THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE MARKET ABUSE REGULATION (EU) NO. 596/2014 AS IT FORMS PART OF UK DOMESTIC LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL) ACT 2018, AS AMENDED. UPON THE PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.
7 May 2024
Genflow Biosciences Plc
Full Text of Final Accounts to 31 December 2023
Genflow Biosciences Plc (LSE:GENF) (OTCQB:GENFF) ("Genflow" or "the Company"), an emerging leader in the field of longevity research, focused on developing therapeutic solutions for the prevention of age-related diseases, sets out below the full, unedited text of its final results for the year ended 31 December 2023, announced earlier today, to assist shareholders and other interested parties.
Contacts
Genflow Biosciences |
Harbor Access |
Dr Eric Leire, CEO | Jonathan Paterson, Investor Relations |
+32-477-495-881 | +1 475 477 9401 |
| Jonathan.Paterson@Harbor-access.com |
| |
Joint Corporate Brokers | |
Clear Capital Markets | Capital Plus Partners Ltd |
Bob Roberts, +44 203 869 6080 | Dominic Berger, +44 203 821 6167 |
| Keith Swann, +44 0203 821 6169 |
| Jon Critchley, +44 0203 821 6168 |
| |
Chairperson's Report
Dear Shareholders,
Introduction
I am pleased to present my statement as the Chairperson of Genflow Biosciences Plc (GENF) (the "Company").
The Company is a preclinical biotechnology company focused on the development of innovative biological interventions (namely gene therapies) which are aimed at tackling the effects of aging, potentially slowing or halting the aging process and so reducing the incidence of age-related diseases and thereby increasing life span.
Over the past year, the Company has achieved numerous important milestones and I would like to sincerely thank our team for its exceptional commitment to execution and delivery.
As mentioned in greater detail in the Strategic report on page 5, the Company's subsidiary Genflow Biosciences SRL (together the "Group") is making great progress with its two principal longevity programs: NASH; now called MASH (Metabolic Dysfunction-Associated Steatohepatitis), as well as its work on Werner Syndrome. Most notably in relation to our MASH program, the Company had its first interaction with the Federal Agency for Medicines and Health Products (FAHMP) which was successful. FAHMP concurred with Genflow's proposal to commence Phase I/II clinical trials in MASH patients rather than with healthy volunteers once we reach the clinical trial phase. We hope that this will provide a first signal of efficacy in humans more speedily and, furthermore, we are hopeful that these trials will showcase the ability of longevity gene-therapy in assisting patients with life-limiting illnesses.
In the same month, we were also able to report that that the Company's shares had successfully commenced trading on the OTCQB Venture Market in the United States. We continue to believe this move expands our reach to a larger investor base and has the potential to enhance liquidity for our shares, making it easier for US investors to trade Company shares. Our acceptance onto the OTCQB also aligned (and continues to do so) with our strategic emphasis on the US due to its significant advancements and understanding in longevity and our ongoing collaborations with US-based institutions.
Another notable achievement this year, was the expansion our intellectual property portfolio through a provisional patent application focusing on the ability to edit the SIRT6 gene, shown to play a key role in longevity and age-related diseases. If granted the patent will represent a significant milestone in the field of gene editing, with potential implications for longevity and other forms of gene therapy.
2024
In January 2024, we announced two exciting collaborations with other biotech companies: a sarcopenia project with Revatis SA and an exosome-mRNA project with EXO Biologics. Both projects are backed by substantial non-diluting and non-reimbursable research grants by the Government of Wallonia in Belgium totalling a combined €2.89m. The first payment of €777,000 is due to be received imminently. The opportunity to collaborate with Revatis SA and EXO Biologics; plus the granting of funding, will allow us to strengthen our cash runway, enabling us to continue executing on our research and conduct additional development programs such as our sarcopenia program and therefore broaden our research pipeline and expand the size of the Company's therapeutic markets.
To strengthen the Company's financial position and increase our institutional investor base, the Company completed a placing and subscription to raise £715,000 (before expenses) recently. We were privileged to have the participation of Premier Miton, a well-known UK institution, in this fundraise.
In addition to this, Genflow Biosciences SRL also received €350,000 in April 2024 from the Wallonia Region representing the second half of the first tranche of the grant.
We have ambitious goals for our MASH and Werner research programs in 2024, including key Investigational New Drug ("IND")-enabling development activities that will help define the pharmacological and toxicological properties of our lead drug candidate, GF-1002, and its potential benefits for MASH patients. Additionally, we plan to start preliminary discussions with the European Medicines Agency (EMA) on Mechanism of Action (MoA) data for the Orphan Drug Application (ODA) for our second compound GF-3001, targeting Werner Syndrome. We also plan to initiate discussion with the FDA regarding our MASH program.
Governance and the Board
Genflow was pleased to further strengthen its exceptional Scientific Advisory Board (SAB) with the appointment of Prof. Sven Francque (University of Antwerp) and Prof. Dr Mary E. Rinella (University of Chicago) in May 2023.
Prof. Dr. Francque is currently Chairman of the Department of Gastroenterology and Hepatology of the University Hospital Antwerp and Full Professor of Medicine at the Faculty of Medicine and Health Sciences of the University of Antwerp in Belgium. He has a longstanding interest and expertise in non-alcoholic fatty liver disease and has conducted research focusing on steatosis.
Prof. Dr. Mary E. Rinella, is the Director of the Metabolic and Fatty Liver Disease Department at the University of Chicago. She has investigated a broad range of topics within fatty liver disease, including the use of non-invasive measures to minimize the use of liver biopsy and the study of new therapies to treat fatty liver disease.
In light of the ongoing progress being achieved by the Company, including its OTCQB listing and evolving focus on the US, leadership of the board and SAB were transitioned to individuals who are based in the US and have strong ties with the US markets and academic research institutions: I was appointed Chairperson of the Board and Vera Gorbunova PhD became Chairperson of the SAB. Dr. Gorbunova's contributions to the field of longevity and her invaluable insights in this sector will be instrumental in guiding the Company's scientific research.
These appointments to the SAB and leadership transitions are aimed at strengthening Genflow's links with the U.S. market, its investors and its research institutions, while continuing our commitment to the UK market, its investors and UK and European research institutions.
Yassine Bendiabdallah, former Chair, remains a key member of our Board and continues to act as a Non-Executive Director, and Dr Eric Verdin remains a key member of the SAB.
Forward look
I would like to extend my gratitude to the members of the Genflow board and wider team for their indispensable contributions to the Company. Their diligent efforts have played a pivotal role in realising the achievements outlined in my report. The Company eagerly anticipates collaborating on forthcoming projects with partners such as Revatis SA and EXO Biologics as we continue to maintain a robust financial position, ensuring our readiness to pursue our objectives for the fiscal year 2024. I look forward to providing further updates as developments materialise.
Tamara Joseph
Non-Executive Chairperson
3 May 2024
Strategic Report
Introduction
We are a pre-clinical biotechnology company committed to using gene therapy technologies to develop drugs that potentially halt, slow or reverse the aging process. Our products will aim at improving the health span (living healthier for longer) and potentially, life expectancy. Our objective is to develop gene therapies that address the growing medical need to prevent and delay age-related diseases by using adeno-associated viruses ("AAV") vectors to deliver copies of a SIRT6 gene variant found in Centenarians.
Research and Development Update
The Company's focus is the creation of innovative interventions in gene therapies that provide hope for halting, slowing or even reversing the aging process. The Group seeks to streamline and accelerate pre-clinical, regulatory, clinical, and production pathways.
Genflow continues with the research, development and safe implementation of its two longevity programs:
1. Metabolic Dysfunction-Associated Steatohepatitis (formerly known as Non-Alcoholic Steatohepatitis ("NASH")) ("MASH") where the Company is seeking to reverse aging fibrotic livers to normal functionality. MASH affects an estimated 35 million people globally and is one of the leading causes of chronic liver disease and liver transplants; and
2. Werner Syndrome where the Company is seeking to improve the life of patients with this accelerated aging disease. The Company is seeking to ensure swift first-in-human trials.
We are pleased to report that our MASH program is advancing, underscoring our firm commitment to combatting this global health issue. In collaboration with Dr. Manlio Vinciguerra, (a Genflow SAB member based at the University of Liverpool), we are gaining a significantly deeper understanding of the biochemical changes that occur in the treatment of MASH using the centenarian SIRT6. This research has led to us clearly identifying the workings of our lead drug candidate, GF-1002 and its potential benefits for MASH patients.
Our studies demonstrate the absorption and distribution of the Company's drug candidates in the human body. The data from these studies, which is owned by the Company, formed a significant part of the presentation to the regulatory authorities in June 2023 which resulted in a favorable response from the Federal Agency for Medicines and Health Products (FAHMP).
We were most pleased to receive written comments from the FAHMP of Belgium which recommended that the Company commence clinical trials of its drug, GF-1002, with patients suffering from MASH, rather than in healthy volunteers. This follows promising results from the Company's research in in-vitro human cells and in-vivo rodent studies. MASH clinical trials are expected to begin in Q2 2025 following dialogue and subsequent agreement with the European Medicine Agency.
As a result of our findings thus far, we have accumulated important data and filed a new patent application for editing the SIRT6 gene, linked to longevity and age-related diseases. If successful, this research could have significant positive implications for the field of gene therapy and beyond. Based on this work, further IP opportunities are also being continually explored.
Additionally, part of these results have been published in a peer controlled journal (reference: Human centenarian-associated SIRT6 mutants modulate hepatocyte metabolism and collagen deposition in multilineage hepatic 3D spheroids - PubMed (nih.gov)) with the Company's CEO and members of its SAB listed as co-authors.
Simultaneously, we are making progress on gene therapy targeting Werner Syndrome, an accelerated aging disease. Here, our vision is clear: to enhance the quality of life for affected patients and expedite the path towards swift and successful first-in-human trials under orphan drug designation. Our lead compound GF-3001, is a topical delivery of SIRT6 to the fibroblasts in the skin. The Company has already conducted a preliminary feasibility study for a clinical site in Northern Sardinia, Italy.
Note that all costs in relation to the Group's research and development activity have been recognized as an expense in the Consolidated Statement of Comprehensive Income due to the Group being in the research phase of its journey.
Strategic Development - Collaborative Research Agreements
Since incorporation, the Company has entered into several scientific collaborations with top-tier longevity research institutions and, in early-2024, was pleased to announce it had entered into new collaborative research agreements with two prestigious organisations in the biotechnology space.
The two new research programs are a part of a broader innovation partnership that the Walloon Government, dedicated to Advanced Therapy Medicinal Products (ATMPs).
Sarcopenia Research Program with Revatis SA
Genflow, together with Revatis SA, launched a 3-year sarcopenia research program, generously funded by a grant totalling €1.34m. Sarcopenia, the progressive loss of muscle mass and function associated with aging, poses a significant health risk and affects the quality of life for millions of elderly people worldwide.
mRNA Delivery Research with EXO Biologics
Genflow and EXO Biologics initiated a 3-year scientific program, supported by a grant of €1.55m. The project focuses on the development of a novel mRNA delivery system using exosomes to encapsulate and transport Genflow's proprietary centenarian SIRT6 gene. The Company plan to use these loaded exosomes for topical delivery to patients with Werner Syndrome.
Outlook for 2024
Our key objectives for 2024 are:
· Continuing to identify suitable grant funding to support the Group's project pipeline.
· Undertake key Investigational New Drug (IND)-enabling development activities that will help define the pharmacological and toxicological properties of our lead drug candidate, GF-1002, and its potential benefits for MASH patients.
· Select site and QMS framework for clinical readiness, expected by the end of 2025 for the MASH program.
· Commence preliminary discussions with the European Medicines Agency (EMA) on Mechanism of Action (MoA) data for Orphan Drug Application (ODA) for our second compound GF-3001, targeting Werner Syndrome.
· Select Contract Development and Manufacturing Organization (CDMO) for advancing the GMP manufacturing of the MASH clinical lot of lead drug candidate, GF-1002.
· Develop and implement project management, budgeting and governance for collaborative partners, in line with clinical and pre-clinal activities that will enable IND applications.
· Move key patent applications under the Patent Cooperation Treaty (PCT) to the national phase, while further expanding our development pipeline with new products and new indications.
Intellectual Property
Genflow BE holds an exclusive worldwide patent license along with the University of Rochester concerning the GF-1002 compound and its administration to treat humans and pets. The GF-1002 patent application principally relates to the cDNA of the variant of the human sirtuin 6 gene found in Centenarians. This represents the broadest possible scope for a "gene patent application" since it encompasses any use of the variant, including specifically, the Group's product GF-1002, but also any product that contains the variant for use in any application. Genflow's collaborative partners include: the University of Rochester, The Trustees of Columbia University in the City of New York, and Albert Einstein College of Medicine, New York.
Genflow BE also holds a provisional patent application focussing on the ability to edit the SIRT6 gene. This gene has been shown to play a role in longevity and age-related diseases. If granted, the patent will represent a significant breakthrough in the field of gene editing, with potential implications for longevity and other forms of gene therapy.
Late in 2022, the Company filed a new patent application with the United States Patent and Trademark Office that relates to methods of administration of variants of SIRT6, and the gene variant's therapeutic uses for the treatment of two disorders involving the liver: Non-alcoholic fatty liver disease NAFLD, and MASH. The application was filed via Genflow Biosciences SRL ("Genflow BE").
Investment To Date
The Company has an agreement with the Wallonia region in Southern Belgium to receive a non-dilutive research grant award of up to €3.375m. To date, the Company has accessed funding under tranche one of the grant which totals €767,000, of which partial payment was received in the previous reporting period, and the balance received in April 2024. The Company expects to apply for the second tranche of funding in 2024.
Additionally, the Company's research with Revatis SA and EXO Biologics is backed by substantial non-diluting and non-reimbursable research grants by the Government of Wallonia in Belgium, of which a combined total of €1.55m is receivable. Funding for the two research programs, as part of the Wallonia Recovery Plan by the Walloon Government in Belgium, will be disbursed annually to the Company, contingent upon Genflow and its collaborators achieving specific, activity-based milestones.
The Scientific Advisory Board (SAB)
Genflow has established what the Directors believe is a strong scientific advisory board ("SAB") experienced in the field of longevity. The role of the SAB is to provide the Company with specific guidance on its research & development programmes. Furthermore, the Company can benefit from constant external perspectives which the members of the SAB can bring to steer its research & development strategies. Details of the SAB members are as follows:
Dr Vera Gorbunova
Dr Vera Gorbunova, PhD is the Co-Director of the Rochester Ageing Research Center, University of Rochester New York. Dr Gorbunova is an endowed Professor of Biology at the University and a Co-Director of the Rochester Ageing Research Center. Her research is focused on understanding the mechanisms of longevity and genome stability and on the studies of exceptionally long-lived mammals. Her work has received awards from the Ellison Medical Foundation, the Glenn Foundation, American Federation for Ageing Research, and from the National Institutes of Health. Her work was awarded the Cozzarelli Prize from PNAS, the prize for research on ageing from ADPS/Alianz, (France), the Prince Hitachi Prize in Comparative Oncology, (Japan), and the Davey prize from Wilmot Cancer Center.
Dr Eric Verdin
Dr Eric Verdin, M.D. has been Chief Executive Officer and President of Buck Institute For Age Research since 18 November 2016. Dr Verdin served as an Associate Director and Senior Investigator at the Gladstone Institute of Virology and Immunology and a Professor of Medicine at the University of California. Dr Verdin's laboratory work focuses on the role of protein acetylation in biological processes, particularly in modulating the immune response. Specifically, his laboratory studies histone deacetylase enzymes (HDACs) that remove acetyl groups from histones and non-histone proteins.
Dr Matthew Hirschey
Dr Matthew Hirschey, PhD is an Assistant Professor in the Departments of Medicine (Division of Endocrinology, Metabolism and Nutrition) and Pharmacology & Cancer Biology at Duke University Medical Center and a faculty member of the Sarah W. Stedman Nutrition and Metabolism Center and the newly formed Duke Molecular Physiology Institute. His research focuses on mitochondrial metabolism, with a particular interest in how cells use metabolites and chemical modifications to sense metabolism. He, and his lab, study the regulation of this process by a family of enzymes called sirtuins, and how sirtuins maintain energy homeostasis. His work has appeared in several leading journals, including Nature, Science, Cell Metabolism and Molecular Cell. He has received several awards including an Innovator Award from the American Heart Association, a New Scholar in Ageing Award from the Ellison Medical Foundation, and the Helmholtz Young Investigator in Diabetes (HeIDi) Award. His work is supported by grants from the American Heart Association, the Mallinckrodt Foundation, Friedreich's Ataxia Research Alliance, the Ellison Medical Foundation, and the National Institutes of Health.
Dr Manlio Vinciguerra
Dr Manlio Vinciguerra, PhD is a Principal Investigator at the International Clinical Research Center (ICRC), Brno, Czech Republic. Previously he held a position of Senior Lecturer at the Institute for Liver and Digestive Health at University College London (UCL), London, United Kingdom. He received his PhD in Internal Medicine (2004) and research training at the University of Geneva, Switzerland, and at the European Molecular Biology Laboratory (EMBL), in Italy and in Germany (2005-2011). He obtained a degree in Biomolecular Sciences from the University of Catania, Italy, in 1999. Dr. Vinciguerra unravelled important cellular signalling and epigenetics mechanisms involved in metabolic and infectious processes, stress and ageing in the heart and in the liver, such as PI3K/AKT/mTOR pathway and sirtuins, using a systems biology approach in cells and rodent models. He is a member of Who's Who in Gerontology.
Professor Dr. Sven Francque
Professor Francque is a renowned expert in the field of NAFLD and its advanced form, nonalcoholic steatohepatitis now known as Metabolism-Associated Steatohepatitis (MASH). He has a long-standing interest and expertise in NAFLD and MASH, with research focusing on the vascular changes in steatosis and their contribution to disease progression. Genflow stands to gain significant value from Professor Francque's extensive knowledge of MASH, particularly in identifying new targets and potential therapies for the disease. Moreover, Professor Francque's expertise in clinical research and clinical trial design will be invaluable in the development of clinical trial programs for the Company's novel therapeutics. His membership of the SAB will play a vital role in shaping and broadening the Company's strategy and direction, and his vast experience will be integral to achieving the Company's goal of improving the lives of patients with MASH.
Dr. Mary E. Rinella, MD
Mary Rinella, MD, is a board-certified transplant hepatolgist at University of Chicago Medicine. Dr. Rinella is an expert in fatty liver disease (steatotic liver disease). She has become an expert in the various types of fatty liver diseases during her 20-year tenure, while also learning extensively about autoimmune and biliary liver diseases. Dr. Rinella has significant experience treating these illnesses, utilizing remedies such as nutritional intervention, the use of medications, endoscopy and clinical trials to deliver the most advanced treatment options. Dr. Rinella earned her medical degree at the University of Illinois School of Medicine before completing her residency and fellowship at the University of Chicago and Northwestern University, respectively. Her studies on the matters have led to over 150 articles published in prestigious journals such as Nature Reviews Gastroenterology & Hepatology, Gastroenterology, Hepatology, Journal of the American Medical Association (JAMA), The Lancet and more.
In order to align the objectives of the SAB members with that of the Group, a portion of the SAB member's remuneration is in the form of Ordinary Shares in the Company.
Organisational Progress
Since incorporation, the Company has made significant progress in its commitment to best practice in Corporate Governance.
The Company is proud to uphold a good standard of corporate governance by putting in place:
· An effective board of directors that is collectively responsible for ensuring success in the long term, led by a chairperson who is committed to continuous improvement
· A board that features a balance of competencies, experience, diversity, company knowledge and independence
· Directors that are able to dedicate sufficient time to their responsibilities, receive a great induction and have the opportunity to regularly update their skillset
· Regular evaluation of the board performance as well as that of the individual directors and committees.
The Company's Corporate Governance policy has been further detailed in the Corporate Governance Report on page 17.
Being a great place to work
Underlying our strategy is our dedication to ensuring we are able to attract and retain great talent by being, and remaining a great place to work. As our business grows, we believe our success will require ideas that can only come from people encouraged to be themselves at work, enabled to contribute to their full potential, and empowered to challenge conventional thinking. For us that means being an inclusive and diverse workplace, attracting and retaining the best people. Genflow's current staff based is made up of Directors and contractors, however we plan to take on more employees as we grow, and we are committed to implementing the aforementioned strategy from the start of our journey.
Diversity Statement
The Company's culture allows and encourages every person to make a unique and positive contribution to the organisation irrespective of their differences. The Company encourages contributions from all groups and actively seeks to maintain a diverse board of Directors, which will in turn be reflected in its workforce when the Company begins to recruit.
Roles by gender
| 2023 | 2022 | ||
| Female | Male | Female | Male |
Non-executive Director | 1 | 3 | 2 | 4 |
Executive Director | - | 1 | - | 1 |
In 2023, 20% of the board was made up of women. As the Company grows and develops it is eager to increase its gender diversity by appointing more women to its Board, adding new perspectives and contributions. However, at present, the Board and Company remains fairly small and only meets one out of two gender diversity targets set by the Listing Rules.
Roles by ethnicity
One fifth of the Company's board is formed of individuals from ethic minority backgrounds, as defined by the Listing Rules.
Financial Overview
As at 31 December 2023, the Group had cash reserves of £683,974 (2022: £2,356,225) and is debt free.
Group administration expenses for the 2023 year totaled £1,798,559 (2022: £1,822,232) which consisted of professional, legal and consulting fees of £215,971 (2022: £381,534) and PR and marketing costs of £106,819 (2022: £165,889). Expenditure on research and development was £960,314 for the year (2022: £724,465), all of which has been recognised as an expense due to the Group being in the research phase.
During the year ended 31 December 2023, the Company recognized grant income of £169,854 (2022: £487,293) relating to tranche one of non-dilutive research grant award from the regional government of Wallonia in southern Belgium SPW ("Wallonia Grant"). The ongoing agreement with the Walloon region allows Genflow BE to claim reimbursement in further tranches of €767,253, up to the amount of €3.375 million.
Other Comprehensive Income was charged with a translation gain of £11,853 (2022: £75,158 loss) upon converting the Subsidiary's results for the year since acquisition to GBP.
Key Performance Indicators ("KPIs")
The Board monitors the activities and performance of the Group on a regular basis. The Board uses financial indicators based on budget versus actual to assess the performance of the Group. The indicators set out below will be used by the Board to assess performance.
The main financial KPI for the Group at this stage are the level of cash and cash equivalents. Non-financial KPIs are more relevant at this stage, in line with the monitoring of progress of key milestones in the R&D phase. These below key KPIs allow the Board to monitor costs and plan future research and development activities.
| 2023 | 2022 |
Cash and cash equivalents | £683,974 | £2,356,225 |
Interaction with health authorities | 1 | - |
Intellectual property held | 4 | 2 |
In vivo data for targeted indication (Werner and MASH) | 2 | 2 |
Due to the Group being in the early stages of research and development, it is yet to reach its key milestones such as completing clinical trials. However, the Group continues to hit soft-milestones as its journey progresses.
Statement by the directors in performance of their statutory duties in accordance with s172(1) of the Companies Act 2006
The Director's believe they have acted in the way most likely to promote the success of the Group for the benefit of its members as a whole, as required by s172(1) 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 Group's employees;
· Foster the Group's relationships with suppliers and others; and
· Consider the impact of the Group's operations on the community and environment.
The application of the s172 requirements are demonstrated throughout this report and the financial statements as a whole, with the following examples representing some of the key decisions made in 2023 and up to the date of the approval of these financial statements:
· Entering into Collaboration Agreements with prestigious organisations to widen the Group's ability to obtain valuable research and to tap into the knowledge of other researchers.
· Exploring non-dilutive financing opportunities such as regional government grants to expedite areas of key research and development without diluting the holding of existing shareholders.
· Expanding on the Company's portfolio of intellectual property by filing new patent applications in order to protect the Company's research and development progress.
· Attending the annual AGM and prepared to answer any questions raised by shareholders.
· Presenting at conferences and published recordings on the Group's research and development.
· Securing arrangements with SAB members who are experts in sub-sectors of the longevity field, to enhance the skills and experience required for the Company as it progresses.
· Expanding organisational capability through appointing experienced Board members to govern and lead the Company.
· Intending to limit the use of animal models to what is necessary by the regulatory authorities (FDA, EMA, MHRA) and to that extent, the Company will seek to use alternatives, such as artificial organs built with human cell organoids, in testing rather than using animal models. These organoids mimic the function of a natural organ, therefore they deliver more relevant information on the potential safety and efficacy of the drug in humans. However, these organoids do not reflect the interaction of the organ with other organs, therefore testing on animals cannot always be avoided.
· Ensuring all experiments using animal models are put to an independent ethical committee for appropriate approval.
Principles 2 and 3 of the Corporate Governance Statement on page 17 provides further evidence for how Section 172(1) has been applied to strategic issues, risks or opportunities across key stakeholder groups.
By order of the Board
Eric Leire
Chief Executive Officer
3 May 2024
Operating Risks and Uncertainties
Set out below are the key operating risks and uncertainties affecting the Group.
Research and development risk
The Group operates in the biotechnology development sectors and will carry out complex scientific research. If the research, preclinical testing or clinical trials of any of its product candidates fail, meaning that these candidates will not be licensed or marketed, this would result in a complete absence of revenue from these failed candidates. Additionally, any positive results
from trials carried out on animals may not necessarily transfer to humans. For example, the mouse model study for Werner Syndrome cannot yet be seen to be fully reliable.
Mitigation: The Company will minimise this risk by broadening its drug candidate portfolio. Furthermore, the Company establishing a culture of collaboration with other research organisations with complementary expertise. Translational projects such as pre-clinical development of SIRT6-AAV require the integration of many scientific disciplines and breaking down of the 'cultural' barriers that sometimes exist between the disciplines.
Timeline risk
Failure can occur at any stage of clinical development and, as a result, enforced delays to the clinical development plan could hinder or prevent commercialisation of the Group's product candidates. Many markets where the Group intends to market its future products, including the US, Europe and Asia, expect proposed new pharmaceutical products to pass stringent standards. As a result, clinical trial design is extremely important, but costly and time-consuming, in order to satisfy national government regulatory authorities, clinical investigators, hospital ethics committees, institutional review boards, customers and distributors.
Mitigation: The Company intends to minimise this risk by retaining the skills and knowledge of the Scientific Advisory Board and monitoring R&D progress against budget and millstones. The Company will also apply for Orphan Drug Designation which provides a form of scientific advice, allowing sponsors to get answers to their questions on the types of studies needed to demonstrate the medicine's quality, benefits and risks, and information on the significant benefit of the medicine.
Risks related to future funding requirements
The funds raised by the Company, plus the Wallonia Grant are intended to support the Group's pre-clinical development activities. Additional capital will have to be raised to support clinical trial activities through established and highly-regulated pathways to assess safety, tolerability and efficacy of each of its products before applications can be made to individual countries or markets. Furthermore, such clinical trials are typically expensive, complex and can take considerable time to complete.
Whilst the Company believes that it has raised sufficient funds to enable it to undertake all work preparatory to large animal studies over the next 18 months, the Company will need to raise further funds to complete the development and commercialisation of its products and to proceed with any future product candidates.
Mitigation: The Company keeps close control over budgeted vs actual expenditure to minimise over spending and to track progress against milestones. The Group will also seek to look at alternative funding such as grants. The Group also has further fundraising at its disposal, however, it cannot be guaranteed that further funding from investors will be available when required.
Risk related to dependence on key personnel
The Group is highly dependent on the expertise and experience of the Directors, senior management and the Scientific Advisory Board and in particular Dr Eric Leire and Dr Vera Gorbunova. Recruiting and retaining qualified personnel (such as Dr Eric Leire and Dr Vera Gorbunova), consultants and advisers with the relevant gene therapy expertise will be important to its success.
Mitigation: The Company minimises this risk by bringing additional competencies within the management team, offering an attractive remuneration package and including share-based compensation within the remuneration packages of Board members and key personnel. Furthermore, the Company is entering into scientific collaborations with organisations in UK, Europe and USA which allows the Company to utilise the experience of personnel within these organisations.
The Exclusive Licence Agreement risk
The success of the Group's business is highly dependent upon the Exclusive Licence granted to Genflow BE by the University of Rochester. Under the terms of the Exclusive Licence Agreement, Genflow BE is required to maintain high standards and meet various development milestones and expenditure requirements.
If the Group fails to meet its obligations under the Exclusive Licence Agreement or if the Exclusive Licence is terminated for any reason, it could have a material adverse effect on the business, results of operations, financial condition and prospects of the Group.
Mitigation: The Company put in place a mitigation strategy upon entering into the License Agreement by designing a licensing agreement that aligns the interests of all parties involved. Furthermore, the licensee's obligations included in the agreement are realistic and proportionate to meet with appropriate monitoring by the Board.
IP risk
There is no guarantee that the patent applications will result in granted patents or provide the appropriate level of protection. The Exclusive Licence granted to Genflow BE pursuant to the Exclusive Licence Agreement is conditional upon the success of the GF-1002 patent application. The commercial success of the Group is dependent, in part, on non-infringement of patents by other third parties. An adverse judgment against the Group may give rise to significant liability in monetary damages, legal fees and a requirement to cease manufacturing, marketing or selling products.
Mitigation: A constant monitoring of third parties' activities by IP counsel will reduce this risk and enable the Group to quickly react in case of infringement. Moreover, the Group has the right to file infringement complaints with the courts and to defend its patent rights.
Risk related to the use of Adeno Associated Viruses
There is a risk that safety issues may arise when the Group's products are tested. This risk is common to all new classes of clinical treatment and, as with all other biotechnology product companies, there is a general risk that trials may not be successful.
Mitigation: The Company minimises this risk by engineering its AAVs as safer non immunologic gene delivery vectors. Furthermore, in parallel to the design of improved AAVs, the Company is also exploring other 'back-up' gene delivery methods such as exosomes.
Directors' Report
The Directors present their Report, together with the Group financial statements and Independent Auditor's Report, for the year ended 31 December 2023.
Principal Activities and Business Review
The Company is a preclinical biotechnology company focused on the development of innovative biological interventions (namely gene therapies) which are aimed at tackling the effects of aging, potentially slowing or halting the aging process and so reducing the incidence of age-related diseases and thereby increasing health span.
A detailed review of the business of the Group during the year and an indication of likely future developments may be found in the Chairperson's Statement on page 3.
Principal risks and uncertainties are discussed on page 10.
Section 172 of The Companies Act has been considered in the Strategic Report on page 5. The Board is committed to consideration of all stakeholders in their decision making and conduct of the Group's business.
Results and Dividends
The loss of the Group for the year ended 31 December 2023 from continued operations amounts to £1,628,705 (2022: £1,335,325).
The Directors do not recommend the payment of a dividend for the year.
Directors
The Directors who held office during the year and up to the date of signature of the financial statements were as follows:
Tamara Joseph
Eric Leire
Peter King-Lewis
Guy-Charles Fenneau De La Horie
Yassine Bendiabdallah
Directors' Interests
The Directors who served during the year ended 31 December 2023 had the following beneficial interests in the shares of the Company at year end:
Director | 31 December 2022 | 31 December 2023 | As at the date of this report | |||
Ordinary Shares | Options | Ordinary Shares | Options | Ordinary Shares | Options | |
Eric Leire (1) | 120,414,999 | - | 120,414,999 | - | 124,414,999 | - |
Yassine Bendiabdallah | 470,500 | - | 470,500 | - | 1,270,500 | - |
Peter King-Lewis | 382,000 | - | 382,000 | - | 1,182,000 | - |
Guy-Charles Fenneau De La Horie | 300,000 | - | 300,000 | - | 1,100,000 | - |
Tamara Joseph | - | - | - | - | 800,000 | - |
(1) Eric's wife, Ms J Pattison, holds 150,360 Ordinary Shares.
Substantial Shareholdings
The Company is aware that, as at 3 May 2024, other than the Directors, the interests of Shareholders holding three per cent or more of the issued share capital of the Company were as shown in the table below:
Shareholder | Shares held | Percentage of holdings |
Eric Leire | 120,414,999 | 35.5% |
Premier Miton | 32,000,000 | 9.2% |
Adrian Beeston | 17,475,000 | 5.0% |
Jonathan Mark Swann | 16,874,000 | 4.8% |
Samantha Bauer | 14,500,000 | 4.1% |
Longevity Tech Fund | 10,499,998 | 3.0% |
Sarah Beeston | 10,000,000 | 2.9% |
Political Contribution
The Group did not make any contributions to political parties during the year.
Corporate Responsibility
Environmental
As a development stage biotechnology business, the Group's operations are at a relatively small scale. As such, the Group's environmental impact is relatively small when compared with larger businesses in the sector. Nevertheless, the Board recognises its responsibility to protect the environment (particularly as the business scales up) and is fully committed to conserving natural resources and striving for environmental sustainability, by ensuring that its facilities (and the facilities of academic and contracted collaborators) are operated to optimise energy usage; minimise waste production; and protect nature and people.
TCFD recommendations serve as a global foundation for effective climate-related disclosures and set out recommended disclosures structured under four core elements of how companies operate:
o Governance - The organisation's governance around climate-related risks and opportunities;
o Strategy - The actual and potential impacts of climate-related risks and opportunities for an organisation's businesses, strategy, and financial planning;
o Risk Management - The processes used by the organisation to identify, assess, and manage climate-related risks; and
o Metrics and Targets - The metrics and targets used to assess and manage relevant climate-related risks and opportunities.
These are supported by recommended disclosures that build on the framework with information intended to help investors and others understand how reporting companies assess climate-related risks and opportunities.
The table below shows the Group's current progress against the TCFD recommendations.
TCFD Pillar | Recommended Disclosure | Genflow Response |
Governance | · The board's oversight of climate-related risks and opportunities · Management's role in assessing and managing climate related risks and opportunities | As a research stage biotechnology business, the Group's operations are at a relatively small scale and so is its environmental impact. The Board has oversight of climate-related matters (which include risks and opportunities). The Board is supported by the Audit Committee, which is responsible for keeping under review the adequacy and effectiveness of the Group's internal control and risk management systems, which consider climate-related risks. |
Strategy | · Climate-related risks and opportunities identification · Climate-related risks and opportunities impacts · Resilience of the organisation's strategy | Genflow is committed to a net zero and healthier planet, and this is part of the Group's strategic long-term priorities. The Board is committed to conserving natural resources and striving for environmental sustainability, by ensuring that its facilities (and the facilities of academic and contracted collaborators) are operated to optimise energy usage; minimise waste production; and protect nature and people. As Genflow progresses towards testing, ESG will be at the heart of the Board and management's vision and strategy to enable climate-related risks and opportunities to be identified and suitably mitigated/actioned. The information collected will allow the Board to challenge the Group's strategy to ensure it is as resilient as possible. |
Risk Management | · Identifying and assessing climate-related risks · Managing climate-related risks · Integration into overall risk management | Given the small scale of its current operations, Genflow has the ability to embed climate-related risk management systems into its overall internal control systems from the start of its journey, thus almost eliminating the occurrence of transition risk. As operations scale up, the identification, assessment and effective management of climate-related risks and opportunities will be actively discussed during Board and management meetings. |
Metrics and Targets | · Climate-related metrics · Scope 1, Scope 2, and Scope 3 emissions. · Climate-related targets
| As the Group's operations scale up, it will continue to monitor its energy use and its status as a low energy user. The Group will seek to collect, structure, and effectively disclose related performance data for the material, climate-related risks and opportunities identified where relevant. The Board will also look to adopt the Sustainability Accounting Standards Board (SASB) recommended disclosures once it is operating on a larger scale. |
Greenhouse gas emissions
The Company used less than 40,000kWh of energy in the United Kingdom during 2023 and therefore, does not report on energy consumption and emissions under the Companies (Directors' Report) and Limited Liability Partnerships (Energy and Carbon Report) Regulations 2018.
Social
The Board is committed to creating a positive, inclusive and welcoming work environment for its employees, workers, job applicants and academic and business partners. The Group ensures that people receive equal treatment, regardless of gender, gender-identity, age, disability, religion, belief, political views, sexual orientation, marital status, nationality or race, physical or mental health.
The Directors believe that diversity is fundamental to the Group and to the success of developing innovative therapeutic treatments. The Board is committed to creating a diverse environment, where the rights and differences of everyone, directly or indirectly operating within the Group, are valued.
Health and safety
The Company operates a comprehensive health and safety programme which will seek to ensure the wellbeing and security of its employees once it begins to recruit. The Board will at all times work to ensure that the Group complies with the highest standards of ethical and safety standards. In addition, the Group uses hazardous, or potentially hazardous, chemical and biological materials during its research and development programmes. These materials are necessary for the core research activities undertaken by the Group. The Group is committed to ensuring that hazardous chemicals and biological materials are acquired, stored, transferred, modified, handled, and disposed of in a way that minimises any potential adverse effects to human health and to the environment. Their use is based on both an understanding of the hazards they present and on the corresponding controls aimed at managing the risk of exposure. The Group complies with the local and national guidelines in all matters of health and safety.
For scientific and regulatory reasons, animal studies remain a crucial part of the Group's work to deliver safe and effective therapies, which benefit animal and patients' health and the wellbeing of our society. At present it is not possible, either due to lack of suitable alternatives, or because animal studies are required by regulatory authorities, for the Group to eliminate the need for animal studies in its work. The Group recognises the ethical responsibility to treat all animals respectfully, while striving to minimise their pain or distress, and to avoid it completely when possible. To this end, the Group strictly complies with all applicable international and local legislation and regulatory guidelines and, furthermore, is committed to following the high standards of internationally recognised practices on the humane treatment of animals. The Group upholds and embraces the "3Rs" of animal research, namely:
· the replacement of animals when possible and/or acceptable;
· the reduction of the numbers of experiments and of animals required by each experiment; and
· the minimisation of pain and distress, by means of refinement of animal studies procedures.
Principal Risks and Uncertainties
The management of the business and the execution of the Group's strategy are subject to a number of risks. Risks are formally reviewed by the Board, and appropriate processes are put in place to monitor and mitigate them. The principal business risks affecting the Group are set out on page 10.
Financial Risk Management
The Group's operations expose it to a variety of financial risks that include the effect of changes in foreign currency exchange rates, funding risk, credit risk, liquidity risk and interest rate risk. The Group has a risk management programme in place that seeks to limit the adverse effects on the financial performance of the Group. The Group does not use derivative financial instruments to manage foreign currency risk and, as such, no hedge accounting is applied.
Details of the Group's financial risk management policies are set out in Note 3 to the financial statements.
Internal Controls
The Board recognises the importance of both financial and non-financial controls and has reviewed the Group's control environment and any related shortfalls during the year. Since the Group was established, the Directors are satisfied that, given the current size and activities of the Group, adequate internal controls have been implemented. Whilst they are aware that no system can provide absolute assurance against material misstatement or loss, in light of the current activity and proposed future development of the Group, continuing reviews of internal controls will be undertaken to ensure that they are adequate and effective.
Going Concern
Management has prepared a forecast covering 12 month post-year end and believe that current cash reserves will adequately cover the working capital requirements of the Group, in addition to meeting research and development commitments. As such, the Directors have a reasonable expectation that the Group has, and will have access, to adequate resources to continue in operational existence for the foreseeable future and, therefore, continue to adopt the going concern basis in preparing the Annual Report and financial statements. Further details on their assumptions and their conclusion thereon are included in the statement on going concern in Note 2.4 of the financial statements.
Directors' and Officers' Indemnity Insurance
During the financial year, the Company maintained insurance cover for its Directors and Officers under a Directors' and Officers' liability insurance policy. The Company has not provided any qualifying indemnity cover for the Directors.
Events after the reporting period
Events after the reporting year are set out in Note 20 to the financial statements.
Provision of Information to Auditor
So far as each of the Directors is aware at the time this report is approved:
· there is no relevant audit information of which the Company's auditor is unaware; and
· the Directors have taken all steps that they ought to have taken to make themselves aware of any relevant audit information and to establish that the auditor is aware of that information.
Auditor
PKF Littlejohn LLP has signified its willingness to continue in office as auditor.
This report was approved by the Board on 3 May 2024 and signed on its behalf.
Tamara Joseph
Non-Executive Chairperson
3 May 2024
Statement of Directors' Responsibilities
The Directors are responsible for preparing the Annual Report and the financial statements in accordance with applicable law and regulation.
Company law in the United Kingdom requires the Directors to prepare Group and Company financial statements for each financial year which give a true and fair view of the state of affairs of the Company and the Group and of the profit or loss of the Group for that year. Additionally, the Financial Conduct Authority's Disclosure Guidance and Transparency Rules require the Directors to prepare the Group financial statements in accordance with UK-adopted international financial reporting standards in accordance with the requirements of the Companies Act 2006; the Company financial statements are prepared on the same basis.
In preparing the Group and Company financial statements, the Directors are required to:
• select suitable accounting policies and then apply them consistently;
• make judgements and estimates that are reasonable and prudent;
• state whether applicable accounting standards have been followed, subject to any material departures disclosed and explained in the financial statements;
• prepare the financial statements on the going concern basis unless it is inappropriate to presume that the group and company will continue in business.
So far as each Director is aware, there is no relevant audit information of which the Company's auditors are unaware, and the Directors have taken all the steps that they ought to have taken as Directors in order to make themselves aware of any relevant audit information and to establish that the Company's auditors are aware of that information.
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 Group and Company and enable them to ensure that the financial statements comply with the Companies Act 2006.
They are also responsible for safeguarding the assets of the Group and Company and for taking reasonable steps for the prevention and detection of fraud and other irregularities.
The maintenance and integrity of the Company's website is the responsibility of the Directors: the work carried out by the auditors does not involve consideration of these matters and, accordingly, the auditors accept no responsibility for any changes that may have occurred to the financial statements since they were initially presented on the website.
Legislation in the United Kingdom governing the preparation and dissemination of the financial statements may differ from legislation in other jurisdictions.
Corporate Governance Report
The Group is not required to comply with the UK Code of Corporate Governance and has not voluntarily adopted it. However, the Directors recognise the importance of sound corporate governance and the Board intends, to the extent it considers appropriate in light of the Group's size, stage of development and resources, to implement certain corporate governance recommendations.
The Directors have responsibility for the overall corporate governance of the Group and recognise the need for the highest standards of behaviour and accountability. As such, the Company follows the QCA Corporate Governance Code ("the Code") as its code of corporate governance. The Code is published by the Quoted Companies Alliance ("QCA") and is available at www.theqca.com.
Corporate Governance Report
The QCA Code sets out 10 principles that should be applied. These are listed below together with a short explanation of how the Group and Company applies each of the principles:
Principle One
Business Model and Strategy
The Board has concluded that the highest medium and long term value can be delivered to its shareholders by the adoption of a focussed strategy for the Group.
The Group's strategy is to focus on the development of innovative biological interventions (namely gene therapies) which are aimed at tackling the effects of aging, potentially slowing or halting the aging process and so reducing the incidence of age-related diseases and thereby increasing health span. Further details on the Group strategy is set out in the Strategic Report on page 5.
Principle Two
Understanding Shareholder Needs and Expectations
The Board is committed to maintaining good communication and having constructive dialogue with its shareholders. Shareholders are encouraged to attend the Company's Annual General Meeting. Investors also have access to current information on the Company though its website, www.genflowbio.com, and via communication with Directors, in particular, Eric Leire, (Chief Executive Officer) who is responsible for shareholder liaison.
The Company's annual report, Notice of Annual General Meetings (AGM) is sent to all shareholders and can be downloaded from the Company's website. Copies of the interim report and other investor presentations are available on the Company's website.
At the AGM, separate resolutions are proposed on each substantial issue. For each proposed resolution, proxy forms are issued which provide voting shareholders with an opportunity to vote in advance of the AGM if they are unable to vote in person. The Company's registrars count the proxy votes which are properly recorded and the results of the AGM are announced through regulatory news flow ("RNS") . The Board is keen to ensure that the voting decisions of shareholders are reviewed and monitored and that approvals sought at the Company's AGM are, as much as possible, within the recommended guidelines of the QCA Code.
Shareholders are kept up to date via RNS on matters of a material substance and regulatory nature. Periodic updates are provided to the market and any deviations to these updates are announced via RNS.
Non-deal roadshows may be arranged throughout the year to meet with existing shareholders and potential new stakeholders to maintain, as much as possible, transparency and dialogue with the market. Additionally investor presentations can be found on the Company's website.
Principle Three
Considering wider stakeholder and social responsibilities
The Board recognises that the long term success of the Company is reliant upon the efforts of the management and employees of the Company and its scientific advisory board, contractors, suppliers, regulators and other stakeholders. As the Group grows and develops, the Board have plans to put in place a range of processes and systems to ensure that there is close oversight and contact with its key resources and relationships. For example, all employees of the Company will participate in structured Company-wide annual assessment processes which are designed to ensure that there is an open and confidential dialogue with each person in the Company to help ensure successful two way communication with agreement on goals, targets and aspirations of the employee and the Company. The Board recognises that these feedback processes will help to ensure that the Company can respond to new issues and opportunities that arise to further the success of employees and the Company. The Company has close ongoing relationships with a broad range of its stakeholders and provides them with the opportunity to raise issues and provide feedback to the Company.
Principle Four
Risk Management
In addition to its other roles and responsibilities, the Audit Committee is responsible to the Board for ensuring that procedures are in place and are being implemented effectively to identify, evaluate and manage the significant risks faced by the Company. The risk assessment matrix below sets out those risks, and identifies their ownership and the controls that are in place. This matrix is updated as changes arise in the nature of risks or the controls that are implemented to mitigate them. The Audit Committee reviews the risk matrix and the effectiveness of scenario testing on a regular basis. The following principal risks and controls to mitigate them, have been identified:
Activity | Risk | Impact | Control(s) |
Environmental Risk | Negative environmental impact of operations | The Group's operations are at a relatively small scale. As such, the Group's environmental impact is relatively small. | Ongoing monitoring to ensure that its facilities and the facilities of academic and contracted collaborators are operated to optimise energy usage minimise waste production and protect nature and people.
|
Research and development Risk | The research, preclinical testing or clinical trials of any product candidates could fail, meaning that these candidates will not be licensed or marketed. | This could result in a complete absence of revenue from these failed candidates. | Ongoing monitoring of results, assessment by independent experts on viability of studies and the retention of the SAB members. |
Availability of licenses Risk | Failure to meet obligations under the Exclusive Licence Agreement could result in its termination. | The Group would not have any right to commercialise GF-1002 which could have a material adverse effect on the business, result of operations, financial condition and prospects of the Group. | Ongoing monitoring of the Company's obligations under the Exclusive Licence Agreement including the payments of amounts due and reporting obligations.
|
Grant and infringement of patents Risk
| There is no guarantee that the Patent Applications will result in granted patents. Also, the Company may not be able to monitor infringement of its patents by third parties, allowing competitors to increase their market share.
| The commercial success of the Group is dependent, in part, on non-infringement of patents by other third parties.
| Provide ongoing assistance as may be required by the applicants to the Patent Application.
In addition to IP protection, the Company also relies on trade secrets to create entry barriers to potential competitors.
|
Dependence on key personnel Risk
| The Group is highly dependent on the expertise and experience of the Directors, senior management and the Scientific Advisory Board. | A loss of key personnel could result in a loss of knowledge and personnel taking their knowledge to competitors. | Recruiting and retaining and incentivising qualified personnel, consultants and advisers with the relevant gene therapy expertise. |
Strategic Risk | Market downturn
Failure to deliver commerciality | Change in macro-economic conditions
| Ongoing monitoring of economic events and markets
Active marketing and experienced management |
Financial Risk | Misappropriation of funds
IT security
Ability to raise further capital | Fraudulent activity and loss of funds
Loss of critical financial data
The Group may be required to reduce the scope of its development | Robust financial controls and split of duties
Regular back up of data online and locally.
Ongoing monitoring of economic events and markets.
|
Regulatory Risk
| The Group will need to obtain various approvals from a number of regulatory authorities in order to market its future products. | The Group's activities will be adversely affected by regulatory factors such as the suspension of licences and changes to regulatory requirements that will govern any novel gene therapy.
| Proactive engagement with Government at all levels. |
The Directors have established procedures, as represented by this statement, for the purpose of providing a system of internal control. An internal audit function is not considered necessary or practical due to the size of the Company and the close day to day control exercised by the Executive Director. However, the Board will continue to monitor the need for an internal audit function. The Board works closely with and has regular ongoing dialogue with the outsourced finance function and has established appropriate reporting and control mechanisms to ensure the effectiveness of its control systems.
Principle Five
A Well-Functioning Board of Directors
As at the date hereof, the Board comprises, an Executive Director: Eric Leire, a Non-Executive Chairperson Tamara Jospeh and three Non-Executive Directors Yassine Bendiabdallah, Peter King-Lewis and Guy-Charles Fanneau de la Horie.
Details of the current Directors are set out within Principle Six below. Executive and Non-Executive Directors are subject to re-election at intervals as set out in the Company's articles of association (Article 29.1). The service agreement and letters of appointment of all Directors are available for inspection on reasonable notice at the Company's registered office during normal business hours.
The Board meets in-person at least once per year and has quarterly Board calls. During the year, the Company has established an Audit Committee, the members of which are included in Principle Six below. A Remuneration Committee and Nomination Committee was also established and seeks to follow the guiding principles laid out by the Quoted Company Alliance (QCA). No Board member may influence decisions relating to their own specific remuneration.
Dr Bendiabdallah, Ms Joseph, Dr Fanneau De La Horie and Dr King-Lewis are considered to be Independent Directors and as such the Company is in compliance with the requirement to have a minimum of two independent non-executive directors on its Board. The Board notes that the expectation of the QCA Code is that the Chairperson will not have an executive capacity and that the role of the Chairperson and Chief Executive Officer ("CEO") are not held by the same person. The Board shall review further appointments as scale and complexity grows.
The Company shall report annually on the number of Board and committee meetings held during the year and the attendance record of individual Directors. To date in the current financial year, the Directors have a 100% record of attendance at such meetings. Directors meet formally and informally both in person and by telephone. Formal board meetings held and attended during the year are detailed below:
| Meetings Attended | Meetings eligible to attend |
Eric Leire | 4 | 4 |
Yassine Bendiabdallah | 7 | 7 |
Peter King-Lewis | 6 | 6 |
Guy-Charles Fanneau De La Horie | 6 | 6 |
Tamara Joseph | 5 | 5 |
Principle Six
Appropriate Skills and Experience of the Directors
The Board consists of five Directors and, in addition, the Company engages the services of Westend Corporate LLP to act as the Company Secretary and to provide general financial and corporate assistance. The Company believes that the current balance of skills in the Board as a whole, reflects a very broad range of commercial and professional skills across geographies and industries and two of the Directors have experience in public markets.
The Board shall review annually the appropriateness and opportunity for continuing professional development whether formal or informal.
Tamara Joseph, Non-Executive Chairperson
Tamara is a seasoned health care leader, having extensive experience in both early-stage and commercial biotech companies in the US and other markets. Her expertise in the biotech sector includes public and private financings, M&A, global expansions, and a Nasdaq uplisting. She has also supported Nasdaq financings of over $1B. Her experience, spanning over 25 years, includes acting as a member of the executive team (as Chief Legal Officer and General Counsel) at multiple US publicly listed companies, as well as leading IT, Public and Government Affairs, and People & Culture teams.
Tamara served as Chief Legal Officer at Nasdaq-listed Spero Therapeutics Inc., a multi-asset, clinical-stage biopharmaceutical company in Cambridge, Massachusetts, at Nasdaq-listed, Millendo Therapeutics Inc., to support its transition to a publicly-traded company, and as General Counsel at Enzyvant Therapeutics Inc., a rare disease company focused on regenerative medicine which is now a subdivision of Sumitomo Pharma. Previously, Tamara has served as an adviser to the boards of five US publicly traded US biotechs, including Cubist Pharmaceuticals Inc. Tamara has a BA in Economics from Duke University, a JD from the University of Michigan Law School, and LLM degrees from the College of Europe in Belgium and the University of Paris. She began her legal career at the law firms of Morrison & Foerster and Fried Frank, working in New York, Los Angeles, Brussels and Paris. She also serves as a non-executive board member for the non-profit organizations of BINA Farm Center and Heluna Health, a $1B+ agency focused on improving population health.
Tamara Joseph is a member of the Audit Committee.
Dr Eric Leire, Chief Executive Officer
Dr Eric Leire, MD, MBA, brings to the Company a solid biotechnology expertise through his experience in the pharmaceutical industry (Pfizer, Schering Plough and Pharmacia), biotechnology (CEO of several private and public biotech companies such as APT Therapeutics and Paringenix), academia (Research Associate at the Harvard AIDS Institute) and Private Equity (partner at Biofund Venture Capital). He is the inventor of several patents. He also serves on the board of several biotechnology companies such as Pherecydes (ALPH.PA), Inhatarget, Immunethep andBSIM Therapeutics. Furthermore, Eric has been CEO of several cell and gene therapy companies such as Enochian Biosciences (Nasdaq: ENOB) and DanDrit Biotechnologies (OTC.QB: DDRT). He has also served as Non-Executive Director on the board of several cell and gene therapy companies such as Genizon (Canada) and FIT Biotechnology (Finland). He holds an MD from Grenoble University and an MBA from HEC, Paris and Kellogg, Northwestern University.
Dr Yassine Bendiabdallah, Non-Executive Director
Dr Yassine Bendiabdallah (MPharm, PhD, IP) is a Functional Medicine Healthy Ageing Specialist and an expert in Bio-identical Hormone therapy (BHRT). His previous academic degree as an anti-cancer drug discovery scientist with Cancer Research UK at University College London has earned him various distinctions and publications in peer-reviewed academic journals. After a few years in academia, he embarked on an entrepreneurial journey and co-founded the Zen Healthcare group of pharmacies and wellness clinics with multiple sites in London and worldwide partnerships. His current role is a clinical director and clinician with interests including age reversal therapies, functional approaches to medicine and intravenous micronutrient therapies. He also co-founded Pasithea Therapeutics, an innovative biotech company and mental health group of clinics and was, until March 2023, Chief Operations Officer and head of UK Clinics. He is a director and board member of a number of companies within the healthcare industry.
Dr Yassine Bendiabdallah is the chairman of the Audit Committee and Remuneration and Nomination Committee.
Dr Peter King-Lewis, Non-Executive Director
Dr Peter King-Lewis studied Medicine at St Bartholomew's Hospital in London. Prior to that he served for ten years as a Submarine Seaman Officer and Diver in The Royal Navy. Having completed Post Graduate Training in General Practice (St Bartholomew's, St Thomas', The Chelsea and Westminster and The Priory Roehampton) he founded a Private General Practice in Central London. Continuing his interest in Hyperbaric Medicine he was an HSE approved Medical Examiner of Divers. He has a strong interest in Bioidentical Hormones and has practiced Acupuncture alongside more conventional medicine. Dr King-Lewis also started and runs OfficeGP Ltd which provides Primary Care in the workplace for a variety of companies. During the last 27 years he has also been the President of The Independent Doctors Federation and Hon Sec, President and Trustee of the Chelsea Clinical Society.
Dr Peter King-Lewis is a member of the Remuneration and Nomination Committee.
Dr Guy-Charles Fanneau De La Horie, Non-Executive Director
Over the past 20 years, Guy-Charles has built, and led, biotech executive teams where he has acted as Chief Executive Officer. During his tenures, he has successfully led IPOs and completed multiple fundraisings. Guy-Charles' expertise in the biotech field in both public and private companies encompasses launching and selling new drugs in untapped markets, with successful early access programs. Specifically, Guy-Charles has served as Chief Executive Officer at three biotech companies, including, until very recently, Euronext Growth traded, Pherecydes Pharma, a biotech company that develops treatments against resistant bacterial infections; and Neovacs, a therapeutic vaccine company. Guy-Charles has also held senior positions at Biogen, a Nasdaq listed global biotechnology company. Guy-Charles managed the IPO and associated successful financing of Neovacs in 2010, and in 2021, led Pherecydes Pharma through an oversubscribed placing.
Dr Guy-Charles Fanneau De La Horie is a member of the Remuneration and Nomination Committee.
Principle Seven
Evaluate Board performance based on clear and relevant objectives, seeking continuous improvement
Internal evaluation of the Board, the Committees and individual Directors is to be undertaken on an annual basis in the form of peer appraisal and discussions to determine the effectiveness and performance of the various governance components, as well as the Directors' continued independence.
The results and recommendations that come out of the appraisals for the Directors shall identify the key corporate and financial targets that are relevant to each Director and their personal targets in terms of career development and training. Progress against previous targets shall also be assessed where relevant.
Principle Eight
Corporate Culture
The Board recognises that its decisions regarding strategy and risk will impact the corporate culture of the Company as a whole and that this will impact the performance of the Company. The Board is very aware that the tone and culture set by the Board will greatly impact all aspects of the Company as a whole and the way that its scientific advisory board members, research collaborators and employees behave. The corporate governance arrangements that the Board has adopted are designed to ensure that the Company delivers long term value to its shareholders and that shareholders have the opportunity to express their views and expectations for the Company in a manner that encourages open dialogue with the Board. A large part of the Company's activities are centred upon what needs to be an open and respectful dialogue with employees, clients and other stakeholders.
Therefore, the importance of sound ethical values and behaviours is crucial to the ability of the Company to successfully achieve its corporate objectives. The Directors believe that diversity is fundamental to the Group and to the success of developing innovative therapeutic treatments. The Board is committed to creating a diverse environment, where the rights and differences of everyone, directly or indirectly operating within the Group, are valued.
The Board places great importance on this aspect of corporate life and seeks to ensure that this flows through all that the Company does. The Directors consider that at present the Company has an open culture facilitating comprehensive dialogue and feedback and enabling positive and constructive challenge. The Company has adopted, with effect from the date of Admission, a code for Directors' and employees' dealings in securities which is appropriate for a company whose securities are traded and is in accordance with the requirements of the Market Abuse Regulation which came into effect in 2016.
Issues of bribery and corruption are taken seriously, The Company has a zero-tolerance approach to bribery and corruption and has an anti-bribery and corruption policy in place to protect the Company, its employees and those third parties to which the business engages with. The policy is provided to staff upon joining the business and training is provided to ensure that all employees within the business are aware of the importance of preventing bribery and corruption. Each employment contract specifies that the employee will comply with the policies. There are strong financial controls across the business to ensure on going monitoring and early detection.
Principle Nine
Maintenance of Governance Structures and Processes
Ultimate authority for all aspects of the Company's activities rests with the Board, the respective responsibilities of the Chairperson and Chief Executive Officer arising as a consequence of delegation by the Board. The Board has adopted appropriate delegations of authority which set out matters which are reserved to the Board. The Chairperson is responsible for the effectiveness of the Board, while management of the Company's business and primary contact with shareholders has been delegated by the Board to the Chief Executive Officer.
Audit Committee
The Audit Committee comprises Ms Joseph and Dr Bendiabdallah, who chairs this committee. This committee has primary responsibility for monitoring the quality of internal controls and ensuring that the financial performance of the Company is properly measured and reported. It receives reports from the executive management and auditors relating to the interim and annual accounts and the accounting and internal control systems in use throughout the Company. The Audit Committee shall meet not less than twice in each financial year and it has unrestricted access to the Company's auditors.
Remuneration and Nomination Committee
The Remuneration comprises Dr King-Lewis, Dr Fanneau De La Horie and Dr Bendiabdallah, who chairs this committee. The Remuneration and Nomination Committee reviews: remuneration, including making recommendations to the Company and the Board on the Company's policy on executive remuneration, including setting the overarching principles, parameters and governance framework of each of the Company's Executive Directors and certain senior executives; and the composition and make-up of the Board and any committees of the Board and evaluating the balance of skills, knowledge and experience and the size, structure and composition of the Board and committees of the Board, retirements and appointments of additional and replacement directors and committee members and will make appropriate recommendations to the Board on such matters.
Non-Executive Directors
The Board has adopted guidelines for the appointment of Non-Executive Directors which have been in place and which have been observed throughout the year. These provide for the orderly and constructive succession and rotation of the Chairperson and Non-Executive Directors insofar as both the Chairperson and Non-Executive Directors will be appointed for an initial term of three years and may, at the Board's discretion believing it to be in the best interests of the Company, be appointed for subsequent terms. The Chairperson may serve as a Non-Executive Director before commencing a first term as Chairperson.
In accordance with the Companies Act 2006, the Board complies with: a duty to act within their powers; a duty to promote the success of the Company; a duty to exercise independent judgement; a duty to exercise reasonable care, skill and diligence; a duty to avoid conflicts of interest; a duty not to accept benefits from third parties and a duty to declare any interest in a proposed transaction or arrangement.
Principle Ten
Shareholder Communication
The Board is committed to maintaining good communication and having constructive dialogue with its shareholders in compliance with regulations applicable to companies whose shares trade on the Standard Segment of the London Stock Exchange. All shareholders are encouraged to attend the Company's Annual General Meeting where they will be given the opportunity to interact with the Directors.
Copies of all Annual Reports, Notices of Meetings, Circulars sent to shareholders and Prospectus (in respect of the last 5 years) are included on the Company's website www.genflowbio.com.
Tamara Joseph
Non-Executive Chairperson
3 May 2024
Audit Committee Report
Dear Shareholders,
I am pleased to present the Group's Audit Committee report for the year to 31 December 2023.
Meeting Attendance
The Audit Committee met once in 2023, with the Company's auditors in attendance. Y Bendiabdallah chaired the meetings and the Committee's second board member T Joseph attended.
Composition of the Audit Committee
In line with the QCA, the Committee comprises two independent Non-Executive Directors, including the Chair. The members of the Audit Committee are Y Bendiabdallah and T Joseph. All current members of the Audit Committee have held, or currently hold, board-level positions in Biotech with international reach.
The Audit Committee's membership, as a whole, has competence relevant to the sector in which the Group operates and is able to function effectively with the appropriate degree of challenge.
Committee Duties
The Audit Committee is committed to:
External Auditor
The external auditor, PKF Littlejohn LLP ("PKF"), was reappointed after consideration by the audit committee and scrutiny of their independence, objectivity and capabilities. The Audit Committee also received and reviewed a report from the external auditor setting out to its satisfaction how its independence and objectivity is safeguarded when providing non-audit services. The value of non-audit services provided by PKF in respect of the year ending 31 December 2023 amounted to £nil (2022: £nil). During the year there were no circumstances where PKF was engaged to provide services prohibited by the FRC's 2019 ethical standard or which might have led to a conflict of interest.
Financial Statements
The Audit Committee reviewed and agreed the external auditor's strategy and approach in advance of their audit for the year ended 31 December 2023, and reviewed reports on the outcome of the audit.
Going Concern and Viability
The Audit Committee reviews supporting papers from management to support the Going Concern statement set out in note 2.4 and the Directors report. This includes sensitivity analysis over key assumptions. Following this review, the Audit Committee recommended to the Board the approval of both statements.
Internal Audit
The Group does not have a formal internal audit function due to the size of the Group and the low number of transactions during the year. The Audit Committee considers this is appropriate given the close involvement of the executive director and external accountant on a day-to-day basis. However, the need for an internal audit function will be kept under review by the Audit Committee on behalf of the Board.
The Year Ahead
The Audit Committee is focused on maintaining a framework of internal control, the effectiveness of which will be regularly reviewed by the Audit Committee in light of an ongoing assessment of significant risks facing the Company and the Group. The Audit Committee is committed to assisting the Board in discharging its duties regarding the financial statements, accounting policies and the maintenance of proper internal business, and operational and financial controls.
This report was approved by the Board on 3 May 2024.
Yassine Bendiabdallah
Chairman of the Audit Committee
3 May 2024
Remuneration and Nomination Committee Report
Dear Shareholders,
I am pleased to present the Group's Remuneration and Nomination Committee report for the year to 31 December 2023.
Committee Composition and Meeting Attendance
The Committee is made up of Independent, Non-Executive Directors and shall meet not less than twice in each financial year. The Remuneration and Nomination Committee last met on 16 October 2023.
Committee Duties
The Remuneration Committee is responsible for:
· Determining and agreeing with the Board the framework or broad policy for the remuneration of the executive offices and other senior managers;
· Take into account all factors which it deems necessary including the level of the Company's remuneration relative to other companies to ensure that members of the company are provided with appropriate incentives to encourage enhanced performance and are, in a fair and reasonable manner, rewarded for their individual contributions to the success of the Company; and
· Determining each year whether awards will be made, and if so, the overall amounts of such awards, the individual awards to executive directors and other senior executives and the performance targets to be used.
Remuneration Policy
Due to the Group being in the early stages of its journey and the Board's collective commitment to conserve cash, a bonus and incentive awards scheme does not form part of the executive or non-executive remuneration package. This will be kept under review by the Committee as the Group's activity progresses.
Directors notice periods
The Executive Director is subject to a twelve month notice period and all non-executive Directors are subject to a three month notice period.
Loss of office
None of the Directors contractually have claim to compensation for loss of office.
Base salary
The Committee's objective is to provide a competitive base salary reflective of the skills and experience of the relevant individual. These will be reviewed annually or on a significant change of responsibilities or change in market practice or a change in the size or complexity of the business. The Remuneration Committee also takes into account external market data and pay and employment conditions elsewhere in the Group and industry when considering increases to base salary levels. There are no performance criteria associated with receiving this benefit.
Pension
Pensions are provided to aid recruitment and retention by allowing the Directors to make provision for long-term retirement benefits. These are comparable with similar roles in similar companies. A Pension scheme has been set-up where by Directors receive 3% per cent of their base salary. There is no performance criteria associated with receiving this benefit.
Non-Executive Directors
Non-Executive Directors each receive a market rate basic fee, subject to time commitment requirements, for holding the office of Non-Executive Director which is set by the board as a whole.
Annual Report on directors' remuneration
Executive Directors (audited)
The remuneration of the Executive Directors for the year ended 31 December 2023 and period ended 31 December 2022 was as shown in the table below:
|
| 31 December 2023 | ||||
| Directors' fees | Bonus
| Taxable benefits | Pension benefits | Options issued | Total
|
| £ | £ | £ | £ | £ | £ |
Eric Leire | 232,008 | - | - | - | - | 232,008 |
| 232,008 | - | - | - | - | 232,008 |
|
| 31 December 2022 | ||||
| Directors' fees | Bonus
| Taxable benefits | Pension benefits | Options issued | Total
|
| £ | £ | £ | £ | £ | £ |
Eric Leire | 235,432 | - | - | - | - | 235,432 |
| 235,432 | - | - | - | - | 235,432 |
The Company has presented an annual percentage change of nil% (2022: 63%) in the amount paid to the CEO.
Non-Executive Directors (audited)
The basic fee for the Non-Executive Directors for 2023 and 2022 was £30,000.
The remuneration of the Non-Executive Directors for the year ended 31 December 2023 and period ended 31 December 2022 was as shown in the table below:
|
| 31 December 2023 | ||||
| Directors' fees | Bonus
| Taxable benefits | Pension benefits | Options issued | Total
|
| £ | £ | £ | £ | £ | £ |
Yassine Bendiabdallah | 30,000 | - | - | 713 | - | 30,713 |
Peter King-Lewis | 30,000 | - | - | 713 | - | 30,713 |
Guy-Charles Fanneau de La Horie | 30,000 | - | - | - | - | 30,000 |
Tamara Joseph | 30,000 | - | - | - | - | 30,000 |
| 120,000 | - | - | 1,426 | - | 121,426 |
|
| 31 December 2022 | ||||
| Directors' fees | Bonus
| Taxable benefits | Pension benefits | Options issued | Total
|
| £ | £ | £ | £ | £ | £ |
Yassine Bendiabdallah | 28,810 | - | - | 653 | - | 29,463 |
Peter King-Lewis | 28,810 | - | - | 653 | - | 29,463 |
Gabrielle Silver | 13,810 | - | - | 297 | - | 14,107 |
Andrew Scott | 12,522 | - | - | 179 | - | 12,701 |
Guy-Charles Fanneau de La Horie | 15,000 | - | - | - | - | 15,000 |
Tamara Joseph | 15,000 | - | - | - | - | 15,000 |
| 113,952 | - | - | 1,782 | - | 115,734 |
Statement of Directors' shareholding and share interests (audited)
The tables below set out the Directors' interests (including those of their connected persons) in Genflow Biosciences Plc shares as at 31 December 2023.
Executive Directors
| Shares owned outright |
|
|
Eric Leire (1) | 120,414,999 |
· Eric indirectly holds a further 150,360 Ordinary Shares by way of his wife's shareholding.
There were no changes in the Executive Director's interests between the year end and the date of this report.
Non-Executive Directors
As at the date of this report, Non-Executive Directors' interests were as follows;
| Shares owned outright |
|
|
Yassine Bendiabdallah | 470,500 |
Peter King-Lewis | 382,000 |
Tamara Joseph | - |
Guy-Charles Fanneau De La Horie | 300,000 |
Group spend on pay
During the year, the Group's administration expenses totalled £1,798,559 (2022: £1,822,232) of which 21.04% (2022: 19.8%) represented remuneration paid to Directors of the Company.
Shareholder Voting at the Annual General Meeting
The Directors' Remuneration Report for the period ended 31 December 2022 was approved by the shareholders at the adjourned Annual General Meeting held on 8 June 2023.
The votes cast were as follows:
| Number of votes | % of votes cast |
For | 128,514,675 | 99.9% |
Against | 71,531 | 0.1% |
Withheld | - | - |
The year ahead
The Committee has been charged by the Board to ensure that the Group's pay and benefits practices are competitive, able to attract high calibre people and to ensure those people are suitably incentivised to perform and remain with the Group over the long term. The Committee will continue to meet twice a year to ensure remuneration remains aligned with the Company's objectives and strategy.
The Committee and I are focused on ensuring that reward at the Company continues to be closely aligned with the delivery of long-term shareholder value.
This report was approved by the Board on 3 May 2024.
Yassine Bendiabdallah
Chairman of the Remuneration Committee
3 May 2024
Independent Auditor's Report to the Members of Genflow Biosciences plc
Opinion
We have audited the financial statements of Genflow Biosciences Plc (the 'parent company') and its subsidiaries (the 'group') for the year ended 31 December 2023 which comprise the Consolidated and Parent Company Statements of Financial Position, the Consolidated Statement of Comprehensive Income, the Consolidated Statement of Changes in Equity, the Parent Company Statement of Changes in Equity, the Consolidated and Parent Company Statements of Cash Flows and notes to the financial statements, including significant accounting policies. The financial reporting framework that has been applied in their preparation is applicable law and UK-adopted international accounting standards and as regards the parent company financial statements, as applied in accordance with the provisions of the Companies Act 2006.
In our opinion:
· the financial statements give a true and fair view of the state of the group's and of the parent company's affairs as at 31 December 2023 and of the group's loss for the year then ended;
· the group financial statements have been properly prepared in accordance with UK-adopted international accounting standards;
· the parent company financial statements have been properly prepared in accordance with UK-adopted international accounting standards and as applied in accordance with the provisions of the Companies Act 2006; and
· the financial statements have been prepared in accordance with the requirements of the Companies Act 2006.
Basis for opinion
We conducted our audit in accordance with International Standards on Auditing (UK) (ISAs (UK)) and applicable law. Our responsibilities under those standards are further described in the Auditor's responsibilities for the audit of the financial statements section of our report. We are independent of the group and parent company in accordance with the ethical requirements that are relevant to our audit of the financial statements in the UK, including the FRC's Ethical Standard as applied to listed public interest entities, and we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Conclusions relating to going concern
In auditing the financial statements, we have concluded that the director's use of the going concern basis of accounting in the preparation of the financial statements is appropriate. Our evaluation of the directors' assessment of the group's and parent company's ability to continue to adopt the going concern basis of accounting included management's assessment of going concern and associated cashflow forecasts for a period of more than 12 months from the date of approval of the financial statements. We reviewed management's assessment and made enquiries of management to confirm key assumptions and inputs used in the assessment. We evaluated the inputs to the cashflow forecast for reasonableness, including all grant income receivable and the recent equity fundraise, which are expected to cover working capital for the going concern period. We also performed sensitivity analysis to test the going concern model.
Based on the work we have performed, we have not identified any material uncertainties relating to events or conditions that, individually or collectively, may cast significant doubt on the group's or parent company's ability to continue as a going concern for a period of at least twelve months from when the financial statements are authorised for issue.
Our responsibilities and the responsibilities of the directors with respect to going concern are described in the relevant sections of this report.
Our application of materiality
We apply the concept of materiality both in planning and performing our audit, and in evaluating the effect of misstatements. At the planning stage, materiality is used to determine the financial statement areas that are included within the scope of our audit and the extent of sample sizes during the audit. This is reviewed accordingly during fieldwork and completion dependent on adjustments made during the audit.
The group was audited to a level of materiality for the financial statements as a whole of £79,900 (PY: £64,500), a benchmark calculated using 5% of the loss before tax of the group (PY: 5% of the loss before tax). We consider the loss before tax to be the most significant determinant of the group's financial position and performance used by shareholders and investors for the current period, with the significant balances in the period being the administrative expenditure and loss for the period.
The performance materiality applied at the group level was £56,000 (PY: £45,150) and we have reported misstatements during our audit work above £3,995 (PY: £3,225), as well as differences below that threshold that, in our view, warranted reporting on qualitative grounds. The group performance materiality was set by us at 70% of materiality (PY: 70% of materiality). This was deemed reasonable due to the relatively low level of transactions and simple nature of these transactions and also due to this being the third year we are performing the audit. Performance materiality was set to ensure sufficient coverage of the key balances.
The materiality applied to the parent company was £72,000 (PY: £44,000) being 5% of the loss before tax (PY: 5% of loss before tax). Loss before tax was deemed an appropriate benchmark for materiality calculation as it provides the best indication of annual performance during the research phase and given no development assets are capitalised. Performance materiality was £50,400 (PY: £30,800) and this was set by us at 70% of materiality (PY: 70% of materiality). This was deemed reasonable due to the relatively low level of transactions and simple nature of these transactions and also due to this being the third year we are performing the audit.
No component auditors were used and both subsidiaries were audited by us. Genflow Biosciences SRL was assessed as a significant component and was audited to a materiality of £47,000 (PY: £23,000) being 5% of the loss before tax (PY: 5% of loss before tax), with performance materiality applied of £33,000 (PY: £16,100). We agreed with the audit committee that we would report any individual audit difference in excess of £2,350 (PY: £1,150) for Genflow Biosciences SRL and differences below this threshold that, in our review, warranted reporting on qualitative grounds.
Our approach to the audit
In designing our audit, we determined materiality and assessed the risks of material misstatement in the financial statements. We looked at areas involving significant accounting estimates and judgements by the directors including the recoverability and recognition of grant income and the carrying value of investments - parent company. We also addressed the risk of management override of internal controls, including among other matters, consideration of whether there was evidence of bias that represented a risk of material misstatement due to fraud. Procedures were then performed to address the risks identified and for the most significant assessed risks of material misstatement, the procedures performed are outlined below in the Key audit matters section of this report.
The audit of the parent company and its subsidiaries was performed in London by us, using a team with specific experience of auditing publicly listed entities.
Key audit matters
Key audit matters are those matters that, in our professional judgment, were of most significance in our audit of the financial statements of the current period and include the most significant assessed risks of material misstatement (whether or not due to fraud) we identified, including those which had the greatest effect on: the overall audit strategy, the allocation of resources in the audit; and directing the efforts of the engagement team. These matters were addressed in the context of our audit of the financial statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters.
Key Audit Matter | How our scope addressed this matter |
Recoverability and recognition of grant income (Group only - see Note 2.7 and 10 in the financial statements) |
|
The Group received a non-dilutive research grant award of up to €3.375m from the regional government of Wallonia in southern Belgium SPW. The Grant contributes to the costs of the pre-clinical research and development program.
There is a significant risk that the grant income recognised is not yet earned by the group due to the conditions set out in the grant not being met, and as such the recoverability and recognition of grant income has been deemed a key audit matter.
| Our work in this area included:
· Documenting our understanding and performing a walkthrough of the information system and key controls relevant to research and development expenditure and submission of grant claims; · Evaluating the effectiveness of the design and implementation of the key controls in respect of grant income; · Substantive testing of receipts relating to grant income, including accrued income balances recognised at the year-end; · Reviewing the grant terms and conditions, together with the grant claims, and ensuring compliance with the terms therein; · Confirming the treatment of grant income is in accordance with IAS 20, Accounting for Government Grants and Disclosure of Government Assistance being the applicable accounting standard; and · Reviewing post year-end receipts to ensure recoverability and completeness of income recorded in the accounting period.
We are satisfied that grant income is recoverable and has been recognised appropriately by management.
|
Carrying value of investment (Parent company - see Note 9 in the financial statements) | |
Genflow Biosciences Plc is the ultimate parent company of the group. The carrying value of investment in subsidiary undertakings as at 31 December 2023 amounted to £770,187 (2022: £1,058,266). The value of the investment in subsidiaries is material in the parent company financial statements. There is a significant risk the carrying amount of the investment which is subject to management's estimation and judgement might not reflect any possible impairment and as such this has been deemed to be a key audit matter.
| Our work in this area included:
· Considering the valuation of the investments in the year and evaluating for any potential impairment indicators; · Obtaining management's impairment review and reviewing the reasonableness of key assumptions and inputs; · Assessing progress of the research and development activities in the underlying subsidiaries; · Reviewing the reassignment of the loan in Genflow Biosciences SRL from Genflow Biosciences Plc to Genflow Biosciences Inc, including reviewing the signed agreements and accounting treatment of this in all the impacted entities; and · Vouching the increase in the loan in Genflow Biosciences Inc to bank statements.
Management's assessment of the carrying value of investments was concluded as reasonable.
|
Other information
The other information comprises the information included in the annual report, other than the financial statements and our auditor's report thereon. The directors are responsible for the other information contained within the annual report. Our opinion on the group and parent company financial statements does not cover the other information and, except to the extent otherwise explicitly stated in our report, we do not express any form of assurance conclusion thereon. Our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the course of the audit, or otherwise appears to be materially misstated. If we identify such material inconsistencies or apparent material misstatements, we are required to determine whether this gives rise to a material misstatement in the financial statements themselves. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact.
We have nothing to report in this regard.
Opinions on other matters prescribed by the Companies Act 2006
In our opinion the part of the directors' remuneration report to be audited has been properly prepared in accordance with the Companies Act 2006.
In our opinion, based on the work undertaken in the course of the audit:
· the information given in the strategic report and the directors' report for the financial year for which the financial statements are prepared is consistent with the financial statements; and
· the strategic report and the directors' report have been prepared in accordance with applicable legal requirements.
Matters on which we are required to report by exception
In the light of the knowledge and understanding of the group and the parent company and their environment obtained in the course of the audit, we have not identified material misstatements in the strategic report or the directors' report.
We have nothing to report in respect of the following matters in relation to which the Companies Act 2006 requires us to report to you if, in our opinion:
· adequate accounting records have not been kept by the parent company, or returns adequate for our audit have not been received from branches not visited by us; or
· the parent company financial statements and the part of the directors' remuneration report to be audited are not in agreement with the accounting records and returns; or
· certain disclosures of directors' remuneration specified by law are not made; or
· we have not received all the information and explanations we require for our audit.
Responsibilities of directors
As explained more fully in the statement of directors responsibilities, the directors are responsible for the preparation of the group and parent company financial statements and for being satisfied that they give a true and fair view, and for such internal control as the directors determine is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the group and parent company financial statements, the directors are responsible for assessing the group's and the parent company's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the directors either intend to liquidate the group or the parent company or to cease operations, or have no realistic alternative but to do so.
Auditor's responsibilities for the audit of the financial statements
Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor's report that includes our opinion. Reasonable assurance is a high level of assurance but is not a guarantee that an audit conducted in accordance with ISAs (UK) will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements.
Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design procedures in line with our responsibilities, outlined above, to detect material misstatements in respect of irregularities, including fraud. The extent to which our procedures are capable of detecting irregularities, including fraud is detailed below:
We obtained an understanding of the group and parent company and the sector in which they operate to identify laws and regulations that could reasonably be expected to have a direct effect on the financial statements. We obtained our understanding in this regard through detailed discussions with management about and potential instances of non-compliance with laws and regulations both in the UK and in overseas subsidiaries. We also selected a specific audit team based on experience with auditing entities within this industry of a similar size.
· We determined the principal laws and regulations relevant to the group and parent company in this regard to be those arising from:
o Main Market Listing Rules;
o The Companies Act 2006;
o UK Employment law;
o The Prospectus Directive;
o Anti Bribery Legislation;
o Market Abuse Directive;
o Financial Services and Market Act;
o Disclosure and Transparency Rules;
o Belgium and US law and company reporting requirements; and
o Local tax and employment law.
· We designed our audit procedures to ensure the audit team considered whether there were any indications of non-compliance by the group and parent company with those laws and regulations. These procedures included, but were not limited to:
o Conducting inquiries of management and those charged with governance regarding potential instances of non-compliance;
o Review of Board minutes and other correspondence from management;
o Review of regulatory news service announcements; and
o Review of legal and professional fees for evidence of any litigation or claims against the group.
These procedures were carried out for all entities within the group to ensure no instances of non-compliance within the parent company or any of its subsidiaries.
· We also identified the potential risks of material misstatement of the financial statements due to fraud. We considered, in addition to the non-rebuttable presumption of a risk of fraud arising from management override of controls, that a potential for management bias exists in relation to the recoverability and recognition of grant income and the carrying value of investment - parent company. See key audit matters section above.
· As in all of our audits, we addressed the risk of fraud arising from management override of controls by performing audit procedures which included, but were not limited to: testing over all journals on a risk based approach to identify any unusual transactions that could be indicative of fraud; reviewing accounting estimates for evidence of bias; evaluating the business rationale of any significant transactions that are unusual or outside the normal course of business; and reviewing transactions through the bank statements to identify potentially large or unusual transactions that do not appear to be in line with our understanding of business operations.
In our audit procedures, we have considered matters of non-compliance with laws and regulations, including fraud at the group and component levels. We have performed audit procedures on all material components within the Group.
Because of the inherent limitations of an audit, there is a risk that we will not detect all irregularities, including those leading to a material misstatement in the financial statements or non-compliance with regulation. This risk increases the more that compliance with a law or regulation is removed from the events and transactions reflected in the financial statements, as we will be less likely to become aware of instances of non-compliance. The risk is also greater regarding irregularities occurring due to fraud rather than error, as fraud involves intentional concealment, forgery, collusion, omission or misrepresentation.
A further description of our responsibilities for the audit of the financial statements is located on the Financial Reporting Council's website at: www.frc.org.uk/auditorsresponsibilities.This description forms part of our auditor's report.
Other matters which we are required to address
We were appointed by the Audit Committee on 21 January 2022 to audit the financial statements for the period ending 31 December 2021 and subsequent financial periods. Our total uninterrupted period of engagement is 3 years, covering the periods ending 31 December 2021 to 31 December 2023.
The non-audit services prohibited by the FRC's Ethical Standard were not provided to the group or the parent company and we remain independent of the group and the parent company in conducting our audit.
Our audit opinion is consistent with the additional report to the audit committee.
Use of our report
This report is made solely to the company's members, as a body, in accordance with Chapter 3 of Part 16 of the Companies Act 2006. Our audit work has been undertaken so that we might state to the company's members those matters we are required to state to them in an auditor's report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone, other than the company and the company's members as a body, for our audit work, for this report, or for the opinions we have formed.
David Thompson (Senior Statutory Auditor) 15 Westferry Circus
For and on behalf of PKF Littlejohn LLP Canary Wharf
Statutory Auditor London E14 4HD
3 May 2024
Consolidated and Company Statement of Financial Position
| | Group | Company | ||
| Notes | Year ended 31 December 2023 £ | Year ended 31 December 2022 £ | Year ended 31 December 2023 £ | Year ended 31 December 2022 £ |
Non-Current Assets | |
| | | |
Property, plant & equipment | | 3,394 | 2,351 | - | - |
Investments | 9 | - | - | 770,187 | 1,058,266 |
Total non-current assets | | 3,394 | 2,351 | 770,187 | 1,058,266 |
Current Assets | |
| |
| |
Trade and other receivables | 10 | 384,285 | 258,885 | 144,338 | 153,874 |
Cash and cash equivalents | 11 | 683,974 | 2,356,225 | 247,539 | 1,639,776 |
Total current assets | | 1,068,259 | 2,615,110 | 391,877 | 1,793,650 |
Total Assets | | 1,071,653 | 2,617,461 | 1,162,064 | 2,851,916 |
Current Liabilities | |
| |
| |
Trade and other payables | 12 | 345,738 | 250,988 | 117,014 | 71,515 |
Total Liabilities | | 345,738 | 250,988 | 117,014 | 71,515 |
Net Assets | | 725,915 | 2,366,473 | 1,045,050 | 2,780,401 |
Equity attributable to owners of the Parent | |
| |
| |
Share capital | 14 | 87,752 | 87,752 | 87,752 | 87,752 |
Share premium | 14 | 4,190,900 | 4,190,900 | 4,190,900 | 4,190,900 |
Other reserves | 15 | 219,488 | 231,341 | - | - |
Retained earnings | | (3,772,225) | (2,143,520) | (3,233,602) | (1,498,251) |
Total Equity | | 725,915 | 2,366,473 | 1,045,050 | 2,780,401 |
The Company has taken advantage of the exemption under Section 408 of the Companies Act 2006 from presenting its own profit and loss account. During the year ended 31 December 2023, the Company made a loss for the year of £1,735,351 (2022: £882,842).
The financial statements were approved and authorised for issue by the Board of Directors on 3 May 2024 and were signed on its behalf by:
Eric Leire
Chief Executive Officer
Consolidated Statement of Comprehensive Income
| | Group | |
Continuing Operations | Notes | Year ended 31 December 2023 £ | Year ended 31 December 2022 £ |
Other operating income | | 169,854 | 487,293 |
Operating Profit | | 169,854 | 487,293 |
Administration expenses | 6 | (1,798,559) | (1,822,236) |
Operating Loss | | (1,628,705) | (1,334,943) |
Net finance costs | | - | (382) |
Loss before Taxation | | (1,628,705) | (1,335,325) |
Income tax | 8 | - | - |
Loss for the year from continuing operations | | (1,628,705) | (1,335,325) |
Loss attributable to: | |
| |
- owners of the Parent | | (1,628,705) | (1,335,325) |
| | (1,628,705) | (1,335,325) |
Other Comprehensive Income: | | | |
Items that may be subsequently reclassified to profit or loss | |
| |
Exchange differences on translating foreign operations | |
(11,853) |
75,158 |
Total Comprehensive Income | | (1,640,558) | (1,260,167) |
Attributable to: | |
| |
- owners of the Parent | | (1,640,558) | (1,260,167) |
Total Comprehensive Income from continuing operations | | (1,640,558) | (1,260,167) |
Earnings per share (pence) from continuing operations attributable to owners of the Parent - Basic & Diluted | 16 | (0.557) | (0.457) |
Consolidated Statement of Changes in Shareholders' Equity
|
|
|
| |||
|
| Attributable to Equity Shareholders- Group | ||||
|
| Share capital £ | Share premium £ | Other reserves £ | Retained losses £ | Total equity £ |
As at 1 January 2022 |
| 73,371 | 633,765 | 156,183 | (808,195) | 55,124 |
Loss for the period | | - | - | - | (1,335,325) | (1,335,325) |
Other comprehensive income | | | | | | |
Exchange differences on translating foreign operations | | - | - | 75,158 | - | 75,158 |
Total comprehensive income for the period |
| - | - | 75,158 | (1,335,325) | (1,260,167) |
Transactions with owners | | | | | | |
Issue of ordinary shares | 14 | 14,381 | 3,820,539 | - | - | 3,834,920 |
Cost of capital - share issue costs | 14 | - | (263,404) | - | - | (263,404) |
Total transactions with owners | | 14,381 | 3,557,135 | - | - | 3,571,516 |
As at 31 December 2022 | | 87,752 | 4,190,900 | 231,341 | (2,143,520) | 2,366,473 |
As at 1 January 2023 |
| 87,752 | 4,190,900 | 231,341 | (2,143,520) | 2,366,473 |
Loss for the period | | - | - | - | (1,628,705) | (1,628,705) |
Other comprehensive income | | | | | | |
Exchange differences on translating foreign operations | | - | - | (11,853) | - | (11,853) |
Total comprehensive income for the period |
| - | - | (11,853) | (1,628,705) | (1,640,558) |
As at 31 December 2023 |
| 87,752 | 4,190,900 | 219,488 | (3,772,225) | 725,915 |
Company Statement of Changes in Shareholders' Equity
|
|
|
| ||
|
| Attributable to Equity Shareholders- Company | |||
|
| Share capital £ | Share premium £ | Retained losses £ | Total equity £ |
As at 18 January 2022 |
| 73,371 | 633,765 | (615,409) | 91,727 |
Loss for the period | | - | - | (882,842) | (882,842) |
Other comprehensive income | | - | - | - | - |
Total comprehensive income for the period |
| - | - | (882,842) | (882,842) |
Transactions with owners | | | | | |
Issue of ordinary shares | 14 | 14,381 | 3,820,539 | - | 3,834,920 |
Cost of Capital - share issue costs | 14 | - | (263,404) | - | (263,404) |
Total transactions with owners | | 14,381 | 3,557,135 | - | 3,571,516 |
As at 31 December 2022 |
| 87,752 | 4,190,900 | (1,498,251) | 2,780,401 |
As at 1 January 2023 |
| 87,752 | 4,190,900 | (1,498,251) | 2,780,401 |
Loss for the period | | - | - | (1,735,351) | (1,735,351) |
Other comprehensive income | |
- |
- |
- |
- |
Total comprehensive income for the period |
| - | - | (1,735,351) | (1,735,351) |
As at 31 December 2023 |
| 87,752 | 4,190,900 | (3,233,602) | 1,045,050 |
Consolidated and Company Statement of Cash flows
|
| Group | Company | ||
| Notes | Year ended 31 December 2023 | Year ended 31 December 2022 | Year ended 31 December 2023 | Year ended 31 December 2022 |
Cash flows from operating activities | |
|
|
|
|
Loss after taxation | | (1,628,705) | (1,335,325) | (1,735,351) | (882,842) |
Adjustments for: | |
| |
| |
Depreciation & amortisation | | 1,034 | 129 | - | - |
Forgiveness of loan | | - | - | 1,116,367 | - |
Share based payments | | - | 72,000 | - | 72,000 |
Increase in trade and other receivables | 10 | (131,014) | (206,339) | 12 | (102,371) |
Increase/(decrease) in trade and other payables | 12 | 103,228 | 29,561 | 55,023 | (137,108) |
Foreign exchange | | - | 71,120 | - | - |
Net cash used in operating activities |
| (1,655,457) | (1,368,324) | (563,949) | (1,050,321) |
Cash flows from investing activities | |
| |
| |
Purchase of property, plant & equipment | | (2,439) | (2,480) | - | - |
Cash paid for acquisitions | | - | - | - | - |
Loans granted to subsidiaries | | - | - | (828,288) | (975,985) |
Net cash used in investing activities | | (2,439) | (2,480) | (828,288) | (975,985) |
Cash flows from financing activities | |
| |
| |
Proceeds from issue of shares | 14 | - | 3,762,920 | - | 3,762,920 |
Share issue costs | 14 | - | (263,404) | - | (263,404) |
Net cash generated from financing activities | | - | 3,499,516 | - | 3,499,516 |
Net (decrease)/increase in cash and cash equivalents | | (1,657,896) | 2,128,183 | (1,392,237) | 1,473,210 |
Cash and cash equivalents at beginning of year | | 2,356,225 | 224,004 | 1,639,776 | 166,566 |
FX on cash | | (14,355) | 4,038 | - | - |
Cash and cash equivalents at end of year | 11 | 683,974 | 2,356,225 | 247,539 | 1,639,776 |
Non-cash investing and financing activities Consultancy fees settle in shares
| |
- |
(72,000)
|
-
|
(72,000) |
Notes to the Financial Statements
ACCOUNTING POLICIES
1. General Information
The principal activity of Genflow Biosciences Plc ("the Company") and its subsidiaries (together "the Group") is the research and development of gene therapy targeting the upstream biology of aging.
The Company is incorporated and domiciled in the United Kingdom. The Company was incorporated on 18 January 2021 and commenced trading on this date.
The address of its registered office is 6 Heddon Street, London, W1B 4BT.
2. 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 periods presented, unless otherwise stated.
2.1 Basis of Preparation of Financial Statements
The financial statements of the Company are prepared in accordance with Part 15 of the Companies Act 2006, which applies to companies generally.
The Group financial statements have been prepared in accordance with UK-adopted international accounting standards and the Companies Act 2006. The Group financial statements have been prepared under the historical cost convention.
The financial statements are presented in UK Pounds Sterling rounded to the nearest pound.
The preparation of financial statements in conformity with IFRSs 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. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in Note 4.
2.2 Changes in accounting policy and disclosures
(a) New and amended standards mandatory for the first time for the financial periods beginning on or after 1 January 2023
The International Accounting Standards Board (IASB) issued various amendments and revisions to International Financial Reporting Standards and IFRIC interpretations. The amendments and revisions were applicable for the year ended 31 December 2023 but did not result in any material changes to the financial statements of the Group or Company.
b) New standards, amendments and interpretations in issue but not yet effective or not yet endorsed and not early adopted
Standards, amendments and interpretations that are not yet effective and have not been early adopted are as follows:
Standard | Impact on initial application | Effective date |
IFRS 16 (Amendments) | Property, plant, and equipment | 1 January 2024 |
IAS 1 (Amendments) | Classification of Liabilities as Current or Non-Current. | 1 January 2024 |
IFRS S1* | Disclosure of Sustainability-related Financial Information | 1 January 2024 |
IFRS S2* | Climate-related Disclosures | 1 January 2024 |
| | |
* IFRS S1/S2 are subject to local regulation.
The Group is evaluating the impact of the new and amended standards above which are not expected to have a material impact on future Group financial statements.
2.3 Basis of Consolidation
The Group financial statements consolidate the financial statements of Genflow Biosciences Plc and the financial statements of all of its subsidiary undertakings made up to 31 December 2023.
Subsidiaries are entities over which the Group has control. The Group controls an entity when the Group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. Where an entity does not have returns, the Group's power over the investee is assessed as to whether control is held. Subsidiaries are fully consolidated from the date on which control is transferred to the Group. They are deconsolidated from the date that control ceases.
The Group applies merger accounting to account for the acquisition of subsidiaries under common control. The consideration transferred for the acquisition of a subsidiary is equal to the assets transferred without any restatement to fair value, the liabilities incurred to the former owners of the acquiree and the equity interests issued by the Group. The difference that arises on consolidation is deducted from, or added to, reserves.
Acquisition-related costs are expensed as incurred unless they result from the issuance of shares, in which case they are offset against the premium on those shares within equity.
Investments in subsidiaries are accounted for at cost less impairment.
Inter-company transactions, balances, income and expenses on transactions between group companies are eliminated. Profits and losses resulting from intercompany transactions that are recognised in assets are also eliminated.
Where considered appropriate, adjustments are made to the financial information of subsidiaries to bring the accounting policies used into line with those used by other members of the Group. All intercompany transactions and balances between Group enterprises are eliminated on consolidation.
2.4 Going Concern
The Group's business activities, together with the factors likely to affect its future development, performance and position, are set out in the Chairman's Report from page 3. In addition, Note 3 to the financial statements includes the Group's objectives, policies and processes for managing its capital; its financial risk management objectives; and details of its exposure to credit and liquidity risk.
Although the Group's assets are not generating revenue streams, an operating loss has been reported and an operating loss is expected in the 12 months to 31 December 2024, the Directors believe that the Group will have sufficient funds to meet its immediate working capital requirements over the next 12 months from the date of approval of these financial statements. As at 31 December 2023, the Group has cash resources of £683,974 and completed a placing of £715,000 (before expenses) in April 2024. The Group also received the second half of the initial grant reimbursement from the Wallonia Region, totalling €340,000 in April, in addition to securing further grant funding of €1.55m, of which €777,273 is due to be received imminently.
Management plan to use these funds to meet the working capital requirements of the Group and to further its research and development activities. Management has prepared forecast covering 18 month post-year end and believe that current cash reserves will adequately cover the working capital requirements of the Group in addition to meeting research and development commitments.
As such, the Directors have a reasonable expectation that the Group has and will have future access to adequate resources to continue in operational existence for the foreseeable future and, therefore, continue to adopt the going concern basis in preparing the Annual Report and financial statements.
2.5 Segment Reporting
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker, who is responsible for allocating resources and assessing performance of the operating segments, has been identified as the Board of Directors that makes strategic decisions.
Segment results, include items directly attributable to a segment as well as those that can be allocated on a reasonable basis.
2.6 Foreign Currencies
(a) Functional and presentation currency
Items included in the financial statements of the Group's entities are measured using the currency of the primary economic environment in which the entity operates (the 'functional currency'). The functional currency of the Company is Sterling, the functional currency of the US subsidiary is US Dollars and the functional currency of the Belgian subsidiary is Euros. The financial statements are presented in Pounds Sterling, rounded to the nearest pound.
(b) Transactions and balances
Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions or valuation where such items are re-measured. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in the Income Statement.
(c) Group companies
The results and financial position of all the Group's entities (none of which has the currency of a hyperinflationary economy) that have a functional currency different from the presentation currency are translated into the presentation currency as follows:
· assets and liabilities for each statement of financial position presented are translated at the closing rate at the date of that statement of financial position;
· income and expenses for each statement of comprehensive income presented are translated at average exchange rates (unless this average is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions); and
· all resulting exchange differences are recognised in other comprehensive income where material.
On consolidation, exchange differences arising from the translation of the net investment in foreign entities, and of monetary items receivable from foreign subsidiaries for which settlement is neither planned nor likely to occur in the foreseeable future, are taken to other comprehensive income. When a foreign operation is sold, such exchange differences are recognised in the income statement as part of the gain or loss on sale.
2.7 Grant income recognition
Grant income is recognised within other operating income. Grants are recognised as due to the Group when there is reasonable assurance that:
• the Group will comply with the conditions attached to the payments; and
• the grants or contributions will be received.
Amounts recognised as due to the Group are credited to the Statement of Comprehensive Income if the conditions attaching to the grant have been met. Monies advanced as grants for which conditions have not been satisfied are carried in the Balance Sheet as a creditor. Where the conditions to the grant have been met but the grant income is yet to be received, a debtor will be recognised equal to the submission made, accruing evenly over the period in which the submission relates.
2.8 Research and development
Expenditure on research activities undertaken with the prospect of gaining new scientific or technical knowledge and understanding is recognised in the income statement as an expense as incurred. Development costs that are directly attributable to the design and testing of identifiable and unique products controlled by the Group are recognised as intangible assets where the following criteria are met:
o It is technically feasible to complete the asset so that it will be available for use;
o Management intends to complete the asset and use or sell it;
o There is an ability to use or sell the asset;
o It can be demonstrated how the asset will generate probable future economic benefits;
o Adequate technical, financial and other resources to complete the development and to use or sell the asset are available; and
o The expenditure attributable to the asset during its development can be reliably measured.
Directly attributable costs that are capitalised as part of the asset include the product development employee costs and an appropriate portion of relevant overheads. Other development expenditures that do not meet these criteria are recognised as an expense as incurred. Development costs previously recognised as an expense are not recognised as an asset in a subsequent period.
2.9 Financial Assets
(a) Classification
The Group classifies its financial assets in the following categories: at amortised cost including trade receivables and other financial assets at amortised cost, at fair value through other comprehensive income and at fair value through profit or loss, loans and receivables, and available-for-sale. The classification depends on the purpose for which the financial assets were acquired. Management determines the classification of its financial assets at initial recognition.
(b) Recognition and measurement
Amortised cost
Trade and other receivables are recognised initially at the amount of consideration that is unconditional, unless they contain significant financing components, in which case they are recognised at fair value. The group holds the trade and other receivables with the objective of collecting the contractual cash flows, and so it measures them subsequently at amortised cost using the effective interest method.
The group classifies its 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 the contractual cash flows; and
· the contractual terms give rise to cash flows that are solely payments of principle and interest.
(c) Impairment of financial assets
The Group recognises an allowance for expected credit losses (ECLs) for all debt instruments not held at fair value through profit or loss. ECLs are based on the difference between the contractual cash flows due in accordance with the contract and all the cash flows that the Group expects to receive, discounted at an approximation of the original effective interest rate. The expected cash flows will include cash flows from the sale of collateral held or other credit enhancements that are integral to the contractual terms.
ECLs are recognised in two stages. For credit exposures for which there has not been a significant increase in credit risk since initial recognition, ECLs are provided for credit losses that result from default events that are possible within the next 12-months (a 12-month ECL). For those credit exposures for which there has been a significant increase in credit risk since initial recognition, a loss allowance is required for credit losses expected over the remaining life of the exposure, irrespective of the timing of the default (a lifetime ECL).
For trade receivables (not subject to provisional pricing) and other receivables due in less than 12 months, the Group applies the simplified approach in calculating ECLs, as permitted by IFRS 9. Therefore, the Group does not track changes in credit risk, but instead, recognises a loss allowance based on the financial asset's lifetime ECL at each reporting date.
The Group considers a financial asset in default when contractual payments are 90 days past due. However, in certain cases, the Group may also consider a financial asset to be in default when internal or external information indicates that the Group is unlikely to receive the outstanding contractual amounts in full before taking into account any credit enhancements held by the Group. A financial asset is written off when there is no reasonable expectation of recovering the contractual cash flows and usually occurs when past due for more than one year and not subject to enforcement activity.
At each reporting date, the Group assesses whether financial assets carried at amortised cost are credit impaired. A financial asset is credit-impaired when one or more events that have a detrimental impact on the estimated future cash flows of the financial asset have occurred.
(d) Derecognition
The Group derecognises a financial asset only when the contractual rights to the cash flows from the asset expire, or when it transfers the financial asset and substantially all the risks and rewards of ownership of the asset to another entity.
On derecognition of a financial asset measured at amortised cost, the difference between the asset's carrying amount and the sum of the consideration received and receivable is recognised in profit or loss. This is the same treatment for a financial asset measured at fair value through profit and loss.
2.10 Financial Liabilities
Financial liabilities are classified, at initial recognition, as financial liabilities at fair value through profit or loss, loans and borrowings, payables, or as derivatives designated as hedging instruments in an effective hedge, as appropriate. All financial liabilities are recognised initially at fair value and, in the case of loans and borrowings and payables, net of directly attributable transaction costs. The Group's financial liabilities include trade and other payables.
Subsequent measurement
The measurement of financial liabilities depends on their classification, as described below:
Trade and other payables
Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Accounts payable are classified as current liabilities if payment is due within one year or less. If not, they are presented as non-current liabilities.
Trade payables are recognised initially at fair value, and subsequently measured at amortised cost using the effective interest method.
Derecognition
A financial liability is derecognised when the associated obligation is discharged or cancelled or expires.
When an existing financial liability is replaced by another from the same lender on substantially different terms, or the terms of an existing liability are substantially modified, such an exchange or modification is treated as the derecognition of the original liability and the recognition of a new liability. The difference in the respective carrying amounts is recognised in profit or loss and other comprehensive income.
2.11 Cash and Cash Equivalents
Cash and cash equivalents comprise cash at bank and in hand and are subject to an insignificant risk of changes in value.
2.12 Taxation
Tax is recognised in the Income Statement, except to the extent that it relates to items recognised in other comprehensive income or directly in equity. In this case, the tax is also recognised in other comprehensive income or directly in equity, respectively.
Deferred income tax is recognised, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. Deferred income tax is determined using tax rates (and laws) that have been enacted, or substantially enacted, by the end of the reporting year and are expected to apply when the related deferred income tax asset is realised, or the deferred income tax liability is settled.
Deferred income tax assets are recognised only to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilised.
Deferred income tax assets are recognised on deductible temporary differences arising from investments in subsidiaries, associates and joint arrangements only to the extent that it is probable the temporary difference will reverse in the future and there is sufficient taxable profit available against which the temporary difference can be utilised.
Deferred income tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets against current tax liabilities, and when the deferred income tax assets and liabilities relate to income taxes levied by the same taxation authority on either the taxable entity or different taxable entities where there is an intention to settle the balances on a net basis.
There has been no tax credit or expense for the period relating to current or deferred tax.
2.13 Share Capital and reserves
Ordinary shares are classified as equity.
Share Premium - the reserve for shares issued above the nominal value. This also includes the cost of share issues that occurred.
Retained Earnings - the retained earnings reserve includes all current and prior periods retained profit and losses.
Other Reserves - consists of the following;
- Merger Reserve - represents the difference between the value of shares issued by the Company in exchange for the value of shares acquired in respect of the acquisition of subsidiaries.
- Foreign Currency Translation Reserve - represents the translation differences arising from translating the financial statement items from functional currency to presentational currency.
2.14 Earnings per share
Basic earnings per share is calculated by dividing:
- the profit attributable to owners of the company, excluding any costs of servicing equity other than ordinary shares;
- by the weighted average number of ordinary shares outstanding during the financial year, adjusted for bonus elements in ordinary shares issued during the year and excluding treasury shares (note 14).
Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account:
- the after-income tax effect of interest and other financing costs associated with dilutive potential ordinary shares; and
- the weighted average number of additional ordinary shares that would have been outstanding, assuming the conversion of all dilutive potential ordinary shares.
2.15 Operating Leases
Leases of assets under which the short-term exemption under IFRS 16 has been taken and which a significant amount of the risks and benefits of ownership are effectively retained by the lessor are classified as operating leases. Operating lease payments are charged to the income statement on a straight-line basis over the period of the respective leases. During the year the Group has one lease agreement in place on a one-month rolling basis, which is exempt from disclosure under IFRS 16.
3. Financial Risk Management
3.1 Financial Risk Factors
The Group's activities expose it to a variety of financial risks being market risk (including, interest rate risk and currency risk), credit risk and liquidity risk. The Group's overall risk management programme focuses on the unpredictability of financial markets and seeks to minimise potential adverse effects on the Group's financial performance.
Market Risk
(a) Foreign currency risks
The Group operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the Euro against the UK pound. Foreign exchange risk arises from future commercial transactions, recognised assets and liabilities and net investments in foreign operations. The Parent Company sends funds to the operating subsidiary to fund research and development and is at risk of being exposed to unfavourable exchange rates. The Company mitigates this risk by buying Euros when exchange rates are favourable and holding them in a designated foreign currency account. The Company only issues loan funding to the subsidiary in Euros. The Group negotiates all material contracts for activities in relation to its subsidiary in Euros. The Directors will continue to assess the effect of movements in exchange rates on the Group's financial operations and initiate suitable risk management measures where necessary.
An analysis of the Group's net monetary assets by functional currency of the underlying companies at the year-end is as follows:
| Currency | Total | ||
| GBP 2022 | EUR 2022 | USD 2022 |
2022 |
Currency of net monetary assets | £ | £ | £ | £ |
Pound Sterling | 1,623,713 | - | - | 1,623,713 |
Euro | 4,059 | 716,449 | - | 720,508 |
US Dollar | 1,992 | - | - | 1,992 |
Australian Dollar | 10,012 | - | - | 10,012 |
At 31 December 2022 | 1,639,776 | 716,449 | - | 2,356,225 |
| Currency | Total | ||
| GBP 2023 | EUR 2023 | USD 2023 |
2023 |
Currency of net monetary assets | £ | £ | £ | £ |
Pound Sterling | 244,487 | - | - | 244,487 |
Euro | 370 | 436,435 | - | 436,805 |
US Dollar | 2,682 | - | - | 2,682 |
Australian Dollar | - | - | - | - |
At 31 December 2023 | 247,539 | 436,435 | - | 683,974 |
The table above indicates that the Company's primary exposure is to exchange rate movements between UK Pound Sterling and the Euro. The table below shows the impact of changes in exchange rates on the result and financial position of the Company.
| 2023 £ | 2022 £ |
Pound Sterling 10% weakening against Euro | (43,681) | (72,051) |
Pound Sterling 10% strengthening against Euro | 43,681 | 72,051 |
Pound Sterling 20% weakening against Euro | (87,361) | (144,102) |
Pound Sterling 20% strengthening against Euro | 87,361 | 144,102 |
(b) Interest rate risk
As the Group has no borrowings, it is not exposed to interest rate risk on financial liabilities. The Group's interest rate risk arises from its cash held on short-term deposit, which is not significant.
Credit Risk
Credit risk arises from cash and cash equivalents as well as outstanding receivables. The Group does not currently generate sales and any receivable balances are granted after careful assessment by Management to ensure there is a high chance of recoverability. Management does not expect any losses from non-performance of these receivables.
The Group considers the credit ratings of banks in which it holds funds in order to reduce exposure to credit risk.
Liquidity Risk
The Group's continued future operations depend on the ability to raise sufficient working capital through the issue of equity share capital or debt. The Directors are reasonably confident that adequate funding will be forthcoming with which to finance operations. Controls over expenditure are carefully managed. See note 2.4 for further details on going concern and liquidity.
3.2 Capital Risk Management
The Group's objectives when managing capital are to safeguard the Group's ability to continue as a going concern, in order to provide returns for shareholders and to enable the Group to continue its research and development activities. The Group has no debt at 31 December 2023 and defines capital based on the total equity of the Company. The Group monitors its level of cash resources available against future planned operational activities and the Company may issue new shares in order to raise further funds from time to time.
4. Critical Accounting Estimates and Judgements
The preparation of the Group financial statements in conformity with IFRSs requires Management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of expenses during the year. Actual results may vary from the estimates used to produce these financial statements.
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 significant items subject to such estimates and assumptions are as follows;
Research and development
IAS 38 Intangible Assets requires management to differentiate between research and the development phase of R&D activities and their related costs. In accordance with IAS 38, an intangible asset arising from development shall be recognised if, and only, if, an entity can demonstrate certain criteria. The Board continually monitor its activities against the prescribed criteria to determine the point in which the Group would enter the development phase of its activities. The entity is currently in the phases of formulation, design and evaluation of its product and therefore management are confident that the entity is in the research phase. As a result, any expenditure arising from R&D activities are expensed in the Statement of Comprehensive Income.
Intercompany loans
In the prior year management assessed the recovery profile of the Parent Company loans granted to subsidiaries and noted the research and development timetable would mean that repayment of the amounts loaned would not commence in the short to medium term and accordingly the loans were considered to not be repayable and have been classified as an investment in subsidiary. Management performed an assessment over whether the investment in Genflow US of £684,860 and loans to Genflow BE of £85,326 were impaired. The determination of the assumptions is subjective and requires the exercise of considerable judgement about the outcome of research and development activity, probability of technical and regulatory success, amount and timing of projected future cash flow or changes in market conditions. Any changes in key assumptions could materially affect whether an impairment exists. Several factors such as Genflow BE receiving positive feedback from regulatory agencies and successful patent applications give management comfort that no impairment indicators exist.
Impairment of receivables
Included in other receivables is an amount of £303,791 (2022: £92,535) as at 31 December 2023 in respect of grant income. As at 31 December 2023, the Directors were confident that the amount will be recovered in full and therefore did not recognised any impairment to the carrying value of this amount. The full amount was received in April 2024.
5. Segmental Information
As at 31 December 2023, the Group operates in two geographical areas, the UK and Belgium. The Parent Company operates in one geographical area, the UK. Activities in the UK are mainly administrative in nature whilst activities in Belgium relate to research and development. The US entity is dormant. The reports used by the chief operating decision maker are based on these geographical segments.
2023 |
| Belgium £ | UK £ | Total £ |
|
|
|
|
|
Other operating income | | 169,854 | - | 169,854 |
Administrative expenses | | (1,084,700) | (713,859) | (1,798,559) |
Loss from operations per reportable segment | | (914,845) | (713,860) | (1,628,705) |
Reportable segment assets | | 771,258 | 297,001 | 1,068,259 |
Reportable segment liabilities | | 228,724 | 117,014 | 345,738 |
2022 |
| Belgium £ | UK £ | Total £ |
|
|
|
|
|
Other operating income | | 487,293 | - | 487,293 |
Administrative expenses | | (887,130) | (935,106) | (1,822,236) |
Other losses | | - | - | - |
Loss from operations per reportable segment | | (399,837) | (935,106) | (1,334,943) |
Reportable segment assets | | 821,460 | 1,793,650 | 2,615,110 |
Reportable segment liabilities | | 179,473 | 71,515 | 250,988 |
6. Expenses by Nature
| Group | |
| 31 December 2023 £ | 31 December 2022 £ |
| | |
Directors' fees | 362,312 | 349,384 |
Directors' pensions | 1,093 | 1,782 |
Directors' social security contributions | 14,945 | 9,329 |
Fees payable to the Company's auditors for the audit of the Parent Company and group financial statements | 53,285 | 41,790 |
Professional, legal and consulting fees | 215,971 | 381,534 |
PR and marketing | 106,819 | 165,889 |
Accounting related services | 7,839 | 7,245 |
Insurance | 22,476 | 33,423 |
Office and administrative expenses | 18,897 | 4,496 |
IT and software services | 5,828 | 2,249 |
Travel and entertainment | 23,830 | 14,193 |
Research and development costs | 960,314 | 724,465 |
Share based payments | - | 72,000 |
Other expenses | 3,916 | 14,327 |
Depreciation | 1,034 | 130 |
Total administrative expenses | 1,798,559 | 1,822,236 |
7. Employees
The average monthly number of employees, including Directors, during the year was 5 (2022: 5). There were no employees during the year other than the Directors. See the Remuneration and Nomination Committee Report on page 24 for details of remuneration paid to Directors serving during the year.
8. Taxation
| Group | Company | ||
Tax recognised in profit or loss | 2023 £ | 2022 £ | 2023 £ | 2022 £ |
Current tax | - | - | - | - |
Deferred tax | - | - | - | - |
Total tax charge in the Statement Of Comprehensive Income | - | - | - | - |
The tax on the Group's loss differs from the theoretical amount that would arise using the weighted average tax rate
applicable to the losses of the consolidated entities as follows:
|
|
|
Group | 2023 £ | 2022 £ |
Loss before tax | (1,628,705) | (1,335,325) |
Tax at the weighted average rate of 23.5% (Company: 19%) | (382,746) | (272,405) |
Expenditure not deductible for tax purposes | 40,754 | 25,343 |
Net tax effect of losses carried forward on which no deferred tax asset is recognised | 341,992 | 247,062 |
Income tax for the year | - | - |
The weighted average applicable tax rate of 23.5% used is a combination of the 23.5% standard rate of corporation tax in the UK (UK corporation tax changed from 19% to 25% in the period), 21% US corporation tax and 25% Belgian corporation tax.
The Group has accumulated tax losses of approximately £3,521,598 (2022: £2,066,314) and the Company had accumulated tax losses of approximately £1,951,009 (2022: £1,384,255) available to carry forward against future taxable profits. A deferred tax asset has not been recognised because of uncertainty over future taxable profits against which the losses may be utilized.
9. Investment in Subsidiary Undertakings
|
|
| |
| Company | ||
| 2023 £ | 2022 £ | |
Shares in subsidiary undertakings |
|
| |
At beginning of the period | 1,058,266 | 68,131 | |
Additions to investments | - | - | |
Additions to loans | 763,346 | - | |
Loan reassignment | (1,116,367) | - | |
Loans receivable | 64,942 | 990,135 | |
At period end | 770,187 | 1,058,266 | |
During the year, £143,428 (2022: £990,135) was loaned by the Company to Genflow Biosciences Srl and £Nil (2022: £Nil) was repaid. During the year, £1,116,367 owing from Genflow Biosciences Srl was reassigned to Genflow Biosciences Inc in return for cash consideration of £1. £64,942 was owing to the Company by Genflow Biosciences Srl at the year end.
Also during the year, £684,860 was loaned by the Company to Genflow Biosciences Inc.
The additions and resignment to the loans owing to the Company by Genflow Biosciences Inc at the year-end is in respect of working capital and is not expected to be repaid. As such, it forms part of the amount invested into Genflow Biosciences Inc by the Company.
Investments in Group undertakings are stated at cost less impairment.
Details of subsidiaries at 31 December 2023 are as follows:
Name of subsidiary | Country of incorporation | Share capital held by Group | Share capital held by Company | Principal activities |
Registered office address |
Genflow Biosciences Inc. | United States | £20,383 | 100% | Dormant | Harvard Square, One Miffin Place #400, Cambr idge, MA 02138 |
Genflow Biosciences SRL | Belgium | £684,183 | 100% | Research and development | Rue Auguste Piccard 48 6041 Gosselies |
10. Trade and Other Receivables
| Group | Company | |||
| 2023 £ | 2022 £ | 2023 £ | 2022 £ |
|
VAT receivable | 36,278 | 32,612 | 6,337 | 15,861 |
|
Prepayments | 41,041 | 131,414 | 41,041 | 38,879 |
|
Other receivables | 306,966 | 94,859 | 96,960 | 99,134 |
|
| 384,285 | 258,885 | 144,338 | 153,874 |
|
Included in other receivables is £303,791 due from the Wallonia Region of Southern Belgium in respect of an R&D grant awarded to Genflow Biosciences SRL. The balance was received in full post year end.
The Company is entitled to claim up to 70% of qualifying expenditure which has been spent on R&D activities. To date, the Company has received £332,527. Grant income of £169,854 (2022 - £487,293) has been recognised within the Consolidated Statement of Other Comprehensive Income.
Trade and other receivables are all due within one year. The fair value of all receivables is the same as their carrying values stated above. These assets, excluding prepayments, are the only form of financial asset within the Group, together with cash and cash equivalents. There are no trade receivables therefore an ageing analysis has not been provided.
The carrying amounts of the Group's trade and other receivables are denominated in the following currencies:
| Group | Company | ||
| 2023 £ | 2022 £ | 2023 £ | 2022 £ |
|
|
|
|
|
UK Pounds | 49,462 | 153,874 | 144,338 | 153,874 |
Euros | 333,881 | 103,949 | - | - |
US Dollars | 942 | 1,062 | - | - |
Current receivables | 384,285 | 258,885 | 144,338 | 153,874 |
The maximum exposure to credit risk at the reporting date is the carrying value of each class of receivable mentioned above. The Group does not hold any collateral as security. All trade and other receivables are considered fully recoverable and performing.
11. Cash and Cash Equivalents
| Group | Company | ||
| 2023 £ | 2022 £ | 2023 £ | 2022 £ |
Cash at bank and in hand | 683,974 | 2,356,225 | 247,539 | 1,639.776 |
The Group's cash is held with facilities with an A credit rating.
The carrying amounts of the Group and Company's cash and cash equivalents are denominated in the following currencies:
| Group | Company | ||
| 2023 £ | 2022 £ | 2023 £ | 2022 £ |
|
|
|
|
|
UK Pounds | 244,487 | 1,623,713 | 246,744 | 1,623,713 |
Euros | 436,805 | 720,508 | 370 | 4,059 |
US Dollars | 2,682 | 1,992 | 425 | 1,992 |
Australian Dollars | - | 10,012 | - | 10,012 |
Cash at bank and in hand | 683,974 | 2,356,225 | 247,539 | 1,639,776 |
12. Trade and Other Payables
| Group | Company | ||
| 2023 £ | 2022 £ | 2023 £ | 2022 £ |
Trade payables | 254,695 | 83,590 | 52,480 | 2,053 |
Other payables | 31,029 | 8,799 | 9,717 | 4,217 |
Accrued expenses | 60,014 | 158,599 | 54,817 | 65,245 |
| 345,738 | 250,988 | 117,014 | 71,515 |
All trade and other payables are due for payment within twelve months of the year end. Trade payables are settled within normal commercial terms, usually between 30-60 days.
The carrying amounts of the Group and Company's trade and other payables are denominated in the following currencies:
| Group | Company | ||
| 2023 £ | 2022 £ | 2023 £ | 2022 £ |
|
|
|
|
|
UK Pounds | 117,014 | 69,270 | 117,014 | 71,515 |
Euros | 228,724 | 144,053 | - | - |
Current payables | 345,738 | 213,323 | 117,014 | 71,515 |
13. Financial Instruments by Category
| 31 December 2023 | 31 December 2022 | ||
Group Assets per Statement of Financial Position | At amortised cost | Total | At amortised cost | Total |
Trade and other receivables (excluding prepayments) | 343,244 | 371,981 | 127,471 | 127,471 |
Cash and cash equivalents | 683,974 | 683,974 | 2,356,225 | 2,356,225 |
Total | 1,027,218 | 1,055,955 | 2,483,696 | 2,483,696 |
Liabilities per Statement of Financial Position |
|
|
|
|
Trade and other payables | 345,738 | 345,738 | 250,988 | 250,988 |
Total | 345,738 | 345,738 | 250,988 | 250,988 |
| 31 December 2023 | 31 December 2022 | ||
Company Assets per Statement of Financial Position | At amortised cost | Total | At amortised cost | Total |
Trade and other receivables (excluding prepayments) | 103,297 | 103,297 | 114,995 | 114,995 |
Cash and cash equivalents | 247,539 | 247,539 | 1,639,776 | 1,639,776 |
Total | 350,836 | 350,836 | 1,754,771 | 1,754,771 |
Liabilities per Statement of Financial Position |
|
|
|
|
Trade and other payables | 117,014 | 117,014 | 71,515 | 71,515 |
Total | 117,014 | 117,014 | 71,515 | 71,515 |
14. Share Capital and Share Premium
Issued share capital
Company | Number of shares | Ordinary shares £ | Share premium £ | Total £ |
| ||
At 1 January 2022 | 244,570,118 | 73,371 | 633,765 | 707,136 | |||
Issue of new shares - 17 January 2022 | 47,036,500 | 14,111 | 3,748,809 | 3,762,920 | |||
Issue of new shares - 17 January 2022 | 900,000 | 270 | 71,730 | 72,000 | |||
Cost of Capital - 15 February 2022 | - | - | (263,404) | (263,404) | |||
At 31 December 2022 | 292,506,618 | 87,752 | 4,190,900 | 4,278,652 |
| ||
At 1 January 2023 | 292,506,618 | 87,752 | 4,190,900 | 4,278,652 |
| ||
At 31 December 2023 | 292,506,618 | 87,752 | 4,190,900 | 4,278,652 |
| ||
15. Other reserves
Group | Foreign currency translation differences | Merger reserve | Total |
| £ | £ | £ |
At 31 December 2021 | (14,065) | 170,248 | 156,183 |
Currency translation differences | 75,158 | - | 75,158 |
Acquisition of subsidiaries | - | - | - |
As at 31 December 2022 | 61,093 | 170,248 | 231,341 |
Currency translation differences | (11,853) | - | (11,853) |
Acquisition of subsidiaries | - | - | - |
As at 31 December 2023 | 49,240 | 170,248 | 219,488 |
16. Earnings per Share
The calculation of the total basic loss per share of 0.557 pence (2022: 0.457 pence) is based on the loss attributable to equity owners of the group of £1,628,705 (2022: £1,335,325) and on the weighted average number of ordinary shares of 292,506,618 (2022: 292,506,618) in issue during the year.
In accordance with IAS 33, basic and diluted earnings per share are identical as the effect of the exercise of share options or warrants would be to decrease the loss per share.
17. Commitments
During the period, Genflow Biosciences Srl entered into various collaboration agreements which contain commitments and milestone payments, as follows;
- Organips: Amounts payable of €75.000 in relation to the study of cent SIRT9 in liver organoids (MASH and Werner).
- IVEX Labs; Amounts have been payable under the contact in place with IVEX Labs in connection with the study of cloning mouse Sirt6 and human SIRT6 (both wild-type and centenarian variants) into AAV2 ("Task1"). A final payment of €50,000 is payable on completion of the research, receipt of reports for Tasks 1-2, a final report and other deliverables due.
- CSZBio; €10,240 payable per month over two years from June 2021.
18. Related Party Transactions
Group
During the year, £143,427 (2022: £990,135) was loaned by the Company to Genflow Biosciences Srl and £Nil (2022: £Nil) was repaid. During the year, £1,116,367 owing from Genflow Biosciences Srl was reassigned to Genflow Biosciences Inc in return for cash consideration of £1. At the period end, £64,944 is owing from Genflow Biosciences Srl.
Also during the year, £684,860 was loaned by the Company to Genflow Biosciences Inc.
Company
During the period, the Company charged Genflow Biosciences Srl management fees totalling £94,876 in respect of administration costs and salaries.
19. Ultimate Controlling Party
The Directors believe there to be no ultimate controlling party.
20. Events after the Reporting Date
On 18 January 2024, the Group was awarded two non-diluting and non-reimbursable research grants by the Government of Wallonia in Belgium which will total €1.55m.
On 4 April 2024, the Company raised £715,000 (before expenses) by way of a placing and subscription of 57,200,000 new Ordinary Shares of 1.25 pence each.
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