EVE Health Advances Libbo Pilot Study and Apixaban Solubility Breakthrough

Libbo Pilot Study Set for Q4 Dosing After Protocol Finalisation

EVE Health Group (ASX:EVE) has reached a key milestone in its Libbo® erectile dysfunction program by finalising the pilot clinical study protocol and engaging a contract research organisation and clinical site to conduct the trial. The study will compare Libbo’s vardenafil 10mg oral soluble film against an approved reference product in healthy males.

While dosing was initially expected earlier, EVE now anticipates pilot dosing to commence in Q4 2026, with data expected in early 2027. The delay reflects additional regulatory and comparative testing steps, which the company describes as important de-risking measures ahead of a planned pivotal bioequivalence study. No safety or formulation issues have been reported.

Apixaban Solubility Milestone Supports Reformulation Pipeline

On the pharmaceutical innovation front, EVE reported a breakthrough in solubility for apixaban, the active ingredient in Eliquis®, achieving solubility exceeding 50 mg/mL using its proprietary solubilisation technology. This represents an improvement of more than 80 times over apixaban’s baseline aqueous solubility of approximately 0.6 mg/mL.

This milestone bolsters EVE’s ongoing apixaban reformulation program, for which a provisional patent application is already in place. The enhanced solubility could have implications for improved drug delivery and bioavailability, although clinical validation remains pending.

Leadership Shift to Accelerate Commercialisation

EVE appointed Ben Rohr as Chief Executive Officer effective 27 April 2026, a move aimed at sharpening the company’s commercial focus and disciplined growth. Rohr, previously Chief Operating Officer, was instrumental in integrating the Nextract acquisition and advancing core products Dyspro® and Libbo® toward regulatory and commercial milestones.

Rohr’s elevation signals the board’s intent to accelerate the commercial rollout of EVE’s product portfolio amid ongoing clinical and regulatory activities.

Financial Position and Operational Cash Flow

During the June quarter, EVE recorded a net operating cash outflow of $465,000, driven by research, manufacturing, marketing, and staff costs. The company ended the period with $1.24 million in cash and cash equivalents, representing an estimated runway of approximately three quarters at current burn rates.

No significant investing activities were reported, and financing activities showed a minor net cash outflow. Payments to related parties amounted to $83,000 for the quarter.

Next Steps for Libbo and Broader Pipeline

EVE plans to focus on completing the remaining testing and regulatory steps for the Libbo pilot study, with dosing expected in Q4 2026 and data anticipated early next year. Subject to satisfactory pilot results, the company intends to progress to a pivotal bioequivalence study supporting regulatory registration under the Australian Register of Therapeutic Goods (ARTG).

Beyond Libbo, EVE is advancing its reformulation pipeline, targeting therapies for premature ejaculation, combination erectile dysfunction and premature ejaculation, and anticoagulation. The company continues to pursue licensing and supply partnerships aligned with its capital-light, partner-led business model.