• Peer-reviewed publication validates up to 5x faster onset of SPONTAN
• Clinical data confirms dual-product platform supporting SPONTAN and ROXUS
• Addresses US$3.7 billion ED market, 50% of patients discontinue oral treatments

LTR Pharma Limited (ASX:LTP) has announced that clinical data from its Phase I pharmacokinetic study of SPONTAN (SDS-089), the company's lead intranasal vardenafil formulation for erectile dysfunction (ED), has been published in the peer-reviewed European Journal of Pharmaceutical Sciences. The publication provides independent validation of SPONTAN's differentiated profile, showing peak plasma concentrations in approximately 10 minutes versus 45 minutes for conventional oral tablets. Key clinical findings include ultra-rapid onset, with SPONTAN reaching peak plasma concentration in a median of 10 minutes compared to 45 minutes for oral tablets, superior efficiency with higher bioavailability per milligram, and comparable duration with a similar half-life of approximately 4 hours. The publication also notes that current oral PDE5 inhibitors face significant limitations, including delayed onset, reduced efficacy with food intake, and the need for careful timing around sexual activity, contributing to discontinuation rates of approximately 50% within the first year. The clinical validation extends to the company's broader intranasal vardenafil portfolio, including ROXUS. The publication in this leading pharmaceutical sciences journal represents important third-party validation of LTR's innovative drug delivery platform and its potential to transform ED treatment.

The publication strengthens the regulatory pathway and physician adoption of SPONTAN as LTR Pharma advances regulatory submissions for the United States via the 505(b)(2) pathway and other key markets.