Immunic, Inc. Reports Top-Line Data from Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Patients with Moderate-to-Severe Ulcerative Colitis and Provides Corporate Update - Trial Did Not Achieve Primary Endpoint in th

Immunic, Inc. Reports

Top-Line Data from Phase 2 CALDOSE-1 Trial of

Vidofludimus Calcium in Patients with Moderate-to-Severe Ulcerative Colitis and Provides Corporate Update

Trial Did Not Achieve Primary Endpoint in the Ulcerative Colitis (UC) Population Caused by Unexpected Interference Between Vidofludimus

Calcium and Concurrent Use of Corticosteroids -

In UC Population Without Concurrent Steroid Use, Pooled Vidofludimus Calcium Data Suggest Activity in Clinical Remission Over Placebo;

Counterbalanced by Interference Observed in the UC Population with Concurrent Steroid Use -

Company Does Not Plan Further Development Activities in Ulcerative Colitis Without a Partner -

Focus to Remain on Ongoing Phase 3 Development of Vidofludimus Calcium in Multiple Sclerosis, and Ongoing IMU-935 and IMU-856

Programs with Clinical Data for Both Expected in 2022 -

$93.1 Million in Cash and Cash Equivalents as of May 31, 2022 Expected to Fund Immunic

Into the Fourth Quarter of 2023 -

Conference Call and Webcast, Including a Corporate Update, to be Held today,

June 2, 2022 at 8:00am ET -

June 2, 2022 - Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a

pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today reported top-line

data from its phase 2 CALDOSE-1 trial of lead asset, vidofludimus calcium (IMU-838), the company's

selective oral DHODH inhibitor, in patients with moderate-to-severe ulcerative colitis (UC) (clinicaltrials.gov: NCT03341962).

The trial did not achieve the primary endpoint

of clinical remission for the pooled 30 and 45 mg/day active dose groups of vidofludimus calcium

versus placebo at week 10. In addition, no meaningful differences were observed between the three active dose groups for the overall

intent-to-treat patient population (10 mg/day: 14.9%, 30 mg/day: 10.6%, 45 mg/day: 13.6%, placebo: 12.5%) or for the trial's other

secondary endpoints, including symptomatic remission, or endoscopic healing.

Consistent with prior data sets in other patient

populations, administration of vidofludimus calcium in this trial was observed to be safe

and well-tolerated. No new safety signals were observed. As compared to placebo, there were no increased rates of infections and infestations,

no elevated rates of liver events or liver enzyme elevations, and no elevated rates for changes in hematology-related laboratory variables.

The most common adverse events in this trial were anemia (15/263 patients, 5.7%), headache

(9/263 patients, 3.4%) and COVID-19 (7/263 patients, 2.7%). Most adverse events were generally mild in severity.

As is common for the design of clinical trials

in UC, the use of oral systemic corticosteroids ( 20 mg/day prednisolone equivalent) was allowed in CALDOSE-1 in patients who had been

treated with corticosteroids for at least four weeks before randomization. Doses of corticosteroids were required to be kept constant

throughout the induction phase (weaning was not allowed in this phase of the trial), and the distribution of patients using corticosteroids

was equal throughout all treatment groups.

Surprisingly, CALDOSE-1 data suggest a previously

unknown treatment interference between the efficacy of vidofludimus calcium and the concurrent use of corticosteroids in the UC patient

population. More specifically, the non-steroid patient population showed an 11.4% advantage in clinical remission for vidofludimus calcium

over placebo (pooled vidofludimus calcium treatment groups at week 10: 14.7%, placebo: 3.3%). Such a difference in clinical remission

between active treatment and placebo would traditionally be considered as confirming therapeutic activity. In contrast, patients concomitantly

taking vidofludimus calcium and corticosteroids during induction treatment had a lower rate of clinical remission at week 10 (11.5%) than

placebo patients (20.6%) and also lower than the group of vidofludimus calcium monotherapy without concurrent use of steroids (14.7%).

This treatment interference between vidofludimus calcium and corticosteroids was not expected by currently available preclinical or clinical

"We are disappointed with the results of

the CALDOSE-1 trial. The interference of vidofludimus calcium with concurrent corticosteroid use is surprising, and we will further explore

the mechanism behind this unexpected observation. We believe that this finding has no consequences for our ongoing program in multiple

sclerosis as corticosteroids are not used chronically in this patient population," stated Andreas Muehler, M.D., Chief Medical Officer

of Immunic. "We are also happy to see that, once again, the study data confirm the very favorable

safety and tolerability profile of vidofludimus calcium observed in other trials. Importantly, we want to thank all of the investigators,

study personnel, patients and caretakers involved in this trial for their participation and tremendous contributions."

"Putting the CALDOSE-1 data in context with

the wealth of compelling opportunities we have across our clinical development portfolio, we do not intend to move forward with phase

3 development of vidofludimus calcium in UC on our own," commented Daniel Vitt, Ph.D., Chief Executive Officer and President of

Immunic. "We will use this opportunity to focus our vidofludimus calcium-related efforts

around the ongoing multiple sclerosis program, including the phase 3 trials in relapsing multiple

sclerosis (RMS) and the phase 2 trial in progressive multiple sclerosis (PMS). As

evidenced by data from our phase 2 EMPhASIS trial, we believe vidofludimus calcium holds the potential for meaningful differentiation

based on anticipated strong efficacy, unprecedented safety and tolerability, oral delivery, and neuroprotective effects. We also eagerly

await further clinical data for IMU-935 and IMU-856 later this year, including phase 1b data of IMU-935 in moderate-to-severe psoriasis

patients in the second half, and phase 1 safety data of IMU-856 in healthy human subjects in the third quarter. Both of these investigational

medicines hold tremendous potential in their intended indications and beyond. Despite our disappointment with the overall CALDOSE-1 data,

the second half of 2022 remains an exciting time for Immunic, and we hope to share successful data in the near future."

Calcium in Multiple Sclerosis

of analysis from the Cohort 2 dataset, final data for the phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting multiple

sclerosis (RRMS) are available. In the final data set combining patients from both Cohort 1 (30 mg, 45 mg and placebo) and Cohort 2 (10

mg and placebo), placebo adjusted reductions in gadolinium-enhancing lesions at 24 weeks for the 10 mg, 30 mg, and 45 mg dose groups of

vidofludimus calcium were 13%, 78%, and 74%, respectively. The company believes this data provides further corroboration for the selection

of the 30 mg dose for the ongoing phase 3 program in RMS.

the final data also provide evidence of dose-proportional neuroprotective activity. For instance, the baseline adjusted decreases in the

biomarker serum neurofilament light chain (NfL) at 24 weeks for the 10 mg, 30 mg, and 45 mg dose groups of vidofludimus calcium were 9%,

18%, and 26%, respectively, as compared to placebo. The company believes this observation suggests that higher doses, such as 45 mg vidofludimus

calcium, may be preferrable in indications where neuroprotective effects are most important, such as in PMS.

enrollment in both the phase 3 ENSURE program of vidofludimus calcium in patients with RMS and the phase 2 CALLIPER trial of vidofludimus

calcium in patients with PMS remain ongoing.

1b clinical trial of IMU-935, the company's highly potent and selective oral IL-17 inhibitor, is

ongoing in patents with moderate-to-severe psoriasis. This week, the company received regulatory approval to proceed with the trial in

Europe, which should expedite enrollment of the high dose cohort, which is currently being started. Initial results from the psoriasis

portion of the phase 1 clinical trial are targeted for the second half of 2022.

in Healthy Human Subjects and Celiac Disease

continues to expect a third quarter 2022 release of data from both the single and multiple ascending dose parts of the ongoing

phase 1 clinical trial of IMU-856, an orally available and systemically acting small molecule shown

preclinically to regulate intestinal barrier function and regenerate bowel epithelium. Recently, Immunic also started the third

part of this phase 1 clinical trial in patients with celiac disease, which is currently ongoing.

Cash and cash equivalents as of May 31, 2022 were

$93.1 million. The company expects to have funding into the fourth quarter of 2023.

will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_XgdotnImTHKxQiLFa958mA

or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations.

Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.

An archived replay of the webcast will be available

approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations.

phase 2 CALDOSE-1 trial was a multicenter, randomized, double-blind, placebo-controlled, dose-finding study which included 263 UC patients

from 78 study sites in the United States, Western, Central and Eastern Europe. The trial was designed to evaluate the efficacy and safety

of vidofludimus calcium in patients with moderate-to-severe UC. The primary endpoint comprised a composite of a patient-reported

outcome and endoscopy-assessed outcome, also referred to as clinical remission, both evaluated following ten weeks of induction treatment.

Patients were randomized into four arms: three active dosing arms of 10 mg, 30 mg and 45 mg of vidofludimus

calcium, as well as placebo.

CALDOSE-1 was the first trial of vidofludimus

calcium that allowed chronic co-medication with corticosteroids. Explanation for the observed interference is not yet available and this

finding was not predicted based on any prior preclinical or clinical data. The company does intend to explore this potential topic scientifically.

In the meantime, the company plans to only develop vidofludimus calcium in indications, such as multiple sclerosis, where chronic corticosteroid

administration does not play a role in routine treatment.