LONDON--(Marketwire - July 29, 2010) -
London, UK, and Cambridge, MA: 29 July 2010 Antisoma plc (LSE: ASM; USOTC: ATSMY) today announces its preliminary results for the year ended 30 June 2010. These results have been prepared under International Financial Reporting Standards (‘IFRS’) as adopted for use by the European Union.
Key events of 2009/2010
AS1413 * Positive final data reported from secondary AML phase II trial * Secondary AML phase III trial over 75% enrolled * FDA Fast Track status awarded * Phase III data expected H1 2011 AS1411 * Positive long-term follow-up data from phase II AML trial * Renal cancer phase II trial shows further evidence of activity * New non-clinical data indicate potential in major cancer types * Orphan drug status for AML obtained in US and EU * Phase IIb trial in AML ongoing; headline data expected H1 2011 ASA404 * Front-line lung cancer phase III trial discontinued for futility Financial highlights * Cash at 30 June 2010 of GBP 32.1 million (30 June 2009: GBP 67.0 million) * Cash life extends well beyond key phase III results * Revenues of GBP 20.3 million (2009: GBP 25.2 million) * Reflects half of the USD 60 million up-front payment from sanofi-aventis (GBP 19.7 million) for the divestment of oral fludarabine * Full year loss of GBP 18.7 million (2009: loss of GBP 16.4 million)
Commenting on the results, Glyn Edwards, CEO of Antisoma, said: “We have two promising cancer drugs, AS1413 and AS1411, both of which we expect to report key trial data by mid-2011, and cash resources to take us well past these data.”
A webcast and conference call will be held today at 10.30 am BST. The webcast can be accessed via Antisoma’s website at http://www.antisoma.com/asm/media/webcast/ and the call by dialling +44 (0) 207 806 1964 (US toll-free +1 718 354 1390) and using the Confirmation Code: 9656482. A recording of the webcast will also be available afterwards on the Antisoma website.
Enquiries: Antisoma plc +44 (0)7909 915 068 Glyn Edwards, Chief Executive Officer Eric Dodd, Chief Financial Officer Daniel Elger, VP, Marketing & Communications Buchanan Communications +44 (0)20 7466 5000 Mark Court, Lisa Baderoon, Catherine Breen
Except for the historical information presented, certain matters described in this announcement are forward looking statements that are subject to a number of risks and uncertainties that could cause actual results to differ materially from results, performance or achievements expressed or implied by such statements. These risks and uncertainties may be associated with product discovery and development, including statements regarding the Group’s clinical development programmes, the expected timing of clinical trials and regulatory filings. Such statements are based on management’s current expectations, but actual results may differ materially.
Joint Chief Executive and Chairman’s statement
Overview
We have had a challenging year, including a disappointment in March, when a phase III trial evaluating ASA404 as a first-line treatment for lung cancer was discontinued for futility. We recognise that ASA404 was considered the Company’s most significant asset, but we are fortunate in having another late-stage cancer drug, AS1413, with substantial market potential. Addressing an indication in acute leukaemia where there is high unmet need, poor satisfaction with currently available generic therapies and clear potential for post-launch growth, AS1413 could readily achieve peak sales comparable in scale to the royalties that we might have obtained through our alliance on ASA404. We expect data from the phase III pivotal study of this compound in the first half of 2011.
AS1413 phase III trial nears enrolment target
AS1413 is a novel chemotherapy that we are testing in a large randomised phase III trial in patients with secondary acute myeloid leukaemia (secondary AML). The trial, known as ACCEDE, is approaching its enrolment target, which is to screen 450 patients in order to provide 420 evaluable patients. Enrolment should be completed in the third quarter of 2010 and we expect to announce results in the first half of 2011.
During the year, we have presented new findings supporting AS1413 at major scientific and medical meetings. In December, we reported positive final data from a phase II trial of AS1413 in secondary AML at the American Society of Hematology (ASH) Annual Meeting. We saw an encouraging number of longer- term responders, with 30% of patients who achieved remission after treatment with AS1413 still alive after 2 years. A presentation at the American Association of Cancer Research (AACR) Annual Meeting in April reinforced the differentiation of AS1413 from currently available leukaemia treatments and its potential to provide unique benefits for patients. Presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Annual Meeting in June highlighted the importance of multi-drug resistance as a barrier to successful treatment of AML. A key feature of AS1413 is its ability to evade multi-drug resistance mechanisms.
In June we announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to AS1413 for the treatment of secondary AML. Fast-track designated drugs usually qualify for Priority Review, an expedited review process available to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.
There is interest from potential partners in licensing AS1413. We have decided to take a pragmatic stance to realising the value of the drug, and have therefore widened our partnering discussions to include US rights, which we had previously planned to retain. However, as we have the resources ourselves to complete development of AS1413, we will only strike a deal ahead of the phase III data if terms are sufficiently favourable.
We believe that AS1413 could ultimately find application in a number of blood cancer settings, with potential sales running to hundreds of millions of dollars annually.
AS1411 phase IIb trial ongoing
AS1411 is the most advanced aptamer in trials for cancer. In March we initiated a 90-patient phase IIb study in patients with AML. This trial follows an earlier 60-patient randomised phase II trial in AML, in which use of AS1411 in combination with cytarabine produced a higher remission rate than cytarabine alone, without imposing any significant additional side-effects. At this year’s ASCO meeting, we presented long-term follow up data from the earlier study, showing that five of the eight patients who responded to an AS1411-based regimen, all of whom had advanced disease on entry to the study, had substantial survival durations (from 12 to over 20 months). Headline data from the phase IIb study are expected in the first half of 2011.
We continue to accumulate evidence that AS1411 has potential in a variety of different cancers. Non-clinical data presented at AACR in April showed activity in a model of colorectal cancer and positive findings when AS1411 was combined with various approved treatments for blood cancers. At the ASCO meeting in June we presented data from a 35-patient phase II study of AS1411 in advanced renal cancer, which provided further evidence of activity in this setting.
In October we announced that AS1411 had been granted orphan drug status in the US and the EU for the treatment of AML. These grants will provide seven years of market exclusivity in the US and ten years of exclusivity in the EU if AS1411 is approved as a treatment for AML.
DCAM auto-immune programme progressing towards partnering
We have an important pre-clinical programme in auto-immune diseases. This comprises a series of molecules collectively known as DCAMs (dendritic cell auto-immune modulators). They are highly specific, small-molecule inhibitors of wild-type Flt3, and are designed for oral treatment of various auto-immune conditions. Positive results have already been achieved in animal models of inflammatory bowel disease and rheumatoid arthritis, and we are now working towards establishing a licensing partnership for further development of the programme.
Other pipeline developments
During the period, we discontinued development of a phase II product, AS1402, divested a phase I product, P2045, to Bryan Oncor, and put on hold further development of AS1409. We have also discontinued a number of preclinical programmes as we focus our resources on development of our late-stage products, AS1413 and AS1411.
Cash conservation measures enacted
We are no longer anticipating further revenues from the ASA404 programme, and have therefore taken steps to reduce our cash utilisation and ensure that our funds take us comfortably past key clinical data on AS1413 and AS1411, which are expected during the first half of 2011. We finished the period with cash and short-term deposits of GBP 32.1 million (2009: GBP 67.0 million).
Total revenues for the year ended 30 June 2010 were GBP 20.3 million, compared with GBP 25.2 million last year. This year’s revenues reflect half of the USD 60.0 million up-front payment from sanofi-aventis (GBP 19.7 million) for oral fludarabine, which was deferred from the previous financial year, and the first of five annual contingent payments due under the agreement.
Total operating expenses have increased from GBP 40.8 million last year to GBP 43.4 million this year, mainly reflecting an increase in general and administrative costs, which were GBP 7.9 million (2009: GBP 4.9 million), reflecting impairments made to intangible assets and lower foreign exchange gains during the year. Research and development (R&D) costs were GBP 35.5 million (2009: GBP 35.9 million).
We have recorded a full-year loss of GBP 18.7 million (2009: GBP 16.4 million). At this stage in our development, profits and losses reflect the balance between recognition of deferred revenues and our ongoing operating expenses.
Board and management changes
Regrettably, we have had to restructure the business and make headcount reductions as part of our effort to conserve cash resources. As part of the restructuring, our former Chief Operating Officer, Dr Ursula Ney, left the Company and the Antisoma Board in April. Ursula made a very significant contribution to the development of Antisoma, and we wish her well with future ventures. In June we closed our laboratories at BioPark in Hertfordshire, leaving our operations concentrated at our headquarters in London and at our Cambridge, MA, site and reducing our total headcount to around sixty.
Outlook
We believe we have the product assets, people and financial resources to build value for the future. We look forward to a number of important clinical milestones in the near term, notably phase III data on AS1413 and phase IIb data on AS1411, both of which we expect in the first half of 2011.
Glyn Edwards
Chief Executive Officer
Barry Price
Chairman
Unaudited consolidated income statement for the year ended 30 June 2010 2010 2009 Notes GBP GBP -------------------------------------------------------------------- Revenue 2 20,346 25,230 Cost of sales - (9,085) --------------------------------------------------------------------- Gross profit 20,346 16,145 Research and development expenditure (35,500) (35,904) Administrative expenses (7,888) (4,884) --------------------------------------------------------------------- Total operating expenses (43,388) (40,788) --------------------------------------------------------------------- Operating loss (23,042) (24,643) Finance income 1,678 5,055 --------------------------------------------------------------------- Loss before taxation (21,364) (19,588) Taxation 2,712 3,161 --------------------------------------------------------------------- Loss for the year (18,652) (16,427) --------------------------------------------------------------------- Loss per ordinary share Basic (3.0)p (2.7)p --------------------------------------------------------------------- Diluted (3.0)p (2.7)p --------------------------------------------------------------------- All amounts arise from continuing operations. Unaudited consolidated statement of comprehensive income for the year ended 30 June 2010 2010 2009 GBP GBP --------------------------------------------------------------------------- Loss for the year (18,652) (16,427) Exchange translation difference on consolidation 1,000 8,923 -------------------------------------------------------------------------- Other comprehensive income for the period net of tax 1,000 8,923 --------------------------------------------------------------------------- Total recognised expense for the year (17,652) (7,504) --------------------------------------------------------------------------- Unaudited consolidated statement of financial position as at 30 June 2010 2010 2009 Notes GBP GBP ---------------------------------------------------------------- ASSETS Non-current assets Goodwill 7,353 6,708 Intangible assets 51,824 51,257 Property, plant and equipment 1,173 1,967 ---------------------------------------------------------------- 60,350 59,932 ---------------------------------------------------------------- Current assets Trade and other receivables 2,106 1,701 Current tax receivable 3,614 3,484 Short-term deposits 21,965 27,824 Cash and cash equivalents 10,098 39,215 ---------------------------------------------------------------- 37,783 72,224 LIABILITIES Current liabilities Trade and other payables (7,220) (7,417) Deferred income - (19,690) Provisions (3,071) (1,902) ---------------------------------------------------------------- Net current assets 27,492 43,215 ---------------------------------------------------------------- Total assets less current liabilities 87,842 103,147 ---------------------------------------------------------------- Non-current liabilities Deferred tax liabilities (7,353) (6,708) Provisions (28) (224) ---------------------------------------------------------------- (7,381) (6,932) ---------------------------------------------------------------- Net assets 80,461 96,215 ---------------------------------------------------------------- Shareholders’ equity Share capital 10,628 10,480 Share premium 122,070 119,783 Shares to be issued - 2,273 Other reserves 47,919 46,919 Profit and loss account (100,156) (83,240) ---------------------------------------------------------------- Total shareholders’ equity 80,461 96,215 ---------------------------------------------------------------- Unaudited consolidated statement of changes in equity for the year ended 30 June 2010 --------------------------------------------------------------------------- Shares Other Other Profit Share Share to reserve: reserve: and Total retranslation merger loss be capital premium issued GBP GBP GBP GBP GBP GBP GBP At 1 July 2008 10,467 119,629 2,273 (1,259) 39,255 (68,158) 102,207 Total comprehensive income for the year - - - 8,923 - ( 16,427) (7,504) New share capital issued 13 154 - - - - 167 Share options: value of employee services - - - - - 1,345 1,345 --------------------------------------------------------------------------- At 30 June 2009 10,480 119,783 2,273 7,664 39,255 (83,240) 96,215 --------------------------------------------------------------------------- At 1 July 2009 10,480 119,783 2,273 7,664 39,255 (83,240) 96,215 Total comprehensive income for the year - - - 1,000 - (18,652) (17,652) New share capital issued 148 2,287 (2,273) - - - 162 Share options: value of employee services - - - - - 1,736 1,736 --------------------------------------------------------------------------- At 30 June 2010 10,628 122,070 - 8,664 39,255 (100,156) 80,461 --------------------------------------------------------------------------- Unaudited consolidated statement of cash flows for the year ended 30 June 2010 2010 2009 GBP GBP ---------------------------------------------------------------- Cash flows from operating activities Loss for the year (18,652) (16,427) Adjustments for: Foreign exchange gain (779) (2,238) Finance income (1,678) (5,055) Tax credit (2,712) (3,161) Depreciation of property plant and equipment 673 650 Loss on disposal of property, plant and equipment 534 - Impairment of an intangible asset 1,261 - Derecognition of an intangible asset - 8,750 Share-based payments 1,736 1,345 ---------------------------------------------------------------- Operating cash flows before movement in working capital (19,617) (16,136) (Increase)/decrease in trade and other receivables (420) 385 (Decrease)/increase in trade and other payables (19,089) 12,829 ---------------------------------------------------------------- Cash used in operations (39,126) (2,922) Interest received 442 1,951 Income taxes paid 582 (620) Research and development tax credit received 2,000 - ---------------------------------------------------------------- Net cash used in operating activities (36,102) (1,591) ---------------------------------------------------------------- Cash flows from investing activities Purchase of property, plant and equipment (459) (232) Sale of property, plant and equipment 68 8 Purchase of intangible assets - (1,779) Sale/(purchase) of short-term deposits 5,859 (17,824) ---------------------------------------------------------------- Net cash used in investing activities 5,468 (19,827) ---------------------------------------------------------------- Cash flows from financing activities Proceeds from issue of ordinary share capital 162 167 ---------------------------------------------------------------- Net cash generated from financing activities 162 167 ---------------------------------------------------------------- Net decrease in cash and cash equivalents (30,472) (21,251) Exchange gains on cash and bank overdrafts 1,355 3,605 Cash and cash equivalents at beginning of year 39,215 56,861 ---------------------------------------------------------------- Cash and cash equivalents at end of year 10,098 39,215
Notes to the financial information for the year ended 30 June 2010
1. Basis of preparation
The financial information in this preliminary announcement has not been audited and does not constitute statutory accounts as defined in Section 406 of the Companies Act 2006. The information has been extracted from the consolidated financial statements for the year ended 30 June 2010. The financial statements will be delivered to the Registrar of Companies after the Annual General Meeting. The consolidated financial statements for the year ended 30 June 2009 have been delivered to the Registrar of Companies and were given an unqualified audit opinion by the Company’s auditors.
The financial information in this statement has been prepared in accordance with International Financial Reporting Standards (‘IFRS’) as endorsed by the European Union, International Financial Reporting Interpretation Committee (‘IFRIC’) interpretations and those parts of the Companies Act 2006 applicable to companies reporting under IFRS. There have been no new standards during the year that have significantly impacted the results of the Group.
2. Segmental information
Primary reporting segment - business segment The Directors are of the opinion that under IFRS 8 - ‘Operating segments’ the Group has only one business segment, being drug development.
Secondary reporting segment - geographical segment
The Group’s geographical segments are determined by location of operations. All revenue has been derived from external customers located in the US and Europe. The principal sources of revenue for the Group in the two years ended 30 June 2010 were:
--------------------------------------------------------------------------- 2010 2009 GBP GBP --------------------------------------------------------------------------- US Recognition of net income from the divestment of Oral Fludarabine Sanofi-Aventis 20,346 19,690 Europe Recognition of upfront and milestone payments on a time apportioned basis: Novartis - 5,401 R&D services and materials recharged: Novartis - 139 --------------------------------------------------------------------------- Total revenues 20,346 25,230 --------------------------------------------------------------------------- The following table shows the carrying value of segment assets by location of assets: --------------------------------------------- 2010 2009 GBP GBP --------------------------------------------- Total assets UK 67,490 105,331 US 30,643 26,825 --------------------------------------------- Total 98,133 132,156 --------------------------------------------- Total assets are allocated based on where the assets are located. The following table shows the costs in the period to acquire property, plant, equipment and intangibles by location of assets: ------------------------------------------------- 2010 2009 GBP GBP ------------------------------------------------- Capital expenditure UK 355 1,875 US 104 136 ------------------------------------------------- Total 459 2,011 -------------------------------------------------
Capital expenditure is allocated based on where the assets are located.
ENDS
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Source: Antisoma plc via Thomson Reuters ONE
