LONDON, May 13, 2004 (PRIMEZONE) -- Antisoma plc (LSE:ASM), the biotechnology company developing novel anti-cancer drugs, today announces its results for the three months ended 31 March 2004.
Summary
- Cash and cash equivalents as at 31 March 2004 of GBP39.7 million
vs GBP34.9 million at 31 March 2003
- Revenues increased to GBP5.0 million for the quarter from GBP4.2
million in the same period last year
- Operating loss increased to GBP1.2 million for the quarter from
GBP0.1 million in the same period last year
- R1549 discontinued following results of phase III ovarian cancer
study
- AS1404 completes phase I trials
- AS1405 starts clinical trials in brain cancer
- Ursula Ney joins as Chief Operating Officer
Dr Barry Price, Chairman of Antisoma, commented: "Whilst we were
disappointed with the R1549 results, we go forward with confidence as
we have three drugs in clinical trials, almost GBP40 million in the
bank and a strong alliance with Roche. We remain focused on adding
value to our oncology portfolio, both by advancing existing
programmes and by judicious acquisition of new drugs. We are
evaluating a range of opportunities and expect to in-license a new
clinical product this year."
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 company'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
We suffered a setback at the end of the April when R1549 was found
not to improve outcomes for patients in our ovarian cancer phase III
study. Though development of R1549 has now been halted, findings from
the trial will be of interest to clinicians concerned with ovarian
cancer, and will therefore be presented at the American Society of
Clinical Oncology meeting this June. As Roche's William Burns
highlighted, results of this kind are unfortunately 'not unexpected
in the development of novel treatment modalities.' Recognising the
risks intrinsic to drug development, we had taken steps to ensure
that our long-term growth prospects were not overly dependent on any
one product. We have established a broad pipeline, including three
products in clinical trials as well as a variety of promising
preclinical drugs. We also have almost GBP40 million to support our
drug development activities and a strong alliance with Roche, which
provides us with a clear route through which to advance more drugs
into late-stage trials and towards commercialisation.
AS1404
In March, we successfully completed the third and final phase I study
of AS1404 as a monotherapy. We are now preparing plans for a phase II
programme of combination studies, which is scheduled to start during
the second half of 2004.
AS1404 belongs to a class of drugs called 'vascular targeting agents'
that specifically disrupt tumour blood vessels and, as such, the drug
has potential against a wide variety of cancers. AS1404 is considered
most likely to provide a benefit when used alongside other therapies
and it is intended that separate trials will be conducted in
different tumour types, each combining AS1404 with an established
cancer treatment. In at least one of the trials, AS1404 will be given
with taxane drugs because this combination has shown particular
promise in preclinical work.
AS1405
During the period, AS1405 started its first clinical trial in
patients with a highly malignant brain cancer called glioma. The
phase I trial will provide information on safety, dosing and
distribution of the drug, as well as looking for any initial signs of
anti-tumour activity. Patients included in the study have suffered a
relapse of their glioma with regrowth of the tumour after their
initial treatment. In the trial, the majority of the new tumour
growth is removed by surgery, then AS1405 is injected into the cavity
left in the brain. AS1405 is a radiolabelled antibody that binds to a
protein found around new tumour blood vessels. It delivers a targeted
dose of radiation with the aim of preventing or delaying the relapse
of cancer.
Because glioma is a relatively rare cancer, a so-called 'niche
indication', AS1405 is not included in Antisoma's alliance with
Roche. Antisoma intends to pursue alternative routes to
commercialisation, with the intention to maximise its retained share
of the product's value. Given the very poor results with current
treatments for glioma, Antisoma considers this an attractive
opportunity. The Company estimates that on the basis of the need for
a suitable surgical history, and taking together newly diagnosed
patients and those with recurrent disease, some 29,000 patients could
be eligible for the treatment each year in North America, Europe and
Japan.
R1550
Recruitment is progressing into the phase I study of R1550 being
conducted in the USA by Roche. The drug is being evaluated in women
with locally advanced or metastatic (spreading) breast cancer.
Management
We announced in February the appointment of Dr Ursula Ney as Chief
Operating Officer. Reporting to CEO Glyn Edwards, her role is to
oversee both the company's established drug development programmes
and its business development activities. Dr Ney was previously CEO of
Charterhouse Therapeutics Ltd and spent thirteen years at Celltech
plc, where she was Director of Development from 1993 to 2001 and
served on the Celltech plc board from 2000 to 2001.
Financial Review
Results of operations - nine months ended 31 March 2004
Revenues for the nine months ended 31 March 2004 totalled GBP14.3
million (2003: GBP7.1 million). Revenues represent amounts earned
under the Roche agreements of GBP6.8 million (2003: GBP3.0 million)
recognised from the (GBP23.2 million) upfront payment received and
GBP7.5 million (2003: GBP2.8 million) in relation to the development
costs of R1549 and R1550. Revenues in the comparative period also
included GBP1.3 million under the now terminated agreement with
Abbott Laboratories. The Roche agreements were signed on 16 November
2002 and the revenues for the comparative period reflect amounts
earned from that date.
Operating expenses increased to GBP16.6 million (2003: GBP12.3
million), including research and development expenses of GBP12.7
million (2003: GBP9.2 million). The increase in operating expenditure
represents increased development expenditure in our clinical and
preclinical portfolios, the costs associated with the acquisition of
additional royalty rights from Cytogen and the in-licensing of the
telomerase inhibitor programme together with a general increase in
Company activities.
A claim for Research and Development tax relief amounting to GBP1.2
million on qualifying expenditure for the year ended 30 June 2003 was
made in the period. This compares with tax relief claimed in the
prior year of GBP1.1 million.
Losses for the nine months ended 31 March 2004 decreased to GBP0.2
million (2003: GBP3.4 million), primarily as a result of the impact
of the increased revenues, offset by increased operating expenses.
Results of operations - three months ended 31 March 2004
Revenues for the three months ended 31 March 2004 totalled GBP5.0
million (2003: GBP4.2 million), representing GBP2.3 million (2003:
GBP2.3 million) revenue recognised from the upfront payments received
under the Roche agreement and GBP2.7 million (2003: GBP1.9 million)
in relation to reimbursement of development costs for R1549 and
R1550.
Operating expenses of GBP6.3 million (2003: GBP4.3 million) include
research and development spending of GBP5.0 million (2003: GBP3.1
million).
Net profits for the three months to 31 March 2004 were GBP0.3 million
(2003: GBP0.2 million).
Liquidity and capital resources
Cash at bank and held in short-term investments totalled GBP39.7
million at 31 March 2004 (GBP34.9 million at 31 March 2003). Net cash
outflow from operating activities for the quarter was GBP3.4 million
(quarter ended 31 March 2003: GBP7.1 million). The net cash outflow
for the nine-month period was GBP7.5 million compared with a net cash
inflow of GBP10.3 million for the nine months ended 31 March 2003.
Debtors have increased to GBP4.6 million from GBP3.6 million at 31
March 2003 as a result of the claim for Research and Development tax
relief, which was received shortly after the period end. Creditors
have decreased to GBP15.7 million from GBP22.9 million at 31 March
2003, largely as a result of the recognition of deferred income
relating to the upfront payments received from Roche.
The increase in fixed assets of GBP1.1 million represents the
extension of the office and laboratory facilities and the purchase of
associated equipment.
Loss per share
The profit per share for the quarter ended 31 March 2004 was 0.1p
(2003: 0.1p - restated to take account of the bonus element of the
Placing and Open Offer). Loss per share for the nine months ended 31
March 2003 has decreased from 1.6p (similarly restated) to 0.1p in
the nine months ended 31 March 2004, reflecting the impact of the
increased revenues from Roche.
Outlook
We expect to make significant advances in our oncology pipeline over
the next eighteen months. Our phase II programme of combination
studies on AS1404 is planned to start later this year, and multiple
trials of this agent will be underway in different cancers during
2005. Key data are expected from a number of our clinical programmes
during that year. Management believes that investors' prospects for
returns are maximised by having multiple drugs in late-stage trials,
as each of these provides short- to medium-term upside potential. We
therefore remain committed not only to the development of our
existing pipeline products but also to our previously announced plans
to add a further clinical product to our portfolio during 2004.
Consolidated profit and loss account
For the nine months ended 31 March 2004
9 months 9 months 3 months Year
ended ended ended ended
31 Mar 31 Mar 31 Mar 30 June
2004 2003 2004 2003
unaudited unaudited unaudited audited
GBP'000 GBP'000 GBP'000 GBP'000
Revenue 14,298 7,097 5,019 11,837
Operating expenses (16,611) (12,268) (6,268) (17,212)
-------- -------- -------- --------
Operating loss (2,313) (5,171) (1,249) (5,375)
Interest receivable 943 677 391 978
-------- -------- -------- --------
Loss on ordinary (1,370) (4,494) (858) (4,397)
activities
before taxation
Taxation on ordinary 1,178 1,098 1,178 1,098
activities -------- -------- -------- --------
(Loss)/profit on (192) (3,396) 320 (3,299)
ordinary -------- -------- -------- --------
activities after
taxation
(Loss)/earnings per
1p share
Basic and diluted (0.1p) (1.6p)* 0.1p (1.5p)*
-------- -------- -------- --------
Weighted average 241,816 216,124* 266,077 219,892*
number -------- -------- -------- --------
of shares (000's)
* Loss per share and weighted average number of shares for the nine
months ended 31 March 2003 and the year ended 30 June 2003 have been
restated to take account of the bonus element of the Placing and Open
Offer. The bonus arises because the shares were issued at a discount
to market price.
Consolidated balance sheet
at 31 March 2004
31 Mar 31 Mar 30 June
2004 2003 2003
unaudited unaudited audited
GBP'000 GBP'000 GBP'000
Fixed assets 1,368 284 263
-------- -------- --------
Current assets
Debtors 4,637 3,564 3,529
Short term investments 22,669 33,459 31,854
Cash at bank and in hand 17,071 1,476 2,141
-------- -------- --------
44,377 38,499 37,524
Creditors: amounts falling due (13,856) (11,895) (13,013)
within -------- -------- --------
one year
Net current assets 30, 521 26,604 24,511
-------- -------- --------
Total assets less current 31,889 26,888 24,774
liabilities
Creditors: amounts falling due (1,872) (10,995) (8,715)
after more
than one year
Provisions for liabilities and (109) - (70)
charges -------- -------- --------
Net assets 29,908 15,893 15,989
-------- -------- --------
Capital and reserves
Called up share capital 6,993 6,613 6,613
Share premium account 69,683 55,952 55,952
Other reserves 4,300 4,300 4,300
Profit and loss account (51,068) (50,972) (50,876)
-------- -------- --------
Total shareholders' funds 29,908 15,893 15,989
-------- -------- --------
Shareholders' funds analysed as:
Equity shareholders' funds 25,576 11,561 11,657
Non-equity shareholders' funds 4,332 4,332 4,332
-------- -------- --------
29,908 15,893 15,989
-------- -------- --------
Consolidated cash flow statement
for the nine months ended 31 March 2004
9 months 9 months 3 months Year
ended ended ended ended
31 Mar 31 Mar 31 Mar 30 June
2004 2003 2004 2003
unaudited unaudited unaudited audited
GBP'000 GBP'000 GBP'000 GBP'000
Net cash (7,470) 10,346 (3,419) 9,185
(outflow)/inflow -------- -------- -------- --------
from
operating activities
Returns on
investments and
servicing of finance
Interest received 957 651 415 897
Net cash inflow from 957 651 415 897
returns on -------- -------- -------- --------
investments and
servicing of finance
Net cash inflow from - 1,098 - 1,098
taxation -------- -------- -------- --------
Capital expenditure
and financial
investment
Purchase of tangible (1,431) (186) (348) (212)
fixed assets -------- -------- -------- --------
Sale of tangible - - - 1
fixed assets
Purchase of (423) - - -
intangible fixed
assets
(1,854) (186) (348) (211)
-------- -------- -------- --------
Net cash (8,367) 11,909 (3,352) 10,969
(outflow)/inflow -------- -------- -------- --------
before
management of liquid
resources and
financing
Management of liquid
resources
Purchase/(Sale) of 9,185 (15,500) 3,785 (13,895)
current asset -------- -------- -------- --------
Investments
Financing
Issue of shares 15,204 4,147 - 4,147
Expenses paid in (1,092) - 7 -
connection with
share issues
14,112 4,147 7 4,147
-------- -------- -------- --------
Increase/(decrease) 14,930 556 440 1,221
in cash -------- -------- -------- --------
Notes to the financial statements
1. Basis of reporting
The interim financial statements have been prepared in accordance
with UK Generally Accepted Accounting Principles ('UK GAAP') on the
basis of the accounting policies set out in the Group's 2003
statutory accounts.
The statements were approved by the Board of Directors on 11 May 2004
and are unaudited.
The financial information contained in this announcement does not
constitute statutory accounts within the meaning of Section 240 of
the Companies Act 1985. The figures for the year ended 30 June 2003
have been extracted from the statutory accounts which have been filed
with the Registrar of Companies and which are available on request
from the Company Secretary, Antisoma plc, West Africa House, Hanger
Lane, Ealing, London W5 3QR. The auditors' report on those accounts
was unqualified and did not contain any statement under section
237(2) or section 237(3) of the Companies Act 1985.
2. Operating expenses
9 months 9 months 3 months Year
ended ended ended ended
31 Mar 31 Mar 31 Mar 30 June
2004 2003 2004 2003
unaudited unaudited unaudited audited
GBP'000 GBP'000 GBP'000 GBP'000
Administrative 3,894 3,098 1,240 4,179
expenses
Research and 12,717 9,170 5,028 13,033
development -------- -------- -------- --------
Operating expenses 16,611 12,268 6,268 17,212
-------- -------- -------- --------
This information is provided by RNS
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