• Ethics approval received for SPONTAN® Phase II pharmacokinetic and multiple-dose clinical study
• Study designed to characterise single and multiple-dose pharmacokinetics, with ~50% of participants aged 65+
• Study expected to generate prescribing information for doctors treating men aged 65+

LTR Pharma Limited (ASX:LTP) has received Human Research Ethics Committee (HREC) approval from Bellberry for the SPONTAN® Phase II clinical study, enabling the company to progress toward patient recruitment in early 2026. The randomised cross-over study will be conducted at Scientia Clinical Research in Sydney and will recruit approximately 27 healthy male participants across three cohorts, with around 50% of participants aged 65 years or older. This geriatric cohort is expected to provide important clinical data to guide prescribers on dosing considerations for older men, a group that is frequently prescribed lower doses of oral PDE5 inhibitors due to pharmacokinetic or tolerability factors. Each participant will complete a 15-day residential period, receiving both single and multiple doses of SPONTAN, along with a control vardenafil tablet. Southern Star Research has been appointed as the Clinical Research Organisation, with Resolian Bioanalytics conducting pharmacokinetic blood sample analysis. Initial data is expected in Q2 CY 2026, with full study results mid-2026. 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 study, which demonstrated 470% faster absorption versus oral tablets.

With ROXUS on track for US market entry in the first half of 2026 and SPONTAN progressing through clinical development, LTR Pharma continues to execute its multi-market commercial strategy.