Euronext Brussels-noted adipose stem cell player TiGenix NV wants to offer 2.75 million American Depositary Shares (ADS) in an IPO at Nasdaq Global Market representing 55 million of its ordinary shares which had went up from €0.91 yesterday to €0.96 (10.a.m.).
It’s not the first time that the Leuven-based cell therapy developer announced to go public in the US. In March 2016, TiGenix scrapped IPO plans, citing unfavourable market conditions. Now, after having exchanged Canaccord and KBC Securities by BofA Merrill Lynch and Cowen and Company as joint book-running managers, with Chardan Canaccord Genuity as lead manager, and BTIG as co-manager, the Belgian allogenic stem cell specialist wants to expand its investor base in the US. The 2.75 million American Depositary Shares offered allow investors to acquire shares in the foreign company, which published its prospectus in October. Additionally, TiGenix intends to grant the underwriters a 30-day option to purchase additional ordinary shares in the form of ADSs, provided that the number of such additional ADSs will not exceed 15% of the ADSs sold in the offering. Each of the ADSs offered represents the right to receive 20 ordinary shares. The final issuance price per ADS sold in the offering will be determined following the bookbuilding process. The registration statement filed with the U.S. SEC but has not yet become effective.
Tigenix currently has three cell therapies based on the expansion of donor-derived adipose stem cells in clinical development. In March 2016, the company applied to gain EU market authorisation for its lead candidate Cx601 to treat complex perianal fistulas locally in patients with Crohn’s disease, an orphan condition affecting 120,000 patients globally. Cx601 met the primary endpoint of combined remission of complex perianal fistulas at twenty-four weeks in a randomised, double-blind pivotal Phase III study. According to TiGenix, the results of the follow-up analysis after fifty-two weeks were also positive: the same endpoint of combined remission was also met. Additionally, the results confirmed a favourable safety and tolerability profile of Cx601.
In July 2016, when Takeda announced that it aquired the exlusive global commercialisation rights for Cx601 outside the US for up to €355m and double digit royalties on net sales, the European Medicines Agency informed TiGenix it had major objections related to the stability of the master cell stock proposed, donor selection, viral safety and the potential inadequacy of the primary endpoint of the trial, which the company also plans to use in a pivotal Phase III US trail due to start in H1/2017. These objections would preclude a recommendation for EU marketing authorisation. After having had a clarification meeting with EMA experts in August, TiGenix said, it will submit data of the follow-up analysis after fifty-two weeks in December 2016 to the EMA to address all concerns. The company expects to gain EU market approval by the second half of 2017.
Further cell therapies in clinical development comprise Cx611 for which TiGenix is currently preparing a European Phase I/II clinical trial in severe sepsis starting in Q4/2016, and Cx621, a Phase I candidate to be developed in autoimmune disorders. Another clinical candidate has come in from the acquisition of Spanish regmed company Coretherapix in July 2015: AlloCSC-01, which employs allogeneic cardiac stem cells injected into the heart to repair damaged tissue following myocardial infarction, is currently in Phase I/II safety testing. TiGenix expects Phase II results in H1/2017.