Highlights

  • Mavrox fulfilled the first patient-specific ROXUS prescriptions in the United States on 6 October 2026, with Strive Pharmacy handling fulfilment.
  • SPONTAN 5 mg reached median peak concentration in 10 minutes versus 60 for oral vardenafil, with no serious adverse events.
  • LTR Pharma targets a SPONTAN Phase III start in the first half of 2027; regulatory approval has not been obtained.
  • Cash closed at A$18,166,153 with no debt, and the company estimated about 11 quarters of funding at the current outflow.

6 October 2026: the first patient-specific ROXUS prescriptions were fulfilled in the United States. LTR Pharma Limited (ASX:LTP) reported on 28 October 2026 that Mavrox filled the orders, with Strive Pharmacy doing the fulfilment. The milestone follows a Telehealth Distribution Agreement with Shed Holdings LLC signed on 17 July 2026 and a Compounding and Supply Agreement with Strive Specialties Inc. signed on 20 July 2026. Fulfilment began after the quarter ended, so quarterly customer receipts of A$366,035 included no patient sales: about A$296,000 related to ROXUS raw materials and about A$70,000 to SPONTAN supply in Australia.

The SPONTAN clinical program

The final Phase II Clinical Study Report from Southern Star Research, dated 1 October 2026, confirmed the interim results and completed the pharmacokinetic dataset agreed with the US Food and Drug Administration. Phase III is targeted to start in the first half of calendar 2027.

The pharmacokinetic study involved 27 participants, 14 of them aged 65 or older. Median time to peak concentration was 10 minutes for SPONTAN 5 mg and 11 minutes for 2.5 mg, against 60 minutes for oral vardenafil 20 mg. The company said the difference between SPONTAN 5 mg and vardenafil was statistically significant. Peak concentration averaged 8.9 ng/mL for 5 mg against 19.8 ng/mL for vardenafil, which the company said reflects lower doses. There were no serious adverse events, grade 3 or higher adverse events or discontinuations. Efficacy in a controlled trial is yet to be demonstrated.

Real-world and Australian use

A retrospective study of 147 men previously treated with oral PDE5 inhibitors, reported on 11 August 2026, found the composite endpoint was met by 68 per cent overall (100 of 147). The figure was 93 per cent (42 of 45) among those seeking convenience or spontaneity, 57 per cent (58 of 102) among those with an inadequate response to oral therapy and 64 per cent (56 of 87) after prostatectomy. Being retrospective, the study does not substitute for controlled trial results.

In Australia, more than 2,000 bottles of SPONTAN had been dispensed as at 20 October 2026 through the Special Access Scheme, with more than 120 clinicians prescribing on more than one occasion.

Other developments

A Bellberry ethics committee approved an investigator-initiated study of SPONTAN in pulmonary arterial hypertension, led by Professor David Celermajer at Royal Prince Alfred Hospital, announced on 22 October 2026. On 1 September 2026, the company also signed an exclusive pilot agreement with Marius Pharmaceuticals for KYZATREX in Australia, with a six-month evaluation period.

Cash and milestones

Net operating cash outflow was A$1,588,423. Option exercises brought in A$129,230. Cash at quarter end was A$18,166,153 against A$19,642,346 in the prior quarter.

Targets for the second half of calendar 2026 are submission-enabling work for SPONTAN (manufacturing and controls, human factors, leachables and non-clinical toxicology) and the start of the OROFLOW pilot study. The Phase III start and the pulmonary hypertension study follow in the first half of 2027. Regulatory approval of SPONTAN has not been obtained.