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Meanwhile, as part of its dual-track strategy for early commercialisation, the 503A compounding model with ROXUS® provides a fast-track entry into the growing US personalised medicine sector.

Combined with the active prescribing and real-world data collection already taking place in Australia under the TGA’s processes for early access (e.g., the Special Access Scheme), this dual-track approach positions LTR Pharma to build a global market presence while advancing toward full regulatory approvals via the FDA.

LTR Pharma is redefining drug delivery with a fast-acting intranasal spray platform targeting large, underserved markets. With a dual-track regulatory strategy, validated clinical results, and early commercial traction in both Australia and the United States, the Company is positioned for both near-term revenue and long-term global growth.

LTR Pharma is advancing a clear and efficient regulatory strategy, which is designed to accelerate entry to global markets. In the United States, SPONTAN® is progressing through the FDA’s 505(b)(2) pathway – an expedited pathway leveraging existing clinical data to reduce development time and cost.

ED affects over 300 million men globally, with high dissatisfaction and discontinuation rates among current therapies, LTR Pharma is offering new solutions.

LTR Pharma has completed a successful Phase I human proof-of-concept study, demonstrating that its product, SPONTAN®, works six times faster than traditional oral PDE5 inhibitors.

The company is on track to launch the first FDA-cleared nasal spray PDE5 inhibitor, addressing an unmet need in a global market projected to reach US$6.0 billion by 2028.

LTR is executing a two-pronged commercialisation plan—SPONTAN® for full FDA and TGA approvals, and ROXUS® for earlier US market access via the compounding pharmacy model.

LTR is targeting 2026 commercial entry into the US personalised medicine market through 503A pharmacies – valued at over US$6B and growing.

LTR works with proven commercial and regulatory partners, including Aptar Pharma (device and regulatory co-development) and Symbion (distribution).

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