"Cinclus Pharma has now entered late-stage clinical development following the initiation of its first Phase III study, and patient recruitment has so far progressed well. Topline results are expected in the second half of 2026 and have the potential to represent a significant value driver for the company. We are at an exciting stage in the development of linaprazan glurate, a drug candidate with the potential to improve quality of life for patients suffering from severe acid-related diseases who are not adequately helped by current treatment options.", said Christer Ahlberg, CEO of Cinclus Pharma
Financial summary, July-September 2025
» Net sales amounted to TSEK 9,744 (0)
» Operating income/loss (EBIT) amounted to TSEK -44,122 (-39,148).
» Net income/loss for the period was TSEK -40,666 (-36,547) and earnings (loss) per share before and after dilution were SEK -0.87 (-0.79).
» Total cash flow for the period amounted to TSEK -47,500 (-40,470).
» Cash and cash equivalents at the end of the period amounted to TSEK 540,220 (566,716).
Financial summary, January-September 2025
» Net sales amounted to TSEK 43,839 (0).
» Operating income/loss (EBIT) amounted to TSEK -137,547 (-112,750).
» Net income/loss for the period was TSEK -122,788 (-113,772) and earnings (loss) per share before and after dilution were SEK -2.64 (-3.36).
» Total cash flow for the period amounted to TSEK -27,023 (556,030).
» Cash and cash equivalents at the end of the period amounted to TSEK 540,220 (566,716).
Significant events during the period July-September 2025
» Cinclus Pharma announced in August that the company had received feedback from regulatory authorities, which means that the Phase III study HEEALING 1 can be initiated in Europe. The study will be conducted in seven European countries, and the company plans to extend development to the US through the second healing study, HEEALING 2, which will also evaluate maintenance therapy.
» In September, the first patient with erosive gastroesophageal reflux disease (GERD) was screened in Cinclus Pharma's Phase III study of linaprazan glurate.
Significant events after the end of the period
» In early October, it was announced that the first patient had been dosed in the company's phase III study, HEEALING 1, which aims to confirm the efficacy of linaprazan glurate in patients with erosive gastroesophageal reflux disease.
» In the beginning of October Cinclus Pharma presented an abstract on linaprazan glurate at the United European Gastroenterology Week (UEGW) in Berlin. The abstract highlights positive data on the optimized tablet formulation developed for Phase III studies and future commercialization.
» In October Cinclus Pharma received positive feedback from a recent Chemistry, Manufacturing and Controls (CMC) meeting with the FDA. During the meeting, the FDA provided clear guidance and alignment with the company's proposed CMC strategy preperation for the upcoming new drug application (NDA) submission.
» Cinclus Pharma announced in November that it had sponsored a scientific abstract highlighting the clinical and economic costs of PPI treatment failures in patients with severe erosive GERD. The abstract was presented at the ISPOR (International Society for Pharmacoeconomics and Outcomes Research) Europe 2025 conference in Glasgow.
Presentation of the interim report
A webcast will be held on November 20, 2025, at 10:00 CET via Inderes. If you wish to participate via webcast please use the link below. Via the webcast you are able to ask written questions.
https://cinclus-pharma.events.inderes.com/q3-report-2025
If you wish to participate via teleconference please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference.
https://events.inderes.com/cinclus-pharma/q3-report-2025/dial-in
For additional information, please contact:
Christer Ahlberg, CEO
Phone: +46 70 675 33 30
e-mail: christer.ahlberg@cincluspharma.com
Henrik Vikström, IR
Phone: +46 70 952 80 06
e-mail: henrik.vikström@cincluspharma.com
About Cinclus Pharma
Cinclus Pharma Holding AB (publ) is a late-stage clinical pharmaceutical company developing drugs for the treatment of acid-related diseases and disorders of the upper gastrointestinal tract. The company's leading drug candidate is linaprazan glurate, a prodrug of P-CAB linaprazan, which was originally developed by AstraZeneca. Linaprazan glurate has the potential to heal erosions in the esophageal mucosa and relieve symptoms of gastroesophageal reflux disease (GERD) more effectively than current treatments like proton pump inhibitors (PPI). The safety and efficacy of linaprazan and linaprazan glurate have been documented in over 30 phase I and two phase II studies involving more than 3,000 participants. The first Phase III study commenced in 2025. GERD affects approximately 133 million adults in the US and EU, and there is a significant need for new drugs to treat the most severe cases: around 10 million patients. Linaprazan glurate is developed to meet these needs. For more information, visit www.cincluspharma.com.