Immupharma Regulatory News (IMM)

RNS Number : 5579T

Immupharma PLC

30 September 2010

 

For Immediate Release

30 September 2010

 

Immupharma plc

INTERIM RESULTS ANNOUNCEMENT

For the six months ended 30 June 2010

 

ImmuPharma plc (LSE:IMM) ("Immupharma" or the "Company" or the "Group"), the specialist discovery and development pharmaceutical company is pleased to announce its interim results for the six months ended 30 June 2010.

 

INTERIM HIGHLIGHTS

 

·; First patients dosed with IPP-204106, ImmuPharma's anti-cancer compound with a novel and promising mechanism of action, in a Phase IIa cancer trial, after receipt of an Investigational New Drug (IND) approval from AFSSAPS, Agence Francaise de Securite Sanitaire des Produits de Sante.

·; Cephalon, Inc (Cephalon), ImmuPharma's partner for Rigerimod (LupuzorTM), commenced the recruitment of lupus patients for a Phase IIb trial being conducted largely in the US. This study has been designed to provide US-based investigators and the US FDA with clinical data obtained mainly in the USA. The data generated from this trial will be part of the package to be submitted to the FDA and other regulatory authorities for approval. Positive Phase IIb data from outside the USA has previously been announced.

·; Cephalon has also initiated development of LupuzorTM in Japan through its partner Symbio Pharmaceuticals.

·; ImmuPharma remains committed to its other compounds in R&D.

·; Strong cash position of £20m (as at 30 June 2010)

·; Received Best Drug Development Company in Europe 2010 Award from the New Economy

·; Basic and diluted loss per share were 0.10p and 0.10p respectively (31 December 2009: basic and diluted earnings per share 10.46p and 9.99p respectively)

 

Commenting on the progress to date and the outlook for ImmuPharma, Dimitri Dimitriou, Chief Executive Officer, said:

 

"The first half of 2010 has seen ImmuPharma build on the success of 2009 with Cephalon, our partner for LupuzorTM, moving ahead with a large trial in the US. At the same time, we are focusing our own efforts on our promising cancer drug and are proud to have initiated a clinical trial dosing cancer patients in France. We look forward to building on this success during the rest of 2010 and in the coming years."

 

 

Richard Warr, ImmuPharma's Chairman added:

 

"The entry of our cancer compound into clinical trials is a landmark event for ImmuPharma. The company now has two potential blockbuster drugs in the clinic and a strong corporate partnership with Cephalon. In addition ImmuPharma is pleased to report a strong balance sheet and an enviable cash position."

 

 

For further information, please contact:

ImmuPharma PLC:

Dimitri Dimitriou, Chief Executive Officer +44 20 7152 4080

Richard Warr, Chairman

Tracy Weimar, VP, Operations

 

Buchanan Communications

Lisa Baderoon, Mark Court, George Prassas +44 20 7466 5000

 

Panmure, Gordon & Co., NOMAD & Broker

Andrew Burnett +44 20 7459 3600

 

Execution Noble & Co, Joint Broker

James Bromhead +44 20 7456 9191

 

 

 

 

ImmuPharma plc

 

Statement from the Chairman and the Chief Executive Officer

 

 

INTERIM HIGHLIGHTS

 

Summary

 

The first half of 2010 has seen ImmuPharma progress after the successful licensing of LupuzorTM to Cephalon in 2009. The Group has made great strides in developing our partnership with Cephalon as well as advancing plans for our other promising programmes. While Cephalon moves forward with a large Phase IIb trial for LupuzorTM in the US and Europe, ImmuPharma received an Investigational New Drug (IND) approval from AFSSAPS, Agence Francaise de Securite Sanitaire des Produits de Sante, for a Phase IIa study in patients of IPP-204106, our anti-cancer compound with a novel and promising mechanism of action. The first patients have been dosed and the trial is progressing well. We were also delighted to receive the award for Best Drug Development Company in Europe 2010 from the New Economy.

 

Our pipeline now includes 5 drug candidates. The most advanced, LupuzorTM has been licensed to Cephalon, Inc. who has taken over responsibility for its development and all associated costs. Our next priority program is IPP-204106 for the treatment of cancer. It has been awarded grants totalling €1.15m by French government organisations. Three other earlier stage programmes are in preclinical development for - inflammatory disorders, moderate to severe pain and serious hospital infections. In addition to our lead compounds, our long-term pipeline includes a patented chemical library of over 300,000 small molecules and a technology for converting small peptides to drugs that can be applied to potentially generate further compounds for the Company.

 

Development Pipeline

 

·; LupuzorTM

 

Since licensing LupuzorTM to Cephalon in 2009, ImmuPharma has placed a priority on developing the working relationship with our partner. Cephalon has started the recruitment of lupus patients for a Phase IIb trial in the US and Europe. This study was designed to allow US-based investigators and the FDA to evaluate Rigerimod (LupuzorTM) as a treatment for lupus on the basis of data derived mainly from the USA. A large number of centres are involved and the data generated from this trial will be part of the package to be submitted to the FDA and other regulatory authorities for approval. In addition to the US trial and in order to prepare for the commercial development in Japan, Cephalon has also initiated development of LupuzorTM in Japan through its partner Symbio Pharmaceuticals. Under the agreement, Cephalon retains all commercialisation rights to Rigerimod (LupuzorTM) in Japan, and Symbio is granted an exclusive right to conduct a Japanese-based Phase I clinical study which is mandatory for a future filing of Rigerimod (LupuzorTM) with Japanese regulatory bodies. 

 

·; IPP-204106, treatment for cancer

 

IP-204106 is ImmuPharma's lead compound for cancer. The rights for this compound have been obtained through the Company'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. In June, ImmuPharma received an Investigational New Drug (IND) approval from AFSSAPS, Agence Francaise de Securite Sanitaire des Produits de Sante, for a Phase IIa study. The first patients have been dosed and the trial is progressing.

 

 

ImmuPharma plc

 

Statement from the Chairman and Chief Executive Officer

 

Development Pipeline (continued)

 

 

·; Other Pipeline Compounds

 

More limited progress has been made on ImmuPharma's other pipeline compounds for inflammation, pain, MRSA and other hospital-acquired infections during the period. The Group remains committed to their development either alone or with a partner.

 

Financial Review

 

After the cash inflow attributable to the Cephalon license agreement in 2009, the first six months of 2010 demonstrate ImmuPharma's refocused priorities on the development of its other pipeline candidates. ImmuPharma's cash balance remains strong at £20 million (£22.5 million at 31 December 2009). Basic and diluted loss per share was 0.10p and 0.10p respectively (31 December 2009: earnings per share 10.46p and 9.99p). In line with the Company's current policy, no interim dividend is proposed.

 

The Group continues to use International Financial Reporting Standards as its accounting basis.

 

Operating loss for the period was £2,521,050. Research and development expense was £975,454 reflecting primarily the activities around the development of IPP-204106, our anti-cancer compound. Administrative expenses were £1,545,713.

 

On 2 March 2010 ImmuPharma (UK) Limited, a 100% owned subsidiary of ImmuPharma plc, was entered in to a Members Voluntary Liquidation.

 

Outlook

 

With a strong cash position, the focus of the Group is on continuing the development of our strong relationship with our license partner for LupuzorTM, Cephalon, and the development of our other pipeline candidates, in particular our promising cancer compound, IPP-204106, and discovery pipeline. We are looking forward to announcing the preliminary results of the Phase IIb trial for LupuzorTM and our Phase IIa trial for IPP-204106 in the coming months. 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

 

29 September 2010

 

 

ImmuPharma plc

 

CONSOLIDATED INCOME STATEMENT

FOR THE PERIOD ENDED 30 JUNE 2010

 

	Note	6 months ended 30 June 2010		Year  ended 31 December 2009 Restated		6 months ended 30 June 2009 Restated
		£		£		£
Continuing operations
Revenue	4	117		22,054,544		21,569,869
Royalty expense	4	-		(4,155,765)		(4,301,044)
Research and development expenses		(975,454)		(4,034,173)		(1,961,398)
Administrative expenses		(1,545,713)		(3,564,833)		(1,532,255)
Operating (loss)/profit		(2,521,050)		10,299,773		13,775,172
Finance costs		(1,190)		(1,260,190)		(152,918)
Finance income		2,444,845		61,243		31,006
(Loss)/profit before taxation		(77,395)		9,100,826		13,653,260
Tax		(181)		(997,448)		(1,992,325)
(Loss)/profit for the period		(77,577)		8,103,378		11,660,935
Attributable to:
Equity holders of the parent company		(77,577)		8,103,378		11,660,935
(Loss)/earnings per ordinary share
Basic	2	(0.10)p		10.46p		15.05p

 

Diluted	2	(0.10)p		9.99p		13.69p

 

ImmuPharma plc

 

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME FOR THE PERIOD ENDED 30 JUNE 2010

 

 

	6 months ended 30 June  2010		Year  ended 31 December 2009		6 months ended 30 June  2009
	£		£		£
Profit/(loss) for the financial period	(77,577)		8,103,378		11,660,935
Other comprehensive income
Exchange differences on translation of foreign operations	(1,101,186)		(1,644,702)		(1,495,946)
Other comprehensive income for the period, net of tax	(1,101,186)		(1,644,702)		(1,495,946)
Total comprehensive income for the period	(1,178,763)		6,458,676		10,164,989

 

 

 

 

 

ImmuPharma plc

 

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 30 JUNE 2010

 

 

		30 June 2010		31 December 2009		30 June 2009
		£		£		£
Non-current assets
Intangible assets		705,108		746,705		748,697
Property, plant and equipment		12,378		9,336		9,894
Total non-current assets		717,486		756,041		758,591
Current assets
Trade and other receivables		1,172,703		1,361,458		422,369
Cash and cash equivalents		20,008,493		22,525,509		27,123,016
Total current assets		21,181,196		23,886,967		27,545,385
Current liabilities
Financial liabilities - borrowings		30,682		32,549		42,207
Trade and other payables		4,021,735		5,306,660		4,317,812
Tax payable		-		620,275		1,881,169
Provisions		81,448		174,529		160,612
Total current liabilities		4,133,866		6,134,013		6,401,800
Net current assets		17,047,330		17,752,954		21,143,585
Non-current liabilities
Financial liabilities - borrowings		759,370		425,671		409,008
Net assets		17,005,446		18,083,324		21,493,168
EQUITY
Ordinary shares		8,109,146		8,109,146		7,748,118
Share premium		7,302,645		7,302,645		5,486,985
Merger reserve		106,148		106,148		106,148
Other reserves		(3,888,675)		(2,888,375)		(760,850)
Retained earnings		5,376,182		5,453,759		8,912,767
Total equity		17,005,446		18,083,324		21,493,168

 

ImmuPharma plc

 

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE PERIOD ENDED 30 JUNE 2010

		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 2009	7,748,118		5,486,985		106,148		(3,541,203)		1,001,825		3,186,649		(2,748,168)		11,240,354
	Total comprehensive income for the year	-		-		-		-		(1,495,946)		-		11,660,935		10,164,989
	Share based payments	-		-		-		-		-		87,825		-		87,825
	At 30 June 2009	7,748,118		5,486,985		106,148		(3,541,203)		(494,121)		3,274,474		8,912,767		21,493,168
	At 1 January 2009	7,748,118		5,486,985		106,148		(3,541,203)		1,001,825		3,186,649		(2,748,168)		11,240,354
	Total comprehensive income for the year	-		-		-		-		(1,644,702)		-		8,103,377		6,468,165
	New issue of equity capital	36,500		118,625		-		-		-		-		-		155,125
	Share based payments	-		-		-		-		-		229,169		-		229,169
	Share option exercise	-		-		-		-		-		(98,550)		98,550		-
	Exercise of warrants	324,528		1,697,035		-		-		-		(2,021,563)		-		-
	At 31 December 2009	8,109,146		7,302,645		106,148		(3,541,203)		(642,877)		1,295,705		5,453,759		18,083,324
	Total comprehensive income for the year	-		-		-		-		(1,101,186)		-		(77,577)		(1,178,763)
	Share based payments	-		-		-		-		-		100,886		-		100,886
	At 30 June 2010	8,109,146		7,302,645		106,148		(3,541,203)		(1,744,063)		1,396,591		5,376,182		17,005,446
	Attributable to:-
	Equity holders of the parent company	8,109,146		7,302,645		106,148		(3,541,203)		(1,744,063)		1,396,591		5,376,182		17,005,446

ImmuPharma plc

 

CONSOLIDATED STATEMENT OF CASHFLOWS

FOR THE PERIOD ENDED 30 JUNE 2010

 

	Notes		6 months ended 30 June 2010			Year  ended 31 December 2009 Restated		6 months ended 30 June  2009 Restated
			£			£		£
Cash flows from operating activities
Cash (used in)/generated from operations	3		(3,194,309)			13,735,260		17,597,171
Tax paid			(594,679)			(510,591)		-
Interest paid			(1,190)			(1,260,190)		(152,918)
Net cash (used in)/generated from operating activities			(3,790,178)			11,964,479		17,444,253
Investing activities
Purchase of property, plant and equipment			(6,434)			(3,611)		(908)
Purchase of intangibles assets			(1,696)			(779)		(841)
Finance income			2,444,844			61,243		31,006
Net cash from investing activities			2,436,714			56,853		29,257
Financing activities
Net proceeds from share issue - Company			-			155,124		-
Decrease in bank overdraft			(276)			1,546		15,096
New loans			383,618			3,796		1,706
Loan repayments			-			(303,962)		(297,663)
Net cash generated from/(used in) financing activities			383,342			(143,496)		(280,861)
Effects of exchange rates on cash and cash equivalents			(1,546,894)		(1,810,744)			(2,528,050)
Net (decrease)/increase in cash and cash equivalents			(2,517,016)			10,067,092		14,664,599
Cash and cash equivalents at start of period			22,525,509			12,458,417		12,458,417
Cash and cash equivalents at end of period			20,008,493			22,525,509		27,123,016

 

 

ImmuPharma plc

 

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2010

 

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 International Financial Reporting Interpretations Committee (IFRIC) 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 2010.

 

For the period ended 30 June 2010 the Group is required to adopt IFRS 3 Business Combinations (revised) and IAS 27 Consolidated and Separate Financial Statements (revised). The adoption of these revised standards has had no impact on the financial information for the six months ended 30 June 2010, the year ended 31 December 2009 or the six months ended 30 June 2009.

 

The Directors have considered the accounting policy with respect to the treatment of foreign exchange gains and losses on foreign currency cash balances and consider it appropriate to change the policy to reflect such foreign exchange gains and losses within Finance Income and Finance Costs respectively rather than within Administrative Expenses. The Directors consider that this presentation provides more relevant information about the group's financial performance. This adjustment has decreased Administrative Expenses and increased Finance Costs for the periods ended 30 June 2009 or 31 December 2009 by £151,171 and £1,257,212 respectively. This has had no impact on the profit for the periods ended 30 June 2009 or 31 December 2009 or on the total equity of the group as at those dates.

 

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 for the year ended 31 December 2009 set out in this interim report does not constitute the Group's statutory accounts for that period. The statutory accounts for the year ended 31 December 2009 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 2010 and 30 June 2009 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 2010

(continued)

 

 

2 EARNINGS PER SHARE

 

	6 months ended 30 June 2010		Year ended 31 December 2009		6 months ended 30 June 2009
	£		£		£
Earnings
Earnings for the purposes of basic and diluted earnings per share being net (loss)/profit attributable to equity shareholders	(77,577)		8,103,378		11,660,935
Number of shares
Weighted average number of ordinary shares for the purposes of basic earnings per share	81,092,463		77,498,096		77,482,183
Effect of dilutive potential ordinary shares:
Share options	2,853,842		2,922,796		4,475,000
Warrants	685,540		685,540		3,245,280
	84,631,845		81,608,096		85,202,463
Basic (loss)/earnings per share	(0.10)p		10.46p		15.05p
Diluted (loss)/earnings per share	(0.10)p		9.99p		13.69p

 

 

ImmuPharma plc

 

NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2010

(continued)

 

3	CASH GENERATED FROM/(USED IN) OPERATIONS
					30 June 2010		31 December 2009 Restated		30 June 2009 Restated
					£		£		£
	Operating (loss)/profit				(2,521,050)		10,299,773		13,775,172
	Depreciation and amortisation				18,908		40,739		20,722
	Share-based payments				100,886		229,169		87,825
	Decrease/(increase) in debtors				174,532		(1,284,377)		316,928
	(Decrease)/increase in creditors				(874,504)		4,322,235		3,282,720
	(Decrease)/increase in provisions				(93,081)		127,721		113,804
	Cash (used in)/generated from operations				(3,194,309)		13,735,260		17,597,171

 

4	LUPUZORTM REVENUE AND ROYALTY EXPENSE
	In February 2009 Cephalon Inc exercised its option to license the exclusive worldwide rights to Lupuzor and made a non refundable payment of $30million to the Group.   Under the terms of the licence agreement, the Group is entitled to various future cash milestone payments and royalties on commercial sales of Lupuzor. Cephalon Inc will be responsible for all future costs and activities, including Phase III clinical trials, regulatory filing and the subsequent commercialisation and sale of the product worldwide.

 

5	SUBSEQUENT EVENTS
	There have been no subsequent events since 30 June 2010.

 

 

 

 

 

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