Immunic Reports Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease, Providing Clinical Proof-of-Concept for New Therapeutic Approach to Gastrointestinal Disorders - Positive Effects Demonstrated O

Immunic Reports Positive Results From Phase

1b Clinical Trial of IMU-856 in Celiac Disease, Providing Clinical Proof-of-Concept for New Therapeutic Approach to Gastrointestinal Disorders

Positive Effects Demonstrated Over Placebo

in Four Key Dimensions of Celiac Disease Pathophysiology: Protection of Gut Architecture, Improvement of Patients'

Symptoms, Biomarker Response, and Enhancement of Nutrient Absorption -

Corroborates Hypothesized Ability of IMU-856 to Renew Gut Wall and Restore

No Safety or Tolerability Issues Detected -

Conference Call and Webcast to be Held Today, May 4, 2023 at 8:00 am ET -

May 4, 2023 - Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of

orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today

announced positive results from the part C portion of its phase 1 clinical trial of IMU-856 in patients with celiac disease. The company

believes that this data set provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders

by promoting regeneration of bowel architecture.

four key dimensions of celiac disease pathophysiology and outcomes are summarized as follows:

believes that this data provides first clinical evidence that IMU-856's ability, observed

in preclinical studies, to re-establish proper gut cell renewal translates into clinical benefits for patients with celiac disease. Most

importantly, the observed protection of intestinal villi from gluten-induced destruction, independent of targeting immune mechanisms

involved specifically in celiac disease, appears to be unique among proposed therapeutic

approaches and may be applicable to other gastrointestinal diseases.

IMU-856 was observed to be safe and well-tolerated

in this trial. There were no investigational medicinal product-related serious or treatment-emergent adverse events nor was there any

dose-dependency in adverse events. Moreover, the rates of treatment-emergent adverse events in non-disease-related parameters were

comparable between the active treatment groups and placebo.

believe today's data strongly corroborates IMU-856's potential to regenerate the gut wall as measured through a variety of

key parameters," commented Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "IMU-856 was designed to

restore a healthy gut without targeting the immune system, thus avoiding the immune dysfunction inherent in current approaches. Ultimately,

IMU-856 could represent a possible game-changer in not only celiac disease, but also other gastrointestinal disorders with high unmet

needs such as ulcerative colitis, Crohn's disease, or irritable bowel syndrome with diarrhea. We are eagerly preparing clinical

phase 2b testing of IMU-856 in ongoing active celiac disease, while also considering other potential clinical applications for this first-in-class

and orally available molecule."

a study designed to provide initial clinical proof-of-concept in a 28-day treatment setting, the resulting data set significantly exceeded

our expectations," stated Andreas Muehler, M.D., Chief Medical Officer of Immunic. "The

study demonstrated consistent and meaningful improvements for IMU-856 treatment over placebo

in four key dimensions of celiac disease. We were delighted to see the dose-dependency, the consistency of improvement over placebo in

a wide array of key histologic, symptomatic, nutritional and immunologic parameters, as well as a clean safety and tolerability

profile. We were particularly excited to see the level of protection against histological deterioration

by IMU-856 during gluten challenge, with some actively treated patients even displaying

histologic improvements despite repeated daily exposure to

gluten. Moreover, the data on malabsorption testing and the enterocyte health marker citrulline

are also striking as they address mechanisms known to be relevant for potential future medical

complications in celiac disease patients. Given the large unmet need in celiac disease, along with the recognized inadequacy of strict

gluten avoidance for many patients, we believe that IMU-856 represents a particularly promising clinical approach for this serious health

Part C of the phase 1 clinical trial of IMU-856

was structured as a double-blind, randomized, placebo-controlled trial designed to assess the safety and tolerability of IMU-856 in patients

with celiac disease during periods of gluten-free diet and gluten challenge. The trial was conducted at sites in Australia and New Zealand.

A total of 43 patients were enrolled in two consecutive cohorts with 80 mg or 160 mg of IMU-856 or placebo given once-daily over 28 days.

Secondary objectives included pharmacokinetics as well as acute and chronic disease markers, including those evaluating gastrointestinal

architecture and inflammation.

data from the phase 1b clinical trial of IMU-856 in celiac disease will be filed on a Form 8-K and discussed during the management presentation

to be held today at 8:00 am ET.

post-hoc statistical analysis, Exact Wilcoxon Two-Sample Test comparison between IMU-856 (80 mg and 160 mg pooled) and placebo for villous

height absolute changes between baseline and Day 29 (Disease Analysis Set, n=35).

Immunic will host a webcast today, May 4, 2023,

at 8:00 am ET to discuss these results. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_EbVhqfsaTGCXeAromYvIcA

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.

Celiac disease is a multifactorial, complex

autoimmune disease caused by an inappropriate immune reaction against a degradation product of gluten in genetically susceptible individuals.

It is characterized by epithelial injury of the small intestine, elevated intestinal permeability, and nutrient malabsorption. Celiac

disease causes debilitating signs and symptoms of malabsorption such as diarrhea, steatorrhea,

fatigue, weight loss, anemia, and osteopenia, and can lead to serious complications such

as enteropathy-associated T-cell lymphoma. In children, nutrient malabsorption can affect growth and development, in addition to causing

the symptoms seen in adults. There is currently no known cure or treatment for celiac disease and patients must adhere to a strict, life-long

gluten-free diet which can help manage symptoms and avoid disease flareups. Celiac disease is estimated to affect 1 in 100 people, worldwide.

In the United States, alone, it is estimated that approximately one million people are undiagnosed

and are, therefore, at risk for long-term health complications.

IMU-856 is an orally available and systemically

acting small molecule modulator that targets a protein which serves as a transcriptional regulator of intestinal barrier function and

regeneration of bowel epithelium. Based on preclinical data, the compound may represent a unique treatment approach, as the mechanism

of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal

diseases such as celiac disease, inflammatory bowel disease, irritable bowel syndrome with diarrhea and other intestinal barrier function

associated diseases. Immunic believes that, because IMU-856 has been shown in preclinical investigations to avoid suppression of immune

cells, it may therefore have the potential to maintain immune surveillance for patients during therapy, an important advantage versus

immunosuppressive medications. IMU-856 demonstrated positive results in a phase 1b clinical trial in celiac disease patients in four

key dimensions of the disease's pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. Currently, the

company is preparing for phase 2 clinical testing in this patient population. IMU-856 is an investigational drug product that has not

been approved in any jurisdiction.

(Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic

inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), currently in phase 3 clinical

trials for the treatment of multiple sclerosis and which has shown therapeutic activity in phase 2 clinical trials in patients suffering

from relapsing-remitting multiple sclerosis and moderate-to-severe ulcerative colitis, selectively inhibits activated immune cells and

shows combined anti-inflammatory, anti-viral and neuroprotective effects. IMU-856 is targeted to restore intestinal barrier function

and regenerate bowel epithelium, which would be applicable in numerous gastrointestinal diseases, such as celiac disease, where it is

currently in preparations for a phase 2 clinical trial. For further information, please visit: www.imux.com.

Statement Regarding Forward-Looking Statements

press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the

safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts,

included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses,

sufficiency of cash, expected timing and results of clinical trials, prospects, plans and objectives of management are forward-looking

statements. Examples of such statements include, but are not limited to, statements relating to Immunic's three development programs

and the targeted diseases; the potential for IMU-856 to safely and effectively target diseases; interpretation of preclinical and clinical

data for IMU-856 and potential effects; the timing of current and future clinical trials and anticipated clinical milestones; the nature,

strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product

candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections

disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements

are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance

could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation,

the COVID-19 pandemic, impacts of the Ukraine - Russia conflict on clinical trials, risks and uncertainties associated with the