TIDMDDDD
RNS Number : 0353O
4d Pharma PLC
30 September 2019
4D PHARMA PLC
("4D", "4D Pharma" or "the Company")
Interim results for the six months ended 30 June 2019
4D pharma plc (AIM: DDDD), a pharmaceutical company leading the
development of Live Biotherapeutics, is pleased to announce the
interim results for the Company and its subsidiaries (together "the
Group") for the six months ended 30 June 2019.
Financial highlights
-- Net assets as at 30 June 2019 of GBP35.0 million (30 June
2018: GBP58.7 million and 31 December 2018: GBP45.8 million).
-- Cash and cash equivalents and short-term deposits at 30 June
2019 of GBP12.9 million (30 June 2018: GBP36.6 million and 31
December 2018: GBP26.2 million).
-- Loss and comprehensive income for the six months ended 30
June 2019 of GBP11.3 million (30 June 2018: GBP11.3 million; 12
months ended 31 December 2018: GBP24.3 million).
-- Research and development expenditure for the six months ended
30 June 2019 of GBP10.8 million (30 June 2018: GBP11.8 million; 12
months ended 31 December 2018: GBP24.9 million).
Operational and clinical highlights
-- Commencement of a Phase I/II study of MRx0518 in combination
with Keytruda in collaboration with MSD (tradename of Merck &
Co., Inc., Kenilworth, N.J., USA). The two-part study is evaluating
the safety, tolerability and preliminary clinical benefit of the
combination in patients with melanoma, non-small-cell lung
carcinoma ("NSCLC"), renal and bladder cancers who have relapsed on
prior anti-PD-1 therapy.
-- Commencement of a Phase Ib study of MRx0518 as a monotherapy
in the neoadjuvant setting. The two-part study will evaluate the
safety, tolerability and anti-tumour immunological effects of
MRx0518 in patients with multiple solid tumour types.
-- Presentation of first data of 4D's second-generation
immuno-oncology candidate, MRx1299, outlining the mechanism of
action and preliminary efficacy in preclinical models. Publication
of the mechanism of action of MRx0518, outlining the bacterial
effector molecule and host receptor which mediate its therapeutic
effect.
-- Appointment of two new Non-Executive Directors. The Company
has welcomed Ed Baracchini, PhD, and Professor Axel Glasmacher, who
bring significant biopharma industry experience to the Board of
Directors.
Since the period end
-- Appointment of Sandy Macrae, currently CEO of US-based
Sangamo Therapeutics, as a Non-Executive Director.
-- Commencement of a Phase I/II study of MRx-4DP0004 in patients
with poorly controlled asthma. The study will enrol 90 asthma
patients not adequately controlled on their current inhaler
maintenance therapy. This is the world's first clinical study of a
Live Biotherapeutic in patients with poorly controlled asthma.
Chairman's statement
David Norwood, Chairman of 4D pharma, commented: "As our lead
programmes progress towards generation of clinical data, the
Company continues to advance research in the field with the
exciting developments in our neurodegeneration programmes.
Alongside this we continue to strengthen the business corporately
as we welcome the new members to the Board. I would once again like
to thank the Board, our employees and our shareholders for their
continued support."
For further information please contact:
4D +44 (0)113 895 0130
Duncan Peyton, Chief Executive Officer
N+1 Singer - Nominated Adviser and Joint Broker
Aubrey Powell/ Justin McKeegan/ Alex Bond
(Corporate Finance) +44 (0) 20 7496 3000
--------------------
Tom Salvesen (Corporate Broking)
--------------------
Bryan Garnier & Co. Limited - Joint Broker
--------------------
Dominic Wilson / Phil Walker +44 (0)20 7332 2500
--------------------
For further information please also visit:
www.4dpharmaplc.com.
Chairman and Chief Executive Officer's Joint Review
David Norwood, Non-Executive Chairman, and Duncan Peyton, Chief
Executive Officer
Live Biotherapeutics: transforming the way we treat disease
Proof-of-concept data on the horizon
The microbiome space, with 4D at the forefront, has continued to
deliver a large body of data supporting the role of the microbiome
in a variety of diseases. Given the nascent stage of the field,
what has been lacking thus far is robust clinical proof-of-concept
data to validate the overwhelming body of preclinical evidence.
We want 4D to be the first to deliver this data and have
continued to invest in our clinical operations. So far in 2019, we
have commenced three key studies in cancer and asthma and continue
to make progress with our Phase II study in IBS. Before the end of
the year, we expect to see the first readouts from these studies,
with more to follow in 2020.
Differentiation: beyond the gut
The influence of the gut microbiome in organs which are
anatomically distant from the gut is now widely accepted. The
academic community, as well as microbiome industry leaders such as
4D, have continued to present work that demonstrates the impact
that Live Biotherapeutics can have in diseases such as cancer,
Alzheimer's disease and Parkinson's disease.
4D is now leading the development of Live Biotherapeutics that
target diseases which manifest at sites away from the gut. As well
as launching numerous clinical studies, we have continued to
publish our research in the fields of cancer and asthma in leading
scientific journals and at international conferences throughout
2019. More recently, our research team have utilised the MicroRx(R)
platform to target the gut-brain axis, identifying new candidates
for neurodegenerative conditions such as Parkinson's disease. These
indications have been historically challenging for the
pharmaceutical industry and Live Biotherapeutics represent a novel
therapeutic approach that could fundamentally change the way these
diseases are treated. This year, we have presented our work in this
space for the first time; identifying single-strain Live
Biotherapeutic candidates with striking effects on
neurodegeneration and neuroinflammation that could represent a new
paradigm in the treatment of neurodegenerative disease.
Delivering clinical progress
Oncology
So far in 2019, 4D has initiated two parallel studies to
evaluate MRx0518 in different clinical settings, capturing the full
spectrum of cancer disease stages.
The first of these two studies, being conducted in collaboration
with MSD, is evaluating the combination of MRx0518 and MSD's
Keytruda(R) in patients with advanced malignancies. The gut
microbiome is known to influence patient response to checkpoint
inhibitors, such as Keytruda(R) , which have transformed treatment
for patients with late-stage disease. Although these therapies can
be highly efficacious, only a minority of patients respond and
there is a significant unmet need to find novel combinations which
can boost response rates.
The patients enrolled in this study will have already received
multiple previous lines of therapy and represent a population with
very high unmet need and limited treatment options. The trial is
assessing the potential for MRx0518 to re-engage the immune system
in patients with melanoma, non-small-cell lung cancer, renal and
bladder cancers who have lost response to prior checkpoint
inhibitor therapy. Recruitment for the study is progressing well
and we anticipate completion of Part A of the study, which will
assess the safety and tolerability of MRx0518 in 12 patients, by
the end of 2019, with preliminary efficacy data from this cohort to
follow shortly after in 2020.
The second study, in collaboration with Imperial College London,
is evaluating MRx0518 as a neoadjuvant monotherapy in newly
diagnosed patients who have not previously received treatment for
their cancer. The study employs a novel design, whereby patients
are dosed with MRx0518 in the 2-4 week period following diagnosis
and prior to surgery. In addition to being treatment naïve, study
participants will not be administered concurrent therapies during
the MRx0518 dosing period. This allows for a 'clean' evaluation of
the anti-tumour immunological effects of MRx0518 in patients for
the first time. We expect to see the first readouts from this study
in 2020.
Asthma
Continuing our push towards diseases beyond the GI tract, we
have initiated a Phase I/II study of MRx-4DP0004, in patients with
poorly controlled asthma. Despite the availability of inhaler
treatments, many asthma patients still struggle to achieve adequate
control of their disease. MRx-4DP0004 has a unique mechanism of
action, targeting both neutrophilic and eosinophilic airway
inflammation, which may mean that it is able to treat patients in a
way not currently possible with existing therapies.
The clinical study, which is led by Professor Chris Brightling,
will enrol up to 90 patients who are not adequately controlled on
their current inhaler maintenance therapy and will be offered
MRx-4DP0004 as an add-on. As a first-in-man study, the primary
endpoint will be safety and tolerability; however, the study will
also assess a suite of secondary endpoints to assess the effects of
MRx-4DP0004 on a range of efficacy metrics. Recruitment for this
study is progressing well and we anticipate a readout before the
end of 2020.
Irritable Bowel Syndrome
We continue to make progress with our Phase II study of Blautix
in patients with IBS-C and IBS-D. This study, which is one of the
largest Live Biotherapeutic trials ever conducted, is illustrative
of our commitment to generating robust clinical data sets to
demonstrate the efficacy of our products. In 2019, we significantly
expanded the number of clinical study sites across the US and
Europe and are pleased with the impact that has had on patient
recruitment. We anticipate that the first readout from this study,
an interim analysis of the microbiome data from a subset of
patients, will be available early in Q4 this year.
Additions to the Board of Directors
Over the coming months and through 2020, we expect key data
readouts from ongoing clinical studies in oncology, IBS and asthma,
the results of which will have significant impact on the Company's
development strategy and long-term value. We have brought in
additional leadership and experience to our Board of Directors to
help guide the Company through this critical period of our
development and beyond.
Early in 2019, we welcomed Ed Baracchini, PhD, and Professor
Axel Glasmacher as Non-Executive Directors, both of whom bring a
wealth of experience in the biopharmaceutical industry. Having
previously held roles as Chief Business Officer at Xencor and SVP
Business Development at Metabasis Therapeutics, among others, Ed
Baracchini has brought valuable biotech commercial expertise to the
board. Professor Axel Glasmacher most recently held the role of SVP
and Head of Oncology Global Clinical R&D at Celgene. His work
led to the approvals of Revlimid(R) , Idhifa(R) , and Vidaza(R) and
his track record of developing novel therapeutics through to
approval will be of great value to the Company.
More recently, we welcomed Dr. Sandy Macrae as Non-Executive
Director, bringing over 20 years of pharmaceutical industry
experience to our board. Dr. Macrae currently serves as President
and CEO of Sangamo Therapeutics, Inc, a role he has held since
2016. During this time the company has seen its market
capitalisation increase from around $350 million to approximately
$1.35 billion at the time of his appointment. We look forward to
working with him at this exciting time in the Company's
development.
Conclusion
In the first half of this year, we have laid the foundations for
clinical success through the initiation of key studies in oncology
and asthma, as well as continuing to make good progress in our
Phase II trial in IBS. The second half of 2019 will see the first
readouts from these studies, with further data expected throughout
2020. The next 6-12 months promise to be an exciting time for 4D
pharma.
David Norwood
Non-Executive Chairman
Duncan Peyton
Chief Executive Officer
27 September 2019
Group Statement of Total Comprehensive Income
For the six months to 30 June 2019
Unaudited Unaudited
six months six months Audited
ended ended year to
30 June 30 June 31 December
2019 2018 2018
Notes GBP000 GBP000 GBP000
-------------------------------------------- ------ ----------- ----------- ------------
Research and development costs (10,796) (11,829) (24,908)
Administrative expenses (2,337) (1,969) (4,212)
Foreign currency (losses)/gains (739) 605 749
Other operating income 16 - -
-------------------------------------------- ------ ----------- ----------- ------------
Operating loss (13,856) (13,193) (28,371)
Finance income 65 190 282
Finance expense (286) (167) (348)
-------------------------------------------- ------ ----------- ----------- ------------
Loss before taxation (14,077) (13,170) (28,437)
Taxation 4 2,086 2,520 4,747
-------------------------------------------- ------ ----------- ----------- ------------
Loss for the period (11,991) (10,650) (23,690)
Other comprehensive income
Exchange differences on translating
foreign operations 658 (652) (601)
-------------------------------------------- ------ ----------- ----------- ------------
Loss for the period and total comprehensive
income for the period (11,333) (11,302) (24,291)
-------------------------------------------- ------ ----------- ----------- ------------
Loss per share
Basic and diluted for the period 5 (18.31)p (16.26)p (36.17)p
-------------------------------------------- ------ ----------- ----------- ------------
Group Statement of Financial Position
At 30 June 2019
At At At
30 June 30 June 31 December
2019 2018 2018
Notes GBP000 GBP000 GBP000
------------------------------------------- ------ -------- -------- ------------
Assets
Non-current assets
Property, plant and equipment 5,686 5,001 4,865
Intangible assets 14,258 14,515 14,445
Taxation receivables 247 84 137
------------------------------------------- ------ -------- -------- ------------
20,191 19,600 19,447
------------------------------------------- ------ -------- -------- ------------
Current assets
Inventories 288 262 290
Trade and other receivables 1,713 2,193 1,248
Taxation receivables 7,470 6,442 5,393
Short-term investments and cash on deposit - 15,151 10,174
Cash and cash equivalents 12,895 21,405 16,053
------------------------------------------- ------ -------- -------- ------------
22,366 45,453 33,158
------------------------------------------- ------ -------- -------- ------------
Total assets 42,557 65,053 52,605
------------------------------------------- ------ -------- -------- ------------
Liabilities
Current liabilities
Trade and other payables 6 3,380 3,251 5,177
------------------------------------------- ------ -------- -------- ------------
3,380 3,251 5,177
------------------------------------------- ------ -------- -------- ------------
Non-current liabilities
Deferred tax 965 965 966
Other payables 6 3,244 2,165 699
------------------------------------------- ------ -------- -------- ------------
4,209 3,130 1,665
------------------------------------------- ------ -------- -------- ------------
Total liabilities 7,589 6,381 6,842
------------------------------------------- ------ -------- -------- ------------
Net assets 34,968 58,672 45,763
------------------------------------------- ------ -------- -------- ------------
Capital and reserves
Share capital 164 164 164
Share premium 108,296 108,296 108,296
Merger reserve 958 958 958
Translation reserve 725 16 67
Other reserve (864) (864) (864)
Share-based payments reserve 699 628 708
Retained earnings (75,010) (50,526) (63,566)
------------------------------------------- ------ -------- -------- ------------
Total equity 34,968 58,672 45,763
------------------------------------------- ------ -------- -------- ------------
Approved by the Board and authorised for issue on 27 September
2019.
Duncan Peyton
Director
27 September 2019
Group Statement of Changes in Equity
For the six months to 30 June 2019
Share-
based
Share Share Merger Translation Other payment Retained
capital premium reserve reserve reserve reserve earnings Total
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
---------------------------------- -------- -------- -------- ----------- -------- -------- --------- --------
At 1 January 2018 164 108,296 958 668 (864) 440 (39,876) 69,786
Loss and total comprehensive
income for the period - - - - - - (10,650) (10,650)
Foreign currency gains/losses
arising on consolidation of
subsidiaries - - - (652) - - - (652)
Issue of share-based compensation - - - - - 188 - 188
---------------------------------- -------- -------- -------- ----------- -------- -------- --------- --------
At 30 June 2018 164 108,296 958 16 (864) 628 (50,526) 58,672
Loss and total comprehensive
income for the year - - - - - - (13,040) (13,040)
Foreign currency gains/losses
arising on consolidation of
subsidiaries - - - 51 - - - 51
Issue of share-based compensation - - - - - 80 - 80
---------------------------------- -------- -------- -------- ----------- -------- -------- --------- --------
At 31 December 2018 164 108,296 958 67 (864) 708 (63,566) 45,763
Loss and total comprehensive
income for the year - - - - - - (11,991) (11,991)
Foreign currency gains/losses
arising on consolidation of
subsidiaries - - - 658 - - - 658
Issue of share-based compensation - - - - - 538 - 538
Non-vesting share-based
compensation - - - - - (547) 547 -
---------------------------------- -------- -------- -------- ----------- -------- -------- --------- --------
At 30 June 2019 164 108,296 958 725 (864) 699 (75,010) 34,968
---------------------------------- -------- -------- -------- ----------- -------- -------- --------- --------
Group Cash Flow Statement
For the six months to 30 June 2019
Unaudited Unaudited
six months six months Audited
ended ended year to
30 June 30 June 31 December
2019 2018 2018
GBP000 GBP000 GBP000
-------------------------------------------- ----------- ----------- ------------
Loss after taxation (11,991) (10,650) (23,690)
Adjustments for:
Depreciation of property, plant and
equipment 531 443 905
Amortisation of intangible assets 144 148 296
Loss on disposal of property, plant
and equipment 29 - 1
Finance income (65) (190) (282)
Finance expense 286 167 348
Share-based compensation 538 188 268
--------------------------------------------- ----------- ----------- ------------
Cash flows from operations before movements
in working capital (10,528) (9,894) (22,154)
Changes in working capital:
Decrease/(increase) in inventories 2 (9) (37)
(Increase)/decrease in trade and other
receivables (584) 393 1,894
Increase in taxation receivables (2,190) (2,164) (1,166)
Increase/(decrease) in trade and other
payables 187 (1,614) (1,474)
--------------------------------------------- ----------- ----------- ------------
Cash outflow from operating activities (13,113) (13,288) (22,937)
--------------------------------------------- ----------- ----------- ------------
Cash flows from investing activities
Purchases of property, plant and equipment (271) (259) (537)
Purchase of software and other intangibles (18) (4) (4)
Acquisition of subsidiaries net of cash
acquired - - (660)
Interest received 76 115 378
Monies drawn from deposit 10,174 22,982 27,959
--------------------------------------------- ----------- ----------- ------------
Net cash inflow from investing activities 9,961 22,834 27,136
--------------------------------------------- ----------- ----------- ------------
Cash flows from financing activities
Hire purchase payments (6) (6) (10)
Interest paid - - (1)
--------------------------------------------- ----------- ----------- ------------
Net cash outflow from financing activities (6) (6) (11)
--------------------------------------------- ----------- ----------- ------------
(Decrease)/increase in cash and cash
equivalents (3,158) 9,540 4,188
Cash and cash equivalents at the start
of the year 16,053 11,865 11,865
--------------------------------------------- ----------- ----------- ------------
Cash and cash equivalents at the end
of the year 12,895 21,405 16,053
--------------------------------------------- ----------- ----------- ------------
The cash outflow of GBP660,000 in respect of the acquisition of
subsidiaries net of cash acquired relates to the investment by the
Group in 4D Pharma León S.L.U. in 2016. The outflow in the
financial year to 2018 represents the final instrument of deferred
consideration concerning successful GMP certification attained
during the previous reporting period.
Notes to the Interim Financial Report
For the six months ended 30 June 2019
1. Basis of preparation
The Group's half-yearly financial information, which is
unaudited, consolidates the results of 4D pharma plc and its
subsidiary undertakings up to 30 June 2019. The Group's accounting
reference date is 31 December. 4D pharma plc's shares are quoted on
the AIM Market of the London Stock Exchange ("AIM").
The Company is a public limited liability company incorporated,
registered and domiciled in the UK. The consolidated financial
information is presented in round thousands of Pounds Sterling
(GBP000).
The financial information for the six months ended 30 June 2019
and 30 June 2018 are unaudited.
Full audited financial statements of the Group in respect of the
period ended 31 December 2018, which received an unqualified audit
opinion and did not contain a statement under section 498(2) or (3)
of the Companies Act 2006, have been delivered to the Registrar of
Companies.
The accounting policies used in the preparation of the financial
information for the six months ended 30 June 2019 are in accordance
with the recognition and measurement criteria of International
Financial Reporting Standards as adopted by the European Union
("IFRS") and are consistent with those which will be adopted in the
annual financial statements for the year ending 31 December
2019.
Whilst the financial information included has been prepared in
accordance with the recognition and measurement criteria of IFRS,
the financial information does not contain sufficient information
to comply with IFRS.
4D pharma plc has not applied IAS 34 Interim Financial
Reporting, which is not mandatory for UK AIM listed groups, in the
preparation of this interim financial report.
2. Going concern
The Group and parent company are subject to a number of risks
similar to those of other development stage pharmaceutical
companies. These risks include, amongst others, generation of
revenues in due course from the development portfolio and risks
associated with research, development and obtaining regulatory
approval of its products. Ultimately, the attainment of profitable
operations is dependent on future uncertain events which include
obtaining adequate financing to fulfil the Group's commercial and
development activities and generating a level of revenue to support
the Group's cost structure.
The Directors have prepared detailed financial forecasts and
cash flows looking beyond twelve months from the date of the
approval of these financial statements. In developing these
forecasts, the Directors have made assumptions based upon their
view of the current and future economic conditions that are
expected to prevail over the forecast period. The Directors
estimate that the cash held by the Group together with known
receivables will be sufficient to support the current level of
activities into the fourth quarter of 2019. The Directors are
continuing to explore sources of finance available to the Group and
have a reasonable expectation that they will be able to secure
sufficient cash inflows into the Group to continue its activities
for not less than twelve months from the date of approval of these
accounts. They have therefore prepared the financial statements on
a going concern basis.
Because the additional finance is not committed at the date of
approval of these financial statements, these circumstances
represent an uncertainty as to the Group's ability to continue as a
going concern. Should the Group be unable to obtain further finance
such that the going concern basis of preparation were no longer
appropriate, adjustments would be required including provisions to
reduce the balance sheet values of assets to their recoverable
amounts, and to provide for future liabilities that may arise.
3. Significant accounting policies
For periods commencing 1 January 2019 and onwards "IFRS 16
Leases" came into effect. IFRS 16 distinguishes leases and service
contracts on the basis of whether an identifiable asset is
controlled by a customer. Distinctions of operating leases (off
Statement of Financial Position) and finance leases (on Statement
of Financial Position) are removed for lessee accounting and are
replaced by a model where a right-of-use and corresponding
liability have to be recognised for all leases (i.e. all on
Statement of Financial Position) except for short-term leases and
low value assets.
Having undertaken a review of outstanding leases the Group have
adopted the modified retrospective approach with no reserves
adjustment after due consideration of the impact on the overall
financial results. The adoption of this approach resulted in the
Group recognising additional right-of-use property lease assets and
lease liabilities of GBP1,186,274. In addition, the overall effect
of the changes arising through the recognition of interest and
depreciation, whilst removing items formerly recognised as
operating leases, is an increase in loss for the period to 30 June
2019 of GBP52,330.
4. Taxation
The tax credit is made up as follows:
Unaudited Unaudited
six months six months Audited
ended ended year to
30 June 30 June 31 December
2019 2018 2018
GBP000 GBP000 GBP000
----------------------------------------------- ----------- ----------- ------------
Current income tax
Total current income tax 2,086 2,520 4,760
Adjustment in respect of prior years - - (13)
----------------------------------------------- ----------- ----------- ------------
Total income tax credit recognised in the year 2,086 2,520 4,747
----------------------------------------------- ----------- ----------- ------------
5. Loss per share
Basic and diluted
Unaudited Unaudited
six months six months Audited
ended ended year to
30 June 30 June 31 December
2019 2018 2018
GBP000 GBP000 GBP000
------------------------------------------------------ ----------- ----------- ------------
Loss for the year attributable to equity shareholders (11,991) (10,650) (23,690)
------------------------------------------------------ ----------- ----------- ------------
Weighted average number of shares
Ordinary shares in issue 65,493,842 65,493,842 65,493,842
------------------------------------------------------ ----------- ----------- ------------
Basic loss per share (pence) (18.31)p (16.26)p (36.17)p
------------------------------------------------------ ----------- ----------- ------------
The basic and diluted loss per share are the same as the effect
of share options is anti-dilutive.
6. Other payables
Unaudited Unaudited
six months six months Audited
ended ended year to
30 June 30 June 31 December
2019 2018 2018
GBP000 GBP000 GBP000
--------------------------------- ----------- ----------- ------------
Non-current payables
Contingent consideration 2,145 2,144 684
Hire purchase and finance leases 1,099 21 15
--------------------------------- ----------- ----------- ------------
3,244 2,165 699
--------------------------------- ----------- ----------- ------------
Contingent consideration
The non-current contingent consideration is made up as
follows:
Unaudited Unaudited
six months six months Audited
ended ended year to
30 June 30 June 31 December
2019 2018 2018
GBP000 GBP000 GBP000
---------------------- ----------- ----------- ------------
Brought forward 2,325 1,979 1,979
Unwinding of discount 195 165 346
---------------------- ----------- ----------- ------------
2,520 2,144 2,325
---------------------- ----------- ----------- ------------
Analysed as follows:
Within one year 375 - 1,641
More than one year 2,145 2,144 684
---------------------- ----------- ----------- ------------
2,520 2,144 2,325
---------------------- ----------- ----------- ------------
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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