Evgen Pharma plc

06/13/2019 | Press release | Distributed by Public on 06/13/2019 00:32

Full Year Results

For immediate release 13 June 2019

Evgen Pharma plc

('Evgen', the 'Company' or the 'Group')

Final Results for the year ended 31 March 2019

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 2019.

Highlights

§ Clinical proof of concept clearly demonstrated in final top line data released from STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer) Phase IIa clinical study

§ Dosing and three month visits completed in ongoing SAS (SFX-01 After Subarachnoid Haemorrhage) Phase IIb clinical study. Results expected in Q3 or early Q4 of this calendar year

§ SFX-01 featured in a Nature Reviews Drug Discovery as a prominent Nrf2/KEAP1 activator

§ Susan Clement-Davies, ex-Torreya and Citigroup, appointed as Non-Executive Director

§ First European notice of grant for SFX-01 composition of matter patent

§ Financial performance in line with expectations:

- Total comprehensive loss of £2.6m(2018: loss of £2.6m)

- Net cash outflow of £1.6m(2018: outflow of 0.2m)

- Cash and short-term investments and cash on deposit at 31 March 2019 of £2.0m (31 March 2018: £3.6m)

§ Heavily oversubscribed fundraising in May 2019 raised £5.0m before expenses

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

'This has been an exciting year for Evgen. With our positive Phase II breast cancer data already announced, and further clinical data due this year, we look forward to maintaining the momentum in our development programmes and continuing to create value in the business.'

This announcement contains inside information as contained in Article 7 of the Market Abuse Regulation No. 596/2014.

Enquiries:

Evgen Pharmaplc

Dr Stephen Franklin, CEO

Richard Moulson, CFO

www.evgen.com

c/o +44 (0) 20 7466 5000

finnCap

Geoff Nash, Teddy Whiley (Corporate Finance)

Alice Lane, Manasa Patil (ECM)

www.finncap.com

+44 (0) 20 7220 0500

WG Partners LLP

Nigel Barnes, Claes Spång

+44 (0) 20 3705 9330

Buchanan

Mark Court, Sophie Wills, Tilly Abraham

[email protected]

+44 (0) 20 7466 5000

Notes for editors:

About Evgen Pharma plc

Evgen is a clinical stage drug development company whose lead programmes are in breast cancer and subarachnoid haemorrhage, a type of stroke. 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 commenced operations in January 2008 and has its headquarters at The Colony, Wilmslow, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. 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

Evgen has made considerable progress during the past year. Patient enrolment and treatment was completed in both Phase II trials of our lead product candidate, SFX-01. These comprised a Phase IIa trial in metastatic breast cancer (''mBC'') and a Phase IIb trial in subarachnoid haemorrhage ('SAH').

Most importantly, we released top line data from the mBC trial that clearly demonstrated clinical proof of concept for SFX-01. SFX-01 was well tolerated and was effective at stabilising disease and inducing responses in patients whose disease has progressed on hormonal therapies. The data provide the impetus to embark on randomised studies in these populations of breast cancer patients, which we are currently planning. This result is particularly gratifying given the advanced nature of the disease in the patient group treated. Whilst the efficacy data has been well-received by clinicians and other informed commentators we have also been much encouraged by the safety and tolerability profile which is unusually good for an oncology product. This positions SFX-01 for use alongside existing breast cancer drugs in a number of different treatment pathways.

We stepped up our attendance at international conferences during the year, presenting at The World Orphan Drug Congress in the US, the San Antonio Breast Cancer Symposium 2018 and at a closed meeting in Madrid - the latter meeting included senior scientists from pharmaceutical companies and academia with a common interest in the Nrf-2 pathway. This was followed by inclusion of SFX-01 in a Nature Reviews Drug Discovery paper focussing on the Nrf-2/ KEAP1 pathway, in which scientific interest is escalating and for which SFX-01 is a potent activator.

Early data from a collaboration with Imperial College has provided further insight into the potential mechanism of action of SFX-01 in mBC, identifying potential biomarkers for determining the efficacy of SFX-01 in this indication.

We were very pleased with the oversubscribed fundraising completed in May 2019 which achieved £5.0m before expenses in difficult market conditions. This provides us with a strengthened balance sheet; the resources to undertake product formulation that will facilitate the next mBC trial and other investigator-led clinical studies; and funds to complete further toxicology studies that will remove current restrictions on the duration of clinical trial treatment phases.

During the current financial year we expect to report secondary endpoints from the mBC trial and the full read-out from our SAH trial. We also anticipate an agreement to support at least one investigator-led Phase II trial in a new indication. There are therefore a number of events that could lead to substantial value enhancement in the business.

CHAIRMAN AND CHIEF EXECUTIVE OFFICER'S REVIEW

OPERATIONAL OVERVIEW

Background

Evgen is developing a platform comprising expertise, intellectual property and clinical data, around a new class of pharmaceuticals based on a molecule called sulforaphane. Sulforaphane has attracted huge scientific interest and has been shown to have anti-cancer and neuroprotective qualities in a wide range of preclinical and clinical studies, for example breast cancer, prostate cancer, multiple sclerosis and autism. In particular, we are seeking to exploit sulforaphane's modulation of two separate and unrelated mechanistic targets: Nrf2 and STAT3.

Evgen has exclusive rights to the only technology (Sulforadex®) 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.

Objective and strategy

Evgen's ambition is to be the world leader in sulforaphane and sulforaphane-like compounds, establishing a leading position in this new class of pharmaceuticals. The strategy to achieve this objective is to:

• continue clinical development of SFX-01 in SAH and metastatic breast cancer (see below);

• capitalise on the broad potential of SFX-01 by appraising and, if commercially appropriate, initiating clinical studies in additional cancer and neurological indications;

• support investigator-initiated studies (i.e. academic units typically with grant funding) in new areas to increase scientific understanding and expand the clinical applications of SFX-01 in a cost-effective manner (see below);

• expand our 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 when attractive terms are achievable;

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

Pipeline

SFX-01 IN BREAST CANCER

Breast cancer is the biggest cause of cancer deaths in women worldwide. In around 75% of breast cancers, the hormone oestrogen plays a key part in tumour growth. Such tumours express the oestrogen receptor (ER+) and, if the cancer is metastatic, endocrine therapy is the main treatment. It is thought that hormone independent cancer stem-like cells ('CSCs') are implicated in the development of resistance to hormone therapy and the spread of the disease by metastases. Since 2012, Evgen has worked with University of Manchester scientists at the Cancer Research UK Manchester Institute and together we have generated promising data showing SFX-01 reduces the number of CSCs 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 CSC population. Crucially, the data also showed that SFX-01 is unique, compared with existing therapies, in deactivating phosphorylated STAT3, a key agent in cancer proliferation and resistance to current standards of care.

STEM ('SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer') is a multi-centre, Phase IIa clinical trial led by Principal Investigator Dr Sacha Howell of the Christie Hospital in Manchester. The trial has completed, having treated 46 patients from 14 sites in the UK, France, Spain and Belgium. Top line data was released in March 2019 showing that trial the met its primary endpoints of safety/tolerability and clinical benefit rate (CBR) as measured by RECIST (Response Evaluation Criteria In Solid Tumours).

All STEM patients had been on endocrine therapy prior to entry to the trial and, having responded to such therapy for at least six months, then presented with progressive disease, thereby demonstrating the start of resistance to the hormone therapy. Once entered into the trial, patients continued to receive their failing hormone therapy in addition to SFX-01 and have regular scans through to week 24. Patients discontinued the trial when one of the scans shows disease progression or at week 24.

After 24 weeks, for responding patients, there was a compassionate use programme that provides continued access to SFX-01 with follow-up for safety.

In March 2019 we announced top line final data from the trial demonstrating clinical proof of concept by showing that:

• SFX-01 can both stabilise and shrink endocrine resistant metastatic breast cancers;

• SFX-01 was well tolerated with no safety concerns arising.

In particular:

• The Clinical Benefit Rate across all patients was c. 24%;

• Disease stabilisation was seen in patients from all participating countries;

• An objective response was seen in 2 patients (4%), being a reduction in tumour size of at least 30% on one scan;

• 13 patients entered the compassionate use programme after 24 weeks.

The data showed an excellent and unusually good safety and tolerability profile for an anti-cancer drug. It was significantly better than that for everolimus or exemestane, drugs currently used at the same stage of the treatment pathway as that in which we anticipate SFX-01 being deployed.

In a subsequent independent review of the data, Dr Mary Stuart, a worldwide acknowledged expert in the breast cancer field, concluded:

'Patients participating in the STEM study had generally poor prognosis, with over 70% of patients having visceral disease. If these patients had remained on their therapy without any change, they would have continued to have unchecked disease progression. However, the STEM results show that SFX-01 has promising evidence of activity and suggests it may reverse resistance to endocrine therapy.'

We believe SFX-01 will initially be used in second-line mBC therapy where the market opportunity is substantial. We are working on a trial design to show benefit in this setting, likely to be a randomised, placebo-controlled phase IIb trial.

SFX-01 IN SUBARACHNOID HAEMORRHAGE

Aneurysmal SAH is a form of stroke, caused by a ruptured aneurysm which leads to a bleed in the subarachnoid space of the brain. It is a relatively rare condition, accounting for around 5% of all strokes. It is fatal in approximately 50% of cases with approximately 15% dying before they reach hospital. A delayed cerebral ischaemia (DCI), which happens 3-14 days after the initial haemorrhage, remains the single most important cause of morbidity and mortality in those patients that survive the initial bleed. Over 60% of surviving patients suffer some permanent neurological deficit.

Nimodipine, the current standard of care, is a generic and has been used 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.

SFX-01 is aimed at reducing the neurological damage associated with the DCI via the up-regulation of the Nrf2-ARE (nuclear factor erythroid2-related factor 2-antioxidant response element) pathway. Sulforaphane, the active principal in SFX-01, is a well-known activator of the Nrf2-ARE pathway which plays a protective role in many physiological stress processes such as inflammatory damage, oxidative stress, and the accumulation of toxic metabolites, which are all involved in the DCI following SAH. The trial is a double-blind, placebo-controlled study of 90 patients; 45 receiving nimodipine and placebo and 45 receiving nimodipine and SFX-01. The primary endpoints are Transcranial Doppler (essentially blood flow as measured by ultrasound through the brain's blood vessels and a measure of the DCI), safety and pharmacokinetics.

Importantly, secondary endpoints include a cognitive measurement of clinical improvement ('the modified Rankin Scale') assessed at 7, 28, 90 and 180 days post haemorrhage. Potential follow-on studies would almost certainly have primary clinical endpoints based on such clinical outcomes.

The trial has completed the recruitment, treatment and 3 month assessment phases, leaving a small number of patients still awaiting their 6 month cognitive assessments. Patients were recruited from 3 centres: University Hospital Southampton, Western General Hospital in Edinburgh and St Bartholomew's Hospital in London.

As announced in March 2019 we have decided to announce the primary endpoints (safety, tolerability and measures of blood flow in the brain) and secondary endpoints (relating to cognitive function) at the same time, rather than announcing them separately as previously indicated. This approach fully protects the blinded integrity of the secondary endpoint data which continues to be collected post-dosing for six months from the initial haemorrhage. We anticipate the read-out to be at the end of Q3 or early Q4 of this calendar year.

Preclinical work and investigator-led clinical studies

In addition to our core in-house programmes, we continue to support academic research and we will facilitate investigator-initiated studies (completely or largely funded by the investigator or relevant charities) to broaden the range of applications for SFX-01 and increase our mechanistic understanding in these different disease areas.

Currently, we are working with research groups conducting pre-clinical work to investigate the potential of SFX-01, inter alia, in; triple negative breast cancer (University of Manchester, UK), prostate cancer (Tulane University, US), glioblastoma (University of L'Aquila, Italy), osteoarthritis (RVC, University of London, UK) and ischaemic stroke and autism (both at King's College London, UK). Furthermore, we are working with the University of Dundee to support their grant applications which could potentially finance a clinical trial in patients with non-alcoholic steatohepatitis (NASH), a form of fatty liver disease.

Data from an earlier collaboration with the University of Southampton was published showing that SFX-01 reduces residual disability after experimental autoimmune encephalomyelitis (a model for multiple sclerosis) both prophylactically and after disease induction.

We are hopeful that some of these projects will progress into clinical evaluation over the next few years funded by third parties.

Finally, we have a mechanistic collaboration with Imperial College London to use advanced chemical proteomics technology to detect targets for SFX-01 and other sulforaphane analogues in live cells or tissues in specific disease model systems. This should provide greater understanding of mechanism(s) of action and contribute data important for current and future clinical development. The first data from this collaboration was presented at the end of March providing further elucidation of the potential mechanism of action of SFX-01 in metastatic breast cancer, and suggesting biomarkers for determining the efficacy of SFX-01 in this indication. In particular, that SFX-01 influences growth hormone signalling and that phosphorylated STAT3 and, interestingly, MIF (macrophage migration inhibitory factor) may be a useful biomarker for response to SFX-01.

Recent advances in sulforaphane science

In the calendar year 2018 there were 233 scientific publications studying sulforaphane, up from 184 in 2017 (source: Pubmed). Some highlights include:

• Sulforaphane has been shown, again, to suppress the growth of triple negative breast cancer stem-like cells in in-vitro and in-vivo (Castro et al., Cancer Prev Res, 2019). The researchers, based at the NCI (National Cancer Institute) in the United States, found that sulforaphane significantly decreased the expression of cancer-specific and various stem cell markers, and concluded that it warrants clinical evaluation;

• The preclinical and clinical evidence associated with sulforaphane as a potential treatment for autism continues. Nadeen et al. (Behav Brain Res, 2019) showed that sulforaphane ameliorated autism-like symptoms in a preclinical animal model through the activation of Nrf-2 which (a) suppressed Th17 related signalling and (b) rectified the oxidant-antioxidant imbalance in periphery and brain in a preclinical model; Th17 immune responses and oxidative stress are reported to be elevated in human autistic subjects. Furthermore, in a small open label clinical study Bent et al. (Mol Autism, 2018) dosed children with autism for 12 weeks with a frozen botanical extract containing sulforaphane. There was a statistically significant improvement in social responsiveness (Social Responsiveness Scale-SRS) from baseline and changes in urinary metabolites were correlated with changes in symptoms;

• A number of recent studies point towards sulforaphane as a potential treatment for neuropsychiatric disorders, including schizophrenia. Excess oxidative stress is increasingly thought to participate in the pathophysiology of brain disorders, and decreases in the major antioxidant, glutathione (GSH), have been reported in multiple studies. Activation of Nrf-2 leads to increased expression of genes that produce GSH. Sedlak et al. (Mol Neuropsychiatry, 2018) reported that sulforaphane increased GSH levels in the blood and specific areas of the brain in healthy human subjects following 7 days of daily oral administration. The publication concludes with the statement: 'This clinical pilot study suggests the value of exploring relationships between peripheral GSH and clinical/ neuropsychological measures, as well as the influences sulforaphane has on functional measures that are altered in neuropsychiatric disorders.'.

INTELLECTUAL PROPERTY UPDATE

During, and since, the last reporting period our IP portfolio has been further 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 and Hong Kong and further applications are pending in Japan, EU and Hong Kong;

• The principal manufacturing patent application, entitled 'Methods of Synthesising Sulforaphane' is granted in Australia, China, Europe, Japan and the US 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.

In May 2018, in an important development, the Group gained a patent in Europe containing claims to a particular method of stabilising sulforaphane by complexation with alpha-cyclodextrin; a similar divisional application remains pending in Japan. In April 2019, the Group also received notification of the intention to grant a compositional patent in Europe directed to a composition comprising a complex of sulforaphane and alpha-cyclodextrin. The Group has long held broad compositional patent protection in the United States since patent grant in 2011 and in Canada since grant in 2014.

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 Review, and below are the other indicators (financial measures) considered pertinent to the business.

2019 (£m)

Year-end cash and short-term investments and cash

on deposit held: (2018: £3.6m)

2.0

The reduction in year-end cash reflects working capital, pre-clinical and clinical expenditures during the year offset in part by the fundraising in October 2018 which raised £750k before expenses.

2019 (£m)

Net cash outflow (including short-term investments)
(2018 outflow: £0.2m)

1.6

The net cash outflow again reflects working capital, pre-clinical and clinical expenditures during the year offset in part by the fundraising completed during the year.

2019 (£m)

Operating loss: (2018: £3.0m)

3.1

The operating loss reflects pre-clinical and clinical activity in the year and related product manufacture.

PEOPLE

We were delighted to welcome Susan Clement-Davies as a non-executive director. Susan brings a wealth of experience in capital markets, M&A and licensing/partnering, particularly in the life science sector, from her time with Citigroup and Torreya. We would like thank Marc D'Abbadie, who resigned from the Board in November 2018, for his support and contribution which has been much appreciated.

Financial review

The financial performance for the year ended 31 March 2019 was in line with expectations.

Losses

The total loss for the year was £2.6m (31 March 2018: £2.6m) including a charge for share-based compensation of £0.1m (2018: £0.1m). Operating expenses excluding share based compensation increased slightly to £3.0m (2018: £2.9m) reflecting similar levels of both clinical activity and general and administrative 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. This amounted to £0.1m (2018: £0.1m) and has no impact on cash flows.

Headcount

Average headcount of the Group for the year was 8 (2018: 9).

Taxation

The Group has elected to claim research and development tax credits under the small or medium enterprise research and development scheme of £0.49m (2018: £0.44m).

Share capital

In October 2018, 5,555,558 ordinary shares of 0.25p each were issued pursuant to a placing to existing and new shareholders at 13.5p per share. The placing raised £0.75m before expenses.

A total of 158,918 ordinary shares of 0.25 p each were issued pursuant to exercises of share options granted under individual share option grants. These options had exercise prices of between nil and 10.6p per share.

A share placing was completed in May 2019 after the year end which raised £5.0m before expenses in difficult market conditions. This provides us with a strengthened balance sheet, the resources to undertake product formulation that will facilitate the next mBC trial and other investigator-led clinical studies, and funds to complete further toxicology studies that will remove current restrictions on the duration of clinical trial treatment phases. The placing comprised the issue of 33,333,329 ordinary shares of 0.25p each to existing and new shareholders at 15.0p per share.

Cash flows and financial position

The cash position at 31 March 2019 decreased to £2.0m (31 March 2018: £3.6m). Continued clinical expenditure on the two phase II trials of SFX-01 and recurring general and administrative costs were partially offset by the share placing proceeds (£0.75m before expenses) and receipt of the 2018 tax credit (£0.44m).

OUTLOOK

The outlook for Evgen is positive. Our metastatic breast cancer Phase II trial achieved its primary endpoints and we have a further Phase II trial to report in the current year in a different disease area. Furthermore, we support investigator-led academic studies in new disease areas and these are generating preclinical data which may ultimately support further trials, either of SFX-01 or novel analogues. These include further opportunities in cancer and neurology but also in other fields. All have considerable commercial opportunity and we look forward to the future with confidence.

Barry Clare Dr Stephen Franklin

Chairman Chief Executive Officer

Consolidated Statement of Comprehensive Income

for the year ended 31 March 2019

Notes

Year ended

31 March 2019

£'000

Year ended

31 March 2018

£'000

Operating expenses

Operating expenses

(2,985)

(2,915)

Share based compensation

(135)

(111)

Total operating expenses

(3,120)

(3,026)

Operating loss

(3,120)

(3,026)

Loss on ordinary activities before taxation

(3,120)

(3,026)

Taxation

496

443

Loss and total comprehensive expense attributable to equity holders of the parent for the year

(2,624)

(2,583)

Loss per share attributable to equity holders of the parent (pence)

5

Basic loss per share

(2.74)

(3.28)

Diluted loss per share

(2.74)

(3.28)

Consolidated Statement of Financial Position

as at 31 March 2019

Notes

As at

31 March 2019

£'000

As at

31 March 2018

£'000

ASSETS

Non-current assets

Property, plant and equipment

6

12

Intangible assets

98

113

Investments in subsidiary undertaking

-

-

Total non-current assets

104

125

Current assets

Trade and other receivables

135

77

Current tax receivable

492

432

Cash and cash equivalents

2,033

3,626

Total current assets

2,660

4,135

Total assets

2,764

4,260

LIABILITIES AND EQUITY

Current liabilities

Trade and other payables

688

389

Total current liabilities

688

389

Equity

Ordinary shares

6

247

233

Share premium

6

13,240

12,560

Merger reserve

6

2,067

2,067

Share based compensation

6

1,722

1,587

Retained deficit

6

(15,200)

(12,576)

Total equity attributable to equity holders of the parent

2,076

3,871

Total liabilities and equity

2,764

4,260

Consolidated Statement of Changes in Equity

for the year ended 31 March 2019

Ordinary

shares

£'000

Share

premium

£'000

Merger

reserve

£'000

Share

based

compensation

£'000

Retained

deficit

£'000

Total

£'000

Balance at 31 March 2017

183

10,495

2,067

1,476

(9,993)

4,228

Total comprehensive expense for the period

-

-

-

-

(2,583)

(2,583)

Transactions with owners

Share issue - cash

48

2,034

-

-

-

2,082

Share issue - options exercised

2

31

-

-

-

33

Share based compensation

- share options

-

-

-

111

-

111

Total transactions with owners

50

2,065

-

111

-

2,226

Balance at 31 March 2018

233

12,560

2,067

1,587

(12,576)

3,871

Total comprehensive expense for the period

-

-

-

-

(2,624)

(2,624)

Transactions with owners

Share issue - cash

14

668

-

-

-

682

Share issue - options exercised

-

12

-

-

-

12

Share based compensation

- share options

-

-

-

135

-

135

Total transactions with owners

14

680

-

135

-

829

Balance at 31 March 2019

247

13,240

2,067

1,722

(15,200)

2,076

Consolidated Statements of Cash Flows

for the year ended 31 March 2019

Year ended 31 March 2019

£'000

Year ended 31 March 2018

£'000

Cash flows from operating activities

Loss before taxation

(3,120)

(3,026)

Depreciation and amortisation

21

21

Share based compensation

135

111

(2,964)

(2,894)

Changes in working capital

(Increase)/decrease in trade and other receivables

(58)

7

Increase/(decrease) in trade and other payables

299

(125)

Cash used in operations

241

(118)

Taxation received

436

671

Net cash used in operating activities

(2,287)

(2,341)

Cash flows (used in)/generated from investing activities

Acquisition of tangible fixed assets

-

(7)

Net cash (used in)/generated from investing activities

-

(7)

Cash flows from financing activities

Proceeds from issue of shares

761

2,333

Issue costs

(67)

(218)

Net cash generated from financing activities

694

2,115

Movements in cash and cash equivalents in the period

(1,593)

(233)

Cash and cash equivalents at start of period

3,626

3,859

Cash and cash equivalents at end of period

2,033

3,626

1. General information

Evgen Pharma Plc ('Evgen' or 'the Company') is a public limited company incorporated and domiciled 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 2019 has been extracted from the Group's audited financial statements which were approved by the Board of Directors on 12 June 2019 and which, if adopted by the members at the Annual General Meeting, will be delivered to the Registrar of Companies for England and Wales.

The financial information for the year ended 31 March 2018 has been extracted from the Group's audited financial statements which were approved by the Board of Directors on 12 June 2018 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, 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.

The report of the auditor on the 31 March 2019 financial statements was unqualified and did not contain a statement under Section 498(2) or Section 498(3) of the Companies Act 2006.

This announcement was approved by the board of directors and authorised for issue on 12 June 2019.

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 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.

At 31 March 2019, the Group had cash and cash equivalents, including short-term investments and cash on deposit, of £2.0 million. Subsequent to the year end the Company received £5m before expenses through a share placing.

The Directors estimate that the cash held by the Group together with known receivables will be sufficient to support the current level of activities beyond the end of 2020.

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.

The results and assets for this segment can be determined by reference to the Consolidated Statement of Comprehensive Income and Consolidated Statement of Financial Position.

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 2019 the Group had 9,075,599 (2018: 8,665,255) share options which are outstanding and potentially dilutive.

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

Year ended
31 March 2019

£'000

Year ended
31 March 2018

£'000

Loss for the year attributable to equity holders for basic loss and adjusted for the effects of dilution

(2,624)

(2,583)

Year ended
31 March 2019

Number

Year ended
31 March 2018

Number

Weighted average number of ordinary shares for basic loss per share

95,857,230

78,697,455

Effects of dilution:

Share options

-

-

Weighted average number of ordinary shares adjusted for the effects of dilution

95,857,230

78,697,455

Year ended
31 March 2019

Pence

Year ended
31 March 2018

Pence

Loss per share - basic and diluted

(2.74)

(3.28)

The loss and the weighted average number of ordinary shares for the years ended 31 March 2018 and 2019 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.

Subsequent to the year end 33,333,329 ordinary shares were issued pursuant to a share placing. Had this event occurred during the reporting period the number of shares used in the loss per share calculation would have been significantly different.

6. Share issues

Ordinary shares

Company

Ordinary shares of 0.25p each

Number

Share Capital

£'000

At 31 March 2018

93,276,858

233

Issued on exercise of options

158,918

-

Issued under placing agreement

5,555,558

14

At 31 March 2019

98,991,334

247

On 10 July 2018 80,000 ordinary shares were issued in connection with the exercise of share options at an exercise price of 7.3p per share payable in cash.

On 18 October 2018 5,555,558 ordinary shares were issued at a price of £0.135 raising £0.8 million which after share issue expenses of £0.1 million gave net consideration of £0.7 million.

On 19 December 2018 18,918 ordinary shares were issued in connection with the exercise of nil cost share options. On the same date 60,000 share options were issued for cash at an exercise price of 10.612p per share.

Subsequent to the year end 33,333,329 ordinary shares were issued at a price of £0.15 raising £5.0 million which after share issue expenses of £0.3 million gave net consideration of £4.7 million.

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 2019 and 2018 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 parties

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 5 of the consolidated financial statements. Directors' emoluments are disclosed in the Remuneration Committee Report.

During the year ended 31 March 2019, the Group purchased services totalling £131,661 (year ended 31 March 2018: £187,822) from The Clinical Trial Company Limited, a company of which Richard Moulson, a Director, is also a Director. The amount owed to The Clinical Trial Company Limited at 31 March 2019 was £13,922 (31 March 2018: £2,077).

During the year ended 31 March 2019, the Group purchased consultancy services totalling £1,800 (year ended 31 March 2018: £nil) from Dr Alan Barge, a Director. The amount owed to Dr Alan Barge at 31 March 2019 was £nil (31 March 2018: £nil).

During the year ended 31 March 2019, the Group purchased consultancy services totalling £14,950 (year ended 31 March 2018: £17,970) from FD Consult Ltd, a company controlled by Richard Moulson. The amount owed to FD Consult Ltd at 31 March 2019 was £nil (31 March 2018: £nil).

During the year ended 31 March 2019, the Group was charged monitoring and Director fees totalling £15,986 relating to Marc D'Abbadie's services (year ended 31 March 2018: £26,500) by 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 2019 was £nil (31 March 2018: £nil).

8. 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.