Kalaris Therapeutics (KLRS) investor relations material

Study design and objectives

• Phase 1a single ascending dose study evaluated safety, tolerability, pharmacokinetics, and anti-VEGF activity of TH103 in treatment-naïve neovascular AMD patients across multiple U.S. centers.

• Doses tested were 0.5 mg, 1.5 mg, 2.5 mg, and 5.0 mg, with primary analysis at Month 1 and follow-up to Month 6.

• Criteria for retreatment included significant increase in central subfield thickness or new macular hemorrhage.

Patient characteristics

• 17 treatment-naïve and 3 treatment-experienced patients participated, mean age 78, with balanced gender distribution.

• Baseline BCVA ranged from 36 to 73 ETDRS letters, and mean CST was 476 μm.

• No study dropouts and 100% protocol adherence were reported.

Efficacy outcomes

• Mean BCVA improved by 9.2 letters at Month 1 after a single TH103 injection; 53% gained ≥10 letters.

• Mean CST decreased by 118 μm at Month 1, with rapid and robust reduction in retinal fluid volumes.

• 89–99% resolution of total and intraretinal fluid observed by Week 12.