A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, FIRST-IN-HUMAN, PHASE 1B/2A STUDY TO EVALUATE SAFETY AND EFFICACY OF SINGLE-DOSE TRI-001 IN PATIENTS WITH CHRONIC LIMB THREATENING ISCHEMIA (CLTI) DUE TO PERIPHERAL ARTERIAL DISEASE (PAD)

Patients with Chronic Limb Threatening Ischemia (CLTI) due to Peripheral Arterial Disease (PAD)

• The safety profile by assessing the occurrence of Adverse Events (AEs) and clinically significant changes in safety assessments (including vital signs, 12-lead electrocardiogram [ECG], safety laboratory testing [biochemistry, haematology, urinalysis], and other disease related safety measures) • Percentage change from baseline of the target wound size at Month 12

Key Secondary Endpoints: • Time to complete wound healing of the target wound* on the index leg • Change in rest pain score (Numeric Pain Rating Scale [NPRS], score 0-10) at Month 12 • Change in Vascular Quality of Life (VascuQoL)-6 score at Month 12 • Amputation Free Survival (AFS) of the index leg • Occurrence of Major Adverse Limb Event (MALE) of a vascular cause of the index leg • Occurrence of Major Adverse Cardiac Event (MACE), Important Secondary Endpoints: • Change in number of eligible wounds* present on the index leg at Month 12 • Change in haemodynamic and metabolic measurements of the index leg at Month 12 whenever it’s applicable: o Toe Brachial Index (TBI) o Ankle Brachial Index (ABI) o Transcutaneous oxygen pressure (TcPO2) • All-cause mortality, Other Secondary Endpoints: • Occurrence of minor amputations of the index leg

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