes to the financial statements form an integral part of these financial statements.

 

Consolidated Statement of Cash Flow

	Note	Year ended 31 December 2023	Year ended 31 December 2022
		£	£
Cash flow from operating activities
Loss before income tax		(1,932,233)	(1,634,303)
Adjustments for:
Foreign Exchange		26,533	(9,918)
Share based payment	20	10,402	8,427
Depreciation	14	3,890	-
Taxation	10	187,693	18,886
Interest income		(1,469)	-
Interest expense		58	-
Changes in working capital:
Increase in trade and other receivables		(55,851)	(20,318)
Increase in trade and other payables		27,444	59,750
Net cash used in operating activities		(1,733,533)	(1,577,476)
Cash flow from Investing activities
Purchase of Property, Plant & Equipment		(54,042)	-
Acquisition of subsidiary, net of cash acquired		-	(103,478)
Interest received		1,469	-
Net Cash used in investing activities		(52,573)	(103,478)
Cash flows from financing activities
Proceeds from the issue of ordinary shares	19	-	3,121,202
Share issue costs	19	-	(18,990)
Interest paid		(58)	-
Net cash (used in)/generated from financing activities		(58)	3,102,212
Net (decrease)/increase in cash and cash equivalents		(1,786,164)	1,421,258
Cash and cash equivalents at the beginning of the period		2,322,974	899,721
Foreign exchange impact on cash		512	1,995
Cash and cash equivalents at the end of the period	16	537,322	2,322,974

 

 

COMPANY Statement of Cash Flow

	Note	Year ended 31 December 2023	Year ended 31 December 2022
		£	£
Cash flow from operating activities
Loss before income tax		(1,546,488)	(1,287,740)
Adjustments for:
Non-cash adjustment
Depreciation	14	3,890	-
Share based payment	20	10,402	8,427
Taxation		36,334	-
Changes in working capital:
Increase in trade and other receivables		(60,678)	(34,288)
Increase in trade and other payables		(892)	56,153
Net cash used in operating activities		(1,557,432)	(1,257,448)
Cash flow from Investing activities
Purchase of Property, Plant & Equipment	14	(54,042)	-
Acquisition of subsidiary		-	(109,079)
Borrowings to subsidiaries		(361,330)	(318,822)
Net Cash used in investing activities		(415,372)	(427,901)
Cash flows from financing activities
Proceeds from the issue of ordinary shares	19	-	3,121,202
Share issue costs	19	-	(18,990)
Net Cash from financing activities		-	3,102,212
Net (decrease)/increase in cash and cash equivalents		(1,972,804)	1,416,863
Cash and cash equivalents at the beginning of the period		2,274,478	857,614
Foreign exchange impact on cash		-	-
Cash and cash equivalents at the end of the period	16	301,674	2,274,477

 

The notes to the financial statements form an integral part of these financial statements.

 

Notes to the Financial Statements

1.      General Information 

Roquefort Therapeutics plc, the Group's ultimate parent company, was incorporated on 17 August 2020 as a public company limited by shares in England and Wales with company number 12819145 under the Companies Act.

 

The address of its registered office is 85 Great Portland Street, First Floor, London W1W 7LT, United Kingdom.

 

The principal activity of the Company is to develop pre-clinical next generation medicines focused on hard-to- treat cancers.

 

The Company listed on the London Stock Exchange ("LSE") on 22 March 2021.

 

The consolidated financial statements of the Group have been prepared in accordance with UK adopted International Accounting Standards as issued by the International Accounting Standards Board (IASB) and endorsed by the UK Endorsement Board. They have been prepared under the assumption that the Group operates on a going concern basis.

 

2.      New Standards and Interpretations

New and revised accounting standards adopted for the year ended 31 December 2023 did not have any material impact on the Group's accounting policies. There are a number of standards, amendments to standards, and interpretations which have been issued by the IASB that are effective in future accounting periods that the Group has decided not to adopt early.

 

The following amendments are effective for the period beginning 1 January 2023:

·     IFRS 17 Insurance Contracts;

·     Disclosure of Accounting Policies (Amendments to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2 Making Materiality Judgements);

·     Definition of Accounting Estimates (Amendments to IAS 8 Accounting Policies, Changes in Accounting Estimates and Errors);

·     Deferred Tax related to Assets and Liabilities arising from a single transaction (Amendments to IAS 12 Income taxes); and

·     International Tax Reform - Pilar Two Model Rules (Amendment to AS 12 Income Taxes) (effective immediately upon the issue of the amendments and retrospectively).

 

The following amendments are effective for the period beginning 1 January 2024:

·     IFRS 16 Leases (Amendment - Liability in a Sale and Leaseback);

·     IAS 1 Presentation of Financial Statements (Amendment - Classification of Liabilities as Current or Non-current) with Covenants; and

·     Amendment to IAS 7 and IFRS 7 - Supplier finance;

 

The following amendments are effective for the period beginning 1 January 2025:

·     Lack of Exchangeability (Amendments to IAS 21 The effects of changes in foreign exchange rates)

 

The Group is currently assessing the impact of these new accounting standards and amendments. The Group does not believe that the amendments to IAS 1 will have a significant impact on the classification of its liabilities. The Group does not expect any other standards issued by the IASB, but not yet effective, to have a material impact on the Group.

 

3.      Summary of Significant Accounting Policies

The principal accounting policies applied in the preparation of these financial statements are set out below. These policies have been consistently applied to all the period presented, unless otherwise stated.

 

a)     Basis of Preparation

The financial statements of Roquefort Therapeutics plc have been prepared in accordance with UK adopted International Accounting Standards, and the Companies Act 2006.

 

The financial statements have been prepared on an accrual basis and under the historical cost convention.

 

b)     Going Concern

The Directors have prepared financial forecasts to estimate the likely cash requirements of the Group over the period to 30 June 2025, given its stage of development and lack of recurring revenues. In preparing these financial forecasts, the Directors have made certain assumptions with regards to the timing and amount of future expenditure over which they have control. The Directors have considered the sensitivity of the financial forecasts to changes in key assumptions, including, among others, potential cost overruns within committed spend and changes in exchange rates.

 

The Group's available resources are sufficient to cover the Group's plans to complete existing pre-clinical development activities during 2024, however, they are not sufficient to cover existing committed costs and the costs of planned activities for at least 12 months from the date of signing these consolidated and company financial statements.

 

The Directors plan to raise further funds during 2024 (either through licencing deals and/or other financing arrangements) and have reasonable expectations that sufficient cash will be raised (either through licencing deals and/or other financing arrangements) to fund the planned operations of the Group for a period of at least 12 months from the date of approval of these financial statements. The funding requirement indicates that a material uncertainty exists which may cast significant doubt over the Group's and Company's ability to continue as a going concern, and therefore its ability to realise its assets and discharge its liabilities in the normal course of business.

 

After due consideration of these forecasts, current cash resources, including the sensitivity of key inputs and success in raising new funding the Directors consider that the Group will have adequate financial resources to continue in operational existence for the foreseeable future (being a period of at least 12 months from the date of this report) and, for this reason, the financial statements have been prepared on a going concern basis. The financial statements do not include the adjustments that would be required should the going concern basis of preparation no longer be appropriate.

 

c)      Basis of Consolidation

The Group's financial statements consolidate those of the parent company and its subsidiaries as of 31 December 2023. Lyramid Pty Ltd and Oncogeni Ltd have reporting dates at 31 December whilst the reporting date of Tumorkine Pty Ltd is 30 June.

 

All transactions and balances between Group companies are eliminated on consolidation, including unrealised gains and losses on transactions between Group companies. Where unrealised losses on intra-group asset sales are reversed on consolidation, the underlying asset is also tested for impairment from a Group perspective. Amounts reported in the financial statements of its subsidiary have been adjusted where necessary to ensure consistency with the accounting policies adopted by the Group.

 

Profit or loss and other comprehensive income of subsidiaries acquired or disposed of during the year are recognised from the effective date of acquisition, or up to the effective date of disposal, as applicable.

The Group attributes total comprehensive income or loss of subsidiaries between the owners of the parent and the non-controlling interests based on their respective ownership interests.

 

d)     Revenue From Contracts with Customers

The Group recognises revenue as follows:

 

Commercialisation and milestone revenue

Commercialisation and milestone revenue generally includes non-refundable upfront license and collaboration fees; milestone payments, the receipt of which is dependent upon the achievement of certain clinical, regulatory or commercial milestones; as well as royalties on product sales of licensed products, if and when such product sales occur; and revenue from the supply of products. Payment is generally due on standard terms of 30 to 60 days.

 

Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue or deferred consideration, depending on the nature of arrangement. Amounts expected to be recognised as revenue within the 12 months following the consolidated balance sheet date are classified within current liabilities. Amounts not expected to be recognised as revenue within the 12 months following the consolidated balance sheet date are classified within non-current liabilities.

 

Milestone revenue

The Group applies the five-step method under the standard to measure and recognise milestone revenue. The receipt of milestone payments is often contingent on meeting certain clinical, regulatory or commercial targets, and is therefore considered variable consideration. The Group estimates the transaction price of the contingent milestone using the most likely amount method.

 

The Group includes in the transaction price some or all of the amount of the contingent milestone only to the extent that it is highly probable that a significant reversal in the amount of cumulative revenue recognised will not occur when the uncertainty associated with the contingent milestone is subsequently resolved.

 

Milestone payments that are not within the control of the Company, such as regulatory approvals, are not considered highly probable of being achieved until those approvals are received.

 

Any changes in the transaction price are allocated to all performance obligations in the contract unless the variable consideration relates only to one or more, but not all, of the performance obligations.

 

e)     Business Combinations

The Group applies the acquisition method in accounting for business combinations. The consideration transferred by the Group to obtain control of a subsidiary is calculated as the sum of the acquisition date fair values of assets transferred, liabilities incurred and the equity interests issued by the Group, which includes the fair value of any asset or liability arising from a contingent consideration arrangement. Acquisition costs are expensed as incurred.

 

Assets acquired and liabilities assumed are generally measured at their acquisition-date fair values.

 

f)      Foreign Currency Translation

i)     Functional and Presentation Currency

The financial statements are presented in Pounds Sterling (GBP), which is the Group's functional and presentation currency.

 

ii)    Transactions and Balances

Foreign currency monetary assets and liabilities are translated at the rates ruling at the reporting date. Exchange differences arising on the retranslation of assets and liabilities are recognised immediately in profit or loss.

 

iii)    Foreign operations

In the Group's financial statements, all assets, liabilities and transactions of Group entities with a functional currency other than GBP are translated into GBP upon consolidation. The functional currencies of entities within the Group have remained unchanged during the reporting period.

 

On consolidation, assets and liabilities have been translated into GBP at the closing rate at the reporting date. Goodwill and fair value adjustments arising on the acquisition of a foreign entity have been treated as assets and liabilities of the foreign entity and translated into GBP at the closing rate on the acquisition date. Income and expenses have been translated into GBP at the average rate of over the reporting period. Exchange differences are charged or credited to other comprehensive income and recognised in the currency translation reserve in equity. On disposal of a foreign operation, the related cumulative translation differences recognised in equity are reclassified to profit or loss and are recognised as part of the gain or loss on disposal.

 

g)     Segment Reporting

Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-makers. The chief operating decision-makers, who are responsible for allocating resources and assessing performance of the operating segments, has been identified as the executive Board of Directors.

 

All operations and information are reviewed together so that at present there is only one reportable operating segment.

 

In the opinion of the Directors, during the period the Group operated in the single business segment of biotechnology.

 

In 2023 the Group derived more than 10% of its revenue from a single external customer.

 

h)     Property, Plant & Equipment

Property, plant and equipment is stated at cost less accumulated depreciation and, where appropriate, less provisions for impairment.

 

The initial recognition and subsequent measurement of property, plant and equipment are:

 

Initial recognition

Property, plant and equipment is initially recognised at acquisition cost, including any costs directly attributable to bringing the assets to the location and condition necessary for them to be capable of operating. In most circumstances, the cost will be its purchase cost, together with the cost of delivery.

 

Subsequent measurement

An asset will only be depreciated once it is ready for use. Depreciation is charged so as to write off the cost of property, plant and equipment, less its estimated residual value, over the expected useful economic lives of the assets.

 

Depreciation is charged on a straight-line basis as follows:

·     Equipment 3 years

 

The disposal or retirement of an asset is determined by comparing the sales proceeds with the carrying amount. Any gains or losses are recognised within the Consolidated Statement of Comprehensive Income.

 

i)      Goodwill and Intangible Assets

Goodwill represents the future economic benefits arising from a business combination that are not individually identified and separately recognised. Goodwill is carried at cost less accumulated impairment losses. Refer to Note (j) for a description of impairment testing procedures.

 

Transactions where the definition of a business combination, per IFRS 3, is not met due to the asset or group of assets not meeting the definition of a business, or where the concentration test affords the Directors the option not to treat as a business, are recognised as an asset acquisition. The Group identifies and recognises the individual identifiable assets acquired and liabilities assumed and allocates the cost of the group of assets and liabilities (including directly attributable costs of making the acquisition) to the individual identifiable assets and liabilities on the basis of their relative fair values at the date of purchase.

 

Other intangible assets, including licences and patents, that are acquired by the Group and have finite useful lives are measured at cost less accumulated amortisation and any accumulated impairment losses. Refer to Note (j) for amortisation procedures.

 

j)      Impairment Testing of Goodwill, Other Intangible Assets and Property, Plant and Equipment

For impairment assessment purposes, assets are grouped at the lowest levels for which there are largely independent cash inflows (cash-generating units). As a result, some assets are tested individually for impairment, and some are tested at cash-generating unit level. Goodwill is allocated to those cash-generating units that are expected to benefit from synergies of a related business combination and represent the lowest level within the Group at which management monitors goodwill.

 

Cash-generating units to which goodwill has been allocated are tested for impairment at least annually. All other individual assets or cash-generating units are tested for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.

 

An impairment loss is recognised for the amount by which the asset's (or cash-generating unit's) carrying amount exceeds its recoverable amount, which is the higher of fair value less costs of disposal and value-in-use. To determine the value-in-use, management estimates expected future cash flows from each cash-generating unit and determines a suitable discount rate in order to calculate the present value of those cash flows. The data used for impairment testing procedures are directly linked to the Group's latest approved budget, adjusted as necessary to exclude the effects of future reorganisations and asset enhancements. Discount factors are determined individually for each cash-generating unit and reflect current market assessments of the time value of money and asset-specific risk factors.

 

Impairment losses for cash-generating units reduce first the carrying amount of any goodwill allocated to that cash-generating unit. Any remaining impairment loss is charged pro rata to the other assets in the cash-generating unit.

 

Amortisation is calculated to write off the cost of intangible assets less their estimated residual values using the straightOline method over their estimated useful lives, from the date the assets are available for use and is recognised in profit or loss. The available for use date is determined as the date from which a product is commercialised - this had yet to occur, for all intangible assets, at 31 December 2023 and 2022. Goodwill is not amortised.

 

k)     Financial Instruments

IFRS 9 requires an entity to address the classification, measurement and recognition of financial assets and liabilities.

 

i)     Classification

The Group classifies its financial assets in the following measurement categories:

·     those to be measured at amortised cost.

 

The classification depends on the Group's business model for managing the financial assets and the contractual terms of the cash flows.

 

The Group classifies financial assets as at amortised cost only if both of the following criteria are met:

·     the asset is held within a business model whose objective is to collect contractual cash flows; and

·     the contractual terms give rise to cash flows that are solely payment of principal and interest.

 

ii)    Recognition

Purchases and sales of financial assets are recognised on trade date (that is, the date on which the Group commits to purchase or sell the asset). Financial assets are derecognised when the rights to receive cash flows from the financial assets have expired or have been transferred and the Group has transferred substantially all the risks and rewards of ownership.

 

iii)    Measurement

At initial recognition, the Group measures a financial asset at its fair value plus, in the case of a financial asset not at fair value through profit or loss (FVPL), transaction costs that are directly attributable to the acquisition of the financial asset.

 

Transaction costs of financial assets carried at FVPL are expensed in profit or loss.

 

Receivables

Amortised cost: Assets that are held for collection of contractual cash flows, where those cash flows represent solely payments of principal and interest, are measured at amortised cost. Interest income from these financial assets is included in finance income using the effective interest rate method. Any gain or loss arising on derecognition is recognised directly in profit or loss and presented in other gains/(losses) together with foreign exchange gains and losses. Impairment losses are presented as a separate line item in the statement of profit or loss.

 

iv)   Impairment

The Group assesses, on a forward-looking basis, the expected credit losses associated with any debt instruments carried at amortised cost. For trade receivables, the Group applies the simplified approach permitted by IFRS 9, which requires expected lifetime losses to be recognised from initial recognition of the receivables.

 

l)      Taxation

Taxation comprises current and deferred tax.

 

Current tax is based on taxable profit or loss for the period. Taxable profit or loss differs from profit or loss as reported in the income statement because it excludes items of income and expense that are taxable or deductible in other years and it further excludes items that are never taxable or deductible. The asset or liability for current tax is calculated using tax rates that have been enacted or substantively enacted by the balance sheet date.

 

Deferred tax is recognised on differences between the carrying amounts of assets and liabilities in the financial information and the corresponding tax bases used in the computation of taxable profit and is accounted for using the balance sheet liability method. Deferred tax liabilities are generally recognised for all taxable temporary differences and deferred tax assets are recognised to the extent that it is probable that taxable profits will be available against which deductible temporary differences can be utilised. Such assets and liabilities are not recognised if the temporary difference arises from initial recognition of goodwill or from the initial recognition (other than in a business combination) of other assets and liabilities in a transaction that affects neither the taxable profit nor the accounting profit.

 

Deferred tax liabilities are recognised for taxable temporary differences arising on investments in subsidiaries and associates, and interests in joint ventures, except where the Group is able to control the reversal of the temporary difference and it is probable that the temporary difference will not reverse in the foreseeable future.

 

The carrying amount of deferred tax assets is reviewed at each balance sheet date and reduced to the extent that it is no longer probable that sufficient taxable profits will be available to allow all or part of the asset to be recovered.

 

Deferred tax is calculated at the tax rates that are expected to apply in the period when the liability is settled, or the asset realised. Deferred tax is charged or credited to profit or loss, except when it relates to items charged or credited directly to equity, in which case the deferred tax is also dealt with in equity.

 

Deferred tax assets and liabilities are offset when there is a legally enforceable right to set off current tax assets against current tax liabilities and when they relate to income taxes levied by the same taxation authority and the Group intends to settle its current tax assets and liabilities on a net basis.

 

R&D tax rebate receivable represents refundable tax offsets, in cash, from the Australian Taxation Office in relation to expenditure incurred in the current year for eligible research and development activities. Research and development activities are refundable at a rate of 43.5% for each dollar spent, subject to meeting certain eligibility criteria. Funds are expected to be received subsequent to the lodgement of the income tax return and research and development tax incentive schedule for the current financial year. The Group recognises a taxation credit, in the year the cash is received, which generally relates to expenses during the prior period. In future periods (which will include UK R&D tax credits), once an established pattern of successful claims is recorded, the Group will consider an accruals basis, recording the tax credit and a receivable in the period the eligible expenditure was incurred.

 

m)    Cash and Cash Equivalents

Cash and cash equivalents comprise cash at bank and in hand and demand deposits with banks and other financial institutions, that are readily convertible into known amounts of cash, and which are subject to an insignificant risk of changes in value.

 

n)     Equity, Reserves and Dividend Payments

Share capital represents the nominal (par) value of shares that have been issued.

 

Share premium includes any premiums received on issue of share capital. Any transaction costs directly associated with the issuing of shares are deducted from share premium, net of any related income tax benefits.

 

Share based payments represents the value of equity settled share-based payments provided to employees, including key management personnel, and third parties for services provided.

 

Translation reserve comprises foreign currency translation differences arising from the translation of financial statements of the Group's foreign entities into GBP on consolidation.

 

Retained losses represent the cumulative retained losses of the Group at the reporting date.

 

Merger relieve reserve arises from the acquisition of Oncogeni Ltd and Lyramid Pty Ltd whereby the excess of the fair value of the issued ordinary share capital issued over the nominal value of these shares is transferred to his reserve in accordance with section 612 of the Companies Act 2006

 

All transactions with owners of the parent are recorded separately within equity.

 

No dividends are proposed for the period.

 

o)     Earnings Per Ordinary Share

The Company presents basic and diluted earnings per share data for its Ordinary Shares.

 

Basic earnings per Ordinary Share is calculated by dividing the profit or loss attributable to Shareholders by the weighted average number of Ordinary Shares outstanding during the period.

 

Diluted earnings per Ordinary Share is calculated by adjusting the earnings and number of Ordinary Shares for the effects of dilutive potential Ordinary Shares.

 

p)     Employee Benefits

Provision is made for Lyramid Pty Ltd's liability for employee benefits arising from services rendered by employees up to the end of the reporting period. In determining the liability, consideration is given to employee wage increases and the probability that the employee may satisfy vesting requirements.

 

Short term obligations

Liability for wages and salaries, including non-monetary benefits, annual leave, long service leave and accumulating sick leave expected to be settled within 12 months of the reporting date are recognised in other payables in respect of employees' services up to the reporting date and are measured at the amounts expected to be paid when the liabilities are settled.

 

Other long-term employee benefit obligations

Liability for annual leave and long service leave not expected to be settled within 12 months from the reporting date is recognised in the provision for employee benefits and measured as the present value of expected future payments to be made in respect of services provided by employees up to the reporting date, using the projected unit credit method. Consideration is given to expected future wage and salary levels, of employee departures and period of service.

 

Retirement benefit obligations

Contributions for retirement benefit obligations are recognised as an expense as they become payable. Prepaid contributions are recognised as an asset to the extent that a cash refund or a reduction in the future payment is available. Contributions are paid into the fund nominated by the employee.

 

Employee benefits provision

The liability for employee benefits expected to be settled more than 12 months from the reporting date are recognised and measured at the present value of the estimated future cash flows to be made in respect of all employees at the reporting date. In determining the present value of the liability, estimates of attrition rates and pay increases through promotion and inflation have been taken into account.

 

q)     Leases

Leases are accounted for by recognising a right-of-use asset and a lease liability, except for leases of low value assets and leases with a duration of 12 months or less, for which the lease cost is expensed in the period to which it relates.

 

A lease liability is recognised at the commencement date of a lease. The lease liability is initially recognised at the present value of the lease payments to be made over the term of the lease, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, the consolidated entity's incremental borrowing rate.

 

Lease payments comprise of fixed payments less any lease incentives receivable, variable lease payments that depend on an index or a rate, amounts expected to be paid under residual value guarantees, exercise price of a purchase option when the exercise of the option is reasonably certain to occur, and any anticipated termination penalties.

 

The variable lease payments that do not depend on an index or a rate are expensed in the period in which they are incurred. Lease liabilities are measured at amortised cost using the effective interest method. The carrying amounts are remeasured if there is a change in the following: future lease payments arising from a change in an index or a rate used; residual guarantee; lease term; certainty of a purchase option and termination penalties. When a lease liability is remeasured, an adjustment is made to the corresponding right-of use asset, or to profit or loss if the carrying amount of the right-of-use asset is fully written down.

 

Right-of-use assets are initially measured at the amount of the lease liability, reduced for any lease incentives received, and increased for: lease payments made at or before commencement of the lease; initial direct costs incurred; and the amount of any provision recognised where the Group is contractually required to dismantle, remove or restore the leased asset.

 

For contracts that both convey a right to the Group to use an identified asset and require services to be provided to the Group by the lessor, the Group has elected to account for the entire contract as a lease, i.e. it does not allocate any amount of the contractual payments to, and account separately for, any services provided by the supplier as part of the contract.

 

r)      Share-Based Payments

The Company has applied the requirements of IFRS 2 Share-based payments.

 

The Company issues equity settled share-based payments to the Directors and to third parties for the provision of services provided for assistance in raising private equity. Equity settled share-based payments are measured at fair value at the date of grant, or the date of the service provided. The fair value determined at the grant date or service date of the equity settled share-based payment is recognised as an expense, or recognised against share premium where the service received relates to assistance in raising equity, with a corresponding credit to the share based payment reserve. The fair value determined at the grant date of equity settled share based payment is expensed on a straight-line basis over the life of the vesting period, based on the Company's estimate of shares that will eventually vest. Once an option or warrant vests, no further adjustment is made to the aggregate expensed.

 

The fair value is measured by use of the Black Scholes model as the Directors view this as providing the most reliable measure of valuation. The expected life used in the model has been adjusted, based on management's best estimates, for the effects of non-transferability, exercise restrictions and behavioural considerations. The market price used in the model is the quoted LSE closing price. The fair value calculated is inherently subjective and uncertain due to the assumptions made and the limitation of the calculation used.

 

s)      Financial Risk Management Objectives and Policies

The Group does not enter into any forward exchange rate contracts.

 

The main financial risks arising from the Group's activities are market risk, interest rate risk, foreign exchange risk, credit risk, liquidity risk and capital risk management. Further details on the risk disclosures can be found in Note 22.

 

t)      Significant Accounting Judgements, Estimates and Assumptions

The preparation of the financial statements in conformity with International Financial Reporting Standards requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the Group's accounting policies.

 

Estimates and judgements are continually evaluated, and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. The Directors consider the significant accounting judgements, estimates and assumptions used within the financial statements to be:

 

Impairment of intercompany loans

The Group and the Company assess at each reporting date whether there is any objective evidence that loans to subsidiaries are impaired. To determine whether there is objective evidence of impairment, a considerable amount of estimation is required to determine future credit losses over the 12 month period of life time of the loan.

 

Impairment of intangible assets and goodwill

As at 31 December 2023 The Group has £5,343,505 of intangible assets which relate to £5,061,594 of in-progress research and development and £281,911 of goodwill related to the expected tax benefits of the capitalised amounts. The Group has assessed whether there are any indicators of impairment by estimating the recoverable amount of each asset or cash-generating unit based on probable future cashflows.

 

Business combinations

Management uses valuation techniques when determining the fair values of certain assets and liabilities acquired in a business combination (see Notes 3 and 4). In particular, the fair value of contingent consideration is dependent on the market capitalisation of the Group exceeding a threshold amount.

 

In the prior year Management had performed the optional concentration test available under IFRS3, in order to determine that the acquisition of Oncogeni Ltd can be treated as an asset acquisition. Judgement is required to determine whether 'substantially all' the fair value is concentrated in a single asset or group of assets, and when considering a group of assets, assessing whether those assets are similar. In determining whether assets are similar, judgement is required to consider the nature of each single identifiable asset and the risks associated with managing and creating outputs from the assets (that is, the risk characteristics). Management has considered that the two separate in-progress research and development programs, MK cell therapy and STAT-6 siRNA therapeutics, are similar as they are both pre-clinical stage oncology treatments.

 

4.      Acquisitions

 

Acquisition of Oncogeni Limited

 

On 16 September 2022, the Group acquired 100% of the equity instruments of Oncogeni Ltd, a UK based business, thereby obtaining control. The acquisition was assessed as being complementary to the Group's existing pre- clinical drug development business. The Group applied the concentration test under IFRS3 and considered it as an asset acquisition.

 

The details of the asset acquisition are as follows:

 

Fair value of consideration transferred	£
Equity consideration	3,750,000
Costs directly attributable to acquisition	109,079
Total	3,859,079
Recognised amounts of identifiable net assets at book values
Trade and other receivables	7,294
Cash and cash equivalents	5,601
Total current assets	12,895
Trade and other payables	15,792
Total current liabilities	15,792
Identifiable net liabilities	2,897
Intangible asset at cost	3,861,975
Consideration transferred settled in cash	-
Cash and cash equivalents acquired	5,601
Net cash inflow on acquisition	5,601

Consideration transferred

The acquisition of Oncogeni was settled for a consideration of £3,750,000, all of which was payable in shares. £109,079 of costs directly attributable to the acquisition have been included in the consideration of the transaction.

 

Identifiable net assets

The carrying value of the trade and other receivables acquired as part of the business combination amounted to £7,294. As of the acquisition date, the Group's best estimate of the contractual cash flow not expected to be collected amounted to zero.

 

5.      Investments in Subsidiaries

The parent company has investments in the following subsidiary undertakings which are unlisted:

Name	Incorporation date	Country of incorporation	Registered address	Holding	Proportion of voting rights	Principal activity
Oncogeni Ltd	29 May 2019	England	85 Great Portland Street,	Ordinary	100%	Biotechnology
			First Floor, London,	shares		research
			England, W1W 7LT			company
Lyramid Pty	1 July 2016	Australia	Suite 4,	Ordinary	100%	Biotechnology
Limited			246-250 Railway Parade,	shares		research
			West Leederville,			company
			WA 6007, Australia
Tumorkine Pty	11 March 2022	Australia	Suite 4,	Ordinary	100%	Dormant
Limited			246-250 Railway Parade,	shares
			West Leederville,
			WA 6007, Australia

 

 

6.      Directors' and Employees' Remuneration

 

The aggregate remuneration comprised:

	Group Year ended 31 December 2023 £	Group Year ended 31 December 2022 £	Company Year ended 31 December 2023 £	Company Year ended 31 December 2022 £
Wages and salaries N.I and other Social Security Pension costs Share-based payments	929,019 98,363 54,949 5,616	509,301 33,814 23,804 5,619	808,135 98,363 43,460 5,616	383,350 33,814 12,270 5,619
	1,087,947	572,538	955,574	435,053

 

Remuneration of Key Management Personnel

	Year ended 31 December 2023 £	Year ended 31 December 2022 £
Salaries and short-term employee benefits	613,000	308,692
Long term benefits	-	-
Post-employment benefits	41,700	12,162
Share based payment charge	5,616	5,619
	660,316	326,473

 

Key management personnel has been defined as the directors of Roquefort Therapeutics plc only.

 

The total remuneration of the highest paid director was £305,800 (2022: £118,305), including pension contributions of £27,800 (2022: £4,054).

 

Further information about the remuneration of individual directors is provided in the Directors' Remuneration Report.

 

Average number of employees during the year (including Directors full time equivalent)

 

	Year ended 31 December 2023 £	Year ended 31 December 2022 £
Continuing operations	10	5

 

At 31 December 2023 the Company had nine (9) employees in total; seven (7) Directors & (2) laboratory staff.

 

Lyramid Pty Ltd has one (1) employee engaged in Research & Development.

 

Oncogeni Ltd has no employees.

 

7.      Revenue

	Year ended 31 December 2023 £	Year ended 31 December 2022 £
Licence revenue	200,000	-

 

Revenue in 2023 was fully generated in the UK and represents licencing revenue for exclusive worldwide use (excluding Japan) for certain Midkine antibodies in the field of medical diagnostics. Future revenue is subject to the reaching of certain commercial milestones with the initial £200,000 representing the initial non-refundable deposit. The Company expects the next milestone to be achieved in Q4 of 2024. The total revenue was generated from one customer.

8.      Other Comprehensive Income

Items credited/(charged) to the other comprehensive income line of the statement of comprehensive income relate to the impact of foreign exchange movements on cash and cash equivalents balances. The corresponding movement is offset against the foreign exchange reserve in the statement of financial position:

 

	Year ended 31 December 2023 £	Year ended 31 December 2022 £
Opening Balance	(14,365)	624
Foreign exchange impact	27,045	(14,989)
Closing Balance	12,680	(14,365)

 

9.      Operating Loss

The following items have been charged/(credited) to the statement of comprehensive income in arriving at the Group's operating loss from continuing operations:

 

	Year ended 31 December 2023 £	Year ended 31 December 2022 £
Directors' and employee costs Legal fees Consulting and professional fees Other expenditure	856,333 28,182 217,876 396,802	365,564 46,373 209,768 684,856
Administrative expenses Share based payments to directors and senior management Research and development expenditure1	1,499,193 10,402 620,159	1,306,561 8,427 319,315
Total operating expenditure	2,129,754	1,634,303

 

¹Includes short term license expense of £178,923 for right of use of a laboratory and its equipment during the year (2022: £81,250).

 

During the year the Group obtained the following services from its auditor:

 

	Year ended 31 December 2023 £	Year ended 31 December 2022 £
Audit Services Statutory audit - Group and Company Non-audit services	65,000 -	157,336 -
	65,000	157,336

 

The Group incurred no finance costs during the year ended 31 December 2023 (2022: £nil).

 

10.   Taxation

	Year ended 31 December 2023 £	Year ended 31 December 2022 £
Current tax	-	-
Deferred tax	-	-
Australian R&D rebate1	151,359	18,886
UK R&D rebate	36,334	-
Income tax credit	187,693	18,886

 

¹R&D tax rebate receivable represents refundable tax offsets, in cash, from the Australian Taxation Office ("ATO") in relation to expenditure incurred in the prior year for eligible research and development activities

 

Income tax can be reconciled to the loss in the statement of comprehensive income as follows:

 

	Year ended 31 December 2023 £	Year ended 31 December 2022 £
Loss	(1,932,233)	(1,615,417)
R&D tax rebate	(151,359)	(18,886)
	(2,083,592)	(1,634,303)
Tax at the corporation rate of 25% (2022: 19%)	520,898	310,517
Effect of overseas tax rates1	-	21,642
Expenditure disallowable for taxation	(65,298)	(82,705)
Share based payment temporary difference on which
no deferred tax asset has been recognised	(2,601)	(1,067)
Remeasurement of deferred tax for changes in tax rates	5,678	74,363
Tax losses on which no deferred tax asset has been recognised	(458,677)	(322,750)
Total tax (charge)/credit	-	-
UK	-	-
Overseas	-	-
Total tax (charge)/credit)	-	-

 

¹In the current year the UK corporation tax was increased to 25% which is equal to the Australian Small Company tax rate of 25%.

The Group has accumulated tax losses of approximately £3,301,716 (2022: £1,557,117) that are available, under current legislation, to be carried forward indefinitely against future profits.

 

The tax losses can be broken down to the following:

 

	Year ended 31 December 2023 £	Year ended 31 December 2022 £
Australia	(350,039)	(125,138)
United Kingdom	(2,951,677)	(1,431,979)
Carried forward tax losses	(3,301,716)	(1,557,117)

 

A deferred tax asset has not been recognised in respect of these losses due to the uncertainty of future profits. The amount of the deferred tax asset not recognised is approximately £837,982 (2022: £389,279).

 

	Year ended 31 December 2023 £ UK                            AU		Year ended
			31 December 2022
			£
			UK	AU
Opening balance	(372,176)	(31,285)	-	-
Tax effect of temporary differences:
Accumulated losses	(392,477)	(56,225)	(357,995)	(31,285)
Deductible temporary differences	36,334	-	(14,181)	-
Deferred tax (asset) not recognised	(728,319)	(87,510)	(372,176)	(31,285)

 

The Company calculated the UK deferred tax balances at 25% and the Australian deferred tax balances at the current small company tax rate of 25%, which is expected to continue in future periods.

 

11.   Earnings Per Share

	Year ended 31 December 2023 £	Year ended 31 December 2022 £
Loss attributable to equity shareholders	(1,744,540)	(1,615,417)
Weighted average number of ordinary shares	129,149,998	103,479,476
Loss per share in pence
Basic	(1.35)	(1.56)
Diluted	(1.35)	(1.56)

 

There is no difference between the diluted loss per share and the basic loss per share presented. Share options and warrants could potentially dilute basic earnings per share in the future but were not included in the calculation of diluted earnings per share as they are anti-dilutive for the year presented.

 

As at the end of the financial period there were 23,875,000 (2022: 35,272,000) warrants in issue. 

 

12.   Intangible Assets

	In-progress R&D £	Goodwill £	Total £
Cost
At 1 January 2023	5,061,594	281,911	5,343,505
Acquired through asset acquisition	-	-	-
At 31 December 2023	5,061,594	281,911	5,343,505
Amortisation
At 1 January 2023	-	-	-
Amortisation	-	-	-
Impairment Charge	-	-	-
At 31 December 2023	-	-	-
Carrying value
At 31 December 2023	5,061,594	281,911	5,343,505

 

	In-progress R&D £	Goodwill £	Total £
Cost At 1 January 2022	1,199,619	281,911	1,481,530
Acquired through asset acquisition	3,861,975	-	3,861,975
At 31 December 2022	5,061,594	281,911	5,343,505
Amortisation At 1 January 2022	-	-	-
Amortisation	-	-	-
Impairment Charge	-	-	-
At 31 December 2022	-	-	-
Carrying value
At 31 December 2022	5,061,594	281,911	5,343,505

 

The Directors have concluded that there has been no impairment of the goodwill associated with the acquisition of Lyramid Pty Limited at 31 December 2023. The Goodwill represents the offsetting balance to the deferred tax liability for the acquisition of Lyramid Pty Ltd.

 

At 31 December 2023, the Group performed its annual impairment test in relation to intangible assets not yet available for use and identified no indicators of impairment in line with IAS 36 Impairment of Assets, as all acquired in-progress R&D programs are in active development and progressing as planned. At the test date, it was determined that due to the ongoing pre-clinical research and development in-progress R&D acquired, there was too much uncertainty to estimate a value-in-use, based on discounted future cash flows from the assets. The Group estimated fair value less costs to sell, by referring to market transactions for pre-clinical and clinical oncology drug candidates. Due to the nature of oncology drug development, the fair value is not considered to be particularly sensitive to any one underlying valuation assumption other than the ultimate outcome of drug development and commercialisation, which is binary.

 

Accordingly, the Group has concluded that the estimated recoverable amount of the assets did exceed the carrying amount and therefore no impairment was identified.

 

13.   Investments

	Investment	Investment in	Shares in subsidiary
Company	in Lyramid Pty Ltd £	Oncogeni Ltd £	undertakings £
Cost at 1 January 2023	1,015,695	3,859,079	4,874,774
Additions	-	-	-
Cost at 31 December 2023	1,015,695	3,859,079	4,874,774
Impairment
At 1 January 2023	-	-	-
Charge for the period	-	-	-
At 31 December 2023	-	-	-
Net book value at 31 December 2023	1,015,695	3,859,079	4,874,774

 

Company	Investment in Lyramid Pty Ltd £	Investment in Oncogeni Ltd £	Shares in subsidiary undertakings £
Cost at 1 January 2022	1,015,695	-	1,015,695
Additions	-	3,859,079	3,859,079
Cost at 31 December 2022	1,015,695	3,859,079	4,874,774
Impairment At 1 January 2022	-	-	-
Charge for the period	-	-	-
At 31 December 2022	-	-	-
Net book value at 31 December 2022	1,015,695	3,859,079	4,874,774

 

The Directors have concluded that there has been no impairment to the investment in Oncogeni Ltd or Lyramid Pty Limited at 31 December 2023.

 

Impairment review disclosures required by IAS36 are included in note 12 to the financial statements.

 

14.   Property, Plant & Equipment

Group and Company	Equipment	Total
Cost As at 1 January 2022	-	-
Additions	-	-
Disposals	-	-
As at 31 December 2022	-	-
Additions	54,042	54,042
Disposals	-	-
As at 31 December 2023	54,042	54,042
Accumulated depreciation As at 1 January 2022	-	-
Charge for the period	-	-
Disposals	-	-
As at 31 December 2022	-	-
Charge for the period	(3,890)	(3,890)
Disposals	-	-
As at 31 December 2023	(3,890)	(3,890)
Net book value As at 31 December 2022	-	-
As at 31 December 2023	50,152	50,152

 

As at 31 December 2023 the Group did not have any right to use assets.

 

15.   Trade and Other Receivables

	Group 31 December 2023 £	Group 31 December 2022 £	Company 31 December 2023 £	Company 31 December 2022 £
Other receivables Prepayments and accrued income	105,242 52,347	45,124 56,614	95,054 29,934	- 64,309
	157,589	101,738	124,988	64,309

 

There are no material differences between the fair value of trade and other receivables and their carrying value at the year end.

 

No receivables were past due or impaired at the year end.

 

16.   Cash and Cash Equivalents

	Group 31 December 2023 £	Group 31 December 2022 £	Company 31 December 2023 £	Company 31 December 2022 £
Cash at bank and in hand	537,322	2,322,974	301,674	2,274,478

 

The Directors consider the carrying amount of cash and cash equivalents approximates to their fair value.

 

17.   Trade and Other Payables

	Group 31 December 2023 £	Group 31 December 2022 £	Company 31 December 2023 £	Company 31 December 2022 £
Trade creditors Accruals and other creditors	144,841 162,273	68,379 211,291	82,058 100,854	26,210 157,594
	307,114	279,670	182,912	183,804

 

The fair value of trade and other payables approximates their current book values.

 

18.   Deferred Tax Liabilities

	Group £	Company £
At 1 January 2022	281,911	-
Released in year	-	-
Additions	-	-
At 31 December 2022	281,911	-
At 1 January 2023	281,911	-
Additions	-	-
At 31 December 2023	281,911	-

 

Deferred tax liability is the expected tax implication from the amortisation of the intangible asset acquired as part of the Lyramid Pty Ltd transaction.

 

19.   Share Capital

		Issued and fully paid
Group and Company	Ordinary Shares No.	Share Capital £	Share Premium £	Total £
As at 1 January 2022	71,900,000	719,000	3,460,595	4,179,595
Issue of ordinary shares1	50,000,000	500,000	-	500,000
Issue of ordinary shares2	7,249,998	72,500	942,499	1,014,999
As at 31 December 2022	129,149,998	1,291,500	4,403,094	5,694,594
As at 31 December 2023	129,149,998	1,291,500	4,403,094	5,694,594

 

¹On 16 September 2022, the Company issued 50,000,000 ordinary shares of £0.01 to acquire Oncogeni Ltd, recorded at the market price of £0.075 per share.

²On 16 September 2022, the Company issued 7,249,998 ordinary shares of £0.01 for cash at a placing price of £0.14 per share.

 

20.   Share Based Payment Reserve

The share-based payments reserve is used to recognise the value of equity-settled share-based payments provided to employees, including key management personnel and external parties as part of their remuneration.

 

Group and Company	2023 £	2022 £
Opening balance	375,135	366,708
NED and Advisor warrants issued1	10,402	8,427
At 31 December	385,537	375,135

 

¹On 26 June 2022, Ms Jean Duvall, Dr Simon Sinclair and Professor Trevor Jones were awarded 300,000 NED and Advisor warrants each. These warrants entitle the warrant holder to subscribe for one ordinary share at £0.15 per ordinary share. 50% Warrants are exercisable one year after grant date with the remaining balance exercisable two years after grant date (April 2024). The expense in 2023 represents the warrants that have vested in the current year.

 

The fair value of the services received in return for the warrants granted are measured by reference to the fair value of the warrants granted. The estimate of the fair value of the warrants granted is measured based on the Black-Scholes valuations model. Measurement inputs and assumptions are as follows:

 

Warrant	Number of warrants	Share Price	Exercise Price	Expected volatility	Expected life	Risk free rate	Expected dividends
Director	750,000	£0.05	£0.05	50.00%	5	0.15%	0.00%
Director	750,000	£0.05	£0.10	50.00%	5	0.15%	0.00%
Broker Placing	480,000	£0.05	£0.05	50.00%	3	0.15%	0.00%
Completion	3,000,000	£0.10	£0.10	50.00%	3	0.15%	0.00%
Senior Mgt	4,500,000	£0.10	£0.15	50.00%	5	0.15%	0.00%
Optiva	1,320,000	£0.10	£0.10	50.00%	3	0.15%	0.00%
Orana	175,000	£0.10	£0.10	50.00%	3	0.15%	0.00%
NED and Advisor	900,000	£0.08	£0.15	50.00%	5	0.15%	0.00%
TOTAL	11,875,000

 

Warrants		Number of Warrants	Exercise Price	Expiry date
As at 1 January 2022		34,475,000	£0.105	-
Issued on 28 April 20221		900,000	£0.15	28 April 2027
At 31 December 2022		35,375,000	£0.106
Expired during the year		(11,500,00)	£0.102	21 March 2023
As at 31 December 2023		23,875,000	£0.109

 

¹50% of the warrants vest on 28 April 2023 and the remainder vest on 28 April 2024

 

The weighted average time to expiry of the warrants as at 31 December 2023 is 3.99 years (2022: 3.10 years). Of the total number of options outstanding at 31 December 2023, 23,425,000 (2022: 34,475,000) had vested and were exercisable

 

The expected volatility was calculated using the Exponentially Weighted Moving Average Mode. Due to limited trading history comparable listed peer company information was used.

 

21.   Merger Relief Reserve

Under Companies Act Section 612, Merger relief reserve applies when a company has secured at least a 90% equity holding in another company in return for an allotment of equity shares in the issuing company. It requires that section 610 does not apply to the premium on those shares (i.e. no share premium recognised) and instead a Merger relief reserve is recognised.

 

Group and Company	£
At 1 January 2022	450,000
Acquisition of Oncogeni Ltd1	3,250,000
At 31 December 2022	3,700,000
At 31 December 2023	3,700,000

 

¹The issue on 16 September 2022 of 50,000,000 new shares relating to the acquisition of Oncogeni Ltd. The reserve reflects the difference between the nominal value of shares at the date of issue of £0.01 and the share price immediately preceding the issue of £0.75 per share. The shares issued formed part of the consideration for the acquisition of 100% of the equity of Oncogeni and therefore qualify for merger relief.

 

22.   Financial Instruments and Risk Management

Capital Risk Management

The Group manages its capital to ensure that it will be able to continue as a going concern while maximising the return to stakeholders. The overall strategy of the Group is to minimise costs and liquidity risk.

 

The capital structure of the Group consists of equity attributable to equity holders of the Group, comprising issued share capital, reserves and retained earnings as disclosed in the Statement of Changes of Equity.

 

The Group is exposed to a number of risks through its normal operations, the most significant of which are interest, credit, foreign exchange, commodity and liquidity risks. The management of these risks is vested to the Board of Directors.

The sensitivity has been prepared assuming the liability outstanding was outstanding for the whole period. In all cases presented, a negative number in profit and loss represents an increase in finance expense / decrease in interest income.

 

Credit Risk

Credit risk is the risk of financial loss to the Group if a customer or counterparty to a financial instrument fails to meet its contractual obligations and arises principally from the Group's receivables from customers. Indicators that there is no reasonable expectation of recovery include, amongst others, failure to make contractual payments for a period of greater than 120 days past due.

 

The carrying amount of financial assets represents the maximum credit exposure.

 

The principal financial assets of the Group are bank balances. The Group deposits surplus liquid funds with counterparty banks that have high credit ratings, and the Directors consider the credit risk to be minimal.

 

The Group's maximum exposure to credit by class of individual financial instrument is shown in the table below:

 

	Carrying value at 31 December 2023 £	Maximum exposure at 31 December 2023 £
Trade receivables	-	-
Other receivables	105,242	105,242
Cash and cash equivalents	537,322	537,322
	642,564	642,564

 

	Carrying value at 31 December	Maximum exposure at 31 December
	2022	2022
	£	£
Trade receivables	56,614	56,614
Other receivables	45,124	45,124
Cash and cash equivalents	2,322,974	2,322,974
	2,424,711	2,424,711

The Group operates in a global market with income and costs possibly arising in a number of currencies and is exposed to foreign currency risk arising from commercial transactions, translation of assets and liabilities and net investment in foreign subsidiaries. Exposure to commercial transactions arise from sales or purchases by operating companies in currencies other than the Group's functional currency. Currency exposures are reviewed regularly.

The Group has a limited level of exposure to foreign exchange risk through their foreign currency denominated cash balances and a portion of the Group's costs being incurred in Australian Dollars. Accordingly, movements in the Sterling exchange rate against these currencies could have a detrimental effect on the Group's results and financial condition.

 

Currency risk is managed by maintaining some cash deposits in currencies other than Sterling.

 

The table below shows the currency profiles of cash and cash equivalents:

	At 31 December 2023	At 31 December 2022
	£	£
Sterling	501,373	2,279,240
Australian Dollars	34,825	43,734
US Dollars	1,124	-
	537,322	2,322,974

 

	At 31 December 2023 £ +10% weaker       (10%) stronger	At 31 December 2022 £ +10% weaker         (10%) stronger
Net Loss1	(22,276)                 22,276	(34,181)                    34,181
Carrying value of net assets2	(4,749)                    4,749	(594)                          594

 

¹10% weaker relates to the Great British Pound weakening against the currency and therefore the Group would incur greater expenditure in its functional currency

²10% weaker relates to the Great British Pound weakening against the currency and therefore the net liabilities (excluding intercompany borrowings) denominated in AUD will increase

 

Foreign currency sensitivity analysis

As at 31 December 2023, the sensitivity analysis assumes a +/-10% change of the AUD/GBP, exchange rates, which represents management's assessment of a reasonably possible change in foreign exchange rates (2022: 10%). The sensitivity analysis was applied on net loss on the Australian operations and the carrying value of financial assets and liabilities.

 

Liquidity Risk

Liquidity risk is the risk that the Group will encounter difficulty in meeting the obligations associated with its financial liabilities that are settled by delivering cash or another financial asset. The Group's approach to managing liquidity is to ensure, as far as possible, that it will have sufficient liquidity to meet its liabilities when they are due, under both normal and stressed conditions, without incurring unacceptable losses or risking damage to the Group's reputation.

 

The Group seeks to manage liquidity risk by regularly reviewing cash flow budgets and forecasts to ensure that sufficient liquidity is available to meet foreseeable needs and to invest cash assets safely and profitably. The Group deems there is sufficient liquidity for the foreseeable future.

 

The principal current asset of the business is cash and cash equivalents and is therefore the principal financial instrument employed by the Group to meet its liquidity requirements. The Board ensures that the business maintains surplus cash reserves to minimise any liquidity risk.

 

The financial liabilities of the Group and Company, predominantly trade and other payables, are mostly due within 3 months (2022: 3 months) of the Consolidated Statement of Financial Position date; therefore, the undiscounted amount payable is the same as their carrying value. Further analysis of the lease commitment is provided in note 24. All other non-current liabilities are due between 1 to 5 years after the period end. The Group does not have any borrowings or payables on demand which would increase the risk of the Group not holding sufficient reserves for repayment.

 

The Group had cash and cash equivalents at period end as below:

 

	At 31 December 2023 £	At 31 December 2022 £
Cash and cash equivalents	537,322	2,322,974
	537,322	2,322,974

 

Interest Rate Risk

The Group is exposed to interest rate risk whereby the risk can be a reduction of interest received on cash surpluses held and an increase in interest on borrowings the Group may have. The maximum exposure to interest rate risk at the reporting date by class of financial asset was:

 

	At 31 December 2023 £	At 31 December 2022 £
Bank balances	537,322	2,322,974
	537,322	2,322,974

 

The Group does not currently earn interest on its cash deposits.

 

23.   Financial Assets and Financial Liabilities

Group     31 December 2023 Financial assets/liabilities	Financial Assets At amortised Cost £	Financial Liabilities At amortised Cost £	Total £
Trade and other receivables	70,243	-	70,243
Cash and cash equivalents	537,322	-	537,322
Trade and other payables	-	(307,114)	(307,114)
	607,565	(307,114)	300,451

 

Group	Financial	Financial
	Assets	Liabilities
	At amortised	At amortised
31 December 2022	Cost	Cost	Total
Financial assets/liabilities	£	£	£
Trade and other receivables	101,738	-	101,738
Cash and cash equivalents	2,322,974	-	2,322,974
Trade and other payables	-	(279,670)	(279,670)
	2,424,712	(279,670)	2,145,042

 

Company     31 December 2023 Financial assets/liabilities	Financial Assets At amortised Cost £	Financial Liabilities At amortised Cost £	Total £
Trade and other receivables	95,054	-	95,054
Intercompany receivables	812,951	-	812,951
Cash and cash equivalents	301,674	-	301,674
Trade and other payables	-	(182,912)	(182,912)
	1,209,679	(182,912)	1,026,767

 

Company	Financial	Financial
	Assets	Liabilities
	At amortised	At amortised
31 December 2022	Cost	Cost	Total
Financial assets/liabilities	£	£	£
Trade and other receivables	64,309	-	64,309
Intercompany receivables	451,622	-	451,622
Cash and cash equivalents	2,274,478	-	2,274,478
Trade and other payables	-	(183,802)	(183,802)
	2,790,409	(183,802)	2,606,607

 

24.   Commitments

	At 31 December 2023 £	At 31 December 2022 £
Committed at the reporting date but not recognised as liabilities, payable:
Laboratory rental	-	37,500
Research & Development	20,619	105,655

 

25.   Contingent Liabilities

The purchase agreement for Lyramid Pty Ltd in December 2021 included an additional contingent deferred consideration to the Seller to be satisfied in the form of Ordinary Shares as follows:

 

(a)    if prior to fifth anniversary of Admission (on 21 December 2021), the Company's market capitalisation exceeds £25,000,000 for a period of 5 or more consecutive trading days the Company shall issue to the Seller (or its nominee) 5,000,000 Ordinary Shares; and

 

(b)   if prior to fifth anniversary of Admission (on 21 December 2021) the Company's market capitalisation exceeds £50,000,000 for a period of 5 or more consecutive trading days the Company shall issue to the Seller (or its nominee) a further 5,000,000 Ordinary Share. The fair value of contingent deferred consideration was estimated to be nil at acquisition, at 31 December 2022 and at 31 December 2023.

 

As there is inherent uncertainty as to when, and if, the milestone will be achieved the Group has disclosed the amount as a contingent liability as at year end.

 

There were no other contingent liabilities at 31 December 2023 or 31 December 2022

 

26.   Related Party Transactions

In 2023 £177,942 was paid to Cell Therapy Ltd, a Company in which CEO Ajan Reginald is also a Director, for the recharge of a license to use a laboratory with equipment and associated running costs including electricity and cleaning (2022: £122,518). As at 31 December 2023, the Company owed Cell therapy £22,329 (2022: £15,043).

 

27.   Post reporting date events

There have been no significant events subsequent to 31 December 2023.

 

28.   Ultimate controlling party

As at 31 December 2023, there was no ultimate controlling party of the Company.