Bone Therapeutics has merged with French inflammatory/autoimmune company Medsenic in a €40m deal and changed its name into BioSenic.
The combination of Medsenic and Bone Therapeutics will expand Bone Therapeutics' allogeneic cell therapy-based product portfolio in orthopedics by drugs to treat systemic autoimmune diseases, such as cGvHD (chronic Graft versus Host Disease), lupus, and sclerosis. This will enable the merged public company BioSenic to target both tissue inflammation and repair. Bone Therapeutics will bring in its bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in hospitals. French Medsenics’ arsenic TriOxide (ATO) platform are best described by a double basic effect on immune cells: firstly, an increase in oxidative stress in activated B, T or other cells of the innate/adaptative immune system to the point they will enter apoptosis, secondly, a boost on several pro-inflammatory cytokines involved in inflammatory or autoimmune cell pathways.
The new board will include Jean Stéphenne and Jean-Luc Vandebroek that are transitioning to the Biosenic Board, while all other Bone Therapeutics Board directors have terminated their mandate. Pr. Francois Rieger, chairman and CEO of Medsenic, has been appointed as chairman and CEO of BioSenic SA. Other board members are Ms Véronique Pomi-Schneiter, deputy CEO of Biosenic, formerly in charge of Medsenic operations, Mr Jean-François Rax, representing Cap Innovest, Ms Revital Rattenbach, independent director and Mr Terry Sadler, independent director. The Executive team now consists of François Rieger (CEO), Véronique Pomi-Schneiter (deputy CEO), and Anne Leselbaum (CMO).
Under the deal, Medsenic‘ shareholders have contributed 51% of the total outstanding share capital of Medsenic, valued at €40,800,207, at a subscription price per share of €0.45, which values Bone Therapeutics at €10m. In exchange for the in-kind contribution of 51% of Medsenic‘ shares, 90,668,594 shares were issued by BioSenic to Medsenic shareholders.
The Medsenic shareholders have agreed to an initial lock-up of nine months as from the date of the ESM, provided that on February 28 2023, 2% of the new shares held by each of Véronique Pomi-Schneiter and François Rieger shall be released from the lock-up. BioSenic will maintain its status as a Belgian listed company, while significantly broadening its diverse therapeutic portfolio.
The ESM also approved the issue of 24,463,421 subscription rights allowing holders to subscribe for a new share of the company if the ALLOB interim Phase IIB results, a clinical trial focusing on the regenerative properties of proprietary ALLOB cells in cases of difficult, in risk of delayed-union, tibial fractures, are positive at a subscription price per share of €0.45. One ALLOB Subscription Right was issued and granted to each outstanding share of BioSenic prior to completion of the transaction.
In the contribution agreement, the existing shareholders of Medsenic have agreed to contribute in kind the totality of the remaining Medsenic shares held by within the next 24 to 36 months from the completion of the combination, meaning that, in the medium to long run, all existing pipeline from both organisations will be directly or indirectly held by BioSenic.
A Phase III study of cGvHD is currently anticipated to start in H1/2023 following the Phase II clinical study with arsenic trioxide in the first-line treatment of chronic GvH disease positive results. A Phase IIa clinical trial for Lupus had previously confirmed safe for patients and efficient on the course of the autoimmune disease: a Phase IIb clinical trial for severe Lupus is in planning stage. Also, preclinical work gives good grounds for a Phase II clinical trial on systemic sclerosis.
The Phase IIb trial of ALLOB, a randomized, double-blind, placebo-controlled study in patients with high-risk tibial fractures, is still ongoing and set to report important interim results in the H1/2023.