Immunic, Inc. Reports Year End 2021 Financial Results and Highlights Recent Activity - Initiated Enrollment in Phase 3 ENSURE Program of Vidofludimus Calcium for the Treatment of Relapsing Multiple Sclerosis; Final Cohor

Immunic, Inc. Reports Year End

2021 Financial Results

and Highlights Recent Activity

Initiated Enrollment in Phase 3 ENSURE Program of Vidofludimus Calcium for the Treatment of Relapsing Multiple Sclerosis; Final Cohort

2 Data from the Phase 2 EMPhASIS Trial Confirms Phase 3 Dose Selection -

Completed Enrollment of Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Moderate-to-Severe Ulcerative Colitis; Top-Line Data Expected

Reported Positive Results from the Single and Multiple Ascending Dose Parts of the Phase 1

Clinical Trial of IMU-935; Part C Portion in Psoriasis Patients Ongoing with Data Expected in the

Second Half of 2022 -

Current Cash and Cash Equivalents Expected to Fund Immunic Through the First Quarter of 2023 -

Webcast to be Held Today, February 24, 2022, at 8:00 am ET -

February 24, 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 announced financial results for the fourth quarter and year ended December 31, 2021 and highlighted recent activity.

"2021 was another year of tremendous achievement

for Immunic, punctuated by significant clinical progress across our key pipeline programs, including our lead product candidate, selective

oral DHODH inhibitor, vidofludimus calcium (IMU-838) and IMU-935, a highly potent and selective oral IL-17 inhibitor. These activities,

in particular, clear the way for several important data readouts this year, which are potentially transformative for the company,"

stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Notably, at the end of October, we completed enrollment

in our phase 2 CALDOSE-1 trial of vidofludimus calcium in patients with moderate-to-severe ulcerative colitis (UC) and expect top-line

data for the induction phase to be available in June of 2022. Additionally, during the fourth quarter, we enrolled the first patients

in our phase 3 ENSURE program of vidofludimus calcium in patients with relapsing multiple sclerosis (RMS). Based on the drug's highly

significant activity in preventing lesion formation in our phase 2 EMPhASIS trial in RRMS, the consistent correlation observed between

lesion formation and clinical relapse in third-party clinical trials, and vidofludimus calcium's outstanding safety and tolerability

profile to date, we believe that this program should provide a straightforward path towards possible regulatory approval in RMS."

"We also reported positive unblinded safety,

pharmacodynamic and pharmacokinetic (PK) data from the healthy volunteer portions of our ongoing phase 1 clinical trial of IMU-935 and

expanded the trial, as planned, to treat patients with moderate-to-severe psoriasis. Based on the strength of preclinical data highlighting

the therapeutic potential of IMU-935 to affect metastatic castration-resistant prostate cancer (mCRPC), we initiated an open-label phase

1 dose escalation trial of IMU-935 in mCRPC, for which initial clinical safety data are expected to be available in the third quarter

of this year. Most recently, we were successful in expanding and strengthening our intellectual property portfolio for IMU-935 with the

receipt of multiple Notice of Allowances for composition-of-matter patents in the United States, Europe and Australia, providing protection

into at least 2038."

Fourth Quarter 2021 and Subsequent Highlights

Final Cohort 2 Data from the Phase 2 EMPhASIS

Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis (RRMS) Now Available

Final data of Cohort 2 from Immunic's phase

2 EMPhASIS trial of vidofludimus calcium in RRMS are now available. The company believes that this data set provides additional support

for the previously determined dose selection for the ongoing ENSURE and CALLPER trials in RMS and PMS, respectively.

Recall that the EMPhASIS trial comprised two cohorts.

Cohort 1 compared the efficacy and safety of 30 mg or 45 mg once daily of vidofludimus calcium with placebo in RRMS, while Cohort 2 compared

the efficacy and safety of 10 mg once daily of vidofludimus calcium with placebo in RRMS. Full data from Cohort 1 was published in the

third quarter of 2020, while 12-week interim data from Cohort 2 was released in the second quarter of 2021.

In the newly available, final Cohort 2 data set,

the anti-inflammatory effects of vidofludimus calcium at the 10 mg dose were observed to be lower (13% reduction of gadolinium-enhancing

magnetic resonance imaging lesions up to 24 weeks, as compared to placebo) than those found with the 30 mg vidofludimus calcium dose in

the pooled Cohort 1 and 2 data (78% reduction), providing further support for the selection of 30 mg dosing in the ongoing ENSURE trials

in RMS. Final Cohort 2 data also provide evidence of dose-proportional neuroprotective activity. For instance, the highest decrease of

the biomarker serum neurofilament light chain was observed with the 45 mg dose of vidofludimus calcium versus placebo (-26.0% median of

differences between percentage change of serum neurofilament, Hodges-Lehmann estimation), a substantial decrease was seen with the 30

mg dose (-18.0%), while the smallest decrease was observed with the 10 mg dose of Cohort 2 (-9.0%). The 10 mg group in Cohort 2 also showed

a signal with respect to improvement in Expanded Disability Status Scale (EDSS), consistent with those signals seen with the higher doses

in Cohort 1, although all of these early signals need to be confirmed in a larger patient population with longer follow-up periods. Taken

together, these last two observations suggest that higher doses, such as 45 mg vidofludimus calcium, may be preferred doses for clinical

trials in which neuroprotective effects are the main mechanism for improvement, such as in PMS.

While Cohort 1 blinded treatment was completed

right before the COVID-19 pandemic started, final Cohort 2 data provide additional evidence that ongoing vidofludimus calcium treatment

may reduce the risk of COVID-19 infections, presumably related to its known antiviral activity. In the entire Cohort 2 population of 59

patients, who were enrolled during pandemic conditions, incidental COVID-19 infections in the active treatment group were less frequent

(8.5%, n=4/47) than in the placebo group (25.0%, n=3/12). Additionally, Immunic recently obtained new preclinical data underlining that

vidofludimus calcium shows potent anti-EBV activity. The company also confirmed that vidofludimus calcium can be detected to a noteworthy

degree in the cerebrospinal fluid of animals, after oral dosing. Immunic believes that this finding suggests that vidofludimus calcium

may be able to act directly within the central nervous system.

Anticipated Clinical Milestones

Financial and Operating Results

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_d6PSP8F3RCWrEcchTzfi6Q

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 clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating

chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, vidofludimus

calcium (IMU-838), a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme

DHODH and exhibits a host-based antiviral effect, is currently being developed as a treatment option for multiple sclerosis, ulcerative

colitis, Crohn's disease, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor ROR /ROR t,

is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barr syndrome. IMU-856, which targets

the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction. For further

information, please visit: www.imux.com.

Statement Regarding Forward-Looking Statements

This 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, 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 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, 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, 2020, filed with the SEC on February 26, 2021, 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