TIDMEVG
RNS Number : 0244C
Evgen Pharma PLC
13 June 2019
For immediate release 13 June 2019
Evgen Pharma plc
("Evgen", the "Company" or the "Group")
Final Results for the year ended 31 March 2019
Evgen Pharma plc (AIM: EVG), the clinical stage drug development
company focused on the treatment of cancer and neurological
conditions, announces its final results for the year ended 31 March
2019.
Highlights
-- Clinical proof of concept clearly demonstrated in final top
line data released from STEM (SFX-01 in the Treatment and
Evaluation of Metastatic Breast Cancer) Phase IIa clinical
study
-- Dosing and three month visits completed in ongoing SAS
(SFX-01 After Subarachnoid Haemorrhage) Phase IIb clinical study.
Results expected in Q3 or early Q4 of this calendar year
-- SFX-01 featured in a Nature Reviews Drug Discovery as a
prominent Nrf2/KEAP1 activator
-- Susan Clement-Davies, ex-Torreya and Citigroup, appointed as
Non-Executive Director
-- First European notice of grant for SFX-01 composition of
matter patent
-- Financial performance in line with expectations:
- Total comprehensive loss of GBP2.6m (2018: loss of GBP2.6m)
- Net cash outflow of GBP1.6m (2018: outflow of 0.2m)
- Cash and short-term investments and cash on deposit at 31
March 2019 of GBP2.0m (31 March 2018: GBP3.6m)
-- Heavily oversubscribed fundraising in May 2019 raised GBP5.0m
before expenses
Dr Stephen Franklin, Chief Executive Officer of Evgen Pharma,
said:
"This has been an exciting year for Evgen. With our positive
Phase II breast cancer data already announced, and further clinical
data due this year, we look forward to maintaining the momentum in
our development programmes and continuing to create value in the
business."
This announcement contains inside information as contained in
Article 7 of the Market Abuse Regulation No. 596/2014.
Enquiries:
Evgen Pharma plc c/o +44 (0) 20 7466 5000
Dr Stephen Franklin, CEO
Richard Moulson, CFO
www.evgen.com
finnCap
Geoff Nash, Teddy Whiley (Corporate
Finance)
Alice Lane, Manasa Patil (ECM)
www.finncap.com +44 (0) 20 7220 0500
WG Partners LLP
Nigel Barnes, Claes Spång +44 (0) 20 3705 9330
Buchanan
Mark Court, Sophie Wills, Tilly
Abraham
evgen@buchanan.uk.com +44 (0) 20 7466 5000
Notes for editors:
About Evgen Pharma plc
Evgen is a clinical stage drug development company whose lead
programmes are in breast cancer and subarachnoid haemorrhage, a
type of stroke. 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.
Evgen commenced operations in January 2008 and has its
headquarters at The Colony, Wilmslow, Cheshire, and its registered
office is at the Liverpool Science Park, Liverpool. It joined the
AIM market of the London Stock Exchange in October 2015 and trades
under the ticker symbol EVG.
For further information, please visit: www.evgen.com
CHAIRMAN'S STATEMENT
Evgen has made considerable progress during the past year.
Patient enrolment and treatment was completed in both Phase II
trials of our lead product candidate, SFX-01. These comprised a
Phase IIa trial in metastatic breast cancer ("mBC") and a Phase IIb
trial in subarachnoid haemorrhage ("SAH").
Most importantly, we released top line data from the mBC trial
that clearly demonstrated clinical proof of concept for SFX-01.
SFX-01 was well tolerated and was effective at stabilising disease
and inducing responses in patients whose disease has progressed on
hormonal therapies. The data provide the impetus to embark on
randomised studies in these populations of breast cancer patients,
which we are currently planning. This result is particularly
gratifying given the advanced nature of the disease in the patient
group treated. Whilst the efficacy data has been well-received by
clinicians and other informed commentators we have also been much
encouraged by the safety and tolerability profile which is
unusually good for an oncology product. This positions SFX-01 for
use alongside existing breast cancer drugs in a number of different
treatment pathways.
We stepped up our attendance at international conferences during
the year, presenting at The World Orphan Drug Congress in the US,
the San Antonio Breast Cancer Symposium 2018 and at a closed
meeting in Madrid - the latter meeting included senior scientists
from pharmaceutical companies and academia with a common interest
in the Nrf-2 pathway. This was followed by inclusion of SFX-01 in a
Nature Reviews Drug Discovery paper focussing on the Nrf-2/ KEAP1
pathway, in which scientific interest is escalating and for which
SFX-01 is a potent activator.
Early data from a collaboration with Imperial College has
provided further insight into the potential mechanism of action of
SFX-01 in mBC, identifying potential biomarkers for determining the
efficacy of SFX-01 in this indication.
We were very pleased with the oversubscribed fundraising
completed in May 2019 which achieved GBP5.0m before expenses in
difficult market conditions. This provides us with a strengthened
balance sheet; the resources to undertake product formulation that
will facilitate the next mBC trial and other investigator-led
clinical studies; and funds to complete further toxicology studies
that will remove current restrictions on the duration of clinical
trial treatment phases.
During the current financial year we expect to report secondary
endpoints from the mBC trial and the full read-out from our SAH
trial. We also anticipate an agreement to support at least one
investigator-led Phase II trial in a new indication. There are
therefore a number of events that could lead to substantial value
enhancement in the business.
CHAIRMAN AND CHIEF EXECUTIVE OFFICER'S REVIEW
OPERATIONAL OVERVIEW
Background
Evgen is developing a platform comprising expertise,
intellectual property and clinical data, around a new class of
pharmaceuticals based on a molecule called sulforaphane.
Sulforaphane has attracted huge scientific interest and has been
shown to have anti-cancer and neuroprotective qualities in a wide
range of preclinical and clinical studies, for example breast
cancer, prostate cancer, multiple sclerosis and autism. In
particular, we are seeking to exploit sulforaphane's modulation of
two separate and unrelated mechanistic targets: Nrf2 and STAT3.
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.
Objective and strategy
Evgen's ambition is to be the world leader in sulforaphane and
sulforaphane-like compounds, establishing a leading position in
this new class of pharmaceuticals. The strategy to achieve this
objective is to:
-- continue clinical development of SFX-01 in SAH and metastatic
breast cancer (see below);
-- capitalise on the broad potential of SFX-01 by appraising
and, if commercially appropriate, initiating clinical studies in
additional cancer and neurological indications;
-- support investigator-initiated studies (i.e. academic units
typically with grant funding) in new areas to increase scientific
understanding and expand the clinical applications of SFX-01 in a
cost-effective manner (see below);
-- expand our intellectual property portfolio, including
specific dose regimes, product formulations and new uses, and
composition of matter based on novel sulforaphane analogues;
-- complete one or more licensing agreements when attractive
terms are achievable;
-- in due course, opportunistically diversify the product
pipeline, where the Directors believe such opportunities have a
good strategic fit.
Pipeline
SFX-01 IN BREAST CANCER
Breast cancer is the biggest cause of cancer deaths in women
worldwide. In around 75% of breast cancers, the hormone oestrogen
plays a key part in tumour growth. Such tumours express the
oestrogen receptor (ER+) and, if the cancer is metastatic,
endocrine therapy is the main treatment. It is thought that hormone
independent cancer stem-like cells ('CSCs') are implicated in the
development of resistance to hormone therapy and the spread of the
disease by metastases. Since 2012, Evgen has worked with University
of Manchester scientists at the Cancer Research UK Manchester
Institute and together we have generated promising data showing
SFX-01 reduces the number of CSCs in patient-derived breast cancer
tissue in xenograft models. The xenograft studies used a
combination of hormone therapy and SFX-01, with the role of SFX-01
being to target the CSC population. Crucially, the data also showed
that SFX-01 is unique, compared with existing therapies, in
deactivating phosphorylated STAT3, a key agent in cancer
proliferation and resistance to current standards of care.
STEM ('SFX-01 in the Treatment and Evaluation of Metastatic
Breast Cancer') is a multi-centre, Phase IIa clinical trial led by
Principal Investigator Dr Sacha Howell of the Christie Hospital in
Manchester. The trial has completed, having treated 46 patients
from 14 sites in the UK, France, Spain and Belgium. Top line data
was released in March 2019 showing that trial the met its primary
endpoints of safety/tolerability and clinical benefit rate (CBR) as
measured by RECIST (Response Evaluation Criteria In Solid
Tumours).
All STEM patients had been on endocrine therapy prior to entry
to the trial and, having responded to such therapy for at least six
months, then presented with progressive disease, thereby
demonstrating the start of resistance to the hormone therapy. Once
entered into the trial, patients continued to receive their failing
hormone therapy in addition to SFX-01 and have regular scans
through to week 24. Patients discontinued the trial when one of the
scans shows disease progression or at week 24.
After 24 weeks, for responding patients, there was a
compassionate use programme that provides continued access to
SFX-01 with follow-up for safety.
In March 2019 we announced top line final data from the trial
demonstrating clinical proof of concept by showing that:
-- SFX-01 can both stabilise and shrink endocrine resistant
metastatic breast cancers;
-- SFX-01 was well tolerated with no safety concerns
arising.
In particular:
-- The Clinical Benefit Rate across all patients was c. 24%;
-- Disease stabilisation was seen in patients from all
participating countries;
-- An objective response was seen in 2 patients (4%), being a
reduction in tumour size of at least 30% on one scan;
-- 13 patients entered the compassionate use programme after 24
weeks.
The data showed an excellent and unusually good safety and
tolerability profile for an anti-cancer drug. It was significantly
better than that for everolimus or exemestane, drugs currently used
at the same stage of the treatment pathway as that in which we
anticipate SFX-01 being deployed.
In a subsequent independent review of the data, Dr Mary Stuart,
a worldwide acknowledged expert in the breast cancer field,
concluded:
"Patients participating in the STEM study had generally poor
prognosis, with over 70% of patients having visceral disease. If
these patients had remained on their therapy without any change,
they would have continued to have unchecked disease progression.
However, the STEM results show that SFX-01 has promising evidence
of activity and suggests it may reverse resistance to endocrine
therapy."
We believe SFX-01 will initially be used in second-line mBC
therapy where the market opportunity is substantial. We are working
on a trial design to show benefit in this setting, likely to be a
randomised, placebo-controlled phase IIb trial.
SFX-01 IN SUBARACHNOID HAEMORRHAGE
Aneurysmal SAH is a form of stroke, caused by a ruptured
aneurysm which leads to a bleed in the subarachnoid space of the
brain. It is a relatively rare condition, accounting for around 5%
of all strokes. It is fatal in approximately 50% of cases with
approximately 15% dying before they reach hospital. A delayed
cerebral ischaemia (DCI), which happens 3-14 days after the initial
haemorrhage, remains the single most important cause of morbidity
and mortality in those patients that survive the initial bleed.
Over 60% of surviving patients suffer some permanent neurological
deficit.
Nimodipine, the current standard of care, is a generic and has
been used for more than 20 years, during which time there have been
no significant clinical advances in the treatment of SAH. Whilst
SAH is relatively rare, the market potential for this devastating
condition, with its high unmet clinical need, is significant.
SFX-01 is aimed at reducing the neurological damage associated
with the DCI via the up-regulation of the Nrf2-ARE (nuclear factor
erythroid2-related factor 2-antioxidant response element) pathway.
Sulforaphane, the active principal in SFX-01, is a well-known
activator of the Nrf2-ARE pathway which plays a protective role in
many physiological stress processes such as inflammatory damage,
oxidative stress, and the accumulation of toxic metabolites, which
are all involved in the DCI following SAH. The trial is a
double-blind, placebo-controlled study of 90 patients; 45 receiving
nimodipine and placebo and 45 receiving nimodipine and SFX-01. The
primary endpoints are Transcranial Doppler (essentially blood flow
as measured by ultrasound through the brain's blood vessels and a
measure of the DCI), safety and pharmacokinetics.
Importantly, secondary endpoints include a cognitive measurement
of clinical improvement ("the modified Rankin Scale") assessed at
7, 28, 90 and 180 days post haemorrhage. Potential follow-on
studies would almost certainly have primary clinical endpoints
based on such clinical outcomes.
The trial has completed the recruitment, treatment and 3 month
assessment phases, leaving a small number of patients still
awaiting their 6 month cognitive assessments. Patients were
recruited from 3 centres: University Hospital Southampton, Western
General Hospital in Edinburgh and St Bartholomew's Hospital in
London.
As announced in March 2019 we have decided to announce the
primary endpoints (safety, tolerability and measures of blood flow
in the brain) and secondary endpoints (relating to cognitive
function) at the same time, rather than announcing them separately
as previously indicated. This approach fully protects the blinded
integrity of the secondary endpoint data which continues to be
collected post-dosing for six months from the initial haemorrhage.
We anticipate the read-out to be at the end of Q3 or early Q4 of
this calendar year.
Preclinical work and investigator-led clinical studies
In addition to our core in-house programmes, we continue to
support academic research and we will facilitate
investigator-initiated studies (completely or largely funded by the
investigator or relevant charities) to broaden the range of
applications for SFX-01 and increase our mechanistic understanding
in these different disease areas.
Currently, we are working with research groups conducting
pre-clinical work to investigate the potential of SFX-01, inter
alia, in; triple negative breast cancer (University of Manchester,
UK), prostate cancer (Tulane University, US), glioblastoma
(University of L'Aquila, Italy), osteoarthritis (RVC, University of
London, UK) and ischaemic stroke and autism (both at King's College
London, UK). Furthermore, we are working with the University of
Dundee to support their grant applications which could potentially
finance a clinical trial in patients with non-alcoholic
steatohepatitis (NASH), a form of fatty liver disease.
Data from an earlier collaboration with the University of
Southampton was published showing that SFX-01 reduces residual
disability after experimental autoimmune encephalomyelitis (a model
for multiple sclerosis) both prophylactically and after disease
induction.
We are hopeful that some of these projects will progress into
clinical evaluation over the next few years funded by third
parties.
Finally, we have a mechanistic collaboration with Imperial
College London to use advanced chemical proteomics technology to
detect targets for SFX-01 and other sulforaphane analogues in live
cells or tissues in specific disease model systems. This should
provide greater understanding of mechanism(s) of action and
contribute data important for current and future clinical
development. The first data from this collaboration was presented
at the end of March providing further elucidation of the potential
mechanism of action of SFX-01 in metastatic breast cancer, and
suggesting biomarkers for determining the efficacy of SFX-01 in
this indication. In particular, that SFX-01 influences growth
hormone signalling and that phosphorylated STAT3 and,
interestingly, MIF (macrophage migration inhibitory factor) may be
a useful biomarker for response to SFX-01.
Recent advances in sulforaphane science
In the calendar year 2018 there were 233 scientific publications
studying sulforaphane, up from 184 in 2017 (source: Pubmed). Some
highlights include:
-- Sulforaphane has been shown, again, to suppress the growth of
triple negative breast cancer stem-like cells in in-vitro and
in-vivo (Castro et al., Cancer Prev Res, 2019). The researchers,
based at the NCI (National Cancer Institute) in the United States,
found that sulforaphane significantly decreased the expression of
cancer-specific and various stem cell markers, and concluded that
it warrants clinical evaluation;
-- The preclinical and clinical evidence associated with
sulforaphane as a potential treatment for autism continues. Nadeen
et al. (Behav Brain Res, 2019) showed that sulforaphane ameliorated
autism-like symptoms in a preclinical animal model through the
activation of Nrf-2 which (a) suppressed Th17 related signalling
and (b) rectified the oxidant-antioxidant imbalance in periphery
and brain in a preclinical model; Th17 immune responses and
oxidative stress are reported to be elevated in human autistic
subjects. Furthermore, in a small open label clinical study Bent et
al. (Mol Autism, 2018) dosed children with autism for 12 weeks with
a frozen botanical extract containing sulforaphane. There was a
statistically significant improvement in social responsiveness
(Social Responsiveness Scale-SRS) from baseline and changes in
urinary metabolites were correlated with changes in symptoms;
-- A number of recent studies point towards sulforaphane as a
potential treatment for neuropsychiatric disorders, including
schizophrenia. Excess oxidative stress is increasingly thought to
participate in the pathophysiology of brain disorders, and
decreases in the major antioxidant, glutathione (GSH), have been
reported in multiple studies. Activation of Nrf-2 leads to
increased expression of genes that produce GSH. Sedlak et al. (Mol
Neuropsychiatry, 2018) reported that sulforaphane increased GSH
levels in the blood and specific areas of the brain in healthy
human subjects following 7 days of daily oral administration. The
publication concludes with the statement: "This clinical pilot
study suggests the value of exploring relationships between
peripheral GSH and clinical/ neuropsychological measures, as well
as the influences sulforaphane has on functional measures that are
altered in neuropsychiatric disorders.".
INTELLECTUAL PROPERTY UPDATE
During, and since, the last reporting period our IP portfolio
has been further strengthened with a number of key patents being
granted.
The current status of the intellectual property portfolio is as
follows:
-- From the "parent" patent family entitled "Stabilised
Sulforaphane" patents are granted in Australia, Canada, EU, US and
Hong Kong and further applications are pending in Japan, EU and
Hong Kong;
-- The principal manufacturing patent application, entitled
"Methods of Synthesising Sulforaphane" is granted in Australia,
China, Europe, Japan and the US and further applications are
pending in Brazil, Canada, US and India;
-- A second manufacturing patent which is directed to methods of
isolating and purifying sulforaphane or analogues from natural
sources has been granted in Europe, US, Japan and China;
-- The patent application providing protection around novel
analogues based on sulforaphane, and entitled "Sulforaphane-Derived
Compounds" is granted in Australia, China, Europe, Japan and the US
and pending in Canada.
In May 2018, in an important development, the Group gained a
patent in Europe containing claims to a particular method of
stabilising sulforaphane by complexation with alpha-cyclodextrin; a
similar divisional application remains pending in Japan. In April
2019, the Group also received notification of the intention to
grant a compositional patent in Europe directed to a composition
comprising a complex of sulforaphane and alpha-cyclodextrin. The
Group has long held broad compositional patent protection in the
United States since patent grant in 2011 and in Canada since grant
in 2014.
KEY PERFORMANCE INDICATORS
Key Performance Indicators include a range of financial and
non-financial measures (such as clinical trial progress). Details
about the progress of our development programs (non-financial
measures) are included elsewhere in this Review, and below are the
other indicators (financial measures) considered pertinent to the
business.
2019 (GBPm)
============
Year-end cash and short-term investments and cash
on deposit held: (2018: GBP3.6m) 2.0
=================================================== ============
The reduction in year-end cash reflects working capital,
pre-clinical and clinical expenditures during the year offset in
part by the fundraising in October 2018 which raised GBP750k before
expenses.
2019 (GBPm)
============
Net cash outflow (including short-term investments)
(2018 outflow: GBP0.2m) 1.6
===================================================== ============
The net cash outflow again reflects working capital,
pre-clinical and clinical expenditures during the year offset in
part by the fundraising completed during the year.
2019 (GBPm)
============
Operating loss: (2018: GBP3.0m) 3.1
================================= ============
The operating loss reflects pre-clinical and clinical activity
in the year and related product manufacture.
PEOPLE
We were delighted to welcome Susan Clement-Davies as a
non-executive director. Susan brings a wealth of experience in
capital markets, M&A and licensing/partnering, particularly in
the life science sector, from her time with Citigroup and Torreya.
We would like thank Marc D'Abbadie, who resigned from the Board in
November 2018, for his support and contribution which has been much
appreciated.
Financial review
The financial performance for the year ended 31 March 2019 was
in line with expectations.
Losses
The total loss for the year was GBP2.6m (31 March 2018: GBP2.6m)
including a charge for share-based compensation of GBP0.1m (2018:
GBP0.1m). Operating expenses excluding share based compensation
increased slightly to GBP3.0m (2018: GBP2.9m) reflecting similar
levels of both clinical activity and general and administrative
costs.
Share based compensation
Accounting standards require a charge to be made against the
grant of share options and recognised in the Consolidated Statement
of Comprehensive Income. This amounted to GBP0.1m (2018: GBP0.1m)
and has no impact on cash flows.
Headcount
Average headcount of the Group for the year was 8 (2018: 9).
Taxation
The Group has elected to claim research and development tax
credits under the small or medium enterprise research and
development scheme of GBP0.49m (2018: GBP0.44m).
Share capital
In October 2018, 5,555,558 ordinary shares of 0.25p each were
issued pursuant to a placing to existing and new shareholders at
13.5p per share. The placing raised GBP0.75m before expenses.
A total of 158,918 ordinary shares of 0.25 p each were issued
pursuant to exercises of share options granted under individual
share option grants. These options had exercise prices of between
nil and 10.6p per share.
A share placing was completed in May 2019 after the year end
which raised GBP5.0m before expenses in difficult market
conditions. This provides us with a strengthened balance sheet, the
resources to undertake product formulation that will facilitate the
next mBC trial and other investigator-led clinical studies, and
funds to complete further toxicology studies that will remove
current restrictions on the duration of clinical trial treatment
phases. The placing comprised the issue of 33,333,329 ordinary
shares of 0.25p each to existing and new shareholders at 15.0p per
share.
Cash flows and financial position
The cash position at 31 March 2019 decreased to GBP2.0m (31
March 2018: GBP3.6m). Continued clinical expenditure on the two
phase II trials of SFX-01 and recurring general and administrative
costs were partially offset by the share placing proceeds (GBP0.75m
before expenses) and receipt of the 2018 tax credit (GBP0.44m).
OUTLOOK
The outlook for Evgen is positive. Our metastatic breast cancer
Phase II trial achieved its primary endpoints and we have a further
Phase II trial to report in the current year in a different disease
area. Furthermore, we support investigator-led academic studies in
new disease areas and these are generating preclinical data which
may ultimately support further trials, either of SFX-01 or novel
analogues. These include further opportunities in cancer and
neurology but also in other fields. All have considerable
commercial opportunity and we look forward to the future with
confidence.
Barry Clare Dr Stephen Franklin
Chairman Chief Executive Officer
Consolidated Statement of Comprehensive Income
for the year ended 31 March 2019
Notes Year ended Year ended
31 March 31 March
2019 2018
GBP'000 GBP'000
Operating expenses
------ ----------- -----------
Operating expenses (2,985) (2,915)
------ ----------- -----------
Share based compensation (135) (111)
------ ----------- -----------
Total operating expenses (3,120) (3,026)
------ ----------- -----------
Operating loss (3,120) (3,026)
------ ----------- -----------
Loss on ordinary activities before taxation (3,120) (3,026)
------ ----------- -----------
Taxation 496 443
------ ----------- -----------
Loss and total comprehensive expense attributable
to equity holders of the parent for the year (2,624) (2,583)
------ ----------- -----------
Loss per share attributable to equity holders
of the parent (pence) 5
------ ----------- -----------
Basic loss per share (2.74) (3.28)
------ ----------- -----------
Diluted loss per share (2.74) (3.28)
------ ----------- -----------
Consolidated Statement of Financial Position
as at 31 March 2019
Notes As at As at
31 March 31 March
2019 2018
GBP'000 GBP'000
ASSETS
------ ---------- ----------
Non-current assets
------ ---------- ----------
Property, plant and equipment 6 12
------ ---------- ----------
Intangible assets 98 113
------ ---------- ----------
Investments in subsidiary - -
undertaking
------ ---------- ----------
Total non-current assets 104 125
------ ---------- ----------
Current assets
------ ---------- ----------
Trade and other receivables 135 77
------ ---------- ----------
Current tax receivable 492 432
------ ---------- ----------
Cash and cash equivalents 2,033 3,626
------ ---------- ----------
Total current assets 2,660 4,135
------ ---------- ----------
Total assets 2,764 4,260
------ ---------- ----------
LIABILITIES AND EQUITY
------ ---------- ----------
Current liabilities
------ ---------- ----------
Trade and other payables 688 389
------ ---------- ----------
Total current liabilities 688 389
------ ---------- ----------
Equity
------ ---------- ----------
Ordinary shares 6 247 233
------ ---------- ----------
Share premium 6 13,240 12,560
------ ---------- ----------
Merger reserve 6 2,067 2,067
------ ---------- ----------
Share based compensation 6 1,722 1,587
------ ---------- ----------
Retained deficit 6 (15,200) (12,576)
------ ---------- ----------
Total equity attributable
to equity holders of the
parent 2,076 3,871
------ ---------- ----------
Total liabilities and
equity 2,764 4,260
------ ---------- ----------
Consolidated Statement of Changes in Equity
for the year ended 31 March 2019
Ordinary Share Merger Share Retained Total
shares premium reserve based deficit GBP'000
GBP'000 GBP'000 GBP'000 compensation GBP'000
GBP'000
Balance at 31 March 2017 183 10,495 2,067 1,476 (9,993) 4,228
--------- --------- --------- -------------- --------- ---------
Total comprehensive expense for
the period - - - - (2,583) (2,583)
--------- --------- --------- -------------- --------- ---------
Transactions with owners
--------- --------- --------- -------------- --------- ---------
Share issue - cash 48 2,034 - - - 2,082
--------- --------- --------- -------------- --------- ---------
Share issue - options exercised 2 31 - - - 33
--------- --------- --------- -------------- --------- ---------
Share based compensation
--------- --------- --------- -------------- --------- ---------
- share options - - - 111 - 111
--------- --------- --------- -------------- --------- ---------
Total transactions with owners 50 2,065 - 111 - 2,226
--------- --------- --------- -------------- --------- ---------
Balance at 31 March 2018 233 12,560 2,067 1,587 (12,576) 3,871
--------- --------- --------- -------------- --------- ---------
Total comprehensive expense for
the period - - - - (2,624) (2,624)
--------- --------- --------- -------------- --------- ---------
Transactions with owners
--------- --------- --------- -------------- --------- ---------
Share issue - cash 14 668 - - - 682
--------- --------- --------- -------------- --------- ---------
Share issue - options exercised - 12 - - - 12
--------- --------- --------- -------------- --------- ---------
Share based compensation
--------- --------- --------- -------------- --------- ---------
- share options - - - 135 - 135
--------- --------- --------- -------------- --------- ---------
Total transactions with owners 14 680 - 135 - 829
--------- --------- --------- -------------- --------- ---------
Balance at 31 March 2019 247 13,240 2,067 1,722 (15,200) 2,076
--------- --------- --------- -------------- --------- ---------
Consolidated Statements of Cash Flows
for the year ended 31 March 2019
Year ended Year ended
31 March 31 March
2019 2018
GBP'000 GBP'000
Cash flows from operating
activities
----------- -----------
Loss before taxation (3,120) (3,026)
----------- -----------
Depreciation and amortisation 21 21
----------- -----------
Share based compensation 135 111
----------- -----------
(2,964) (2,894)
----------- -----------
Changes in working capital
----------- -----------
(Increase)/decrease in
trade and other receivables (58) 7
----------- -----------
Increase/(decrease) in
trade and other payables 299 (125)
----------- -----------
Cash used in operations 241 (118)
----------- -----------
Taxation received 436 671
----------- -----------
Net cash used in operating
activities (2,287) (2,341)
----------- -----------
Cash flows (used in)/generated
from investing activities
----------- -----------
Acquisition of tangible
fixed assets - (7)
----------- -----------
Net cash (used in)/generated
from investing activities - (7)
----------- -----------
Cash flows from financing
activities
----------- -----------
Proceeds from issue of
shares 761 2,333
----------- -----------
Issue costs (67) (218)
----------- -----------
Net cash generated from
financing activities 694 2,115
----------- -----------
Movements in cash and
cash equivalents in the
period (1,593) (233)
----------- -----------
Cash and cash equivalents
at start of period 3,626 3,859
----------- -----------
Cash and cash equivalents
at end of period 2,033 3,626
----------- -----------
1. General information
Evgen Pharma Plc ('Evgen' or 'the Company') is a public limited
company incorporated and domiciled in England & Wales and is
admitted to trading 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 Company
is clinical stage drug development.
2. Basis of preparation and significant accounting policies
The financial information set out herein does not constitute
statutory accounts as defined in Section 434 of the Companies Act
2006. The financial information for the year ended 31 March 2019
has been extracted from the Group's audited financial statements
which were approved by the Board of Directors on 12 June 2019 and
which, if adopted by the members at the Annual General Meeting,
will be delivered to the Registrar of Companies for England and
Wales.
The financial information for the year ended 31 March 2018 has
been extracted from the Group's audited financial statements which
were approved by the Board of Directors on 12 June 2018 and which
have been delivered to the Registrar of Companies for England and
Wales. The report of the auditor on these financial statements was
unqualified, did not contain a statement under Section 498(2) or
Section 498(3) of the Companies Act 2006, but did include a matter
to which the auditors drew attention by way of emphasis without
qualifying their report.
The report of the auditor on the 31 March 2019 financial
statements was unqualified and did not contain a statement under
Section 498(2) or Section 498(3) of the Companies Act 2006.
This announcement was approved by the board of directors and
authorised for issue on 12 June 2019.
3. Going concern
As part of their going concern review the Directors have
followed the guidelines published by the Financial Reporting
Council entitled "Guidance on Risk Management and Internal Control
and Related Financial and Business Reporting". 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.
At 31 March 2019, the Group had cash and cash equivalents,
including short-term investments and cash on deposit, of GBP2.0
million. Subsequent to the year end the Company received GBP5m
before expenses through a share placing.
The Directors estimate that the cash held by the Group together
with known receivables will be sufficient to support the current
level of activities beyond the end of 2020.
4. Segmental information
Operating segments are reported in a manner consistent with the
internal reporting provided to the chief operating decision-maker.
The chief operating decision-maker is responsible for allocating
resources and assessing performance of operating segments.
The Directors consider that there are no identifiable business
segments that are subject to risks and returns different to the
core business. The information reported to the Directors, for the
purposes of resource allocation and assessment of performance is
based wholly on the overall activities of the Group. The Group has
therefore determined that it has only one reportable segment under
IFRS 8.
The results and assets for this segment can be determined by
reference to the Consolidated Statement of Comprehensive Income and
Consolidated Statement of Financial Position.
5. 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 year.
For diluted loss per share, the loss for the year attributable
to equity holders and the weighted average number of ordinary
shares outstanding during the year is adjusted to assume conversion
of all dilutive potential ordinary shares.
As at 31 March 2019 the Group had 9,075,599 (2018: 8,665,255)
share options which are outstanding and potentially dilutive.
The calculation of the Group's basic and diluted loss per share
is based on the following data:
Year ended Year ended
31 March 31 March
2019 2018
GBP'000 GBP'000
Loss for the year attributable to equity holders
for basic loss and adjusted for the effects of dilution (2,624) (2,583)
----------- -----------
Year ended Year ended
31 March 31 March
2019 2018
Number Number
Weighted average number of ordinary shares for basic
loss per share 95,857,230 78,697,455
----------- -----------
Effects of dilution:
----------- -----------
Share options - -
----------- -----------
Weighted average number of ordinary shares adjusted
for the effects of dilution 95,857,230 78,697,455
----------- -----------
Year ended Year ended
31 March 31 March
2019 2018
Pence Pence
Loss per share - basic and diluted (2.74) (3.28)
----------- -----------
The loss and the weighted average number of ordinary shares for
the years ended 31 March 2018 and 2019 used for calculating the
diluted loss per share are identical to those for the basic loss
per share. This is because the outstanding share options would have
the effect of reducing the loss per ordinary share and would
therefore not be dilutive under the terms of International
Accounting Standard ("IAS") No 33.
Subsequent to the year end 33,333,329 ordinary shares were
issued pursuant to a share placing. Had this event occurred during
the reporting period the number of shares used in the loss per
share calculation would have been significantly different.
6. Share issues
Ordinary shares
Company
Ordinary shares of 0.25p each Number Share Capital
GBP'000
----------- --------------
At 31 March 2018 93,276,858 233
----------- --------------
Issued on exercise of options 158,918 -
----------- --------------
Issued under placing agreement 5,555,558 14
----------- --------------
At 31 March 2019 98,991,334 247
----------- --------------
On 10 July 2018 80,000 ordinary shares were issued in connection
with the exercise of share options at an exercise price of 7.3p per
share payable in cash.
On 18 October 2018 5,555,558 ordinary shares were issued at a
price of GBP0.135 raising GBP0.8 million which after share issue
expenses of GBP0.1 million gave net consideration of GBP0.7
million.
On 19 December 2018 18,918 ordinary shares were issued in
connection with the exercise of nil cost share options. On the same
date 60,000 share options were issued for cash at an exercise price
of 10.612p per share.
Subsequent to the year end 33,333,329 ordinary shares were
issued at a price of GBP0.15 raising GBP5.0 million which after
share issue expenses of GBP0.3 million gave net consideration of
GBP4.7 million.
Other reserves
The share premium reserve represents the difference between the
net proceeds of equity issues and the nominal share capital of the
shares issued.
The merger reserves at 31 March 2019 and 2018 arose from the
acquisition of Evgen's sole subsidiary, Evgen Ltd, in 2014 which is
accounted for using the merger method of accounting.
The share based compensation reserve reflects the aggregate fair
value of equity-settled share based payment transactions.
Reserves classified as retained deficit represent accumulated
losses. None of the reserves are distributable.
7. Related parties
Group
Transactions between the Company and its subsidiaries, which are
related parties, have been eliminated on consolidation and are not
disclosed in this note.
Key management compensation is disclosed in note 5 of the
consolidated financial statements. Directors' emoluments are
disclosed in the Remuneration Committee Report.
During the year ended 31 March 2019, the Group purchased
services totalling GBP131,661 (year ended 31 March 2018:
GBP187,822) from The Clinical Trial Company Limited, a company of
which Richard Moulson, a Director, is also a Director. The amount
owed to The Clinical Trial Company Limited at 31 March 2019 was
GBP13,922 (31 March 2018: GBP2,077).
During the year ended 31 March 2019, the Group purchased
consultancy services totalling GBP1,800 (year ended 31 March 2018:
GBPnil) from Dr Alan Barge, a Director. The amount owed to Dr Alan
Barge at 31 March 2019 was GBPnil (31 March 2018: GBPnil).
During the year ended 31 March 2019, the Group purchased
consultancy services totalling GBP14,950 (year ended 31 March 2018:
GBP17,970) from FD Consult Ltd, a company controlled by Richard
Moulson. The amount owed to FD Consult Ltd at 31 March 2019 was
GBPnil (31 March 2018: GBPnil).
During the year ended 31 March 2019, the Group was charged
monitoring and Director fees totalling GBP15,986 relating to Marc
D'Abbadie's services (year ended 31 March 2018: GBP26,500) by SPARK
Impact Limited, manager of North West Fund for Biomedical, a
shareholder. The amount owed to SPARK Impact, manager of North West
Fund for Biomedical at 31 March 2019 was GBPnil (31 March 2018:
GBPnil).
8. Report and accounts
A copy of the Annual Report and Accounts will shortly be sent to
all shareholders with notice of the Annual General Meeting and will
also be available to download from the Group's website at
www.evgen.com.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
FR LLFLRREIFLIA
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