Interim Results
ReNeuron Group plc
03 December 2007
Guildford, UK: 3 December 2007
ReNeuron Group plc
Interim Results for the six months ended 30 September 2007
Highlights
• Successful completion of further pre-clinical studies in support of IND
application to commence initial clinical trial in the US with ReN001 stem
cell therapy for stroke
• Amendments to IND application completed and filed with FDA
• Insulin-producing islets generated in ReN002 diabetes programme
• Acquisition of business assets of AmCyte for US$4.0 million, together with
further £1.5 million fundraising before expenses, both achieved via share
placing
• Research collaboration initiated with King's College London regarding
enhancements to stem cell expansion technology
• Other therapeutic and non-therapeutic programmes progressing to plan
• Net loss of £3.1 million (2006: £3.3 million); net cash outflow from
operating activities £2.9 million (2006: £3.0 million); cash and cash
equivalents at 30 September 2007 of £5.7 million (2006: £2.8 million)
Commenting on the results, Professor Trevor Jones, Chairman, said:
'ReNeuron's principal focus in the period under review has been to address the
FDA's questions and requests for further data regarding the clinical trial
application for our ReN001 therapy. We have now completed the process of
submitting our responses and IND amendments to the FDA. Based on the data we
have generated over the course of this year, we remain confident of achieving
our objective of commencing an initial clinical trial with ReN001 in 2008.
'Progress with our other therapeutic programmes has given us further cause for
encouragement. The acquisition of the cell encapsulation technology from AmCyte
has greatly bolstered our ReN002 programme for Type 1 diabetes, and our
programmes for Parkinson's disease and diseases of the retina have also made
good progress in the period. We look forward to reporting further progress
across these programmes over the coming months.'
Enquiries:
Michael Hunt, Chief Executive Officer
ReNeuron Group plc +44 (0)1483 302560
David Yates
Lara Mott
Financial Dynamics - Europe +44 (0)20 7831 3113
Robert Stanislaro
Financial Dynamics - US +1 (212) 850 5657
Chairman's and Chief Executive Officer's Joint Statement
Review of Operations
ReN001 stem cell therapy for stroke
During the period, we have successfully completed a number of further
pre-clinical studies in support of our Investigational New Drug (IND)
application with the US Food and Drug Administration (FDA) to commence initial
clinical trials with ReN001 in the US. This application is currently on
clinical hold, pending resolution of a number of questions and requests for
further information made by the FDA.
The most important of these pre-clinical studies was one examining the long-term
safety profile of ReN001 in a specialised rodent stroke model. The data from
this study, conducted in the US, showed no unusual or adverse safety effects in
either control or treatment groups. We have interacted with the FDA during the
year in order to seek confirmation that our approach to responding to certain of
the FDA's requests for further data is appropriate from their perspective.
Based on these interactions, we have collated the data from the key studies
undertaken over the course of the year into a series of IND amendments and full
responses to the FDA's requests. We have completed the process of submitting
these responses and IND amendments to the FDA and we will make further
announcements regarding the outcome in due course.
During the period, we have instigated formal contact with other key regulatory
agencies in respect of the ReN001 therapy, including the UK Medicines and
Healthcare Products Regulatory Agency (MHRA). This is with a view to subsequent
clinical trial applications, where appropriate, in order to build the clinical
profile for ReN001 in these territories. We have been most encouraged by the
initial feedback we have received from these agencies.
We are also delighted to welcome a leading UK-based neurologist onto ReNeuron's
Clinical Advisory Board. Professor Philip Bath, BSc, MB, BS, MD, FRCPath, FRCP
FESC is the Stroke Association Professor of Stroke Medicine at the University of
Nottingham. He is an expert in pharmaceutical studies in stroke at both
pre-clinical and clinical level and we welcome the invaluable expertise and
experience Professor Bath will bring to the Company.
Based on the above progress with our ReN001 therapy, we believe ReNeuron is
well-placed to achieve its near-term objective in 2008 of taking its first stem
cell therapy into man in an area of significant unmet medical need.
Other therapeutic and non-therapeutic programmes
A principal aim of our commercial strategy is to drive the development of
ReNeuron's other therapeutic programmes as quickly and efficiently as possible,
thus giving the business a pipeline of stem cell therapies at clinical or late
pre-clinical stage. To this end, we have been greatly encouraged by the
progress made during the period, both by our in-house research teams and our
external collaborators on these programmes.
During the period, we announced that we had used our patented c-mycER stem cell
expansion technology to generate stable human pancreatic cell lines for our
ReN002 programme for Type I diabetes. The cell lines formed islet cell
clusters which were shown to secrete insulin in response to glucose
concentrations, as well as expressing the appropriate phenotypic markers for
insulin-producing islet cells.
The above ReN002 development was closely followed in the period by ReNeuron's
acquisition of the business assets of AmCyte, a development stage cell therapy
company based in Santa Monica, California. The acquisition was financed by the
issue of new Ordinary shares in ReNeuron to raise US$4.0 million for the AmCyte
vendors. The deal was completed in conjunction with a further equity
fundraising by ReNeuron of £1.5 million, before expenses, to provide working
capital for the ongoing acquired operation. The acquired assets are held in a
new US subsidiary, ReNeuron Inc.
The rationale for the acquisition is to combine ReNeuron's own
well-characterised, scalable pancreatic cells with AmCyte's clinically-tested
cell encapsulation system, in order to overcome the two principle obstacles
facing islet cell therapy for Type 1 diabetes: the lack of suitable donated
pancreatic tissue from which to derive high quality insulin-producing islet
cells, and the immune rejection typically seen when transplanting raw islets
into diabetes patients. The acquisition also brings ReNeuron a talented
research and development team based in California, one of the world's leading
centres for both academic and commercial stem cell research and development.
Since the acquisition, we have relocated the US team into a more compact,
purpose-built research facility in Santa Monica. We have also commenced initial
in vitro and in vivo studies looking at the characteristics of both 'naked' and
encapsulated ReN002 islet cells, the early results from which are promising.
We are also seeing encouraging data emerging in our ReN003 and ReN004 programmes
for, respectively, retinal diseases and Parkinson's disease. During the period,
we extended our research collaboration with the Schepens Eye Research Institute
at Harvard Medical School, the objectives of the initial research collaboration
having been met. We are also on track to meet the research objectives under the
grant awarded by the Michael J. Fox Foundation for Parkinson's Research in
respect of our ReN004 programme.
We aim to make further specific announcements regarding progress with the above
therapeutic programmes over the coming months.
We have made good progress during the period with the development of our ReNcell
(R) products for non-therapeutic applications in research and in the
pharmaceutical industry. Whilst early royalty income from our first-generation
ReNcell(R) neural cell lines is modest, we believe the commercial potential of
our next-generation ReNcell(R) liver and pancreatic cell lines is significantly
greater, with a good deal of early interest being expressed from commercial
organisations. Based on successful initial results, we extended our
collaboration with CellSeed, Inc. of Japan in the period, focused on the
development of novel liver cell culture systems utilising our ReNcell(R) liver
cell line.
During the period, we also entered into a research collaboration with King's
College London, part-funded by the UK government under its Knowledge Transfer
Partnership (KTP) scheme. This project seeks to enhance the efficiency of our
c-mycER cell expansion technology when applied to the selection and scaling of
future cell line products.
Summary of Results
The Group has adopted International Financial Reporting standards (IFRS) for the
first time in the preparation of the interim results for the six months to 30
September 2007. In accordance with IFRS1 'First-time Adoption of IFRS', the
comparative results for the six months ended 30 September 2006 and the year
ended 31 March 2007 have been restated to accord with IFRS. The impact of IFRS
on the Group's accounting policies and financial results are detailed in the
notes to these interim financial statements.
In the six months to 30 September 2007, revenues were £4,000 (2006: £42,000),
representing royalty income from the Group's non-therapeutic licensing
activities.
Net operating expenses were £3.5 million in the period (2006: £3.5 million).
An increase in research and development expenditure in the period to £2.6
million (2006: £2.5 million) was offset be an equivalent decrease in
administrative costs to £0.9 million (2006: £1.0 million). Full year operating
expenses are forecast to be higher than the prior year, however, due to the
additional operational expenses of the Group's US operation, included in the
consolidated accounts from 1 August 2007.
Other operating income increased in the period to £0.2 million (2006: £0.1
million) as a result of higher grant income received. Interest received also
increased in the period to £0.2 million (2006: £0.1 million), due to higher
average cash balances over the period. The resulting net loss for the period
decreased to £3.1 million (2006: £3.3 million).
Net cash outflow from operating activities decreased in the period to £2.9
million (2006: £3.0 million). During the period, the Group acquired the
business assets of AmCyte, financed by a placing of new Ordinary shares raising
US$4.0 million for the AmCyte vendors. In conjunction with the acquisition, the
Group raised a further £1.5 million, before expenses, by way of a placing of new
Ordinary shares.
Cash and cash equivalents decreased by £2.0 million in the period (2006: £2.3
million), reflecting the above operational and financing activities. As at 30
September 2007, the Group had cash and cash equivalents totalling £5.7 million
(2006: £2.8 million). The directors estimate that the Group's current cash
resources are sufficient to meet expenditure requirements into the third quarter
of 2008. The directors are confident of raising further funds sufficient for
the needs of the business from equity issues and other sources. Consequently,
the going concern basis has been adopted in the preparation of these interim
financial statements.
Outlook
ReNeuron's principal focus in the period under review has been to address the
FDA's questions and requests for further data regarding the clinical trial
application for our ReN001 therapy. We have now completed the process of
submitting our responses and IND amendments to the FDA. Based on the data we
have generated over the course of this year, we remain confident of achieving
our objective of commencing an initial clinical trial with ReN001 in 2008.
Progress with our other therapeutic programmes has given us further cause for
encouragement. The acquisition of the cell encapsulation technology from AmCyte
has greatly bolstered our ReN002 programme for Type 1 diabetes, and our
programmes for Parkinson's disease and diseases of the retina have also made
good progress in the period. We look forward to reporting further progress
across these programmes over the coming months.
Professor Trevor Jones Michael Hunt
Chairman Chief Executive Officer
3 December 2007
Note to editors:
ReNeuron is a leading, UK-based stem cell therapy business. It is applying its
novel stem cell platform technologies in the development of ground-breaking stem
cell therapies to serve significant and unmet or poorly-met clinical needs. The
Company operates from laboratories in Surrey, UK and Los Angeles, California,
USA.
ReNeuron has used its c-mycER technology to generate genetically stable neural
stem cell lines. This technology platform has multi-national patent protection
and is fully regulated by means of a chemically-induced safety switch. Cell
growth can therefore be completely arrested prior to in vivo implantation.
ReNeuron has filed for approval to commence initial clinical studies in the US
with its lead ReN001 stem cell therapy for chronic stroke disability. This
represents the world's first such filing concerning a neural stem cell treatment
for a major neurological disorder. There are an estimated 50 million stroke
survivors worldwide, approximately one half of which are left with permanent
disabilities. The annual health and social costs of caring for these patients
is estimated to be in excess of £5 billion in the UK and in excess of US$50
billion in the US.
In addition to its stroke programme, ReNeuron is developing stem cell therapies
for Parkinson's disease, Huntington's disease, Type 1 diabetes and diseases of
the retina. The Company recently announced the acquisition of the business
assets of AmCyte in the US, bringing clinically-tested cell encapsulation
technology to ReNeuron's ReN002 diabetes programme.
ReNeuron has leveraged its stem cell technologies into non-therapeutic areas -
its ReNcell(R) range of cell lines for use in research and in drug discovery
applications in the pharmaceutical industry. ReNeuron's ReNcell(R)CX and
ReNcell(R)VM neural cell lines are marketed worldwide under license by Millipore
Corporation.
ReNeuron's shares are traded on the London AIM market under the symbol RENE.L.
Further information on ReNeuron and its products can be found at
www.reneuron.com.
Data sources: UK Stroke Association; American Stroke Association.
This announcement contains forward-looking statements with respect to the
financial condition, results of operations and business achievements/performance
of ReNeuron and certain of the plans and objectives of management of ReNeuron
with respect thereto. These statements may generally, but not always, be
identified by the use of words such as 'should', 'expects', 'estimates',
'believes' or similar expressions. This announcement also contains
forward-looking statements attributed to certain third parties relating to their
estimates regarding the growth of markets and demand for products. By their
nature, forward-looking statements involve risk and uncertainty because they
reflect ReNeuron's current expectations and assumptions as to future events and
circumstances that may not prove accurate. A number of factors could cause
ReNeuron's actual financial condition, results of operations and business
achievements/performance to differ materially from the estimates made or implied
in such forward-looking statements and, accordingly, reliance should not be
placed on such statements.
The terms 'ReNeuron', 'the Company' or 'the Group' used in this statement refer
to ReNeuron Group plc and/or its subsidiary undertakings, depending on the
context.
Unaudited Consolidated Income Statement
For the six months ended 30 September 2007
Six months Six months
ended 30 ended 30 Year ended
September September 31 March
2007 2006 2007
Note £'000 £'000 £'000
Revenue 4 42 49
Net operating expenses 3 (3,485) (3,531) (6,276)
Other operating income 184 137 263
______ ______ ______
Operating Loss (3,297) (3,352) (5,964)
Finance income 190 87 192
Loss before income taxes (3,107) (3,265) (5,772)
Tax credit on loss on ordinary - - 523
activities
______ ______ ______
Loss for the period (3,107) (3,265) (5,249)
______ ______ ______
Loss per ordinary share
Basic and diluted 5 (2.2p) (3.4p) (4.9p)
Unaudited Consolidated Balance Sheet
As at 30 September 2007
30 September 30 September 31 March
2007 2006 2007
Note £'000 £'000 £'000
Non-current assets
Intangible assets 3,419 972 1,272
Property, plant and equipment 1,020 1,115 1,044
Financial assets 125 81 125
______ ______ ______
4,564 2,168 2,441
Current assets
Trade and other receivables 1,164 920 879
Cash and cash equivalents 5,711 2,791 7,676
______ ______ ______
6,875 3,711 8,555
Current liabilities
Trade and other payables (1,113) (1,382) (813)
Financial liabilities (1) (2) (2)
______ ______ ______
(1,114) (1,384) (815)
______ ______ ______
Net current assets 5,761 2,327 7,740
______ ______ ______
Non current liabilities
Financial liabilities - (1) -
______ ______ ______
Net assets 10,325 4,494 10,181
______ ______ ______
Shareholders' equity
Share capital 1,542 997 1,377
Share premium 14,357 5,659 13,213
Capital redemption reserve 8,964 8,964 8,964
Merger reserve 2,223 365 365
Warrant reserve 113 436 113
Share-based credit reserve 250 106 166
Retained deficit (17,124) (12,033) (14,017)
______ ______ ______
Capital and reserves attributable to
the Group's equity shareholders
10,325 4,494 10,181
______ ______ ______
Unaudited Consolidated Statement of Changes in Equity
Share Capital
Share capital premium redemption Merger
account reserve Reserve
£'000 £'000 £'000 £'000
As at 1 April 2006 9,355 5,472 - 365
Issue of new ordinary shares 606 187 - -
Sub-division of ordinary shares (8,964) - 8,964 -
Share-based credit - - - -
Loss for the period - - - -
______ ______ ______ ______
As at 30 September 2006 997 5,659 8,964 365
Issue of new ordinary shares 380 7,311 - -
Costs of share issue - (193) - -
Exercise of warrants - 436 - -
Issue of warrants - - - -
Share-based credit - - - -
Loss for the period - - - -
______ ______ ______ ______
As at 31 March 2007 1,377 13,213 8,964 365
Shares issued for acquisition 93 - - 1,858
Issue of new ordinary shares 72 1,437 - -
Costs of share issue - (293) - -
Share-based credit - - - -
Loss for the period - - - -
______ ______ ______ ______
As at 30 September 2007 1,542 14,357 8,964 2,223
______ ______ ______ ______
(continued from table above)
Share-based
Warrant credit Profit and
reserve reserve loss account Total Equity
£'000 £'000 £'000 £'000
As at 1 April 2006 436 56 (8,768) 6,916
Issue of new ordinary shares - - - 793
Sub-division of ordinary shares - - - -
Share-based credit - 50 - 50
Loss for then period - - (3,265) (3,265)
______ ______ ______ ______
As at 30 September 2006 436 106 (12,033) 4,494
Issue of new ordinary shares - - - 7,691
Costs of share issue - - - (193)
Exercise of warrants (436) - - -
Issue of warrants 113 - - 113
Share-based credit - 60 - 60
Loss for the period - - (1,984) (1,984)
______ ______ ______ ______
As at 31 March 2007 113 166 (14,017) 10,181
Shares issued for acquisition - - - 1,951
Issue of new ordinary shares - - - 1,509
Costs of share issue - - - (293)
Share-based credit - 84 - 84
Loss for the period - - (3,107) (3,107)
______ ______ ______ ______
As at 30 September 2007 113 250 (17,124) 10,325
______ ______ ______ ______
Unaudited Consolidated cash flow statement
For the six months ended 30 September 2007
Six months Six months
ended 30 ended 30 Year ended
September September 31 March
2007 2006 2007
Note £'000 £'000 £'000
Operating loss (3,297) (3,352) (5,964)
Depreciation 82 115 200
Share-based payment charge 84 50 223
Interest received 190 87 192
Income tax credit received - - 503
Changes in working capital
Debtors (285) 26 43
Creditors 292 35 (534)
______ ______ ______
Cash flow from operating activities (2,934) (3,039) (5,337)
Capital expenditure (29) (18) (32)
Purchase of subsidiary 4 (216) - -
______ ______ ______
Cash flows from investing activities (245) (18) (32)
Finance lease principal payments (1) (1) (2)
Net funds from placing 1,215 715 7,913
______ ______ ______
Cash flows from financing activities 1,214 714 7,911
______ ______ ______
Net (decrease)/increase in cash and
cash equivalents
(1,965) (2,343) 2,542
Cash equivalents at the start of 7,676 5,134 5,134
period
______ ______ ______
Cash equivalents at the end of period 5,711 2,791 7,676
______ ______ ______
Notes to the interim financial statements
for the six months ended 30 September 2007.
1. Accounting policies and basis of preparation
1.1 Basis of preparation
These unaudited interim financial statements have been prepared in accordance
with the European Union endorsed International Financial Reporting Standards
(IFRS), the interpretations of International Financial Reporting Interpretations
Committee (IFRIC) and the Companies Act 1985 applicable to companies reporting
under IFRS and that are expected to apply for the annual financial statements to
31 March 2008.
The financial information contained in this interim report does not constitute
statutory accounts within the meaning of Section 240 of the Companies Act 1985.
Statutory accounts of ReNeuron Group plc and its subsidiaries in respect of the
year ended 31 March 2007, which were approved by the Board on 6 July 2007, have
been delivered to the Registrar of Companies, upon which the Company's auditors
have given a report which was unqualified and did not contain a statement under
Section 237(2) or 237(3) of that Act.
1.2 New Accounting policies on adoption of IFRS
These condensed consolidated financial statements for ReNeuron Group plc have
been prepared in accordance with International Accounting Standard (IAS) 34, '
Interim Financial Reporting', and are covered by IFRS 1, 'First-time Adoption of
IFRS', because they refer to part of the period covered by the group's first
IFRS financial statements for the year ending 31 March 2008.
The accounting policies have changed from the previous year when the financial
statements were prepared under applicable United Kingdom Generally Accepted
Accounting Principles (UK GAAP). The comparative information has been adjusted
in line with IFRS. The new accounting policies are set out in full below. An
analysis and reconciliation of the effects of the transition to IFRS are
provided in note 6.
The accounting policies that have been applied in the opening balance sheet have
also been applied throughout all periods presented in these financial
statements. When preparing the Group's IFRS balance sheet at 1 April 2006, the
date of transition, the following optional exemption from full retrospective
application of IFRS accounting policies has been adopted:
IFRS 3, 'Business combinations'.
The accounting policies following adoption of IFRS are set out below:
Share-based payments
The Group has applied the requirements of IFRS 2 'Share-based Payment'. In
accordance with the transitional provisions, IFRS 2 has been applied to all
grants of equity-settled awards after 7 November 2002 that were unvested at 1
April 2006.
The Group operates a number of equity-settled, share-based compensation plans.
The fair value of share-based payments under such schemes is expensed on a
straight-line basis over the vesting period, based on the Group's estimate of
shares that will eventually vest and adjusted for the effect of non market-based
vesting conditions. Fair value is determined by use of the Black Scholes Option
Pricing Model at the date of grant, as adjusted based on management's best
estimate for the effects of share liquidity and behavioural considerations.
For equity settled share based payments where employees of subsidiary
undertakings are rewarded with shares issued by the parent company, the expense
associated with the services provided is recognised in the employing company's
accounts.
Where warrants have been issued as recompense for services supplied these are
considered equity settled share based payments. The fair value of warrants,
calculated using the Black-Scholes model, is charged to the profit and loss
account and corresponding credit is made to the warrant reserve.
Warrants
Where warrants have been issued together with ordinary shares, the proportion of
the proceeds received that relates to the warrants is determined by reference to
the relative market values of the warrants. The proportion of the proceeds that
relates to the warrants is credited to a warrant reserve within shareholders'
funds.
Where warrants have been issued as recompense for services supplied these are
considered equity settled share based payments and are accounted for in
accordance with IFRS 2.
Property, plant and equipment
Property, plant and equipment is stated as cost, net of depreciation and any
provision for impairment. Depreciation is calculated so as to write off the cost
less their estimated residual values, on a straight-line basis over the expected
useful economic lives of the assets concerned. The principal annual rates used
for this purpose are:
Leasehold improvements Term of the lease
Plant and equipment 3-8 years
Computers 5 years
Computer software 3 years
Investments
Investments are shown at cost less any provision for impairment.
Goodwill
Purchased goodwill (representing the excess of the fair value of the
consideration given over the fair value of the separable net assets acquired) is
not amortised, but is regularly reviewed for impairment. Determining whether
goodwill is impaired requires an estimation of the value in use, which is
calculated by estimating the future cash flow expected to arise from the cash
generating unit, discounted by a suitable discount rate in order to calculate
the present value. No provision for impairment was made in the period.
Negative goodwill arose on the acquisition of ReNeuron (UK) Limited as the cost
of the acquisition was less than the fair value of the identifiable assets and
liabilities of the acquired entities. In accordance with IFRS3, negative
goodwill is recognised in the profit and loss account in the period in which it
occurs.
Intangible assets
Intangible fixed assets, relating to intellectual property rights acquired
through licensing or assigning patents and know-how are carried at historic cost
less accumulated amortisation, where the useful life of the asset is finite and
the asset is likely to generate economic benefits exceeding costs. Where a
finite useful life of the acquired intangible asset cannot be determined, the
asset is not subject to amortisation but is tested annually for impairment. No
amortisation has been charged to date, as the products underpinned by the
intellectual property rights are not yet available for commercial use.
Development expenditure
Expenditure on product development is capitalised as an intangible asset and
amortised over the expected useful life of the product concerned. Capitalisation
commences from the point at which technical feasibility and commercial viability
of the product can be demonstrated and the Group is satisfied that it is
probable that future economic benefits will result from the product once
completed. Capitalisation ceases when the product receives regulatory approval
for launch. No such costs have been capitalised to date.
Expenditure on research activities and development activities that do not meet
the above criteria, including ongoing costs associated with acquired
intellectual property rights and intellectual property rights generated
internally by the Group, is charged to the income statement as incurred.
Revenue
Revenue is measured at the fair value of the consideration received from the
provision of services net of Value Added Tax. Revenue from services is
recognised as revenue when the conditions in the contract for services have been
satisfied. Revenue also includes income received under licensing and from
collaborations with third parties.
Pension schemes
The Group operates a defined contribution pension scheme. Contributions payable
for the year are charged to the income statement. Differences between
contributions payable in the year and contributions actually paid are shown as
either accruals or prepayments in the balance sheet.
Operating leases
Costs in respect of operating leases are charged to the profit and loss account
on a straight-line basis over the lease term. Benefits such as rent-free
periods, and amounts received or receivable as incentives to take on operating
leases, are spread on a straight-line basis over the lease term, or, if shorter,
over the period to the review date on which the rent is first expected to be
adjusted to the prevailing market rent.
Deferred Tax
Deferred tax is provided in full, using the liability method, on temporary
differences arising between the tax bases of assets and liabilities and their
carrying amounts in the consolidated financial statements. However, deferred tax
is not accounted for if it arises from initial recognition of an asset or
liability in a transaction other than a business combination that at the time of
the transaction affects neither accounting nor taxable profit or loss. Deferred
tax is determined using tax rates (and laws) that have been enacted or
substantially enacted by the balance sheet date and are expected to apply when
the related deferred tax asset is realised or the deferred tax liability is
settled.
Deferred tax assets are recognised to the extent that it is probable that future
taxable profit will be available against which the temporary differences can be
utilised.
Deferred tax is provided on temporary differences arising on investments in
subsidiaries and associates, except where the timing of the reversal of the
temporary difference is controlled by the group and it is probable that the
temporary difference will not reverse in the foreseeable future.
Foreign Exchange
The consolidated financial statements are presented in pounds sterling ('£'),
which is the company's functional and presentation currency. Foreign currency
transactions are translated into the functional currency using the exchange
rates prevailing at the dates of the transactions. Foreign exchange gains and
losses resulting from the settlement of such transactions and from the
translation at year-end exchange rates of monetary assets and liabilities
denominated in foreign currencies are recognised in the income statement.
Government and other grants
Revenue grants are credited to the profit and loss account on a case-by-case
basis, assessed by the level of expenditure incurred on the specific grant
project, when it is reasonably certain that amounts will not need to be repaid.
Going concern
The Company is developing its technologies for the marketplace and as such
absorbs cash until sufficient funds from either licensing or products sold are
generated. The directors estimate that the cash held by the company will not be
sufficient to support the current level of activities for the next twelve
months. However, the directors are confident of raising further funds by the
issue of equity or other financial instruments. Consequently, the directors have
adopted the going concern basis in the preparation of the financial statements.
If further funds were not to be raised, adjustments would have to be made to
revise the balance sheet value of assets to their realisable amounts and to
provide for further liabilities that may arise.
2. Segment information
The Group's principal activity is the research and development of stem cell
therapies designed to reverse a range of major diseases. Due to the early stage
of development of all of these therapies, the Group reports its operations
collectively within one business segment. Activities are also reported by
geographical segment in the Group's full year financial statements.
3. Net operating expenses
Six months Six months
ended 30 ended 30 Year ended
September September 31 March
2007 2006 2007
£'000 £'000 £'000
Administrative expenses 928 1,009 1,858
Research and development expenditure 2,557 2,522 4,418
______ ______ ______
3,485 3,531 6,276
______ ______ ______
4. Acquisition
On 27 July 2007, the group entered into arrangements to purchase the business
assets of AmCyte, Inc. and AmCyte Diabetes, Inc. (together 'AmCyte'), based in
Santa Monica, California. This was effected by the transfer of the assets into a
new company, ReNeuron, Inc., a company registered in Delaware, USA in
consideration of the issue of shares in ReNeuron, Inc. to AmCyte. ReNeuron Group
plc then acquired 100% of the share capital of ReNeuron, Inc. from AmCyte in
consideration of the issue of 9,291,521 ordinary shares in ReNeuron Group plc,
which shares were placed with investors raising $4.0 million for the AmCyte
vendors.
The acquired business contributed no revenue and a loss of £135,000 in the
period from 1 August 2007 to 30 September 2007.
Details of net assets acquired and goodwill are as follows:
£'000
Purchase consideration:
Shares issued 1,951
Direct costs relating to the acquisition 216
______
Total purchase consideration 2,167
Fair value of assets acquired:
Property, plant and equipment 21
Intangible assets 2,146
______
2,167
______
Goodwill Nil
______
No goodwill has been recognised on the acquisition of the AmCyte business
assets.
The fair value amounts above are provisional and will be finalised in the
financial statements for the year ended 31 March 2008.
The value of the acquired assets, as stated in the accounts of ReNeuron, Inc.
were as follows:
£'000
Property, plant and equipment 21
5. Loss per share
The basic and diluted loss per share is calculated by dividing the loss for the
financial period of £3,107,000 (September 2006: £3,265,000, March 2007:
£5,249,000) by 143,153,064 shares (September 2006: 96,659,058 shares, March
2007: 106,445,554), being the weighted average number of ordinary 10p or 1p
shares in issue during the period.
Potential ordinary shares are not treated as dilutive as their conversion to
ordinary shares does not increase the net loss per share.
6. Impact of conversion to IFRS
The adjustments necessary to comply with IFRS 1, 'First-time adoption of IFRS'
are set out below.
Reconciliation of Equity at Transition Date, 1 April 2006
IFRS
UK GAAP Adjustments IFRS
Note £'000 £'000 £'000
Non-current assets
Negative goodwill a (1,421) 1,421 -
Intangible fixed assets b - 894 894
Property, plant and equipment c 1,208 4 1,212
Financial assets d - 81 81
______ ______ ______
(213) 2,400 2,187
Current assets
Debtors - due after more than one d 81 (81) -
year
Trade and other receivables 946 - 946
Cash and cash equivalents 5,134 - 5,134
______ ______ ______
6,161 (81) 6,080
Current Liabilities
Trade and other payables e, f (1,320) (27) (1,347)
Financial liabilities c - (2) (2)
______ ______ ______
(1,320) (29) (1,349)
______ ______ ______
Net current assets 4,841 (110) 4,731
______ ______ ______
Non current liabilities
Financial liabilities c - (2) (2)
______ ______ ______
Net assets 4,628 2,288 6,916
______ ______ ______
Shareholders' equity
Ordinary shares 9,355 - 9,355
Share premium account 5,472 - 5,472
Capital redemption reserve - - -
Merger reserve 365 - 365
Warrant reserve 436 - 436
Share-based credit reserve g - 56 56
Retained deficit a, b, e, g (11,000) 2,232 (8,768)
______ ______ ______
Capital and reserves attributable to
the Group's equity shareholders
4,628 2,288 6,916
______ ______ ______
Reconciliation of Income Statement for six months ended 30 September 2006
IFRS
UK GAAP Adjustments IFRS
Note £'000 £'000 £'000
Revenue 42 - 42
Net operating expenses a, b, e, f (3,483) (48) (3,531)
Other operating income 137 - 137
_______ _______ _______
Operating Loss (3,304) (48) (3,352)
Finance income 87 - 87
_______ _______ _______
Loss before income taxes (3,217) (48) (3,265)
Tax credit on loss on ordinary - - -
activities
_______ _______ _______
Loss for the period (3,217) (48) (3,265)
_______ _______ _______
Reconciliation of Equity at 30 September 2006
IFRS
UK GAAP Adjustments IFRS
Note £'000 £'000 £'000
Non-current assets
Negative goodwill a (1,327) 1,327 -
Intangible fixed assets b - 972 972
Property, plant and equipment c 1,112 3 1,115
Financial assets d - 81 81
______ ______ ______
(215) 2,383 2,168
Current assets
Debtors - due after more than one d 81 (81) -
year
Trade and other receivables 920 - 920
Cash and cash equivalents 2,791 - 2,791
______ ______ ______
3,792 (81) 3,711
Current Liabilities
Trade and other payables e, f (1,345) (37) (1,382)
Financial liabilities c - (2) (2)
______ ______ ______
(1,345) (39) (1,384)
______ ______ ______
Net current assets 2,447 (120) 2,327
______ ______ ______
Non current liabilities
Financial liabilities e - (1) (1)
______ ______ ______
Net assets 2,232 2,262 4,494
______ ______ ______
Shareholders' equity
Ordinary shares 997 - 997
Share premium account b 5,637 22 5,659
Capital redemption reserve 8,964 - 8,964
Merger reserve 365 - 365
Warrant reserve 436 - 436
Share-based credit reserve - 106 106
Retained deficit a, b ,e, (14,167) 2,134 (12,033)
f, g
______ ______ ______
Capital and reserves attributable to
the Group's equity shareholders
2,232 2,262 4,494
______ ______ ______
Reconciliation of Income Statement for year ended 31 March 2007
IFRS
UK GAAP Adjustments IFRS
Note £'000 £'000 £'000
Revenue 49 - 49
Net operating expenses a, b, e, (6,223) (53) (6,276)
f
Other operating income 263 - 263
______ ______ ______
Operating Loss (5,911) (53) (5,964)
Finance income 192 - 192
______ ______ ______
Loss before income taxes (5,719) (53) (5,772)
Tax credit on loss on ordinary 523 - 523
activities
______ ______ ______
Loss for the period (5,196) (53) (5,249)
______ ______ ______
Reconciliation of Equity at 31 March 2007
IFRS
UK GAAP Adjustments IFRS
Note £'000 £'000 £'000
Non-current assets
Negative goodwill a (1,233) 1,233 -
Intangible fixed assets b - 1,272 1,272
Property, plant and equipment c 1,042 2 1,044
Financial assets d - 125 125
______ ______ ______
(191) 2,632 2,441
Current assets
Debtors - due after more than one year d 125 (125) -
Trade and other receivables 879 - 879
Cash and cash equivalents 7,676 - 7,676
______ ______ ______
8,680 (125) 8,555
Current Liabilities
Trade and other payables e, f (782) (31) (813)
Financial liabilities c - (2) (2)
______ ______ ______
(782) (33) (815)
______ ______ ______
Net current assets 7,898 (158) 7,740
______ ______ ______
Non current liabilities
Financial liabilities e - - -
______ ______ ______
Net assets 7,707 2,474 10,181
______ ______ ______
Shareholders' equity
Ordinary shares 1,377 - 1,377
Share premium account b 12,974 239 13,213
Capital redemption reserve 8,964 - 8,964
Merger reserve 365 - 365
Warrant reserve 113 - 113
Share based credit reserve - 166 166
Retained deficit a, b ,e, (16,086) 2,069 (14,017)
f, g
______ ______ ______
Capital and reserves attributable to
the Group's equity shareholders
7,707 2,474 10,181
______ ______ ______
Summary of notes to IFRS reconciliations
Note Reason for adjustment To Income Statement
6 months to 30 September
2006
To Balance Sheet
1 April 2006
£'000 £'000
a Negative goodwill release 1,421 (94)
(see further comment below)
b Share issues to StemCells, Inc.
(see further comment below)
Intangible assets 894
Provision for intangibles 56
c Restatement of an operating lease as a finance
lease:
Fixed assets - net book value
4
Finance lease creditor
(4)
Depreciation
(1)
Rentals expense
1
d Landlord deposit at fair value:
Restated as a non-current financial asset (no
change to total equity)
e Accrual for holiday pay (15) 15
f Accrual for employee bonuses (12) (25)
g Separate recognition of share-based credit
reserve from retained deficit (no change to
total equity)
(continued from table above)
Note Reason for adjustment To Income
Statement
12 months to To Balance Sheet
31 March 31 March
2007 2007
£'000 £'000
a Negative goodwill release (188) 1,233
(see further comment below)
b Share issues to StemCells, Inc.
(see further comment below)
Intangible assets 1,272
Provision for intangibles 139
c Restatement of an operating lease as a finance
lease:
Fixed assets - net book value
2
Finance lease creditor
(2)
Depreciation
(2)
Rentals expense
2
d Landlord deposit at fair value:
Restated as a non-current financial asset (no
change to total equity)
e Accrual for holiday pay (2) (17)
f Accrual for employee bonuses (2) (14)
g Separate recognition of share-based credit
reserve from retained deficit (no change to
total equity)
Note a: Negative goodwill release
Negative goodwill was previously amortised in accordance with UK GAAP. Under
IFRS, negative goodwill is not permitted to be held on the balance sheet but is
recognised in the profit and loss account in the period it arises. The balance
on the transition date and subsequent charges made under UK GAAP have therefore
been reversed.
Note b: Share issues to StemCells, Inc.
Ordinary shares have been issued to StemCells, Inc. under licence and
subscription and share exchange agreements. The shares issued were previously
accounted for at a value of 10p. The underlying intangible asset created was
previously provided for in full. Under IFRS, the shares issued have been
recognised at fair value at the time of issue, being equivalent to the market
value of the shares on the date of issue. The related intangible asset has been
held on the balance sheet in accordance with IFRS, the previous provision
against this intangible asset having been reversed.
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