TIDMHEMO
RNS Number : 5079A
Hemogenyx Pharmaceuticals PLC
30 September 2020
30 September 2020
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or "the Company")
Half-year Report
Interim Results for the period ended 30 June 2020
Hemogenyx Pharmaceuticals plc (LSE: HEMO), the Standard Listed
biopharmaceutical group developing therapies designed to transform
blood disease treatment, announces unaudited interim results for
the six-month period ended 30 June 2020.
All financial amounts are stated in GBP British pounds unless
otherwise indicated.
Key highlights
CAR-T cells
-- Successfully constructed Chimeric Antigen Receptor (CAR)
programmed T cells ("HEMO-CAR-T") for the potential treatment of
Acute Myeloid Leukemia (AML) and tested in vitro and in vivo
-- Post period end, entered into a Sponsored Research Agreement
with the University of Pennsylvania to advance HEMO-CAR-T toward
clinical trials; the agreement is envisaged as the first step of a
larger programme that aims to achieve clinical proof of concept for
HEMO-CAR-T for the treatment of AML
CDX bi-speci c antibodies
-- Extended development agreement with a leading global
pharmaceutical company ("GlobalCo") to finalise manufacturability
work and successfully bring CDX bi-specific antibody to a state of
readiness for pre-clinical development
-- Discussions regarding a potential licensing deal are
continuing with GlobalCo following the extension of the Development
Agreement
COVID-19 Project
-- Deployment of groundbreaking research capabilities and
technologies to develop treatments for COVID-19: using its
humanised mice the Company seeks to discover human neutralising
antibodies that could be used to fight SARS-CoV-2 infections, the
virus that causes COVID-19
Autoimmune diseases
-- Entered into an agreement with Eli Lilly and Company in June
2020 to perform research and development activities aimed at the
discovery and validation of novel materials to be used for the
treatment of Lupus
Human Postnatal Hemogenic Endothelial Cell ("Hu-PHEC") cell
therapy
-- A patent application entitled Post-Natal Hemogenic
Endothelial Cells and Their Isolation and Use was approved by the
United States Patent and Trademark Office and a corresponding
patent was granted by the European Patent Office
Funding
-- Raised a total of GBP3.15 million through the issue of equity
in January and June to support the Company's drug development
programmes and for working capital
Fuller details on these developments are contained in the
Interim Management Report below.
Commenting on the Outlook for Hemogenyx Pharmaceuticals, Sir
Marc Feldmann, Chairman, said:
"The Board is very pleased with the progress being made with the
development of CDX bi-specific antibodies and the development of
CAR-T technology for the treatment of leukaemia, as well as the
potential value that can be created through the Company's updated
humanised mouse model. The Company's efforts to combat the COVID-19
global pandemic and other viral pathogens are of special
importance. The Board believes that the Company is well advanced on
the planned development steps for its CDX antibodies, and will
provide further updates to shareholders as we progress toward the
completion of our collaboration with GlobalCo and enter
pre-clinical development. In all, the Company is on track to
achieve the inflection point in its development to which I referred
in the 2019 annual report."
Concert Party Update
At the time of the Company's admission to the Standard Listing
segment of the Official List in October 2017, various shareholders
were deemed to be acting in concert, further details of which are
provided in the Silver Falcon plc prospectus which can be viewed on
the Company's website. It has now been agreed with the Takeover
Panel that this original concert party can be broken up into two
smaller concert parties and several individual shareholders, none
of which are interested in shares carrying 30% or more of the
voting rights of the Company.
Interim Management Report
Hemogenyx Pharmaceuticals presents an update on the Company's
activities for the six months ended 30 June 2020.
Hemogenyx Pharmaceuticals plc is the holding company for
Hemogenyx LLC, a US-based biotechnology company 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.
The Company is developing several distinct and complementary
product candidates, as well as a platform technology that it uses
as an engine for novel product development. These products are:
CDX antibodies - CDX bi-speci c antibodies for the treatment of
AML and conditioning for bone marrow transplants. CDX antibodies
act by redirecting a patient's own immune cells to eliminate
unwanted leukaemic and blood stem cells, preparing a patient for
bone marrow transplantation;
HEMO-CAR-T - CAR-T* cells for the treatment of AML and
conditioning for bone marrow transplants;
Hu-PHEC - a cell replacement product using Human Postnatal
Hemogenic Endothelial Cells to generate cancer-free,
patient-matched blood stem cells after transplant into the
patient;
Anti-SARS-CoV-2 - a neutralising antibody based treatment for
COVID-19.
* CAR-T therapy is a treatment in which a patient's own T cells,
a type of immune cell, are modified to recognise and kill the
patient's cancer cells. The procedure involves: isolating T cells
from the patient; modifying the isolated T cells in a laboratory
using a CAR (Chimeric Antigen Receptor) gene construct (which
allows the cells to recognise the patient's cancer); amplifying
(growing to large numbers) the newly modified cells; and
re-introducing the cells back into the patient.
The Company has also developed a platform technology for disease
modelling and drug discovery:
Advanced Hematopoietic Chimeras ( " AHC") - The Company has
developed a new type of humanised mice to advance the development
of its CDX antibodies. The unique properties of the AHC give them a
functional human immune system that converts them into a platform
technology that is opening up exciting opportunities for the
Company. These include disease modelling (blood cancers and severe
autoimmune diseases) and pre-clinical testing of novel drugs and
treatments. AHC are a source of revenue for the Company via paid
collaborations with biopharmaceutical companies and research
institutions. In addition, the Company's wholly owned subsidiary
Immugenyx, LLC has developed Advanced peripheral blood
Hematopoietic Chimeras ("ApbHC"), a novel type of humanised mouse
that presents several advantages over other mouse models. Immugenyx
was established by the Company to develop and commercialise the
Company's humanised mice, and the new ApbHC represents a
significant further development in that direction.
To date, Hemogenyx Pharmaceuticals has made impressive progress
on its products whilst efficiently using the Company's limited
financial resources. The Company's main areas of focus are to
progress its CDX antibodies to readiness for clinical trials, to
advance HEMO-CAR-T through pre-clinical development toward clinical
trials, and to develop a novel treatment for COVID-19.
H1 progress update
During the first half of the year, Hemogenyx Pharmaceuticals
made significant progress on several fronts:
CAR-T cells
Hemogenyx Pharmaceuticals successfully constructed and tested
Chimeric Antigen Receptor (CAR) programmed T cells ("HEMO-CAR-T")
for the potential treatment of Acute Myeloid Leukemia (AML).
HEMO-CAR-T was constructed using Hemogenyx Pharmaceuticals'
proprietary humanised monoclonal antibody against a target on the
surface of AML cells. The Company has demonstrated that HEMO-CAR-T
is able to programme human T cells (convert them into HEMO-CAR-T)
to identify and destroy human AML-derived cells in vitro and in
vivo.
Following the period end, the company entered into a Sponsored
Research Agreement with the University of Pennsylvania ("Penn")
designed to advance HEMO-CAR-T toward clinical trials. The
agreement is envisaged as the first step of a larger programme that
aims to achieve clinical proof of concept for HEMO-CAR-T for the
treatment of AML.
Dr Saar Gill, Assistant Professor of Medicine, a
hematologist-oncologist physician scientist and Scientific
co-Director of the Cell Therapy and Transplantation programme at
the University of Pennsylvania, serves as Principal Investigator on
behalf of Penn. Dr Gill's laboratory is part of the Center for
Cellular Immunotherapies ("CCI") whose Director, Dr Carl H. June,
conducted pioneering clinical trials of genetically engineered
cells including CAR-T cells in patients with HIV and diverse forms
of cancer. This work will significantly accelerate the development
of the Company's CAR-T product candidate, putting it on a direct
path to clinical trials and a possible new treatment for AML, for
which there is currently no real effective treatment.
CDX bi-speci c antibodies
Hemogenyx Pharmaceuticals extended its development agreement
with a leading global pharmaceutical company ("GlobalCo") to
finalise manufacturability work and successfully bring its CDX
bi-specific antibody to a state of readiness for pre-clinical
development. Preliminary discussions regarding a potential
licensing deal are continuing with GlobalCo following the extension
of the Development Agreement.
Humanised mice
The collaboration agreement with Janssen Research &
Development, LLC, one of the Janssen Pharmaceutical Companies of
Johnson & Johnson, on the development of a model of systemic
lupus erythematosus (SLE) is progressing.
Autoimmune diseases
The Company entered into a Biological Investigation and Material
Supply Agreement with Eli Lilly and Company in June 2020 to perform
research and development activities aimed at the discovery and
validation of novel materials to be used for the treatment of
systemic lupus erythematosus ("Lupus") and possibly other
autoimmune diseases. This work complements the Company's own
development efforts in these areas.
COVID-19 project
As announced in April 2020, Hemogenyx Pharmaceuticals is
deploying its groundbreaking research capabilities and technologies
to develop treatments for COVID-19. Using the exceptional
characteristics of its ApbHC humanised mice, the Company seeks to
discover human neutralising antibodies - antibodies that are
typically developed by the human immune system to neutralise
invading viral pathogens - that could be used to fight infections
of SARS-CoV-2, the virus that causes COVID-19.
The Company had already been developing treatments to be
deployed against other viral pathogens prior to the onset of
COVID-19, both independently and with a number of pharmaceutical
company partners. The Company's ApbHC mice were developed in part
as a discovery platform for the development of such treatments.
Hemogenyx Pharmaceuticals' scientists have been transplanting cells
from blood samples from convalescent COVID-19 patients into its
mice, with the goal of recreating and isolating a set of
anti-SARS-CoV-2 virus antibodies.
In addition to the COVID-19 work, this initiative aims to
demonstrate how the Company's technology can be deployed rapidly in
emergencies in order to discover human neutralising antibodies
against a host of viral pathogens, including mutations into
possible new strains of COVID-19 and also what infectious disease
experts in the bioprotection and biodefence sectors call "Disease
X", meaning as-yet unknown viruses that may may break out and that
may represent a similar or greater threat than the one presented by
COVID-19.
Human Postnatal Hemogenic Endothelial Cell ("Hu-PHEC") cell
therapy
The Company is developing Hu-PHEC, a cell replacement product
candidate that aims to generate cancer-free, patient-matched blood
stem cells after transplantation into the patient.
A patent application entitled Post-Natal Hemogenic Endothelial
Cells and Their Isolation and Use was approved by the United States
Patent and Trademark Office and issued on 25 February 2020 as
Patent Number 10,570,373. A corresponding patent was granted by the
European Patent Office on 13 May 2020 as Patent Number 3068875.
Financial Results
During the six months ended 30 June 2020 the Company recorded a
loss of GBP 835,189 (H1 2019: GBP706,670 loss). The increase in
loss from the comparable period in 2019 reflects a continued
increase in operational development, and in particular
diversification of activities, made possible by the fundraisings
completed in January and June 2020.
The Company recorded consultancy income of GBP82,880 during the
period ended 30 June 2020 (H1 2019: GBP82,763) which relates to
funds received from a third party under a research collaboration
programme associated with humanised mice.
The Company continued to draw on the cash provided by
convertible loan facilities from Orgenesis Inc. for a maximum of
US$2,000,000. As at 31 December 2019 a total of US$1,500,000 of the
total facilities available had been drawn down, and the remaining
US$500,000 was drawn down in February 2020.
On 30 January 2020 the Company announced that it had raised
GBP648,200 before expenses through a placing and subscription of
36,011,116 ordinary shares at a price of 1.8p per share. An
exercise of warrants at 5.25p per share resulted in the allotment
and admission to trading on 22 May 2020 of 668,000 ordinary shares
for a consideration of GBP35,070. The Company raised a further
GBP2,500,000 before expenses on 5 June 2020 through an
oversubscribed placing of 35,714,286 ordinary shares at a price of
7p per share.
Outlook
The Board remains very pleased with progress, in particular the
rapid advances in the Company's new CAR-T project and its very
significant partnership with the University of Pennsylvania that
promise to accelerate the Company towards clinical trial stage. The
finalisation of the CDX antibody research agreement with GlobalCo
is also greatly anticipated, along with the outcome of commercial
discussions with GlobalCo. The Company has been able to make strong
progress across its main developments thanks to the exceptional
productivity of its team of scientists. The Board believes that the
Company is well advanced on the planned development steps that were
described in the 2019 annual report and the goals set out for the
use of funds raised this year, and will provide further updates to
shareholders as the Company progresses. The Company looks forward
to the future with confidence.
Responsibility Statement
We confirm that to the best of our knowledge:
-- the Half Year Report has been prepared in accordance with
International Accounting Standards 34, Interim Financial Reporting,
as adopted by the EU; and
-- gives a true and fair view of the assets, liabilities,
financial position and loss of the Group; and
-- the Half Year Report includes a fair review of the
information required by DTR 4.2.7R of the Disclosure and
Transparency Rules, being an indication of important events that
have occurred during the first six months of the financial year and
their impact on the set of interim financial statements; and a
description of the principal risks and uncertainties for the
remaining six months of the year; and
-- the Half Year Report includes a fair review of the
information required by DTR 4.2.8R of the Disclosure and
Transparency Rules, being the information required on related party
transactions.
The Half Year Report was approved by the Board of Directors and
the above responsibility statement was signed on its behalf by:
Dr Vladislav Sandler
CEO
30 September 2020
Market Abuse Regulation (MAR) Disclosure
Certain information contained in this announcement would have
been deemed inside information for the purposes of Article 7 of
Regulation (EU) No 596/2014 until the release of this
announcement.
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,
Soltan Tagiev
Tel: +44 (0)20 7469
Peterhouse Capital Limited 0930
Lucy Williams, Duncan Vasey, Charles
Goodfellow
Condensed Consolidated Interim Statement of Comprehensive
Loss
For the six months ended 30 June 2020
6 months 6 months
to 30 June to 30 June
2020 2019
Continuing Operations Note Unaudited Unaudited
GBP GBP
Revenue - -
Administrative Expenses 861,034 759,598
Depreciation 48,566 27,554
Operating Loss (909,600) (787,152)
Other Income 5 90,273 82,763
Finance Income 1,895 9,220
Finance Costs (17,757) (11,501)
Loss before Taxation (835,189) (706,670)
------------------- -------------------
Loss attributable to:
* Equity owners (832,314) (706,670)
* Non-controlling interests (2,875) -
Loss for the period (835,189) (706,670)
------------------- -------------------
Other comprehensive income
Items that may be reclassified
subsequently to profit
or loss:
Translation of foreign
operations (34,412) (3,137)
Total comprehensive income
for the period (869,601) (709,807)
Total comprehensive income
attributable to:
* Equity owners (869,601) (709,807)
* Non-controlling interests (2,875) -
Basic and diluted earnings
(per share) 6 (0.002) (0.002)
Condensed Consolidated Interim Statement of Financial
Position
As at 30 June 2020
30 June Year Ended
2020 31 December
Unaudited 2019
Note Audited
Assets GBP GBP
----- ----------------- -----------------
Non-current assets
Property, plant and equipment 7 102,776 123,922
Right of use asset 97,625 109,442
Intangible asset 280,507 262,050
Total non-current assets 480,908 495,414
Current assets
Trade and other receivables 34,442 55,804
Cash and cash equivalents 3,360,173 498,679
Total current assets 3,394,615 554,483
Total assets 3,875,523 1,049,897
================= =================
Equity and Liabilities
Equity attributable to
shareholders
Paid-in Capital
Called up share capital 8 4,336,363 3,612,429
Share premium 10,125,965 7,699,789
Other reserves 419,976 399,229
Reverse asset acquisition
reserve (6,157,894) (6,157,894)
Foreign currency translation
reserve 18,811 53,223
Retained Earnings (6,785,608) (5,953,294)
Equity attributable to
owners of the Company 1,957,613 (346,518)
Non-controlling interests (5,304) (2,517)
----------------- -----------------
Total Equity 1,952,309 (349,035)
----------------- -----------------
Liabilities
Non-current liabilities
Lease liabilities 56,994 73,192
Borrowings 9 1,650,626 1,144,167
Total non-current liabilities 1,707,620 1,217,359
Current liabilities
Trade and other payables 170,054 141,677
Lease liabilities 45,540 39,896
Total Current Liabilities 215,594 181,573
Total Liabilities 1,923,214 1,398,932
----------------- -----------------
Total equity and liabilities 3,875,523 1,049,897
================= =================
The 2019 comparatives are the audited consolidated group for the
year ended 31 December, 2019 as published on 30 April 2020.
Condensed Consolidated Interim Statement of Changes in
Equity
For the six months ended 30 June 2020
Foreign
Called Other Reverse currency Non-Controlling
up Share Share reserves acquisition translation Retained interests Total
Capital Premium reserve reserve losses Equity
GBP GBP GBP GBP GBP GBP GBP GBP
---------------- ---------------- ----------- -------------- ------------ -------------------------- ----------------- ---------------------------------
As at 1 January
2019 3,601,762 7,340,267 620,059 (6,157,894) 37,047 (4,482,075) - 959,166
Loss in period - - - - (706,670) (706,670)
Other
comprehensive
income - - - - (3,137) - - (3,137)
---------------- ---------------- ----------- -------------- ------------ -------------------------- ----------------- ---------------------------------
Total
comprehensive
income for
the
period - - - - (3,137) (706,670) - (709,807)
---------------- ---------------- ----------- -------------- ------------ -------------------------- ----------------- ---------------------------------
Embedded
derivative
- Convertible
loans - - 6,280 - - - - 6,280
Issue of
options
(Note 8) - - 27,516 - - - - 27,516
Market value
of warrants - 37,658 (37,658) - - - - -
---------------- ---------------- ----------- -------------- ------------ -------------------------- ----------------- ---------------------------------
As at 30 June
2019
(unaudited) 3,601,762 7,377,925 616,197 (6,157,894) 33,910 (5,188,745) - 283,155
---------------- ---------------- ----------- -------------- ------------ -------------------------- ----------------- ---------------------------------
As at 1 January
2020 3,612,429 7,699,789 399,229 (6,157,894) 53,223 (5,953,294) (2,517) (349,035)
---------------- ---------------- ----------- -------------- ------------ -------------------------- ----------------- ---------------------------------
Loss in period - - - - (832,314) (2,875) (835,189)
Other
comprehensive
income - - - - (34,412) - - (34,412)
---------------- ---------------- ----------- -------------- ------------ -------------------------- ----------------- ---------------------------------
Total
comprehensive
income for
the
period - - - - (34,412) (832,314) (2,875) (869,601)
Issue of share
capital 723,934 2,459,336 - - - - 88 3,183,358
Issue of
options
(Note 8) - - 20,747 - - - - 20,747
Share issue
costs - (33,160) - - - - - (33,160)
---------------- ---------------- ----------- -------------- ------------ -------------------------- ----------------- ---------------------------------
As at 30 June
2020
(unaudited) 4,336,363 10,125,965 419,976 (6,157,894) 18,811 (6,785,608) (5,304) 1,952,309
---------------- ---------------- ----------- -------------- ------------ -------------------------- ----------------- ---------------------------------
Condensed Consolidated Interim Statement of Cash Flows
For the six months ended 30 June 2020
6 months 6 months
to 30 June to 30 June
2020 2019
Group Note Unaudited Unaudited
----- ---------------- ----------------
GBP GBP
Cash flows generated from operating
activities
Loss for the period (835,189) (706,670)
Depreciation 48,567 27,554
Other non-cash items interest/professional
fees (shares issued) 88 -
Foreign exchange gain 1,827 (6,920)
Interest income (1,895) (9,220)
Interest expense 17,757 11,501
Share based payments 10 20,747 27,516
Decrease in trade and other payables (55,281) (75,039)
Increase in trade and other receivables 25,246 58,477
Net cash outflow used in operating
activities (778,133) (672,801)
---------------- ----------------
Cash flows generated from financing
activities
Proceeds from issuance of equity
securities 3,183,270 -
Share issue costs (33,160) -
Proceeds from borrowings 484,215 -
Payment of lease liabilities (21,096) -
---------------- ----------------
Net cash flow generated from financing
activities 3,613,229 -
---------------- ----------------
Cash flows generated from investing
activities
Interest income 1,895 9,220
Purchase of property, plant & equipment - (7,098)
---------------- ----------------
Net cash flow generated from investing
activities 1,895 2,122
---------------- ----------------
Net increase / (decrease) in cash
and cash equivalents 2,836,991 (670,679)
Effect of exchange rates on cash 24,503 953
Cash and cash equivalents at the
beginning of the period 498,679 1,762,428
---------------- ----------------
Cash and cash equivalents at the
end of the period 3,360,173 1,092,702
---------------- ----------------
Major non-cash transactions
There were no major non-cash transactions during the period.
Notes to the Condensed Consolidated Interim Financial
Statements
1. General Information
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. 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 5 Fleet Place,
London EC4M 7RD, and it is listed on the London Stock Exchange.
2. Interim financial information
The condensed consolidated interim financial statements are for
the six months period ended 30 June 2020. The condensed
consolidated interim financial statements do not include all the
information required for full annual financial statements and
should be read in conjunction with the consolidated financial
statements of the Group for the year ended 31 December 2019, which
were prepared under International Financial Reporting Standards
(IFRS) as adopted by the European Union (EU).
The condensed consolidated interim financial statements have not
been audited nor have they been reviewed by the Group's auditors
under ISRE 2410 of the Auditing Practices Board. These condensed
consolidated interim financial statements do not constitute
statutory accounts as defined in Section 434 of the Companies Act
2006. The Group's statutory financial statements for the year ended
31 December 2019 prepared under IFRS have been filed with the
Registrar of Companies. The auditor's report on those financial
statements was unqualified and did not contain a statement under
Section 498(2) of the Companies Act 2006.
3. Basis of preparation and changes to the Group's Accounting Policies
The principal accounting policies applied in the preparation of
these consolidated interim condensed financial statements are set
out below. These policies have been consistently applied to all the
periods presented, unless otherwise stated.
Basis of Preparation
The condensed consolidated interim financial statements have
been prepared in accordance with IAS 34 'Interim Financial
Reporting'. The accounting policies adopted in this report are
consistent with those of the annual financial statements for the
year to 31 December 2019 as described in those financial
statements. A number of new or amended standards became applicable
for the current reporting period, but they did not have any impact
on the group's accounting policies and did not require
retrospective adjustments.
Going Concern
The preparation of interim financial statements requires an
assessment on the validity of the going concern assumption.
The Directors have given particular thought to the impact on the
Group that may result from the novel coronavirus and any other
potential pandemics that may arise. The Group's New York operations
are classed as an essential business and are not subject to
closure, and so work continues with prudent hygiene and distancing
measures in place including limited work in the laboratory on rota
and work from home. The Group is allowing for extended delivery
times for some supplies, and for slower progress with collaboration
partners. The Board and UK management continue to operate remotely,
as usual. At present the Group believes that there should be no
material disruption to its work, but the Board continues to monitor
these risks and the Group's business continuity plans.
The Company raised GBP648,200 and GBP2,500,000 before expenses
through equity placings during the period and further funds were
received following the exercise of warrants. The Group had cash and
cash equivalents totalling GBP3,360,173 as at 30 June 2020.
Notwithstanding the Company's cash balance at reporting date,
Hemogenyx Pharmaceuticals may elect to raise additional capital
within the next year to further the development and
commercialisation of current product candidates. The Company cannot
be certain that 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 favorable
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
unfavorable terms.
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 in United Kingdom and
adequate amounts are transferred to the USA operating business on
approval from the board.
The Group currently has one reportable segment: a biotechnology
business focused on the discovery, development and
commercialisation of innovative treatments relating to bone
marrow/hematopoietic (blood-forming) stem cell (BM/HSC) transplants
for blood disease and treatment of blood diseases such as AML and
autoimmune diseases.
Accounting Policies
The accounting policies applied by the Group in these
half-yearly results are the same as those applied by the Group in
its consolidated financial information in its 2019 Annual Report
and Accounts, with the exception of the new standards the Group
adopted as of 1 January 2020, included below.
The same accounting policies, presentation and methods of
computation have been followed in these condensed interim financial
statements as were applied in the preparation of the Group's annual
financial statements for the year ended 31 December 2019 except for
the impact of the adoption of the Standards and interpretations
described below.
Changes in accounting policy and disclosures
(a) Accounting developments during 2020
-- Amendments to References to the Conceptual Framework in IFRS
Standards - effective 1 January 2020.
-- Amendments to IAS 1 and IAS 8: Definition of Material - effective 1 January 2020
(b) New standards, amendments and interpretations in issue but
not yet effective or not yet endorsed and not early adopted
-- Amendments to IFRS 3: Business Combinations Amendments to IAS
1: Classification of Liabilities as Current or Non-Current
4. Significant accounting judgments, 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. Actual results may differ from these
estimates.
In preparing these condensed interim financial statements, the
significant judgements made by management in applying the Group's
accounting policies and the key sources of estimation uncertainty
were the same as those applied to the consolidated financial
statements for the year ended 31 December 2019.
5. Other income
Other income during the period ended 30 June 2020 consists of
GBP82,880 (H1 2019: GBP82,763) received from a third party under a
research collaboration programme relating to humanised mice, and a
GBP7,393 (H1 2019: GBPnil) tax credit received from US Inland
Revenue.
6. Earnings per share
The calculation of the Basic and fully diluted earnings per
share is calculated by dividing the loss for the six months from
continuing operations of GBP832,314 (six months to 30 June 2019:
GBP706,670) attributable to equity owners of the Group by the
weighted average number of ordinary shares in issue during those
periods of 396,250,052 and 360,176,186 respectively.
Dilutive loss per Ordinary Share equals basic loss per Ordinary
Share as, due to the losses incurred in the six months to 30 June
2020 and six months to 30 June 2019 , there is no dilutive effect
from the subsisting share options.
7. Property, Plant and Equipment
During the six months ended 30 June 2020, the Group acquired
assets with a cost of GBPNil (the six months ended 30 June 2019:
GBP7,098).
8. Called up Share Capital
Group Ordinary shares
Number GBP
-------------------------------------------- ---- ---------------- ----------
As at 1 January 2019 and 30 June 2019 360,176,184 3,601,762
As at 1 January 2020 361,242,853 3,612,429
-------------------------------------------------- ---------------- ------------
Issue of shares - placement 30 Jan 2020 36,011,116 360,111
Issue of shares for exercise of warrants
18 May 2020 668,000 6,680
Issue of shares - placement 4 Jun 2020 35,714,286 357,143
-------------------------------------------------- ---------------- ------------
As at 30 June 2020 433,636,255 4,336,363
-------------------------------------------------- ---------------- ------------
9. Borrowings
Included in borrowings is an amount of GBP79,871 (US$98,947)
received during the period under the United States Government's
Paycheck Protection Program in response to the COVID-19 pandemic.
The loan can be converted into a grant at the election of the
Company as long as at least 60% of the amount is applied to payroll
expenditure and there is no reduction in employee headcount.
10. Share-based payments
Options
During the six months to 30 June 2020 no options were issued to
directors or employees and no options were cancelled.
A schedule of options granted is below:
Number options
------------------------------------------ ---------------
Employees, including directors 2 1,206,951
Members of the Scientific Advisory Board 9 ,346,125
Total 30,553,076
------------------------------------------ ---------------
The weighted average fair value of the options granted during
the six months ended 30 June 2020 was GBPNil (30 June 2019:
GBP0.0078).
There were no options issued for the six months ended 30 June
2020. The following table lists the inputs to the models used for
the plan for the six months ended 30 June 2019:
January 2019
(EMP)
-------------------------- -------------
Expected volatility % 52.12
Risk-free interest rate % 0.956
Expected life of options
(years) 5
Weighted average exercise
price - pence 3.5
Expected dividend yield -
Model used Black Scholes
-------------------------- -------------
For the six months ended 30 June 2020, the Group has recognised
GBP20,747 of share-based payment expense in the statement of profit
or loss (30 June 2019: GBP27,516).
11. Events after the reporting period
Following the period end, Hemogenyx Pharmaceuticals entered into
a Sponsored Research Agreement with the University of Pennsylvania
to advance HEMO-CAR-T toward clinical trials. The agreement is
envisaged as the first step of a larger programme that aims to
achieve clinical proof of concept for HEMO-CAR-T for the treatment
of AML.
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END
IR EANNNALFEEFA
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September 30, 2020 02:00 ET (06:00 GMT)
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