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, including the EEA, UK, and Switzerland, covering all aspects from development to market launch.

• The alliance leverages Zentiva’s pan-European commercial reach, operational strength, and expertise in gastroenterology, R&D, regulatory affairs, and commercialization.

• Zentiva is transitioning from generics to specialty pharma, operates in over 20 countries, delivers medicines to over 100 million people, and projects €1.5bn sales and €375m EBITDA for FY24.

• Cinclus Pharma is a late-stage clinical company focused on acid-related upper GI diseases, with linaprazan glurate as its lead asset, originally developed by AstraZeneca.

• A webcast and Q&A session are scheduled for stakeholders to discuss the partnership.

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 expected in 2026.

• Tiered double-digit 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, positioning for significant global value capture.

• The partnership de-risks the path to European approval and may accelerate development and reduce financial risk.

Product and market overview

• Linaprazan glurate is a next-generation potassium-competitive acid blocker (PCAB) targeting severe erosive GERD, aiming for best-in-class acid control and symptom relief.

• Phase II trials showed ~93% healing in severe patients and 100% healing in partial PPI responders after eight weeks at the optimal dose.

• Maintains gastric pH above 4 for 96% of the day at Phase 3 dose, supporting enhanced ulcer healing.

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

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