Q1 FY27 highlights: Libbo® patient pathway live, pilot dosing targeted for Q4 2026
In its Q1 FY27 quarterly activities report for the quarter ended 30 September 2026, EVE Health Group (ASX: EVE) reported that the patient pathway for its Libbo® erectile dysfunction oral film operated end to end. Products were supplied to patients ahead of full product registration.
The Company closed the quarter with $836,000 in cash and no borrowings. Key points from the report include:
- Pathway operating: patient education, telehealth consultation, pharmacy fulfilment and discreet home delivery are now fully operational.
- Pilot study progressing: dosing is targeted for Q4 2026, subject to completion of the remaining testing and regulatory steps, with pilot data anticipated in early 2027.
- Path to registration: pilot data will inform the design of the pivotal bioequivalence study that underpins the registration pathway.
- Reformulation pipeline: programs progressed across men’s health and cardio-metabolic areas.
- Cash: closing cash of $836,000 at 30 September 2026 with no borrowings.
Mr Ben Rohr, Chief Executive Officer
“During the quarter, we continued to build the patient access arrangements for our oral film program and prepare for the next stage of clinical development. Our priorities are to progress the pilot study, use its findings to inform subsequent development and advance selected opportunities across our reformulation pipeline.”
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Commercial pathway and Libbo® clinical progress
Patient access pathway
EVE continued to develop its men’s health patient access pathway during the quarter. It combines condition-focused information through LibX.com.au, telehealth services provided by hubMed, pharmacy fulfilment arrangements with Chemist2U and discreet home delivery.
These arrangements are intended to support access for eligible patients through applicable Australian prescribing pathways, including the Special Access Scheme Category B (SAS-B), where the necessary patient-specific approvals are obtained.
For investors, the pathway gives EVE an established patient acquisition model, telehealth prescribing workflow, pharmacy logistics and regulatory compliance processes, which the Company will continue to refine.
Pilot study and route to registration
EVE continued preparations for a pilot pharmacokinetic study of its erectile dysfunction oral soluble film. The study will compare the film with a registered reference tablet in fasted healthy male participants and include assessments relevant to the film format.
The Company is targeting commencement of dosing in Q4 2026, subject to completion of the remaining testing and regulatory steps. Results are anticipated in early 2027.
Findings are expected to inform the design of the pivotal bioequivalence study. Subject to satisfactory pilot outcomes, regulatory requirements and study readiness, EVE is targeting commencement of that study in Q1 2027 and a potential registration submission in the second half of 2027.
Understanding oral films and why bioequivalence matters
An oral soluble film is a dosage format that is an alternative to existing tablet products. EVE is developing its film on that basis.
A pharmacokinetic study measures how a drug moves through the body, while a bioequivalence study compares a new product against an existing registered product. For EVE, the pilot is described as an important early step in the clinical milestones that underpin its path to full product registration.
The Company cites an estimated 322 million men worldwide affected by erectile dysfunction in 2025. EVE considers that patient preferences and variability in response to currently available therapies may provide opportunities for differentiated delivery formats.
Pipeline, Dyspro® and Meluka Australia
EVE’s reformulation platform supports a pipeline spanning men’s health and cardio-metabolic indications, consistent with its proposed partner-led commercial strategy. Programs include:
- Premature ejaculation (earlier-stage)
- A combined erectile dysfunction and premature ejaculation therapy (earlier-stage)
- An apixaban anticoagulation reformulation program in pre-bioequivalence development
- Exploratory lipid-lowering programs involving rosuvastatin and atorvastatin
Development progress and commercial opportunities remain subject to further technical assessment and partner engagement.
The reformulated drug pipeline was framed earlier in 2026 around combined addressable markets above US$30 billion, with oral spray programs and an apixaban reformulation positioned for licensing to partners with existing regulatory and distribution capability.
For Dyspro®, its women’s health product, the Company continued work including preparation of a case study report examining patient experiences. The report is being progressed and is expected to inform the assessment of future development and commercialisation activities.
Meluka Australia continued to generate sales through its online consumer health business. Trading strengthened month by month, supported by its established product range and purchasing by returning customers.
Cash position: $836,000 closing balance and no borrowings
Cash and cash equivalents fell from $1,238,000 at the start of the quarter to $836,000 at quarter end, after net operating cash outflow of $402,000. Closing cash comprised bank balances of $686,000 and call deposits of $150,000.
| Item | Current quarter ($A’000) |
|---|---|
| Receipts from customers | 208 |
| Advertising and marketing | (215) |
| Staff costs | (174) |
| Product manufacturing and operating costs | (111) |
| Administration and corporate costs | (95) |
| Research and development | (22) |
| Net operating cash flow | (402) |
| Closing cash | 836 |
Appendix 4C item 8.5 states 2.1 estimated quarters of funding available.
Payments to related parties totalled $67,000, comprising $64,000 in directors’ fees and $3,000 in office overheads paid to Mitchell River Group Pty Ltd.
What happens next for EVE
The report sets out the following forward milestones:
- Pilot study dosing: targeted for Q4 2026, subject to completion of the remaining testing and regulatory steps. EVE is responsible for the study.
- Pilot data: anticipated in early 2027, and expected to inform the design of the pivotal bioequivalence study.
- Pivotal bioequivalence study: targeted to commence in Q1 2027, subject to satisfactory pilot outcomes, regulatory requirements and study readiness.
- Potential registration submission: second half of 2027, subject to successful completion of the necessary clinical and regulatory work.
- Research and Development Tax Incentive claim for the year ended 30 June 2026: the Company expects to finalise it and receive a cash refund under the programme in the December quarter.
Licensing, supply and development discussions with pharmaceutical partners in international markets remain preliminary, and there is no assurance that they will result in binding agreements.
Ready to Learn More About EVE Health’s Libbo® Program?
EVE Health Group has its Libbo® patient pathway fully operational, with pilot study dosing targeted for Q4 2026 and a potential registration submission in the second half of 2027. The Company closed the quarter with $836,000 in cash and no borrowings while it advances its reformulation pipeline.
Investors seeking more detail on the clinical timeline and pipeline can visit the EVE Health Group website for the latest updates. Explore the Company’s projects to assess how its oral film strategy may develop.