Highlights

  • LTR Pharma (ASX:LTP) ended FY26 with A$19.7 million in cash and no debt.
  • SPONTAN Phase II recruitment was completed, with interim data supporting further FDA pathway progress.
  • The company established a US commercial pathway for ROXUS through agreements with Shed Holdings and Strive Pharmacy.
  • More than 1,000 SPONTAN prescriptions were issued in Australia through approved access pathways.
  • LTR Pharma traded at AUD 0.48, flat at 0.00% during the morning session on 28 August 2026.

LTR Pharma Limited (ASX:LTP) has released its FY26 full-year results, outlining progress across its intranasal drug delivery platform, including advancement of SPONTAN through Phase II development, expansion of Australian prescribing activity and preparation for the planned US commercial pathway for ROXUS.

During the morning session on 28 August 2026, LTR Pharma (ASX:LTP) was trading at AUD 0.48, flat at 0.00%. The stock remains down 5.88% over the past year.

Financial Position

LTR Pharma ended FY26 with A$19.7 million in cash and no debt, compared with A$31.8 million at 30 June 2025.

The company recorded net operating cash outflow of approximately A$10.8 million during FY26, reflecting increased Investment in clinical development, regulatory activities and preparations for commercial execution. Research and Development expenditure increased to approximately A$6.7 million, with a significant portion directed towards the SPONTAN Phase II program and related development activities.

Revenue and other income for FY26 was approximately A$1.6 million, compared with A$2.1 million in FY25. The company said the reduction mainly reflected a lower Research and Development Tax Incentive rebate due to a greater proportion of development expenditure being incurred outside Australia.

The statutory loss after tax for FY26 was approximately A$14.2 million, compared with A$5.6 million in FY25. The FY26 result included approximately A$3.1 million of non-cash share-based payment expenses, alongside equity-accounting and Impairment impacts associated with investments in associates.

SPONTAN Progress

During FY26, LTR Pharma completed recruitment for its SPONTAN Phase II pharmacokinetic and multiple-dose study, enrolling 27 healthy adult males, including 14 participants aged 65 years or older.

Interim results showed a median time to peak plasma concentration of approximately 10 minutes for a 5 mg intranasal SPONTAN dose, compared with approximately 60 minutes for a 20 mg oral vardenafil tablet.

The company reported that pharmacokinetic profiles in the older participant group were comparable with the broader adult cohort, with no evidence of drug accumulation following repeat dosing and no serious or severe treatment-emergent adverse events reported in the interim analysis.

LTR Pharma said these results address elements of the FDA’s Pre-IND feedback and support continued advancement of SPONTAN through the 505(b)(2) development pathway.

Australian Adoption

SPONTAN continued to expand its real-world footprint in Australia during FY26, with more than 1,000 prescriptions issued through the Therapeutic Goods Administration’s Special Access Scheme and Authorised Prescriber pathways.

The company said the growing prescribing base, repeat prescribing activity and emerging real-world evidence are supporting future regulatory, commercial and market-access activities.

Australian distribution continued through Symbion’s national pharmacy network, including more than 600 TerryWhite Chemmart pharmacies.

ROXUS Pathway

LTR Pharma progressed its ROXUS US commercial strategy during FY26 by establishing a contracted commercial framework. The company entered into binding term sheets with Shed Holdings and Strive Pharmacy.

The agreement with Shed Holdings provides exclusive direct-to-consumer telehealth distribution of ROXUS through its Shed and Mavrox platforms, including a commitment to support delivery of at least 150,000 ROXUS prescription units during the first 12 months following commercial launch.

The agreement with Strive Pharmacy provides exclusive US Section 503A pharmacy fulfilment for ROXUS. Under the structure, LTR Pharma retains ownership of the ROXUS brand, intellectual property and product supply, while partners provide patient acquisition, prescribing, compounding and fulfilment infrastructure.

Platform Expansion

LTR Pharma also progressed OROFLOW®, its intranasal platform beyond erectile dysfunction applications. In June 2026, the South Eastern Sydney Local Health District Human Research Ethics Committee approved the first investigator-initiated pilot study of OROFLOW.

The program is being developed as an intranasal treatment for oesophageal motility disorders and represents the first clinical evaluation of LTR Pharma’s intranasal platform outside erectile dysfunction.

The company said the study will assess whether its formulation and intranasal delivery expertise can be applied to other established medicines where rapid, predictable or tablet-free administration may provide clinical benefits.

FY27 Priorities

LTR Pharma enters FY27 focused on commercial execution and late-stage clinical development. The company’s priorities include executing the planned US commercial launch pathway for ROXUS, completing full statistical analysis of the SPONTAN Phase II program, progressing SPONTAN towards Phase III planning and continuing expansion of SPONTAN awareness in Australia.

The company will also continue generating initial clinical evidence for OROFLOW and evaluating additional indications and strategic partnerships that could utilise its intranasal drug-delivery platform.

Investor Takeaway

LTR Pharma’s FY26 update highlights a transition towards commercial execution, supported by SPONTAN clinical progress, growing Australian prescription activity and development of the ROXUS US pathway. Investors may continue watching regulatory progress, commercial launch preparation, clinical milestones and expansion of the company’s intranasal platform.