Argent BioPharma Licences CannEpil Globally in US$5.5m Debt-Clearing Transaction

Argent BioPharma (ASX: RGT) has entered a binding global licensing framework with Splash Beverage Group Inc, securing US$5.5 million in upfront consideration for exclusive global commercialisation rights to CannEpil, its pharmaceutical-grade cannabinoid combination therapy developed for the management of drug-resistant epilepsy.

Drug-resistant epilepsy—also referred to as refractory epilepsy—affects about one-third of all epilepsy patients worldwide, and remains one of the largest unmet needs in neurology.

The transaction is designed to strengthen Argent’s balance sheet and simplify its capital structure while preserving long-term exposure to CannEpil’s commercial future, with Argent to satisfy the upfront consideration through the forgiveness of about US$5.5m of outstanding convertible notes held by Mercer Street Global Opportunity Fund.

Argent will retain 100% ownership of existing CannEpil intellectual property, future intellectual property from development activities and clinical programs, manufacturing know-how, and associated regulatory assets.

The company will continue to manufacture CannEpil for Splash Beverage through its European Union good manufacturing practice (EU-GMP) facilities and existing EU-GMP production affiliates.

CannEpil Pathway Retained

Formulated as a standardised 20:1 cannabidiol to tetrahydrocannabinol oral solution for drug-resistant epilepsy, CannEpil has established regulatory and commercial access pathways across Ireland, the United Kingdom, Germany, and Australia.

The product is also supported by real-world clinical evidence, peer-reviewed publications, EU-GMP manufacturing infrastructure and an active Food and Drug Administration investigational new drug program in the US.

Argent will receive a 15% royalty on aggregate net revenues from future CannEpil sales generated by Splash Beverage, its affiliates, and sublicensees, payable for the longer of 10 years from first commercial sale in each country or the expiry of the last-to-expire patent covering CannEpil in that country.

Splash Beverage will be responsible for development and regulatory approval of CannEpil, with the US prioritised.

The agreement requires Splash Beverage to use commercially reasonable efforts to start a Phase I clinical trial within 24 months, start a Phase II trial within 48 months, and file a New Drug Application with the FDA following successful clinical trials.

Manufacturing Role Preserved

Argent retains the primary right to manufacture CannEpil for supply to Splash Beverage under market-competitive pricing terms.

The agreement has an initial 20-year term with automatic five-year renewals unless terminated earlier or not renewed, and remains subject to conditions including the debt exchange with Mercer, required Argent and Splash Beverage board and shareholder approvals, and no material adverse effect occurring for either party.

Chair Roby Zomer described the CannEpil licensing transaction as one of the most significant milestones achieved by Argent BioPharma to date.

“We believe this structure achieves a highly attractive outcome for shareholders by simultaneously strengthening the company’s financial position, simplifying its capital structure, and creating a pathway for the global commercialisation of CannEpil,” Mr Zomer said.

“As we continue to advance our broader neuro-immune portfolio and US growth strategy, this transaction positions Argent BioPharma with a stronger balance sheet, a clearer strategic focus, and ongoing participation in the long-term value creation potential of CannEpil.”