Final Results

RNS Number : 6408Z

Evgen Pharma PLC

31 May 2016

 

For immediate release                                                                                                                 31 May 2016

Evgen Pharma plc

("Evgen Pharma", the "Company" or the "Group")

Final Results for the year ended 31 March 2016

Evgen Pharma plc (AIM: EVG), the clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces its final results for the year ended 31 March 2016.

Period Highlights

§ Successful admission to AIM and £7m (gross) share placing on 21 October 2015

§ Financial performance in line with expectations

-     Loss of £3.1m (2015: £2.3m) reflecting higher activity levels post admission to AIM

-     Loss per share 6.29p (2015: loss per share 7.79p)

-     Cash (and short term investments and cash on deposit) at 31 March 2016 increased to £7.1m (31 March 2015: £0.2m), reflecting successful completion of a pre-IPO fund raising and a placing on AIM admission

§ Lead product SFX-01 data shows promise as adjunct to hormonal therapy in patient-derived xenografts using cancer tissues from early and late stage breast cancer patients (data presented at the American Association of Cancer Research)

§ Exclusive worldwide licence to a wide range of novel compounds from the Spanish National Research Council (CSIC) and the University of Seville

Post-Period Highlights

§ First patient dosed in the SAS (SFX-01 After Subarachnoid Haemorrhage) Phase II clinical study at University Hospital Southampton

§ Dr Alan Barge recently appointed interim Chief Medical Officer, having previously joined the Board at admission

§ Preclinical study underway comparing SFX-01 with approved MS drug, Tecfidera®

§ Collaboration with the University of Liverpool, the University of Seville and CSIC to progress the novel compounds in-licensed from Spain

§ Collaboration with Professor Antonio Cuadrado at the Autonomous University of Madrid where SFX-01 will be tested in some leading-edge models of Parkinson's disease

Dr Stephen Franklin, Chief Executive Officer of Evgen Pharma, said:

"I am very pleased with the significant progress the Company has made since joining AIM in October last year.  We are already treating patients in a Phase II trial of our lead product, SFX-01, in subarachnoid haemorrhage and we are fully funded to complete a Phase II trial in breast cancer which will begin later this year.  These two trials represent significant value inflexion points for Evgen Pharma.

"In addition, we are expecting results later this year of a head-to-head preclinical study of SFX-01 against Tecfidera®, the market leading oral treatment for the relapsing form of multiple sclerosis."

Analyst meeting

A meeting for analysts will be held at 10am this morning, 31 May 2016, at the offices of Buchanan, 107 Cheapside, London EC2V 6DN.  Please contact Buchanan on 020 7466 5000 for further information.

Enquiries:

Evgen Pharma plc                                                Dr Stephen Franklin, CEO John Bradshaw, CFO Barry Clare, Chairman www.evgen.com	c/o [phone]
Buchanan                                               Mark Court, Sophie Cowles, Stephanie Watson	[phone]
Northland Capital Partners Limited Matthew Johnson, Gerry Beaney, Margarita Mitropoulou (Corporate Finance) John Howes, Rob Rees (Corporate Broking)	[phone]

Notes for editors:

About Evgen Pharma plc

Evgen Pharma is a clinical stage drug development company whose lead programmes are in breast cancer and subarachnoid haemorrhage, a type of stroke.  It is also carrying out preclinical work in multiple sclerosis and has a clinical interest in prostate cancer.  The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane.  The lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin. 

Evgen Pharma commenced operations in January 2008 and is based in Liverpool, UK, at the Liverpool Science Park.  It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.  For further information, please visit www.evgen.com

CHAIRMAN'S AND CHIEF EXECUTIVE OFFICER'S STATEMENT

OVERVIEW

We are extremely pleased by the significant progress Evgen Pharma has made in the year ended 31 March 2016.  Highlights of the year include oversubscribed fundraisings in the form of a pre-IPO investment round (£2m in gross proceeds) and the subsequent IPO in October 2015 (£7m in gross proceeds).  The year has been transformational for the business as we now have sufficient capital to complete two Phase II clinical trials on lead product SFX-01; these trials represent the most significant value inflexion points since Evgen Pharma commenced operations in 2008.

During the year, our long-standing collaboration with the Cancer Research UK Manchester Institute resulted in the presentation of promising data showing SFX-01 reducing cancer stem cells in patient-derived breast cancer tissue in xenograft models.  This preclinical data underpins the rationale for STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer), a Phase II clinical study that is expected to start recruitment later this year.

During the reporting period, we secured MHRA Clinical Trial Approval for SAS (SFX-01 After Subarachnoid Haemorrhage), a Phase II clinical study that has now commenced patient recruitment and treatment.

On the preclinical side, the study on SFX-01 versus BG-12 (Biogen's Tecfidera^®) in various in vivo models of RR-MS (relapsing remitting multiple sclerosis) has commenced and is due to report in the latter part of 2016.

During the year, we have also expanded our pipeline by in-licensing a range of novel analogues based on sulforaphane, the active principle of SFX-01.  We would like to take this opportunity to announce that this month we initiated a new collaboration between the University of Seville, the Spanish National Research Council (CSIC) and the University of Liverpool in the UK.  This collaboration will synthesise, and subsequently screen, novel analogues with a view to identifying the most promising compounds to expand the Company's therapeutic pipeline.

The outlook for Evgen Pharma is positive, with all programmes on track and with sufficient capital to complete the two principal Phase II trials. 

OPERATIONAL REVIEW

Background

The Evgen Pharma business opportunity is built around a naturally occurring compound called sulforaphane.  Sulforaphane can be derived at relatively low and variable levels from the consumption of brassica plants, such as broccoli.  Glucoraphanin (the stable precursor molecule) converts to sulforaphane when the plant tissue is damaged and this conversion typically starts in the mouth and continues in the digestive tract of mammals, including people.

Sulforaphane has attracted huge scientific interest.  A large and growing number of scientific research papers has been published worldwide, underlining the compound's medical potential in multiple diseases.  Sulforaphane has been shown to have anti-cancer and neuroprotective qualities in a wide range of preclinical and/or clinical studies, for example breast cancer, prostate cancer, multiple sclerosis and autism.  However, the daily dose of sulforaphane required to elicit these potential therapeutic effects is far greater than can practically and consistently be derived from dietary sources.  The development of a concentrated form of pure sulforaphane - of the sort that could be presented in a tablet or similar medicinal format - has been held back owing to its inherent instability.  When chemically synthesised, sulforaphane is a liquid and the molecule spontaneously breaks down unless stored at very low temperatures.

Evgen Pharma's core technology seeks to unlock the therapeutic potential of sulforaphane.  The Company's patent-protected Sulforadex^® technology enables the scalable manufacturing of synthetic sulforaphane stabilised in a novel composition.  The stabilised composition is also a solid powder and can easily be formulated into pills and other medicinal formats.  The Sulforadex^® technology is also applicable to novel compounds based upon the core sulforaphane structure, giving the Group the opportunity to develop a broad clinical pipeline and to become the world leader in sulforaphane and sulforaphane-like pharmaceuticals.

Evgen Pharma secured exclusive rights to Sulforadex^® in 2011 and rapidly began building a company with a capital efficient business model and a highly experienced team to exploit the therapeutic potential of sulforaphane.  The initial product to use the Sulforadex^® technology is code-named SFX-01, which is a synthetic copy of sulforaphane stabilised by an alpha-cyclodextrin lattice.  SFX-01 has been advanced through preclinical and Phase I clinical trials and is now in Phase II.  Novel analogues of sulforaphane are also being synthesised and screened with a view to identifying the most promising compounds and expanding the Group's pipeline.

Objective and Strategy

The Group's objective is to establish a leading position in the development and commercialisation of pharmaceuticals based upon sulforaphane and related analogues.  The strategy to achieve this objective is to:

§ focus current resources on two Phase II clinical studies: STEM and SAS (see below);

§ commercially appraise, and if appropriate, develop new investment propositions for future clinical studies in multiple sclerosis and/or prostate cancer.

§ support investigator-initiated studies (i.e. academic units typically with grant funding) in areas outside of the above to expand scientific understanding and keep abreast of other potential clinical applications (see below);

§ expand the Group's intellectual property portfolio, including specific dose regimes, product formulations and new uses, and composition of matter based on novel sulforaphane analogues;

§ complete one or more licensing agreements after the first two Phase II clinical studies have reported;

§ in due course, opportunistically diversify the product pipeline, where the Directors believe such opportunities have a good strategic fit.

Group-Sponsored Programmes

The Group is initially focusing on demonstrating the efficacy of SFX-01 in one oncology indication and one neurology indication to demonstrate the potential breadth of application of SFX-01 as an anti-cancer agent and neuroprotectant respectively:

§ STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer), a 60 patient multi-centre trial; and

§ SAS (SFX-01 After Subarachnoid Haemorrhage - SAH), a 90 patient trial in the UK.

The Group also has a clinical interest in other oncology and neurology indications, for example prostate cancer and multiple sclerosis.

Investigator-Initiated Studies

In addition to the Company's core in-house programmes, we will continue to support investigator-initiated studies (completely or largely funded by the investigator) to help contribute to the fundamental scientific understanding of sulforaphane and thereby demonstrating the potential wider utility of SFX-01 and related analogues.

The Company has previously supported research by Professor Andrew Pitsillides (Professor of Skeletal Dynamics at the RVC, London) into the potential of SFX-01 in osteoarthritis.  During the year, that data was presented at the 4th Joint Meeting of European Calcified Tissue Society (ECTS) and the International Bone and Mineral Society (IBMS) in Rotterdam.  The positive results found that osteoarthritic mice treated with SFX‑01 had significantly improved bone architecture, gait balance and movement in comparison with an untreated sample group.

We are pleased to report that this month we entered into a new collaboration with Professor Antonio Cuadrado at the Autonomous University of Madrid where SFX-01 will be tested in some leading-edge models of Parkinson's Disease.  Professor Cuadrado has previously published on the therapeutic potential of sulforaphane in Parkinson's Disease; research that was grant funded by the Michael J Fox Foundation.

PIPELINE

SFX-01 in breast cancer (STEM: SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer)

According to World Cancer Research Fund International, breast cancer is the most common cancer globally, with nearly 1.7 million new cases diagnosed in 2012, and is the second most common cause of cancer death.  This represents about 12% of all new cancer cases and 25% of all cancers in women.  70-75% of breast cancers express the estrogen receptor (ER), and are amenable to treatment with endocrine therapies.

However, the emergence of resistance to treatment and progression of disease is common, occurring in up to 50% of patients.  It is thought that this is due, in a large part, to hormone independent cancer stem cells.  Therefore, when conventional therapies targeting cancer cells are used leaving the cancer stem cells unimpaired, there is a high chance of developing resistance and the patient progressing.

Evgen Pharma is very fortunate to have been working with the Cancer Research UK Manchester Institute since 2012.  Earlier this year, this collaboration resulted in the presentation of promising data showing SFX-01 reducing the number of cancer stem cells in patient-derived breast cancer tissue in xenograft models.  The xenograft studies used a combination of hormone therapy and SFX-01, with the role of SFX-01 being to reduce the population of the hormone independent cancer stem cells.  The data was presented at the American Association of Cancer Research annual conference in Philadelphia in April 2015.

STEM, a Phase II clinical trial, will investigate oral SFX-01 in combination with different hormone-based therapies (tamoxifen, aromatase inhibitors or fulvestrant) and is expected to begin recruiting later this year at Manchester's Christie Hospital NHS Foundation Trust and a number of other sites across Europe.  The trial, in about 60 patients with ER+ metastatic breast cancer, will assess the potential reversal of resistance to hormone therapy and the impact on clinical benefit.  The trial is designed to also create the opportunity to potentially stratify and help select patients best suited for treatment with SFX-01.

SFX-01 in subarachnoid haemorrhage (SAS:  SFX-01 After Subarachnoid Haemorrhage)

Subarachnoid haemorrhage (SAH) is a form of stroke, characterised by a bleed into the subarachnoid space around the outside of the brain.  It is a relatively rare condition, accounting for around 5% of strokes in the UK each year.  Owing to this rarity, SFX-01 could be eligible for orphan designation in Europe and the USA in this indication.

The Phase II trial, SAS, is a randomised, double blind, placebo controlled study comparing oral SFX-01 with placebo.  The trial will recruit 90 patients, 45 in each treatment arm with all patients receiving nimodipine, the current standard of care.  Patients will be dosed within 48 hours of experiencing SAH and approval has also been obtained in this study to provide for emergency dosing prior to consent.  The primary endpoints include safety, pharmacokinetics and efficacy.

Nimodipine has been generic for more than 20 years, during which time there have been no significant clinical advances in the treatment of SAH.  Whilst SAH is relatively rare, the market potential for this devastating condition, with its high unmet clinical need, is significant.  In October 2015, Credit Suisse (commissioned by a US peer) estimated potential peak sales of $1.7bn by 2032 for a Phase III development product based on the intraventricular delivery of a nimodipine-based formulation.

SFX-01 potentially represents a new class of drug in aneurysmal SAH with a mechanism of action that specifically targets the Nrf-2 pathway, which in turn reduces the oxidative stress and the toxicity caused by free haemoglobin from the haemorrhage.  Sulforaphane, the active ingredient of SFX-01, has been shown to be neuroprotective in multiple models of cerebral damage, including SAH. 

SAS recruited its first patient on 30 April 2016 and it is expected to report in H1 2018 (calendar year).  Further details of the study are available at: https://clinicaltrials.gov/ct2/show/study/NCT02614742

The Chief Investigator is Mr Diederik Bulters, Consultant Neurosurgeon and Honorary Senior Clinical Lecturer, at the Wessex Neurological Centre in Southampton.             

SFX-01 in multiple sclerosis

The principal mechanism of action of SFX-01 in SAH is via sulforaphane's ability to upregulate the Nrf2 pathway, resulting in a wide range of antioxidant and anti-inflammatory effects.  It is this pathway that is implicated in Biogen's oral treatment for multiple sclerosis, BG-12 known as Tecfidera^®.  In April, Biogen announced first-quarter sales of $946 million for Tecfidera^®, up 15% from last year.  The preclinical study on SFX-01 versus BG12 (Biogen's Tecfidera^®) in various animal models of RR-MS (relapsing remitting multiple sclerosis) has commenced and is due to report in the latter part of 2016.

Early stage pipeline

SFX-01 is a synthetic and stable sulforaphane, which has been shown to have excellent pharmacokinetics and a bioavailability of around 80%.  When the synthetic sulforaphane is released from its sugar lattice it has the same half-life in the body as naturally occurring sulforaphane and has been shown to be equipotent.

Medicinal chemists at the University of Seville have created a range of novel compounds based upon the sulforaphane core structure.  In the year under review, Evgen Pharma announced that it had exercised its option to in-license the Seville intellectual property presenting the Group with more than 60 new chemical entities based upon sulforaphane.  Patent protection for these compounds is pending in Europe, United States, China, Japan, Australia, and Canada and is already granted in Spain.  This month saw the initiation of a new collaboration between Evgen Pharma, University of Seville, the Spanish National Research Council (CSIC) and the University of Liverpool - the objective being to synthesise new compounds and screen for activity, with the first results expected in early 2017.

KEY PERFORMANCE INDICATORS

The Group's Key Performance Indicators include a range of financial and non-financial measures.  Details about the progress of our development programs (non-financial measures) are included elsewhere in this Operational Review, and below are the other indicators (financial measures) considered pertinent to the business.

Year-end cash, short term investments and cash on deposit held: £7.1m              (2015: £0.2m)

Increase in year-end cash, short term investments and cash on deposit held following equity placings in August and October 2015.

Cash flows (including short term deposits): Net inflow (outflow) of £6.9m          (2015: (£0.2)m)

Reflecting the successful equity placings in August and October 2015.

Operating loss: £2.4m                                                                                                                    (2015: £1.2m)

Reflecting the increased activity since admission to AIM in October 2015.

PEOPLE

We were delighted to welcome Dr Alan Barge to the Board as a Non-executive Director at the time of our admission to AIM in October.  Alan, who has worked in a consultancy role with Evgen Pharma since 2013, is a highly experienced pharmaceutical executive with particular experience of oncology.  He is currently Chief Medical Officer at Singapore-based ASLAN Pharmaceuticals PTE and a former Clinical Vice President and Head of Oncology and Infection at AstraZeneca.  Alan was recently appointed the Company's interim Chief Medical Officer, following the departure of Dr Hamina Patel, who had been part-time Chief Medical Officer since January 2016.

We would like to take this opportunity to welcome David Chadwick, who joined recently as our Senior Clinical Study Manager having previously worked as Senior Clinical Project Manager for Quintiles.

We thank all our academic and clinical partners, suppliers and staff for their continued support and enthusiasm.  We would also like to thank our investors for their continued support.

OUTLOOK

The outlook for Evgen Pharma is positive, with all programmes on track and with sufficient capital to complete the two principal Phase II trials. 

The STEM trial is expected to receive a Clinical Trial Approval in the summer and is anticipated to commence recruitment later in 2016.  STEM is expected to report in the first half of 2018 although interim efficacy readouts are possible with the trial design.  The success of the IPO in 2015 has allowed us to expand the scope of the STEM trial and it is now going to be a multi-centre study (c. 60 patients) and will look at SFX-01 in combination with three different endocrine therapies (i.e. three arms to the study).

The SAS trial is also scheduled to report in the first half of 2018 and is expected to have an interim safety read out in late 2016. 

We look forward to the future with confidence.

Barry Clare                                                                                          Dr Stephen Franklin

Chairman                                                                                            CEO

27 May 2016                                                                                       27 May 2016

FINANCIAL REVIEW

The financial performance for the year ended 31 March 2016 was in line with expectations.

Losses

The total loss for the year was £3.1m (31 March 2015: £2.3m) including a charge for share based compensation of £0.5m (2015: £0.2m) and a finance charge related to a convertible loan of £0.8m (31 March 2015: £1.1m).  Non-recurring administrative expenses are composed of warrant charges (£0.3m) and IPO costs (£0.4m) (31 March 2015: aborted IPO costs £0.3m).  

Share based compensation

As part of the IPO process, a number of share options were granted to Directors and key personnel.  This had no cash impact on the results for the year, however accounting standards require this share based compensation to be recognised in the Consolidated Statement of Comprehensive Income, resulting in a charge of £0.5m (2015: £0.2m).  In addition, share based compensation of £0.3m (2015 - £nil) has been recognised in the Consolidated Statement of Comprehensive Income in connection with the issue of warrants at IPO.

Headcount

Average headcount of the Group for the year was 7 (2015: 7).

Taxation

The Group has elected to claim research and development tax credits under the small or medium enterprise research and development scheme.

Convertible loans

At the time of the admission to AIM convertible loans of £1.8m were converted to equity.

Share capital

Evgen Pharma plc was incorporated on 2 October 2014 and on that date 1 ordinary share of £2.00 was issued at par.

On 5 December 2014 12,595 ordinary shares of £2:00 each, 18,849 ordinary A shares of £2.00 each and 5,017 ordinary B shares of £2:00 each were allotted and issued to the shareholders of Evgen Limited.

On 26 August 2015 9,569 ordinary shares of £2.00 each were allotted to subscribers raising a total of £2 million (gross).

On 12 October 2015 each ordinary share of £2.00 each was converted into 800 ordinary shares of £0.0025 each, each ordinary A share of £2.00 each was converted into 800 A shares of £0.0025 each and ordinary B share of £2.00 each was converted into 800 B shares of £0.0025 each.  Following this there were 17,732,000 ordinary shares, 15,079,200 A shares and 4,013,600 B shares in issue.

On 21 October 2015 7,776,918 ordinary shares were issued in connection with a bonus issue.

On 21 October 2015 6,553,330 A shares and 2,796,895 ordinary shares were issued in connection with the conversion of loan notes.

On 21 October 2015 all A shares and B shares then in issue were converted to ordinary shares, immediately following this conversion there were 53,951,943 ordinary shares in issue.

On 21 October 2015, following admission to AIM, 18,918,919 ordinary shares of £0.0025 were issued at a price of £0.37 raising £7 million which after share issue expenses of £0.7 million gave net consideration of £6.3 million.

On 14 January 2016 272,000 ordinary shares were issued in connection with the exercise of share options.

Cash flows and financial position

The cash (including short term deposits) position at 31 March 2016 increased to £7.1m (31 March 2015: £0.2m), reflecting the successful completion of an equity fund raising in August 2015 which raised £2.0m (£1.9m after expenses) and the fact that on 21 October 2015 the Company was admitted to trading on AIM after raising £7m (£6.3m after expenses) in an oversubscribed placing.  On admission the convertible loan and associated accrued interest was converted into ordinary shares of £0.0025 each. 

Barry Clare                                                                                          Dr Stephen Franklin

Chairman                                                                                            CEO

27 May 2016                                                                                       27 May 2016

Consolidated Statement of Comprehensive Income

for the year ended 31 March 2016

					Unaudited
			Year		Year
		Ended			Ended
		31 March			31 March
		2016			2015
	Note	£'000			£'000
Operating expenses
Operating expenses		(1,232)			(796)
Share based compensation		(519)			(155)
Non-recurring administrative expenses		(683)			(295)
Total operating expenses		(2,434)			(1,246)
Operating loss		(2,434)			(1,246)
Finance income		8			-
Finance expense		(791)			(1,057)
Loss on ordinary activities before taxation		(3,217)			(2,303)
Taxation		85			30
Loss and total comprehensive expense attributable		(3,132)			(2,273)
to equity holders of the parent for the year
Loss per share attributable to equity holders of the parent (pence)
Basic loss per share	5	(6.29)			(7.79)
Diluted loss per share	5	(6.29)			(7.79)

Consolidated Statement of Financial Position

as at 31 March 2016

		Unaudited
		As at	As at
		31 March	31 March
		2016	2015
	Note	£'000	£'000
ASSETS
Non-current assets
Property, plant and equipment		6	1
Intangible assets		74	45
Total non-current assets		80	46
Current assets
Trade and other receivables		79	117
Current tax receivable		115	30
Short-term investments and cash on deposit		2,006	-
Cash and cash equivalents		5,120	163
Total current assets		7,320	310
Total assets		7,400	356
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables		313	477
Loans		-	3
Total current liabilities		313	480
Non-current liabilities
Loans		-	1,063
Total non-current liabilities		-	1,063
Equity
Ordinary shares	6	183	73
Share premium	6	10,495	-
Merger reserve		2,067	2,067
Shares to be issued		-	1,750
Share based compensation		1,267	466
Retained deficit		(6,925)	(5,543)
Total equity attributable to equity holders of the parent		7,087	(1,187)
Total liabilities and equity		7,400	356

Consolidated Statement of Changes in Equity

for the year ended 31 March 2016

Attributable to ordinary shareholders
				Shares	Share
	Ordinary	Share	Merger	to be	based	Retained deficit
	shares	premium	Reserve	issued	compensation		Total
	£'000	£'000	£'000	£'000	£'000	£'000	£'000
Balance at 31 March 2014	73	-	2,067	1,000	311	(3,270)	181
Total comprehensive expense	-	-	-	-	-	(2,273)	(2,273)
for the period
Transactions with owners
Equity element of loan note	-	-	-	750	-	-	750
Share based compensation - share options	-	-	-	-	155	-	155
Total transactions with owners	-	-	-	750	155	(2,273)	(1,368)
Balance at 31 March 2015	73	-	2,067	1,750	466	(5,543)	(1,187)
Total comprehensive expense	-	-	-	-	-	(3,132)	(3,132)
for the period
Transactions with owners
Equity element of loan note	-	-	-	(1,750)		1,750	-
Share based compensation - share options	-	-	-		519	-	519
Share based compensation - warrants	-	-	-	-	282	-	282
Share issue - cash	19	1,840	-	-	-	-	1,859
Share issue - cash	47	6,645	-	-	-	-	6,692
Share issue - loan note conversion	23	2,017	-	-	-	-	2,040
Share issue - bonus issue	20	(20)	-	-	-	-	-
Share issue - options exercised	1	13	-	-	-	-	14
Total transactions with owners	110	10,495	-	(1,750)	801	1,750	11,406
Balance at 31 March 2016	183	10,495	2,067	-	1,267	(6,925)	7,087

Consolidated Statements of Cash Flows

for the year ended 31 March 2016

	Unaudited
	Year	Year
	Ended	Ended
	31 March	31 March
	2016	2015
	£'000	£'000
Cash flows from operating activities
Loss for the period	(3,217)	(2,303)
Finance expense	791	1,057
Depreciation and amortisation	8	7
Share based compensation	801	155
	(1,617)	(1,084)
Changes in working capital
Increase in trade and other receivables	(47)	(20)
Increase in trade and other payables	104	101
Cash used in operations	57	81
Taxation received	-	103
Net cash used in operating activities	(1,560)	(900)
Cash flows from investing activities
Acquisition of intangible assets	(36)	-
Purchase of property, plant and equipment	(6)	(1)
Short-term investments and cash on deposit	(2,006)	-
Net cash (used in)/generated from investing activities	(2,048)	(1)
Cash flows from financing activities
Proceeds from issue of shares	9,014	-
Issue costs	(449)	-
Proceeds from issue of convertible loan notes	-	750
Net cash generated from financing activities	8,565	750
Movements in cash and cash equivalents in the period	4,957	(151)
Cash and cash equivalents at start of period	163	314
Cash and cash equivalents at end of period	5,120	163

1.     General information

EVGEN PHARMA PLC ('Evgen' or 'the Company') is a public limited company incorporated in England & Wales and is admitted to trading on the AIM market of the London Stock Exchange under the symbol EVG. The address of its registered office is Liverpool Science Park Innovation Centre 2, 146 Brownlow Hill, Liverpool, Merseyside L3 5RF.  The principal activity of the Company is clinical stage drug development

2.     Basis of preparation and significant accounting policies

The financial information set out herein does not constitute statutory accounts as defined in Section 434 of the Companies Act 2006.  The financial information for the year ended 31 March 2016 has been extracted from the Group's audited financial statements which were approved by the Board of Directors on 31 May 2016 and which, if adopted by the members at the Annual General Meeting, will be delivered to the Registrar of Companies for England and Wales. 

Unaudited statutory accounts for Evgen Limited for the year ended 31 March 2015, prepared under UK GAAP, were approved by the Board on 28 June 2015 and delivered to the Registrar of Companies.

The report of the auditor on the 31 March 2016 financial statements was unqualified, did not include any references to any matters to which the auditors drew attention by way of emphasis without qualifying their report and did not contain a statement under Section 498(2) or Section 498(3) of the Companies Act 2006.

The information included in this preliminary announcement has been prepared on a going concern basis under the historical cost convention, and in accordance with International Financial Reporting Standards (IFRSs) as adopted by the EU and the International Financial Reporting Interpretations Committee (IFRIC) interpretations issued by the International Accounting Standards Board ("IASB") that are effective or issued and early adopted as at the date of these financial statements and in accordance with the provisions of the Companies Act 2006.

The information in this preliminary statement has been extracted from the audited financial statements for the year ended 31 March 2016 and as such, does not contain all the information required to be disclosed in the financial statements prepared in accordance with the International Financial Reporting Standards ('IFRS').

This announcement was approved by the board of directors and authorised for issue on 27 May 2016.

3.     Going concern

As part of their going concern review the Directors have followed the guidelines published by the Financial Reporting Council entitled ''Guidance on Risk Management and Internal Control and Related Financial and Business Reporting''.

The Directors have prepared detailed financial forecasts and cash flows looking beyond 12 months from the date of approval of this financial information. In developing these forecasts, the Directors have made assumptions based upon their view of the current and future economic conditions that will prevail over the forecast period.

On the basis of the above projections, the Directors are confident that the Group has sufficient working capital to honour all of its obligations to creditors as and when they fall due.  Thus they have adopted the going concern basis of accounting in preparing the financial information.

4.     Segmental information

Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker is responsible for allocating resources and assessing performance of operating segments.

The Directors consider that there are no identifiable business segments that are subject to risks and returns different to the core business. The information reported to the Directors, for the purposes of resource allocation and assessment of performance is based wholly on the overall activities of the Group. The Group has therefore determined that it has only one reportable segment under IFRS 8.

5.     Loss per share

Basic loss per share is calculated by dividing the loss for the period attributable to equity holders by the weighted average number of ordinary shares outstanding during the year.

For diluted loss per share, the loss for the year attributable to equity holders and the weighted average number of ordinary shares outstanding during the year is adjusted to assume conversion of all dilutive potential ordinary shares.

As at 31 March 2016 and 31 March 2015, the Group has no dilutive potential ordinary shares in issue.

The calculation of the Group's basic and diluted loss per share is based on the following data:

		Unaudited
	Year	Year
	Ended	Ended
	31 March	31 March
	2016	2015
	£'000	£'000
Loss for the year attributable to equity holders for basic loss and adjusted for the effects of dilution	(3,132)	(2,273)

	As at	As at
	31 March	31 March
	2016	2015
	Number	Number
Weighted average number of ordinary shares for basis loss per share	49,797,654	29,169,600
Effects of dilution:
Share options	-	-
Weighted average number of ordinary shares adjusted for the effects of dilution	49,797,654	29,169,600

	Year	Year
	Ended	Ended
	31 March	31 March
	2016	2015
	Pence	Pence
Loss per share - basic and diluted	(6.29)	(7.79)

The loss and the weighted average number of ordinary shares for the years ended 31 March 2015 and 2016 used for calculating the diluted loss per share are identical to those for the basic loss per share. This is because the outstanding share options would have the effect of reducing the loss per ordinary share and would therefore not be dilutive under the terms of International Accounting Standard (''IAS'') No 33.  The number of shares included in the comparative figures for 2015 has been adjusted to take into account the share restructuring performed in the year ended 31 March 2016.

6.     Share issues

Ordinary shares

		Company
		Share
		Capital
	Number	£'000
Issued and fully paid
Issued subscriber shares	1	-
Issued on acquisition of Evgen Limited	36,461	73
Issued for cash consideration	9,569	19
Subdivision of shares	36,778,769	-
Issued on loan conversion	9,350,225	23
Bonus issue	7,776,918	20
Issued under placing agreement	18,918,919	47
Issued on exercise of options	272,000	1
At 31 March 2016	73,142,862	183

On 2 October 2014 the Company was incorporated with one ordinary share of £2.00 was subscribed for £nil paid.

On 5 December 2014 the Company entered into an agreement to acquire the entire share capital of Evgen Limited, satisfied by the issue of 12,595 ordinary shares of £2.00 each, 18,849 ordinary A shares of £2.00 each and 5,017 ordinary B shares of £2.00 and the original ordinary share credited as being fully paid.

On 26 August 2015 9,569 ordinary shares of £2.00 each were allotted to subscribers raising a total of £2 million (gross).

On 12 October 2015 each ordinary share of £2.00 each was converted into 800 ordinary shares of £0.0025 each, each ordinary A share of £2.00 each was converted into 800 A shares of £0.0025 each and ordinary B share of £2:00 each was converted into 800 B shares of £0.0025 each.  Following this there were 17,732,000 ordinary shares, 15,079,200 A shares and 4,013,600 B shares in issue.

On 21 October 2015 7,776,918 ordinary shares were issued in connection with a bonus issue.

On 21 October 2015 6,553,330 A shares and 2,796,895 ordinary shares were issued in connection with the conversion of loan notes.

On 21 October 2015 all A shares and B shares then in issue were converted to ordinary shares, immediately following this conversion there were 53,951,943 ordinary shares in issue.

On 21 October 2015, following admission to the Alternative Investment Market of the London Stock Exchange, 18,918,919 ordinary shares of £0.0025 were issued at a price of £0.37 raising £7 million which after expenses of £0.7 million gave net consideration of £6.3 million.

On 14 January 2016 272,000 ordinary shares were issued in connection with the exercise of share options.

The Group and Company does not have an authorised share capital as provided by the Companies Act 2006.

7.     Related parties

Transactions between the Company and its subsidiaries, which are related parties, have been eliminated on consolidation and are not disclosed in this note.

During the year ended 31 March 2016, the Group purchased consultancy services totalling £46,750 (Year ended 31 March 2015: £13,500) from Clarat Partners LLP, a partnership of which Barry Clare, a director, is a member. The amount owed to Clarat Partners LLP at 31 March 2016 was £nil (31 March 2015: £nil).

During the year ended 31 March 2016, the Group purchased consultancy and accounting services totalling £50,840 (Year ended 31 March 2015: £13,000) from Bradshaw Daniel Limited, a company controlled by John Bradshaw, a director. The amount owed to Bradshaw Daniel Limited at 31 March 2016 was £2,556 (31 March 2015: £1,217).

During the year ended 31 March 2016, the Group was charged monitoring and director fees totalling £20,104 (Year ended 31 March 2015: £21,000) from SPARK Impact Limited, manager of North West Fund for Biomedical, a shareholder. The amount owed to SPARK Impact, manager of North West Fund for Biomedical at 31 March 2016 was £nil (31 March 2015: £nil).

During the year ended 31 March 2016, the Group was charged monitoring and director fees totalling £21,451 (Year ended 31 March 2015: £21,000) from Enterprise Ventures Limited, manager of Rising Stars Growth Fund II, a shareholder. The amount owed to Enterprise Ventures Limited, manager of Rising Stars Growth Fund II at 31 March 2016 was £nil (31 March 2015: £nil).

8.     Report and accounts

A copy of the Annual Report and Accounts will be sent to all shareholders with notice of the Annual General Meeting shortly and will also be available to download from the Group's website at www.evgen.com.

 

END

 

 

FR EAESEDDXKEAF