TIDMHEMO
RNS Number : 7869X
Hemogenyx Pharmaceuticals PLC
28 April 2023
28 April 2023
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF ARTICLE 7 OF REGULATION 2014/596/EU AS IT FORMS PART OF LAW IN
THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT
2018. UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE
INFORMATION IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.
Final Results for the Year Ended 31 December 2022
Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical
group developing new therapies and treatments for deadly blood
diseases, announces its results for the year ended 31 December
2022.
Key Highlights
-- Nearing completion of the IND application to the FDA to enter
phase I clinical trials for HEMO-CAR-T for the treatment of R/R
AML.
-- CBR platform extended into treatment of multiple viral
infections beyond COVID-19 using single CBR-based therapeutic.
-- Initiated IND-enabling activities for CDX bi-specific
antibody for treatment of R/R AML.
-- Successfully set up and qualified GMP manufacturing and
analytical testing of cell therapies and implemented Quality System
in a new purpose-built R&D/manufacturing facility.
The full annual report and accounts for 2022 are published on
the Company's web site at https://hemogenyx.com and will be
available from Companies House and the National Storage
Mechanism.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this news release contain forward-looking
information. These statements address future events and conditions
and, as such, involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the statements.
Such factors include without limitation the completion of planned
expenditures, the ability to complete exploration programs on
schedule and the success of exploration programs. Readers are
cautioned not to place undue reliance on the forward-looking
information, which speak only as of the date of this news
release.
Enquiries:
Hemogenyx Pharmaceuticals plc https://hemogenyx.com
Dr Vladislav Sandler, Chief Executive
Officer & Co-Founder headquarters@hemogenyx.com
Peter Redmond, Director peter.redmond@hemogenyx.com
Tel: +44 (0)20 3470
SP Angel Corporate Finance LLP 0470
Matthew Johnson, Vadim Alexandre,
Adam Cowl
Tel: +44 (0)20 7469
Peterhouse Capital Limited 0930
Lucy Williams, Duncan Vasey, Charles
Goodfellow
About Hemogenyx Pharmaceuticals plc
Hemogenyx Pharmaceuticals is a publicly traded company (LSE:
HEMO) headquartered in London, with its US operating subsidiaries,
Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New
York City at its state-of-the-art research facility.
The Company is a pre-clinical stage biopharmaceutical group
developing new medicines and treatments to treat blood and
autoimmune disease and to bring the curative power of bone marrow
transplantation to a greater number of patients suffering from
otherwise incurable life-threatening diseases. Hemogenyx
Pharmaceuticals is developing several distinct and complementary
product candidates, as well as platform technologies that it uses
as engines for novel product development.
Chairman's Statement
I am pleased to announce the Company's results for the year
ended 31 December 2022. During the year we focussed heavily on
bringing our major development project, the key HEMO-CAR-T product
candidate, towards its Investigational New Drug ("IND") application
to enable us to move into clinical trials. At the same time, we
also advanced the development of our other main pipeline assets,
our CD3-FLT3 CDX antibody and the Chimeric Bait Receptor ("CBR")
platform.
After the year end, in January, we successfully raised
GBP4,056,250 in new equity capital at 2.5p per share which will
give us the funds to take the Company through the IND process and
into the beginning of clinical trials for HEMO-CAR-T and enable us
to further advance the CBR project.
HEMO-CAR-T
Our work during the period under review has primarily focussed
on bringing our lead product, HEMO-CAR-T, through the preparatory
process to clinical trials, a process which has been more complex
and hence longer and more intensive than we had anticipated but
which has now reached an advanced stage. We have continued to move
other projects forward, in particular our CBR technology, but our
main object has been to take HEMO-CAR-T, and with it the Company,
to the next critical level of being a clinical-stage company. We
have been particularly concerned to cover all aspects in preparing
the IND documentation so as to minimise any possible delays and
questions that may arise from its review by the US Food and Drug
Administration ("FDA"). The IND submission process is very
detailed, as it should be to ensure the safety of this key
potential treatment for patients suffering from advanced stage
relapsed or refractory ("R/R") acute myeloid leukaemia ("AML"). We
received constructive early feedback and guidance from a "pre-IND
submission" to the FDA which have helped to shape the final
submission, along with advice from our Medical Director and a
committee of "Key Opinion Leaders" who are experts in the treatment
of leukaemias, as well as the design and conduct of clinical
trials. We expect to submit the IND application in the very near
future.
During the last quarter of 2022 and the early months of the
current year we successfully carried out the final processes and
underwent the internal and third-party tests necessary to complete
the detailed IND submission pack. These included Process
Development runs of the end-to-end process for the manufacture of
HEMO-CAR-T cells and exhaustively documented engineering, or
Process Qualification, runs under real-world conditions.
These cell manufacturing dry runs were followed by analytical
release tests that were conducted both by the Company and a third
party to ensure that the manufactured HEMO-CAR-T cells comply with
a set of required quality attributes. Among these are the
viability, potency and sterility of the resulting cells.
CDX
CDX, our CD3-FLT3 bispecific antibody, will provide an
alternative means of treating AML and of conditioning patients for
bone marrow transplants when fully developed. While concentrating
our efforts on HEMO-CAR-T as the asset most ready to take the
Company to the important clinical trial stage of its maturity, we
have taken further steps to develop this important asset during the
year. In January 2022, we entered into a service agreement to
develop a "master cell line" that will be used to produce CDX
antibodies for future clinical trials and patient treatments. We
are utilising Selexis' SUREtechnology Platform(TM), a suite of cell
line development tools and technologies that reduces the time,
effort and cost in developing high-performance mammalian cell
lines. The platform facilitates the rapid, stable, and importantly
cost-effective production of recombinant proteins and vaccines,
providing seamless integration of the development continuum from
discovery to commercialisation. This is an important step in moving
CDX towards clinical trials.
The Company's existing intellectual property protection for CDX
was further strengthened by the China National Intellectual
Property Administration granting a patent to it, which joins
patents previously granted in the US for CDX and monoclonal
antibodies used for the development of both CDX and HEMO-CAR-T.
Exploration of ways to finance and further the pre-clinical and
clinical testing of CDX continued with early-stage conversations
with potential development partners.
CBR
Work has also continued in an encouraging manner on the
development of our CBR platform. As shareholders are aware, the
essence of the CBR-based approach is programming immune cells using
a novel type of modifiable synthetic receptor to destroy viral
pathogens and potentially to programme immune cells to destroy
certain malignant cancer cells. The Company has also developed an
associated derivative technology, the Bait Macrophage Engager
("BME"), whose constructs act like antibodies, directing immune
cells to neutralise them. We believe this novel approach holds
great promise and the invention is the subject of a seminal
provisional patent application that was filed in March 2022.
This project was initiated prior to the COVID-19 pandemic as a
new way to combat emerging viral diseases and potentially as-yet
unknown infections (referred to as "Disease X"). The platform has
been successfully tested in the laboratory against variants of the
SARS-CoV-2 virus that causes COVID-19 as they have emerged.
Detailed subsequent work suggests that its use could be expanded to
certain cancers, and has provided evidence that the CBR platform is
applicable in principle to almost any known form of virus.
The Company has successfully demonstrated in vitro that immune
cells programmed with a CBR-based construct against SARS-CoV-2
selectively consume a live synthetic virus. Importantly, the
function of the CBR construct was not affected by known mutations
of the spike protein that endows the virus with the ability to
infect cells. The Company has now begun in vivo tests with a
partner in a biosafety level 3 ("BSL3") facility to demonstrate
that CBR could be used against infectious replicating SARS-CoV-2
virus. Work also continues in relation to CBR's applicability to
certain cancers.
In recent months, further progress has been made. As announced
in January 2023, our scientists have identified a target protein
that can be incorporated into a single multipurpose CBR-based
therapeutic capable of treating multiple viruses that belong to
different viral families, instead of having to make a separate CBR
construct for every virus. Among them are Dengue, Ebola, Marburg,
Zika and Chikungunya. These viruses are among the most dangerous to
humans, causing serious and often fatal diseases, and for which few
effective treatment options exist.
The Company's technology utilises synthetic biology and
artificial intelligence approaches to advance medicine to protect
society from future pandemics that may challenge the global
economy, health, and national defence. When fully developed, we
would be able to create front-line treatments that may prevent the
development of the next pandemic. Moreover, these new therapeutic
tools can be used to protect against bio-terrorism, potentially
rendering a universe of viral bio-weapons ineffective.
We continue to believe that this platform has the capacity to be
extremely valuable.
New Custom R&D Facility
In July 2022, we officially opened our new custom-designed
laboratory in the Mink Building in the Manhattanville area of New
York City, a state-of-the-art research facility of some 10,000
square feet that includes two clean rooms for cell therapy
manufacturing. We can now manufacture cells in-house, accelerating
and simplifying the commercialisation of our cell therapy product
candidates. The facility is near to world-class educational
institutions that play a leading role in the rich local life
sciences ecosystem, including Columbia University and City
College.
New Appointments
We made two important appointments during the year: Dr Koen van
Besien was appointed as our Medical Director, and we also welcomed
a Director of Quality, Stuart Tinch.
Dr van Besien, who is Chief of the Division of Hematology and
head of the Wesley Center for Immunotherapy at University Hospitals
Seidman Cancer Center, has been associated with the Company since
its founding as a member of our Scientific Advisory Board. Now that
we are moving closer to clinical trials, he has stepped up to a
position in which he is engaged in refining the protocol for those
trials and their implementation.
Stuart Tinch brings over seven years of Good Manufacturing
Practice ("GMP") expertise to Hemogenyx Pharmaceuticals. He will be
instrumental in creating a culture and system of quality to ensure
that the Company's therapies are held to the standards of current
GMP regulations.
Financial Results
Overall, the Group made a loss of GBP3,986,982 (2021:
GBP5,108,310 loss) during the period under review. The increased
operating loss of GBP3,997,548 (31 December 2021: GBP2,702,754)
marks the increasing volume of work and need to engage external
service providers as our assets are taken towards the crucial
clinical trial stage of their development.
It only remains for me to thank our CEO Dr Vladislav Sandler and
his scientific team for their excellent and highly productive work
under a tight budget, as well as my fellow directors, and to look
forward with confidence to the achievement of important milestones
during the present financial year.
Prof Sir Marc Feldmann AC, FRS
MB BS, PhD, FRCP, FRCPath, FAA, F Med Sci
Chairman
27 April 2023
Directors' Report for the year ended 31 December 2022
The Directors present their report with the audited financial
statements of the Group for the year ended 31 December 2022.
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 three companies that are located outside of the
UK. The principal laboratory of the Group is located in Brooklyn,
New York, USA. The Group also had a subsidiary in Liège, Belgium
that was dissolved on 30 March 2022.
Results and Dividends
The Consolidated Statement of Comprehensive Income set out on
page 44 shows a loss for the year amounting to GBP3,986,982 (2021:
GBP5,108,310). The Directors do not propose a dividend in respect
of the year ended 31 December 2022 (31 December 2021: 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 Appointed Date Resigned
---------------------------- --------------- --------------
Professor Sir Marc Feldmann 9 April 2018 -
Dr Vladislav Sandler 4 October 2017 -
Alexis Sandler 4 October 2017 -
Peter Redmond 29 July 2015 -
---------------------------- --------------- --------------
The Directors of the Company who held office at 31 December 2022
had the following beneficial interests in the Ordinary shares of
the Company at 31 December 2022 according to the register of
directors' interests:
Director At 31 December 2022 At 31 December 2021
---------------------------- ----------------------- -------------------
Professor Sir Marc Feldmann - -
Peter Redmond* 5,596,270 5,596,270
Dr Vladislav Sandler 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 20 for detail on option plans):
Options
-----------------------------------------------------------------------------------------------
Number of options Options granted
at start of or acquired Options lapsed Number of options
Date of grant year during year during year at end of year
-------------------- ---------------- --------------- ------------------
Professor Sir
Marc Feldmann
9 Apr 2018 18,002,568 - - 18,002,568
------------------ -------------------- ---------------- --------------- ------------------
18,002,568 - - 18,002,568
------------------ -------------------- ---------------- --------------- ------------------
Dr Vladislav Sandler
20 August 2020 5,000,000 - - 5,000,000
5,000,000 - - 5,000,000
------------------ -------------------- ---------------- --------------- ------------------
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 2022, the total number of issued Ordinary
Shares with voting rights in the Company was 979,749,321 (now:
1,141,999,321). The Company has been notified of the following
interests of 3 per cent or more in its issued share capital as at
the date of approval of this report:
Party Name Number of Ordinary Shares % of Share Capital
------------------ ------------------------- ------------------
Alexis Sandler 75,090,685 6.58
Vladislav Sandler 41,544,677 3.64
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 18 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 25 of the financial
statements.
Future Developments and Events Subsequent to the Year End
On 26 January 2023 the Company announced that it issued and
allotted 162,250,000 new ordinary shares at 2.5 pence per
share.
The net proceeds from the Placing will be used to facilitate
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 based
on its CBR platform.
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 8 respectively.
Corporate Governance
The Corporate Governance report is disclosed on page 24 of the
full accounts.
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 8 respectively. In addition, Note 25 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 (2021:
GBPnil).
Charitable Donations
There were no charitable donations made by the Group in
thecurrent or prior year.
Greenhouse gas emissions
The Company used less than 40,000kWh of energy in the United
Kingdom during 2022 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 Company and of the profit or
loss of the Company 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 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:
-- 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 27 April 2023
Dr Vladislav Sandler
CEO
Consolidated Statement of Comprehensive Income
Year Ended Year Ended
31 December 31 December
Group - Continuing Operations Note 2022 2021
GBP GBP
--------------------- -------------------
Revenue - -
Administrative Expenses 6 (3,433,476) (2,576,414)
12,
Depreciation Expense 13 (564,072) (126,340)
Operating Loss (3,997,548) (2,702,754)
Other Income 7 - 171,875
Finance Income 10,599 17,958
Finance Costs (33) (2,595,389)
Loss before Taxation (3,986,982) (5,108,310)
--------------------- -------------------
Income tax 10 - -
--------------------- -------------------
Loss for the year (3,986,982) (5,108,310)
--------------------- -------------------
Loss attributable to:
* Owners of Hemogenyx Pharmaceuticals plc (3,979,314) (5,099,228)
* Non-controlling interests (7,668) (9,082)
--------------------- -------------------
(3,986,982) (5,108,310)
--------------------- -------------------
Items that may be reclassified
subsequently to profit or loss:
Translation of foreign operations (954,642) (18,025)
Other comprehensive income for
the year (954,642) (18,025)
Total comprehensive loss for the
year (4,941,624) (5,126,335)
Attributable to:
Owners of Hemogenyx Pharmaceuticals
plc (4,933,956) (5,117,253)
Non-controlling interests (7,668) (9,082)
--------------------- -------------------
Total comprehensive loss for the
year (4,941,624) (5,126,335)
Basic and diluted earnings loss
per share attributable to the equity
owners of the Company 11 (0.005) (0.007)
---------------------
The Notes to the Financial Statements form an integral part of
these Financial Statements.
Consolidated Statement of Financial Position
Group
31 December 31 December
Note 2022 2021
Assets GBP GBP
----- -------------- ----------------
Non-current assets
Property, plant and equipment 12 1,023,252 787,887
Right of use asset 13 2,892,261 9,242
Security deposit 26 140,821 142,599
Intangible asset 14 441,493 441,493
Total non-current assets 4,497,827 1,381,221
Current assets
Trade and other receivables 17 62,024 298,220
Cash and cash equivalents 2,532,758 6,840,969
Total current assets 2,594,782 7,139,189
Total assets 7,092,609 8,520,410
============== ================
Equity and Liabilities
Equity attributable to shareholders
Paid-in Capital
Called up share capital 18 9,797,493 9,797,493
Share premium 19 16,808,647 16,808,647
Other reserves 20 921,801 904,226
Reverse asset acquisition
reserve 4 (6,157,894) (6,157,894)
Foreign currency translation
reserve (980,563) (25,921)
Retained Earnings (17,114,056) (13,134,742)
-------------- ----------------
Equity attributable to owners
of the Company 3,275,428 8,191,809
Non-controlling interests (31,908) (24,240)
-------------- ----------------
Total equity 3,243,520 8,167,569
-------------- ----------------
Liabilities
Non-current liabilities
Lease liabilities 13 3,100,678 -
Total non-current liabilities 3,100,678 -
Current liabilities
Trade and other payables 22 426,254 342,689
Borrowings 23 - -
Lease liabilities 13 322,157 10,152
-------------- ----------------
Total current liabilities 748,411 352,841
Total liabilities 3,849,089 352,841
-------------- ----------------
Total equity and liabilities 7,092,609 8,520,410
============== ================
This report was approved by the Board and authorised for issue
on 27 April 2023 and signed on its behalf by Dr Vladislav Sandler,
CEO
The Notes to the Financial Statements form an integral part of
these Financial Statements.
Company Statement of Financial Position
Company
31 December 31 December
Note 2022 2021
GBP GBP
--------------
Assets
Non-current assets
Loan to subsidiaries 15 14,451,733 13,214,507
Investment in subsidiary 16 8,000,000 8,000,000
Total non-current assets 22,451,733 21,214,507
Current assets
Trade and other receivables 17 20,405 15,478
Cash and cash equivalents 88,909 111,245
Total current assets 109,314 126,723
Total assets 22,561,047 21,341,230
============== ==============
Equity and Liabilities
Equity attributable to shareholders
Foreign currency translation reserve
Paid-in Capital
Called up share capital 18 9,797,493 9,797,493
Share premium 19 16,808,647 16,808,647
Other reserves 20 920,697 903,122
Retained Earnings (5,100,447) (6,302,461)
Total Equity 22,246,390 21,206,801
Liabilities
Current liabilities
Trade and other payables 22 134,657 134,429
Total current liabilities 134,657 134,429
Total liabilities 134,657 134,429
-------------- --------------
Total equity and liabilities 22,561,047 21,341,230
============== ==============
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 gain/(loss) attributable to Hemogenyx Pharmaceuticals plc
for the year ended 31 December 2022 was GBP1,202,014 (2021:
(GBP3,166,171)).
This report was approved by the Board and authorised for issue
on 27 April 2023 and signed on its behalf by Dr Vladislav Sandler,
CEO
The Notes to the Financial Statements form an integral part of
these Financial Statements.
Consolidated Statement of Changes in Equity
Group
Foreign
Called Reverse currency Non-
up Share Share Other acquisition translation Retained Controlling Total
Capital Premium reserves reserve reserve earnings interests Equity
GBP GBP GBP GBP GBP GBP GBP GBP
------------------ ----------------- ---------- ------------------ --------------- -------------------- ---------------- ----------------
As at 1
January
2021 4,336,363 9,990,965 764,815 (6,157,894) (7,896) (8,035,514) (15,158) 875,681
------------------ ----------------- ---------- ------------------ --------------- -------------------- ---------------- ----------------
Loss in year - - - - - (5,099,228) (9,082) (5,108,310)
Other
Comprehensive
Income - - - - (18,025) - - (18,025)
------------------ ----------------- ---------- ------------------ --------------- -------------------- ---------------- ----------------
Total
comprehensive
income for
the year - - - - (18,025) (5,099,228) (9,082) (5,126,335)
------------------ ----------------- ---------- ------------------ --------------- -------------------- ---------------- ----------------
Conversion
of debt to
equity 5,373,710 5,026,290 - - - - - 10,400,000
Shares issued
to arrangers
of debt
facility 77,420 522,580 - - - - - 600,000
Shares issued
to consultant 10,000 56,337 - - - - - 66,337
Charge
recognised
upon
conversion
of debt - 1,212,475 - - - - - 1,212,475
Issue of
options - - 153,355 - - - - 153,355
Adjustment
to Embedded
derivative
on
convertible
note - - (13,944) - - - - (13,944)
As at 31
December 2021 9,797,493 16,808,647 904,226 (6,157,894) (25,921) (13,134,742) (24,240) 8,167,569
------------------ ----------------- ---------- ------------------ --------------- -------------------- ---------------- ----------------
Loss in year - - - - - (3,979,314) (7,668) (3,986,982)
Other
Comprehensive
Income - - - - (954,642) - - (954,642)
------------------ ----------------- ---------- ------------------ --------------- -------------------- ---------------- ----------------
Total
comprehensive
income for
the year - - - - (954,642) (3,979,314) (7,668) (4,941,625)
------------------ ----------------- ---------- ------------------ --------------- -------------------- ---------------- ----------------
Extension
of options - - 17,575 - - - - 17,575
As at 31
December 2022 9,797,493 16,808,647 921,801 (6,157,894) (980,563) (17,114,056) (31,908) 3,243,520
------------------ ----------------- ---------- ------------------ --------------- -------------------- ---------------- ----------------
The notes to the financial statements form an integral part of
these financial statements.
Company Statement of Changes in Equity
Company
Foreign
Called currency
up Share Share translation Other Retained Total
Capital Premium reserve reserves earnings Equity
GBP GBP GBP GBP GBP GBP
---------------- ---------------- ------------ ---------- ------------------ ------------------------
As at 31
December
2020 4,336,363 9,990,965 - 749,767 (3,136,290) 11,940,805
---------------- ---------------- ------------ ---------- ------------------ ------------------------
Loss in year - - - - (3,166,171) (3,166,171)
Other
Comprehensive
Income - - - - - -
---------------- ---------------- ------------ ---------- ------------------ ------------------------
Total
comprehensive
income for
the
year - - - - (3,166,171) (3,166,171)
Conversion of
debt
to equity 5,373,710 5,026,290 - 10,400,000
Shares issued
to
arrangers of
debt
facility 77,420 522,580 - - 600,000
Shares issued
to
consultant 10,000 56,337 - - - 66,337
Charge
recognised
upon
conversion
of debt - 1,212,475 - - - 1,212,475
Issue of
options - - - 153,355 - 153,355
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
Extension of
stock
options - - - 17,575 - 17,575
As at 31
December
2022 9,797,493 16,808,647 - 920,697 (5,100,447) 22,426,390
---------------- ---------------- ------------ ---------- ------------------ ------------------------
The notes to the financial statements form an integral part of
these financial statements.
Consolidated Statement of Cash Flows
Year Ended Year Ended
31 December 31 December
Group Note 2022 2021
GBP GBP
------------- -----------------
Cash flows generated from operating activities
Loss before income tax (3,986,982) (5,108,310)
Depreciation 12 195,246 126,340
Other non-cash items 81 77
Interest income (10,599) (17,958)
Interest expense 33 923,361
Beneficial conversion charge related
to convertible debt 23 - 1,212,475
Share based payments 20 17,575 153,355
Changes in right of use asset and lease
liability, net 627,515 -
Foreign exchange gain 12,937 (18,025)
(Decrease)/Increase in trade and other
payables (27,120) 298,070
Increase in trade and other receivables (2,109) (196,683)
Decrease in prepaid and deposits 271,819 -
Net cash outflow used in operating activities (2,910,604) (2,627,298)
------------- -----------------
Cash flows generated from financing activities
Proceeds from issuance of debt and equity
securities - 12,000,000
Repayment of loans and borrowings 23 - (3,183,281)
Payment of lease liabilities (110,144) (39,079)
Net cash flow (used in)/generated from
financing activities (110,144) 8,777,640
------------- -----------------
Cash flows generated from investing activities
Interest income 10,599 17,958
Payment of security deposit for lease (1,908) (138,913)
Payment for intangible assets - (181,743)
Purchase of property & equipment (428,945) (636,255)
Net cash flow generated from/(used in)
investing activities (420,254) (938,953)
------------- -----------------
Net (decrease)/increase in cash and cash
equivalents (3,432,002) 5,211,389
Effect of exchange rates on cash (876,209) (182,719)
Cash and cash equivalents at the beginning
of the year 6,840,969 1,812,299
------------- -----------------
Cash and cash equivalents at the end
of the year 2,532,758 6,840,969
------------- -----------------
The notes to the financial statements form an integral part of
these financial statements.
Company Statement of Cash Flows
Year Ended Year Ended
31 December 31 December
Company Note 2022 2021
GBP GBP
------------------ -----------------
Cash flows generated from operating
activities
Gain/(loss) before income tax 1,202,014 (3,166,171)
Foreign exchange gain (1,539,778) (184,759)
Interest expense - 883,692
Beneficial conversion charge related
to convertible debt - 1,212,475
Share based payments 20 17,575 153,356
(Increase)/decrease in trade and
other receivables (4,927) 45,970
Increase in trade and other payables 228 -
Adjustments to net loss for cash
items - (5,822)
Net cash outflow used in operating
activities (324,888) (1,061,259)
------------------ -----------------
Cash flows generated from financing
activities
Proceeds from issuance of debt and
equity securities - 12,000,000
Repayment of loans and borrowings - (1,600,000)
Net cash flow generated from financing
activities - 10,400,000
------------------ -----------------
Cash flows generated from/(used in)
investing activities
Loan from/(to) related parties 301,421 (10,263,778)
Net cash flow generated from/(used
in) investing activities 301,421 (10,263,778)
------------------ -----------------
Net decrease in cash and cash equivalents (23,467) (925,037)
Effect of exchange rates on cash 1,131 68
Cash and cash equivalents at the
beginning of the year 111,245 1,036,214
------------------ -----------------
Cash and cash equivalents at the
end of the year 88,909 111,245
------------------ -----------------
The Notes to the Financial Statements form an integral part of
these Financial Statements.
Notes to the Financial Statements
1. General i nformation
The Group's business is preclinical-stage biotechnology focused
on the discovery, development and commercialisation of innovative
treatments relating to bone marrow/hematopoietic (blood-forming)
stem cell (BM/HSC) transplants for blood diseases, including
leukaemia, lymphoma and bone marrow failure, autoimmune disease,
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 p olicies
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 c onsolidation
The consolidated financial statements comprise the financial
statements of Hemogenyx Pharmaceuticals plc and its subsidiaries as
at 31 December 2022. 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 4 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 2022 was GBP1,202,024 (2021:
GBP3,166,171).
On 30 March 2022, the Company formally dissolved its Belgian
subsidiary Hemogenyx-Cell SPRL.
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.
(iii) Government grants
Government grants relate to financial grants from governments,
public authorities, and similar local, national or international
bodies. These are recognised when there is a reasonable assurance
that the Company will comply with the conditions attaching to them,
and that the grant will be received. Government grants relating to
research and development are off-set against the relevant
costs.
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 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. As there is no quoted price in an active
market, fair value cannot be reliably measured.
Going concern
The preparation of financial statements requires an assessment
on the validity of the going concern assumption.
The Company did not raise any outside funding during the year
ended 31 December 2022. The Company had cash and cash equivalents
totalling GBP2,532,758 as at 31 December 2022. On 26 January 2023
the Company raised gross placing proceeds of GBP4,056,250, which
will be used to facilitate 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 based on its CBR platform.
The Directors, having made due and careful enquiry, are of the
opinion that the Group and Company have 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 Group and 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.
Notwithstanding the Group's cash balance, should the Group elect
to raise additional capital within the next year, it 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.
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 ("GBP"). 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 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 in to
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.
Deferred Financing Costs
Deferred financing costs represent direct expenditures made by
the Company for the financing transaction completed in January
2021. These costs were offset against the proceeds received in 2021
from the financing transactions.
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 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.
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 15, Revenue from Contracts with Customers
The Company follows IFRS 15, which establishes principles for
reporting useful information to users of financial statements about
the nature, amount, timing, and uncertainty of revenue and cash
flows arising from an entity's contracts with customers. The
standard establishes a five-step principle-based approach for
revenue recognition and is based on the concept of recognising an
amount that reflects the consideration for performance obligations
only when they are satisfied, and the control of goods or services
is transferred.
Historically, the majority of the Group's revenue has been
derived from fees related to collaboration agreements.
Management reviewed contracts where the Group received
consideration in order to determine whether or not they should be
accounted for in accordance with IFRS 15. To date, Hemogenyx
Pharmaceuticals has entered into few transactions that meet the
scope of IFRS 15. Instead, most income has been generated through
collaboration agreements and grants with counterparties that do not
meet the definition of a customer, and therefore the contracts fall
outside the scope of IFRS 15 and have been accounted for in
accordance with IAS 20.
Income is recognised at either a point-in-time or over time,
depending on the nature of the services and existence of acceptance
clauses.
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.
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 2022
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 2022 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 1 January 2023
as Current or Non-Current.
------------------------------ ---------------
IAS 8 (Amendments) Accounting estimates 1 January 2023
------------------------------ ---------------
IAS 17 (Amendments) Insurance 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 20 for
details.
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 14 for further details.
4. Reverse acquisition and LSE listing
On 4 October 2017, the Company acquired the entire issued share
capital of Hemogenyx Pharmaceuticals LLC, a private company
incorporated in the United States, by way of a share for share
exchange . In substance, the shareholders of Hemogenyx
Pharmaceuticals LLC acquired a controlling interest in the Company
and the transaction has therefore been accounted for as a reverse
acquisition. Following the completion of the transaction the
Company changed its name to Hemogenyx Pharmaceuticals plc.
The reverse acquisition reserve that arose from the reverse
takeover is $6,157,894 at December 31, 2022 and 2021 and is made up
of the following:
Components
GBP
--------------------
Pre-acquisition losses of Hemogenyx Pharmaceuticals
plc1 (799,763)
Hemogenyx Pharmaceuticals LLC issued capital
at acquisition2 1,010,849
Investment in Hemogenyx Pharmaceuticals LLC3 (8,000,000)
Reverse acquisition expense4 1,631,020
As at December 31, 2022 and 2021 (6,157,894)
--------------------
The movements on the Reverse acquisition reserve are as
follows:
1. These consolidated financial statements present the legal
capital structure of the Company. However, under reverse
acquisition accounting rules, the Company was not acquired until 4
October 2017 and therefore the entry above is required to eliminate
the initial retained losses of the Company.
2. Hemogenyx Pharmaceuticals LLC had issued share capital of
equivalent to GBP1,010,849 as at 4 October 2017. As these financial
statements present the capital structure of the parent entity, the
issue of equity by Hemogenyx Pharmaceuticals LLC has been recorded
in this reserve.
3. The Company issued 228,571,428 shares at GBP0.035 each,
totalling GBP8,000,000 for the entire issued capital of Hemogenyx
Pharmaceuticals LLC. The above entry is required to eliminate the
balance sheet impact of this transaction.
4. The entry above represents the difference between the value
of the equity issued by the Company, and the deemed consideration
given by Hemogenyx Pharmaceuticals LLC to acquire the Company.
5. 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 2022 and 2021:
Year Ended Year Ended
31 December 31 December
2022 2021
GBP GBP
------------- -------------
Segment assets
United Kingdom
- -
* Non-current
------------- -------------
* Current 109,314 126,723
United States
* Non-current 4,497,827 1,381,221
------------- -------------
* Current 2,464,581 6,992,630
Belgium (Discontinued operation)
- -
* Non-current
-------------
* Current 20,887 19,836
Total
* Non-current 4,497,827 1,381,221
------------- -------------
* Current 2,594,782 7,139,189
Capital expenditure
United Kingdom - -
United States 430,611 636,255
Belgium (Discontinued operation) - -
------------- -------------
430,611 636,255
------------- -------------
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:
GBP5,706.
6. Expenses by nature
Group Group
Year Ended Year Ended
31 December 31 December
2022 2021
GBP GBP
------------- -------------
Laboratory expenses 402,940 37,583
Consumable equipment and supplies 2,196,822 283,647
Contractors & consultants 290,688 468,505
Travel 44,057 10,603
Staff Costs 1,424,301 1,023,783
Insurance 77,652 56,363
Other 167,621 285,844
Legal and professional fees 362,334 537,954
Foreign exchange loss / (gain) (1,532,939) (127,868)
------------- -------------
Total Administrative Expenses 3,433,476 2,576,414
7. Other income
Other income during the period ended 31 December 2022 consists
of GBP0 (2021: GBP171,875, comprising GBP71,932 arising from the
forgiveness of a US governmental loan programme (the Payroll
Protection Program) and GBP99,943 received from a third party under
a research collaboration programme relating to humanised mice).
8. Employees
Group Group Company Company
Year Ended 31 Year Ended 31 Year Ended 31 Year Ended 31
December 2022 December 2021 December 2022 December 2021
GBP GBP GBP GBP
Wages and salaries 1,288,215 810,851 115,000 115,000
Social security 90,220 41,377 1,542 1,408
Share based payments 17,575 153,356 17,575 137,390
Pension contributions 28,291 18,199 - -
------------------------ --------------------- --------------------- --------------------- ---------------------
1,424,301 1,023,783 134,117 253,798
----------------------- --------------------- --------------------- --------------------- ---------------------
Average number of people (including Executive Directors)
employed:
Group Group Company Company
Year Ended Year Ended Year Ended Year Ended
31 December 31 December 31 December 31 December
2022 2021 2022 2021
Research & development 9 7 - -
Administration 5 3 2 2
14 10 2 2
------------- ------------- ------------- -------------
9. Auditor's remuneration
Group Group
Year Ended Year Ended
31 December 31 December
2022 2021
GBP GBP
------------- -------------
Fees payable to the Company auditor:
Audit of the financial statements of the
Group and Company 50,000 46,700
50,000 46,700
------------- -------------
10. Income tax
Group Group
Year Ended
Year Ended 31 December 31 December
2022 2021
GBP GBP
----------------------- -------------
Current Tax: - -
Tax on loss on ordinary activities - -
----------------------- -------------
Loss on ordinary activities
before tax (3,986,982) (5,108,310)
Analysis of charge in the
year:
Loss on ordinary activities
multiplied by weighted average
tax rate for the group of
27.36% (2020: 22.40%) (1,090,838) (1,145,371)
Disallowed items 330,370 405,711
US R&D credit and timing
differences (323,215) (136,371)
Tax losses carried forward 1,083,683 1,200,007
----------------------- -------------
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 2022 are 19% and 28% in the UK and the USA
respectively.
The Group has accumulated tax losses arising in the UK of
approximately GBP3,225,000 (Dec 2021: GBP4,450,000) 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 $11,377,000 (Dec 2021: $6,700,000) 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.
11. 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
GBP3,979,314 (2021: GBP5,099,228) by the weighted average number of
ordinary shares in issue during the year of 979,749,321 (2021:
773,952,166).
Dilutive loss per Ordinary Share equals basic loss per Ordinary
Share as, due to the losses incurred in 2022 and 2021 , there is no
dilutive effect from the subsisting share options. See Note 20 for
details of stock options and warrants outstanding.
12. Property and equipment
Property, Computer Leasehold Total
plant & equipment Improve-ments
Group equipment
GBP GBP GBP GBP
----------------------------- -------------- ----------- --------------- ---------------
Cost
31 December 2020 425,108 10,957 - 436,065
----------------------------- -------------- ----------- --------------- ---------------
Additions - 8,508 627,747 636,255
Foreign exchange movement 5,063 263 16,408 21,734
----------------------------- -------------- ----------- --------------- ---------------
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
----------------------------- -------------- ----------- --------------- ---------------
Accumulated depreciation
and impairment losses
31 December 2020 209,783 3,424 - 213,207
----------------------------- -------------- ----------- --------------- ---------------
Depreciation 84,645 5,322 - 89,967
Foreign exchange movement 2,881 112 - 2,993
----------------------------- -------------- ----------- --------------- ---------------
31 December 2021 297,309 8,858 - 306,167
----------------------------- -------------- ----------- --------------- ---------------
Depreciation 116,493 8,129 75,226 199,848
Foreign exchange movement 54,693 677 42,900 98,270
----------------------------- -------------- ----------- --------------- ---------------
31 December 2022 468,495 17,664 118,127 604,285
----------------------------- -------------- ----------- --------------- ---------------
Carrying amounts
------------------ ------------- ------- -------- ----------
31 December 2020 215,325 7,533 - 222,858
------------------ ------------- ------- -------- ----------
31 December 2021 132,862 10,870 644,155 787,887
------------------ ------------- ------- -------- ----------
31 December 2022 403,918 15,290 604,044 1,023,252
------------------ ------------- ------- -------- ----------
13. 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:
Group & Company
Right of use Lease liability Income statement
asset GBP GBP
GBP
---------------------- ------------- --- ---------------- --- -----------------
Carrying value
at 31 December 2020 45,885 (48,754) (40,531)
---------------------- ------------- --- ---------------- --- -----------------
Depreciation (36,373) - (36,373)
Interest - (1,560) (1,560)
Lease payments - 39,167 -
Foreign exchange
movements (270) 995 -
Carrying 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)
Carrying value
at 31 December 2022 2,892,261 (3,422,835) (539,748)
---------------------- ------------- --- ---------------- --- -----------------
14. Intangible assets
On 15 January 201 5, the Com pany entered into an E xclusive
License Ag ree ment with Cornell University to grant to the Co
mpany patent rig hts to pat e nt PCT/US14/65469 entitled Post-Natal
He mat opoietic Endothelial Cells and Their I s olation and Use and
rights to any prod uct or method deriving theref rom. T he Co mpany
paid Co r nell University USD $3 4 7,500 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
GBP181,743 GBP or $250,000 USD 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, 2022, the Company has not incurred any development or
sales-based payment obligations to the licensor.
Cost Intellectual
Property
GBP
-------------
31 December 2020 254,955
Additions 181,743
Exchange movements 4,795
-------------
31 December 2021 441,493
-------------
Additions -
Exchange movements -
-------------
31 December 2022 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.
15. Loan to subsidiary
Company Company
Year Ended Year Ended
31 December 31 December
2022 2021
GBP GBP
------------- -------------
Hemogenyx Pharmaceuticals
LLC 14,451,112 13,213,951
Immugenyx LLC 621 556
14,451,733 13,214,507
------------- -------------
Hemogenyx Pharmaceuticals plc has made cumulative loans to
Hemogenyx Pharmaceuticals LLC of US$17,883,274 (GBP14,4551,112) as
at 31 December 2022 (Dec 2021: US$17,883,274 (GBP13,213,951)) and
Immugenyx LLC of US$752 (GBP621) as at 31 December 2022 (Dec 2021:
US$752 (GBP556)). 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
2022 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.
16. Investment in subsidiary
Proportion Proportion
of ordinary of ordinary
shares held shares held
directly ultimately
Address of the registered Nature of by parent by parent
Name office business (%) (%)
----------------------------- ----------------------------- ----------------- -------------- -------------
Hemogenyx UK 6(th) Floor, 60 Gracechurch Holding Company 100 -
Limited Street, London, EC3V
0HR
9 East Lookerman
Street, Suite 3A,
Hemogenyx Pharmaceuticals Dover, Kent, Delaware, Biomedical
LLC USA, 19901 sciences - 100
c/o Corporation Service
Company, 251 Little
Falls Drive, Wilmington, Biomedical
Immugenyx LLC Delaware, USA, 19808 sciences - 92.2
Hemogenyx-Cell Avenue du Parc Industriel
SPRL (dissolved 89, 4041 Milmort, Biomedical
in 2022) Belgique 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 2022, Hemogenyx Pharmaceuticals LLC, Dr Sandler, and Ms
Sirochinsky each own 500,000, 40,000, and 2,500 shares in Immugenyx
LLC, respectively.
17. Trade and other receivables
Group Group Company Company
Year Ended Year Ended Year Ended Year Ended
31 December 31 December 31 December 31 December
2022 2021 2022 2021
GBP GBP GBP GBP
-------------------- ------------- -------------------- --------------------
VAT receivable 9,664 6,127 9,664 6,127
Trade and other receivables 146 1,386 - -
Prepayments 52,214 290,707 10,741 9,351
Total trade and other
receivables 62,024 298,220 20,405 15,478
-------------------- ------------- -------------------- --------------------
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.
18. Called up share capital
Group & Company Number of shares GBP
--------------------------------------------------------------- ----------------- ----------
As at 31 December 2020 433,636,255 4,336,363
--------------------------------------------------------------- ----------------- ----------
Conversion of debt to issue of shares - placement 25 Feb 2021 13,131,313 131,313
Conversion of debt to issue of shares - placement 26 Mar 2021 14,285,714 142,857
Conversion of debt to issue of shares - placement 16 Apr 2021 24,547,803 245,478
Conversion of debt to issue of shares - placement 26 Apr 2021 29,850,746 298,508
Conversion of debt to issue of shares - placement 5 May 2021 22,222,222 222,222
Conversion of debt to issue of shares - placement 18 May 2021 433,333,333 4,333,333
Shares issued as arrangement fees for debt issuance 8,741,935 87,419
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
--------------------------------------------------------------- ----------------- ----------
During 2021, the Company issued 546,113,066 ordinary shares upon
conversion of debt - See Note 23. During 2022, the Company did not
issue any ordinary shares.
19. Share premium
Group & Company GBP
As at 31 December 2020 9,990,965
------------------------------------------- -----------
Issue of shares - placement 5,548,969
Issues of shares - consultant 66,337
Charge recognised upon conversion of debt 1,212,475
------------------------------------------- -----------
As at 31 December 2021 16,808,647
------------------------------------------- -----------
As at 31 December 2022 16,808,647
------------------------------------------- -----------
20. Other reserves
Year Ended Year Ended
Group: 31 December 31 December
2022 2021
GBP GBP
------------- -------------
As at start of year 904,226 764,815
Charge for the year - employees 17,575 153,355
Convertible Note embedded derivative - (13,944)
------------- -------------
As at end of year 921,801 904,226
------------- -------------
Year Ended Year Ended
Company: 31 December 31 December
2022 2021
GBP GBP
------------- -------------
As at start of year 903,122 749,767
Charge for the year - employees 17,575 153,355
As at end of year 920,697 903,122
------------- -------------
The expense recognised for employee and non-employee services
during the year is shown in the following table:
Year Ended Year Ended
Group and Company: 31 December 31 December
2022 2021
GBP GBP
------------ ------------
Expense arising from equity-settled share-based
payment transactions 17,575 153,355
Total expense arising from share-based
payment transactions 17,575 153,355
------------ ------------
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.
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.
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. 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* 47,227,020
Members of the Scientific Advisory Board 12,481,912
Total 59,708,931
------------------------------------------ ---------------
* 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: 2022 2022 2021 2021
Number Weighted Average Exercise Number Weighted Average Exercise
Price pence Price pence
------------ ---------------------------- ---------- ----------------------------
Outstanding at the beginning
of the year 45,081,506 4.4 42,465,787 4.6
Granted during the year - - 3,090,441 2.1
Lapsed during the year (14,588,497) 3.5 (474,722) 9.0
Extended during the year 4,806,577 3.5 - -
------------ ----------------------------
Outstanding at end of year 35,299,586 4.6 45,081,506 4.4
------------ ---------------------------- ---------- ----------------------------
Exercisable at end of year 35,299,586 4.6 43,278,749 3.5
------------ ---------------------------- ---------- ----------------------------
The weighted average remaining contractual life for the share
options outstanding as at 31 December 2021 is 2.93 years (2021:
2.08 years). The weighted average fair value of options granted
during the year was nil (2021: 0.7 pence).
The following table lists the inputs to the models used for the
two plans for the years ended 31 December 2021 and 31 December
2022:
July October 2022 modification
2021 (EMP)
(EMP)
--------------------------------- --- ------------- -------------------------
Expected volatility % 65 68-424
Risk-free interest rate % 0.17 0.64-1.87
Expected life of options (years) 3 2
WAEP - pence 2.1 3.5
Expected dividend yield - -
Model used Black Scholes Black Scholes
-------------------------------------- ------------- -------------------------
21. 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.
22. Trade and other payables
Group Group Company Company
Year Ended Year Ended Year Ended Year Ended
31 December 31 December 31 December 31 December
2022 2021 2022 2021
GBP GBP GBP GBP
------------------------------- ------------- ------------- ------------- -------------
Trade and other payables 374,342 295,829 82,745 87,569
Accruals and deferred
income 51,912 46,860 51,912 46,860
Total 426,254 342,689 134,657 134,429
------------------------------- ------------- ------------- ------------- -------------
Current liabilities 426,254 342,689 134,657 134,429
23. Borrowings
Borrowings may be comprised of borrowings and convertible notes.
The Group follows IFRS 9, and as a result, where instruments
contain liability classified embedded derivatives, an election is
taken to fair value the entire financial instrument through profit
or loss rather than split out the embedded derivative. At 31
December 2022 and 2021, there were no borrowings outstanding. The
notes payable consisted of the following:
Group & Company Year Ended Year Ended
31 December 31 December
2022 2021
------------------------------------------ -------------- -------------
GBP GBP
Borrowings
Balance at 1 January - 753,717
Drawdowns - -
Paydowns - (791,641)
Interest expense - 14,354
Value of embedded derivative transferred
to Other Reserves - 6,972
Foreign exchange movement - 16,598
------------------------------------------ -------------- -------------
Balance at 31 December - -
Convertible Notes
Balance at 1 January - 753,065
Drawdowns - -
Paydowns - (791,641)
Interest expense - 14,300
Value of embedded derivative transferred
to Other Reserves - 6,972
Foreign exchange movement - 17,304
------------------------------------------ -------------- -------------
Balance at 31 December - -
Balance at 1 January - 72,596
Payroll Protection Loan borrowing - -
Payroll Protection Loan forgiveness - (71,932)
Foreign exchange movement - (664)
------------------------------------------ -------------- -------------
Balance at 31 December - -
------------------------------------------ -------------- -------------
Total Borrowings at 31 December - -
------------------------------------------ -------------- -------------
A summary of the prior debt facilities is as follows:
Mint Transactions
In November 2020, Mint Capital Limited ("Mint") and the Company
entered into a Financing Facility agreement ("Financing Facility")
whereby Mint conditionally agreed to subscribe for up to GBP60
million in aggregate principal amount of Convertible Loan Notes
pursuant to an agreement entered into with the Company (the
"Subscription Agreement"). The shareholders of the Company approved
the facility in January 2021 and a prospectus was published on 29
January 2021.
The key terms of the Convertible Loan Notes included:
-- A principal amount of up to GBP60,000,000, split into
denominations of GBP50,000 per Convertible Loan Note. The
Convertible Loan Notes were to be subscribed for at par.
-- The Convertible Loan Notes were to be issued in up to nine
tranches. A tranche of GBP12,000,000 in principal amount was issued
on 3 February 2021. The subsequent eight tranches were to be
issuable at the sole discretion of, and in the amounts determined
by, the Company at respective intervals of 90 days after the
Initial Issue Date. The aggregate maximum principal amount of the
Convertible Loan Notes was limited to GBP60,000,000.
-- No interest was payable on the Convertible Loan Notes.
-- The Convertible Loan Notes were unsecured.
-- Each tranche of Convertible Loan Notes issued was to be
redeemable at par on the date falling 36 months after the relevant
Issue Date (the "Maturity Date").
-- Each of the Convertible Loan Notes was convertible into
ordinary shares of GBP0.01 (1 pence) each in the capital of the
Company ("Ordinary Shares") at any time during the period
commencing on the fifth business day following the relevant Issue
Date and ending at 5.00 p.m. London time on the business day
immediately prior to the relevant Maturity Date (the "Conversion
Period").
-- The price used for the conversion (the "Conversion Price")
was equal to a 10 per cent discount to the lesser of (i) 125 per
cent. of the closing-bid price as reported by Bloomberg for one
Ordinary Share one trading day before the relevant Issue Date
(subject to adjustment to reflect any sub-division or consolidation
of the Ordinary Shares) and (ii) the lowest closing bid-price as
reported by Bloomberg for an Ordinary Share from the three
consecutive trading days ending on the day prior to the date of
service of the relevant conversion notice (or if such conversion
notice was served after 4.35pm on any such date, then the three
consecutive trading days ending on the day such conversion notice
was served. In no event was the Conversion Price to be less than
the nominal value of an Ordinary Share.
-- A holder was not permitted to submit a conversion notice in
respect of the Convertible Loan Notes if the total Ordinary Shares
held by the holder following the execution of such conversion
notice would exceed 29.9% of the Company's total Ordinary
Shares.
-- If the Company were to commit an "event of default" then the
notes could be redeemed at 114-120% of the principal amount of the
convertible loan at the option of the holder.
-- The Company had the ability to redeem the convertible loan
under certain circumstances at 114% of the principal amount of the
convertible loan.
-- Subject to limited exceptions, the Convertible Loan Notes were not transferable.
-- Prior to conversion, the Convertible Loan Notes did not
entitle the holder to any voting rights in the Company.
Arrangement fee
The Company agreed to pay a fee of 5% of the aggregate principal
value of the Convertible Loan Notes issued to the arranger for the
Facility (the "Arranger"). The company issued 7,741,935 shares in
February 2021 as an arrangement fee to the arranger of the
Financing Facility.
Draw Down
The Company received GBP12,000,000 from the first drawn down of
the Financing Facility agreement in February 2021. The price of the
conversion of the convertible loan notes issued under the Financing
Facility agreement into common shares of the Company, as defined by
the Financing Facility agreement, was the lesser of (i) 8.4375p and
(ii) 90% of the lowest closing bid price as reported on Bloomberg
from the three closing bid prices immediately preceding a
conversion.
The Company received a conversion notice from Mint in respect of
GBP650,000 in principal amount of Convertible Loan Notes and issued
13,131,313 shares to Mint in March 2021. Further conversion notices
were received from Mint in respect of GBP900,000 and GBP950,000 in
principal amount of Convertible Loan Notes. The Company issued a
further 14,285,714 shares to Mint in March 2021, and 24,547,803
shares in April 2021; both of these allotments of shares were
admitted to trading on the London Stock Exchange's main market in
April 2021. Further conversion notices were received from Mint in
respect of GBP900,000 and GBP500,000 in principal amount of
Convertible Loan Notes. The Company issued a further 29,850,746
shares to Mint in April 2021, and 22,222,222 shares in May 2021;
both of these allotments of shares were admitted to trading on the
London Stock Exchange's main market in May 2021.
The Company located a new investor to purchase the remaining
position of Mint and received a conversion notice from the new
investor in respect of GBP6,500,000 in principal amount of
Convertible Loan Notes and issued 433,333,333 shares to such
investor in May 2021. The Company repaid the remaining GBP1,600,000
under the facility and the facility was terminated.
During the year ended 31 December, 2021, the Company recognized
GBP3,883 of financing related costs related to the stated interest
rate on the convertible debt through the date of conversion or
repayment. During the year ended 31 December, 2021, the Company
recognized GBP1,409,582 of financing related costs related to the
costs incurred, including fair value of the shares issued to
arrangers to obtain the credit facility from Mint. During the year
ended 31 December, 2021, the Company recognized GBP1,208,592 of
financing related costs representing the fair value of shares
issued in excess of the outstanding principle and accrued interest
at the date of the conversion.
Convertible Loan Facilities
During 2018 Orgenesis entered in to two debt facility agreements
with the Group, one each with Hemogenyx Pharmaceuticals LLC and
Immugenyx LLC:
1) On 7 November 2018 the Group entered into a loan agreement
with Orgenesis Inc., an organisation with which the Group has an
existing collaboration agreement. The loan amount was for not less
than US$1,000,000 with the proceeds of the loan to be used solely
for the development of the cell therapy technology in accordance
with the plan of the collaboration agreement. Drawdowns totalling
US$1,000,000 had been made with Hemogenyx Pharmaceuticals LLC
receiving the funds. The loan carried an interest rate of 2% and
had a term of three years. Orgenesis had the option to convert both
principal and accrued interest into equity in Hemogenyx-Cell at any
time prior to maturity. Hemogenyx-Cell SPRL ("Hemo-Cell") is a
wholly owned Belgian entity and was incorporated in April 2019 at
which point this loan facility was treated as a borrowing in
accordance with the provisions of IAS39. The loan was repaid in
full in November 2021.
2) On 7 November 2018 the Group entered into a loan agreement,
through its wholly owned subsidiary Immugenyx LLC, with Orgenesis
Inc., an organisation with which the Group has an existing
collaboration agreement. The loan amount was for not less than
US$1,000,000 with the proceeds of the loan to be used solely for
the development of the cell therapy technology in accordance with
the plan of the collaboration agreement. Drawdowns totalling
US$1,000,000 had been made. The loan carried an interest rate of 2%
and had a term of three years. Orgenesis had the option to convert
both principal and accrued interest into equity in Immugenyx LLC at
any time prior to maturity. This loan has been treated in
accordance with the provisions of IAS39. The loan was repaid in
full in November 2021.
Paycheck Protection Program Loan
On 1 May 2020, the Company received loan proceeds in the amount
of $98,947 under the Paycheck Protection Program ("PPP"). The PPP,
established as part of the Coronavirus Aid, Relief and Economic
Security Act, as amended ("CARES Act"), provides for loans to
qualifying businesses for amounts up to 2.5 times of the average
monthly payroll expenses of such qualifying business. The loans and
accrued interest are forgivable after certain time periods further
defined in the CARES Act (the "Covered Period") as long as the
borrower uses the loan proceeds for eligible purposes, including
payroll, benefits, rent and utilities, and maintains its payroll
levels. The amount of loan forgiveness will be reduced if the
borrower terminates employees or reduces salaries during the
Covered Period.
The loan was forgiven in April 2021 by being converted into a
grant at the election of the Company. The Company qualified for
this conversion as at least 60% of the amount of the loan was
applied to payroll expenditure and there was no reduction in
employee headcount, and it was therefore included in other
income.
24. 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.
25. 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.
Fair value hierarchy
Financial instruments that are measured subsequent to initial
recognition at fair value are grouped in Levels 1 to 3 based on the
degree to which the fair value is observable:
-- Level 1 fair value measurements are those derived from quoted
prices (unadjusted) in active markets for identical assets or
liabilities; and
-- Level 2 fair value measurements are those derived from inputs
other than quoted prices included within level 1 that are
observable for the asset or liability, either directly (i.e. as
prices) or indirectly (i.e. derived from prices); and
-- Level 3 fair value measurements are those derived from
valuation techniques that include inputs for the asset or liability
that are not based on observable market data (unobservable
inputs).
The Group did not have any financial instruments in Level 1, 2
and 3.
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 2022 and year ended 31 December 2021:
Group Group Company Company
Year Ended Year Ended Year Ended Year Ended
31 December 31 December 31 December 31 December
2022 2021 2022 2021
GBP GBP GBP GBP
------------- ------------- ------------- --------------
Assets
Trade and other receivables,
except prepayments 9,810 1,696 - 310
Cash and cash equivalents 2,532,758 6,840,969 88,909 111,245
2,542,568 6,842,665 88,909 111,555
------------- ------------- ------------- --------------
Liabilities
Trade and other payables (374,343) (295,829) (82,746) (87,569)
Lease liabilities (3,422,835) (10,152) - -
(3,797,178) (305,981) (82,746) (87,569)
------------- ------------- ------------- --------------
Group 1 January Cash flows 31 December
2021 Non-cash changes 2021
Foreign Interest
Adjustment PPP Loan exchange charge
to reserve Forgiveness movements
------------- ------------ ------------- ------------- ------------- ------------- -------------
Short-term
borrowings
(1) 1,579,378 (1,583,281) 13,944 (71,932) 33,237 28,654 -
Long-term
borrowings - - - - - - -
------------- ------------ ------------- ------------- ------------- ------------- -------------
Total 1,579,378 (1,583,281) 13,944 (71,932) 33,237 28,654 -
------------- ------------ ------------- ------------- ------------- ------------- -------------
(1) At December 31, 2021 the principal and interest on
borrowings was paid in full.
a) Credit risk
The Group had receivables of GBP0 owing from customers (31
December 2021: GBP0). All bank deposits are held with Financial
Institutions with a minimum credit rating of B.
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 Group Company Company
Year Ended Year Ended Year Ended Year Ended
31 December 31 December 31 December 31 December
2022 2021 2022 2021
GBP GBP GBP GBP
------------- ------------- -------------- ---------------
Financial Assets
Cash and cash equivalents 2,532,758 6,840,969 88,909 111,245
------------- ------------- -------------- ---------------
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 2022 and 31 December 2021:
31 December 2022
Functional Currency
Currency of net monetary assets/(liabilities) Pound Sterling US Dollars Euro Total
GBP
GBP GBP GBP
----------------------------------------------- --------------- ----------- ------- ----------
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
----------------------------------------------- --------------- ----------- ------- ----------
31 December 2021
Functional Currency
Currency of net monetary assets/(liabilities) Pound Sterling US Dollars Euro Total
GBP
GBP GBP GBP
----------------------------------------------- --------------- ----------- ------- ----------
Pounds Sterling 99,050 - - 99,050
US Dollars 12,197 6,709,888 - 6,722,085
Euros - - 19,834 19,834
----------------------------------------------- --------------- ----------- ------- ----------
Total 111,245 6,709,888 19,834 6,840,969
----------------------------------------------- --------------- ----------- ------- ----------
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 and liabilities
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.
26. 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 GBP855,301 ($1,035,000) plus GBP413,189 ($500,000)
on receipt of 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 2022, none of
the requirements to make such payments have been met. In addition,
the Group pays an annual licence maintenance fee of up to GBP61,978
($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 GBP156,114 ($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 GBP199.956 (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
GBP1,970,911 ($2,109,957) in milestone payments during the term of
production. From 31 December 2021 through 31 December 2022,
Hemogenyx Pharmaceuticals LLC has paid GBP862,670 ($1,134,059)
under these agreements.
27. Ultimate controlling party
The Directors have determined that there is no controlling party
as no individual shareholder holds a controlling interest in the
Company.
28. Subsequent events
In January 2023, the Company successfully completed its second
and third Process Qualification ("PQ") runs of the end-to-end
process for the manufacture of HEMO-CAR-T cells. At least three
identical manufacturing runs are required for the submission of an
Investigational New Drug ("IND") application to the US Food and
Drug Administration ("FDA"). The IND is needed to obtain
authorisation from the FDA to commence Phase I clinical trials of
HEMO-CAR-T. The process was carried out in the Company's current
Good Manufacturing Practice ("cGMP") compliant clean rooms. This
was followed by analytical release tests conducted by the Company
required to verify the quality of the manufactured HEMO-CAR-T cells
and by tests by a third party to ensure they comply with a set of
required quality attributes. These tests were completed in March
2023. Following completion of all tests, data are being compiled
for inclusion in the IND submission pack.
On 23 January 2023 the Company successfully raised GBP4,056,250
(before expenses) through the allotment and issue of 162,250,000
new ordinary shares at 2.5 pence per share (the "Placing"). The
Placing was conducted by Peterhouse Capital Limited and SP Angel
Corporate Finance LLP as joint placing agents for the Company.
The Company has entered into a preliminary agreement with a
service provider that it is anticipated will project manage and
supervise the running of Phase I clinical trials for its HEMO-CAR-T
cell therapy, subject to negotiation of a Master Services
Agreement.
29. 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.
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END
FR EAFLXAFFDEAA
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