TIDMEVG
RNS Number : 8527B
Evgen Pharma PLC
15 June 2021
Evgen Pharma plc
(the "Company")
Final Results to 31 March 2021
Evgen Pharma plc (AIM: EVG), the clinical stage drug development
company developing sulforaphane based medicines for the treatment
of multiple diseases, announces its audited results for the year
ended 31 March 2021.
Research and Development
-- Phase IIb/III trial using SFX-01 for acute respiratory
distress syndrome ("ARDS"), including COVID-19 patients, sponsored
by the University of Dundee and NHS Tayside, with grant funding
from LifeArc; the "STAR" trial (SFX-01 treatment for acute
respiratory infections). 133 patients recruited to date
-- Safety data review by independent Data Monitoring Committee
("DMC") of 60 randomised patients concluded there were no concerns
regarding patient safety. Further assessment by the DMC of
unblinded data from 100 randomised patients for safety and futility
will be performed imminently
-- Exciting pre-clinical data generated in glioma/glioblastoma -
preparations under way for randomised, blinded Phase I/II clinical
trial to start in H1/2022
-- In vitro data suggests that SFX-01 may suppress tumour growth
in patients with oestrogen receptor positive breast cancer who have
become resistant to CDK4/6 inhibitors such as palbociclib (sold as
Ibrance by Pfizer)
-- Encouraging in vitro data that SFX-01 may also be effective
in treating blood cancers such as the severe form of childhood
leukaemia, juvenile myelomonocytic leukaemia (JMML), linked to new
evidence that SFX-01 inhibits a further pathway of relevance in
many cancers
Corporate
-- Completion of first out-licensing deal with Juvenescence for
use of Sulforadex(R) technology in non-pharmaceutical markets. Up
to $10.5m receivable in milestones with royalties on sales,
expected from mid-2023
-- Funding round of GBP11m (before costs) will accelerate Evgen's development programmes
Strengthened Management Team
-- Senior management team strengthened and expanded with
appointments of Dr Huw Jones (CEO) and, post year end, Dr Glen
Clack as Chief Medical Officer and Dr Helen Kuhlman as Chief
Business Officer
Financial Highlights
-- Financial performance in-line with expectations:
o Post tax loss of GBP2.7m (2020: loss of GBP2.7m)
o Cash outflow from operations of GBP2.9m (2020: outflow of
GBP2.6m)
o Cash and short-term deposits at 31 March 2021 of GBP11.6m (31
March 2020: GBP4.1m)
Barry Clare, Chairman of Evgen Pharma, said: " Over the last 12
months Evgen has substantially strengthened its senior team, made
considerable progress across all areas of its business, raised
significant funding to accelerate the development of its
therapeutic programmes and concluded its first commercial
partnership. I look forward to continuing our success in the
current year and would like to thank our shareholders for their
continued support."
Enquiries:
Evgen Pharma plc www.evgen.com via Walbrook
Dr Huw Jones, CEO
Richard Moulson, CFO
finnCap www.finncap.com +44 (0)20 7220 0500
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane (ECM)
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 drug development 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.
Clinical data from the Company's open-label Phase II STEM trial
has shown that SFX-01 can halt the growth of progressing tumours in
patients with oestrogen-positive (ER+) metastatic breast cancer,
and in some cases significantly shrink the tumour, whilst causing
very few side effects.
The Company has its headquarters at Alderley Park, Cheshire and
its registered office is at the Liverpool Science Park, Liverpool.
It joined the AIM market of the London Stock Exchange in October
2015 and trades under the ticker symbol EVG.
For further information, please visit: www.evgen.com
CHAIRMAN'S STATEMENT
The last year has seen considerable progress in Evgen's
development programmes, our first out-licensing deal, and a
substantial fundraising that will accelerate these programmes. In
addition, we initiated an externally funded Phase IIb/III clinical
trial of SFX-01 in Acute Respiratory Distress Syndrome ('ARDS') in
partnership with The University of Dundee and NHS Tayside, the
sponsors of the trial, which recruited its first patient in
November 2020.
With Dr Huw Jones, who joined us in October 2020 as CEO, and the
more recent appointments of Dr Helen Kuhlman as Chief Business
Officer and Dr Glen Clack as Chief Medical Officer, we have a
broader and stronger senior management to execute our
ambitions.
Following its unblinded safety data review from the first 60
randomised patients in the STAR trial, the independent DMC
concluded that there were no concerns regarding patient safety or
data quality that would prevent continuation of the trial. We
expect to receive its assessment of futility and safety from the
first 100 patients shortly, which will consider whether there is
sufficient evidence of clinical improvement in the treatment arm
compared with placebo to justify continuation of the trial.
Since we successfully completed our Phase IIa trial of SFX-01 in
metastatic breast cancer ('mBC') the treatment pathway has changed
substantially with the launch and rapid uptake of CDK4/6
inhibitors. These are becoming standard of care as first or second
line treatments and hence we have re-assessed how to position
SFX-01 as a STAT3 inhibitor in this landscape. In partnership with
Manchester University and the Institut Curie in Paris we are
assessing whether SFX-01 has anti-cancer activity in CDK4/6
resistant preclinical models. Early data generated so far does show
such activity. Accordingly, we are refreshing the design of our
next mBC clinical trial and starting a dialogue with potential
partners and/or funders of this trial.
Whilst we hypothesise that STAT3 inhibition is the predominant
mechanism of action for SFX-01 in mBC, recent preclinical data has
demonstrated that it also inhibits Src homology region 2
domain-containing phosphatase-2 (SHP2), a mediator of cell
proliferation in blood cancers and a number of solid tumours. Early
preclinical in vitro data from the University of Oxford in which
cell lines from juvenile myelomonocytic leukaemia (JMML) patients
were exposed to SFX-01 showed reduced cell proliferation. JMML is a
rare but very serious blood cancer in children. We have
commissioned further work to assess whether and in what blood
cancers a clinical programme might be initiated.
Also during the year we announced compelling preclinical data
showing that SFX-01 significantly extended survival times in animal
models of glioma, especially when combined with radiotherapy. This
work was conducted at the University of Aquila, Italy and is being
repeated at Auckland University in New Zealand and with a contract
research organisation. To date the results have been consistent
with those obtained at Aquila, strengthening our conviction that we
should proceed to a glioma clinical programme, which we aim to
commence in H1 2022.
In September 2020, we announced our first out-licensing deal
with the JuvLife division of Juvenescence Ltd. JuvLife was
established to provide high quality, science-based consumer
products that will extend a healthy lifespan. The license covers
non-pharmaceutical applications of our Sulforadex technology with
limitations on dosing so that there is no conflict or cross-over
with our core clinical candidates. We have established a good and
supportive working relationship with the JuvLife team, who are
conducting a thorough and professional product development and
marketing programme. We anticipate market launch by the middle of
2023. The deal will generate attractive cashflows from milestones
and royalties and is an opportunity to generate income from an
element of our technology which we would otherwise be unlikely to
exploit commercially.
We were very pleased with the heavily oversubscribed fundraising
completed in March 2021 which raised GBP11m before expenses. This
was characterised by some high-quality institutional names joining
the register for the first time, and strong support from key
existing institutions and retail investors through the Open Offer.
The funding allows us to accelerate our various preclinical and
clinical programmes and to conclude the scale up and formulation
work on SFX-01 so we are able to supply larger, late-stage trials
and early in-market demand.
The biological activity of sulforaphane is undoubted and our
Sulforadex technology provides us with an exceptional opportunity
to build a valuable business. Our pipeline has been broadened with
data showing SFX-01 could be efficacious in several cancers as well
as respiratory diseases such as ARDS. With greater resources and a
strengthened management team we look forward enthusiastically to
further achievements in the current year.
Barry Clare
Chairman
14 June 2021
STRATEGIC REPORT
The Directors present their Strategic Report for the year ended
31 March 2021.
Chief Executive's Report
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 three separate biochemical
pathways; inhibition of pSTAT3 and SHP2, both of importance in
cancer, and up-regulation of Nrf2, a therapeutic target associated
with a broad range of diseases which are characterised by excessive
oxidative stress and inflammation. Sulforaphane has attracted huge
scientific interest and has been shown to have anti-cancer and
anti-inflammatory qualities in a wide range of preclinical and
clinical studies.
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 200 patients in clinical trials and is well-tolerated
with predominantly mild side-effects.
Evgen has exclusive rights to the only technology
(Sulforadex(R)) proven to synthesise this very unstable molecule in
a stabilised composition that will satisfy regulatory and medicinal
needs for a pharmaceutical and that can be used as a
therapeutic.
Our strategy is now sharper and more focused
Following my appointment as CEO our strategy has been refined as
follows:
-- To ensure our selected development programmes meet stringent
scientific and commercial criteria
-- Our core R&D efforts to be focused on our oncology and ARDS pipeline
-- SFX-01 to continue to be provided to academic groups for
preclinical evaluation in selected disease models
-- Consideration will be given to supporting clinical evaluation
of SFX-01 in non-core indications, where there is compelling
preclinical data and an attractive commercial opportunity
-- To leverage the Sulforadex(R) platform by supporting
Juvenescence in bringing products to market outside the
pharmaceutical sector
-- The business model is to establish proof of concept and then conclude partnerships
Evgen will have the right to access the pre-clinical and
clinical data generated by academic partners on fair commercial
terms to advance its clinical and commercial development. Since the
principal funding for these trials will be obtained by the
investigator/ institution they have limited impact on our cash
reserves.
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 and our broader
technology platform.
Operational overview
Clinical pipeline
To date, SFX-01 has been administered to some 200 patients and
demonstrated a good safety and tolerability profile. Evgen has two
clinical development programmes ongoing; one in metastatic breast
cancer (Phase II), and one in Acute Respiratory Distress Syndrome
(Phase IIb/III).
In addition, it is expected that a Phase II trial in
glioma/glioblastoma will be started in 2022.
The Company has started the preparatory work to file an IND
around the end of 2021 to enable clinical studies to be conducted
in the United States.
ARDS in patients with respiratory distress due to COVID-19 and
other infective agents
In June, we won a highly competitive grant process to secure
funding from LifeArc to evaluate SFX-01 in patients with suspected
COVID-19, in conjunction with the University of Dundee ("Dundee")
and NHS Tayside. The trial, sponsored by Dundee, will investigate
whether SFX-01 can reduce the severity, or prevent the onset of
ARDS associated with COVID-19 and pneumonia resulting from other
infectious agents, thus reducing the need for invasive patient
ventilation and potentially improving recovery times.
Nrf2 (nuclear factor erythroid 2 p45-related factor 2) is a
transcription factor that regulates many target genes including
those used in encoding proteins involved in the cellular
antioxidant response, damage repair, protein homeostasis and
maintenance of metabolic balance. It has been discovered that NRF2
is suppressed in lung biopsy samples from patients infected with
the COVID-19 virus. SFX-01 inactivates a protein associated with
regulating NRF2, known as KEAP1 (Kelch-like ECH-associated protein
1) thus allowing accumulation of NRF2 and an increase in expression
of target genes potentially improving the cellular response to the
COVID-19 virus and reducing the risk of the "cytokine storm".
SFX-01 upregulates the Nrf2 pathway, which is part of the natural
human defence against inflammatory and oxidative stress, such as
the inflammation that occurs during a severe viral infection.
Preclinical studies have shown that up-regulating the Nrf2 pathway
reduces the severity of ARDS, the progressive lung damage observed
in COVID-19 and other pneumonia patients which can result in the
need for invasive ventilation in an intensive care unit. Recent
pre-clinical data from Johns Hopkins University in the USA suggests
that sulforaphane has direct anti-viral activity against the virus
that causes COVID-19, adding a second potential mechanism to
support the evaluation of SFX-01 in ARDS. This hypothesis is being
tested in the STAR COVID-19 study.
The Phase IIb/III study will recruit up to 300 patients with
confirmed or suspected COVID-19. Patients will be drawn from both
hospital and community settings and may present with COVID-19 or
other respiratory diseases such as viral pneumonia. Half the group
will receive SFX-01 in addition to standard hospital care while the
other half will receive a placebo and standard hospital care.
Evgen will supply clinical centres with SFX-01 and a placebo as
its contribution to the trial. The financial contribution to the
trial is minimal as the costs of providing SFX-01 for the trial are
not material.
As at 12 June 2020, 133 patients had been recruited and
depending on availability of COVID-19 and other patients with ARDS,
data could be available in the first half of 2022.
In March this year unblinded safety data from the first 60
randomised patients was reviewed by an independent Data Monitoring
Committee ("DMC"). It was concluded that there were no concerns
regarding patient safety or data quality that would prevent
continuation of the trial.
A further assessment, by the DMC, of unblinded data from the
first 100 randomised patients, for safety and futility, will be
performed imminently and will be announced in the coming weeks. The
trial sponsor (University of Dundee/NHS Tayside) are cleaning the
trial data and finalising the statistical basis for performing the
analysis, and the output will be provided to the DMC for review
shortly. The DMC assessment of futility will consider whether there
is sufficient evidence of clinical improvement in the treatment arm
compared with placebo to justify continuation of the trial.
We expect to be able to announce the DMC conclusions later this
month in line with previous guidance as to timing thereof.
Metastatic breast cancer ("mBC")
Since 2012, Evgen has worked with University of Manchester
scientists at the Cancer Research UK Manchester Institute
("Manchester") 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. This data was recently
published in the prestigious journal, Oncogene.
In the open-label Phase II trial of SFX-01 in 46 mBC patients 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 remained
on treatment for over 18 months
-- A mild and favourable side effect profile for an anti-cancer drug.
Since we commenced the trial CDK4/6 inhibitors have grown in
acceptance and are becoming standard of care in first line mBC
treatment. These drugs provide an extended period of progression
free survival, but invariably patients become resistant to them.
Accordingly, we are conducting further preclinical work with
Manchester to assess the impact of SFX-01 in CDK4/6 resistance
models. Early in vitro data suggests that SFX-01 may suppress
tumour growth in patients who have become resistant to CDK4/6
inhibitors. Should this data be reinforced with further in vitro
and in vivo work we will pursue a Phase II placebo-controlled study
in second line mBC treatment of patients who have failed on CDK4/6
inhibitors. Such a trial could commence in 2022.
Broadening of pre-clinical programmes
We continue to support academic research to broaden the
potential range of applications for SFX-01 and increase our
mechanistic understanding in these different disease areas. This
has led to two additional cancer programmes becoming part of our
core strategy.
Compelling data in glioma/glioblastoma
Glioma is the most common form of brain tumour affecting around
5 per 100,000 people. The more severe, grade IV classification,
glioblastoma, is a very serious form of brain tumour representing
45% of all cases and has a poor prognosis with median survival of
around 14 months. The five-year survival of the severe grades is
5%. The therapeutic options for glioma are limited to surgery,
radiotherapy and the one drug widely available, temozolomide. There
is a clear unmet need for more treatments for use in conjunction
with the current standard of care.
A collaboration with Dr Claudio Festuccia at the University
d'Aquila, Italy has generated highly positive data for SFX-01 in
pre-clinical models of glioma and glioblastoma. Using standard in
vitro and in vivo pre-clinical models as well as orthotopic models
(where glioma cells are implanted in brain tissue representing a
more disease-relevant model) both tumour shrinkage and
significantly extended survival times were demonstrated.
Furthermore, SFX-01 was also found to potentiate (i.e.
substantially increase) the therapeutic effect of radiotherapy in
these models. Dr Festuccia's work has recently been submitted for
publication.
Further preclinical work has commenced in multiple laboratories
to complete the data set required for a clinical trial application
and/or partnering discussions. To date such work has built on Dr
Festuccia's results from in vitro experiments and has confirmed the
in vitro efficacy of SFX-01 in multiple, highly disease relevant,
patient-derived cells. The preclinical work should be completed in
2021 and a phase Ib/II clinical study could commence in H2 of
2022.
Early data in JMML points to potential use of SFX-01 in blood
cancers
Professor Philip Eaton at Queen Mary University of London has
shown that SFX-01 inhibits activity of the non-receptor
phosphotyrosine phosphatase, SHP2 (coded by the PTPN11 gene). SHP2
is thought to be a significant factor in some cancers. Professor
Eaton's work has recently been submitted for publication.
Following on from this work an in vitro project was conducted by
another world-renowned academic institution to study the effect of
SFX-01 on cells from patients with Juvenile Myelomonocytic
Leukaemia ('JMML'). SHP2 is a mediator of the cell proliferation
seen in JMML patients. Whilst this is preliminary data from a small
sample size, we were encouraged to see a statistically significant
effect in reducing cell proliferation and increasing apoptosis
(cell death).
JMML is an invasive and rare childhood cancer with very high
clinical lethality and limited treatment options, usually stem cell
transplantation. It occurs with an estimated incidence of 1.2 cases
per million annually. We are evaluating whether to pursue a
development programme in this very rare disease and/or investigate
whether SFX-01 should be evaluated in other cancers that are also
mediated by SHP2.
Out-licensing
First commercial out-licensing deal signed, with
Juvenescence
In September 2020 we announced the licensing of our
Sulforadex(R) sulforaphane stabilisation technology in a number of
non-pharmaceutical applications to Juvenescence Ltd
("Juvenescence"). In particular, Juvenescence intends to market and
sell a high-end nutritional health product containing a defined
dose of sulforaphane extracted from natural sources. Under the
terms of the license agreement (the "Agreement"), we will receive
milestone and option payments of up to $10.5m together with
royalties on future product sales which are anticipated from
mid-2023.
This agreement monetises one element of Evgen's sulforaphane
technology platform within a timescale considerably shorter than
that typical of pharmaceutical development. Our focus will remain
on progressing the therapeutic programmes, and the Agreement
contains provisions which ensure a clear differentiation between
potential nutritional health products and pharmaceutical products,
including limitations on daily dose.
The natural source of sulforaphane to be used by Juvenescence
contrasts with the synthetic sulforaphane which is used in SFX-01,
the Company's lead therapeutic product. Juvenescence is making good
progress and it is envisaged that product launch will occur in
around two years' time.
Non-clinical programmes
Our long-term toxicology work has now concluded and we are
pleased to note that the final data demonstrates an acceptable
toxicology profile for conducting clinical trials in chronic
diseases where longer term dosing is required. These data are
consistent with our observations of patients who received SFX-01
for extended periods in the mBC trial.
Scale-up of our formulation and manufacturing processes has
progressed. In particular, a commercial scale process for producing
a key intermediate in drug substance manufacture has been developed
by a well-regarded contract manufacturing organisation. Following
the February fundraise we are now working on the scale up of API
and finished product formulation with a major contract
manufacturer, with the aim of having a scaled-up product with
further enhanced IP protection available for clinical trials in
early 2022.
Intellectual property update
Our IP portfolio continues to be strengthened with a number of
key patents being granted. The current status of the intellectual
property portfolio is as follows:
-- From the "parent" patent family entitled "Stabilised
Sulforaphane" patents are granted in Australia, Canada, EU, US,
Japan and Hong Kong
-- The principal manufacturing patent application, entitled
"Methods of Synthesising Sulforaphane" is granted in Australia,
China, Europe, Japan, US and Canada and further applications are
pending in Brazil, Canada, US and India
-- A second manufacturing patent which is directed to methods of
isolating and purifying sulforaphane or analogues from natural
sources has been granted in Europe, US, Japan and China
-- The patent application providing protection around novel
analogues based on sulforaphane, and entitled "Sulforaphane-Derived
Compounds" is granted in Australia, China, Europe, Japan and the US
and pending in Canada
Furthermore, a new composition of matter filing has been made
which, if successful, would add a further 20 years of patent life
to the key patent family.
People
Key hires in senior team
After 10 years at Evgen, our founding CEO, Dr Steve Franklin,
resigned from the Company at the end of April last year. Dr Huw
Jones joined us in October 2020 as CEO with over 30 years'
experience of leadership roles in public and private R&D-based
companies.
Following our February fundraise we have been able to strengthen
our senior management team in two key roles. Since the year-end Dr
Glen Clack has joined as Chief Medical Officer and Dr Helen Kuhnman
as Chief Business Officer. Both are highly experienced in their
fields and we now have the senior level expertise we need to
accelerate our development and build on the successes in the recent
past.
Key Performance Indicators
Key Performance Indicators include a range of financial and
non-financial measures (such as clinical trial progress). Details
about the progress of our development programs (non-financial
measures) are included elsewhere in this Strategic Report, and
below are the other indicators (financial measures) considered
pertinent to the business.
2021 (GBPm)
Year-end cash and short-term investments and cash on deposit held:
(2020: GBP4.1m) 11.6
------------
The increase in year-end cash reflects the fundraising in
February 2021 which raised GBP11m before expenses (GBP0.7m)
together with receipt of the R&D tax credit (GBP0.47m), offset
in part by working capital, pre-clinical and clinical
expenditures.
2021 (GBPm)
Net cash inflow (including monies placed on fixed term deposits)
(2020 inflow: GBP2.1m) 7.5
------------
The net cash inflow reflects the fundraising completed during
the year less working capital, pre-clinical and clinical
expenditures.
2021 (GBPm)
Operating loss: (2020: GBP3.2m) 3.2
------------
The operating loss reflects pre-clinical and clinical activity
in the year and related product manufacture.
Financial review
The financial performance for the year ended 31 March 2021 was
in line with expectations.
Losses
The total loss for the year was GBP2.7m (31 March 2020: GBP2.7m)
including a credit for share-based compensation of GBP0.1m (2020
debit: GBP0.2m). Operating expenses excluding share-based
compensation were higher at GBP3.5m (2020: GBP3.0m) reflecting some
reduction in payroll costs offset by increased professional fees
and business development costs.
Share-based compensation
Accounting standards require a charge to be made against the
grant of share options and recognised in the Consolidated Statement
of Comprehensive Income. Where such options lapse ahead of their
vesting date the relevant charges are written back. As a
consequence of certain option lapses there was an overall credit
for the year in relation to share-based payments of GBP0.1m (2020
debit: GBP0.2m), which has no impact on cash flows.
Headcount
Average headcount of the Group for the year was 8 (2020: 8).
Taxation
The Group has elected to claim research and development tax
credits under the small or medium enterprise research and
development scheme of GBP0.54m (2020: GBP0.45m).
Share capital
A total of 4,751,178 ordinary shares of 0.25p each were issued
pursuant to exercises of share options granted under individual
share option grants. These options had exercise prices ranging from
0.9p to 5.0p per share.
A share placing and open offer was completed in March 2021 which
raised GBP11m before expenses, through the issue of 137,490,676
shares at 8p per share. This provides us with a strengthened
balance sheet and the resources to; pursue our preclinical oncology
projects including a phase IIa efficacy trial in glioma; complete
our production and formulation work up to and including manufacture
of final product batches which are suitable for Phase III and
in-market use; prepare and apply for an IND in the US to enable
clinical trials in this critical territory; and strengthen our
senior management team with key hires.
Cash flows and financial position
The cash (including short term deposits) position at 31 March
2021 increased to GBP11.6m (31 March 2020: GBP4.1m) as a
consequence of the fundraise. The amount received net of expenses
was GBP10.3m and a further GBP0.47m was received from R&D tax
credits. These receipts were offset by ongoing work in preclinical
projects, toxicology, product development and manufacture and
general running costs.
Employee and engagement
As a very small company in terms of staff, Board members have
multiple points of contact with staff; through Board meeting
feedback, participation in weekly management meetings involving all
staff, and ad hoc interactions in relation to specific matters.
These forums provide staff with an opportunity to give their
views which can then be taken into account in making decisions
likely to affect their interests.
Specific matters of concern to them as employees are dealt with
in management meetings and by email. Corporate developments and
Company performance are discussed weekly in management
meetings.
All staff are eligible for the Group's share option scheme and
this encourages involvement in the Company's performance.
Stakeholder Engagement
The Group has a small number of major suppliers and consultants
that support its delivery of strategy and corporate goals. The
selection of, relationships with, and execution of, contracted work
by these parties is considered at least weekly by the Executive
Directors and at each Board meeting by all Directors. Where
appropriate, the Chairman and/ or non-executive directors
participate in engagement with these parties, and where
appropriate, Board members are involved in meetings with such
parties.
Principal risks and uncertainties
Evgen is a biopharmaceutical company and, in common with other
companies operating in the sector, is subject to a number of risks.
The principal risks and uncertainties identified by the Group for
the year ending 31 March 2021 are set out below.
COVID-19 pandemic
The Board is monitoring the impact of COVID-19 on the Group and
its staff closely. To date, the impact on our staff and programmes
has been limited to some delays in preclinical programmes because
our scientific partners have had access to their laboratories
restricted. Continuation of the pandemic for further sustained
periods may affect:
-- Our ability to conduct and conclude partnering discussions
-- Our ability to initiate and execute new clinical trials,
whether sponsored by Evgen or Clinical Investigators
-- Completion of the current preclinical, clinical and production programmes to agreed timelines.
Development
The Group is at a relatively early stage of development and may
not be successful in its efforts to develop approved or marketable
products. Technical risk is present at each stage of the
development process which is a highly regulated environment which
presents technical and operational risk. There can be no guarantee
that the Group will be able to, or that it will be commercially
advantageous for the Group to, develop its Intellectual Property
through entering into licensing deals with pharmaceutical
companies.
Commercial
The biotechnology and pharmaceutical industries are very
competitive. The Group's competitors include major multinational
pharmaceutical companies, biotechnology companies and research
institutions. Many of its competitors have substantially greater
financial, technical and other resources. The Group's competitors
may succeed in developing, acquiring or licensing drug product
candidates that are more effective or less costly than those the
Group is developing, or may develop, and this may have a material
adverse impact on the Group.
Regulatory
The Group's operations are subject to laws, regulatory
approvals, and certain government directives, recommendations and
guidelines. There can be no assurance that future legislation will
not impose further government regulation which may adversely affect
the business or financial condition of the Group.
Intellectual property (IP)
The Group's success depends in part on its ability to obtain and
maintain patent protection for its technology and potential
products in the United States, Europe and other countries. If the
Group is unable to obtain and maintain patent protection for its
technology and potential products, or if the scope of patent
protection is not sufficiently broad, competitors could develop and
commercialise similar technology and products, which could
materially affect the Group's ability to successfully commercialise
its technology and potential products. The Group is exposed to
additional IP risks, including infringement of IP rights,
involvement in lawsuits and the inability to protect the
confidentiality of its trade secrets which could have an adverse
effect on the success of the Group.
Financial
The Group has a limited operating history, has incurred
significant losses since its inception and does not have any
approved or revenue generating products. The Group expects to incur
losses for the foreseeable future, and there is no certainty that
the business will generate a profit. The Group may not be able to
raise additional funds that will be required to support its product
development programs or commercialisation efforts, and any
additional funds that are raise may cause dilution to existing
shareholders.
Operational
The Group's future development and prospects depend to a
material extent on the experience, performance and continued
service of its senior management team including the Directors. The
Directors believe the senior management team is appropriately
structured for the Group's size and stage of development and is not
overly dependent on any one individual. The Group has entered into
contractual arrangements with these individuals with the aim of
securing the services of each of them. Retention of these services
or the identification of suitable replacements cannot be
guaranteed. The loss of the service of any of the Directors or
senior management and the cost of recruiting replacements may have
a material adverse effect on the Group and its commercial and
financial performance.
Outlook
As expected, the March review on 60 patients by the DMC found no
reason to discontinue the trial on safety grounds. We look forward
to its assessment of futility which we expect later this month.
We are excited at the prospect of initiating an efficacy trial
in glioma, and potentially JMML given the preclinical data
generated in both indications. Initial data showing SFX-01 may be
of benefit to mBC patients who have developed resistance to CDK4/6
inhibitors is also very encouraging. With a strengthened senior
team and our partner Juvenescence progressing well towards market
launch within two years we are building an exciting and valuable
business.
Dr Huw Jones
Chief Executive
14 June 2021
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
for the year ended 31 March 2021
Year Year
ended ended
31 March 31 March
2021 2020
Notes GBP'000 GBP'000
------------------------------------------------ ------ ---------- ----------
Revenue 194 -
------------------------------------------------ ------ ---------- ----------
Operating expenses
Operating expenses (3,519) (2,998)
Share based compensation 4 112 (168)
------------------------------------------------ ------ ---------- ----------
Total operating expenses (3,407) (3,166)
------------------------------------------------ ------ ---------- ----------
Operating loss (3,213) (3,166)
------------------------------------------------ ------ ---------- ----------
Loss on ordinary activities before taxation (3,213) (3,166)
Taxation 539 451
------------------------------------------------ ------ ---------- ----------
Loss and total comprehensive expense attributable to
equity holders of the parent for the year (2,674) (2,715)
-------------------------------------------------------- ---------- ----------
Loss per share attributable to equity holders
of the parent (pence) 5
Basic loss per share (1.82) (2.10)
Diluted loss per share (1.82) (2.10)
------------------------------------------------ ------ ---------- ----------
CONSOLIDATED AND COMPANY STATEMENTS OF FINANCIAL POSITION
as on 31 March 2021
Group Company
As at As at As at As at
31 March 31 March 31 March 31 March
2021 2020 2021 2020
Notes GBP'000 GBP'000 GBP'000 GBP'000
--------------------------------------- --------- --------- --------- --------- ---------
ASSETS
Non-current assets
Property, plant and equipment 5 2 2 -
Intangible assets 66 82 - -
Investments in subsidiary undertaking - - 73 73
--------------------------------------- --------- --------- --------- --------- ---------
Total non-current assets 71 84 75 73
Current assets
Trade and other receivables 235 196 10,513 8,362
Current tax receivable 519 446 21 59
Short-term investments and cash
on deposit 6,000 - 6,000 -
Cash and cash equivalents 5,593 4,131 5,122 4,001
--------------------------------------- --------- --------- --------- --------- ---------
Total current assets 12,347 4,773 21,656 12,422
--------------------------------------- --------- --------- --------- --------- ---------
Total assets 12,418 4,857 21,731 12,495
--------------------------------------- --------- --------- --------- --------- ---------
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables 607 653 562 395
--------------------------------------- --------- --------- --------- --------- ---------
Total current liabilities 607 653 562 395
--------------------------------------- --------- --------- --------- --------- ---------
Equity 6
Ordinary shares 687 331 687 331
Share premium 27,870 17,831 27,870 17,831
Merger reserve 2,067 2,067 - -
Share based compensation 359 1,890 359 1,274
Retained deficit (19,172) (17,915) (7,747) (7,336)
--------------------------------------- --------- --------- --------- --------- ---------
Total equity attributable to equity
holders of the parent 11,811 4,204 21,169 12,100
--------------------------------------- --------- --------- --------- --------- ---------
Total liabilities and equity 12,418 4,857 21,731 12,495
--------------------------------------- --------- --------- --------- --------- ---------
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
for the year ended 31 March 2021
Ordinary Share Merger Share based Retained
shares premium reserve compensation deficit Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------------------ --------- -------- -------- ------------- --------- --------
Balance on 31 March 2019 247 13,240 2,067 1,722 (15,200) 2,076
Total comprehensive expense
for the period - - - - (2,715) (2,715)
Transactions with owners
Share issue - cash 83 4,589 - - - 4,672
Share issue - options
exercised 1 2 - - - 3
Share based compensation
- share options - - - 168 - 168
------------------------------
Total transactions with
owners 84 4,591 - 168 - 4,843
------------------------------ --------- -------- -------- ------------- --------- --------
Balance on 31 March 2020 331 17,831 2,067 1,890 (17,915) 4,204
------------------------------ --------- -------- -------- ------------- --------- --------
Total comprehensive expense
for the period - - - - (2,674) (2,674)
Transactions with owners
Share issue - cash 344 9,938 - - - 10,282
Share issue - options
exercised 12 101 - (2) - 111
Share issue - lapsed options - - - (1,417) 1,417 -
Share based compensation
- share options - - - (112) - (112)
------------------------------ --------
Total transactions with
owners 356 10,039 - (1,531) 1,417 10,281
------------------------------ --------- -------- -------- ------------- --------- --------
Balance on 31 March 2021 687 27,870 2,067 359 (19,172) 11,811
------------------------------ --------- -------- -------- ------------- --------- --------
CONSOLIDATED AND COMPANY STATEMENT OF CASH FLOWS
for the year ended 31 March 2021
Group Company
Year ended Year ended Year ended Year ended
31 March 31 March 31 March 31 March
2021 2020 2021 2020
GBP'000 GBP'000 GBP'000 GBP'000
---------------------------------------- ----------- ----------- ----------- -----------
Cash flows from operating activities
Loss before taxation (3,213) (3,166) (1,251) (2,291)
Depreciation and amortisation 18 21 - -
Share based compensation (112) 168 (112) 168
---------------------------------------- ----------- ----------- ----------- -----------
(3,307) (2,977) (1,363) (2,123)
Changes in working capital
(Increase)/decrease in trade
and other receivables (39) (61) (2,150) (800)
(Decrease)/increase in trade
and other payables (46) (35) 167 177
---------------------------------------- ----------- ----------- ----------- -----------
Cash used in operations (85) (96) (1,983) (623)
Taxation received 466 497 76 169
---------------------------------------- ----------- ----------- ----------- -----------
Net cash (outflow) / inflow from
operating activities (2,926) (2,576) (3,270) (2,577)
Cash flows from investing activities
Monies placed on fixed-term deposit (6,000) - (6,000) -
Acquisition of tangible fixed
assets (5) (1) (2) -
---------------------------------------- ----------- ----------- ----------- -----------
Net cash (outflow)/inflow from
investing activities (6,005) (1) (6,002) -
Cash flows from financing activities
Proceeds from issue of shares 11,110 5,003 11,110 5,003
Issue costs (717) (328) (717) (328)
---------------------------------------- ----------- -----------
Net cash inflow from financing
activities 10,393 4,675 10,393 4,675
---------------------------------------- ----------- ----------- ----------- -----------
Movements in cash and cash equivalents
in the period 1,462 2,098 1,121 2,098
---------------------------------------- ----------- ----------- ----------- -----------
Cash and cash equivalents at
start of period 4,131 2,033 4,001 1,903
---------------------------------------- ----------- ----------- ----------- -----------
Cash and cash equivalents at
end of period 5,593 4,131 5,122 4,001
---------------------------------------- ----------- ----------- ----------- -----------
1. General information
Evgen Pharma plc ('the Company') is a public limited company
incorporated in England & Wales and was admitted to trading on
the AIM market of the London Stock Exchange under the symbol EVG on
21 October 2015. 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
The financial information for the year ended 31 March 2020 has
been extracted from the Group's audited financial statements which
were approved by the Board of Directors on 12 June 2020, 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 and 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 in
connection with a material uncertainty relating to going
concern.
The report of the auditor on the 31 March 2021 financial
statements was unqualified, did not contain a statement under
Section 498(2) or Section 498(3) of the Companies Act 2006 and did
not include a matter to which the auditors drew attention by way of
emphasis without qualifying their report.
The information included in this preliminary announcement has
been prepared on a going concern basis under the historical cost
convention, and in accordance with in International Accounting
Standards in conformity with the requirements of the Companies Act
2006, IFRIC interpretations and the Companies Act 2006 applicable
to companies operating under IFRS.
3. Going concern
On 31 March 2021, the Group had cash and cash equivalents,
including short-term investments and cash on deposit, of GBP11.59
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 to the middle of 2023. They have therefore
prepared the financial statements on a going concern basis.
4. Share based payment charge
During the years ended 31 March 2021 and 31 March 2020, the
Group issued a number of share options to certain employees. A
Black-Scholes model was used to calculate the appropriate charge
for these periods. The use of this model to calculate a charge
involves using a number of estimates and judgements to establish
the appropriate inputs to be entered into the model, covering areas
such as the use of an appropriate interest rate and dividend rate,
exercise restrictions and behavioural considerations. A significant
element of judgement is therefore involved in the calculation of
the charge.
Where such options lapse ahead of their vesting date the
relevant charges are written back. As a consequence of certain
option lapses there was an overall credit for the year in relation
to share-based payments of GBP0.1m (2020 debit: GBP0.2m)
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.
As on 31 March 2021 the Group had 6,402,754 (2020: 9,531,367)
share options outstanding which are potentially dilutive. The
calculation of the Group's basic and diluted loss per share is
based on the following data:
Year ended Year ended
31 March 31 March
2021 2020
GBP'000 GBP'000
Loss for the year attributable to equity
holders for basic loss (2,674) (2,715)
----------------------------------------------- ------------ ------------
Year ended Year ended
31 March 31 March
2021 2020
Number Number
Weighted average number of ordinary
shares for basic loss per share 147,019,536 129,315,418
----------------------------------------------- ------------ ------------
Effects of dilution:
Share options - -
Weighted average number of ordinary
shares adjusted for the effects of dilution 147,019,536 129,315,418
----------------------------------------------- ------------ ------------
Year ended Year ended
31 March 31 March
2021 2020
Pence Pence
Loss per share - basic and diluted (1.82) (2.10)
----------------------------------------------- ------------ ------------
The loss and the weighted average number of ordinary shares for
the years ended 31 March 2021 and 2020 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. Issued capital and reserves
Ordinary shares
Company
Ordinary shares of 0.25p each Share Capital
Number GBP'000
As on 31 Mar 2020 132,646,263 331
-------------------------------- ------------ --------
Issued on exercise of options 4,751,178 12
Issued under placing agreement 137,490,676 344
As on 31 Mar 2021 274,888,117 687
-------------------------------- ------------ --------
On 6 July 2020 1,940,800 ordinary shares were issued in
connection with the exercise of share options at an exercise price
of 2.65375 pence per share payable in cash, 884,000 ordinary shares
were issued in connection with the exercise of share options at an
exercise price of 0.8875 pence per share payable in cash and
132,800 ordinary shares were issued in connection with the exercise
of share options at an exercise price of 0.875 pence per share
payable in cash.
On 7 July 2020 778,378 ordinary shares were issued in connection
with the exercise of share options with nil exercise price.
On 24 July 2020 1,015,200 ordinary shares were issued in
connection with the exercise of share options at an exercise price
of 5.0 pence per share payable in cash.
On 3 March 2021 137,490,676 ordinary shares were issued at a
price of GBP0.08 raising GBP11.0 million which after share issue
expenses of GBP0.7 million gave net consideration of GBP10.3
million.
The ordinary shares rank pari passu in all respects in relation
to dividends and repayment of capital and have equal voting rights
with one vote per share. There are no restrictions on the
transferability of the shares.
The Group and Company do not have an authorised share capital as
provided by the Companies Act 2006.
Other reserves:
The share premium reserve represents the difference between the
net proceeds of equity issues and the nominal share capital of the
shares issued.
The merger reserves on 31 March 2021 and 2020 arose from the
acquisition of Evgen's sole subsidiary, Evgen Ltd, in 2014 which is
accounted for using the merger method of accounting.
The share-based compensation reserve reflects the aggregate fair
value of equity-settled share-based payment transactions.
Reserves classified as retained deficit represent accumulated
losses. None of the reserves are distributable.
7. Related party transactions
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 2021, the Group purchased
consultancy services totalling GBP19,225 (year ended 31 March 2020:
GBP15,069) from FD Consult Ltd, a company controlled by Richard
Moulson. The amount owed to FD Consult Ltd on 31 March 2021 was
GBPnil (31 March 2020: GBPnil).
8. Report and accounts
A copy of the Annual Report and Accounts will shortly be sent to
all shareholders shortly with notice of the Annual General Meeting
and will also be available to download from the Group's website at
www.evgen.com .
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END
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