First Patients Dosed in SPONTAN Phase II Clinical Study

• First patients dosed in SPONTAN® Phase II pharmacokinetic study
• Study on track with initial data expected Q2 CY2026
• Data expected to support FDA regulatory submission and represents a key value inflection milestone

LTR Pharma Limited (ASX:LTP) has announced that the first patients have been dosed in its Phase II pharmacokinetic clinical study of SPONTAN®, its rapid-acting intranasal spray for the treatment of erectile dysfunction. The Phase II study is assessing single- and multiple-dose pharmacokinetics in approximately 27 healthy male participants across three cohorts, with around half of the participants aged 65 years or older. This data is expected to inform future prescribing information for older men, a population frequently managed with dose adjustments when using oral erectile dysfunction therapies. The resulting data is expected to play an important role in advancing SPONTAN's U.S. regulatory pathway and supporting the Company's broader commercial strategy. Recruitment for the study commenced on 13 January 2026, and the initial data is expected in Q2 CY2026. LTR Pharma's Executive Chairman, Lee Rodne, stated that with the first patients now dosed, the Phase II program is actively generating data, which will complete an important component of the FDA regulatory package, including pharmacokinetic insights for older patients.