Syntara (SNT) investor relations material

Program background and unmet need

• Scarring is a major global health issue with no FDA-approved therapies that remodel scars at the biological level.

• Current treatments are symptomatic, fragmented, and often ineffective, with high recurrence rates.

• LOX enzymes are identified as a key driver of scar rigidity, making them a compelling therapeutic target.

• Pan-LOX inhibition is proposed as a first-in-class approach to address the mechanical root of scar persistence.

• Modern imaging and split-scar trial designs now enable objective, precise measurement of treatment effects.

Preclinical and early clinical development

• Initial compound SNT-6302 showed a 30% reduction in scar collagen and improved vascularization in a three-month study.

• Some patients experienced skin reddening, prompting the development of next-generation SNT-9465.

• SNT-9465 was engineered for improved tolerability, stability, and water solubility, suitable for daily topical use.

• Preclinical and phase 1a studies confirmed dose-dependent skin penetration and LOX inhibition without safety concerns.

Phase 1a/1b study design and objectives

• The phase 1a single ascending dose study in healthy volunteers showed no redness or rashes, unlike the first-generation product.

• The phase 1b study uses a randomized, double-blind, placebo-controlled split-scar design in 20 adults with hypertrophic sternotomy scars.

• Each participant serves as their own control, reducing variability and improving signal detection.

• Primary endpoint is safety; secondary endpoints include PK/PD, objective scar volume, elasticity, vascularity, and patient-reported outcomes.

• Advanced imaging (OCT, 3D, elastography) and validated scales (POSAS) are used for comprehensive assessment.