• Recruitment complete for the SPONTAN Phase II pharmacokinetic clinical study
• Final cohort of eight participants now undergoing dosing
• Study includes a dedicated 65+ cohort to generate clinical data for a key demographic

LTR Pharma Limited has announced the completion of recruitment for its Phase II pharmacokinetic clinical study of SPONTAN, its rapid-acting intranasal spray for the treatment of erectile dysfunction. All 27 participants have been enrolled across three cohorts, with the final cohort of eight participants now residing at the clinical research facility for the 15-day dosing period. In line with FDA guidance for geriatric-use assessments, approximately half of all participants are aged 65 years or older. Dosing is underway, with participants undertaking a 15-day residential period receiving single and multiple doses of SPONTAN and a control vardenafil tablet. The Phase II study represents a key requirement in LTR Pharma's FDA 505(b)(2) development pathway, building on the Company's completed Phase I Pharmacokinetic Study, which demonstrated 5x faster absorption versus oral tablets. Initial data is expected in Q2 CY2026.