TIDMIMM
RNS Number : 0547P
Immupharma PLC
27 September 2013
27 SEPTEMBER 2013
ImmuPharma PLC
INTERIM RESULTS ANNOUNCEMENT
for the six months ended 30 June 2013
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
2013.
Key Highlights:
-- Lupuzor(TM)
o FDA grants positive amendment to SPA for Lupuzor Phase III
trial
o The Centre National de la Recherche Scientifique (CNRS),
Europe's largest fundamental research institution, re-affirms the
effectiveness of Lupuzor(TM) (peptide P140)
o GBP50M equity finance facility secured from Henderson Global's
subsidiary Darwin Strategic to assist with Phase III trial
funding
o Recent appointment of Torreya Partners, a leading boutique
advisory firm with offices in New York and London that provides
strategic advice and assistance on M&A and licensing in the
sector, to advise on our corporate deal discussions for Lupuzor(TM)
.
-- Appointment of worldwide key opinion leaders to Lupuzor "Scientific Advisory Board"
-- Nucant cancer programme IPP-204106
o Phase I/IIa clinical trial continues with the next generation
"polyplexed Nucant" formulation in three European hospitals
including the prestigious Institute Jules Bordet in Belgium
o The trial is progressing according to protocol and its
objective is to identify the optimal dose for treating patients
before a Phase II efficacy trial
-- Continued strong cash position as at 30 June 2013 of GBP7.7m (2012: GBP10.1m)
-- Loss for the period of GBP1.8m (2012: GBP1.8m)
-- Basic and diluted loss per share of 2.17p (2012: 2.17p)
Commenting on outlook Dimitri Dimitriou, Chief Executive Officer
said:
"We are delighted and excited with the progress we made on the
advancement of development of our lead compound Lupuzor(TM) towards
Phase III trials, specifically the updated SPA from the FDA, the
appointment of a world-class scientific advisory board as well as
the financing facility with Darwin Strategic. We look forward to
working with Torreya Partners as we continue our discussions for a
deal on Lupuzor(TM)."
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,
Hannah Woodley
ImmuPharma plc
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 2013. During the first six months of 2013, ImmuPharma
has been focused on securing support for the further development of
Lupuzor(TM) , our lead compound for the treatment of lupus. This
has involved numerous, ongoing discussions with potential partners.
Furthermore, ImmuPharma is pleased to report that an updated
Special Protocol Assessment has been secured with the US Food and
Drug Administration (FDA) allowing a reduced number of patients in
the pivotal Phase III trial. This importantly means that the cost
of the Phase III programme for Lupuzor(TM) should be notably
reduced. In addition, ImmuPharma has been successful in securing a
GBP50m equity finance facility from Darwin Strategic Limited, that
could be utilized for the completion of the Phase III programme for
Lupuzor(TM) while continuing discussions with major pharmaceutical
companies for a potential corporate deal which are now being
supported by the engagement of Torreya Partners, one of the most
specialised advisory boutiques in the life sciences M&A field.
ImmuPharma has also been delighted to confirm the appointment of 5
key opinion leaders to our Scientific Advisory Board for the Phase
III programme for Lupuzor(TM) . Separately, ImmuPharma's cancer
programme continues to progress in its clinical trial in Belgium
and France.
Our next priority program is IPP-204106 for the treatment of
cancer. The clinical trial of the next generation formulation of
this nucant is ongoing in Belgium and France. The cancer programme
has been awarded grants totalling EUR1.72m by French government
organisations which are supporting its development process. We are
further investigating the role of the nucant family of peptides in
the control of angiogenesis where we have demonstrated its critical
role in restoring 'normal' vascularisation in pathological cases.
This paves the way for the development of these peptides in the
treatment of diabetic retinopathy and age-related macular
degeneration. We have also further developed novel and patented
technologies to stabilise natural peptides thereby allowing the
creation of new peptide-like structures that are able to interact
with protein. Protein interrelations are important in a large
spectrum of diseases especially those involving G protein coupled
receptors (GPCRs). These developments also involve our patented
chemical library of over 300,000 peptide-like small molecules.
Development Pipeline
-- Lupuzor(TM)
Lupuzor(TM) has been granted Fast Track status by the US FDA and
approved to start Phase III under Special Protocol Assessment.
ImmuPharma has been in discussions with a number of possible
partner companies to progress Lupuzor(TM) 's development and
commercialisation. The recently obtained GBP50m equity finance
facility from Darwin Strategic allows ImmuPharma further
flexibility in structuring the further development of Lupuzor(TM)
.
-- 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. Results from the initial trial in
cancer patients demonstrated that it met its safety endpoints and
showed stabilisation of disease in 21% of patients. During 2013,
ImmuPharma has been conducting a further clinical trial of the next
generation nucant formulation. This trial is currently ongoing
according to protocol with the objective of identifying the optimal
dose for treating patients before progressing to a Phase II
efficacy trial.
ImmuPharma plc
Statement from the Chairman and the Chief Executive Officer
Financial Review
ImmuPharma's cash balance remains strong at GBP7.67 million
(GBP8.89 million at 31 December 2012). Basic and diluted loss per
share were 2.17p and 2.17p respectively (31 December 2012: 4.71p
and 4.71p). 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 GBP1,852,929
(GBP1,968,657 for the six months ended 30 June 2012). Research and
development expenditure was GBP842,332 (GBP806,141 for the six
months ended 30 June 2012) reflecting primarily the activities for
the development of IPP-204106, our anti-cancer compound.
Administrative expenses were GBP1,010,597 (GBP1,162,516 for the six
months ended 30 June 2012). Included in finance costs is GBP117,900
expense for the 1,500,000 warrants issued to Darwin Strategic
Limited as part of the GBP50m equity finance facility agreed in
May. The value of the warrants has been derived by using a Black
Scholes pricing model with the full valuation amount being
recognised as expense in the current period.Finance income for the
period was GBP136,800 which is attributable to favourable foreign
exchange movements during the period.
Given the stage of ImmuPharma's development, the fact that
losses have continued to be made is in line with the sector, since
there is minimal revenue and business activities are concerned with
clinical trial expenditure, maintaining the infrastructure of the
Group and seeking a corporate deal on 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,
in particular our promising cancer compound, IPP-204106.
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
26 September 2013
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 2013 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.
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