TIDMIMM
RNS Number : 7653L
Immupharma PLC
30 April 2015
30 APRIL 2015
PRELIMINARY RESULTS ANNOUNCEMENT
for the year ended 31 December 2014
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the
specialist drug discovery and development company, is pleased to
announce its preliminary audited results for the year ended 31
December 2014.
Key Highlights:
-- Lupuzor(TM)
o Agreement signed with Simbec-Orion, an international clinical
research organisation, to undertake crucial Phase III clinical
trial including a commitment to reinvest a significant proportion
of its fees in new ordinary shares at a fixed price of 150p per
share, representing a premium of 191% over yesterday's closing
mid-market price (post-period end).
o Simbec-Orion agreement provides many options for the Company's
future corporate strategy including the possibility of generating
our own sales.
o Granted an amended Special Protocol Assessment ("SPA") by the
FDA in 2013 reducing the number of patients required to complete
Phase III.
o World class Scientific Advisory Board of prominent physicians
and advisers in the field of lupus to provide guidance and support
for Lupuzor(TM) 's phase III programme.
-- Nucant programme IPP-204106
o Phase I/IIa clinical trial of the next generation "polyplexed
Nucant" formulation in three European hospitals including the
prestigious Institute Jules Bordet, Belgium, has now been
completed.
o Focus on angiogenesis applications in:
-- Cancer: development of novel applications of the Nucant
family of peptides targeting combination therapies.
-- Ophthalmology: age-related macular degeneration, diabetic
retinopathy.
-- CNRS collaboration and the University of Bordeaux (co-owned patents):
o Collaboration established with the University of Bordeaux in
coordination with the Centre Nationale de la Recherche Scientifique
("CNRS") to identify and patent novel peptide drugs
o Patented Urelix technology targeted to have first application
in diabetes.
-- Successful share placement primarily with key institutional
investors, which raised gross proceeds to the Company of GBP3.4
million in October.
-- Advance assurance received (post-period end) from HMRC that
the Company qualifies for the Enterprise Investment Scheme.
-- Continued availability of Darwin GBP50 million equity finance facility
-- Cash position as at 31 December 2014 of GBP5.4m (2013: GBP5.4m)
-- Loss for the period of GBP2.9m (2013: GBP3.7m).
-- Basic and diluted loss per share was 3.43p (2013: 4.52p)
-- Continued successful relationship with the CNRS, the largest
fundamental research institute in Europe
Commenting on the year's performance and outlook Dimitri
Dimitriou, Chief Executive Officer said:
2014 has been a year of substantial progress on all fronts, and
this has continued into 2015. Our recent deal with a leading
Contract Research Organisation (Simbec-Orion) is a key part of our
strategy to retain the rights to Lupuzor(TM) until
commercialisation. This means that many options remain open
including further corporate deals and commercialising ourselves in
certain territories, following on the successful path of all the
leading "big-biotech" companies. The Nucant program and the new
research facilities in collaboration with the CNRS in Bordeaux
continue to provide further promise for the Group. We were
delighted to have received the additional backing of key
institutional investors in October with a successful share
placement of GBP3.4 million. We would like to thank our
shareholders and the CNRS, our research partner, for their support
and we look forward to providing further updates during the course
of 2015.
For further information please contact:
+ 44 (0) 20
ImmuPharma plc 7152 4080
Dimitri Dimitriou, Chief Executive
Officer
Dr Robert Zimmer, President and
Chief Scientific Officer
Richard Warr, Chairman
Tracy Weimar, Vice President, Operations
and Finance
Lisa Baderoon, Head of Investor + 44 (0) 7721
Relations 413496
Panmure Gordon (UK) Limited, NOMAD +44 (0) 20
& Broker 7886 2500
Hugh Morgan, Fred Walsh, Duncan
Monteith, Corporate Finance
Charles Leigh-Pemberton, Corporate
Broking
ImmuPharma plc
Report of the Chairman, the Chief Executive Officer and the
President
We are pleased to report on a number of exciting developments
for the Group. Post-period end, we announced an agreement with
Simbec-Orion, an international clinical research organisation, to
begin the pivotal Phase III clinical trial for Lupuzor(TM) .
Further, we announced that the Phase I/IIa trial of our cancer
program has been completed and further therapeutic applications
have been identified. In October, our French subsidiary, Ureka
Sarl, was awarded a grant of approximately EUR400,000 to develop
its proprietary Urelix(TM) technology. Further, the Company
concluded a successful share placement that month resulting in
gross proceeds to the Company of approximately GBP3.4 million. In
January 2015, the Company received advance assurance from HMRC (the
UK tax authorities) that it would qualify for Enterprise Investment
Scheme status.
In January 2015, the Company finalised an agreement with
Simbec-Orion, an international clinical research organisation, to
undertake the crucial Phase III clinical trial for Lupuzor(TM) .
This is a pivotal study designed to demonstrate the safety and
efficacy of Lupuzor(TM) and is the last step prior to the filing
for approval. Since reacquiring the rights to Lupuzor(TM) from
Cephalon, Inc arising from its acquisition by Teva Pharmaceuticals,
ImmuPharma has been focused on assessing creative options to
complete the final development phase. The Company is delighted to
be able to report that it is moving ahead into Phase III with
Simbec-Orion. This arrangement opens many options for our future
strategy including further corporate deals in parallel with the
possibility of following in the path of the "big biotechs" by
generating our own sales.
Lupuzor(TM) has received approval from the US Food and Drug
Administration (FDA) to start Phase III with a Special Protocol
Assessment (SPA) as well as having received Fast Track designation.
ImmuPharma was granted an amended SPA during 2013. Under the new
SPA, the necessary number of patients for the Phase III programme
has been reduced. This number is lower than other lupus development
candidates in clinical trials and underpins the significant
efficacy shown by Lupuzor(TM) . Importantly, this means that the
total cost of Phase III is now greatly reduced.
ImmuPharma has also reached a milestone with our nucleolin
antagonist ("Nucant") peptide program with the completion of the
Phase I/IIa clinical trial of the next generation "polyplexed
Nucant" and the award of new patents for an "optically pure"
version of the Nucant family. The composition of matter patent
provides longer exclusivity, additional protection of the Nucant
program and a multitude of other indications in addition to cancer.
We anticipate being able to announce the results and future plans
for the program in cancer particularly in the field of combination
therapy. In addition, the Nucant program has shown some modulation
of angiogenesis with multiple applications in cancer as well as in
non-cancerous but highly critical clinical indications including
ophthalmology. ImmuPharma has been awarded a grant to further
investigate the Nucant's potential in this therapeutic area.
ImmuPharma's collaboration with the CNRS (Centre National de la
Recherche Scientifique), INSERM (Institut National de la Santé et
de la Recherche Medicale) and the University of Bordeaux at the
Institut Européen de Chimie et Biologie (IECB) has become well
established during the year. This collaboration filed a new patent
controlling a breakthrough peptide technology called 'Urelix(TM) '
which allows the mimicry of long natural peptides in the
configuration used to bind their receptor and improve their
stability to enzymatic degradation as well as greater efficacy. The
potential of this technology is substantial and has potential
application in many serious diseases. In October, the ImmuPharma
subsidiary involved with this collaboration, Ureka sarl, was
awarded a grant of approximately EUR400,000 to support this
work.
In October, we were delighted to have successfully completed a
share placement of approximately GBP3.4 million principally through
ImmuPharma's long standing institutional shareholders. The funds
raised are being used to support the Company as it progresses with
the pivotal Phase III trial for Lupuzor(TM) . The Company also
recently received advance assurance from HMRC that it will qualify
for Enterprise Investment Scheme status. This should provide the
Company with further investor interest over the coming year.
During the year, the profile of Lupuzor(TM) was featured at both
the European Lupus Conference in Athens and through a presentation
at the Immunology Frontier Research Center of Osaka University, an
internationally renowned research center in the field of immunology
in Japan.
ImmuPharma plc
Report of the Chairman, the Chief Executive Officer and the
President (continued)
Our key objectives for 2015 are to work with our development
partner Simbec-Orion on the final development phase of Lupuzor(TM)
, to advance our Nucant programme in cancer and other indications
and to focus on our peptide technology collaboration in Bordeaux.
We value the support and look forward to enhancing our key
relationship with the CNRS, the largest fundamental research
institution in Europe. As in previous years, this is to be achieved
with solid financial management and carefully controlled
expenditure.
The Board would like to thank its shareholders for their ongoing
support as well as its corporate and scientific advisers and the
CNRS in France for their collaboration.
Richard Warr Dimitri F. Dimitriou Dr Robert Zimmer
Chairman Chief Executive Officer President
ImmuPharma plc
Financial Review
During 2014, the Group focused on securing funding and/or a
partner for Lupuzor(TM) 's Phase III trial, progressing our cancer
program and establishing our peptide technology collaboration with
the University of Bordeaux and the CNRS.
Income Statement
The overall loss for the year ended 31 December 2014 was GBP2.9
million down from GBP3.7 million for the year ended 31 December
2013. The decrease in overall loss was mainly attributable to
reduced expenditure on the Group's cancer program. Research and
development expenditure decreased to GBP1.5 million (2013: GBP2.1
million) due to the Group's cancer program completing the active
phase of the Phase I/IIa trial during the year. Administrative
expenses were steady at GBP2.2 million (2013: GBP2.2 million). Net
finance income was GBP84,741 for 2014 including a gain on foreign
exchange of GBP26,177. This contrasts with net finance loss of
GBP205,755 for 2013 including a loss on foreign exchange of
GBP148,166. Total comprehensive loss for the year was GBP3.1
million which was down from GBP3.5 million in 2013.
As in previous years, IFRS2, relating to share-based payments
has had an impact on the Group's results. There is a charge in the
financial statements of GBP43,275 (2013: GBP8,844) which represents
the remaining outstanding charge for options previously granted.
This is a notional amount stipulated by IFRS2 (and calculated using
a statistical model) as a result of granting the options. This is
the final amount to be charged to the financial statements for
these options.
Balance Sheet
Cash and cash equivalents at 31 December 2014 amounted to GBP5.4
million (2013: GBP5.4 million). Financial borrowings were GBP0.8
million (2013: GBP1.1 million). This balance is primarily the
conditional advance from the French Government for use in the
development of our cancer programme. No interest is payable.
Darwin Equity Finance Facility
In May 2013, ImmuPharma agreed a GBP50 million equity finance
facility with Darwin Strategic Limited. Although the facility has
not been utilised to date, it gives ImmuPharma increased
flexibility in securing the necessary support to begin Phase III
for Lupuzor(TM) .
Results
The Group recorded a loss for the year of GBP2.9 million (2013:
GBP3.7 million). Basic and diluted loss per share was 3.43p (2013:
4.52p). No dividend is proposed.
Treasury Policy
The policy continues to be that surplus funds of the Group are
held in interest-bearing bank accounts on short or medium
maturities, until commitments to future expenditure are made, when
adequate funds are released to enable future expenditure to be
incurred. The Group's Treasury Policy and controls are
straightforward and approved by the Board.
Financial Strategy
The overall strategy is to successfully find a suitable partner
and/or funding to advance Lupuzor(TM) and to maintain a tight
control over cash resources whilst enabling controlled development
of the product pipeline.
Tracy Weimar
Vice President, Operations and Finance
ImmuPharma plc
CONSOLIDATED INCOME STATEMENT
FOR THE YEAR ENDED 31 DECEMBER 2014
Notes Year ended Year ended
31 December 31 December
2014 2013
GBP GBP
Continuing operations
Revenue 184,815 -
Research and development
expenses (1,457,298) (2,072,906)
Administrative expenses (2,152,417) (2,155,229)
Operating loss (3,424,900) (4,228,135)
Finance costs (14,195) (266,121)
Finance income 98,936 60,366
Loss before taxation (3,340,159) (4,433,890)
Tax 468,679 744,544
Loss for the year (2,871,480) (3,689,346)
Attributable to:
Equity holders of the
parent company (2,871,480) (3,689,346)
Earnings per ordinary
share
Basic 2 (3.43p) (4.52p)
Diluted 2 (3.43p) (4.52p)
ImmuPharma plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 31 DECEMBER 2014
Year ended Year ended
31 December 31 December
2014 2013
GBP GBP
Loss for the financial year (2,871,480) (3,689,346)
Other comprehensive income
Items that may be reclassified
subsequently to profit or
loss:
Exchange differences on
translation of foreign operations (230,357) 154,725
Other comprehensive (loss)/income
for the year, net of tax (230,357) 154,725
Total comprehensive loss
for the year (3,101,837) (3,534,621)
ImmuPharma plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2014
31 December 31 December
2014 2013
GBP GBP
Non-current assets
Intangible assets 560,537 602,070
Property, plant and equipment 366,363 97,149
Total non-current assets 926,900 699,219
Current assets
Trade and other receivables 721,410 1,109,737
Cash and cash equivalents 5,424,033 5,396,296
Total current assets 6,145,443 6,506,033
Current liabilities
Financial liabilities
- borrowings 417,852 346,935
Trade and other payables 549,652 628,372
Provisions 23,468 56,600
Total current liabilities 990,972 1,031,907
Net current assets 5,154,471 5,474,126
Non-current liabilities
Financial liabilities
- borrowings 375,989 769,601
Net assets 5,705,382 5,403,744
EQUITY
Ordinary shares 8,862,246 8,228,246
Share premium 10,490,920 7,764,720
Merger reserve 106,148 106,148
Other reserves (3,647,195) (3,460,113)
Retained earnings (10,106,737) (7,235,257)
Total equity 5,705,382 5,403,744
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2014
Other
Other Other reserves-
Merger reserves reserves - Equity Retained
reserve - Translation shares Earnings
Share Share Acquisition Reserve to be Total
capital premium reserve issued equity
GBP GBP GBP GBP GBP GBP GBP GBP
At 1 January
2013 8,153,246 7,445,970 106,148 (3,541,203) (1,733,740) 1,592,311 (3,604,861) 8,417,871
Loss for the
financial
year - - - - - - (3,689,346) (3,689,346)
Exchange
differences
on
translation
of foreign
operations - - - - 154,725 - - 154,725
Share based
payments - - - - - 126,744 - 126,744
New issue of
equity
capital 75,000 318,750 - - - (58,950) 58,950 393,750
---------- ----------- --------- ------------- ------------- ---------- ------------- ------------
At 31
December
2013 8,228,246 7,764,720 106,148 (3,541,203) (1,579,015) 1,660,105 (7,235,257) 5,403,744
Loss for the
financial
year - - - - - - (2,871,480) (2,871,480)
Exchange
differences
on
translation
of foreign
operations - - - - (230,357) - - (230,357)
Share based
payments - - - - - 43,275 - 43,275
New issue of
equity
capital 634,000 2,726,200 - - - - - 3,360,200
At 31
December
2014 8,862,246 10,490,920 106,148 (3,541,203) (1,809,372) 1,703,380 (10,106,737) 5,705,382
Attributable
to:-
Equity
holders of
the parent
company 8,862,246 10,490,920 106,148 (3,541,203) (1,809,372) 1,703,380 (10,106,737) 5,705,382
ImmuPharma plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 31 DECEMBER 2014
Notes Year ended Year ended
31 December 31 December
2014 2013
GBP GBP
Cash flows from operating
activities
Cash used in operations 3 (3,231,366) (4,211,836)
Tax 754,996 297,969
Interest paid (14,195) (55)
Net cash used in operating
activities (2,490,565) (3,913,867)
Investing activities
Purchase of property,
plant and equipment (342,275) (3,054)
Purchase of intangibles (5,656) -
Interest received 72,759 60,366
Net cash (used in)/ generated
from investing activities (275,172) 57,312
Financing activities
Decrease in bank overdraft (146) (25,041)
Loan repayments (395,326) (177,220)
Net proceeds from issue
of new share capital 3,360,200 393,750
Net cash generated from
financing activities 2,964,728 191,489
Net increase/(decrease)
in cash and cash equivalents 198,991 (3,665,066)
Cash and cash equivalents
at beginning of year 5,396,296 8,893,267
Effects of exchange rates
on cash and cash equivalents (171,254) 168,095
Cash and cash equivalents
at end of year 5,424,033 5,396,296
ImmuPharma plc
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2014
1 ACCOUNTING POLICIES
The financial information set out in this announcement does not
comprise the Group's statutory accounts as defined in section 434
of the Companies Act 2006 for the year ended 31 December 2014 or 31
December 2013.
The financial information has been extracted from the statutory
accounts for the years ended 31 December 2014 and 31 December 2013.
The auditors reported on those accounts; their reports were
unqualified and did not contain a statement under either Section
498(2) or Section 498(3) of the Companies Act 2006 in respect of
the years ended 31 December 2014 and 31 December 2013 and did not
include references to any matters to which the auditor drew
attention by way of emphasis.
The Group's statutory accounts for the year ended 31 December
2013 have been delivered to the Registrar of Companies, whereas
those for the year ended 31 December 2014 will be delivered to the
Registrar of Companies following the Company's Annual General
Meeting.
The accounting policies are consistent with those applied in the
preparation of the interim results for the period ended 30 June
2014 and the statutory accounts for the year ended 31 December
2013, which have been prepared in accordance with International
Financial Reporting Standards ("IFRS").
The financial information is for the year ended 31 December 2014
and the comparatives are for the year ended 31 December 2013.
The Group's statutory accounts incorporate the financial
statements of ImmuPharma plc and other entities controlled by the
company ("the subsidiaries"). Control is achieved where the company
has the power to govern the financial and operating policies of an
investee entity so as to obtain benefits from its activities.
ImmuPharma plc
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2014 (continued)
2 EARNINGS PER SHARE Year ended Year
31 December ended
2014 31 December
2013
GBP GBP
Earnings
Earnings for the purposes
of basic earnings per share
being net loss after tax attributable
to equity shareholders (2,871,480) (3,689,346)
Number of shares
Weighted average number of
ordinary shares for the purposes
of basic earnings per share 83,602,573 81,663,119
Basic earnings per share (3.43)p (4.52)p
Diluted earnings per share (3.43)p (4.52)p
The Group has granted share options in respect
of equity shares to be issued.
There is no difference between basic earnings
per share and diluted earnings per share as
the share options are anti-dilutive.
ImmuPharma plc
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER 2014 (continued)
3 CASH USED IN OPERATIONS
31 December 31 December
2014 2013
GBP GBP
Operating loss (3,424,900) (4,228,135)
Depreciation
and amortisation 99,166 55,914
Share-based payments 43,275 8,844
Decrease in
trade and other
receivables 172,445 232,576
Decrease in
trade and other
payables (114,397) (159,098)
Increase/(decrease)
in provisions (33,132) 26,229
Gain/(loss) on
foreign exchange 26,177 (148,166)
Loss on disposal -
of fixed asset
investment -
Cash used in
operations (3,231,366) (4,211,836)
4 SUBSEQUENT EVENTS
In January 2015, the Group entered into a
Collaboration Agreement with Simbec-Orion
Group Limited, an international clinical research
organisation, to execute the Group's pivotal
phase III clinical study for Lupuzor(TM) .
Simbec-Orion has agreed that it will reinvest
a significant proportion of its fees in new
ordinary shares at a fixed price of 150p per
share. It is expected that over the duration
of the study, Simbec-Orion will subscribe
for approximately 900,000 new ordinary shares.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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