• SPONTAN achieves 18-month shelf life under ICH conditions
• Confirms commercial-scale manufacturing and distribution capabilities
• Supports strategic discussions with leading pharmaceutical partners
• Ongoing stability studies provide pathway for further shelf-life extensions

LTR Pharma Limited (ASX:LTP) announced that its SPONTAN® product has achieved an 18-month shelf life under international pharmaceutical stability standards. This achievement demonstrates the robustness of SPONTAN's formulation, delivery device, and packaging system under standard storage conditions. The 18-month shelf life exceeds current requirements for the company's growing Australian pharmacy network and provides the stability foundation essential for international market entry and partnership discussions. Achieving extended shelf life is a major technical milestone for a liquid nasal spray formulation, as it must maintain active ingredient stability in solution whilst ensuring consistent device performance throughout the shelf life. SPONTAN has demonstrated both chemical stability and device reliability across the full 18 months under ICH conditions, strengthening its Chemistry, Manufacturing, and Controls (CMC) package for regulatory submissions. This positions SPONTAN competitively against oral PDE5 inhibitors while preserving its key advantage of rapid onset of action within 10 minutes. LTR Pharma's ongoing stability program will continue through 24 months and beyond, with interim data potentially supporting further shelf-life extensions. This milestone validates the company's manufacturing strength and positions SPONTAN as a commercially viable alternative to traditional ED treatments, as LTR Pharma expands its Australian footprint and advances regulatory pathways in the US and other key markets.

LTR Pharma's lead products, SPONTAN® and ROXUS®, are fast-acting intranasal sprays for the treatment of erectile dysfunction, enabling onset of action in 10 minutes or less.

With the 18-month shelf life achievement, LTR Pharma is on track to transform ED treatment worldwide through its innovative intranasal formulation that meets international distribution standards.