TIDMEVG
RNS Number : 9776I
Evgen Pharma PLC
08 December 2022
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 2022.
Operational highlights
-- Regulatory approval given by MHRA for PK/PD healthy volunteer study of new SFX-01 formulation
-- Scale-up of SFX-01 manufacturing achieved to GMP standards
-- New formulation of SFX-01 generated in an enteric coated tablet to GMP standards
-- Progress with Manchester University collaboration
investigating potential use of SFX-01 in breast cancer patients
with resistance to CDK4/6 inhibitors
-- C ollaboration with University La Sapienza di Roma on
potential radio-sensitisation properties of SFX-01
-- Collaboration with University of Michigan, to investigate the
potential anti-tumour effects of SFX-01 in colorectal cancer
Post period end
-- Substantial out-licensing deal signed with STALICLA SA for
neurodevelopmental disorders with total milestones of $160.5m,
double digit royalties. Up to $6m in initial milestones to be
received before end 2023
-- Positive regulatory scientific advice received from the
Netherlands regulatory authority on GBM programme
-- Healthy volunteer study of new SFX-01 formulation commenced on schedule
-- Emerging evidence of radio-sensitisation demonstrated for
SFX-01 in vitro by a new academic collaboration, Prof Marampon's
group in Rome, underpinning the mode of action in glioblastoma and
potentially other cancers
-- First phase of glioblastoma phase I/II trial to be conducted
as an Investigator Sponsored Study at the Erasmus University
Medical Centre, Rotterdam
Financial highlights
-- Financial performance in-line with expectations:
o Post-tax loss of GBP2.1m (2021: loss of GBP1.5m)
o Cash outflow from operations of GBP1.9m (2021: outflow of
GBP1.5m)
o Cash deposits, cash and cash equivalents balance at 30
September 2022 of GBP7.2m (30 September 2021: GBP10.1m)
-- Cash runway to end of 2024, before further milestones from the STALICLA SA out-license
Dr Huw Jones, Chief Executive Officer of Evgen Pharma, said:
"During the period the regulatory authorities have been highly
supportive of our efforts through approvals for our clinical work
and receipt of scientific advice, whilst our manufacturing effort
is producing commercial grade tablets. Two new academic
collaborations have been commenced, and we have seen pre-clinical
progress in our key focus areas of breast cancer and
glioblastoma.
"Post period there has been a transformative transaction
completed with STALICLA SA. This deal not only broadens the
application of SFX-01 into new indications; autism spectrum
disorder (ASD) and other neurodevelopmental disorders, but also
provides substantial cash payments if we hit our milestones
successfully. Our human volunteer clinical trial has commenced on
time underpinning both our internal programmes and the ASD study
with our new partner. Our collaboration in Rome has yielded data on
radio-sensitising mechanisms of SFX-01 supportive of its use in
cancers requiring radiotherapy e.g. brain cancer.
"We look forward to seeing clinical data on our new enteric
coated tablet in the first half of next year and to seeing
continued data flow from our numerous academic collaborations.
Later in the calendar year we anticipate further milestone payments
from STALICLA on the basis of a successful partnership. Our cash
runway is substantial at a turbulent time for our industry which
sets a good foundation for the busy times ahead."
Enquiries:
Evgen Pharma PLC
Dr Huw Jones, CEO
Richard Moulson, CFO +44 1625 466591
FinnCap (Nominated Advisor and
Broker)
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane/ Nigel Birks (ECM) +44 20 7220 0500
----------------------
Instinctif Partners +44 207 457 2020
Melanie Toyne-Sewell / Rozi Morris Evgen@Instinctif.com
/ Agnes Stephens / Adam Loudon
----------------------
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 naturally occurring
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. In September 2021 the FDA granted Orphan Drug status to
SFX-01 in malignant glioma.
The Company also has a wide number of collaborations with
leading academic centres in the UK, Europe and AsiaPac as part of
the continuing strategy to build safety and efficacy data sets
around the compound. With respect to non-core areas, Evgen signed
an out-licensing deal with JuvLife, the dietary products and
functional foods division of Juvenescence Ltd, for the development
of a naturally-sourced sulforaphane nutritional health supplement,
stabilised using Evgen's Sulforadex(R) technology. Evgen also has a
licensing deal with STALICLA SA in neurodevelopmental disorders and
schizophrenia.
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
OVERVIEW
This has been a period of significant progress for Evgen, from
progress in academic collaborations to scale-up of GMP
manufacturing and with financial performance in-line with
expectations.
Strategy update
The aim for the current financial year is to drive the progress
of the clinical programmes, whilst building further value through
additional partnering and scientific collaborations.
Academic collaborations have made good progress during the
period with encouraging data, particularly in
radio-sensitisation.
On the clinical side, the healthy volunteer
pharmacokinetic/pharmacodynamic ("PK/PD") study of the new SFX-01
formulation started on schedule and will provide a broad set of
data regarding the performance of the new formulation by H2 2023 -
giving key insights into how it acts within the human body. This
data will be important for the further investigation of SFX-01 in
glioblastoma ("GBM"). On the advice of k ey opinion leaders,
additional pre-clinical work and an early-stage clinical trial of
SFX-01 in patients with GBM will be conducted to generate more data
on how SFX-01 enters the brain tumour, and interacts with molecular
targets in such tissue. This early clinical work should further
de-risk the Phase 2 clinical trial, as well as extending the cash
runway.
The ongoing scale-up and production of the new formulation of
SFX-01 to GMP standards has been a major focus of activity, and is
a key development which will be important for future clinical
studies conducted by Evgen and its partners.
Considerable progress has been made in business development
which culminated with a substantial partnership signed post period
end.
Conclusion
Post period saw a transformative development for Evgen, with the
very substantial out-licensing deal with STALICLA SA (STALICLA),
announced in October 2022, extending the application of SFX-01 into
neurodevelopmental disorders and underpinning the potential for the
lead compound beyond oncology and inflammation. This reduces the
Company's risk profile, and the non-dilutive upfront payments and
initial milestones also significantly extend the Company's cash
runway, leaving it well positioned to execute further on its growth
strategy.
The Board looks forward to continuing to progress its strategy
which remains clearly focused on commercialising the undoubted
potential of SFX-01.
OPERATIONAL UPDATE
PIPELINE
Phase I study of biomarkers including PK/PD assessment
An important use of proceeds from the fundraise completed in
March 2021 is to examine the performance of Evgen's new
enteric-coated tablet formulation of lead asset SFX-01 in a Phase
I/Ib study of healthy volunteers. This new commercial-scale tablet
formulation is being tested in a placebo-controlled,
dose-escalating, randomised trial to determine how it is absorbed
and circulates in the body, and how it engages with target
molecules.
The study will assess PK and PD characteristics relevant to
Evgen's diseases of interest. It has been designed to yield a rich
data set to inform forthcoming efficacy studies, including the
proposed phase II study in autism spectrum disorder ("ASD") that
our partner, STALICLA, will run.
Following the regulatory approval announced on 3 October 2022
the study is now open for recruitment and the first eight subjects,
from an anticipated total of 24, entered the trial on schedule. The
results of the trial are expected in the second quarter of
2023.
Metastatic breast cancer ("mBC")
Since the start of the 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, Evgen is
conducting further pre-clinical work with its collaborators at the
Manchester Breast Centre to assess the impact of SFX-01 in CDK4/6
resistance models. 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 currently approved drugs on the market.
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 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.
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 . The Erasmus group has extensive experience in
glioblastoma research, with several studies and numerous
publications in this field. Evgen has already received positive and
supportive regulatory scientific advice from the Dutch Medicines
Evaluation Board, which also stated that there are no specific
concerns related to the clinical safety profile of SFX-01 based on
available data. If the pre-clinical and ISS clinical work is
successful, the trial programme is likely to be continued as an
Evgen-sponsored trial. Evgen will update on the timing of this
trial in due course.
PRE-CLINICAL PROJECTS
Based on previous findings from pre-clinical work in glioma, in
May this year 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 has provided evidence that this might be the case, and this
implies a role for SFX-01 in a variety of cancers where
radiotherapy is a standard treatment. In vivo experiments will
begin in Q1 2023.
A further collaboration commenced in June with Dr Grace Chen of
the University of Michigan to investigate the potential anti-tumour
effects of SFX-01 in colorectal cancer. 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.
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 the Company licensed the global rights for lead asset
SFX-01 in neurodevelopmental disorders and schizophrenia to
STALICLA , 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 study (anticipated during Q2 2023).
Thereafter, milestone payments up to commercial launch are $26.5m,
including $5m on grant of IND by the FDA (anticipated in late
2023). Total milestones of $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 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 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
ideal patients for other ASD drug trials and is a key
differentiator for STALICLA in developing drugs for such a wide
spectrum disorder as ASD.
Evgen's partnership with STALICLA will enable the targeting of
patient groups most likely to benefit from SFX-01, not only
de-risking the clinical development but potentially bringing a
therapeutic option to those individuals who are currently
underserved, in a quick and efficient manner.
Juvenescence partnership
The partnership with Juvenescence continues to make progress and
Evgen is supporting its development with the know-how and expertise
we have in making sulforaphane-based compounds for human use. 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.
FINANCIAL REVIEW
The financial performance for the six-month period to 30
September 2022 was in line with expectations. Operating losses
increased in the period by GBP0.70m to GBP2.22m compared with
GBP1.52m in the prior period; this reflects the increase in
clinical trial activity and the related manufacturing process
development and product manufacture to support this. Consequently,
the total comprehensive loss for the period was GBP2.15m (30
September 2021: GBP1.52m).
The net cash outflow for the period was GBP1.86m (2021:
GBP1.54m); the similar comparison with the prior period reflects
working capital movements and the receipt of the R&D credit of
GBP0.48m, which was received after the period end in the 2021/2022
financial year.
The cash position (including cash deposits, short term
investments and cash equivalents) at 30 September 2022 stood at
GBP7.17m (30 September 2021: GBP10.05m).
The Directors estimate that the cash held by the Group
(including short-term investments and cash on deposit) 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.
OUTLOOK
In the last six months Evgen has commenced its PK/PD study on
schedule and progressed the glioblastoma programme as well as
starting two pre-clinical cancer programmes with attractive
potential. The PK/PD study will yield important data to support
future clinical efficacy trials of the Company's and its partner's
programmes.
The very substantial out-licensing deal with STALICLA extends
the application of SFX-01 into neurodevelopmental disorders, both
reducing Evgen's risk profile and potentially providing substantial
non-dilutive cash receipts.
The Board would like to thank all our shareholders for their
support and look forward to progressing the Company's strategy
which remains clearly focused on commercialising the undoubted
potential of SFX-01.
Barry Clare Dr Huw Jones
Chairman CEO
8 December 2022
Consolidated Statement of Comprehensive Income
for the six months ended 30 September 2022 - unaudited
Six months Six months
ended ended Year ended
30 September 30 September 31 March
2022 2021 2022
GBP'000 GBP'000 GBP'000
Notes Unaudited Unaudited Audited
--------------------------------------------- ------ -------------- -------------- -----------
Operating expenses
Operating expenses (2,163) (1,443) (3,047)
Share based compensation 4 (59) (81) (146)
--------------------------------------------- ------ -------------- -------------- -----------
Total operating expenses (2,222) (1,524) (3,193)
Operating loss (2,222) (1,524) (3,193)
Finance income 22 - 24
--------------------------------------------- ------ -------------- -------------- -----------
Loss on ordinary activities before
taxation (2,200) (1,524) (3,169)
Taxation 51 - 439
--------------------------------------------- ------ -------------- -------------- -----------
Loss and total comprehensive expense attributable
to equity holders of the parent for the
period (2,149) (1,524) (2,730)
----------------------------------------------------- -------------- -------------- -----------
Loss per share attributable to equity
holders of the parent (pence)
--------------------------------------------- ------ -------------- -------------- -----------
Basic loss per share 3 (0.78) (0.55) (0.99)
Diluted loss per share 3 (0.78) (0.55) (0.99)
--------------------------------------------- ------ -------------- -------------- -----------
Consolidated Statement of Financial Position
as at 30 September 2022 - unaudited
As at As at As at
30 September 30 September 31 March
2022 2021 2022
GBP'000 GBP'000 GBP'000
Notes Unaudited Unaudited Audited
------------------------------------- ------ -------------- -------------- ----------
ASSETS
Non-current assets
Property, plant and equipment 5 7 5
Intangible assets 47 59 53
------------------------------------- ------ -------------- -------------- ----------
Total non-current assets 52 66 58
Current assets
Trade and other receivables 346 116 125
Current tax receivable - 519 425
Short-term investments and cash on
deposit 4,520 6,000 4,520
Cash and cash equivalents 2,653 4,050 4,510
------------------------------------- ------ -------------- -------------- ----------
Total current assets 7,519 10,685 9,580
Total assets 7,571 10,751 9,638
------------------------------------- ------ -------------- -------------- ----------
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables 434 383 411
------------------------------------- ------ -------------- -------------- ----------
Total current liabilities 434 383 411
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 549 440 490
Retained deficit (24,036) (20,696) (21,887)
------------------------------------- ------ -------------- -------------- ----------
Total equity attributable to equity
holders of the parent 7,137 10,368 9,227
Total liabilities and equity 7,571 10,751 9,638
------------------------------------- ------ -------------- -------------- ----------
The registered number of Evgen Pharma plc is 09246681.
Consolidated Statement of Changes in Equity
for the six months ended 30 September 2022 - 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 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 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 2021 687 27,870 2,067 359 (19,172) 11,811
Total comprehensive expense
for the period - - - - (2,730) (2,730)
Transactions with owners
Share issue - lapsed options - - - (15) 15 -
Share based compensation
- share options - - - 146 - 146
------------------------------ --------
Total transactions with
owners - - - 131 15 146
------------------------------ --------- -------- -------- ------------- --------- --------
Balance at 31 March 2022 687 27,870 2,067 490 (21,887) 9,227
------------------------------ --------- -------- -------- ------------- --------- --------
Consolidated Statement of Cash Flows
for the six months ended 30 September 2022 - unaudited
Six months Six months
ended ended Year ended
30 September 30 September 31 March
2022 2021 2022
GBP'000 GBP'000 GBP'000
Unaudited Unaudited Audited
----------------------------------------------- -------------- -------------- -------------
Cash flows from operating activities
Loss before taxation for the period (2,200) (1,524) (3,169)
Interest (income) / expense (22) - (24)
Depreciation and amortisation 7 9 16
Share based compensation 59 81 146
----------------------------------------------- -------------- -------------- -------------
(2,156) (1,434) (3,031)
Changes in working capital
(Increase)/decrease in trade and other
receivables (220) 119 110
(Decrease)/increase in trade and other
payables 23 (224) (196)
----------------------------------------------- -------------- -------------- -------------
Cash used in operations (197) (105) (86)
Taxation received 475 - 533
----------------------------------------------- -------------- -------------- -------------
Net cash used in operating activities (1,878) (1,539) (2,584)
Cash flows (used in)/generated from
investing activities
Monies received from / (placed on) fixed-term
deposit - - 1,480
Interest income / (expense) 22 - 24
Acquisition of tangible fixed assets (1) (4) (3)
----------------------------------------------- -------------- -------------- -------------
Net cash (used in)/generated from investing
activities 21 (4) 1,501
Cash flows from financing activities
Net proceeds from issue of shares - - -
Net cash generated from financing activities - - -
----------------------------------------------- -------------- -------------- -------------
Movements in cash and cash equivalents
in the period (1,857) (1,543) (1,083)
----------------------------------------------- -------------- -------------- -------------
Cash and cash equivalents at start of
period 4,510 5,593 5,593
----------------------------------------------- -------------- -------------- -------------
Cash and cash equivalents at end of
period 2,653 4,050 4,510
----------------------------------------------- -------------- -------------- -------------
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 2022. 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 2021 and 30 September 2022 is
unaudited.
Full audited financial statements of the Group in respect of the
period ended 31 March 2022, 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 2022 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 2023.
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 2022, the Group had cash and cash equivalents,
including short-term investments and cash on deposit, of GBP7.17
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 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 2022
2022 2021
GBP'000 GBP'000 GBP'000
Unaudited Unaudited Audited
Loss for the period attributable to
equity holders (2,149) (1,524) (2,730)
-------------------------------------- -------------- -------------- -----------
As at As at As at
30 September 30 September 31 March
2022 2021 2022
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 (0.78) (0.55) (0.99)
-------------------------------------- -------------- -------------- ------------
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 2022
Number WAEP
Outstanding at 1 April 2022 10,587,665 0.35
Granted during the period - -
Exercised during the period - -
Lapsed/cancelled during the period (272,000) 5.00
-------------------------------------- ------------- ---------------------
Outstanding at 30 September 2022 10,315,665 0.23
-------------------------------------- ------------- ---------------------
WAEP is an abbreviation for weighted average exercise price.
During the six-month period ended 30 September 2022, a
share-based payment charge of GBP59,113 (six months to 30 September
2021: GBP80,607) 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 2022 274,888,117 687
---------------------------------- ------------ --------
Issued on exercise of options - -
Issued under placing agreement - -
At 30 September 2022 274,888,117 687
---------------------------------- ------------ --------
No new shares were issued during six-month period ended 30
September 2022.
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.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
IR BKOBKFBDDKBK
(END) Dow Jones Newswires
December 08, 2022 02:00 ET (07:00 GMT)
Evgen Pharma (LSE:EVG)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Evgen Pharma (LSE:EVG)
Gráfica de Acción Histórica
De May 2023 a May 2024
