Immunic, Inc. Reports First Quarter 2023 Financial Results and Provides Corporate Update - Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease Provide Proof-of-Concept for a New Therapeutic Approac

Immunic, Inc. Reports First

Quarter 2023 Financial Results

and Provides Corporate Update

Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease Provide Proof-of-Concept for a New Therapeutic Approach to

Treat Gastrointestinal Diseases by Promoting Regeneration of Bowel Architecture -

Interim Results From Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in the Second Half of 2023

$97.1 Million in Cash, Cash Equivalents and Investments Expected to Fund Immunic Into the Fourth Quarter of 2024 -

Webcast to be Held Today, May 11, 2023, at 8:00 am ET -

May 11, 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 financial results for the first quarter ended March 31, 2023, and provided a corporate

"In the first quarter of 2023, we reported

outstanding results from two key clinical programs. First, we reported positive data from the maintenance

phase of our phase 2b CALDOSE-1 trial of vidofludimus calcium in patients with moderate-to-severe ulcerative colitis (UC), and, most recently,

announced positive results from our phase 1b clinical trial of IMU-856 in patients with celiac disease, which far exceeded our expectations,"

stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "In the phase 1b trial, IMU-856, designed to restore

a healthy gut without suppressing the immune system, demonstrated consistent and meaningful

improvements over placebo in four key dimensions of celiac disease pathophysiology:

histology, disease symptoms, biomarkers and nutrient absorption. The impressive data set provides

first clinical proof-of-concept for IMU-856 and demonstrates its potential to treat gastrointestinal diseases with an entirely new therapeutic

approach. Based on this data, we are now preparing for a phase 2b clinical trial of IMU-856 in ongoing active celiac disease patients,

while also considering further potential clinical applications in other gastrointestinal disorders. Importantly, during a recent presentation

at Digestive Disease Week, we unveiled IMU-856's mode of action as a potent modulator of SIRT6 (Sirtuin 6),

through which it restores and regenerates bowel wall architecture."

continued, "Data from the maintenance phase of our phase 2b CALDOSE-1 trial of vidofludimus calcium in patients with moderate-to-severe

UC were also extremely encouraging, as they demonstrated statistically significant activity of vidofludimus calcium as compared to placebo,

while confirming the very favorable safety and tolerability profile observed in other trials. Based on this positive outcome, we are exploring

a variety of value creating options for the UC program and other inflammatory bowel disease indications."

during the quarter, we continued to progress vidofludimus calcium for the treatment of multiple sclerosis (MS). Our next value inflection

point will be a second half 2023 interim biomarker analysis of our phase 2 CALLIPER trial in progressive MS, which is designed

to corroborate the neuroprotective potential of vidofludimus calcium and could therefore be an additional differentiator for the drug

in the MS market. Based on the strong clinical activity observed thus far and the solidly established safety and tolerability profile,

to date, we continue to believe that vidofludimus calcium has the potential to be a unique treatment option targeted to the complex pathophysiology

of MS," concluded Dr. Vitt.

First Quarter 2023 and Subsequent Highlights

Anticipated Clinical Milestones

Financial and Operating Results

Immunic 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_ab5Mb3dMSBCsDvygg-RyAA

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.

(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.

Cautionary Statement

Regarding Forward-Looking Statements

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 development, 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 development programs

and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical

and clinical data for Immunic's development programs; 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; the development and commercial potential

of any product candidates of the company; and the company's expected cash runway. 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, increasing inflation, impacts of the Ukraine -

Russia conflict on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization

and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources

to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials

may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property,

risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes.

A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors,"

in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on February 23, 2023, and

in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov

or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims

any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which

they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of

Head of Investor Relations and Communications

Rx Communications Group

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)