REG - Hemogenyx Pharma Plc - Half-year Report
27/09/2024 07:00
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RNS Number : 9028F Hemogenyx Pharmaceuticals PLC 27 September 2024
27 September 2024
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
Half-year Report
Interim Results for the period ended 30 June 2024
Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group
developing therapies designed to transform blood disease treatment, whose
shares are admitted to the equity shares (transition) category of the Official
List, announces its unaudited interim results for the six-month period ended
30 June 2024.
All financial amounts are stated in GBP British pounds unless otherwise
indicated.
Key Highlights
· The U.S. Food and Drug Administration ("FDA") lifted the clinical
hold on the Investigational New Drug ("IND") application for HEMO-CAR-T.
· Raised £3.325 million to advance HEMO-CAR-T towards Phase I
clinical trials.
· Phase I clinical trials expected to begin shortly at M.D.
Anderson Cancer Center ("MD Anderson") in Texas.
· Continuing to make advancements with the Company's Chimeric Bait
Receptor ("CBR") and bispecific antibody ("CDX") programmes.
Fuller details of these developments are contained in the Interim Management
Report below.
Interim Management Report
We are pleased to present Hemogenyx Pharmaceuticals' half year report for the
period ending 30 June 2024. The past six months have been a time of
significant progress and strategic advancement for our company as we continue
to develop novel therapies inter alia for the treatment of serious blood
diseases.
During the first half of 2024, the Company has been mainly focussed on getting
its lead product, HEMO-CAR-T, into clinical trials, while continuing to
progress its other main product candidates, CBR and CDX.
HEMO-CAR-T
In February 2024, the FDA lifted the clinical hold on the IND application for
HEMO-CAR-T, our treatment for acute myeloid leukemia ("AML"), which had been
imposed in June 2023. The FDA confirmed that we have satisfactorily addressed
all issues identified in its prior clinical hold letter, allowing us to
proceed with the Phase I clinical study of HEMO-CAR-T. Following the reopening
of the IND, we successfully raised £3.325 million (before expenses) at 2p per
share, issuing 166,250,000 ordinary shares, to advance HEMO-CAR-T into Phase I
clinical trials.
The trials are expected to begin shortly at MD Anderson in Texas, one of the
leading cancer treatment centers in the U.S. As shareholders know, we have
been collaborating with the University of Pennsylvania Medical Center ("Penn")
to conduct the trials at their facility. While Penn remains supportive and
wishes to participate, several issues have delayed their proposed schedule.
Fortunately, we connected with MD Anderson regarding their participation in
the trials. MD Anderson is a large and highly reputable centre for cancer
treatment, including AML, and they are confident in maintaining a consistent
and reliable flow of trial candidates. It is important to note that every
patient from the very first one treated in the HEMO-CAR-T clinical study will
produce valuable data regarding the safety and potentially efficacy of the
treatment.
We are now in the final stages of the opening a clinical site at MD Anderson
and expect to treat the first patient soon. Penn remains eager to
participate in the trials at a later stage, and we hope they will do so,
though likely not until 2025.
While we have been discussing partnerships with potential hospital
collaborators, we have made significant progress with HEMO-CAR-T during the
period under review. We have evaluated its potential to treat pediatric AML
and a subset of pediatric acute lymphoblastic leukemia ("ALL") in young
patients. An amendment to include pediatric AML in our clinical protocol has
been reviewed by independent experts, and we will extend the protocol
accordingly. If approved as expected, we plan to initiate clinical trials for
pediatric AML and a subset of ALL at MD Anderson. These indications are of
particular concern because current treatments are risky and have low success
rates. There is an urgent need for effective therapies, and we believe
HEMO-CAR-T can provide a valuable solution.
In addition, the Company recently announced that it has successfully completed
the development of a clinical-grade assay for use in HEMO-CAR-T clinical
trials, a project the Company has been working on for some time. This assay is
designed to assess and ensure the proper identification and recruitment of
suitable patients for the clinical trials.
We are continuing our collaboration with Prevail Infoworks, the contract
research organization that will manage and oversee the planning and execution
of our clinical trials. Currently, they are working closely with us to bring
HEMO-CAR-T into the clinic. When the trials commence, we will manufacture the
HEMO-CAR-T cells at our New York facility for use in each individual patient.
Prevail Infoworks will coordinate the logistical aspects of the trials,
including patient enrolment, data management, regulatory compliance, and
overall trial monitoring, ensuring that the studies are conducted efficiently
and effectively.
Although we had hoped to start the trials sooner, we have used this time to
further advance development of the HEMO-CAR-T program, which will make the
execution and assessment of the trials easier. Developing the clinical-grade
assay and focusing on pediatric opportunities are significant steps forward.
These advancements will help us carry out the clinical trials more effectively
and broaden the potential use of HEMO-CAR-T to additional leukaemia patients
who currently have very limited treatment options.
CBR and CDX
As we have been waiting for the HEMO-CAR-T clinical trials to commence, we
have been able to apply more effort to progress our other product candidates,
in particular the CBR and the CDX programs.
Our CBR platform is an advanced immunotherapy designed to reprogram or
redirect immune cells, such as macrophages, to prevent and combat infections
from both existing and emerging viral threats, as well as to eliminate
specific types of cancer. Our research originally focused on the former where,
for example, we established in vitro that CBR could treat viruses such as
COVID and potentially a much wider range of viruses. More recently, we have
established that it could also be used against a range of cancers. We are
developing and testing multiple CBR constructs to identify the best candidates
for targeting rare cancers such as epithelial ovarian carcinoma. Selected CBR
candidates will undergo rigorous testing to advance them to IND enabling
studies. In addition, we have established a means of delivering CBR
intranasally, for treating airborne viral infections which would significantly
ease the use of CBRs in the field. We have also recently made improvements in
the stability of mRNA-based CBRs to further enhance the effectiveness of this
treatment.
Regarding CDX, we have been advancing the studies required for an IND
application. CDX is designed to prepare patients with AML for bone marrow
transplants and, we believe, may also be directly capable of treating relapsed
or refractory AML. Meanwhile, we have developed a new and improved version of
CDX. Our scientists used bispecific pairing technology to create this version,
and it has shown significantly enhanced effectiveness in the laboratory (in
vitro) tests. Additional animal (in vivo) studies are currently underway.
HEMO-CAR-T and CDX offer different yet complementary approaches to treating
AML. CDX is specifically designed to target AML cells and has the potential to
condition patients for bone marrow transplants. By directly attacking AML and
preparing patients for transplants, CDX provides a dual strategy in combating
this aggressive cancer. On the other hand, HEMO-CAR-T involves modifying a
patient's T-cells to seek out and destroy cancer cells. By developing both
therapies, we increase our chances of success and aim to offer effective
treatment options to a broader range of AML patients.
Financial Results
During the six months ended 30 June 2024, the Group recorded a loss before
taxation of £2,815,604 (2023: £4,323,564 loss), including operating costs of
£2,369,455 (2023: £3,896,308). For further comparison, the operating costs
for the twelve months to 31 December 2023 were £5,820,165. The reduction in
costs for the period ended 30 June 2024 compared to the same period in 2023 is
due to two principal factors: a significant favourable movement in the UK
sterling and US dollar exchange rate accounting for a variance of £1,039,436
and a reduction in research and development costs of £413,419. This is
primarily due to a reduction in payments to WuXi in respect of the Company's
advancement to the clinical trial phase. These costs concluded in March 2024.
The Company had cash and cash equivalents totalling £1,642,762 as of 30 June
2024.
Conclusion
We have now reached a pivotal stage where our lead product, HEMO-CAR-T, is set
to enter the clinic, a development that undeniably elevates us to a
clinical-stage company. Meanwhile, our other product candidates are also
making significant strides forward. We are confident in our ability to finance
their development through a combination of equity capital, industry
partnerships, and non-dilutive funding. We look forward to bringing our
potentially life-saving therapies into use and delivering positive returns to
our shareholders.
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 2024.
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
26 September 2024
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 2024
6 months to 6 months to
Continuing Operations Note 30 June 2024 Unaudited 30 June 2023 Unaudited
£ £
Revenue - -
Administrative Expenses (2,369,455) (3,896,308)
Depreciation (321,685) (319,909)
Operating Loss (2,691,140) (4,216,217)
Finance Income 17,328 54,692
Finance Costs (141,792) (162,039)
Loss before Taxation (2,815,604) (4,323,564)
Loss attributable to:
- Equity owners (2,812,832) (4,321,103)
- Non-controlling interests (2,772) (2,461)
Loss for the period (2,815,604) (4,323,564)
Other comprehensive income
Items that may be reclassified subsequently to profit or loss:
Translation of foreign operations (102,482) 751,572
Total comprehensive income for the period (2,918,086) (3,571,992)
Total comprehensive income attributable to:
- Equity owners (2,915,314) (3,569,531)
- Non-controlling interests (2,772) (2,461)
Basic and diluted earnings (per share) 5 (0.002) (0.003)
Condensed Consolidated Interim Statement of Financial Position as at 30 June 2024
As at As at
30 June 2024 31 December 2023
Note Unaudited Audited
Assets £ £
Non-current assets
Property, plant and equipment 6 854,335 966,423
Security deposit 166,165 153,668
Right of use asset 9 2,152,630 2,346,015
Intangible asset 472,503 470,173
Total non-current assets 3,645,633 3,936,279
Current assets
Trade and other receivables 827,867 922,013
Cash and cash equivalents 1,642,762 1,247,601
Total current assets 2,470,629 2,169,614
Total assets 6,116,262 6,105,893
Equity and Liabilities
Equity attributable to shareholders
Paid-in Capital
Called up share capital 7 13,418,160 11,755,660
Share premium 7 21,436,546 19,938,556
Other reserves 1,164,637 1,164,637
Reverse asset acquisition reserve (6,157,894) (6,157,894)
Foreign currency translation reserve (179,978) (77,496)
Retained Earnings (26,617,566) (23,804,734)
Equity attributable to owners of the Company 2,818,729
3,063,905
Non-controlling interests (40,495) (37,723)
Total Equity 3,023,410 2,781,006
Liabilities
Non-current liabilities
Lease 2,528,588 2,672,802
liabilities
9
2,528,588 2,672,802
Current liabilities
Trade and other 308,660 379,001
payables
Lease 255,604 273,084
liabilities
9
Total Current Liabilities 564,264 652,085
3,092,852 3,324,887
Total Liabilities
Total equity and liabilities 6,116,262 6,105,893
The 2023 comparatives are the audited consolidated group accounts for the year
ended 31 December 2023 as published on 25 April 2024.
Condensed Consolidated Interim Statement of Changes in Equity for the six months ended 30 June 2024 and 30 June 2023
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 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 year - - - - 751,572 (4,321,103) (2,461) (3,571,992)
Issue of options - - 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 2023 (unaudited) 9,813,718 20,710,328 962,274 (6,157,894) (228,991) (21,435,159) (34,369) 3,629,907
As at 1 January 2024 11,755,660 19,938,556 1,164,637 (6,157,894) (77,496) (23,804,734) (37,723) 2,781,006
Loss in period - - - - - (2,812,832) (2,772) (2,815,604)
Other comprehensive income
- - - - (102,482) - - (102,482)
Total comprehensive income for the period - - - - (102,482) (2,812,832) (2,772) (2,918,086)
Issue of shares 1,662,500 1,662,500 - - - - - 3,325,000
(Note 7)
Cost of capital (Note 7) - (164,510) - - - - - (164,510)
As at 30 June 2024 (unaudited) 13,418,160 21,436,546 1,164,637 (6,157,894) (179,978) (26,617,566) (40,495) 3,023,410
Condensed Consolidated Interim Statement of Cash Flows for the six months
ended 30 June 2024
6 months to 6 months to
30 June 2024 30 June 2023
Group Note Unaudited Unaudited
£ £
Cash flows generated from operating activities
Loss for the period (2,815,604) (4,323,564)
Depreciation 6, 9 321,685 319,909
Foreign exchange gain (14,630) 197,148
Interest income (17,328) (54,692)
Interest expense 141,792 162,039
Share based payments 8 - 40,473
(Decrease) in trade and other payables (65,400) 136,578
(Increase)/decrease in trade and other receivables (17) 5,600
Decrease/(Increase) in prepaid and deposits 98,682 (25,866)
Net cash outflow used in operating activities (2,350,820) (3,542,375)
Cash flows generated from financing activities
Proceeds from issuance of shares, net of direct costs 7 3,160,490 3,917,906
Payment of lease liabilities 9 (317,872) (318,079)
Net cash flow generated from financing activities 2,842,618 3,599,827
Cash flows generated from investing activities
Interest income 17,328 54,692
Purchase of property, plant & equipment 6 - (13,161)
Net cash flow generated from investing activities 17,328 41,531
Net increase in cash and cash equivalents 509,126 98,983
Effect of exchange rates on cash and cash equivalents (113,965) 453,111
Cash and cash equivalents at the beginning of the period 1,247,601 2,532,758
Cash and cash equivalents at the end of the period 1,642,762 3,084,852
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 2024. 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 2023, 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 2023 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 2023 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 £3,325,000 (before expenses) through the
allotment and issue of 166,250,000 new ordinary shares at 2 pence per share
during the period to 30 June 2024. The proceeds raised were used to enable the
Company to progress towards the testing of HEMO-CAR-T in patients in Phase I
clinical trials and to provide continuing working capital for the Company's
operations. A small portion of the funds were used for the development of the
Company's other product candidates, including the necessary maintenance and
prosecution of the Company's patent applications.
Substantial funding will be required by the Company to progress through Phase
I clinical trials over the next two years. To the extent that the Company
raises additional funds by issuing equity securities, the Company's
shareholders 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 will 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. There can be no assurance that either
the funding shortfall will be addressed in whole or in part, neither is there
an assurance that the Group will have access to any financing on terms which
are acceptable, or at all, in which case the Group's product development
activities would have to cease and the Company would no longer be adequately
capitalised.
At present, the Company has insufficient working capital for its foreseeable
requirements over the 12 months from the date of issuing these interim
results. However, the Directors believe that the Company can access additional
financing. The Directors, therefore, have made an informed judgment, at the
time of approving these financial statements that the Company will be able to
raise sufficient funds to continue in operation for the foreseeable future.
Segmental Reporting
The Group's operations are located in New York, USA,; the parent company is a
British public company which is administered 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
2023 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
The International Accounting Standards Board (IASB) issued various amendments
and revisions to International Financial Reporting Standards and IFRIC
interpretations. The amendments and revisions were applicable for the period
ended 30 June 2024 but did not result in any material changes to the financial
statements of the Company.
4. Significant accounting judgements, estimates and assumptions
The preparation of the financial statements in conformity with International
Financial Reporting Standards requires the use of certain critical accounting
estimates. It also requires management to exercise its judgement in the
process of applying the Company's accounting policies. 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 2023.
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 £2,918,086
(six months to 30 June 2023: £3,571,992 loss) attributable to equity owners
of the Group by the weighted average number of ordinary shares in issue during
those periods of 1,226,900,920 and 1,042,923,486 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 2024 and six months to 30
June 2023, there is no dilutive effect from the subsisting share options.
6. Property, Plant and Equipment
During the six months ended 30 June 2024, the Group did not acquire any PPE
assets (six months ended 30 June 2023: £13,161) and incurred depreciation
expense of £116,804 (six months ended 30 June 2023: £109,769).
7. Issued capital
Shares Called up share capital Share premium
£ £
As at 31 December 2023 1,175,565,988 11,755,660 19,938,555
Issue of shares 166,250,000 1,662,500 1,662,500
Share issuance costs - - (164,510)
As at 30 June 2024 1,341,815,988 13,418,160 21,436,545
During the six months ending 30 June 2024, the Company sold 166,250,000 shares
of ordinary stock at a price of 2p per share as part of a private placement of
its securities.
8. Share-based payments
Options
During the six months to 30 June 2024, no options were issued to directors or
employees and 7,501,070 options lapsed during the six months to 30 June 2024.
A schedule of options granted since inception for all plans as at 30 June 2024
is shown below:
Number of options
Members of the Scientific Advisory Board 12,481,912
Employees, including directors 104,326,986
Total 116,808,898
For the six months ended 30 June 2024, the Company did not recognise any
share-based payment expense in the statement of profit or loss (30 June 2023:
£40,473).
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 2024, the Group incurred a right of use
asset depreciation expense of £204,881 (six months ended 30 June 2023:
£210,140), incurred lease liability interest expense of £141,689 (six months
ended 30 June 2023: £165,202) and made lease payments in the amount of
£369,982 (six months ended 30 June 2023: £318,079).
10. Events after the reporting date
There were no events after the reporting date.
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