EVE Advances Libbo Trial and Apixaban Solubility with New CEO

Libbo Clinical Program Advances with Pilot Study Ready to Start

EVE Health Group (ASX:EVE) has cleared a key hurdle in its erectile dysfunction treatment program with the finalisation of the pilot clinical study protocol for Libbo®, its vardenafil 10mg oral soluble film. The company has engaged a contract research organisation and clinical site to conduct the study, which will compare Libbo against an approved vardenafil tablet in healthy male volunteers.

While initial dosing was originally anticipated earlier, EVE now expects pilot dosing to commence in Q4 2026, with data anticipated in early 2027. The delay reflects additional regulatory and comparative testing steps the company deems necessary to de-risk the subsequent pivotal bioequivalence study, which is central to Libbo's registration pathway under the Australian Register of Therapeutic Goods (ARTG). Notably, the company reported no safety or formulation issues affecting the timeline.

Significant Apixaban Solubility Milestone Achieved

In a separate but related development, EVE has demonstrated a remarkable improvement in the solubility of apixaban, the active pharmaceutical ingredient in Eliquis®, using its proprietary solubilisation technology. Testing revealed solubility exceeding 50 mg/mL, a dramatic increase from apixaban's baseline aqueous solubility of approximately 0.6 mg/mL. This breakthrough supports EVE's ongoing reformulation program targeting anticoagulant therapies, for which a provisional patent application is already in place.

Leadership Reshuffle to Sharpen Commercial Focus

On the corporate front, EVE appointed Ben Rohr as Chief Executive Officer effective 27 April 2026. Rohr, formerly Chief Operating Officer, has been instrumental in executing the company’s strategy, including leading the integration of the Nextract acquisition and advancing key products Dyspro® and Libbo® towards regulatory and commercial milestones. His elevation reflects the board’s intent to accelerate commercialisation and deliver disciplined growth across the business.

Financial Position and Future Plans

EVE reported a net operating cash outflow of $465,000 for the quarter ending June 2026, with cash and equivalents standing at $1.238 million. This provides an estimated runway of about three quarters at current burn rates, highlighting the importance of forthcoming clinical data and potential partner licensing deals to sustain momentum.

Looking ahead, EVE plans to progress Libbo into a pivotal bioequivalence study pending satisfactory pilot results and continue advancing its broader reformulation pipeline, which includes therapies for premature ejaculation and combination erectile dysfunction treatments. The company remains committed to a capital-light, partner-led commercial model, seeking alliances with pharmaceutical partners possessing established regulatory and distribution capabilities.

CEO Ben Rohr emphasised the significance of the pilot study milestone, stating it marks EVE's transition into clinical execution and lays the foundation for regulatory registration efforts. With a leadership team aligned to commercial and regulatory priorities, the company is positioned to advance its pipeline in the coming months.