REG - Hemogenyx Pharma Plc - Half-year Report
28/09/2023 12:30
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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 £0.06) for the total sum of
US$830,000 (approximately £668,000). 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 £4,056,250 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
(£668,000) at approximately £0.06, 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 £4,323,564 (2022: £1,141,304 loss), including operating costs of
£3,896,308 (2022: £1,111,010). For further comparison, the operating costs
for the twelve months to 31 December 2022 were £3,433,476. 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 £3,084,852 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 (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
Condensed Consolidated Interim Statement of Comprehensive Loss for the six
months ended 30 June 2023
6 months to 6 months to
Continuing Operations Note 30 June 2023 Unaudited 30 June 2022 Unaudited
£ £
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 £ £
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 2,817,216 3,100,678
liabilities
9
2,817,216 3,100,678
Current liabilities
Trade and other 328,969 426,254
payables
Lease 447,839 322,157
liabilities
9
Total Current Liabilities 776,808 748,411
3,594,024 3,849,089
Total Liabilities
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
Foreign currency translation reserve
Called up Non- Controlling interests
Share Capital Share Premium Retained
Reverse acquisition reserve losses
Other Total Equity
reserves
£ £ £ £ £ £ £ £
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 16,225 4,040,025 - - - - - 4,056,250
(Note 7)
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 to
30 June 2023 30 June 2022
Group Note Unaudited Unaudited
£ £
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 £4,056,250 (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 (£668,000) 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 £3,571,992(six
months to 30 June 2022: £1,141,304 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 £13,161 (six months ended 30 June 2022: £1,553) and incurred
depreciation expense of £109,769 (six months ended 30 June 2022: £32,233).
7. Issued capital
Shares Called up share capital Share premium
£ £
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 £40,473 (30 June 2022:
£12,079).
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 £210,140 (six months ended 30 June 2022:
£4,968), incurred lease liability interest expense of £165,202 (six months
ended 30 June 2022: £45) and made lease payments in the amount of £318,079
(six months ended 30 June 2022: £5,441).
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 £0.06) for the total sum of US$830,000
(approximately £668,000).
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.
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