XLON:HEMO ESEF Annual Report
HEMOGENYX PHARMACEUTICALS PLC (XLON:HEMO)
ESEF Annual Report
2024-05-02
For: 2023-12-31
View Original
Added on
September 22, 2026
Registered Number: 08401609
Annual Report & Financial Statements for
the Year Ended 31 December 2023
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
Contents
Page
Company Information 1
Chairman’s Statement 3
Board of Directors and Senior Management 8
Directors’ Strategic Report 10
Directors’ Report 21
Governance Report 26
Directors’ Remuneration Report 33
Independent Auditor’s Report 39
Consolidated Statement of Comprehensive Income 46
Consolidated Statement of Financial Position 47
Company Statement of Financial Position 48
Consolidated Statement of Changes in Equity 49
Company Statement of Changes in Equity 50
Consolidated Statement of Cash Flows 51
Company Statement of Cash Flows 52
Notes to the Financial Statements 53
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
1
Company Information
Directors
Dr Vladislav Sandler (Chief Executive Officer)
Professor Sir Marc Feldmann (Chairman)
Alexis Sandler (Non-Executive Director)
Peter Redmond (Non-Executive Director)
Company Secretary
Ben Harber
Registered Office
6th Floor
60 Gracechurch Street
EC3V 0HR
Registered Number (England and Wales)
08401609
Joint Brokers
SP Angel Corporate Finance LLP
Prince Frederick House
35-39 Maddox Street
London
W1S 2PP
Peterhouse Capital Limited
80 Cheapside
London
EC2V 6EE
Independent Auditor
PKF Littlejohn LLP
Statutory Auditor
15 Westferry Circus
Canary Wharf
London
E14 4HD
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
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UK Solicitors
Cooley (UK) LLP
Dashwood
69 Old Broad Street
London
EC2M 1QS
US Solicitors
Rubin & Rudman LLP
50 Rowes Wharf
Boston
Massachusetts 02110
Principal Bankers
Metro Bank plc
One Southampton Row
London
WC1B 5HA
Registrar
Computershare Investor Services plc
The Pavilions
Bridgwater Road
Bristol
BS13 8AE
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
3
Chairman’s Statement
I am pleased to report the Company’s results for the year ended 31 December 2023. The period was a
vital one in the progression of the Company. Development work on our lead HEMO-CAR-T product
candidate was completed and we were able to submit an Investigational New Drug (“IND”) application
to the Food and Drug Administration (“FDA”) to enable us to move into clinical trials for HEMO-CAR-
T. Unfortunately, the FDA decided that certain aspects of the data initially provided did not meet its
rigorous safety standards, so it imposed a clinical hold pending further development of the product. We
worked hard in the final months of the year to meet the FDA’s additional requirements and, as a result,
the clinical hold was lifted in January 2024. Hemogenyx Pharmaceuticals is thereby established as a
“clinical stage” company and we are now proceeding to the next step in the development of HEMO-
CAR-T, the commencement of Phase I clinical trials.
At the same time, we continued to move forward, insofar as funding would allow, with our other main
pipeline assets, our Chimeric Bait Receptor (“CBR”) platform and our CDX bi-specific CD3-FLT3
antibody (“CDX”). Significant progress was made on the former, as will be described more fully below.
Fundraising
We raised capital on a number of occasions in the period under review.
In January 2023, we were successful in raising £4,056,250 in new equity capital at 2.5p per share which
was intended to take us through the IND process and to the stage of clinical trials for HEMO-CAR-T.
The clinical hold delayed matters for some months and of course diminished our cash resources. In
December 2023, we therefore raised a further £534,375 at 2.375p per share to take us to the next key
stage.
In September, Prevail Partners LLC (“Prevail Partners”) made a strategic investment of $830,000
(£680,000) through a subscription for 11,066,067 new ordinary shares in the Company at a price of
$0.075 (about 6p), at a premium of approximately 240% to the then share price. Prevail Partners is the
investment partner of Prevail Infoworks Inc. (“Infoworks”), a contract research organisation that we have
engaged to provide a variety of services necessary for the implementation and management of the clinical
trials of HEMO-CAR-T. The price at which Prevail Partners made its investment in Hemogenyx
Pharmaceuticals demonstrated its confidence in our HEMO-CAR-T product candidate. Further
information on our association with Prevail Partners and Infoworks is described in the section headed
“HEMO-CAR-T” below.
Since the period end, and following the lifting of the clinical hold, we raised a further £3.325 million at
2p per share to enable us to move to clinical trials.
While we accept that recent market conditions have been very difficult, we have been disappointed by
the successively lower price at which we have had to carry out our fundraisings in the UK market, in the
light of the progress we have made and the view taken by Prevail Partners concerning our status. The
capital recently raised will undoubtedly take us materially further forward and we are now looking at a
number of strategies for the future development of all three of our current product candidates.
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Annual Report & Financial Statements for the
Year Ended 31 December 2023
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Results for the Period
The Group incurred a loss for the year to 31 December 2023 of £6,696,493 (31 December 2022:
£3,986,982 loss).
In the year to 31 December 2023 the loss mainly arose from operational expenses pursuing the Group’s
objectives listed in the Strategic Report on page 10, as well as salaries, consulting and professional fees,
and general administration expenses. These expenses have been met from the proceeds of equity placings
that were undertaken during the period, as further detailed in the Fundraising section above.
HEMO-CAR-T
The principal objective of HEMO-CAR-T is, as shareholders will know, to provide a new and more
effective treatment and potential cure for relapsed and/or refractory acute myeloid leukaemia (“R/R
AML”).
AML is the most common type of acute leukaemia in adults and has poor survival rates; it is currently
treated using chemotherapy, rather than the potentially more benign and effective form of cell therapy
being developed by Hemogenyx Pharmaceuticals. The successful development of a new therapy for AML
would have a major impact on treatment and survival rates for the disease.
Development work on HEMO-CAR-T was largely completed during 2022 and work in 2023 was mainly
devoted to preparing the IND application to the FDA, an essential step before being able to commence
clinical trials. The FDA’s concern, as shareholders will be aware, is primarily with the safety of a
treatment, and it rightly works to a very high standard. The work in preparing the IND application was
extremely detailed and resulted in an application document running to over 3,000 pages. It was finally
submitted in May 2023. As mentioned above, the FDA was not satisfied with a particular aspect of the
detail provided and therefore imposed a clinical hold on the HEMO-CAR-T programme in June. Our
scientific team worked on resolving the matter through the latter part of the year and on remanufacturing
of the CAR-T components. This resulted in the clinical hold being lifted in January 2024. Although this
was a setback, it is important to say that the FDA’s concerns were limited to one issue, and we were able
to satisfy them much more quickly than many other companies whose prospective treatments were put
on clinical hold.
The removal of the clinical hold has enabled us to proceed with taking HEMO-CAR-T into clinical trials
with the objective of getting an initial patient injected in the coming months. The Company has been
actively putting the necessary pieces in place for some time, including discussions with the Hospital of
the University of Pennsylvania, one of the leading cancer treatment hospitals in the US, in order to initiate
the clinical trials process.
Also, crucially, in September 2023, Hemogenyx Pharmaceuticals contracted with Infoworks, a well-
established and experienced contract research organisation (“CRO”), through a Master Services and
Contract Agreement for Infoworks to provide clinical services and technologies for the forthcoming
Phase I clinical trials over an initial term of 40 months. An initial work plan was agreed, including clinical
site coordination, project management, data management, clinical monitoring, and pharmacovigilance
(safety management) services, with the use of InfoWorks’ integrated real-time data analytics platform for
clinical support and real-time analysis. This vital link brings us Infoworks’ operational expertise and will
ensure smooth execution of the clinical trials and fast, reliable data to lower our clinical risk and speed
up our regulatory timeline.
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At the same time, Prevail Partners, the investing affiliate of Infoworks, made the investment at a premium
in the Company described more fully in the section headed “Fundraising” above.
Chimeric Bait Receptor
While our Chimeric Bait Receptor (“CBR”) was initially envisaged as a potential cure for a very wide
range of viral diseases, it has recently become clear that it is also potentially a viable approach for the
treatment of a range of cancers. The development of CBR as a cure for viral infections continues, and we
remain excited about that, but its potential efficacy against cancer may provide a quicker route to
successful development, approval and use.
While we have had limited resources to apply to the development of our proprietary CBR technology
platform, there have been a number of key developments and discoveries during the period under review
and in the early part of 2024. We have been able to achieve as much as we have done because development
of novel CBR constructs is facilitated and accelerated by in silico simulations using Artificial Intelligence
(“AI”) tools and pipelines. In the wake of the COVID-19 pandemic, and in the face of global threats of
emerging as well as engineered biological threats, the need for a nimble and proactive solution against
future infectious agents became clear. We developed CBR as a novel, highly innovative, and patented
immunotherapy initially for COVID-19. However, CBR has been designed to prevent and defeat infection
by any known or emerging virus, potentially subverting the next global pandemic, and rendering virally-
engineered bioweapons ineffective. To achieve proof of concept, we successfully designed a CBR
construct (“CBR-COVID19”) to programme macrophages to neutralise the SARS-CoV-2 virus. We have
also demonstrated that CBR-COVID19 is insensitive to several known variants of SARS-CoV-2 that
make the original SARS-CoV-2 virus more infectious and challenge existing vaccine approaches. We are
testing the efficacy of CBR-COVID19 against live infectious replicating SARS-CoV-2 virus in a major
Biosafety Level 3 facility.
One of the ultimate threats from emerging viruses, whether natural or man-made, is their uncertainty and
unpredictability. Current therapeutic responses require extensive knowledge of the agent(s) as well as
time-consuming and duplicative research efforts to develop effective treatments after an outbreak has
begun. In this light, our first-in-class CBR platform allows for minimal lead time between first infection
or pre-emptive intelligence and first response, providing protection for those on the front line of such a
threat at a scale that has thus far not been achieved.
As we announced in February 2024, CBR in relation to viruses is innovative in three ways: it will be an
off-the-shelf therapeutic against airborne viral infections, it will be effective against emerging mutations
of the targeted viruses, and it will be able to be stored, deployed and administered in the field using a
standard atomiser/inhaler. These innovative features have been tested in the laboratory, and the ability of
CBR to be delivered intranasally in spray form has been tested by our scientists in vivo in small animals.
This recent work on the intranasal delivery of CBR is a breakthrough, enabling its development as an off-
the-shelf prevention and/or treatment that will be cost-effective and simple to administer, making it ideal
for the protection both of the civilian population and in biodefence.
Moving onto cancer-related CBR innovations, we have found that a number of difficult conditions can
potentially be treated using CBR. We have established that macrophages programmed with CBR have
several potential advantages compared to other existing anti-cancer therapies. Our studies suggest that
they can, inter alia, penetrate solid tumours, provide a better safety profile for treatment, and potentially
cross the blood-brain barrier to target brain cancers and/or certain neurodegenerative diseases.
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As announced last November, we have now demonstrated that CBR could be used effectively in the
treatment of a number of cancer conditions, in particular that CBR-programmed macrophages show
promise for treatment of Non-Hodgkin Lymphoma (“NHL”). Our scientists have demonstrated that
human macrophages, a type of immune cells, programmed with a purpose designed CBR, are able to
eliminate NHL-derived cells with high efficiency in vitro. This result suggests that the Company may be
able to develop an efficient treatment for people suffering from relapsed and/or refractory stage III/IV
metastasized NHL. Our work also suggests that such CBRs can also be adapted to target several solid
tumours such as epithelial ovarian cancer. NHL is the eleventh most common cancer in humans, with a
poor rate of recovery and cure from present treatments. There are currently an estimated 540,000 new
cases diagnosed globally with an estimated 260,000 deaths per year. The successful development of a
new CBR-related therapy for NHL could have a major impact on treatment and survival rates for the
disease.
Our work further suggests that such CBRs can be adapted to target several solid tumours such as epithelial
ovarian cancer. We have also begun to see evidence that a CBR-based approach may also potentially be
effective against certain neurodegenerative diseases, some of which are currently very difficult or
impossible to treat, including possibly Alzheimer’s disease. In this regard, in February 2024 we
announced a further significant development for CBR, this time in relation to brain cancers and
potentially to neurodegenerative diseases. We have established that CBR can be delivered into the brain
via programmed microglial cells. Delivery of therapeutics across the blood-brain barrier is one of the
most difficult problems in the treatment of brain diseases. Our scientists have developed a means of
transplanting human blood stem cells (“HSC”) that allows their engraftment and differentiation into
immune cells that reside in the brain, carrying out their work in vivo in the brains of immune-
compromised mice. We believe that HSCs genetically modified to make CBR and transplanted back into
a patient would give rise to microglial cells which could potentially find and destroy brain cancer cells.
Meanwhile, we continue to look to our patent position and, in September 2023, our patent application for
CBR with the World Intellectual Property Organization was published, though it remains to be approved.
In summary, we should say that the considerable potential breadth and versatility of CBR has become
increasingly evident over the past fifteen months, and evidence of its practical viability has been
considerably established. It is not too much to say that CBR, which we always considered to have great
potential, can now be seen as possibly revolutionary, now that its widespread probable applicability to
difficult or presently untreatable conditions is being established in multiple preclinical studies.
CDX bi-specific antibody
CDX remains an important part of the Company’s product candidate portfolio, although it remains to a
certain extent in abeyance while we push on with HEMO-CAR-T. However, some steps have been taken
with CDX, including approval of the patent application in the USA entitled “Method of Eliminating
Hematopoietic Stem Cells/Hematopoietic Progenitors (HSC/HP) in a Patient Using Bi-specific
Antibodies” as patent No. 11,945,866. This is a significant addition to the patent protection for CDX,
which remains one of our key product candidates for the future. It also solidifies the Company’s position
as a leader in the area of conditioning of patients for bone marrow transplants.
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Conclusion
It remains for me to thank the Board and our strong, highly committed group of scientists for their hard
and effective work, and to look forward to another successful year in the future development of
Hemogenyx Pharmaceuticals in this new phase as a clinical-stage company.
Prof Sir Marc Feldmann AC, FRS
MB BS, PhD, FRCP, FRCPath, FAA, F Med Sci
Chairman
24 April 2024
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Board of Directors and Senior Management
Professor Sir Marc Feldmann – Non-Executive Director & Chairman
–
appointed
9
April
2018
Professor Sir Marc Feldmann is a pre-eminent medically trained immunologist at the University of
Oxford where he was Head of the Kennedy Institute of Rheumatology until 2014 and now Emeritus
Professor, and a Visiting Professor at Rockefeller University, New York. He trained in medicine at
Melbourne University and then earned a Ph.D. in Immunology at the Walter & Eliza Hall Institute with
Sir Gus Nossal, before working in London at the Imperial Cancer Research Fund. Sir Marc's main
research interests are immunoregulation, understanding mechanisms of autoimmunity and the role of
cytokines in disease, and working out how to fill unmet medical needs.
His work in London led to the generation of a new hypothesis for the mechanism of autoimmunity, linking
upregulated antigen presentation and cytokine expression. Testing this hypothesis led to the discovery,
with colleague Sir Ravinder Maini, of the pivotal role of TNFα (Tumour Necrosis Factor alpha) in the
pathogenesis of rheumatoid arthritis. This major discovery has revolutionised therapy not only of
rheumatoid arthritis but other chronic inflammatory diseases (e.g. inflammatory bowel disease, psoriasis,
and ankylosing spondylitis), and helped change the perception of monoclonal antibodies from niche
products to mainstream therapeutics. Anti-TNF therapeutics are the current leading drug class with 2022
sales exceeding US$42 billion.
This has led to much scientific recognition, for example election to the Royal Society and Academy of
Medical Sciences in London, the National Academy of Sciences USA and the Australian Academy of
Science, and multiple major International prizes including the Crafoord Prize of the Royal Swedish
Academy of Sciences, the Albert Lasker Clinical Research Award (NY), the Ernst Schering Prize, the
Paul Janssen Award for Biomedical Research, the Canada-Gairdner Award, and more recently the Tang
prize. He was also the first recipient in biology or medicine of the EU/European Patent Office Inventor
of the Year Award in the Lifetime Achievement category. In addition, Sir Marc has advised more than
20 of the largest pharmaceutical and biotech companies in the world and has mentored some of the most
successful scientists, many of whom have become senior figures in the commercial pharmaceutical world.
Sir Marc was knighted in the 2010 Queen's Birthday Honours, and was honoured in Australia with the
knighthood equivalent, the Companion of the Order of Australia.
Sir Marc has been at the forefront of promoting effective scientific-medical-pharmaceutical interactions.
He has built up a huge network of friends and collaborators who meet regularly in Oxford and who will
help Hemogenyx Pharmaceuticals to grow.
Dr Vladislav Sandler – Chief Executive Officer
–
appointed
4
October
2017
Dr Vladislav Sandler is the Co-Founder and CEO of Hemogenyx Pharmaceuticals and a research
Assistant Professor at the State University of New York (SUNY) Downstate. Dr Sandler is a widely
published stem cell scientist with decades of experience in scientific research. In particular, Dr Sandler
has extensive experience developing novel methods of direct reprogramming of somatic cells into
functional and engraftable hematopoietic stem cells, as well as developing novel sources of pluri- and
multi-potent cells.
Dr Sandler has conducted his research at many leading institutions in Russia, Israel, Canada and the
United States, including at the Children's Hospital at Harvard Medical School, the Salk Institute for
Biological Sciences, Harvard University and Albert Einstein College of Medicine, among others. He also
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led a team of scientists at Advanced Cell Technologies, Inc. and was most recently on the faculty of Weill
Cornell Medical College. While at Cornell, Dr Sandler made the significant discovery that the cells that
give rise to blood stem cells during mammalian development continue to exist after birth, and he
developed the method of isolation of these cells from humans. As a result of this important work, Dr
Sandler was awarded the inaugural Daedalus Fund Award for Innovation at Cornell. He went on to found
Hemogenyx Pharmaceuticals in order to further pursue this significant scientific discovery and his
dedication to the translation of science into clinical practice.
Dr Sandler has published numerous peer-reviewed papers and has received a number of awards and
fellowships for his scientific research. Dr Sandler received his PhD from the University of British
Columbia. He is a member of the International Society for Stem Cell Research.
Alexis Sandler – Non-Executive Director
–
appointed
4
October
2017
Alexis M. Sandler is the co-founder of Hemogenyx Pharmaceuticals, for which she has served as the
Chief Operating Officer. Ms Sandler is an attorney specialising in intellectual property, with over 20
years of experience representing a range companies and institutions.
Ms Sandler is the General Counsel of The Frick Collection. A talented and respected attorney with a wide
range of experience and expertise, Ms Sandler previously served for nearly a decade as in-house counsel
for The Museum of Modern Art. Prior to that, she worked as the director of business and legal affairs for
a major media and entertainment company, and in private practice for several prominent law firms.
Ms Sandler received her AB from Harvard University and her JD from the UCLA School of Law and is
a member of the State Bar of New York and the State Bar of California.
Peter Redmond – Non-Executive Director
–
appointed
4
October
2017
Peter Redmond is a corporate financier with over 40 years’ experience in corporate finance and venture
capital. He has acted on and assisted a wide range of companies to attain a listing over many years on the
former Unlisted Securities Market, the Main Market of the London Stock Exchange and AIM, whether
by IPO or in many cases via reverse takeovers, across a wide range of sectors, ranging from
pharmaceuticals, through technology, financial services and natural resources. In recent years has done
so as a director and investor in the companies concerned.
He was a founder director of a number of investment companies listed on the Standard List of the Stock
Exchange, all of which went on to complete significant reverse takeovers resulting in admission as active
businesses on AIM or back onto the Standard List. In particular, he was a founder director of Silver
Falcon plc, the Company into which Hemogenyx Pharmaceuticals reversed, and he took a leading role in
negotiating and effecting the reverse takeover. He undertook the same role in the rescue, reconstruction
and refinancing of many AIM-quoted companies that had previously run into difficulties and took a
significant active part in fundraising for the above companies – in particular Standard-listed URA
Holdings plc, of which he remains a director.
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Directors’ Strategic Report for the year ended 31 December 2023
The Directors present their Strategic Report of Hemogenyx Pharmaceuticals plc for the year ended 31
December 2023.
Introduction
This Strategic Report comprises a number of sections, namely: the Group’s objectives, the Group’s
strategy and business model, a review of the Group’s business using key performance indicators, and the
principal risks and uncertainties facing the business.
The disclosures under s172 of the Companies Act 2006 are included in the Governance Report on page
26.
Objectives
The Group’s objective is to develop breakthrough therapies for the treatment of blood and autoimmune
diseases, certain cancers and of viral infections.
Strategy and Business Model
The Group’s long-term strategy is to create a suite of products to address current problems associated
with the treatment of blood disorders such as leukaemia-type cancers and autoimmune diseases, with the
treatment of viral infections and certain non-blood cancer conditions, and with bone marrow – or
hematopoietic stem cell – conditioning preparatory to blood stem-cell transplants. The latter represents
an important part of the solution to treating blood-related diseases, with the opportunity to improve
outcomes through reduced blood stem cell transplant rejection and relapse, and if successful potentially
provides long-term cures for these diseases.
The Group’s business model aims to advance its therapies through clinical proof-of-concept, taking them
towards a final stage of development. This is intended to be achieved either through the Company itself
taking the product into and through clinical trials or by the licensing of one or more of its therapies to
partners in return for potential upfront payments, research funding support, success milestone and royalty
payments.
Operational Review and Outlook
The operational review and outlook are set out in the Chairman’s Statement on page 3.
Financial Review
The Group incurred a loss for the year to 31 December 2023 of £6,696,493 (31 December 2022:
£3,986,982 loss).
In the year to 31 December 2023 the loss mainly arose from operational expenses pursuing the Group’s
objectives listed above as well as salaries, consulting and professional fees, and general administration
expenses. These expenses have been met from the proceeds of equity placings that were undertaken
during the period.
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Cash flow and cash position
Cash used in operations totalled £6,105,570 (31 December 2022: £2,910,604).
As at 31 December 2023, the Group had a cash balance of £1,247,601 (31 December 2022 - £2,532,758).
Key Performance Indicators (“KPIs”)
The Directors have identified the KPIs below that they feel are the most vital measurements for the Group
to monitor given its current stage of development. KPIs are monitored on an annual basis to ensure that
they remain the most important and relevant measure of performance and progress.
Cash management
In the year the Company undertook several fundraises in furtherance of its research and development
strategy, raising a total of £5,254,000 (before expenses). As at 31 December 2023 the cash position was
£1,247,601 (31 December 2022: £2,532,758).
The Group carefully plans expenditure with rolling cash flow forecasts and tight financial control. The
Group takes a collaborative cost sharing approach with business partners and avoids long-term
commitments as far as possible.
As detailed in the Future Developments and Events Subsequent to the Year End note on page 23, in
February 2024 the Company successfully raised £3,325,000 (before expenses) to progress its recently-
approved clinical trials.
Intellectual property
The Group is focused on developing new conditioning treatments, drugs and cell therapy products for
blood and autoimmune diseases, HSC/BM transplantation, certain cancers and viral infections. The
Group, or its licensors, has applied for patents to protect its proprietary technology and future products,
which are in varying stages of development.
The success of the Group will depend largely on the Group’s ability to implement successful drug
development programmes, obtain the required regulatory approvals (in various territories), protect and
exploit its own intellectual property and know-how and the intellectual property and know-how licensed
to it, and to generate a cash flow in accordance with the strategy of the Group. Intellectual property is
protected by the Group through taking a pro-active approach to filing patents over its products and
technologies, as well as the diligent maintenance and protection of such patents and licences.
The Group patent portfolio currently includes:
CDX bi-specific antibodies (“CDX”)
The patent application relating to CDX bi-specific antibodies was filed by Hemogenyx Pharmaceuticals
LLC in the USA on 4 April 2016 ("CDX Patent") and awarded as Patent Number US 11,021,536 B2 on
1 June 2021. The invention summarised in the patent application is a method of eliminating hematopoietic
stem cells/hematopoietic progenitors ("HSC"/"HP") in a patient using bi-specific antibodies specifically
binding to a protein predominantly expressed on the surface of HSC/HP and to a protein uniquely
expressed on a surface of immune cells. The bound bi-specific antibodies redirect immune cells to
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eliminate HSC/HP. The invention relates to the required conditioning of a patient prior to a BM/HSC
transplant. In this respect, the invention serves two main purposes:
▪
it provides adequate immunosuppression of the patient and clears sufficient niche space in the
bone marrow for the transplant of HSC. This allows transplanted cells to engraft in the recipient;
and
▪
it could potentially help to eradicate the source of malignancy.
On 4 April 2017, an international PCT (Patent Cooperation Treaty) application was filed by Hemogenyx
Pharmaceuticals which includes additional claims that extend the CDX Patent set out in the provisional
patent application. These claims protect specific sequences of several high-quality clones discovered and
validated by the Group. The claim extension transforms the original "method" provisional patent
application into a "composition of matter" PCT application. A patent was granted in China in July 2022
covering both transplant conditioning and AML treatment applications. An additional composition of
matter patent application titled Bispecific Anti-FLT3/CD3 Antibodies and Methods of Use (covering novel
sequences of the antibodies discovered and validated by the Company in collaboration with Eli Lilly &
Company) was filed following completion of the Lilly collaboration agreement and was published by the
World Intellectual Property Organization on 23 February 2023 as publication number WO/2023/023489.
Furthermore, on the 2 February 2024 the United States Patent and Trademark Office granted a patent to
the Company entitled Method of Eliminating Hematopoietic Stem Cells/Hematopoietic Progenitors
(HSC/HP) in s Patient Using Bi-specific Antibodies. The original patent application is issued as U.S.
Patent No. 11,945,866 on 2 April 2024.
Monoclonal antibodies
In July 2019 the Group filed a composition of matter patent application entitled Monoclonal Antibodies
to Human FLT3/FLK2 Receptor Protein in relation to newly-discovered monoclonal antibodies against
a target protein expressed on the surface of hematopoietic stem cells/hematopoietic progenitors and a
number of leukaemias, such as acute myeloid leukaemia (“AML”). The patent was granted on 31 August
2021 as Patent Number US 11,104,738. This patent covers composition of matter (sequences) of
monoclonal antibodies to the human FLT3/FLK2 receptor protein that is found on the surface of acute
myeloid leukaemia cells, hematopoietic (blood-forming) stem cells and progenitors (“HSC/HP”), and
dendritic cells. It also covers a method of application of the Group’s bi-specific CDX antibodies for
conditioning patients for bone marrow transplantation.
HEMO-CAR-T
A PCT patent application titled Anti-FLT3 Antibodies, CARs, CAR T Cells and Methods of Use was
published by the World Intellectual Property Organization on 23 February 2023 under number
WO/2023/023491, detailing the Company’s Chimeric Antigen Receptor sequences including anti-FLT3
antibodies.
Hu-PHEC cell therapy
The patent relating to Hu-PHEC was filed by Cornell University in several jurisdictions on 13 November
2014. The patent was approved and issued in the United States of America on 25 February 2020 and
published by the European Patent Office on 13 May 2020. The invention summarises a method of
isolation and identification of post-natal hemogenic endothelial cells, as well as the provision of
substantially purified populations of post-natal hemogenic endothelial cells, compositions of post-natal
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endothelial cells and methods to utilise post-natal hemogenic endothelial cells to regenerate the
hematopoietic system in a patient.
Advanced Hematopoietic Chimeras
The provisional patent application relating to the Group’s proprietary humanised mouse model, the
Advanced Hematopoietic Chimera (“AHC”), is an application filed by Dr Sandler and Dr Rita Simone in
the USA on 20 February 2018. The invention summarised in the patent application is mice whose
hematopoietic system is at least 40% humanised and methods for preparing the same. The patent was
assigned to the Group’s subsidiary Immugenyx LLC on 24 May 2018. In June 2019 the Group announced
that Immugenyx LLC has further refined its work to develop the Advanced peripheral blood
Hematopoietic Chimera ("ApbHC") as a research and development tool. The major advantage of the
ApbHC compared to other humanised mouse models known to the Group is the absence of Graft versus
Host Disease, a disease that complicates and often renders impossible the efficient use of peripheral blood
mononuclear cells in transplanted mice. The ApbHC can potentially be used for testing multi-specific
antibodies, including its own bi-specific CDX antibody, as well as for the development and testing of
new cell therapies involving immune cell programming such as CAR-T. ApbHC can also potentially be
used for the modelling of autoimmune diseases, such as Systemic Lupus Erythematosus (aka Lupus),
with a goal of developing fundamentally new treatments for those diseases.
Chimeric Bait Receptor (“CBR”)
In March 2022, the Company filed a seminal provisional patent application protecting its rights to the
intellectual property covering its CBR platform technology, a new paradigm for treating viral infections
from which constructs targeting viral pathogens and potentially malignancies may be derived and for
certain cancer and neurological conditions On 7 September 2023 the Company filed patent application
number WO2023168292 Chimeric Bait Receptors and Uses Thereof with the World Intellectual Property
Organization. At the time of reporting, it remains to be reviewed and approved by national patent
authorities.
Product development
The Group develops therapies for the treatment of AML, for the treatment of a range of viral conditions
and certain other cancers and conditions and for the transformation of bone marrow and blood stem cell
transplant procedures.
HEMO-CAR-T is a therapy for the treatment of AML in which a patient’s own T-cells, a type of immune
cell, are modified to recognise and kill the patient’s cancer cells. The procedure involves: isolating T-
cells from the patient; modifying the isolated T-cells in a laboratory using a CAR gene construct (which
allows the cells to recognise the patient’s cancer); amplifying (growing to large numbers) the newly
modified cells; and re-introducing the cells back into the patient.
CBR is a broad and versatile range of potential treatments based on the methodology of programming
immune cells using a novel type of modifiable synthetic receptor to destroy viral pathogens. This
approach can also potentially be used to programme immune cells to destroy malignant cells causing
certain types of cancer and potentially also some neurological conditions.
CDX aims to replace the need for existing methods of preparation of patients for transplantation, such as
chemotherapy and radiation treatments, and at the same time address the problem of finding matching
stem cell donors whilst reducing the risk of blood stem cell rejection after transplantation.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
14
The Group’s lead product, HEMO-CAR-T, is at the stage of commencing clinical trials. Its other key
products, CDX antibodies, the CBR platform, and CBR, are currently in preclinical development. In
addition, the Group’s advanced hematopoietic chimeric (“AHC”) mice have been the subject of
collaborations with other pharmaceutical companies to evaluate AHCs’ effectiveness as platforms for
disease modelling and drug discovery, and are being used by the Company currently for its own product
development.
The Directors monitor product development through pre-clinical results. The CDX and CAR-T products
have been successfully evaluated in the Group’s proprietary humanised mouse model, achieving proof of
concept. Furthermore, we have achieved notable demonstrations of both CDX’s and HEMO-CAR-T’s
activity versus AML cells in vitro and in vivo. If successful, the Company may be able to use the CDX
and/or CAR-T products to eliminate R/R acute myeloid leukaemia (“AML”) in patients who qualify for
bone marrow transplantation. The Company is also investigating the possibility of using its CDX
antibodies in combination with other treatments for AML to increase their effectiveness.
A CBR construct designed to target SARS-CoV-2 has been tested in vitro, and in vivo tests against live
replicating viruses are ongoing, as is work on CBR for use against certain cancers such as Non-Hodgkin
Lymphoma (“NHL”) certain solid tumours and neurological conditions.
Diversity
Hemogenyx Pharmaceuticals is committed to workplace diversity which includes but is not limited to
gender, age, ethnicity and cultural background.
Hemogenyx Pharmaceuticals’ Diversity Policy defines initiatives which assist the Company in
maintaining and improving the diversity of its workforce. The table below highlights the proportion of
men and women engaged by the Group:
Men Women
Organisation as a whole 7 9
Executive management team 2 -
Board 3 1
Board of Advisors
The Group engages the services of a Board of Advisors who are highly experienced in both the clinical
development of treatments and regulatory processes to commercialisation. In addition to Professor Sir
Marc Feldmann, who runs the Board of Advisors in addition to his role as Chairman, the advisors are:
Dr H. Michael Shepard, Ph.D.
SCIENTIFIC ADVISOR
▪
Led the discovery and development of many successful cancer treatments
including Herceptin/trastuzumab – annual sales exceed $6.5 billion worldwide
▪
Received Harvard Medical School's prestigious Warren Alpert Prize in recognition
of contributions to the field of cancer treatment research
▪
Founded NewBiotics, Inc., acquired by Kiadis Pharma
▪
Founded BioLogix, acquired by Symphogen
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
15
Dr Koen van Besien M.D.
CLINICAL ADVISOR
▪
Hematology Chief and Director of the Wesley Center for Immunotherapy at University Hospitals
Seidman Cancer Center
▪
Professor of Medicine at NYP-Weill Cornell College of Medicine
▪
Developed novel methods of transplantation for those patients who lack matching donors
▪
>200 publications in peer reviewed journals
▪
Editor in Chief of the journal Leukemia and Lymphoma
Corporate Responsibility
We have defined the scope of our Group’s responsible business practices as falling within the following
key focus areas:
▪
Health and Safety – ensuring the safety and well-being of our staff
▪
Environment – managing our environmental impact areas of waste, energy and water
▪
Employees – supporting our people to develop and flourish within the business
▪
Community – positive interaction with the communities in which we operate
▪
Ethical Standards – operating to the highest ethical standards
We remain committed to ensuring these activities become embedded in how we operate and contribute
towards the success of our business. This includes not only identifying and managing business risk but
exploring opportunities to add value to the business.
Greenhouse Gas Emissions
Given the nature of its activities, there is limited scope for the Group to have a major impact on
environmental matters. Nevertheless, the Directors are mindful of their responsibilities in this regard and
strive to seek opportunities where improvements may be made.
Climate-related Financial Disclosures
The Financial Stability Board’s Task Force on Climate-related Financial Disclosures (TCFD)
recommendations serve as a global foundation for effective reporting on the operational and financial
implications of the interrelationship between climate change and business, and set out recommended
disclosures structured under four core elements:
•
Governance – The organisation’s governance around climate-related risks and opportunities
•
Strategy – The actual and potential impacts of climate-related risks and opportunities for an
organisation’s businesses, strategy, and financial planning
•
Risk Management – The processes used by the organisation to identify, assess, and manage
climate-related risks; and
•
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 our current progress against the TCFD recommendations.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
16
TCFD Pillar Recommended Disclosure Hemogenyx Pharmaceuticals Summary
Governance
•
Board’s oversight of
climate-related risks and
opportunities
•
Management’s role in
assessing and managing
climate-related risks and
opportunities
As a development stage biopharmaceutical
business, the Group’s operations are at a
relatively small scale and so therefore is its
environmental impact. Nevertheless, the
Board recognises its responsibility to protect
the environment (particularly as the business
scales up).
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
Hemogenyx Pharmaceuticals 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; minimising waste production; and
protecting nature and people.
As Hemogenyx Pharmaceuticals enters the
next stage of its development, clinical trials,
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.
In the short-term, clinical trials are not
expected to have any impact on the Company’s
environmental impact as research will remain
small and within the same facilities it currently
operates from. However, this will be
continually monitored.
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,
Hemogenyx Pharmaceuticals has the ability to
embed climate-related risk management
systems into its overall internal control
systems from an early stage of its journey, thus
almost eliminating the occurrence of transition
risk.
As operations scale up in the coming years, the
identification, assessment and effective
management of climate-related risks and
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
17
TCFD Pillar Recommended Disclosure Hemogenyx Pharmaceuticals Summary
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. 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 SASB
recommended disclosures in the next 2-3
years.
The Group already minimises business travel,
and therefore energy use and emissions,
through the use of Internet-based
communications tools. It has a policy of
preferring devices with low energy
consumption where a choice is available, and
switching them off when not in use.
Principal Risks and Uncertainties
The Group operates in an uncertain environment and is subject to a number of risk factors. The Directors
have carried out a robust assessment of the principal risks facing the Group, including those that threaten
its business model, future performance, solvency or liquidity. They consider the following risk factors
are of particular relevance to the Group’s activities and to any investment in the Group. It should be noted
that the list is not exhaustive and that other risk factors not presently known or currently deemed
immaterial may apply.
The risk factors are summarised below:
Risks relating to the Group’s business strategy
The Group’s business is relatively undeveloped
The operations of Hemogenyx Pharmaceuticals are at a relatively early stage and, to date, no commercial
sales of its products have been made. The ability of the Group to achieve commercialisation is dependent
on a number of factors, many of which are outside of the Group’s control. Examples of factors outside of
the Group’s control are capital market conditions, FDA approval and competition.
Business strategy of the Group
The development of clinical products for new medical treatments is inherently uncertain, with high failure
rates in clinical studies for both early and late-stage development products and such clinical studies can
be expensive, time-consuming and complicated and there is no certainty as to the outcome of such
studies. Even once clinical studies have been successfully carried out, later phase trials may not
successfully replicate or improve on such outcomes.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
18
Staffing and key personnel
The Group is reliant on a number of the key personnel, in particular Dr Vladislav Sandler who is the
founder of Hemogenyx Pharmaceuticals (refer to Corporate Governance Report for further detail). Whilst
the Group has endeavoured to ensure that it has contractual arrangements which include non-compete
restrictions in place with such persons to lessen the risk of them ceasing to be involved with the Group,
in the event that the Group was to lose the services of such individuals, its results could be adversely
affected.
Costs of commercialisation
The ability of the Group to bring its products to first commercial sale will be dependent in part on the
overall costs of manufacturing and the costs involved could be significant and there is no guarantee that
the sale prices achievable for its products will be viable and sustainable.
Clinical studies and timelines risk
Hemogenyx Pharmaceuticals is currently progressing its product candidates through preclinical
development and into the first stages of clinical trials. Although encouraging results have been achieved
so far, there can be no certainty that these results can be reproduced in clinical trials. The monies raised
in Placings and Subscriptions support those preclinical development activities.
The development of clinical products for new medical treatments is inherently uncertain, with high
failure rates in clinical studies for both early- and late-stage development products. Furthermore, such
clinical studies (Phase 1, Phase 2a/2b, Phase 3) are typically expensive, complex, can take considerable
time to complete and have uncertain outcomes.
Furthermore, as a result of adverse, undesirable, unintended or inconclusive results from any testing or
clinical trials (which have yet to be designed), the future progress, planning and potential treatment
outcome of the products and clinical programmes may be affected and may potentially prevent or limit
the commercial use of one, many or all of the Company's products. In addition, later phase clinical trials
may fail to show the desired safety and efficacy obtained in earlier studies, and a successful
completion of one stage of clinical development of an investigational clinical product does not ensure
that subsequent stages of clinical development will be successful.
Failure can occur at any stage of clinical development and, as a result, enforced delays to the clinical
development plan could delay or prevent commercialisation of the Company's product candidates.
Various factors associated with the potential failure or delay in completing a clinical programme include,
but are not limited to:
▪
Delays in securing clinical investigators or clinical study sites;
▪
Delays in securing any regulatory authority, hospital ethics committee, or institutional review
board approval or approvals necessary to commence a clinical study;
▪
Delays or failure to recruit a sufficient number of clinical study participants in accordance with
the clinical study protocol;
▪
Difficulty or inability to monitor subjects adequately during or after treatment;
▪
Inability to replicate in Phase 3 controlled studies any safety and efficacy data obtained from
controlled Phase 2a/2b clinical studies;
▪
Difficulty or inability to secure clinical investigator compliance to follow the approved clinical
study protocol; and
▪
Unexpected adverse events or any other safety or related issues.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
19
Research and development risk
The Group operates in the biotechnology and bio-pharmaceutical development sectors and carries out
complex scientific research. If the research or preclinical testing or clinical trials of any of Hemogenyx
Pharmaceuticals’ 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. Positive results from
preclinical and early clinical studies do not guarantee positive results from clinical trials required to
permit application for regulatory approval. Furthermore, the Group may discontinue the development
of candidates if results are not positive or unlikely to further its progress towards a meaningful outcome
or collaboration.
Intellectual property (IP) infringement
The Group may be subject to future litigation concerning its own IP and the IP of others. Adverse
judgements in relation to its IP would likely have negative outcomes for its results of operations.
Intellectual property (IP) control
The Group is partially reliant on an exclusive, world-wide licence of a patent from Cornell University for
its Hu-PHEC line of business. The exclusivity and exploitable territory for this licence depend on the Group
meeting various developmental milestones.
Environmental and other regulatory requirements
The event of a breach with any environmental or regulatory requirements may give rise to reputational,
financial or other sanctions against the Group, and therefore the Board considers these risks seriously and
designs, maintains and reviews its policies and processes so as to mitigate or avoid these risks. Whilst the
Board has a good record of compliance, there is no assurance that the Group’s activities will always be
compliant.
Financing
The Group’s ability to develop its products through to commercial sales will depend upon the Group’s
ability to obtain financing primarily through a further raising of new equity capital. Although the Group
has been successful in raising new equity capital, there can be no guarantee that it will be able to do so in
the future. The Group may not be successful in procuring the requisite funds on terms which are
acceptable to it (or at all) and, if such funding is unavailable, would raise questions over its ability to
further develop its products through to commercialisation. Further, Shareholders’ holdings of Ordinary
Shares may be materially diluted if debt financing is not available.
Market conditions
Market conditions, including general economic conditions and their effect on exchange rates, interest
rates and inflations rates, may impact the ultimate value of the Group regardless of its operating
performance. The Group also faces competition from other organisations, some of which may have
greater resources or be more established in a particular territory. The Board considers and reviews all
market conditions to try and mitigate any risks that may arise from these.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
20
Political and country risk
The departure of the UK from the EU is now complete and its impact on the business, whose current
operations are principally in the US, has been negligible. Any further changes in international trade, tariff
and import/export regulations may impose unexpected duty costs or other non-tariff barriers on the
Group. The Company is monitoring matters and will seek advice, where necessary, as to how to mitigate
the risks arising. The Company has not experienced and does not anticipate that there will be any impact,
including on its personnel or supply chain, as a result of the on-going war in Ukraine or the situation in
the Middle East save for a general increase in inflation such as of the cost of energy.
Approved by the Board on 24 April 2024
Dr Vladislav Sandler
CEO
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
21
Directors’ Report for the year ended 31 December 2023
The Directors present their report with the audited financial statements of the Group for the year ended
31 December 2023.
The Company’s Ordinary Shares were admitted to listing on the London Stock Exchange under the name
Silver Falcon plc, on the Official List pursuant to Chapters 14 of the Listing Rules, which sets out the
requirements for Standard Listings, on 9 November 2015.
On 4 October 2017 the Company’s shareholders voted in favour of acquiring the biotechnology company
Hemogenyx Pharmaceuticals Limited, with shares being readmitted to trading on 5 October 2017 under
the name Hemogenyx Pharmaceuticals plc.
Principal Activity
The Group’s principal activity is the discovery, development and commercialisation of a suite of products
to address current problems associated with the treatment of blood disorders such as cancers and
autoimmune diseases, with bone marrow, or hematopoietic stem cell, transplants, and with viral
infections. The Company's leading technologies aim to change the way in which bone
marrow/hematopoietic stem cell ("BM"/"HSC") transplants are performed and improve their efficacy.
Hemogenyx Pharmaceuticals’ distinct and complementary products include immunotherapy product
candidates for the treatment of AML and other blood malignancies and patient conditioning (the CDX
bi-specific antibody and CAR-T therapy), and a cell therapy product for BM/HSC transplantation (the
Hu-PHEC). Each of these products holds the potential to revolutionise the way BM/HSC transplants are
being performed or diseases of the blood are treated, offering solutions that mitigate the dangers and
limitations associated with the current standard of care. Additionally, the Group has two platform
technologies: its Advanced peripheral blood Hematopoietic Chimeras, a form of humanised mouse used
to model diseases including autoimmune conditions and to test multi-specific antibody treatments; and
Chimeric Bait Receptors or CBR, a novel way to create constructs potentially capable of programming
immune cells to attract and destroy a wide range of viruses and malignant (cancer-causing) cells.
The Group has two companies that are located outside of the UK. The principal laboratory of the Group
is located in Manhattan, New York, USA.
Results and Dividends
The Consolidated Statement of Comprehensive Income set out on page 46 shows a loss for the year
amounting to £6,696,493 (2022: £3,986,982). The Directors do not propose a dividend in respect of the
year ended 31 December 2023 (31 December 2022: nil).
Directors and Directors’ Interests
The Directors who held office during the year and up to the date of this report were as follows:
Date Appointe
d
Date Resigned
Professor Sir Marc Feldman
n
9 April 2018 -
Dr Vladislav Sandle
r
4 October 2017 -
Alexis Sandle
r
4 October 2017 -
Peter Redmond 29 July 2015 -
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
22
The Directors of the Company who held office at 31 December 2023 had the following beneficial interests
in the Ordinary shares of the Company at 31 December 2023 according to the register of directors’
interests:
Director At 31 December 2023 At 31 December 2022
Professor Sir Marc Feldmann - -
Peter Redmond* 5,596,270 5,596,270
Dr Vladislav Sandle
r
41,544,677 41,544,677
Alexis Sandler 75,090,685 75,090,685
* Peter Redmond holds the majority of these shares through Catalyst Corporate Consultants Ltd of which
he is the sole shareholder.
At the date of this report, there have been no further changes to the Directors’ beneficial interest in the
Ordinary shares of the Company as disclosed in the table above.
According to the Register of Directors’ Interests, no rights to subscribe for shares in or debentures of
Group companies were granted to any of the Directors or their immediate families, or exercised by them,
during the financial year, save for the annual grant of 10,000 ownership units in Immugenyx LLC due to
Dr Vladislav Sandler under the terms of his appointment as CEO and Chief Scientific Officer of that
company. Grants of options are as indicated below (see Note 18 for detail on option plans):
Date of grant
Number of options
at start of year
Options
Options granted or
acquired during
year
Options lapsed
during year
Number of options
at end of year
Professor Sir Marc
Feldmann
9 Apr 2018 18,002,568 - (4,500,642) 13,501,926
18,002,568 - (4,500,642) 13,501,926
Dr Vladislav Sandler
20 August 2020
5,000,000
22,839,986
-
27,839,986
5,000,000 22,839,986 - 27,839,986
Peter Redmond
13 July 2020
2,200,000
- - 2,200,000
2,200,000 - - 2,200,000
Qualifying Third Party Indemnity Provision
At the date of this report, the Company has a third-party indemnity policy in place for all Directors.
Substantial Shareholders
As at 31 December 2023, the total number of issued Ordinary Shares with voting rights in the Company
was 1,175,565,988 (now: 1,341,815,988). The Company has been notified of the following interests of 3
per cent or more in its issued share capital as at the date of approval of this report:
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
23
Party Name Number of Ordinary Shares % of Share Capital
Alexis Sandle
r
75,090,685 5.60
Vladislav Sandler 41,544,677 3.10
Share Capital
Details of the issued share capital, together with details of the movement in issued share capital during
the year, are shown in Note 16 to the financial statements.
Financial Instruments
Details of the use of the Company’s financial risk management objectives and policies as well as exposure
to financial risk are contained in the Accounting Policies and Note 22 of the financial statements.
Future Developments and Events Subsequent to the Year End
On 29 February 2024 the Company announced that it issued and allotted 166,250,000 new ordinary shares
at 2 pence per share. The net proceeds from the Placing will be used to allow the Company to progress
HEMO-CAR-T to Phase I clinical trials.
Further details of the Group’s future developments and events subsequent to the year end are set out in
the Chairman’s Statement and Directors’ Strategic Report on pages 3 and 10 respectively.
Corporate Governance
The Corporate Governance report is disclosed on page 26.
Going Concern
The Company’s business activities, together with facts likely to affect its future operations and financial
and liquidity positions are set out in the Chairman’s Statement and Directors’ Strategic Report on pages 3
and 10 respectively. In addition, Note 22 to the financial statements discloses the Company’s capital risk
management policy and Note 2 details further considerations made by the Directors in respect of going
concern.
The Directors, having made due and careful enquiry, are of the opinion that the Company has or will have
access to sufficient funding in order to execute its operations over the next 12 months. The Directors
therefore have made an informed judgment, at the time of approving the financial statements, that there
is a reasonable expectation that the Company has adequate resources to continue in operational existence
for the foreseeable future. As a result, the Directors have adopted the going concern basis of accounting in
the preparation of the annual financial statements.
Political Donations
The Group made no political donations during the year (2022: £nil).
Charitable Donations
There were no charitable donations made by the Group in the current or prior year.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
24
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.
Auditors
The auditors, PKF Littlejohn LLP, have expressed their willingness to continue in office and a resolution
to reappoint them will be proposed at the Annual General Meeting.
Statement of Directors’ Responsibilities
The Directors are responsible for preparing the Annual Report and the financial statements in accordance
with applicable law and regulations.
Company law requires the Directors to prepare financial statements for each financial year. Under that
law the Directors have elected to prepare the Group and Company financial statements in accordance
with UK-adopted international accounting standards.
Under Company law the Directors must not approve the financial statements unless they are satisfied that
they give a true and fair view of the state of affairs of the Group and of the profit or loss of the Group for
that year.
In preparing these financial statements, the Directors are required to:
•
Select suitable accounting policies and then apply them consistently;
•
Make judgments and accounting estimates that are reasonable and prudent;
•
State whether applicable UK-adopted international accounting standards have been followed,
subject to any material departures disclosed and explained in the financial statements; and
•
Prepare the financial statements on the going concern basis unless it is inappropriate to presume
that the Group and Company will continue in business.
The Directors are responsible for keeping adequate accounting records that are sufficient to show and
explain the Group and parent company’s transactions and disclose with reasonable accuracy at any time
the financial position of the Group and parent company and enable them to ensure that the financial
statements and the Directors’ remuneration report comply with the Companies Act 2006. They are also
responsible for safeguarding the assets of the Group and parent company and hence for taking reasonable
steps for the prevention and detection of fraud and other irregularities. They are also responsible to make
a statement that they consider that the annual report and accounts, taken as a whole, is fair, balanced, and
understandable and provides the information necessary for the shareholders to assess the Group and
parent company’s position and performance, business model and strategy.
The Directors are responsible for the maintenance and integrity of the corporate and financial information
included on the Company’s website. Legislation in the United Kingdom governing the preparation and
dissemination of the financial statements may differ from legislation in other jurisdictions.
Directors’ Responsibility Statement Pursuant to Disclosure and Transparency Rules
Each of the Directors, whose names and functions are listed on page 1, confirms that, to the best of their
knowledge and belief:
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
25
•
the group and company financial statements have been prepared in accordance with UK-
adopted international accounting standards, and give a true and fair view of the assets,
liabilities, financial position and loss of the Group; and
•
the Annual Report and financial statements, including the Business review, includes a fair
review of the development and performance of the business and the position of the Group and
parent company, together with a description of the principal risks and uncertainties that they
face.
Disclosure of Information to Auditors
So far as the Directors are aware, there is no relevant audit information of which the Company’s auditors
are unaware, and each Director has taken all the steps that he ought to have taken as a Director in order
to make himself aware of any relevant audit information and to establish that the Company’s auditors are
aware of that information.
Approved by the Board on 24 April 2024
Dr Vladislav Sandler
CEO
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
26
Governance Report
Introduction
The Company recognises the importance of, and is committed to, high standards of Corporate
Governance. The Company has voluntarily applied the main and supporting principles set out in the UK
Code of Corporate Governance published by the Financial Reporting Council in 2018 ("the Code"). The
Code has been followed to the extent practicable for a company of its size and nature. The Code can be
found at https://frc.org.uk/our-work/publications/Corporate-Governance. The ways in which the
Company has applied the Code are explained below:
▪
The Code requires that a smaller company should have at least two Independent Non-Executive
Directors. As at 31 December 2023 the Board consisted of an Executive Director and three Non-
Executive Directors. The Non-Executive Directors are interested in either ordinary shares in the
Company, options over ordinary shares in the Company, or both, and cannot therefore be
considered fully independent under the Code. The remuneration of the Non-Executive Directors
includes options and this is contrary to best practice, and thus the Company is not in full
compliance. However, the Directors consider the present structure and arrangements to be
adequate given the size and stage of development of the Company, and all are considered to be
independent in character and judgement.
▪
Directors appointed by the Board are subject to election by shareholders at the Annual General
Meeting of the Company following their appointment and thereafter are subject to re-election in
accordance with the Company’s articles of association. The terms and conditions of appointment
of Non-Executive Directors will be made available upon written request.
The Board has voluntarily adopted a code for Directors’ dealings based on the Model Code contained in
the Listing Rules of the UK Listing Authority that was previously in force. The Board will be responsible
for taking all proper and reasonable steps to ensure compliance with the code by the Directors.
Compliance with the code is being undertaken on a voluntary basis and the FCA will not havethe authority
to (and will not) monitor the Company’s voluntary compliance with it, nor to impose sanctions in respect of
any failure by the Company to so comply. In addition, the Company will take all proper and reasonable
steps to ensure compliance by the Founders with the Code for dealings in the Ordinary Shares.
The Company is small with a modest resource base. The Company has a clear mandate to optimise the
allocation of limited resources to support its development plans. As such, the Company strives to maintain
a balance between conservation of limited resources and maintaining robust corporate governance
practices. As the Company evolves, the Board is committed to enhancing the Company’s corporate
governance policies and practices deemed appropriate for the size and maturity of the organisation.
Set out below are the Company’s corporate governance practices for the year ended 31 December 2023.
Committees
The Company has established audit, remuneration and nomination committees.
Audit Committee
The Audit Committee has responsibility for, among other things, the monitoring of the integrity of the
financial statements of the Company and its Group and the involvement of the Group's auditors in that
process. It focuses in particular on compliance with accounting policies and ensuring that an effective
system of external audit and financial control is maintained, including considering the scope of the annual
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
27
audit and the extent of the non-audit work undertaken by external auditors and advising on the
appointment of external auditors. The ultimate responsibility for reviewing and approving the annual
report and accounts and the half-yearly reports remains with the Board. The Audit Committee will meet
at least three times a year at the appropriate times in the financial reporting and audit cycle.
The members of the Audit Committee are Peter Redmond, who acts as chairman of the committee, and
Professor Sir Marc Feldmann.
The Group’s external auditor is PKF Littlejohn LLP who has served as external auditor for nine years.
The role of external auditor last went to tender in 2015. The Audit Committee closely monitors the level
of audit and non-audit services that it provides to the Company and Group.
Having assessed the performance, objectivity and independence of the auditor, the Committee will be
recommending the reappointment of PKF Littlejohn LLP as auditor to the Company at the 2024 Annual
General Meeting.
During the year to 31 December 2023 the Audit Committee considered the following key issues in
relation to the Financial Statements:
Issue Action
•
Accounting policies
The Committee reviewed and discussed the significant
accounting policies with management and the external auditor and
reached the conclusion that each policy was appropriate to the
Group.
•
Carrying value of investment in
Hemogenyx Pharmaceuticals LLC
The Committee reviewed the impairment assessment report
prepared by management and agreed that given the reasonable
expectation that the Group will achieve its milestone targets over
the next 18 months no impairment to the value of the investment
in Hemogenyx Pharmaceuticals LLC was required as at 31
December 2023.
•
Carrying value
intangible assets
of licensed
The Committee reviewed the impairment assessment report
prepared by management and agreed that given the licenses are
still active and the licensing parties have not expressed a want to
revoke the Company’s rights no impairment to the value of
licensed intangible assets, being rights to certain intellectual
property of Cornell University and Eli Lilly and Company, was
required as at 31 December 2023.
•
Going concern review
The Committee considered the ability of the Group to operate as
a Going Concern considering cash flow forecasts for the next 12
months and milestone achievements. It was determined by the
Committee that it was reasonable to expect that the Group has or
will have access to sufficient funding in order to achieve its 12-
month milestone targets and that it was appropriate for the
Financial Statements to be prepared on a going concern basis.
•
Review of audit
services and fees
and non-audit
The external auditor is not engaged by the Group to carry out any
non-audit work in respect of which it might, in the future, be
required to express an audit opinion.
The Committee reviewed the fees charged for the provision of
audit and non-audit services and determined that they were in line
with fees charged to companies of similar size and stage of
development.
The Committee considered and was satisfied the external
auditor’s assessment of its own independence.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
28
Remuneration Committee
The remuneration committee reviews the performance of the Executive Directors and makes
recommendations to the Board on matters relating to their remuneration and terms of employment. The
committee also makes recommendations to the Board on proposals for the granting of share awards and
other equity incentives pursuant to any share award scheme or equity incentive scheme in operation from
time to time. The Remuneration Committee will meet at least twice a year.
The members of the Remuneration Committee are Peter Redmond, who acts as chairman of the
committee, and Alexis Sandler.
Nomination Committee
The Nomination Committee is responsible for considering and making recommendations to the Board in
respect of appointments to the Board, the Board committees and the chairmanship of the Board
committees. It is also responsible for keeping the structure, size and composition of the Board under
regular review, and for making recommendations to the Board with regard to any changes necessary,
taking into account the skills and expertise that will be needed on the Board in the future. The Nomination
Committee meets at least once a year.
The members of the Nomination Committee are Peter Redmond, who acts as chairman of the committee,
Professor Sir Marc Feldmann, and Alexis Sandler.
Leadership
The Company is headed by an effective Board which is collectively responsible for the long-term success
of the Company.
The role of the Board: the Board sets the Company’s strategy, ensuring that the necessary resources are
in place to achieve the agreed strategic priorities, and reviews management and financial performance. It
is accountable to shareholders for the creation and delivery of strong, sustainable financial performance
and long-term shareholder value. To achieve this, the Board directs and monitors the Company’s affairs
within a framework of controls which enable risk to be assessed and managed effectively. The Board also
has responsibility for setting the Company’s core values and standards of business conduct and for
ensuring that these, together with the Company’s obligations to its stakeholders, are widely understood
throughout the Company. The Board has a formal schedule of matters reserved which is provided later
in this report.
Board Meetings: the core activities of the Board are carried out in scheduled meetings of the Board. These
meetings are timed to link to key events in the Company’s corporate calendar and regular reviews of the
business are conducted. Additional meetings and conference calls are arranged to consider matters which
require decisions outside the scheduled meetings. During the year, the Board met formally on 12
occasions.
Outside the scheduled meetings of the Board, the Directors maintain frequent contact with each other to
discuss any issues of concern they may have relating to the Company or their areas of responsibility, and
to keep them fully briefed on the Company’s operations.
Matters reserved specifically for the Board: the Board has a formal schedule of matters reserved that can
only be decided by the Board. The key matters reserved are the consideration and approval of:
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
29
•
The Company’s overall strategy;
•
Financial statements and dividend policy;
•
Management structure including succession planning, appointments and remuneration;
material acquisitions and disposal, material contracts, major capital expenditure projects and
budgets;
•
Capital structure, debt and equity financing and other matters;
•
Risk management and internal controls;
•
The Company’s corporate governance and compliance arrangements; and
•
Corporate policies
Summary of the Board’s work in the year: during the year, the Board considered all relevant matters
within its remit, but focused in particular on the development and risk diversification of the Company.
Attendance at Board meetings
Number held and
entitled to attend
Number
attended
Dr Vladislav Sandle
r
12 12
Professor Sir Marc Feldman
n
12 4
Alexis Sandle
r
12 11
Peter Redmond 12 12
The Board is pleased with the high level of attendance and participation of Directors at Board and
committee meetings.
The Chairman sets the Board Agenda and ensures adequate time for discussion.
Non-Executive Directors: the Non-Executive Directors bring a broad range of business and commercial
experience to the Company and have a particular responsibility to challenge independently and
constructively the performance of the Executive management (where appointed) and to monitor the
performance of the management team in the delivery of the agreed objectives and targets.
All directors with the exception of the CEO and Professor Sir Marc Feldmann were appointed for an
initial term of 12 months. These terms were extended by mutual agreement after satisfactory performance
and re-election by shareholders.
Other governance matters: all of the Directors are aware that independent professional advice is available
to each Director in order to properly discharge their duties as a Director. In addition, each Director and
Board committee has access to the advice of the Company Secretary.
The Company Secretary: the Company Secretary is Ben Harber. He is responsible for the Board
complying with UK procedures.
Effectiveness
For the period under review the Board comprised a Chief Executive Officer, a Non-Executive Chairman,
and two independent Non-Executive Directors. Biographical details of the Board members are set out on
page 8 of this report.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
30
The Directors are of the view that the Board and its committees consist of Directors with an appropriate
balance of skills, experience, independence and diverse backgrounds to enable them to discharge their
duties and responsibilities effectively.
Independence: the Non-Executive Directors bring a broad range of business and commercial experience
to the Company. The Board considers each of the Non-Executive Directors to be independent in character
and judgement.
Appointments: the Board is responsible for reviewing and the structure, size and composition of the Board
and making recommendations to the board with regards to any required changes.
Commitments: all Directors have disclosed any significant commitments to the Board and confirmed that
they have sufficient time to discharge their duties.
Induction: all new Directors received an induction as soon as practical on joining the Board.
Conflict of interest: a Director has a duty to avoid a situation in which he or she has, or can have, a direct or
indirect interest that conflicts, or possibly may conflict with the interests of the Company. The Board had
satisfied itself that there is no compromise to the independence of those Directors who have appointments
on the Boards of, or relationships with, companies outside the Company. The Board requires Directors
to declare all appointments and other situations which could result in a possible conflict of interest.
Board performance and evaluation: Hemogenyx Pharmaceuticals plc has a policy of appraising Board
performance annually. Having reviewed various approaches to Board appraisal, it has concluded that for
a company of its current scale, an internal process in which all Board members submit answers to a
questionnaire that considers the functionality of the Board and its committees is most appropriate at this
stage.
Accountability
The Board is committed to providing shareholders with a clear assessment of the Company’s position
and prospects. This is achieved through this report and as required in other periodic financial and trading
statements.
Going concern: the Company’s business activities, together with factors likely to affect its future
operations, financial position, and liquidity position are set out in the Chairman’s Statement and the
principal risks and uncertainties sections of the Directors’ Strategic Report. In addition, the Notes to the
Financial Statements disclose the Company’s financial risk management practices with respect to its
capital structure, liquidity risk, interest rate risk, credit risk, and other related matters.
The Directors, having made due and careful enquiry, are of the opinion that the Company has or will have
adequate working capital to execute its operations and has the ability to access additional financing over
the next 12 months. The Directors, therefore, have made an informed judgement, at the time of approving
financial statements, that there is a reasonable expectation that the Company has adequate resources to
continue in operational existence for the foreseeable future. As a result, the Directors have continued to
adopt the going concern basis of accounting in preparing the annual financial statements.
Internal controls: the Board of Directors reviews the effectiveness of the Company’s system of internal
controls in line with the requirement of the Code. The internal control system is designed to manage the
risk of failure to achieve its business objectives. This covers internal financial and operational controls,
compliances and risk management. The Company has necessary procedures in place for the year under
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
31
review and up to the date of approval of the Annual Report and financial statements. The Directors
acknowledge their responsibility for the Company’s system of internal controls and for reviewing its
effectiveness. The Board confirms the need for an ongoing process for identification, evaluation and
management of significant risks faced by the Company. The Directors carry out a risk assessment before
signing up to any commitments.
Workforce policies and practices
The Board is responsible for ensuring that workforce policies and practices are consistent with the
Group’s values and support its long-term sustainable success, and that staff are able to raise any matters
of concern. The Non-executive Director designated to engage with the workforce on these matters is
Alexis Sandler. Ms Sandler, and in turn the Board, review the Group’s policies and procedures, including
anti-harassment and discrimination policies, sexual harassment reporting procedures, and procedures for
reporting grievances or other concerns, and oversee the proportionate and independent investigation of
any matters arising from them. These policies are provided to workers prior to the start of their work with
the Group, and hard copies are posted prominently in the Group’s operating premises together with other
legally required notices.
Relations with stakeholders
The Company is committed to a continuous dialogue with shareholders as it believes that this is essential
to ensure a greater understanding of and confidence amongst its shareholders in the medium- and longer-
term strategy of the Group and in the Board’s ability to oversee its implementation. It is the responsibility
of the Board as a whole to ensure that a satisfactory dialogue takes place.
Section 172 of the Companies Act 2006 requires Directors to take into consideration the interests of
stakeholders in their decision making. The Board is committed to understanding and engaging with all
key stakeholder groups of the Company in order to maximise value and promote long-term Company
success in line with our strategic objectives. The Board recognises its duties under Section 172 and
continuously has regard to how the Company’s activities and decisions will impact employees, those with
which it has a business relationship, the community and environment and its reputation for high standards
of business conduct. In weighing all of the relevant factors, the Board, acting in good faith and fairly
between members, makes decisions and takes actions that it considers will best lead to the long-term
success of the Company.
During the year, the Board assessed its current activities between the Board and its stakeholders, which
demonstrated that the Board actively engages with its stakeholders and takes their various objectives into
consideration when making decisions. Specifically, actions the Board has taken to engage with its
stakeholders in 2023 include:
•
Attended the 2023 AGM and prepared to answer any questions raised by shareholders;
•
Arranged meetings with certain stakeholders to provide them with updates on the Company’s
research and development activities and other general corporate updates;
•
Made presentations at conferences and published recordings and slide decks on the Company’s
research and development;
•
Evaluated the relationships with the Company’s various collaborators through management and
identified ways to strengthen relationships and arrangements with key collaborations; and
•
Monitored company culture and engaged with employees on efforts to continuously improve
company culture and morale.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
32
The Board believes that appropriate steps and considerations have been taken during the year so that each
Director has an understanding of the various key stakeholders of the Company. The Board recognises its
responsibility to contemplate all such stakeholder needs and concerns as part of its discussions, decision-
making, and in the course of taking actions, and will continue to make stakeholder engagement a top
priority in the coming years.
The Board’s primary shareholder contact is through Peter Redmond, the Non-Executive Director
responsible for shareholder relations. The Chairman, the CEO and other Directors, as appropriate, make
themselves available for contact with major shareholders and other stakeholders in order to understand
their issues and concerns.
The Company plans to use the AGM as an opportunity to communicate with its shareholders. Notice of
the AGM will be issued shortly and at least 21 days before the date of the meeting. To ensure compliance
with the Governance Code, the Board proposes separate resolutions for each issue, and proxy forms allow
shareholders who are unable to attend the AGM to vote for or against or to withhold their vote on each
resolution. The results of all proxy voting will be published on the Group’s web site after the AGM.
Shareholders who attend the AGM will have the opportunity to ask questions.
The Group’s web site at https://hemogenyx.com is the primary source of information on the Group. The
web site includes an overview of the activities of the Group and all recent Group announcements.
Viability statement
In accordance with the UK Corporate Governance Code published in July 2018, the Directors have
assessed the prospects of the Group and concluded that it is appropriate to adopt the going concern basis
of accounting based on the amount of cash on hand at the end of the year and at the time of publication
of this report. The assessment of going concern is disclosed in Note 2.
The Board’s assessment of the Group’s current position and principal risks are disclosed in the Directors’
Strategic Report on page 10 of this report.
Dr Vladislav Sandler
CEO
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
33
Directors’ Remuneration Report
The Company has an established remuneration committee. The Committee reviews the scale and structure
of the Directors’ fees, taking into account the interests of shareholders and the performance of the
Company and directors.
The items included in this report are unaudited unless otherwise stated.
Statement of Hemogenyx Pharmaceutical plc’s Policy on Directors’ Remuneration by the
Chairman of the Remuneration Committee
As Chairman of the Remuneration Committee I am pleased to introduce our Directors’ Remuneration
Report. One of the Remuneration Committee’s aims is to provide clear, transparent remuneration
reporting for our shareholders which adheres to the best practice corporate governance principles that are
required for listed organisations.
The Directors’ Remuneration Policy, which is set out on page 33 of this report, will be submitted to
shareholders for approval at our Annual General Meeting.
A key focus of the Directors’ Remuneration Policy is to align the interests of the Directors to the long-
term interests of the shareholders and aims to support a high-performance culture with appropriate reward
for superior performance, without creating incentives that will encourage excessive risk taking or
unsustainable company performance. This is underpinned through the implementation and operation of
incentive plans.
Key Activities of the Remuneration Committee
The key activities of the Remuneration Committee are:
▪
to determine and agree with the Board the framework or broad policy for the remuneration of the
Company’s chairman, chief executive, the executive directors, the company secretary and such
other members of the executive management as it is designated to consider;
▪
in determining such policy, take into account all factors which it deems necessary including
relevant legal and regulatory requirements, the provisions and recommendations of the UK
Corporate Governance Code (the “Code”) and associated guidance. The objective of such policy
shall be to ensure that members of the executive management of the Company are provided with
appropriate incentives to encourage enhanced performance and are, in a fair and responsible
manner, rewarded for their individual contributions to the success of the Company;
▪
recommend and monitor the level and structure of remuneration for senior management;
▪
when setting remuneration policy for directors, review and have regard to the remuneration
trends across the Company, and review the on-going appropriateness and relevance of the
remuneration policy;
▪
obtain reliable, up-to-date information about remuneration in other companies. To help it fulfil
its obligations the Committee shall have full authority to appoint remuneration consultants and
to commission or purchase any reports, surveys or information which it deems necessary, within
any budgetary restraints imposed by the Board;
▪
be exclusively responsible for establishing the selection criteria, selecting, appointing and setting
the terms of reference for any remuneration consultants who advise the Committee;
▪
approve the design of, and determine targets for, any performance related pay schemes operated
by the Company and approve the total annual payments made under such schemes;
▪
review the design of all share incentive plans for approval by the Board and shareholders. For
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
34
any such plans, determine each year whether awards will be made, and if so, the overall amount
of such awards, the individual awards to executive directors, company secretary and other
designated senior executives and the performance targets to be used;
▪
ensure that contractual terms on termination, and any payments made, are fair to the individual,
and the Company, that failure is not rewarded and that the duty to mitigate loss is fully
recognised; and
▪
oversee any major changes in employee benefits structures throughout the Company.
Members
The Remuneration Committee comprises the following independent Non-Executive Directors:
Name
Position
Date of appointment
Peter Redmond Chairman 5 October 2017
Alexis Sandler Member 5 October 2017
Remuneration Components
The Company remunerates directors in line with best market practice in the industry in which it operates.
The components of Director remuneration that are considered by the Board for the remuneration of
directors in future years are likely to consist of:
•
Base salaries
•
Pension and other benefits
•
Annual bonus
•
Share incentive arrangements
The Executive Director has entered into a service agreement with the Company and the Non-Executive
Directors have entered into letters of appointment with the Company.
All such contracts impose certain restrictions as regards the use of confidential information and intellectual
property and the Executive Director’s service contract imposes restrictive covenants which apply
following the termination of the agreement.
The Executive Director Dr Vladislav Sandler is entitled to pay at a rate of £1,500 per day for time spent in
the UK on the Company’s business. In addition, Dr Sandler has a separate contract with Hemogenyx
Pharmaceuticals LLC effective 1 September 2017 appointing him as CEO and Chief Scientific Officer of
that company for an initial three-year term with automatic continuation and setting out his duties in relation
to his day-to-day to work in connection with Hemogenyx Pharmaceuticals’ product candidates. Pursuant to
this contract, Dr Sandler was entitled to receive $275,000 in 2022 which rose to $324,000 in March 2023 and
four weeks’ holiday a year. Dr Sandler is also subject to certain non-compete and non-interference covenants
in the event of its termination (subject to certain limited exceptions). Dr Sandler also has a separate contract
with Immugenyx LLC effective from 1 January 2019 appointing him as CEO and Chief Scientific Officer of
that company for an initial three-year term with automatic continuation and setting out his duties in relation
to his day-to-day work in connection with Immugenyx’s development of its AHC. Pursuant to this contract,
Dr Sandler receives $64,889 (2022: $64,889) and 10,000 ownership units in Immugenyx LLC per annum.
This contract has the same noncompete and non-interference covenants in the event of its termination as his
contract with Hemogenyx Pharmaceuticals LLC.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
35
Other Matters
The Company does not currently have any annual or long-term incentive schemes or any other scheme
interests in place for any of the Directors.
The Company has established a workplace pension scheme but it does not presently have any employees
qualifying under the auto-enrolment pension rules who have not opted out of the scheme. It makes
matching contributions to a 401(k) pension plan for employees in the US of up to 4%. The Company has
not paid out any excess retirement benefits to any Directors or past Directors. The Company has not paid
any compensation to past Directors.
Recruitment Policy
Base salary levels will take into account market data for the relevant role, internal relativities, their
individual experience and their current base salary. Where an individual is recruited at below market
norms, they may be re-aligned over time (e.g. two to three years), subject to performance in the role.
Benefits will generally be in accordance with the approved policy.
For external and internal appointments, the Board may agree that the Company will meet certain
relocation and/or incidental expenses as appropriate.
Payment for Loss of Office
The Committee will honour Executive Directors’ contractual entitlements. Service contracts do not
contain liquidated damages clauses. If a contract is to be terminated, the Committee will determine such
mitigation as it considers fair and reasonable in each case. There is no agreement between the Company
and its Executive Directors or employees, providing for compensation for loss of office or employment
that occurs because of a takeover bid.
The Committee reserves the right to make additional payments where such payments are made in good
faith in discharge of an existing legal obligation (or by way of damages for breach of such an obligation);
or by way of settlement or compromise of any claim arising in connection with the termination of an
Executive Director’s office or employment.
Service Agreements and Letters of Appointment
The Executive Director’s service agreement had an initial term of two years and may subsequently be
terminated by the Company or the Executive Director by giving 6 months’ notice.
Name
Date of service
agreement
Notice period by
Company (months)
Notice period by
Director (months)
Dr Vladislav Sandler 4 October 2017 6 6
The Non-Executive Directors of the Company do not have service contracts but are appointed by letters
of appointment. Each Non-Executive Director’s term of office runs for an initial period of one year unless
terminated earlier upon written notice or upon their resignations.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
36
The terms of the Non-Executive Directors’ appointments are subject to their re-election by the
Company’s shareholders at any Annual General Meeting at which the Non-Executive Directors stand for
re-election.
The details of each Non-Executive Director’s current term are set out below:
Name
Date of service
a
g
reemen
t
Current
term
(
y
ears)
Notice
period by
Company
(months)
Notice
period by
Director
(months)
Date of
resi
g
nation
Alexis Sandle
r
4 October 2017 1 3 3 -
Peter Redmond 4 October 2017 1 3 3 -
Professor Sir Marc Feldman
n
9 April 2018 -* 3 3 -
* A new service agreement is pending. Sir Marc has indicated his willingness to continue in office on
agreed terms, and is putting himself forward for re-election by shareholders as a Director at the 2024
Annual General Meeting.
Executive Directors’ Remuneration (audited)
The table below sets out the remuneration received by each Executive Director for the years ended 31
December 2023 and 2022. Dr Vladislav Sandler was the highest paid Director:
Basic salary Pension Total
2023 2023 2023
Executive Directors £’000 £’000 £’000
Dr Vladislav Sandler 389 8 397
Total 389 8 397
Basic salary Pension Total
2022 2022 2022
Executive Directors £’000 £’000 £’000
Dr Vladislav Sandler 276 6 282
Total 276 6 282
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
37
Non-Executive Directors’ Remuneration (audited)
The table below sets out the remuneration received by each Non-Executive Director during the years
ended 31 December 2023 and 2022:
Basic salary
2023
£’000
Total
2023
£’000
Alexis Sandle
r
60 60
Peter Redmond 50 50
Professor Sir Marc Feldman
n
15 15
Total 125 125
Basic salary
2022
£’000
Total
2022
£’000
Alexis Sandle
r
57 57
Peter Redmond 50 50
Professor Sir Marc Feldman
n
15 15
Total 122 122
Relative importance of spend on pay
The table below illustrates the year-on-year change in total remuneration compared to distributions to
shareholders and loss before tax for the financial years ended 31 December 2023 and 2022:
Distributions to
shareholders
£
Total employee pay
(including stock
based
compensation)
Operational cash
outflow
£
£
Year ended 31 December 2023 - 2,151,045 6,104,791
Year ended 31 December 2022 - 1,424,301 2,910,604
Percentage change N/A 51.0% 109.7%
Total employee pay includes wages and salaries, social security costs, healthcare cost, 401K scheme cost
and share-based payments for employees in continuing operations. Further details on Employee
remuneration are provided in Note 6.
Operational cash outflow has been shown in the table above as cash flow monitoring and forecasting is
an important consideration for the Remuneration Committee and Board of Directors when determining
cash-based remuneration for directors and employees.
Historical share price performance comparison
The chart below compares the share price performance (based on a notional investment of £100) of
Hemogenyx Pharmaceuticals plc against the FTSE SmallCap and FTSE Techmark Mediscience for the
period November 2015 to December 2023 calculated on a month end spot basis. The FTSE SmallCap has
been chosen to provide a wider market comparator constituting companies of an appropriate size and the
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
38
FTSE Techmark Mediscience chosen due to sector relevance:
Hemogenyx Pharmaceuticals plc was listed in November 2015 (under the name Silver Falcon plc) and
therefore no historical share price data exists prior to this period. There was also no data between
December 2015 and October 2017 pending completion of a transaction. It is for these reasons that the
historical investment performance is not reflective of the current Group.
Consideration of shareholder views
The Board considers shareholder feedback received and guidance from shareholder bodies. This
feedback, plus any additional feedback received from time to time, is considered as part of the Company’s
annual policy on remuneration.
Approved on behalf of the Board of Directors.
Peter Redmond
Director & Remuneration Committee Chairman
24 April 2024
FTSE Techmark Mediscience FTSE small cap HEMO
500
450
400
350
300
250
200
150
100
50
0
Investment Performance Comparison
Nov-15
Feb-16
May-16
Aug-16
Nov-16
Feb-17
May-17
Aug-17
Nov-17
Feb-18
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Aug-18
Nov-18
Feb-19
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Aug-23
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
39
Independent Auditor’s Report to the Members of Hemogenyx Pharmaceuticals PLC
Opinion
We have audited the financial statements of Hemogenyx Pharmaceuticals plc (the ‘parent company’) and
its subsidiaries (the ‘group’) for the year ended 31 December 2023 which comprise the Consolidated
Statement of Comprehensive Income, the Consolidated and Company Statements of Financial Position,
the Consolidated and Company Statements of Changes in Equity, the Consolidated and 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 to 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
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 the parent company’s ability to continue to adopt the going concern basis
of accounting included the procedures as noted in the Key Audit Matters section of our report.
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.
In relation to the entities reporting on how they have applied the UK Corporate Governance Code, we
have nothing material to add or draw attention to in relation to the directors’ statement in the financial
statements about whether the director’s considered it appropriate to adopt the going concern basis of
accounting.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
40
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
For the purposes of determining whether the financial statements are free from material misstatement, we
define materiality as the magnitude or nature of misstatement that makes it probable that the economic
decisions of a reasonably knowledgeable person, relying on the financial statements, would be changed,
or influenced. We also determine a level of performance materiality which we use to assess the extent of
testing needed to reduce to an appropriately low level the probability that the aggregate of uncorrected
and undetected misstatements exceeds materiality for the financial statements as a whole.
Materiality for the group financial statements as a whole was set at £132,000 (2022: £115,000). This was
calculated based on 2% of total expenses for the year, which is unchanged from the prior year. Using our
professional judgement, we have determined this to be the principal benchmark within the financial
statements as it will be most relevant to stakeholders in assessing the financial performance of the group
during its years of development as the group is not currently revenue generating.
Materiality for the parent company financial statements as a whole was set at £29,000 (2022: £10,000)
based on 2% of total expenses, which is unchanged from the prior year. We have determined this level
of materiality for the parent company to gain sufficient coverage of expenses.
Performance materiality for the group financial statements was set at £92,400 (2022: £80,500) and the
parent company was set at £20,300 (2022: £7,000), being 70% of materiality for the financial statements
as a whole respectively. A benchmark of 70% for performance materiality was applied to provide
sufficient coverage of significant and residual risks.
We agreed to report to those charged with governance all corrected and uncorrected misstatements we
identified through our audit with a value in excess of £6,600 (2022: £5,750) for the group financial
statements and £1,450 (2022: £500) for the parent company financial statements. We also agreed to report
any other audit misstatements below that threshold that we believe warranted reporting on qualitative
grounds.
Our approach to the audit
The scope of our audit was influenced by our application of materiality. The quantitative and qualitative
thresholds for materiality determine the scope of our audit and the nature, timing, and extent of our audit
procedures.
The group includes the listed parent company and its US-based subsidiaries. We assessed the structure
of the group, its accounting processes and controls, and the industry in which it operates in order to
determine the scope of our audit work and ensure that we obtained sufficient and appropriate audit
evidence on which to base our group audit opinion. Those entities of the group which were considered to
be a significant component, being Hemogenyx Pharmaceuticals LLC, was subject to full scope audit
procedures by us. We did not rely on the work of any component auditors. Procedures were performed
to address the assessed risks of material misstatement at component level.
As part of our planning, we assessed the risk of material misstatement including those that required
significant auditor consideration at the component and group level. Procedures were than performed to
address the risk 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.
Key audit matters
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
41
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
Carrying value of investments in, and
loans to, subsidiary undertakings (Parent
company – Note 2, Note 13 and Note 14 )
Investments held by the parent company
in subsidiaries, as at 31 December 2023,
totalled £8.0m in the Company Statement
of Financial Position. Loans to those
subsidiaries, as at 31 December 2023, are
reported as £18.1m.
These are significant balances due to the
parent company. If the subsidiary
undertakings are unable to generate
sufficient future profits in the foreseeable
future, there is a risk that both the
investment and loans held in those entities
are overstated.
Given the aforementioned, the carrying
value of investments in and loans to
subsidiary undertakings was deemed to
be a key audit matter.
As part of our audit, we have performed the
following procedures:
•
Reviewed and challenged the
directors’ assessment of the carrying
value of investments and loans to
subsidiary undertakings, and their
conclusions thereon;
•
Reviewed and assessed the
subsidiary’s financial performance
and development progress to
corroborate the directors’ evaluation
of recoverability;
•
Reviewed and assessed the current
state of development, and scientific
and commercial progress of the
products under development;
•
Reviewed board minutes for any
indications of changes in investments
held by the parent company;
•
Agreed ownership documents of all
the subsidiaries in the group; and
•
Reviewed the market capitalisation of
the group to provide further assurance
of the carrying value of the
investments and loans to subsidiary
undertakings subsequent to the year
end.
Through the performance of the above
testing, we conclude that management’s
assessment of the carrying value of
investments in, and loans to, subsidiary
undertakings is reasonable.
Going concern (Group and parent
company – Note 2)
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
42
When preparing financial statements,
those charged with governance should
satisfy themselves as to whether the going
concern basis is appropriate.
ISA (UK) 570 “Going concern”
specifically requires the auditor to
conclude on; whether a material
uncertainty related to going concern
exists; the appropriateness of the
Directors use of the going concern
assumption in the preparation of the
financial statements; and the
appropriateness of any relevant
disclosures in the financial statements.
As the group and parent company are
required to raise additional funds in
discrete tranches on a regular basis, the
timing of which is uncertain, going
concern was deemed to be a key audit
matter.
Other information
As part of our audit, we have performed the
following procedures:
•
Reviewed management’s assessment
of going concern to 31 December
2025 and assessed the reasonableness
of key assumptions and inputs used by
management;
•
Evaluated and corroborated the key
assumptions and inputs underlying
the budgets and cash flow forecasts,
including sensitivity analysis against
the base case scenario;
•
Discussed with management how
they intend to fund the clinical trials
and other clinical programs, including
an assessment of the funding options
currently under negotiation;
•
Compared management’s forecasts to
actual results through the subsequent
events period and performed inquiries
to the date of this report;
•
Assessed the probability of obtaining
additional sources of funds when
required, together with the ability to
defer research and development
expenditure; and
•
Assessed the disclosures made
regarding going concern in the
financial statements for consistency
with management’s assessment.
The group intends to progress its key
development project to clinical trials together
with the performance of other clinical
programs. Significant additional funds will be
required in order to progress as planned, which
are not yet agreed and unconditional. As
disclosed in Note 2, the group has a high
proportion of discretionary expenditure which
it is able to defer, if sufficient funding is not
available.
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 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
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
43
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 company and its 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, 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.
Corporate governance statement
We have reviewed the directors' statement in relation to going concern, longer-term viability and that part
of the Corporate Governance Statement relating to the group’s and parent company's compliance with
the provisions of the UK Corporate Governance Code specified for our review by the Listing Rules.
Based on the work undertaken as part of our audit, we have concluded that each of the following elements
of the Corporate Governance Statement is materially consistent with the financial statements or our
knowledge obtained during the audit:
•
Directors' statement with regards the appropriateness of adopting the going concern basis of
accounting and any material uncertainties identified set out on page 23;
•
Directors’ explanation as to their assessment of the group’s prospects, the period this assessment
covers and why the period is appropriate set out on page 32;
•
Directors’ statement on whether they have a reasonable expectation that the group will be able to
continue in operation and meet its liabilities set out on page 55;
•
Directors' statement that they consider the annual report and the financial statements, taken as a
whole, to be fair, balanced and understandable set out on page 24;
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
44
•
Board’s confirmation that it has carried out a robust assessment of the emerging and principal
risks set out on page 18;
•
The section of the annual report that describes the review of effectiveness of risk management
and internal control systems set out on page 31; and
•
The section describing the work of the audit committee set out on page 26.
Responsibilities of directors
As explained more fully in the directors’ responsibilities statement, 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 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 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 discussions
with management, application of our cumulative audit knowledge and experience of the sector.
•
We determined the principal laws and regulations relevant to the group and parent company in
this regard to be those arising from the Companies Act 2006, FCA Listing Rules, the Disclosure
Guidance and Transparency Rules Sourcebook, the UK Corporate Governance Code and US Food
and Drug Administration.
•
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 Making inquiries of management;
o Reviewing legal and professional fees;
o Reviewing board and audit committee minutes; and
o Reviewing regulated news service publications.
•
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
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
45
carrying value of investments in, and loans to, subsidiary undertakings - parent company. See
key audit matters section above.
•
As in all 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: the testing of journals;
reviewing accounting estimates for evidence of bias; and evaluating the business rationale of any
significant transactions that are unusual or outside the normal course of business.
•
Compliance with laws and regulations at the subsidiary level was ensured through inquiry of
management and review of correspondence for any instances of non-compliance.
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/auditorsresponsibilitieshttp://www.frc.org.uk/auditorsresponsibilitieshttp://www.frc.or
g.uk/auditors/audit-assurance/auditor-s-responsibilities-for-the-audit-of-the-fi/description-of-the-
auditor’s-responsibilities-forhttps://www.frc.org.uk/auditors/audit-assurance/standards-and-
guidance/2010-ethical-standards-for-auditors-(1). 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 30 June 2023 to audit the financial statements for the
period ending 31 December 2023 and subsequent financial periods. Our total uninterrupted period of
engagement is 9 years, covering the periods ending 31 December 2015 to 31 December 2023.
The non-audit services prohibited by the FRC’s Ethical Standard were not provided to the company and
we remain independent of the 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
Date:
24 April 2024
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
46
Consolidated Statement of Comprehensive Income
Group - Continuing Operations Note
Year Ended 31
December 2023
Year Ended 31
December 2022
£ £
Revenue
Administrative Expenses
5
(5,820,165 ) (3,433,476 )
Depreciation Expense 10,11
(645,681 ) (564,072 )
Operating Loss
(6,465,846 ) (3,997,548 )
Finance Income
(33 )
Finance Costs
(315,991 )
Loss before Taxation
(6,696,493 ) (3,986,982 )
Income tax
8
Loss for the year
(6,696,493 ) (3,986,982 )
Loss attributable to:
- Owners of Hemogenyx Pharmaceuticals plc
(6,690,678 ) (3,979,314 )
- Non-controlling interests
(5,815 )
(7,668 )
(6,696,493 ) (3,986,982 )
Items that may be reclassified subsequently to profit or loss:
Translation of foreign operations
Other comprehensive income for the year
Total comprehensive loss for the year
(5,793,426 ) (4,941,624 )
Attributable to:
Owners of Hemogenyx Pharmaceuticals plc
(5,787,611 ) (4,933,956 )
Non-controlling interests
(5,815 ) (7,668 )
Total comprehensive loss for the year
(5,793,426 ) (4,941,624 )
Basic and diluted earnings loss per share attributable to the
equity owners of the Company
9
(0.006 )
(0.005 )
The Notes to the Financial Statements form an integral part of these Financial Statements.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
47
Consolidated Statement of Financial Position
Group
Note 31 December 2023 31 December 2022
Assets £ £
Non-current assets
Property, plant and equipment 10
Right of use asset 11
Security deposit 23
Intangible asset 12
Total non-current assets
Current assets
Trade and other receivables
15
Cash and cash equivalents
Total current assets
Total assets
Equity and Liabilities
Equity attributable to shareholders
Paid-in Capital
Called up share capital
16
Share premium 17
Other reserves 18
Reverse asset acquisition reserve
(6,157,894 ) (6,157,894 )
Foreign currency translation reserve
(77,496 ) (980,563 )
Retained Earnings
(23,804,734 ) (17,114,056 )
Equity attributable to owners of the Company
Non-controlling interests
(37,723 ) (31,908 )
Total equity
Liabilities
Non-current liabilities
Lease liabilities
11
Total non-current liabilities
Current liabilities
Trade and other payables
20
Lease liabilities 11
Total current liabilities
Total liabilities
Total equity and liabilities 6,105,893 7,092,609
This report was approved by the Board and authorised for issue on 24 April 2024 and signed on its
behalf by:
Dr Vladislav Sandler
CEO
The Notes to the Financial Statements form an integral part of these Financial Statements.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
48
Company Statement of Financial Position
Company
Note
31 December
2023
31 December
2022
£ £
Assets
Non-current assets
Loan to subsidiaries 13
18,097,857 14,451,733
Investment in subsidiary 14
8,000,000 8,000,000
Total non-current assets
26,097,857 22,451,733
Current assets
Trade and other receivables
15
14,820
20,405
Cash and cash equivalents
219,236 88,909
Total current assets
234,056 109,314
Total assets
26,331,913 22,561,047
Equity and Liabilities
Equity attributable to shareholders
Foreign currency translation reserve
Paid-in Capital
Called up share capital
16
11,755,660
9,797,493
Share premium
17 19,938,556 16,808,647
Other reserves 18
1,163,533 920,697
Retained Earnings
(6,721,085) (5,100,447)
Total Equity
26,136,664 22,246,390
Liabilities
Current liabilities
Trade and other payables
20
195,249
134,657
Total current liabilities
195,249 134,657
Total liabilities
195,249 134,657
Total equity and liabilities
26,331,913 22,561,047
Hemogenyx Pharmaceuticals plc has used the exemption granted under s408 of the Companies Act 2006
that allows for the non-disclosure of the Income Statement of the parent company. The after-tax loss
attributable to Hemogenyx Pharmaceuticals plc for the year ended 31 December 2023 was £1,620,638
(2022: profit of £1,202,014).
This report was approved by the Board and authorised for issue on 24 April 2024 and signed on its
behalf by:
Dr Vladislav Sandler
CEO
The Notes to the Financial Statements form an integral part of these Financial Statements.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
49
Consolidated Statement of Changes in Equity
Group
Called up
Other
Reverse
Foreign
currency
Non-
Share Share reserves acquisition translation Retaine
d
Controlling
Capital Premiu
m
reserve reserve earnings interests Total Equity
£ £
£ £ £
£
£
£
As at 1 January
2022
(6,157,894 )
(25,921 )
(13,134,742 )
(24,240 )
Loss in year
Other
Comprehensive
Income
-
(954,642 )
(3,979,314 )
(7,668 )
(3,986,982 )
(954,642 )
Total
comprehensive
income for the year
(954,642 )
(3,979,314 )
(7,668 )
(4,941,624 )
Extension of
options
As at 31 December
2022
(6,157,894 )
(980,563 )
(17,114,056 )
(31,908 )
Loss in year
Other
Comprehensive
Income
(6,690,678 )
(5,815 )
(6,696,493 )
Total
comprehensive
income for the
year
(6,690,678 )
(5,815 )
(5,793,426 )
Issue of shares 1,958,167 3,296,458 - - - - - 5,254,625
Cost of capital - (166,549 ) - - - - - (166,549 )
Issue of options - - 242,836 - - - - 242,836
As at 31 December
2023
(6,157,894 )
(77,496 )
(23,804,734 )
(37,723 )
The notes to the financial statements form an integral part of these financial statements.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
50
Company Statement of Changes in Equity
Company
Called up
Share
Capital
Share
Premium
Foreign
currency
translation
reserve
Other
reserves
Retained
earnings
Total
Equity
£ £
£ £
£ £
As at 31 December 2021
9,797,493
16,808,647
-
903,122
(6,302,461)
21,206,801
Income in year
-
-
-
-
1,202,014
1,202,014
Other Comprehensive
Income
-
-
-
-
-
-
Total comprehensive income
for the year
-
-
-
-
1,202,014
1,202,014
Issue of options - -
- 17,575
- 17,575
As at 31 December 2022
9,797,493
16,808,647
-
920,697
(5,100,447)
22,426,390
Loss in year
-
-
-
-
(1,620,638)
(1,620,638)
Other Comprehensive
Income
-
-
-
-
-
-
Total comprehensive
income for the year
-
-
-
-
(1,620,638)
(1,620,638)
Issue of shares 1,958,167 3,296,458 - - - 5,254,625
Cost of capital - (166,549) - - - (166,549)
Issue of options - - - 242,836 - 242,836
As at 31 December 2023
11,755,660
19,938,556
-
1,163,533
(6,721,085)
26,136,664
The notes to the financial statements form an integral part of these financial statements.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
51
Consolidated Statement of Cash Flows
Group Note
Year Ended
31 December
2023
Year Ended
31 December
2022
£ £
Cash flows generated from operating activities
Loss before income tax
(6,696,493 ) (3,986,982 )
Depreciation 10 645,681 195,246
Other non-cash items
Interest income
(85,344 ) (10,599 )
Interest expense
Share based payments 18 242,836 17,575
Changes in right of use asset and lease liability, net
Foreign exchange gain (loss)
(1,485 ) 12,937
(Decrease)/Increase in trade and other payables
Decrease/(Increase) in trade and other receivables
Decrease/(Increase) in prepaid and deposits
(866,644 ) 271,819
Net cash outflow used in operating activities
(6,105,570 ) (2,910,604 )
Cash flows generated from financing activities
Proceeds from issuance equity securities, net of issue costs
Payment of lease liabilities
(638,765 ) (110,144 )
Net cash flow generated from/(used in) financing activities
Cash flows generated from investing activities
Interest income
Payment of security deposit for lease
Purchase of property & equipment
(117,285 ) (428,945 )
Net cash flow used in investing activities
(31,941 ) (420,254 )
Net decrease in cash and cash equivalents
(1,688,200 ) (3,432,002 )
Effect of exchange rates on cash
Cash and cash equivalents at the beginning of the year
Cash and cash equivalents at the end of the year
The notes to the financial statements form an integral part of these financial statements.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
52
Company Statement of Cash Flows
Company Note
Year Ended
31 December
2023
Year Ended
31 December
2022
£ £
Cash flows generated from operating activities
(Loss)/gain before income tax
(1,620,638) 1,202,014
Foreign exchange gain 910,832 (1,539,778)
Share based payments 19 242,836 17,575
Increase/(decrease) in trade and other receivables 5,585 (4,927)
Increase in trade and other payables 60,592 228
Net cash outflow used in operating activities (400,793) (324,888
)
Cash flows generated from financing activities
Proceeds from issuance of equity securities, net of issue costs 5,088,076
-
Net cash flow generated from financing activities 5,088,076
-
Cash flows generated from/(used in) investing activities
Loan (to)/from related parties (4,556,312) 301,421
Net cash flow (used in)/generated from investing activities (4,556,312) 301,421
Net Increase/(decrease) in cash and cash equivalents 130,971 (23,467)
Effect of exchange rates on cash (644) 1,131
Cash and cash equivalents at the beginning of the year 88,909 111,24
5
Cash and cash equivalents at the end of the year 219,236 88,90
9
The Notes to the Financial Statements form an integral part of these Financial Statements.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
53
Notes to the Financial Statements
1.
General information
The Group’s business is clinical-stage biotechnology focused on the discovery, development and
commercialisation of innovative treatments relating to the treatment of blood cancers, certain solid
cancers, autoimmune diseases, and viral infections. The products under development are designed to
address a range of problems that occur with current standard of care treatments.
The Company’s registered office is located at 6
th
floor, 60 Gracechurch Street, London, EC3V 0HR,
and the Company’s shares are listed on the main market of the London Stock Exchange.
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 years presented, unless otherwise
stated.
Basis of preparation
The financial statements have been prepared in accordance with UK-adopted international
accounting standards and with requirements of the Companies Act 2006. The financial statements
have been prepared under the historical cost convention.
Basis of consolidation
The consolidated financial statements comprise the financial statements of Hemogenyx
Pharmaceuticals plc and its subsidiaries as at 31 December 2023. The financial statements of the
subsidiaries are prepared for the same reporting period as the parent company, using consistent
accounting policies.
All intra-group balances, transactions, income and expenses and profits and losses resulting from
intra-group transactions that are recognised in assets, are eliminated in full.
Subsidiaries are fully consolidated from the date of acquisition, being the date on which the Group
obtains control, and continue to be consolidated until the date that such control ceases. Hemogenyx
Pharmaceuticals plc owns the majority of the shareholdings and has operational control over all its
subsidiaries. Please refer to Note 14 for information on the consolidation of Hemogenyx
Pharmaceuticals LLC.
Hemogenyx Pharmaceuticals plc has used the exemption granted under s408 of the Companies Act
2006 that allows for the non-disclosure of the Income Statement of the parent company. The after-
tax loss attributable to Hemogenyx Pharmaceuticals plc for the year ended 31 December 2023 was
£1,620,638 (2022: profit of £1,202,024).
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
54
Research and development expenditure
(i)
Research and development
Expenditure on research activities, undertaken with the prospect of gaining new scientific or
technical knowledge and understanding, is expensed in profit or loss as incurred. Development
activities involve a plan or design for the production of new or substantially improved products and
processes. Development expenditures are capitalised only if development costs can be measured
reliably, the product or process is technically and commercially feasible, future economic benefits
are probable, and the Company intends to, and has sufficient resources to, complete development
and to use or sell the asset. No development costs have been capitalised to date.
(ii)
Clinical trial expenses
Clinical trial-related expenses are a component of the Company's research and development costs.
These expenses include fees paid to contract research organisations, clinical sites, and other
organisations who conduct development activities on the Company's behalf. The amount of clinical
trial expenses recognised in the period related to clinical agreements is based on estimates of the
work performed using an accrual basis of accounting. These estimates incorporate factors such as
patient enrolment, services provided, contractual terms, and prior experience with similar contracts.
Intangibles
Research and development
Research expenditure is written off as incurred. Development costs are capitalised only if the
expenditure can be measured reliably, the product or process is technically and commercially
feasible, future economic benefits are probable, the Group intends to and has sufficient resources to
complete development and to use or sell the asset, and it is able to measure reliably the expenditure
attributable to the intangible asset during its development.
The Group’s view is that capitalised assets have a finite useful life and to that extent they should be
amortised over their respective unexpired periods with provision made for impairment when
required. Assets capitalised are not amortised until the associated product is available for use or sale.
Amortisation is calculated using the straight-line method to allocate the costs of development over
the estimated useful economic lives. Estimated useful economic life is assessed by reference to the
remaining patent life and may be adjusted after taking into consideration product and market
characteristics such as fundamental building blocks and product life cycle specific to the category of
expenditure.
Intellectual property (IP)
IP assets (comprising patents, know-how, copyright and licences) acquired by the Group as a result
of a business combination are initially recognised at fair value or as a purchase at cost and are
capitalised.
Internally generated IP costs are written off as incurred except where IAS 38 criteria, as described in
research and development above, would require such costs to be capitalised.
The Group’s view is that capitalised IP assets have a finite useful life and to that extent they should
be amortised over their respective unexpired periods with provision made for impairment when
required. Capitalised IP assets are not amortised until the Group is generating an economic return
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
55
from the underlying asset and as such no amortisation has been incurred to date as the products to
which they relate are not ready to be sold on the open market. When the trials are completed and the
products attain the necessary accreditation and clearance from the regulators, the Group will assess
the estimated useful economic like and the IP will be amortised using the straight-line method over
their estimated useful economic lives.
Fixed assets
All property and equipment are stated at historical cost less accumulated depreciation or impairment
value. Cost includes the original purchase price and expenditure that is directly attributable to the
acquisition of the items to bring the asset to its working condition. Depreciation is provided at rates
calculated to write off the cost less estimated residual value of each asset over its expected useful
economic life. Right of Use assets are depreciated over their expected useful economic life on the
same basis as owned assets, or where shorter, the lease term. Assets are reviewed for impairment
when events or changes in circumstances indicate that the carrying amount may not be recoverable.
The following rates are used:
| Computer equipment | 33% | Straight-line |
| Leasehold improvements | 12.5% | Straight-line |
| Property & equipment | ||
| 20% - 50% | Straight-line |
Impairment of non-financial assets
The Group is required to review, at least annually, whether there are indications (events or changes
in circumstances) that non-financial assets have suffered impairment and that the carrying amount
may exceed the recoverable amount. If there are indications of impairment, then an impairment
review is undertaken. An impairment charge is recognised within operating costs for the amount by
which the carrying amount exceeds its recoverable amount. The recoverable amount is the higher of
the asset’s fair value less costs to sell and the value-in-use. In the event that an intangible asset will
no longer be used, for example, when a patent is abandoned, the balance of unamortised expenditure
is written off.
Impairment reviews require the estimation of the recoverable amount based on value-in-use
calculations. Non-financial assets relate typically to investments in related parties and in-process
development and patents and require broader assumptions than for developed technology. Key
assumptions taken into consideration relate to technological, market and financial risks and include
the chance of product launch taking into account the stage of development of the asset, the scale of
milestone and royalty payments, overall market opportunities, market size and competitor activity,
revenue projections, estimated useful lives of assets (such as patents), contractual relationships and
discount rates to determine present values of cash flows.
Investments
Equity investments in subsidiaries are held at cost, less any provision for impairment.
Going concern
The preparation of financial statements requires an assessment on the validity of the going concern
assumption.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
56
The Company successfully raised £5.25 million (before expenses) through the allotment and issue
of new ordinary shares during the year ended 31 December 2023, and a further £3.25 million in early
2024. These proceeds were raised in order to facilitate the progression of the Company's HEMO-
CAR-T product candidate into clinical trials and to enable the Company to continue development of
product candidates for the treatment of viral infections and cancers based on its CBR platform.
Funding will be required by the Company to complete Phase I clinical development.
The Company cannot be certain that such additional funding will be available on acceptable terms,
or at all. To the extent that the Company raises additional funds by issuing equity securities, the
Company’s stockholders may experience dilution. Any debt financing, if available, may involve
restrictive covenants. If the Company is unable to raise additional capital when required or on
acceptable terms, it may have to (i) significantly delay, scale back or discontinue the development
and/or commercialisation of one or more product candidates; (ii) seek collaborators for product
candidates at an earlier stage than otherwise would be desirable and on terms that are less favourable
than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to technologies,
product candidates or products that it would otherwise seek to develop or commercialise on
unfavourable terms.
However, the Directors are of the opinion that the Company has adequate working capital to execute
its operations for the present time and is confident in its ability to access additional financing over
the next 12 months. The Directors, therefore, have made an informed judgement, at the time of
approving these financial statements, that there is a reasonable expectation that the Company has
adequate resources to continue in operational existence for the foreseeable future. As a result, the
Directors have continued to adopt the going concern basis of accounting in preparing the annual
financial statements.
Trade and other receivables and payables
Trade and other receivables are amounts due from customers for services performed in the ordinary
course of business. If collection is expected in one year or less (or in the normal operating cycle of
the business if longer), they are classified as current assets. If not, they are presented as non-current
assets.
Trade and other receivables are recognised initially at fair value, and subsequently measured at
amortised cost using the effective interest method, less provision for impairment.
Other liabilities measured at amortised cost are obligations to pay for goods or services that have
been acquired in the ordinary course of business from suppliers. The liabilities are classified as
current liabilities if payment is due within one year or less (or in the normal operating cycle of the
business if longer). If not, they are presented as non-current liabilities.
The liabilities are recognised initially at fair value, and subsequently measured at amortised cost using
the effective interest method.
Foreign currencies
Functional and presentation currency
The Company’s presentation currency is the British Pound Sterling (“£”). The functional currency
for the Company, being the currency of the primary economic environment in which the Company
operates, is the British Pound Sterling. The individual financial statements of each of the Company’s
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
57
wholly owned subsidiaries are prepared in the currency of the primary economic environment in
which it operates (its functional currency).
The financial statements of Hemogenyx Pharmaceuticals LLC, Immugenyx LLC and Hemogenyx-
Cell SPRL have been translated into Pound Sterling in accordance with IAS 21 The Effects of
Changes in Foreign Exchange Rates. This standard requires that assets and liabilities be translated
using the exchange rate at period end, and income, expenses and cash flow items are translated using
the rate that approximates the exchange rates at the dates of the transactions (i.e. the average rate for
the period). The foreign exchange differences on translation of Hemogenyx Pharmaceuticals LLC,
Immugenyx LLC and Hemogenyx-Cell SPRL are recognised in other comprehensive income (loss).
Foreign currency transactions
Foreign currency transactions are translated into the functional currency using the exchange rates
prevailing on the dates of the transactions. Foreign exchange gains and losses resulting from the
settlement of such transactions and from the translation at period-end exchange rates of monetary
assets and liabilities denominated in foreign currencies are recognised in profit and loss.
Share capital
Ordinary Shares are classified as equity. Equity instruments issued by the Hemogenyx
Pharmaceuticals Group are recorded at the proceeds received, net of direct issue costs.
Cash
Cash consists of cash bank deposit balances.
Share-based payments
The Group has applied the requirements of IFRS 2 Share-based Payment for all grants of equity
instruments.
The Group issues equity-settled share-based payments to the directors, senior management and
employees (“Employee Share Options”), to corporate finance advisers for assistance in raising
private equity, and to its Scientific Advisory Board members (“Non-employee Share Options”). In
2021, the Group adopted the “Hemogenyx Pharmaceuticals plc 2021 Equity Incentive Plan with
Non-Employee Sub-Plan” (the “EIP”) for the grant of options, restricted shares, and restricted share
units to employees, directors and consultants of the Company and its subsidiaries over ordinary
shares in the capital of the Company, which was approved by the Company’s shareholders at the
2022 AGM. Equity-settled share-based payments are measured at fair value at the date of grant for
Employee Share Options and the date of service for Non-employee Share Options. The fair value
determined at the grant date or service date, as applicable, of the equity-settled share-based payments
is expensed, with a corresponding credit to equity, on a straight-line basis over the vesting period,
based on the Group’s estimate of shares that will eventually vest. At each subsequent reporting date,
the Group calculates the estimated cumulative charge for each award having regard to any change in
the number of options that are expected to vest and the expired portion of the vesting period. The
change in this cumulative charge since the last reporting date is expensed with a corresponding credit
being made to equity. Once an option vests, no further adjustment is made to the aggregate amount
expensed.
The fair value is calculated using the Black Scholes method for both Employee and Non-employee
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
58
Share Options as management views the Black Scholes method as providing the most reliable
measure of valuation. The expected life used in the model has been adjusted, based on management’s
best estimate, for the effects of non-transferability exercise restrictions and behavioural
considerations. The market price used in the model is the issue price of Company shares at the last
placement of shares immediately preceding the calculation date. The fair values calculated are
inherently subjective and uncertain due to the assumptions made and the limitation of the calculations
used.
Taxation
Current tax
Current taxation is based on the results for the year as adjusted for items that are non-assessable or
disallowed. It is calculated using rates that have been enacted, or substantially enacted, by the balance
sheet date. Current income tax assets and liabilities are measured at the amount expected to be
recovered from or paid to the relevant taxation authorities.
Deferred tax
Deferred income tax is recognised on all temporary differences arising between the tax bases of assets
and liabilities and their carrying amounts in the financial statements, with the following exceptions:
▪
where the temporary difference arises from the initial recognition of goodwill or of an
asset or liability in a transaction that is not a business combination and, at the time of the
transaction, affects neither accounting nor taxable profit or loss;
▪
in respect of taxable temporary differences associated with investment in subsidiaries,
associates and joint ventures, where the timing of the reversal of the temporary
differences can be controlled and it is probable that the temporary differences will not
reverse in the foreseeable future; and
▪
deferred income tax assets are recognised only to the extent that it is probable that taxable
profit will be available against which the deductible temporary differences, carried
forward tax credits or tax losses can be utilised.
Deferred income tax assets and liabilities are measured on an undiscounted basis at the tax rates that
are expected to apply when the related asset is realised or liability is settled, based on tax rates and
laws enacted or substantively enacted at the statement of financial position date.
The carrying amount of deferred income tax assets is reviewed at each statement of financial position
date. Deferred income tax assets and liabilities are offset, only if a legally enforcement right exists
to set off current tax assets against current tax liabilities, the deferred income taxes related to the
same taxation authority and that authority permits the Company to make a single net payment.
Income tax is charged or credited directly to equity if it relates to items that are credited or charged to
equity. Otherwise, income tax is recognised in the statement of comprehensive income.
Financial Assets and Liabilities
Financial assets and liabilities are recognised in the Company’s statement of financial position when
the Company becomes a party to the contractual provisions of the instrument. The Company
currently does not use derivative financial instruments to manage or hedge financial exposures or
liabilities.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
59
Loans and receivables are non-derivative financial assets with fixed or determinable payments that
are not quoted in an active market. They are included in current assets, except for maturities greater
than 12 months after the end of the reporting period. These are classified as non-current assets. The
Company’s loans and receivables comprise Trade and Other Receivables and Cash and Cash
Equivalents in the Statement of Financial Position.
Impairment of Financial Assets
The Company and Group assess at each reporting date whether a financial asset is impaired and will
recognise the impairment loss immediately through the consolidated statement of comprehensive
loss.
Interest Bearing Loans and Borrowings
Borrowings are initially recognised at the fair value of consideration received less directly
attributable transaction costs. After initial recognition, borrowings are subsequently measured at
amortised cost using the effective interest rate method. Where borrowings are provided by
shareholders at an interest rate discounted to market rates, the difference on initial fair value is taken
to equity as a capital contribution.
Where the Group has entered into a hybrid instrument whereby there is a debt instrument and an
embedded derivative financial liability, the fair value of the debt instrument less the fair value of the
derivative financial liability is equal to loan recognised on initial measurement.
IFRS 16, Leases
IFRS 16 requires lessees to recognise a lease liability reflecting future lease payments and a ‘right-
of-use asset’ for virtually all lease contracts. IFRS 16 includes an optional exemption for certain
short-term leases and leases of low-value assets; however, this exemption can only be applied by
lessees. For lessors, the accounting remains substantially unchanged. IFRS 16 provides updated
guidance on the definition of a lease (as well as the guidance on the combination and separation of
contracts); under IFRS 16, a contract is, or contains, a lease if the contract conveys the right to control
the use of an identified asset for a period of time in exchange for consideration.
The right-of-use asset and lease liability are both based on the present value of lease payments due
over the term of the lease, with the asset being depreciated in accordance with IAS 16 Property,
Plant and Equipment and the liability increased for the accretion of interest and reduced by lease
payments.
Segmental reporting
The Group’s operations are located in New York, USA with the head office located in the United
Kingdom. The main assets of the Group, cash and cash equivalents, are held primarily in the United
Kingdom and the United States, while the fixed assets and right of use assets are held in the United
States. The Board ensures that adequate amounts are transferred internally to allow all companies to
carry out their operations on a timely basis.
The Group currently has one reportable segment – a biotechnology company focused on the
discovery, development and commercialisation of innovative treatments relating to blood and
immune system disorders and viral infections.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
60
New Accounting Standards and Interpretations issued and applied in the Financial Statements
(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 2023 | ||
| IAS 8 (Amendments) | Accounting estimates | 1 January 2023 |
| IAS 17 (Amendments) | Insurance | 1 January 2023 |
| IAS 12 (Amendments) | Deferred Tax | 1 January 2023 |
*
Subject to endorsement
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.
3.
Significant accounting judgements, estimates and assumptions
The preparation of the financial statements in conformity with International Financial Reporting
Standards requires the use of certain critical accounting estimates. It also requires management to
exercise its judgement in the process of applying the Company’s accounting policies.
Estimates and judgements are continually evaluated, and are based on historical experience and other
factors, including expectations of future events that are believed to be reasonable under the
circumstances. The estimates and assumptions that have a significant risk of causing a material
adjustment to the carrying amounts of assets and liabilities within the next financial year are
discussed below.
The principal areas in which judgement is applied are as follows:
Valuation of stock options
Management uses the Black Scholes model to value the share options. The model requires use of
assumptions regarding volatility, risk free interest rate and a calculation of the value of the option at
the time of the grant. Please see Note 18 for details.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
61
Intangible assets impairment
When there is an indicator of a significant and permanent reduction in the value of intangible assets,
an impairment review is carried out. The impairment analysis is principally based on estimated
discounted future cash flows. 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. See Note 12 for further details.
4.
Segment Information
The Group has one reportable segment, the discovery, development, and commercialisation of
innovative treatments relating to blood and immune system disorders and viral infections, and
administrative functions in the United Kingdom, and therefore the segmental information is the same
as that presented in the primary statements.
The following tables present expenditure and certain asset information regarding the Group’s
geographical segments for the year ended 31 December 2023 and 2022:
| Year Ended | Year Ended | |
| 31 December 2023 | 31 December 2022 | |
| £ | £ | |
| SEGMENT ASSETS | ||
| United Kingdom | ||
| - Non-current | ||
| - | - | |
| - Current | ||
| 234,056 | 109,314 | |
| United States | ||
| - Non-current | 3,936,279 | 4,497,827 |
| - Current | 1,915,093 | 2,464,581 |
| Belgium (Discontinued operation) | ||
| - | ||
| Non-current | ||
| - | - | |
| - | ||
| Current | ||
| 20,465 | 20,887 | |
| Total | ||
| - | ||
| Non-current | ||
| 3,936,279 | ||
| 4,497,827 | ||
| - | ||
| Current | ||
| 2,169,614 | 2,594,782 | |
| CAPITAL EXPENDITURE | ||
| United Kingdo | ||
m | ||
| - | - | |
| United States | 117,285 | 430,611 |
| Belgium (Discontinued operation) | - | - |
| 117,285 | 430,611 |
Capital expenditure consists of the purchase of property, plant and equipment.
The Group also had a subsidiary in Liège, Belgium that was dissolved on 30 March 2022.
The loss arising from this discontinued operation was £2,890 (2022: £5,706).
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
62
5.
Expenses by nature
| Group | Group | |
| Year Ended 31 | ||
| December 2023 | ||
| Year Ended 31 | ||
| December 2022 | ||
| £ | £ | |
| Laboratory expenses | 90,632 | 402,940 |
| Consumable equipment and supplies | 1,682,203 | 2,196,822 |
| Contractors & consultants | 336,804 | 290,688 |
| Travel | 30,863 | 44,057 |
| Staff Costs | 2,151,045 | 1,424,301 |
| Insurance | 123,344 | 77,652 |
| Other | ||
| 135,746 | 167,621 | |
| Legal and professional fees | 352,230 | 362,334 |
| Foreign exchange loss / (gain) | 907,298 | (1,532,939) |
| Total Administrative Expenses | 5,820,165 | 3,433,476 |
6. Employees
| Group | ||||
| Year Ended 31 | ||||
| Group | ||||
| Year Ended 31 | ||||
| Company | ||||
| Year Ended 31 | ||||
| Company | ||||
| Year Ended 31 | ||||
| December 2023 | December 2022 | December 2023 | December 2022 | |
| £ | £ | £ | £ | |
| Wages and salaries | 1,736,928 | 1,288,215 | 115,000 | 115,000 |
| Social security | 124,005 | 90,220 | 8,660 | 1,542 |
| Share based payments | 242,836 | 17,575 | 242,836 | 17,575 |
| Pension contributions | 47,276 | 28,291 | - | - |
| 2,151,045 | 1,424,301 | 366,496 | 134,117 |
Average number of people (including Executive Directors) employed:
| Group | ||||
| Year Ended 31 | ||||
| December | ||||
| Group | ||||
| Year Ended 31 | ||||
| December | ||||
| Company | ||||
| Year Ended 31 | ||||
| December | ||||
| Company | ||||
| Year Ended 31 | ||||
| December | ||||
| 2023 | 2022 | 2023 | 2022 | |
| Research & | ||||
| development | 12 | |||
| 9 | ||||
| - | ||||
| - | ||||
| Administration | 5 | 5 | 3 | 3 |
| 17 | 14 | 3 | 2 |
7. Auditor’s remuneration
| Group | Group | |
| Year Ended | ||
| Year Ended 31 | ||
| December 2023 | ||
| 31 December | ||
| 2022 |
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
63
| £ | £ | |
| Fees payable to the Company auditor: | ||
| Audit of the financial statements of the Group and | ||
| Company | 52,500 | 50,000 |
| 52,500 | 50,000 |
8.
Income tax
| Group | Group | |
| Year Ended 31 | ||
| December 2023 | ||
| Year Ended 31 | ||
| December 2022 | ||
| £ | ||
| £ | ||
| Current Tax: | - | |
| - | ||
| Tax on loss on ordinary activities | - | - |
| Loss on ordinary activities before tax | (6,696,493) | (3,986,982) |
| Analysis of charge in the year: | ||
| Loss on ordinary activities multiplied by weighted average tax | ||
| rate for the group of 25.78% (2022: 27.36%) | ||
| (1,726,356) | (1,090,838) | |
| Disallowed items | 172,329 | 330,370 |
| US R&D credit and timing differences | 231,595 | (323,215) |
| Tax losses carried forward | 1,322,432 | 1,083,683 |
| Current tax credit | - | - |
Weighted average tax rate is calculated by reference to the tax rates effective in each of the
jurisdictions. The tax rates effective at 31 December 2023 are 25% and 28% in the UK and the USA
respectively.
The Group has accumulated tax losses arising in the UK of approximately £4,100,000 (31 December
2022: £3,225,000) that should be available, under current legislation, to be carried forward against
future profits. No deferred tax asset has been recognised against these losses.
The Group has tax losses carried forward in the US of approximately $18,031,000 (31 December
2022: $11,377,000) available under current rules until 2037. Of the total Federal net operating losses,
the amounts incurred after 2017 of approximately $9,000,000 will carry forward indefinitely. No
deferred tax asset has been recognised against these losses. Sections 382 and 383 of the US Internal
Revenue Code, and similar state regulations, contain provisions that may limit the tax loss carried
forward available to be used to offset income in any given year upon the occurrence of certain events,
including changes in the ownership interests of significant stockholders. In the event of a cumulative
change in ownership in excess of 50% over a three-year period, the amount of the NOL carry
forwards that the Company may utilise in any one year may be limited.
9.
Earnings per share
The calculation of the basic and fully diluted earnings per share is calculated by dividing the loss for
the year from continuing operations attributable to equity owners of the Group of £6,696,493 (2022:
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
64
£3,979,314) by the weighted average number of ordinary shares in issue during the year of
1,129,136,727 (2022: 979,749,321).
Dilutive loss per Ordinary Share equals basic loss per Ordinary Share as, due to the losses incurred
in 2023 and 2022, there is no dilutive effect from
the subsisting share options. See Note 18 fo
r
details of stock options and warrants outstanding.
10. Property and equipment
| Property, plant | ||||
| Computer | Leasehold | Total | ||
| Group | & equipment | |||
| equipment | Improvements | |||
| £ | ||||
| £ | £ | £ | ||
| Cost | ||||
| 31 December 2021 | 430,171 | |||
| 19,728 | 644,155 | 1,094,054 | ||
| Additions | 417,897 | |||
| 11,161 | 1,553 | 430,611 | ||
| Foreign exchange movement | 26,011 | |||
| 2,065 | 76,463 | 104,539 | ||
| Disposals | (1,666) | |||
| - | - | (1,666) | ||
| 31 December 2022 | 872,413 | |||
| 32,954 | 722,171 | 1,627,538 | ||
| Additions | 103,948 | |||
| 13,337 | - | 117,285 | ||
| Foreign exchange movement | (41,424) | |||
| (1,810) | (34,518) | (77,753) | ||
| Disposals | - | |||
| - | - | - | ||
| 31 December 2023 | 934,937 | |||
| 44,480 | 687,653 | 1,667,070 | ||
| Accumulated depreciation and | ||||
| impairment losses | ||||
| 31 December 2021 | 297,309 | |||
| 8,858 | - | 306,167 | ||
| Depreciation | 116,493 | 8,129 | 75,226 | 199,848 |
| Foreign exchange movemen | ||||
t | ||||
| 54,693 | 677 | 42,900 | 98,270 | |
| 31 December 2022 | 468,495 | 17,664 | 118,127 | 604,285 |
| Depreciation | 126,281 | |||
| 10,577 | 88,543 | 225,401 | ||
| Foreign exchange movement | (78,160) | |||
| (1,796) | (49,083) | (129,039) | ||
| 31 December 2023 | 516,616 | |||
| 26,444 | 157,587 | 700,647 | ||
| Carrying amounts | ||||
| 31 December 2021 | 132,862 | |||
| 10,870 | 644,155 | 787,887 | ||
| 31 December 2022 | 403,918 | 15,290 | 604,044 | 1,023,252 |
| 31 December 2023 | 418,321 | 18,036 | 530,066 | 966,423 |
11.
Leases
The Group follows IFRS 16 with respect to its leases, whereby the Group recognises right-of-use
assets and lease liabilities for all leases on its balance sheet. Each of the two US subsidiaries has an
agreement for the lease of laboratory facilities to which IFRS 16 has been applied.
The key impacts on the Statement of Comprehensive Income and the Statement of Financial Position
are as follows:
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
65
Group & Compan
y
| Right of use | |||
| asset | |||
| Lease | |||
| liability | |||
| Income | |||
| statement | |||
| £ | £ | £ | |
| Carr | |||
y | |||
| in | |||
g | |||
| value at 31 December 2021 | 9,242 | (10,152) | (37,932) |
| Additions | 3,249,244 | (3,249,244) | - |
| Depreciation | (366,302) | - | (366,302) |
| Interest | - | (274,802) | (274,802) |
| Lease payments | - | 106,321 | - |
| Foreign exchange movements | 77 | 5,042 | (4,965) |
| Carr | |||
y | |||
| in | |||
g | |||
| value at 31 December 2022 | 2,892,261 | (3,422,835) | (539,748) |
| Additions | - | - | - |
| Depreciation | (420,280) | - | (420,280) |
| Interest | - | (315,991) | (315,991) |
| Lease payments | - | 638,765 | - |
| Foreign exchange movements | (125,966) | 154,175 | 28,210 |
| Carr | |||
y | |||
| in | |||
g | |||
| value at 31 December 2023 | 2,346,015 | (2,945,886) | (599,871) |
12.
Intangible assets
On 15 January 2015, the Company entered into an Exclusive License Agreement with Cornell
University to grant to the Company patent rights to patent PCT/US14/65469 entitled Post-Natal
Hematopoietic Endothelial Cells and Their Isolation and Use and rights to any product or method
deriving therefrom. The Company paid Cornell University USD $347,500 for such licence rights.
In October 2021, the Company entered into a licence with Eli Lilly & Company to use a patented
product derived from jointly-developed intellectual property in the CDX antibody for a term ending
on the latest of (a) the twelfth (12th) anniversary of the date of First Commercial Sale of a particular
Licensed Product in a particular country; (b) the first day on which there is not at least one Licensed
Patent having a Valid Claim Covering the manufacture, use, or sale of such Licensed Product in
such country; or (c) the expiration of the last-to-expire Data Exclusivity Period for such Licensed
Product in such country. The Company paid £181,743 or $250,000 as an up-front payment and will
make milestone payments of up to $1 million through to Phase II clinical trials. Lilly is also eligible
to receive substantial additional milestone payments based on the achievement of prespecified
milestones, as well as tiered single-digit royalties on sales and a percentage of any cash payments
received in respect of any sublicence of the licensed intellectual property. Through December 31,
2023, the Company has not incurred any development or sales-based payment obligations to the
licensor.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
66
| Cost | Intellectual Property |
| £ | |
| 31 December 2021 | 441,493 |
| Additions | - |
| Exchange movements | - |
| 31 December 2022 | 441,493 |
| Additions | - |
| Exchange movements | - |
| 31 December 2023 | 441,493 |
The carrying value of intangible assets is reviewed for indications of impairment whenever events
or changes in circumstances indicate that the carrying value may exceed the recoverable amount. The
products to which they relate are not ready to be sold on the open market. When the trials are
completed and the products attain the necessary accreditation and clearance from the regulators, the
Group will assess the estimated useful economic life and the IP will be amortised using the straight-
line method over their estimated useful economic lives. The directors are of the view that no
impairment is required as the test results to date have been very positive and these products are now
being moved on towards the clinical trial phase. Accordingly, the directors continue to believe that
the products will eventually attain the necessary accreditation and clearance from the regulators and
so no impairment has been considered necessary.
Amortisation will be charged to operating costs in the Statement of Comprehensive Income when
the Group achieves product sales.
13.
Loan to subsidiary
| Company | Company | |
| Year Ended 31 | ||
| December 2023 | ||
| Year Ended 31 | ||
| December 2022 | ||
| £ | £ | |
| Hemogenyx Pharmaceuticals LLC | 18,097,368 | 14,451,112 |
| Immugenyx LLC | 592 | 621 |
| 18,097,960 | 14,451,733 |
Hemogenyx Pharmaceuticals plc has made cumulative loans to Hemogenyx Pharmaceuticals LLC
of US$22,998,308 (£18,097,368) as at 31 December 2023 (31 December 2022: US$17,883,274
(£14,4551,112)) and Immugenyx LLC of US$752 (£592) as at 31 December 2023 (31 December
2022: US$752 (£621)). The loans are interest free and will be repaid when Hemogenyx LLC’s
operational cash flow allows. Management has undertaken an impairment assessment of the loan as
at 31 December 2023 and has determined that that there was no impairment required due to continued
progress of the product candidates. The interest rate and impairment assessment are reviewed on an
annual basis.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
67
14.
Investment in subsidiary
| Name | ||||
| Address of the registered | ||||
| office | ||||
| Nature of | ||||
| business | ||||
| Proportion of | ||||
| ordinary | ||||
| shares held | ||||
| directly by | ||||
| parent (%) | ||||
| Proportion of | ||||
| ordinary | ||||
| shares held | ||||
| ultimately by | ||||
| parent (%) | ||||
| Hemogenyx UK Limited | 6 | |||
| th | ||||
| Floor, 60 Gracechurch | Holding | 100 | - | |
| Street, London, EC3V 0HR | Company | |||
| Hemogenyx | ||||
| Pharmaceuticals LLC | ||||
| 9 East Lookerman Street, | ||||
| Suite 3A, Dover, Kent, | ||||
| Delaware, USA, 19901 | ||||
| Biomedical | ||||
| sciences | ||||
| - | 100 | |||
| Immugenyx LLC | c/o Corporation Service | |||
| Company, 251 Little Falls | ||||
| Drive, Wilmington, | ||||
| Delaware, USA, 19808 | ||||
| Biomedical | ||||
| sciences | ||||
| - | 90.3 | |||
| Hemogenyx-Cell SPRL | ||||
| (dissolved in 2022) | ||||
| Avenue du Parc Industriel | ||||
| 89, 4041 Milmort, Belgique | ||||
| Biomedical | ||||
| sciences | ||||
| - | 100 |
The remaining shares in Immugenyx LLC are held by Dr Vladislav Sandler and by a prior employee,
Carina Sirochinsky, as part of their compensation under their respective roles as CEO and Director
of Operations. Ms Sirochinsky’s role as Director of Operations ended on the termination of her
employment on 1 July 2021. Dr Sandler and Ms Sirochinsky receive(d) 10,000 and 1,000 shares
respectively for each year of employment from January 2019. At 31 December 2023, Hemogenyx
Pharmaceuticals LLC, Dr Sandler, and Ms Sirochinsky each own 500,000, 50,000, and 2,500 shares
in Immugenyx LLC, respectively.
15. Trade and other receivables
| Group | ||||
| Year Ended | ||||
| 31 December | ||||
| Group | ||||
| Year Ended | ||||
| 31 December | ||||
| Company | ||||
| Year Ended | ||||
| 31 December | ||||
| Company | ||||
| Year Ended | ||||
| 31 December | ||||
| 2023 | 2022 | 2023 | 2022 | |
| £ | £ | £ | £ | |
| VAT receivable | 4,064 | 9,664 | 4,064 | 9,664 |
| Trade and other receivables | 1,074 | 146 | - | - |
| Prepayments | 916,875 | 52,214 | 10,757 | 10,741 |
| Total trade and other receivables | ||||
| 922,013 | ||||
| 62,024 | ||||
| 14,820 | ||||
| 20,405 |
There are no material differences between the fair value of trade and other receivables and their
carrying value at the year-end. No receivables were past due or impaired at the year end.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
68
16. Called up share capital
| Group & Compan | ||
y | ||
| Number of shares | £ | |
| As at 31 December 2021 | 979,749,321 | 9,797,493 |
| No shares issued during 2022 | - | - |
| As at 31 December 2022 | 979,749,321 | 9,797,493 |
| Issue of shares | ||
– | ||
| placement 2 Feb 2023 | 162,250,000 | 1,622,500 |
| Issue of shares | ||
– | ||
| placement 27 Sept 2023 | 11,066,667 | 110,667 |
| Issue of shares | ||
– | ||
| placement 4 Dec 2023 | 22,500,000 | 225,000 |
| As at 31 December 2023 | 1,175,565,988 | 11,755,660 |
During 2022, the Company did not issue any ordinary shares.
During 2023, the Company issued 195,816,667 ordinary shares.
17. Share premium
| Group & Company | |
| £ | |
| As at 31 December 2021 | 16,808,647 |
| As at 31 December 2022 | 16,808,647 |
| Issue of shares | |
– | |
| placement 2 Feb 2023 | 2,433,750 |
| Issue of shares | |
– | |
| placement 27 Sep2023 | 553,333 |
| Issue of shares | |
– | |
| placement 4 Dec 2023 | 309,375 |
| Cost of capital | (166,549) |
| As at 31 December 2023 | 19,938,556 |
18.
Other reserves
| Group: | ||
| Year Ended 31 | ||
| December 2023 | ||
| Year Ended 31 | ||
| December 2022 | ||
| £ | £ | |
| As at start of year | ||
| 921,801 | ||
| 904,226 | ||
| Charge for the year - employees | 242,836 | |
| 17,575 | ||
| As at end of year | ||
| 1,164,637 | ||
| 921,801 |
| Company: | ||
| Year Ended 31 | ||
| December 2023 | ||
| Year Ended 31 | ||
| December 2022 | ||
| £ | £ | |
| As at start of year | ||
| 920,697 | ||
| 903,122 | ||
| Charge for the year - employees | 242,836 | |
| 17,575 | ||
| As at end of year | ||
| 1,163,533 | ||
| 920,697 |
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
69
The expense recognised for employee and non-employee services during the year is shown in the
following table:
| Group and Company: | ||
| Year Ended 31 | ||
| December 2023 | ||
| Year Ended 31 | ||
| December 2022 | ||
| £ | £ | |
| Expense arising from equity-settled share-based payment | ||
| transactions | 242,836 | 17,575 |
| Total expense arising from share-based payment transactions | 242,836 | 17,575 |
Employee Plan
Under the Employee Plan (“EMP”) share options are granted to directors and employees at the
complete discretion of the Company. The fair value of the options is determined by the Company at
the date of the grant. Options granted vest in tranches on each of the following events/dates:
(i) Admission to the LSE (“Admission”);
(ii) On the date falling six (6) months after Admission;
(iii) On the date falling twelve (12) months after Admission; and
(iv) On the date falling twenty-four (24) months after Admission
On the provision that the option holder remains an employee of the Group.
Options granted to most other option holders from 4 January 2018 onwards vest in equal tranches of
12.5% every three months from the date of grant, until fully vested.
The fair value of the options is determined using the Black Scholes method as stated in Note 2. The
contractual life of each option granted is between two and five years. There are no cash settlement
alternatives.
Options are settled when the Company receives a notice of exercise and cash proceeds from the
option holder equal to the aggregate exercise price of the options being exercised.
As part of the EMP, certain share options have been granted to a Director of the Company which
contain vesting conditions that are contingent on the authorisation of the FDA to commence clinical
trials.
Non-Employee Plan
Under the Non-Employee Plan (“NEMP”) share options are granted to non-employees at the
complete discretion of the Company. The exercise price of the options is determined by the Company
at the date of the grant. The options vest at the date of the grant.
The fair value of the options is determined using the Black Scholes method as stated in Note 2 and
not the value of services provided as this is deemed the most appropriate method of valuation. In all
cases non-employee option holders received cash remuneration in consideration for services
rendered in accordance with agreed letters of engagement. The contractual life of each option granted
ranges from two to five years. There are no cash settlement alternatives. Volatility was determined
by calculating the volatility for three similar listed companies and applying the average of the four
volatilities calculated.
Options are settled when the Company receives a notice of exercise and cash proceeds from the
option holder equal to the aggregate exercise price of the options being exercised.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
70
2021 Equity Incentive Plan with Non-Employee Sub-Plan
Under the 2021 Equity Incentive Plan with Non-Employee Sub-Plan” (the “EIP”) share options,
restricted shares, and restricted share units may be granted to employees, directors and consultants
of the Company and its subsidiaries at the discretion of the Company in an aggregate amount up to
30,000,000 shares. This was increased to 90,000,000 shares in April 2023. The fair value of awards
made under this plan is determined in the same way as for the EMP and NEMP described above.
A schedule of options granted since inception for all plans is below:
| Number options | |
| Employees, including directors* | 104,326,986 |
| Members of the Scientific Advisory Board | 12,481,912 |
| Total | 116,808,898 |
* Details of options held by individual directors are disclosed in the Directors’ Report.
In October 2022, the expiration date of options to acquire 4,806,577 ordinary shares (which were
scheduled to expire in October 2022) was extended by two years by the Board of Directors of the
Company. The Company recognised this transaction as a modification of a share-based instrument
for financial reporting purposes. The change in the fair value of the stock option before and after the
modification amounted to approximately $5,400, which was recorded as part of expense related to
share-based payment transactions. The fair value was determined using the Black Scholes model
using the assumptions noted below.
| Group & Company: | 2023 | |||
| Number | ||||
| 2023 | ||||
| Weighted | ||||
| Average | ||||
| Exercise Price, | ||||
| 2022 | ||||
| Number | ||||
| 2022 | ||||
| Weighted | ||||
| Average | ||||
| Exercise Price, | ||||
| pence | pence | |||
| Outstanding at the beginning of the year | ||||
| 35,299,586 | 4.6 | 45,081,506 | 4.4 | |
| Granted during the year | ||||
| 57,099,966 | 2.7 | - | - | |
| Lapsed during the year | ||||
| (4,500,642) | 3.5 | (14,588,497) | 3.5 | |
| Extended during the year | - | - | 4,806,577 | 3.5 |
| Outstanding at end of year | 87,898,910 | 3.4 | 35,299,586 | 4.6 |
| Exercisable at end of year | 87,898,910 | 3.4 | 35,299,586 | 4.6 |
The weighted average remaining contractual life for the share options outstanding as at 31 December
2023 is 4.73 years (2022: 2.93 years). The weighted average fair value of options granted during the
year was 2.7 pence (2022: nil).
The following table lists the inputs to the models used for the two plans for the years ended 31
December 2023 and 31 December 2022:
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
71
| April | ||
| 2023 | ||
| (EMP) | ||
| October 2022 | ||
| modification | ||
| (EMP) | ||
| Expected volatility % | 92 | 68-424 |
| Risk | ||
| -free interest rate % | 3.75 | 0.64-1.87 |
| Expected life of options (years) | 3 | 2 |
| WAEP | ||
– | ||
| pence | 2.7 | 3.5 |
| Expected dividend yield | ||
| - | - | |
| Model used | Black Scholes | Black Scholes |
19.
Capital and reserves
The nature and purpose of equity and reserves are as follows:
Share capital comprises the nominal value of the ordinary issued share capital of the Company.
Share premium represents consideration less nominal value of issued shares and costs directly
attributable to the issue of new shares.
Other reserves represents the value of options in connection with share-based payments, warrants
connected with share placements issued by the Company, and the value of the deemed embedded
derivative connected with the Convertible Note liability.
Reverse asset acquisition reserve is the reserve created in accordance with the acquisition of
Hemogenyx Pharmaceuticals LLC on 5 October 2017.
Foreign currency translation reserve is used to recognise the exchange differences arising on
translation of the assets and liabilities of foreign branches and subsidiaries with functional currencies
other than Pounds Sterling, as well as the revaluation of intercompany loans.
Retained earnings represent the cumulative retained losses of the Company at the reporting date.
20.
Trade and other payables
| Group | ||||
| Year Ended 31 | ||||
| December | ||||
| Group | ||||
| Year Ended 31 | ||||
| December | ||||
| Company | ||||
| Year Ended 31 | ||||
| December | ||||
| Company | ||||
| Year Ended 31 | ||||
| December | ||||
| Current | 2023 | 2022 | 2023 | 2022 |
| £ | £ | £ | £ | |
| Trade and other payables | 301,707 | 374,342 | 117,956 | 82,745 |
| Accruals and deferred income | 77,294 | 51,912 | 77,293 | 51,912 |
| Total | 379,001 | 426,254 | 195,249 | 134,657 |
21.
Related party disclosures
There were no related party disclosures other than Directors’ remuneration as disclosed in the
Remuneration Report section of the Directors’ Report. There are no key management personnel other
than the Directors and the Company Secretary.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
72
22.
Financial instruments
The Group’s financial instruments consist of cash, amounts receivable, accounts payable and accrued
liabilities.
Fair value of financial assets and liabilities
Fair values have been determined for measurement and/or disclosure purposes based on the following
methods. When applicable, further information about the assumptions made in determining fair
values is disclosed in the notes specific to that asset or liability.
The carrying amount for cash, accounts receivable, and accounts payable and accrued liabilities on
the statement of financial position approximate their fair value because of the limited term of these
instruments. The fair value of deferred payment approximates its fair value. The investment is carried
at cost as it is not traded on an active market.
Financial risk management objectives and policies
The Company has exposure to the following risks from its use of financial instruments:
•
Credit risk
•
Liquidity and funding risk
•
Market risk
The following table sets out the amortised costs categories of financial instruments held by the Company
as at the year ended 31 December 2023 and year ended 31 December 2022:
| Group | ||||
| Year Ended 31 | ||||
| December | ||||
| Group | ||||
| Year Ended 31 | ||||
| December 2022 | ||||
| Company | ||||
| Year Ended 31 | ||||
| December | ||||
| Company | ||||
| Year Ended 31 | ||||
| December 2022 | ||||
| 2023 | ||||
| £ | ||||
| £ | ||||
| 2023 | ||||
| £ | ||||
| £ | ||||
| Assets | ||||
| Trade and other receivables, | ||||
| except prepayments | ||||
| 5,138 | ||||
| 9,810 | ||||
| - | ||||
| - | ||||
| Cash and cash equivalents | 1,247,601 | 2,532,758 | 219,236 | 88,909 |
| 1,252,739 | 2,542,568 | 219,236 | 88,909 | |
| Liabilities | ||||
| Trade and other payables | ||||
| (301,707) | ||||
| (374,343) | ||||
| (119,249) | ||||
| (82,746) | ||||
| Lease liabilities | (2,945,886) | (3,422,835) | - | - |
| (3,247,593) | ||||
| (3,797,178) | ||||
| (119,249) | ||||
| (82,746) |
a) Credit risk
The Group had receivables of £0 owing from customers (31 December 2022: £0). All bank deposits
are held with Financial Institutions with a minimum credit rating of B.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
73
b)
Liquidity and funding risk
The Group regularly reviews its major funding positions to ensure that it has adequate financial
resources in meeting its financial obligations. The Group takes liquidity risk into consideration when
deciding its sources of funds. The principle liquidity risk facing the business is the risk of going
concern which has been discussed in Note 2.
c)
Market risk
Interest rate risk
Interest rate risk is the risk that the value of financial instruments will fluctuate due to changes in
market interest rates. The Group's income and operating cash flows are substantially independent of
changes in market interest rates as the Group has no significant interest-bearing assets. The
borrowings issued at fixed rates expose the Group to fair value interest rate risk. The Company's
management monitors the interest rate fluctuations on a continuous basis and acts accordingly.
The Company has floating rate financial assets in the form of deposit accounts with major banking
institutions; however, it is not currently subjected to any other interest rate risk.
Based on cash balances as above as at the statement of financial position date, a rise in interest rates
of 1% would not have a material impact on the profit and loss of the Company and such is not
disclosed.
In relation to sensitivity analysis, there was no material difference to disclosures made on financial
assets and liabilities.
At the reporting date the interest rate profile of interest-bearing financial instruments was:
| Group | ||||
| Year Ended 31 | ||||
| December | ||||
| Group | ||||
| Year Ended 31 | ||||
| December | ||||
| Company | ||||
| Year Ended 31 | ||||
| December | ||||
| Company | ||||
| Year Ended 31 | ||||
| December | ||||
| 2023 | 2022 | 2023 | 2022 | |
| £ | £ | £ | £ | |
| Financial Assets | ||||
| Cash and cash equivalents | 1,247,601 | 2,532,758 | 219,236 | 88,909 |
Foreign currency risk
The Group operates internationally and has monetary assets and liabilities in currencies other than
the functional currency of the operating company involved.
The Group seeks to manage its exposure to this risk by ensuring that where possible, the majority of
expenditure and cash of individual subsidiaries within the Group are denominated in the same
currency as the functional currency of that subsidiary.
The Group has not entered into any derivative instruments to manage foreign exchange fluctuations.
The following table shows a currency of net monetary assets and liabilities by functional currency of
the underlying companies for the years ended 31 December 2023 and 31 December 2022:
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
74
| 31 December 2023 | ||||
| Functional Currency | ||||
| Currency of net monetary | ||||
| assets/(liabilities) | ||||
| Pound | ||||
| Sterling | ||||
| £ | ||||
| US Dollars | ||||
| £ | ||||
| Euro | ||||
| £ | ||||
| Total | ||||
| £ | ||||
| Pounds Sterlin | ||||
g | ||||
| 206,397 | - | - | 206,397 | |
| US Dollars | 12,839 | 1,007,900 | - | 1,020,739 |
| Euros | - | - | 20,465 | 20,465 |
| Total | 219,236 | 1,007,900 | 20,465 | 1,247,601 |
| 31 December 2022 | ||||
| Functional Currency | ||||
| Currency of net monetary | ||||
| assets/(liabilities) | ||||
| Pound | ||||
| Sterling | ||||
| US Dollars | Euro | Total | ||
| £ | £ | £ | £ | |
| Pounds Sterling | ||||
| 75,358 | ||||
| - | ||||
| - | ||||
| 75,358 | ||||
| US Dollars | 13,551 | 2,422,962 | - | 2,436,513 |
| Euros | - | - | 20,887 | 20,887 |
| Total | 88,909 | 2,422,962 | 20,887 | 2,532,758 |
Capital risk management
The Group defines capital as the total equity of the Company. 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 benefits for other stakeholders and to maintain an optimal capital
structure to reduce the cost of capital.
In order to maintain or adjust the capital structure, the Group may adjust the amount of dividends paid
to shareholders, return capital to shareholders, issue new shares or sell assets to reduce debt.
Fair value of financial assets andliabilities
There are no material differences between the fair value of the Group’s financial assets and liabilities
and their carrying values in the financial statements.
23.
Commitments
Licences
Milestone and royalty payments that may become due under licence agreements are dependent on,
among other factors, clinical trials, regulatory approvals and ultimately the successful development
of new drugs, the outcomes and timings of which are uncertain.
For the licence from Cornell University to the patent of the Hu-PHEC technology, the Group’s
minimum future payments contingent upon meeting certain development, regulatory and
commercialisation milestones total £855,301 ($1,035,000) plus £413,189 ($500,000) on receipt of
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
75
marketing approval from each additional market excluding the United States of America and the
European Union. Upon commencement of commercial production, the Group will pay a royalty
between 2 to 5% on all net sales. Through 31 December 2023, none of the requirements to make
such payments have been met. In addition, the Group pays an annual licence maintenance fee of up
to £61,978 ($75,000) until commercial sales are achieved.
For the licence to Eli Lilly and Company’s (“Lilly”) contributions to the intellectual property in the
CDX bispecific antibody, future payments will be contingent upon meeting certain similar
development, regulatory and commercialisation milestones and so do not meet the definition of
commitments pending further developments. This licence is subject to an up-front payment to Lilly
of $250,000 and milestone payments of up to $1 million through to Phase II clinical trials. Lilly is
also eligible to receive substantial additional milestone payments based on the achievement of
prespecified milestones, as well as tiered single-digit royalties on sales. In addition, the Company
will pay Lilly a percentage of any cash payments received in respect of any sublicence of the licensed
intellectual property.
Leases
In August 2021, Hemogenyx LLC entered into a lease for a 9,357 square foot purpose-built
laboratory for eight years beginning on 1 April 2022. The lease contains escalating monthly payments
ranging from approximately $64,300 to $76,500 per month over the lease term. The Group paid a
security deposit of £156,114 ($188,005) during the year ended 31 December 2021 for such facility
lease.
Service agreements
In December 2021, Hemogenyx Pharmaceuticals LLC entered into a service agreement to establish
Research Cell Banks (RCBs) for production of the Company’s proprietary recombinant protein(s)
encoded by cDNAs. From 31 December 2021 through 31 December 2022, Hemogenyx
Pharmaceuticals LLC has paid £199.956 (CHF 214,063) under this agreement. Under the terms of
the agreement, Hemogenyx Pharmaceuticals LLC may pay up to CHF 590,000 at its discretion in
aggregate, inclusive of the amounts already paid.
In December 2021, Hemogenyx Pharmaceuticals LLC entered into service agreements with another
party to produce components of the Company’s CAR-T product candidate. Under the terms of the
agreement, Hemogenyx Pharmaceuticals LLC must pay an aggregate of £1,970,911 ($2,109,957) in
milestone payments during the term of production. From 31 December 2021 through 31 December
2023, Hemogenyx Pharmaceuticals LLC has paid £1 ($1,134,059) under these agreements.
In September 2023, Hemogenyx Pharmaceuticals entered into a Master Services and Contract
Agreement for a third party to provide clinical services and technologies for the forthcoming Phase
I clinical trials for an initial term of 38 months, paying an aggregate of 2,530,057. This includes an
upfront payment of 986,713 and monthly instalments over 38 months of 41,712 commencing in April
2024. No sums other than an upfront fee were paid during the year ended 31 December 2023.
Share options
As detailed further in Note 18, certain share options contain contingent vesting conditions.
Hemogenyx Pharmaceuticals plc
Annual Report & Financial Statements for the
Year Ended 31 December 2023
76
24.
Ultimate controlling party
The Directors have determined that there is no controlling party as no individual shareholder holds a
controlling interest in the Company.
25.
Subsequent events
In February 2024 the Company was granted a patent by the United States Patent and Trademark
Office entitled Method of Eliminating Hematopoietic Stem Cells/Hematopoietic Progenitors
(HSC/HP) in a Patient Using Bi-specific Antibodies.
Also in February 2024, the Company was informed by the FDA that it had lifted the clinical hold on
the IND application for HEMO-CAR-T for the treatment of acute myeloid leukemia. The FDA
confirmed that the Company had addressed all issues identified in its prior clinical hold letter
satisfactorily and consents to the Company proceeding with its Phase I clinical study of HEMO-
CAR-T.
The Company successfully raised US$4.2 million (£3.325 million) before expenses through the
allotment and issue of 166,250,000 new ordinary shares at 2 pence per share. The funds were raised
to allow the Company to progress HEMO-CAR-T to phase 1 clinical trials.
26.
Copies of the annual report
Copies of the annual report will be available on the Company’s web site at https://hemogenyx.com
and from the Company’s registered office, 6
th
floor, 60 Gracechurch Street, London, EC3V 0HR.