• TGA provides regulatory clearance for SPONTAN® Phase II clinical study in Australia
• Study includes 65+ cohort to generate prescribing data for older men
• Patient recruitment expected to commence Q1 CY2026

LTR Pharma Limited (ASX:LTP) has announced that the Therapeutic Goods Administration (TGA) has confirmed and accepted the Company's Clinical Trial Notification (CTN) for the SPONTAN® Phase II clinical study, providing regulatory clearance for the commencement of clinical trial activities in Australia. This regulatory clearance completes all requirements for study initiation following the recent Human Research Ethics Committee (HREC) approval granted by Bellberry. The Phase II study will assess single- and multiple-dose pharmacokinetics in approximately 27 healthy male participants across three cohorts. In line with FDA guidance for geriatric-use assessments, approximately half of all participants will be aged 65 years or older. The study is expected to generate important prescribing insights for physicians treating older men, a population that is frequently prescribed lower doses of oral PDE5 inhibitors such as Viagra and Cialis. With regulatory clearance now in place, site activation activities are underway, and patient recruitment is expected to commence in Q1 CY2026. LTR Pharma Executive Chairman, Lee Rodne, stated that the TGA's regulatory clearance of the CTN represents an important milestone that enables the formal commencement of the Phase II study, and that the study is designed to provide valuable clinical insights for physicians treating erectile dysfunction in men aged 65 and over.