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
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+32-477-495-881
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+1 475 477 9401
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Jonathan.Paterson@Harbor-access.com
|
|
|
Joint Corporate Brokers
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Clear Capital Markets
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Capital Plus Partners Ltd
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Bob Roberts, +44 203 869
6080
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Dominic Berger, +44 203 821
6167
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Keith Swann, +44 0203 821
6169
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Jon Critchley, +44 0203 821
6168
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|
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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:
·
Monitoring the integrity of the financial
statements and financial performance;
·
Reviewing financial statements, significant
financial returns to regulators and any financial information of a
sensitive nature;
·
Reviewing and challenging internal financial
controls and risk management systems including the review of
matters of a non-financial nature, including environmental
matters;
· Reviewing and challenging accounting policies, accounting
methods and adherence to accounting standards;
· Reviewing and making recommendation with regards to the
external auditor, including appointment, independence, objectivity,
effectiveness, performance and remuneration;
·
Consulting with the external auditor on the scope
of their work and reviewing all major points arising from the
audit;
·
Ensuring full functionality of the whistleblowing
policy.
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.