We're on track, says Pharmaxis boss at first half-year

Recently floated Pharmaxis (ASX:PXS) has filed its first half-year results, and according to CEO Alan Robertson, the company's performance is right on track with its predictions in last year's prospectus.

The Sydney company had revenues of AUD$975,000 from grants, interest and other sources, and a net loss of $2.06 million. But with $27.7 million from the company's November IPO sitting in the bank, Pharmaxis has enough to last for two years.

"We spent less money than I was expecting. I don't know whether that is good or bad -- it's a double-edged sword, I guess," Robertson said.

The important thing, he said, was to extract the maximum value out of the company's cash reserves, to allow it to reach its milestones.

With three clinical trials to be completed by the end of the financial year, Pharmaxis has a busy year ahead. Its Phase III clinical study for the Aridol lung function test has recruited 100 out of the 600 patients required for the trial, and Robertson said he did not see any problems with enrolments as the trial progresses.

Discussions with regulatory agencies in Australia and Europe have been positive about the trial design and the company will file for registration once the trial is complete. "We hope to be registered in mid-2005," Robertson said.

Bronchitol is now being tested in two 60-patient Phase II clinical trials, for cystic fibrosis and bronchiectasis. Robertson said interim results from the first 20 patients enrolled in the bronchiectasis trial would be released this month. "We expect the results to give us the confidence to go ahead and enrol the remaining 40 patients in the trial," he said.

The Phase II trials should be completed by mid-year and the company plans to move into Phase III trials for both indications, plus a third trial for chronic bronchitis next year.

Waiting in the wings are several additional research programs for drugs to treat automimmune diseases including multiple sclerosis and rheumatoid arthritis.

Robertson said he expected to complete pre-clinical studies on PSX25, a selective inhibitor of T cell migration, by Q4 this year, and would commence Phase I clinical trials in 2005. Scale-up of manufacturing to pilot scale has been successfully completed and the first batch of GLP-grade material will be delivered this month.

Evaluation of PXS2000, a selective activator of peripheral cannabinoid receptors, for therapeutic use in multiple sclerosis and rheumatoid arthritis is ongoing. But the company has also recently identified a closely related compound, PXS2030, and plans to compare the two molecules in animal models before deciding which to take into preclinical development.

And a provisional patent application has been lodged in the US for a new class of anti-inflammatory agents.

"It's going to be a good year for us," Robertson said.

Pharmaxis's shares were trading at $0.42 at the time of writing.