Cinclus Pharma (CINPHA) investor relations material

Market opportunity and disease overview

• Linaprazan glurate targets severe erosive GERD, a chronic and progressive disease affecting up to 10 million patients in the US and Europe, and 90 million globally.

• The market is dynamic with high relapse rates and chronic patient cycles, offering significant switch opportunities.

• Erosive GERD represents about one-third of all GERD cases, with severe C and D classifications as the primary focus.

• Up to 50% of patients are not healed by current PPIs, and many suffer from nighttime pain, impacting quality of life.

• The disease can progress to more severe conditions, including cancer, if not effectively treated.

Product differentiation and clinical development

• Linaprazan glurate offers 24-hour acid control, aiming for best-in-class P-CAB status and targeting unmet needs in severe patients.

• Phase III program is ongoing, with the first trial readout expected in Q4 this year; approval targeted for 2030.

• Partnerships are established for commercialization in Europe and Asia, with an ongoing launch in China.

• The product aims to deliver both healing and symptom relief, with superiority over lansoprazole as a key goal.

• Phase II data showed a strong delta in healing rates versus lansoprazole, with over 50% improvement.

Scientific rationale and competitive landscape

• Acid control (pH above 4) is linearly correlated with healing, supported by extensive meta-analyses.

• P-CABs have demonstrated market leadership in Asia, overtaking PPIs due to superior acid control.

• Linaprazan glurate achieved 96% acid control in phase II, with promising four-week healing data.

• Other P-CABs like vonoprazan and tegoprazan have shown high healing rates and incremental benefits over PPIs.

• The ongoing phase III trial uses lansoprazole as a comparator, enabling indirect comparison with other P-CABs.