• Extractables study completed with co-development partner Aptar Pharma
• All identified compounds below ICH safety thresholds
• Leachables study initiated to support FDA regulatory submission

LTR Pharma Limited (ASX:LTP) has announced the completion of extractables studies for SPONTAN, its intranasal spray for erectile dysfunction, and the commencement of leachables studies as part of its regulatory development program. The extractables study, conducted under the supervision of Aptar Pharma, evaluated the bottle and pump components of SPONTAN's container closure system. The study confirmed that all detected compounds were below ICH safety thresholds - the internationally recognised standards adopted by the FDA and regulatory authorities worldwide for pharmaceutical impurities. The leachables study has now commenced under Aptar Pharma's management, evaluating the potential migration of the compounds from packaging into SPONTAN under real-world storage conditions. SPONTAN utilises industry-standard bottle and pump components used in multiple FDA-approved nasal spray products. The study will run for at least 24 months to support shelf-life requirements. Both extractables and leachables data are required for the Chemistry, Manufacturing and Controls (CMC) section of LTR Pharma's planned New Drug Application. With extractables complete and meeting safety thresholds, the company continues progressing through the regulatory pathway.

The company has not provided any high-importance, price-sensitive forward-looking financial metrics.

The company continues to progress SPONTAN through established regulatory pathways while building commercial foundations through its Australian early access programmes and planned US market entry with ROXUS.