LONDON, Sept. 15, 2005 (PRIMEZONE) -- Cancer drug developer Antisoma plc (LSE:ASM) today announces its preliminary results for the year ended 30 June 2005.
Highlights of 2004/2005
Advances across the pipeline
-- AS1404 enters phase II development in three cancers
-- Lung cancer study reaches patient recruitment target
(in August 2005)
-- Prostate and ovarian cancer trials also on track
-- AS1411 phase I study reopened (in September 2005) after promising
data reported at ASCO
-- AS1410 selected as lead telomere targeting agent and
manufacturing agreement signed
-- AS1409 fully acquired from EMD-Lexigen collaboration and enters
manufacturing
Acquisition strengthens portfolio
-- Aptamera acquired for 16.0 million pounds in shares -- Promising aptamer drug AS1411 added to pipeline
Financial highlights
-- Cash and liquid resources at 30 June 2005 of 25.0 million pounds (2004: 38.8 million pounds)
-- Full-year net loss of 7.1 million pounds (2004: 0.6 million pounds)
-- Revenues of 6.3 million pounds (2004: 18.1 million pounds)
-- Plan to list on NASDAQ announced; application made for US Level I 'ADR' programme
Commenting on the results, Glyn Edwards, Chief Executive Officer of Antisoma, said: "This has been a year of great progress. We have succeeded both in advancing our established pipeline products and in bringing in an exciting new drug, AS1411, through our acquisition of Aptamera. We look forward with confidence to a year including many important development milestones and results, starting with the first findings from our phase II study of AS1404 in lung cancer."
Except for the historical information presented, certain matters discussed in this preliminary 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 this preliminary announcement. 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.
Joint Chief Executive and Chairman's Statement
Antisoma has made sustained progress throughout the past year, delivering on pledges to advance the drugs in its pipeline and to enhance its portfolio by acquiring a new clinical product. Our achievements illustrate some of the key features of our "search and develop" business model, whereby we acquire promising early-stage cancer drugs and add to their value through effective development programmes:
- Our expertise has enabled us to identify and bring in exciting product candidates from across the world, as illustrated by the positive market reaction to this year's acquisition of Aptamera and its aptamer drug AS1411.
- We have a successful track record in acquiring diverse products from different sources, which has allowed us to build a balanced pipeline and avoid dependence on any particular technology. With a portfolio of drugs in development, we can focus our resources on those most likely to provide shareholder returns, as we did this year by ceasing development of AS1405 to devote more resources to AS1411.
- We have a strong infrastructure for developing new drugs, so we are able to add value rapidly to the drugs that we acquire -- as shown by AS1404, which we have advanced through one phase I and, during the past year, into three phase II trials in different cancers.
- We have two potential routes to commercialise our products, taking some products through development ourselves to retain all their upside potential while the large-market products in our portfolio enter our alliance with Roche, providing us with returns through progress-based milestone payments and royalties on any sales. With this two-stranded approach we can address a range of market opportunities and provide ourselves with various options for the further growth of the Company. During the past year we have acquired AS1411 for independent development while AS1404 and R1550 have continued to progress within the alliance, the latter funded in full by Roche.
The programme of phase II trials for AS1404 is the largest in the Company's history, and is now close to yielding important findings on the efficacy of this drug, which targets the blood vessels on which tumours rely to grow and spread. Three trials in different cancers are evaluating AS1404 in combination with chemotherapy drugs, building on positive preclinical data and the successful completion of phase I trials. The first phase II trial, in non-small cell lung cancer, began in September 2004 and reached its recruitment target during August 2005. We expect to report the first outcomes from this trial -- rates at which patients' tumours respond to treatment -- during this year, with further data on time to disease progression and survival available during 2006. Also anticipated next year are efficacy results from the other AS1404 phase II studies, in prostate and ovarian cancers, which started in May and June 2005, respectively.
Our other clinical products are progressing well through phase I development. Our antibody drug R1550 is now being developed and funded by Roche, and is currently in a US phase I trial in patients with metastatic (spreading) or locally advanced breast cancer. This trial is now most likely to report during the first half of 2006. The aptamer drug AS1411 recently re-entered trials following its incorporation into our pipeline through the acquisition of Aptamera, which is described below.
In addition to our three clinical products, we have two drugs nearing the completion of preclinical development. Last July we announced that we had gained exclusive rights over the antibody-cytokine fusion drug AS1409 (huBC1-huIL12) by acquiring the interest of our collaborator EMD-Lexigen. We have since initiated manufacturing of AS1409 with the intention of starting trials during 2006. During November, we announced that we had selected a lead candidate, AS1410, from our programme of telomere targeting agents, and in June we announced that we had initiated manufacturing and expected AS1410 to enter the clinic in the first half of 2006. Both AS1409 and AS1410 are novel and exciting drugs with substantial potential that will be eligible for potential inclusion into our alliance with Roche.
Company acquisition further diversifies pipeline
In February we completed the acquisition of the private US company, Aptamera, through the issue of 66.5 million new shares, valuing Aptamera at 16.7 million pounds, including acquisition costs. We bought Aptamera on the strength of its lead drug, the aptamer AS1411. In May, promising phase I data on AS1411 were reported at the annual meeting of the American Society of Clinical Oncology (ASCO), with findings of particular interest in three renal cancer patients. We have since been granted US orphan drug status in renal cancer and in September 2005 announced the reopening of the phase I study for recruitment of additional patients with renal and lung cancers. The acquisition of AS1411 adds a DNA aptamer to the three antibody products and two small-molecule drugs among our six priority programmes. These drugs all have distinct mechanisms of action and work via five different targets, providing us with a very high level of pipeline diversity and consequent lack of dependence on any particular technology.
A global company
During the year we announced our intention to list our shares on the NASDAQ market in the US in addition to our listing on the London Stock Exchange. The application to list will be made when the Company's situation and market conditions allow. We already have a significant US shareholder base, which expanded greatly this year through the acquisition of Aptamera. Listing in the US would increase our exposure to the US capital markets, a step that the Directors believe would enhance our long-term growth prospects and our ability to exploit new opportunities for development. As an interim step, we have filed an application for a Level I programme of American Depositary Receipts (ADRs) to enable dollar-denominated trading of our ordinary shares prior to the listing.
As we increase our operational and investor activity in the US, we are pleased to welcome Mr Dale Boden as a Non-Executive Director. Dale is based in Louisville, Kentucky, where we retain a substantial shareholder base following the acquisition of Aptamera. He is President of BF Capital, Inc., a US private investment firm, and serves on the boards of several US companies. We would like to thank Dr Mark Rogers, former Chairman of Aptamera, for serving on the Antisoma Board during the integration of Aptamera from February until June 2005.
Dr Miroslav Ravic, our Chief Clinical Officer, has recently left the Company to pursue his own private business interests. We would like to take this opportunity to thank him for his contribution and wish him well for the future.
Sound finances
Our financial results this year reflect the Company's continued investment in its clinical pipeline, the acquisition of Aptamera and changes in costs and revenues relating to R1549 and R1550. We closed the year with 25.0 million pounds in cash and liquid resources, compared with 38.8 million pounds last year. The money invested has advanced multiple programmes to a stage where we expect to reach significant milestones in development during 2005 or 2006. Our current resources are sufficient to reach these milestones on the three clinical and two most advanced preclinical programmes. The Company will continue to review its cash position in the light of results from its product pipeline and will seek to maintain the financial resources necessary to execute its development programmes.
Total operating costs have fallen to 17.4 million pounds from 21.2 million pounds last year with research and development costs 4.1 million pounds lower at 12.5 million pounds. These figures mask a significant increase in investment in Antisoma's development programmes, which is more than offset in the totals by the near-cessation of expenditure on two programmes -- R1549 and R1550 -- where Antisoma was previously bearing costs and recharging these to Roche.
Reduced revenue, from 18.1 million pounds last year to 6.3 million pounds this year, also reflects reductions in refunding of expenditure by Roche (0.4 pounds compared with 8.7 million pounds for 2004), as well as declining recognition of revenues relating to the 2002 alliance agreement with Roche (5.9 pounds compared with 9.4 million pounds for 2004).
Losses of 7.1 million pounds compared with a 0.6 million pounds loss last year reflect the decrease in revenue partly offset by decreased development expenditure and the recognition of research and development tax credits in respect of the 2004 and 2005 tax years.
Revenues for the six months to 30 June 2005 have fallen to 1.5 million pounds (2004: 8.8 million pounds). This reflects the cessation of development of R1549 and transfer of R1550 to Roche as mentioned above and the absence of any deferred revenue from R1550, which was fully recognised as at 31 December 2004. Operating expenses and development costs were also lower at 9.8 million pounds and 7.5 million pounds, respectively (2004: 10.9 million pounds and 8.9 million pounds, respectively), again reflecting the changes in expenditure on R1549 and R1550 partially offset by increased development costs for other products.
The consolidated balance sheet at 30 June 2005 shows intangible assets of 6.2 million pounds representing the unamortised goodwill arising on consolidation of Aptamera under UK GAAP.
Important newsflow ahead Antisoma moves into a new year with a strong and diverse pipeline of cancer drugs together with the human and capital resources to add further value to its assets. We continue to benefit from the support provided by our strategic alliance partner, Roche, as we approach important newsflow on the products currently included in the alliance, AS1404 and R1550. Both these drugs have potential across a wide range of cancers. In the coming months we will know much more about the efficacy and value of AS1404 and the next steps for development of R1550. Meanwhile, we are delighted to be taking our AS1411 aptamer drug back into patients after very promising results from its first phase I trial and expect to push two more innovative cancer drugs into the clinic in 2006.
Glyn Edwards Chief Executive Officer
Barry Price Chairman
Consolidated profit and loss account
for the year ended 30 June 2005
unaudited audited
2005 2004
'000 pounds '000 pounds
Revenue 6,268 18,118
Operating expenses (17,385) (21,244)
Operating loss (11,117) (3,126)
Interest receivable 1,505 1,340
Loss on ordinary activities before
taxation (9,612) (1,786)
Taxation on loss on ordinary activities 2,477 1,178
Loss on ordinary activities after
taxation and retained loss for the year (7,135) (608)
Loss per 1p share
Basic and diluted 2.44p 0.25p
Consolidated statement of total recognised gains and losses
For the year ended 30 June 2005
unaudited audited
2005 2004
'000 pounds '000 pounds
Loss for the financial year (7,135) (608)
Currency translation differences
on foreign currency net investments (6) -
Total recognised gains and losses
relating to the year (7,141) (608)
Consolidated balance sheet
as at 30 June 2005
unaudited audited
2005 2004
'000 pounds '000 pounds
Fixed assets
Intangible assets 16,206 -
Tangible assets 979 1,280
17,185 1,280
Current assets
Debtors 2,666 2,167
Short-term deposits 23,937 22,381
Cash at bank and in hand 1,108 16,452
27,711 41,000
Creditors: amounts falling due
within one year (5,705) (10,291)
Net current assets 22,006 30,709
Total assets less current liabilities 39,191 31,989
Creditors: amounts falling due
after more than one year (886) (2,485)
Provisions for liabilities and charges (29) (12)
Net assets 38,276 29,492
Capital and reserves
Called up share capital 7,659 6,993
Share premium account 84,942 69,683
Other reserves 4,300 4,300
Profit and loss account (58,625) (51,484)
Total shareholders' funds 38,276 29,492
Shareholders' funds analysed as:
Equity shareholders' funds 33,944 25,160
Non-equity shareholders' funds 4,332 4,332
38,276 29,492
Consolidated cash flow statement
for the year ended 30 June 2005
unaudited audited
2005 2004
'000 pounds '000 pounds
Net cash outflow from operating
activities (15,347) (9,616)
Returns on investments and
servicing of finance
Interest received 1,561 1,318
Net cash inflow from taxation 877 1,178
Capital expenditure and
financial investment
Purchase of tangible fixed assets (130) (1,458)
Sale of tangible fixed assets - 2
Purchase of intangible fixed assets - (697)
Net cash outflow for
capital expenditure and
financial investment (130) (2,153)
Acquisitions
Cash at bank and in hand acquired
with subsidiaries 1 -
Acquisition expenses (704) -
Net cash outflow from acquisitions (703) -
Net cash outflow before management
of liquid
resources and financing (13,742) (9,273)
Management of liquid resources
(Purchase)/sale of current
asset investments (1,556) 9,473
Financing
Issue of shares - 15,204
Expenses paid in connection
with share issues (46) (1,093)
(46) 14,111
(Decrease)/increase in cash (15,344) 14,311
Notes to the financial statements for the year ended 30 June 2005
1. Basis of reporting
The preliminary 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 2004 statutory accounts. The acquisition of Aptamera, Inc. was accounted for using the principles of acquisition accounting. Goodwill in respect of the acquisition of Aptamera, Inc. is being amortised over 15 years from the date of acquisition, which the Directors estimate represents its useful economic life. The statements were approved by the Board of Directors on 13 September 2005 and are unaudited.
As set out in the Joint Chief Executive and Chairman's Statement the Company ended the year with 25 million pounds in cash and liquid resources. The Directors are confident that the Group has sufficient funds to meet the requirements of the business for the foreseeable future. The financial information in this preliminary statement is therefore prepared on the going concern basis.
2. Operating expenses
2005 2004
unaudited audited
Pounds '000 Pounds '000
Administrative expenses 4,926 4,660
Research and
development costs 12,459 16,584
Total operating expenses 17,385 21,244
3. Reconciliation of operating loss to net cash
outflow from operating activities
2005 2004
unaudited audited
Pounds '000 Pounds '000
Operating loss (11,117) (3,126)
Depreciation 435 440
Amortisation of intangibles 463 697
Decrease in debtors 1,053 1,383
Decrease in creditors (6,181) (9,010)
Net cash outflow
from operating activities (15,347) (9,616)
4. Reconciliation of net cash flow to movement
in net funds
2005 2004
unaudited audited
Pounds '000 Pounds '000
(Decrease)/increase
in cash for the year (15,344) 14,311
Cash outflow/(inflow)
from purchase/(sale) of
current asset investments 1,556 (9,473)
Movement in net funds
in the year (13,788) 4,838
Net funds at start
of the year 38,833 33,995
Net funds at end of
the year 25,045 38,833
5. Reconciliation of movements in Group
shareholders' funds
2005 2004
unaudited audited
Pounds '000 Pounds '000
Opening shareholders' funds 29,492 15,989
Issue of shares 15,971 15,204
Expenses of share issue (46) (1,093)
Loss for the year (7,135) (608)
Other recognised
gains and losses (6) --
Closing shareholders' funds 38,276 29,492
The financial information set out in the announcement does not constitute the Group's statutory accounts for the years ended 30 June 2005 or 2004 within the meaning of section 240 of the Companies Act 1985. The financial information for the year ended 30 June 2004 is derived from the statutory accounts for that year which have been delivered to the Registrar of Companies and which are available on request from the Company Secretary, Antisoma plc, West Africa House, Hanger Lane, London, W5 3QR. The auditors' report on those accounts was unqualified and did not contain a statement under either section 237 (2) or 237 (3) of the Companies Act 1985. The statutory accounts for the year ended 30 June 2005 will be finalised on the basis of the financial information presented by the Directors in this preliminary announcement and will be delivered to the Registrar of Companies following the Company's Annual General Meeting.