Immunic

About Immunic

Immunic, Inc. is a clinical-stage biopharmaceutical company focused on developing oral therapies for chronic inflammatory and autoimmune diseases. Founded in April 2016 as Immunic AG in Planegg-Martinsried, Germany, the company began its research and development activities after acquiring the intellectual property for IMU-838 and IMU-935 from 4SC AG. The founding team included Dr. Daniel Vitt, the current CEO, Dr. Andreas Mühler as Chief Medical Officer, and Dr. Hella Kohlhof as Chief Scientific Officer. Dr. Vitt co-founded the biotech company 4SC AG in 1997 before co-founding and leading Immunic. In April 2019, Immunic AG completed a reverse merger with Vital Therapies, Inc., becoming Immunic, Inc., a Delaware-incorporated company publicly traded on the Nasdaq stock market under the ticker symbol IMUX. The company is now headquartered in New York, with its primary research and development operations remaining in Germany.

The company's business model is centered on advancing its pipeline of drug candidates through clinical trials to address unmet medical needs. As a clinical-stage company, Immunic does not currently generate revenue from product sales; its financial structure relies on securing funding through strategic financing, such as private placements and public offerings, to support its substantial research and development expenditures. The company’s strategy involves developing its assets to a stage where they can be commercialized, potentially through partnerships or licensing agreements with larger pharmaceutical companies.

Immunic's lead product candidate is vidofludimus calcium (IMU-838), an oral small molecule for the treatment of multiple sclerosis (MS). This drug has a dual mechanism of action, providing both neuroprotective and anti-inflammatory effects by activating the Nurr1 nuclear receptor and inhibiting the DHODH enzyme. This selective modulation is designed to dampen overactive immune cells without compromising the entire immune system. Vidofludimus calcium is currently in Phase 3 clinical trials for relapsing multiple sclerosis (RMS) and has completed Phase 2 trials for progressive multiple sclerosis (PMS). Another key asset in the pipeline is IMU-856, an oral modulator targeting the protein SIRT6. This candidate aims to restore intestinal barrier function and regenerate bowel epithelium, offering a potential treatment for gastrointestinal disorders like celiac disease. Phase 1 clinical trials have shown positive results in improving histology, symptoms, biomarkers, and nutrient absorption in celiac patients. Preclinical data also suggests potential for IMU-856 in weight management due to its observed effects on GLP-1 levels. A third program, IMU-381, is a next-generation molecule in preclinical development for gastrointestinal diseases.