20 August 2019
Scancell Holdings Plc
("Scancell" or the "Company")
Final Results for the year ended 30 April 2019
Immunotherapy pipeline advances; new investment provides further endorsement of future potential
Scancell Holdings plc, the developer of novel immunotherapies for the treatment of cancer, today announces its results for the year ended 30 April 2019.
Highlights:
· The Company received regulatory and ethical approval for the UK arm of the SCIB1 Phase 2 clinical trial
· Scancell exercised its option to a worldwide commercial licence for the use of Ichor Medical Systems' TriGrid® 2.0 electroporation delivery system with SCIB1
· Patents granted in Europe and Japan providing broad protection of Scancell's Moditope® technology; a patent granted in the US that provides protection for Modi-1; and a further European patent granted relating to FG88, a monoclonal antibody directed against tumour associated glycans
· Strategic research collaboration with the Rheumatology Unit at the Karolinska Institute expanded to explore the potential of Moditope® to develop multiple immunotherapeutic agents for a range of different cancers
· Pre-clinical development underway with Modi-2, including progress made in the characterisation of homocitrullinated peptides allowing Modi-2 to potentially address tumours with a particularly immunosuppressive environment
· Dr Samantha Paston appointed as Head of Research and Dr Adrian Parry appointed as Head of Manufacturing
· Professor Lindy Durrant received the Waldenström award from the Swedish Society of Oncology
· £1.1m raised in an open offer to shareholders, following a placing of £6.9m at the end of the previous financial year
· Loss for the 12-month period of £5.63 million (2018: loss: £4.19 million)
· Group cash balance at 30 April 2019 was £4.56 million (30 April 2018: £10.30 million)
Post Period Highlights:
· Initiation of the UK arm of the SCIB1 Phase 2 clinical trial in patients with advanced melanoma also receiving the checkpoint inhibitor pembrolizumab (Keytruda®); following withdrawal of the IND for the US arm of the study, the Company plans to re-submit this to allow for US patient recruitment to proceed in due course
· Gross proceeds of £3.9m raised by the issue of 77,559,311 new ordinary shares to Vulpes Life Sciences Fund
· Martin Diggle, Co-Founder and Portfolio Manager of Vulpes Investment Management, appointed to the Board of Directors as a Non-Executive Director
· Clinical Advisory Board established, chaired by Professor Robert Coleman, to provide strategic guidance around the Moditope® clinical development programme
· Modi-1 manufacturing and toxicity testing underway to support anticipated start of Phase 1/2 study in
H1 2020
· Cancer Research UK planning a Phase 1/2 trial to investigate the safety and efficacy of SCIB2
using a new nanoparticle formulation in patients with solid tumours
Cliff Holloway, CEO of Scancell, commented:
"We have made strong progress this year in advancing our pipeline of novel immunotherapies. Importantly, post period, we were pleased to initiate the UK arm of the SCIB1 Phase 2 trial, whilst disappointed with the need to withdraw our IND application to achieve this. We intend to resubmit the IND at the earliest opportunity.
We have expanded our R&D team and established a Clinical Advisory Board who will inform the clinical strategy for the planned Modi-1 trial in several solid tumour indications. We also welcome Vulpes as a significant shareholder and Board member. Vulpes' investment into Scancell provides further endorsement of the Company's future potential."
A full copy of the announcement can be found on the Scancell website: www.scancell.co.uk
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For Further Information:
Scancell Holdings Plc |
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Dr John Chiplin, Chairman |
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+44 (0) 20 3727 1000 |
Dr Cliff Holloway, CEO |
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Panmure Gordon (UK) Limited (Nominated Adviser and Corporate broker) |
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Freddy Crossley/Emma Earl |
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+44 (0) 20 7886 2500 |
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FTI Consulting Simon Conway/Natalie Garland-Collins |
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+44 (0) 20 3727 1000 |
About Scancell
Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.
ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system. They can be used as monotherapy or in combination with checkpoint inhibitors. This platform has the potential to enhance tumour destruction, prevent disease recurrence and extend survival.
· SCIB1, the lead programme, is being developed for the treatment of melanoma. A phase 1/2 clinical trial has so far successfully demonstrated survival data of more than five years.
· SCIB2 is being developed for the treatment of non-small cell lung cancer and other solid tumours. Scancell has entered into a clinical development partnership with Cancer Research UK for SCIB2.
Moditope® represents a completely new class of potent and selective immunotherapy agents. It stimulates the production of killer CD4 T cells which overcome the immune suppression induced by tumours, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system. Moditope® alone, or in combination with other agents, has the potential to treat a wide variety of cancers.
· Modi-1 is being developed for the treatment of multiple solid tumours.
For further details, please see our website: www.scancell.co.uk
CHAIRMAN'S STATEMENT
I am pleased to report the Company's final results for the year ended 30 April 2019. At the beginning of this financial year the Company raised £1.1m (net of costs) through an Open Offer to shareholders following an earlier fund raise of £6.9m (net of costs) and I'd like to thank our shareholders for their continued support. Since the year end the Company has raised a further £3.9m from Vulpes Life Science Fund through a subscription for new shares. This new investment capital increases funds available to advance our product pipeline and, in particular the transition of our lead Moditope® platform asset Modi-1 into the clinic. Progress has been made in all areas and we are particularly pleased that the SCIB1-002 clinical trial, which will assess the efficacy and safety of SCIB1 and pembrolizumab in patients with advanced melanoma, is now underway.
ImmunoBody® platform
Scancell's ImmunoBody® immunotherapy platform uses the body's immune system to identify, attack and destroy tumours. This is achieved by delivering a DNA plasmid to enhance the uptake and presentation of cancer antigens to harness high avidity T cell responses. Each ImmunoBodyÒ vaccine can be designed to target a particular cancer in a highly specific manner, offering the potential for enhanced efficacy and safety compared with more conventional approaches.
SCIB1 melanoma vaccine and Phase 2 clinical trial
As mentioned in last year's Annual Report, in July 2018, Scancell exercised its option to a worldwide commercial licence for the use of Ichor's proprietary TriGrid® 2.0 electroporation delivery system with SCIB1. This licence enables Scancell to use the TriGrid® 2.0, the proposed commercial version of this device, in the Phase 2 clinical study of Scancell's lead ImmunoBody®, SCIB1, in patients with advanced melanoma who are also receiving the checkpoint inhibitor pembrolizumab (Keytruda®). Although pembrolizumab is an approved therapy for advanced melanoma, response to treatment is limited to only a subset of patients (circa 30%). The Phase 2 study is therefore designed to assess whether the addition of SCIB1 treatment will result in an improvement in the tumour response rate, progression-free survival and overall survival in 25 patients with advanced melanoma who are also eligible for treatment with pembrolizumab.
As reported at the half year, following the submission of an Investigational New Drug (IND) application for the clinical study to the US Food and Drug Administration ("FDA" or "Agency"), the FDA had responded requesting additional information, with respect to Ichor's new TriGrid® 2.0 electroporation delivery system and its use in combination with SCIB1. Scancell has previously used Ichor's TriGrid® 1.0 delivery system in the SCIB1 Phase 1/2 clinical study in patients with Stage III/IV malignant melanoma. In this study SCIB1 was shown to have a favourable safety profile with no dose-limiting toxicities and no serious adverse events related to study drug or the delivery device, in addition to inducing strong immune responses and enhancing survival.
In order to initiate patient recruitment in the UK under the Investigational New Drug (IND) application submitted to the Agency, prior approval of the IND is required. Whilst there has been extensive dialogue between Ichor and the Agency, a timely resolution to the device-specific questions has yet to be agreed. Therefore, as reported on 19 August 2019, having considered the ethical issues related to patients awaiting enrolment into the UK sites, Scancell decided to withdraw its IND application in the US to allow the UK arm of the trial to proceed with immediate effect. Scancell will resubmit the IND at a later date with the intent to initiate clinical sites in the US, following further clarification from the Agency regarding Ichor's TriGrid® 2.0 delivery device.
SCIB2 vaccine
SCIB2, Scancell's second ImmunoBody® therapy, targets an antigen called NY-ESO-1, which is expressed on a range of solid tumours, including non-small cell lung cancer (NSCLC), oesophageal, ovarian, bladder and prostate cancers, as well as neuroblastoma, melanoma and sarcoma.
In May 2019 Scancell and Cancer Research UK provided an update on their clinical development partnership for the development of Scancell's ImmunoBody® vaccine, SCIB2, as a potential treatment for patients with solid tumours, including NSCLC.
Pre-clinical studies have demonstrated that administration of the SCIB2 DNA plasmid as a liposomal nanoparticle results in potent immune responses and prolonged survival. The nanoparticle technology utilises known lipid carriers that are optimised to deliver SCIB2 DNA to immune cells. The liposomal nanoparticles protect the DNA from degradation and facilitate efficient uptake, expression and T-cell activation against cancer cells. The nanoparticle delivery system provides an alternative approach to electroporation, which has been used to deliver the SCIB1 ImmunoBody® agent to patients. This new nanoparticle approach to deliver SCIB2 is expected to achieve results that are as effective as, or even better than, electroporation.
Cancer Research UK are now planning a clinical trial to investigate the safety and efficacy of the SCIB2-nanoparticle complex in patients with solid tumours.
Moditope® platform
Scancell's Moditope® is an immunotherapy platform targeting tumour associated stress-induced post-translational modifications (siPTMs) to stimulate the production of unprecedented killer T-helper cell (CD4 T-cells) responses that induce anti-tumour activity without toxicity. Moditope® vaccines comprise citrullinated or homocitrullinated tumour-associated peptide epitopes which stimulate the production of cytotoxic CD4 T-cells which identify, target and destroy the tumour cells. Pre-clinical studies have shown that conjugation of the Modi-1 peptides to Amplivant® enhances anti-tumour immune responses 10-100 fold and resulted in highly efficient tumour eradication, including protection against tumour recurrence.
Modi-1
Modi-1 consists of two citrullinated vimentin peptides and one citrullinated enolase peptide. Vimentin and enolase peptides are highly expressed in triple negative breast cancer (TNBC), ovarian cancer, head and neck cancer, as well as many other cancers.
A defined manufacturing process is a key component for CMC (Chemistry, Manufacturing and Control) regulatory submissions required to support the filing of a clinical trial application (CTA) in the UK. Good Manufacturing Practice (GMP) synthesis of the bulk Modi-1 peptide conjugates is underway at the PolyPeptide Group's facilities in The Netherlands. An agreement was signed with AMRI (Glasgow, UK), a global contract and manufacturing organisation, at the end of April 2019, to formulate, manufacture and package the Modi-1 GMP final product for clinical testing. The preclinical toxicity testing programme required prior to the start of the clinical trial is underway to support the planned Phase 1/2 clinical study, which is anticipated to commence in H1 2020.
Modi-2
Whilst Modi-1 acts by stimulating the production of CD4 T cells using citrullinated tumour-associated peptide epitopes, Modi-2 exploits a new modification, stimulating the production of cytotoxic CD4 T cells using homocitrullinated tumour-associated peptide epitopes. Whereas citrullination involves the conversion of the amino acid arginine to citrulline, the process of homocitrullination involves the conversion of lysine to homocitrulline. Scancell believes this second mechanism of action has the potential to broaden the utilisation of the Moditope® platform.
Modi-2 is currently in pre-clinical development and work is underway to characterise specific homocitrullinated peptides for clinical development that have the potential to address different cancer indications to Modi-1, including tumours with a particularly immunosuppressive environment.
The data generated to date clearly demonstrates the potential of homocitrullinated, as well as citrullinated, tumour-associated peptide epitopes to be developed for the treatment of solid cancers.
Collaborations
Scancell was pleased to extend its strategic research collaboration with the Rheumatology Unit at the Karolinska Institute, Sweden. The expanded agreement will explore the potential of the Moditope® platform to develop multiple immunotherapeutic agents for a range of different cancers. Scancell's research has shown that citrullinated proteins are involved in the control of tumour growth and we believe that this expanded collaboration will help us to further develop Moditope®, not only for use in cancer vaccines, but also other cancer immunotherapy approaches including T-cell receptor (TCR) based therapeutics which is also the subject of Scancell's research collaboration with BioNTech announced in January 2018.
Patents
The European Patent Office granted a European Patent for the Company's Moditope® Immunotherapy platform with effect from 13 June 2018. This patent provides broad protection for the Company's pipeline of Moditope® vaccines, including any citrullinated epitopes for the treatment of cancer, in all major European territories. This is a key patent for Scancell and endorses our work in identifying a new class of cancer vaccine capable of inducing potent immune responses to (siPTMs), in this case, through citrullination of cellular proteins.
A US patent was granted on 19 March 2019 and claims methods of stimulating an immune response to a tumour and methods of treating cancer using peptides included in the Modi-1 product. Additional claims that aim to protect other aspects of the Moditope® platform are being pursued in the US.
In April 2019, the Japanese Patent Office granted a patent that provides further protection for Scancell's Moditope® immunotherapy platform. This patent covers using any citrullinated tumour-associated T cell epitope to treat patients with cancer.
The grant of these patents is in addition to the grant of patents in South Africa and Australia, and acceptance for grant in China. Counterparts to these patents continue to be prosecuted in other territories of importance to Scancell in order to further expand Scancell's IP portfolio.
Clinical Advisory Board
In May 2019 the Group created a Clinical Advisory Board ('CAB') as part of a wider strategy to fully develop and deliver the full potential of the Moditope® platform across multiple tumour types. The CAB is chaired by Professor Robert Coleman, Emeritus Professor of Medical Oncology at Weston Park Hospital and the University of Sheffield and together with Professor Coleman includes a further five world-leading clinicians. The initial focus of the Board is to inform the clinical strategy for the planned Modi-1 clinical trial and to ensure the best possible outcome in several solid tumour indications, including ovarian cancer, head and neck cancer, and triple negative breast cancer.
Monoclonal antibodies
Monoclonal antibody therapeutics have proven to be effective in the treatment of many cancer indications and identification of new products against novel targets are highly sought after in the field. In April 2018, Scancell acquired, from the University of Nottingham, a number of novel monoclonal antibodies against tumour-associated glycans with the aim to further develop and identify lead therapeutic candidates.
Glycans are sugar molecules that are present on cell surface glycoproteins and glycolipids. The pattern of these glycans differ between tumour cells and healthy cells. Glycans are involved in regulation of many physiological processes and inhibition of these leads to rapid cell death. Antibodies that target such tumour glycan signatures therefore provide an attractive strategy for immunotherapy. The novel monoclonal antibody platform acquired by Scancell not only enables high avidity monoclonal antibodies recognising glycans to be developed but also provides a method to enhance their anti-tumour efficacy. This technology offers a new opportunity for collaboration and commercial transactions with antibody engineering companies looking for differentiated therapeutic targets.
Corporate
During the financial year Scancell announced the appointment of Dr Samantha Paston as Head of Research and Dr Adrian Parry as Head of Manufacturing. Dr Paston started in her role in mid-January 2019 and Dr Parry joined the Company in early February 2019. These two appointments are significant for Scancell as we expand our R&D and manufacturing capabilities in order to further advance our ImmunoBody® and Moditope® pipeline products through clinical development.
Staff
The Board recognises that the progress made over the year would not have been possible without the dedication and support of all our staff and, on behalf of the directors, I offer our thanks to them.
Financial
Profit or Loss and Other Comprehensive Income Statement
The Group made an operating loss for the year to 30 April 2019 of £6.73 million (2018: loss of £4.94 million).
There has been a significant increase in development expenditure to £4.15 million (2018: £2.86 million) and the main reasons for this are: the manufacture of a new GMP batch of SCIB1; the commencement of GMP manufacture of Modi-1; regulatory and set up costs arising as the Company prepares for the upcoming clinical trials with SCIB1 and Modi-1; together with the impact of a full year's cost of R&D staff who were recruited at the end of the 2017/18 year.
The increase in administrative expenditure is due to a significant increase in patent costs and licence fees. The increases in patent costs reflects the Company's continued protection and extension of its intellectual property portfolio.
The loss before taxation amounted to £6.87 million (2018: £4.94 million) The R&D tax credit increased to £1.09 million (2018: £0.74 million) as a result of the increased development expenditure in the year.
Overall the loss for the year was £5.63 million (2018: loss £4.19 million).
Statement of Financial Position
At 30 April 2019 the net assets of the Group amounted to £9.34 million (2018: £13.94 million) including cash at bank of £4.56 million (2018: £10.30 million).
The tax receivable due at the end of the year amounted to £1.83 million (2018: £0.74 million) and relates to the R&D tax credit for the 2018/19 and 2017/18 financial years. The amount outstanding in respect of the prior year was received in May 2019, shortly after the year end.
The increase in trade and other receivables to £678k (2018: £97k) arises as a result of an increase in pre-paid expenditure relating to the manufacture of Modi-1 which will be expensed during the 2019/20 financial year together with increased VAT recoverable as a result of increased expenditure on manufacturing during the last month of the financial year.
The trade and other payables haves also increased to £1.21 million (2018: £0.70 million) as a result of the increase in manufacturing and development expenditure in the last month of the year. All balances owing to suppliers at the end of the year were paid in accordance with their terms and conditions.
Consolidated Cash Flow Statement
As can be seen in the Consolidated Cash Flow Statement, the main reason for the decrease in cash over the previous year as that cash used in operations of £7.03 million (2018: £4.81 million) was offset by net proceeds from the issue of shares amounting to £1.28 million (2018: £11.70 million). In addition, the tax credit of £744k in respect of the prior year was not received until May 2019, after the year end.
Outlook
It has been a busy and productive year for Scancell. In addition to expanding our research and development team and establishing a Clinical Advisory Board of world class clinical oncologists, we further advanced our ImmunoBody®, Moditope® and anti-glycan antibody pipeline and expanded our intellectual property portfolio.
Notwithstanding the US regulatory delays in initiating the Phase 2 clinical trial for our lead ImmunoBody®, SCIB1, which have been disappointing, the Company is now making good progress having recently started this clinical study in the UK.
GMP manufacture of our lead Moditope® vaccine, Modi-1, is progressing well and this is a key milestone towards clinical trials which are anticipated to commence in H1 2020. The design of this study is currently under review following input from our Clinical Advisory Board and will aim to identify clinical signals in several cancer indications in parallel and determine the broad clinical utility of this novel cancer vaccine.
Our monoclonal antibodies and associated technologies are now firmly established as a third platform in the Scancell portfolio and we look forward to updating the market on the development of these assets in due course.
We were pleased to welcome Vulpes as a shareholder in June and their investment not only strengthens our cash position, but also provides a sound endorsement of Scancell's future potential.
John Chiplin
Chairman
CONSOLIDATED PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME STATEMENT for the year ended 30 April 2019 |
|
2019 £ |
2018 £ |
|
|
|
|
Development expenses |
(4,151,950) |
(2,855,264) |
|
|
|
Administrative expenses |
(2,577,062) |
(2,086,536) |
|
|
-------------------------- |
-------------------------- |
OPERATING LOSS (note 2) |
|
(6,729,012) |
(4,941,800) |
|
|
|
|
Interest receivable and similar income |
|
15,002 |
2,753 |
|
-------------------------- |
-------------------------- |
LOSS BEFORE TAXATION |
(6,714,010) |
(4,939,047) |
|
|
|
|
Taxation (note 3) |
|
1,086,523 |
744,538 |
|
-------------------------- |
-------------------------- |
LOSS AND TOTAL COMPREHENSIVE INCOME FOR THE YEAR |
(5,627,487) |
(4,194,509) |
|
-------------------------- |
-------------------------- |
EARNINGS PER ORDINARY SHARE (pence)
(note 4)
Continuing operations |
|
|
Basic |
(1.45)p |
(1.34)p |
|
|
|
Diluted |
(1.45)p |
(1.34)p |
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CONSOLIDATED STATEMENT OF FINANCIAL POSITION
as at 30 April 2019
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2019 |
2018 |
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ASSETS |
£ |
£ |
Non-current assets |
|
|
|
|
Plant and machinery |
|
58,514 |
76,910 |
|
Goodwill |
|
3,415,120 |
3,415,120 |
|
|
3,473,634 |
3,492,030 |
|
|
|
|
|
|
|
|
|
Current assets
Trade and other receivables |
|
677,614 |
97,304 |
Tax receivables |
1,831,061 |
744,538 |
Cash and cash equivalents |
4,559,949 |
10,303,168 |
|
7,068,624 |
11,145,010 |
|
|
|
TOTAL ASSETS |
10,542,258 |
14,637,040 |
LIABILITIES |
|
|
Current Liabilities |
|
|
Trade and other payables |
|
(1,205,410) |
(696,090) |
TOTAL LIABILITIES |
(1,205,410) |
(696,090) |
|
|
|
NET ASSETS |
9,336,848 |
13,940,950 |
SHAREHOLDERS' EQUITY
Called up share capital |
|
387,797 |
374,469 |
Share premium |
|
34,638,688 |
33,374,624 |
Share option reserve |
|
381,562 |
635,569 |
Profit and loss account |
|
(26,071,199) |
(20,443,712) |
TOTAL SHAREHOLDERS' EQUITY |
|
9,336,848 |
13,940,950 |
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
for the year ended 30 April 2019
|
Share |
Share |
Share |
Retained |
|
|
Capital |
Premium |
Option |
Earnings |
Total |
|
£ |
£ |
£ |
£ |
£ |
Balance 1st May 2017 |
261,558 |
21,785,295 |
701,675 |
(16,249,203) |
6,499,325 |
|
|
|
|
|
|
Share issue |
112,911 |
12,426,409 |
|
|
12,539,320 |
Expenses of issue |
|
(837,080) |
|
|
(837,080) |
Loss for the year |
|
|
|
(4,194,509) |
(4,194,509) |
Share option charge |
|
|
(66,106) |
|
(66,106) |
|
|
|
|
|
|
Balance 30 April 2018 |
374,469 |
33,374,624 |
635,569 |
(20,443,712) |
13,940,950 |
|
|
|
|
|
|
Share issue |
10,143 |
1,206,998 |
|
|
1,217,141 |
Expenses of issue |
|
(83,057) |
|
|
(83,057) |
Exercise of share options |
3,185 |
140,123 |
|
|
143,308 |
Loss for the year |
|
|
|
(5,627,487) |
(5,627,487) |
Share option charge |
|
|
(254,007) |
|
(254,007) |
|
|
|
|
|
|
Balance 30 April 2019 |
387,797 |
34,638,688 |
381,562 |
(26,071,199) |
9,336,848 |
|
|
|
|
|
|
CONSOLIDATED CASH FLOW STATEMENT
for the year ended 30 April 2019
|
|
2019 |
2018 |
|
|
£ |
£ |
Cash flows from operating activities |
|
|
|
(Loss) before tax |
|
(6,714,010) |
(4,939,047) |
Adjustments for: |
|
|
|
Finance income |
|
(15,002) |
(2,753) |
Depreciation |
|
21,060 |
27,612 |
Share-based payment credit |
|
(254,007) |
(66,106) |
Cash flows from operations before changes in working capital |
|
(6,961,959) |
(4,980,294) |
|
|
|
|
(increase)/Decrease in amounts receivable |
|
(580,307) |
4,499 |
Increase in amounts payable |
|
509,317 |
164,211 |
Cash used in operations |
|
(7,032,949) |
(4,811,584) |
|
|
|
|
Tax credits received |
|
- |
748,837 |
|
|
|
|
Net cash used in operating activities |
|
(7,032,949) |
(4,062,747) |
Investing activities |
|
|
|
Purchase of tangible fixed assets |
|
(2,664) |
(11,413) |
Finance income |
|
15,002 |
2,753 |
Net cash generated from investing activities |
|
12,338 |
(8,660) |
|
|
|
|
Financing activities |
|
|
|
Proceeds from issue of share capital |
|
1,217,141 |
12,539,320 |
Expenses of share issue |
|
(83,057) |
(837,080) |
Exercise of share options |
|
143,308 |
- |
Net cash generated from financing activities |
|
1,277,392 |
11,702,240 |
|
|
|
|
Net (decrease)/increase in cash and cash equivalents |
|
(5,743,219) |
7,630,833 |
|
|
|
|
Cash and cash equivalents at beginning of the year |
|
10,303,168 |
2,672,335 |
|
|
|
|
Cash and cash equivalents at end of the year |
|
4,559,949 |
10,303,168 |
|
|
|
|
NOTES TO THE FINANCIAL INFORMATION
For the year ended 30 April 2019
1 BASIS OF PREPARATION
These financial results do not comprise statutory accounts for the year ended 30 April 2019 within the meaning of Section 434 of the Companies Act 2006. The financial information in this announcement has been extracted from the audited financial statements for the year ended 30 April 2019.
The financial statements have been prepared on the going concern basis on the grounds that the directors have reviewed the funding available and the group's cash flow forecast and are content that sufficient resources are available to enable the group to continue in operation for at least twelve months from the date of approval of these financial statements.
The financial information has been prepared in accordance with International Financial Reporting Standards ('IFRS'), as adopted by the European Union, and with those parts of the Companies Act 2006 applicable to companies reporting under IFRS.
The financial statements have been prepared under the historical cost convention and in accordance with applicable accounting standards.
2 OPERATING LOSS
|
2019 |
2018 |
|
£ |
£ |
Operating Loss is stated after charging: |
|
|
Depreciation on tangible fixed assets |
21,060 |
27,612 |
Operating lease rentals |
95,964 |
66,257 |
Research and development |
4,151,950 |
2,855,264 |
Auditors' remuneration - fee payable for audit of the company |
16,000 |
8,250 |
Auditors' remuneration - fee payable for audit of the subsidiary company |
16,000 |
11,000 |
Auditors' remuneration for non-audit services |
- |
1,500 |
Directors' remuneration |
631,042 |
680,204 |
3 TAXATION
Analysis of the tax credit
The tax credit on the loss on ordinary activities for the year was as follows: |
2019 |
2018 |
Current tax |
£ |
£ |
UK corporation tax credits due on R&D expenditure |
1,082,575 |
744,538 |
Adjustment to prior year |
3,948 |
- |
|
1,086,523 |
744,538 |
Factors affecting the tax charge
The tax assessed for the years is lower than the applicable rate of corporation tax in the UK.
The difference is explained below:
|
2019 |
2018 |
|
£ |
£ |
Loss on ordinary activities before tax |
(6,714,010) |
(4,939,047) |
Loss on ordinary activities multiplied by the small company rate of tax in the UK (19 %) |
(1,275,662) |
(938,419) |
Effects of: |
|
|
Disallowed expenditure |
7,668 |
(12,276) |
Timing differences |
(5,447) |
2,462 |
Enhanced tax relief on R&D expenditure |
(801,788) |
(550,403) |
Reduced tax relief for losses surrendered for R&D tax credits |
335,972 |
232,289 |
Prior year (under)/ over provision |
(3,948) |
- |
Unrelieved losses carried forward |
656,682 |
521,809 |
Current tax (credit) |
(1,086,523) |
(744,538) |
The Group has tax losses to carry forward against future profits of approximately £18,960,000 (2018: £15,504,000).
A deferred tax asset has not been recognised in respect of these losses as the Group does not anticipate sufficient taxable profits to arise in the foreseeable future to fully utilise them.
The estimated value of the deferred tax asset not recognised measured at the prevailing rate of tax when the timing differences are expected to reverse is £3,202,000 (2018: £2,625,000).
4 EARNINGS PER SHARE
Basic earnings per share
The earnings and weighted average number of ordinary shares used in the calculation of basic earnings per share is as follows:
|
|
2019 £ |
2018 £ |
Earnings used in calculation of basic earnings per share |
|
(5,627,487) |
(4,194,509) |
|
|
|
|
|
|
Number |
Number |
Weighted average number of ordinary shares of 0.1p each for the calculation of basic earnings per share |
|
386,965,910 |
312,726,405 |
Diluted earnings per share
As the Group is reporting a loss from continuing operations for both years then, in accordance with IAS 33, the share options are not considered dilutive because the exercise of the share options would have the effect of reducing the loss per share.
The Company issued 10,142,838 shares on 9 May 2018 and Ichor exercised 3,184,620 shares on 17 July 2018. At the year end the issued share capital amounted to 387,796,556 ordinary shares.
5 DELIVERY OF ACCOUNTS
The audited statutory accounts in respect of the prior year ended 30 April 2018 have been delivered to the Registrar of Companies. The auditors issued an unqualified audit opinion which did not contain any statement under section 498(2) or 498(3) of the Companies Act 2006.
6 AVAILABILITY OF ACCOUNTS
This announcement is not being posted to shareholders. Copies of this announcement can be downloaded from the Company's website: www.scancell.co.uk together with copies of the Report and Accounts.
