Bioniche Life Sciences (TSX:BNC) was heavily traded last week after the company announced its final prospectus had been filed for a $5-million equity raise.
The additional funds give the company financial runway into 2016, by which time it expects to have heard from FDA on the potential approval of its experimental drug mycobacterial cell wall-nucleic acid complex (MCNA). Bioniche recently announced it expects to file a biologics license application (BLA), with FDA in Q1 2015, for MCNA in the treatment of bacillus Calmette-Guerin refractory/relapsing high-grade non-muscle-invasive bladder cancer. The company would then likely receive a BLA approval decision from FDA late in 2015.
In the near term, Bioniche investors will also be watching for news on another FDA decision – orphan drug status for MCNA. Bioniche filed for orphan drug designation in July of this year. Generally FDA responds to these submissions within 90 days, meaning a likely verdict in October. Orphan drug designation would provide added exclusivity for MCNA in the U.S. market.
The company also expects to have MCNA Phase III data published in a leading peer reviewed medical journal before end of year. This will be investors’ first opportunity to thoroughly assess the clinical evidence that will be main component of its BLA submission next year.
At press time, shares of Bioniche Life Sciences on the TSX were down 8.8% to $0.26.