REG - Hemogenyx Pharma Plc - Final Results
25/04/2024 07:00
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RNS Number : 9423L Hemogenyx Pharmaceuticals PLC 25 April 2024
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.
25 April 2024
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
Final Results
Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group
developing new therapies and treatments for blood diseases, announces its
final audited results for the year ended 31 December 2023. The Annual Report
is available to view on the Company's web site at https://hemogenyx.com
(https://hemogenyx.com) .
Key Highlights
· Investigational New Drug ("IND") application submitted in May
2023 seeking authorisation from the U.S. Food and Drug
Administration ("FDA") to begin a Phase I clinical trial of HEMO-CAR-T for
treating acute myeloid leukaemia (AML)
· After a clinical hold period, to address manufacturing issues,
HEMO-CAR-T was granted authority from the FDA in February 2024 to commence
Phase I clinical trials
· Continuing development of Chimeric Bait Receptor ("CBR")
antiviral/biodefence platform and filed a patent application entitled Chimeric
Bait Receptors and Uses Thereof
· Successfully raised £5.25 million (before expenses) in total
through the allotment and issue of new ordinary shares during the year ended
31 December 2023, and a further £3.25 million in early 2024
· Entered into agreement with Prevail InfoWorks Inc. 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 Chairman's Statement
below.
Chairman's Statement
I am pleased to report the Company's results for the year ended 31 December
2023. The period was a vital one in the progression of the Company.
Development work on our lead HEMO-CAR-T product candidate was completed and we
were able to submit an Investigational New Drug ("IND") application to the
Food and Drug Administration ("FDA") to enable us to move into clinical trials
for HEMO-CAR-T. Unfortunately, the FDA decided that certain aspects of the
data initially provided did not meet its rigorous safety standards, so it
imposed a clinical hold pending further development of the product. We worked
hard in the final months of the year to meet the FDA's additional requirements
and, as a result, the clinical hold was lifted in January 2024. Hemogenyx
Pharmaceuticals is thereby established as a "clinical stage" company and we
are now proceeding to the next step in the development of HEMO-CAR-T, the
commencement of Phase I clinical trials.
At the same time, we continued to move forward, insofar as funding would
allow, with our other main pipeline assets, our Chimeric Bait Receptor ("CBR")
platform and our CDX bi-specific CD3-FLT3 antibody ("CDX"). Significant
progress was made on the former, as will be described more fully below.
Fundraising
We raised capital on a number of occasions in the period under review.
In January 2023, we were successful in raising £4,056,250 in new equity
capital at 2.5p per share which was intended to take us through the IND
process and to the stage of clinical trials for HEMO-CAR-T. The clinical hold
delayed matters for some months and of course diminished our cash resources.
In December 2023, we therefore raised a further £534,375 at 2.375p per share
to take us to the next key stage.
In September, Prevail Partners LLC ("Prevail Partners") made a strategic
investment of $830,000 (£680,000) through a subscription for 11,066,067 new
ordinary shares in the Company at a price of $0.075 (about 6p), at a premium
of approximately 240% to the then share price. Prevail Partners is the
investment partner of Prevail Infoworks Inc. ("Infoworks"), a contract
research organisation that we have engaged to provide a variety of services
necessary for the implementation and management of the clinical trials of
HEMO-CAR-T. The price at which Prevail Partners made its investment in
Hemogenyx Pharmaceuticals demonstrated its confidence in our HEMO-CAR-T
product candidate. Further information on our association with Prevail
Partners and Infoworks is described in the section headed "HEMO-CAR-T" below.
Since the period end, and following the lifting of the clinical hold, we
raised a further £3.325 million at 2p per share to enable us to move into
clinical trials.
While we accept that recent market conditions have been very difficult, we
have been disappointed by the successively lower price at which we have had to
carry out our fundraisings in the UK market, in the light of the progress we
have made and the view taken by Prevail Partners concerning our status. The
capital recently raised will undoubtedly take us materially further forward
and we are now looking at a number of strategies for the future development of
all three of our current product candidates.
Results for the Period
The Group incurred a loss for the year to 31 December 2023 of £6,696,493 (31
December 2022: £3,986,982 loss).
In the year to 31 December 2023 the loss mainly arose from operational
expenses pursuing the Group's objectives listed in the Strategic Report on
page 10, as well as salaries, consulting and professional fees, and general
administration expenses. These expenses have been met from the proceeds of
equity placings that were undertaken during the period, as further detailed in
the Fundraising section above.
HEMO-CAR-T
The principal objective of HEMO-CAR-T is, as shareholders will know, to
provide a new and more effective treatment and potential cure for relapsed
and/or refractory acute myeloid leukaemia ("R/R AML").
AML is the most common type of acute leukaemia in adults and has poor survival
rates; it is currently treated using chemotherapy, rather than the potentially
more benign and effective form of cell therapy being developed by Hemogenyx
Pharmaceuticals. The successful development of a new therapy for AML would
have a major impact on treatment and survival rates for the disease.
Development work on HEMO-CAR-T was largely completed during 2022 and work in
2023 was mainly devoted to preparing the IND application to the FDA, an
essential step before being able to commence clinical trials. The FDA's
concern, as shareholders will be aware, is primarily with the safety of a
treatment, and it rightly works to a very high standard. The work in preparing
the IND application was extremely detailed and resulted in an application
document running to over 3,000 pages. It was finally submitted in May 2023. As
mentioned above, the FDA was not satisfied with a particular aspect of the
detail provided and therefore imposed a clinical hold on the HEMO-CAR-T
programme in June. Our scientific team worked on resolving the matter through
the latter part of the year and on remanufacturing of the CAR-T components.
This resulted in the clinical hold being lifted in January 2024. Although this
was a setback, it is important to say that the FDA's concerns were limited to
one issue, and we were able to satisfy them much more quickly than many other
companies whose prospective treatments were put on clinical hold.
The removal of the clinical hold has enabled us to proceed with taking
HEMO-CAR-T into clinical trials with the objective of getting an initial
patient injected in the coming months. The Company has been actively putting
the necessary pieces in place for some time, including discussions with the
Hospital of the University of Pennsylvania, one of the leading cancer
treatment hospitals in the US, in order to initiate the clinical trials
process.
Also, crucially, in September 2023, Hemogenyx Pharmaceuticals contracted with
Infoworks, a well-established and experienced contract research organisation
("CRO"), through a Master Services and Contract Agreement for Infoworks to
provide clinical services and technologies for the forthcoming Phase I
clinical trials over an initial term of 40 months. An initial work plan was
agreed, including clinical site coordination, project management, data
management, clinical monitoring, and pharmacovigilance (safety management)
services, with the use of InfoWorks' integrated real-time data analytics
platform for clinical support and real-time analysis. This vital link brings
us Infoworks' operational expertise and will ensure smooth execution of the
clinical trials and fast, reliable data to lower our clinical risk and speed
up our regulatory timeline.
At the same time, Prevail Partners, the investing affiliate of Infoworks, made
the investment at a premium in the Company described more fully in the section
headed "Fundraising" above.
Chimeric Bait Receptor
While our Chimeric Bait Receptor ("CBR") was initially envisaged as a
potential cure for a very wide range of viral diseases, it has recently become
clear that it is also potentially a viable approach for the treatment of a
range of cancers. The development of CBR as a cure for viral infections
continues, and we remain excited about that, but its potential efficacy
against cancer may provide a quicker route to successful development, approval
and use.
While we have had limited resources to apply to the development of our
proprietary CBR technology platform, there have been a number of key
developments and discoveries during the period under review and in the early
part of 2024. We have been able to achieve as much as we have done because
development of novel CBR constructs is facilitated and accelerated by in
silico simulations using Artificial Intelligence ("AI") tools and pipelines.
In the wake of the COVID-19 pandemic, and in the face of global threats of
emerging as well as engineered biological threats, the need for a nimble and
proactive solution against future infectious agents became clear. We developed
CBR as a novel, highly innovative, and patented immunotherapy initially for
COVID-19. However, CBR has been designed to prevent and defeat infection by
any known or emerging virus, potentially subverting the next global pandemic,
and rendering virally-engineered bioweapons ineffective. To achieve proof of
concept, we successfully designed a CBR construct ("CBR-COVID19") to programme
macrophages to neutralise the SARS-CoV-2 virus. We have also demonstrated that
CBR-COVID19 is insensitive to several known variants of SARS-CoV-2 that make
the original SARS-CoV-2 virus more infectious and challenge existing vaccine
approaches. We are testing the efficacy of CBR-COVID19 against live infectious
replicating SARS-CoV-2 virus in a major Biosafety Level 3 facility.
One of the ultimate threats from emerging viruses, whether natural or
man-made, is their uncertainty and unpredictability. Current therapeutic
responses require extensive knowledge of the agent(s) as well as
time-consuming and duplicative research efforts to develop effective
treatments after an outbreak has begun. In this light, our first-in-class CBR
platform allows for minimal lead time between first infection or pre-emptive
intelligence and first response, providing protection for those on the front
line of such a threat at a scale that has thus far not been achieved.
As we announced in February 2024, CBR in relation to viruses is innovative in
three ways: it will be an off-the-shelf therapeutic against airborne viral
infections, it will be effective against emerging mutations of the targeted
viruses, and it will be able to be stored, deployed and administered in the
field using a standard atomiser/inhaler. These innovative features have been
tested in the laboratory, and the ability of CBR to be delivered intranasally
in spray form has been tested by our scientists in vivo in small animals. This
recent work on the intranasal delivery of CBR is a breakthrough, enabling its
development as an off-the-shelf prevention and/or treatment that will be
cost-effective and simple to administer, making it ideal for the protection
both of the civilian population and in biodefence.
Moving onto cancer-related CBR innovations, we have found that a number of
difficult conditions can potentially be treated using CBR. We have established
that macrophages programmed with CBR have several potential advantages
compared to other existing anti-cancer therapies. Our studies suggest that
they can, inter alia, penetrate solid tumours, provide a better safety profile
for treatment, and potentially cross the blood-brain barrier to target brain
cancers and/or certain neurodegenerative diseases.
As announced last November, we have now demonstrated that CBR could be used
effectively in the treatment of a number of cancer conditions, in particular
that CBR-programmed macrophages show promise for treatment of Non-Hodgkin
Lymphoma ("NHL"). Our scientists have demonstrated that human macrophages, a
type of immune cells, programmed with a purpose designed CBR, are able to
eliminate NHL-derived cells with high efficiency in vitro. This result
suggests that the Company may be able to develop an efficient treatment for
people suffering from relapsed and/or refractory stage III/IV metastasized
NHL. Our work also suggests that such CBRs can also be adapted to target
several solid tumours such as epithelial ovarian cancer. NHL is the eleventh
most common cancer in humans, with a poor rate of recovery and cure from
present treatments. There are currently an estimated 540,000 new cases
diagnosed globally with an estimated 260,000 deaths per year. The successful
development of a new CBR-related therapy for NHL could have a major impact on
treatment and survival rates for the disease.
Our work further suggests that such CBRs can be adapted to target several
solid tumours such as epithelial ovarian cancer. We have also begun to see
evidence that a CBR-based approach may also potentially be effective against
certain neurodegenerative diseases, some of which are currently very difficult
or impossible to treat, including possibly Alzheimer's disease. In this
regard, in February 2024 we announced a further significant development for
CBR, this time in relation to brain cancers and potentially to
neurodegenerative diseases. We have established that CBR can be delivered into
the brain via programmed microglial cells. Delivery of therapeutics across the
blood-brain barrier is one of the most difficult problems in the treatment of
brain diseases. Our scientists have developed a means of transplanting human
blood stem cells ("HSC") that allows their engraftment and differentiation
into immune cells that reside in the brain, carrying out their work in vivo in
the brains of immune-compromised mice. We believe that HSCs genetically
modified to make CBR and transplanted back into a patient would give rise to
microglial cells which could potentially find and destroy brain cancer cells.
Meanwhile, we continue to look to our patent position and, in September 2023,
our patent application for CBR with the World Intellectual Property
Organization was published, though it remains to be approved.
In summary, we should say that the considerable potential breadth and
versatility of CBR has become increasingly evident over the past fifteen
months, and evidence of its practical viability has been considerably
established. It is not too much to say that CBR, which we always considered to
have great potential, can now be seen as possibly revolutionary, now that its
widespread probable applicability to difficult or presently untreatable
conditions is being established in multiple preclinical studies.
CDX bi-specific antibody
CDX remains an important part of the Company's product candidate portfolio,
although it remains to a certain extent in abeyance while we push on with
HEMO-CAR-T. However, some steps have been taken with CDX, including approval
of the patent application in the USA entitled "Method of Eliminating
Hematopoietic Stem Cells/Hematopoietic Progenitors (HSC/HP) in a Patient Using
Bi-specific Antibodies" as patent No. 11,945,866. This is a significant
addition to the patent protection for CDX, which remains one of our key
product candidates for the future. It also solidifies the Company's position
as a leader in the area of conditioning of patients for bone marrow
transplants.
Conclusion
It remains for me to thank the Board and our strong, highly committed group of
scientists for their hard and effective work, and to look forward to another
successful year in the future development of Hemogenyx Pharmaceuticals in this
new phase as a clinical-stage company.
Prof Sir Marc Feldmann AC, FRS
MB BS, PhD, FRCP, FRCPath, FAA, F Med Sci
Chairman
Enquiries:
Hemogenyx Pharmaceuticals plc https://hemogenyx.com (https://hemogenyx.com/)
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder headquarters@hemogenyx.com (mailto:headquarters@hemogenyx.com)
Peter Redmond, Director peter.redmond@hemogenyx.com (mailto: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
Consolidated Statement of Comprehensive Income
Group - Continuing Operations Year Ended 31 December 2023 Year Ended 31 December 2022
£ £
Revenue - -
Administrative Expenses (5,820,165) (3,433,476)
Depreciation Expense (645,681) (564,072)
Operating Loss (6,465,846) (3,997,548)
Finance Income 85,344 10,599
Finance Costs (315,991) (33)
Loss before Taxation (6,696,493) (3,986,982)
Income tax - -
Loss for the year (6,696,493) (3,986,982)
Loss attributable to:
- Owners of Hemogenyx Pharmaceuticals plc (6,690,678) (3,979,314)
- Non-controlling interests (5,815) (7,668)
(6,696,493) (3,986,982)
Items that may be reclassified subsequently to profit or loss:
Translation of foreign operations 903,067 (954,642)
Other comprehensive income for the year 903,067 (954,642)
Total comprehensive loss for the year (5,793,426) (4,941,624)
Attributable to:
Owners of Hemogenyx Pharmaceuticals plc (5,787,611) (4,933,956)
Non-controlling interests (5,815) (7,668)
Total comprehensive loss for the year (5,793,426) (4,941,624)
Basic and diluted earnings loss per share attributable to the equity owners of
the Company
(0.006) (0.005)
Consolidated Statement of Financial Position
Group
31 December 2023 31 December 2022
Assets £ £
Non-current assets
Property, plant and equipment 966,423 1,023,252
Right of use asset 2,346,015 2,892,261
Security deposit 153,668 140,821
Intangible asset 470,173 441,493
Total non-current assets 3,936,279 4,497,827
Current assets
Trade and other receivables 922,013 62,024
Cash and cash equivalents 1,247,601 2,532,758
Total current assets 2,169,614 2,594,782
Total assets 6,105,893 7,092,609
Equity and Liabilities
Equity attributable to shareholders
Paid-in Capital
Called up share capital 11,755,660 9,797,493
Share premium 19,938,556 16,808,647
Other reserves 1,164,637 921,801
Reverse asset acquisition reserve (6,157,894) (6,157,894)
Foreign currency translation reserve (77,496) (980,563)
Retained Earnings (23,804,734) (17,114,056)
Equity attributable to owners of the Company 2,818,729 3,275,428
Non-controlling interests (37,723) (31,908)
Total equity 2,781,006 3,243,520
Liabilities
Non-current liabilities
Lease liabilities 2,672,802 3,100,678
Total non-current liabilities 2,672,802 3,100,678
Current liabilities
Trade and other payables 379,001 426,254
Lease liabilities 273,084 322,157
Total current liabilities 652,085 748,411
Total liabilities 3,324,887 3,849,089
Total equity and liabilities 6,105,893 7,092,609
Company Statement of Financial Position
Company
31 December 2023 31 December 2022
£ £
Assets
Non-current assets
Loan to subsidiaries 18,097,857 14,451,733
Investment in subsidiary 8,000,000 8,000,000
Total non-current assets 26,097,857 22,451,733
Current assets
Trade and other receivables 14,820 20,405
Cash and cash equivalents 219,236 88,909
Total current assets 234,056 109,314
Total assets 26,331,913 22,561,047
Equity and Liabilities
Equity attributable to shareholders
Foreign currency translation reserve
Paid-in Capital
Called up share capital 11,755,660 9,797,493
Share premium 19,938,556 16,808,647
Other reserves 1,163,533 920,697
Retained Earnings (6,721,085) (5,100,447)
Total Equity 26,136,664 22,246,390
Liabilities
Current liabilities
Trade and other payables 195,249 134,657
Total current liabilities 195,249 134,657
Total liabilities 195,249 134,657
Total equity and liabilities 26,331,913 22,561,047
Hemogenyx Pharmaceuticals plc has used the exemption granted under s408 of the
Companies Act 2006 that allows for the non-disclosure of the Income Statement
of the parent company. The after-tax loss attributable to Hemogenyx
Pharmaceuticals plc for the year ended 31 December 2023 was £1,620,638 (2022:
profit of £1,202,014).
Consolidated Statement of Changes in Equity
Group
Called up Share Capital Share Premium Foreign currency translation reserve Retained earnings Total Equity
Other reserves Reverse acquisition reserve Non-
Controlling interests
£ £ £ £ £ £ £ £
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 year - - (3,979,314) (3,986,982)
- - - (7,668)
Other Comprehensive Income - - - (954,642)
- - (954,642) -
Total comprehensive income for the year - - (3,979,314) (4,941,624)
- - (954,642) (7,668)
Extension of options - 17,575
- - 17,575 - - -
As at 31 December 2022 9,797,493 16,808,647 (6,157,894) (980,563) 3,243,520
921,801 (17,114,056) (31,908)
Loss in year - - (6,690,678) (6,696,493)
- - - (5,815)
Other Comprehensive Income - - -
- - 903,067 - 903,067
Total comprehensive income for the year - - (6,690,678) (5,793,426)
- - 903,067 (5,815)
Issue of shares 1,958,167 3,296,458 - - - - - 5,254,625
Cost of capital - (166,549) - - - - - (166,549)
Issue of options - - 242,836 - - - - 242,836
As at 31 December 2023 11,755,660 19,938,556 (23,804,734) 2,781,006
1,164,637 (6,157,894) (77,496) (37,723)
Company Statement of Changes in Equity
Company
Called up Share Capital Share Premium Foreign currency translation reserve Other reserves Retained earnings Total Equity
£ £ £ £ £ £
As at 31 December 2021 9,797,493 16,808,647 (6,302,461) 21,206,801
- 903,122
Income in year - - 1,202,014 1,202,014
- -
Other Comprehensive Income - - - -
- -
Total comprehensive income for the year - - 1,202,014 1,202,014
- -
Issue of options - - - 17,575 - 17,575
As at 31 December 2022 9,797,493 16,808,647 (5,100,447) 22,426,390
- 920,697
Loss in year - - (1,620,638) (1,620,638)
- -
Other Comprehensive Income - - - -
- -
Total comprehensive income for the year - - (1,620,638) (1,620,638)
- -
Issue of shares 1,958,167 3,296,458 - - - 5,254,625
Cost of capital - (166,549) - - - (166,549)
Issue of options - - - 242,836 - 242,836
As at 31 December 2023 11,755,660 19,938,556 (6,721,085) 26,136,664
- 1,163,533
Consolidated Statement of Cash Flows
Group Year Ended Year Ended
31 December 2023 31 December 2022
£ £
Cash flows generated from operating activities
Loss before income tax (6,696,493) (3,986,982)
Depreciation 645,681 195,246
Other non-cash items 81 81
Interest income (85,344) (10,599)
Interest expense 315,991 33
Share based payments 242,836 17,575
Changes in right of use asset and lease liability, net 306,759 627,515
Foreign exchange gain (loss) (1,485) 12,937
(Decrease)/Increase in trade and other payables 28,579 (27,120)
Decrease/(Increase) in trade and other receivables 4,469 (2,109)
Decrease/(Increase) in prepaid and deposits (866,644) 271,819
Net cash outflow used in operating activities (6,105,570) (2,910,604)
Cash flows generated from financing activities
Proceeds from issuance equity securities, net of issue costs 5,088,076 -
Payment of lease liabilities (638,765) (110,144)
Net cash flow generated from/(used in) financing activities 4,449,311 (110,144)
Cash flows generated from investing activities
Interest income 85,344 10,599
Payment of security deposit for lease - (1,908)
Purchase of property & equipment (117,285) (428,945)
Net cash flow used in investing activities (31,941) (420,254)
Net decrease in cash and cash equivalents (1,688,200) (3,432,002)
Effect of exchange rates on cash 403,043 (876,209)
Cash and cash equivalents at the beginning of the year 2,532,758 6,840,969
Cash and cash equivalents at the end of the year 1,247,601 2,532,758
Company Statement of Cash Flows
Company Year Ended 31 December 2023 Year Ended 31 December 2022
£ £
Cash flows generated from operating activities
(Loss)/gain before income tax (1,620,638) 1,202,014
Foreign exchange gain 910,832 (1,539,778)
Share based payments 242,836 17,575
Increase/(decrease) in trade and other receivables 5,585 (4,927)
Increase in trade and other payables 60,592 228
Net cash outflow used in operating activities (400,793) (324,888)
Cash flows generated from financing activities
Proceeds from issuance of equity securities, net of issue costs 5,088,076 -
Net cash flow generated from financing activities 5,088,076 -
Cash flows generated from/(used in) investing activities
Loan (to)/from related parties (4,556,312) 301,421
Net cash flow (used in)/generated from investing activities (4,556,312) 301,421
Net Increase/(decrease) in cash and cash equivalents 130,971 (23,467)
Effect of exchange rates on cash (644) 1,131
Cash and cash equivalents at the beginning of the year 88,909 111,245
Cash and cash equivalents at the end of the year 219,236 88,909
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