• Achieved key clinical, regulatory and commercial milestones for lead product SPONTAN
• Progressed ROXUS development towards planned US launch in H1 2026
• Increased strategic investment in LevOmega to ~43% ownership

During the period, LTR Pharma achieved significant regulatory and clinical milestones for its lead product SPONTAN, an intranasal vardenafil formulation for the treatment of erectile dysfunction. The company received ethics approval and TGA clearance to commence a Phase II pharmacokinetic and multiple-dose study, which is designed to generate geriatric-use data relevant for prescribing in older men. SPONTAN's Phase I pharmacokinetic data were also published in a peer-reviewed journal, independently validating its differentiated profile. In the real-world setting, SPONTAN surpassed 1,000 prescriptions under the TGA Special Access Scheme, providing valuable clinical insights. The company also progressed development of ROXUS, its intranasal spray for erectile dysfunction, toward a planned US market entry in H1 2026, including commercial infrastructure development. To support US expansion, LTR Pharma appointed two leading US erectile dysfunction specialists to its Scientific Advisory Board. The company also increased its strategic investment in LevOmega, a developer of pharmaceutical-grade omega-3 ingredients, to approximately 43% ownership. Financially, LTR Pharma maintained a strong cash position of $25.8 million as of 31 December 2025, providing funding runway to execute its clinical programs and US commercial preparations.

The company did not provide any high-importance, price-sensitive forward-looking financial metrics in the announcement.

LTR Pharma enters the second half of FY26 with advancing clinical programs, regulatory alignment, and continued preparation for US market entry. Key priorities include completion of the SPONTAN Phase II study, progressing ROXUS towards US launch in H1 2026, and supporting the development of OROFLOW, a novel intranasal spray for oesophageal motility disorders. The company will also continue to support the technical validation and development activities of LevOmega.