Kuros Biosciences Announces Results from Two Prospective Randomized Clinical Trials

STRUCTURE and MAXA

Kuros Biosciences AG / Key word(s): Study/Study results Kuros Biosciences Announces Results from Two Prospective Randomized Clinical Trials: STRUCTURE and MAXA 27-Dec-2023 / 07:00 CET/CEST Release of an ad hoc announcement pursuant to Art. 53 LR The issuer is solely responsible for the content of this announcement.

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• In the MAXA trial, standalone MagnetOs outperformed the gold standard autograft by 73% in posterior spinal fusion in a difficult-to-treat real life patient population (20% smokers). In the STRUCTURE trial, MagnetOs mixed with autograft showed posterolateral fusion rates comparable to autograft fusion rates in the less challenging interbody space
• In the STRUCTURE trial, according to an interim analysis, Fibrin-PTH did not outperform autograft for interbody fusion, although patients showed excellent clinical outcomes
• Considering the outstanding clinical results of MagnetOs in the MAXA and STRUCTURE trials, and the recent FDA interbody clearance, Kuros has decided not to proceed to Phase 3 with Fibrin-PTH and focus its resources on MagnetOs   
• Focusing on the MagnetOs program will result in lower development costs and lower expenses in the near-term, extending Kuros’ cash runway, while still addressing a $2.4Bn annual bone graft market similar to that originally anticipated for both MagnetOs and Fibrin-PTH together

Schlieren (Zurich), Switzerland, December 27, 2023 – Kuros Biosciences, a leader in next generation bone graft technologies, today announced results from two prospective, randomized clinical studies – the STRUCTURE and MAXA trials. In the MAXA trial, MagnetOs showed a 73% higher fusion rate relative to autograft in the challenging posterolateral space.  In the STRUCTURE trial, Fibrin-PTH, while demonstrating excellent clinical outcomes, showed fusion rates comparable to autograft in the less challenging interbody space.  As a result, Kuros will focus its resources to amplify the continued commercialization of its MagnetOs bone graft family of products.