Immunic, Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update - Vidofludimus Calcium Substantially Reduced 24-Week Confirmed Disability Worsening in Phase 2 CALLIPER Trial in Overall Progressi

Immunic, Inc. Reports Second Quarter 2025

Financial Results and Provides Corporate Update

Vidofludimus Calcium Substantially Reduced 24-Week Confirmed Disability Worsening in Phase 2 CALLIPER Trial in Overall Progressive Multiple

Sclerosis Study Population and Across Subtypes, Reinforcing the Drug's Neuroprotective Potential and Ability to Slow

Disease Progression -

Completed Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data

Expected by End of 2026 -

New Long-Term Open-Label Extension Data From Phase 2 EMPhASIS Trial in Relapsing-Remitting Multiple Sclerosis Showed High Rates of Patients

Remaining Free of 12-Week and 24-Week Confirmed Disability Worsening -

Strengthened Balance Sheet with Two Financings Totaling $70.1 Million in Gross Proceeds -

August 7, 2025 - 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 second quarter and six months ended June 30, 2025, and

provided a corporate update.

"During the second quarter and more recently,

we have made substantial clinical progress in advancing our potentially transformative lead asset, vidofludimus calcium (IMU-838), an

orally available nuclear receptor-related 1 (Nurr1) activator," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "Most

notable was the on-time completion of enrollment of our twin phase 3 ENSURE trials, bringing us one step closer to delivering a novel

treatment option for people living with relapsing multiple sclerosis (RMS). The unique neuroprotective effects observed to date also support

the phase 3 ENSURE trials, where confirmed disability worsening will be analyzed. Top-line data from both trials, expected by the end

of 2026, will allow for a synchronized readout and a pooled analysis of this clinical endpoint. The growing body of evidence we have amassed

continues to strengthen our confidence that, if approved, vidofludimus calcium, with a distinct combination of neuroprotective, anti-inflammatory

and anti-viral properties observed, as well as a well-established safety and tolerability profile, has the potential to emerge as a differentiated

oral therapy that addresses the complex pathophysiology of multiple sclerosis (MS)."

"We also reported strong results from our

phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), showing a 23.8% reduction in time to 24-week confirmed disability worsening

(24wCDW) in the overall study population compared to placebo. In the high unmet need subgroup of primary progressive MS (PPMS), this effect

was 31.3%, exceeding outcomes observed in previous PPMS trials. In another high unmet need subtype, non-active SPMS (naSPMS), the reduction

was 19.2%. Moreover, patients without gadolinium-enhancing lesions at baseline, who often do not benefit from existing treatments, saw

24wCDW reductions of 33.7% for the overall PMS population, as well as 34.4% and 29.8% for the PPMS and naSPMS subgroups, respectively.

Since time to 24wCDW is a recognized regulatory endpoint for assessing clinical benefit in PMS, we believe these findings strongly support

advancing vidofludimus calcium into phase 3 development in progressive forms of MS. With only one approved treatment currently available

for PPMS, vidofludimus calcium may be a highly promising option for this underserved $6+ billion market, where reduction of disease progression

would allow patients to remain more independent, manage symptoms more easily and achieve better long-term outcomes."

Management noted that, among the continued stream

of positive data for vidofludimus calcium was the new readout from the long-term open-label extension (OLE) phase of the phase 2 EMPhASIS

trial in relapsing-remitting multiple sclerosis (RRMS), which further reinforced the strong efficacy signals previously observed in this

trial. Data showed that at week 144, 92.3% of patients remained free of 12-week confirmed disability worsening (12wCDW), and 92.7% were

free of 24wCDW. This, and previously announced results across the MS program-including the top-line EMPhASIS and CALLIPER data-further

support the potential of vidofludimus calcium to slow disease progression. These findings also continue to highlight its neuroprotective

effects, which are believed to be mediated through activation of the Nurr1 target. Based on the strength of the data, a total of five

abstracts have been selected for presentation at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis

(ECTRIMS) in September, including one oral presentation and one late-breaking poster - a major achievement for the company.

Dr. Vitt added, "Beyond vidofludimus calcium,

compelling clinical and preclinical data for IMU-856, our orally available and systemically acting small molecule modulator that targets

sirtuin 6 (SIRT6), indicates the drug's strong promise as a potential novel therapeutic for gastrointestinal disorders. Based on

encouraging data available to date, we are preparing for further clinical testing while exploring potential financing, licensing, or partnership

opportunities to advance the program. Additionally, IMU-856 has shown potential as an oral treatment option for weight management. More

specifically, a post hoc analysis of our phase 1b clinical trial results showed up to a 250% increase in GLP-1 levels versus placebo in

fasting celiac disease patients, mimicking natural post-meal responses and suggesting that IMU-856 may activate enteroendocrine pathways

physiologically, offering a broader mechanism than current injectable incretin mimetics. If validated in future trials, this once-daily

oral small molecule could become a convenient treatment alternative for weight management."

Second Quarter 2025 and Subsequent Highlights

Anticipated Clinical Milestones

Financial and Operating Results

Research and Development (R&D)

Expenses were $21.4 million for the three months ended June 30, 2025, as compared to $18.3 million for the three months ended June

30, 2024. The $3.0 million increase reflects (i) a $2.6 million increase in external development costs related to the vidofludimus calcium

programs and (ii) a $0.6 million increase in personnel expenses. The increase was offset by a $0.2 million decrease related costs across

numerous categories.

For the six months ended June 30, 2025,

R&D expenses were $42.9 million, as compared to $37.1 million for the six months ended June 30, 2024. The $5.8 million increase reflects

a $7.3 million increase in external development costs related to the vidofludimus calcium programs. The increase was offset by a $1.5

million decrease in external development costs related to IMU-856 due to the completion of the phase 1b clinical trial in celiac disease

For the six months ended June 30, 2025,

G&A expenses were $11.0 million, as compared to $9.6 million for the same period ended June 30, 2024. The $1.4 million increase was

due to (i) a $0.7 million increase related to personnel expenses, (ii) a $0.5 million increase in legal and consultancy expenses and (iii)

a $0.2 million increase related costs across numerous categories.

For the six months ended June 30, 2025,

interest income was $0.4 million, as compared to $2.2 million for the same period ended June 30, 2024. The $1.8 million decrease was due

to a lower average cash balance.

For the six months ended June 30, 2025,

Other Income (Expense) was $1.2 million, as compared to ($1.7 million) for the same period ending June 30, 2024. The $2.8 million increase

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 in 2024, (ii) a $1.0 million grant income of the German Federal

Ministry of Finance recognized in the first quarter 2025 and (iii) a $0.1 million increase across numerous categories.

Net loss for the six months ended June

30, 2025, was approximately $52.3 million, or $0.45 per basic and diluted share, based on 116,844,985 weighted average common shares outstanding,

compared to a net loss of approximately $51.0 million or $0.51 per basic and diluted share, based on 99,607,158 weighted average common

shares outstanding for the same period ended June 30, 2024.

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 clinical

trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has

already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive

multiple sclerosis. 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 as well as inflammatory

bowel disease, Graft-versus-Host-Disease and weight management. 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, 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

feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of