Half Yearly Report

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  £50M 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 £7.7m (2012: £10.1m)

·      Loss for the period of £1.8m (2012:  £1.8m)

·      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™."

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, 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 £50m 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 €1.72m 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 £50m 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 £7.67 million (£8.89 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 £1,852,929 (£1,968,657 for the six months ended 30 June 2012).  Research and development expenditure was £842,332 (£806,141 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 £1,010,597 (£1,162,516 for the six months ended 30 June 2012).  Included in finance costs is £117,900 expense for the 1,500,000 warrants issued to Darwin Strategic Limited as part of the £50m 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 £136,800 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.

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 the 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 2013 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                                                                                                                    26 September 2013

ImmuPharma plc

CONSOLIDATED INCOME STATEMENT

FOR THE PERIOD ENDED 30 JUNE 2013

	Note	Unaudited 6 months ended 30 June 2013		Audited Year  ended 31 December 2012		Unaudited 6 months ended 30 June 2012
		£		£		£
Continuing operations
Revenue		-		-		-
Research and development expenses		(842,332)		(1,620,331)		(806,141)
Administrative expenses		(1,010,597)		(2,554,722)		(1,162,516)
Operating loss		(1,852,929)		(4,175,053)		(1,968,657)
Finance costs		(117,956)		(80,752)		(652)
Finance income		136,800		87,552		200,985
Loss before taxation		(1,834,085)		(4,168,253)		(1,768,324)
Tax		64,134		324,219		(560)
Loss for the period		(1,769,951)		(3,844,034)		(1,768,884)
Attributable to:
Equity holders of the parent company		(1,769,951)		(3,844,034)		(1,768,884)
Loss per ordinary share
Basic	2	(2.17)p		(4.71)p		(2.17)p

Diluted	2	(2.17)p		(4.71)p		(2.17)p

ImmuPharma plc

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE PERIOD ENDED 30 JUNE 2013

	Unaudited 6 months ended 30 June  2013		Audited Year  ended 31 December 2012		Unaudited 6 months ended 30 June  2012
	£		£		£
Loss for the financial period	(1,769,951)		(3,844,034)		(1,768,884)
Other comprehensive income
Items that may be reclassified subsequently to profit or loss:
Exchange differences on translation of foreign operations	337,464		(311,193)		(340,113)
Total items that may be reclassified subsequently to profit or loss	337,464		(311,193)		(340,113)
Other comprehensive income for the period	337,464		(311,193)		(340,113)
Total comprehensive income for the period	(1,432,487)		(4,155,227)		(2,108,997)

ImmuPharma plc

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2013

		Unaudited 30 June 2013		Audited 31 December 2012		Unaudited 30 June 2012
		£		£		£
Non-current assets
Intangible assets		622,749		627,677		641,397
Property, plant and equipment		110,392		114,834		121,844
Total non-current assets		733,141		742,511		763,241
Current assets
Trade and other receivables		203,651		873,620		751,207
Cash and cash equivalents		7,669,029		8,893,267		10,131,441
Total current assets		7,872,680		9,766,877		10,882,648
Current liabilities
Financial liabilities - borrowings		239,053		249,951		131,767
Trade and other payables		256,406		773,002		304,935
Provisions		-		30,371		22,088
Total current liabilities		495,459		1,053,324		458,790
Net current assets		7,377,221		8,713,563		10,423,858
Non-current liabilities
Financial liabilities - borrowings		1,002,656		1,038,203		756,534
Net assets		7,107,706		8,417,871		10,430,565
EQUITY
Ordinary shares		8,153,246		8,153,246		8,153,246
Share premium		7,445,970		7,445,970		7,445,970
Merger reserve		106,148		106,148		106,148
Other reserves		(3,222,846)		(3,682,632)		(3,745,088)
Retained earnings		(5,374,812)		(3,604,861)		(1,529,711)
Total equity		7,107,706		8,417,871		10,430,565

ImmuPharma plc

 

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE PERIOD ENDED 30 JUNE 2013

		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 2012	8,153,246		7,445,970		106,148		(3,541,203)		(1,422,547)		1,525,239		239,173		12,506,026
	Loss for the financial period	-		-		-		-		-		-		(1,768,884)		(1,768,884)
	Exchange differences on translation of foreign operations	-		-		-		-		(340,113)		-		-		(340,113)
	Share based payments	-		-		-		-		-		33,536		-		33,536
	At 30 June 2012	8,153,246		7,445,970		106,148		(3,541,203)		(1,762,660)		1,558,775		(1,529,711)		10,430,565
	At 1 January 2012	8,153,246		7,445,970		106,148		(3,541,203)		(1,422,547)		1,525,239		239,173		12,506,026
	Loss for the financial year	-		-		-		-		-		-		(3,844,034)		(3,844,034)
	Exchange differences on translation of foreign operations	-		-		-		-		(311,193)		-		-		(311,193)
	Share based payments	-		-		-		-		-		67,072		-		67,072
	At 31 December 2012	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
	Attributable to:-
	Equity holders of the parent company	8,153,246		7,445,970		106,148		(3,541,203)		(1,396,276)		1,714,633		(5,374,812)		7,107,706

ImmuPharma plc

CONSOLIDATED STATEMENT OF CASHFLOWS

FOR THE PERIOD ENDED 30 JUNE 2013

	Notes		Unaudited 6 months ended 30 June 2013			Audited Year  ended 31 December 2012		Unaudited 6 months ended 30 June 2012
			£			£		£
Cash flows from operating activities
Cash used in operations	3		(1,812,601)			(3,448,910)		(1,744,981)
Tax			302,373			196,197		-
Interest paid			(56)			(4,425)		(652)
Net cash used in operating activities			(1,510,284)			(3,257,138)		(1,745,633)
Investing activities
Purchase of property, plant and equipment			(1,337)			(12,632)		(11,405)
Finance income			11,491			87,552		1,726
Net cash generated from/(used in) investing activities			10,154			74,920		(9,679)
Financing activities
(Decrease)/increase in bank overdraft			(25,861)			21,741		(3,195)
New loans			-			475,020		-
Loan repayments			(90,208)			(139,892)		(48,533)
Net cash (used in)/generated from financing activities			(116,069)			356,869		(51,728)
Net decrease in cash and cash equivalents			(1,616,199)			(2,825,349)		(1,807,040)
Cash and cash equivalents at start of period			8,893,267			12,164,784		12,164,784
Effects of exchange rates on cash and cash equivalents			391,961		(446,168)			(226,303)
Cash and cash equivalents at end of period			7,669,029			8,893,267		10,131,441

ImmuPharma plc

 

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2013

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 2013.

The accounting policies applied are consistent with those that were applied to the financial statements for the year ending 31 December 2012.

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 2012 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 2013 and 30 June 2012 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 2013

(continued)

2              LOSS PER SHARE

	Unaudited 6 months ended 30 June 2013		Audited Year ended 31 December 2012		Unaudited 6 months ended 30 June 2012
	£		£		£
Loss
Loss for the purposes of basic and diluted loss per share being net loss attributable to equity shareholders	(1,769,951)		(3,844,034)		(1,768,884)
Number of shares
Weighted average number of ordinary shares for the purposes of basic loss per share	81,532,463		81,532,463		81,532,463
Basic loss per share	(2.17)p		(4.71)p		(2.17)p
Diluted loss per share	(2.17)p		(4.71)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 2013

(continued)

3		CASH USED IN OPERATIONS
						Unaudited 30 June 2013		Audited 31 December 2012		Unaudited 30 June 2012
						£		£		£
	Operating loss					(1,852,929)		(4,175,053)		(1,968,657)
	Depreciation & amortisation					27,319		50,923		27,142
	Share-based payments					4,422		67,072		33,536
	Decrease in trade & other receivables					452,874		785,805		642,556
	Decrease in trade & other payables					(537,824)		(16,963)		(586,015)
	Decrease in provisions					(30,371)		(84,367)		(92,650)
	Gain/(loss) on foreign exchange					123,908		(76,327)		199,107
	Cash used in operations					(1,812,601)		(3,448,910)		(1,744,981)

4	SUBSEQUENT EVENTS
	There have been no subsequent events since 30 June 2013 which would have a material effect on these Interim Results.

 

END

 

 

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