30 Sep 2009 07:00
SILENCE THERAPEUTICS plc ("Silence Therapeutics" or "the Group") INTERIM RESULTS FOR THE SIX months ended 30 June 2009
London, UK, 30 September 2009 - Silence Therapeutics plc today announces its unaudited interim financial results for the six months ended 30 June 2009.
Operational Highlights
* Silence commenced a phase I clinical study of Atu027, its lead therapeutic
product candidate. Dosing of patients with advanced solid tumours began in
June following the approval of a Clinical Trial Application from the German
regulator BfArM * Quark initiated phase I/II clinical trials of QPI-1002, another product candidate based on Silence's proprietary chemistry. Quark is developing QPI-1002 for use in kidney transplant surgery * The European Patent Office (EPO) granted a patent on protein kinase N3 (PKN3), the target gene for Silence's lead compound Atu027
* The Technical Board of Appeal of the European Patent Office revoked in its
entirety European patent EP1 214 945, which is a fundamental competitor
patent owned by Alnylam Europe AG
Post period
* In August Silence announced a delivery collaboration agreement with
Dainippon Sumitomo Pharma Co., Ltd. of Japan to demonstrate the functional
delivery of Silence's proprietary small interfering RNA molecules to
specific targets
Financial Highlights
* Revenue for the six months ended 30 June 2009 was 856,626 (six months
ended 30 June 2008: 124,338)
* Research & Development costs were reduced to 2.55m (six months ended 30
June 2008: 3.1m) following the completion of the extensive pre-clinical
programme for Atu027
* Administrative expenses were reduced to 1.92m (six months ended 30 June
2008: 2.3m)
* In January Silence raised 2.65m via a share placing. The cash position as
of 30 June 2009 was 3.1m (as at 31 December 2008: 3.35m)
Merger discussions
Silence Therapeutics plc yesterday announced that the Company is in mergerdiscussions. The Company expects the proposed transaction to be treated as areverse takeover under the AIM Rules. Accordingly, trading in the Company'sshares has been suspended pending publication of an Admission document. Theproposed transaction is subject to due diligence and would be conditional uponshareholder approval.
A further announcement will be made in due course.
Enquiries:
For further information, please contact the following:
Silence Therapeutics plc Powerscourt +44(0)20 7491 6520 +44(0)20 7250 1446 Iain Ross, Chairman & CEO Paul Durman Melvyn Davies, Finance Director Kay Larsen Nominated Advisers Nomura Code Securities Limited +44(0)20 7776 1200 Chris Collins SILENCE THERAPEUTICS PLCCONSOLIDATED INCOME STATEMENTSIX MONTHS ENDED 30 JUNE 2009 Six months Six months Year ended ended ended 31 December 30 June 2009 30 June 2008 2008 GBP GBP GBP Revenue 856,626 124,338 2,208,699 Research and development (2,554,426) (3,071,040) (6,712,032) direct costs Gross Loss (1,697,800) (2,946,702) (4,503,333) Administrative expenses (1,915,498) (2,301,875) (3,288,304) Operating Loss (3,613,298) (5,248,577) (7,791,637) Finance income 38,667 326,498 356,996
Loss for the period before tax (3,574,631) (4,922,079) (7,434,641)
Taxation credit for the period - 20,000 -
Retained loss for the period after taxation attributable to Equity Holders transferred from reserves (3,574,631) (4,902,079) (7,434,641)
Loss per Ordinary Equity Share (2.66)p (4.09)p (6.20)p
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All transactions arose from continuing activities.
SILENCE THERAPEUTICS PLCCONSOLIDATED BALANCE SHEETAT 30 JUNE 2009 30 June 31 December 30 June 2009 2008 2008 GBP GBP GBP Non-current assets Property, plant and equipment 396,288 535,909 448,230 Goodwill 7,704,390 8,611,087 7,175,906 Other intangible assets 733,492 812,696 738,953 8,834,170 9,959,692 8,363,089 Current assets Trade and other receivables 724,331 1,068,702 996,292 Cash and cash equivalents 3,057,038 3,350,187 5,661,213 3,781,369 4,418,889 6,657,505 Current liabilities Trade and other payables 828,676 934,601 786,393 Net current assets 2,952,693 3,484,288 5,871,112 Net assets 11,786,863 13,443,980 14,234,201 Capital and Reserves attributable to the Company's Equity Holders Share capital 1,349,134 1,199,134 1,198,835 Share premium account 40,467,956 37,967,956 37,964,447 Merger reserve 6,140,874 6,140,874 6,140,874 Share-based payment reserve 3,234,333 2,901,584 3,285,862 Translation reserve 2,226,254 3,291,489 1,171,096 Profit and loss account (41,631,688) (38,057,057) (35,526,913) Equity Holders' funds 11,786,863 13,443,980 14,234,201 SILENCE THERAPEUTICS PLC
CONSOLIDATED STATEMENT OF CHANGES IN NET EQUITY
FOR THE SIX MONTHS ENDED 30 JUNE 2009
Shares Share Merger Share-based Translation Profit and Shareholder Premium Reserve Payment Reserve Loss Account Funds Reserve GBP GBP GBP GBP GBP GBP GBP
at 1 January 2009 1,199,134 37,967,956 6,140,874 2,901,584 3,291,489 (38,057,057) 13,443,980
Shares issued in 150,000 2,500,000
2,650,000 the period Loss for 6 months (3,574,631) (3,574,631)to 30 June 2009 Charge based on - - - 332,749 - - 332,749 options issued Translation - - - - (1,065,235) - (1,065,235)adjustment at 30 June 2009 1,349,134 40,467,956 6,140,874 3,234,333 2,226,254 (41,631,688) 11,786,863 SILENCE THERAPEUTICS PLC
CONSOLIDATED CASH FLOW STATEMENT
FOR THE SIX MONTHS ENDED 30 JUNE 2009
Six months Six months to to Year ended 30 June 30 June 31 December 2009 2008 2008 Cash flows from operating GBP GBP GBP activities Loss before taxation (3,574,631) (4,922,079) (7,434,641) Adjustments for: Depreciation charges 63,476 52,816 116,489 Amortisation charges 128,499 137,877 306,916 Loss on sale of fixed assets - - 307
Charge for the period in respect 339,845 926,016 544,158
of share-based payments Foreign exchange movement (91,810) (76,182) 73,410 Recovery of loan provided for in - (18,000) (31,000) previous years Finance income (38,667) (308,498) (253,634) (3,095,954) (4,208,050) (6,677,955)
Decrease in trade and other 271,961 494,568 668,891
receivables Increase/(decrease) in trade 42,283 (1,015,553) (1,032,708)payables Cash absorbed by operations (2,781,710) (4,729,035) (7,041,812) Income taxes received - - 60,000 Net cash outflow from operating (2,781,710) (4,729,035) (6,981,812)activities Cash flows from investing activities
Recovery of loan made in previous - 18,000 31,000
years Interest received 38,667 308,498 253,634 Additions to property, plant and (6,347) (70,822) (135,584) equipment
Additions to intangible assets (104,146) (39,817) (135,752)
Cash (absorbed in)/generated from (71,826) 215,859 13,298
investing activities Cash flows from financing activities Proceeds from issue of share 2,650,000 - 3,808 capital and options Net (decrease) in cash and cash (203,536) (4,513,176) (6,964,706)equivalents Cash and cash equivalents at 3,350,187 10,174,389 10,174,389 beginning of period Net (decrease) in cash and cash (203,536) (4,513,176) (6,964,706)equivalents Effect of exchange rate (89,613) - 140,504 fluctuations on cash held Cash and cash equivalents at end 3,057,038 5,661,213 3,350,187 of period SILENCE THERAPEUTICS PLCNOTES1. Basis of preparationThe financial information has been prepared in accordance with InternationalFinancial Reporting Standards (IFRS) and using the same accounting policies asin the preparation of the audited accounts for the year ended 31 December 2008.
The accounts are drawn up in compliance with IAS 34, Interim Financial Reporting.
The above financial information does not constitute statutory accounts withinthe meaning of Section 435, Companies Act 2006. The information relating to thesix months ended 30 June 2009 is neither audited nor reviewed. Informationrelating to the year ended 31 December 2008 has been extracted from thestatutory accounts of the Group which have been audited by the Group's auditorsGrant Thornton UK LLP and whose report thereon is unqualified.
2. Segment Reporting
Six Months Ended 30 June 2009
Business RNAi Immunotherapy Unallocated Consolidated Segments Therapeutics Group items GBP GBP GBP GBP Revenue 555,626 301,000 - 856,626 Operating (2,925,128) 244,651 (932,821) (3,613,298) results Net finance - 507 38,160 38,667 income Net result for (2,925,128) 245,158 (894,661) (3,574,631) the period Segment assets 10,016,507 387,707 2,211,325 12,615,539 Segment (632,976) (51,820) (143,880) (828,676) liabilities Costs to acquire 6,347 - - 6,347 property, plant and equipment
Costs to acquire 104,146 - - 104,146
intangible Assets
Depreciation and 190,475 1,500 - 191,975
amortisation Charge for 127,706 1,158 210,981 339,845 non-cash expenses
Six months ended 30 June 2008
Business RNAi Immunotherapy Unallocated Consolidated Segments Therapeutics Group items GBP GBP GBP GBP Revenue 98,338 26,000 - 124,338 Operating (3,569,350) (180,804) (1,498,423) (5,248,577) results Net finance 165,662 17,371 143,465 326,498 income Net result for (3,403,688) (163,433) (1,354,958) (4,922,079) the period Segment assets 9,924,389 1,981,913 3,114,292 15,020,594 Segment (567,048) (148,956) (70,389) (786,393) liabilities Costs to acquire 70,423 399 - 70,822 property, plant and equipment
Costs to acquire 39,817 - - 39,817
intangible Assets
Depreciation and 189,193 1,500 - 190,693
amortisation Charge for 249,308 343 676,365 926,016 non-cash expenses 3. Earnings per shareThe loss per share is based on the loss for the period after taxationattributable to Equity Holders of 3,574,631 (year ended 31 December 2008 -loss 7,434,641; six months ended 30 June 2008 - loss 4,902,079) and on theweighted average of 134,250,409 ordinary shares in issue during the period(year ended 31 December 2008 - 119,885,617 six months ended 30 June 2008 -119,883,536). The options outstanding at 30 June 2008, 31 December 2008 and 30June 2009 are considered to be non-dilutive in that their conversion intoordinary shares would decrease the net loss per share. Consequently, there isno diluted earnings per share to report for either year.
4. Taxation
The credit for UK Corporation Tax arises from the Group taking advantage of thelegislation regarding the treatment and surrender of tax losses arising fromcertain qualifying research and development expenditure.
Notes to Editors:
About Silence Therapeutics plc (www.silence-therapeutics.com )
Silence Therapeutics plc (AIM: SLN) is a leading European RNAi-focused biotechnology company.
RNA interference (RNAi), is a Nobel Prize winning technology and one of themost exciting areas of drug discovery today. It represents a completely newapproach to selectively 'silence' or inactivate disease relevant genes and assuch it has the potential to create a new class of therapeutic products. RNAicould therefore offer a therapeutic approach to a broad range of diseases(cancer, infectious diseases, inherited diseases), many of which have beenregarded as incurable and are not addressed by current therapeutics, thereforeproviding a large market opportunity.
Silence Therapeutics has developed a platform of novel short interfering RNA
('siRNA') molecules, AtuRNAi, which provide a number of advantages overconventional siRNA molecules, including increased stability against nucleasedegradation. In addition, the Company has developed a proprietary systemicdelivery system, AtuPLEX. This system enables the functional delivery of siRNAmolecules to targeted diseased tissues and cells, while increasing theirbioavailability and intracellular uptake.Following the granting of its patents in Europe, the USA and Australia, SilenceTherapeutics is one of only two companies worldwide with a proprietary positionon composition of matter for siRNA therapeutics.Silence's lead internal product, Atu027, is a proprietary AtuRNAi molecule inclinical development for systemic cancer indications. Atu027 has successfullycompleted single and repeat dose toxicology and geno-toxicology studies, aswell as a 28-day toxicology study using multiple dosing regimens. In June 2009,the Company started an open-label, single-centre, dose-escalation Phase I studywith Atu027 in patients with advanced solid (malignant) tumours involvingsingle as well as repeated intravenous administration. Atu027 specificallytargets PKN3, a molecule involved in cancer growth and metastasis formation.Atu027 is Silence's most advanced clinical candidate for a systemicallydelivered short interfering RNA (siRNA) using the Company's proprietary AtuPLEXdelivery technology.
In March 2008 Silence Therapeutics announced a collaboration with AstraZeneca
focused on the development of a range of novel delivery approachesfor siRNA molecules. Under the terms of the agreement both Silence Therapeuticsand AstraZeneca will be allowed to commercialize the truly novel deliverysystems that the two partners develop together.Silence Therapeutics has granted a licence to AstraZeneca to develop novelAtuRNAi therapeutics against five specific targets. This collaboration was thefirst industry validation of the potential application of Silence Therapeutics'proprietary AtuRNAi molecules and solidified the Company's leadership positionin field of RNAi therapeutics.The Company's AtuRNAi technology also has been sublicensed to Pfizer viaQuark's license to them of the compound RTP-801i-14 for the treatment ofage-related macular degeneration (AMD) and a number of other indications. Thiscompound entered a phase II clinical study in July 2008. Silence Therapeuticsalso has licensed to Quark rights to the AtuRNAi structure for Quark'sproprietary compound, AKIi-5 and DGFi, which are both in Phase I human clinicalstudies for treatment of acute kidney injury and delayed graft function inkidney transplantation respectively.
Forward-Looking Statements
This press release includes forward-looking statements that are subject to risks, uncertainties and other factors. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. All forward--looking statements are based on information currently available to Silence Therapeutics and Silence Therapeutics assumes no obligation to update any such forward-looking statements.
Silence Therapeutics is based in London, UK, and Berlin, Germany, and is listed on AIM.
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