The company, which is based in the BioPark in Gosselies, Belgium, is looking to address unmet medical needs in orthopedics and other diseases.
The EIB financing is to be used to accelerate the clinical development of ALLOB, its allogeneic cell therapy platform, as well as the potential commercialization of its enhanced viscosupplement, JTA-004.
EIB loan details
The EIB loan financing is to be disbursed in two tranches of €8m each, subject to conditions precedent. The first tranche of €8m will become available upon approval of the issuance of associated warrants by Bone Therapeutics’ General Meetings before the end of August 2021.
The second €8m 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.
Clinical trials in progress
ALLOB is an allogeneic cell therapy platform consisting of human allogeneic bone-forming cells derived from ex-vivo cultured bone marrow mesenchymal stromal cells (MSC) from healthy adult donors.
The product 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.
JTA-004, which consists of a combination of plasma proteins, hyaluronic acid and a fast-acting analgesic, is designed to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. It is being evaluated in a registrational phase III clinical trial for the treatment of osteoarthritic pain in the knee; topline results of that study are expected in Q3 2021.
Following a positive outcome of the study, the developer said it plans to submit a marketing authorization application to European regulatory authorities in the first half of 2022. It is continuing to engage with potential partners to develop and commercialize JTA-004 in Europe, US, and Asia.
October 2020 saw Bone Therapeutics sign an exclusive license agreement with Link Health Pharma Co and Shenzhen Pregene Biopharma Company for the manufacturing, clinical development and commercialization of ALLOB in Greater China, Taiwan, Singapore, South Korea, and Thailand.
Terms of the agreement included up to €55m total in upfront and milestone payments, with €10m expected in the next two years as well as tiered double-digit royalties on net sales.
Subsequently, Bone Therapeutics signed a manufacturing collaboration with Catalent to streamline the production of ALLOB.
In January 2021, the Belgian innovator signed an agreement for a process development partnership with MSC specialist, Rigenerand. It said the alliance will focus on further developing and enhancing Bone Therapeutics’ bone-forming cells with the potential to broaden their therapeutic targets and explore new mechanisms of action.
In December 2020, Bone Therapeutics successfully raised €10m through a private placement with current and new institutional investors both in Europe and in the US, and it welcomed CPH Banque as new cornerstone investor to support its long-term growth.