AGI Therapeutics reports loss of €8.9m

Gastro-intestinal drugs development firm AGI Therapeutics has reported an $8.9 million pre-tax loss for the six months to the end of June.

This compares to a loss of $7.46 million over the same period in 2007 and equates to a basic loss per share of 13.3 cent.

The company said it had reached 75 per cent of its target enrolment into the first of two Phase III - or human trials - of its Rezular drug to treat forms of irritable bowel syndrome.

AGI said in July that the US Food and Drug Administration had agreed to a statistical plan to be used to analyse the Rezular data had seen the target enrolment revised to 680.

Phase III trials are the last hurdle before a drug can be considered for licensing.

The company also said it would seek to progress talks with possible partners for the drug in anticipation of drug trials data next year.

The increased losses were attributed to an acceleration in research and development spending from $8.3 million over the period, up from $7 million over the same period in 2007.

"The significant increase in R&D costs reflects the increased number of clinical programmes associated with the company's products in development, particularly the ongoing ARDIS Phase III programme for Rezular", the company said in a statement.  

Revenues for the six month period were unchanged at $288,000 while general and administrative expenses increased from $1.7 million to $2.01 million.

Cash and cash-equivalents at the end of June were €32.7 million, compared to €45 million over the same period last year.

John Devane AGI's CEO said the first half of the year had seen the company concentrate on its Phase III programme for Rezular.

He said in addition to Rezular the company was advancing other products and in February had started a Phase II clinical study of its transdermal mecamylamine patch AGI-004 for patients suffering from chemotherapy induced diarrhoea.

Davy analyst Jack Gorman said the statement indicates that it has over 500 patients enrolled in its Phase III study of Rezular and appeared to have an addition rate of just over ten a week.

"As such, AGI remains on track to dose the last patient by end 2008/early 2009, implying first Phase III data during the second quarter 2009."

He remains optimistic that Rezular can prove to be "a transforming product" for AGI and added that the net cash reserves of $32.8 million was sufficient to fund the business "well into 2010".