Antisoma PLC Reports Half-Year Results For The Six Months To 31 December 2009

LONDON, UK--(Marketwire - February 18, 2010) -



London, UK, and Cambridge, MA: 18 February 2010 Antisoma plc (LSE: ASM; USOTC: ATSMY) announces its interim financial information for the period ended 31 December 2009.

Highlights

Potential blockbuster ASA404 advancing with Novartis

* Enrolment completed in first-line lung cancer phase III trial

* First-line lung cancer phase III data expected in mid-2011 (announced today); Novartis plans filings in 2011

* Enrolment ongoing in second-line lung cancer phase III trial

* Plans announced for phase Ib/II trial in breast cancer

* Investigator-initiated trials started in other cancers (announced today)


Novel blood cancer treatment AS1413 leads US commercial strategy

* Positive final data reported from secondary AML phase II trial

* Secondary AML phase III trial now over half enrolled (announced today)

* Preparations underway for potential commercialisation in US

* Antisoma plans first filings in 2011


Aptamer AS1411 continues to show potential

* Clinical data suggest distinctive efficacy and safety profile

* Renal cancer phase II trial provides new evidence of activity

* Other indications prioritised over renal cancer for commercial reasons

* Plans announced for phase IIb trial in AML


Financial highlights

* Loss after tax of GBP18.3 million (H1 2008: loss after tax of GBP 5.0 million)

* Cash at 31 December 2009 of GBP 49.6 million (31 December 2008: GBP 52.7 million)

* No revenues in this period (2008: GBP 5.5 million); recognition of GBP 19.7 million from oral fludarabine divestment expected in half-year ended 30 June 2010


Glyn Edwards, CEO of Antisoma, said: "We now have two drugs - ASA404 and AS1413 - that are well into pivotal phase III trials. Success with either drug will enable us to make a rapid transition into a company directly involved in product commercialisation and capable of generating recurring revenues based on product sales."


Eric Dodd, Antisoma's CFO, added: "We continue to manage our cash resources prudently and to focus our investment on key products with potential to create significant value for shareholders."

A webcast and conference call will be held today at 9.30 am GMT. The webcast can be accessed via Antisoma's website at www.antisoma.com and the call by dialling +44 (0)20 7075 1520 and using the participant PIN code 468563#.

A second conference call will be held at 2.00 pm GMT/9.00 am EST. Call numbers are +44(0)20 7075 1520 or from the US (toll-free) 1 866 793 4273; the participant PIN code for this call is 468563#.

A recording of the webcast will be available afterwards on Antisoma's website.


Enquiries:

  Antisoma plc                                   + 44 (0) 7909 915068
  Glyn Edwards, Chief Executive Officer
  Eric Dodd, Chief Financial Officer
  Daniel Elger, VP, Marketing & Communications

  Buchanan Communications                        +44 (0)20 7466 5000
  (All media enquiries)
  Mark Court, Lisa Baderoon, Catherine Breen

  The Trout Group                                +1 617 583 1308
  (US investor enquiries)
  Seth Lewis

Except for the historical information presented, certain matters discussed in this statement 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.

Chairman's report

Overview

During the past six months, our two most important products, ASA404 and AS1413, made substantial progress through their pivotal phase III studies. With Novartis funding all development work on ASA404 and the phase III trial of AS1413 over half way to completion, our need for further investment to reach key data on these drugs is now limited. As a result, we are able to devote some of our cash resources of almost GBP 50 million to investment in earlier stage programmes, which could enhance long-term value, and to the start of preparations for commercialisation of AS1413 in the US.

Significant progress for potential blockbuster ASA404

The key registration trial of ASA404 is the phase III ATTRACT-1 study testing the drug in combination with chemotherapy as a first-line treatment for non-small cell lung cancer. In September, we announced that this trial had completed enrolment of 1200 patients. We are now in the follow-up phase of the study. An interim look will take place soon, but unless this shows clear futility or dramatic early efficacy, neither of which we expect, the study will continue until its scheduled completion. Latest information, based on death rates in the study, indicates that data are likely to be available in mid- 2011. Novartis plans to file for marketing authorisations during 2011 if these data are positive.

Novartis is also conducting another phase III trial, called ATTRACT-2, in patients with non-small cell lung cancer who have already received treatment with other drugs. This study is designed to support applications to market ASA404 as a second-line treatment. Enrolment of 900 patients is ongoing.

At the company's R&D Day in December, Novartis outlined plans to evaluate ASA404 in another major indication, HER2-negative metastatic breast cancer. A phase Ib/II trial combining ASA404 with taxanes will begin this year.

Investigator-initiated trials with ASA404 have begun. These include two phase II studies combining ASA404 with taxane-based regimens, one in bladder cancer and the other in small cell lung cancer, and a phase I study evaluating ASA404 combined with carboplatin, paclitaxel and cetuximab in patients with a variety of solid tumours.

Antisoma has the option to co-commercialise ASA404 with Novartis in the US, which fits with Antisoma's plans to become directly involved in the commercialisation of its products. The arrangement with Novartis could yield substantial milestone payments based on the progress of ASA404 as well as royalties on all sales of the drug worldwide.

Exciting blood cancer drug AS1413 is on track

AS1413 is being tested in a pivotal phase III trial (ACCEDE) in patients with secondary acute myeloid leukaemia (secondary AML). This form of leukaemia follows previous bone marrow disease or treatment for other cancers, and it responds poorly to currently available treatments.

In December, we reported positive final data from a phase II trial of AS1413 in secondary AML. We saw an encouraging number of longer-term responders, and 30% of patients who achieved remission after treatment with AS1413 were still alive after 2 years. This adds to earlier findings from the trial showing a response rate of 39% that compares favourably with historical data in similar patients.

The ACCEDE study seeks to build on our promising phase II data. It is a randomised controlled trial that compares AS1413 plus cytarabine (the treatment given in our phase II trial) to standard current treatment for AML: daunorubicin plus cytarabine. We are now over half way towards the enrolment target of 450 patients, and expect to see the results of the trial in late 2010 or early 2011.

Should the ACCEDE study be positive, we plan to market the drug ourselves in the US while seeking partners for marketing in other territories.

AS1411 shows promise

In December, we announced that our phase II study of AS1411 in renal cancer had provided further evidence of activity in this setting, and reinforcement of the findings from previous trials that the drug is very well tolerated. Because of the now highly competitive nature of the renal cancer market, we have decided not to pursue further development of AS1411 for this indication. However, the latest data add to a picture of activity across various cancers.

In the immediate future, our focus with AS1411 is in AML, where we have reported positive data from a randomised phase II trial. A phase IIb trial combining AS1411 with cytarabine in patients with relapsed and refractory AML will start soon, and is intended to pave the way for a potential registration study in this setting.

Other pipeline developments

During the period, we discontinued development of AS1402 after early data from a phase II trial in breast cancer indicated that the drug would be unlikely to offer a significant benefit to patients. We are strong believers in running robust "go/no-go" trials during early development, so that our resources can be focused on drugs likely to offer real benefits to patients and consequent commercial success.

In August, we divested a phase I product, P2045, to Bryan Oncor, a company focusing on the development of radiopharmaceutical products.

Financial review

Overview

We have a solid financial position that reflects the careful use of the substantial cash resources we have built up, notably from last year's divestment of oral fludarabine to sanofi-aventis and from payments made by Novartis, our development and commercialisation partner for ASA404. Novartis is funding all development work on ASA404 while we are investing in our other pipeline products, particularly AS1413, which is in a pivotal phase III trial.

Results of operations

The group had no revenues in the period.

Total operating expenses for the six months ended 31 December 2009 were £21.3 million (2008: £20.0 million). Research and development expenditure has increased by £1.3m, reflecting continued investment in the phase III trial of AS1413. Within administrative expenses, we have recognised impairment losses of £0.3 million, reflecting discontinuation of certain projects.

During the period, foreign exchange rates have been less volatile than in the previous year. We have made exchange gains of £1.3 million on translation of our US dollar and Euro balances into sterling (2008: £6.7 million).

Our loss of £18.3 million reflects the difference between our revenues, finance income and tax credit and our operating expenses, as we continue to invest in our cancer drug pipeline.

Liquidity and capital resources

Cash, cash equivalents and short-term deposits amounted to £49.6 million as at 31 December 2009 (30 June 2009: £67.0 million; 31 December 2008: £52.7 million). Net cash used in operating activities for the six months ended 31 December 2009 was £18.4 million (six months ended 31 December 2008: £19.2 million).

In managing our cash resources, we have maintained a conservative treasury policy with short deposit terms and diversified counterparty risk.

Taxation

We have recognised a credit of £1.5 million in respect of an R&D tax credit receivable for the first six months of the financial year.

Loss per share

The basic loss per share for the half-year ended 31 December 2009 was 3.0p. The loss per share for the half-year ended 31 December 2008 was 0.8p.

Outlook

We are moving forward with our plans to transition from a company focused on developing cancer drugs into one that can also successfully commercialise them. While our principal focus is the completion of phase III trials on ASA404 and AS1413, we also continue to advance the earlier stage products in our portfolio and to explore opportunities to add new drugs to the pipeline.

Barry Price
Chairman


Interim Report for the six months ended 31 December 2009





Consolidated Income Statement
for the six months ended 31 December 2009

-----------------------------------------------------------------------
                                           6 months  6 months     Year
                                           ended 31  ended 31 ended 30
                                           December  December     June

                                               2009      2008     2009

                                          unaudited unaudited  audited

                                    Notes     £'000     £'000    £'000
-----------------------------------------------------------------------


 Revenue                                          -     5,514   25,230

 Cost of sales                                    -         -  (9,085)
-----------------------------------------------------------------------
 Gross profit                                     -     5,514   16,145

 Research and development
 expenditure                               (18,040)  (16,775) (35,904)

 Administrative expenses                    (3,297)   (3,208)  (4,884)
-----------------------------------------------------------------------
 Total operating expenses                  (21,337)  (19,983) (40,788)


-----------------------------------------------------------------------
 Operating loss                            (21,337)  (14,469) (24,643)



 Finance income                       4       1,555     8,011    5,055


-----------------------------------------------------------------------
 Loss before taxation                      (19,782)   (6,458) (19,588)



 Taxation                                     1,502     1,493    3,161


-----------------------------------------------------------------------
 Loss for the period                       (18,280)   (4,965) (16,427)
-----------------------------------------------------------------------


 Loss per ordinary share

 Basic                                5      (3.0)p    (0.8)p   (2.7)p
-----------------------------------------------------------------------
 Diluted                              5      (3.0)p    (0.8)p   (2.7)p
-----------------------------------------------------------------------


Consolidated Statement of Comprehensive Income
for the six months ended 31 December 2009

---------------------------------------------------------------------------
                                                6 months  6 months     Year
                                                ended 31  ended 31 ended 30
                                                December  December     June

                                                    2009      2008     2009

                                               unaudited unaudited  audited

                                                   £'000     £'000    £'000
---------------------------------------------------------------------------


 Loss for the period                            (18,280)   (4,965) (16,427)



 Exchange translation difference on
 consolidation                                       447    12,484    8,923
---------------------------------------------------------------------------
 Other comprehensive income for the period net of
 tax                                                 447    12,484    8,923


---------------------------------------------------------------------------
 Total comprehensive income for the period      (17,833)     7,519  (7,504)
---------------------------------------------------------------------------



Consolidated Statement of Financial Position
as at 31 December 2009

--------------------------------------------------------------------------
                                              As at 31  As at 31 As at 30
                                              December  December     June

                                                  2009      2008     2009

                                             unaudited unaudited  audited

                                       Notes     £'000     £'000    £'000
--------------------------------------------------------------------------
                                                                        A

 ASSETS

 Non-current assets

 Goodwill                                        6,957     7,642    6,708

 Intangible assets                              51,615    62,653   51,257

 Property, plant and equipment                   1,960     2,282    1,967
--------------------------------------------------------------------------
                                                60,532    72,577   59,932
--------------------------------------------------------------------------
 Current assets

 Trade and other receivables                     1,947     1,904    1,701

 Current tax receivable                          4,984     1,493    3,484

 Short-term deposits                            42,267    10,000   27,824

 Cash and cash equivalents                       7,377    42,700   39,215
--------------------------------------------------------------------------
                                                56,575    56,097   72,224

 LIABILITIES

 Current liabilities

 Trade and other payables                      (8,046)   (9,740)  (7,417)

 Current tax payable                                 -     (297)        -

 Deferred income                              (19,690)         - (19,690)

 Provisions                                    (2,664)     (477)  (1,902)
--------------------------------------------------------------------------
 Net current assets                             26,175    45,583   43,215
--------------------------------------------------------------------------
 Total assets less current liabilities          86,707   118,160  103,147
--------------------------------------------------------------------------


 Non-current liabilities

 Deferred tax liabilities                      (6,957)   (7,642)  (6,708)

 Provisions                                      (454)     (145)    (224)
--------------------------------------------------------------------------
                                               (7,411)   (7,787)  (6,932)


--------------------------------------------------------------------------
 Net assets                                    79, 296   110,373   96,215
--------------------------------------------------------------------------


 Shareholders' equity

 Share capital                                  10,592    10,468   10,480

 Share premium                                 122,015   119,649  119,783

 Shares to be issued                     6           -     2,273    2,273

 Other reserves                                 47,366    50,480   46,919

 Profit and loss account                     (100,677)  (72,497) (83,240)
--------------------------------------------------------------------------
 Total shareholders' equity                     79,296   110,373   96,215
--------------------------------------------------------------------------



Consolidated Statement of Changes in Equity
for the six months ended 31 December 2009

---------------------------------------------------------------------------
                         Shares         Other    Other Profit and
          Share    Share   to be      reserve: reserve:       loss    Total

         capital  premium  issued retranslation    merger   account

          £'000    £'000   £'000         £'000     £'000     £'000    £'000
---------------------------------------------------------------------------


 At 1
 July
 2008    10,467  119,629    2,273       (1,259)   39,255   (68,158) 102,207

 Total
 comprehensive
 income
 for
 the
 period       -        -       -        12,484         -   (4,965)    7,519

 New share
 capital
 issued       1       20       -             -         -         -       21

 Share
 options:
 value of
 employee
 services     -        -       -             -         -       626      626
---------------------------------------------------------------------------
 At 31
 December
 2008    10,468  119,649   2,273        11,225    39,255  (72,497)  110,373
---------------------------------------------------------------------------


 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
 period       -        -       -           447         -  (18,280) (17,833)

 New share
 capital
 issued     112    2,232 (2,273)             -         -         -       71

 Share
 options:
 value of
 employee
 services     -        -       -             -         -       843      843
---------------------------------------------------------------------------
 At 31
 December
 2009    10,592  122,015       -         8,111    39,255 (100,677)   79,296
---------------------------------------------------------------------------



Consolidated Statement of Cash Flows
for the six months ended 31 December 2009

---------------------------------------------------------------------------


                                                6 months  6 months     Year
                                                ended 31  ended 31 ended 30
                                                December  December     June

                                                    2009      2008     2009

                                               unaudited unaudited  audited

                                                   £'000     £'000    £'000
---------------------------------------------------------------------------


 Cash flows from operating activities

 Loss for the period/year                       (18,280)   (4,965) (16,427)

 Add back:

 Foreign exchange gain                             (187)   (1,076)  (2,238)

 Finance income                                  (1,555)   (8,011)  (5,055)

 Tax credit                                      (1,502)   (1,493)  (3,161)

 Depreciation of property plant and equipment        337       318      650

 Impairment of intangible assets                     343         -        -

 Derecognition of an intangible asset                  -         -    8,750

 Share-based payments                                843       626    1,345
---------------------------------------------------------------------------
 Operating cash flows before movement in
 working capital                                (20,001)  (14,601) (16,136)

 (Increase)/decrease in debtors                    (319)     1,237      385

 Increase/(decrease) in creditors and
 provisions                                        1,643   (6,963)   12,829
---------------------------------------------------------------------------
 Cash used in operations                        (18,677)  (20,327)  (2,922)

 Interest received                                   243     1,136    1,951

 Income taxes received/(paid)                          2         -    (620)
---------------------------------------------------------------------------
 Net cash used in operating activities          (18,432)  (19,191)  (1,591)
---------------------------------------------------------------------------


 Cash flows from investing activities

 Purchase of property, plant and equipment         (330)     (200)    (232)

 Sale of property, plant and equipment                 -         -        8

 Purchase of intangible assets                         -   (1,779)  (1,779)

 Purchase of short-term deposits                (14,443)         - (17,824)
---------------------------------------------------------------------------
 Net cash used in investing activities          (14,773)   (1,979) (19,827)
---------------------------------------------------------------------------


 Cash flows from financing activities

 Proceeds from issue of ordinary share capital        71        21      167
---------------------------------------------------------------------------
 Net cash generated from financing activities         71        21      167
---------------------------------------------------------------------------


 Net decrease in cash and cash equivalents      (33,134)  (21,149) (21,251)

 Exchange gains/(losses) on cash and bank
 overdrafts                                        1,296     6,988    3,605

 Cash and cash equivalents at beginning of the
 period                                           39,215    56,861   56,861
---------------------------------------------------------------------------
 Cash and cash equivalents at end of the period    7,377    42,700   39,215
---------------------------------------------------------------------------

Notes to the interim accounts

1. Basis of Preparation and Accounting Policies

The interim financial statements do not comprise statutory accounts within the meaning of Section 434 of the Companies Act 2006. Statutory accounts for the year ended 30 June 2009 were approved by the Board of Directors on 24 September 2009 and delivered to the Registrar of Companies. The report of the auditors on those accounts was unqualified, did not contain an emphasis of matter paragraph and did not contain any statement under Section 498 of the Companies Act 2006. This condensed consolidated interim financial information has been reviewed, not audited.

This condensed consolidated half-yearly financial information for the six months ended 31 December 2009 has been prepared in accordance with the Disclosure and Transparency Rules of the Financial Services Authority and with IAS 34 - 'Interim Financial Reporting' as adopted by the European Union. This half- yearly condensed consolidated financial report should be read in conjunction with the annual financial statements for the year ended 30 June 2009, which have been prepared in accordance with IFRS as adopted by the European Union. Except as described below, the accounting policies adopted are consistent with those of the annual financial statements for the year ended 30 June 2009, as described in those financial statements.

Taxes on income in interim periods are accrued using the tax rate that would be applicable to total expected annual earnings.

The following new standards, amendments to standards or interpretations are mandatory for the first time for the financial year beginning 1 July 2009 and have been applied by the Group:

* IAS 1 (revised), 'Presentation of financial statements'. The revised standard prohibits the presentation of items of income and expenses (that is 'non-owner changes in equity') in the statement of changes in equity, requiring 'non-owner changes in equity' to be presented separately from owner changes in equity. All 'non-owner changes in equity' are required to be shown in a performance statement. Entities can choose whether to present one performance statement (the statement of comprehensive income) or two statements (the income statement and statement of comprehensive income). The Group has elected to present two statements. The interim financial statements have been prepared under the revised disclosure requirements.

* IFRS 8, 'Operating segments'. IFRS 8 replaces IAS 14, 'Segment reporting'. It requires a 'management approach' under which segment information is presented on the same basis as that used for internal reporting purposes. Management considers that there is only one reportable segment: drug development. Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker has been identified as the Senior Management Team that makes strategic decisions. Assets, liabilities and overheads are allocated to this one segment.

* IFRS 2 (amendment), 'Share-based payment'. IFRS 2 (amendment) deals with vesting conditions and cancellations. The amendment does not have a material impact on the Group's financial statements.

* IAS 32 (amendment), 'Financial instruments: Presentation'. The amendment does not have a material impact on the Group's financial statements.


The following new standards, amendments to standards or interpretations are mandatory for the first time for the financial year beginning 1 July 2009 and have been applied by, but are not currently relevant to the Group:

* IAS 39 (amendment), 'Financial instruments: Recognition and measurement'. The amendment does not have an impact on the Group's financial statements.

* IFRS 3 (revised), 'Business combinations' and consequential amendments to IAS 27, 'Consolidated and separate financial statements', IAS 28, 'Investments in associates' and IAS 31, 'Interests in joint ventures', effective prospectively to business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after 1 July 2009. The revised standard continues to apply the acquisition method to business combinations, with some significant changes.

There are no other new Standards likely to have an effect on the financial statements for the year ending 30 June 2010.

2. Segmental information

Antisoma's operating segments are being reported based on the financial information provided to the Senior Management Team, which is used to make strategic decisions. The directors are of the opinion that under IFRS 8 - 'Operating segments' the Group has only one operating segment, being drug development.

The Senior Management Team assesses the performance of the operating segment on financial information which is measured and presented in a manner consistent with that in the financial statements.

All revenue is derived from customers whose operations are located in the US and Europe.

The following table shows the carrying value of segment assets by location of assets:


-----------------------------------------------------------
                    6 months      6 months
                       ended         ended     Year ended
                 31 Dec 2009   31 Dec 2008   30 June 2009

                       £'000         £'000          £'000
-----------------------------------------------------------
  Total assets

  UK                  89,301        97,030        105,331

  US                  27,806        31,644         26,825
-----------------------------------------------------------
  Total              117,107       128,674        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:

------------------------------------------------------------------
                           6 months      6 months
                              ended         ended     Year ended
                        31 Dec 2009   31 Dec 2008   30 June 2009

                   
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