Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis

Key Inclusion Criteria:

• OA in at least one knee (the 'target knee'), confirmed using centrally read X-raywith a Kellgren-Lawrence (KL) score of 2 or 3

• Western Ontario & McMaster University Osteoarthritis Index (WOMAC) pain score ≥ 20 (on a 50-point numerical rating scale) in the target knee during the seven daysprior to Screening

• Persistent moderate to severe symptoms in the target knee, despite failure orintolerance of a 3-month trial of at least 2 conservative therapies (e.g., activitymodification, weight loss, physical therapy, opioids, and anti-inflammatorymedications, and injection of hyaluronic acid or steroids)

• Successful extraction of synovial fluid at Screening

• Negative pregnancy test at Screening and Baseline (subjects of childbearingpotential [SOCBP])

Key Exclusion Criteria:

• Current or documented history of inflammatory arthritis (such as gout or rheumatoidarthritis), inflammation of connective tissue, or other immunological disease

• Any form of joint degeneration as part of another syndrome (e.g., Ehler's Danlos,Stickler syndrome, etc.)

• Surgery in the target knee within the 6 months prior to screening

• Previous partial or total joint replacement in target knee

• Significant and clinically evident malalignment of the target knee that would impactthe subject's function, as determined by the Investigator

• Body mass index (BMI) > 38 kg/m2

• Clinically significant abnormal laboratory values at Screening in laboratoryparameters that in the opinion of the Investigator, could represent a potential riskto participant safety:

• Plans to have, elective surgery of other joints or spine or intra-articularinjections in the target knee, within the next 12 months