"The past year was marked by significant progress for Cinclus Pharma. Our first Phase III study has had a promising start, and we expect to present topline results during the second half of the year. The strategic licensing agreement with Zentiva provides a strong platform for successful commercialization in Europe and lays a solid foundation for expansion into other markets. Following the inclusion of linaprazan glurate on China's national reimbursement list, our Chinese partner plans to launch the product on the market in 2026. With superior acid control compared to existing treatment options, linaprazan glurate has the potential to meet the substantial medical need among patients suffering from the more severe forms of erosive GERD, which we aim to confirm in the ongoing Phase III study", says Christer Ahlberg CEO of Cinclus Pharma.
Financial summary, October-December 2025
» Net sales amounted to TSEK 13,632 (4,580).
» Operating income/loss (EBIT) amounted to TSEK -62,011 (-56,889).
» Net income/loss for the period was TSEK -61,184 (-54,259) and earnings/loss per share before and after dilution were SEK -1.31 (-1.17).
» Total cash flow for the period amounted to TSEK -50,814 (-79,197).
» Cash and cash equivalents at the end of the period amounted to TSEK 487,254 (566,716).
Financial summary, January-December 2025
» Net sales amounted to TSEK 57,470 (4,580).
» Operating income/loss (EBIT) amounted to TSEK -199,558 (-169,639).
» Net income/loss for the period was TSEK -183,972 (-168,031) and earnings/loss per share before and after dilution were SEK -3.95 (-4.54).
» Total cash flow for the period amounted to TSEK -77,836 (476,833).
» Cash and cash equivalents at the end of the period amounted to TSEK 487,254 (566,716).
Significant events during the period October-December 2025
» 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 preparation 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 Europe 2025 conference in Glasgow.
» Cinclus Pharma hosted a virtual event to share insights on clinical practice for erosive Gastroesophageal Reflux Disease (GERD) patients in December. The event featured Professor Prateek Sharma from the Cancer Center in Kansas City who provided insights on the current treatment landscape and the unmet medical need among patients with erosive GERD, as well as the potential of Cinclus Pharma's drug candidate linaprazan glurate.
» Cinclus Pharma has recruited Magnus Christensen as CFO. He will assume his new role in the spring of 2026.
» Linaprazan glurate earns China's National Reimbursement Listing for the treatment of erosive GERD. This enables broad patient access, and the product is now expected to be launched on the Chinese market in 2026.
Significant events after the end of the period
» At an Extraordinary General Meeting on 19 January, Kjell Andersson was elected as a new board member after Peter Unge had announced his wish to step down from his position on the company's board.
» In January, Cinclus Pharma announced that the European Medicines Agency (EMA) has provided positive feedback following scientific advice regarding Chemistry, Manufacturing and Controls (CMC) for linaprazan glurate.
» In February, FDA provided a positive assessment of Cinclus Pharma's nonclincial development plan for linaprazan glurate following a scientific advice meeting.
Presentation of the interim report
A webcast will be held on February 18, 2026, 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/q4-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/q4-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.
