Immunic, Inc. Reports Positive Top-line Data from Phase 2 EMPhASIS Trial of IMU-838 in Patients with Relapsing-Remitting Multiple Sclerosis - Study Meets Primary and Key Secondary Endpoints with High Statistical Signific

Inc. Reports Positive Top-line Data from Phase 2 EMPhASIS Trial of IMU-838 in Patients with Relapsing-Remitting Multiple Sclerosis

Study Meets Primary and Key Secondary Endpoints with High Statistical Significance Indicating Activity for IMU-838

in Relapsing-Remitting Multiple Sclerosis -

Statistically Significant Reduction of 62% and 70% in Combined Unique Active Magnetic Resonance Imaging Lesions in

45mg and 30mg Patient Cohorts, As Compared to Placebo -

Data Supports Previously Observed Favorable Safety Profile of IMU-838 in Relapsing-Remitting Multiple Sclerosis Patient

Company Also Reports Second Quarter 2020 Financial Results With $48.6 Million in Cash and

Conference Call and Webcast to be Held on August 3, 2020 at 8:30am ET -

YORK, August 2, 2020 - Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused

on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced

positive top-line data from its phase 2 EMPhASIS trial of lead asset, IMU-838, the company's

selective oral DHODH inhibitor, in patients with relapsing-remitting multiple sclerosis (RRMS). The study achieved all primary

and key secondary endpoints, indicating activity in RRMS patients. In particular, the study

met its primary endpoint, demonstrating a statistically significant reduction in the

cumulative number of combined unique active (CUA) magnetic resonance imaging (MRI) lesions up to week 24 in patients receiving

45mg of IMU-838 once daily, by 62% (p=0.0002), as compared to placebo. The

study also met its key secondary endpoint, showing a statistically significant reduction

in the cumulative number of CUA MRI lesions for the 30mg once daily dose, by

70% (p<0.0001), as compared to placebo.

All other secondary endpoints, including

those based on other MRI parameters and on clinical endpoints such as relapse events, also provided a noticeable signal and numerical

benefit for the IMU-838 treatment groups, as compared to placebo. Given the study's design, sample size and the patient's

follow-up duration, full statistical analysis of these secondary endpoints was not deemed appropriate or included in the analysis

plan. Nonetheless, we believe data on these endpoints provides useful information for the further development path towards potential

Consistent with prior data sets in other

patient populations, administration of IMU-838 in this trial was observed to

be safe and well-tolerated, thereby providing evidence of an attractive target product

profile for IMU-838 in the RRMS patient population. The rate of treatment-emergent adverse events was 42.9% of IMU-838-treated

patients compared with 43.5% of patients on placebo. Likewise, serious treatment-emergent adverse events were rare and only observed

in 3 out of 140 IMU-838-treated patients, and in 1 out of 69 patients on placebo. The rate

of treatment withdrawals in the 24-week blinded treatment period was only 5.0% in the pooled IMU-838 treatment arms versus 7.2%

in the placebo group. In addition, the rate of discontinuations due to adverse events or protocol-specified discontinuation criteria

were equivalent between the pooled IMU-838 treatment arms and placebo. There was no

increase in liver or renal events for the IMU-838 treatment arms versus placebo. Analysis of the full EMPhASIS data is ongoing

and will be presented at an upcoming scientific meeting.

in the EMPhASIS trial exhibited robust responses across all study endpoints included

in the top-line analysis. In addition to showing consistent activity by IMU-838

in RRMS using different measures, the study data also supports the previously observed favorable safety and tolerability profile

of IMU-838 in RRMS patients," commented Andreas Muehler, M.D., Chief Medical Officer of Immunic. "We believe

this data strongly supports our goal of developing IMU-838 as an easy, safe and convenient

oral treatment option for patients with RRMS and other autoimmune diseases. We are

extremely encouraged by these results and intend to now focus on the development plan with the goal of eventually making IMU-838

available as a best-in-class, once-daily oral therapy for RRMS."

phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed

to assess the efficacy and safety of IMU-838 in patients with RRMS. Of the 210 patients randomized in 36 centers across four European

countries, 209 patients received at least one dose of IMU-838 or placebo (placebo

n=69, 30mg IMU-838 n=71, 45mg IMU-838 n=69), and 197 patients completed the blinded

24-week treatment period. All enrolled patients were required to have shown disease activity based on clinical evidence of relapse

and additional MRI criteria. The primary and key secondary endpoints were the cumulative number of CUA MRI lesions, up to week

24, for 45mg and 30mg of IMU-838, respectively. MRI was performed at baseline and at weeks 6, 12, 18 and 24, and was evaluated

centrally by an independent, blinded MRI reader.

The study includes an optional, extended treatment period for up to 9.5 years to evaluate long-term safety and tolerability of

positive phase 2 results impressively show the robust activity of IMU-838 in RRMS and provide further evidence of the

favorable safety profile already observed in other patient populations, representing

more than 650 human subjects and patients, to date," stated Daniel Vitt, Ph.D., Chief Executive Officer and

President of Immunic. "We believe that these phase 2 data of IMU-838 speak

volumes about its potential to provide a new, convenient, once daily oral front-line treatment

option to patients suffering from RRMS, bolstered by a unique combination of potential efficacy, safety and

tolerability. Given the strength of these top-line results, we

will continue to prepare a clinical phase 3 program for IMU-838 in RRMS and, after a full review of the data, anticipate providing a

further update on development strategy. We are also looking forward to reading out

clinical data from the other ongoing phase 2 trials of IMU-838 in COVID-19, primary sclerosing cholangitis and ulcerative

colitis in the upcoming months."

Second Quarter 2020 and Subsequent Highlights

Financial and Operating Results

For the six months ended June

30, 2020, R&D expenses were $16.4 million compared to $9.4 million for the same period ended June 30, 2019. The $7.0 million

increase was primarily attributable to (i) a $3.2 million increase in external development costs for lead development program,

IMU-838, related to the phase 2 clinical trials in patients with relapsing-remitting multiple sclerosis, ulcerative colitis and

COVID-19, (ii) a $1.2 million increase in drug supply costs related to IMU-838, (iii) $2.2 million of an increase in license fees,

preclinical, drug supply and phase 1 preparation costs related to IMU-856, (iv) $1.2 million in costs for drug supply and the start

of the phase 1 trial in September 2019 for the IMU-935 program and (v) $0.7 million of increased employee and other costs. The

increase was offset by a contingent payment under the asset purchase agreement with 4SC AG settled in stock valued at $1.5 million

at the transaction with Vital Therapies in the second quarter of 2019.

For the six months ended June

30, 2020, G&A expenses were $4.8 million compared to $10.3 million for the same period ended June 30, 2019. The $5.5 million

improvement was primarily due to one-time costs related to the transaction with Vital Therapies including $6.4 million of stock-based

compensation for the executives, key employees and members of the board of directors and $2.1 million in investment banking and

legal fees in the first six months of 2019. The decrease was partially offset by (i) a $1.6 million increase in personnel expenses,

(ii) $0.8 million of increased legal and consultancy costs and (iii) $0.6 million of increased costs across numerous categories

primarily due to becoming a public company and expanding operations into the United States.

For the six months ended June

30, 2020, other income was $1.3 million compared to $0.6 million for the same period ended June 30, 2019. The $0.6 million increase

was primarily attributable to (i) $0.3 million of research and development tax incentives for clinical trials in Australia as a

result of increased spending on clinical trials in Australia and (ii) $0.3 million recognized deferred income attributable to reimbursements

of research and development expenses in connection with the option and license agreement with Daiichi Sankyo.

Net loss for the six months ended

June 30, 2020 was approximately $19.9 million, or $1.70 per basic and diluted share, based on 11,722,725 weighted average common

shares outstanding, compared to a net loss of approximately $19.0 million, or $3.60 per basic and dilutes share, based on 5,282,412

weighted average common shares outstanding for the same period ended June 30, 2019.

Conference Call and Webcast Information

management team will host a public conference call and webcast on August 3, 2020 at 8:30 a.m. Eastern Time to provide

a corporate update and to discuss the top-line data from the phase 2 EMPhASIS trial of IMU-838 in relapsing-remitting multiple

participate in the conference call, dial 1-877-870-4263 (USA) or 1-412-317-0790 (International) and ask to be joined into the Immunic,

Inc. call. A live, listen-only webcast of the conference call can be accessed at https://www.webcaster4.com/Webcast/Page/2301/35524

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

archived replay of conference call and webcast will be available approximately one hour after the completion for one year on Immunic's

website at: ir.imux.com.

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