Interim Results
31 January 2011
Scancell Holdings Plc
("Scancell" or the "Company")
Unaudited Interim Results
for the six month period to 31st October 2010
Scancell Holdings plc, the developer of therapeutic cancer and infectious
disease vaccines based on its patented Immunobody® platform, is pleased to
announce the interim results for the six month period ended 31st October 2010.
Highlights:
* Successful progression of SCIB1, Scancell's lead vaccine for melanoma,
which entered clinical trials in June 2010
* Raised £2.5 million in April 2010 with new and current shareholders
* Moved from PLUS to AIM in July 2010
* Secured licensing agreements with:
* the National Institutes of Health (an agency of the United States
Department of Health and Human Services); and
* Cancer Research Technology Ltd (Cancer Research UK's commercialisation and
development arm)
* Entered strategic collaborations with:
* ImmuneRegen BioSciences, Inc.®; and
* immatics biotechnologies GmbH
Post-period Highlights:
* Four patients recruited to date for the clinical trials
* Approval obtained to open a fourth UK patient recruitment site and to
expand the patient population in the Phase I part of the study, to include
all patients with Stage III and Stage IV malignant melanoma
* Escalation of the dose and recruitment of the next group of patients in
SCIB1 trial approved by the Cohort Review Committee
For further information contact:
Scancell Holdings Plc + 44 (0)207 245 1100
Professor Lindy Durrant
Hansard Communications + 44 (0)207 245 1100
Kirsty Corcoran/Adam Reynolds
Zeus Capital - Nominated Adviser/Joint Broker + 44 (0)161 831 1512
Ross Andrews/Tom Rowley
Matrix Corporate Capital LLP - Joint Broker + 44 (0)20 3206 7340
Robert Naylor/Stephen Waterman
CHAIRMAN'S STATEMENT
In the six months to 31st October 2010 Scancell successfully met the commercial
and scientific objectives it had set out in line with the Company's strategy in
what proved to be an exciting and busy period. The progression of Scancell's
first vaccine, SCIB1 for melanoma which entered clinical trials in June 2010,
was a particular highlight. Having successfully raised £2.5 million in April
2010, the Company also moved from PLUS to AIM in July 2010.
Financial
Profit and Loss Account
The Company made an overall operating loss for the six month period to 31st
October 2010 of £835,540 (2009: restated loss of £661,794). The reduction in
direct costs reflects the slower than anticipated recruitment of patients for
the clinical trials. An increase in administrative costs has arisen as the
company has increased the costs of protecting its intellectual property and
incurred "one-off" costs in moving to AIM.
Overall the loss for the six month period was £802,170 (2009: restated loss £
626,126).
Balance Sheet
The cash at bank at 31st October 2010 was £1,740,925 (2009: £1,104,229).
SCIB1 Phase I Clinical Trial
During the period, Scancell met an important milestone when SCIB1, its
ImmunoBody® vaccine being developed for the treatment of melanoma, entered
clinical trials. Following receipt of the Clinical Trial Approval in May 2010
from the Gene Therapy Advisory Committee and the Medicines and Healthcare
Products Regulatory Agency Medicines Division, Scancell was able to commence
its Phase I clinical trial of SCIB1 in June 2010. All patients in the clinical
trial are being treated with Scancell's SCIB1 vaccine which is being delivered
using Ichor Medical Systems' TriGridâ„¢ electroporation delivery device. To date,
four patients have been enrolled on the trial, which is currently taking place
at three centres and is evaluating the safety and tolerability of SCIB1 in
patients with late stage (Stage IV or inoperable Stage III) melanoma.
During the past year, data has emerged from studies of two new treatments in
Stage IV melanoma patients: firstly, a study of PLX 4032, a B-raf inhibitor,
demonstrated a survival benefit versus decarbazine (although the magnitude of
the response has not yet been reported) in patients with the BRAF gene mutation
(50-60% of patients); secondly, a Phase III trial of the anti-CTLA4 monoclonal
antibody ipilimumab demonstrated prolonged survival, with 23.5% of treated
patients still alive after two years. Ipilimumab is expected to receive
approval for use in patients with advanced metastatic melanoma later this year,
although it can also cause potentially life-threatening side effects. Despite
these advances there is still a profound need for more effective and safer
treatments of this devastating disease.
With these two trials running, the recruitment rate of patients for Scancell's
Phase I study has been slower than anticipated, as some otherwise suitable
patients have been recruited into B-raf studies or offered ipilimumab on a
compassionate use basis. By the time the patients have failed to respond to one
of these treatments, they are often too ill to enter the SCIB1 trial.
The Company is pleased to have obtained the approval from the Gene Therapy
Advisory Committee (`GTAC') and the Medicines and Healthcare products
Regulatory Agency (`MHRA') Medicines Division to open a fourth trial centre in
Leeds. This approval along with that of Scancell's protocol amendment allowing
inclusion of all Stage III and Stage IV malignant melanoma patients, is
expected to improved recruitment in 2011. These earlier stage patients are
anticipated to make better immune responses (as late stage cancer patients
often have weakened immune systems) which should have a positive effect on the
trial outcome. The Phase II trial, which will be conducted in less severely ill
patients, is not expected to experience an issue with patient recruitment.
Scancell's first group of patients receiving the lowest dose of SCIB1 has now
been evaluated by the Cohort Review Committee. The review of the safety data of
the first three patients after three treatments has resulted in the approval of
an escalation of the dose and recruitment of the next group of patients which
marks a positive progression in the trial.
Agreements and Collaborations
Scancell secured two key agreements during the period under review:
* A worldwide non-exclusive licensing agreement with the National Institutes
of Health, an agency of the United States Department of Health and Human
Services, for use of the melanoma antigens TRP-2 and gp100 as key
components of SCIB1; and
* A licensing agreement with Cancer Research Technology Ltd, Cancer Research
UK's commercialisation and development arm to use a human antibody known as
105AD7 for the development of new ImmunoBody® vaccines for any
immunotherapy indication.
The Company also entered two important strategic collaborations in the period:
* With ImmuneRegen BioSciences, Inc.®, a wholly owned subsidiary of IR
BioSciences Holdings, Inc. (OTC BB:IRBS.OB), to investigate the synergy
between ImmuneRegen's Homspera® and Scancell's ImmunoBody® vaccine
technologies. An initial treatment utilising a DNA vaccine based on the
ImmunoBody® technology, in combination with Homspera® has shown a
significantly improved immune response of the vaccine in an animal model.
Follow-up studies are currently being performed to optimise the effects of
Homspera in enhancing the next generation of Scancell's cancer vaccines;
and
* With immatics biotechnologies GmbH to explore the development of novel
ImmunoBody® vaccines for colorectal cancer.
Outlook
SCIB1's progress in the clinic remains on track, and the Board is delighted to
have received the approval from the Cohort Review Committee to escalate the
dose of SCIB1 and begin recruitment of the next group of patients.
As mentioned in the AGM Statement on the 14 December 2010, the delay
experienced in patient recruitment might have resource implications for
Scancell. It may be difficult to generate revenues from a commercial deal on
the ImmunoBody® technology until the Phase I clinical trial has been completed
in late 2011. It could therefore be necessary to augment the Company's capital
resources to complete the Phase II study. However, the Board is confident that
by recruiting earlier stage patients and opening both the announced Leeds
centre and a fifth centre yet to be confirmed, Scancell remains well placed to
complete the clinical study by the end of 2012.
The Directors believe that positive data from the SCIB1 study, along with
SCIB2, the second ImmunoBody® product that the Company is designing and will
test to the proof of principle stage, would significantly enhance the value of
the business. The Company maintains its intention to position itself as a
company with clinical stage products and the potential for a technology
platform capable of generating a new product pipeline for a trade sale to a
leading pharmaceutical or biotechnology company operating in the oncology
market.
The Board is pleased with the Company's advancement over the period, and would
like to thank all those involved with Scancell for their dedication and support
that has enabled the progress to date.
David Evans
Chairman
Scancell Holdings plc
31 January 2011
Unaudited Consolidated Income Statement for the six months to 31st October 2010
Unaudited Unaudited Audited
six months six months Year to
(restated)
31/10/2010 31/09/2009 30/04/2010
£ £ £
REVENUE - - -
Cost of sales 377,655 425,178 1,091,351
_________ ________ _________
GROSS LOSS (377,655) (425,178) (1,091,351)
Administrative Expenses 457,885 274,379 751,365
_________ ________ _________
(835,540) (699,557) (1,842,716)
Other operating Income - 37,763 37,650
_________ ________ _________
OPERATING LOSS (835,540) (661,794) (1,805,066)
Interest receivable and similar 620 1,782 2,427
income
_________ _______ ________
LOSS ON ORDINARY ACTIVITIES (834,920) (660,012) (1,802,639)
BEFORE TAXATION
Tax on loss on ordinary (32,750) (33,876) (65,510)
activities
_________ ________ _________
LOSS FOR THE PERIOD ATTRIBUTABLE (802,170) (626,136) (1,737,129)
TO EQUITY HOLDERS OF THE PARENT
_________ ________ ________
BASIC EARNINGS PER SHARE (pence) (Note 2) (5.0) (6.1) (16.2)
Unaudited Consolidated interim statement of financial position as at 31st
October 2010
Unaudited Unaudited Audited
(restated)
31/10/2010 31/10/2009 30/04/2010
£ £ £
ASSETS
Non-current assets
Plant and equipment 119,231 79,437 131,763
Goodwill 3,415,120 3,415,120 3,415,120
_______________ _______________ ______________
3,534,351 3,494,557 3,546,883
Current assets
Trade and other 121,495 132,462 57,819
receivables
Income tax assets 97,567 82,034 64,817
Cash and cash 1,740,925 1,104,229 2,830,145
equivalents
_______________ _______________ ______________
1,959,987 1,318,725 2,952,781
_______________ _______________ ______________
TOTAL ASSETS 5,494,338 4,813,282 6,499,664
_______________ _______________ _______________
LIABILITIES
Current liabilities
Trade and other 171,368 153,098 451,787
payables
_______________ ______________ ______________
NET CURRENT ASSETS 1,788,619 1,165,627 2,500,994
_______________ _______________ _______________
NET ASSETS 5,322,970 4,660,184 6,047,877
_______________ _______________ ______________
TOTAL EQUITY
Called up share capital 159,266 102,756 158,733
Share premium account 8,345,275 5,911,105 8,321,808
Retained earnings (3,181,571) (1,353,677) (2,432,664)
_______________ _______________ _______________
Attributable to equity 5,322,970 4,660,184 6,047,877
holders of the parent
_______________ _______________ ______________
Unaudited consolidated interim cash flow statement for the six month period to
31st October 2010
Unaudited Unaudited Audited
6 months 6 months Year
restated)
31/10/2010 31/10/2009 30/04/2010
£ £ £
Loss from operations (835,540) (661,794) (1,805,066)
Adjustments for:
Depreciation and amortisation 16,236 11,324 22,649
Government Grants - (37,500) (37,500)
Share based payment expense 53,263 32,006 64,012
Operating cash flows before (766,041) (655,964) (1,755,905)
movements in working capital
Movement in receivables (63,676) 82,445 18,817
Movement in payables (280,419) (13,633) 232,696
Net cash (outflow)/ inflow from (1,110,136) (587,152) (1,504,392)
operations
Income taxes received - 141,525 190,376
Net cash from/(used by) operating (1,110,136) (445,627) (1,314,016)
activities
Investing activities
Purchases of plant and equipment (3,704) (8,496) (72,148)
Interest received 620 1,782 2,427
Net cash used by investing (3,084) (6,714) (69,721)
activities
Financing activities
Proceeds from issue of shares for 24,000 - 2,519,040
cash
Grants received - 37,500 175,772
Net cash from financing activities 24,000 37,500 2,694,812
Net increase/(decrease) in cash and (1,089,220) (414,841) 1,311,075
cash equivalents
Cash and cash equivalents at 2,830,145 1,519,070 1,519,070
beginning of period
Cash and cash equivalents at end of 1,740,925 1,104,229 2,830,145
period
Unaudited consolidated interim statement of changes in equity
Share Share Retained Total
Capital Premium Earnings
Account
£ £ £ £
At 1st May 2010 158,733 8,321,808 (2,432,664) 6,047,877
Loss for the period - - (802,170) (802,170)
Share issue 533 23,467 - 24,000
Share based payments - - 53,263 53,263
___________ ___________ ___________ ___________
At 31st October 2010 159,266 8,345,275 (3,181,571) 5,322,970
___________ ___________ ___________ ___________
At 1st May 2009 102,756 5,911,105 (759,547) 5,254,314
Loss for the period - - (626,136) (626,136)
Share based payments - - 32,006 32,006
___________ ___________ ___________ ___________
At 31st October 2009 102,756 5,911,105 (1,353,677) 4,660,184
___________ ___________ ___________ ___________
At 1st May 2009 102,756 5,911,105 (759,547) 5,254,314
Loss for the year - - (1,737,129) (1,737,129)
Share issue 55,977 2,463,063 - 2,519,040
Share issue costs - (52,360) - (52,360)
Share option costs - - 64,012 64,012
___________ ___________ ___________ ___________
At 30th April 2010 158,733 8,321,808 (2,432,664) 6,047,877
___________ ___________ ___________ ___________
Notes to the Interim Financial Statements for the period to 31 October 2010
1. Basis of preparation
This interim statement for the six month period to 31st October 2010 is
unaudited and was approved by the directors on 31st January 2011. The financial
information contained in the interim report has been prepared in accordance
with the accounting policies set out in the annual report and accounts for the
year ended 30th April 2010.
The financial information contained in the interim report does not constitute
statutory accounts as defined in section 434 of the Companies Act 2006. The
financial information for the full preceding year is based on the statutory
accounts for the year ended 30th April 2010. Thos accounts, upon which the
auditors, Champion Accountants LLP, issued an unqualified audit opinion, and
whose report did not contain any matters to which they drew attention by way of
emphasis, nor contained a statement under section 498(2) or 498(3) of the
Companies Act 2006, have been delivered to the Registrar of Companies.
As permitted, this interim report has been prepared in accordance with AIM Rule
18 and not in accordance with IAS 34 "Interim Financial Reporting" therefore it
is not fully in compliance with IFRS as adopted by the European Union.
2. Earnings per share
Basic earnings per share is calculated by dividing the earnings attributable to
ordinary shareholders by the weighted average number of ordinary shares
outstanding during the year.
The calculations of earnings per share are based on the following losses and
numbers of shares.
6 months to 6 months to Year ended
31/10/2010 31/10/2009 30/04/2010
Loss after taxation (802,170) (626,136) (1,737,129)
Weighted average number of 15,898,458 10,275,551 10,733,335
shares
Basic earnings per share (5.0)p (6.1)p (16.2)p
3. Taxation
Taxation for the six months ended 31st October 2010 is based on the effective
rates of taxation which are estimated to apply for the year ended 30th April
2011.
4. Subsequent events
On 13 January 2011 the company issued 25,131 shares of 0.1 pence each at 95.5
pence per share in respect of annual advisory fees. At the date of this
announcement there are 15,951,790 ordinary shares of 0.1 pence each in issue.
5. Interim results
These results were approved by the Board of Directors on Monday 31st January
2011. Copies of the interim report are available to the public from the
Company's registered office and the Company's website, www.scancell.co.uk.
Scancell Holdings plc