TIDMPRX
RNS Number : 2570F
Proximagen Group PLC
13 June 2012
13 June 2012
PROXIMAGEN GROUP PLC
("Proximagen" or the "Company")
Interim results for the six months ended 31 May 2012
London, UK, 13 June 2012 - Proximagen Group plc (AIM: PRX), the
rapidly growing company with a focus on the treatment of disorders
of the central nervous system and inflammatory diseases, is pleased
to announce its interim results for the six months ended 31 May
2012.
Highlights:
-- Phase I clinical trial of oral VAP-1 antagonist for rheumatoid arthritis initiated
-- Grant awarded under the MJFF's Therapeutics Development
Initiative Fall 2011 Program to fund research of Proximagen's D1
programme in Parkinson's disease
-- Continued strong R&D investment of GBP3.1 million in the
period alongside further significant investment made in our
clinical development programmes by our partners
-- Strong balance sheet with cash balance of GBP48.0 million
Commenting on the interim results, Kenneth Mulvany, Chief
Executive Officer of Proximagen, said:
"The Company continued to make good progress in the first half
of the year, and we are pleased with the preliminary positive
safety data that we are seeing from our VAP-1 Phase I study. Our
pipeline is now more diverse and advanced than ever before and we
now have four compounds in clinical development and more than ten
earlier stage assets being progressed. We continue to apply our
risk-mitigated approach with the objective of bringing forward new
therapies for patients and generating shareholder value."
For further information, please contact:
Proximagen Group plc Tel: +44 (0)20 7400
7700
Kenneth Mulvany, Chief Executive
Officer
James Hunter, Finance Director
Cenkos Securities plc (Nominated Tel: +44 (0)20 7397
Adviser and Broker) 8900
Bobbie Hilliam
M:Communications (Media enquiries) Tel: +44 (0)20 7920
2330
Mary-Jane Elliott/Sarah Macleod/Hollie proximagen@mcomgroup.com
Vile
Chairman's and Chief Executive's Statement
Overview
Proximagen has continued to make good progress across its
pipeline during the first half of 2012. The Company's pipeline now
consists of over 15 programmes, covering neurology, inflammation
and oncology. Four programmes are in clinical development, with
three of these programmes either in or being prepared for clinical
proof of concept studies. We have three pre-clinical programmes
readying for their first time in-man studies and eight programmes
in earlier stages of development, all based on strong scientific
foundations. We continue to adopt our managed risk approach to
development, as is evidenced by the external funding that has been
secured by the Company from industry, governmental and charitable
sources.
Advancement of our clinical pipeline during the period
Our VAP-1 antagonist, a first in class, orally administered,
small molecule for rheumatoid arthritis (RA), has successfully
completed its Phase I Single Ascending Dose (SAD) study in 30-40
patients. A Multiple Ascending Dose (MAD) study has now initiated,
with data from this study due by the end of 2012. The drug
candidate, which acts by stopping leukocyte trafficking to inflamed
areas, was shown to be highly efficacious in models of RA that have
strong translational correlation with efficacy in human clinical
trials.
Both of our two clinical stage epilepsy programmes, naluzotan (a
selective 5-HT1a agonist) for the treatment of refractive epilepsy,
and tonabersat, a putative gap junction blocker that inhibits
intercellular signalling and cortical spreading depolarisation
(CSD), a phenomenon which is heavily implicated in the
pathophysiology of epilepsy, have continued to progress through
clinical development in line with management's expectations.
Advancement of our pre-clinical pipeline during the period
We are continuing to invest in our pipeline of pre-clinical
assets and have been pleased with the progress shown in these
assets. In particular, we have been encouraged by recent data from
a study investigating the lead compound from our Dopamine D1
Positive Allosteric Modulator (PAM) programme that has demonstrated
proof of concept in a leading disease model for cognitive
enhancement.
Proximagen's D1 PAM compound, acquired from GlaxoSmithKline in
late 2010, demonstrated comparable efficacy to the cholinesterase
inhibitor standard of care, donepezil (Aricept). D1 PAMs have the
potential both to treat the motor symptoms of Parkinson's disease
(PD) with reduced side-effects, and to improve the cognitive
deficits often seen in PD patients. D1 PAMs specifically bind to
the allosteric site of D1 receptors and increase or potentiate the
effects of dopamine or D1 agonists. D1 receptor agonism is an
approach that has been clinically validated in PD patients.
Cognitive impairment can be a problem from the earliest stages
of PD, contributing significantly to the morbidity and mortality of
the disease. Cognitive impairment is also a characteristic of
Alzheimer's disease, schizophrenia and Attention Deficit
Hyperactivity Disorder (ADHD). According to Datamonitor, sales of
therapeutics for cognitive impairment and other dementias will
reach $15.5 billion in 2018 (from $5.3 billion in 2008). These D1
PAM studies have been funded by a grant from The Michael J Fox
Foundation awarded to Proximagen in December 2011 under its
Therapeutics Development Initiative Fall 2011 Program.
Financial review
Statement of comprehensive income
Revenue represents the Michael J Fox Foundation grant awarded to
develop the D1 programme and the recognition of revenue under the
terms of the tonabersat licensing agreement with our partner
Upsher-Smith. This licensing income is being recognised as the
programme is being developed. The grant revenue is recognised as
income over the period necessary to match the grant on a systematic
basis to the costs that it is intended to compensate.
Expenditure on R&D was GBP3.1 million, compared with GBP2.5
million for the same period last year.
Administrative expenses of GBP1.9 million represent an increase
of GBP0.4m over the same period in 2011 when administrative
expenses were GBP1.5 million.
The operating loss for the six months ended 31 May 2012 was
GBP4.9 million (31 May 2011: loss of GBP3.9 million). The loss
after tax was GBP4.0 million (31 May 2011: loss of GBP3.1 million)
and the loss per share was 6.3p (31 May 2011: loss of 5.5p).
Balance sheet and cash flow
At 31 May 2012, net assets amounted to GBP48.8 million (30
November 2011: GBP52.6 million), including cash and cash
equivalents of GBP48.0 million (30 November 2011: GBP51.6 million).
Cash outflow, excluding the realization of financial assets, for
the six months to 31 May 2012 was GBP3.6 million (six months ended
31 May 2011: GBP3.4 million).
Peter Allen
Kenneth Mulvany
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
For the six months ended 31 May 2012
Note Six months Six months Year ended
ended 31 ended 31 30November
May 2012 May 2011 2011
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Revenue 3 134 191 224
Cost of sales - (28) (29)
Operating costs
Research and development (3,061) (2,515) (4,830)
Administrative
expenses (1,925) (1,542) (3,129)
------------ ------------ --------------
Total operating
costs (4,986) (4,057) (7,959)
Operating loss (4,852) (3,894) (7,764)
Finance income 306 254 540
Finance costs - (7) (11)
Loss before tax (4,546) (3,647) (7,235)
Income tax credit 4 569 519 986
------------ ------------ --------------
Loss for the period (3,977) (3,128) (6,249)
Total comprehensive
expense for the
period (3,977) (3,128) (6,249)
------------ ------------ --------------
Basic and diluted
loss per share
(pence per share) 5 (6.3) (5.5) (10.7)
CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS AT 31 MAY
2012
Note 31 May 2012 31 May 30 November
2011 2011
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Non-current assets
Intangible assets 1,293 1,283 1,293
Property, plant
and equipment 6 295 181 143
------------ ------------ ------------
1,588 1,464 1,436
------------ ------------ ------------
Current assets
Trade and other
receivables 762 647 566
Current tax receivable 805 519 986
Cash and cash
equivalents 48,000 44,743 51,587
------------ ------------ ------------
Total current
assets 49,567 45,909 53,139
------------ ------------ ------------
Total assets 51,155 47,373 54,575
------------ ------------ ------------
Current liabilities
Trade and other
payables (2,345) (2,065) (1,939)
Net current assets 47,222 43,844 51,200
------------ ------------ ------------
Net assets 48,810 45,308 52,636
------------ ------------ ------------
Equity
Ordinary shares 631 574 631
Share premium 73,498 63,236 73,498
Merger reserve 299 299 299
Share-based payment
reserve 832 551 681
Retained losses (26,450) (19,352) (22,473)
------------ ------------ ------------
Total equity 48,810 45,308 52,636
------------ ------------ ------------
CONSOLIDATED STATEMENT OF CASH FLOWS
For the six months ended 31 May 2012
Six months Six months Year ended
ended ended 30 November
31 May 2012 31 May 2011
2011
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Cash flows from operating
activities
Loss before tax (4,546) (3,647) (7,235)
Adjustments for:
Depreciation 45 57 105
Gain on sale of assets - - (4)
Net finance income (306) (247) (529)
Share-based payment
charge 151 122 252
Movement in deferred
income (36) (132) (165)
------------- ------------ -------------
Cash flow from operations
before changes in
working capital (4,692) (3,847) (7,576)
Changes in working
capital
(Increase)/Decrease
in trade and other
receivables (204) 112 235
Increase/(Decrease)
in trade and other
payables 442 (504) (597)
------------ -------------
Cash used in operations (4,454) (4,239) (7,938)
Income taxes received 750 933 933
Net cash used in
operating activities (3,704) (3,306) (7,005)
------------- ------------ -------------
Cash flow from investing
activities
Financial assets
realised - 10,000 10,000
Interest received 314 327 570
Intellectual property
acquired - (425) (435)
Purchase of property,
plant and equipment (197) (18) (26)
Proceeds from sale
of property, plant
and equipment - 1 4
Net cash generated
from investing activities 117 9,885 10,113
------------- ------------ -------------
Cash flows from financing
activities
Net proceeds from
the issue of ordinary
shares - 1 10,320
Net cash generated
from financing activities - 1 10,320
Foreign exchange
loss - (7) (11)
------------- ------------ -------------
Net (decrease)/increase
in cash and cash
equivalents (3,587) 6,573 13,417
------------- ------------ -------------
Cash and cash equivalents
at the beginning
of the period 51,587 38,170 38,170
------------- ------------ -------------
Cash and cash equivalents
at end of the period 48,000 44,743 51,587
------------- ------------ -------------
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
Ordinary Shares Share Premium Merger reserve Share- based payment Retained Total
reserve earnings
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
Six months ended 31
May 2012
(Unaudited)
Balance at 1 December
2011 631 73,498 299 681 (22,473) 52,636
Loss for the period - - - - (3,977) (3,977)
Total comprehensive
expense for the
period - - - - (3,977) (3,977)
Share-based payments - - - 151 - 151
Balance at 31 May
2012 631 73,498 299 832 (26,450) 48,810
---------------- -------------- --------------- --------------------- ---------- --------
Six months ended 31
May 2011
(Unaudited)
Balance at 1 December
2010 574 63,235 299 429 (16,224) 48,313
Loss for the period - - - - (3,128) (3,128)
Total comprehensive
expense for the
period - - - - (3,128) (3,128)
Share-based payments - - - 122 - 122
Issue of share
capital - 1 - - - 1
Balance at 31 May
2011 574 63,236 299 551 (19,352) 45,308
---------------- -------------- --------------- --------------------- ---------- --------
Year ended 30 November 2011
(Audited)
Balance at 1 December 2010 574 63,235 299 429 (16,224) 48,313
Loss for the year - - - - (6,249) (6,249)
Total comprehensive expense for the year - - - - (6,249) (6,249)
Share based payments - - - 252 - 252
Issue of share capital 57 10,263 - - - 10,320
Balance at 30 November 2011 631 73,498 299 681 (22,473) 52,636
---- ------- ---- ---- --------- --------
Notes
1. General information
This interim condensed consolidated financial information of the
group is for the six months ended 31 May 2012 and was approved by
the Directors of the Company on 12 June 2012. The group comprises
of the parent Proximagen Group plc and its subsidiaries Proximagen
Limited, Cambridge Biotechnology Limited, and Minster Research
Limited.
The interim condensed consolidated financial information set out
above does not constitute statutory accounts within the meaning of
Section 434 of the Companies Act 2006. The comparative figures for
the year ended 30 November 2011 were derived from the audited
statutory accounts for that year which have been delivered to the
Registrar of Companies. That report of the auditors was unqualified
and did not contain an emphasis of matter statement. The audit
report contained no statements under sections 498(2) or (3) of the
Companies Act 2006.
The interim condensed consolidated financial information is not
audited or reviewed and does not include all the information and
disclosures required in the annual financial statements, and should
be read in conjunction with the Group's annual financial statements
as at 30 November 2011 which have been prepared in accordance with
International Financial Reporting Standards (IFRS) as adopted by
the European Union.
2. Basis of preparation and accounting policies
Basis of preparation
The interim condensed consolidated financial information for the
six months ended 31 May 2012 has been prepared in accordance with
IAS 34 Interim Financial Reporting.
Accounting policies
The accounting policies, presentation and methods of computation
are the same as those applied in the Group's annual financial
statements as at 30 November 2011.
The Group also adopted the following new/revised standards and
interpretations which became effective on 1 January 2011 and
therefore were effective for the period to 31 May 2012:
-- Amendment to IAS24 - Related party disclosures
-- Improvements to IFRS (issued in May 2010)
The adoption of these Standards and Interpretations during the
Interim Report period had no material impact on the financial
statements of the Group or its accounting policies.
Going concern
The Directors have made an assessment of the working capital
requirements of the Group for the next twelve months, considered
against available cash and cash equivalents of GBP48.0 million.
After making appropriate enquiries, the Directors have a reasonable
expectation that the Company and the Group have adequate resources
to continue in operational existence for the foreseeable future.
Accordingly, they continue to adopt the going concern basis in
preparing the interim financial statements.
3. Revenue
Six months Six months Year ended
ended 31 ended 31 30 November
May 2012 May 2011 2011
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
Services rendered - 59 59
Grant income 98 - -
Licence revenues 36 132 165
Total 134 191 224
Six months Six months Year ended
ended 31 ended 31 30 November
May 2012 May 2011 2011
(Unaudited) (Unaudited) (Audited)
GBP'000 GBP'000 GBP'000
United Kingdom - - -
Rest of Europe - - -
United States of America 134 191 224
------------ ------------
Total 134 191 224
Two customers (31 May 2011 and 30 November 2011: one customer)
generated revenue individually over 10% of total Group
revenues.
The Group's operations are all based in the United Kingdom and
there is only one operating segment, Research and Development.
Consequently no further segmental disclosures are provided.
4. Tax on loss on ordinary activities
The tax credit for the current period represents an estimate of
the research and development tax credit receivable in respect of
Research & Development expenditure incurred in the current
period.
5. Loss per share
31 May 2012 31 May 2011 30 November
2011
(Unaudited) (Unaudited) (Audited)
Loss after tax for GBP3,977,000 GBP3,128,000 GBP6,249,000
the period
Weighted average number
of shares 63,119,601 57,378,643 58,354,269
The loss attributable to ordinary shareholders and weighted
average number of ordinary shares for the purpose of calculating
the diluted loss per ordinary share are identical to those used for
basic loss per share. This is because the exercise of share options
would have the effect of reducing the loss per ordinary share and
is therefore not dilutive under the terms of IAS 33.
6. Fixed Assets
During the six months ended 31 May 2012, the Group acquired
assets with cost of GBP197,000 (six months ended 31 May 2011:
GBP18,000).
7. Called up share capital
No new shares were issued for cash in the period in respect of
the exercise of options by a member of staff (six months ended 31
May 2011: 13,500).
8. Share-based payments
During the six months ended 31 May 2012, 302,795 share options
were granted to employees. The fair value of options granted during
the six months ended 31 May 2012 was estimated on the date of grant
using the following assumptions:
Expected volatility (%) 37
Weighted average risk free rate (%) 0.88
Weighted average expected life (years) 4.14
Weighted average share price (GBP) 1.42
For the six months ended 31 May 2012, the Group recognised
GBP151,000 of share-based payment transactions expense in the
consolidated statement of comprehensive income (six months ended 31
May 2011: GBP122,000).
9. Key management compensation
Key management compensation including share-based payments
amounted to GBP683,000 for the six months ended 31 May 2012. The
key management during the period comprised the two executive
directors, the Head of Development, Stevo Knezevic (until 9 April
2012), and the Head of Non-clinical Development, Bruce
Campbell.
Key management compensation including share-based payments
amounted to GBP668,000 for the six months ended 31 May 2011. The
key management during this period comprised the two executive
directors, the Head of Development, Stevo Knezevic, and the Head of
Non-clinical Development, Bruce Campbell.
10. Events after the balance sheet date
There have been no reportable events since the balance sheet
date save as otherwise announced as at the date of this
announcement.
11. Availability of information
Copies of these interim results are available at the Registered
Office of the Company, 3rd Floor, 91-93
Farringdon Road, London, EC1M 3LN and on the Company's website,
www.proximagen.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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