SPONTAN Phase II data show rapid onset, support FDA pathway

• Median Tmax of 10 minutes for SPONTAN® (5 mg) versus 60 minutes for oral vardenafil (20mg)
• Pharmacokinetic profile consistent across adult and geriatric populations
• No serious adverse events, no Grade 3 or 4 treatment-emergent adverse events, and no treatment-related discontinuations

LTR Pharma Limited (ASX:LTP) reports interim Phase II pharmacokinetic (PK) and safety data for SPONTAN®, demonstrating a rapid time to peak concentration (median Tmax 10 minutes) and a consistent safety profile, with no serious or severe treatment-emergent adverse events observed. The data support the Company's planned FDA 505(b)(2) regulatory pathway, subject to completion of final statistical analysis. These results indicate a pharmacokinetic profile distinct from oral PDE5 inhibitors, consistent with rapid-onset, on-demand use. The interim results indicate that the Study has characterised the key pharmacokinetic parameters requested by the FDA, including rapid absorption, repeat-dose behaviour, and consistency across adult and geriatric populations, subject to final statistical analysis. The treatment phase of the Study has been completed, and a preliminary analysis of the data has been undertaken. The analysis demonstrates a rapid-onset pharmacokinetic profile and favourable safety in both adult and geriatric populations. The Study was designed in accordance with FDA Pre-IND guidance and supports LTR Pharma's planned 505(b)(2) development pathway. Statistical analysis of the dataset is ongoing. Full results, including final pharmacokinetic, safety, and dose-proportionality analyses, are expected to be released in Q3 CY2026.

The complete dataset will be used to support LTR Pharma's planned FDA 505(b)(2) submission and ongoing regulatory engagement in Australia, the United States, and other key markets.