TiGenix (EBR:TIG) is set to learn whether Wall Street will be more receptive to biotech IPOs this year than it was at the back end of 2015. The cell therapy specialist filed to list on Nasdaq just before Christmas, sparking a 20% rise in its stock price in Europe in the final days of the year.
|TiGenix CEO Eduardo Bravo|
Leuven, Belgium-based TiGenix is turning to Nasdaq in search of money to bankroll its clinical trial program, the centerpiece of which is a cell therapy treatment of complex perianal fistulas in Crohn's disease patients. Last year, TiGenix generated late-phase data on the product, a suspension of allogeneic expanded adipose-derived stem cells (eASC) called Cx601, to support an imminent filing for approval in Europe. Some of the anticipated IPO haul will go toward building out sales infrastructure in Europe, with another tranche being set aside to move Cx601 into a Phase III trial in the U.S.
TiGenix is hoping the FDA will grant fast-track status to Cx601. And, having spoken to the regulator, the company thinks it may be able to file for approval on the basis of one U.S. Phase III trial and data from the 289-person European study, in which TiGenix calculated that patients receiving Cx601 had a 44% greater chance of achieving combined remission than people in the placebo arm. The plan is to submit an IND to FDA by the end of this year with a view to starting the study early in 2017. TiGenix has agreed on the design of the trial, which has the same endpoint as the European study, with the FDA.
If TiGenix can hit its as-yet-undisclosed fundraising target, it will funnel cash into a pair of programs that are earlier in clinical development. TiGenix is looking for the IPO haul to fund a Phase II trial of Cx611, another product from its allogeneic eASC-based platform, in severe sepsis "until well into the stage of recruitment." Management is aiming to have enough cash left to take a third candidate, the acute myocardial infarction drug AlloCSC-01, through to the end of Phase I/II.
TiGenix's ability to execute this multifront clinical development program will depend on whether it can persuade U.S. public investors to open their wallets. A hardening of attitudes toward biotech late in 2015 drove antibiotic specialist Basilea Pharmaceutica (SWX:BSLN) to drop plans for its $190 million Nasdaq IPO. TiGenix lacks the profile of Basilea, which commands a market cap of around 5 times the size of the cell therapy player, but this should translate into a more modest fundraising target. In the United Kingdom, smaller IPOs have succeeded despite large offerings faltering.
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