Ark Therapeutics has posted a reasonable set of financials for 2008 which saw a narrowing of losses but lower revenues as analysts wait for a possible approval of Cerepro, the UK firm’s gene-based therapy for brain cancer.
Net loss was £15.9 million, down 12.6% on the previous year, while revenues fell 17.4% to £929,000. Ark ended 2008 with a healthy level of cash and equivalents of £40.6 million.
However most interest in the firm surrounds Cerepro (sitimagene ceradenovec) for operable malignant glioma which was accepted for review at the European Medicines Agency at the end of last year. Ark did not give any specific updates, but a decision is expected from the regulator in the second half of the year.
Last month, however, the company announced that the first named patient supply for Cerepro has been approved by the French Medicines Control Agency (AFSSAPS) following an application made by a neurosurgeon in the country. An earlier application to make Cerepro available through the process, which allows use of a medicine without marketing authorisation, was denied in France in 2007.
Nigel Parker, Ark’s chief executive, said the firm had made solid progress in 2008. He noted that “we have strengthened the underlying pre-clinical pipeline to be in a position to take three more gene-based products into the Phase I/IIa trial stage in 2009” and “we anticipate a busy period of newsflow during the coming year”.
Franc Gregori, an analyst at Charles Stanley issued a note saying that Cerepro is progressing well, as are the other two drugs that are in Phase III; Vitor (imidapril), an oral therapy for treating the weight loss and muscle wasting, or cachexia, associated with cancer, and Trinam, a vascular endothelial growth factor (VEGF-D) gene packaged in an adenoviral vector (Ad 5) to prevent haemodialysis access surgery complications. However he added that “we would have appreciated more detail on the likely positioning and promotional platform for Cerepro”.
Robin Davison at Edison Investment Research said that data from an interim analysis of Cerepro, which will be shared with the EMEA shortly, should “reduce regulatory risk”. That risk is “non-trivial”, he noted as this is a “pioneering product”, but the data may strengthen the case for the drug versus potential competitors such as Roche’s Avastin (bevacizumab), which is already being used off-label in the USA.
Mr Davison believes that Ark offers “an attractive risk/reward ratio”, given the pipeline and the firm’s “valuable” gene therapy manufacturing facility in Finland.
