Final Results
Embargoed Release: 07:00hrs, Wednesday 9 September 2009
GB00B39J5N63
Scancell Holdings plc
(`Scancell Holdings' or `the Company')
Preliminary Results for the Year Ended 30 April 2009
The Directors of Scancell Holdings plc, the parent company of Scancell Limited
(`Scancell'), the developer of therapeutic cancer and infectious disease
vaccines based on its patented ImmunoBody® platform, are pleased to announce
the preliminary results for Scancell for the year ended 30th April 2009 (`the
Period').
Highlights:
* Admitted to Plus markets and raised £1.559,502
* Signed deal with Cobra Biomanufacturing Plc to commence Good Manufacturing
Practice manufacture of Scancell's SCIB1 DNA vaccine
* Awarded £250,000 Grant for Research and Development by the East Midlands
Development Agency
* Preparations for scheduled 2010 Phase 1 clinical trials of Scancell's first
cancer vaccine for melanoma, SCIB1, continued on time and on budget
* Voted ACQ Magazine Plus Company of the year
Post Period Highlights:
* Merck Serono: signed licensing agreement for two key patents required for
further development and commercialisation of protein ImmunoBody® vaccines
* Ichor Medical Systems: agreement signed to use Ichor's TriGridâ„¢
electroporation device for the delivery of SCIB1
* ImmunoVaccine Technologies Inc.: signed a research agreement to explore
using IVT's DepoVax™ delivery system for Scancell's future ImmunoBody® DNA
infectious disease and animal health vaccines
* Zeus Capital appointed as Corporate Advisor
David Evans, Non-Executive Chairman of Scancell, commented:
"I am pleased to report on Scancell's first successful year as a public
company. The Company continues to make good progress towards commencing Phase 1
clinical trials on its first therapeutic cancer vaccine SCIB1 in 2010..Scancell
has also entered into a number of significant agreements that will support both
SCIB1 and the development of future ImmunoBody® vaccines."
For further information contact:
Professor Lindy Durrant Scancell Holdings Plc + 44 207 245 1100
Adam Reynolds/Vikki Krause Hansard Group + 44 7515 922906
Ross Andrews Zeus Capital + 44 (0)161 831 1512
About Scancell
Scancell is developing novel therapeutic vaccines for the treatment of cancer
and infectious diseases based on its groundbreaking ImmunoBody® technology
platform. Scancell's first cancer vaccine SCIB1 is being developed for the
treatment of melanoma and will enter clinical trials in early 2010.
Treating cancer by vaccination allows small non-toxic doses of a vaccine to be
administered to a patient, stimulating an immune response. Effective cancer
vaccines need to target dendritic cells to stimulate both parts of the cellular
immune system; the helper cell system where inflammation is stimulated at the
tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system
cells are primed to recognise and kill specific cells.
A limitation of many cancer vaccines currently in development is that they
cannot specifically target dendritic cells in vivo. Several groups have
demonstrated successful vaccination by growing dendritic cells ex vivo, pulsing
them with tumour antigens and re-infusing them. However, this procedure is
patient specific, time consuming and expensive. Scancell has developed its
breakthrough patent protected ImmunoBody® technology to overcome these
limitations.
An ImmunoBody® is a DNA vaccine encoding a human antibody or fusion protein
engineered to express helper cell and CTL epitopes from tumour antigens
over-expressed by cancer cells. Antibodies are ideal vectors for carrying T
cell epitopes from tumour antigens as they can effectively target dendritic
cells via their Fc receptors, allowing efficient stimulation of high avidity
and high frequency helper and CTL responses.
The ImmunoBody® technology can be adapted to provide the basis for treating any
tumour type and may also be of potential utility in the development of vaccines
against hepatitis, HIV and other chronic infectious diseases.
Chief Executive Officer's Statement:
Overview
During the Period the Company continued to make good progress towards its goal
of commencing Phase 1 clinical trials of its first therapeutic cancer vaccine
for melanoma, SCIB1, in the UK during H1 2010. It remains on target to submit
an application for Clinical Trial Authorisation (`CTA') of SCIB1 later this
year or early next year. In addition, Scancell has signed agreements with Ichor
Medical Systems and MerckSerono to further support the commercialisation of
SCIB1 and the ImmunoBody® platform as a whole.
Financials
The Financial Statements have been prepared utilising merger accounting rules
as set out in Financial Reporting Standard 6.
Profit and Loss Account
The Company made an overall operating loss of £902,226 (2008:£509,688)
reflecting the increased expenditure on the ImmunoBody® platform and in
accordance with management plans. These costs were partially offset by the
proportion of the grant received from the East Midlands Development Agency
towards the cost of progressing SCIB1 through GMP production and collating data
for the application for CTA to commence Phase 1 clinical trials.
Interest receivable amounted to £57,282 (2008:£60,649) resulting in a net loss
before taxation of £844,944 (2008:£449,039).
The taxation credit of £184, 913 (2008:£43,372) reflected the higher amounts
spent on Research and Development. The Loss after Taxation amounted to £660,031
(2008: £405,307).
Balance sheet
The Company has a simple Balance Sheet with the largest asset recognised being
its cash balances which at 30 April 2009 stood at £1,519,070 (2008:£997,747).
The net increase in cash reflects inter alia the offset of the proceeds of the
issue of 22 September last year (£1,559,502) and the losses incurred during the
year.
Investor Relations
Whilst raising monies on PLUS last year in the teeth of the financial crisis
enveloping London was a significant achievement in its own right we have
inevitably suffered subsequently with the share-price halving from its IPO
price at one stage over the past year. This in part is a function of liquidity
and partly because up until now we have kept our head down and sought to
deliver against our plans. We are now at a stage where we feel we can more
actively engage with the wider body public and we have engaged in a more
pro-active campaign to get across the fundamental underlying strength of our
science. To that end in particular we have organised a seminar on 10 September
to communicate our story and to which all shareholders are welcome.
Our aim is to continue to communicate the positive message we have in a way
that we believe will more fairly reflect the underlying value of the Company.
ImmunoBody® Platform progress
The Company is pleased to report that during the Period Scancell continued to
advance and develop its core technology, the ImmunoBody® Platform. Scancell's
lead ImmunoBody® product, SCIB1, is a melanoma vaccine that has repeatedly
shown good anti-tumour effects in animal studies.
Scancell's patent-protected ImmunoBody® vaccines overcome the current
limitations of most cancer vaccines by generating the high-avidity T-cells that
kill cancer cells. The Immunobody® platform technology can be adapted to
provide the basis for treating any tumour type. It may also be utilised in the
development of vaccines against chronic infectious diseases including hepatitis
and HIV.
Post the year-end, Scancell secured a licensing agreement with Merck Serono,
for two key patents required for the further development and commercialisation
of protein ImmunoBody® vaccines. Under the agreement, Scancell has
non-exclusive worldwide rights to use the two patents to further develop and
commercialise ImmunoBody® vaccines in all therapeutic areas in both humans and
animals. Scancell has also granted Merck Serono an option to negotiate an
exclusive license under Scancell's ImmunoBody® platform technology for up to
five Merck Serono targets.
In addition, Scancell signed a research agreement with Canadian vaccine
development company ImmunoVaccine Technologies Inc. (`IVT'), to explore using
IVT's DepoVax™ delivery system for Scancell's novel ImmunoBody® DNA vaccines.
DepoVaxâ„¢ has the potential to be a more practical delivery method for
Scancell's future ImmunoBody® DNA infectious disease and animal health vaccines
for which alternative delivery methods such as electroporation may be less
suitable.
SCIB1 progress:
SCIB1 remains on track to enter Phase 1 clinical trials in H1 2010. The Company
secured a deal with Cobra Biomanufacturing Plc (`Cobra') for the manufacture of
its SCIB1 vaccine in January 2009, enabling Scancell to meet its target, as
stated in the October 2008 Interim Results, of commencing Good Manufacturing
Practice (`GMP') in Q1 2009. Cobra's biopharmaceutical manufacturing is
compliant with cGMP standards worldwide.
Since the year-end, Scancell signed an agreement with Ichor Medical Systems
(`Ichor') to use Ichor's TriGridâ„¢ electroporation device for the delivery of
SCIB1 during Scancell's forthcoming pre-clinical and clinical studies of SCIB1.
In vivo electroporation is widely regarded as an effective method of enhancing
the potency of DNA vaccines by up to 100 -fold compared to conventional methods
of delivery. Scancell is confident that TriGridâ„¢ will provide the most
effective delivery system for its SCIB1 melanoma vaccine as it enters clinical
trials.
Scancell also has the option to license TriGridâ„¢ for commercial use on payment
of certain undisclosed milestones and royalties.
SCIB2:
Scancell's second ImmunoBody®, SCIB2, is an anti-angiogenic vaccine that is
expected to have utility in the treatment of any solid tumour, either as
monotherapy or in combination with tumour specific vaccines such as SCIB1.
Scancell has produced and tested a range of potential candidates from which a
second ImmunoBody® vaccine, SCIB2, will be selected and tested to the animal
proof of principle stage.
Arana Therapeutics
Under an agreement dated 1 December 2006 Scancell Limited sold its pre-clinical
pipeline of cell killing monoclonal antibodies to Peptech UK Limited now part
of Arana Therapeutics plc which itself has been acquired by Cephalon post 30
April 2009. Potentially there is a further payment due of £2,850,000 dependent
upon achievement by December 2011 of a key milestone. The outcome of this
milestone is uncertain but we continue to monitor the progress of the lead
candidate through regular updates from Arana.
Outlook
Scancell has successfully completed its first year as a listed company. It
remains on course to start clinical trials with SCIB1, its first cancer
vaccine, for melanoma, in 2010 and has developed key relationships with
prominent and influential businesses in the industry. It is immensely pleasing
that the ambitious goals set out by the Company in September 2008, both for the
development of SCIB1 and the ImmunoBody® Platform, have, and continue to be
completed on time and on budget. The Company will continue to develop and
deepen its existing alliances in addition to forging new relationships to
further develop and strengthen its position as a key player in the cancer
vaccine field.
To be able to execute the above in timely fashion the Company will need to
raise additional monies which we estimate to be no less than £1.5m The Company
has kept tight control over its cash and at 31 August 2009 the cash balances
amounted to £1.4 million. I have no doubts about our ability to manage our cash
resources in a manner that does not jeopardise existing Shareholder Value and
we will seek to raise additional monies at a time of our choosing.
I remain very confident that our approach of developing high-avidity T-Cells
marks us out as a world-leader in the field and that we will succeed in
creating significant strategic value for all Shareholders.
The directors of the Issuer accept responsibility for this announcement.
David Evans
Chairman
Scancell Holdings plc
8 September 2009
Consolidated Profit and Loss Account
For the Year ended 30.04.09
Year ended Year ended
30.04.2009 30.04.2008
£ £
TURNOVER - 231
Cost of sales 713,278 241,262
GROSS LOSS (713,278) (241,031)
Administrative expenses 401,579 268,657
Other operating income 212,631 -
OPERATING LOSS (902,226) (509,688)
Interest receivable and similar 57,282 60,649
income
LOSS ON ORDINARY ACTIVITIES (844,944) (449,039)
BEFORE TAXATION
Tax on (loss)/profit on ordinary (184,913) (43,732)
activities
LOSS FOR THE FINANCIAL YEAR (660,031) (405,307)
ENDED AFTER TAXATION
Basic earnings per share (pence) 1 (7.17) (5.60)
for loss attributable to equity
shareholders
Consolidated Balance Sheet
30.04.09
30.04.2009 30.04.2008
£ £
FIXED ASSETS
Tangible assets 82,265 86,652
Investments - -
CURRENT ASSETS
Debtors 404,590 51,145
Cash in bank and in hand 1,519,070 997,747
1,923,660 1,048,892
CREDITORS
Amounts falling due within one 166,731 88,351
year
NET CURRENT ASSETS 1,756,929 960,541
TOTAL ASSETS LESS CURRENT 1,839,194 1,047,193
LIABILITIES
CAPITAL AND RESERVES
Called up share capital 102,756 76,030
Share premium 1,425,306 -
Merger reserve 5,043,428 5,043,428
Profit and los account (4,732,296) (4,072,265)
1,839,194 1,047,193
Consolidated Cash Flow Statement
for the Year Ended 30.04.09
Year Ended Year Ended
30.04.2009 30.04.2008
£ £
Net cash outflow from operating (1,216,070) (439,442)
activities
Returns on investments and 57,282 60,649
servicing of finance
Taxation 38,962 (148,727)
Capital Expenditure (23,383) (516)
(1,143,209) (528,036)
Financing 1,664,532 20,845
Increase in cash in the Year 521,323 (507,191)
Ended
Reconcilliation of net cash flow
to movements in net funds
Increase in cash in the Year 521,323 (507,191)
Ended
Change in net funds resulting 521,323 (507,191)
from cash flows
Movement in net funds in the 521,323 (507,191)
Year Ended
Net funds at 1 May 997,747 1,504,938
Net funds at 1 May 1,519,070 997,747
NOTES TO THE FINANCIAL STATEMENTS
For the 12 months ended 30 April 2009
1. BASIC EARNINGS PER SHARE
Basic earnings per share is calculated by dividing the net loss for the year
attributable to ordinary equity holders by the weighted average number of
ordinary shares outstanding during the year.
Earnings per share have been calculated in the net basis on the loss on
ordinary activities after taxation of £660,031 (2008 £405,037) using the
weighted average number of ordinary shares in issue of 9,203,513 (2008
7,237,884 as adjusted).
2. CONTINUING OPERATIONS
None of the company's activities were acquired or discontinued during the
current year or previous year.
3. TOTAL RECOGNISED GAINS AND LOSSES
The company has no recognised gains and losses other than the losses for the
current Year Ended or the previous year.
4. MERGER INFORMATION
Scancell Limited and Scancell Holdings plc merged on 6th June 2008, this was
effected by the existing shareholders of Scancell Limited being give 4 shares
in Scancell Holdings plc for each of their original shares, this transfer was
completed on 14th July 2008.
No significant accounting adjustments were required to achieve consistency of
accounting policies as a result of the merger.
Scancell Limited had losses in the current period of £37,239 prior to the
merger, and had net assets of £1,009,954.
Scancell Holdings Plc had losses in the current period of nil prior to the
merger, and had net assets of nil at that time.
The comparative results in these financial statements relate wholly to Scancell
Limited.
5. GOING CONCERN
The Directors have reviewed the funding position for the forward period and
considered the viability of business plans and budgets. These show that it can
continue to trade until the end of 2010 and, if the performance criteria under
the agreement with Arana Therapeutics plc are achieved, well beyond that
period.
The Company will require further funding to allow it to fully exploit its
ImmunoBody® platform. To be able to execute our plans in timely fashion the
Company will need to raise additional monies which we estimate to be no less
than £1.5m
The Directors consider that based on the funding it has and the further steps
being taken, the Company will be able to meet all it's obligations for the
foreseeable future. Accordingly, the Directors consider that the going concern
basis is appropriate for the preparation of these financial statements.
6. DIVIDENDS
No dividends will be distributed for the year ended 30 April 2009.
The accounts are not the companies' statutory accounts
The statutory accounts for the year ended 30 April 2009 have not yet been
delivered to the Registrar of Companies
The auditor has reported on the statutory accounts for the year and the audit
report was unqualified and did not contain any statements under sections 498(2)
or 498(3) of the Companies Act 2006