Cinclus Pharma says Phase III study is nearing full enrollment

Cinclus Pharma said patient enrollment in its first Phase III study has continued to progress well, with expected topline results in the fourth quarter of 2026. The company said a strengthened financial position enables an efficient start to HEEALING 2, the final part of the Phase III program for erosive GERD.

During January-March 2026, the company said the European Medicines Agency had issued a positive opinion following completed scientific advice regarding CMC (Chemistry, Manufacturing and Controls) for linaprazan glurate. The FDA also issued a positive assessment of the company’s preclinical development plan for linaprazan glurate following completed scientific advice. In February, the company said the FDA had determined that a single pivotal study will become the new standard for market approval of drugs in the US.

In March, the company announced that a financing agreement of EUR 28 million had been entered into with Claret Capital Partners, enabling an earlier start of the final stage of the Phase III program. The financing is structured as a secured loan facility with warrants and convertible instruments.

For the first quarter, net sales amounted to TSEK 10,036. Operating profit (EBIT) amounted to TSEK -90,854, the result for the period was TSEK -88,768 and earnings per share before and after dilution were SEK -1.91. Total cash flow for the period amounted to TSEK -12,712, and cash and cash equivalents at the end of the period amounted to TSEK 475,849.

The company said linaprazan glurate is being developed for the treatment of acid-related diseases and disorders of the upper gastrointestinal tract. The first Phase III study commenced in 2025.