Genkyotex to merge with a French public biotech company

Genticel is a biotechnology company developing innovative immunotherapies. Genkyotex is a Swiss privately-held biopharmaceutical company and the leader in NOX therapies. The transaction would create a European group with a pipeline of first-in-class NOX inhibitors in fibrosis and inflammatory pain. The transaction successfully completes the strategic review process announced by Genticel on several occasions since July 2016

Genkyotex, headquartered in Geneva, Switzerland, with a subsidiary located in Archamps, France, is developing a portfolio of NADPH oxidase (NOX) oral small molecule inhibitors, which have therapeutic potential for the treatment of multiple significant clinical indications with substantial unmet need.

Genkyotex’s therapeutic approach is based on a selective inhibition of NOX enzymes, which drive a broad range of disease processes, including fibrosis, inflammatory pain, angiogenesis, cancer growth, and neurodegeneration. The seven NOX enzymes form an important new therapeutic target because they modulate multiple signaling pathways implicated in disease by selectively oxidizing key proteins, lipids or DNA.

Genkyotex is currently developing two first-in-class NOX inhibitors and is conducting research on multiple pre-clinical molecules:

• GKT831, a NOX1 and NOX4 inhibitor for fibrotic indications, is expected to enter a Phase II clinical trial in primary biliary cholangitis (PBC), an orphan fibrotic liver disease, during the first half of 2017. Published animal model data highlight the anti-fibrotic and anti-inflammatory mechanism of action of GKT831. The drug candidate has the potential to be developed in fibrotic diseases in the liver, like PBC and non-alcoholic steatohepatitis (NASH), as well as in fibrotic diseases in other organs.
• GKT771, a NOX1 inhibitor targeting multiple pathways in angiogenesis, pain and inflammation, is expected to enter a Phase I clinical study during the second half of 2017.
• Genkyotex also has several ongoing pre-clinical programs evaluating the therapeutic potential of NOX inhibitors in central nervous system (CNS) diseases, hearing loss and oncology indications.

The combined consolidated cash position of Genkyotex and Genticel should enable the new group to complete both its Phase II study in PBC with GKT831 and its first Phase I study with GKT771.

Benedikt Timmerman, Founder, Chairman of the Management Board and CEO of Genticel, commented: “Genticel has evaluated many companies and drug candidates in Europe and the US with the intention of building the most promising drug pipeline possible for the company. Following the structured process communicated publicly on several occasions since last July, we elected to move forward with Genkyotex due to its leadership in a novel drug class, which we believe has significant therapeutic potential. Genkyotex has generated promising data for its lead compounds and its management team has extensive biotechnology industry expertise and experience. Based on these key factors and the strong consolidated cash position for the combined entity, I am confident that this transaction will create a leading biotechnology company with the potential to create significant long-term shareholder value.”

Elias Papatheodorou, CEO of Genkyotex, concluded: “This transaction is an important step forward for Genkyotex as we become part of a publicly listed group, which will enable the acceleration of our clinical development and research programs. We are currently the leader in the field of NOX therapeutic discovery and development, and are preparing to initiate our Phase II clinical trial with our lead product candidate, GKT831, in PBC. The combined strong cash positions of the two companies will enable us to complete this important trial, enter early clinical development with our second product candidate, GKT771, and continue our discovery activities in other therapeutic fields. In addition, Genticel’s partnership with the Serum Institute could have a positive impact on the combined company and help support the pursuit of its development strategy.”  

Terms of the Proposed Transaction

Genticel and Genkyotex’s shareholders have entered on December 22, 2017 into a contribution agreement determining the terms and conditions of the contribution in kind by the existing shareholders of Genkyotex of 100% of the shares they hold in Genkyotex (on a fully diluted basis) to Genticel, pursuant to article L. 225-147 of the French Code de commerce. Subject to the approval of Genticel’s shareholders at a general meeting to be held on February 28, 2017, at the latest, Genkyotex’s shareholders will receive 11.83551 shares of Genticel for each contributed share of Genkyotex. This exchange ratio has been agreed to between Genticel and the shareholders of Genkyotex, based on the actual value of Genkyotex established at 120,000,000 Euros and of Genticel established at 30,000,000 Euros.

Genticel is expected to issue a maximum total number of 62,279,9752 new shares to Genkyotex’s shareholders who, upon completion of the proposed transaction, will hold 80% of Genticel’s share capital and voting rights (this percentage does not take into account any new shares which may be issued upon exercise of any outstanding warrants and employee warrants issued by Genticel).

The completion of the transaction is subject to certain standard conditions, notably, the registration of an information document (Document E) with the French financial market authority (Autorité des marchés financier – “AMF”) in accordance with article 212-34 of the AMF’s general regulation and its communication in due time to Genticel’s shareholders together with the reports of the contribution appraisers on the value of the contribution and of the fairness of the exchange ratio, the approval of the proposed contribution by Genticel’s shareholders, and the issuance of the new Genticel shares to the Genkyotex shareholders in remuneration of their contributed shares.

The principal shareholders of Genticel, representing, together with certain employees or corporate officers, a total of 51% of the share capital and voting rights of Genticel, have also undertaken, subject to the contribution appraisers confirmation of the above mentioned valuation, to vote in favor of the proposed contribution transaction at the shareholders’ meeting scheduled to take place as detailed below.

Upon and subject to the approval and completion of the transaction, no shareholder of Genkyotex or Genticel is expected alone or in concert to control or to hold more than 30% of the shares or voting rights of Genticel.

Upon and subject to the approval of the transaction by Genticel’s shareholders, Elias Papatheodorou will become the CEO of the group, while Benedikt Timmerman will resign from his mandate as Chairman of the Management Board and will focus on business development for the combined entity.