Kalaris Therapeutics (KLRS) Corporate presentation summary

Thesis and market

• TH103 targets persistent retinal-disease treatment burden; the global branded retinal neovascular/exudative disease market exceeds $15B and is growing.

• Anti-VEGF treatment can require visits every 1–2 months; efforts to reduce visit frequency can lead to undertreatment and lower efficacy.

• TH103 was invented by VEGF pioneer Napoleone Ferrara and is being developed for prevalent retinal diseases.

TH103 design and evidence

• Fully humanized recombinant fusion protein for intravitreal delivery; targets VEGF as a soluble decoy receptor and binds HSPG, aiming to enhance inhibition and ocular retention.

• In preclinical studies, TH103 achieved 100% inhibition of VEGF-induced endothelial cell proliferation vs. 80% for aflibercept; studies also indicated prolonged retinal retention and bioactivity.

• Phase 1a SAD in treatment-naïve nAMD patients showed mean BCVA gain of 9.2 letters and mean CST reduction of 118 μm at Month 1 after one injection; mean IRF resolution was 93%.

• Single-dose durability signals: 41% of patients had no retreatment through ≥4 months, 35% through ≥5 months and 29% through ≥6 months.

• No DLTs or treatment-emergent SAEs were observed in Phase 1a; transient IOI occurred in 2 patients dosed at 2.5 mg with batch #1, none of 6 at 2.5 mg with batch #2, and 1 patient at 5.0 mg with batch #2.

Development and execution

• Phase 1b/2 MAD trial in nAMD is enrolling; preliminary data are expected in 2H 2027, with a potential Phase 3 start in 2028 subject to results.

• Cash runway is expected to extend into 2028; planned expansion includes DME, DR and RVO, subject to IND submission and clearance.

• Manufacturing refinements target remaining host-cell protein subtypes; process scale-up is underway to support Phase 3 and commercial supply.

• U.S. exclusivity is projected through the early 2040s; composition-of-matter and method-of-use patent protection spans multiple jurisdictions.