LONDON, Feb. 16, 2005 (PRIMEZONE) -- Cancer drug developer Antisoma plc (LSE:ASM) today announces its interim results for the period ended 31 December 2004.
Highlights
- Acquisition of U.S. company Aptamera Inc, adding clinical product AS1411 to pipeline (announced January 2005)
- AS1404 enters phase II combination studies
- AS1410 selected as lead candidate from telomere-targeting-agent programme
- GMP manufacturing of AS1409 initiated
- Cash and short-term investments at 31 December 2004 of 32.3 million pounds(30 June 2004: 38.8 million pounds)
- Operating losses for the six months to 31 December 2004 of 2.8 million pounds (six months ended 31 December 2003: 1.1 million pounds)
Barry Price, Chairman of Antisoma, commented: "We have advanced our portfolio considerably during the last six months, taking AS1404 into phase II and adding an exciting new cancer drug through the strategic acquisition of Aptamera. We look forward to a series of major milestones in 2005, with important progress expected on all four of our products in clinical trials."
For further information please visit the Company's web site at www.antisoma.com
Enquiries: Glyn Edwards, Chief Executive Officer Antisoma plc +44 (0)20 8799 8200 Raymond Spencer, Chief Financial Officer Antisoma plc +44 (0)20 8799 8200 (UK enquiries) Buchanan Communications Mark Court +44 (0)20 7466 5000 (mainland European enquiries) De Facto Communications Richard Anderson +44 (0)20 7940 1000
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
During the past six months we have advanced our established development programmes and delivered on our pledge to add a new clinical product to the Antisoma portfolio.
Early in February, we completed the acquisition of the American cancer company Aptamera Inc. We bought this company on the strength of its lead drug, the aptamer AS1411 (formerly AGRO100), which has shown promising signs of anti-cancer activity in a phase I clinical trial. We will report more fully on these findings in due course. Meanwhile, we are working on detailed plans for further trials, which we plan to start during this year. AS1411 is a cutting-edge product, one of the most advanced in development among anti-cancer aptamers. At the same time, it represents a technology whose application in treating human disease has recently received substantial validation through the FDA's approval of the first aptamer drug, Pfizer and Eyetech's Macugen for the eye disease AMD.
As a result of our acquisition, we are pleased to welcome Mark C. Rogers, the former chairman of Aptamera, to the Antisoma board as a Non-Executive Director. He brings wide-ranging experience gained within the medical and biotech sectors in the United States.
An important development in our established portfolio was the start in September of phase II combination studies on our vascular targeting agent AS1404. The first trial to start was in non-small cell lung cancer, where AS1404 is combined with carboplatin and paclitaxel. We expect the first efficacy findings from this study during the second half of 2005. In November, we confirmed our plans to start additional combination studies in ovarian and prostate cancers during the coming year.
We have also been progressing our preclinical programmes. In 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. Since then, we have initiated GMP manufacturing of the drug. We have presented new data in support of both AS1406 (antibody targeted RNase) and our programme of telomere targeting agents (TTAs). During November, we announced that we had selected a lead candidate, AS1410, from the TTA programme to take forward into clinical trials. We plan to start clinical trials on both AS1409 and AS1410 during 2006.
Financial Review Results of operations -- six months ended 31 December 2004
Revenues for the six months ended 31 December 2004 totalled 4.8 million pounds (six months ended 31 December 2003: 9.3 million pounds). In the current period all the revenue arose from our agreement with Roche and represents 4.5 million pounds recognised from the 23.2 million pounds upfront payments received following signature of the agreement in November 2002 and 0.3 million pounds in relation to development costs of R1549 and R1550. In the comparative period, revenue included 4.6 million pounds recognised from the upfront payment and 4.7 million pounds in relation to development costs for the same products. The reduction in revenues results from the wind-down of the R1549 programme and the transfer of responsibility for the R1550 clinical programme to Roche.
Operating expenses fell by 2.8 million pounds in the six month period ended 31 December 2004 to 7.5 million pounds (six months ended 31 December 2003: 10.3 million pounds), including research and development expenses of 5.0 million pounds (six months ended 31 December 2003: 7.7 million pounds). The 2.7m pounds decrease in R&D expenses reflects a reduction in the costs of development for R1549 and R1550, offset by an increase in other development costs.
Losses for the six months ended 31 December 2004, after recognition of a 1.4 million pounds (six months ended 31 December 2003: nil pounds) tax credit for the surrender of R&D tax losses, are 0.6 million pounds (six months ended 31 December 2003: 0.5 million pounds).
Liquidity and capital resources Cash at bank and held in short-term investments totalled 32.3 million pounds at 31 December 2004, 38.8 million pounds at 30 June 2004 and 43.1 million pounds at 31 December 2003.
Debtors have decreased to 2.4 million pounds from 2.8 million pounds at 31 December 2003 due to a reduction in the amounts receivable from Roche for the development of R1549 and R1550. Total creditors have decreased to 6.8 million pounds from 17.4 million pounds at 31 December 2003, largely as a result of the recognition of deferred income relating to upfront payments received from Roche.
Loss per share The loss per share for the half-year ended 31 December 2004 was 0.21p (six months ended 31 December 2003: 0.22p)
Future operations and revenue recognition
Following the discontinuation of R1549 and transfer of development of R1550 to Roche, the costs and revenues associated with the development of these products will be minimal with effect from 1 January 2005. Antisoma received upfront amounts from Roche in December 2002 and January 2003 totalling 23.2 million pounds, of which 19.2 million pounds has been recognised to date. The upfront amount related to R1549 has now been fully recognised, leaving a balance of deferred revenue of 4 million pounds relating to R1550 and AS1404, which will be fully recognised by 31 December 2005, and an option over new clinical products, which will be fully recognised by 30 November 2007.
Subsequent events The acquisition of Aptamera Inc. was completed on 4 February 2005 for a total consideration to the shareholders of Aptamera Inc of 66,500,041 new ordinary 1p shares, representing approximately 20% of the enlarged ordinary share capital.
Outlook
We look forward to important milestones on all four of our clinical products. During 2005 we expect the first findings from phase II studies on AS1404, data from the phase I study that Roche is performing on R1550, the start of a phase II study on AS1405, reporting of data from Aptamera's phase I study on AS1411 and the start of a new study on AS1411.
Barry Price Chairman February 2005