TIDMEVG
RNS Number : 8743H
Evgen Pharma PLC
13 June 2017
For immediate release 13 June 2017
Evgen Pharma plc
("Evgen Pharma", the "Company" or the "Group")
Final Results for the year ended 31 March 2017
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
2017.
Highlights
-- First patient dosed in the ongoing SAS (SFX-01 After
Subarachnoid Haemorrhage) Phase II clinical study
-- First patient dosed in the ongoing STEM (SFX-01 in the
Treatment and Evaluation of Metastatic Breast Cancer) Phase IIa
clinical study
-- Orphan drug designation granted by the US Food & Drug
Administration for the use of stabilised sulforaphane in
subarachnoid haemorrhage ("SAH")
-- Positive data from preclinical studies of SFX-01 in various
models of the relapsing remitting form of multiple sclerosis ("MS")
presented at leading MS conference
-- Additional patents granted over manufacturing processes for
SFX-01
-- Recently, and subsequent to the period, the first patient to
enter the STEM trial has now been accepted onto the compassionate
use programme, having demonstrated no disease progression during
the trial
-- Financial performance in line with expectations:
- Total comprehensive loss of GBP3.1m (2016: loss of GBP3.1m)
- Net cash outflow (before short-term investment movements) of
GBP3.3m (2016: inflow of GBP6.9m)
- Cash and short term investments and cash on deposit at 31
March 2017 of GBP3.9m (31 March 2016: GBP7.1m)
Dr Stephen Franklin, Chief Executive Officer of Evgen Pharma,
said:
"We are very pleased to have progressed our SFX-01 product
candidate into two phase II clinical trials: in breast cancer and
in subarachnoid haemorrhage. This is a significant step for Evgen
Pharma, and for sulforaphane-based science.
"The increasing body of evidence that sulforaphane has broad
therapeutic potential, combined with our expanding IP portfolio
over technology for manufacturing sulforaphane-based drugs at
commercial scale, gives Evgen Pharma confidence in its clinical
strategy."
Analyst meeting
A meeting for analysts will be held at 11.00am this morning, 13
June 2017, at the offices of Buchanan, 107 Cheapside, London EC2V
6DN. Please contact Buchanan on 020 7466 5000 for further
information.
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 Cowles, Stephanie Watson 5000
Northland Capital Partners Limited
Matthew Johnson, Gerry Beaney, Margarita Mitropoulou
(Corporate Finance) +44 (0) 20 3861
John Howes, Rob Rees (Corporate Broking) 6625
Notes for editors:
About Evgen Pharma plc
Evgen Pharma is a clinical stage drug development company whose
lead programmes are in breast cancer and subarachnoid haemorrhage,
a type of stroke. It is also carrying out preclinical work in
multiple sclerosis and has a clinical interest in prostate cancer.
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 Pharma 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
OVERVIEW
Evgen Pharma has had another year of strong progress in the
development of our lead product, SFX-01. We commenced dosing in two
clinical trials, which have the potential to provide significant
value inflexion points.
In oncology, we started a 60 patient open label study in
metastatic breast cancer, which is currently recruiting in the UK
and Belgium. This follows promising data from our long-standing
collaboration with the Cancer Research UK Manchester Institute,
showing a reduction in cancer stem cells in patient-derived breast
cancer tissue in xenograft models.
In neurology, we started a randomised, double blind, placebo
controlled study, which is recruiting 90 patients in subarachnoid
haemorrhage ("SAH") at two UK centres. Positive interim safety
reviews from the independent Data Safety Monitoring Board confirm,
thus far, the safety of SFX-01.
In an encouraging development, our commercialisation opportunity
increased with the granting of orphan drug designation for SFX-01
in SAH by the US Food & Drug Administration ("FDA") in August
2016.
At a preclinical level, we released data at the 32nd Congress of
the European Committee and Research in Multiple Sclerosis from a
study on SFX-01 versus BG-12 (Biogen's Tecfidera(R) ) in various in
vivo models of relapsing remitting multiple sclerosis. This data
showed that SFX-01 appeared to be superior to Tecfidera(R) in a
relevant multiple sclerosis model enabling superior neurological
recovery in the chronic stage post-relapse.
In December, we also presented our promising preclinical breast
cancer data at the 2016 San Antonio Breast Cancer Symposium.
During the year our partners at the University of Seville, the
Spanish National Research Council and the University of Liverpool
started a programme to synthesise and screen a series of novel,
proprietary, sulforaphane analogues. All compounds have now been
synthesised in Spain and the screening is underway in the UK.
Towards the year end our intellectual property position in
connection with sulforaphane was reinforced with the grant of two
US patents associated with the manufacturing of SFX-01. These add a
further layer of protection to the granted US patent relating to
composition of the active pharmaceutical ingredient. As detailed in
this announcement, a number of patents have now been granted in
other territories or have received Notification of Allowance.
Finally, we were very pleased to pass through an MHRA Good
Clinical Practice inspection in March 2017, which was a major
endorsement of the Company's transition into a clinical stage
company.
We remain very positive over the prospects for the Group as we
progress our two principal Phase II trials and work on additional
applications of SFX-01.
CHIEF EXECUTIVE OFFICER'S REVIEW
OPERATIONAL OVERVIEW
Background
The Evgen Pharma business opportunity is built around a
naturally occurring compound called sulforaphane, a compound first
isolated from the brassica family of plants.
Sulforaphane has attracted huge scientific interest. A large and
growing number of scientific research papers have been published
worldwide, underlining the compound's medical potential in multiple
diseases (95 papers published in 2017 to the end of May), and
increasing our understanding of the mechanism(s) of action of the
compound. Sulforaphane has been shown to have anti-cancer and
neuroprotective qualities in a wide range of preclinical and
clinical studies, for example in breast cancer, prostate cancer,
multiple sclerosis and autism. However, the daily dose of
sulforaphane required to elicit these potential therapeutic effects
is far greater than can practically and consistently be delivered
from dietary sources.
When chemically synthesised, sulforaphane is a liquid and the
molecule spontaneously breaks down unless stored at very low
temperatures. Evgen Pharma's core technology seeks to unlock the
therapeutic potential of sulforaphane, overcoming its inherent
instability. The Company's patent-protected Sulforadex(R)
technology enables the scalable manufacturing of synthetic
sulforaphane stabilised in a novel composition. This stabilised
composition is a solid powder that can be formulated into pills and
other medicinal formats. The Sulforadex(R) technology is also
applicable to novel compounds based upon the core sulforaphane
structure, giving us the opportunity to develop a broad clinical
pipeline and to become the world leader in sulforaphane and
sulforaphane-like pharmaceuticals.
Evgen Pharma's first product developed using the Sulforadex(R)
technology is SFX-01, a synthetic copy of sulforaphane stabilised
by an alpha-cyclodextrin lattice. 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 SAH.
Our assets include novel analogues of sulforaphane that have
been synthesised and are being screened with a view to identifying
the most promising compounds thereby reinforcing our leading
position in the sulforaphane field.
Objective and strategy
Our objective is to establish a leading position in the
development and commercialisation of pharmaceuticals based upon
sulforaphane and related analogues. 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, and exploring other
types of disease where sulforaphane may be effective;
-- 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 Pharma 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 Pharma 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 investigator-initiated studies (completely or largely
funded by the investigator or relevant charities) to broaden the
range of applications for SFX-01.
In particular, three collaborations (in two new therapeutic
areas) have progressed well and are presenting near-term clinical
development opportunities:
-- Autism: a third-party, small (40 patient), randomised placebo
controlled trial has shown that sulforaphane (delivered as a frozen
botanical extract) significantly improved behavioural measures and
there are now five clinical trials (with over 300 patients in
aggregate) investigating the use of sulforaphane in autism. None of
these is using a viable pharmaceutical product. Evgen Pharma has
been approached by a UK consortium led by Dr Michael Absoud (St
Thomas' Hospital) that wishes to trial SFX-01 for the treatment of
autism in children using a randomised double blind Phase II trial.
This is a relatively near-term opportunity to initiate an
Investigator Initiated Study using non-dilutive grant funding.
-- Regenerative medicine (bone): Evgen Pharma has ongoing
collaborations with the Mayo Clinic (US) and London's Royal
Veterinary College (RVC); both are interested in SFX-01 as an agent
that could potentially drive bone regeneration. With an interest in
osteoporosis, the Mayo Clinic has previously shown that
sulforaphane increases bone mass via an epigenetic mechanism that
increases osteoblast differentiation. The RVC has previously
presented data showing that SFX-01 improves bone architecture and
gait in a naturally occurring model of osteoarthritis and a new
scientific paper to this effect is in review.
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 Pharma has worked with 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. This data was first presented at the American
Association of Cancer Research annual conference in Philadelphia in
April 2015 and further preclinical data was presented in December
2016 at the San Antonio Breast Cancer Symposium.
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 will recruit 60 patients from multiple sites
in the UK and up to four other European countries. Two sites are
currently open for recruitment in each of the UK and Belgium and a
total of 9 patients have been enrolled to date. As previously
announced, due to protracted regulatory submissions in France,
Spain and the Czech Republic, we are projecting the read-out from
the study in the second half of calendar year 2018. As the study is
open label, the Company will issue an interim data analysis in the
first half of calendar year 2018.
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 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 Company has recently announced that the first patient to
enter the STEM trial is now approaching week 24, having
demonstrated no disease progression for three consecutive scans. On
this basis, the Company has initiated a compassionate use
programme, so that patients can continue to receive SFX-01 after
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 will be a continued access programme and a
follow-up for safety.
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 around
the outside 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, has been generic 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
erythroid 2-related factor 2-antioxidant response element) pathway.
Sulforaphane, the active principle 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 cerebral vasospasm following SAH. On 30
April 2016, the first patient was dosed in the Company's Phase II
clinical trial entitled 'SAS: SFX-01 After Subarachnoid
haemorrhage'. 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
cerebral vasospasm), 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 34 patients have been recruited into the trial at one UK
centre; University Hospital Southampton (UK). As previously
announced, the Data Safety Monitoring Board ("DSMB"), a panel of
independent experts, has now met on two occasions to analyse the
unblinded data for safety and confirmed there are no safety issues
attributable to SFX-01. The DSMB has however recommended that
patients should henceforward be assigned to an arm of the study on
a stratified basis to help correct an imbalance of baseline disease
severity across the study's two arms: in one arm patients receive
nimodipine, the current standard of care, plus placebo and in the
other patients receive nimodipine plus SFX-01. The Company has
accepted the DSMB's recommendation and recruitment will continue
once this stratification process has been designed and
implemented.
As part of its risk mitigation strategy, the Company has
initiated a second site (Queen Elizabeth Hospital Birmingham, UK)
to accelerate patient recruitment, and recruitment at both centres
is expected to recommence in the coming weeks. The Company is now
anticipating the read-out from the study around the end of calendar
year 2018.
SFX-01 in multiple sclerosis
The principal mechanism of action of SFX-01 in SAH is via
sulforaphane's ability to upregulate the Nrf2 pathway, resulting in
a wide range of antioxidant and anti-inflammatory effects. It is
this pathway that is implicated in Biogen IDEC's treatment for
multiple sclerosis, Tecfidera(R). In-vitro studies have shown that
sulforaphane is a more potent activator of Nrf2 than dimethyl
fumerate, the active ingredient in Tecfidera(R). In September 2016,
Evgen presented a late-breaking abstract and poster at the 32nd
Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS) in London. The poster was entitled
"Efficacy of SFX-01, a sulforaphane-based drug in experimental
autoimmune encephalomyelitis". The study concluded that: "SFX-01
appears to be superior to BG-12 in the therapeutic EAE model.
SFX-01 appears to exert maximum effects later in the course of the
disease by enabling superior neurological recovery in the chronic
stage after relapse. SFX-01 is a promising drug candidate in MS,
and warrants further investigation."
The Group has completed a strategic review of the multiple
sclerosis opportunity and has concluded that it would be prudent to
appraise two further data sets prior to building a new direct
investment and/or partnering proposition. Firstly, a review of the
pharmacokinetic data from the cerebrospinal fluid (CSF) of the SAS
trial confirming that the SFX-01 dose used results in brain-side
delivery at concentrations expected to be therapeutically active.
Secondly, a further dose-ranging preclinical experiment with
histology at all doses. Together, and for minimal new investment,
these data sets would significantly improve the risk profile
associated with a significant investment in a Phase II trial.
Early stage pipeline
SFX-01 is a synthetic and stable sulforaphane, which has been
shown to have excellent pharmacokinetics and a bioavailability of
around 80%. When the synthetic sulforaphane is released from its
sugar lattice in the gastrointestinal tract it has the same
half-life in the body as naturally occurring sulforaphane and has
been shown to be equipotent. Medicinal chemists at the University
of Seville have gone on to create a range of novel compounds based
upon the sulforaphane core structure. Evgen has in-licenced the
Seville intellectual property presenting us with multiple new
chemical entities based upon sulforaphane.
During the year our partners at the University of Seville, the
Spanish National Research Council and the University of Liverpool
started a programme to synthesise and screen a series of novel,
proprietary, sulforaphane analogues. All compounds have now been
synthesised in Spain and the screening is underway in the UK.
INTELLECTUAL PROPERTY UPDATE
During the year a number of patent applications have moved to
grant or have moved to Notice of Allowance:
-- The core composition of matter patent, entitled, "Stabilized
Sulforaphane," with expiry no later than 2028, is granted in the
United States, Canada and Australia and is pending in Europe, Japan
and Hong Kong.
-- The core manufacturing patent entitled "Scale-up process for
Sulforadex", with expiry no later than 2033, is granted in the
United States and is proceeding to grant in Australia and Japan. It
is pending in Brazil, Canada, China, Europe and India.
-- A further manufacturing patent entitled "Improving purity of
Sulforaphane in a sample", with expiry no later than 2033, is
granted in the United States and is pending in China, Europe and
Japan.
-- The novel sulforaphane analogues composition of matter patent
entitled "Sulforaphane-Derived Compounds, Production method thereof
and the Medical, Food and Cosmetic use of same", with expiry no
later than 2033, is granted in Spain and is proceeding to grant in
Australia. It is pending in Canada, China, Europe, Japan and the
United States.
Further patent protection associated with product formulation
and dosing regimes is continually under review with new
applications anticipated in 2018.
RECENT ADVANCES IN SULFORAPHANE SCIENCE
The scientific literature around sulforaphane continues to
expand with 2016 seeing a record number of 172 peer-reviewed
publications; and a further 95 by the end of May 2017.
The past 12 months have seen a number of papers support the
hypothesis that sulforaphane targets cancer stem cells.
Sulforaphane has been shown to enhance the activity of taxanes
against triple negative breast cancer by killing cancer stem cells
and has been shown to target cancer stem-like cells in both
pancreatic cancer and glioblastoma.
The literature around sulforaphane's mechanism of action has
also moved forward. A recent proteomic analysis to specifically
identify sulforaphane binding targets in breast cancer cell lines
has confirmed Keap1 as a potent high confidence target at
concentrations that can be realistically administered to subjects.
Other potent binders were MIF (macrophage migration inhibitory
factor), NF-kB and STAT3. Interestingly, in two other recent
studies, sulforaphane has been shown to induce programmed cell
death in glioblastoma calls via STAT3 and improve the efficacy of a
chemotherapy in gastric cancer cells by targeting cancer stem-like
cells via the STAT3 pathway.
Finally, a study published in December 2016 further validated
our selection of subarachnoid haemorrhage for clinical
investigation. The administration of sulforaphane to rats following
subarachnoid haemorrhage was demonstrated to enhance the activity
of the Nrf2 pathway, attenuate the cerebral vasospasm, and
significantly ameliorate two behavioural functions disrupted by the
haemorrhage.
Global clinical trial activity
At the time of writing, there are 47 clinical trials registered
as evaluating sulforaphane. Eleven are actively recruiting and two
of those are registered by Evgen Pharma (SFX-01 in the Treatment
and Evaluation of Metastatic Breast Cancer and SFX-01 After
Subarachnoid Haemorrhage).
Only the Evgen Pharma trials are evaluating a drug development
product in the form of a synthetic sulforaphane. The remaining
trials are using botanical extracts derived from broccoli seeds
and/or sprouts. Some contain no sulforaphane but rely upon the
variable conversion by gut microflora, others have had sulforaphane
enzymatically released and then the extract is frozen prior to use
in the clinic.
Other than our own registered trials, no other clinical
programme is using a pharmaceutical development product that can
reliably deliver standardised doses of sulforaphane. Of the nine
"non-Evgen" trials, four are in autism; an area where SFX-01 has
attracted the attention of clinicians in the UK with access to
grant funding for a substantive Phase II study.
KEY PERFORMANCE INDICATORS
The Group's 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 Chief
Executive Officer's Review, and below are the other indicators
(financial measures) considered pertinent to the business.
Year-end cash, short term investments and cash on deposit held:
GBP3.9m (2016: GBP7.1m)
The reduction in year-end cash reflects working capital,
pre-clinical and clinical expenditures during the year. Equity
placings in August and October 2015 raised gross proceeds of
GBP9.0m.
Cash flows (before short term investment movements): net
(outflow) of GBP3.3m (2016: inflow of GBP6.9m)
The net cash outflow again reflects working capital,
pre-clinical and clinical expenditures during the year.
Operating loss: GBP3.7m (2016: GBP2.4m)
The increase in operating loss reflects greater clinical
activity in the year.
FINANCIAL REVIEW
The financial performance for the year ended 31 March 2017 was
in line with expectations.
Losses
The total loss for the year was GBP3.1m (31 March 2016: GBP3.1m)
including a charge for share-based compensation of GBP0.2m (2016:
GBP0.5m). Operating expenses excluding non-recurring administrative
expenses increased to GBP3.5m (2016: GBP1.2m) principally because
of costs associated with conducting clinical trials which commenced
recruitment during the year. These include the manufacture of
product for the trials, payments to sub-contractors who manage the
trials and payments to the clinical sites running the trials. In
addition, staff costs excluding share based payments increased by
GBP0.3m with more senior level capability.
There were no non-recurring administration expenses during the
year (31 March 2016: warrant charges GBP0.3m and IPO costs
GBP0.4m).
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 GBP0.2m (2015: GBP0.5m)
and has no impact on cash flows.
Headcount
Average headcount of the Group for the year was 8 (2016: 7).
Taxation
The Group has elected to claim research and development tax
credits under the small or medium enterprise research and
development scheme of GBP0.58m (2016: GBP0.09m). The substantial
increase reflects expenditures associated with conducting clinical
trials.
Share capital
A total of 129,729 ordinary shares of 0.25 pence each were
issued pursuant to exercises of share options granted under The
Evgen Pharma plc Long Term Incentive Plan (2016: 272,000). These
options had an exercise price of nil pence per share and the
nominal value was credited against the share premium account.
Cash flows and financial position
The cash position (including short-term deposits) at 31 March
2017 decreased to GBP3.9m (31 March 2016: increased to GBP7.1m),
reflecting increased clinical expenditure as SFX-01 progressed into
two Phase II trials and general and administrative costs.
PEOPLE
We were delighted to welcome Dr Bob Holland and Dr Tom Morris
who became Medical Advisers (in neurology and oncology
respectively) to the Company in September 2016. Dr Holland had a
long career at AstraZeneca having been their VP and Head of
Personalised Healthcare & Biomarkers and prior to that their VP
and Head of Neuroscience Therapeutic Area. Dr Morris has held
various medical roles in oncology at AstraZeneca including Senior
Medical Director for Oncology, Executive Director of Clinical
Programs and Medical Science Director for the Oncology Therapy
Area.
John Bradshaw resigned as Finance Director in February 2017 to
focus on his work with a new healthcare investment vehicle and Mark
Wyatt left the Board at the year end to spend more time on his
directorships of earlier stage companies in his investment
portfolio with Enterprise Ventures. We were very pleased to welcome
Richard Moulson to the Board as Chief Financial Officer. Richard
brings considerable experience in life science and technology
companies at CFO level.
David Howat, Chief Development Officer, left at the year end and
we thank him for his contribution to establishing Evgen Pharma as a
clinical-stage company. David Chadwick, who joined us in April 2016
was promoted to Head of Clinical Operations in January 2017. We are
building out our drug development capability with additional staff
to support David Chadwick and through a relationship with APTrans,
a consultancy comprising mainly ex-AstraZeneca staff with deep and
relevant expertise in a number of drug development disciplines such
as toxicology and clinical pharmacology.
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 Pharma is positive. We have two Phase II
trials of SFX-01 ongoing in different disease areas and
pre-clinical and clinical data that supports clinical investigation
in new indications. 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 2017 12 June 2017
Consolidated Statement of Comprehensive Income
for the year ended 31 March 2017
Year Year
Ended Ended
31 March 31 March
2017 2016
Note GBP'000 GBP'000
---------------------------------- ----- --------- ---------
Operating expenses
Operating expenses (3,449) (1,232)
Share based compensation (209) (519)
Non-recurring administrative
expenses - (683)
Total operating expenses (3,658) (2,434)
---------------------------------- ----- --------- ---------
Operating loss (3,658) (2,434)
Finance income 17 8
Finance expense (3) (791)
Loss on ordinary activities
before taxation (3,644) (3,217)
Taxation 576 85
---------------------------------- ----- --------- ---------
Loss and total comprehensive
expense attributable (3,068) (3,132)
to equity holders of the parent
for the year
Loss per share attributable
to equity holders of the parent
(pence)
Basic loss per share 5 (4.19) (6.29)
Diluted loss per share 5 (4.19) (6.29)
---------------------------------- ----- --------- ---------
Consolidated Statement of Financial Position
as at 31 March 2017
As at As at
31 March 31 March
2017 2016
Note GBP'000 GBP'000
------------------------------- ----- --------- ---------
ASSETS
Non-current assets
Property, plant and equipment 11 6
Intangible assets 128 74
Total non-current assets 139 80
Current assets
Trade and other receivables 84 79
Current tax receivable 660 115
Short-term investments and
cash on deposit - 2,006
Cash and cash equivalents 3,859 5,120
Total current assets 4,603 7,320
Total assets 4,742 7,400
------------------------------- ----- --------- ---------
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables 514 313
Total current liabilities 514 313
Equity
Ordinary shares 6 183 183
Share premium 10,495 10,495
Merger reserve 2,067 2,067
Share based compensation 1,476 1,267
Retained deficit (9,993) (6,925)
------------------------------- ----- --------- ---------
Total equity attributable
to equity holders of the
parent 4,228 7,087
Total liabilities and equity 4,742 7,400
------------------------------- ----- --------- ---------
Consolidated Statement of Changes in Equity
for the year ended 31 March 2017
Attributable to ordinary shareholders
Shares Share
Ordinary Share Merger to be based Retained
shares premium Reserve issued compensation deficit Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Balance at
31 March
2015 73 - 2,067 1,750 466 (5,543) (1,187)
Total comprehensive
expense - - - - - (3,132) (3,132)
for the
period
Transactions
with owners
Equity element
of loan note - - - (1,750) - 1,750 -
Share based
compensation
- share options - - - - 519 - 519
Share based
compensation
- warrants - - - - 282 - 282
Share issue
- cash 19 1,840 - - - - 1,859
Share issue
- cash 47 6,645 - - - - 6,692
Share issue
- loan note
conversion 23 2,017 - - - - 2,040
Share issue
- bonus issue 20 (20) - - - - -
Share issue
- options
exercised 1 13 - - - - 14
Total transactions
with owners 110 10,495 - (1,750) 801 1,750 11,406
---------------------- ---- -------- -------- -------- ------------- --------- --------
Balance at
31 March
2016 183 10,495 2,067 - 1,267 (6,925) 7,087
Total comprehensive
expense - - - - - (3,068) (3,068)
for the
period
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 - 1,467 (9,993) 4,228
---------------------- ---- -------- -------- -------- ------------- --------- --------
Consolidated Statements of Cash Flows
for the year ended 31 March 2017
Year Year
Ended Ended
31 March 31 March
2017 2016
GBP'000 GBP'000
----------------------------------------- --------- ---------
Cash flows from operating activities
Loss before taxation (3,644) (3,217)
Finance expense 3 791
Depreciation and amortisation 17 8
Share based compensation 209 801
(3,415) (1,617)
Changes in working capital
Increase in trade and other receivables (4) (47)
Increase in trade and other payables 198 104
----------------------------------------- --------- ---------
Cash used in operations 194 57
Taxation received 30 -
----------------------------------------- --------- ---------
Net cash used in operating activities (3,191) (1,560)
Cash flows from investing activities
Acquisition of intangible assets (68) (36)
Purchase of property, plant and
equipment (8) (6)
Short-term investments and cash
on deposit 2,006 (2,006)
Net cash generated/(used in) from
investing activities 1,930 (2,048)
Cash flows from financing activities
Proceeds from issue of shares - 9,014
Issue costs - (449)
----------------------------------------- --------- ---------
Net cash generated from financing
activities - 8,565
Movements in cash and cash equivalents
in the period (1,261) 4,957
----------------------------------------- --------- ---------
Cash and cash equivalents at start
of period 5,120 163
----------------------------------------- --------- ---------
Cash and cash equivalents at end
of period 3,859 5,120
----------------------------------------- --------- ---------
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 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, 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 2016 has
been extracted from the Group's audited financial statements which
were approved by the Board of Directors on 27 May 2016 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 include any references to any matters to which
the auditors drew attention by way of emphasis without qualifying
their report and did not contain a statement under Section 498(2)
or Section 498(3) of the Companies Act 2006.
The report of the auditor on the 31 March 2017 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:
'Emphasis of matter - Going concern
In forming our opinion on the financial statements, which is not
modified, we have considered the adequacy of the disclosure made in
note 2 to the financial statements concerning the Group's and
Company's ability to continue as a going concern. The going concern
status of the Group and Company 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
fundraising does not occur in the short to medium term they would
have an immediate requirement to seek alternative sources of
funding. This condition indicates the existence of a material
uncertainty which may cast significant doubt about the Group's and
Company's ability to continue as a going concern. The financial
statements do not include the adjustments that would result if the
Group or Company was unable to continue as a going concern.'
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
2017 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 2017.
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 the Going Concern Basis of Accounting
and Reporting on Solvency Risks - Guidance for directors of
companies that do not apply the UK Corporate Governance Code". 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 into the first quarter of 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 from further fundraising 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 and Company'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 2017 and 31 March 2016, 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
2017 2016
GBP'000 GBP'000
----------------------------------------------- -------------- --------------
Loss for the year attributable to equity
holders for basic loss and adjusted for
the effects of dilution (3,068) (3,132)
----------------------------------------------- -------------- --------------
As at As at
31 March 31 March
2017 2016
Number Number
------------------------------------------------- ---------------- -----------------
Weighted average number of ordinary shares
for basis loss per share 73,153,169 49,797,654
Effects of dilution:
Share options - -
------------------------------------------------- ---------------- -----------------
Weighted average number of ordinary shares
adjusted for the effects of dilution 73,153,169 49,797,654
------------------------------------------------- ---------------- -----------------
Year Year
Ended Ended
31 March 31 March
2017 2016
Pence Pence
----------------------------------------- -------------- --------------
Loss per share - basic and diluted (4.19) (6.29)
----------------------------------------- -------------- --------------
The loss and the weighted average number of ordinary shares for
the years ended 31 March 2017 and 2016 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
---------------------------------------- ----------- -------------
Issued and fully paid
Issued subscriber shares 1 -
Issued on acquisition of Evgen Limited 36,461 73
Issued for cash consideration 9,569 19
Subdivision of shares 36,778,769 -
Issued on loan conversion 9,350,225 23
Bonus issue 7,776,918 20
Issued under placing agreement 18,918,919 47
Issued on exercise of options 272,000 1
---------------------------------------- ----------- -------------
At 31 March 2016 73,142,862 183
---------------------------------------- ----------- -------------
Issued on exercise of options 129,729 -
---------------------------------------- ----------- -------------
At 31 March 2017 73,272,591 183
---------------------------------------- ----------- -------------
On 2 October 2014 the Company was incorporated with one ordinary
share of GBP2.00 subscribed for GBPnil paid.
On 5 December 2014 the Company entered into an agreement to
acquire the entire share capital of Evgen Limited, satisfied by the
issue of 12,595 ordinary shares of GBP2.00 each, 18,849 ordinary A
shares of GBP2.00 each and 5,017 ordinary B shares of GBP2.00 and
the original ordinary share credited as being fully paid.
On 26 August 2015 9,569 ordinary shares of GBP2.00 each were
allotted to subscribers raising a total of GBP2 million
(gross).
On 12 October 2015 each ordinary share of GBP2.00 each was
converted into 800 ordinary shares of GBP0.0025 each, each ordinary
A share of GBP2.00 each was converted into 800 A shares of
GBP0.0025 each and each ordinary B share of GBP2:00 was converted
into 800 B shares of GBP0.0025 each. Following this there were
17,732,000 ordinary shares, 15,079,200 A shares and 4,013,600 B
shares in issue.
On 21 October 2015 7,776,918 ordinary shares were issued in
connection with a bonus issue.
On 21 October 2015 6,553,330 A shares and 2,796,895 ordinary
shares were issued in connection with the conversion of loan
notes.
On 21 October 2015 all A shares and B shares then in issue were
converted to ordinary shares, immediately following this conversion
there were 53,951,943 ordinary shares in issue.
On 21 October 2015, following admission to the Alternative
Investment Market of the London Stock Exchange, 18,918,919 ordinary
shares of GBP0.0025 were issued at a price of GBP0.37 raising GBP7
million which after expenses of GBP0.7 million gave net
consideration of GBP6.3 million.
On 14 January 2016 272,000 ordinary shares were issued in
connection with the exercise of share options.
On 3 March 2017 129,729 ordinary shares were issued in
connection with the exercise of share options.
The Group and Company do not have an authorised share capital as
provided by the Companies Act 2006.
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.
During the year ended 31 March 2017, the Group purchased
consultancy services totalling GBPnil (year ended 31 March 2016:
GBP46,750) from Clarat Partners LLP, a partnership of which Barry
Clare, a director, is a member. The amount owed to Clarat Partners
LLP at 31 March 2017 was GBPnil (31 March 2016: GBPnil).
During the year ended 31 March 2017, the Group purchased
consultancy services totalling GBP3,600 (year ended 31 March 2016:
GBPnil) from Dr Alan Barge, a director. The amount owed to Dr Alan
Barge at 31 March 2017 was GBPnil (31 March 2016: GBPnil).
During the year ended 31 March 2017, the Group purchased
consultancy and accounting services totalling GBP40,160 (year ended
31 March 2016: GBP50,840) from Bradshaw Daniel Limited, a company
controlled by John Bradshaw, a director until 1 March 2017. The
amount owed to Bradshaw Daniel Limited at 31 March 2017 was
GBP4,497 (31 March 2015: GBP2,556).
During the year ended 31 March 2017 the Group purchased services
totalling GBP179,819 (year ended 31 March 2016: GBP96,367) from The
Clinical Trial Company Limited, a company in which Richard Moulson,
a director, is also a director. The amount owed to this company at
31 March 2017 was GBPnil (31 March 2016: GBPnil).
During the year ended 31 March 2017, the Group was charged
monitoring and director fees totalling GBP26,500 (year ended 31
March 2016: GBP20,104) 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 2017
was GBPnil (31 March 2016: GBPnil).
During the year ended 31 March 2017, the Group was charged
monitoring and director fees totalling GBP22,500 (year ended 31
March 2016: GBP21,451) 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 2017 was GBPnil (31 March 2016: 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 company news service from the London Stock Exchange
END
FR SFFFUEFWSEEM
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