TIDMEVG
RNS Number : 6408Z
Evgen Pharma PLC
31 May 2016
For immediate release 31 May 2016
Evgen Pharma plc
("Evgen Pharma", the "Company" or the "Group")
Final Results for the year ended 31 March 2016
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
2016.
Period Highlights
-- Successful admission to AIM and GBP7m (gross) share placing
on 21 October 2015
-- Financial performance in line with expectations
- Loss of GBP3.1m (2015: GBP2.3m) reflecting higher activity levels post admission to AIM
- Loss per share 6.29p (2015: loss per share 7.79p)
- Cash (and short term investments and cash on deposit) at 31
March 2016 increased to GBP7.1m (31 March 2015: GBP0.2m),
reflecting successful completion of a pre-IPO fund raising and a
placing on AIM admission
-- Lead product SFX-01 data shows promise as adjunct to hormonal
therapy in patient-derived xenografts using cancer tissues from
early and late stage breast cancer patients (data presented at the
American Association of Cancer Research)
-- Exclusive worldwide licence to a wide range of novel
compounds from the Spanish National Research Council (CSIC) and the
University of Seville
Post-Period Highlights
-- First patient dosed in the SAS (SFX-01 After Subarachnoid
Haemorrhage) Phase II clinical study at University Hospital
Southampton
-- Dr Alan Barge recently appointed interim Chief Medical
Officer, having previously joined the Board at admission
-- Preclinical study underway comparing SFX-01 with approved MS
drug, Tecfidera(R)
-- Collaboration with the University of Liverpool, the
University of Seville and CSIC to progress the novel compounds
in-licensed from Spain
-- Collaboration with Professor Antonio Cuadrado at the
Autonomous University of Madrid where SFX-01 will be tested in some
leading-edge models of Parkinson's disease
Dr Stephen Franklin, Chief Executive Officer of Evgen Pharma,
said:
"I am very pleased with the significant progress the Company has
made since joining AIM in October last year. We are already
treating patients in a Phase II trial of our lead product, SFX-01,
in subarachnoid haemorrhage and we are fully funded to complete a
Phase II trial in breast cancer which will begin later this year.
These two trials represent significant value inflexion points for
Evgen Pharma.
"In addition, we are expecting results later this year of a
head-to-head preclinical study of SFX-01 against Tecfidera(R), the
market leading oral treatment for the relapsing form of multiple
sclerosis."
Analyst meeting
A meeting for analysts will be held at 10am this morning, 31 May
2016, 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)
Dr Stephen Franklin, CEO 20 7466 5000
John Bradshaw, CFO
Barry Clare, Chairman
www.evgen.com
Buchanan
Mark Court, Sophie Cowles, Stephanie +44 (0) 20
Watson 7466 5000
Northland Capital Partners Limited
Matthew Johnson, Gerry Beaney,
Margarita Mitropoulou
(Corporate Finance)
John Howes, Rob Rees (Corporate +44 (0) 20
Broking) 3861 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 is based
in Liverpool, UK, at the Liverpool Science Park. It joined the AIM
market of the London Stock Exchange in October 2015 and trades
under the ticker symbol EVG. For further information, please visit
www.evgen.com
CHAIRMAN'S AND CHIEF EXECUTIVE OFFICER'S STATEMENT
OVERVIEW
We are extremely pleased by the significant progress Evgen
Pharma has made in the year ended 31 March 2016. Highlights of the
year include oversubscribed fundraisings in the form of a pre-IPO
investment round (GBP2m in gross proceeds) and the subsequent IPO
in October 2015 (GBP7m in gross proceeds). The year has been
transformational for the business as we now have sufficient capital
to complete two Phase II clinical trials on lead product SFX-01;
these trials represent the most significant value inflexion points
since Evgen Pharma commenced operations in 2008.
During the year, our long-standing collaboration with the Cancer
Research UK Manchester Institute resulted in the presentation of
promising data showing SFX-01 reducing cancer stem cells in
patient-derived breast cancer tissue in xenograft models. This
preclinical data underpins the rationale for STEM (SFX-01 in the
Treatment and Evaluation of Metastatic Breast Cancer), a Phase II
clinical study that is expected to start recruitment later this
year.
During the reporting period, we secured MHRA Clinical Trial
Approval for SAS (SFX-01 After Subarachnoid Haemorrhage), a Phase
II clinical study that has now commenced patient recruitment and
treatment.
On the preclinical side, the study on SFX-01 versus BG-12
(Biogen's Tecfidera(R) ) in various in vivo models of RR-MS
(relapsing remitting multiple sclerosis) has commenced and is due
to report in the latter part of 2016.
During the year, we have also expanded our pipeline by
in-licensing a range of novel analogues based on sulforaphane, the
active principle of SFX-01. We would like to take this opportunity
to announce that this month we initiated a new collaboration
between the University of Seville, the Spanish National Research
Council (CSIC) and the University of Liverpool in the UK. This
collaboration will synthesise, and subsequently screen, novel
analogues with a view to identifying the most promising compounds
to expand the Company's therapeutic pipeline.
The outlook for Evgen Pharma is positive, with all programmes on
track and with sufficient capital to complete the two principal
Phase II trials.
OPERATIONAL REVIEW
Background
The Evgen Pharma business opportunity is built around a
naturally occurring compound called sulforaphane. Sulforaphane can
be derived at relatively low and variable levels from the
consumption of brassica plants, such as broccoli. Glucoraphanin
(the stable precursor molecule) converts to sulforaphane when the
plant tissue is damaged and this conversion typically starts in the
mouth and continues in the digestive tract of mammals, including
people.
Sulforaphane has attracted huge scientific interest. A large and
growing number of scientific research papers has been published
worldwide, underlining the compound's medical potential in multiple
diseases. Sulforaphane has been shown to have anti-cancer and
neuroprotective qualities in a wide range of preclinical and/or
clinical studies, for example 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 derived
from dietary sources. The development of a concentrated form of
pure sulforaphane - of the sort that could be presented in a tablet
or similar medicinal format - has been held back owing to its
inherent instability. 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. The Company's patent-protected
Sulforadex(R) technology enables the scalable manufacturing of
synthetic sulforaphane stabilised in a novel composition. The
stabilised composition is also a solid powder and can easily 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 the Group the
opportunity to develop a broad clinical pipeline and to become the
world leader in sulforaphane and sulforaphane-like
pharmaceuticals.
Evgen Pharma secured exclusive rights to Sulforadex(R) in 2011
and rapidly began building a company with a capital efficient
business model and a highly experienced team to exploit the
therapeutic potential of sulforaphane. The initial product to use
the Sulforadex(R) technology is code-named SFX-01, which is 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. Novel analogues of
sulforaphane are also being synthesised and screened with a view to
identifying the most promising compounds and expanding the Group's
pipeline.
Objective and Strategy
The Group's 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:
-- focus current resources on two Phase II clinical studies:
STEM and SAS (see below);
-- commercially appraise, and if appropriate, develop new
investment propositions for future clinical studies in multiple
sclerosis and/or prostate cancer.
-- support investigator-initiated studies (i.e. academic units
typically with grant funding) in areas outside of the above to
expand scientific understanding and keep abreast of other potential
clinical applications (see below);
-- expand the Group's 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 after the first two
Phase II clinical studies have reported;
-- in due course, opportunistically diversify the product
pipeline, where the Directors believe such opportunities have a
good strategic fit.
Group-Sponsored Programmes
The Group 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; and
-- SAS (SFX-01 After Subarachnoid Haemorrhage - SAH), a 90
patient trial in the UK.
The Group also has a clinical interest in other oncology and
neurology indications, for example prostate cancer and multiple
sclerosis.
Investigator-Initiated Studies
In addition to the Company's core in-house programmes, we will
continue to support investigator-initiated studies (completely or
largely funded by the investigator) to help contribute to the
fundamental scientific understanding of sulforaphane and thereby
demonstrating the potential wider utility of SFX-01 and related
analogues.
The Company has previously supported research by Professor
Andrew Pitsillides (Professor of Skeletal Dynamics at the RVC,
London) into the potential of SFX-01 in osteoarthritis. During the
year, that data was presented at the 4th Joint Meeting of European
Calcified Tissue Society (ECTS) and the International Bone and
Mineral Society (IBMS) in Rotterdam. The positive results found
that osteoarthritic mice treated with SFX--01 had significantly
improved bone architecture, gait balance and movement in comparison
with an untreated sample group.
We are pleased to report that this month we entered into a new
collaboration with Professor Antonio Cuadrado at the Autonomous
University of Madrid where SFX-01 will be tested in some
leading-edge models of Parkinson's Disease. Professor Cuadrado has
previously published on the therapeutic potential of sulforaphane
in Parkinson's Disease; research that was grant funded by the
Michael J Fox Foundation.
PIPELINE
SFX-01 in breast cancer (STEM: SFX-01 in the Treatment and
Evaluation of Metastatic Breast Cancer)
According to World Cancer Research Fund International, breast
cancer is the most common cancer globally, with nearly 1.7 million
new cases diagnosed in 2012, and is the second most common cause of
cancer death. This represents about 12% of all new cancer cases and
25% of all cancers in women. 70-75% of breast cancers express the
estrogen receptor (ER), and are amenable to treatment with
endocrine therapies.
However, the emergence of resistance to treatment and
progression of disease is common, occurring in up to 50% of
patients. It is thought that this is due, in a large part, to
hormone independent cancer stem cells. Therefore, when conventional
therapies targeting cancer cells are used leaving the cancer stem
cells unimpaired, there is a high chance of developing resistance
and the patient progressing.
Evgen Pharma is very fortunate to have been working with the
Cancer Research UK Manchester Institute since 2012. Earlier this
year, this collaboration resulted in the presentation of promising
data showing SFX-01 reducing 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 reduce the population of the
hormone independent cancer stem cells. The data was presented at
the American Association of Cancer Research annual conference in
Philadelphia in April 2015.
STEM, a Phase II clinical trial, will investigate oral SFX-01 in
combination with different hormone-based therapies (tamoxifen,
aromatase inhibitors or fulvestrant) and is expected to begin
recruiting later this year at Manchester's Christie Hospital NHS
Foundation Trust and a number of other sites across Europe. The
trial, in about 60 patients with ER+ metastatic breast cancer, will
assess the potential reversal of resistance to hormone therapy and
the impact on clinical benefit. The trial is designed to also
create the opportunity to potentially stratify and help select
patients best suited for treatment with SFX-01.
SFX-01 in subarachnoid haemorrhage (SAS: SFX-01 After
Subarachnoid Haemorrhage)
Subarachnoid haemorrhage (SAH) is a form of stroke,
characterised by a bleed into the subarachnoid space around the
outside of the brain. It is a relatively rare condition, accounting
for around 5% of strokes in the UK each year. Owing to this rarity,
SFX-01 could be eligible for orphan designation in Europe and the
USA in this indication.
The Phase II trial, SAS, is a randomised, double blind, placebo
controlled study comparing oral SFX-01 with placebo. The trial will
recruit 90 patients, 45 in each treatment arm with all patients
receiving nimodipine, the current standard of care. Patients will
be dosed within 48 hours of experiencing SAH and approval has also
been obtained in this study to provide for emergency dosing prior
to consent. The primary endpoints include safety, pharmacokinetics
and efficacy.
Nimodipine 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
(commissioned by a US peer) 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 potentially represents a new class of drug in aneurysmal
SAH with a mechanism of action that specifically targets the Nrf-2
pathway, which in turn reduces the oxidative stress and the
toxicity caused by free haemoglobin from the haemorrhage.
Sulforaphane, the active ingredient of SFX-01, has been shown to be
neuroprotective in multiple models of cerebral damage, including
SAH.
SAS recruited its first patient on 30 April 2016 and it is
expected to report in H1 2018 (calendar year). Further details of
the study are available at:
https://clinicaltrials.gov/ct2/show/study/NCT02614742
The Chief Investigator is Mr Diederik Bulters, Consultant
Neurosurgeon and Honorary Senior Clinical Lecturer, at the Wessex
Neurological Centre in Southampton.
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's oral treatment for
multiple sclerosis, BG-12 known as Tecfidera(R) . In April, Biogen
announced first-quarter sales of $946 million for Tecfidera(R) , up
15% from last year. The preclinical study on SFX-01 versus BG12
(Biogen's Tecfidera(R) ) in various animal models of RR-MS
(relapsing remitting multiple sclerosis) has commenced and is due
to report in the latter part of 2016.
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 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 created a
range of novel compounds based upon the sulforaphane core
structure. In the year under review, Evgen Pharma announced that it
had exercised its option to in-license the Seville intellectual
property presenting the Group with more than 60 new chemical
entities based upon sulforaphane. Patent protection for these
compounds is pending in Europe, United States, China, Japan,
Australia, and Canada and is already granted in Spain. This month
saw the initiation of a new collaboration between Evgen Pharma,
University of Seville, the Spanish National Research Council (CSIC)
and the University of Liverpool - the objective being to synthesise
new compounds and screen for activity, with the first results
expected in early 2017.
KEY PERFORMANCE INDICATORS
The Group's Key Performance Indicators include a range of
financial and non-financial measures. Details about the progress of
our development programs (non-financial measures) are included
elsewhere in this Operational 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:
GBP7.1m (2015: GBP0.2m)
Increase in year-end cash, short term investments and cash on
deposit held following equity placings in August and October
2015.
Cash flows (including short term deposits): Net inflow (outflow)
of GBP6.9m (2015: (GBP0.2)m)
Reflecting the successful equity placings in August and October
2015.
Operating loss: GBP2.4m (2015: GBP1.2m)
Reflecting the increased activity since admission to AIM in
October 2015.
PEOPLE
We were delighted to welcome Dr Alan Barge to the Board as a
Non-executive Director at the time of our admission to AIM in
October. Alan, who has worked in a consultancy role with Evgen
Pharma since 2013, is a highly experienced pharmaceutical executive
with particular experience of oncology. He is currently Chief
Medical Officer at Singapore-based ASLAN Pharmaceuticals PTE and a
former Clinical Vice President and Head of Oncology and Infection
at AstraZeneca. Alan was recently appointed the Company's interim
Chief Medical Officer, following the departure of Dr Hamina Patel,
who had been part-time Chief Medical Officer since January
2016.
We would like to take this opportunity to welcome David
Chadwick, who joined recently as our Senior Clinical Study Manager
having previously worked as Senior Clinical Project Manager for
Quintiles.
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, with all programmes on
track and with sufficient capital to complete the two principal
Phase II trials.
The STEM trial is expected to receive a Clinical Trial Approval
in the summer and is anticipated to commence recruitment later in
2016. STEM is expected to report in the first half of 2018 although
interim efficacy readouts are possible with the trial design. The
success of the IPO in 2015 has allowed us to expand the scope of
the STEM trial and it is now going to be a multi-centre study (c.
60 patients) and will look at SFX-01 in combination with three
different endocrine therapies (i.e. three arms to the study).
The SAS trial is also scheduled to report in the first half of
2018 and is expected to have an interim safety read out in late
2016.
We look forward to the future with confidence.
Barry Clare Dr Stephen Franklin
Chairman CEO
27 May 2016 27 May 2016
FINANCIAL REVIEW
The financial performance for the year ended 31 March 2016 was
in line with expectations.
Losses
The total loss for the year was GBP3.1m (31 March 2015: GBP2.3m)
including a charge for share based compensation of GBP0.5m (2015:
GBP0.2m) and a finance charge related to a convertible loan of
GBP0.8m (31 March 2015: GBP1.1m). Non-recurring administrative
expenses are composed of warrant charges (GBP0.3m) and IPO costs
(GBP0.4m) (31 March 2015: aborted IPO costs GBP0.3m).
Share based compensation
As part of the IPO process, a number of share options were
granted to Directors and key personnel. This had no cash impact on
the results for the year, however accounting standards require this
share based compensation to be recognised in the Consolidated
Statement of Comprehensive Income, resulting in a charge of GBP0.5m
(2015: GBP0.2m). In addition, share based compensation of GBP0.3m
(2015 - GBPnil) has been recognised in the Consolidated Statement
of Comprehensive Income in connection with the issue of warrants at
IPO.
Headcount
Average headcount of the Group for the year was 7 (2015: 7).
Taxation
The Group has elected to claim research and development tax
credits under the small or medium enterprise research and
development scheme.
Convertible loans
At the time of the admission to AIM convertible loans of GBP1.8m
were converted to equity.
Share capital
Evgen Pharma plc was incorporated on 2 October 2014 and on that
date 1 ordinary share of GBP2.00 was issued at par.
On 5 December 2014 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 each were allotted and issued to the shareholders
of Evgen Limited.
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 ordinary B share of GBP2.00 each 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 AIM, 18,918,919
ordinary shares of GBP0.0025 were issued at a price of GBP0.37
raising GBP7 million which after share issue 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.
Cash flows and financial position
The cash (including short term deposits) position at 31 March
2016 increased to GBP7.1m (31 March 2015: GBP0.2m), reflecting the
successful completion of an equity fund raising in August 2015
which raised GBP2.0m (GBP1.9m after expenses) and the fact that on
21 October 2015 the Company was admitted to trading on AIM after
raising GBP7m (GBP6.3m after expenses) in an oversubscribed
placing. On admission the convertible loan and associated accrued
interest was converted into ordinary shares of GBP0.0025 each.
Barry Clare Dr Stephen Franklin
Chairman CEO
27 May 2016 27 May 2016
Consolidated Statement of Comprehensive Income
for the year ended 31 March 2016
Unaudited
Year Year
Ended Ended
31 March 31 March
2016 2015
Note GBP'000 GBP'000
------------------------------ ----- --------- ----------
Operating expenses
Operating expenses (1,232) (796)
Share based compensation (519) (155)
Non-recurring administrative
expenses (683) (295)
Total operating expenses (2,434) (1,246)
------------------------------ ----- --------- ----------
Operating loss (2,434) (1,246)
Finance income 8 -
Finance expense (791) (1,057)
Loss on ordinary activities
before taxation (3,217) (2,303)
Taxation 85 30
------------------------------ ----- --------- ----------
Loss and total comprehensive
expense attributable (3,132) (2,273)
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 (6.29) (7.79)
Diluted loss per share 5 (6.29) (7.79)
------------------------------ ----- --------- ----------
Consolidated Statement of Financial Position
as at 31 March 2016
Unaudited
As at As at
31 March 31 March
2016 2015
Note GBP'000 GBP'000
------------------------------- ----- --------- ---------
ASSETS
Non-current assets
Property, plant and
equipment 6 1
Intangible assets 74 45
Total non-current assets 80 46
Current assets
Trade and other receivables 79 117
Current tax receivable 115 30
Short-term investments 2,006 -
and cash on deposit
Cash and cash equivalents 5,120 163
Total current assets 7,320 310
Total assets 7,400 356
------------------------------- ----- --------- ---------
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables 313 477
Loans - 3
Total current liabilities 313 480
Non-current liabilities
Loans - 1,063
Total non-current liabilities - 1,063
Equity
Ordinary shares 6 183 73
Share premium 6 10,495 -
Merger reserve 2,067 2,067
Shares to be issued - 1,750
Share based compensation 1,267 466
Retained deficit (6,925) (5,543)
------------------------------- ----- --------- ---------
Total equity attributable
to equity holders of
the parent 7,087 (1,187)
Total liabilities and
equity 7,400 356
------------------------------- ----- --------- ---------
Consolidated Statement of Changes in Equity
for the year ended 31 March 2016
Attributable to ordinary shareholders
Shares Share
Ordinary Share Merger to based Retained
be deficit
shares premium Reserve issued compensation Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Balance
at 31 March
2014 73 - 2,067 1,000 311 (3,270) 181
Total comprehensive
expense - - - - - (2,273) (2,273)
for the
period
Transactions
with owners
Equity element
of loan
note - - - 750 - - 750
Share based
compensation
- share
options - - - - 155 - 155
Total transactions
with owners - - - 750 155 (2,273) (1,368)
--------------------- --------- -------- -------- -------- ------------- --------- --------
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
--------------------- --------- -------- -------- -------- ------------- --------- --------
Consolidated Statements of Cash Flows
for the year ended 31 March 2016
Unaudited
Year Year
Ended Ended
31 March 31 March
2016 2015
GBP'000 GBP'000
------------------------------------ --------- ---------
Cash flows from operating
activities
Loss for the period (3,217) (2,303)
Finance expense 791 1,057
Depreciation and amortisation 8 7
Share based compensation 801 155
(1,617) (1,084)
Changes in working capital
Increase in trade and other
receivables (47) (20)
Increase in trade and other
payables 104 101
------------------------------------ --------- ---------
Cash used in operations 57 81
Taxation received - 103
------------------------------------ --------- ---------
Net cash used in operating
activities (1,560) (900)
Cash flows from investing
activities
Acquisition of intangible (36) -
assets
Purchase of property, plant
and equipment (6) (1)
Short-term investments and (2,006) -
cash on deposit
Net cash (used in)/generated
from investing activities (2,048) (1)
Cash flows from financing
activities
Proceeds from issue of shares 9,014 -
Issue costs (449) -
------------------------------------ --------- ---------
Proceeds from issue of convertible
loan notes - 750
------------------------------------ --------- ---------
Net cash generated from
financing activities 8,565 750
Movements in cash and cash
equivalents in the period 4,957 (151)
------------------------------------ --------- ---------
Cash and cash equivalents
at start of period 163 314
------------------------------------ --------- ---------
Cash and cash equivalents
at end of period 5,120 163
------------------------------------ --------- ---------
1. General information
EVGEN PHARMA PLC ('Evgen' or 'the Company') is a public limited
company incorporated 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 2016
has been extracted from the Group's audited financial statements
which were approved by the Board of Directors on 31 May 2016 and
which, if adopted by the members at the Annual General Meeting,
will be delivered to the Registrar of Companies for England and
Wales.
Unaudited statutory accounts for Evgen Limited for the year
ended 31 March 2015, prepared under UK GAAP, were approved by the
Board on 28 June 2015 and delivered to the Registrar of
Companies.
The report of the auditor on the 31 March 2016 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 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
2016 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 27 May 2016.
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 approval of
this financial information. 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.
On the basis of the above projections, the Directors are
confident that the Group has sufficient working capital to honour
all of its obligations to creditors as and when they fall due. Thus
they have adopted the going concern basis of accounting in
preparing the financial information.
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 2016 and 31 March 2015, the Group has 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:
Unaudited
Year Year
Ended Ended
31 March 31 March
2016 2015
GBP'000 GBP'000
----------------------------------------------- -------------- ---------------
Loss for the year attributable to equity
holders for basic loss and adjusted for
the effects of dilution (3,132) (2,273)
----------------------------------------------- -------------- ---------------
As at As at
31 March 31 March
2016 2015
Number Number
------------------------------------------------- ---------------- ----------------
Weighted average number of ordinary shares
for basis loss per share 49,797,654 29,169,600
Effects of dilution:
Share options - -
Weighted average number of ordinary shares
adjusted for the effects of dilution 49,797,654 29,169,600
------------------------------------------------- ---------------- ----------------
Year Year
Ended Ended
31 March 31 March
2016 2015
Pence Pence
----------------------------------------- -------------- --------------
Loss per share - basic and diluted (6.29) (7.79)
----------------------------------------- -------------- --------------
The loss and the weighted average number of ordinary shares for
the years ended 31 March 2015 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. The number of shares included in
the comparative figures for 2015 has been adjusted to take into
account the share restructuring performed in the year ended 31
March 2016.
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
-------------------------------- ----------- -------------
On 2 October 2014 the Company was incorporated with one ordinary
share of GBP2.00 was 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 ordinary B share of GBP2:00 each 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.
The Group and Company does 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 2016, the Group purchased
consultancy services totalling GBP46,750 (Year ended 31 March 2015:
GBP13,500) 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 2016 was GBPnil (31 March 2015: GBPnil).
During the year ended 31 March 2016, the Group purchased
consultancy and accounting services totalling GBP50,840 (Year ended
31 March 2015: GBP13,000) from Bradshaw Daniel Limited, a company
controlled by John Bradshaw, a director. The amount owed to
Bradshaw Daniel Limited at 31 March 2016 was GBP2,556 (31 March
2015: GBP1,217).
During the year ended 31 March 2016, the Group was charged
monitoring and director fees totalling GBP20,104 (Year ended 31
March 2015: GBP21,000) from 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 2016
was GBPnil (31 March 2015: GBPnil).
During the year ended 31 March 2016, the Group was charged
monitoring and director fees totalling GBP21,451 (Year ended 31
March 2015: GBP21,000) from 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 2016 was GBPnil (31 March 2015: GBPnil).
8. Report and accounts
A copy of the Annual Report and Accounts will be sent to all
shareholders with notice of the Annual General Meeting shortly 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 EAESEDDXKEAF
(END) Dow Jones Newswires
May 31, 2016 02:01 ET (06:01 GMT)
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