Cinclus Pharma (CINPHA) Q3 2025 earnings summary

Executive summary

• Phase III HEEALING 1 trial for linaprazan glurate initiated in Europe for severe erosive GERD, enrolling ~500 patients across 7 countries, with first patient dosed in October 2025 and topline results expected in H2 2026.

• Linaprazan glurate demonstrates superior 24-hour acid control and healing rates versus PPIs and first-generation PCABs, supporting best-in-class positioning.

• Strategic partnerships and licensing agreements secured with Zentiva for Europe (up to EUR 220 million plus royalties) and Sinorda for Asia.

• Positive regulatory feedback received in Europe and from the FDA on CMC and quality strategy, supporting future NDA submission.

• Optimized tablet formulation presented at major European gastroenterology congresses.

Financial highlights

• Net sales for Q3 2025 were SEK 9.7 million, mainly from Zentiva licensing revenue; Jan–Sep 2025 net sales reached TSEK 43,839.

• Operating loss for Q3 2025 was SEK 44.1 million, and net loss was SEK 40.7 million; Jan–Sep net loss was TSEK -122,788.

• Cash and cash equivalents at period end were SEK 540.2 million, providing runway into 2027 and through the HEEALING 1 readout.

• R&D expenses for Q3 2025 were SEK 45.6 million, representing 85–86% of operating expenses.

• Non-current and current liabilities increased due to contract liabilities from the Zentiva deal.

Outlook and guidance

• Financial resources are sufficient to fund operations into 2027, covering the phase III trial and commercialization preparations.

• Topline results from HEEALING 1 are anticipated in H2 2026, with further studies planned in Europe and the U.S.

• Additional clinical sites may be added to ensure timely trial completion.

• Additional financing will be needed for a second Phase III study and further indications.