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.

• Phase III HEALING 1 trial underway, with first patient dosed in Q4 2025; topline results expected in H2 2026.

• Strategic partnerships with Zentiva (Europe, up to €220m deal) and Sinorda (China) support commercialization and market access.

• Regulatory progress includes positive FDA and EMA feedback on CMC and non-clinical plans, with no additional tox studies required for NDA submission.

• China’s National Reimbursement Listing granted for linaprazan glurate, supporting a 2026 launch.

Financial highlights

• Q4 2025 net sales: SEK 13.6 million, up from SEK 4.6 million in Q4 2024; full-year 2025 net sales: SEK 57.5 million, mainly from licensing income.

• Operating loss for Q4 2025: SEK 62 million; full-year 2025 operating loss: TSEK -199,558, reflecting increased R&D spend.

• Net loss for Q4 2025: SEK 61.2 million; full-year 2025 net loss: TSEK -183,972.

• Cash at year-end 2025: SEK 487 million, supporting ongoing phase III activities.

• R&D expenses for Q4 2025: SEK 61 million, representing 80% of total operating expenses.

Outlook and guidance

• HEALING 1 phase III trial recruitment on track; topline results expected in H2 2026.

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

• Anticipated China launch in 2026 following price and reimbursement approval.

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

• Financing is sufficient through H1 2027.