TIDMHEMO
RNS Number : 0331O
Hemogenyx Pharmaceuticals PLC
28 September 2023
28 September 2023
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
Half-year Report
Interim Results for the period ended 30 June 2023
Hemogenyx Pharmaceuticals plc (LSE: HEMO), the Standard Listed
biopharmaceutical group developing therapies designed to transform
blood disease treatment, announces its unaudited interim results
for the six-month period ended 30 June 2023.
All financial amounts are stated in GBP British pounds unless
otherwise indicated.
Key Highlights
-- Applied for Investigational New Drug ("IND") status for the
Company's lead product HEMO-CAR-T with the U.S. Food and Drug
Administration ("FDA").
-- IND application placed on clinical hold, with the FDA later
accepting the Company's plan for resolving outstanding issues.
-- Continuing development of Chimeric Bait Receptor ("CBR") antiviral/biodefence platform.
-- Following the period end, the Company received a strategic
investment of US$833,000 from Prevail Partners, LLC ("Prevail
Partners") at a large premium to share price.
-- Entered into agreement with Prevail InfoWorks Inc. ("Prevail
InfoWorks") to provide clinical services and technologies for the
Company's upcoming Phase I clinical trial of HEMO CAR-T.
Fuller details of these developments are contained in the
Interim Management Report below.
Commenting on the outlook for Hemogenyx Pharmaceuticals,
Vladislav Sandler, Chief Executive Officer, said:
"While the placing of HEMO-CAR-T on clinical hold was a setback,
we are clear on the particular area in which additional information
is required, and we are encouraged by the FDA's response to our
plans to resolve the issues. We remain confident and committed to
progressing HEMO CAR-T to clinical trials as the Company's next
step. We have put measures in place to allow us to achieve this
milestone, including the new agreement with Prevail InfoWorks and
the investment by Prevail Partners, which gives a clear signal of
the project's value even at this pre-clinical phase. Meanwhile, the
prospects for our other cutting-edge assets continue to be
positive, and CBR in particular is beginning to attract real
attention."
Interim Management Report
We are pleased to provide an update on the Company's activities
over the six-month period ended 30 June 2023. Although it is not
all plain sailing, we are now developing on a number of fronts
which, while adding materially to operating costs, puts us into a
far stronger position for further development. In particular, we
are now seeing major benefits from our state-of-the-art research
and manufacturing facilities and we have also made cautious but
significant additions to our scientific and manufacturing team.
HEMO-CAR-T
The Company has continued to focus on its lead product
candidate, HEMO-CAR-T, throughout 2023 and, as shareholders are
aware, after substantial work we submitted an IND application to
the FDA in May 2023. The FDA considered that in certain respects
they needed additional information and therefore placed the project
on clinical hold in June. We received a detailed explanation from
the FDA as to the areas needing additional work and we have since
then been working with our manufacturing partner, WuXi, to address
FDA concerns.
We are taking great care to provide a very thorough response
with the aim that the IND application, when resubmitted, is as full
and complete as possible. Having responded to the FDA with a
detailed plan, supported by laboratory tests, to address its
comments, we were pleased earlier this month when the FDA confirmed
that it accepts our plan and that this plan will satisfactorily
address its comments. This will enable the agency to remove the
clinical hold so that we can proceed to clinical trials. There
remains work to be done on this, but we are confident of eventual
success.
The reason for the clinical hold relates to a splicing that
occurs during the manufacturing process of the lentivirus that is
used to produce CAR-T cells. The Company has identified the source
of the splicing deficiency and has already developed a method to
eliminate it. The lentivirus is being remanufactured.
On 14 September, we were able to announce a very important
further step towards the development of HEMO CAR-T which also
represents a real validation of the product's perceived value. We
received a strategic investment from Prevail Partners, a corporate
investment fund investing in clinical stage therapeutics companies.
Prevail Partners has agreed to invest in Hemogenyx Pharmaceuticals
through a subscription to 11,066,667 new ordinary shares at a price
of US$0.075 per share (approximately GBP0.06) for the total sum of
US$830,000 (approximately GBP668,000). Such investment, at a
significant premium to the Company's share price at the time,
represents a vote of confidence by a specialist professional group
with knowledge and experience of the pharmaceutical industry.
The investment by Prevail Partners sits alongside the agreement
entered with Prevail Infoworks, a Philadelphia, PA based Contract
Research Organization (CRO) and affiliate of Prevail Partners, to
provide clinical services and technologies for the Company's
upcoming Phase I study of its anti-FLT3 chimeric antigen
receptor-redirected T cells ("CAR-T cells") in subjects with
relapsed/refractory acute myeloid leukemia (AML). Further details
may be found below in Note 10 to the financial statements titled
'Events after the reporting period'.
CBR
Meanwhile, we have continued to work on our other major product
candidates, in particular our Chimeric Bait Receptor ("CBR")
platform which, as shareholders are aware, is focussed on
developing a new approach which we believe will provide effective
cures for a wide range - indeed perhaps the full range - of viral
infections, including diseases for which no cures are available at
present. In the wake of the COVID-19 pandemic, and facing global
threats of biological warfare and the fast spreading of pandemics
from previously unknown diseases, the need for proactive solutions
against future infectious agents has become clear. To address this
imminent threat, our CBR immunotherapy is designed to prevent and
combat infection by any known or emerging virus.
We have designed a set of novel CBR constructs to programme the
immune cells that are responsible for innate immunity to eliminate
viral infections. Additionally, we have designed and currently test
bait-macrophage engagers ("BMEs") to redirect immune cells to fight
viral infections. Our technology utilises a synthetic biology
approach to advance medicine to protect society from future
pandemics and even future bioweapons that may challenge the global
economy and public health. Our early work concentrated on
SARS-CoV-2 virus and its variants, but we also believe that
CBR-based treatments will be able to deal with a much wider range
of viruses.
We have strengthened our team with the recruitment of additional
scientists during the period, inter alia to work on our CBR/BME
platform. The project has begun to attract high-level interest from
authorities. This interest is gratifying and, given our limited
resources and the need to focus on our lead product HEMO-CAR-T, we
have made considerable progress and plan to devote further internal
resources to this project as soon as HEMO-CAR-T enters clinical
trials.
CDX Antibody
CDX, our CD3-FLT3 bispecific antibody, will provide an
alternative means of treating acute myeloid leukemia and of
conditioning patients for bone marrow transplants when fully
developed. We continue to explore potential partnership
arrangements to take that forward. This remains a potentially
valuable part of our portfolio and we will also work to take this
forward once our lead product has moved into the clinic.
Fundraising
In January 2023, we announced that the Company had raised
GBP4,056,250 before expenses through the placing and subscription
of 162,250,000 new ordinary shares at a price of 2.5p per
share.
In addition, following the period end, we raised a further
US$833,000 (GBP668,000) at approximately GBP0.06, as more fully
described in the section headed "HEMO-CAR-T" above.
Financial Results
During the six months ended 30 June 2023, the Group recorded a
loss before taxation of GBP4,323,564 (2022: GBP1,141,304 loss),
including operating costs of GBP3,896,308 (2022: GBP1,111,010). For
further comparison, the operating costs for the twelve months to 31
December 2022 were GBP3,433,476 . The increased operating loss
marks the increasing volume of work and need to engage external
service providers as the Company's assets are taken towards the
crucial clinical trial stage of their development. These include
significant payments to WuXi and other consultants engaged in
development services, increased costs for our research and
manufacturing facility and additional payroll costs as we added to
our specialist scientific team. The increase in cost is an
inevitable corollary of developing the Company on a broader scale
and moving forward its key projects.
The Company had cash and cash equivalents totalling GBP3,084,852
as of 30 June 2023.
The Future
In the immediate future, we remain laser-focused on resubmitting
our IND application for HEMO-CAR-T to the FDA as soon as we can,
and on preparing for its move into clinical trials.
Responsibility Statement
We confirm that to the best of our knowledge:
-- the Half Year Report has been prepared in accordance with
International Accounting Standard 34 'Interim Financial Reporting';
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; there were no such transactions in the six months
ended 30 June 2023.
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
28 September 2023
Market Abuse Regulation (MAR) Disclosure
The information contained within this announcement is deemed to
constitute inside information as stipulated under the Market Abuse
Regulation ("MAR") (EU) No. 596/2014, as incorporated into UK law
by the European Union (Withdrawal) Act 2018. Upon the publication
of this announcement, this inside information is now considered to
be in the public domain.
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
SP Angel Corporate Finance LLP Tel: +44 (0)20 3470 0470
Matthew Johnson, Vadim Alexandre,
Adam Cowl
Peterhouse Capital Limited Tel: +44 (0)20 7469 0930
Lucy Williams, Duncan Vasey, Charles
Goodfellow
Condensed Consolidated Interim Statement of Comprehensive Loss
for the six months ended 30 June 2023
6 months to 6 months
Continuing Operations Note 30 June 2023 Unaudited to
30 June 2022
Unaudited
GBP GBP
Revenue - -
Administrative Expenses (3,896,308) (1,111,010)
Depreciation (319,909) (32,233)
------------------------- ----------------
Operating Loss (4,216,217) (1,143,243)
Finance Income 54,692 1,956
Finance Costs (162,039) (17)
------------------------- ----------------
Loss before Taxation (4,323,564) (1,141,304)
------------------------- ----------------
Loss attributable to:
- Equity owners (4,321,103) (1,127,675)
- Non-controlling interests (2,461) (13,629)
------------------------- ----------------
Loss for the period (4,323,564) (1,141,304)
------------------------- ----------------
Other comprehensive income
Items that may be reclassified
subsequently to profit or loss:
Translation of foreign operations 751,572 (159,349)
------------------------- ----------------
Total comprehensive income for
the period (3,571,992) (1,300,653)
------------------------- ----------------
Total comprehensive income attributable
to:
- Equity owners (3,569,531) (1,287,024)
- Non-controlling interests (2,461) (13,629)
------------------------- ----------------
Basic and diluted earnings (per
share) 5 (0.003) (0.002)
Condensed Consolidated Interim Statement of Financial Position
as at 30 June 2023
As at As at
30 June 2023 31 December
2022
Note Unaudited Audited
Assets GBP GBP
-------- ----------------------------- ------------------------
Non-current assets
Property, plant and equipment 6 926,643 1,023,252
Security deposit 140,821 140,821
Right of use asset 9 2,550,017 2,892,261
Intangible asset 441,493 441,493
Total non-current assets 4,058,974 4,497,827
Current assets
Trade and other receivables 80,105 62,024
Cash and cash equivalents 3,084,852 2,532,758
Total current assets 3,164,957 2,594,782
Total assets 7,223,931 7,092,609
============================= ========================
Equity and Liabilities
Equity attributable to
shareholders
Paid-in Capital
Called up share capital 7 9,813,718 9,797,493
Share premium 7 20,710,328 16,808,647
Other reserves 962,274 921,801
Reverse asset acquisition
reserve (6,157,894) (6,157,894)
Foreign currency translation
reserve (228,991) (980,563)
Retained Earnings (21,435,159) (17,114,056)
----------------------------- ------------------------
Equity attributable to
owners of the Company 3,664,276 3,275,428
Non-controlling interests (34,369) (31,908)
----------------------------- ------------------------
Total Equity 3,629,907 3,243,520
Liabilities
Non-current liabilities
Lease liabilities 9 2,817,216 3,100,678
--------------------------------- --------------------
Current liabilities 2,817,216 3,100,678
Trade and other payables 328,969 426,254
Lease liabilities 9 447,839 322,157
Total Current Liabilities 776,808 748,411
--------------------------------- --------------------
Total Liabilities 3,594,024 3,849,089
--------------------------------- --------------------
Total equity and liabilities 7,223,931 7,092,609
================================= ====================
The 2022 comparatives are the audited consolidated group
accounts for the year ended 31 December 2022 as published on 27
April 2023.
Condensed Consolidated Interim Statement of Changes in Equity
for the six months ended 30 June 2023 and 30 June 2022
Called Foreign
up Reverse currency Non-
Share Share Other acquisition translation Retained Controlling Total
Capital Premium reserves reserve reserve losses interests Equity
GBP GBP GBP GBP GBP GBP GBP GBP
--------------- --------------- --------- ------------------- --------------- ---------------- ------------------- -----------
As at 1
January
2022 9,797,493 16,808,647 904,226 (6,157,894) (25,921) (13,134,742) (24,240) 8,167,569
--------------- --------------- --------- ------------------- --------------- ---------------- ------------------- -----------
Loss in period - - - - - (1,127,675) (13,629) (1,141,304)
Other
comprehensive
income - - - - (159,349) - - (159,349)
--------------- --------------- --------- ------------------- --------------- ---------------- ------------------- -----------
Total
comprehensive
income for the
year - - - - (159,349) (1,127,675) (13,629) (1,300,653)
--------------- --------------- --------- ------------------- --------------- ---------------- ------------------- -----------
Issue of
options
(Note 8) - - 12,079 - - - - 12,079
As at 30 June
2022 (unaudited) 9,797,493 16,808,647 916,305 (6,157,894) (185,270) (14,262,417) (37,869) 6,878,995
--------- ---------- ------- ----------- ---------- ------------ -------- ---------
As at 1
January
2023 9,797,493 16,808,647 921,801 (6,157,894) (980,563) (17,114,056) (31,908) 3,243,520
----------- -------------- --------- ------------- --------------- ---------------- ---------- -----------
Loss in period - - - - - (4,321,103) (2,461) (4,323,564)
Other
comprehensive
income - - - - 751,572 - - 751,572
----------- -------------- --------- ------------- --------------- ---------------- ---------- -----------
Total
comprehensive
income for the
period - - - - 751,572 (4,321,103) (2,461) (3,571,992)
----------- -------------- --------- ------------- --------------- ---------------- ---------- -----------
Issue of
options
(Note 8) - - 40,473 - - - - 40,473
Issue of shares
(Note 7) 16,225 4,040,025 - - - - - 4,056,250
Cost of capital
(Note 7) - (138,344) - - - - - (138,344)
As at 30 June
203 (unaudited) 9,813,718 20,710,328 962,274 (6,157,894) (228,991) (21,435,159) (34,369) 3,629,907
--------- ---------- ------- ----------- ---------- ------------ -------- ---------
Condensed Consolidated Interim Statement of Cash Flows for the
six months ended 30 June 2023
6 months to 6 months
30 June 2023 to
Group Note Unaudited 30 June
2022
Unaudited
------- -------------------------------------- -----------------------------------
GBP GBP
Cash flows generated from
operating
activities
Loss for the period (4,323,564) (1,141,304)
Depreciation 6 319,909 32,233
Other non-cash items,
including forgiveness
of PPP loan - 2,205
Foreign exchange gain 197,148 1,058
Interest income (54,692) (1,956)
Interest expense 162,039 20
Share based payments 8 40,473 12,079
Changes in right of use asset
and lease
liability, net 314,611 -
(Decrease)/increase in trade
and other
payables (20,727) 500,752
Decrease/(increase) in trade
and other
receivables 5,600 (342,383)
Increase in prepaid and
deposits (25,866) -
-------------------------------------- -----------------------------------
Net cash outflow used in
operating
activities (3,385,069) (937,298)
-------------------------------------- -----------------------------------
Cash flows generated from
financing
activities
Proceeds from issuance of
shares, net
of direct costs 7 3,917,906 -
Payment of lease liabilities 9 (318,079) (5,441)
-------------------------------------- -----------------------------------
Net cash flow generated
from/(used
in) financing activities 3,599,827 (5,441)
-------------------------------------- -----------------------------------
Cash flows generated from
investing
activities
Interest income 54,692 1,956
Purchase of property, plant &
equipment 6 (13,161) (1,553)
-------------------------------------- -----------------------------------
Net cash flow generated from
investing
activities 41,531 403
-------------------------------------- -----------------------------------
Net increase (decrease) in
cash and
cash equivalents 256,289 (942,335)
Effect of exchange rates on
cash and
cash equivalents 295,805 (99,139)
Cash and cash equivalents
at the beginning
of the period 2,532,758 6,840,969
-------------------------------------- -----------------------------------
Cash and cash equivalents at
the end
of the period 3,084,852 5,799,496
-------------------------------------- -----------------------------------
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, and viral infections.
The products under development are designed to address a range of
problems that occur with the current standard of care
treatments.
The Company's registered office is located at 6th Floor, 60
Gracechurch Street, London, EC3V 0HR, and the Company's shares are
listed on the main market of the London Stock Exchange.
2. Interim financial information
The condensed consolidated interim financial statements are for
the six-month period ended 30 June 2023. 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 2022, which were prepared under
International Financial Reporting Standards (IFRS).
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 2022 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 2022 as described in those financial
statements. Several 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 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 during the period to 30 June 2023 and a
further $830,000 (GBP668,000) through the allotment and issue of
11,066,667 Ordinary Shares, after the period end. These proceeds
were raised in order to facilitate the progression of the Company's
HEMO-CAR-T product candidate into clinical trials and to enable the
Company to continue development of product candidates for the
treatment of viral infections based on its CBR platform.
Substantial funding will be required by the Company during the
clinical trial phase and further funding will be sought by the
Company prior to the commencement of the Phase I clinical
trials.
The Company cannot be certain that such additional funding will
be available on acceptable terms, or at all. To the extent that the
Company raises additional funds by issuing equity securities, the
Company's stockholders may experience dilution. Any debt financing,
if available, may involve restrictive covenants. If the Company is
unable to raise additional capital when required or on acceptable
terms, it may have to (i) significantly delay, scale back or
discontinue the development and/or commercialisation of one or more
product candidates; (ii) seek collaborators for product candidates
at an earlier stage than otherwise would be desirable and on terms
that are less favourable than might otherwise be available; or
(iii) relinquish or otherwise dispose of rights to technologies,
product candidates or products that it would otherwise seek to
develop or commercialise on unfavourable terms.
However, the Directors are of the opinion that the Company has
adequate working capital to execute its operations for the present
time and is confident in its ability to access additional financing
over the next 12 months. The Directors, therefore, have made an
informed judgement, at the time of approving these financial
statements, that there is a reasonable expectation that the Company
has adequate resources to continue in operational existence for the
foreseeable future. As a result, the Directors have continued to
adopt the going concern basis of accounting in preparing the annual
financial statements.
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
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, and viral infections.
Accounting Policies
The accounting policies, presentation and methods of computation
applied by the Group in these condensed interim financial
statements are the same as those applied by the Group in its
consolidated financial information in its 2022 Annual Report and
Accounts. The new standards, described below, will be adopted by
the Group when effective, and have had no impact on these half
yearly results.
New and amended accounting standards and interpretations
On 12 February 2021 the IASB issued an amendment to IAS 1
concerning accounting policy disclosures, and an amendment to IAS 8
concerning the definition of accounting estimates. On 7 May 2021
the IASB issued an amendment to IAS 12 concerning deferred tax
related to assets and liabilities arising from a single
transaction. The Company does not expect a material impact from the
application of these two amendments, which are effective for annual
reporting periods beginning on or after 1 January 2023. The Company
adopted these amendments as required, and the impact was not
material.
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 2022.
5. Earnings per share
Basic and fully diluted earnings per share are calculated by
dividing the loss for the six months from continuing operations of
GBP3,571,992(six months to 30 June 2022: GBP1,141,304 loss)
attributable to equity owners of the Group by the weighted average
number of ordinary shares in issue during those periods of
1,042,923,486 and 773,952,166 respectively.
Diluted loss per Ordinary Share equals basic loss per Ordinary
Share as, due to the losses incurred in the six months to 30 June
2023 and six months to 30 June 2022, there is no dilutive effect
from the subsisting share options.
6. Property, Plant and Equipment
During the six months ended 30 June 2023, the Group acquired
assets with a cost of GBP13,161 (six months ended 30 June 2022:
GBP1,553) and incurred depreciation expense of GBP109,769 (six
months ended 30 June 2022: GBP32,233).
7. Issued capital
Shares Called up share
capital Share premium
GBP GBP
---------------------- -------------- ---------------- --------------
As at 31 December
2022 979,749,321 9,797,493 16,808,647
---------------------- -------------- ---------------- --------------
Issue of shares 162,250,000 16,225 4,040,025
Share issuance costs - - (138,344)
As at 30 June 2023 1,141,999,321 9,813,718 20,710,328
---------------------- -------------- ---------------- --------------
During the six months ending 30 June 2023, the Company sold
162,250,000 shares of ordinary stock at a price of 2.5p per share
as part of a private placement of its securities.
8. Share-based payments
Options
During the six months to 30 June 2023, 22,839,986 options with
an exercise price of 2.5p per ordinary share and 34,259,980 options
with an exercise price of 2.875p per ordinary share were issued
under the Company's 2021 Equity Incentive Plan. The first tranche
of 22,839,986 options vests over 5 years and the second tranche of
34,259,980 options vests contingent upon authorisation by the FDA
to commence clinical trials of HEMO-CAR-T. No options lapsed during
the six months to 30 June 2023.
A schedule of options granted since inception for all plans as
at 30 June 2023 is shown below:
Number of options
------------------------------------------ -----------------
Members of the Scientific Advisory Board 12,481,912
Employees, including directors 104,326,986
------------------------------------------ -----------------
Total 116,808,897
------------------------------------------ -----------------
For the six months ended 30 June 2023, the Company recognised
share-based payment expense in the statement of profit or loss of
GBP40,473 (30 June 2022: GBP12,079).
9. Right of use assets and 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. One of the US subsidiaries has an
agreement for the lease of laboratory facilities to which IFRS 16
has been applied.
During the six months ended 30 June 2023, the Group incurred a
right of use asset depreciation expense of GBP210,140 (six months
ended 30 June 2022: GBP4,968), incurred lease liability interest
expense of GBP165,202 (six months ended 30 June 2022: GBP45) and
made lease payments in the amount of GBP318,079 (six months ended
30 June 2022: GBP5,441).
10. Events after the reporting period
On 10 July 2023, the Company announced that it had received a
full review letter from the FDA regarding the IND application for
the Company's product candidate CAR T-cells for the treatment of
AML to the effect that HEMO-CAR-T be put on clinical hold.
On 7 September 2023, the Company's patent under application
number "WO2023168292 Chimeric Bait Receptors and Uses Thereof" was
published by the World Intellectual Property Organization. It
remains to be reviewed and approved by national patent
authorities.
On 14 September 2023, the Company announced that the FDA has
accepted its plan to address the FDA's concerns that resulted in a
clinical hold of the HEMO-CAR-T IND application.
On 18 September 2023, the Company finalised a funding
arrangement with investment fund Prevail Partners, LLC, which
agreed to invest in the Company through a subscription to
11,066,667 ordinary shares at a price of US$0.075 per share
(approximately GBP0.06) for the total sum of US$830,000
(approximately GBP668,000).
On the same date, the Company also announced that its wholly
owned subsidiary, Hemogenyx Pharmaceuticals LLC, has signed a
Master Service and Technology Agreement ("MSTA") with Prevail
InfoWorks, Inc., an affiliate of Prevail Partners. Under the terms
of the MSTA, Prevail InfoWorks is to provide clinical services and
technologies for the Company's upcoming Phase I study of its CAR-T
cells in subjects with relapsed/refractory AML over an initial term
of 40 months.
The subscription funds will in large part defray the payment
made by the Company for the first stage of the work being
undertaken by InfoWorks under the MSTA.
This information is provided by RNS, the news service of the
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(END) Dow Jones Newswires
September 28, 2023 07:28 ET (11:28 GMT)
Hemogenyx Pharmaceuticals (LSE:HEMO)
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Hemogenyx Pharmaceuticals (LSE:HEMO)
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