Immupharma Regulatory News (IMM)

28 Sep 2007 07:02

Immupharma PLC28 September 2007 For Immediate Release 28 September 2007 ImmuPharma PLC INTERIM RESULTS ANNOUNCEMENT For the six month ended 30 June 2007 ImmuPharma plc (LSE:IMM), the specialist pharmaceutical discovery anddevelopment company is pleased to announce its interim results for the sixmonths ended 30 June 2007. INTERIM HIGHLIGHTS • Submitted file to the FDA for phase II / III programme for lead drug for Lupus • Discovered new lead drug candidate for inflammation • Continued development progress of other R&D assets • Appointed two board members with pharma industry experience • Appointed Teather & Greenwood (now Landsbanki) as nominated adviser and broker while retaining Dawnay, Day Corporate Finance as joint financial adviser • Cash and cash equivalents at 30th June 2007 were £4,826,994, compared to £6,459,918 at 31st December 2006. On outlook, Dimitri Dimitriou, Chief Executive Officer, said: "The focus of the Group continues to be on the progression of its lead drugcandidates and discovery pipeline. ImmuPharma is in discussions with a number oflarge pharmaceutical and biotech companies for potential collaborations whilstalso considering the option of further progressing the development of some ofits assets independently." For further information please contact: ImmuPharma PLC:Dimitri Dimitriou, Chief Executive +44 20 7152 4080OfficerDr Robert Zimmer, President & Chief + 33 389 32 76 50Scientific OfficerRichard Warr, Chairman +44 20 7152 4080 Buchanan Communications + 44 20 7466 5000Lisa BaderoonRebecca Skye Dietrich Landsbanki Securities (UK) LimitedThilo Hoffmann +44 20 7426 7710 Statement from the Chairman, Chief Executive Officer and Chief Scientific Officer In the first six months of 2007, we have continued to progress our keydevelopment assets and have discovered a new series of lead drug candidates forinflammation. In parallel, we have strengthened the management team with theappointment of Ms Tracy Weimar (former Director of Business Development atGlaxoSmithKline) as Vice President of Operations and also appointed to the BoardDr Franco Di Muzio, former Glaxo senior executive and Dr Ajay Agrawal with 20years' experience in the biotech and pharmaceutical industry. Our pipeline now includes 4 drug candidates, the most advanced one for SystemicLupus Erythematosus having completed a phase II study and the 3 others inpreclinical development - one for moderate to severe pain, one for serioushospital infections and one for inflammatory disorders. In addition to our leadcompounds, our long-term pipeline includes a patented chemical library of over300,000 small molecules and a technology for converting small peptides to drugsthat can be applied to generate more compounds for the Company. IPP-201101, treatment of Lupus Following the successful completion of a Phase II study in the last quarter of2006, an IND (Investigational New Drug) was submitted to the US Food and DrugAdministration (FDA) for the initiation of a Phase II/III development program. ImmuPharma believes that IPP-201101, which was developed through itscollaboration with CNRS, has the potential to be a novel first-line drug therapyfor the treatment of Lupus by specifically modulating the immune system andhalting disease progression in a substantial proportion of patients. IPP-201101has a unique mechanism of action that modulates the activity of the CD4+ cellswhich are involved in the cell-mediated immune response which leads to the Lupusdisease. Estimates of the size of the market opportunity for the treatment of Lupus vary,but analysts estimate that, assuming launch in 2010, IPP-201101 could generatepeak annual sales of between $1 billion and $6 billion. IPP-201007, treatment of inflammation Arising from research activities on its proprietary chemical library, ImmuPharmahas discovered several new lead drug candidates in the form of a new molecularseries with potential application in inflammatory/allergic conditions such asasthma and rheumatoid arthritis. These molecules, in the programme code-namedIPP-201007, have utility as selective phospholipase A2 subtype inhibitors andare already patented through ImmuPharma's library broad patent. IPP-102199, treatment of moderate and severe pain Progress continues to be made on IPP-102199, ImmuPharma's lead drug candidatefor the treatment of moderate and severe pain, which is being developed as apotential morphine replacement. Its advantages may include longer pain reliefand reduced opioid side effects such as respiratory depression and dependency. IPP-203101, treatment of MRSA and other hospital-acquired infections Progress also continues to be made on IPP-203101, ImmuPharma's lead drugcandidate for the treatment of MRSA and other hospital-acquired infections.ImmuPharma, in conjunction with CNRS, has discovered a novel class ofantibiotics that can kill bacteria by disrupting their membranes with smallelectrical charges. The potential for IPP-203101 therefore exists due to itsunusual mechanism of action to work even in cases of bacterial resistance toother antibiotics. The Discovery Pipeline In addition to these lead drug candidates, ImmuPharma has a promisingproprietary discovery engine that would augment the Company's long-termcapabilities to sustain the generation of further novel compounds that eitherfit with ImmuPharma's strategic focus for internal development or allowout-licensing opportunities. During 2007, ImmuPharma has discovered the new lead candidates for inflammation,IPP-201007, from these research activities. CORPORATE HIGHLIGHTS In the first half of 2007, ImmuPharma appointed Tracy Weimar as Vice-Presidentof Operations. Her most recent position was Director, Worldwide BusinessDevelopment at GlaxoSmithKline where she was involved in a number of corporatelicensing deals. Ms Weimar holds an MBA from the London Business School and a BAin Economics from the University of California, Berkeley. Ms Weimar has alsospent 5 years as tax consultant in a major accounting firm in the US and the UK.Since joining the Company, Ms Weimar has also been appointed Company Secretaryand assumed responsibility for finance from Mr Walker Taylor who stepped downfrom the Board but remains an employee of the Company. The Company also made two board appointments - Dr. Franco Di Muzio and Dr AjayAgrawal joined as non-executive Directors to replace Mr Douglas Paterson and MrTony Johnson (who is now involved with the company in a scientific capacity). Dr. Di Muzio has 40 years experience in the pharmaceutical and other industries,encompassing international management experience in business development,strategic marketing, international finance, and M&A. After graduating inEconomics and Business in 1963, Dr Di Muzio worked for Colgate Palmolive andNestle before becoming Executive Vice President of Bristol Myers Squibb'smedical equipment and products division, Weck International Inc., in charge ofEurope, Asia, Middle East and Africa. In 1990, he joined Glaxo Wellcome plc (nowGlaxoSmithKline plc) in London as Area Managing Director and Head of all GW'sbusiness in the Middle East, Africa and Turkey. Following early retirement fromGlaxo Wellcome, in the beginning of 1998, he joined Alza International, the thenworld leader in drug delivery systems, as Managing Director, based in London, incharge of the Company's business expansion in all markets outside the US andremained there until the company's acquisition by Johnson & Johnson in 2000. Dr Agrawal has almost 20 years' experience in the biotech and pharmaceuticalindustry worldwide. He was a founder of polyMASC Pharmaceuticals plc, London in1995, the first UK biotech company, derived from a university that was directlylisted on AIM, raising approximately $40 million in 1995, and subsequentlymerged with a NASDAQ-listed company, Valentis Inc (USA) in 1999 to become one ofthe biggest companies in the delivery of biologics at that time. He currently sits on the editorial advisory board of three international tradejournals FINANCIAL HIGHLIGHTS Our financial results are in line with expectations and show our focused levelof activity in developing our key assets. The Group has adopted International Financial Reporting Standards as itsaccounting basis. ImmuPharma's drug candidates are not yet marketed and therefore the Group doesnot have revenues yet. Our financial results reflect the activities of theCompany undertaken for the development of our potential products. The loss ofthe Group for the six months was £1,539,057. Basic and diluted loss per sharewere 2.25p. No interim dividend is proposed. The operating loss was £1,633,440. It represents principally the employment costand overhead of maintaining the Group, together with expenditure on researchcarried out by Contract Research Organisations. Cash and cash equivalents at 30th June 2007 were £4,826,994, compared to£6,459,918 at 31st December 2006. OUTLOOK The focus of the Group continues to be on the progression of its lead drugcandidates and discovery pipeline. ImmuPharma is in discussions with a number oflarge pharmaceutical and biotech companies for potential collaborations whilstalso considering the option of further progressing the development of some ofits assets independently. Richard Warr, MA, Chairman Dimitri Dimitriou, MSc, Chief Executive Officer Dr Robert Zimmer, MD, PhD, President and Chief Scientific Officer For company information, visit www.immupharma.com Independent Review Report to ImmuPharma plc We have been instructed by the Company to review the financial information forthe six months ended 30 June 2007 which comprises the Consolidated IncomeStatement, the Consolidated Statement of Recognised Income and Expense, theConsolidated Balance Sheet, the Consolidated Cash Flow Statement, and therelated notes 1 to 10. We have read the other information contained in theinterim report and considered whether it contains any apparent misstatements ormaterial inconsistencies with the financial information. This report is made solely to the Company in accordance with the terms of ourengagement to assist the Company in meeting the requirements of the AIM Rules ofthe London Stock Exchange. Our review has been undertaken so that we might stateto the Company those matters we are required to state to it in this report andfor no other purpose. To the fullest extent permitted by law, we do not acceptor 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, including the financial information contained therein, isthe responsibility of, and has been approved by, the directors. The directorsare responsible for preparing the interim report in accordance with the AIMRules of the London Stock Exchange which require that the accounting policiesand presentation applied to the interim figures should be consistent with thoseapplied in preparing the preceding annual accounts except where any changes, andthe reasons for them, are disclosed. Review work performed We conducted our review in accordance with guidance contained in Bulletin 1999/4issued by the Auditing Practices Board for use in the United Kingdom. A reviewconsists principally of making enquiries of Group management and applyinganalytical procedures to the financial information and underlying financial dataand based thereon, assessing whether the accounting policies and presentationhave been consistently applied unless otherwise disclosed. A review excludesaudit procedures such as tests of controls and verification of assets,liabilities and transactions. It is substantially less in scope than an auditperformed in accordance with International Auditing Standards (UK and Ireland)and therefore provides a lower level of assurance than an audit. Accordingly, wedo not express an audit opinion on the financial information. Review conclusion On the basis of our review we are not aware of any material modifications thatshould be made to the financial information as presented for the six monthsended 30 June 2007. Nexia Smith & Williamson 25 MoorgateChartered Accountants LondonRegistered Auditors EC2R 6AY2007 ImmuPharma plc CONSOLIDATED INCOME STATEMENT FOR THE PERIOD ENDED 30 JUNE 2007 6 months 9 months 3 months ended ended 31 ended December 30 June 30 June Note 2007 2006 2006 £ £ £Continuing operationsRevenue 26,366 44,818 1,782Research and development (790,661) (568,139) (227,371)expensesAdministrative expenses (869,145) (1,447,998) (125,348) Operating loss (1,633,440) (1,971,319) (350,937) Finance costs (8,723) (7,739) (1,738)Investment revenues 103,239 64,307 27,563 Loss before taxation (1,538,924) (1,914,751) (325,112) Tax (132) 54,713 214 Loss for the period (1,539,057) (1,860,038) (324,898) Loss per ordinary share Basic and diluted 6 (2.25)p (2.72)p (0.48)p ImmuPharma plc CONSOLIDATED STATEMENT OF RECOGNISED INCOME AND EXPENSEFOR THE PERIOD ENDED 30 JUNE 2007 6 months 9 months 3 months ended ended 31 ended December 30 June 30 June 2006 2007 2006 £ £ £ Exchange differences ontranslation of foreign operations (112) (4,143) (9,770)Loss for the financial period (1,539,057) (1,860,038) (324,898) Total recognised income and (1,539,169) (1, (334,668)expense for the period 864,181) Attributable to:Equity holders of the parent (1,539,169) (1,864,181) (334,668)company ImmuPharma plc CONSOLIDATED BALANCE SHEET AS AT 30 JUNE 2007 30 June 31 December 30 June 2007 2006 Notes 2006 £ £ £Non-current assetsProperty, plant and 15,628 11,503 14,100equipmentIntangible assets 737,250 748,878 758,460 Total non-current assets 752,878 760,381 772,560 Current assetsTrade and other receivables 110,463 103,801 97,702Cash and cash equivalents 4,826,994 6,459,918 2,409,915 Total current assets 4,937,457 6,563,719 2,507,617 Current liabilitiesFinancial liabilities - 212,855 192,987 528,284borrowings and grantsTrade and other payables 565,213 747,615 499,594Provisions 104,915 94,218 - Total current liabilities 882,983 1,034,820 1,027,878 Net current assets 4,054,474 5,528,899 1,479,739 Non-current liabilitiesFinancial liabilities - 369,959 403,634 82,987borrowings Net assets 4,437,393 5,885,646 2,169,312 EQUITYOrdinary shares 7 7,277,615 7,277,615 6,813,815Share premium 7 3,558,340 3,558,340 1,607,990Merger reserve 7 106,148 106,148 106,148Other reserves 7 (622,837) (713,641) (3,550,965)Retained earnings 7 (5,881,873) (4,342,816) (2,807,676) Total equity 4,437,393 5,885,646 2,169,312 ImmuPharma plc CONSOLIDATED CASH FLOW STATEMENT FOR THE PERIOD ENDED 30 JUNE 2007 Notes 6 months 9 months 3 months ended ended 31 ended December 30 June 2007 30 June 2006 2006 £ £ £Cash flows from operatingactivitiesCash used in operations 8 (1,707,156) (1,236,598) (627,510)Tax (132) - -Interest paid (8,723) (7,739) (1,738) Net cash used in operating (1,716,011) (1,244,337) (629,248)activities Investing activitiesPurchase of property, plant (6,344) (2,389) (3,642)and equipmentAcquisition of intangibles - - (1,514)assetsInterest received 103,239 64,307 27,563Tax received - - 214 Net cash from investing 96,895 61,918 22,621activities Financing activitiesNet proceeds from share - 2,609,150 -issues(Decrease)/increase in bank (24) 2,556 327overdraftNew loans 100,000 384,754 333,085Loan repayments (113,784) (68,586) -Equity shares to be issued - 2,021,563 - Net cash (used in)/from (13,808) 4,949,437 333,412financing activities Net (decrease)/increase incash and cash equivalents (1,632,924) 3,767,018 (273,215) Cash and cash equivalents at 6,459,918 2,692,900 2,692,900start of period Effect of foreign exchange - - (9,770)rate changes Cash and cash equivalents at 4,826,994 6,459,918 2,409,915 end of period ImmuPharma plc NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2007 1 The financial information set out in this interim statement has been preparedunder International Financial Reporting Standards (IFRS) on the basis of theaccounting policies set out in the statutory accounts of ImmuPharma plc for theperiod ended 31 December 2006. This interim statement has not been audited buthas been reviewed by the Company's auditors, Nexia Smith & Williamson. 2 The financial information does not constitute statutory accounts within themeaning of Section 240 of the Companies Act 1985. Statutory accounts forImmuPharma plc for the period ended 31 December 2006 reported under IFRS, onwhich the auditors gave an unqualified opinion and contained no statement unders237(2) or s237(3), are available at the Registrar of Companies. 3 Copies of this statement will be posted to shareholders. Further copies areavailable free of charge on request from the Company Secretary at the Company'sregistered office, 50 Broadway, London, SW1H 0BL. 4 COMPARATIVE INFORMATION The financial information in respect of the period ended 31 December 2006 isderived from the audited statutory accounts of the Group for that period. Thefinancial information in respect of the period ended 30 June 2006 was notaudited but was reviewed by the Company's auditors, Nexia Smith & Williamson. 5 SEGMENT INFORMATION A segment is a distinguishable component of the Group that is engaged inproviding products or services (business segment), or in providing products orservices within a particular economic environment (geographical segment), whichis subject to risks and rewards that are different from those of other segments. No analysis of the Group's turnover and contribution to profit from operationsby geographical segment or business segment has been presented as all of theGroup's operating activities are in respect of the development of pharmaceuticalproducts and all are carried out within Europe. ImmuPharma plc NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2007 (continued) 6 EARNINGS PER SHARE 9 months 6 months ended 31 3 months ended 30 December ended 30 June 2007 June 2006 2006 £ £ £ EarningsEarnings for the purposes of basic (1,539,057) (1,860,038) (324,898)earnings per share being net lossattributable to equity shareholders Number of sharesWeighted average number of 68,388,353 68,388,353 68,138,149ordinary shares for the purposesof basic earnings per share Basic and diluted loss per share (2.25)p (2.72)p (0.48)p The Group has granted share options and warrants in respect of equity shares tobe issued. As a result of the net loss for the period, there are no dilutiveeffects of these options and warrants. ImmuPharma plc NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2007 (continued) 7 STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY Share Share Merger Other Retained Total capital premium reserve reserves* Earnings equity £ £ £ £ £ £ At 1 April 6,813,815 1,607,990 106,148 (3,541,195) (2,482,778) 2,503,980 2006 Exchange differences on translating foreign - - - (4,143) - (4,143) operations Loss for the period ended 31 December - - - - (1,860,038) (1,860,038) 2006 Total recognised income and expense for the period - - - (4,143) (1,860,038) (1,864,181) Equity shares to be issued - - - 2,021,563 - 2,021,563 New issue of equity share capital 463,800 2,305,200 - - - 2,769,000 Less: expenses of new share - (159,850) - - - (159,850) issue At 31 7,277,615 3,558,340 106,148 (713,641) (4,342,816) 5,885,646 December 2006 Exchange differences on translating foreign - - - (112) - (112) operations Loss for the period ended 30 June 2007 - - - - (1,539,057) (1,539,057) Total recognised income and expense for the period - - - (112) (1,539,057) (1,539,169) Equity shares to be issued - - - 90,916 - 90,916 At 30 June 7,277,615 3,558,340 106,148 (622,837) (5,881,873) 4,437,393 2007 * other reserves as at 30 June 2007 comprises a reverse acquisition reserve £(3,541,203), a translation reserve £(4,247) and equity shares to be issued of£2,922,613. ImmuPharma plc NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2007 (continued) 8 CASH USED IN OPERATIONS 30 June 31 December 30 June 2007 2006 2006 £ £ £ Operating loss (1,633,440) (1,971,319) (350,937) Depreciation and amortisation 13,847 19,032 9,620 Share-based payments 90,916 615,134 - Decrease/(increase) (6,662) 108,483 59,869 in debtors (Decrease)/increase (182,514) (102,146) (346,062) in creditors Increase in 10,697 94,218 - provisions Cash used in (1,707,156) (1,236,598) (627,510) operations 9 RELATED PARTY TRANSACTIONS Included within other creditors is an amount of £2,986 (31 December 2006: £3,791) due to R Zimmer, and an amount of £40 (31 December 2006: £40) due to D Dimitriou. No interest or formal repayment terms apply to these loans. Included within financial liabilities is an amount of £53,364 due to R Zimmer. The loan is repayable on demand. Interest is payable at 3.5% per annum. During the period an amount of £19,998 (31 December 2006: £13,187) was paid to the wife of Dr R Zimmer in respect of services provided to ImmuPharma AG. R Zimmer and D Dimitriou are both directors and shareholders of this company. 10 POST BALANCE SHEET EVENTS On 31 July 2007 630,000 share options were executed and granted to the executive directors and 250,000 share options were executed and granted to employees of ImmuPharma Plc and directors of other group companies. This information is provided by RNS The company news service from the London Stock Exchange