Quarterly Activities Report and 4C

LTR Pharma has today released its Quarterly Activities Report and Appendix 4C Quarterly Cash Flow report for the quarter ended 31 December 2025 

Key highlights from this period include: 

• SPONTAN® surpasses 1,000 prescriptions under TGA Special Access Scheme (SAS), representing an important milestone in real-world clinical use. 

• Ethics approval and TGA regulatory clearance received for the SPONTAN Phase II pharmacokinetic study. 

• Subsequent to quarter end, first patients dosed in Phase II study, with initial data expected Q2 CY2026. 

• ROXUS® development progressing on track toward a planned US market launch in H1 CY2026 via the 503(a) personalised medicine pathway. 

LTR Pharma closes the quarter with a strong cash balance of A$25.9 million at 31 December 2025, supporting continued execution of SPONTAN Phase II activities and ROXUS US launch preparation. 

Executive Chairman, Lee Rodne, commented: 

"This quarter marked significant clinical and regulatory progress for LTR Pharma. Reaching over 1,000 SPONTAN prescriptions under the TGA Special Access Scheme represents an important milestone in real-world clinical use, particularly in higher-need patient populations. The insights generated through SAS prescribing are informing our broader clinical and regulatory strategy, while we continue to progress the Phase II study and prepare for ROXUS market entry in the United States.” 

Click to read the ASX release.