BONE THERAPEUTICS, the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces that it has signed a loan agreement of up to €16 million with the European Investment Bank (EIB).
The EIB financing will support and prepare Bone Therapeutics’ lead asset, the enhanced viscosupplement JTA-004 for future regulatory approval and commercialization. JTA-004, is being evaluated in a registrational phase III clinical trial for the treatment of osteoarthritic pain in the knee. This is the most prevalent knee condition affecting an estimated 250 million patients world-wide. Topline results of this study are soon expected in the third quarter of 2021. Following a positive outcome of the study, Bone Therapeutics plans to submit a marketing authorization application to European regulatory authorities in the first half of 2022. Bone Therapeutics continues to engage with potential partners to develop and commercialize JTA-004 in Europe, US and Asia.
The EIB financing will also be used to accelerate the clinical development of ALLOB, Bone Therapeutics’ scalable allogeneic cell therapy platform. ALLOB is currently being tested in a phase IIb study in patients with difficult-to-heal tibial fractures. Patient recruitment of this study is currently anticipated to be completed in H1 2022 and the planned top line results are expected in H2 2022.
“Bone Therapeutics is building towards a very important set of milestones, including moving towards potential regulatory approval and commercialization of a therapy for over 250 million patients, as well as continuing with clinical development of its allogeneic cell therapy platform ALLOB. In addition, we are building on our success in orthopedics and moving our formidable MSC capabilities to target wider indications. The support of a major European financial institution such as the EIB will be an additional important component to this activity,” said Jean-Luc Vandebroek, Chief Financial Officer, Bone Therapeutics. “This financing committed by the EIB will allow Bone Therapeutics to further advance the clinical development of its lead product candidates JTA-004 and ALLOB, further accelerating paths to approval and commercialization.”
The EIB loan financing will be disbursed in two tranches of €8 million each, subject to conditions precedent. The first tranche of €8 million will become available upon approval of the issuance of associated warrants by Bone Therapeutics’ General Meetings before the end of August 2021. The second €8 million tranche will be released when specific clinical and commercial milestones have been achieved.
The loan facility will be in the form of a senior loan, repayable to the EIB in a single payment five years following the disbursement of each of the two tranches. The loan carries a fixed interest of 2% per year paid annually and a 3% capitalized interest.