SOURCE: Antisoma plc

September 14, 2009 11:55 ET

Antisoma's preliminary results for the year ended 30 June 2009

LONDON, UK and CAMBRIDGE, MA--(Marketwire - September 14, 2009) - Antisoma plc (LSE: ASM; USOTC: ATSMY) today announces its preliminary results for the year ended 30 June 2009. These results have been prepared under International Financial Reporting Standards ('IFRS') as adopted for use by the European Union.

Highlights of 2008/2009

ASA404 programme advances and expands

  * Strong partnership maintained with Novartis
  * Phase III trial in first-line lung cancer completes enrollment
    of 1200 patients (September 2009)
  * Phase III trial in second-line lung cancer initiated
  * Breast cancer selected as next indication for development

AS1413 development gains momentum

  * Phase III trial in secondary AML expanded
  * Phase II trial shows durable responses in secondary AML

AS1411 programme advances

  * Positive data from phase II trial in AML
  * Plans announced for phase IIb development in AML
  * Phase II trial in renal cancer completes patient enrolment

Value realised from oral fludarabine asset

  * Drug approved by FDA
  * Divested to sanofi-aventis in USD 65 million deal

Strong cash position

  * Oral fludarabine divestment extends cash runway to mid-2011
  * Cash life now extends beyond expected timing of key phase III
    data
  * Cash and short-term deposits of GBP 67.0 million at 30 June
    2009
  * Full-year loss of GBP 16.4 million

Commenting on the results, Glyn Edwards, CEO of Antisoma, said: "We have made important progress this year, with gathering momentum on our two phase III programmes, positive phase II data for a third product and our first product approval from the FDA. With the pipeline maturing, we now have a dual focus on driving products towards regulatory approvals and on building a strong platform for product commercialisation."

Eric Dodd, Antisoma's CFO, added: "The successful divestment of oral fludarabine to sanofi-aventis has added significantly to our cash resources, further strengthening our balance sheet. We can now fund all our priority programmes until mid-2011, beyond the time we expect key phase III data for ASA404 and AS1413."

A webcast and conference call will be held today at 9:30 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 UK Toll (US Toll +1 718 354 1390) and using the Confirmation Code: 9656482. A recording of the webcast will also be available afterwards on the Antisoma website.

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.

Joint Chief Executive and Chairman's statement

Overview

We have seen excellent progress this year on both of our phase III drugs, ASA404 and AS1413. Our partner Novartis has advanced and expanded the ASA404 programme in lung cancer. Meanwhile, we have enlarged the AS1413 phase III trial in secondary acute myeloid leukaemia (secondary AML) and reported new data supporting this trial. We have also presented positive phase II data for a third product, AS1411, and were successful in gaining FDA approval for - and then divesting - a non-core asset, oral fludarabine. With the funds from this divestment, we have sufficient cash to fund all our priority programmes until mid-2011, which is after the time we expect key phase III data for both ASA404 and AS1413. We are therefore confident in our ability to reach these two potentially transformational sets of results within the current cash life of the business.

ASA404 programme advances and expands

Our Tumour-Vascular Disrupting Agent, ASA404, is making good progress in the capable hands of our partner, Novartis. Earlier this month, we announced that the 1200-patient phase III trial (ATTRACT-1) testing the drug as a first-line treatment for non-small cell lung cancer (the main form of lung cancer) had completed patient enrolment. ATTRACT-1 builds on phase II data showing a five-month improvement in median survival when ASA404 was added to standard first-line chemotherapy for lung cancer. We expect that final data from the ATTRACT-1 study will be available in late 2010 or early 2011 and that filings for marketing licences will follow during 2011 if these data are positive.

In January Novartis started a second, 900-patient phase III trial (ATTRACT-2), testing ASA404 in patients who have already received one round of treatment for non-small cell lung cancer. This trial is designed to support applications to market ASA404 as a second-line treatment. We are very pleased that Novartis has decided to evaluate ASA404 in both the first-line and second-line settings, as this will ensure that a broad spectrum of lung cancer patients could be eligible for treatment with the drug.

During the year, the results of the two phase II trials supporting phase III development in lung cancer were published in the British Journal of Cancer and Lung Cancer. We also announced further encouraging findings from a phase II trial in prostate cancer.

In February, we announced that Novartis had decided on priorities for the further development of ASA404. After lung cancer, the next priority will be HER2-negative metastatic breast cancer. The decision to expand the development programme to include breast as well as lung cancer underlines the broad potential of ASA404.

In addition to the USD 100 million that we have already received from Novartis, we can earn substantial further milestone payments based on progress of ASA404 in development and achievement of sales targets. We will also earn royalties on all sales of the drug worldwide, and have a strategically important option to co-commercialise ASA404 in the US.

AS1413 development gains momentum

AS1413 is a novel chemotherapy drug with promising potential as a treatment for blood cancers. A key property of AS1413 is its ability to evade multi-drug resistance mechanisms. These are molecular pumps used by cancer cells to expel drugs, including some of the major chemotherapies in use today. By evading these mechanisms, AS1413 has the potential to work in settings where other treatments are compromised.

We are developing AS1413 initially as a treatment for secondary acute myeloid leukaemia (secondary AML), a form of AML that evolves from prior bone marrow disease or develops following radiotherapy or chemotherapy for other cancers. Patients with secondary AML often have multi-drug resistant disease and there are no drugs approved specifically for this condition.

We are enrolling patients into a pivotal, randomised phase III trial of AS1413 in secondary AML. This trial, called ACCEDE, compares AS1413 plus cytarabine with daunorubicin plus cytarabine, the most common initial treatment for AML. It is being conducted under a Special Protocol Assessment (SPA) agreed with the US Food and Drug Administration (FDA). During the period, we gained agreement from the FDA for an expansion of the trial to 450 patients. In tandem with this expansion, we have increased the number of hospitals involved in the study in the US and opened the trial to recruitment in a variety of countries across Europe, Asia, Australia and Latin America.

The ACCEDE study builds on data from an 88-patient phase II trial of AS1413 in secondary AML. This reported a 39% complete remission rate in patients receiving AS1413 plus cytarabine, which compares favourably with rates of around 25% seen in secondary AML patients receiving daunorubicin plus cytarabine in two previous studies. Long-term follow up data from the AS1413 phase II trial were presented at the American Society of Hematology (ASH) meeting in December. These included the highly encouraging finding that among those patients who showed a complete response to treatment, some 40% were still in remission 18 months after receiving AS1413.

Data from the ACCEDE trial are expected to be available in late 2010 or early 2011. Should results be positive, we plan to market the drug ourselves in the US while seeking partners for marketing in other countries. We believe that beyond the initial opportunity in secondary AML, AS1413 could also have potential in a variety of other blood cancer settings.

AS1411 development advances

Our aptamer drug AS1411 has been the subject of considerable interest this year, with the reporting of the first phase II data on the drug and further data expected in the near future.

At the most recent ASH and ASCO meetings, we reported data from a phase II trial in AML - the first randomised trial to test an aptamer drug as a treatment for cancer. Combination of AS1411 with high-dose chemotherapy increased the response rate compared with chemotherapy alone in patients with disease unresponsive to or relapsed after other treatments. This was achieved without any significant increase in side effects. Following these positive findings, we are planning phase IIb studies with AS1411 in AML. These will be designed to identify the best way for us to approach a pivotal study that would support applications for marketing.

In parallel with the trial in AML, we have been running a single-arm phase II trial in renal cancer. This completed patient enrolment in May, and is expected to report initial data later this year and final data in the first half of 2010.

Like AS1413, AS1411 is unpartnered. We plan to continue development through late-stage trials and to commercialise the product ourselves in the US while seeking partners for other territories.

Other pipeline developments

We have had a number of developments in our earlier stage pipeline. We discontinued development of our antibody drug AS1402 when it became clear that a phase II trial in breast cancer was very unlikely to yield sufficiently positive efficacy data to support further development. Our antibody-cytokine fusion protein AS1409 completed a phase I trial in melanoma and renal cancer, providing encouraging evidence of anti-cancer activity which was presented at the ASCO meeting in June. We are now considering next steps for this product. Our phase I radiolabelled peptide, P2045, was divested to Bryan Oncor, a company with a focus on radiopharmaceuticals. Finally, we continue to make progress with our pre-clinical programmes, including AMPK activators licensed from Betagenon; PPM1D inhibitors being developed through a collaboration with The Institute of Cancer Research; and the Flt-3 programme in autoimmune diseases, acquired last year with Xanthus Pharmaceuticals.

Value realised from oral fludarabine asset

Antisoma acquired oral fludarabine with the acquisition of Xanthus in June 2008. In December, we were successful in gaining FDA approval for the marketing of this drug in chronic lymphocytic leukaemia (CLL). This enabled us to conclude, as planned, a lucrative divestment deal. In May, we sold our rights to market the drug in the US to sanofi-aventis in return for an initial payment of USD 60 million (GBP 39.4 million).

Strong cash position maintained

Antisoma expects its cash resources to last until mid-2011, beyond the time when data are expected from the key phase III studies of ASA404 and AS1413. Divesting of oral fludarabine has removed any potential funding shortfall up to the phase III results. We finished the period with cash and short-term deposits of GBP 67.0 million, which is similar to last year (2008: GBP 66.9 million).

Total revenues for the year ended 30 June 2009 were GBP 25.2 million, compared with GBP 39.5 million last year. This year's revenues reflect recognition of the balance of the USD 100 million upfront and lung cancer phase III initiation milestones from Novartis (GBP 5.4 million) and half of the USD 60 million upfront payment from sanofi-aventis (GBP 19.7 million). The balance of the sanofi-aventis upfront payment is expected to be recognised in the financial year 2009-2010.

Total operating expenses have increased from GBP 28.7 million last year to GBP 40.8 million this year, mainly reflecting an increase in research and development (R&D) costs from GBP 22.2 million to GBP 35.9 million. General and administrative costs were GBP 4.9 million (2008: GBP 6.5 million).

We have recorded a full-year loss of GBP 16.4 million, compared with a profit of GBP 12.3 million last year. At this stage in our development, profits and losses reflect the balance between recognition of deferred revenues and our ongoing operating expenses. This year, operating expenses exceeded the revenues recognised from the Novartis and sanofi-aventis deals.

Preparing for commercialization

In line with our plan to become a company that markets as well as develops cancer drugs, we have made two appointments of individuals with significant commercial experience. Eric Dodd joined in November as Chief Financial Officer, following a career in technology businesses, and Michael Lewis, a senior commercial executive at the medical device company Gambro, has joined our Board as a Non-Executive Director. The Board wishes to thank Raymond Spencer, our former Chief Financial Officer who left Antisoma in December 2008, for his contribution to the development of the Company.

Outlook

We anticipate important pipeline developments in the near future, notably the initiation by Novartis of trials to evaluate ASA404 in a second major cancer indication, metastatic breast cancer. We will also be reporting the first data from our phase II trial of AS1411 in renal cancer before the end of the year, with final data to follow in the first half of 2010.

More broadly, we are moving forward with our plan to transform Antisoma from a drug development company into a business with marketed oncology products. With two drugs now well into phase III testing, our pipeline is advancing in a manner that clearly fits with this objective. The recent announcement that the key phase III trial of ASA404 in lung cancer is fully enrolled emphasises our proximity to potential marketing applications and opportunities to begin generating sustainable revenues from product sales. We look forward to the next period of evolution, confident in the knowledge that we have the financial and human resources to support the advancement of our key assets towards commercialisation.

Glyn Edwards
Chief Executive Officer

Barry Price
Chairman


Unaudited consolidated income statement
for the year ended 30 June 2009


                                               2009  2008[1]
                                     Notes GBP '000 GBP '000

Revenue                                2     25,230   39,527
Cost of sales                               (9,085)        -
Gross profit                                 16,145   39,527

Research and development expenditure       (35,904) (22,249)
Administrative expenses                     (4,884)  (6,480)
Total operating expenses                   (40,788) (28,729)

Operating (loss)/profit                    (24,643)   10,798

Finance income                                5,055    2,578

(Loss)/profit before taxation              (19,588)   13,376

Taxation                                      3,161  (1,047)

(Loss)/profit for the year                 (16,427)   12,329

(Loss)/earnings per ordinary share
Basic                                        (2.7)p     2.7p
Diluted                                      (2.7)p     2.6p

All amounts arise from continuing operations.

[1] Certain costs have been reclassified between research and development expenditure and administrative expenses as disclosed in Note 1.


Unaudited consolidated statement of recognised income and expense for the year ended 30 June 2009

                                                     2009     2008
                                                 GBP '000 GBP '000

(Loss)/profit for the year                       (16,427)   12,329

Exchange translation difference on consolidation    8,923    (235)

Total recognised (expense)/income for the year    (7,504)   12,094


Unaudited consolidated balance sheet
as at 30 June 2009

                                                 2009  2008[1]
                                       Notes GBP '000 GBP '000
ASSETS
Non-current assets
Goodwill                                        6,708    5,559
Intangible assets                              51,257   47,149
Property, plant and equipment                   1,967    2,358
                                               59,932   55,066
Current assets
Trade and other receivables                     1,701    2,113
Current tax receivable                          3,484        -
Short-term deposits                            27,824   10,000
Cash and cash equivalents                      39,215   56,861
                                               72,224   68,974
LIABILITIES
Current liabilities
Trade and other payables                      (7,417)  (9,866)
Current income tax liabilities                      -    (297)
Deferred income                              (19,690)  (5,401)
Provisions                                    (1,902)    (629)

Net current assets                             43,215   52,781
Total assets less current liabilities         103,147  107,847
Non-current liabilities
Deferred income tax liabilities               (6,708)  (5,559)
Provisions                                      (224)     (81)
                                              (6,932)  (5,640)

Net assets                                     96,215  102,207

Shareholders' equity
Share capital                                  10,480   10,467
Share premium                                 119,783  119,629
Shares to be issued                             2,273    2,273
Other reserves                                 46,919   37,996
Profit and loss account                      (83,240) (68,158)
Total shareholders' equity               3     96,215  102,207

[1]Cash and cash equivalents and short-term deposits have been reclassified as disclosed in Note 1.

Unaudited consolidated cash flow statement
for the year ended 30 June 2009

                                                        2009  2008[1]
                                                    GBP '000 GBP '000

Cash flows from operating activities
(Loss)/profit for the year                          (16,427)   12,329
Adjustments for:
   Foreign exchange gain                             (2,238)        -
   Finance income                                    (5,055)  (2,578)
   Tax (credit)/charge                               (3,161)    1,047
   Depreciation of property plant and equipment          650      213
   Derecognition of an intangible asset                8,750        -
   Share-based payments                                1,345    1,051
Operating cash flows before movement in working
capital                                             (16,136)   12,062
Decrease in trade and other receivables                  385      961
Increase/(decrease) in trade and other
payables and deferred income                          12,829 (28,506)
Cash used in operations                              (2,922) (15,483)
Interest received                                      1,951    2,753
Income taxes paid                                      (620)        -
Research and development tax credit received               -    2,011
Net cash used in operating activities                (1,591) (10,719)

Cash flows from investing activities
Purchase of property, plant and equipment              (232)  (1,969)
Sale of property, plant and equipment                      8        -
Purchase of intangible assets                        (1,779)  (1,605)
Purchase of short-term deposits                     (17,824)  (5,000)
Net cash outflow in respect of acquisitions                -    (237)
Net cash used in investing activities               (19,827)  (8,811)

Cash flows from financing activities
Proceeds from issue of ordinary share capital            167   20,966
Expenses paid in connection with issue of ordinary
share capital                                              -    (980)
Net cash generated from financing activities             167   19,986

Net (decrease)/increase in cash and cash
equivalents                                         (21,251)      456
Exchange gains/(losses) on cash and cash
equivalents                                            3,605      (9)
Cash and cash equivalents at beginning of year        56,861   56,414
Cash and cash equivalents at end of year              39,215   56,861

[1] Cash and cash equivalents and short-term deposits have been reclassified as disclosed in Note 1

Notes to the financial information for the year ended 30 June 2009

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 435 of the Companies Act 2006. The information has been extracted from the consolidated financial statements for the year ended 30 June 2009. 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 2008 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.

Reclassification

The Directors have reviewed the classification of certain items within the Income Statement and Balance Sheet and believe, in order to aid comparison, it is more appropriate to classify the following differently than was reported in prior periods:

The Group's definition of cash and cash equivalents has been restated to reflect more accurately the underlying substance of the deposits. Historically cash was classified as a deposit when its duration was over 90 days whereas it now includes all cash deposited for more than three months. The impact of the change is to increase cash and cash equivalents and reduce short-term deposits by GBP nil (2008: GBP 23,000,000). The relevant comparatives in the cash flow statement have been amended to reflect this adjustment.

Certain costs were previously included within administrative expenses and have been reclassified in Research & Development in order to be consistent with industry sector accounting practices. The impact of the change is to increase research and development costs and reduce administrative expenses by GBP 8,177,000 (2008: GBP 3,817,000). Reallocated costs include business development, facilities and a proportion of other overheads directly attributable to research and development activities. There is no impact on operating profit/loss or earnings/loss per share.

2. Segmental information

Primary reporting segment - business segment

The Directors are of the opinion that under IAS 14 - 'Segmental information' 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 2009 were:

                                                        2009     2008
                                                    GBP '000 GBP '000
US
Recognition of income from the divestment of oral
fludarabine
           sanofi-aventis                             19,690        -
Europe
Recognition of upfront and milestone payments on a
time apportioned basis:
           Novartis                                    5,401   38,806
           Other                                           -      265
R&D services and materials
recharged:
           Novartis                                      139      456
Total revenues                                        25,230   39,527


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

                       2009     2008
                   GBP '000 GBP '000
Total assets
UK                  105,331   75,264
US                   26,825   48,776
Total               132,156  124,040

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:

                              2009     2008
                          GBP '000 GBP '000
Capital expenditure
UK                           1,875    3,574
US                             136   26,900
Total                        2,011   30,474

Capital expenditure is allocated based on where the assets are located.


3. Statement of changes in equity

Group

                                           Other    Other
                            Shares      reserve: reserve:   Profit
             Share   Share   to be                             and
           capital premium  issued retranslation   merger     loss    Total
           GBP'000 GBP'000 GBP'000       GBP'000  GBP'000  GBP'000  GBP'000

At 1 July
2007         8,795 100,451       -       (1,024)   19,595 (81,538)   46,279
Profit for
the year         -       -       -             -        -   12,329   12,329
New share
capital
issued       1,672  20,158       -             -   19,660        -   41,490
Expenses on
share issue
taken to
share premium    -   (980)       -             -        -        -    (980)
Share capital
to be issued     -       -   2,273             -        -        -    2,273
Share
options:
value of
employee
services         -       -       -             -        -    1,051    1,051
Foreign
exchange
adjustments
on
consolidation    -       -       -         (235)        -        -    (235)

At 30 June
2008        10,467 119,629   2,273       (1,259)   39,255 (68,158)  102,207

At 1 July
2008        10,467 119,629   2,273       (1,259)   39,255 (68,158)  102,207
Loss for the
year                     -       -             -        - (16,427) (16,427)
New share
capital
issued          13     154       -             -        -        -      167
Share
options:
value of
employee
services         -       -       -             -        -    1,345    1,345
Foreign
exchange
adjustments
on
consolidation    -       -       -         8,923        -        -    8,923

At 30 June
2009        10,480 119,783   2,273         7,664   39,255 (83,240)   96,215

This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.



Copyright © Hugin AS 2009. All rights reserved.

Contact Information

  • 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
    (All media enquiries)
    Mark Court, Lisa Baderoon

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