TIDMEVG
RNS Number : 7347U
Evgen Pharma PLC
07 December 2021
Evgen Pharma plc
("Evgen" or "the Company" or "the Group")
Half year Report
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 2021.
Operational highlights
-- Malignant glioma Orphan Drug Designation for SFX-01 granted by FDA
-- Encouraging early in vitro data for SFX-01 in Juvenile
Myelomonocytic Leukaemia ("JMML") at the MRC Weatherall Institute,
University of Oxford
-- Final preclinical work in glioblastoma ("GBM") completed and
in late-stage preparation for a Phase Ib/II trial
-- In vitro pre-clinical work supports SFX-01 use in metastatic
breast cancer patients who have become resistant to the widely-used
class of CDK4/6 inhibitor drugs
-- Publication of positive preclinical in vitro and in vivo data
in GBM from two independent groups of collaborators in Italy and
New Zealand
-- Scale-up of the active ingredient in SFX-01 to commercial
scale achieved with a number of process improvements
-- New formulation of SFX-01 generated in tablet form enabling
scale up to supply late-stage clinical trials and commercial
use
-- Dr Helen Kuhlman and Dr Glen Clack appointed as Chief
Business Officer and Chief Medical Officer respectively, completing
the senior management team
Financial highlights
-- Financial performance in-line with expectations:
o Post-tax loss of GBP1.5m (2020: loss of GBP1.8m)
o Cash outflow from operations of GBP1.5m (2020: outflow of
GBP1.9m)
o Cash deposits, cash and cash equivalents balance at 30
September 2021 of GBP10.1m (30 September 2020: GBP2.3m)
Dr Huw Jones, Chief Executive Officer of Evgen Pharma, said:
"The last six months has yielded further positive preclinical data
to support the potential of SFX-01 in a number of cancers and an
Orphan Drug Designation in the USA for malignant glioma. With the
scale up and refinement of the SFX-01 production process and design
of the Phase I and Phase II clinical trials running in parallel, we
look forward to commencing further important clinical programmes in
H1 2022. With our strengthened senior management team that brings
further expertise, we look forward to a successful second half of
the year and I would like to extend my thanks to our shareholders
for their continued support."
Enquiries:
Evgen Pharma plc www.evgen.com via Walbrook
Dr Huw Jones, CEO
Richard Moulson, CFO
finnCap www.finncap.com +44 (0)20 7220 0500
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane (ECM)
Walbrook PR +44 (0)20 7933 87870 or evgen@walbrookpr.com
+44 (0)7876 741 001 / + 44 (0)7867
Anna Dunphy / Phillip Marriage 984 082
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 naturally occurring
compound sulforaphane and novel proprietary analogues based on
sulforaphane. The lead product, SFX-01, is a patented composition
of synthetic sulforaphane and alpha-cyclodextrin.
Clinical data from the Company's open-label Phase II STEM trial
has shown that SFX-01 can halt the growth of progressing tumours in
patients with oestrogen-positive (ER+) metastatic breast cancer,
and in some cases significantly shrink the tumour, whilst causing
very few side effects. It has been used to treat over 200 patients
in clinical trials and is well-tolerated with predominately mild
side-effects.
The Company has its headquarters at Alderley Park, Cheshire, and
its registered office is at the Liverpool Science Park, Liverpool.
It is listed on the AIM market of the London Stock Exchange and
trades under the ticker symbol EVG.
For further information, please visit: www.evgen.com
For research on the Company, please visit:
http://evgen.com/investors/analyst-coverage/
CHAIRMAN'S AND CHIEF EXECUTIVE'S STATEMENT
We are pleased to present the financial results of Evgen for the
six months ended 30 September 2021 and to provide an update on the
significant progress made by the Group during the period.
INTRODUCTION
Evgen is a clinical stage drug development company focused on
the development of sulforaphane-based compounds, a new class of
pharmaceuticals which are synthesised in a proprietary,
well-tolerated, stable formulation. We have a comprehensive
intellectual property estate covering this technology. Our pipeline
exploits sulforaphane's activity in three separate biochemical
pathways; inhibition of pSTAT3 and SHP2, both of importance in
cancer, and up-regulation of Nrf2, a therapeutic target associated
with a broad range of diseases which are characterised by excessive
oxidative stress and inflammation. Sulforaphane has attracted huge
scientific interest and has been shown to have anti-cancer and
anti-inflammatory qualities in a wide range of preclinical and
clinical studies. However clinical grade delivery of sulforaphane
has proved elusive. Evgen is the only company to be generating such
a product for clinical use to the exacting standards of
pharmaceutical products.
Our lead product, SFX-01, has demonstrated efficacy in a Phase
II trial for advanced metastatic breast cancer. It has been used to
treat over 200 patients in clinical trials and is well-tolerated,
with a good safety profile and predominantly mild side-effects.
Evgen has exclusive rights to the only technology
(Sulforadex(R)) proven to synthesise this very unstable molecule in
a stabilised composition that will satisfy regulatory and medicinal
needs for a pharmaceutical and that can be used as a therapeutic.
We have a strong balance sheet and robust IP around sulforaphane
and Sulforadex(R).
PIPELINE
Phase I study of biomarkers including pharmacokinetic and
pharmacodynamic ('PK/PD') assessment
An important use of proceeds from the fundraise completed in
March this year was to conduct a Phase I study in healthy
volunteers to assess PK/PD characteristics of SFX-01, and
potentially other biomarkers relevant to our diseases of interest,
with our commercial-scale tablet formulation. Whilst an initial
Phase 1 study was completed prior to the first efficacy trials
conducted by Evgen, as our knowledge of how SFX-01 behaves in the
body has developed it has become evident that a further study would
be beneficial in informing the design of future efficacy trials,
particularly dosing regimens using our new dosage form.
Design of this trial is almost complete and a dialogue with the
MHRA has commenced. The intention is to start the trial in Q2 next
year as soon as the new tablet formulation of SFX-01 has been
finalised and manufactured in sufficient quantities.
Metastatic breast cancer ("mBC")
Since we commenced our phase II 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, we are
conducting further preclinical work with our collaborators at the
Cancer Research UK Manchester Institute to assess the impact of
SFX-01 in CDK4/6 resistance models. To date this work has
demonstrated encouraging in vitro data and accordingly we are
arranging access to in vivo models for experiments that, if
successful, would support a trial in second line mBC treatment of
patients who have failed on CDK4/6 inhibitors. This would be
designed as a Phase II placebo-controlled study and most likely
would be conducted in partnership.
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%. The therapeutic options for glioma are limited to
surgery, radiotherapy and the one drug widely available,
temozolomide. There is a clear unmet need for more treatments for
use in conjunction with the current standard of care.
A collaboration with Dr Claudio Festuccia and colleagues at the
Universities of d'Aquila, Rome and Rieti, Italy has generated
highly positive data for SFX-01 in pre-clinical models of glioma
and glioblastoma. Using standard in vitro and in vivo pre-clinical
models as well as orthotopic models (where glioma cells are
implanted in brain tissue representing a more disease-relevant
model) both tumour shrinkage and significantly extended survival
times were demonstrated. Furthermore, SFX-01 was also found to
potentiate (i.e. substantially increase) the therapeutic effect of
radiotherapy in these models. The first of two papers relating to
this has been published in a peer-reviewed journal and a second
paper is being finalised for submission. (Colapietro et al,
Pharmaceuticals, 2021, 14, 1082.)
Further preclinical work conducted generated by Dr Euphemia
Leung and Prof Bruce Baguley of the University of Auckland, New
Zealand in GBM cells has been published in the pre-print journal
BioRxIV (Leung, Wright and Baguley, 2021
https://www.biorxiv.org/content/10.1101/2021.09.14.459936v1 ). This
in vitro data is of SFX-01 in GBM cells and 3D spheroids from
several patients in New Zealand, together with the more commonly
used commercially available cell lines. 3D spheroids are
aggregations of tumour cells that more closely reflect the
structure of tumours in patients. In these in vitro experiments,
SFX-01 demonstrated inhibition of glioblastoma cell growth,
supporting the results from the work of Dr Festuccia.
We are now at a late stage in designing a Phase Ib/II clinical
study and liaising with potential trial sites in the UK and across
Europe. The trial could commence in Q2 2022.
Evgen recently announced the grant of Orphan Drug Designation in
the USA for Malignant Glioma, affording the programme additional
data protection and other incentives.
SFX-01 in leukaemias
Professor Philip Eaton at Queen Mary University of London has
shown that SFX-01 inhibits activity of the non-receptor
phosphotyrosine phosphatase, SHP2 (coded by the PTPN11 gene). SHP2
is thought to be a significant factor in many cancers. Professor
Eaton's work has recently been submitted for publication.
Following on from this work, an in vitro project was conducted
by another world-renowned academic institution, The Wetherall
Institute, University of Oxford to study the effect of SFX01 on
cell lines from patients with Juvenile Myelomonocytic Leukaemia
('JMML'). SHP2 is a mediator of the cell proliferation seen in JMML
patients. Whilst this is preliminary data from a small sample size,
we were encouraged to see a statistically significant effect in
reducing cell proliferation and increasing apoptosis (cell
death).
JMML is an invasive and very rare childhood cancer that may not
have sufficient commercial opportunity to be an appropriate
programme for Evgen to pursue. Accordingly, we are in dialogue with
leading clinicians in this field that may be interested in
conducting investigator-led trials.
We are also evaluating other leukaemias which would meet our
scientific and commercial criteria for development, and if we
conclude there is an opportunity would anticipate starting
pre-clinical work in Q1 2022.
ARDS in COVID-19 and other patients
Whilst the STAR Phase IIb/III study conducted at the University
of Dundee study provided further data to support the benign safety
and tolerability of SFX-01, regrettably the interim analysis did
not show efficacy sufficient to justify continuation of the trial.
We are awaiting the full data set to analyse biomarker information
that will inform our future programmes.
BUSINESS DEVELOPMENT
Juvenescence partnership
Our first commercial out-licensing deal signed, with
Juvenescence in September 2020, monetises one element of Evgen's
sulforaphane technology platform, being the application of our
Sulforadex stabilisation technology in the dietary supplement
market. This gives a commercialisation timescale considerably
shorter than that typical of pharmaceutical development.
Juvenescence is making good progress with sourcing
naturally-derived sulforaphane, production scale-up and regulatory
strategy. It is envisaged that product launch will occur in around
two years' time at which point milestone payments of over GBP1m
will have been received.
NON-CLINICAL ACTIVITIES
The funds raised in 2019 were allocated in part to completion of
long-term toxicology and manufacturing process development work.
This is now close to completion and we have achieved the
following:
-- Six-month toxicology satisfactorily completed with data that
supports continued clinical development of SFX-01
-- Technology transfer of production process to a UK-based
manufacturer of pharmaceutical products and scale-up of both a key
intermediate and the active ingredient in SFX-01 achieved, with a
number of process improvements
-- Good progress with new formulation of SFX-01 in tablet form
and commercial scale-up on-going.
The new tablet formulation of SFX-01 will be used in all future
clinical trials in place of the prototype capsule that patients
have been treated with to date, and which was not suitable for
in-market use.
Regarding regulatory matters, we have asked for scientific
advice from the MHRA in connection with the Phase 1 PK/PD study and
progressed our work on IND submission. We expect to hold a pre-IND
meeting with the FDA in Q1/2022.
FINANCIAL REVIEW
The financial performance for the six-month period to 30
September 2021 was in line with expectations. Operating losses
decreased in the period by GBP0.33m from GBP1.85m to GBP1.52m; this
reflects the long term toxicology programme and manufacturing
process development that was concentrated in the prior period,
together with some product manufacture for the STAR-Covid-19 trial.
Consequently the total comprehensive loss for the period was
GBP1.52m (30 September 2020: GBP1.84m).
The net cash outflow for the period was GBP1.54m (30 September
2020: GBP1.83m) reflecting the lower level of toxicology and
manufacturing work noted above.
The cash position (including cash deposits, short term
investments and cash equivalents) at 30 September 2021 stood at
GBP10.05m (30 September 2020: GBP2.31m), reflecting the funding
round in March 2021. Since the period end HMRC has remitted R&D
tax credits of GBP0.53m.
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 Q3 2023. They have therefore prepared the
financial statements on a going concern basis.
OUTLOOK
In the last six months we have broadened our preclinical data
sets in mBC, GBM and leukaemia to underpin clinical trials in these
diseases and focused on preparing for the next clinical trials. In
particular we have developed trial designs for the Phase I PK/PD
study, and in collaboration with senior GBM clinicians, the design
of the GBM proof of principle study. In parallel we have progressed
a new and commercially viable formulation of SFX-01 that will
deployed in these trials. Accordingly, we can look forward to
exciting clinical progress in 2022.
We would like to thank all our shareholders for their support
and look forward to progressing with our strategy which remains
clearly focused on commercialising the undoubted potential of
SFX-01.
Barry Clare Huw Jones
Chairman CEO
6 December 2021
Consolidated Statement of Comprehensive Income
for the six months ended 30 September 2021 - unaudited
Six months Six months Year
ended ended ended
30 September 30 September 31 March
2021 2020 2021
GBP'000 GBP'000 GBP'000
Notes Unaudited Unaudited Audited
--------------------------------------------- ------ -------------- -------------- ----------
Revenue - 194 194
Operating expenses
Operating expenses (1,443) (1,965) (3,519)
Share based compensation 4 (81) (82) 112
--------------------------------------------- ------ -------------- -------------- ----------
Total operating expenses (1,524) (2,047) (3,407)
Operating loss (1,524) (1,853) (3,213)
Other income - 10 -
--------------------------------------------- ------ -------------- -------------- ----------
Loss on ordinary activities before taxation (1,524) (1,843) (3,213)
Taxation - - 539
--------------------------------------------- ------ -------------- -------------- ----------
Loss and total comprehensive expense attributable
to equity holders of the parent for the period (1,524) (1,843) (2,674)
----------------------------------------------------- -------------- -------------- ----------
Loss per share attributable to equity
holders of the parent (pence)
--------------------------------------------- ------ -------------- -------------- ----------
Basic loss per share 3 (0.55) (1.38) (1.82)
Diluted loss per share 3 (0.55) (1.38) (1.82)
--------------------------------------------- ------ -------------- -------------- ----------
Consolidated Statement of Financial Position
as at 30 September 2021 - unaudited
As at As at As at
30 September 30 September 31 March
2021 2020 2021
GBP'000 GBP'000 GBP'000
Notes Unaudited Unaudited Audited
------------------------------------- ------ ------------- ------------- ---------
ASSETS
Non-current assets
Property, plant and equipment 7 1 5
Intangible assets 59 74 66
------------------------------------- ------ ------------- ------------- ---------
Total non-current assets 66 75 71
Current assets
Trade and other receivables 116 161 235
Current tax receivable 519 446 519
Short-term investments and cash on
deposit 6,000 - 6,000
Cash and cash equivalents 4,050 2,306 5,593
------------------------------------- ------ ------------- ------------- ---------
Total current assets 10,685 2,913 12,347
Total assets 10,751 2,988 12,418
------------------------------------- ------ ------------- ------------- ---------
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables 383 434 607
------------------------------------- ------ ------------- ------------- ---------
Total current liabilities 383 434 607
Equity
Ordinary shares 5 687 343 687
Share premium 27,870 17,932 27,870
Merger reserve 2,067 2,067 2,067
Share based compensation 440 1,970 359
Retained deficit (20,696) (19,758) (19,172)
------------------------------------- ------ ------------- ------------- ---------
Total equity attributable to equity
holders of the parent 10,368 2,554 11,811
Total liabilities and equity 10,751 2,988 12,418
------------------------------------- ------ ------------- ------------- ---------
Consolidated Statement of Changes in Equity
for the six months ended 30 September 2021 - 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 2021 687 27,870 2,067 359 (19,172) 11,811
Total comprehensive expense
for the period - - - - (1,524) (1,524)
Transactions with owners
Share based compensation -
share options - - - 81 - 81
---------------------------------
Total transactions with owners - - - 81 - 81
--------------------------------- --------- -------- -------- ------------- --------- --------
Balance at 30 September 2021 687 27,870 2,067 440 (20,696) 10,368
--------------------------------- --------- -------- -------- ------------- --------- --------
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 2020 331 17,831 2,067 1,890 (17,915) 4,204
Total comprehensive expense
for the period - - - - (1,843) (1,843)
Transactions with owners
Share issue - options exercised 12 101 - - - 113
Share based compensation -
share options - - - 80 - 80
---------------------------------
Total transactions with owners 12 101 - 80 - 193
--------------------------------- --------- -------- -------- ------------- --------- --------
Balance at 30 September 2020 343 17,932 2,067 1,970 (19,758) 2,554
--------------------------------- --------- -------- -------- ------------- --------- --------
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 2020 331 17,831 2,067 1,890 (17,915) 4,204
Total comprehensive expense
for the period - - - - (2,674) (2,674)
Transactions with owners
Share issue - cash 344 9,938 - - - 10,282
Share issue - options exercised 12 101 - (2) - 111
Share issue - lapsed options - - - (1,417) 1,417 -
Share based compensation -
share options - - - (112) - (112)
--------------------------------- --------
Total transactions with owners 356 10,039 - (1,531) 1,417 10,281
--------------------------------- --------- -------- -------- ------------- --------- --------
Balance at 31 March 2021 687 27,870 2,067 359 (19,172) 11,811
--------------------------------- --------- -------- -------- ------------- --------- --------
The registered number of Evgen Pharma plc is 09246681.
Consolidated Statement of Cash Flows
for the six months ended 30 September 2021 - unaudited
Six months Six months Year
ended ended ended
30 September 30 September 31 March
2021 2020 2021
GBP'000 GBP'000 GBP'000
Unaudited Unaudited Audited
---------------------------------------------- -------------- -------------- ----------
Cash flows from operating activities
Loss before taxation for the period (1,524) (1,843) (3,213)
Depreciation and amortisation 9 9 18
Share based compensation 81 82 (112)
---------------------------------------------- -------------- -------------- ----------
(1,434) (1,752) (3,307)
Changes in working capital
(Increase)/decrease in trade and other
receivables 119 35 (39)
(Decrease)/increase in trade and other
payables (224) (219) (46)
---------------------------------------------- -------------- -------------- ----------
Cash used in operations (105) (184) (85)
Taxation received - - 466
---------------------------------------------- -------------- -------------- ----------
Net cash used in operating activities (1,539) (1,936) (2,926)
Cash flows (used in)/generated from investing activities
Monies placed on fixed-term deposit - - (6,000)
Acquisition of tangible fixed assets (4) - (5)
---------------------------------------------- -------------- -------------- ----------
Net cash (used in)/generated from investing
activities (4) - (6,005)
Cash flows from financing activities
Net proceeds from issue of shares - 111 10,393
Net cash generated from financing activities - 111 10,393
---------------------------------------------- -------------- -------------- ----------
Movements in cash and cash equivalents
in the period (1,543) (1,825) 1,462
---------------------------------------------- -------------- -------------- ----------
Cash and cash equivalents at start of period 5,593 4,131 4,131
---------------------------------------------- -------------- -------------- ----------
Cash and cash equivalents at end of period 4,050 2,306 5,593
---------------------------------------------- -------------- -------------- ----------
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 Liverpool Science Park
Innovation Centre 2, 146 Brownlow Hill, Liverpool, Merseyside, L3
5RF. 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 2021. 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
(AIM).
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 2020 and 30 September 2021 is
unaudited.
Full audited financial statements of the Group in respect of the
period ended 31 March 2021, 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 2021 are in
accordance with the recognition and measurement criteria of
international accounting standards in conformity with the
requirements of the Companies Act 2006 as adopted by the UK and are
consistent with those which will be adopted in the annual financial
statements for the year ending 31 March 2022.
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 2021, the Group had cash and cash equivalents,
including short-term investments and cash on deposit, of GBP10.05
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
including short-term investments and cash on deposit, held by the
Group together with known receivables will be sufficient to support
the current level of activities into the third quarter of calendar
year 2023. 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
30 September 30 September 31 March
2021 2020 2021
GBP'000 GBP'000 GBP'000
Unaudited Unaudited Audited
Loss for the period attributable to
equity holders (1,524) (1,843) (2,674)
----------------------------------------------- -------------- -------------- ------------
As at As at As at
30 September 30 September 31 March
2021 2020 2021
Number Number Number
Unaudited Unaudited Audited
Weighted average number of ordinary
shares 274,888,117 133,726,538 147,019,536
----------------------------------------------- -------------- -------------- ------------
Effects of dilution:
Share options - - -
Weighted average number of ordinary
shares adjusted for the effects of dilution 274,888,117 133,726,538 147,019,536
----------------------------------------------- -------------- -------------- ------------
Pence Pence Pence
Loss per share - basic and diluted (0.55) (1.38) (1.82)
----------------------------------------------- -------------- -------------- ------------
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
2021
Number WAEP
Outstanding at 1 April 2021 6,402,754 GBP0.01
Granted during the period 4,743,291 GBP0.00
Exercised during the period - -
Lapsed/cancelled during the period - -
Outstanding at 30 September 2021 11,146,045 GBP0.01
----------------------------------- ----------- --------------
WAEP is an abbreviation for weighted average exercise price.
During the six-month period ended 30 September 2021, a
share-based payment charge of GBP80,607 (six months to 30 September
2020: GBP81,504) was expensed to the consolidated Statement of
Comprehensive Income.
The fair values of the options granted have been calculated
using a Black-Scholes model.
Assumptions used were an option life of 5 years, a risk-free
rate of 2 per cent., a volatility of 60 per cent. and no dividend
yield.
5. ISSUED CAPITAL AND RESERVES
Ordinary shares
Company
Share Capital
Number GBP'000
As at 31 March 2021 274,888,117 687
---------------------------------- ------------ --------
Issued on exercise of options - -
Issued under placing agreement - -
At 30 September 2021 274,888,117 687
---------------------------------- ------------ --------
No new shares were issued during six-month period ended 30
September 2021.
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