SOURCE: Antisoma plc

February 21, 2008 02:18 ET

Antisoma plc reports half-year results

LONDON--(Marketwire - February 21, 2008) - Cancer drug developer Antisoma plc (LSE: ASM; USOTC:ATSMY) announces its interim financial information for the period ended 31 December 2007.

Highlights

ASA404

* Positive survival data from second phase II lung cancer trial

* Encouraging interim findings from phase II prostate cancer trial

* Broad patient population selected for phase III lung cancer trial

AS1411

* Advanced into phase II in AML (acute myeloid leukaemia)

AS1409

* Phase I trial started in renal cancer and melanoma (announced today)

Financial highlights

* Six month revenues of £16.5 million (2006: £0.3 million)

* Profit before tax of £4.1 million (2006: loss £7.5 million)

* Cash resources at 31 December 2007 of £50.4 million (2006: £33.6 million)


Glyn Edwards, CEO of Antisoma, said: "We continue to advance our portfolio of cancer drugs, with our lead drug ASA404 about to enter phase III and the first phase II data on AS1411 expected soon. We have strengthened our financial position considerably by partnering ASA404 with Novartis, leaving us well placed to realise further value from our current pipeline and to enhance our portfolio with new drugs when opportunities arise."

An analyst presentation is scheduled for 09:30 GMT on Thursday, February 21st, and a webcast will be available to all on Antisoma's website at www.antisoma.com.

For live viewing of the webcast, it is recommended that viewers log on 15 minutes early in order to register and download any necessary software.

Enquiries:

Glyn
Edwards
Chief Executive Officer

Raymond
Spencer
Chief Financial Officer

Daniel
Elger
Director of Communications,
Antisoma
plc
+44 (0)7909 915 068

Mark Court, Lisa Baderoon, Rebecca Skye Dietrich
Buchanan Communications
+44 (0)20 7466 5000

Brian Korb
The Trout Group
+1 212 477 9007

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 we have advanced our pipeline of cancer drugs, building on the global licensing deal we signed with Novartis in April for our vascular disrupting agent, ASA404. We have announced further supportive data from phase II trials of ASA404 in lung and prostate cancers. We have also started phase II testing of our aptamer drug, AS1411, and have made preparations to start phase II testing of AS1402 later this year. Today we announce that we have taken a fourth drug, AS1409, into clinical trials. Our investment in these programmes is underpinned by a strong financial position, with the business currently having cash resources exceeding £50 million and a further $25 million payment expected from Novartis in the near future.

ASA404 - strong phase II data support imminent phase III study

Our licensing partner, Novartis, will soon start a phase III trial of ASA404 in non-small cell lung cancer. This will be a large, multicentre, multicountry trial designed to support applications for marketing authorisations. Lung cancer is an area of high unmet medical need and is amongst the most prevalent cancers worldwide. Importantly, the ASA404 trial will include a broad range of lung cancer patients. More details will be announced shortly, when the trial begins.

The phase III trial will build on two positive phase II trials in lung cancer. A randomised trial showed a substantial improvement in patients' survival when ASA404 was added to standard chemotherapy. Patients receiving ASA404 had a median survival of 14 months, compared with 8.8 months for those receiving chemotherapy alone. In September, we presented results from a second lung cancer trial at the World Congress on Lung Cancer. These strongly corroborated the findings from the first trial: patients receiving ASA404 with chemotherapy had a median survival of 14.9 months.

ASA404 also has potential against a variety of other solid tumours. A randomised phase II study is ongoing in hormone-refractory prostate cancer. Positive PSA data were presented at the ASCO meeting last summer, and in October we announced further encouraging interim data from the trial. We now look forward to median survival data, which are expected in the second half of this calendar year.

AS1411 - enters phase II in AML

In August we announced the start of the phase II programme for our aptamer drug, AS1411. This has begun with a 70-patient randomised trial in AML (acute myeloid leukaemia). We are comparing patients receiving the standard current therapy, cytarabine, with patients receiving cytarabine plus AS1411. Two different doses of AS1411, 10 and 40 mg/kg/day, are being tested. The first data from the trial - comparing outcomes in the 10 mg/kg/day group with those of patients on standard therapy - will be available during the second quarter of this calendar year.

Preclinical data support development of AS1411 across a range of both solid and blood cancers. New mechanistic data supporting the trial in AML were presented at the American Society of Hematology meeting in December. Our increasing understanding of the drug's effects is being used to determine which other indications should be prioritised for development. Details of these plans will be announced in the near future. They will include phase II development in renal cancer, where promising evidence of activity was seen in phase I.

AS1402 - advancing to phase II this year

Our antibody drug AS1402 is on track to enter a randomised phase II trial in breast cancer during 2008. We are now close to finalising plans for this study.

AS1409 - enters the clinic

Our targeted IL-12 drug AS1409 has entered the clinic in a phase I trial in melanoma and renal cancer (see separate announcement today).

US operation established

We have opened an office in Princeton, New Jersey, to support the increasing scale of our clinical trials work, much of which is being carried out in the United States.

Financial review

Results of operations

We received $75 million (£38.2 million) from Novartis shortly after signing the ASA404 agreement in April 2007. This is being recognised as revenue on a time-apportioned basis between April 2007 and June 2008. In the six months ended 31 December 2007 we have recorded revenues totalling £16.5 million, compared with £0.3 million for the period ended 31 December 2006.

Total operating expenses for the six months ended 31 December 2007 were £13.9 million (2006: £8.1 million). The rise of £3.6 million in research and development expenditure reflects increased investment in the development of AS1411, AS1402 and AS1409, offset by Novartis assuming liability for costs relating to the development of ASA404. The increase of £2.2 million in administrative expenses is attributable to a number of factors, including foreign exchange losses, costs associated with preparation for a potential NASDAQ listing, activities to acquire new oncology assets and general growth within the Group. We plan to continue the expansion of our development activities, with ongoing investment in our current drug portfolio and an intention to add new oncology assets to our pipeline.

The agreement with Novartis has resulted in profits after tax of £6.2 million for the six months ended 31 December 2007, compared with losses of £6.4 million for the six-month period ended 31 December 2006.

Liquidity and capital resources

Cash, cash equivalents and short-term deposits amounted to £50.4 million as at 31 December 2007 (30 June 2007: £61.4 million; 31 December 2006: £33.6 million). Net cash used in operating activities for the six months ended 31 December 2007 was £10.7 million (six months ended 31 December 2006: £6.5 million). In addition a milestone payment of $25 million will be due from Novartis following their commencement of a phase III clinical study of ASA404 in lung cancer.

Taxation

During the period to 31 December 2007 we have received an R&D tax credit amounting to £2.0 million (31 December 2006: £2.1 million). Additionally, we have recognised a tax credit in the period of £2.1 million. This represents an increase in the deferred tax asset less a provision for current taxation on interest received.

Profit/(Loss) per share

The basic profit per share for the half-year ended 31 December 2007 was 1.38p. The loss per share for the half-year ended 31 December 2006 was 1.66p.

Outlook

2008 promises to be a significant year for Antisoma, with ASA404 progressing to phase III and other drugs advancing through development. The first phase II data on AS1411 are expected in the second quarter, followed by survival data from the ASA404 prostate cancer trial in the second half. With a strong balance sheet, we are well placed to invest in and add value to our current pipeline and to add further promising drugs to our portfolio when opportunities arise.

Barry Price
Chairman
21 February 2008


Consolidated income statement
for the six months ended 31 December 2007

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

                                         2007       2006         2007
                                    unaudited  unaudited      audited
                              Notes     £'000      £'000        £'000

Revenue                                16,526        334        7,956

Research and development                                     (14,511)
expenditure                           (9,426)    (5,837)
Administrative expenses               (4,482)    (2,272)      (7,324)
Total operating expenses             (13,908)    (8,109)     (21,835)

Operating profit/(loss)                 2,618    (7,775)     (13,879)

Interest receivable                     1,502        281        1,176

Profit/(loss) before taxation           4,120    (7,494)     (12,703)

Taxation                                2,050      1,142        2,953

Profit/(loss) for the period    4       6,170    (6,352)      (9,750)

Profit/(loss) per ordinary
share
Basic                           3       1.38p    (1.66)p      (2.36)p
Diluted                         3       1.33p    (1.66)p      (2.36)p


All income and expenses above arise from continuing operations


Consolidated statement of recognised income and expense
for the six months ended 31 December 2007

                                       6 months   6 months       Year
                                       ended 31   ended 31   ended 30
                                       December   December       June
                                           2007       2006       2007
                                      unaudited  unaudited    audited
                                          £'000      £'000      £'000

Profit/(loss) for the period              6,170    (6,352)    (9,750)

Exchange translation difference on
consolidation                                71    (1,260)    (1,638)

Total recognised gain/(expense) for
the period                                6,241    (7,612)   (11,388)



Consolidated balance sheet
as at 31 December 2007

                                       As at 31   As at 31   As at 30
                                       December   December       June
                                           2007       2006       2007
                                      unaudited  unaudited    audited
                                Notes     £'000      £'000      £'000
                                                                    A
ASSETS
Non-current assets
Goodwill                                  5,548      5,623      5,523
Intangible assets                        19,136     17,748     19,065
Property, plant and equipment               531        477        485
Deferred tax asset                        3,158          -        750
                                         28,373     23,848     25,823
Current assets
Trade and other receivables               1,751        601      2,460
Current tax assets                            -      1,142      2,011
Short-term deposits                      33,536          -     10,000
Cash and cash equivalents                16,842     33,585     51,414
                                         52,129     35,328     65,885
LIABILITIES
Current liabilities
Trade and other payables                (5,484)    (3,251)    (7,492)
Deferred income                        (15,823)      (573)   (31,905)
Income tax payable                        (358)          -          -
Provisions                                (150)      (219)      (341)
Net current assets                       30,314     31,285     26,147
Total assets less current
liabilities                              58,687     55,133     51,970

Non-current liabilities
Deferred tax liabilities                (5,548)    (5,623)    (5,523)
Provisions                                 (77)      (148)      (168)
                                        (5,625)    (5,771)    (5,691)

Net assets                               53,062     49,362     46,279

Shareholders' equity
Share capital                    4        8,797      8,783      8,795
Share premium                    4      100,483    100,265    100,451
Other reserves                   4       18,642     18,949     18,571
Profit and loss account          4     (74,860)   (78,635)   (81,538)
Total shareholders' equity               53,062     49,362     46,279


Consolidated cash flow statement
for the six months ended 31 December 2007

                                          6 months  6 months     Year
                                          ended 31  ended 31 ended 30
                                          December  December     June
                                              2007      2006     2007
                                         unaudited unaudited  audited
                                             £'000     £'000    £'000

Cash flows from operating
activities
Profit/(loss) for the period/year            6,170   (6,352)  (9,750)
Add back:
Foreign exchange                               136         -      848
Interest                                   (1,502)     (281)  (1,176)
Tax                                        (2,050)   (1,142)  (2,953)
Adjustments for:
Impairment of acquired intellectual
property rights                                  -         -      144
Depreciation of property, plant and
equipment                                      162       158      321
Share-based payments                           508       398      893
Operating cash flows before movement in
working capital                              3,424   (7,219) (11,673)
Decrease/(increase) in debtors               1,239        42  (1,500)
(Decrease)/increase in creditors          (18,372)   (1,759)   34,323
Cash generated from/(used in)
operations                                (13,709)   (8,936)   21,150
Interest received                              972       374    1,144
Research and development tax credit
received                                     2,011     2,092    2,092
Net cash (used in)/generated from
operating activities                      (10,726)   (6,470)   24,386

Cash flows from investing activities
Purchase of property, plant and
equipment                                    (208)      (17)    (188)
Purchase of intangible assets                    -         -  (1,839)
(Purchase)/sale of short-term deposits    (23,536)     5,506  (4,494)
Net cash (used in)/generated from
investing activities                      (23,744)     5,489  (6,521)

Cash flows from financing activities
Proceeds from issue of ordinary share
capital                                         34    26,305   26,503
Expenses paid in connection with issue
of ordinary share capital                        -   (1,151)  (1,518)
Net cash generated from financing
activities                                      34    25,154   24,985

Net (decrease)/increase in cash and cash
equivalents                               (34,436)    24,173   42,850
Exchange gains/(losses) on cash and
bank overdrafts                              (136)         -    (848)
Cash and cash equivalents at beginning
of year                                     51,414     9,412    9,412
Cash and cash equivalents at end of
year                                        16,842    33,585   51,414


For a full version of this report including notes and the Auditors' Independent review report go to www.antisoma.com


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