Cinclus Pharma (CINPHA) Investor Update summary

Strategic partnership and licensing agreement

• Entered a major partnership with Zentiva for commercialization and manufacturing of linaprazan glurate across Europe, EEA, UK, and Switzerland, marking a significant milestone and validation for the product.

• The alliance covers all aspects needed for a successful European launch, leveraging both companies' expertise in gastroenterology, R&D, regulatory affairs, and commercialization.

• Zentiva’s commercial reach and operational strength across Europe are key to the partnership’s strategic rationale.

• The agreement de-risks the path to European approval and positions the product for global value capture.

• Zentiva views the deal as a key milestone in expanding into high-value specialty medicines.

Deal structure and financials

• Total deal value is up to EUR 220 million, including an upfront payment of EUR 13 million and a EUR 5 million milestone in 2026.

• Tiered royalties on European net sales start in the high teens and exceed 20% at the top sales tier, beginning from first sales.

• The agreement spans at least 10 years, covering the period of regulatory or patent exclusivity.

• Cinclus retains full commercial rights for linaprazan glurate outside Europe, including the US.

• The deal includes a near-term milestone payment in 2026.

Product positioning and clinical development

• Linaprazan glurate is a next-generation potassium-competitive acid blocker (PCAB) targeting severe GERD patients, especially those unhealed after PPI treatment.

• Phase II trials showed 93% healing in severe patients and 100% healing in partial responders after eight weeks.

• Safety and efficacy have been demonstrated in over 30 phase I and two phase II studies with more than 3,000 participants.

• Phase III studies are planned to begin in Q3 2025, focusing on European sites.

• Linaprazan glurate aims to outperform current treatments like PPIs in healing esophageal erosions and relieving GERD symptoms.