TIDMEVG
RNS Number : 0465X
Evgen Pharma PLC
17 December 2019
Evgen Pharma plc
("Evgen" or "the Company" or "the Group")
Half year Report
Evgen Pharma plc (AIM: EVG), the clinical stage drug development
company developing sulforaphane based medicines for the treatment
of multiple diseases, announces its unaudited interim results for
the six months ended 30 September 2019.
Operational highlights
-- Positive results from the STEM trial of SFX-01 in metastatic
breast cancer presented at European Society of Medical Oncology
Congress in Barcelona, demonstrating the stabilisation of
previously progressive disease and objective responses in some
patients
-- Five patients who participated in the STEM trial received
SFX-01 treatment for over one year with no tumour progression
-- Results from the SFX-01 After Subarachnoid Haemorrhage
("SAS") trial did not meet primary or secondary efficacy endpoints,
however the treatment was well tolerated with no safety
concerns
-- Agreements in principle reached with Guy's and St Thomas' NHS
Foundation Trust and University of Dundee to support clinical
trials of SFX-01 in autism and non-alcoholic steatohepatitis
("NASH") respectively
-- Research collaboration with King's College London and the
British Heart Foundation to investigate how SFX-01 mediates
upregulation of Nrf2 in the blood-brain barrier endothelium
in-vivo
Financial highlights
-- Financial performance in-line with expectations:
o Total comprehensive loss of GBP1.6m (2018: loss of
GBP1.8m)
o Cash outflow from operations of GBP1.7m (2018: outflow of
GBP1.5m)
o Cash balance at 30 September 2019 of GBP5.1m (30 September
2018: GBP2.2m)
-- Oversubscribed fundraising in April 2019 raised GBP5.0m before expenses
Stephen Franklin, Chief Executive Officer of Evgen Pharma, said:
"We have now completed two Phase II trials on SFX-01, in different
conditions and with quite separate mechanistic hypotheses. Our
selections of metastatic breast cancer ("mBC") and Subarachnoid
Haemorrhage ("SAH") were based on strong preclinical data sets. The
mBC clinical result was positive, demonstrating the stabilisation
of previously progressive disease in 24% of patients and objective
responses in some others. We were surprised that the SAH trial did
not similarly follow the preclinical data, albeit this is a
particularly challenging indication. However, the scientific
evidence for sulforaphane and SFX-01 as a potent Nrf2 activator is
compelling, and the clinical belief in Nrf2 activation as a
therapeutic strategy is affirmed by the endorsement of our clinical
investigator partners, who wish to test SFX-01 in various diseases
where Nrf2 activation is important. We therefore remain committed
to the on-going clinical development of SFX-01 both in breast
cancer, and in supporting trials in a range of other diseases which
may benefit from Nrf2 up-regulation".
"We therefore move forward with the confidence that clinical
success will ultimately prevail and we will, at that point, see a
major ground shift in the Company's valuation. Between now and that
point we will focus on delivering our development plan; the
fundamentals that are needed to underpin sustainable share price
growth and ultimately deliver the undoubted potential of
SFX-01".
"We will be arranging to meet institutional and retail investors
in early 2020 and look forward to this opportunity to discuss our
strategy for the next stage in our development."
Enquiries:
Evgen Pharma plc www.evgen.com via Walbrook
Dr Stephen Franklin, CEO
Richard Moulson, CFO
finnCap www.finncap.com +44 (0) 20 7220 0500
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane, Manasa Patil (ECM)
WG Partners LLP +44 (0) 20 3705 9330
Nigel Barnes / Claes SpÄng
Walbrook PR +44 (0)20 7933 87870 or evgen@walbrookpr.com
+44 (0)7980 541 893 / +44 (0)7876
Paul McManus / Anna Dunphy 741 001
About Evgen Pharma plc
Evgen Pharma is a clinical stage company developing sulforaphane
based medicines for the treatment of multiple diseases The
Company's core technology is Sulforadex(R), a method for
synthesising and stabilising the naturally occurring compound
sulforaphane and novel proprietary analogues based on sulforaphane.
The lead product, SFX-01, is a patented composition of synthetic
sulforaphane and alpha-cyclodextrin.
The Company 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. Our lead
product, SFX-01, has demonstrated efficacy in a Phase II trial for
advanced metastatic breast cancer. It has been used to treat over
150 patients in clinical trials and is well-tolerated with
predominately mild side-effects.
Evgen shares are traded on the AIM market of the London Stock
under the ticker symbol EVG.
For further information, please visit: www.evgen.com
CHAIRMAN'S AND CHIEF EXECUTIVE'S STATEMENT
We are pleased to present the financial results of Evgen for the
six months ended 30 September 2019 and to provide an update on the
progress made by the Group during the period.
INTRODUCTION
Evgen is a clinical stage drug development company focussed on
the development of sulforaphane-based compounds, a new class of
pharmaceuticals which are synthesised in a proprietary,
well-tolerated, stable formulation. We have a comprehensive
intellectual property package over this technology. Our pipeline
exploits sulforaphane's activity in two separate biochemical
pathways; inhibition of pSTAT3, of importance in controlling cancer
metastases, and up-regulation of Nrf2, a therapeutic target
associated with a broad range of diseases which are characterised
by excessive oxidative stress and inflammation.
Our lead product, SFX-01, has demonstrated efficacy in a Phase
II trial for advanced metastatic breast cancer. It has been used to
treat over 150 patients in clinical trials and is well-tolerated
with predominantly mild side-effects.
CLINICAL TRIAL RESULTS AND STRATEGY REVIEW
Our aim on going public was to complete two Phase II trials on
SFX-01 in different conditions with quite separate mechanistic
hypotheses; the objective being to manage the risk profile
typically associated with Phase II trials and demonstrate efficacy
in at least one indication. To this end, we have had a success with
the STEM trial, with SFX-01 being tested in 46 patients that had
become resistant to all currently approved hormone therapies. In
this difficult to treat population, SFX-01 halted the progressive
disease for at least six months in 25% of patients, with at least
two patients showing demonstrable tumour shrinkage. Furthermore,
five patients went on to have their progressive disease halted for
at least a year, and one patient continues to receive SFX-01
treatment after over 18 months. Given that the ultimate aim is to
target patients earlier in the disease pathway (i.e. prior to them
being resistant to all approved hormone therapies), we believe that
the results from STEM bode well for the probability of success of a
randomised, double blind follow-on trial. The details of that trial
design and associated costings will be finalised in Q1 2020, when
we will escalate the activity associated with securing non-dilutive
funding to pay for all, or substantially all, of a follow-on
trial.
We were surprised that the strong preclinical data for SFX-01 in
SAH was not reflected in the SAS trial. Whilst we recognised that
trials in stroke are challenging, we were nevertheless confident of
observing some favourable effects given the strength of the
preclinical data. The study met our expectations with regard to
safety and tolerability, but missed the other key primary endpoint
associated with the modulation of blood flow in the middle cerebral
artery; this blood flow being a means of measuring the onset of
vasospasm that leads to the Delayed Cerebral Ischaemia ("DCI").
Several cognitive measures constituted secondary endpoints, and,
whilst the study was not powered to demonstrate statistical
efficacy for these endpoints, we had expected to see a favourable
trend across the different questionnaire-based tests that ascertain
the extent of any cognitive deficit.
Further analysis of the SAS data and samples continues,
including a transcriptomic analysis of genes that may have been up
or down-regulated following SFX-01 treatment. This may be
insightful and valuable for future trials in a number of disease
areas.
Importantly, we have concluded that the SAS results are likely
to be specific to that condition and because animal models for SAH
can translate poorly to SAH in patients. In addition our dosing
regime, restricted to a maximum of 28 days, may have been too short
to impact cognitive measures at three and six months. There remains
a strong rationale for clinically testing SFX-01 in any condition
that is mechanistically linked to Nrf2, as evidenced by the recent
positive developments at Reata (NASDAQ: RETA). Reata, who have also
suffered clinical trial setbacks, are developing Nrf2 activators
based on triterpenoids and recent top-line results in pivotal
trials in Friedriech's Ataxia and Alport Syndrome have seen their
share price soar in the last two months with a current market
capitalisation of over US$6bn. This illustrates that the
fundamentals of Nrf2 activation as a therapeutic strategy are sound
and SFX-01 is a potent and well tolerated Nrf2 activator; on this
basis we advance with the same confidence in SFX-01 and believe
that the main driver to ultimate success is perseverance.
Given the funding constraints suffered by small cap drug
development companies in the UK, our strategy is to move to a
business model where we facilitate multiple clinical trials on
SFX-01 in risk-sharing arrangements, with the objective of
attracting non-dilutive funding from grants and/or charities to
wholly or substantially fund future clinical activity. This
strategy has two discrete parts:
(1) Our first priority is to ensure the continued development of
the breast cancer programme. We will design and cost a clinical
trial protocol and then seek non-dilutive funding for Evgen and/or
an affiliated clinical institution to sponsor the trial
(2) In parallel we aim to leverage the extensive pre-clinical
and clinical data that shows the potential for SFX-01, as a
sulforaphane delivery platform, to be used in diseases that are
beyond our capacity to pursue
We will therefore support a number of Investigator-Initiated
Trials - these are trials led by a clinician from a well renowned
institution, with that institution being the sponsor for the trial.
We have announced two of these (in NASH and autism) and are in
discussions for others. Evgen will provide support as required (in
the confines of an investigator sponsored study), sharing our
knowledge, experience and the methods and laboratories used for
pharmacodynamic and pharmacokinetic endpoints.
Evgen will have the right to access the clinical data on fair
commercial terms to advance its clinical and commercial
development. The principal funding for these trials will be
obtained by the investigator/institution and therefore
non-dilutive.
Finally, we are now in a period where we are using funds from
the last investment round to complete the technical package
required to support this strategy. This involves investment in
Chemistry, Manufacturing and Controls ("CMC") in developing a
tablet formulation for world-wide distribution to multiple clinical
centres, and investment in the toxicology package to be able to
support trials of longer dosing duration (i.e. over 28 days). By
the time this CMC investment period is complete, we could initiate
a portfolio of clinical trials such as those described above.
We believe this strategy offers the best route to enhance
shareholder value and the opportunity for all stakeholders to
benefit from the undoubted potential of SFX-01.
CLINICAL PROGRAMMES
Metastatic 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 has been the principal approach to 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 marketed therapies, in deactivating
phosphorylated STAT3, a key agent in driving cancer metastases and
resistance to current standards of care.
In March 2019, we announced positive results from the
open--label Phase II trial of SFX--01 in 46 patients with
oestrogen--positive metastatic breast cancer. In particular we
demonstrated:
-- Conclusive evidence of anti--cancer activity via objective responses (tumour shrinkage)
-- 24% of patients showed a durable clinical benefit for at
least six months, despite the late stage of disease and patients'
established resistance to hormone therapy. Of these, five patients
were still receiving SFX-01 at 12 months and one patient still
remains on treatment after 18 months
-- A mild and favourable side effect profile for an anti--cancer drug.
All STEM patients had ER+ metastatic breast cancer and had
previously received 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 continued to
receive their failing hormone therapy in addition to SFX-01 and
have regular scans through to week 24. Patients discontinued the
trial when one of the scans shows disease progression, or at week
24. Those patients who did not progress by week 24 were allowed to
continue to receive treatment in an extension phase until disease
progression.
In due course, we will be embarking on a campaign to source
non-dilutive funds for a follow-on placebo-controlled randomised
trial in ER+ metastatic breast cancer, to generate the data that
would maximise the likelihood of a corporate
partnership/out-licensing deal. Such funding may be sourced from
direct grants, cancer charities or possibly via investigator-led
trials.
Based upon consultation with our clinicians and KOLs, our
preferred market positioning of SFX-01 is in combination with
hormone therapy following progression on CDK4/6 inhibitors.
Resistance to CDK4/6i (which will ultimately manifest in all
patients) will become the new challenge that needs to be
addressed.
Key activities through 2020 that will facilitate the next mBC
clinical trial are:
-- Ensuring our preclinical data package is sufficient and
robust to support the study design
-- Finalising the Clinical Trial Protocol synopsis and
establishing full costings
-- Using the funds we raised last April to:
- Finalise the development of the new tablet formulation for mBC
study and also investigator-led trials in new indications
- Expand the toxicology package to enable longer-term dosing in investigator-led trials
-- Securing non-dilutive funding to fund part, or all, of the
mBC study.
Autism spectrum disorder ("ASD")
There has been continuing academic interest in the benefits that
sulforaphane may provide in patients with ASD. Encouraging clinical
data was seen in a small investigator-led placebo-controlled trial
of juvenile patients in the US using sulforaphane derived from
botanical sources and stored at -20(o) C. Notwithstanding the
strength of the data there is no opportunity to move this programme
through to a regulated ASD drug using the botanical source. There
are now six investigator-led trials in autism registered on
Clintrials.org using similar botanical preparations.
In September 2019, we signed a Memorandum of Understanding with
Guy's and St Thomas' NHS Foundation Trust ("Guy's and St Thomas'")
to provide SFX-01 for a potential large Phase II clinical trial in
ASD patients.
Under the terms of the agreement, Evgen has agreed to supply
SFX-01 and placebo to support a potential future trial to be
sponsored by Guy's and St Thomas' and led by Dr Michael Absoud,
Consultant in paediatric neurodisability at the Evelina London
Children's Hospital ("Evelina"), which is part of Guy's and St
Thomas'. The Trust have agreed to lead the process to secure grant
funding and gain clinical trial approval for a randomised, double
blind, Phase II clinical trial. Evgen will retain the option to
acquire, on fair commercial terms, the clinical data to enable
subsequent development, regulatory approval and commercialisation
of SFX-01 in ASD.
There are currently no approved medicines for treating the three
core symptoms of autism - communication difficulties, social
challenges and repetitive behaviour - which have long represented a
huge area of unmet clinical need for affected families.
Based on its novel mode-of-action, SFX-01 has the potential to
become a first-in-class treatment for the core symptoms of ASD,
disrupting the current GBP3bn ASD market (which includes the use of
anti-depressants and anti-psychotics for the treatment of non-core
symptoms), making a significant impact on the enormous economic
burden to the UK.
Non-alcoholic steatohepatitis ("NASH")
Earlier in the month, we announced that we have also signed a
Memorandum of Understanding with the University of Dundee to supply
SFX-01 for a potential future clinical trial in NASH, led by John
Dillon, Professor of Hepatology and Gastroenterology in the
University's School of Medicine.
With the assistance of Evgen, Professor Dillon will lead the
process to secure appropriate grant funding and obtain clinical
trial regulatory approval. The intention is to utilise advanced MRI
scanning technology to investigate whether SFX-01 can reverse the
hallmarks of NASH in a proof-of-concept clinical trial. Clinical
data arising from a successful trial will support subsequent
development of SFX-01 in NASH and liver fibrosis. Evgen will be
granted an option to acquire the clinical data on fair commercial
terms to enable it to advance development and
commercialisation.
Non-alcoholic fatty liver disease ("NAFLD") is now regarded as
the most common liver condition in the developed world, affecting
up to 30% of the general population. NAFLD represents a spectrum of
phenotypes ranging from simple steatosis (fatty infiltration),
through NASH to cirrhosis. Approximately 30% of adults in the
general population have NAFLD, and 10%-20% of these have NASH.
Amongst patients with NASH, 20-30% are at risk of developing
cirrhosis and subsequently dying from end-stage liver disease
within 20 years. In view of the tens of thousands of individuals
who are likely to develop NASH in the next decade, this disease
will represent a major burden to healthcare in the UK.
Professor John Dillon and colleagues have previously published
research that showed that drug-induced activation of the Nrf2
pathway could reverse insulin resistance, suppress hepatic
steatosis, and mitigated against NASH and liver fibrosis. On this
basis, Professor John Dillon approached Evgen, the developer of
SFX-01, a development stage drug that is known to activate the Nrf2
pathway and has demonstrated excellent safety and tolerability in
previous clinical trials.
Subarachnoid haemorrhage ("SAH")
In November we announced results from our trial of SFX-01 in
SAH. Unfortunately the primary endpoint of reducing blood flow
velocity in the middle cerebral artery was not achieved, with no
significant difference between the SFX-01 and placebo arms.
Furthermore, whilst the secondary endpoints were not statistically
powered, there were no consistent differences seen between SFX-01
and placebo in key cognition, quality of life and clinical outcomes
at three and six months. This was surprising given the strong
preclinical data for sulforaphane in animal models of SAH and other
forms of stroke.
SFX-01 was however shown to be well-tolerated with no safety
concerns.
In the multi-centre, randomised, double-blind,
placebo-controlled SAS Phase II clinical trial, patients were dosed
for a maximum of 28 days following a SAH, covering the period at
which they are at risk of a DCI. Patients were then monitored for a
further five months to assess their recovery by collecting
endpoints including cognitive measurements.
After an extensive post-mortem with our clinical advisors, we
have concluded that the results of the SAS trial cannot be used to
discount the viability of a trial in any other indication linked to
the Nrf2 pathway; including those of the central nervous system.
SAH is a traumatic and serious condition and the likelihood is that
the animal models that are used to best mimic a SAH are poorly
prognostic of the clinical condition. What we do know is that Nrf2
pathway remains an attractive target for therapeutic intervention
in many diseases characterised by oxidative stress and
inflammation, and that SFX-01 is a potent activator of the Nrf2
pathway with a relatively benign safety profile. On this basis,
there is no sound rationale for believing the SAS trial read-out is
of any relevance to any other indication.
NON-CLINICAL PROGRAMMES
Following the oversubscribed placing completed in April, we are
making good progress with the activities set out in the use of
funds statement relating to the fundraising.
Specifically, we have contracted with a large CRO to start the
extended toxicology programme that is needed to support a broader
diversity of clinical trial designs - including being able to dose
for greater than 28 days in patients that do not have a terminal
disease. The pilot work has started and the full programme will
start in early 2020 and conclude later in the year.
With regard to the formulation work to develop a new tablet -
required to scale manufacturing and support multiple trials - we
have also contracted with a large and well-established Contract,
Development and Manufacturing Organisation to initiate that
work.
INTELLECTUAL PROPERTY UPDATE
In August 2019 we announced the grant of further intellectual
property rights in Europe pertaining to the novel composition,
SFX-01.
The newly granted patent leads with a product claim covering "a
composition comprising a complex of sulforaphane and
alpha-cyclodextrin". Composition-of-matter patents have already
been granted in the USA and other territories. Furthermore, patents
in Europe, the US and other territories relating to the method of
production have also been granted.
Furthermore, our non-clinical programmes are leading to
potentially new composition of matter patents that if filed and
granted, would extend our patented product life substantially.
FINANCIAL REVIEW
The financial performance for the six-month period to 30
September 2019 was in line with expectations. The total
comprehensive loss for the period was GBP1.6m (30 September 2018:
GBP1.8m). The net cash inflow for the period was GBP3.0m (30
September 2018: outflow of GBP1.5m).
The cash position at 30 September 2018 stood at GBP5.1m (30
September 2018: GBP2.2m), reflecting the April 2019 fundraise of
GBP5.0m before expenses. Since the period end the Group has
received GBP328k in cash from R&D tax credits.
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 third quarter of calendar year 2021.
They have therefore prepared the financial statements on a going
concern basis.
OUTLOOK
Our focus in the year to date has been on completing the two
ongoing trials and refining the next stages of clinical
development. We have also been working with academic clinicians to
support investigator-initiated trials in non-core indications which
would broaden the clinical use of SFX-01 and reduce shareholder
risk.
We would like to thank all our shareholders for their support
and look forward to progressing with our strategy which remains
clearly focused on commercialising the undoubted potential of
SFX-01.
Barry Clare Stephen Franklin
Chairman CEO
16 December 2019
Consolidated Statement of Comprehensive Income
for the six months ended 30 September 2019 - unaudited
Six months Six months Year ended
ended ended 31 March
30 September 30 September 2019
2019 2018
GBP'000 GBP'000 GBP'000
Notes unaudited unaudited audited
-------------------------------------- ------ -------------- -------------- -----------
Operating expenses
Operating expenses (1,526) (1,727) (2,985)
Share-based compensation 4 (84) (60) (135)
Total operating expenses (1,610) (1,787) (3,120)
Operating loss (1,610) (1,787) (3,120)
Loss on ordinary activities before
taxation (1,610) (1,787) (3,120)
Taxation 5 - 496
-------------------------------------- ------ -------------- -------------- -----------
Loss and total comprehensive expense
attributable to equity holders for
the period (1,605) (1,787) (2,624)
-------------------------------------- ------ -------------- -------------- -----------
Loss earnings per share (pence)
-------------------------------------- ------ -------------- -------------- -----------
Basic loss per share 3 (1.43) (1.91) (2.74)
Diluted loss per share 3 (1.43) (1.91) (2.74)
-------------------------------------- ------ -------------- -------------- -----------
Consolidated Statement of Financial Position
as at 30 September 2019 - unaudited
As at As at As at 31
30 September 30 September March
2019 2018 2019
GBP'000 GBP'000 GBP'000
Notes unaudited unaudited audited
------------------------------- ------ -------------- -------------- ---------
ASSETS
Non-current assets
Property, plant and equipment 3 10 6
Intangible assets 89 105 98
-------------------------------- ------ -------------- -------------- ---------
Total non-current assets 92 115 104
Current assets
Trade and other receivables 113 126 135
Current tax receivable 328 432 492
Cash and cash equivalents 5,050 2,158 2,033
-------------------------------- ------ -------------- -------------- ---------
Total current assets 5,491 2,716 2,660
Total assets 5,583 2,831 2,764
-------------------------------- ------ -------------- -------------- ---------
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables 353 682 688
Total current liabilities 353 682 688
Equity
Share capital 5 331 233 247
Share premium 17,831 12,565 13,240
Merger reserve 2,067 2,067 2,067
Share based compensation 1,806 1,647 1,722
Accumulated losses (16,805) (14,363) (15,200)
-------------------------------- ------ -------------- -------------- ---------
Total equity 5,230 2,149 2,076
Total liabilities and equity 5,583 2,831 2,764
-------------------------------- ------ -------------- -------------- ---------
Consolidated Statement of Changes in Equity
for the six months ended 30 September 2019 - unaudited
Share Share Merger Share based Accumulated
capital premium reserve compensation losses Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Balance at 1 April 2019 247 13,240 2,067 1,722 (15,200) 2,076
Total comprehensive
expense for the period - - - - (1,605) (1,605)
Transactions with owners
Share issues 84 4,919 - - - 5,003
Share issue - costs (328) (328)
Share-based compensation
- share options - - - 84 - 84
Total transactions with
owners 84 4,591 - 84 - 4,759
-------------------------- --------- --------- --------- -------------- ------------ --------
Balance at 30 September
2019 331 17,831 2,067 1,806 (16,805) 5,230
-------------------------- --------- --------- --------- -------------- ------------ --------
Share Share Merger Share based Accumulated
capital premium reserve compensation losses Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Balance at 1 April 2018 233 12,560 2,067 1,587 (12,576) 3,871
Total comprehensive
expense for the period - - - - (1,787) (1,787)
Transactions with owners
Share issue - 5 - - - 5
Share-based compensation
- share options - - - 60 - 60
Total transactions with
owners - 5 - 60 - 65
-------------------------- --------- --------- --------- -------------- ------------ --------
Balance at 30 September
2018 233 12,565 2,067 1,647 (14,363) 2,149
-------------------------- --------- --------- --------- -------------- ------------ --------
Share Share Merger Share based Accumulated
capital premium reserve compensation losses Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Balance at 1 April 2018 233 12,560 2,067 1,587 (12,576) 3,871
Total comprehensive
expense for the period - - - - (2,624) (2,624)
Transactions with owners
Share issue - cash 14 668 - - - 682
Share issue - options
exercised - 12 - - - 12
Share-based compensation
- share options - - - 135 - 135
Total transactions with
owners 14 680 - 135 - 829
-------------------------- --------- --------- --------- -------------- ------------ --------
Balance at 31 March
2019 247 13,240 2,067 1,722 (15,200) 2,076
-------------------------- --------- --------- --------- -------------- ------------ --------
The registered number of Evgen Pharma plc is 09246681.
Consolidated Statement of Cash Flows
for the six months ended 30 September 2019 - unaudited
Six months Six months Year ended
ended ended 31 March
30 September 30 September 2019
2019 2018
GBP'000 GBP'000 GBP'000
unaudited unaudited audited
---------------------------------------- -------------- -------------- -----------
Cash flows from operating activities
Loss before taxation for the period (1,610) (1,787) (3,120)
Depreciation and amortisation 12 11 21
Share-based compensation 84 60 135
----------------------------------------- -------------- -------------- -----------
(1,514) (1,716) (2,964)
Changes in working capital
Decrease/(increase) in trade and
other receivables 22 (49) (58)
(Decrease)/increase in trade and
other payables (335) 292 299
----------------------------------------- -------------- -------------- -----------
Cash used in operations (313) 243 241
Taxation received 169 - 436
----------------------------------------- -------------- -------------- -----------
Net cash used in operating activities (1,658) (1,473) (2,287)
----------------------------------------- -------------- -------------- -----------
Cash flows from investing activities
Purchase of property, plant and - - -
equipment
Net cash used in investing activities - - -
---------------------------------------- -------------- -------------- -----------
Cash flows from financing activities
Net proceeds from issue of shares 4,675 5 694
Net cash generated from financing
activities 4,675 5 694
Movements in cash and cash equivalents
in the period 3,017 (1,468) (1,593)
----------------------------------------- -------------- -------------- -----------
Cash and cash equivalents at start
of period 2,033 3,626 3,626
----------------------------------------- -------------- -------------- -----------
Cash and cash equivalents at end
of period 5,050 2,158 2,033
----------------------------------------- -------------- -------------- -----------
1. GENERAL INFORMATION
EVGEN PHARMA PLC ("Evgen", "the Group" 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 Group is clinical stage drug
development.
2. BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES
Basis of preparation
The Group's half-yearly financial information, which is
unaudited, consolidates the results of Evgen Pharma plc and its
subsidiary undertaking up to 30 September 2019. The Group's
accounting reference date is 31 March. Evgen Pharma plc's shares
are quoted on the AIM Market of the London Stock Exchange
(AIM).
The Company is a public limited liability company incorporated
and domiciled in the UK. The consolidated financial information is
presented in round thousands of Pounds Sterling (GBP'000).
The financial information contained in this half-yearly
financial report does not constitute statutory accounts as defined
in section 434 of the Companies Act 2006. It does not therefore
include all of the information and disclosures required in the
annual financial statements. The financial information for the six
months ended 30 September 2018 and 30 September 2019 is
unaudited.
Full audited financial statements of the Group in respect of the
period ended 31 March 2019, which received an unqualified audit
opinion and did not contain a statement under section 498(2) or (3)
of the Companies Act 2006, have been delivered to the Registrar of
Companies.
The accounting policies used in the preparation of the financial
information for the six months ended 30 September 2019 are in
accordance with the recognition and measurement criteria of
International Financial Reporting Standards as adopted by the
European Union ('IFRS') and are consistent with those which will be
adopted in the annual financial statements for the year ending 31
March 2020.
IFRS 16 is not expected to have a material effect on the Group's
figures since there are no material leases of over 12 months.
Whilst the financial information included has been prepared in
accordance with the recognition and measurement criteria of IFRS,
the financial information does not contain sufficient information
to comply with IFRS.
The Group has not applied IAS 34, Interim Financial Reporting,
which is not mandatory for UK AIM listed Groups, in the preparation
of this interim financial report.
Going concern
At 30 September 2019, the Group had cash and cash equivalents,
including short-term investments and cash on deposit, of GBP5.1
million.
The Directors have prepared detailed financial forecasts and
cash flows looking beyond 12 months from the date of the approval
of these financial statements. In developing these forecasts, the
Directors have made assumptions based upon their view of the
current and future economic conditions that will prevail over the
forecast period.
The Directors estimate that the cash held by the Group together
with known receivables will be sufficient to support the current
level of activities into the third quarter of calendar year 2021.
They have therefore prepared the financial statements on a going
concern basis.
Significant management judgement in applying accounting policies
and estimation uncertainty
When preparing the condensed consolidated interim financial
information, the Directors make a number of judgements, estimates
and assumptions about the recognition and measurement of assets,
liabilities, income and expenses.
The following are significant management judgements and
estimates in applying the accounting policies of the Group that
have the most significant effect on the condensed consolidated
interim financial information. Actual results may be substantially
different.
Share-based payments
The Group measures the cost of equity-settled transactions with
employees by reference to the fair value of the equity instruments
at the date at which they are granted. The fair value of the
options granted is determined using the Black-Scholes model, taking
into consideration the best estimate of the expected life of the
option and the estimated number of shares that will eventually
vest.
Research and development expenditure
All research and development costs, whether funded by third
parties under licence and development agreements or not, are
included within operating expenses and classified as such. Research
and development costs relating to clinical trials are recognised
over the period of the clinical trial based on information provided
by clinical research organisations. All other expenditure on
research and development is recognised as the work is
completed.
All ongoing development expenditure is currently expensed in the
period in which it is incurred. Due to the regulatory and other
uncertainties inherent in the development of the Group's
programmes, the criteria for development costs to be recognised as
an asset, as prescribed by IAS 38, 'Intangible assets', are not met
until the product has been submitted for regulatory approval, such
approval has been received and it is probable that future economic
benefits will flow to the Group. The Group does not currently have
any such internal development costs that qualify for capitalisation
as intangible assets.
3. LOSS PER SHARE
Basic loss per share is calculated by dividing the loss for the
period attributable to equity holders by the weighted average
number of ordinary shares outstanding during the period.
For diluted loss per share, the loss for the period attributable
to equity holders and the weighted average number of ordinary
shares outstanding during the period is adjusted to assume
conversion of all dilutive potential ordinary shares. As the effect
of the share options would be to reduce the loss per share, the
diluted loss per share is the same as the basic loss per share.
The calculation of the Group's basic and diluted loss per share
is based on the following data:
Six months Six months
ended ended Year ended
30 September 30 September 31 March
2019 2018 2019
GBP'000 GBP'000 GBP'000
unaudited unaudited audited
------------------------------------- --------------- --------------- -----------
Loss for the period attributable
to equity holders (1,605) (1,787) (2,624)
------------------------------------- --------------- --------------- -----------
As at As at As at
30 September 30 September 31 March
2019 2018 2019
Number Number Number
unaudited unaudited audited
------------------------------------- --------------- --------------- -----------
Weighted average number of ordinary
shares 112,307,585 93,313,143 95,857,230
Weighted average number of ordinary
shares adjusted for the effects of
dilution 112,307,585 93,313,143 95,857,230
------------------------------------- --------------- --------------- -----------
Pence Pence Pence
Loss per share - basic and diluted (1.43) (1.91) (2.74)
------------------------------------- --------------- --------------- -----------
4. SHARE-BASED PAYMENTS
As at the end of the current period, the reconciliation of share
option scheme movements is as follows:
As at 30 September
2019
Number WAEP
----------------------------------- ---------- ----------
Outstanding at 1 April 2019 9,075,599 GBP0.02
Granted during the period 1,104,861 -
Exercised during the period (321,600) (GBP0.01)
Lapsed/cancelled during the period - -
----------------------------------- ---------- ----------
Outstanding at 30 September 2019 9,858,860 GBP0.02
----------------------------------- ---------- ----------
During the six month period ended 30 September 2019, a
share-based payment charge of GBP84,052 (six months to 30 September
2018: GBP60,374) was expensed to the consolidated Statement of
Comprehensive Income.
The fair values of the options granted have been calculated
using a Black-Scholes model.
Assumptions used were an option life of 5 years, a risk-free
rate of 2 per cent., a volatility of 60 per cent. and no dividend
yield.
5. ISSUED CAPITAL AND RESERVES
Ordinary shares
Company
Share Capital
Number GBP'000
--- ----------- -------------
At 31 March 2019 98,991,334 247
----------- -------------
Issued under placing agreement 33,333,329 83
Issued on exercise of options 321,600 1
----------- -------------
At 30 September 2019 132,646,263 331
----------- -------------
On 18 April 2019 13,057,489 new ordinary shares of 0.25p each
were issued at a price of 15p per share pursuant to a share placing
to existing and new shareholders.
On 09 May 2019 a further 20,275,840 new ordinary shares 0.25p
each were issued at a price of 15p per share pursuant to a share
placing to existing and new shareholders.
On 21 May 2019 321,600 new ordinary shares 0.25p each were
issued in connection with the exercise of share options.
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
IR CKADBABDDCBD
(END) Dow Jones Newswires
December 17, 2019 02:00 ET (07:00 GMT)
Evgen Pharma (LSE:EVG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Evgen Pharma (LSE:EVG)
Historical Stock Chart
From Apr 2023 to Apr 2024