TIDMIMM
RNS Number : 9355S
Immupharma PLC
30 September 2014
30 SEPTEMBER 2014
ImmuPharma
INTERIM RESULTS ANNOUNCEMENT
for the six months ended 30 June 2014
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the
specialist drug discovery and development company, is pleased to
announce its interim results for the six months ended 30 June
2014.
Key Highlights:
-- Lupuzor(TM)
o Announced separately today - Phase III activities of lead
compound Lupuzor(TM) will soon commence: Following advanced
discussions and after completing detailed due diligence with a
potential partner, ImmuPharma has started the preparatory steps for
Lupuzor(TM) 's pivotal phase III clinical trials. Before these
initial activities are completed, it is expected that a further
agreement to develop Lupuzor(TM) will be finalised and signed which
will see ImmuPharma and the potential partner fund the phase III
trials. This agreement will also allow the partner to run the phase
III pivotal programme based on the strengthened study protocol
agreed between ImmuPharma and the FDA.
o Positive amendment to SPA for Lupuzor Phase III trial in
place
o GBP50M equity finance facility secured from Henderson Global's
subsidiary Darwin Strategic to assist with Phase III trial
funding
-- Scientific Advisory Board comprising worldwide key opinion
leaders in lupus in place to guide Phase III clinical
development
-- Nucant cancer programme IPP-204106
o Phase I/IIa clinical trial with the next generation
"polyplexed Nucant" formulation in three European hospitals
including the prestigious Institute Jules Bordet in Belgium has
recently been completed.
o Trial results and next steps to be announced in the near
future.
o Patents granted surrounding an "optically pure" version of the
Nucant family.
-- In collaboration with the CNRS, access to pioneering research
around novel peptide drugs through the University of Bordeaux and
the research team incubator, Institut Europeen de Chimie et
Biologie (IECB).
-- Key events:
o ImmuPharma were key sponsors and presenters at the 2014
European Lupus Conference in Athens
o Dr Sylviane Muller, the discoverer of Lupuzor(TM) , presented
at the Immunology Frontier Research Center at Osaka University in
Japan.
-- Continued strong cash position as at 30 June 2014 of GBP5.18m (2013: GBP7.67m)
-- Loss for the period of GBP1.83m (2013: GBP1.85m)
-- Basic and diluted loss per share of 2.23p (2013: 2.17p)
Commenting on outlook Dimitri Dimitriou, Chief Executive Officer
said:
"We are pleased with the progress we made on the advancement of
development of our lead compound Lupuzor(TM) towards Phase III
trials. With the updated SPA from the FDA, the appointment of a
world-class scientific advisory board and the financing facility
with Darwin Strategic, we remain very positive about LupuzorTM's
future. We are also excited by the continued progress of our cancer
and novel programs in Bordeaux and look forward to reporting
further developments in the coming months. "
For further information please contact:
+ 44 (0) 20 7152
ImmuPharma plc 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
Relations + 44 (0) 7721 413496
Panmure, Gordon & Co., NOMAD
& Broker +44 (0) 20 7886 2500
Hugh Morgan, Fred Walsh,
Duncan Monteith
ImmuPharma plc
Statement from the Chairman, President and Chief Executive
Officer
INTERIM HIGHLIGHTS
Summary
We are pleased to report our interim results for the six months
ended 30 June 2014. During this period, ImmuPharma has remained
focused on the progression of our lead drug candidate Lupuzor(TM) ,
a breakthrough treatment for the auto-immune disease lupus, our
Nucant cancer programme and the development of our peptide
technology platform. For Lupuzor(TM) , following advanced
discussions and after completing detailed due diligence with a
potential partner, we are delighted to begin the preparatory steps
for the pivotal Phase III clinical trials. Before these initial
activities are completed, it is expected that a further agreement
to develop Lupuzor(TM) will be finalised and signed which will see
ImmuPharma and the potential partner fund the phase III trials. The
agreement will allow the partner to run the Phase III programme
based on the strengthened study protocol agreed with the US Food
and Drug Administration in 2013. Separately, we were also pleased
with the establishment of a world class Lupus Scientific Advisory
Board and the third party validation from Darwin Strategic with
whom we have a GBP50 million equity finance facility in place.
Our anti-cancer nucleolin antagonist, 'Nucant' cancer programme
has recently completed its Phase I/IIa clinical trial in France and
Belgium, and we are awaiting the results before planning the next
steps with this program that has already demonstrated in our
previous Phase I/IIa study, some activity against several different
types of cancer. There are many different facets to our cancer
program that will feature in the planning of next steps. While safe
doses have been established for the stand alone use of these
compounds, we are investigating the possibility that the compounds
have promising potential as combination therapies . The Nucant's
ability to bind selectively to membrane nucleolin that is seen only
in proliferating cells has led us to develop a Nucant-based
selective targeting system to safely deliver cytotoxic drugs. In
addition, we have been granted new patents surrounding an
'optically pure' version of ImmuPharma's Nucant family which
broadens our usage into other indications. This new patent family
covers millions of peptide constructs and also expands the
potential uses to include angiogenesis related conditions such as
age-related macular degeneration, diabetic retinopathy and wound
healing as well as cancer selective targeting systems. To date, the
cancer program has been awarded grants totalling EUR1.72m by French
government organisations which are supporting its development
process.
ImmuPharma has also initiated the development of a novel and
innovative peptide technology platform through the collaboration
with our longstanding and successful research partner, Centre
Nationale de la Recherche Scientifique (CNRS), thereby gaining
access to pioneering research centred on novel peptide drugs at the
University of Bordeaux and the Institut Européen de Chimie et
Biologie (IECB). IECB is an international and interdisciplinary
research incubator, placed under the joint authority of the CNRS,
INSERM (Institut National de la Santé et de la Recherche Medicale)
and the University of Bordeaux. Through its network, IECB hosts 15
international and multi-disciplinary research teams including the
CNRS team of Dr Gilles Guichard, one of the scientific founders of
ImmuPharma and a leading researcher in peptides. Additionally,
ImmuPharma has established a significant research entity located
within the IECB campus comprising 3 PhDs from Dr Guichard's lab and
ETH Zurich as well as state-of-the-art equipment. The longstanding
collaboration with the CNRS under Dr Guichard and ImmuPharma has
resulted in the filing of a new co-owned patent controlling the
breakthrough peptide technology called 'Urelix', allowing the
mimicry of long, natural peptides particularly in the configuration
used to bind to their receptor, the improvement of their stability
against enzymatic degradation (breakdown of peptides into amino
acids) and greater efficacy. The first therapeutic area being
targeted is diabetes with glucagon-like peptide -1 agonists or
GLP-1 agonists, a class of drugs for the treatment of type 2
diabetes. According to Research and Markets (August, 2011), this
family represents a potential market of approximately $10 billion.
The potential of this technology is substantial and diverse and is
one of the key reasons ImmuPharma has established its own research
team working in close collaboration with Dr Guichard and his CNRS
team. These developments also involve our patented chemical library
of over 300,000 peptide-like small molecules.
ImmuPharma plc
Statement from the Chairman, President and Chief Executive
Officer (continued)
As part of ImmuPharma's continued efforts to position and raise
the profile of Lupuzor(TM) within the lupus scientific community,
two key events were attended by ImmuPharma in the first half of
2014. Dr Sylvianne Muller, discovering scientist of Lupuzor(TM) ,
was invited by the Immunology Frontier Research Center of Osaka
University, an internationally renowned research centre in the
field of immunology, to hold a seminar on the approach of
Lupuzor(TM) for treating lupus patients. ImmuPharma also sponsored
the European Lupus Conference which took place in Athens. The
"European Lupus Meetings" is a major forum for all people
interested in disease with approximately 800 physicians of various
disciplines, health professionals, regulatory agencies,
pharmaceutical industry and patient representatives. Dr Sylvianne
Muller also presented at this conference.
Development Pipeline
-- Lupuzor(TM)
Lupuzor(TM) also referred to as rigerimod or P140 is a potential
treatment for lupus (or Systemic Lupus Erythematosus), a chronic,
potentially life-threatening auto-immune disease, Lupuzor(TM) has a
novel mechanism of action aimed at modulating the body's immune
system so that it does not attack healthy cells, without causing
adverse side effects. It has the potential to halt the progression
of the disease in a substantial proportion of patients.
Lupuzor(TM) has been granted Fast Track status by the US FDA and
approved to start Phase III under Special Protocol Assessment
(SPA). This SPA was subsequently amended due to its strong safety
and efficacy profile to allow for a reduced number of patients in
the pivotal Phase III trial thereby reducing the projected cost of
development considerably. Following advanced discussions and after
completing detailed due diligence with a potential partner,
ImmuPharma is to begin preparations for the Phase III trial. The
GBP50m equity finance facility from Darwin Strategic allows
ImmuPharma further flexibility in structuring the further
development of Lupuzor(TM) .
-- IPP-204106, treatment for cancer
IPP-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 modulating
angiogenesis as well as proliferation. Preclinical data has shown
that nucleolin antagonists inhibit the growth of tumours and
metastasis in many cancer types. Results from the initial Phase
I/IIa trial in cancer patients demonstrated that it met its safety
endpoints and showed stabilisation of disease in 21% of patients.
The further Phase I/IIa clinical trial designed to assess safety of
increasing doses and to identify the optimal dose for treatment
that had been ongoing in France and Belgium has now been
completed.
-- Nucant family
ImmuPharma has been granted new patents surrounding an
"optically pure" version of ImmuPharma's Nucant family which
broadens its usage into other indications. This composition of
matter patent provides longer exclusivity, additional and
reinforced protection of ImmuPharma's Nucant programme and a
multitude of further indications in addition to cancer.
ImmuPharma plc
Statement from the Chairman, President and Chief Executive
Officer (continued)
-- Peptide technology platform collaboration
ImmuPharma have established a collaboration with the CNRS, the
University of Bordeaux and the IECB to develop the novel and
innovative peptide technology platform to explore the stabilisation
of natural peptides into new peptide-like structures that are able
to interact with proteins. Protein interrelations are important in
a large spectrum of diseases especially those involving G protein
coupled receptors (GPCRs).
Financial Review
ImmuPharma's cash balance remains strong at GBP5.18 million
(GBP5.39 million at 31 December 2013). Basic and diluted loss per
share were 2.23p and 2.23p respectively (31 December 2013: 4.52p
and 4.52p). In line with the Company's current policy, no interim
dividend is proposed.
ImmuPharma continues to emphasize prudent and controlled
expenditure. Operating loss for the period was GBP1,818,412
(GBP1,852,929 for the six months ended 30 June 2013). Research and
development expenditure was GBP820,357 (GBP842,332 for the six
months ended 30 June 2013) reflecting primarily the activities for
the development of IPP-204106, our anti-cancer compound.
Administrative expenses were GBP998,055 (GBP1,010,597 for the six
months ended 30 June 2013).
With the unfavourable US dollar to Euro exchange rate during the
period, ImmuPharma France SA took out a temporary, short-term loan
of EUR2.8 million to cover Euro-based expenditure instead of
converting US dollar-based funds. This loan has recently been
repaid. Property, plant and equipment increased during the period
reflecting the investment in the research lab in Bordeaux.
Given the stage of ImmuPharma's development, the fact that
losses have continued to be made is to be expected since there is
minimal revenue and business activity is concerned with clinical
trial expenditure, maintaining the infrastructure of the Group and,
importantly, seeking a license partner for Lupuzor(TM) .
Outlook
With a strong cash position and controlled expenditure, the
focus of the Group is on confirming a solid partnership for
Lupuzor(TM) and the development of our other pipeline
candidates.
Richard Warr, MA, Chairman
Dr Robert Zimmer, MD, PhD, President and Chief Scientific
Officer
Dimitri Dimitriou, MSc, Chief Executive Officer
29 September 2014
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 2014 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 4.
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 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 interim 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 2014 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 2014
ImmuPharma plc
CONSOLIDATED INCOME STATEMENT
FOR THE PERIOD ENDED 30 JUNE 2014
Note Unaudited Audited Unaudited
6 months Year 6 months
ended ended ended
30 June 31 December 30 June
2014 2013 2013
GBP GBP GBP
Continuing operations
Revenue - - -
Research and development
expenses (820,357) (2,072,906) (842,332)
Administrative expenses (998,055) (2,155,229) (1,010,597)
Operating loss (1,818,412) (4,228,135) (1,852,929)
Finance costs (24,908) (266,121) (117,956)
Finance income 10,807 60,366 136,800
Loss before taxation (1,832,513) (4,433,890) (1,834,085)
Tax (962) 744,544 64,134
Loss for the period (1,833,475) (3,689,346) (1,769,951)
Attributable to:
Equity holders of
the parent company (1,833,475) (3,689,346) (1,769,951)
Loss per ordinary
share
Basic 2 (2.23)p (4.52)p (2.17)p
Diluted 2 (2.23)p (4.52)p (2.17)p
ImmuPharma plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE PERIOD ENDED 30 JUNE 2014
Unaudited Audited Unaudited
6 months Year 6 months
ended ended ended
30 June 31 December 30 June
2014 2013 2013
GBP GBP GBP
Loss for the financial
period (1,833,475) (3,689,346) (1,769,951)
Other comprehensive
income
Items that may be reclassified
subsequently to profit
or loss:
Exchange differences
on translation of foreign
operations (139,427) 154,725 337,464
Total items that may
be reclassified subsequently
to profit or loss (139,427) 154,725 337,464
Other comprehensive
income for the period (139,427) 154,725 337,464
Total comprehensive
income for the period (1,972,902) (3,534,621) (1,432,487)
ImmuPharma plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 JUNE 2014
Unaudited Audited Unaudited
30 June 31 December 30 June
2014 2013 2013
GBP GBP GBP
Non-current assets
Intangible assets 582,706 602,070 622,749
Property, plant and
equipment 374,286 97,149 110,392
Total non-current
assets 956,992 699,219 733,141
Current assets
Trade and other receivables 941,199 1,109,737 203,651
Cash and cash equivalents 5,184,713 5,396,296 7,669,029
Total current assets 6,125,912 6,506,033 7,872,680
Current liabilities
Financial liabilities
- borrowings 2,620,021 346,935 239,053
Trade and other payables 414,689 628,372 256,406
Provisions 30,371 56,600 -
Total current liabilities 3,065,081 1,031,907 495,459
Net current assets 3,060,831 5,474,126 7,377,221
Non-current liabilities
Financial liabilities
- borrowings 582,559 769,601 1,002,656
Net assets 3,435,264 5,403,744 7,107,706
EQUITY
Ordinary shares 8,228,246 8,228,246 8,153,246
Share premium 7,764,720 7,764,720 7,445,970
Merger reserve 106,148 106,148 106,148
Other reserves (3,595,118) (3,460,113) (3,222,846)
Retained earnings (9,068,732) (7,235,257) (5,374,812)
Total equity 3,435,264 5,403,744 7,107,706
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE PERIOD ENDED 30 JUNE 2014
Other
reserves
Other -
Other reserves Equity
reserves - - shares
Share Share Merger Acquisition Translation to be Retained Total
capital premium reserve reserve Reserve issued Earnings 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
period - - - - - - (1,769,951) (1,769,951)
Exchange
differences
on
translation
of foreign
operations - - - - 337,464 - - 337,464
Share based
payments - - - - - 122,322 - 122,322
At 30 June
2013 8,153,246 7,445,970 106,148 (3,541,203) (1,396,276) 1,714,633 (5,374,812) 7,107,706
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
period - - - - - - (1,833,475) (1,833,475)
Exchange
differences
on
translation
of foreign
operations - - - - (139,427) - - (139,427)
Share based
payments - - - - - 4,422 - 4,422
At 30 June
2014 8,228,246 7,764,720 106,148 (3,541,203) (1,718,442) 1,664,527 (9,068,732) 3,435,264
Attributable
to:-
Equity
holders
of the
parent
company 8,228,246 7,764,720 106,148 (3,541,203) (1,718,442) 1,664,527 (9,068,732) 3,435,264
ImmuPharma plc
CONSOLIDATED STATEMENT OF CASHFLOWS
FOR THE PERIOD ENDED 30 JUNE 2014
Notes Unaudited Audited Unaudited
6 months Year 6 months
ended ended ended
30 June 31 December 30 June
2014 2013 2013
GBP GBP GBP
Cash flows from
operating activities
Cash used in operations 3 (1,867,038) (4,211,836) (1,812,601)
Tax - 298,024 302,373
Interest paid (15,837) (55) (56)
Net cash used in
operating activities (1,882,875) (3,913,867) (1,510,284)
Investing activities
Purchase of intangible
assets (6,463) - -
Purchase of property,
plant and equipment (333,622) (3,054) (1,337)
Finance income 10,623 60,366 11,491
Net cash (used in)/generated
from investing activities (329,462) 57,312 10,154
Financing activities
Decrease in bank overdraft (466) (25,041) (25,861)
New loans 2,243,590 - -
Loan repayments (54,450) (177,220) (90,208)
Net proceeds from issue - 393,750 -
of new equity capital
Net cash (used in)/generated
from financing activities 2,188,674 191,489 (116,069)
Net decrease in cash
and cash equivalents (23,663) (3,665,066) (1,616,199)
Cash and cash equivalents
at start of period 5,396,296 8,893,267 8,893,267
Effects of exchange
rates on cash and
cash equivalents (187,920) 168,095 391,961
Cash and cash equivalents
at end of period 5,184,713 5,396,296 7,669,029
ImmuPharma plc
NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE
2014
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 2014.
The accounting policies applied are consistent with those that
were applied to the financial statements for the year ending 31
December 2013.
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 set out in this interim report does
not constitute the Group's statutory accounts. The statutory
accounts for the year ended 31 December 2013 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 2014 and 30 June 2013 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
2014
(continued)
2 LOSS PER SHARE
Unaudited Audited Unaudited
6 months Year 6 months
ended ended ended
30 June 31 December 30 June
2014 2013 2013
GBP GBP GBP
Loss
Loss for the purposes
of basic and diluted
loss per share being
net loss attributable
to equity shareholders (1,833,475) (3,689,346) (1,769,951)
Number of shares
Weighted average number
of ordinary shares for
the purposes of basic
loss per share 82,282,463 81,663,119 81,532,463
Basic loss per share (2.23)p (4.52)p (2.17)p
Diluted loss per share (2.23)p (4.52)p (2.17)p
Share options and warrants have not been included in the
calculation of diluted loss per share as they are
anti-dilutive.
ImmuPharma plc
NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE
2014
(continued)
3 CASH USED IN OPERATIONS
Unaudited Audited Unaudited
30 June 31 December 30 June
2014 2013 2013
GBP GBP GBP
Operating loss (1,818,412) (4,228,135) (1,852,929)
Depreciation & amortisation 46,857 55,914 27,319
Share-based payments 4,422 8,844 4,422
Decrease in trade &
other receivables 129,345 232,576 452,874
Decrease in trade &
other payables (194,363) (159,098) (537,824)
Decrease in provisions (26,229) 26,229 (30,371)
Gain/(loss) on
foreign exchange (8,658) (148,166) 123,908
Cash used in
operations (1,867,038) (4,211,836) (1,812,601)
4 SUBSEQUENT EVENTS
There have been no subsequent events since
30 June 2014 which would have a material effect
on these Interim Results.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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