TIDMSCLP
RNS Number : 0051K
Scancell Holdings Plc
16 September 2016
16 September 2016
Scancell Holdings Plc
("Scancell" or the "Company")
Final Results for the year ended 30 April 2016
Landmark four year survival achieved in resected SCIB1
patients
Emerging pipeline of three products across five cancer
indications
Scancell Holdings plc, ('Scancell' or the 'Company') the
developer of novel immunotherapies for the treatment of cancer,
announces results for the year ended 30 April 2016.
Highlights
-- SCIB1 continues to deliver significant survival data from the
Phase 1/2 clinical trial in patients with Stage III/IV melanoma
o Currently 19 of the 20 patients with resected tumours at study
entry remain alive
o Of the 16 patients who received 2-4mg doses of SCIB1
-- Median observation time since entry is 49 months, a landmark
survival milestone
-- Only two new incidences of disease progression have been
recorded since December 2013
o Of the four patients who received 8mg doses of SCIB1
-- Median observation time since entry is 18 months
-- None have progressed and none have died
o As announced on 17 June 2016, treatment for the eight patients
in the long-term continued dosing phase has been suspended due to
the clinical trial supplies no longer being within the original
specification
o New SCIB1 material being manufactured to support a new study
of SCIB1 in combination with a checkpoint inhibitor will also be
made available to these continuation patients (subject to
regulatory approval)
o Plans for the US clinical study of SCIB1 in combination with a
checkpoint inhibitor remain on track, enrolment expected to
commence in Q3 2017
o The final Clinical Study Report will be issued later this year
and will support our US IND submission
-- Continued progress made in development of lead product, Modi-1, from Moditope(R) platform
o Enrolment for first-in-man clinical study in triple negative
breast cancer, ovarian cancer and osteosarcoma expected to commence
in early 2018
-- Strategic collaboration with Karolinska Institutet to explore
the role of citrullination in cancer, a key mechanism underpinning
the Moditope(R) platform
-- GBP6.2m (GBP5.8m net) raised through a firm placing and open
offer involving both existing and new shareholders
-- John Chiplin appointed Chairman
-- Loss for the year of GBP2,583,273 (2015: loss GBP2,414,630)
-- Group cash balance at 30 April 2016 was GBP6,527,435 (30 April 2015: GBP3,059,001)
Post Period Highlights
-- Scancell's executive management team restructured to align
expertise with the strategic direction outlined in fundraising
-- Dr Alan Lewis appointed to Board as Non-Executive Director
-- Opening of new offices in San Diego, US and Oxford, UK to support Company's growth plans
Dr John Chiplin, Executive Chairman of Scancell, said:
"We have continued to make significant progress in the period,
both in terms of the maturing clinical data with SCIB1 and further
scientific developments on both the ImmunoBody(R) and Moditope(R)
platforms. We now have a pipeline of three products across five
cancer indications and clinical success with any one of these
products could transform the value of the business. The Board
believes that further clinical studies could add significant value
to the Company and is continuing to explore a number of funding
options to ensure that the Company has the resources to progress
these programmes further.
"Scancell has arrived at an exciting point in its development.
We now have the opportunity to transform the business from a small
UK-based and largely scientifically-based enterprise into an
international force in immuno-oncology. We remain committed to
driving this process forward in the US and elsewhere, and to
realising the value that has been accumulating over recent years,
both for the benefit of our shareholders and cancer patients."
For Further Information:
Scancell Holdings Plc
Dr John Chiplin, Executive
Chairman +1 858 900 2646
Dr Richard Goodfellow, Scancell Holdings +44 (0) 20 3727
CEO Plc 1000
Freddy Crossley (Corporate +44 (0) 20 7886
Finance) 2500
Tom Salvesen (Corporate Panmure Gordon +44 (0) 20 7886
Broking) & Co 2500
+44 (0) 20 3727
Mo Noonan/Simon Conway FTI Consulting 1000
About Scancell
Scancell is developing novel immunotherapies for the treatment
of cancer based on its ImmunoBody(R) and Moditope(R) technology
platforms.
Scancell's first ImmunoBody(R), SCIB1 is being developed for the
treatment of melanoma. Data from the Phase 1/2 clinical trial
demonstrate that SCIB1, when used as monotherapy, has a marked
effect on tumour load, produces a melanoma-specific immune response
and highly encouraging survival trend without serious side effects.
In patients with resected disease there is increasing evidence to
suggest that SCIB1 may delay or prevent disease recurrence.
Scancell's ImmunoBody(R) vaccines target dendritic cells and
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.
Pre-clinical data on a combination of SCIB1 or SCIB2 and
checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune
checkpoint pathways) have shown enhanced tumour destruction and
significantly longer survival times than when either treatment was
used alone.
Scancell has also identified and patented a series of modified
epitopes that stimulate the production of killer CD4+ T cells that
destroy tumours without toxicity. The Directors believe that the
Moditope(R) platform could play a major role in the development of
safe and effective cancer immunotherapies in the future.
CHAIRMAN'S STATEMENT
I am pleased to report the Company's final results for the year
ended 30 April, 2016. Over the year, we have continued to make good
progress across our two proprietary immuno-oncology platforms, with
a pipeline of three products across five cancer indications under
development.
SCIB1 continues to deliver compelling survival data in patients
with melanoma and plans for our US Phase 2b study of SCIB1 in
combination with a checkpoint inhibitor remain on track. Scancell's
second ImmunoBody(R), SCIB2, will be developed for the treatment of
non-small cell lung cancer in combination with a checkpoint
inhibitor. Progress has also been made in the pre-clinical
development of Modi-1 which is being prepared for clinical trials
in three indications, triple negative breast cancer, ovarian cancer
and osteosarcoma.
In April 2016, the Company raised GBP6.2m (GBP5.8m net proceeds)
from a firm placing and open offer; the firm placing raised gross
proceeds of GBP3.4m and the open offer GBP2.8m. These funds will
enable the Company to:
-- Secure approval of an Investigational New Drug (IND)
application for the SCIB1 checkpoint inhibitor combination study in
patients with melanoma;
-- Manufacture a new batch of SCIB1 for the SCIB1 checkpoint
inhibitor combination study and complete all preparatory work for
the trial in the US;
-- Prepare and file a Clinical Trial Application (CTA) in the UK
for the planned Phase 1/2 clinical trial with Modi-1, manufacture
the product and to complete all of the preparatory work for such a
trial in the UK; and
-- Strengthen the management and infrastructure of the Company
from new offices in San Diego and Oxford.
Financial
Profit and Loss Account
The Group made an operating loss for the year to 30 April, 2016
of GBP3,043,163 (2015: loss of GBP2,959,995). There has been an
increase of 3% in the operating loss over the past two years. The
major reasons for this have been an increase in administrative
expenses during the year as the Company has incurred additional
corporate costs in preparing and developing opportunities within
the US. This increase has been partially offset by a reduction in
development expenses as a result of expenditure on manufacturing
costs being incurred in 2014/15 but not in 2015/16 and reduced
clinical trial costs for the current year as the SCIB1 study closed
in October 2015.
Overall the loss for the year was GBP2,583,273 (2015: loss
GBP2,414,630).
Balance Sheet
The cash at bank at 30 April 2016 was GBP6,527,435 (30 April
2015: GBP3,059,001) and net assets amounted to GBP9,992,281 (30
April 2015: GBP6,754,002).
Two Powerful Proprietary Platforms: ImmunoBody(R) and
Moditope(R)
Scancell is exploiting the unrivalled potential of the immune
system to seek out and destroy cancer using our two proprietary
immuno-oncology platforms.
ImmunoBody(R)
Scancell's potent innovative DNA-based ImmunoBody(R) therapies
generate ultra-high avidity T cell responses that target and
eliminate cancerous tumours. Although there have been some
successes, therapeutic vaccine development has been hampered by
high failure rates that can in large measure be attributed to a
failure to trigger the induction of the high avidity multi-targeted
anti-tumour T cell responses that are required to control the
disease. Pre-clinical studies have confirmed that the ImmunoBody(R)
platform delivers killer T cell responses that are superior in
magnitude to those generated by current cancer vaccines. Moreover,
different T-cell epitopes can be grafted into the framework
allowing for rapid customisation for the targeting of multiple
tumour types.
SCIB1 melanoma vaccine
SCIB1 continues to deliver strong survival data. Currently 19 of
the 20 Stage III/IV patients with resected tumours remain alive.
Despite additional treatment with checkpoint inhibitors and
radiation therapy one patient who first experienced disease
progression in September 2013 died in April 2016. Of the 16
patients who received 2-4mg doses of SCIB1 the median observation
time since entry is now 49 months - a significant survival landmark
and one which suggests that SCIB1 may offer curative potential in
these difficult to treat patients. Indeed there have only been two
new cases of disease progression in this cohort since December
2013. Of the four patients who received 8mg doses of SCIB1, the
median observation time since entry is now 18 months. None of these
patients have progressed and none have died. As Dr Keith Flaherty,
Prof of Medicine at Harvard Medical School commented in July of
this year: "The SCIB1 overall survival and progression free
survival data to date go well beyond established norms for this
group of patients."
The final Clinical Study Report, which will be issued later this
year, will provide safety, immunology and clinical data from all
patients up to 29 October 2015 (the date of the last patient's dose
in the main study) to support our US IND submission.
Following quality control analysis the Company suspended dosing
with the current clinical supplies of SCIB1 as the stored drug
product was no longer within its original specification. With
patient safety of paramount importance, the Company concluded that
the clinical supplies were no longer suitable for further use,
although no new side effects have emerged. The Company has recently
signed a supply agreement with a new GMP manufacturer to supply
materials for a planned new study of SCIB1 in combination with a
checkpoint inhibitor, which will also be made available to those
patients who were receiving long term treatment before their
treatment was interrupted.
Plans for the US Phase 2b study of SCIB1 in combination with a
checkpoint inhibitor remain on track and enrolment is expected to
commence in Q3 2017. The Principal Investigator will be Dr Keith
Flaherty who will be joined by leading clinicians across the US.
This study is designed to meet the need for enhanced response rates
to immune checkpoint therapy which still remain unacceptably low.
SCIB1 induced T cell activation provides a means to increase the
immunogenicity of cancer cells and subsequently the response rate
to immune checkpoint therapy. We have already shown enhanced
response rates and survival times using a combination of SCIB1 and
checkpoint inhibitor treatment in pre-clinical models of
melanoma.
The "second generation" SCIB1 construct, SCIB1 PLUS has now been
characterised and will be developed to support future clinical
trials in the adjuvant indication. This will eliminate the need for
HLA (human leucocyte antigen) testing before treatment and will
effectively double the size of the available market for SCIB1.
SCIB2 lung cancer vaccine
SCIB2 contains multiple T cell epitopes derived from the lung
cancer associated antigen NY-ESO-1. In a mouse lung cancer model,
survival rates with SCIB2 were comparable to that seen with
anti-PD-1 checkpoint treatment and moreover, survival rates were
boosted to 100% when the checkpoint therapy was combined with
SCIB2. At least 80% of patients with non-small cell lung cancer
(NSCLC) fail to respond to checkpoint inhibitors as their tumours
are insufficiently immunogenic. Targeted T-cell activation with
SCIB2 may serve to increase the immunogenicity of lung cancers and
subsequently the response rate to checkpoint therapy. We are
therefore planning to conduct a US based clinical study on NY-ESO-1
NSCLC patients to assess the safety and efficacy of SCIB2 in
combination with a checkpoint inhibitor. The first stages of
manufacture will commence in Q4 2016 with the goal of starting
enrolment early in 2018.
Moditope(R)
Scancell's Moditope(R) platform technology overcomes the immune
suppression induced by tumours themselves, allowing activated T
cells to seek out and kill tumour cells that would otherwise be
hidden from the immune system. This is achieved by stimulating the
production of CD4+ T cells using citrullinated tumour-associated
peptide epitopes which overcome self-tolerance and destroy tumour
cells. Pre-clinical studies have shown unprecedented anti-tumour
effects that can be delivered even in the absence of checkpoint
therapy.
Publication of the scientific data supporting the Moditope(R)
platform in Cancer Research in December 2015 provided further
endorsement of the quality of Scancell's innovative research and
earlier this year we were pleased to announce a strategic
collaboration with Karolinska Institutet to explore the role of
citrullination in cancer, a key mechanism underpinning the
Moditope(R) platform.
Modi-1
Modi-1 is comprised of two citrullinated vimentin peptides and
one citrullinated enolase peptide. Vimentin and enolase peptides
are highly expressed in triple negative breast cancer, ovarian
cancer and osteosarcoma. In animal models a single immunisation of
Modi-1 resulted in a 100% survival rate. We are now actively
planning a first-in-man clinical study to assess the safety and
objective response rate of Modi-1 in all three target cancers which
is expected to commence enrolment in early 2018.
Management and infrastructure changes
In May 2016, the Company made changes to the structure of
Scancell's executive management team to align expertise with the
strategic direction outlined in the fundraising, completed in April
2016. I have assumed the role of Executive Chairman and will be
directly involved in raising the profile of the Company in the US.
Dr Richard Goodfellow became CEO and Professor Lindy Durrant became
Chief Scientific Officer, allowing her to focus fully on her
innovative work that underpins the Company's novel technology
platforms. In order to support the Company's ambitious US growth
plans, an office has been opened in San Diego and Dr Alan Lewis,
who is based in the US has recently joined the Board as a
non-executive director. Alan brings a wealth of industry
experience, both commercially and financially and has extensive
experience in drug discovery and development. In addition, we have
opened an office on the Oxford Science Park from which all UK
development activities will henceforth be coordinated.
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.
Outlook
The Company has made significant progress during the course of
the past year, both in terms of the maturing clinical data with
SCIB1 and further scientific developments on both the ImmunoBody(R)
and Moditope(R) platforms. We now have a pipeline of three products
(SCIB1, SCIB2, Modi-1) across five cancer indications (melanoma,
lung, breast, ovarian cancer and osteosarcoma) and clinical success
with any one of these products could transform the value of the
business. The Board therefore believes that further clinical
studies could add significant value to the Company and is
continuing to explore with its advisors a number of funding options
to ensure that the Company has the resources to progress these
programmes further.
Scancell has arrived at an exciting point in its development. We
now have the opportunity to transform the business from a small UK
based and largely scientifically based enterprise into an
international force in immuno-oncology. I remain committed to
driving this process forward in the US and elsewhere, and to
realising the value that has been accumulating over recent years,
both for the benefit of our shareholders and cancer patients.
John Chiplin
Chairman
CONSOLIDATED PROFIT OR LOSS AND
OTHER COMPREHENSIVE INCOME STATEMENT 2016 2015
FOR THE YEARED 30 APRIL 2016 GBP GBP
Development expenses (2,009,046) (2,118,366)
Administrative expenses (1,034,117) (841,629)
-------------------------- --------------------------
OPERATING LOSS (note 2) (3,043,163) (2,959,995)
Interest receivable and similar
income 13,552 131,513
-------------------------- --------------------------
LOSS BEFORE TAXATION (3,029,611) (2,828,482)
Taxation (note 3) 446,338 413,852
-------------------------- --------------------------
LOSS AND TOTAL COMPREHENSIVE INCOME
FOR THE YEAR (2,583,273) (2,414,630)
-------------------------- --------------------------
EARNINGS PER ORDINARY SHARE (pence)
(note 4)
Continuing operations
Basic (1.14)p (1.07)p
Diluted (1.14)p (1.07)p
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
for the year ended 30 April 2016
Share Share Share Retained
Capital Premium Option Earnings Total
GBP GBP GBP GBP GBP
Balance 1st
May 2014 224,951 16,036,276 522,358 (7,706,321) 9,077,264
Loss for the
year (2,414,630) (2,414,630)
Share option
charge 91,368 91,368
Balance 30
April 2015 224,951 16,036,276 613,726 (10,120,951) 6,754,002
Share issue 36,607 6,186,653 6,223,260
Expenses of
issue (437,634) (437,634)
Loss for the
year (2,583,273) (2,583,273)
Share option
charge 35,926 35,926
Balance at
30 April 2016 261,558 21,785,295 649,652 (12,704,224) 9,992,281
-------- ----------- -------- ------------- ------------
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
as at 30 April 2016
2016 2015
ASSETS GBP GBP
Non-current assets
Plant and machinery 64,611 86,504
Goodwill 3,415,120 3,415,120
------------------ ------------------
3,479,731 3,501,624
----------------- -----------------
Current assets
Trade and other receivables 120,765 136,785
Tax receivables 440,001 660,504
Cash and cash equivalents 6,527,435 3,059,001
------------------- -------------------
7,088,201 3,856,290
-------------------- --------------------
TOTAL ASSETS 10,567,932 7,357,914
------------------- --------------------
LIABILITIES
Current Liabilities
Trade and other payables (575,651) (603,912)
------------------- -------------------
TOTAL LIABILITIES (575,651) (603,912)
------------------- -------------------
NET ASSETS 9,992,281 6,754,002
=========== ===========
SHAREHOLDERS' EQUITY
Called up share capital 261,558 224,951
Share premium 21,785,295 21,785,295
Share option reserve 649,652 613,726
Profit and loss account (12,704,224) (10,120,951)
-------------------- --------------------
TOTAL SHAREHOLDERS' EQUITY 9,992,281 6,754,002
============ ============
CONSOLIDATED CASH FLOW STATEMENT
for the year ended 30 April 2016
2016 2015
GBP GBP
Operating activities
Cash generated from operations (2,997,585) (2,763,460)
Income taxes received 666,841 124,713
-------------------- --------------------
Net cash from operating activities (2,330,744) (2,638,747)
-------------------- --------------------
Investing activities
Grant monies 9,776 64,668
Loan repayment - 49,725
Finance income 3,776 17,121
-------------------- --------------------
Net cash used by investing activities 13,552 131,514
-------------------- --------------------
Financing activities
Proceeds from issue of share capital 6,223,260 -
Expenses of share issue (437,634) -
-------------------- --------------------
Net cash generated from financing
activities 5,785,626 -
-------------------- --------------------
Net increase in cash and cash equivalents 3,468,434 (2,507,233)
Cash and cash equivalents at beginning
of the year 3,059,001 5,566,234
-------------------- --------------------
Cash and cash equivalents at end
of the year 6,527,435 3,059,001
-------------------- --------------------
NOTES TO THE FINANCIAL INFORMATION
For the year ended 30 April 2016
1 BASIS OF PREPARATION
These financial results do not comprise statutory accounts for
the year ended 30 April 2016 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 2016.
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 accounts.
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
2016 2015
GBP GBP
Operating Loss is stated after
charging/(crediting):
Depreciation on tangible fixed
assets 21,893 29,117
Operating lease rentals 12,500 14,523
Research and development 2,009,046 2,118,366
Auditors' remuneration - fee payable
for audit of the company 8,250 7,250
Auditors' remuneration - fee payable
for audit of the subsidiary company 10,775 7,250
Auditors' remuneration for non-audit
services 1,500 1,260
Directors' remuneration 330,448 150,413
=========== ============
3 TAXATION
Analysis of the tax credit
The tax credit on the loss on
ordinary activities for the year
was as follows: 2016 2015
Current tax GBP GBP
UK corporation tax credits due
on R&D expenditure 440,001 422,976
Adjustment to prior year 6,337 (9,124)
_________ _________
_______ _______
446,338 413,852
================================= =================================
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:
2016 2015
GBP GBP
Loss on ordinary activities before
tax (3,029,611) (2,828,482)
======================================== ========================================
Loss on ordinary activities
multiplied
by the small company rate of tax
in the UK (20%) (605,922) (565,696)
Effects of:
Disallowed expenditure 8,733 20,028
Timing differences 7,777 9,010
Enhanced tax relief on R&D
expenditure (343,593) (327,849)
Reduced tax relief for losses
surrendered for R&D tax credits 166,897 160,439
Prior year over provision (6,337) 9,124
Unrelieved losses carried forward 326,107 281,092
_____________________ _____________________
Current tax (credit) (446,338) (413,852)
======================================== ========================================
The Group has tax losses to carry forward against future profits
of approximately GBP11,180,000 (2014: GBP9,575,000)
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 GBP1,888,000 (2015: GBP1,894,300).
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:
2016 2015
GBP GBP
Earnings used in the calculation
of basic earnings per share (2,583,273) (2,414,630)
Profit for the year from discontinued
operations included
in the calculation of basic
earnings per share _____________________ _____________________
Earnings used in calculation
of basic earnings per share
from continuing operations (2,583,273) (2,414,630)
Weighted average number of
ordinary shares of 0.1p each
for the calculation of basic
earnings per share 227,558,335 224,950,683
Diluted earnings per share
As the Group is reporting a loss from continuing operations for
both years then, in accordance with IAS33, the share options are
not considered dilutive because the exercise of the share options
would have the effect of reducing the loss per share.
5 DELIVERY OF ACCOUNTS
The audited statutory accounts in respect of the prior year
ended 30 April 2015 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
FR BRGDCIUBBGLU
(END) Dow Jones Newswires
September 16, 2016 02:00 ET (06:00 GMT)