Key Highlights

  • The first patient-specific ROXUS prescriptions were fulfilled in the United States on 6 October 2026 through Shed's Mavrox platform and Strive Pharmacy.
  • The final Phase II report showed SPONTAN 5 mg reached a median Tmax of 10 minutes versus 60 minutes for a 20 mg oral vardenafil tablet (p<0.0001).
  • A 147-patient real-world study recorded a 68% composite response overall and 93% among men seeking greater convenience and spontaneity.
  • LTR Pharma held A$18.2 million in cash and no debt at 30 September 2026, with net operating cash outflow of A$1.6 million for the quarter.

LTR Pharma Limited (ASX:LTP) used the September 2026 quarter to turn two U.S. agreements into working prescription activity. On 6 October, shortly after the quarter ended, the first patient-specific prescriptions for its compounded intranasal spray ROXUS were fulfilled in the United States, less than three months after the definitive agreements were signed. The company also finalised the SPONTAN Phase II pharmacokinetic report and closed the quarter with A$18.2 million in cash.

ROXUS Moves From Agreements to Fulfilled Prescriptions

LTR Pharma signed a Telehealth Distribution Agreement with Shed Holdings LLC on 17 July 2026, under which Shed sells ROXUS through its men's health telehealth platform, Mavrox and handles patient acquisition and marketing. A Compounding and Supply Agreement with Strive Specialties Inc. followed on 20 July, covering manufacturing and nationwide supply. LTR Pharma remains the product owner, intellectual property holder and supplier.

On 6 October 2026 Mavrox reported that Strive Pharmacy had fulfilled the first patient-specific ROXUS prescriptions. ROXUS is a compounded medication prepared against an individual prescription and has not been reviewed or approved by the U.S. Food and Drug Administration. Customer receipts for the quarter were A$366,035, of which about A$296,000 came from ROXUS raw material supply and about A$70,000 from SPONTAN supply under the Australian Special Access Scheme. The ROXUS receipts relate to raw materials, not fulfilled patient prescriptions, which began after quarter end.

SPONTAN Data Completes the FDA Pharmacokinetic Package

On 1 October 2026 the company released the final Clinical Study Report for its SPONTAN Phase II pharmacokinetic study, prepared by Southern Star Research. The report confirmed the interim results of 1 May 2026 and completed the pharmacokinetic dataset agreed with the FDA for a planned 505(b)(2) submission. Among 27 participants, SPONTAN 5 mg recorded a median Tmax of 10 minutes, SPONTAN 2.5 mg 11 minutes and a 20 mg vardenafil oral tablet 60 minutes. The difference between the 5 mg spray and the tablet was statistically significant at p<0.0001.

Mean Cmax was 8.9 ng/mL for the 5 mg dose against 19.8 ng/mL for the tablet, which the company attributes to lower administered doses. No serious adverse events, Grade 3 or higher events or discontinuations occurred. Fourteen participants were aged 65 or over, and their results were comparable with younger adults, a requirement set at the FDA Pre-IND meeting.

A retrospective cohort of 147 treatment-experienced Australian men, reported on 11 August 2026, recorded a 68% composite response (100 of 147). Response was 93% (42 of 45) among men seeking greater convenience and spontaneity and 64% (56 of 87) in the post-prostatectomy subgroup.

Australian Dispensing, a PAH Study and KYZATREX

As at 20 October 2026, more than 2,000 bottles of SPONTAN had been dispensed in Australia under the TGA Special Access Scheme and Authorised Prescriber pathways, with more than 120 clinicians having prescribed it more than once. On 22 October the Bellberry Human Research Ethics Committee approved an investigator-initiated study led by Professor David Celermajer at Royal Prince Alfred Hospital, assessing haemodynamic effects 15 minutes after a single intranasal dose in untreated pulmonary arterial hypertension.

On 1 September the company also signed an exclusive pilot commercialisation agreement with Marius Pharmaceuticals, Inc. to bring KYZATREX, an FDA-approved oral testosterone undecanoate, to Australia through the Special Access Scheme, with exclusivity during a six-month evaluation period.

Where the Quarter Leaves LTR Pharma

Net operating cash outflow was A$1.6 million, including A$0.6 million of research and development spending, and cash fell from A$19,642,346 to A$18,166,153 with no debt. Payments to related parties totalled A$329,280. Appendix 4C reports 11 estimated quarters of funding. The quarter therefore ended with ROXUS prescriptions being filled in the United States, the SPONTAN pharmacokinetic dataset complete and A$18.2 million on the balance sheet.