September 2026 Quarterly: First U.S. ROXUS® Prescriptions Fulfilled

LTR Pharma Limited (ASX:LTP) has released its Quarterly Activities Report and Appendix 4C for the three months ending on 30 September 2026. The Quarter saw both U.S. commercial term sheets for ROXUS® converted into definitive agreements, followed shortly after the quarter ended by the first ROXUS prescriptions fulfilled in the United States and the final Phase II report completing SPONTAN®’s FDA pharmacokinetic dataset.

Highlights:

  • First ROXUS® prescriptions fulfilled in the U.S. (subsequent to quarter ending), received through Shed’s Mavrox telehealth platform and fulfilled by Strive Pharmacy, less than three months after the definitive agreements
  • Final Phase II report completes the FDA pharmacokinetic dataset (subsequent to quarter ending): SPONTAN®’s six-fold faster absorption than oral vardenafil tablets confirmed; Phase III study targeted to commence 1H CY2027
  • S. commercial framework for ROXUS completed, with definitive agreements executed with Shed and Strive Pharmacy
  • 147-patient real-world study: 93% response in men seeking greater convenience and spontaneity; 64% in post-prostatectomy patients; 68% overall
  • More than 2,000 bottles of SPONTAN® dispensed in Australia (subsequent to quarter ending), with more than 120 clinicians having prescribed SPONTAN on more than one occasion
  • Ethics approval received for an investigator-initiated SPONTAN study in pulmonary arterial hypertension, led by Professor David Celermajer (subsequent to quarter ending)
  • A$18.2 million cash, debt-free, at 30 September 2026; net operating cash outflow A$1.6 million

 

LTR Pharma Executive Chairman, Lee Rodne, said: “This Quarter was about converting agreements into execution. In July we executed definitive agreements with Shed and Strive Pharmacy, securing the telehealth and pharmacy fulfilment components of our U.S. commercial framework for ROXUS®. Less than three months later, on 6 October, the first patient-specific ROXUS prescriptions received through Mavrox were fulfilled in the United States by Strive Pharmacy. We have moved from implementation to serving patients, and our focus is now on supporting our partners as prescribing activity builds.

“The 147-patient real-world study reported a 93% response among men seeking greater convenience and spontaneity, and on 1 October the final Phase II report confirmed SPONTAN®’s six-fold faster absorption and completed the pharmacokinetic dataset agreed with the FDA. We remain disciplined in our capital allocation as we support our U.S. partners in building ROXUS prescription activity and progress SPONTAN’s submission-enabling workstreams and Phase III preparations.”

Read the full ASX announcement

 

ROXUS is a compounded medication prepared for identified individual patient needs based on a valid prescription from a prescribing healthcare practitioner and, as such, is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. Compounded drugs are intended for patients whose prescriber has determined their medical needs are not met by an available FDA-approved drug.