Cinclus Pharma (CINPHA) Q1 2025 earnings summary

Executive summary

• Linaprazan glurate, a next-generation PCAB, is advancing to Phase III for severe eGERD, with 93% healing in severe patients and 100% in partial responders in Phase II, aiming to replace PPIs and first-generation PCABs.

• Preparations for global Phase III studies are complete, with patient recruitment starting in Q3 2025 in Europe and the US; topline results expected in 2026.

• Strong patent protection for linaprazan glurate extends into the 2040s, providing robust defense against generics and supporting commercial potential.

• The addressable eGERD market in the US and EU is substantial, with 10 million severe patients and significant unmet need despite existing PPI therapies.

• Marketing authorization for linaprazan glurate obtained in China via partner Sinorda.

Financial highlights

• Cash and cash equivalents at period end were SEK 523.9 million, supporting operations through H2 2026.

• R&D expenses increased to SEK 38.4 million in Q1 2025, accounting for 83% of OPEX, reflecting Phase III preparations.

• Operating profit (EBIT) was SEK -47.5 million in Q1 2025, down from SEK -36.3 million year-over-year.

• Net loss improved to SEK -33.7 million from SEK -36.9 million in Q1 2024, aided by a positive financial net of SEK 13.9 million.

• Cash position was boosted by a share issue in June 2024 and IPO-related loan conversion.

Outlook and guidance

• Phase III trial for linaprazan glurate in eGERD to initiate in Q3 2025 across 99 sites in the US and Europe, with topline results expected in 2026.

• Cash runway is expected to last through the Phase III topline readout.

• Ongoing evaluation of additional financing options to potentially accelerate development and initiate a second Phase III study.

• Confident in achieving a premium price in Europe, especially the UK, based on cost-effectiveness and superior clinical outcomes.

• No expected impact from US reference pricing proposals; launch targeted for 2029.