TIDMIMM
RNS Number : 2533P
Immupharma PLC
30 September 2011
For Immediate Release 30 September 2011
Immupharma plc
INTERIM RESULTS ANNOUNCEMENT
For the six months ended 30 June 2011
ImmuPharma plc (LSE:IMM) ("Immupharma" or the "Company" or the
"Group"), the specialist discovery and development pharmaceutical
company is pleased to announce its interim results for the six
months ended 30 June 2011.
INTERIM HIGHLIGHTS
-- Cephalon, Inc (Cephalon), ImmuPharma's licensee for Rigerimod
(Lupuzor(TM) ), continues to progress its Phase IIb trial in US and
European lupus patients. This study has been designed to provide
US-based investigators and the US FDA with clinical data obtained
mainly in the USA. This data will be part of the package submitted
to the FDA and other regulatory authorities for approval. We plan
to provide an update on this trial in conjunction with Cephalon
announcing these results. Positive Phase IIb data from outside the
USA has previously been announced. ImmuPharma look forward to
providing an update on Lupuzor(TM) 's progress following the
finalisation of the acquisition of Cephalon by Teva
Pharmaceuticals.
-- The Phase I/IIa trial of IPP-204106, ImmuPharma's anti-cancer
compound with a novel and promising mechanism of action, continues
to progress in cancer patients. A scientific paper on IPP-204106
was published in the prestigious medical journal of the American
Association for Cancer Research
-- Strong cash position of GBP14.3m
-- Basic and diluted loss per share were 2.59p and 2.59p
respectively (30 June 2010: basic and diluted loss per share 0.10p
and 0.10p respectively)
Commenting on the progress to date and the outlook for
ImmuPharma, Dimitri Dimitriou, Chief Executive Officer, said:
"The first half of 2011 has seen ImmuPharma build on the success
of 2010 with Cephalon, our licensee for Lupuzor(TM) , moving ahead
with a large trial in the US. We look forward to providing an
update on Lupuzor(TM) 's progress once Teva's acquisition of
Cephalon is complete. In parallel, we are focusing our own efforts
on our promising cancer drug and are pleased to have seen
encouraging results so far and to have achieved publication in the
journal of the American Association for Cancer Research. We look
forward to building on this success during the rest of 2011 and in
the coming years."
Richard Warr, ImmuPharma's Chairman added:
"ImmuPharma has two potential blockbuster drugs in the clinic,
Lupuzor(TM) and our cancer compound, IPP-204106. We look forward to
providing an update on Lupuzor(TM) following the imminent
finalisation of Teva's acquisition of Cephalon. Moreover,
ImmuPharma is pleased to report a strong balance sheet, controlled
expenditure and a robust cash position."
For further information, please contact:
ImmuPharma PLC:
Dimitri Dimitriou, Chief Executive
Officer +44 20 7152 4080
Richard Warr, Chairman
Tracy Weimar, VP, Operations
Buchanan Communications
Lisa Baderoon, Mark Court +44 20 7466 5000
Panmure, Gordon & Co., NOMAD &
Broker
Andrew Burnett +44 20 7459 3600
Espirito Santo Investment Bank,
Joint Broker
James Bromhead +44 20 7456 9191
Statement from the Chairman and Chief Executive Officer
INTERIM HIGHLIGHTS
Summary
We are pleased to report our interim results for the six months
ended 30 June 2011. Building on the progress made in 2010, the
first six months of 2011 have seen the announcement of substantial
and exciting progress of IPP-204106, our cancer programme. In
February, ImmuPharma announced preliminary results of our ongoing
Phase I/IIa trial in cancer patients. In May, a scientific paper on
IPP-204106 was published in the prestigious American Association
for Cancer Research, a momentous landmark for our collaboration
partner, the CNRS and ImmuPharma. Lupuzor(TM) , our drug candidate
for systemic lupus erythematosus which is licensed to Cephalon,
Inc. (Cephalon), continues to progress through its Phase IIb trial
in patients in multiple centres in the USA and Europe.
Our pipeline includes 5 lead compounds. The most advanced,
Lupuzor(TM) , has been licensed to Cephalon, Inc. which has taken
over responsibility for its development and all associated costs.
Our next priority program is IPP-204106 for the treatment of
cancer. It continues to progress in its Phase I/IIa trial in cancer
patients. It has been awarded grants totalling EUR1.15m by French
government organisations which are supporting its development
process. Three other earlier stage programmes are in preclinical
development for - inflammatory disorders, moderate to severe pain
and serious hospital infections. In addition to our lead compounds,
our long-term pipeline includes a patented chemical library of over
300,000 small molecules and a technology for converting small
peptides to drugs that can potentially be applied to generate
further compounds for the Company.
Development Pipeline
-- Lupuzor(TM)
Since licensing Lupuzor(TM) to Cephalon in 2009, ImmuPharma has
placed a priority on developing a good working relationship with
our licensee. Cephalon has a Phase IIb trial in progress in the USA
and Europe. This study was designed to allow US-based investigators
and the FDA to evaluate Rigerimod (Lupuzor(TM) ) as a treatment for
lupus on the basis of data derived mainly from the USA. A large
number of centres are involved and the data generated from this
trial will be part of the package to be submitted to the FDA and
other regulatory authorities for approval. In addition to the US
trial and in order to prepare for the commercial development in
Japan, Cephalon has also initiated development of Lupuzor(TM) in
Japan through its partner Symbio Pharmaceuticals. Under the
agreement, Cephalon retains all commercialisation rights to
Rigerimod (Lupuzor(TM) ) in Japan, and Symbio is granted an
exclusive right to conduct a Japanese-based Phase I clinical study
which is mandatory for a future filing of Rigerimod (Lupuzor(TM) )
with Japanese regulatory bodies. Cephalon is currently in the
process of being acquired by Teva Pharmaceuticals. Once the
acquisition clearance process is complete (expected Q4 2011), we
look forward to providing a further update on Lupuzor(TM) and its
progress.
-- IPP-204106, treatment for cancer
IP-204106 is ImmuPharma's lead compound for cancer. The rights
for this compound have been obtained through the Group's ongoing
research collaboration with the Centre National de la Recherche
Scientifique (CNRS), France's leading scientific research
organisation. The molecule is a nucleolin antagonist and has a
promising and novel mechanism of action, acting both in preventing
angiogenesis as well as proliferation. Preclinical data has shown
that nucleolin antagonists inhibit the growth of tumours and
metastasis in many cancer types. In February, ImmuPharma reported
progress on the Phase I/IIa trial in cancer patients. This trial is
ongoing with plans for Phase IIb in development.
Statement from the Chairman and Chief Executive Officer
Development Pipeline (continued)
-- Other Pipeline Compounds
More modest progress has been made on ImmuPharma's other
pipeline compounds for inflammation, pain, MRSA and other
hospital-acquired infections during the period. The Group remains
committed to their development either alone or with a partner.
Financial Review
ImmuPharma's cash balance remains strong at GBP14.3 million
(GBP15.6 million at 31 December 2010). Basic and diluted loss per
share were 2.59p and 2.59p respectively (30 June 2010: 0.10p and
0.10p). In line with the Company's current policy, no interim
dividend is proposed.
ImmuPharma continue to emphasise prudent and controlled
expenditure. Operating loss for the period was GBP1,568,140
(GBP2,521,050 for the six months ended 30 June 2010). Research and
development expenditure was GBP579,195 (GBP975,454 for the six
months ended 30 June 2010) reflecting primarily the activities for
the development of IPP-204106, our anti-cancer compound.
Administrative expenses were GBP993,474 (GBP1,545,713 for the six
months ended 30 June 2010). Finance costs for the period were
GBP572,779 which is attributable to adverse foreign exchange
movements during the period.
Outlook
With a strong cash position and controlled expenditure, the
focus of the Group is on continuing the development of our strong
relationship with Cephalon, our license partner for Lupuzor(TM) ,
and the development of our other pipeline candidates, in particular
our promising cancer compound, IPP-204106. We are looking forward
to providing an update on Lupuzor(TM) after the clearance process
for the Teva acquisition of Cephalon is complete (Q4 2011) and to
announcing the preliminary results of our Phase IIa trial for
IPP-204106 in the coming months. Furthermore, in an effort to
maximise the value of our development pipeline, ImmuPharma
continues to be in discussions with a number of pharmaceutical and
biotech companies for potential collaborations.
Richard Warr, MA, Chairman Dimitri Dimitriou, MSc, Chief
Executive Officer
29 September 2011
Independent Review Report To ImmuPharma plc
Introduction
We have been engaged by the Company to review the condensed set
of financial statements in the interim report for the six months
ended 30 June 2011 which comprises the Consolidated Income
Statement, the Consolidated Statement of Comprehensive Income, the
Consolidated Statement of Financial Position, the Consolidated
Statement of Changes in Equity, the Consolidated Statement of
Cashflows, and the related notes 1 to 5.
We have read the other information contained in the interim
report and considered whether it contains any apparent
misstatements or material inconsistencies with the financial
information in the condensed set of financial statements.
This report is made solely to the Company in accordance with the
terms of our engagement to assist the Company in meeting the
requirements of the AIM Rule 18. Our review has been undertaken so
that we might state to the Company those matters we are required to
state to it in this report and for no other purpose. To the fullest
extent permitted by law, we do not accept or assume responsibility
to anyone other than the Company for our review work, for this
report or for the conclusions we have reached.
Directors' responsibilities
The interim report is the responsibility of, and has been
approved by, the directors. The directors are responsible for
preparing the half-yearly report in accordance with AIM Rule
18.
As disclosed in note 1, the annual financial statements of the
Group are prepared in accordance with IFRS as adopted by the
European Union. It is the responsibility of the directors to ensure
that the condensed set of financial statements included in this
interim report have been prepared on a basis consistent with that
which will be adopted in the Group's annual financial
statements.
Our responsibility
Our responsibility is to express to the Company a conclusion on
the condensed set of financial statements in the interim report
based on our review.
Scope of review
We conducted our review in accordance with International
Standard on Review Engagements (UK and Ireland) 2410 "Review of
Interim Financial Information Performed by the Independent Auditor
of the Entity" issued by the Auditing Practices Board for use in
the United Kingdom. A review of interim financial information
consists of making enquiries, primarily of persons responsible for
financial and accounting matters, and applying analytical and other
review procedures.
A review is substantially less in scope than an audit conducted
in accordance with International Standards on Auditing (UK and
Ireland) and consequently does not enable us to obtain assurance
that we would become aware of all significant matters that might be
identified in an audit. Accordingly we do not express an audit
opinion.
Conclusion
Based on our review, nothing has come to our attention that
causes us to believe that the condensed set of financial statements
in the interim report for the six months ended 30 June 2011 is not
prepared, in all material respects, in accordance with the
requirements of the AIM rules.
25 Moorgate
London
Nexia Smith & Williamson EC2R 6AY
Statutory Auditor
Chartered Accountants 29 September 2011
ImmuPharma plc
CONSOLIDATED INCOME STATEMENT
FOR THE PERIOD ENDED 30 JUNE 2011
6 months Year 6 months
ended ended ended
30 June 31 December 30 June
Note 2011 2010 2010
GBP GBP GBP
Continuing operations
Revenue 4 4,529 32,462 117
Royalty expense 4 - - -
Research and
development expenses (579,195) (1,591,124) (975,454)
Administrative
expenses (993,474) (2,620,838) (1,545,713)
Operating loss (1,568,140) (4,179,500) (2,521,050)
Finance costs (572,779) (1,842) (1,190)
Finance income 28,441 1,707,753 2,444,845
Loss before taxation (2,112,478) (2,473,589) (77,395)
Tax (812) 495,312 (181)
Loss for the period (2,113,290) (1,978,277) (77,576)
Attributable to:
Equity holders of the
parent company (2,113,290) (1,978,277) (77,576)
Loss per ordinary
share
Basic 2 (2.59)p (2.44)p (0.10)p
Diluted 2 (2.59)p (2.44)p (0.10)p
============= ============== =============
ImmuPharma plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME FOR THE PERIOD
ENDED 30 JUNE 2011
6 months Year 6 months
ended ended 31 ended
30 June December 30 June
2011 2010 2010
GBP GBP GBP
Loss for the financial period (2,113,290) (1,978,277) (77,576)
Other comprehensive income
Exchange differences on
translation of foreign
operations 683,010 (523,771) (1,101,186)
Other comprehensive income
for the period 683,010 (523,771) (1,101,186)
Total comprehensive income
for the period (1,430,280) (2,502,048) (1,178,762)
ImmuPharma plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 JUNE 2011
30 June 31 December 30 June
2011 2010 2010
GBP GBP GBP
Non-current assets
Intangible assets 712,884 704,940 705,108
Property, plant and equipment 120,990 76,792 12,378
Total non-current assets 833,874 781,732 717,486
Current assets
Trade and other receivables 939,556 1,177,621 1,172,703
Cash and cash equivalents 14,296,173 15,592,941 20,008,493
Total current assets 15,235,729 16,770,562 21,181,196
Current liabilities
Financial liabilities -
borrowings 10,762 36,032 30,682
Trade and other payables 329,094 640,080 4,021,734
Provisions 78,356 134,503 81,448
Total current liabilities 418,212 810,615 4,133,864
Net current assets 14,817,517 15,959,947 17,047,332
Non-current liabilities
Financial liabilities -
borrowings 1,038,562 771,208 759,370
Net assets 14,612,829 15,970,471 17,005,448
EQUITY
Ordinary shares 8,153,246 8,153,246 8,109,146
Share premium 7,445,970 7,445,970 7,302,645
Merger reserve 106,148 106,148 106,148
Other reserves (2,573,798) (3,329,446) (3,888,675)
Retained earnings 1,481,263 3,594,553 5,376,184
Total equity 14,612,829 15,970,471 17,005,448
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE PERIOD ENDED 30 JUNE 2011
Other
reserves
Other Other - Equity
reserves - reserves - shares to
Share Share Merger Acquisition Translation be Retained Total
capital premium reserve reserve Reserve issued Earnings equity
GBP GBP GBP GBP GBP GBP GBP GBP
At 1 January
2010 8,109,146 7,302,645 106,148 (3,541,203) (642,877) 1,295,705 5,453,760 18,083,324
Loss for the
period - - - - - - (77,576) (77,576)
Other
comprehensive
income for
the period - - - - (1,101,186) - - (1,101,186)
Total
comprehensive
income for
the period - - - - (1,101,186) - (77,576) (1,178,762)
Share based
payments - - - - - 100,886 - 100,886
At 30 June
2010 8,109,146 7,302,645 106,148 (3,541,203) (1,744,063) 1,396,591 5,376,184 17,005,448
At 1 January
2010 8,109,146 7,302,645 106,148 (3,541,203) (642,877) 1,295,705 5,453,760 18,083,324
Loss for the
period - - - - - - (1,978,277) (1,978,277)
Other
comprehensive
income for
the year - - - - (523,771) - - (523,771)
Total
comprehensive
income for
the year - - - - (523,771) - (1,978,277) (2,502,048)
New issue of
equity
capital 44,100 143,325 - - - - - 187,425
Share based
payments - - - - - 201,770 - 201,770
Share option
exercise - - - - - (119,070) 119,070 -
At 31 December
2010 8,153,246 7,445,970 106,148 (3,541,203) (1,166,648) 1,378,405 3,594,553 15,970,471
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (continued)
FOR THE PERIOD ENDED 30 JUNE 2011
Other
reserves
Other Other - Equity
reserves - reserves - shares to
Share Share Merger Acquisition Translation be Retained Total
capital premium reserve reserve Reserve issued Earnings equity
GBP GBP GBP GBP GBP GBP GBP GBP
At 31 December
2010 8,153,246 7,445,970 106,148 (3,541,203) (1,166,648) 1,378,405 3,594,553 15,970,471
Loss for the
period - - - - - - (2,113,290) (2,113,290)
Other
comprehensive
income for
the period - - - - 683,010 - - 683,010
Total
comprehensive
income for
the period - - - - 683,010 - (2,113,290) (1,430,280)
Share based
payments - - - - - 72,638 - 72,638
At 30 June
2011 8,153,246 7,445,970 106,148 (3,541,203) (483,638) 1,451,043 1,481,263 14,612,829
Attributable
to:-
Equity holders
of the parent
company 8,153,246 7,445,970 106,148 (3,541,203) (483,638) 1,451,043 1,481,263 14,612,829
ImmuPharma plc
CONSOLIDATED STATEMENT OF CASHFLOWS
FOR THE PERIOD ENDED 30 JUNE 2011
6 months Year 6 months
ended ended 31 ended
30 June December 30 June
Notes 2011 2010 2010
GBP GBP GBP
Cash flows from
operating activities
Cash used in operations 3 (2,165,271) (6,177,037) (3,194,309)
Tax paid - (666,397) (594,679)
Interest paid (560) (1,842) (1,190)
Net cash used in
operating activities (2,165,831) (6,845,276) (3,790,178)
Investing activities
Purchase of property,
plant and equipment (49,156) (76,316) (6,434)
Purchase of intangibles
assets - (2,446) (1,696)
Finance income 28,441 13,073 2,444,844
Net cash from investing
activities (20,715) (65,689) 2,436,714
Financing activities
Net proceeds from share issue
- Company - 187,425 -
Increase/(decrease) in bank
overdraft 4,472 (975) (276)
New loans 219,848 394,885 383,618
Loan repayments (30,921) (26,148) -
Net cash generated from
financing activities 193,399 555,187 383,342
Net decrease in cash and
cash equivalents (1,993,147) (6,355,778) (970,122)
Cash and cash equivalents
at start of period 15,592,941 22,525,509 22,525,509
Effects of exchange rates
on cash and
cash equivalents 696,379 (576,790) (1,546,894)
Cash and cash equivalents
at end of period 14,296,173 15,592,941 20,008,493
ImmuPharma plc
NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE
2011
1 ACCOUNTING POLICIES
Basis of preparation
The interim financial information in this report has been
prepared using accounting policies consistent with IFRS as adopted
by the European Union. IFRS is subject to amendment and
interpretation by the International Accounting Standards Board
(IASB) and the IFRS Interpretations Committee and there is an
ongoing process of review and endorsement by the European
Commission. The financial information has been prepared on the
basis of IFRS that the Directors expect to be adopted by the
European Union and applicable as at 31 December 2011.
The accounting policies applied are consistent with those that
will apply to the financial statements for the year ending 31
December 2011.
Income tax
Taxes on income in the interim periods are accrued using the tax
rate that would be applicable to expected total annual
earnings.
Non-Statutory accounts
The financial information for the year ended 31 December 2010
set out in this interim report does not constitute the Group's
statutory accounts for that period. The statutory accounts for the
year ended 31 December 2010 have been delivered to the Registrar of
Companies. The auditors reported on those accounts; their report
was unqualified, did not contain a statement under either Section
498 (2) or Section 498 (3) of the Companies Act 2006 and did not
include references to any matters to which the auditor drew
attention by way of emphasis. The financial information for the 6
months ended 30 June 2011 and 30 June 2010 is unaudited.
Copies of this statement will be available on the Company's
website - www.immupharma.com.
ImmuPharma plc
NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE
2011
(continued)
2 EARNINGS PER SHARE
6 months
6 months Year ended ended
ended 30 31 December 30 June
June 2011 2010 2010
GBP GBP GBP
Earnings
Earnings for the purposes of
basic and diluted earnings per
share being net loss
attributable to equity
shareholders (2,113,290) (1,978,277) (77,577)
Number of shares
Weighted average number of
ordinary shares for the
purposes of basic earnings per
share 81,533,463 81,171,744 81,092,463
Effect of dilutive potential
ordinary shares:
Share options - - -
Warrants - - -
81,533,463 81,171,744 81,092,463
Basic loss per share (2.59)p (2.44)p (0.10)p
Diluted loss per share (2.59)p (2.44)p (0.10)p
Share options have not been included in the calculation of
diluted loss per shares as they are anti-dilutive.
ImmuPharma plc
NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE
2011
(continued)
3 CASH USED IN OPERATIONS
30 June 31 December 30 June
2011 2010 2010
GBP GBP GBP
Operating loss (1,568,140) (4,179,500) (2,521,050)
Depreciation and
amortisation 16,134 41,882 18,908
Share-based
payments 72,638 201,770 100,886
Decrease in
debtors 273,372 710,366 174,532
Decrease in
creditors (330,179) (4,606,209) (874,504)
Decrease in
provisions (56,147) (40,026) (93,081)
(Loss)/gain on
foreign exchange (572,949) 1,694,680 -
Cash used in
operations (2,165,271) (6,177,037) (3,194,309)
4 LUPUZOR(TM) REVENUE AND ROYALTY EXPENSE
In February 2009 Cephalon Inc exercised its option to license the
exclusive worldwide rights to Lupuzor and made a non refundable payment
of $30 million to the Group. Under the terms of the licence agreement,
the Group is entitled to various future cash milestone payments and
royalties on commercial sales of Lupuzor. Cephalon Inc will be
responsible for all future costs and activities, including Phase III
clinical trials, regulatory filing and the subsequent commercialisation
and sale of the product worldwide.
5 SUBSEQUENT EVENTS
There have been no subsequent events since 30 June 2011.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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