Cinclus Pharma (CINPHA) Q2 2025 earnings summary

Executive summary

• Secured a strategic alliance and licensing agreement with Zentiva for linaprazan glurate in Europe, valued up to EUR 220 million with upfront, milestone payments, and tiered royalties exceeding 20%.

• Phase III trial preparations for linaprazan glurate are complete, with study initiation imminent and topline results expected in 2026.

• Received waivers from EMA and FDA for pediatric studies in H. pylori, expediting development and reducing regulatory burden.

• Published phase II results showing 93% healing in severe patients in four weeks and 100% healing in partial responders post-PPI treatment, supporting continued development.

• Participated in major congresses and sponsored specialist conferences, increasing visibility among gastroenterology experts.

Financial highlights

• Net sales for Q2 and H1 2025 reached SEK 34.1 million, mainly from Zentiva licensing revenue.

• Cash and cash equivalents at period end were SEK 589 million, including Zentiva upfront payment.

• R&D expenses were SEK 54 million in Q2, representing 86% of OpEx, driven by phase III preparations and CMC activities.

• EBIT for Q2 2025 was SEK -45.9 million, impacted by higher OpEx and one-time transaction expenses for the Zentiva deal.

• Net profit for Q2 2025 was SEK -48.5 million, affected by transaction expenses and increased R&D spending.

Outlook and guidance

• Phase III trial for linaprazan glurate is on track to start imminently, with topline data anticipated in 2026.

• European commercialization and launch by Zentiva expected around 2029–2030.

• U.S. commercialization rights retained, with potential for a future deal to fund development through approval.

• Current working capital is sufficient to fund operations through the first Phase III readout, with further financing options under evaluation.