TIDMEVG
RNS Number : 1895R
Evgen Pharma PLC
13 June 2018
For immediate release 13 June 2018
Evgen Pharma plc
("Evgen", the "Company" or the "Group")
Final Results for the year ended 31 March 2018
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
2018.
Highlights
-- Interim data released from ongoing STEM (SFX-01 in the
Treatment and Evaluation of Metastatic Breast Cancer) Phase IIa
clinical study
-- 11 new sites opened for STEM trial in Spain, France, Belgium
and UK and a total of 44 patients recruited to date
-- 2 new sites opened in UK in ongoing SAS (SFX-01 After
Subarachnoid Haemorrhage) Phase IIb clinical study and 65 patients
recruited to date
-- Launch of Scientific and Medical Advisory Board ("SMAB")
with, as initial members, the sulforaphane experts Professor
Giovanni Mann, Professor of Vascular Physiology, King's College,
London, and Professor Albena Dinkova-Kostova, Professor of Chemical
Biology, University of Dundee
-- Further elucidation of SFX-01 mechanism of action in breast
cancer
-- Additional patents granted over SFX-01 including first patent
grant in Europe for SFX-01, relating to manufacturing and scale-up
processes
-- Financial performance in line with expectations:
- Total comprehensive loss of GBP2.6m (2017: loss of GBP3.1m)
- Net cash outflow of GBP0.2m (2017: outflow of GBP3.3m (before
short-term investment movements))
- Cash and short-term investments and cash on deposit at 31
March 2018 of GBP3.63m (31 March 2017: GBP3.86m)
-- Fundraising in December 2017 raised GBP2.1m after
expenses
Dr Stephen Franklin, Chief Executive Officer of Evgen Pharma,
said:
"We are very encouraged by the interim data from the STEM trial
which was announced earlier this week. Patient recruitment in both
trials is on track to report around the end of the year.
"Interest in the potential of sulforaphane continues to gain
momentum. There are now approximately 1,800 peer-reviewed
scientific publications on sulforaphane and, since the beginning of
2018, the publication rate is running at an all-time high of over
five publications per week.
"With the ongoing growth of scientific data supporting the
therapeutic potential of sulforaphane, together with the positive
progress of our Phase II trials, we remain confident in the
prospects for the Company."
Analyst meeting
A meeting for analysts will be held at 10.30am this morning, 13
June 2018, at the offices of Buchanan, 107 Cheapside, London EC2V
6DN. Please contact Buchanan on 020 7466 5000 for further
information.
An updated version of the Company's investor presentation will
be available to download at www.evgen.com from 8.00am today.
Enquiries:
Evgen Pharma plc c/o +44 (0) 20
Dr Stephen Franklin, CEO 7466 5000
Richard Moulson, CFO
www.evgen.com
Buchanan +44 (0) 20 7466
Mark Court, Sophie Wills, Tilly Abraham 5000
Northland Capital Partners Limited
Matthew Johnson, Tom Price
(Corporate Finance) +44 (0) 20 3861
John Howes, Rob Rees (Corporate Broking) 6625
WG Partners LLP +44 (0) 20 3705
Nigel Barnes, Claes Spång 9330
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
For commissioned research on the Company, please visit:
http://evgen.com/investors/analyst-coverage/
CHAIRMAN'S STATEMENT
During the past year, Evgen has focused on the clinical
development of our lead product candidate, SFX-01. We are testing
SFX-01 in two indications, metastatic breast cancer and
subarachnoid haemorrhage ("SAH"), and have now enrolled over two
thirds of the total patients in each trial. In parallel, both our
own research collaborators, and academics elsewhere, have made
considerable progress in understanding the mechanisms of action of
sulforaphane in different disease models. New collaborations were
signed with a number of partners including King's College London
and Imperial College London.
STEM is a 60 patient, Phase IIa open label study in metastatic
breast cancer being conducted across Europe. Earlier this week we
reported data from the first 20 patients to have entered the trial
and we are delighted that the product is proving to be well
tolerated with encouraging signs of anti-tumour activity.
SAS is a Phase IIb randomised, double blind, placebo-controlled
study recruiting 90 patients in SAH at three centres. Being a
blinded trial, data will become available only after recruitment is
complete. Nevertheless, we can say that SFX-01 is demonstrating a
benign safety and tolerance profile, particularly when compared
with other therapies in the breast cancer and SAH areas.
Our collaborators at the University of Manchester presented data
in January showing that SFX--01 targets cancer stem cells in
metastatic breast cancers and potently suppresses a key target
believed to account for resistance to endocrine therapy. These
findings add further support to our presumed mechanism of action
for SFX-01 in breast cancer. Furthermore, and in relation to the
mechanism of action of SFX-01 in subarachnoid haemorrhage, our CEO,
Dr Stephen Franklin was invited to, and presented at, a recent
expert meeting in Madrid which was dedicated to the Nrf2 pathway
and its role in a number of neurodegenerative diseases.
Our intellectual property ("IP") platform around sulforaphane
continues to expand and we have identified, via our collaboration
with the University of Liverpool, CSIC and the University of
Seville, a number of sulforaphane analogues which could be
developed as second-generation oncology products.
During the current financial year we expect to report final data
on both ongoing trials with the opportunity for significant
increases in the Company's valuation. We are very excited at the
prospect of demonstrating the clinical benefits of our sulforaphane
technology, with the capacity to move into pivotal clinical trials
and secure the appropriate industry partners to complete
commercialisation.
CHIEF EXECUTIVE OFFICER'S REVIEW
OPERATIONAL OVERVIEW
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.
Evgen's first product developed using the Sulforadex(R)
technology is SFX-01; a synthetic copy of sulforaphane stabilised
within a cone-shaped sugar molecule called alphacyclodextrin.
SFX-01 has been advanced through preclinical and Phase I clinical
trials and is now in Phase II in two separate indications:
metastatic breast cancer and subarachnoid haemorrhage ("SAH").
Our assets include novel analogues of sulforaphane that have
been synthesised and have undergone a first screening, with a view
to identifying the most promising of these compounds, thereby
reinforcing our leading position in the sulforaphane field.
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.
SPONSORED PROGRAMMES
Evgen is initially focusing on demonstrating the efficacy of
SFX-01 in one oncology indication and one neurology indication to
demonstrate the potential breadth of application of SFX-01 as an
anti-cancer agent and neuroprotectant respectively:
-- STEM (SFX-01 in the Treatment and Evaluation of Metastatic
Breast Cancer), a 60 patient multi-centre trial in Europe
(including the UK); and
-- SAS (SFX-01 After Subarachnoid Haemorrhage), a 90-patient trial in the UK.
Evgen also has a clinical interest in other oncology and
neurology indications, for example prostate cancer and multiple
sclerosis.
INVESTIGATOR-INITIATED STUDIES
In addition to our core in-house programmes, we will 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), ischaemic stroke and autism (both at King's College
London, UK). We are hopeful that some of these projects will
progress into clinical evaluation over the next few years.
Furthermore, we have a mechanistic collaboration with Imperial
College London (UK) and are reviewing the potential to support a
clinical trial in Non-alcoholic Fatty Liver Disease led by the
University of Dundee (UK).
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 cells 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 cancer stem cells 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 cancer stem cell 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 is a multi-centre, Phase IIa clinical trial. Led by
Principal Investigator Dr Sacha Howell of the Christie Hospital in
Manchester, the trial will recruit 60 patients from 14 sites in the
UK, France, Spain and Belgium.
All STEM patients will have ER+ metastatic breast cancer and
will have been on treatment with either tamoxifen, aromatase
inhibitors (AI) or fulvestrant. Prior to entry to the STEM trial,
patients must have previously responded to their current hormone
therapy for at least six months but then present with progressive
disease, thereby demonstrating the start of resistance to the
hormone therapy. Once entered into the trial, patients continue to
receive their failing hormone therapy in addition to SFX-01 and
have regular scans through to week 24. Patients discontinue the
trial when one of the scans shows disease progression or at week
24.
The primary endpoints are safety/tolerability and clinical
benefit rate ("CBR") as measured by RECIST (Response Evaluation
Criteria In Solid Tumours). After 24 weeks, for responding
patients, there is a compassionate use programme that provides
continued access to SFX-01 with follow-up for safety.
On 11 June 2018 we announced an interim update on the first 20
patients to have completed the trial. In particular, that at this
interim stage, in the opinion of the Principal Investigator, Dr
Sacha Howell, and of the Company's Chief Medical Advisor:
-- SFX-01 is proving to be well tolerated with no safety concerns arising
-- SFX-01 shows encouraging early signs of anti-tumour activity:
- Four patients had their disease stabilised (that is, having
come on to the trial with progressive disease, their tumours
stopped progressing) for the full duration of the study through to,
and including, a favourable final scan result at week 24. Of these
four patients, one also had a partial response, which is a
reduction in tumour size of at least 30% on one scan
- In addition to the above four patients, a further two patients
had their disease stabilised through to, and including, the week 18
scan but then showed disease progression at the final week 24 scan.
One of these two patients also demonstrated a partial response on
one scan before disease progression was recorded at the final
scan
All patients that have a favourable week 18 scan are registered
in the compassionate use programme to ensure continuity of drug
between the final week 24 scan and the scan result, which can be
some time later. Those that have a favourable week 24 scan continue
on the programme.
Putting this interim update into a clinical context, the trial's
Principal Investigator, Dr Sacha Howell of the Christie Hospital,
Manchester, UK, said:
"The design of the STEM study, adding the drug to endocrine
therapy on which a patient's cancer was progressing, sets a high
bar for SFX-01. In light of this, these interim results are highly
encouraging. Objective responses indicate activity in this setting,
and disease stabilisation for 6-12+ months represents clinically
meaningful prolongation of response. SFX-01 is generally well
tolerated and the results together, should they look similar in the
final analysis, suggest further investigation of SFX-01 in advanced
breast cancer is warranted."
Prof Francois Duhoux, of University Clinics St-Luc, Brussels,
and the Belgium national coordinator for the trial, said:
"Six of these first 20 patients came through my clinic and I can
confirm the excellent safety profile of SFX-01. These patients have
metastatic disease and have demonstrated progression on their
endocrine therapy prior to coming on the trial, and, instead of
switching to an alternative regimen, they continued their endocrine
therapy with the addition of SFX-01. While we must of course wait
for the results of the entire study before making any definitive
judgment, in this context I think that the initial results
pertaining to efficacy are highly encouraging."
STEM remains on track to report around the end of 2018 with 14
sites having already recruited 44 patients across the UK, Belgium,
Spain and France.
The trial is registered at ClinicalTrials.gov and can be viewed
at this link:
https://clinicaltrials.gov/ct2/show/NCT02970682?term=SFX-01&rank=2
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. In
October 2015, Credit Suisse estimated potential peak sales of
$1.7bn by 2032 for a Phase III development product based on the
intraventricular delivery of a nimodipine-based formulation.
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 is registered at ClinicalTrials.gov and can be viewed
at this link:
https://clinicaltrials.gov/ct2/show/NCT02614742?term=evgen&rank=1.
To date, 44 patients have been recruited from two UK centres:
University Hospital Southampton and the Western General Hospital in
Edinburgh. The Queen Elizabeth Hospital in Birmingham remains an
initiated site but will now unlikely recruit patients due to their
staffing restraints. However, St Bartholomew's Hospital in London
has now also been initiated and is expected to recruit its first
patient imminently. These centres are projected to be sufficient to
meet recruitment targets and we continue to anticipate the read-out
of the primary endpoints of the study around the end of calendar
year.
EARLY STAGE PIPELINE
The Group acquired exclusive worldwide rights to analogues of
sulforaphane from the University of Seville in 2015 as part of our
strategy to secure a leading position in the intellectual property
around sulforaphane--based drugs. Researchers at the University of
Liverpool have evaluated 41 analogues which represent new chemical
entities based on sulforaphane's core structure. The analogues were
assessed for their cytotoxic potential against a breast cancer cell
line and for their ability to activate Nrf2, which is considered to
have a key role in sulforaphane's mechanism of action against
neurological conditions. The research work demonstrated that 21 of
the analogues are at least twice as cytotoxic against (that is,
able to eliminate) breast cancer cells as SFX--01, with the most
potent being eight--fold more cytotoxic, and that none of the
analogues are as potent as SFX--01 as an activator of Nrf2. The
results suggest that some of the analogues merit further study as
anti--cancer agents and they also provide reassurance that SFX--01,
as a synthesised and stabilised copy of naturally occurring
sulforaphane, is the optimal sulforaphane--based active for
development in subarachnoid haemorrhage and potentially other
neurological indications.
INTELLECTUAL PROPERTY UPDATE
During, and since, the last reporting period, our IP portfolio
was further strengthened with a number of key patents being
granted.
The current status of the intellectual property portfolio is as
follows:
-- The "parent" patent application entitled "Stabilised
Sulforaphane" is granted in Australia, Canada, EU and US and
pending in Japan and Hong Kong
-- The principal manufacturing patent application, entitled
"Scale-Up Process" is granted in Australia, China, Europe, Japan
and the US and pending in Brazil and Canada
-- The patent application providing protection around novel
analogues based on sulforaphane, and entitled "Sulforaphane
Derivatives" is granted in Australia, China, Europe, Japan and the
US and pending in Canada
In summary, a large part of the current patent portfolio has now
moved to grant status.
The Company still awaits its position with regard to
compositional claims in Europe and Japan. The recent patent grant
in Europe, entitled "Stabilised Sulforaphane" was expedited to
secure additional process claims but a pending divisional
application (which will likely be examined in 2018) will determine
the extent to which compositional patent protection is secured in
the EU. Likewise, the Japanese position with regard to
compositional claims is expected in 2018.
Further patent protection is reviewed on an on-going basis, and
new applications associated with product formulation and dosing
regimens will be filed at the appropriate time.
RECENT ADVANCES IN SULFORAPHANE SCIENCE
There are now approximately 1,800 peer-reviewed scientific
journals investigating sulforaphane, in terms of its mechanism of
action and its potential therapeutic utility across a range of
diseases. In calendar-year 2017, publications reached a record 187
and this will likely be surpassed again in 2018 as the publications
count has already reached 126.
A recent publication from Mao et al (2018) further supports the
idea that sulforaphane inhibits proliferation, induces apoptosis,
and decreases the "stemness" of cancer cells through a mechanism
related to STAT3 signalling ("Sulforaphane promotes apoptosis, and
inhibits proliferation and self-renewal of nasopharyngeal cancer
cells by targeting STAT signal through miRNA-124-3p").
In the field of neurology research, a publication by Yang et al
(2018) supports the view that sulforaphane treatment may alleviate
ischaemic injuries and cognitive dysfunction ("Protective effects
of sulforaphane in experimental vascular cognitive impairment:
Contribution of the Nrf2 pathway"). They report a
sulforaphane-mediated neuroprotective effect that was associated
with an enhanced activation of Nrf2 and an upregulation of heme
oxygenase 1, resulting in reduced neuronal death and maintenance of
the integrity of the blood brain barrier.
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 Strategic Report, and
below are the other indicators (financial measures) considered
pertinent to the business.
(GBPm)
Year-end cash and short-term investments
and cash on deposit held: (2017: GBP3.9m) 3.6
--------
The reduction in year-end cash reflects working capital,
pre-clinical and clinical expenditures during the year offset
substantially by the fundraising in December 2017 which raised
GBP2.1m net of expenses.
(GBPm)
Cash flows (including short-term investments)
Net cash outflow: (2017: GBP3.3m) 0.2
--------
The net cash outflow again reflects working capital,
pre-clinical and clinical expenditures during the year offset
substantially by the fundraising completed during the year.
(GBPm)
Operating loss: (2017: GBP3.7m) 3.0
--------
The operating loss reflects pre-clinical and clinical activity
in the year and related product manufacture.
FINANCIAL REVIEW
The financial performance for the year ended 31 March 2018 was
in line with expectations.
Losses
The total loss for the year was GBP2.6m (31 March 2017: GBP3.1m)
including a charge for share-based compensation of GBP0.1m (2017:
GBP0.2m). Operating expenses excluding share-based compensation
reduced to GBP2.9m (2017: GBP3.5m) principally because the costs of
the ongoing clinical trials of SFX-01 are in part front-end loaded
due to set-up costs which were incurred in 2017, and because the
SAH clinical trial was put on temporary hold for six months during
the year.
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 (2017: GBP0.2m)
and has no impact on cash flows.
Headcount
The average headcount of the Group for the year was 9 (2017:
10).
Taxation
The Group has elected to claim research and development tax
credits under the small or medium enterprise research and
development scheme of GBP0.44m (2017: GBP0.58m). The reduction
compared with the prior year reflects lower spend on the clinical
development programmes.
Share capital
In December 2017 19,166,667 ordinary shares of 0.25p each were
issued pursuant to a placing to existing and new shareholders at
12p per share. The placing raised GBP2.3m before expenses.
A total of 837,600 ordinary shares of 0.25 pence each were
issued pursuant to exercises of share options granted under
individual share option grants. These options had an exercise
prices of 5p in respect of 628,000 options and 0.875p in respect of
209,600 options.
Cash flows and financial position
The cash position (including short-term deposits) at 31 March
2018 decreased to GBP3.6m (31 March 2017: reduced to GBP3.9m).
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 (GBP2.1m net) and receipt of
the 2016 and 2017 tax credits (GBP0.67m).
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.
The Directors estimate that the cash held by the Group together
with known receivables will be sufficient to support the current
level of activities to the end of December 2018. The Directors are
continuing to explore sources of finance available to the Group and
have confidence that they will be able to secure sufficient cash
inflows for the Group to continue its activities for not less than
12 months from the date of approval of these financial statements;
they have therefore prepared the financial statements on a going
concern basis. Because the additional finance is not committed at
the date of approval of these financial statements, these
circumstances represent an uncertainty as to the Group's ability to
continue as a going concern. Should the Group be unable to obtain
further finance such that the going concern basis of preparation
were no longer appropriate, adjustments would be required including
to reduce balance sheet values of assets to their recoverable
amounts, to provide for further liabilities that might arise and to
reclassify fixed assets as current assets.
PEOPLE
We were delighted to welcome Sally Ross to the senior management
team as Clinical Development Officer. Sally has a strong scientific
and regulatory background from AstraZeneca and Chiltern
International and will support us as we plan for and execute late
stage clinical trials in our lead programmes.
We have also recently established a Scientific and Medical
Advisory Board ('SMAB') to provide us with additional scientific
and clinical expertise to support our development. The first two
members are Professor Giovanni Mann, Professor of Vascular
Physiology at King's College London and Professor Albena
Dinkova-Kostova, Deputy Head of Cancer Research Division /Professor
of Chemical Biology at the University of Dundee School of Medicine.
Both have extensive experience of working with sulforaphane;
Professor Mann in looking at its action and role in neurology and
cardiovascular disease and Professor Dinkova-Kostova in relation to
cancer. Further appointments, including US-based scientists and
clinicians, will be made in due course.
We thank all our academic and clinical partners, suppliers and
staff for their continued support and enthusiasm. We would also
like to thank our investors for their continued support.
OUTLOOK
The outlook for Evgen is positive. We have two Phase II trials
of SFX-01 ongoing in different disease areas, with the potential
for differentiated product formats. 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 the field
of regenerative medicine. All have considerable commercial
opportunity and we look forward to the future with confidence.
Barry Clare Dr Stephen Franklin
Chairman Chief Executive
Officer
12 June 2018 12 June 2018
Consolidated Statement of Comprehensive Income
for the year ended 31 March 2018
Year Year
ended ended
31 March 31 March
2018 2017
Notes GBP'000 GBP'000
Operating expenses
------ ---------- ----------
Operating expenses (2,915) (3,449)
------ ---------- ----------
Share based compensation (111) (209)
------ ---------- ----------
Total operating expenses (3,026) (3,658)
------ ---------- ----------
Operating loss (3,026) (3,658)
------ ---------- ----------
Finance income - 17
------ ---------- ----------
Finance expense - (3)
------ ---------- ----------
Loss on ordinary activities before taxation (3,026) (3,644)
------ ---------- ----------
Taxation 443 576
------ ---------- ----------
Loss and total comprehensive expense attributable
to equity holders of the parent for the year (2,583) (3,068)
------ ---------- ----------
Loss per share attributable to equity holders
of the parent (pence) 5
------ ---------- ----------
Basic loss per share (3.28) (4.19)
------ ---------- ----------
Diluted loss per share (3.28) (4.19)
------ ---------- ----------
Consolidated Statement of Financial Position
as at 31 March 2018
Group
Notes As at As at
31 March 31 March
2018 2017
GBP'000 GBP'000
------ ---------- ----------
ASSETS
------ ---------- ----------
Non-current assets
------ ---------- ----------
Property, plant and equipment 12 11
------ ---------- ----------
Intangible assets 113 128
------ ---------- ----------
Investments in subsidiary - -
undertaking
------ ---------- ----------
Total non-current assets 125 139
------ ---------- ----------
Current assets
------ ---------- ----------
Trade and other receivables 77 84
------ ---------- ----------
Current tax receivable 432 660
------ ---------- ----------
Cash and cash equivalents 3,626 3,859
------ ---------- ----------
Total current assets 4,135 4,603
------ ---------- ----------
Total assets 4,260 4,742
------ ---------- ----------
LIABILITIES AND EQUITY
------ ---------- ----------
Current liabilities
------ ---------- ----------
Trade and other payables 389 514
------ ---------- ----------
Total current liabilities 389 514
------ ---------- ----------
Equity
------ ---------- ----------
Ordinary shares 6 233 183
------ ---------- ----------
Share premium 12,560 10,495
------ ---------- ----------
Merger reserve 2,067 2,067
------ ---------- ----------
Share based compensation 1,587 1,476
------ ---------- ----------
Retained deficit (12,576) (9,993)
------ ---------- ----------
Total equity attributable
to equity holders of the
parent 3,871 4,228
------ ---------- ----------
Total liabilities and equity 4,260 4,742
------ ---------- ----------
Consolidated Statement of Changes in Equity
for the year ended 31 March 2018
Share
Ordinary Share Merger based Retained
shares premium reserve compensation deficit Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
--------- --------- --------- -------------- --------- ---------
Balance at 31 March
2016 183 10,495 2,067 1,267 (6,925) 7,087
--------- --------- --------- -------------- --------- ---------
Total comprehensive
expense for the
period - - - - (3,068) (3,068)
--------- --------- --------- -------------- --------- ---------
Transactions with
owners
--------- --------- --------- -------------- --------- ---------
Share based compensation
--------- --------- --------- -------------- --------- ---------
- share options - - - 209 - 209
--------- --------- --------- -------------- --------- ---------
Total transactions
with owners - - 209 - 209
--------- --------- --------- -------------- --------- ---------
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
--------- --------- --------- -------------- --------- ---------
Consolidated Statements of Cash Flows
for the year ended 31 March 2018
Group
Year Year
ended ended
31 March 31 March
2018 2017
GBP'000 GBP'000
---------- ----------
Cash flows from operating activities
---------- ----------
Loss before taxation (3,026) (3,644)
---------- ----------
Finance expense - 3
---------- ----------
Depreciation and amortisation 21 17
---------- ----------
Share based compensation 111 209
---------- ----------
(2,894) (3,415)
---------- ----------
Changes in working capital
---------- ----------
(Increase)/decrease in trade and
other receivables 7 (4)
---------- ----------
Increase/(decrease) in trade and
other payables (125) 198
---------- ----------
Cash used in operations (118) 194
---------- ----------
Taxation received 671 30
---------- ----------
Net cash used in operating activities (2,341) (3,191)
---------- ----------
Cash flows from investing activities
---------- ----------
Acquisition of intangible assets - (68)
---------- ----------
Purchase of property, plant and
equipment (7) (8)
---------- ----------
Short-term investments and cash
on deposit - 2,006
---------- ----------
Net cash (used in)/generated from
investing activities (7) 1,930
---------- ----------
Cash flows from financing activities
---------- ----------
Proceeds from issue of shares 2,333 -
---------- ----------
Issue costs (218) -
---------- ----------
Net cash generated from financing
activities 2,115 -
---------- ----------
Movements in cash and cash equivalents
in the period (233) (1,261)
---------- ----------
Cash and cash equivalents at start
of period 3,859 5,120
---------- ----------
Cash and cash equivalents at end
of period 3,626 3,859
---------- ----------
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 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, 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 2017 has
been extracted from the Group's audited financial statements which
were approved by the Board of Directors on 12 June 2017 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 2018 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 relating to the basis of
preparation which is reproduced below:
'Material uncertainty related to going concern
We draw attention to note 2 in the financial statements
concerning the group's ability to continue as a going concern. The
going concern status of the group is dependent upon the management
of the timing of settlement of its liabilities and the raising of
further funds in the short to medium term. Forecasts prepared by
management indicate that if they are unable to manage the group's
liabilities as planned or the external fund raising does not occur
in the short to medium term they would have an immediate
requirement to seek alternative sources of funding. As stated in
note 2, these events or conditions, along with other matters set
forth in note 2, indicate that a material uncertainty exists that
may cast doubt on the group's ability to continue as a going
concern. Our opinion is not modified in respect of this
matter.'
The information included in this preliminary announcement has
been prepared on a going concern basis under the historical cost
convention, and in accordance with International Financial
Reporting Standards (IFRSs) as adopted by the EU and the
International Financial Reporting Interpretations Committee (IFRIC)
interpretations issued by the International Accounting Standards
Board ("IASB") that are effective or issued and early adopted as at
the date of these financial statements and in accordance with the
provisions of the Companies Act 2006.
The information in this preliminary statement has been extracted
from the audited financial statements for the year ended 31 March
2018 and as such, does not contain all the information required to
be disclosed in the financial statements prepared in accordance
with the International Financial Reporting Standards ('IFRS').
This announcement was approved by the board of directors and
authorised for issue on 12 June 2018.
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.
The Directors estimate that the cash held by the Group together
with known receivables will be sufficient to support the current
level of activities to the end of December 2018. The Directors are
continuing to explore sources of finance available to the Group and
have confidence that they will be able to secure sufficient cash
inflows for the Group to continue its activities for not less than
12 months from the date of approval of these financial statements;
they have therefore prepared the financial statements on a going
concern basis. Because the additional finance is not committed at
the date of approval of these financial statements, these
circumstances represent an uncertainty as to the Group's ability to
continue as a going concern. Should the Group be unable to obtain
further finance such that the going concern basis of preparation
were no longer appropriate, adjustments would be required including
to reduce balance sheet values of assets to their recoverable
amounts, to provide for further liabilities that might arise and to
reclassify fixed assets as current assets.
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.
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 2018 and 31 March 2017, the Group had no dilutive
potential ordinary shares in issue.
The calculation of the Group's basic and diluted loss per share
is based on the following data:
Year Year
ended ended
31 March 31 March
2018 2017
GBP'000 GBP'000
Loss for the year attributable to equity holders for
basic loss and adjusted for the effects of dilution (2,583) (3,068)
---------- ----------
As at As at
31 March 31 March
2018 2017
Number Number
Weighted average number of ordinary shares for basic loss
per share 78,697,455 73,153,169
----------- -----------
Effects of dilution:
----------- -----------
Share options - -
----------- -----------
Weighted average number of ordinary shares adjusted for
the effects of dilution 78,697,455 73,153,169
----------- -----------
Year Year
ended ended
31 March 31 March
2018 2017
Pence Pence
Loss per share - basic and diluted (3.28) (4.19)
---------- ----------
The loss and the weighted average number of ordinary shares for
the years ended 31 March 2018 and 2017 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.
6. Share issues
Ordinary shares
Company
Share Capital
Number GBP'000
----------- --------------
At 31 March 2017 73,272,591 183
----------- --------------
Issued on exercise of options 837,600 2
----------- --------------
Issued under placing agreement 19,166,667 48
----------- --------------
At 31 March 2018 93,276,858 233
----------- --------------
On 31 August 2017 837,600 ordinary shares were issued in
connection with the exercise of share options.
On 28 December 2017 19,166,667 ordinary shares were issued at a
price of GBP0.12 raising GBP2.3 million which after share issue
expenses of GBP0.2 million gave net consideration of GBP2.1
million.
7. Related parties
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 Directors' Remuneration Report.
During the year ended 31 March 2018, the Group purchased
services totalling GBP187,822 (year ended 31 March 2017:
GBP179,819) 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 2018 was
GBP2,077 (31 March 2017: GBPnil).
During the year ended 31 March 2018, the Group purchased
consultancy services totalling GBPnil (year ended 31 March 2017:
GBP3,600) from Dr Alan Barge, a Director. The amount owed to Dr
Alan Barge at 31 March 2018 was GBPnil (31 March 2017: GBPnil).
During the year ended 31 March 2018, the Group purchased
consultancy services totalling GBP17,970 (year ended 31 March 2017:
GBPnil) from FD Consult Ltd, a company controlled by Richard
Moulson. The amount owed to FD Consult Ltd at 31 March 2018 was
GBPnil (31 March 2017: GBPnil).
During the year ended 31 March 2018, the Group was charged
monitoring and Director fees totalling GBP26,500 (year ended 31
March 2017: 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 2018
was GBPnil (31 March 2017: GBPnil).
During the year ended 31 March 2018, the Group was charged
monitoring and Director fees totalling GBPnil (year ended 31 March
2017: GBP22,500) by Enterprise Ventures Limited, manager of Rising
Stars Growth Fund II, a shareholder. The amount owed to Enterprise
Ventures Limited, manager of Rising Stars Growth Fund II at 31
March 2018 was GBPnil (31 March 2017: 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 SFEESEFASEFM
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