Quarterly Activities Report & Appendix 4C | Period Ended 31 March 2026

LTR Pharma (ASX:LTP) has released its Quarterly Activities Report for the period ended 31 March 2026, highlighting continued progress across clinical development and commercial activities. 

Key highlights for the quarter include: 

• SPONTAN Phase II pharmacokinetic study progressing 

  • Recruitment completed across 27 participants, with dosing of the final cohort underway 

  • Interim PK data expected Q2 CY2026, with final results to follow 

• Phase I data accepted for international presentation 

  • Selected for podium presentation at the World Meeting on Sexual Medicine 2026 

  • Data demonstrated faster absorption and higher dose-normalised bioavailability vs oral vardenafil 

• ROXUS US commercial discussions advancing 

  • Progressing via the FDA 503(a) personalised medicine pathway 

  • Ongoing focus on partner selection and commercial terms 

• Real-world evidence continuing to build 

  • Prescribing under the TGA Special Access Scheme maintained 

  • Independent observational case series reported positive real-world outcomes in five younger men with performance-related erectile difficulties (preliminary, self-reported observations) 

• Strong financial position 

  • A$24.1 million cash balance at 31 March 2026 

  • Debt-free, with approximately 13 quarters of funding runway 

LTR Pharma’s Executive Chairman, Lee Rodne, commented:  

“During the quarter, LTR Pharma progressed SPONTAN ® into the dosing phase of its Phase II study, with pharmacokinetic data expected in Q2 CY2026 to support the FDA 505(b)(2) pathway. In parallel, commercial discussions for ROXUS US market entry via the 503(a) continue to progress, with a disciplined focus on partner selection and commercial terms.” 

Click to read the ASX announcement.