TIDMEVG
RNS Number : 7763R
Evgen Pharma PLC
31 October 2023
Evgen Pharma plc
("Evgen" or "the Company" or "the Group")
Half Year Report to 30 September 2023
31 October 2023 - Evgen Pharma plc (AIM: EVG), the clinical
stage drug development company developing sulforaphane-based
medicines for the treatment of multiple diseases, announces its
unaudited interim results for the six months ended 30 September
2023.
Operational highlights
-- Phase 1/1b SFX-01 healthy volunteer study formally completed.
Quality assurance work completed on schedule and clinical study
report issued. Results consistent with top line data reported in FY
2022/23; no SFX-01 related serious adverse events (SAEs), release
of drug from enteric coated tablets confirmed and in the range seen
in successful laboratory experiments.
-- Non-dilutive funding of c.EUR0.6m secured, towards
glioblastoma pre-clinical and clinical studies with Erasmus
University Medical Center, Rotterdam, NL.
-- C ollaboration with University La Sapienza di Roma, Italy on
SFX-01 in rhabdomyosarcoma models showed radio-sensitisation by
SFX-01 in vivo, complementing earlier in vitro results. These
results support the mechanism of action of SFX-01 in glioblastoma
where radiotherapy is also standard of care.
-- Publication of radiosensitisation data planned by University La Sapienza group.
-- Retirement of Chair Barry Clare, Dr Susan Foden appointed
interim Chair. Appointment of experienced industry executive Toni
Hänninen as CFO.
Post period
-- Discussions continue with partner Stalicla SA on optimal
design of the Phase 2 study in autism spectrum disorder.
-- Further exploratory analysis of gene expression data via RNA
sequencing from the Phase 1/1b healthy volunteer study
commissioned, mining a vast data set of potential changes in gene
expression after exposure to SFX-01.
-- Non-dilutive grant-funded glioblastoma work led by Dr
Marjolein Geurts at the Erasmus University Medical Center, Cancer
Institute, Rotterdam commenced on schedule.
Financial highlights
-- Financial performance in line with expectations:
o Post-tax loss of GBP1.5m (2022: GBP2.1m)
o Cash outflow from operations of GBP1.3m (2022: GBP1.9m)
o Cash deposits, cash and cash equivalents balance on 30
September 2023 of GBP3.7m (30 September 2022: GBP7.2m)
Cash runway remains unchanged to end of 2024 excluding further
milestones from the Stalicla SA out-license agreement.
Chief Executive Officer of Evgen Pharma, said:
"During the period substantial progress was made in
characterizing our commercial grade tablet formulation, further
advancing our knowledge of the mechanism of SFX-01 and moving
towards clinical studies in glioblastoma through non-dilutive
funding. We continue to interrogate the effect of SFX-01 in our
Phase 1/1b study on the expression of genes of interest to our
oncology studies and relevant in autism spectrum disorder in
collaboration with our partner Stalicla SA.
"SFX-01 continues to show promise as a radio-sensitisation agent
in serious cancers where radiotherapy is the mainstay of treatment.
The recent results from our collaborators at La Sapienza in Rome
confirmed the effect in vivo in models of rhabdomyosarcoma. This
gives further strength to our hypothesis in glioblastoma where
similar results were seen in models of this fatal brain cancer.
"Our Chair Barry Clare retired during the period and the board
would like to thank him for his long, dedicated service to the
company. I'm grateful to Dr Susan Foden for agreeing to be our
interim Chair and also welcome Toni Hänninen as CFO.
"In conclusion, we continue to be well positioned to
commercialise the potential of SFX-01 across various indications
through our own studies and in many productive collaborations
."
-Ends-
Enquiries:
Evgen Pharma PLC
Dr Huw Jones, CEO
Toni Hänninen, CFO +44 1625 466591
Cavendish Capital Markets (Nominated Advisor
and Broker)
Geoff Nash / Teddy Whiley (Corporate
Finance)
Nigel Birks/Harriet Ward (ECM) +44 20 7220 0500
Instinctif Partners +44 207 457 2020
Melanie Toyne-Sewell / Rozi Morris / Jack Evgen@Instinctif.com
Kincade
Notes to Editors
About Evgen Pharma plc
Evgen Pharma is a clinical stage drug development company
developing sulforaphane based medicines for the treatment of
multiple diseases. The Company's core technology is Sulforadex(R),
a method for synthesising and stabilising the highly biologically
active compound sulforaphane and novel proprietary analogues based
on sulforaphane.
The Company's lead asset, SFX-01, is a patented composition of
synthetic sulforaphane and alpha-cyclodextrin and has undergone
clinical trials for oestrogen-positive (ER+) metastatic breast
cancer and recently a Phase 1b study of the Company's new enteric
coated tablet formulation. The FDA has granted Orphan Drug status
to SFX-01 in malignant glioma. SFX-01 will be investigated
initially in this indication as an investigator sponsored study in
the Netherlands.
The Company also has a wide number of collaborations with
leading academic centres in the UK, Europe and the US as part of
the continuing strategy to build the scientific data for the
compound. Recently, Evgen completed an out-licensing transaction
with Stalicla SA, a Swiss specialist company in neurodevelopmental
disorders, commencing with autism spectrum disorder. The deal, if
successful, will generate milestone payments of $160.5m and a
double-digit royalty on sales.
The Company has its headquarters and registered office at
Alderley Park, Cheshire. It is listed on AIM in London and trades
under the ticker symbol EVG.
For further information, please visit: www.evgen.com .
OPERATIONAL UPDATE
PIPELINE
Phase I study of performance of new SFX-01 enteric coated tablet
including PK/PD assessment
During the period, the data from the Phase 1/1b human volunteer
study were subject to an extensive quality assurance process as is
customary for regulatory standard clinical trials. The healthy
volunteer study used the Company's new enteric coated tablet
formation of lead asset SFX--01. The data are contained in the
extensive Clinical Study Report (CSR) which has been approved by
the Company and its providers in compliance with good clinical
practice (GCP).
Following the top--level data announced in March 2023, the full
pre--specified pharmacokinetic (PK) and pharmacodynamic (PD)*
dataset from the placebo--controlled, dose--escalating, randomized
study has now been analysed and reported in the approved CSR. The
study aimed to investigate how sulforaphane released from the new
enteric--coated tablet formulation was absorbed from the intestine
and its effects on the physiology of healthy volunteers.
Based on the time course seen, sulforaphane was released by the
new enteric coated tablet beyond the acid environment of the
stomach. No serious adverse events were observed. Total blood
levels of sulforaphane (SFN) and SFN--metabolites were confirmed in
the micromolar range, where efficacy is seen in vitro. An
additional pharmacodynamic exploratory investigation, utilising
mRNA sequencing, has been commissioned.
Biomarkers are being analysed from participants' blood, for
placebo and SFX--01 treated subjects who received 600mg once daily.
The initial analysis identified a number of significant
differentially expressed genes in the SFX--01 treated group,
between blood samples taken before the first dose was administered
(baseline) and blood samples taken after the first dose timepoint
(6 hours after first dose).
Further analysis will be undertaken on this large and complex
dataset to gain insight into the particular genes identified that
are of interest to internal programmes in cancer and, for partner
Stalicla SA, in autism spectrum disorder. Publication of the study
results is planned once the exploratory analysis of the gene
expression data is complete.
Glioblastoma ("GBM")
Glioma is the most common form of brain tumour affecting around
5 per 100,000 people. The more severe, grade IV classification,
glioblastoma, is a very serious form of malignant brain tumour
representing 45% of all cases and has a poor prognosis with median
survival of around 14 months. The five-year survival of the severe
grades is 5%. Therapeutic options for glioma are limited to
surgery, radiotherapy and the one drug widely available,
temozolomide. There is a clear and substantial unmet need for more
treatments for use in conjunction with the current standard of
care.
Evgen has been consulting widely with world-renowned experts in
the treatment of brain cancers with regards to the planned study.
These key opinion leaders have advised that further pre-clinical
work and an early-stage clinical trial of SFX-01 in patients with
GBM should be conducted to acquire more clarity on sulforaphane
entering the brain tumour and its interaction with molecular
targets in the tumour tissue of GBM patients. The Company expects
that this approach will further de-risk the Phase 2 clinical
trial.
The Company has previously received positive and supportive
regulatory scientific advice from the Dutch Medicines Evaluation
Board which also stated that there were no specific concerns
related to the clinical safety profile of SFX-01 based on available
data. This preliminary clinical work will be conducted as an
Investigator Sponsored Study, led by Dr Marjolein Geurts,
neuro-oncologist at the Erasmus University Medical Centre, the
Netherlands . During the period, Dr Geurts received a successful
notice of a grant for pre-clinical and clinical studies of SFX-01
in glioblastoma. The grant was awarded by KWF Dutch Cancer Society
for a project in excess of EUR1m.
The studies funded by the grant will cover use of SFX-01 in
additional pre-clinical glioblastoma models, followed by a clinical
Investigator Sponsored Study (ISS) window-of-opportunity study in
glioblastoma patients, to establish presence of the drug in human
brain tumours and engagement with relevant molecular targets in
excised tumour tissue.
Post period, the grant funded project started on schedule on
earlier this month and a dedicated researcher is scheduled to start
work in November 2023.
Metastatic breast cancer ("mBC")
Since the completion of the Phase 2a trial of SFX-01 in
metastatic breast cancer, CDK4/6 inhibitors have grown in
acceptance and are becoming standard of care in first line mBC
treatment. These drugs provide an extended period of progression
free survival, but invariably patients become resistant to them.
Accordingly, Evgen is conducting further pre-clinical work with its
collaborators.
To date, this work has demonstrated encouraging in vitro data. A
direct target of SFX-01 was shown to be increased in
patient-derived metastatic CDK4/6 resistant cells and in resistant
cell lines. SFX-01 significantly reduces proliferation of these
resistant cells, and in particular, it does so more efficiently
than certain currently approved drugs on the market. The Company is
consulting widely on how to optimize the profile of SFX-01 in the
post CDK4/6 inhibitor setting.
PRE-CLINICAL PROJECTS
Based on previous findings from pre-clinical work in glioma,
Evgen commenced a collaboration with Prof. Francesco Marampon, of
Università Sapienza di Roma to investigate the hypothesis that
SFX-01 could enhance the action of radiotherapy in cancer patients.
Recent in vitro data from radio-sensitisation studies in the rare
childhood cancer rhabdomyosarcoma have provided evidence that this
is the case. During the period, further in vivo experiments in mice
have confirmed the effect of SFX-01 as a radio-sensitising agent.
This implies a potential role for SFX-01 in a variety of cancers
where radiotherapy is a standard treatment. These exciting results
will be submitted for publication in a scientific journal
shortly.
A further collaboration with Dr Grace Chen of the University of
Michigan to investigate the potential anti-tumour effects of SFX-01
in colorectal cancer is ongoing. Specifically, the collaboration
seeks to evaluate the in vivo effects of SFX-01 in models of
colorectal cancer. The activity and mechanism of action of SFX-01
on organoid growth, morphology, stemness and inflammatory markers
will also be investigated using normal and malignant
patient-derived organoids and tumour tissue. Initial results are
expected at the end of 2023/early 2024.
Colorectal cancer is considered to be the third most common form
of cancer worldwide, with between 1.5-2 million annual diagnoses,
and the second leading cause of cancer-related deaths. There has
also been an alarming global rise in early-onset colorectal cancer
occurring in individuals under 50 years of age. Treating colorectal
cancers can be difficult and does not always lead to a cure
especially in advanced stages. Therefore, there is a strong need to
develop chemoprevention strategies as well as better treatment
options.
BUSINESS DEVELOPMENT
STALICLA partnership
In October 2022, the Company licensed the global rights for lead
asset SFX-01 in neurodevelopmental disorders and schizophrenia to
Stalicla SA , a Swiss company specialising in the identification of
specific phenotypes of ASD, using its proprietary precision
medicine platform. Evgen retains the global rights for all other
indications.
The financial terms are $0.5m upfront and $0.5m on completion of
the human volunteer Phase 1/1b stud y. Thereafter, milestone
payments up to commercial launch are $26.5m, including $5m on grant
of IND by the FDA. Total milestones of up to $160.5m are payable to
the Company in relation to the first neurodevelopmental disorder
indication under the license. Royalties payable to Evgen on sales
are in the low to medium double-digit range in all scenarios,
including on-licensing by Stalicla SA and use of SFX-01 in further
licensed indications.
Previous studies with other sources of sulforaphane have shown
evidence of clinical efficacy in improving symptoms of ASD (e.g.
Singh et al 2014). However, patient heterogeneity provides a
challenge in identifying those individuals likely to respond to
therapy. Stalicla SA has a unique, proprietary technology to
identify ASD patients who are most likely to respond to SFX-01.
This screening approach has already been used successfully to
identify patients likely to respond in ASD drug trials and is a key
differentiator for Stalicla SA in developing drugs for such a wide
spectrum disorder as ASD.
Evgen and Stalicla SA continue to work together through the
Joint Development Committee as mandated in the license agreement
together with numerous other interactions on regulatory strategy
and design of the Stalicla-funded Phase 2 clinical study in autism
spectrum disorder.
Juvenescence partnership
As announced on 2 August 2023, the partnership with Juvenescence
has been terminated due to re-organization and re-prioritization by
Juvenescence. Exclusive rights will revert to Evgen during Q4 2023
and the upfront payment received is non-refundable.
FINANCIAL REVIEW
The financial performance for the six-month period to 30
September 2023 was in line with expectations. Operating losses
reduced in the period by GBP0.76m to GBP1.46m compared with
GBP2.22m in the prior period. Use of cash reflects the continuation
of clinical trial activity and the related manufacturing process
development and product manufacture to support this. Consequently,
the total comprehensive loss for the period was GBP1.46m (30
September 2022: GBP2.15m).
The net cash outflow for the period was GBP1.27m (2022:
GBP1.86m); the similar comparison with the prior period reflects
working capital movements and the receipt of the R&D credit of
GBP0.91m, which was received in August 2023 (respective GBP0.48m in
2022).
The total cash position (including cash deposits, short term
investments and cash equivalents) as at 30 September 2023 was
GBP3.73m (30 September 2022: GBP7.17m).
The Directors estimate that the cash held by the Group will be
sufficient to support the current level of activities into Q4 2024.
They have therefore prepared the financial statements on a going
concern basis.
Name change of Nominated Adviser and Broker
The Company also announces that its Nominated Adviser ("NOMAD")
and Broker finnCap Ltd, has changed its name to Cavendish Capital
Markets Limited.
OUTLOOK
In the last six months the Company has completed an insightful
Phase 1/1b volunteer study and continues to analyse gene expression
data from the study. These results will be made public when the
analysis is complete. Evgen continues to work closely with its
partner Stalicla on its programme in ASD and will provide updates
as the programme proceeds.
The Company anticipates publication of the radio-sensitisation
data for SFX-01 in models of rhabdomyosarcoma from collaborator La
Sapienza University, Rome in early 2024.
The grant funded programme in glioblastoma at the Erasmus Cancer
Center, Rotterdam has commenced on schedule and updates will be
provided as data emerge from the collaboration.
The Company's cash position remains healthy with a runway to
late 2024, allowing headroom to continue to further progress the
multiple opportunities for SFX-01.
The Board would like to thank all shareholders for their support
and look forward to progressing the Company's strategy which
remains clearly focused on commercializing the potential of
SFX-01.
Dr Susan Foden Dr Huw Jones
Chair CEO
31 October 2023
Consolidated Statement of Comprehensive Income
for the six months ended 30 September 2023 - unaudited
Six months Six months
ended ended Year ended
30 September 30 September 31 March
2023 2022 2023
GBP'000 GBP'000 GBP'000
Notes Unaudited Unaudited Audited
--------------------------------------------- ------ -------------- -------------- -----------
Revenue 396 - 442
--------------------------------------------- ------ -------------- -------------- -----------
Operating expenses
Operating expenses (1,802) (2,163) (5,389)
Share based compensation 4 (53) (59) (157)
--------------------------------------------- ------ -------------- -------------- -----------
Total operating expenses (1,855) (2,222) (5,546)
Operating loss (1,459) (2,222) (5,104)
Finance income - 22 98
--------------------------------------------- ------ -------------- -------------- -----------
Loss on ordinary activities before
taxation (1,459) (2,200) (5,006)
Taxation - 51 963
--------------------------------------------- ------ -------------- -------------- -----------
Loss and total comprehensive expense attributable
to equity holders of the parent for the
period (1,459) (2,149) (4,043)
----------------------------------------------------- -------------- -------------- -----------
Loss per share attributable to equity
holders of the parent (pence)
--------------------------------------------- ------ -------------- -------------- -----------
Basic loss per share 3 (0.53) (0.78) (1.47)
Diluted loss per share 3 (0.53) (0.78) (1.47)
--------------------------------------------- ------ -------------- -------------- -----------
Consolidated Statement of Financial Position
as at 30 September 2023 - unaudited
As at As at As at
30 September 30 September 31 March
2023 2022 2023
GBP'000 GBP'000 GBP'000
Notes Unaudited Unaudited Audited
------------------------------------- ------ -------------- -------------- ----------
ASSETS
Non-current assets
Property, plant and equipment 1 5 3
Intangible assets 39 47 43
------------------------------------- ------ -------------- -------------- ----------
Total non-current assets 40 52 46
Current assets
Trade and other receivables 582 346 216
Current tax receivable - - 912
Short-term investments and cash on - 4,520 -
deposit
Cash and cash equivalents 3,728 2,653 5,000
------------------------------------- ------ -------------- -------------- ----------
Total current assets 4,310 7,519 6,128
Total assets 4,350 7,571 6,174
------------------------------------- ------ -------------- -------------- ----------
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables 415 434 833
------------------------------------- ------ -------------- -------------- ----------
Total current liabilities 415 434 833
Equity
Ordinary shares 5 687 687 687
Share premium 27,870 27,870 27,870
Merger reserve 2,067 2,067 2,067
Share based compensation 562 549 509
Retained deficit (27,251) (24,036) (25,792)
------------------------------------- ------ -------------- -------------- ----------
Total equity attributable to equity
holders of the parent 3,935 7,137 5,341
Total liabilities and equity 4,350 7,571 6,174
------------------------------------- ------ -------------- -------------- ----------
The registered number of Evgen Pharma plc is 09246681.
Consolidated Statement of Changes in Equity
for the six months ended 30 September 2023 - unaudited
Ordinary Share Merger Share based Retained
shares premium reserve compensation deficit Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------------------ --------- -------- -------- ------------- --------- --------
Balance at 1 April 2023 687 27,870 2,067 509 (25,792) 5,341
Total comprehensive expense
for the period - - - - (1,459) (1,459)
Transactions with owners
Share based compensation
- share options - - - 53 - 53
------------------------------
Total transactions with
owners - - - 53 - 53
------------------------------ --------- -------- -------- ------------- --------- --------
Balance at 30 September
2023 687 27,870 2,067 562 (27,251) 3,935
------------------------------ --------- -------- -------- ------------- --------- --------
Ordinary Share Merger Share based Retained
shares premium reserve compensation deficit Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------------------ --------- -------- -------- ------------- --------- --------
Balance at 1 April 2022 687 27,870 2,067 490 (21,887) 9,227
Total comprehensive expense
for the period - - - - (2,149) (2,149)
Transactions with owners
Share based compensation
- share options - - - 59 - 59
------------------------------
Total transactions with
owners - - - 59 - 59
------------------------------ --------- -------- -------- ------------- --------- --------
Balance at 30 September
2022 687 27,870 2,067 549 (24,036) 7,137
------------------------------ --------- -------- -------- ------------- --------- --------
Ordinary Share Merger Share based Retained
shares premium reserve compensation deficit Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------------------ --------- -------- -------- ------------- --------- --------
Balance at 1 April 2022 687 27,870 2,067 490 (21,887) 9,227
Total comprehensive expense
for the period - - - - (4,043) (4,043)
Transactions with owners
Share issue - lapsed options - - - (138) 138 -
Share based compensation
- share options - - - 157 - 157
------------------------------ --------
Total transactions with
owners - - - 19 138 157
------------------------------ --------- -------- -------- ------------- --------- --------
Balance at 31 March 2023 687 27,870 2,067 509 (25,792) 5,341
------------------------------ --------- -------- -------- ------------- --------- --------
Consolidated Statement of Cash Flows
for the six months ended 30 September 2023 - unaudited
Six months Six months
ended ended Year ended
30 September 30 September 31 March
2023 2022 2023
GBP'000 GBP'000 GBP'000
Unaudited Unaudited Audited
--------------------------------------------- -------------- -------------- -------------
Cash flows from operating activities
Loss before taxation for the period (1,459) (2,200) (5,006)
Interest (income) / expense - (22) (98)
Depreciation and amortisation 6 7 13
Share based compensation 53 59 157
--------------------------------------------- -------------- -------------- -------------
(1,400) (2,156) (4,934)
Changes in working capital
Increase in trade and other receivables (367) (220) (91)
(Decrease)/increase in trade and other
payables (418) 23 423
--------------------------------------------- -------------- -------------- -------------
Cash used in operations (785) (197) 332
Taxation received 913 475 475
--------------------------------------------- -------------- -------------- -------------
Net cash used in operating activities (1,272) (1,878) (4,127)
Cash flows (used in)/generated from
investing activities
Monies received from short term investments - - 4,520
Interest income - 22 98
Acquisition of tangible fixed assets - (1) (1)
--------------------------------------------- -------------- -------------- -------------
Net cash (used in)/generated from investing
activities - 21 4,617
Movements in cash and cash equivalents
in the period (1,272) (1,857) 490
--------------------------------------------- -------------- -------------- -------------
Cash and cash equivalents at start of
period* 5,000 4,510 4,510
--------------------------------------------- -------------- -------------- -------------
Cash and cash equivalents at end of
period* 3,728 2,653 5,000
--------------------------------------------- -------------- -------------- -------------
*Cash balances shown on the cash flow statement exclude
"Short-term investments and cash on deposit" due to their maturity
(at 30 September 2022: GBP4,520, 30 September 2023: nil).
1. GENERAL INFORMATION
EVGEN PHARMA PLC ("Evgen", "the Group" or "the Company") is a
public limited company incorporated in England & Wales whose
shares are traded on the AIM market of the London Stock Exchange
under the symbol EVG.
The address of its registered office is Alderley Park, Congleton
Road, Nether Alderley, SK10 4TG. The principal activity of the
Group is clinical stage drug development.
2. BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES
Basis of preparation
The Group's half-yearly financial information, which is
unaudited, consolidates the results of Evgen Pharma plc and its
subsidiary undertaking up to 30 September 2023. The Group's
accounting reference date is 31 March. Evgen Pharma plc's shares
are quoted on the AIM Market of the London Stock Exchange.
The Company is a public limited liability company incorporated
and domiciled in the UK. The consolidated financial information is
presented in round thousands of Pounds Sterling (GBP'000).
The financial information contained in this half-yearly
financial report does not constitute statutory accounts as defined
in section 434 of the Companies Act 2006. It does not therefore
include all of the information and disclosures required in the
annual financial statements. The financial information for the six
months ended 30 September 2022 and 30 September 2023 is
unaudited.
Full audited financial statements of the Group in respect of the
period ended 31 March 2023, 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 September 2023 are in
accordance with the recognition and measurement criteria of
UK-adopted International Accounting Standards and are consistent
with those which will be adopted in the annual financial statements
for the year ending 31 March 2024.
Whilst the financial information included has been prepared in
accordance with the recognition and measurement criteria of
international accounting standards, the financial information does
not contain sufficient information to comply with international
accounting standards.
The Group 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.
Going concern
At 30 September 2023, the Group had cash and cash equivalents of
GBP3.73 million.
The Directors have prepared detailed financial forecasts and
cash flows looking beyond 12 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 will prevail over the
forecast period.
The Directors estimate that the cash and cash equivalents held
by the Group together with known receivables will be sufficient to
support the current level of activities into the fourth quarter of
calendar year 2024. They have therefore prepared the financial
statements on a going concern basis.
Significant management judgement in applying accounting policies
and estimation uncertainty
When preparing the condensed consolidated interim financial
information, the Directors make a number of judgements, estimates
and assumptions about the recognition and measurement of assets,
liabilities, income and expenses.
The following are significant management judgements and
estimates in applying the accounting policies of the Group that
have the most significant effect on the condensed consolidated
interim financial information. Actual results may be substantially
different.
Share-based payments
The Group measures the cost of equity-settled transactions with
employees by reference to the fair value of the equity instruments
at the date at which they are granted. The fair value of the
options granted is determined using the Black Scholes model, taking
into consideration the best estimate of the expected life of the
options and the estimated number of shares that will eventually
vest.
Research and development expenditure
All research and development costs, whether funded by third
parties under licence and development agreements or not, are
included within operating expenses and classified as such. Research
and development costs relating to clinical trials are recognised
over the period of the clinical trial based on information provided
by clinical research organisations. All other expenditure on
research and development is recognised as the work is
completed.
All ongoing development expenditure is currently expensed in the
period in which it is incurred. Due to the regulatory and other
uncertainties inherent in the development of the Group's
programmes, the criteria for development costs to be recognised as
an asset, as prescribed by IAS 38, 'Intangible assets', are not met
until the product has been submitted for regulatory approval, such
approval has been received and it is probable that future economic
benefits will flow to the Group. The Group does not currently have
any such internal development costs that qualify for capitalisation
as intangible assets.
3. LOSS PER SHARE
Basic loss per share is calculated by dividing the loss for the
period attributable to equity holders by the weighted average
number of ordinary shares outstanding during the period.
For diluted loss per share, the loss for the period attributable
to equity holders and the weighted average number of ordinary
shares outstanding during the period is adjusted to assume
conversion of all dilutive potential ordinary shares. As the effect
of the share options would be to reduce the loss per share, the
diluted loss per share is the same as the basic loss per share.
The calculation of the Group's basic and diluted loss per share
is based on the following data:
Six months Six months Year ended
ended ended 31 March
30 September 30 September 2023
2023 2022
GBP'000 GBP'000 GBP'000
Unaudited Unaudited Audited
Loss for the period attributable to
equity holders (1,459) (2,149) (4,043)
-------------------------------------- -------------- -------------- -----------
As at As at As at
30 September 30 September 31 March
2023 2022 2023
Number Number Number
Unaudited Unaudited Audited
Weighted average number of ordinary
shares 274,888,117 274,888,117 274,888,117
-------------------------------------- -------------- -------------- ------------
Effects of dilution:
Share options - - -
Weighted average number of ordinary
shares adjusted for the effects of
dilution 274,888,117 274,888,117 274,888,117
-------------------------------------- -------------- -------------- ------------
Pence Pence Pence
Loss per share - basic and diluted (0.53) (0.78) (1.47)
-------------------------------------- -------------- -------------- ------------
4. SHARE-BASED PAYMENTS
As at the end of the period, the reconciliation of share option
scheme movements is as follows:
As at 30 September 2023
Number WAEP
Outstanding at 1 April 2023 20,730,039 0.11
Granted during the period - -
Exercised during the period - -
Lapsed/cancelled during the period (1,654,496) 1.44
-------------------------------------- -------------- --------------------
Outstanding at 30 September 2023 19,075,543 0.00
-------------------------------------- -------------- --------------------
WAEP is an abbreviation for weighted average exercise price.
During the six-month period ended 30 September 2023, a
share-based payment charge of GBP52,627 (six months to 30 September
2022: GBP59,113) was expensed to the consolidated Statement of
Comprehensive Income.
The fair values of the options granted have been calculated
using a Black-Scholes model.
5. ISSUED CAPITAL AND RESERVES
Ordinary shares
Company
Share Capital
Number GBP'000
As at 31 March 2023 274,888,117 687
---------------------------------- ------------ --------
Issued on exercise of options - -
Issued under placing agreement - -
At 30 September 2023 274,888,117 687
---------------------------------- ------------ --------
No new shares were issued during six-month period ended 30
September 2023.
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END
IR NKKBDDBDBAKN
(END) Dow Jones Newswires
October 31, 2023 03:00 ET (07:00 GMT)
Evgen Pharma (LSE:EVG)
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Evgen Pharma (LSE:EVG)
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