TiGenix files for $43M IPO to fund stem cell therapy phase 3

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TiGenix is aiming to raise $42.9 million in its second Nasdaq IPO attempt.

TiGenix has taken another step toward its delayed Nasdaq IPO. The stem cell therapy specialist is aiming to net $42.9 million (€39.8 million) through the listing, approximately half of which will go toward a U.S. late-phase trial of Crohn's disease candidate Cx601.

Leuven, Belgium-based TiGenix filed to go public in the U.S. late last year, only to get caught up with Basilea Pharmaceutica and Bavarian Nordic in the retreat of European drugmakers from Nasdaq. TiGenix subsequently topped up its bank account with a €23.75 million placement in Belgium—and added a further €25 million through a hook up with Takeda—before returning to Wall Street with a revamped slate of underwriters in October.

The rough IPO outlined in October has now matured into a plan to offload 2.75 million American Depository Shares for $19.20 a piece, a listing that would gross north of $52 million. Once the costs are taken out, TiGenix would emerge with $42.9 million net, although that figure could rise or fall depending on the final offering price. TiGenix based the $19.20 target on the closing price of TiGenix stock in Brussel at the end of last week.

TiGenix needs the money to ensure it meets its goal of starting a phase 3 trial of Cx601 in the U.S. in the first half of next year. Cx601 has already met the primary endpoint of combined remission of complex perianal fistulas in patients with Crohn’s disease in one phase 3, teeing up an application for approval in Europe and landing TiGenix its deal with Takeda. TiGenix is now transferring technology to its CMO—Lonza—in anticipation of the start of a second, U.S. phase 3 study.

At $42.9 million, the IPO haul would take TiGenix through to the start of enrollment in the phase 3, while leaving more than $6 million leftover to get deep into a phase 2 trial of Cx611 in sepsis. TiGenix plans to set aside another $4 million for a phase 1/2 trial of AlloCSC-01 in acute myocardial infarction.

The deal with Takeda for European rights to Cx601 has allowed TiGenix to focus its cash on these other pipeline prospects and Cx601 in the U.S., although it is still having to commit time and energy to activities on its home continent.

In September, a routine GCP inspection identified major deviations, including a potential violation of patient privacy. The findings followed the raising of major objections by EMA to the Cx601 marketing authorization application filed by TiGenix. EMA’s objections related to the adequacy of the primary endpoint, the stability of the master cell stock, donor selection and viral safety.

TiGenix plans to address the objections and GCP deviations this month in its responses to EMA’s 120-day questions. Management thinks it has reasonable replies to the objections, but acknowledges the failure to allay EMA’s concerns could cause delays to the regulatory decision on Cx601. TiGenix currently expects to get a decision in the second half of next year.

Shares in TiGenix rose more than 7% in Brussels following the update on the IPO.