Cinclus Pharma (CINPHA) investor relations material

Market opportunity and unmet need

• Severe erosive GERD affects 20 million globally, with 10 million in the US and Europe, representing a large unmet medical need.

• Up to 50% of severe patients are not healed by current PPIs, leading to ongoing pain and risk of disease progression.

• Chronic nature of the disease means patients require long-term management, increasing market potential.

• The market is dynamic with frequent switching, favoring new, differentiated entrants.

Product differentiation and clinical progress

• The drug candidate offers 24-hour, 96% acid control, superior to existing PPIs and first-generation PCABs.

• Phase II trials showed superiority over PPIs in severe patients.

• First pivotal phase III trial (HEEALING1) readout expected in Q4, representing a major value inflection point.

• Only one additional phase III trial is required, with expected approval by 2030.

Commercialization strategy and partnerships

• European commercialization secured with Zentiva, with a deal value up to €220 million and 20% royalty.

• China launch underway with Sinorda and Huadong Medicine, supported by full reimbursement and strong pricing.

• US rights remain unpartnered, pending phase III results, with patent protection until 2042 in US and Europe.

• Product is positioned for blockbuster sales due to its unique efficacy and large target population.