Project for Potential Osteoarthritis Global Player

StarryBio is a biotechnology company established to evaluate the potential acquisition and commercialization of regional rights to an investigational cell and gene therapy asset for knee osteoarthritis (the “Asset”). The initial geographic focus is Greater China and the United States, with any expansion into additional territories subject to future clinical results, regulatory developments, and strategic considerations.

The Asset is an allogeneic, gene-modified cell therapy administered as a single intra-articular injection. It is being developed with the aim of reducing pain and improving joint function through proposed immune-modulating and cartilage-related mechanisms. However, its clinical efficacy and potential disease-modifying effects have not been established, and the Asset has not received regulatory approval in the United States.

The U.S. Phase 3 development program enrolled more than 1,000 patients across two pivotal studies conducted under an FDA Special Protocol Assessment (SPA). In July 2026, the first Phase 3 study failed to meet its co-primary efficacy endpoints, as the differences between the treatment and placebo groups were not statistically significant. Although the treatment group showed improvements in pain and function, maintained a favorable safety profile, and had a lower observed rate of total knee replacement than the placebo group, these findings do not change the fact that the study failed to achieve its primary efficacy objectives and should not, by themselves, be regarded as establishing clinical efficacy.

Topline results from the second Phase 3 study are expected in October 2026. StarryBio’s decision to proceed with the proposed acquisition and commercialization project will depend substantially on whether the second study produces sufficiently positive and clinically meaningful results and whether those results support a viable regulatory pathway. Accordingly, the project should currently be regarded as conditional and subject to significant clinical, regulatory, and commercial risks.

If the second Phase 3 study produces favorable results, StarryBio may proceed with further due diligence, regulatory assessment, negotiations for regional rights, and development of a commercialization strategy. If the second study also fails to meet its primary endpoints or otherwise does not provide adequate support for regulatory approval, the Asset’s development program may ultimately be unsuccessful, and StarryBio may decide not to proceed with, or may discontinue, the proposed project.

Therefore, any potential investment in or participation in the project should be evaluated on the understanding that the Asset remains an unapproved investigational therapy, that the first Phase 3 study was unsuccessful on its primary efficacy endpoints, and that the viability of the project is materially dependent on the results of the second Phase 3 study and subsequent regulatory discussions.