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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Reneuron Group Plc | LSE:RENE | London | Ordinary Share | GB00BF5G6K95 | ORD 1P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 3.05 | 0.00 | 01:00:00 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| Pharmaceutical Preparations | 530k | -5.41M | -0.0946 | -0.32 | 1.74M |
From Apr 2019 to Apr 2024
TIDMRENE
RNS Number : 8915Q
ReNeuron Group plc
05 December 2016
Details are given below of an analyst meeting and webcast at 9.00am this morning
5 December 2016 AIM: RENE
ReNeuron Group plc
("ReNeuron" or "the Company")
Interim Results for the six months ended 30 September 2016
ReNeuron Group plc (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, is pleased to announce its interim results for the six months ended 30 September 2016.
Highlights in the period
-- CTX stem cell therapy candidate for motor disability as a result of stroke:
- Positive Phase II efficacy data announced today in PISCES II clinical trial - see separate announcement issued this morning
- Phase I clinical trial data from PISCES I study published in The Lancet - Clinical trial application for controlled, pivotal study planned for H1 2017 in US and UK -- hRPC stem cell therapy candidate for retinitis pigmentosa: - Second dose cohort completed in US Phase I/II clinical trial - Safety and efficacy data from Phase I/II study due during the course of 2017 - Pivotal clinical trial planned to commence in 2018 -- CTX stem cell therapy candidate for critical limb ischaemia: - Phase I clinical trial ongoing - safety data expected in early 2017 -- Exosome nanomedicine platform: - Glioblastoma multiforme selected as first clinical target - Pre-clinical development continues, supported by GBP2.1m Innovate UK grant
-- Loss for the period of GBP7.70 million (2015: loss of GBP4.48 million); cash consumed by operations of GBP6.99 million (2015: GBP5.26 million)
-- Cash, cash equivalents and bank deposits at 30 September 2016 of GBP60.08 million (31 March 2016: GBP65.71 million)
Commenting on the results, Olav Hellebø, ReNeuron's Chief Executive Officer, said:
"Our therapeutic development programmes have progressed well during the period, culminating in today's announcement of positive Phase II data from the PISCES II clinical trial of our CTX cell therapy candidate for stroke disability. The results of this study represent the most important clinical milestone in ReNeuron's history and enable us to progress the CTX treatment into advanced clinical development in this indication. The unmet medical need in chronic stroke disability is enormous and we are delighted that we are now one step closer to being able to offer an effective therapy to these patients.
"We are also very pleased with the pace of progress in the US Phase I/II clinical trial of our hRPC cell therapy candidate for retinitis pigmentosa during the period. ReNeuron remains well-funded to advance all of its therapeutic programmes through to further significant clinical milestones and we look forward to reporting further progress in the months ahead."
Analyst meeting and webcast:
A meeting for analysts will be held at 9.00am today at the offices of Buchanan, 107 Cheapside, London, EC2V 6DN.
For a webcast of the analyst presentation, please log on to the following web address approximately 10 minutes before 9.00am:
http://vm.buchanan.uk.com/2016/reneuron051216/registration.htm
For further details please contact Buchanan on 020 7466 5000.
A recording of the webcast will be made available on ReNeuron's and Buchanan's websites, www.reneuron.com and www.buchanan.uk.com.
Enquiries:
Hot Features
Premium
+44 (0)20 3819
ReNeuron 8400
Olav Hellebø , Chief Executive
Officer
Michael Hunt, Chief Financial
Officer
+44 (0) 20
Buchanan 7466 5000
Mark Court, Sophie Cowles,
Stephanie Watson
+44 (0) 20
Stifel Nicolaus Europe Limited 7710 7600
Jonathan Senior, Stewart Wallace,
Ben Maddison (NOMAD and Broker)
About ReNeuron
ReNeuron is a leading, clinical-stage cell therapy development company. Based in the UK, its primary objective is the development of novel cell-based therapies targeting areas of significant unmet or poorly met medical need.
ReNeuron has used its unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered "off-the-shelf" to any eligible patient without the need for additional immunosuppressive drug treatments. The Company has therapeutic candidates in clinical development for motor disability as a result of stroke, for critical limb ischaemia and for the blindness-causing disease, retinitis pigmentosa.
ReNeuron is also advancing its proprietary exosome technology platform as a potential new nanomedicine targeting cancer and as a potential delivery system for gene therapy treatments.
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.
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.
Review of therapeutic programmes
CTX for stroke disability
During the period under review, we completed dosing in the Phase II clinical trial (PISCES II) of our CTX cell therapy candidate for stroke disability. Today, we have announced positive data from this study. PISCES II is a single arm, open-label study in patients living with disability resulting from ischaemic stroke. All 21 patients in the study have completed three-month follow-up, with ten patients followed for six months and three for twelve months.
The study's primary endpoint was for two patients to reach a minimum two-point improvement in the grasping and lifting test, sub-test number 2, of the Action Research Arm Test ("ARAT"), at three months post-treatment. Three of the 21 patients achieved this at three, six or twelve months respectively after treatment and were within a group of four responders who also showed clinically relevant improvements on the total ARAT score of arm motor performance. Although the ARAT sub-test number 2 study endpoint was not met as some responses came later than the three-month target, the result is nonetheless highly encouraging.
Strongly positive results were also seen in the other endpoints of the study, with seven patients (33%) showing a clinically relevant improvement on the Modified Rankin Scale (a measure of disability and dependence) and eight patients (38%) showing a clinically relevant improvement on the Barthel Index (a measure of performance in activities of daily living). In total, 15 out of 21 patients had a clinically significant response on at least one efficacy measure. Improvements in the ARAT scores, Modified Rankin Scale and Barthel Index were all sustained throughout the follow up period.
The study also demonstrated that the CTX treatment was well tolerated, with no cell-related adverse events. Safety and efficacy data from the study will be presented at forthcoming stroke and rehabilitation medical conferences. The PISCES II study was part-funded by a regenerative medicine and cell therapy development grant from Innovate UK.
The above Phase II data follows the publication in August of long term follow up data from our PISCES I stroke clinical trial in The Lancet. The PISCES I study was the first clinical trial of our CTX cell therapy candidate for stroke disability. The Lancet paper describes two-year follow up clinical data relating to the eleven stroke patients treated in the study. Improvements in neurological status and limb function compared with pre-treatment baseline performance were observed in this study within three months of treatment and maintained throughout long term follow up. The CTX treatment was also well-tolerated by the patients in the PISCES I study, with no cell-related or immunological adverse events reported across the four ascending dose levels.
As a result of the positive data reported from both the PISCES I and PISCES II studies, we intend to apply to the US and European regulatory authorities in early 2017 to commence a randomised, placebo-controlled, pivotal clinical trial in disabled stroke patients. As previously announced, we are also advancing our CTX cell therapy candidate for stroke disability in Japan under regulations in that territory which offer the potential for conditional marketing approval for cell therapies at an earlier stage of clinical development than in the West.
hRPC for retinitis pigmentosa
During the period under review, the Phase I/II clinical trial of our human Retinal Progenitor Cell (hRPC) cell therapy candidate for the blindness-causing disease, retinitis pigmentosa (RP), has also progressed well. This US study, which is being conducted at Massachusetts Eye and Ear Infirmary in Boston, is an open-label, dose escalation study to evaluate the safety, tolerability and preliminary efficacy of our hRPC stem cell therapy candidate in fifteen patients with advanced RP.
Subsequent to the end of the period under review, dosing of the second dose cohort of three patients in the Phase I/II study has been completed. Safety and tolerability data from the Phase I part of the study in the first nine patients are expected in the first half of 2017, with longer term safety data as well as efficacy read-outs from the Phase II part of the study in a further six patients expected in the second half of 2017.
Subject to the outcome of the Phase I/II study, we expect to be able to file an application in early 2018 to commence a pivotal clinical trial of hRPC in RP. A positive outcome from this study is expected to form the basis for subsequent marketing authorisation filings in both the US and Europe.
CTX for critical limb ischaemia
Our CTX cell therapy candidate for critical limb ischaemia (CLI) is currently in a Phase I clinical trial in the UK. CLI is a condition that results in loss of blood flow to the lower limb. The condition is common in diabetics and can ultimately lead to amputation. We expect to have safety data available from the CLI study slightly later than planned, in early 2017. We are encouraged that no adverse safety events have been reported thus far in the patients treated in the Phase I study. The study has been part-funded by a Biomedical Catalyst grant from Innovate UK.
Exosome nanomedicine platform
During the period under review, we have continued to advance our exosome nanomedicine programme. Exosomes are nanoparticles secreted from all cells including ReNeuron's proprietary CTX stem cell line. They play a key role in cell-to-cell signalling and early research with CTX-derived exosomes has demonstrated that they may have a significant effect in regulating cell growth and apoptosis in cancer. During the period under review, we announced that we had selected glioblastoma multiforme (GBM) as the first clinical target for ExoPr0, our first exosome nanomedicine candidate. GBM accounts for 16 per cent of all diagnosed brain cancers, with 25,000 patients diagnosed per annum in the US and Europe combined.
Our exosome nanomedicine programme benefits from an Innovate UK grant to part-fund manufacturing process development as well as pre-clinical efficacy and toxicity testing of the ExoPr0 candidate. We see the optimisation of methods to harvest, characterise and purify CTX-derived exosomes, as well as further clarification of the mechanism of action of ExoPro, as key research priorities ahead of late pre-clinical development of the ExoPro candidate. On this basis, and assuming a successful outcome to the above plan of work, we expect to be able to commence a first human clinical trial with ExoPr0 in 2018.
Financial review
In the six months to 30 September 2016, revenues were GBP22,000 (2015: GBP11,000) in addition to which grant income of GBP366,000 was received and is shown as other operating income (2015: GBP244,000).
Research and development expenditure increased in the period to GBP7.88 million (2015: GBP3.72 million). This increase in R&D expenditure, broadly consistent with the increase in spend seen in the second half of the previous financial year, reflects the increased level of clinical trial activity and associated cell manufacturing and process development costs across the Group's therapeutic programmes. General and administrative expenses increased marginally to GBP2.14 million (2015: GBP1.93 million) in the period.
Finance income, which represents income received from the Group's cash and investments and gains from foreign exchange, was GBP1.00 million in the period (2015: GBP156,000). The increase in finance income reflects the increase in average cash and investment balances compared to the equivalent prior period, as well as a favourable movement in exchange rates during the period on cash and investments held in foreign currency. The total tax credit for the period was GBP940,000 (2015: GBP756,000).
As a result of the above, the total comprehensive loss for the period increased to GBP7.70 million (2015: GBP4.48 million), in line with internal forecasts.
Cash consumed by operations in the period increased to GBP6.99 million (2015: GBP5.26 million), broadly reflecting the increase in operating costs in the period. The Group had cash, cash equivalents and bank deposits totalling GBP60.08 million as at 30 September 2016 (31 March 2016: GBP65.71 million).
Summary and outlook
Our therapeutic development programmes have progressed well during the period, culminating in today's announcement of positive Phase II data from the PISCES II clinical trial of our CTX cell therapy candidate for stroke disability. The results of this study represent the most important clinical milestone in ReNeuron's history and enable us to progress the CTX treatment into advanced clinical development in this indication. The unmet medical need in chronic stroke disability is enormous and we are delighted that we are now one step closer to being able to offer an effective therapy to these patients.
We are also very pleased with the pace of progress in the US Phase I/II clinical trial of our hRPC cell therapy candidate for retinitis pigmentosa during the period. ReNeuron remains well-funded to advance all of its therapeutic programmes through to further significant clinical milestones and we look forward to reporting further progress in the months ahead.
John Berriman Olav Hellebø
Chairman Chief Executive Officer
5 December 2016
Unaudited Consolidated Statement of Comprehensive Income
for the six months ended 30 September 2016
Six months Six months Year
ended ended ended
30 September 30 September 31
March
2016 2015 2016
Note GBP'000 GBP'000 GBP'000
-------------- --------------
Revenue 22 11 29
Research and development
costs (7,883) (3,716) (10,272)
General and administrative
costs (2,137) (1,931) (4,015)
Other operating
income 5 366 244 534
Operating loss (9,632) (5,392) (13,724)
Finance income 997 156 878
---------------------------- ----- -------------- -------------- ---------
Loss before income
taxes (8,635) (5,236) (12,846)
Tax credit on loss
on ordinary activities 940 756 1,492
---------------------------- ----- -------------- -------------- ---------
Total comprehensive
loss for the period (7,695) (4,480) (11,354)
---------------------------- ----- -------------- -------------- ---------
Total comprehensive
loss attributable
to:
- Equity owners
of the Company (7,695) (4,480) (11,354)
---------------------------- ----- -------------- -------------- ---------
Basic and diluted
loss per share 6 (0.2p) (0.2p) (0.4p)
---------------------------- ----- -------------- -------------- ---------
Unaudited Consolidated Statement of Financial Position
as at 30 September 2016
30 September 30 September 31 March
2016 2015 2016
GBP'000 GBP'000 GBP'000
---------------------------------------------- ------------- ------------- ---------
Assets
Non-current assets
Property, plant and equipment 544 145 361
Intangible assets 1,272 1,591 1,591
Investments - bank deposit - - 5,000
Other non-current assets 11 281 11
1,827 2,017 6,963
---------------------------------------------- ------------- ------------- ---------
Current assets
Trade and other receivables 787 832 1,421
Corporation tax receivable 2,363 2,028 2,764
Investments - bank deposit 39,659 49,993 43,283
Cash and cash equivalents 20,417 22,283 17,426
------------- -------------
63,226 75,136 64,894
------------- -------------
Total assets 65,053 77,153 71,857
----------------------------------------------- ------------- ------------- ---------
Equity
Equity attributable to owners of the Company
Share capital 31,646 31,567 31,646
Share premium 97,704 97,704 97,704
Capital redemption reserve 8,964 8,964 8,964
Merger reserve 2,223 2,223 2,223
Accumulated losses (80,074) (66,428) (72,879)
----------------------------------------------- ------------- ------------- ---------
Total equity 60,463 74,030 67,658
----------------------------------------------- ------------- ------------- ---------
Liabilities
Non-current Liabilities
Provisions - 605 -
Financial liabilities: finance leases - 1 -
- 606 -
---------------------------------------------- ------------- ------------- ---------
Current Liabilities
Trade and other payables 4,446 2,516 3,700
Provisions 143 - 498
Financial liabilities: finance leases 1 1 1
4,590 2,517 4,199
---------------------------------------------- ------------- ------------- ---------
Total liabilities 4,590 3,123 4,199
Total equity and liabilities 65,053 77,153 71,857
----------------------------------------------- ------------- ------------- ---------
Unaudited Consolidated Statement of Changes in Equity
for the six months ended 30 September 2016
Share Capital
Share premium Redemption Merger Accumulated Total
losses
capital account Reserve reserve Equity
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
-------- -------- ----------- -------- ------------ --------
As at 1 April
2015 17,888 46,267 8,964 2,223 (62,206) 13,136
Issue of new
ordinary shares 13,679 54,696 - - - 68,375
Costs of share
issue - (3,259) - - - (3,259)
Share-based
credit - - - - 258 258
Loss for the
period - - - - (4,480) (4,480)
As at 30 September
2015 31,567 97,704 8,964 2,223 (66,428) 74,030
Issue of new
ordinary shares 79 - - - - 79
Share-based
credit - - - - 423 423
Loss for the
period - - - - (6,874) (6,874)
As at 31 March
2016 31,646 97,704 8,964 2,223 (72,879) 67,658
Share-based
credit - - - - 500 500
Loss for the
period - - - - (7,695) (7,695)
As at 30 September
2016 31,646 97,704 8,964 2,223 (80,074) 60,463
-------------------- -------- -------- ----------- -------- ------------ --------
Unaudited Consolidated Statement of Cash Flows
for the six months ended 30 September 2016
Six months Six months Year
ended ended ended
30 September 30 September 31 March
2016 2015 2016
Note GBP'000 GBP'000 GBP'000
------------------------------- ----- ------------- ------------- ----------
Cash consumed by operations 7 (6,992) (5,263) (11,920)
Income tax credit received 1,340 - -
Cash outflow from operating
activities (5,652) (5,263) (11,920)
Cash flows from investing
activities
Capital expenditure (255) (18) (293)
Purchase of intangible - - -
asset
Interest received 274 59 345
------------- ------------- ----------
Net cash generated by
investing activities 19 41 52
Cash flows from financing
activities
Finance lease principal - - -
payments
Proceeds from issuance
of ordinary shares - 68,375 68,454
Costs of share issue - (3,259) (3,259)
Bank deposit matured/(placed) 8,624 (49,993) (48,283)
Net cash generated by
financing activities 8,624 15,123 16,912
------------------------------- ----- ------------- ------------- ----------
Net increase in cash
and cash equivalents 8 2,991 9,901 5,044
Cash and cash equivalents
at the start of period 17,426 12,382 12,382
Cash and cash equivalents
at the end of period 9 20,417 22,283 17,426
------------------------------- ----- ------------- ------------- ----------
Notes to the interim financial statements
for the six months ended 30 September 2016
1. General information and basis of preparation
ReNeuron Group plc is an AIM listed company incorporated and domiciled in the United Kingdom under the Companies Act 2006. The Company's registered office and its principal place of business is Pencoed Business Park, Pencoed, Bridgend, CF35 5HY.
These Interim Financial Statements were prepared by the Directors and approved for issue on 5 December 2016. They have not been audited.
These Interim Financial Statements do not comprise statutory accounts within the meaning of section 434 of the Companies Act 2006. Statutory accounts for the year ended 31 March 2016 were approved by the Board of Directors on 22 July 2016 and delivered to the Registrar of Companies. The report of the auditors on those accounts was unqualified and did not contain statements under 498 (2) or (3) of the Companies Act 2006 and did not contain any emphasis of matter.
As permitted these Interim Financial Statements have been prepared in accordance with UK AIM rules and the IAS 34, 'Interim financial reporting' as adopted by the European Union. They should be read in conjunction with the Annual Financial Statements for the year ended 31 March 2016, which have been prepared in accordance with IFRS as adopted by the European Union.
2. Accounting policies
The accounting policies applied are consistent with those of the Annual Financial Statements for the year ended 31 March 2016, as described in those Annual Financial Statements. Where new standards or amendments to existing standards have become effective during the year, there has been no material impact on the net assets or results of the Group.
Certain statements within this report are forward looking. The expectations reflected in these statements are considered reasonable. However, no assurance can be given that they are correct. As these statements involve risks and uncertainties the actual results may differ materially from those expressed or implied by these statements.
3. Going concern
The Group is expected to incur significant further costs as it continues to develop its therapies and technologies through clinical development. The Directors expect that the Group's financial resources will be sufficient to support operations into the second half of 2018. Consequently, the going concern basis has been adopted in the preparation of these interim financial statements.
4. Segment information
Following the adoption of IFRS8 Segment Reporting, the Group has identified the Chief Executive Officer as the Chief Operating Decision Maker (CODM). The CODM manages the business as one segment, the development of cell-based therapies. Since this is the only reporting segment, no further information is included. The information used internally by the CODM is the same as that disclosed in the interim financial statements. The Group's revenue derives wholly from assets located in the United Kingdom. Analysed by location of customer all revenue is derived from the United States of America.
5. Other operating income
Other operating income comprises Government grants from Innovate UK (Technology Strategy Board) in relation to the Group's programmes.
6. Basic and diluted loss per share
The basic and diluted loss per share is calculated by dividing the loss for the financial period of GBP7,695,000 (September 2015: GBP4,480,000, March 2016: GBP11,354,000) by 3,164,618,541 shares (September 2015: 2,058,105,458 shares and March 2016: 2,609,315,899 shares), being the weighted average number of ordinary 1p shares in issue during the period. Potential ordinary shares are not treated as dilutive as the entity is loss-making.
7. Cash consumed by operations
Six months Six months Year
ended ended ended
30 September 30 September 31 March
2016 2015 2016
GBP'000 GBP'000 GBP'000
---------------------------- ------------- ------------- ----------
Loss before income
tax (8,635) (5,236) (12,846)
Adjustment for:
Interest received (274) (59) (345)
Depreciation of
tangible fixed assets 73 34 92
Impairment of intangible 319 - -
assets
Provisions (355) - (107)
Share-based payment
charge 500 258 681
Changes in working
capital
Receivables 634 (432) (751)
Payables 746 172 1,356
Cash consumed by
operations (6,992) (5,263) (11,920)
---------------------------- ------------- ------------- ----------
8. Reconciliation of net cash flow to movement in net debt
Six months Six months Year
ended ended ended
30 September 30 September 31 March
2016 2015 2016
GBP'000 GBP'000 GBP'000
------------- ------------- ----------
Net funds at start
of period 17,425 12,380 12,380
-------------------- ------------- ------------- ----------
Increase in cash
in the period 2,991 9,901 5,044
Cash inflow from
decrease in debt - - 1
Net funds at end
of period 20,416 22,281 17,425
-------------------- ------------- ------------- ----------
9. Analysis of net funds
Six months Six months Year
ended ended ended
30 September 30 September 31
March
2016 2015 2016
GBP'000 GBP'000 GBP'000
------------- ------------- --------
Cash at bank
and in hand 20,417 22,283 17,426
Finance leases (1) (2) (1)
20,416 22,281 17,425
---------------- ------------- ------------- --------
This information is provided by RNS
The company news service from the London Stock Exchange
END
IR FSUEELFMSEDE
(END) Dow Jones Newswires
December 05, 2016 02:46 ET (07:46 GMT)
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