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Cinclus Pharma (CINPHA) investor relations material
Cinclus Pharma Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
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