Cinclus Pharma (CINPHA) Q4 2025 earnings summary

Executive summary

• Linaprazan glurate, a next-generation P-CAB, targets severe erosive GERD with 24-hour acid control and blockbuster potential, addressing high unmet medical needs globally.

• First patient dosed in Phase III HEALING 1 trial in Q4 2025; topline results expected in H2 2026, with financing secured through H1 2027.

• Strategic partnerships with Zentiva (Europe, €220m deal) and Sinorda (China), with launches and reimbursement approvals progressing for 2026.

• Regulatory milestones achieved with positive FDA and EMA feedback on CMC and non-clinical plans, supporting NDA and MAA readiness.

• China’s National Reimbursement Listing granted, supporting 2026 launch.

Financial highlights

• Net sales for 2025 reached SEK 57.5 million, up from SEK 4.6 million in 2024, mainly from licensing income.

• Q4 2025 net sales SEK 13.6 million; operating loss for Q4 was SEK 62 million, net loss SEK 61.2 million.

• R&D expenses for Q4 2025 were SEK 61 million, representing 80–86% of operating expenses.

• Cash and cash equivalents at year-end were SEK 487 million, down from SEK 566.7 million in 2024.

• Cash flow from operating activities improved to SEK -49.9 million from SEK -78.6 million year-over-year.

Outlook and guidance

• HEALING 1 trial recruitment is ahead of projections; topline results expected in H2 2026.

• Second phase III healing and maintenance study planned, including US sites, with maintenance phase expected to last 24 weeks and long-term safety follow-up for at least 52 weeks in 100 patients.

• China launch anticipated in 2026 following reimbursement approval; further expansion planned in Europe and the US.

• €5 million near-term milestone from Zentiva expected in 2026.

• Financing is sufficient through H1 2027.