BONE THERAPEUTICS, the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces that it has entered into a settlement with the Belgian Financial Services and Markets Authority (FSMA). The settlement brings a final resolution to an investigation related to communication issues on past clinical studies dating to 2016 and 2017.
In 2016, Bone Therapeutics decided to direct its strategic focus to its next-generation, scalable, off-the-shelf, allogeneic cell therapy platform, ALLOB. This decision was taken to maximize value creation and to ensure the best use of available resources. The development of PREOB for the treatment of osteoporosis (OP), non-union fractures (NU) and hip osteonecrosis (ON) was discontinued in subsequent years. Following these developments, the FSMA started an inquiry in the framework of Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 (Market Abuse Regulation) in 2018. Bone Therapeutics has fully cooperated with this investigation.
In particular, at the time, Bone Therapeutics encountered difficulties in the clinical development of three programs, ALLOB-OP in preparation, PREOB-NU and PREOB-ON. These difficulties were identified in February and December 2016. The difficulties included a lack of external partners, recruitment delays and failures of acceleration programs. According to the FSMA, Bone Therapeutics, did not clearly communicate on this information until the press releases announcing the discontinuation of the clinical development of these three programs respectively in January 2017, December 2017 and November 2018.
Subsequent to these actions described above, the board and management of Bone Therapeutics have quasi-totally changed. To conclude this chapter definitively, the board and management has taken a number of initiatives to strengthen its market communication procedures. It has also concluded a settlement with the FSMA without an acknowledgment of guilt, and has agreed to a settlement amount of €500,000. This settlement amount has no lasting impact on Bone Therapeutics’ ongoing activities and the development of its future programs.
This settlement will allow Bone Therapeutics’ board of directors and management to fully focus in the future on the development of the modified Mesenchymal Stromal Cell (MSC) platform including ALLOB and the enhanced viscosupplement JTA-004.
The settlement was accepted by the FSMA's Executive Committee on 27 July 2021 and has been published on the FSMA's website.