ADDED
On February 24, 2026, 130,464,825 shares of common stock, $0.0001 par value, were outstanding.
( Immunic," we, us, our or the "Company") is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases.
The Phase 3 ENSURE program of vidofludimus calcium in RMS, comprising twin studies evaluating efficacy, safety, and tolerability of vidofludimus calcium versus placebo, is currently ongoing.
In June 2025, we announced completion of enrollment for both ENSURE trials.
Each of the trials enrolled adult patients with active RMS at more than 100 sites in 15 countries.
In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo.
The top-line data for both ENSURE trials is expected by the end of 2026.
Although we currently believe that this goal is achievable, it is dependent on numerous factors, most of which are not under our direct control and can be difficult to predict.
Our Phase 2 CALLIPER trial of vidofludimus calcium in PMS was designed to corroborate vidofludimus calcium s neuroprotective potential and to evaluate the clinical efficacy, safety and tolerability of vidofludimus calcium in a broad set of 2 PMS patients to determine the suitability of advancing to a confirmatory Phase 3 program.
In 2025, we announced the results from the CALLIPER trial, showing substantial and medically relevant reductions in 24-week confirmed disability progression ( 24wCDW ) across patient populations and subgroups without evidence of focal inflammation; substantial and statistically significant data regarding 24-week confirmed disability improvement ( 24wCDI ); and reductions in the annualized rate of thalamic brain volume loss and volume of new or enlarging T2 lesions.
REMOVED
On March 15, 2025, 90,150,869 shares of common stock, $0.0001 par value, were outstanding.
("Immunic," we, us, our or the "Company") is a biotechnology company developing a clinical pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases.
The Phase 3 ENSURE program of vidofludimus calcium in relapsing multiple sclerosis ( RMS ), comprising twin studies evaluating efficacy, safety, and tolerability of vidofludimus calcium versus placebo, and the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis ( PMS ), designed to corroborate vidofludimus calcium s neuroprotective potential, are ongoing.
Top-line data from the CALLIPER trial, for which the recruitment of 467 total patients was completed in August 2023, is expected to be available in April 2025.
Completion of the first of the ENSURE trials is currently anticipated in the second quarter of 2026; and the completion of the second ENSURE trial in the second half of 2026.
Although we currently believe that each of these goals is achievable, they are each dependent on numerous factors, most of which are not under our direct control and can be difficult to predict.
Preclinical data showed that vidofludimus calcium activates the neuroprotective transcription factor nuclear receptor-related 1 ( Nurr1 ), which is associated with direct neuroprotective properties and may enhance the potential benefit for patients.
We believe that the combined mechanisms of vidofludimus calcium are unique in the MS space and support the therapeutic performance shown in our Phase 2 EMPhASIS trial in RRMS patients, in particular, via data illustrating the potential to reduce magnetic resonance imaging ( MRI ) lesions, prevent relapses, reduce the rate of disability progression, and reduce levels of serum neurofilament light chain ( NfL ), an important biomarker of neuronal damage.
These two effects may indicate the potential for IMU-856 as an oral treatment option for weight management.
Contingent on financing, licensing or partnering, we are currently preparing clinical Phase 2 testing of IMU-856 in patients with ongoing active celiac disease ( OACD ) despite gluten-free diet, while also considering further potential clinical applications in other gastrointestinal disorders.