• SPONTAN surpasses 1,000 prescriptions under TGA Special Access Scheme
• Phase II pharmacokinetic study for SPONTAN underway, initial data expected Q2 2026
• ROXUS development progressing towards US market launch in H1 2026

LTR Pharma Limited (ASX:LTP), a company focused on developing innovative treatments for erectile dysfunction, reported its quarterly activities and financial results for the period ending 31 December 2025. Key highlights include:- SPONTAN surpassed 1,000 prescriptions under the TGA Special Access Scheme, representing an important milestone in real-world clinical use, particularly in higher-need patient populations. The insights from SAS prescribing are informing the company's broader clinical and regulatory strategy.- The company completed all regulatory requirements for the SPONTAN Phase II pharmacokinetic study, with patient recruitment commenced and first patients dosed in Q1 2026. Initial data from this study is expected in Q2 2026.- ROXUS development continues to progress on track toward a planned US market entry in H1 2026 via the FDA 503(a) personalised medicine pathway. The company is advancing commercial infrastructure development to enable launch through men's health clinics and telehealth channels.- LTR Pharma maintained a strong financial position, with a cash balance of A$25.9 million as at 31 December 2025, providing runway to execute its strategic objectives across Australian and US markets. The company's investment in LevOmega Pty Ltd further strengthens its capacity to advance sustainable, pharmaceutical-grade omega-3 products.Looking ahead, LTR Pharma is focused on executing key value-creating milestones, including the completion of the SPONTAN Phase II study, the US market launch of ROXUS in H1 2026, and the progression of its OROFLOW development program.

LTR Pharma expects to complete the SPONTAN Phase II pharmacokinetic study and achieve the US market launch of ROXUS in H1 2026.

The company remains well-capitalised to execute its strategic priorities and is building substantial momentum towards transforming erectile dysfunction treatment globally.