TIDMEVG
RNS Number : 0743O
Evgen Pharma PLC
08 June 2022
Evgen Pharma plc
(the "Company")
Full Year Results
8 June 2022 - 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 2022.
Operational highlights
-- In vitro pre-clinical work supports SFX-01 use in metastatic
breast cancer patients who have become resistant to the widely used
class of CDK4/6 inhibitor drugs
-- Malignant glioma Orphan Drug Designation for SFX-01 granted by FDA
-- Publication of positive preclinical in vitro and in vivo data
in glioblastoma from two independent groups of collaborators, in
Italy and New Zealand
-- Encouraging early in vitro data for SFX-01 in Juvenile
Myelomonocytic Leukaemia ("JMML") at the MRC Weatherall Institute,
University of Oxford
-- Scale-up of the active ingredient in SFX-01 to commercial
scale achieved with a number of process improvements
-- JuvLife partnership around the application of the
Sulforadex(R) technology continues to progress well; US market
launch of a JuvLife nutritional health product is anticipated
around end- 2023
-- New formulation of SFX-01 generated in tablet form enabling
scale-up to supply late-stage clinical trials and commercial
use
-- Dr Helen Kuhlman and Dr Glen Clack appointed as Chief
Business Officer and Chief Medical Officer respectively, completing
the senior management team
-- Outlook:
o Intention to start healthy volunteer trial in Q4 2022 with new
SFX-01 formulation
o Final preclinical work in GBM completed and now in late-stage
preparation for a Phase Ib/IIa trial due to start in Q4 2022
o New academic collaborations with La Sapienza University, Rome
in SFX-01 radiosensitisation and Michigan University in colon
cancer
Financial highlights
-- Financial performance in-line with expectations:
o Cash and short-term deposits at 31 March 2022 of GBP9.0m (31
March 2021: GBP11.6m); Group funded to Q4/2023
o Post-tax loss of GBP2.7m (2021: loss of GBP2.7m)
o Cash outflow from operations of GBP2.6m (2021 outflow of
GBP2.9m)
Dr Huw Jones, CEO of Evgen Pharma, said:
" Our focus during the year has been on achieving the objectives
set at our 2021 fundraise, particularly around manufacturing,
formulation and clinical trials preparation. With this groundwork
now complete, we are pleased to have achieved very visible progress
in each of our development programmes and we are anticipating
another busy year which will include clinical data from both the
Phase I/Ib volunteer and Phase Ib/IIa glioblastoma trials."
Enquiries:
Evgen Pharma plc Tel: +44 207 457 2020
Dr Huw Jones, CEO enquiries@evgen.com
Richard Moulson, CFO
FinnCap (Nominated Advisor and Tel: +44 20 7220 0500
Broker)
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane/Nigel Birks (ECM)
----------------------
Instinctif Partners Tel: +44 207 457 2020
Melanie Toyne-Sewell / Rozi Morris Evgen@Instinctif.com
/ Agnes Stephens / Adam Loudon
----------------------
Notes to Editors
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 Company's lead asset, SFX-01, is a patented composition of
synthetic sulforaphane and alpha-cyclodextrin and has undergone
clinical trials for oestrogen-positive (ER+) metastatic breast
cancer. It will be entering the clinic in glioma/glioblastoma later
in 2022. In September 2021 the FDA granted Orphan Drug status to
SFX-01 in malignant glioma.
The Company also has a wide number of collaborations with
leading academic centres in the UK, Europe and AsiaPac as part of
the continuing strategy to build the data set of safety and
efficacy around the compound. With respect to non-core areas, Evgen
signed an outlicensing deal with JuvLife, the dietary products and
functional foods division of Juvenescence Ltd, for the development
of a naturally-sourced sulforaphane nutritional health supplement,
stabilised using Evgen's Sulforadex(R) technology.
The Company commenced operations in January 2008 and has its
headquarters and registered office at Alderley Park, Cheshire. 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
STRATEGIC REPORT
CHAIRMAN'S STATEMENT
In the last year we have had a strong focus on achieving the
objectives we set out following our 2021 fundraise. In particular
on manufacturing and formulation and clinical trials preparation.
This groundwork sets the stage for very visible progress in our
development programmes in the current year.
We have continued to concentrate our resources on specific
diseases and developing these to proof of concept for onward
out-licensing. This has allowed us to focus on the opportunities we
believe are appropriate to our size, capabilities and resources.
Equally, and because of the breadth of opportunities in
sulforaphane science, we have enabled academic and biopharma
companies to access our technology in other areas where there is a
compelling rationale, at minimal expenditure to Evgen.
We have been prudent in the management of our finances, with a
cash balance as at the end of the year of GBP9.0m (2020: GBP11.6m).
The fundraise in March 2021, which generated gross proceeds of
GBP11m, has enabled us to strengthen our management team and
undertake a number of activities that would otherwise have
constrained our development. We have made much progress, and some
aims, for example the manufacturing technology transfer and
glioblastoma pre-clinical validation, have been completed.
Our partnership with JuvLife, the dietary products and
functional foods division of Juvenescence Ltd, is an additional
application of our Sulforadex(R) technology in a field we would not
otherwise be able to exploit. JuvLife has a well-qualified and
experienced team that has made good progress during the last year.
With a US market launch planned for around the end of 2023, this
monetisation of our sulforaphane technology and expertise will
provide valuable revenues and risk mitigation for shareholders, as
well as validation of our strategy.
Our senior team was completed with the appointments of Dr Helen
Kuhlman as Chief Business Officer and Dr Glen Clack as Chief
Medical Officer. This has resulted in a significantly more active
business development activity, giving us a higher profile amongst
potential partners. It has also brought considerable clinical trial
expertise, both internally and via key opinion leaders, and thus
allowed us to design our clinical trials to give the best chance of
success.
At the end of the year we had sufficient cash resources to fund
us through the potential value enhancement points from both
completion of current pre-clinical projects and, in particular,
clinical data from both the Phase I/Ib volunteer and phase Ib/IIa
glioblastoma trials. We are also going to be seeking to extend our
business partnerships around our technology and development
pipeline. We look forward to reporting further achievements that
add value for our shareholders in the current year.
Barry Clare
Chairman
STRATEGIC REPORT
CHIEF EXECUTIVE'S REPORT
In the past year we have concentrated on the projects and
programmes for which we raised funds in March 2021, as a result, it
has been a busy year for the Company. In particular, we have
focused on pre-clinical projects, technology transfer and scale-up
of manufacturing, and preparations for two clinical trials - a
phase I volunteer study and a glioblastoma efficacy study. The
manufacturing programme was initiated shortly after the funding was
closed and has since been completed. The pre-clinical programmes
have been progressed with some concluded, and we are in the late
stages of preparation for the two clinical trials. More detail of
this progress is described below.
Looking forward, the glioblastoma trial will follow on shortly
after the human volunteer study commences. The goal is to generate
sufficiently compelling efficacy data that a large partner licenses
the programme and progresses it into a registration study(ies).
Equally, the pre-clinical work in mBC is designed to attract a
partner to support the next clinical development in this
indication. At the same time, we will continue seeking new
partnerships and collaborations.
Clinical stage programmes
Metastatic breast cancer ("mBC")
Breast cancer remains the biggest cause of cancer deaths in
women worldwide, and ER+ve/HER2-ve breast cancer accounts for circa
two thirds of all such cancers. The drugs used increasingly in
first line treatment of ER+ve/HER2-ve mBC patients, being CDK4/6
inhibitors, which were first approved for general use in the US in
2017 now have global sales in excess of $5 billion per annum.
Evgen has generated encouraging data with SFX-01 in mBC in a
Phase II clinical trial. Since the commencement of this trial, the
class of drugs known as CDK4/6 inhibitors have increasingly been
adopted in these patients. Evgen is broadening the investigation
into how SFX-01, in combination with other treatments, can improve
outcomes for patients with HR+ breast tumours that have become
resistant to this relatively new class of agents. This includes
research into STAT3 and pSTAT3, a protein that controls
transcription of information from DNA to messenger RNA; and SHP2, a
non-receptor protein tyrosine phosphatase that is associated with
many cancers including breast cancer.
In particular, we are expanding our work with Professor Rob
Clarke at the Manchester Breast Centre with in vitro pre-clinical
work to assess the impact of SFX-01 in CDK4/6 inhibitor resistance
models. An increasing body of in vitro data from these models shows
that SFX-01 may suppress tumour growth and metastasis in patients
who have become resistant to CDK4/6 inhibitors. Encouragingly,
SFX-01 reduces the viability and mammosphere colony formation of
palbociclib-resistant tumour cell lines in vitro.
In addition, this extended collaboration will include in vivo
models to provide the optimum support for clinical trial design
and/or licensing in patients with ER+ve/HER2-ve breast cancer,
where CDK4/6 inhibitors such as palbociclib are showing weakening
effectiveness. Evgen anticipates data from both in vitro and in
vivo work later in the year.
Glioma/glioblastoma
Our brain cancer programme progressed strongly in the last year.
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 malignant 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 and colleagues at the
Universities of L'Aquila, Rome and Rieti, 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 for SFX-01. Furthermore, SFX-01 was also
found to potentiate (i.e. substantially increase) the therapeutic
effect of radiotherapy in these models. The first of two papers
relating to this has been published in a peer-reviewed journal and
a second paper is being finalised for submission. ( Colapietro et
al, Pharmaceuticals, 2021, 14, 1082 ).
Further pre-clinical work conducted by Dr Euphemia Leung and
Prof Bruce Baguley of the University of Auckland, New Zealand in
GBM cells has been published in the pre-print journal BioRxIV (
Leung, Wright and Baguley, 2021 ). This in vitro data describes the
effect of SFX-01 in GBM cells and 3D spheroids from several
patients in New Zealand, together with the more commonly used
commercially available cell lines. 3D spheroids are aggregations of
tumour cells that more closely reflect the structure of tumours in
patients. In these in vitro experiments, SFX-01 demonstrated
inhibition of glioblastoma cell growth, supporting the results from
the work of Dr Festuccia.
In September 2021, we received the grant of Orphan Drug
Designation from the FDA in the US for Malignant Glioma, affording
the programme additional data protection and other financial
incentives.
We are now at a late stage in designing a Phase Ib/IIa clinical
study and liaising with potential trial sites in the UK and across
Europe. The trial is planned to commence in Q4 2022 and will follow
on shortly after the human volunteer study commences. It is
designed as a phase Ib/IIa, randomised, double-blind,
placebo-controlled trial with sequential modules that enable the
trial to be adapted as clinical data is generated. Initially c.20
patients will be recruited; depending on results this may increase
by up to a further 70 patients to achieve proof of concept in both
methylated and unmethylated glioblastoma patients. The goal is to
generate sufficiently compelling efficacy data to attract a partner
to license the programme and progress it into a registration study.
Data from this trial will be released during 2023.
Other clinical trials
An important use of proceeds from the fundraise completed in
March 2021 was to conduct a Phase I/Ib study in healthy volunteers
of our new SFX-01 formulation. The trial will be a
placebo-controlled, dose-escalating, randomised trial that will
assess the pharmacokinetic (how a drug is absorbed and circulates
in the body), and pharmacodynamic (how a drug engages with our
target molecules) properties of the new form and formulation.
The overall design of the trial is now complete, a Clinical
Research Organisation has been contracted to recruit subjects and
conduct the trial, and a dialogue with the MHRA has commenced. The
intention is to start the trial in Q4 this year as soon as the new
tablet formulation of SFX-01 has been finalised and manufactured in
sufficient quantities. We expect to announce the results during the
first half of 2023.
As part of the UK's initiative to fight the global COVID-19
pandemic, Evgen, Dundee University and NHS Tayside worked together
to assess SFX-01 in patients with respiratory distress due to
COVID-19 and other infective agents. The trial was stopped when an
analysis of the interim data did not show sufficient efficacy; with
hindsight, it is probable that the patients enrolled had progressed
too far and were too ill to respond. However, the costs of the
trial were limited because they were mostly covered by the grant
income, and as a positive, the trial added 65 additional patients
to our database of safety and tolerability of SFX-01. Overall, we
are proud that we were part of the COVID-19 effort.
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.
Haematological malignancies
Pre-clinical data has demonstrated that SFX-01 is effective in
in vitro models of certain blood cancers including Juvenile
Myelomonocytic Leukaemia (JMML) and Acute Myelomonocytic Leukaemia
(AML).
JMML is a very rare form of blood cancer that predominantly
affects young children. It is an aggressive and difficult to treat
disease and currently the only effective treatment for most
patients is allogeneic haematopoietic stem cell transplantation
(HSCT).
In a study at the MRC Weatherall Institute, University of
Oxford, the effect of SFX-01 on cells from tissue donated by
patients with JMML through the UK Paediatric MDS/JMML programme was
investigated. The data demonstrated significant reduction of cell
proliferation and increased apoptosis (cell death) of JMML stem
cells in the presence of SFX-01, compared to normal controls. The
study also showed that SFX-01 significantly impacted cell
proliferation and increased cytotoxicity in GDM-1 cells, an AML
cell line.
Whilst this preliminary data is from a small sample size, the
effect is statistically significant in reducing cell proliferation
and increasing apoptosis. A preclinical and clinical strategy for a
development programme of SFX-01 in blood cancers such as JMML and
AML is being assessed.
Other cancers
We have agreed to support two academic groups that have
requested provision of SFX-01 for use in cancer models of interest
to them:
-- A group at the University of Rome, Department of Radiology
and Radiotherapy wishes to investigate SFX-01 as a radio
sensitising agent for the treatment of Rhabdomyosarcoma, a rare
juvenile cancer. This follows the data generated at the University
of L'Aquila showing an enhanced effect from radiotherapy in GBM
models with administration of SFX-01. The data generated could
support the use of SFX-01 in radiotherapy more generally.
-- A group at the University of Michigan wishes to investigate
SFX-01 for anti-inflammatory and anti-tumour activity in two mouse
models of colon cancer, as well as human organoid models of
familial adenomatous polyposis and colorectal cancer.
Outlicensing
With the expansion of the management team, we have substantially
increased our business development activities, including
attendances at a number of relevant conferences and an ongoing
dialogue with industry over potential in-licensing and
out-licensing transactions.
Our first commercial out-licensing deal was signed with
Juvenescence in September 2020. This was for a license to our
Sulforadex(R) sulforaphane stabilisation technology in a number of
non-pharmaceutical applications. JuvLife, the dietary products and
functional foods division of Juvenescence Ltd, has since been
making good progress with the development of a naturally-sourced
sulforaphane nutritional health supplement, stabilised using our
Sulforadex(R) technology. In particular, it has identified a source
of sulforaphane and completed small scale batches of the complexed
product in a commercial facility. The scale-up process is now
underway to enable safety studies to commence.
We have supported this development with our expertise in
sulforaphane science and chemistry. Juvenescence is planning a
market launch around the end of 2023 which will yield milestones of
more than $1.5m at that point, with further sales-related
milestones and royalties to follow.
This agreement monetises one element of Evgen's sulforaphane
technology platform within a timescale considerably shorter than
that typical of pharmaceutical development. It contains provisions
which ensure a clear differentiation between potential nutritional
health products and pharmaceutical products, including limitations
on daily dose.
We will continue to seek such partnerships and collaborations
around both core and non-core assets, including our Sulforadex(R)
technology.
Manufacturing programme
A further use of proceeds from the March 2021 funding was to
transfer our production from a small facility in the US, where the
Sulforadex(R) IP was created, to a global pharmaceutical
manufacturer with the know-how and experience to scale-up the
production process from prototype to in-market. This has been
achieved to the point where a recent manufacturing run achieved
almost a 10x higher yield, in a process which has been simplified
and is significantly more cost-effective. In addition, we have
replaced the hand-filled capsules used previously with an
enteric-coated tablet formulation which can also be produced at
scale. Unlike the capsules, the tablets have a coating which
releases sulforaphane to a targeted part of the intestine. This is
expected to improve the pharmacokinetics of SFX-01 and to minimise
any gastro-intestinal side effects.
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.
We are currently producing sufficient active pharmaceutical
ingredient , drug product and placebo tablets to support multiple
clinical trials.
People
During the year we have strengthened our senior management team
in two key roles: 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 execute our plans and programmes.
Outlook
Since the 2021 fundraise we have achieved a number of key
clinical and operational achievements that will lead to the
commencement of two clinical trials by the end of the calendar
year, with the generation of data during 2023. Potentially we will
also have pre-clinical data sets to support further our breast
cancer programme and that point to trials in other indications. Our
partner Juvenescence is progressing well towards market launch
around the end of 2023 and this will provide commercial revenues to
defray a material part of our cost base. In the meantime, we will
be advancing preclinical studies and our business development
strategy.
I would like to thank our shareholders for their continued
support and to the team for their efforts in driving the strategy
forward. We believe the next 12 months will be extremely busy and
that we will build further value.
Dr Huw Jones
Chief Executive
KEY PERFORMANCE INDICATORS
Key Performance Indicators include a range of financial and
other measures (such as clinical trial progress). Details about the
progress of our development programmes (non-financial measures) are
included elsewhere in this Strategic Report, and below are the
other indicators (financial measures) considered pertinent to the
business.
2022 2021
(GBPm) (GBPm)
----------------------------------------------------- --------- ---------
Year-end cash, short-term investments and cash held
on deposit 9.0 11.6
The decrease in year-end cash reflects working capital,
manufacturing, pre-clinical and clinical expenditures less receipt
of the R&D tax credit (GBP0.53m). There was no fundraising
activity in the year.
2022 2021
(GBPm) (GBPm)
---------------------------------------------------- --------- ---------
Net cash outflow from operating activities (before
monies placed on fixed term deposits) 2.6 2.9
The net cash outflow reflects corporate costs and the costs
incurred in manufacturing scale-up, pre-clinical and clinical
expenditures.
2022 2021
(GBPm)
(GBPm)
---------------- -------- ---------
Operating loss 3.2 3.2
The operating loss reflects pre-clinical and clinical activity
in the year and related product manufacturing costs.
FINANCIAL REVIEW
The financial performance for the year ended 31 March 2022 was
in line with expectations.
Losses
The total loss for the year was GBP2.7m (31 March 2021: GBP2.7m)
including a charge for share-based compensation of GBP0.1m (2021
credit: GBP0.1m). Operating expenses excluding share-based
compensation were lower than in 2021 at GBP3.0m (2021: GBP3.5m)
reflecting completion of toxicology in the prior year and reduced
manufacturing technology transfer costs, offset in part by an
increase in payroll costs with the recruitment of additional senior
staff and preparatory work for the forthcoming clinical trials.
Research and development (R&D) expenditure
Our external spend on R&D expenditure was GBP1.4m, a
reduction of GBP0.6m (31 March 2021: GBP2.0m) on the prior year.
This reflects the completion of the toxicology and technology
transfer costs noted above, and we expect R&D costs to increase
in the current year with manufacture of SFX-01 for the planned
clinical trials and the costs associated with such trials.
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 charge
for the year in relation to share-based payments of GBP0.1m (2021
credit: GBP0.11m), which has no impact on cash flows.
Headcount
Average headcount of the Group for the year was 9 (2021: 8).
Taxation
The Group has elected to claim research and development tax
credits under the small or medium enterprise research and
development scheme of GBP0.44m (2021: GBP0.54m).
Share capital
No issues of shares were made during the year. At 31 March 2022
and 31 March 2021 there were 274,888,117 shares of 0.25p each in
issue.
Cash flows and financial position
The cash position (including short term deposits) at 31 March
2022 decreased to GBP9.0m (31 March 2021: GBP11.6m) reflecting
R&D and corporate costs, less GBP0.53m received from R&D
tax credits.
GOVERNANCE
Employee 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 2022 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 pre-clinical 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 pre-clinical, 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 raised 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.
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
for the year ended 31 March 2022
Year Year
ended ended
31 March 31 March
2022 2021
Notes GBP'000 GBP'000
--------------------------------------------------- ------ ---------- ----------
Revenue - 194
--------------------------------------------------- ------ ---------- ----------
Operating expenses
Operating expenses 3 (3,047) (3,519)
Share based compensation 4 (146) 112
--------------------------------------------------- ------ ---------- ----------
Total operating expenses 3 (3,193) (3,407)
--------------------------------------------------- ------ ---------- ----------
Operating loss 3 (3,193) (3,213)
--------------------------------------------------- ------ ---------- ----------
Finance income 24 -
Loss on ordinary activities before taxation (3,169) (3,213)
Taxation 439 539
--------------------------------------------------- ------ ---------- ----------
Loss and total comprehensive expense attributable
to equity holders of the parent for the year (2,730) (2,674)
--------------------------------------------------- ------ ---------- ----------
Loss per share attributable to equity holders
of the parent (pence) 6
Basic loss per share (0.99) (1.82)
Diluted loss per share (0.99) (1.82)
--------------------------------------------------- ------ ---------- ----------
CONSOLIDATED AND COMPANY STATEMENTS OF FINANCIAL POSITION
as at 31 March 2022
Group Company
As at As at As at As at
31 March 31 March 31 March 31 March
2022 2021 2022 2021
Notes GBP'000 GBP'000 GBP'000 GBP'000
------------------------------------------ ------ --------- --------- --------- ---------
ASSETS
Non-current assets
Property, plant and equipment 5 5 3 2
Intangible assets 53 66 - -
Investments in subsidiary undertaking - - 73 73
------------------------------------------ ------ --------- --------- --------- ---------
Total non-current assets 58 71 76 75
Current assets
Trade and other receivables 125 235 10,487 10,513
Current tax receivable 425 519 361 21
Short-term investments and cash on
deposit 4,520 6,000 4,520 6,000
Cash and cash equivalents 3 4,510 5,593 3,812 5,122
------------------------------------------ ------ --------- --------- --------- ---------
Total current assets 9,580 12,347 19,180 21,656
------------------------------------------ ------ --------- --------- --------- ---------
Total assets 9,638 12,418 19,256 21,731
------------------------------------------ ------ --------- --------- --------- ---------
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables 411 607 369 562
------------------------------------------ ------ --------- --------- --------- ---------
Total current liabilities 411 607 369 562
------------------------------------------ ------ --------- --------- --------- ---------
Equity
Ordinary shares 687 687 687 687
Share premium 27,870 27,870 27,870 27,870
Merger reserve 2,067 2,067 - -
Share based compensation 490 359 490 359
Retained deficit (21,887) (19,172) (10,160) (7,747)
------------------------------------------ ------ --------- --------- --------- ---------
Total equity attributable to equity
holders of the parent 9,227 11,811 18,887 21,169
------------------------------------------ ------ --------- --------- --------- ---------
Total liabilities and equity 9,638 12,418 19,256 21,731
------------------------------------------ ------ --------- --------- --------- ---------
No Statement of Comprehensive Income is presented in these
financial statements for the parent company as provided by Section
408 of the Companies Act 2006. The loss for the financial year
dealt with in the financial statements of the parent company was
GBP2,428k (2021: GBP1,212k).
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
for the year ended 31 March 2022
Share
Ordinary Share Merger based Retained
shares premium reserve compensation deficit Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
--------------------------------- --------- -------- -------- ------------- --------- --------
Balance at 31 March 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 at 31 March 2021 687 27,870 2,067 359 (19,172) 11,811
--------------------------------- --------- -------- -------- ------------- --------- --------
Total comprehensive expense
for the period - - - - (2,730) (2,730)
Transactions with owners
Share issue - lapsed options - - - (15) 15 -
Share based compensation
- share options - - - 146 - 146
--------------------------------- --------
Total transactions with
owners - - - 131 15 146
--------------------------------- --------- -------- -------- ------------- --------- --------
Balance at 31 March 2022 687 27,870 2,067 490 (21,887) 9,227
--------------------------------- --------- -------- -------- ------------- --------- --------
CONSOLIDATED AND COMPANY STATEMENTS OF CASH FLOWS
for the year ended 31 March 2022
Group Company
Year ended Year ended Year ended Year ended
31 March 31 March 31 March 31 March
2022 2021 2022 2021
GBP'000 GBP'000 GBP'000 GBP'000
-------------------------------------- ----------- ----------- ----------- -----------
Cash flows from operating activities
Loss before taxation (3,169) (3,213) (2,803) (1,251)
Interest (income) / expense (24) - (24) -
Depreciation and amortisation 16 18 2 -
Share based compensation 146 (112) 146 (112)
-------------------------------------- ----------- ----------- ----------- -----------
(3,031) (3,307) (2,679) (1,363)
Changes in working capital
Decrease / (increase)in trade
and other receivables 110 (39) 26 (2,150)
(Decrease)/increase in trade
and other payables (196) (46) (193) 167
-------------------------------------- ----------- ----------- ----------- -----------
Cash used in operations (86) (85) (167) (1,983)
Taxation received 533 466 35 76
-------------------------------------- ----------- ----------- ----------- -----------
Net cash used in operating
activities (2,584) (2,926) (2,811) (3,270)
Cash flows (used in)/generated
from investing activities
Monies received from / (placed
on) fixed-term deposit 1,480 (6,000) 1,480 (6,000)
Interest income / (expense) 24 - 24 -
Acquisition of tangible fixed
assets (3) (5) (3) (2)
-------------------------------------- ----------- ----------- ----------- -----------
Net cash (used in)/generated
from investing activities 1,501 (6,005) 1,501 (6,002)
Cash flows from financing activities
Proceeds from issue of shares - 11,110 - 11,110
Issue costs - (717) - (717)
-------------------------------------- ----------- -----------
Net cash generated from financing
activities - 10,393 - 10,393
-------------------------------------- ----------- ----------- ----------- -----------
Movements in cash and cash
equivalents in the period (1,083) 1,462 (1,310) 1,121
-------------------------------------- ----------- ----------- ----------- -----------
Cash and cash equivalents at
start of period 5,593 4,131 5,122 4,001
-------------------------------------- ----------- ----------- ----------- -----------
Cash and cash equivalents at
end of period 4,510 5,593 3,812 5,122
-------------------------------------- ----------- ----------- ----------- -----------
NOTES TO THE FINANCIAL STATEMENTS
1. General information
Evgen Pharma plc ('the Company') is a public limited company
incorporated in England & Wales and whose shares are traded on
the AIM market of the London Stock Exchange under the symbol EVG.
The address of its registered office is Alderley Park, Congleton
Road, Nether Alderley, Cheshire, United Kingdom, SK10 4TG. The
principal activity of the Company is clinical stage drug
development.
2. Significant accounting policies and basis of preparation
Basis of preparation
The financial information does not include all information
required for full annual financial statements and therefore does
not constitute statutory accounts within the meaning of section
435(1) and (2) of the Companies Act 2006 or contain sufficient
information to comply with the disclosure requirements of
UK-adopted International Accounting Standards. These should be read
in conjunction with the Financial Statements of the Group for the
year ended 31 March 2022 which were approved by the Board of
Directors on 07 June 2022.
The report of the auditor for the year ended 31 March 2022 and
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 consolidated financial statements have been prepared under
the historical cost convention.
The consolidated financial statements are presented in Sterling
(GBP) and rounded to the nearest GBP'000. This is the predominant
functional currency of the Group, and is the currency of the
primary economic environment in which it operates.
Basis of consolidation
The financial statements incorporate the financial statements of
the Company and entities controlled by the Company. Control is
achieved when the Company has the power over the investee; is
exposed, or has rights, to variable return from its involvement
with the investee; and, has the ability to use its power to affect
its returns. The Company reassesses whether it controls an investee
if facts and circumstances indicate that there are changes to one
or more of the three elements of control listed above.
Consolidation of a subsidiary begins when the Company obtains
control over the subsidiary and ceases when the Company loses
control of the subsidiary. Specifically, the results of
subsidiaries acquired or disposed of during the period are included
in the Consolidated Statement of Comprehensive Income from the date
the Company gains control until the date when the Company ceases to
control the subsidiary.
Where necessary, adjustments are made to the financial
statements of subsidiaries to bring the accounting policies used
into line with the Group's accounting policies.
All intragroup assets and liabilities, equity, income, expenses
and cash flows relating to transactions between the members of the
Group are eliminated on consolidation.
3. Going concern
At 31 March 2022, the Group had cash and cash equivalents,
including short-term investments and cash on deposit, of GBP9.0
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 fourth quarter 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 2022 and 31 March 2021, 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 risk-free rate and dividend rate,
exercise restrictions and behavioural considerations. A significant
element of judgement is therefore involved in the calculation of
the charge. The total charge recognised in the year to 31 March
2022 was GBP146,125 (year to 31 March 2021: credit of
GBP111,664).
5. Operating loss
An analysis of the Group's operating loss has been arrived at
after charging/(crediting)
Year Year
ended ended
31 March 31 March
2022 2021
GBP'000 GBP'000
------------------------------------------- ---------- ----------
Research and development expenses:
Amortisation of licences 13 16
Other research and development 1,446 2,011
Staff costs (including share-based
compensation) 1,153 716
Establishment and general:
Depreciation of property, plant and
equipment 3 2
Operating lease cost - land and buildings 12 18
Foreign exchange loss/(profit) 2 9
Other administrative expenses 564 635
Total operating expenses 3,193 3,407
--------------------------------------------- ---------- ----------
The Group has one reportable segment, namely the development of
pharmaceutical products all within the United Kingdom.
6. 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 at 31 March 2022 the Group had 10,587,665 (2021: 6,402,754)
share options outstanding which are potentially dilutive.
The calculation of the Group's Year ended Year ended
basic and diluted loss per share 31 March 31 March
is based on the following data: 2022 2021
GBP'000 GBP'000
Loss for the year attributable
to equity holders (2,730) (2,674)
--------------------------------------- ------------ ------------
Year ended Year ended
31 March 31 March
2022 2021
Number Number
Weighted average number of ordinary
shares for basic loss per share 274,888,117 147,019,536
--------------------------------------- ------------ ------------
Effects of dilution:
Share options - -
Weighted average number of ordinary
shares adjusted for the effects
of dilution 274,888,117 147,019,536
--------------------------------------- ------------ ------------
Year ended Year ended
31 March 31 March
2022 2021
Pence Pence
Loss per share - basic and diluted (0.99) (1.82)
--------------------------------------- ------------ ------------
The weighted average numbers of ordinary shares for the years
ended 31 March 2021 and 2022 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.
7. Issued capital and reserves
Ordinary shares
Group and Company
Ordinary shares of Share Share
0.25p each Capital Premium Total
Number GBP'000 GBP'000 GBP'000
As at 31 March 2021
& 31 March 2022 274,888,117 687 27,870 28,557
--------------------- ------------ --------- --------- --------
There were no new shares issued in the year ending 31 March
2022.
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 at 31 March 2022 and 2021 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.
8. Related party transactions
Group
Transactions between the Company and its subsidiaries, which are
related parties, have been eliminated on consolidation and are not
disclosed in this note.
Key management compensation is disclosed in Note 6 of the
consolidated financial statements. Directors' emoluments are
disclosed in the Remuneration Committee Report.
During the year ended 31 March 2022, the Group purchased
consultancy services totalling GBP15,995 (year ended 31 March 2021:
GBP19,225) from FD Consult Ltd, a company controlled by Richard
Moulson. The amount owed to FD Consult Ltd at 31 March 2022 was
GBPnil (31 March 2021: GBPnil).
During the year the Group purchased services from OBN, a company
for which Huw Jones acts as a non-executive director, totalling
GBP1,282 (2021: GBP180). The amount owed to OBN at 31 March 2022
was GBPnil (31 March 2021: GBPnil).
Company
The Company is responsible for financing and setting Group
strategy. The Company's subsidiary carried out the Group's
development strategy and managed the Group's intellectual property.
The Company provides interest free and unsecured funding to its
subsidiary with no fixed date of repayment.
9. Report and accounts
A copy of the Annual Report and Accounts will shortly be sent to
all shareholders with notice of the Annual General Meeting and will
also be available to download from the Group's website at
www.evgen.com .
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
FR FFFEIRVIDIIF
(END) Dow Jones Newswires
June 08, 2022 02:01 ET (06:01 GMT)
Evgen Pharma (LSE:EVG)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Evgen Pharma (LSE:EVG)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024