Last checked at 25 Sep 2008 07:00
For Immediate Release 25 September 2008
ImmuPharma plc
Interim Results Announcement
For the six months ended 30 June 2008
ImmuPharma plc (LSE:IMM), the specialist discovery and development pharmaceutical company is pleased to announce its interim results for the six months ended 30 June 2008.
INTERIM HIGHLIGHTS
First patients dosed in Phase IIb trial of our lead asset for lupus, IPP-201101, during the period under review with subsequent ongoing progress being made and headline efficacy data expected later in the year;
Successfully obtained LUPUZORTM trademark for IPP-201101, our lead asset for lupus
Encouraging pre-clinical data from new portfolio candidate, IPP-204106 for multiple forms of cancer
Raised £2.7m in a share placing from UK and Swiss institutional investors;
In addition to our discovery pipeline, our portfolio now includes five drug candidates:
IPP-201101, LUPUZORTM for the treatment of lupus
IPP-204106, for the treatment of cancer
IPP-201007, for the treatment of inflammation
IPP-102199, for the treatment of moderate and severe pain
IPP-203101, for the treatment of MRSA and other hospital-acquired infections
Commenting on the progress to date and the outlook for ImmuPharma, Dimitri Dimitriou, Chief Executive Officer, said:
"The first half of 2008 has been an exciting time for ImmuPharma with the addition of IPP-204106 for the treatment of cancer, the first patients being dosed with LUPUZOR™ and ongoing progress being made in a Phase IIb trial that is anticipated to report headline efficacy data later in the year, and a successful share placement raising £2.7m. The Company continues to develop its assets and discussions with potential partners."
For further information please contact:
| ImmuPharma PLC: | |
| Dimitri Dimitriou, Chief Executive Officer | +44 20 7152 4080 |
| Dr Robert Zimmer, President & Chief Scientific Officer | + 33 389 32 76 50 |
| Richard Warr, Chairman | +44 20 7152 4080 |
| Buchanan Communications | + 44 20 7466 5000 |
| Lisa Baderoon | |
| Rebecca Skye Dietrich | |
| Panmure Gordon & Co | |
| NOMAD and Broker Andrew Burnett Ashton Clanfield Rakesh Sharma | +44 20 7459 3600 |
Chairman and the Chief Executive Statement
Summary
The first half of 2008 has been an exciting time for ImmuPharma with the addition of a new drug candidate for cancer, the first patients being dosed in a Phase IIb trial of our lead asset and two successful share placements. We have continued to progress our key development assets and have obtained the trademark LUPUZORTM from the US Patent and Trademark Office for our lead drug candidate for lupus, IPP-201101.
Our pipeline now includes five drug candidates, the most advanced one for Systemic Lupus Erythomatosus is currently undergoing a Phase IIb study with our four others compounds in preclinical development for the treatment of cancer, 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 generate more compounds for the company.
Development Pipeline
IPP-201101, treatment of lupus
Following the successful completion of a Phase II study in patients suffering from lupus, where our lead drug candidate (IPP-201101) showed a statistically significant clinical improvement in patients' overall symptoms, ImmuPharma has initiated a Phase IIb, double-blind, placebo-controlled trial in 200 patients in Europe and Latin America. The first patients have been dosed and the Company expects to report headline efficacy data later this year. Analysts estimate that IPP-201101 for the treatment of lupus has blockbuster sales potential.
In May, we were pleased to receive approval of the trademark name LUPUZORTM for IPP-201101 from the US Patent and Trademark Office. ImmuPharma has selected the trademark LUPUZORTM for use in association with its peptide therapy for treating immunological disorders, including systemic lupus erythematosus (SLE).
ImmuPharma believes that IPP-201101, which was developed through its collaboration with CNRS, has the potential to be a novel first-line drug therapy for the treatment of lupus by specifically modulating the immune system and halting disease progression in a substantial proportion of patients. IPP-201101 has a unique mechanism of action that modulates the activity of the CD4+ cells which are involved in the cell-mediated immune response which leads to the lupus disease.
IPP-204106, treatment for cancer
In January, ImmuPharma was pleased to announce the addition of IPP-204106, a novel drug candidate for cancer, to its portfolio. 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 The molecule is a nucleolin antagonist and has a dual 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.
IPP-201007, treatment of inflammation
Arising from research activities on its proprietary chemical library, ImmuPharma has discovered several new lead drug candidates in the form of a new molecular series with potential application in inflammatory/allergic conditions such as asthma and rheumatoid arthritis. These molecules, in the programme code-named IPP-201007, have utility as selective phospholipase A2 subtype inhibitors and are 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 candidate for the treatment of moderate and severe pain, which is being developed as a potential morphine replacement. Its advantages may include longer pain relief and 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 drug candidate for the treatment of MRSA and other hospital-acquired infections. ImmuPharma, in conjunction with CNRS, has discovered a novel class of antibiotics that can kill bacteria by disrupting their membranes with small electrical charges. The potential for IPP-203101 therefore exists due to its unusual mechanism of action to work even in cases of bacterial resistance to other antibiotics.
The Discovery Pipeline
In addition to these lead drug candidates, ImmuPharma has a promising proprietary discovery engine that would augment the company's long-term capabilities to sustain the generation of further novel compounds that either fit with ImmuPharma's strategic focus for internal development or allow out-licensing opportunities.
Share Placements
In July 2008, ImmuPharma successfully completed a share placement in two separate tranches raising a combined £2.7 million. The first tranche of approximately £1.6 million was achieved through principally institutional investors based in the UK. The second tranche of approximately £1.1 million was completed with principally institutional investors based in Switzerland. The funds raised will be invested in the continued development of the Company's clinical and preclinical assets.
Financial Review
Our financial results are in line with expectations and show our focused level of activity in developing our key assets.
The Group continues to use International Financial Reporting Standards as its accounting basis.
ImmuPharma's drug candidates are not yet marketed and therefore the Group does not have revenues at this stage of our development. Our financial results reflect the activities of the company undertaken for the development of our potential products. The loss of the Group for the six months was £1,452,450. Basic and diluted loss per share were 2.00p. No interim dividend is proposed.
The operating loss was £1,490,899. It represents principally the employment cost and overhead of maintaining the Group, together with expenditure on research carried out by Contract Research Organisations.
Cash and cash equivalents at 30 June 2008 were £1,610,442 compared to £3,331,639 at 31st December 2007. It is important to note that the funds raised in the share placement are not reflected in the cash and cash equivalent figure at 30th June 2008 as the placement was completed in early July 2008.
Outlook
The focus of the Group continues to be on the progression of its lead drug candidates and discovery pipeline. ImmuPharma is in discussions with a number of large pharmaceutical and biotech companies for potential collaborations whilst also considering the option of further progressing the development of some of its assets alone, which would require additional financing.
Richard Warr, MA, Chairman Dimitri Dimitriou, MSc, Chief Executive Officer
ImmuPharma plc
CONSOLIDATED INCOME STATEMENT
FOR THE PERIOD ENDED 30 JUNE 2008
| Note | 6 months ended 30 June 2008 | Year ended 31 December 2007 | 6 months ended 30 June 2007 | |||
| £ | £ | £ | ||||
| Continuing operations | ||||||
| Revenue | 97,330 | 63,199 | 26,366 | |||
| Research and development expenses | (796,888) | (1,970,654) | (790,661) | |||
| Administrative expenses | (791,341) | (1,620,348) | (869,145) | |||
| Operating loss | (1,490,899) | (3,527,803) | (1,633,440) | |||
| Finance costs | (4,787) | (14,156) | (8,723) | |||
| Investment revenues | 43,236 | 205,911 | 103,239 | |||
| Loss before taxation | (1,452,450) | (3,336,048) | (1,538,924) | |||
| Tax | - | 253,237 | (132) | |||
| Loss for the period | (1,452,450) | (3,082,811) | (1,539,057) | |||
| Loss per ordinary share | ||||||
| Basic and diluted | 6 | (2.00)p | (4,24)p | (2.25)p | ||
ImmuPharma plc
CONSOLIDATED STATEMENT OF RECOGNISED INCOME AND EXPENSE FOR THE PERIOD ENDED 30 JUNE 2008
| 6 months ended 30 June 2008 | Year ended 31 December 2007 | 6 months ended 30 June 2007 | |||
| £ | £ | £ | |||
| Exchange differences on translation of foreign operations | 15,688 | 115,893 | (112) | ||
| Loss for the financial period | (1,452,450) | (3,082,811) | (1,539,057) | ||
| Total recognised income and expense for the period | (1,436,762) | (2,966,918) | (1,539,169) | ||
| Attributable to: | |||||
| Equity holders of the parent company | (1,436,762) | (2,966,918) | (1,539,169) | ||
ImmuPharma plc
CONSOLIDATED BALANCE SHEET AS AT 30 JUNE 2008
| Notes | 30 June 2008 | 31 December 2007 | 30 June 2007 | |||
| £ | £ | £ | ||||
| Non-current assets | ||||||
| Property, plant and equipment | 14,139 | 12,779 | 15,628 | |||
| Intangible assets | 765,706 | 755,135 | 737,250 | |||
| Total non-current assets | 779,845 | 767,914 | 752,878 | |||
| Current assets | ||||||
| Trade and other receivables | 434,411 | 384,724 | 110,463 | |||
| Cash and cash equivalents | 10 | 1,176,031 | 2,946,915 | 4,826,994 | ||
| Total current assets | 1,610,442 | 3,331,639 | 4,937,457 | |||
| Current liabilities | ||||||
| Financial liabilities - borrowings and grants | 29,251 | 173,581 | 212,855 | |||
| Trade and other payables | 308,486 | 441,380 | 565,213 | |||
| Provisions | 81511 | 88,774 | 104,915 | |||
| Total current liabilities | 419,248 | 703,735 | 882,983 | |||
| Net current assets | 1,191,194 | 2,627,904 | 4,054,474 | |||
| Non-current liabilities | ||||||
| Financial liabilities - borrowings | 308,593 | 345,475 | 369,959 | |||
| Net assets | 1,662,446 | 3,050,343 | 4,437,393 | |||
| EQUITY | ||||||
| Ordinary shares | 7 | 7,277,615 | 7,277,615 | 7,277,615 | ||
| Share premium | 7 | 3,558,340 | 3,558,340 | 3,558,340 | ||
| Merger reserve | 7 | 106,148 | 106,148 | 106,148 | ||
| Other reserves | 7 | (401,580) | (466,133) | (622,837) | ||
| Retained earnings | 7 | (8,878,077) | (7,425,627) | (5,881,873) | ||
| Total equity | 1,662,446 | 3,050,343 | 4,437,393 | |||
ImmuPharma plc
CONSOLIDATED CASH FLOW STATEMENT
FOR THE PERIOD ENDED 30 JUNE 2008
| Notes | 6 months ended 30 June 2008 | Year ended 31 December 2007 | 6 months ended 30 June 2007 | ||||||
| £ | £ | £ | |||||||
| Cash flows from operating activities | |||||||||
| Cash used in operations | 8 | (1,641,070) | (3,760,613) | (1,707,156) | |||||
| Tax | - | - | (132) | ||||||
| Interest paid | (4,787) | (14,156) | (8,723) | ||||||
| Net cash used in operating activities | (1,645,857) | (3,774,769) | (1,716,011) | ||||||
| Investing activities | |||||||||
| Purchase of property, plant and equipment | (3,912) | (7,944) | (6,344) | ||||||
| Acquisition of intangibles assets | (25,556) | (1,407) | - | ||||||
| Interest received | 69,966 | 205,911 | 103,239 | ||||||
| Tax received | - | - | - | ||||||
| Net cash from investing activities | 40,498 | 196,560 | 96,895 | ||||||
| Financing activities | |||||||||
| Net proceeds from share issues | - | - | - | ||||||
| (Decrease)/increase in bank overdraft | 1,695 | (2,004) | (24) | ||||||
| New loans | - | 93,047 | 100,000 | ||||||
| Loan repayments | (182,907) | (168,607) | (113,784) | ||||||
| Equity shares to be issued | - | - | - | ||||||
| Net cash (used in)/from financing activities | (181,212) | (77,564) | (13,808) | ||||||
| Effects of exchange rates on cash and cash equivalents | 15,688 | 142,770 | - | ||||||
| Net (decrease)/increase in cash and cash equivalents | (1,770,884) | (3,513,003) | (1,632,924) | ||||||
| Cash and cash equivalents at start of period | 2,946,915 | 6,459,918 | 6,459,918 | ||||||
| Cash and cash equivalents at end of period | 1,176,031 | 2,946,915 | 4,826,994 | ||||||
ImmuPharma plc
NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2008
1 The financial information set out in this interim statement has been prepared under International Financial Reporting Standards (IFRS) on the basis of the accounting policies set out in the statutory accounts of ImmuPharma plc for the year ended 31 December 2007. This interim statement has not been audited but has been reviewed by the Company's auditors, Nexia Smith & Williamson.
2 The financial information does not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985. Statutory accounts for ImmuPharma plc for the year ended 31 December 2007 reported under IFRS, on which the auditors gave an unqualified opinion and contained no statement under s237(2) or s237(3), are available at the Registrar of Companies.
3 Copies of this statement will be posted to shareholders. Further copies are available free of charge on request from the Company Secretary at the Company's registered office, 50 Broadway, London, SW1H 0BL.
4 COMPARATIVE INFORMATION
The financial information in respect of the year ended 31 December 2007 is derived from the audited statutory accounts of the Group for that period. The financial information in respect of the period ended 30 June 2007 was not audited 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 in providing products or services (business segment), or in providing products or services within a particular economic environment (geographical segment), which is 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 operations by geographical segment or business segment has been presented as all of the Group's operating activities are in respect of the development of pharmaceutical products and all are carried out within Europe.
.
ImmuPharma plc
NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2008
(continued)
6 EARNINGS PER SHARE
| 6 months ended 30 June 2008 | Year ended 31 December 2007 | 6 months ended 30 June 2007 | |||
| £ | £ | £ | |||
| Earnings | |||||
| Earnings for the purposes of basic earnings per share being net loss attributable to equity shareholders | (1,452,450) | (3,082,811) | (1,539,057) | ||
| Number of shares | |||||
| Weighted average number of ordinary shares for the purposes of basic earnings per share | 72,776,149 | 72,776,149 | 68,388,353 | ||
| Basic and diluted loss per share | (2.00)p | (4.24)p | (2.25)p | ||
The Group has granted share options and warrants in respect of equity shares to be issued. As a result of the net loss for the period, there are no dilutive effects of these options and warrants.
ImmuPharma plc
NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2008
(continued)
| 7 | STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY | ||||||||||||
| Share capital | Share premium | Merger reserve | Other reserves* | Retained Earnings | Total equity | ||||||||
| £ | £ | £ | £ | £ | £ | ||||||||
| At 1 January 2007 | 7,277,615 | 3,558,340 | 106,148 | (713,641) | (4,342,816) | 5,885,646 | |||||||
| Exchange differences on translating foreign operations | - | - | - | 115,893 | - | 115,893 | |||||||
| Loss for the year ended 31 December 2007 | - | - | - | - | (3,082,811 | (3,082,811) | |||||||
| Total recognised income and expense for the year | - | - | - | 115,893 | (3,082,811) | (2,966,918) | |||||||
| Equity shares to be issued | - | - | - | 131,615 | - | 131,615 | |||||||
| At 31 December 2007 | 7,277,615 | 3,558,340 | 106,148 | (466,133) | (7,425,627) | 3,050,343 | |||||||
| Exchange differences on translating foreign operations | - | - | - | 15,688 | - | 15,688 | |||||||
| Loss for the period ended 30 June 2008 | - | - | - | - | (1,452,450) | (1,452,450) | |||||||
| Total recognised income and expense for the period | - | - | - | 15,688 | (1,452,450) | (1,436,762) | |||||||
| Equity shares to be issued | - | - | - | 48,865 | - | 48,865 | |||||||
| At 30 June 2008 | 7,277,615 | 3,558,340 | 106,148 | (401,580) | (8,878,077) | 1,662,446 | |||||||
Other reserves as at 30 June 2008 comprises a reverse acquisition reserve £(3,541,203) (2006: £(3,541,203)), a translation reserve £127,446 (2007: £111,758) and equity shares to be issued of £3,012,177 (2006: £2,963,312).
ImmuPharma plc
NOTES TO THE INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2008
(continued)
| 8 | CASH USED IN OPERATIONS | ||||||||
| 30 June 2008 | 31 December 2007 | 30 June 2007 | |||||||
| £ | £ | £ | |||||||
| Operating loss | (1,517,629) | (3,527,803) | (1,633,440) | ||||||
| Depreciation and amortisation | 17,537 | 36,312 | 9,620 | ||||||
| Share-based payments | 48,865 | 131,615 | 90,916 | ||||||
| (Increase)/decrease in debtors | (49,686) | (27,686) | (6,662) | ||||||
| (Decrease)/increase in creditors | (132,894) | (367,607) | (182,514) | ||||||
| (Decrease/increase in provisions | (7,263) | (5,444) | 10,697 | ||||||
| Cash used in operations | (1,641,070) | (3,760,613) | (1,707,156) | ||||||
| 9 | RELATED PARTY TRANSACTIONS | |||
| Included within financial liabilities is an amount of £2,427 due to R Zimmer. The loan is repayable on demand. Interest is payable at 3.5% per annum. | ||||
| During the period an amount of £ (31 December 2007: £43,035) was paid to the wife of Dr R Zimmer in respect of services provided to ImmuPharma AG. | ||||
| R Zimmer is both a director and shareholder of this company. | ||||
| 10 | POST BALANCE SHEET EVENTS |
| On 7 July 2008 2,697,034 new ordinary 10p shares were issued for a cash consideration of £1,618,220. On 15 July 2008 1,876,000 new ordinary 10p shares were issued for a cash consideration of £1,125,600. |