TiGenix has filed an amended F-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). The company has not released any pricing data, but it intends to offer 2.75 million American depositary shares, with each one representing 20 shares. TiGenix expects to list on the Nasdaq under the symbol TIG.

The underwriters for the offering are Merrill Lynch, Cowen, Canaccord Genuity and BTIG.

This advanced biopharmaceutical company is focused on developing and commercializing novel therapeutics from its proprietary technology platforms of allogeneic, or donor-derived, stem cells.

The company has completed and received positive data in a single pivotal Phase 3 trial in Europe and Israel of its most advanced product candidate Cx601, a first-in-class injectable allogeneic stem cell therapy indicated for the treatment of complex perianal fistulas in patients suffering from Crohn’s disease. A complex perianal fistula consists of abnormal tracts between the rectum and the exterior surroundings of the anus, and it is commonly associated with Crohn’s disease. It is a serious clinical condition affecting the anal sphincter and is potentially associated with a perianal abscess.

Cx601 has been granted orphan designation by the European Medicines Agency (EMA), in recognition of its potential application for the treatment of anal fistulas, which affect approximately 120,000 adult patients in the United States and Europe and for which existing treatment options are inadequate. The EMA grants orphan designation to medicinal products for indications that affect no more than five out of 10,000 people in the European Union. The benefits of orphan designation include a streamlined process for obtaining relevant regulatory approvals and up to 10 years of exclusivity in the European market.

In the Phase 3 study, Cx601 met the primary endpoint of combined remission of complex perianal fistulas at 24 weeks. The results of the follow-up analysis after 52 weeks were also positive. The same endpoint of combined remission was also met at 52 weeks, showing that the effect of the treatment is sustained. The results also confirmed the favorable safety and tolerability profile of Cx601.

The company intends to use the net proceeds from this offering to further advance its pipeline, with the remainder going toward working capital and general corporate purposes. In regards to the United States, the company intends to file an investigational New Drug Application to conduct a pivotal Phase 3 trial in the supporting a biologics license application with the U.S. Food and Drug Administration (FDA) and to commence recruitment of patients for the Phase 3 trial.

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