• First patients treated with SPONTAN under TGA Special Access Scheme
• Secured global co-development agreement with Aptar Pharma for FDA submission
• Completed pivotal clinical trial, confirming faster absorption than oral vardenafil

LTR Pharma (ASX:LTP) has achieved defining clinical and commercial milestones in FY25, expanding its nasal spray product portfolio and paving a clear path to market in Australia and the United States. The company's lead product, SPONTAN, is a first-in-class, fast-acting nasal spray for erectile dysfunction using vardenafil. In August 2024, SPONTAN was prescribed for the first time under the TGA's Special Access Scheme and Authorised Prescriber Scheme, marking the beginning of real-world experience for the product. LTR Pharma also secured a strategic partnership with Aptar Pharma, a global leader in nasal drug delivery systems, to provide regulatory, analytical, and device technology support for SPONTAN's FDA submission. In October 2024, the company announced the completion and analysis of its pivotal clinical trial, confirming SPONTAN achieved 470% faster absorption than oral vardenafil, at half the dose, while maintaining excellent safety and bioavailability. The results validate SPONTAN's suitability for the FDA's expedited 505(b)(2) approval pathway. LTR Pharma also showcased SPONTAN's pivotal clinical data at the USANZ Annual Scientific Meeting in February 2025, with Professor Eric Chung presenting the findings. In June 2025, the company completed the required extractables study for SPONTAN's nasal delivery device, keeping the FDA submission process on track.

LTR Pharma expects expedited regulatory approval for SPONTAN by repurposing an already regulatory cleared drug - intranasal delivery of vardenafil, a proven and effective PDE5 inhibitor. The company is also progressing its US-focused personalised ED product ROXUS and expanding its pipeline into gastroenterology with OROFLOW, targeting Oesophageal Motility Disorders.

LTR Pharma is well-positioned to capture market share in the global erectile dysfunction treatment market, which is projected to reach US$6 billion by 2028. The company's breakthrough intranasal platform is designed to address key issues with current oral ED medications, offering patients the ability to be spontaneous, discreet, and confident.