LONDON, Sept. 16, 2004 (PRIMEZONE) -- Cancer drug development company Antisoma plc (LSE:ASM) today announces its preliminary results for the year ended 30 June 2004.
Announced today
* AS1404 starts phase II combination programme: trial centres open for recruitment of patients with non-small cell lung cancer
Key developments 2003/2004
Clinical pipeline
-- AS1404 completes phase I trials -- AS1405 begins phase I trials against brain cancer glioma -- R1549 discontinued after phase III trial results
Licensing deals
-- Programme of telomere targeting agents (TTAs) licensed from
Cancer Research Technology
-- ATTACK programme fully acquired from collaboration with EMD-
Lexigen (in July 2004)
Management and finances
-- Ursula Ney appointed as Chief Operating Officer
-- 14.1 million raised through placing and open offer
-- Cash and liquid resources at 30 June 2004 of 38.8 million
(2003: 34.0 million), representing 14.6p per share*
-- Full-year net loss reduced to 0.6 million (2003: 3.3 million)
-- Revenues increased to 18.1 million (2003: 11.8 million)
Commenting on the results, Glyn Edwards, Chief Executive Officer of Antisoma, said: "Today's announcement highlights our strong financial position and important advances in our cancer drug portfolio. Starting phase II trials on AS1404 puts us amongst a very small group of companies that have reached efficacy studies with vascular targeting agents, drugs that attack established tumour blood vessels and therefore have potential against a wide variety of cancers."
Enquiries:
Antisoma plc Tel: +44 (0)20 8799 8200 Glyn Edwards, Chief Executive Officer Raymond Spencer, Chief Financial Officer
Financial Dynamics Tel: +44 (0) 20 7269 7187 Julia Phillips Mob: +44 (0) 7770 827 263
The full text of Antisoma's annual report will be available on the Company website http://www.antisoma.com from 30 September 2004.
*Cash per share is calculated by dividing cash and liquid resources of 38.8m at 30 June 2004 by the number of ordinary shares in issue at 30 June 2004, being 266,076,589 ordinary shares.
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.
Joint Chief Executive and Chairman's Statement
Antisoma has had a year of mixed fortunes, providing a good illustration of both the risks and the potential in the drug development business. The year's events also serve to highlight the steps we have taken over a number of years to manage the risks intrinsic to our business, and how we have prepared the Company to make the most of future opportunities.
When R1549 failed to demonstrate a benefit in its pivotal trial, we experienced a major share price fall and lost the prospect of reaching profitability in the short term. This was not the outcome we had hoped for but it was one of the results we had planned for, knowing that even amongst drugs reaching phase III trials there is a significant possibility of failure. When the R1549 result was announced in April, we were in the advantageous position of having three other drugs in clinical trials, each based on different technology, as well as a promising pipeline of preclinical drugs and almost 40 million in cash. The depth and diversity of our pipeline and the availability of resources to advance it were the result of the Group's long-term vision to acquire and develop a robust pipeline, thereby avoiding dependence on a single product candidate.
Progress across the remainder of our pipeline has been solid. We have secured new cash resources to advance priority programmes such as AS1404 and to add further to our drug portfolio. We have also strengthened our management team to deal with the increasing scale and diversity of our operations. Our partnership with Roche remains strong and we look forward to entering the third year of our alliance whereby Roche co-develops products from the Antisoma pipeline and will commercialise those that reach the market. This alliance continues to be a positive endorsement of our technology and expertise in oncology.
Progress across the pipeline In March we announced that AS1404 had successfully completed phase I trials and would be progressing to a phase II programme of combination studies. Today we announced the start of the first such study, combining AS1404 with carboplatin and paclitaxel in the treatment of non-small cell lung cancer. This makes us one of the leading companies in the development of 'vascular targeting agents', drugs designed to shut down established tumour blood vessels.
Also in March we announced the entry to clinical trials of AS1405, an antibody-based drug for the brain cancer glioma. A trial in the United States is evaluating AS1405 given to patients who have suffered a relapse of their cancer after initial treatment. These patients have then had their tumours surgically removed, and are receiving the drug as an additional treatment, with the aim of preventing or delaying further regrowth of the cancer. As the prognosis for glioma patients, especially those with recurrent disease, is very poor, the need for new treatments is urgent. The phase I trial will provide information on safety and dosing as well as looking for any signs of anti-tumour activity.
Our third clinical product, R1550, has now been successfully transferred to Roche for development. A phase I trial in the US is recruiting patients with metastatic (spreading) or locally advanced breast cancer, building on an earlier trial which showed that the drug was well tolerated in breast cancer patients.
New products licensed
We have licensed two exciting programmes into our preclinical pipeline during the year. In September 2003, we acquired a programme of telomere targeting agents (TTAs) from Cancer Research Technology. These drugs, developed at the Institute of Cancer Research and the London School of Pharmacy by Professor Stephen Neidle, work by interfering with 'telomeres', structures found at the end of each of the chromosomes into which human DNA is packaged. Telomeres are fundamental to the immortality that allows cancer cells to grow unchecked, so drugs that disrupt them have broad potential as cancer therapeutics.
In November, we announced that we had been collaborating with EMD-Lexigen, a subsidiary of Merck KGaA, on a programme to combine a cytokine -- a protein messenger that acts as a co-ordinator in the immune system -- called IL12 with one of Antisoma's tumour-targeting antibodies, BC1. We describe such combinations as ATTACK (Antitumour Therapy with Targeting Antibodies and CytoKines). Having presented promising animal data at the American Association of Cancer Research, we announced in July 2004 that we had bought out Lexigen's half-stake in the programme and would accelerate its progress towards clinical trials under the name AS1409.
Management strengthened
In February, we welcomed Dr Ursula Ney to the newly-created position of Chief Operating Officer and to the Board of Antisoma plc. Dr. Ney has a wealth of experience in all aspects of drug development, gained in both large pharmaceutical and biotech companies. Reporting to Glyn Edwards, she is now responsible for both the company's established development programmes and the acquisition of new drugs by in-licensing. We also welcomed Birgit Norinder as a new Non-Executive Director during the year. Ms. Norinder serves on the boards of a number of biotechnology companies, and previously held senior executive positions in R&D in several international pharmaceutical companies.
Robust finances
We ended the year with approximately 39 million in cash and liquid resources compared with 34 million last year. Ongoing investment in an increasingly broad pipeline of cancer drug candidates led to an increase in our operating expenses to 21.2 million from 17.2 million last year. Notwithstanding this increased investment, we have successfully enhanced our cash resources through a placing and open offer, which raised 14.1 million net of expenses in December 2003, and through our strategic alliance with Roche.
Our revenues increased to 18.1 million from 11.8 million last year. This reflects reimbursement by Roche of development costs incurred for R1549 and R1550 during the period of 8.7 million (2003: 5.2 million) and ongoing recognition of revenues from upfront payments made under our 2002 deal with Roche of 9.4 million (2003: 5.3 million; this leaves 8.5 million that will be recognised in future periods). The increased revenues mean that, despite the increase in our operating expenses, our losses fell from 3.3 million last year to 0.6 million in 2004, representing a loss per share of 0.25p (2003:1.5p).
Our operating expenses of 21.2 million constituted 16.6 million for research and development costs (2003: 13.0 million) and 4.6 million (2003: 4.2 million) for administrative expenses. Development costs on R1549 were 5.7 million (2003: 5.0 million), whilst expenditure on our other products increased from 8.0 million in 2003 to 10.9 million this year. The Directors expect that total development expenditure will be lower in 2005 following discontinuation of the R1549 programme and full transfer of the R1550 programme to Roche.
Net cash outflow from operating activities in the year was 9.6 million compared to an inflow of 9.2 million last year. This was due principally to the operating loss adjusted for the recognition of revenues from Roche that were received in the year ended 30 June 2003.
Significant newsflow ahead Antisoma moves into the next year with confidence based on the depth and diversity of our cancer drug pipeline, our ongoing partnership with Roche and our strong cash position. The start of phase II trials of AS1404 is indicative of Antisoma's determination to push its products forward and realise their value. Our goal is to progress multiple products through late-stage development to create the best possible chance that one or more will reach the market within the next few years. Commercialisation of any of our products would generate substantial shareholder returns. To maximise our chances of success, we will continue to enhance our product portfolio, including the acquisition of a clinical phase product to further strengthen our later stage pipeline.
Glyn Edwards Chief Executive Officer
Barry Price Chairman
The full press release including tables can be downloaded from the following link: