Immunic, Inc. Reports Third Quarter 2024 Financial Results and Provides Corporate Update - Positive Interim Analysis of Phase 3 ENSURE Program, Unblinded Independent Data Monitoring Committee Confirmed that Predetermined

Immunic, Inc. Reports Third Quarter 2024

Financial Results and Provides Corporate Update

Positive Interim Analysis of Phase 3 ENSURE Program, Unblinded Independent Data Monitoring Committee Confirmed that Predetermined Futility

Criteria Have Not Been Met and Recommended Trials Should

Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis

Top-Line Data from Phase 2 CALLIPER Trial Expected in April 2025 -

Webcast to be Held Today, November 7, at 8:00 am ET -

November 7, 2024 - 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 third quarter and nine months ended September 30, 2024,

and provided a corporate update.

"During the third quarter, we have continued

to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in

relapsing multiple sclerosis (RMS), for our potentially transformative, orally available lead asset, nuclear receptor related 1 (Nurr1)

activator, vidofludimus calcium (IMU-838)," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "As recently reported,

we are progressing, as planned, with our phase 3 ENSURE program in RMS, after an interim, non-binding futility analysis, conducted by

an unblinded Independent Data Monitoring Committee (IDMC), recommended that the trials are not futile and should continue as planned,

without any sample size increase, marking a key milestone for the program. We continue to expect to complete the ENSURE-1 trial in the

second quarter of 2026 and the ENSURE-2 trial in the second half of 2026. Our next important clinical readout for this program is the

CALLIPER top-line data in PMS, which we expect to release in April of next year. As previously reported, the CALLIPER interim data supported

the potential effectiveness of vidofludimus calcium in slowing disease progression in PMS and further substantiated its neuroprotective

capabilities through the activation of Nurr1. Should the top-line data continue to demonstrate this neuroprotective effect, and the phase

2 trial meets its primary and key secondary endpoints, we may be able to position vidofludimus calcium as the first oral treatment option

for non-relapsing secondary progressive MS (SPMS)."

"In September, we had the opportunity to

present four posters at the prestigious 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS),

showcasing data on key aspects of vidofludimus calcium's profile. This included the neurofilament light chain (NfL) interim data

from our phase 2 CALLIPER trial, which showed a clear separation from placebo in NfL levels across the PMS patient population, including

non-relapsing SPMS, a subtype with the highest unmet medical need. We also presented antiviral data suggesting an effect on reducing fatigue,

Nurr1 target data supporting the neuroprotective potential, and pathogenic T cell data further supporting the drug's anti-inflammatory

effects. The presentations at ECTRIMS followed closely on the heels of our MS R&D Day, which featured two world renowned industry

experts alongside Immunic's management team to discuss vidofludimus calcium's unique profile, including its safety and tolerability,

and its potential to significantly elevate today's standard of care. We continue to believe that, if approved, vidofludimus calcium,

with its combined neuroprotective, anti-inflammatory and anti-viral effects, would represent a unique new treatment option targeted to

the complex pathophysiology of MS."

continued, "During the quarter, we continued phase 2 clinical preparations for IMU-856, our orally available, systemically acting

small molecule modulator targeting Sirtuin 6 (SIRT6), a protein which serves as a transcriptional regulator of intestinal barrier function

and physiological regeneration of bowel epithelium, including exploring potential financing, licensing or partnering opportunities to

fund this clinical program. As we have noted previously, based on initial clinical proof-of-concept data, we believe that IMU-856 could

be an entirely new therapeutic approach to treating gastrointestinal disorders by restoring a healthy gut through renewal of the bowel

wall. Data from our phase 1b clinical trial showed that, in patients with celiac disease during periods of gluten-free diet and gluten

challenge, IMU-856 demonstrated positive effects over placebo in four key dimensions of celiac disease pathophysiology: protection of

the gut architecture, improvement of patients' symptoms, biomarker response, and enhancement of nutrient absorption. Based on this

encouraging data, we are considering additional possible clinical applications in other gastrointestinal disorders."

Third Quarter 2024 and Subsequent Highlights

Anticipated Clinical Milestones

Financial and Operating Results

For the nine months ended September

30, 2024, R&D expenses were $58.4 million, as compared to $63.9 million for the nine months ended September 30, 2023. The $5.5 million

decrease reflects (i) a decrease of $4.1 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate

cancer, (ii) a $2.6 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 clinical trial

in celiac disease and (iii) a $0.5 million decrease related costs across numerous categories. The decreases were offset by (i) a $1.2

million increase in personnel costs, $0.2 million of which is related to non-cash stock compensation and the remainder of which is due

to an increase in headcount and (ii) a $0.5 million increase in external development costs related to the vidofludimus calcium program.

For the nine months ended September

30, 2024, G&A expenses were $14.0 million, as compared to $11.9 million for the same period ended September 30, 2023. The $2.1 million

increase was primarily due to (i) a $1.7 million increase in personnel expense in G&A, $0.9 million of which is related to non-cash

stock compensation expense and the remainder of which is related to an increase in headcount, (ii) $0.3 million in legal and consultancy

expenses and (iii) a $0.1 million increase related to costs across numerous categories.

Interest income for the nine months

ended September 30, 2024 was $2.9 million, as compared to $2.5 million for the nine months ended September 30, 2023. The $0.4 million

increase was due to higher interest rates.

For the nine months ended September

30, 2024, other income (expense) was ($1.1 million), as compared to $1.3 million for the same period ending September 30, 2023. The $2.4

million decrease was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing

related to the tranche rights that were established at the time of the deal closing, (ii) the German Federal Ministry of Finance grant

of $1.1 million being recognized in the fourth quarter of 2023 and (iii) a $0.4 million decrease in other grants which were received in

2023. The decrease was offset by a $0.9 million increase in foreign exchange gains.

Net loss for the nine months ended

September 30, 2024, was approximately $75.3 million, or $0.75 per basic and diluted share, based on 99,998,245 weighted average common

shares outstanding, compared to a net loss of approximately $72.0 million or $1.63 per basic and diluted share, based on 44,227,264 weighted

average common shares outstanding for the same period ended September 30, 2023.

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_v2_K1Ze-QKS34X6c9W9ywg 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.

Immunic, Inc. (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), is currently in phase 3 and phase 2

clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in

phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe

ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor

related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate

dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate

bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is

currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule

being developed to specifically address the needs of gastrointestinal diseases. 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, new

management hires and promotions, future operations, future financial position, future revenue, projected expenses, sufficiency of cash

and cash runway, expected timing, development 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; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure