Final Results
ReNeuron Group plc
27 June 2007
Guildford, UK: 27 June 2007
ReNeuron Group plc
Preliminary Results for the Year Ended 31 March 2007
Operational Highlights
• Application filed in November 2006 to commence initial clinical trialin the
US with lead ReN001 stem cell therapy for stroke
o Further FDA guidance recently received, clarifying additional data
requirements in support of application
o Submission of further data in support of application on track for Q4
2007
• Prestigious grant awarded by the Michael J Fox Foundation for ReN004
Parkinson's disease programme
• Research collaboration initiated with Schepens Eye Research Institute
(Harvard Medical School) for ReN003 retinal disease programme
• Insulin-producing islet cells generated in ReN002 diabetes programme
• Worldwide market launch of ReNcell(R) neural stem cell lines for
non-therapeutic applications and collaboration signed to develop ReNcell(R)
liver cell products
• Key European patent granted covering neural stem cell lines
Financial Highlights
• Equity fundings raise £8.1 million before expenses
• Cash and short term investments at 31 March 2007 of £7.7 million (2006:
£5.1 million)
• Loss for the year of £5.2 million (2006 restated: £6.4 million, after
exceptional items of £1.2 million)
• Net cash outflow before management of liquid resources and financing items
£5.4 million (2006: £4.6 million)
Commenting on the results, Professor Trevor Jones, Chairman, said:
'The period under review has been a significant one for ReNeuron, with our
ReN001 stroke therapy having progressed to the point of an initial regulatory
filing with the FDA in the US. We are currently supplementing this filing with
further data and we remain highly confident of achieving our primary near-term
objective of commencing a Phase I clinical trial with ReN001, following
regulatory approval. Beyond ReN001, we have made steady progress with our other
therapeutic programmes and other activities in the period, as well as further
strengthening our patent estate and financial resources. We look forward to
reporting further progress across all aspects of our business over the course of
the current financial year.'
For further information:
Michael Hunt, Chief Executive Officer
ReNeuron Group plc +44 (0)1483 302560
David Yates
Financial Dynamics - Europe +44 (0)20 7831 3113
Jonathan Birt, John Capodanno
Financial Dynamics - US +1 (212) 850 5755
Chairman's and Chief Executive Officer's Joint Statement
Review of Operations
ReN001 stem cell therapy for stroke
ReNeuron's most advanced therapeutic programme is its ReN001 stem cell therapy
for stroke. This treatment is targeted at patients who have suffered a stroke
and have been left disabled by it. During the period, we filed our first
Investigational New Drug (IND) application with the US Food and Drug
Administration (FDA) to commence initial clinical trials with ReN001 in the US.
This filing represents the world's first such application concerning a neural
stem cell treatment for a major neurological disorder.
Subsequent to the IND filing, and in accordance with established procedure, the
FDA placed the application on clinical hold and confirmed its questions and
requests for further information regarding the application. We are currently
working to conclude a number of additional pre-clinical studies in support of
the data package required to address the FDA's requests.
The most important of these is a study examining the long-term safety profile of
ReN001 in a specialised rodent stroke model. We had anticipated the possible
need for such a study and therefore initiated it last year with an experienced
contract research organisation in the US. This study is currently approaching
its end-point, with no significant or unusual adverse safety effects having been
identified thus far in either control or treatment groups. We have been greatly
encouraged by the results from this study to date, given its importance to the
regulatory submission and to our overall knowledge base concerning the long-term
safety characteristics of ReN001.
We have received recent guidance from the FDA providing further clarification of
the data requirements in support of the IND application, and we intend to
maintain our constructive dialogue with the reviewers as we finalise the data
package. Based on this guidance, and on our internal timetables, we remain on
track to submit the data package to the FDA in Q4 2007.
Based on the above progress, and following regulatory approval, we remain highly
confident of achieving the key near-term objective of taking our first stem cell
therapy into man in an area of significant unmet medical need.
As well as demonstrating the safety and efficacy of a potential stem cell
therapy, it is also critical, in order to establish a commercially viable
treatment, to be able to show scalability of the cell product and consistency of
quality throughout the scale-up process. Using ReNeuron's unique and highly
efficient c-mycER stem cell expansion technology, we have now successfully
scaled up our ReN001 product into a series of clinical and commercial grade
banks of cells, manufactured and tested to full Good Manufacturing Practice
(cGMP) standards. It is from these pre-existing cell banks that all future
ReN001 clinical and market product can be derived.
We believe that the ability to scale our ReN001 therapy readily to the volumes
necessary to serve the large numbers of eligible stroke patients will greatly
enhance ReN001's attractiveness to future commercial development partners.
Other therapeutic and non-therapeutic programmes
Our other therapeutic programmes continued to progress well during the period.
A key milestone in the ongoing successful development of these programmes will
be to show, initially in pre-clinical testing, that our c-mycER platform
technology can generate a safe, effective and scalable stem cell product across
each of the cell types we are using to address the diseases targeted. We are
currently working to generate the requisite pre-clinical data for each of these
programmes, in conjunction with our academic and commercial technology
collaborators.
With our ReN005 therapy for Huntington's disease, we have now successfully
produced a master cell bank to cGMP standard for ReN005, from which all future
clinical and commercial product will be derived. During the period, we
initiated a collaboration with the Schepens Eye Research Institute at Harvard
Medical School in the US to progress our ReN003 programme for disorders of the
retina. Also in the period, we were awarded a prestigious grant by the US-based
Michael J. Fox Foundation for Parkinson's Research to develop our ReN004 therapy
for Parkinson's disease. We were delighted to be awarded this grant which we
regard as an important independent validation of the therapeutic approach we are
adopting with our ReN004 programme. More recently, we announced significant
progress with our ReN002 programme for Type 1 (juvenile) diabetes patients,
having used our c-mycER platform to develop functional insulin-producing islet
cells for subsequent pre-clinical testing.
We have made good progress during the period with our ReNcell(R) products for
non-therapeutic applications in research and in the pharmaceutical industry.
Our first generation ReNcell(R)CX and ReNcell(R)VM neural cell lines were
officially launched onto the market through US-based Millipore Corporation. A
paper describing the characteristics of these cell lines was recently published
in the on-line journal, BMC Neuroscience. We have also progressed development
of our second generation ReNcell(R)HEP hepatocyte (liver) cell line for use as a
drug toxicology testing and screening tool. This cell line is currently under
evaluation by a number of commercial parties. In the period, we initiated a
collaboration with Japan-based CellSeed Inc. to develop novel, liver cell
culture systems using the ReNcell(R)HEP cell line in conjunction with CellSeed's
temperature-sensitive polymer technology.
Other activities
During the period, we became a participant in a research project to develop
regenerative, cell-based therapeutic 'units' for implantation into stroke
patients. The project involves academic groups in the UK and US and is funded
under the US National Institutes of Health Quantum Grant Programme. We also
initiated a research collaboration with King's College London during the period,
to further develop our c-mycER stem cell expansion technology. This project is
part-funded by the UK government under its Knowledge Transfer Partnership
scheme.
In February 2007, we entered into a revenue-sharing agreement with the Ludwig
Institute of Cancer Research (LICR) and the US-based Dana-Farber Cancer
Institute, concerning research conducted by these institutions on certain
gene-based cell expansion technology. This technology has been licensed to a
commercial partner and ReNeuron's entitlement to revenues generated from the
licence stems from an earlier agreement between ReNeuron and the LICR.
We have continued to strengthen our intellectual property position during the
period and thereafter. Significantly, in April 2007, we received notification
of grant from the European Patent Office concerning a patent application that
covers the composition, manufacture and use of three of our key human neural
stem cell lines, including those lines that constitute our ReN001 and ReN005
therapies for stroke and Huntington's disease, respectively. A key advantage of
our c-mycER stem cell expansion technology is its ability to generate individual
cell lines which we can then seek to patent in their own right. These cell
lines represent the prototypes of distinct, patent-protected cell-based
therapies or products that can therefore be more readily licensed to commercial
partners in due course.
In the wider context, we were greatly encouraged by the European Parliament
vote, in April 2007, to provide an integrated regulatory framework for the
authorisation and post-marketing vigilance of advanced therapy products, such as
the stem cell therapies ReNeuron is developing. The Regulation has subsequently
been agreed to by the EU Council of Health Ministers, and should be formally
adopted later this year. This development provides regulatory clarity for
businesses like ours, creating a workable regulatory system which will assess
the efficacy and safety of advanced therapies in a consistent manner across
Europe.
During the period, we also secured our near-term financial position by raising
further equity funding totalling £8.1 million, before expenses. This was
achieved through a combination of the placing of new shares and the exercise of
outstanding warrants over the Company's shares.
Summary of results
In the year ended 31 March 2007, turnover was £49,000 (2006: £9,000),
representing initial income from the Group's non-therapeutic licensing
activities.
Net operating expenses before exceptional items increased in the period to £6.2
million (2006 restated: £5.9 million). Of this increase, £0.2 million relates
to non-cash charges arising from the Group's adoption of Financial Reporting
Standard 20, 'Share based payments'. The balance of the net increase in costs
relates to a provision of £0.1 million against intangible assets acquired, the
comparative charge of £0.9 million being treated as an exceptional item in the
prior period. The balance of the overall operational cost base stayed broadly
equivalent across the two periods.
Net operating expenses including exceptional items decreased in the period to
£6.2 million (2006 restated: £7.1 million). There were no exceptional charges
in the period (2006: £1.2 million), and no interest payable (2006: £0.25
million). Other operating income and interest received in total were broadly
equivalent in both periods at £0.5 million. Tax credits booked against research
and development expenditure were also broadly constant in both periods at £0.5
million. The resulting net loss for the period decreased to £5.2 million (2006
restated: £6.4 million), largely as a result of there being no exceptional
charges in the period.
Net cash outflow before use of liquid resources and financing increased in the
period to £5.4 million (2006: £4.6 million). This was due largely to debtor and
creditor balances decreasing in the period by £43,000 and £0.5 million
respectively, compared to respective prior period increases of £0.2 million and
£0.7 million. During the period, short term creditors and accruals decreased
from £1.3 million to £0.8 million, due primarily to payments made in the period
to pre-clinical contract research organisations for work undertaken that was
accrued for in the prior period.
At the Annual General Meeting in September 2006, a resolution was passed to
subdivide each 10p ordinary share in the Company into one new ordinary share of
1p nominal value and one deferred share of 9p nominal value. In order to leave
the total number of issued ordinary shares in circulation unchanged after the
subdivision, the deferred shares so created were repurchased by the Company for
1p in aggregate consideration, and cancelled. A capital redemption reserve of
£9.0 million was consequently created, representing the aggregate nominal value
of the cancelled deferred shares.
As at 31 March 2007, the Group had cash balances totalling £7.7 million (2006:
£5.1 million). During the period, the Group raised £0.7 million and £5.5
million, before expenses, in two share placings, and outstanding warrants over
the Company's shares were also exercised in the period to raise a further £1.9
million. The directors estimate that the Group's current cash resources are
sufficient to meet expenditure requirements for at least the next twelve months.
Consequently, the going concern basis has been adopted in the preparation of
these financial statements.
Summary and outlook
The period under review has been a significant one for ReNeuron, with our ReN001
stroke therapy having progressed to the point of an initial regulatory filing
with the FDA in the US. We are currently supplementing this filing with further
data and we remain highly confident of achieving our primary near-term objective
of commencing a Phase I clinical trial with ReN001, following regulatory
approval. Beyond ReN001, we have made steady progress with our other
therapeutic programmes and other activities in the period, as well as further
strengthening our patent estate and financial resources. We look forward to
reporting further progress across all aspects of our business over the course of
the current financial year.
Professor Trevor Jones Michael Hunt
Chairman Chief Executive Officer
27 June 2007
ReNeuron Group plc consolidated profit and loss account for the year ended 31
March 2007
Year ended 31 March Year ended 31 March
2007 2006 Unaudited
Note Unaudited Restated
£'000 £'000
______ ______
Turnover 49 9
Cost of sales - -
______ ______
Gross profit 49 9
______ ______
Net operating expenses excluding exceptional items 2 (6,223) (5,941)
Exceptional operating costs 3 - (1,167)
______ ______
Net operating expenses including exceptional items (6,223) (7,108)
Other operating income 263 270
______ ______
Operating loss (5,911) (6,829)
Interest receivable and similar income 192 197
Interest payable and similar charges - (250)
______ ______
Loss on ordinary activities before taxation (5,719) (6,882)
Tax credit on loss on ordinary activities 523 513
______ ______
Loss for the financial year 6 (5,196) (6,369)
______ ______
Loss per 1p ordinary share
Basic and diluted 4 (4.9p) (8.8p)
______ ______
All results arise from continuing operations.
Statement of total recognised gains and losses for the year ended 31 March 2007
Year ended 31 March Year ended 31 March
2007 2006
Note Unaudited Unaudited
Restated
£'000 £'000
______ ______
Loss for the period (5,196) (6,369)
______
Total recognised losses for the period (5,196) (6,369)
______
Prior year adjustment - Share based payment 1 (56)
______
Total recognised losses since last annual report (5,252)
______
Reneuron Group plc consolidated balance sheet as at 31 March 2007
Note As at 31 March 2007 As at 31 March 2006
Unaudited Unaudited
Restated
£'000 £'000
______ ______
Fixed assets
Negative goodwill 5 (1,233) (1,421)
Tangible fixed assets 1,042 1,208
______ ______
(191) (213)
______ ______
Current assets
Debtors - due after one year 125 81
Debtors - due within one year 879 946
Cash at bank and in hand 7,676 5,134
______ ______
8,680 6,161
Creditors: amounts falling due within one year (782) (1,320)
______ ______
Net current assets 7,898 4,841
______ ______
Total assets less current liabilities 7,707 4,628
______ ______
Net assets 7,707 4,628
______ ______
Capital and reserves
Called up share capital 6 1,377 9,355
Share premium account 6 12,974 5,472
Capital redemption reserve 6 8,964 -
Warrant reserve 6 113 436
Other reserves 6 365 365
Profit and loss reserve 6 (16,086) (11,000)
______ ______
Total shareholders' funds 6 7,707 4,628
______ ______
ReNeuron Group plc consolidated cash flow statement for the year ended 31 March
2007
Note Year ended 31 March Year ended 31 March
2007 2006
Unaudited Unaudited
Restated
£'000 £'000
______ ______
Net cash outflow from operating activities 7 (6,034) (4,995)
______ ______
Returns on investments and servicing of finance
Interest received 192 179
______ ______
Net cash inflow from returns on investments and servicing 192 179
of finance ______ ______
Taxation
UK corporation tax -- research and development tax credits 503 329
received ______ ______
Capital expenditure
Purchase of tangible fixed assets (32) (92)
______ ______
Net cash outflow from capital expenditure (32) (92)
______ ______
Net cash outflow before use of liquid resources and (5,371) (4,579)
financing ______ ______
Management of liquid resources
Decrease in short term investments - 361
Financing
Increase in loans - 1,000
Issue of ordinary share capital 8,106 9,500
Share issue costs (193) (1,218)
______ ______
Increase in cash in the period 2,542 5,064
______ ______
Notes to the preliminary results for the year ended 31 March 2007
1. Basis of preparation
These preliminary results do not constitute financial statements within the
meaning of Section 240 of the Companies Act 1985. Results for the year ended 31
March 2007 have not been audited. Results for the year ended 31 March 2006 have
been extracted and restated, as noted below, from the statutory financial
statements of the Group that have been filed with the Registrar of Companies and
upon which the auditors reported without qualification. The restated results for
the year ended 31 March 2006 have therefore also been marked as unaudited in
these preliminary results. The statutory accounts and audit report for the year
ended 31 March 2007 have not yet been approved by the directors or the auditors
respectively.
These preliminary results for the year ended 31 March 2007 have been prepared in
accordance with the accounting policies set out in the consolidated statutory
accounts for ReNeuron Group plc for the year ended 31 March 2006, except as
noted below:
Change in accounting policy
During the year, the Group adopted Financial Reporting Standard 20, 'Share based
payments' (FRS 20) and the related Urgent Issues Task Force ('UITF') No.44, '
Group and Treasury Share Transactions'. The comparative numbers have been
restated to reflect the change in accounting policy.
FRS 20 requires the fair value of employee share options to be charged to the
profit and loss account over the period the employee becomes entitled to the
award. The Group has taken advantage of the transitional arrangements in FRS 20
and only applied the requirements to options granted after 1 April 2006, the
effective date for the Group.
The impact of adopting FRS 20 is a charge of £110,000 to the profit and loss
account in the current year in respect of share options granted. A charge of
£56,000 has been reflected in the restated profit and loss account for the prior
year.
The adoption of FRS 20 has also resulted in a charge of £113,000 to the profit
and loss account in the current year in respect of warrants issued during the
year. There has been no impact in respect of warrants on the comparative period.
Going concern
The financial statements have been prepared on the going concern basis. The
directors estimate that cash held by the Group at the date of approval of the
preliminary announcement will be sufficient to continue funding the trading
activities of the Company and the Group for at least a further twelve months
from the date of approval of the preliminary announcement.
Share based payments
The Company issues equity settled share based payments to certain employees.
Equity settled share based payments are measured at fair value at grant date.
Fair value is measured using the Black-Scholes model, taking into account the
terms and conditions upon which the instruments were granted, including the
impact of any non-market based vesting conditions.
The total amount to be expensed over the vesting period is determined by
reference to the fair value of the equity instruments granted and the number of
equity instruments which eventually vest. A corresponding credit is made to
equity.
At each balance sheet date, the Company revises its estimate of the number of
equity instruments that are expected to vest. It recognises the impact of the
revision of original estimates, if any, in the income statement, and a
corresponding adjustment to equity over the remaining vesting period.
Where the Company has granted options over the Company's shares to employees of
its subsidiaries, a capital contribution has been deemed to be made by the
Company and no charge arises in the profit and loss account of the Company.
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 a 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 FRS 20. See share based payment accounting policy above.
2. Net operating expenses excluding exceptional items
Year ended 31 March Year ended 31 March
2007 2006
Unaudited Unaudited
Restated
£'000 £'000
______ ______
Administrative expenses 1,858 1,608
Research and development expenditure 4,365 4,333
______ ______
Net operating expenses excluding exceptional items 6,223 5,941
______ ______
3. Exceptional operating costs
Year ended 31 March Year ended 31 March
2007 2006
Unaudited Unaudited
Restated
£'000 £'000
______ ______
Exceptional administrative expenses:
Share option compensation charge - 273
Exceptional research and development expenditure:
Provision against intangible assets acquired - 894
______ ______
- 1,167
______ ______
Share option compensation charge
In the prior year, a net charge of £273,000 was made to the profit and loss
account in accordance with Urgent Issues Task Force Abstract 17, 'Employee share
schemes' (UITF 17), and identified as exceptional. The charge of £110,000
relating to share based payments in the current year is not considered
exceptional and has been included in operating costs.
Provision against intangible assets acquired
In July 2005, ReNeuron entered into licence and subscription and share exchange
agreements with StemCells, Inc., whereby the Group was granted a licence to
certain intellectual property and patents owned by or exclusively licensed to
StemCells, Inc., and pursuant to which the Company issued, as part consideration
for the licence, a total of 8,939,493 ordinary shares of 10p each to StemCells,
Inc. Due to the early stage nature of the underlying technology, the directors
carried out an impairment review of the intangible asset so created, and
considered that it was appropriate to provide against the asset in full. The
charge in the prior year was considered exceptional, but an equivalent charge of
£139,000 in the current year is not.
4. Loss per share
The basic and diluted loss per share is calculated by dividing the loss for the
financial year attributable to ordinary shareholders by the weighted average
number of ordinary shares in issue during the year. The loss for the financial
year ended 31 March 2007 is £5,196,000 (2006 restated: £6,369,000) and the
weighted average number of 1p ordinary shares in issue during the year ended 31
March 2007 is 106,455,554 (2006: 72,532,756). During the prior year, ordinary
shares had a nominal value of 10p; as a result of the share split in September
2006, as disclosed in Note 6, the nominal value was amended to 1p.
No change in the number of shares has occurred.
Potential dilutive instruments, such as options and warrants, are not treated as
dilutive as the Group has made a loss in each year.
5. Amortisation of negative goodwill
Negative goodwill arose during the period ended 31 March 2004 on the acquisition
of ReNeuron (UK) Limited by ReNeuron Holdings Limited. The amount of negative
goodwill arising on acquisition was £2,916,000. The amount that was in excess of
the fair values of non-monetary assets acquired was immediately amortised to the
profit and loss account. The remaining negative goodwill of £1,883,000, being
equal to the fair values of non-monetary assets acquired, is being amortised
over a period of 10 years, the period over which the non-monetary assets are
expected to be recovered.
6. Share capital and reserves
Share Share premium Capital Warrant
capital account redemption reserve
account reserve
£'000 £'000 £'000 £'000
______ ______ ______ ______
At 1 April 2006 9,355 5,472 - 436
Issue of new ordinary shares 986 7,259 - -
Costs of share issue - (193) - -
Subdivision of ordinary shares (8,964) - 8,964 -
Exercise of Warrants - 436 - (436)
Issue of warrants - - - 113
Recognition of share based payment - - - -
Loss for the financial year - - - -
______ ______ ______ ______
At 31 March 2007 1,377 12,974 8,964 113
______ ______ ______ ______
6. Share capital and reserves (continued from table above)
Other Profit and Total
reserves loss shareholders'
account funds
£'000 £'000 £'000
______ ______ ______
At 1 April 2006 365 (11,000) 4,628
Issue of new ordinary shares - - 8,245
Costs of share issue - - (193)
Subdivision of ordinary shares - - -
Exercise of Warrants - - -
Issue of warrants - - 113
Recognition of share based payment - 110 110
Loss for the financial year - (5,196) (5,196)
______ ______ ______
At 31 March 2007 365 (16,086) 7,707
______ ______ ______
On 26 April 2006, a resolution was passed at an Extraordinary General Meeting
authorising the issuance of up to 170,000,000 new ordinary shares of 10p.
On 28 June 2006, the Company raised £715,000 via a placing of 5,500,000 10p
ordinary shares at 13p each. At the same time, 556,767 shares were issued in
accordance with the licence and subscription and share exchange agreements with
StemCells, Inc.
On 21 September 2006, a resolution was passed at the Annual General Meeting
authorising the subdivision of each 10p ordinary share into one new ordinary
share of 1p nominal value and one deferred share of 9p nominal value. A capital
redemption reserve was created with the value of the deferred shares. The
deferred shares, amounting to 99,604,700 in total and with a nominal value of
£8,964,423, were thereafter repurchased in aggregate by the Company for 1p, and
were cancelled. The repurchase of the deferred shares was financed from the
proceeds of the issue of one ordinary share at nominal value.
On 21 September 2006, a resolution was passed at a Warrant Holders Meeting
authorising an amendment of the price payable on exercise of the warrants from
30p to 10p, and an amendment to the last date for exercise of the warrants from
12 February 2007 to 12 December 2006. A total of 18,919,400 warrants were
exercised at a price of 10p each, and 18,919,400 ordinary shares of 1p were
consequently issued on 19 December 2006. Warrants totalling 80,600 were not
exercised by the expiry date and lapsed. The warrant reserve created on issue of
the warrants was released to share premium.
On 12 February 2007, the Company placed 18,333,333 new ordinary shares of 1p at
a price of 30p, raising £5,500,000 before expenses of £193,000. In conjunction
with the placing, warrants to subscribe 688,145 ordinary 1p shares, exercisable
at a price of 30p per share, were issued to Collins Stewart Limited, the
Company's nominated adviser and broker. At the same time 771,368 shares were
issued in accordance with licence and subscription and share exchange agreements
with StemCells, Inc.
On 19 February 2007, a further 62,543 shares of 1p were issued to StemCells,
Inc. in final satisfaction of the Company's obligation to issue shares under the
licence and subscription and share exchange agreements.
7. Reconciliation of operating loss to net cash outflow from operating activities
Year ended Year ended
31 March 2007 31 March 2006
Unaudited Unaudited
Restated
£'000 £'000
______ ______
Operating loss (5,911) (6,829)
Depreciation of tangible fixed assets 198 265
Amortisation of negative goodwill (188) (188)
Impairment of intangible fixed assets acquired 139 894
Share option compensation charge - 273
Share-based payment charges 223 56
Decrease / (increase) in debtors 43 (199)
(Decrease) / increase in creditors (538) 733
______ ______
Net cash outflow from operating activities (6,034) (4,995)
______ ______
8. Reconciliation of movement in net funds
At 31 March 2007
At 1 April 2006 Unaudited Restated
Unaudited Cashflow
£'000 £'000 £'000
______ ______ ______
Cash at bank and in hand 5,134 2,542 7,676
______ ______ ______
Net funds 5,134 2,542 7,676
______ ______ ______
Notes 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.
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.
ReNeuron has also generated pre-clinical efficacy data with its ReN005 stem cell
therapy for Huntington's disease, a genetic and fatal neurodegenerative disorder
that affects around 1 in 10,000 people. This programme is in pre-clinical
development. In addition to its stroke and Huntington's disease programmes,
ReNeuron is developing stem cell therapies for Parkinson's disease, Type 1
diabetes and diseases of the retina.
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.
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