Half Yearly Report

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  £50M 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 £5.18m (2013: £7.67m)

·      Loss for the period of £1.83m (2013:  £1.85m)

·      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:

ImmuPharma plc	+ 44 (0) 20 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 Relations	+ 44 (0) 7721 413496
Panmure, Gordon & Co., NOMAD & Broker	[phone]
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 £50 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 €1.72m 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 £50m 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 £5.18 million (£5.39 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 £1,818,412 (£1,852,929 for the six months ended 30 June 2013).  Research and development expenditure was £820,357 (£842,332 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 £998,055 (£1,010,597 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 €2.8 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 6 months ended 30 June 2014		Audited Year  ended 31 December 2013		Unaudited 6 months ended 30 June 2013
		£		£		£
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 6 months ended 30 June  2014		Audited Year  ended 31 December 2013		Unaudited 6 months ended 30 June  2013
	£		£		£
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 30 June 2014		Audited 31 December 2013		Unaudited 30 June 2013
		£		£		£
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

		Share capital		Share premium		Merger reserve		Other reserves - Acquisition reserve		Other reserves - Translation Reserve		Other reserves - Equity shares to be issued		Retained Earnings		Total equity
		£		£		£		£		£		£		£		£
	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 6 months ended 30 June 2014			Audited Year  ended 31 December 2013		Unaudited 6 months ended 30 June 2013
			£			£		£
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 of new equity capital			-			393,750		-
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 6 months ended 30 June 2014		Audited Year ended 31 December 2013		Unaudited 6 months ended 30 June 2013
	£		£		£
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 30 June 2014		Audited 31 December 2013		Unaudited 30 June 2013
						£		£		£
	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.

 

END

 

 

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