23rd Sep 2008 07:00
VERONA PHARMA PLC ('Verona Pharma' or the 'Company')
Verona Pharma, the AIM-quoted company developing new therapeutic drugs for the treatment of respiratory diseases, today announces its Interim Results for the six months to 30 June 2008.
OPERATIONAL HIGHLIGHTS 8 January 2008 Raised ‚£2,319,333, before expenses, by way of placing of 57,983,325 new ordinary shares in the Company at 4 pence per share. 19 May 2008 RPL554 passed pivotal safety and toxicology tests establishing it can be given to humans in clinical trials. Progressed document preparation and negotiations with clinical trial site to conduct a combined Phase 1 / 2a trial of RPL554. 18 June 2008 Signed a new collaboration agreement with GlycoMar Limited to advance work on its Novel Anti-Inflammatory Polysaccharides programme towards identifying a suitable candidate for clinical proof of concept studies in humans. Financial Loss after tax of ‚£0.64 million or 0.31 pence per ordinary share. Cash and cash equivalents at 30 June 2008 of ‚£3.17 million.
Professor Clive Page, Chairman of the Company, said: "The first six months of this year was very busy for the Company as we approached commencing clinical studies with our lead project, RPL554. As of the date of this report, we have signed a contract with CHDR (Centre for Human Drug Research) at Leiden, The Netherlands, to carry out a Phase I/IIa clinical trial. We continue to identify projects of interest but, recognising the resource limitations of the Company, we exercise great care before bringing in any further projects into our portfolio. Operating with a tightly-run, cost-efficient staff base, we feel that we are progressing well."
For more information please contact: Professor Clive Page, 07971 504 931 Chairman, Verona Pharma plc David Youngman, 0161 832 2174 WH Ireland Ltd Allan Piper / Andrew Dunn 020 7920 3150 Tavistock Communications
CHAIRMAN AND CEO'S JOINT STATEMENT
The first six months of this year was very busy for the Company as we approached commencing clinical studies with our lead project, RPL554. As of the date of this report, we have signed a contract with CHDR (Centre for Human Drug Research) at Leiden, The Netherlands, to carry out a Phase I/IIa clinical trial. The documentation for the trial is complete, and the process for submitting the proposal, and its accompanying documentation to the appropriate regulatory authorities, is almost complete. Following a complete review by the appropriate personnel at CHDR, the proposal will be submitted to the Ethics Committee at the University of Leiden and the competent authority at The Hague. The first subject is expected to receive the first dose by the end of 2008, with a final report in the second quarter of 2009.
This Phase I/IIa clinical trial is designed to answer as many questions as possible regarding the actions of RPL554 in addition to ascertaining its safety. Thus, in addition to determining its safety in normal and asthmatic subjects, we wish to ascertain whether it provides protection against a bronchoconstrictor and whether it directly produces bronchodilation in a group of asthmatic patients. As a final objective we wish to determine whether the drug reduces the number of inflammatory cells produced in the nose of allergic rhinitic patients challenged with the allergen to which they are sensitive.
To accomplish the above, we have designed a clinical trial with three stages. The first is to test initial doses of the drug in a standard safety study in normal subjects. This will be followed by an ascending dose adaptive trial in asthmatics designed to provide safety information in asthmatics and to determine a dose that is apparently effective in improving airway function in these subjects. Once such a dose is determined this dose will then be formally evaluated in asthmatic and rhinitic patients at a single dose level.
Such a trial should demonstrate the safety of RPL554, and whether it provides (at a safe dose) therapeutic effects in asthmatic and rhinitic patients thereby paving the way for the further clinical development of RPL554. If the trial is successful, Verona Pharma will have achieved a notable landmark in its maturation as a drug discovery and development company.
The high attrition rate in the drug discovery process has always been clearly recognised by the Company and hence it has a strategy of having more than one project underway at all times whilst considering other project opportunities as they may arise. This requires very careful project management and appropriate proportioning of the Company's time and resources. Nevertheless, we have been able to ensure continuous progress with our second project, NAIPS.
NAIPS is short for `Novel Anti-Inflammatory Polysaccharides' and involves searching for novel sources of different types of polysaccharides with anti-inflammatory actions that have none of the anti-coagulant activity found in related molecules such as heparin. To date, we have been successful in identifying a number of compounds, using cellular and related in vitro assays that are potential candidates for anti-inflammatory actions in whole animals. Indeed some of these compounds have been shown to have anti-inflammatory actions in whole animals, in vivo. This is a very encouraging step forward with the project and so we will soon be starting the process of examining our database in order to make educated hypotheses regarding the possibility of totally synthetic analogues of the active compounds. These would be more suitable and have greater potential for use as an anti-inflammatory drug, at first in lungs and then possibly elsewhere.
Our final project is in the area of intractable cough where, with the aid of a large database of technical and experimental information, we have been able to determine a potential route to a new inhaled drug for the treatment of cough. We are currently synthesising and testing suitable candidate chemical compounds in order to proceed further with this project.
In addition to all of the above we have been actively seeking out and vetting a variety of new drug projects that fit into our research focus, namely inflammation-related diseases of the respiratory tract such as asthma and rhinitis. We continue to identify projects of interest but, recognising the resource limitations of the Company, we exercise great care before bringing in any further projects into our portfolio. Operating with a tightly-run, cost-efficient staff base, we feel that we are progressing well.
Professor Clive P. PageChairmanProfessor Michael J. A. WalkerChief Executive OfficerGROUP INCOME STATEMENTFOR THE SIX MONTHS ENDED 30 JUNE 2008 6 months 6 months ended Year ended ended 30 June 30 June 31 December 2008 2007 2007 Notes (unaudited) (unaudited) (audited) ‚£ ‚£ ‚£ Revenue - - - Cost of sales - - - Gross profit/(loss) - - - Research and development (424,113) (289,006) (755,789) Administration expenses (290,966) (220,475) (558,318) Operating loss (715,079) (509,481) (1,314,107) Finance revenue 77,153 51,843 96,844 Loss before taxation (637,926) (457,638) (1,217,263) Taxation - - - Loss for the period (637,926) (457,638) (1,217,263) Loss per ordinary share - basic 2 0.31p 0.32p 0.84pand diluted GROUP BALANCE SHEETAS AT 30 JUNE 2008 As at As at As at 30 June 30 June 31 December 2008 2007 2007 (unaudited) (unaudited) (audited) ‚£ ‚£ ‚£ ASSETS Non current assets Tangible assets 17,736 14,148 16,058 Intangible assets 71,453 66,582 66,626 Goodwill 1,469,112 1,469,112 1,469,112 1,558,301 1,549,842 1,551,796 Current assets Trade and other receivables 93,115 105,138 241,575 Short-term investment - - - Cash and cash equivalents 3,166,163 1,855,000 1,252,063 3,259,278 1,960,138 1,493,638 Total assets 4,817,579 3,509,980 3,045,434 EQUITY AND LIABILITIES Capital and Reserves attributable to Equity holders Called up share capital 207,218 144,275 146,775 Option reserve 405,313 298,056 405,313 Share premium account 6,347,024 4,038,256 4,135,756 Retained losses (2,437,613) (1,040,062) (1,799,687) Total equity 4,521,942 3,440,525 2,888,157 Current liabilities Trade and other payables 295,637 69,455 157,277 Total liabilities 295,637 69,455 157,277 Total equity and liabilities 4,817,579 3,509,980 3,045,434 GROUP CASH FLOW STATEMENTFOR THE SIX MONTHS ENDED 30 JUNE 2008 6 months ended 6 months Year ended ended 30 June 30 June 31 December 2008 2007 2007 (unaudited) (unaudited) (audited) ‚£ ‚£ ‚£
Net cash (outflows) from operating (407,856) (554,868) (1,204,740) activities
Cash flows from investing activities Interest received 65,622 54,802 110,758 Sale of short-term investment - 1,300,000 1,300,000 Purchase of tangible assets (6,684) - (5,291) Purchase of intangible assets (8,693) (8,183) (11,913) Net cash inflow from investing 50,245 1,346,619 1,393,554activities Cash flows from financing activities Proceeds from issue of shares 2,368,533 - - Issue costs (96,822) - - Net cash inflow from financing 2,271,711 - -activities Net increase in cash and cash 1,914,100 791,751 188,814equivalents Cash and cash equivalents at the 1,252,063 1,063,249 1,063,249beginning of the period
Cash and cash equivalents at the end 3,166,163 1,855,000 1,252,063 of the period
Reconciliation of operating loss to net cash Outflow from operating activities Operating loss (715,079) (509,481) (1,314,107) Cost of issuing share options - - 107,257 Decrease /(increase) in trade and 159,991 (55,414) (102,806)other receivables
Increase in trade and other payables 138,360 3,526 91,348
Amortisation of tangible assets 5,006 3,213 6,595 Amortisation of intangible assets 3,866 3,288 6,973 Net cash outflow from operating (407,856) (554,868) (1,204,740)activities GROUP STATEMENT OF CHANGES IN NET EQUITYFOR THE SIX MONTHS ENDED 30 JUNE 2008 Share Share Option Retained capital premium reserve earnings Total ‚£ ‚£ ‚£ ‚£ ‚£ Balance at 1 January 2008 146,775 4,135,756 405,313 (1,799,687) 2,888,157 Issue of shares 60,443 2,308,090 - - 2,368,533 Issue costs - (96,822) - - (96,822) Net loss for the period - - - (637,926) (637,926) Balance at 30 June 2008 207,218 6,347,024 405,313 (2,437,613) 4,521,942(unaudited) Balance at 1 January 2007 144,275 4,038,256 298,056 (582,424) 3,898,163 Net loss for the period - - - (457,638) (457,638) Balance at 30 June 2007 144,275 4,038,256 298,056 (1,040,062) 3,440,525(unaudited) Balance at 1 January 2007 144,275 4,038,256 298,056 (582,424) 3,898,163 Issue of shares 2,500 97,500 - - 100,000 Issue costs - - - - - Share option charge - - 107,257 - 107,257 Net loss for the period - - - (1,217,263) (1,217,263)
Balance at 31 December 2007 146,775 4,135,756 405,313 (1,799,687) 2,888,157 (audited)
NOTES TO THE UNAUDITED FINANCIAL INFORMATION
FOR THE SIX MONTHS ENDED 30 JUNE 2008
1. Publication of non-statutory accounts i) The interim financial information for the six months ended 30 June 2008 is unaudited and does not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985. It was approved by the board of directors on 22 September 2008. The figures for the year ended 31 December 2007 have been extracted from the statutory accounts which have been reported on by the Company's auditor. ii) Accounting policies The interim financial statements for the six months ended 30 June 2008 includes the results of Verona Pharma plc and its wholly-owned subsidiary Rhinopharma Limited. The unaudited results for the period have been prepared on the basis of accounting policies adopted in the audited accounts for the year ended 31 December 2007. iii) The directors do not recommend the payment of a dividend (period to 30 June 2007 - ‚£Nil, year ended 31 December 2007 - ‚£Nil). iv) A copy of this report will be sent to shareholders and copies of the interim report are available on the company's website www.veronapharma.com 2. Earnings per share i) Basic loss per share of (0.31p) (30 June 2007: loss of 0.32p, 31 December 2007: loss of 0.84p) for the Group is calculated by dividing the loss for the period by the weighted average number of ordinary shares in issue of 203,140,230 (30 June 2007: 144,275,000, 31 December 2007: 144,405,137). ii) Diluted loss per share has not been presented since the Company's stock options are anti-dilutive. 3. Subsequent events The Company issued, in aggregate, 8,940,000 new ordinary shares of 0.1p each in the Company in connection with the exercise of 7,940,000 options at 2p each and 1,000,000 options at 2.5p each. These shares were admitted to trading on AIM and dealing commenced on 11 July 2008. 4. Comparatives The comparatives include audited figures for the year ended 31 December 2007 and unaudited figures for the six months ended 30 June 2007.
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