Q1 2004 Cambridge Antibody Technology Earnings Conference Call - Final.

Original Source: FD (FAIR DISCLOSURE) WIRE

OPERATOR: Good morning and good afternoon, ladies and gentlemen, and welcome to today's Cambridge Antibody conference call. At this time all participants are in listen only mode, later we will have a question and answer session when instructions will follow at that time. (OPERATOR INSTRUCTIONS) As a reminder this conference is being recorded. I'd now like to hand over to your host, Mr. Peter Chambre, Chief Executive Officer of Cambridge Antibody.

PETER CHAMBRE, CEO, CAMBRIDGE ANTIBODY TECHNOLOGY GROUP: Hello. I'm pleased welcome you all to today's conference call to discuss CAT's first quarter results. Joining me today is John Aston, our CFO, and David Glover, our Chief Medical Officer.

Before we start the call, I'm obliged to refer you to the notice regarding the application of the safe harbor of the Private Securities Litigation Reform Act of 1995 which you can find at the bottom of this morning's two news releases. For those of you who have not yet seen these releases, can I refer you to CAT's website where both releases, including the Safe Harbor notice, can be found?

After my instruction I'm going to hand over to David Glover to comment on the progress of our product development programs, and then to John Aston to discuss our financial performance in the quarter after which we'll be pleased to take your questions.

Our goal for CAT is clear, transitioning the company to a product based biopharmaceutical business. Last year we set out our strategy of increasing our investment behind a focused number of core programs to accelerate that transition. Against that strategy today's announcements and results represent another very productive quarter. Two major milestones in our core CAT product development programs have been reached -- completion of the recruitment in the second Trabio Phase III trials; and today announcing the preliminary results of the Phase I/II trial for CAT-192 in scleroderma.

Also, over the past three to four months, consistent with our strategy, you've seen some key changes to some of our collaborations. In September we enhanced our collaboration with Genzyme in the area of TGF data (ph) currently around two key programs. We, with Genzyme, believe there is a major opportunity in scleroderma and other fibro (indiscernible) diseases. And today's announcement of the CAT-192 results is a substantial step forward in that process.

Also, in December we greed with Amgen to transfer two 50-50 co development programs to their control. These product development programs were outside our core areas of focus and were transferred to Amgen on terms attractive to CAT. And today we've announced the termination of our collaboration with Elan in the field of neurology and pain. This collaboration too lay outside our core area of focus and its termination frees CAT from the constraints of its exclusive provisions.

In financial terms also our first-quarter results show the progress we're making. An increase in our net cash position, increasing revenues and the first royalties on HUMIRA (indiscernible) and a decrease from last year in the cash outflow before financing. So with that summary, let me now turn over to David Glover to talk about our (indiscernible) programs.

DAVID GLOVER, CMO, CAMBRIDGE ANTIBODY TECHNOLOGY GROUP: Thank you, Peter. Good afternoon, everybody, or good morning. Today's main news, as you are aware, are the preliminary results from our Phase I/II clinical trial of CAT-192 (indiscernible) Human anti-TGFB1 monoclonal antibody in patients with diffused systemic sclerosis. Just to remind you, the primary objective of that trial was to affect safety, (indiscernible) and the pharmacokinetics of CAT-192 following multiple doses in patients. A secondary objective was to evaluate potential clinical outcomes for any future trials in this disease.

We're very pleased that the preliminary results show the primary objective was met. CAT-192 is generally safe and well tolerated with each of the dose levels studied, and the elimination half-life was consistently just over three weeks. We had no treatment related serious adverse events.

The secondary objective, a number of clinical endpoints and biological markers were measured including the modified Rodnan skin score. As I think you may be aware, these are -- or this, the modified (indiscernible) skin score, is potentially indicative of disease progression. When we came to look at the data for these markers, it's clear that both the disease duration in the patients and the patient's gender played an important role in results that we saw. And we also observed that the placebo group's skin score did not deteriorate during the trial as we had anticipated.

So given that the baseline placebo group didn't deteriorate and the FX of disease duration and gender, it's very difficult to draw any definitive conclusions about the efficacy of CAT-192 from the study at …