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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Immupharma Plc | LSE:IMM | London | Ordinary Share | GB0033711010 | ORD 1P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| -0.02 | -0.93% | 2.14 | 2.10 | 2.18 | 2.19 | 2.11 | 2.11 | 1,367,460 | 16:35:10 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| Finance Services | 0 | -3.81M | -0.0114 | -1.92 | 7.3M |
TIDMIMM
RNS Number : 6268A
Immupharma PLC
30 September 2015
FOR IMMEDIATE RELEASE 30 SEPTEMBER 2015
INTERIM RESULTS ANNOUNCEMENT
for the six months ended 30 June 2015
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 2015 (the "Period").
Although we are pleased to report our interim results, we are saddened by the passing of our Chairman, Richard Warr, in late July.
Key Highlights (including post-Period):
-- Lupuzor(TM)
o Phase III pivotal trial has started with development partner Simbec-Orion
o Registration live with the US National Institute of Health with progress trackable on ClinicalTrials.gov website
o A new patent has been filed (co-owned with CNRS) to cover other autoimmune indications - some of which have the potential for Orphan Drug designation
-- Nucant program IPP-204106
o The Phase I/IIa results confirmed that ImmuPharma, from a regulatory perspective, can commence Phase II studies in pancreatic cancer and other indications using an authorised dose
o Nucant program has shown modulation of angiogenesis with multiple indications in addition to cancer
o Grant funded preclinical study of ophthalmological indication of age-related macular degeneration underway
o Composition of matter patent provides longer exclusivity, additional protection of the Nucant program and a multitude of other indications in addition to cancer.
-- Peptide Technology Collaboration Platform
o In collaboration with CNRS, Institut National de la Santé et de la Recherche Medicale (INSERM) and the Institut Européen de Chimie et Biologie (IECB) at the University of Bordeaux, ImmuPharma filed a new patent controlling a breakthrough peptide technology called Urelix(TM)
o Allows the mimicry of long natural peptides in the configuration used to bind their receptor
-- Further notable events:
o Appointment of Tim McCarthy as Non-Executive Chairman (see separate announcement)
o Dr Stephane Mery was appointed as Non-Executive Director
o Dr Sylviane Muller, inventor of Lupuzor(TM) , awarded Centre National de la Recherche Scientifique (CNRS) Medal of Innovation for work on both Lupuzor(TM) 's mechanism of action and its applicability to other autoimmune indications
o ImmuPharma was awarded the New Economy Award for Most Innovative Drug Licensing and Development Company
-- Financials
o Cash position as at 30 June 2015 of GBP3.29m (H1 2014: GBP5.18m)
o Term sheet signed for a proposed financing of up to $14 million - final agreement under negotiation.
o Loss for the Period of GBP1.54m (H1 2014: GBP1.83m)
o Basic and diluted loss per share of 1.74p (H1 2014: 2.23p)
Commenting on the highlights, Dimitri Dimitriou, Chief Executive Officer said:
"2015 has been a year of many changes for the Company. We entered into a collaboration with a prestigious development organisation, Simbec-Orion and started the pivotal Phase III trial for Lupuzor(TM) . We strengthened the Board and our team of advisors. Of important significance we were honoured by the award of a prestigious medal to the inventor of Lupuzor(TM) , with the discovery of new molecules and new potential indications for Lupuzor(TM) . Finally, we sadly lost our Chairman and good friend, Richard Warr."
For further information please contact:
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ImmuPharma plc 4080
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Dr Robert Zimmer, President
and Chief Scientific Officer
Tracy Weimar, Vice President,
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ImmuPharma plc
Statement from the Interim Chairman, the President and the Chief Executive Officer
INTERIM HIGHLIGHTS
Summary
Although we are pleased to highlight our interim results for the six months ended 30 June 2015, we are saddened by the passing of our Chairman, Richard Warr. Richard was one of the three co-founding executive directors of ImmuPharma. In the short term, our senior non-executive director, Franco di Muzio, has been acting as Interim Chairman. In a separate announcement issued today, Tim McCarthy, an experienced healthcare director, has been appointed Non-Executive Chairman with immediate effect. We have further strengthened the Board by the appointment of Dr Stephane Mery, an experienced scientist, investor and industry executive, as a Non-Executive Director.
During 2015, we have made exciting progress on all of our key programs. We have begun the pivotal Phase III trial for Lupuzor(TM) (P140), a breakthrough treatment for the auto-immune disease lupus, with our development partner, Simbec-Orion. Our Nucant program, IPP-204106, is progressing with combination therapy approaches and grant-funded ophthalmological indications. We announced in February that the Phase I/IIa dose-finding adaptive study where the Nucant was associated with chondroitin sulphate demonstrate that the maximum tolerated dose was 9 mg/kg. This was the primary objective of the study. These Phase I/IIa results now allow ImmuPharma, from a regulatory perspective, to commence a Phase II study. Separately, our peptide technology collaboration at the University of Bordeaux is now well established and moving forward.
We were honoured to see our collaborator, Dr Sylviane Muller, the key inventor of Lupuzor(TM) and Research Director at the Centre National de la Recherche Scientifique (CNRS), receive 'The CNRS Medal of Innovation' for her discoveries made on the mechanism of action of Lupuzor(TM) and its applications to other autoimmune diseases. In addition, ImmuPharma was delighted to have been awarded the New Economy Award for Most Innovative Drug Licensing and Development Company.
Development Pipeline Highlights
-- Lupuzor(TM)
Lupuzor(TM) also referred to as IPP-201101 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 immune system and has the potential to halt the progression of the disease in a substantial proportion of patients. A certain number of patients suffering from other autoimmune diseases may, according to preclinical data generated by the group of Sylviane Muller (CNRS), benefit from P140. A Phase II/III study for an orphan indication is expected to be filed this year and may benefit from US and/or French funding or loans.
Lupuzor(TM) has been granted Fast Track status by the US FDA and approval to start a pivotal Phase III trial 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 Phase III trial thereby reducing the projected cost of development considerably.
Together with our development partner, Simbec-Orion, this pivotal Phase III trial has begun and is due to recruit patients. The trial's progress can be tracked on 'Clinicaltrials.gov' and is entitled: 'A 52 week, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200 mcg Dose of IPP-201101 Plus Standard of Care in Patients with Systemic Lupus Erythematosus'.
ImmuPharma plc
Statement from the Interim Chairman, the President and the Chief Executive Officer (continued)
-- IPP-204106, Nucant program
IPP-204106 is ImmuPharma's lead compound for cancer and other indications. The rights for this compound have been obtained through the Group's ongoing research collaboration with the Centre National de la Recherche Scientifique (CNRS). The molecule is a nucleolin antagonist and has a promising and novel mechanism of action, acting on 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 been completed.
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 composition of matter patents surrounding an 'optically pure' version of ImmuPharma's Nucant family which broadens our usage into other indications in addition to cancer. 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.
ImmuPharma has been awarded a grant to investigate the Nucant program's applicability to this ophthalmological indication and progress is underway.
-- Peptide technology platform collaboration
(MORE TO FOLLOW) Dow Jones Newswires
September 30, 2015 02:01 ET (06:01 GMT)
ImmuPharma has also initiated the development of a novel and innovative peptide technology platform through the collaboration with our longstanding and successful research partner, 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 codenamed 'Urelix', allowing the mimicry of long, natural peptides particularly in the configuration used to bind to their receptor, the potential improvement of their stability against enzymatic degradation (breakdown of peptides into amino acids) and greater efficacy.
ImmuPharma plc
Statement from the Interim Chairman, the President and the Chief Executive Officer (continued)
-- Peptide technology platform collaboration (continued)
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 and is initiating the development of novel peptides as glugacon antagonists, one of the novel approaches to treat Type I and Type II 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's subsidiary, Ureka sarl, was awarded a grant of approximately EUR400,000 to support this work.
Financial Review
ImmuPharma's cash balance at 30 June 2015 was GBP3.29 million (GBP5.42 million at 31 December 2014). Basic and diluted loss per share were 1.74p and 1.74p respectively (31 December 2014: 3.43p and 3.43p). In line with the Company's current policy, no interim dividend is proposed.
ImmuPharma continues to emphasise prudent and controlled expenditure. Operating loss for the Period was GBP1,537,274 (GBP1,818,412 for the six months ended 30 June 2014). Research and development expenditure in the Period was GBP494,567 (GBP820,357 for the six months ended 30 June 2014) reflecting primarily the activities for the development of the Urelix(TM) peptide technology collaboration and the Nucant program. Administrative expenses were GBP1,056,266 during the Period (GBP998,055 for the six months ended 30 June 2014).
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 and maintaining the infrastructure of the Group.
Current Activities & Outlook
We have concentrated our efforts over the last period of progressing Lupuzor(TM) through the initial regulatory and feasibility stages of the Pivotal Phase III process to the point where we are now starting to recruit patients within Europe and USA.
ImmuPharma in conjunction with the CNRS are also working hard on progressing the P140 auto immune pipeline, based on Lupuzor(TM) 's strong efficacy and safety profile and illustrated by its mechanism of action as lauded by the inventor Dr Sylviane Muller. We hope to be able to share further data on preclinical studies of other indications of P140 later this year together with plans for progressing a number of indications into clinical studies.
ImmuPharma plc
Statement from the Interim Chairman, President and Chief Executive Officer (continued)
Current Activities & Outlook (continued)
In summary, the focus of the Group is on ensuring the smooth progress of the late stage clinical development of Lupuzor(TM) , exploring other opportunities around Lupuzor(TM) 's mechanism of action and its applicability to other autoimmune conditions with Orphan Drug Status together with progressing ImmuPharma's other pipeline candidates.
We look forward to providing further progress updates over the next period.
Dr Franco di Muzio, Interim Chairman and Senior Non-Executive Director
Dr Robert Zimmer, MD, PhD, President and Chief Scientific Officer
Dimitri Dimitriou, MSc, Chief Executive Officer
29 September 2015
Independent Review Report to ImmuPharma plc
Introduction
We have been engaged by ImmuPharma plc ("the Company") to review the condensed set of consolidated financial statements in the interim report for the six months ended 30 June 2015 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 2015 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 2015
ImmuPharma plc
CONSOLIDATED INCOME STATEMENT
FOR THE PERIOD ENDED 30 JUNE 2015
Note Unaudited Audited Unaudited
6 months Year 6 months
ended ended ended
30 June 31 December 30 June
2015 2014 2014
GBP GBP GBP
Continuing operations
Revenue 13,559 184,815 -
Research and development
expenses (494,567) (1,457,298) (820,357)
Administrative expenses (1,056,266) (2,152,417) (998,055)
Operating loss (1,537,274) (3,424,900) (1,818,412)
Finance costs (7,172) (14,195) (24,908)
Finance income 3,179 98,936 10,807
Loss before taxation (1,541,267) (3,340,159) (1,832,513)
(MORE TO FOLLOW) Dow Jones Newswires
September 30, 2015 02:01 ET (06:01 GMT)
Tax - 468,679 (962) Loss for the period (1,541,267) (2,871,480) (1,833,475) Attributable to: Equity holders of the parent company (1,541,267) (2,871,480) (1,833,475) Loss per ordinary share Basic 2 (1.74)p (3.43)p (2.23)p Diluted 2 (1.74)p (3.43)p (2.23)p
ImmuPharma plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE PERIOD ENDED 30 JUNE 2015
Unaudited Audited Unaudited
6 months Year 6 months
ended ended ended
30 June 31 December 30 June
2015 2014 2014
GBP GBP GBP
Loss for the financial
period (1,541,267) (2,871,480) (1,833,475)
Other comprehensive
income
Items that may be reclassified
subsequently to profit
or loss:
Exchange differences
on translation of foreign
operations (180,262) (230,357) (139,427)
Total items that may
be reclassified subsequently
to profit or loss (180,262) (230,357) (139,427)
Other comprehensive
loss for the period (180,262) (230,357) (139,427)
Total comprehensive
loss for the period (1,721,529) (3,101,837) (1,972,902)
ImmuPharma plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 JUNE 2015
Unaudited Audited Unaudited
30 June 31 December 30 June
2015 2014 2014
GBP GBP GBP
Non-current assets
Intangible assets 530,354 560,537 582,706
Property, plant and
equipment 304,590 366,363 374,286
Total non-current
assets 834,944 926,900 956,992
Current assets
Trade and other receivables 720,547 721,410 941,199
Cash and cash equivalents 3,294,819 5,424,033 5,184,713
Total current assets 4,015,366 6,145,443 6,125,912
Current liabilities
Financial liabilities
- borrowings 295,634 417,852 2,461,928
Trade and other payables 243,464 549,652 414,689
Provisions 9,663 23,468 30,371
Total current liabilities 548,761 990,972 2,906,988
Net current assets 3,466,605 5,154,471 3,218,924
Non-current liabilities
Financial liabilities
- borrowings 317,696 375,989 740,652
Net assets 3,983,853 5,705,382 3,435,264
EQUITY
Ordinary shares 8,862,246 8,862,246 8,228,246
Share premium 10,490,920 10,490,920 7,764,720
Merger reserve 106,148 106,148 106,148
Other reserves (3,827,457) (3,647,195) (3,595,118)
Retained earnings (11,648,004) (10,106,737) (9,068,732)
Total equity 3,983,853 5,705,382 3,435,264
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE PERIOD ENDED 30 JUNE 2015
Other Other Other
Merger reserves - reserves reserves Retained
reserve Acquisition - - Earnings
reserve Translation Equity
Reserve shares
Share Share to be Total
capital premium issued equity
GBP GBP GBP GBP GBP GBP GBP GBP
At 1 January
2014 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
At 1 January
2014 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 & 1
January
2015 8,862,246 10,490,920 106,148 (3,541,203) (1,809,372) 1,703,380 (10,106,737) 5,705,382
Loss for the
financial
period - - - - - - (1,541,267) (1,541,267)
Exchange
differences
on
translation
of foreign
operations - - - - (180,262) - - (180,262)
At 30 June
2015 8,862,246 10,490,920 106,148 (3,541,203) (1,989,634) 1,703,380 (11,648,004) 3,983,853
Attributable
to:-
Equity
holders
of the
parent
company 8,862,246 10,490,920 106,148 (3,541,203) (1,989,634) 1,703,380 (11,648,004) 3,983,853
ImmuPharma plc
CONSOLIDATED STATEMENT OF CASHFLOWS
FOR THE PERIOD ENDED 30 JUNE 2015
Notes Unaudited Audited Unaudited
6 months Year 6 months
ended ended ended
30 June 31 December 30 June
2015 2014 2014
GBP GBP GBP
Cash flows from
operating activities
Cash used in operations 3 (2,329,728) (3,231,366) (1,867,038)
Tax 521,147 754,996 -
Interest paid (189) (14,195) (15,837)
Net cash used in
operating activities (1,808,770) (2,490,565) (1,882,875)
Investing activities
Purchase of intangible
assets - (5,656) (6,463)
Purchase of property,
plant and equipment (12,838) (342,275) (333,622)
Interest received 3,179 72,759 10,623
Net cash used in
investing activities (9,659) (275,172) (329,462)
Financing activities
Decrease in bank overdraft (327) (146) (466)
New loans 21,180 - 2,243,590
Loan repayments (273,016) (395,326) (54,450)
Net proceeds from issue - -
of new equity capital 3,360,200
Net cash (used in)/generated
from financing activities (252,163) 2,964,728 2,188,674
Net (decrease)/increase
in cash and cash equivalents (2,070,592) 198,991 (23,663)
Cash and cash equivalents
at start of period 5,424,033 5,396,296 5,396,296
Effects of exchange
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