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, supported by global partnerships and regulatory progress.

• Phase III HEALING 1 trial initiated in Q4 2025, with first patient dosed and topline results expected in H2 2026; recruitment is ahead of projections and financing is secured through H1 2027.

• Strategic partnerships with Zentiva (Europe, €220m deal, €13m upfront) and Sinorda (China), with launches and reimbursement approvals advancing, including China's National Reimbursement Listing for 2026.

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

• Market trends show rapid global adoption of P-CABs, replacing PPIs and validating commercial opportunity, with linaprazan glurate positioned for premium pricing.

Financial highlights

• Q4 2025 cash position at SEK 487.3 million, supporting ongoing phase III activities; year-end cash and equivalents at TSEK 487,254, down from TSEK 566,716 in 2024.

• Net sales for Q4 2025 reached SEK 13.6 million, up SEK 9.1 million year-over-year; full-year 2025 net sales were TSEK 57,470, mainly from licensing income.

• R&D expenses for Q4 2025 were SEK 60.6 million (80% of operating expenses); for 2025, R&D expenses increased 45% year-over-year, accounting for 84% of operating expenses.

• Operating loss for Q4 2025 was SEK 62 million; full-year EBIT was TSEK -199,558, with net loss for the year at TSEK -183,972.

• Cash flow for Q4 2025 was negative SEK 53 million; total cash flow for 2025 was TSEK -77,836.

Outlook and guidance

• Topline results from HEALING 1 expected in H2 2026; subsequent studies for maintenance and US expansion planned.

• Anticipated launches in China (2026) and Europe, with ongoing price and reimbursement negotiations.

• Near-term milestones from Zentiva partnership, including a €5m payment, expected in 2026.

• Financing is sufficient through H1 2027.