17:00 Tue 20 Aug 2019
Scancell Hlds - Final Results for the year ended 30 April 2019
20 August 2019
("Scancell" or the "Company")
Final Results for the year ended
Immunotherapy pipeline advances; new investment provides further endorsement of future potential
Highlights:
· The Company received regulatory and ethical approval for the
· Scancell exercised its option to a worldwide commercial licence for the use of
· Patents granted in
· Strategic research collaboration with the Rheumatology Unit at the
· 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
· Professor
·
· Loss for the 12-month period of
· Group cash balance at
Post Period Highlights:
· Initiation of the
· Gross proceeds of
·
·
· Modi-1 manufacturing and toxicity testing underway to support anticipated start of Phase 1/2 study in
H1 2020
·
using a new nanoparticle formulation in patients with solid tumours
"We have made strong progress this year in advancing our pipeline of novel immunotherapies. Importantly, post period, we were pleased to initiate the
We have expanded our R&D team and established a
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:
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Dr |
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+44 (0) 20 3727 1000 |
Dr |
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(Nominated Adviser and Corporate broker) |
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+44 (0) 20 7886 2500 |
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FTI Consulting |
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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
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
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
As reported at the half year, following the submission of an Investigational New Drug (IND) application for the clinical study to the
In order to initiate patient recruitment in the
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
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.
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
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
Patents
The
A US patent was granted on
In
The grant of these patents is in addition to the grant of patents in
In
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
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
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
There has been a significant increase in development expenditure to
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
Overall the loss for the year was
Statement of Financial Position
At
The tax receivable due at the end of the year amounted to
The increase in trade and other receivables to
The trade and other payables haves also increased to
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
Outlook
It has been a busy and productive year for Scancell. In addition to expanding our research and development team and establishing a
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
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
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.
Chairman
CONSOLIDATED PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME STATEMENT for the year ended |
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2019 £
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2018 £
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Development expenses |
(4,151,950) |
(2,855,264) |
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Administrative expenses |
(2,577,062) |
(2,086,536) |
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-------------------------- |
-------------------------- |
OPERATING LOSS (note 2) |
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(6,729,012) |
(4,941,800) |
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Interest receivable and similar income |
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15,002 |
2,753 |
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-------------------------- |
-------------------------- |
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LOSS BEFORE TAXATION |
(6,714,010) |
(4,939,047) |
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Taxation (note 3) |
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1,086,523 |
744,538 |
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-------------------------- |
-------------------------- |
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LOSS AND TOTAL COMPREHENSIVE INCOME FOR THE YEAR |
(5,627,487) |
(4,194,509) |
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-------------------------- |
-------------------------- |
EARNINGS PER ORDINARY SHARE (pence)
(note 4)
Continuing operations |
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Basic |
(1.45)p |
(1.34)p |
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Diluted |
(1.45)p |
(1.34)p |
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CONSOLIDATED STATEMENT OF FINANCIAL POSITION
as at
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2019 |
2018 |
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ASSETS |
£ |
£ |
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Non-current assets |
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Plant and machinery |
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58,514 |
76,910 |
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3,415,120 |
3,415,120 |
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3,473,634 |
3,492,030 |
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Current assets
Trade and other receivables |
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677,614 |
97,304 |
Tax receivables |
1,831,061 |
744,538 |
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Cash and cash equivalents |
4,559,949 |
10,303,168 |
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7,068,624 |
11,145,010 |
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TOTAL ASSETS |
10,542,258 |
14,637,040 |
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LIABILITIES |
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Current Liabilities |
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Trade and other payables |
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(1,205,410) |
(696,090) |
TOTAL LIABILITIES |
(1,205,410) |
(696,090) |
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NET ASSETS |
9,336,848 |
13,940,950 |
SHAREHOLDERS' EQUITY
Called up share capital |
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387,797 |
374,469 |
Share premium |
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34,638,688 |
33,374,624 |
Share option reserve |
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381,562 |
635,569 |
Profit and loss account |
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(26,071,199) |
(20,443,712) |
TOTAL SHAREHOLDERS' EQUITY |
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9,336,848 |
13,940,950 |
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
for the year ended
|
Share |
Share |
Share |
Retained |
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Capital |
Premium |
Option |
Earnings |
Total |
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£ |
£ |
£ |
£ |
£ |
Balance |
261,558 |
21,785,295 |
701,675 |
(16,249,203) |
6,499,325 |
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Share issue |
112,911 |
12,426,409 |
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12,539,320 |
Expenses of issue |
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(837,080) |
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(837,080) |
Loss for the year |
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(4,194,509) |
(4,194,509) |
Share option charge |
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(66,106) |
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(66,106) |
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Balance |
374,469 |
33,374,624 |
635,569 |
(20,443,712) |
13,940,950 |
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Share issue |
10,143 |
1,206,998 |
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1,217,141 |
Expenses of issue |
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(83,057) |
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(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) |
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Balance |
387,797 |
34,638,688 |
381,562 |
(26,071,199) |
9,336,848 |
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CONSOLIDATED CASH FLOW STATEMENT
for the year ended
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2019 |
2018 |
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£ |
£ |
Cash flows from operating activities |
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(Loss) before tax |
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(6,714,010) |
(4,939,047) |
Adjustments for: |
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Finance income |
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(15,002) |
(2,753) |
Depreciation |
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21,060 |
27,612 |
Share-based payment credit |
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(254,007) |
(66,106) |
Cash flows from operations before changes in working capital |
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(6,961,959) |
(4,980,294) |
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(increase)/Decrease in amounts receivable |
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(580,307) |
4,499 |
Increase in amounts payable |
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509,317 |
164,211 |
Cash used in operations |
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(7,032,949) |
(4,811,584) |
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Tax credits received |
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- |
748,837 |
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Net cash used in operating activities |
|
(7,032,949) |
(4,062,747) |
Investing activities |
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Purchase of tangible fixed assets |
|
(2,664) |
(11,413) |
Finance income |
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15,002 |
2,753 |
Net cash generated from investing activities |
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12,338 |
(8,660) |
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Financing activities
|
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Proceeds from issue of share capital |
|
1,217,141 |
12,539,320 |
Expenses of share issue |
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(83,057) |
(837,080) |
Exercise of share options |
|
143,308 |
- |
Net cash generated from financing activities |
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1,277,392 |
11,702,240 |
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Net (decrease)/increase in cash and cash equivalents |
|
(5,743,219) |
7,630,833 |
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Cash and cash equivalents at beginning of the year |
|
10,303,168 |
2,672,335 |
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Cash and cash equivalents at end of the year |
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4,559,949 |
10,303,168 |
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NOTES TO THE FINANCIAL INFORMATION
For the year ended
1 BASIS OF PREPARATION
These financial results do not comprise statutory accounts for the year ended
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
The financial statements have been prepared under the historical cost convention and in accordance with applicable accounting standards.
2 OPERATING LOSS
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2019 |
2018 |
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£ |
£ |
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 |
£ |
£ |
|
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
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 |
(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
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:
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2019 £ |
2018 £ |
Earnings used in calculation of basic earnings per share |
|
(5,627,487) |
(4,194,509) |
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Number |
Number |
Weighted average number of ordinary shares of 0.1p each for the calculation of basic earnings per share |
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386,965,910
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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
5 DELIVERY OF ACCOUNTS
The audited statutory accounts in respect of the prior year ended
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.
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