Immunic, Inc. Reports Third Quarter 2023 Financial Results and Provides Corporate Update - Positive Interim Analysis from Phase 2 CALLIPER Trial Showed Improvements in Serum Neurofilament Light Chain for Vidofludimus Cal

Immunic, Inc. Reports Third

Quarter 2023 Financial Results

and Provides Corporate Update

Positive Interim Analysis from Phase 2 CALLIPER Trial Showed Improvements in Serum Neurofilament Light Chain for Vidofludimus Calcium,

Consistent Throughout the Overall Progressive Multiple Sclerosis Population and All Subtypes -

Notice of Allowance for United States Patent Protecting the Treatment of Relapsing Multiple Sclerosis with Vidofludimus and Its Salts

Bolsters Multilayered Intellectual Property Position -

$59.7 Million in Cash and Cash Equivalents as of September 30, 2023 Expected to Fund Immunic Into September of 2024 -

Webcast to be Held Today, November 14, 2023, at 8:00 am ET -

November 14, 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 third quarter ended September 30, 2023, and provided a

have continued to make tangible progress on the clinical development of our lead asset, nuclear receptor related 1 (Nurr1) activator,

vidofludimus calcium (IMU-838). Of particular importance, we completed enrollment of our phase 2 CALLIPER trial in patients with progressive

multiple sclerosis (PMS) and most recently reported a stronger than expected, positive interim biomarker analysis of this trial.

Notably, the clear separation observed in serum neurofilament light chain (NfL) over placebo in

this patient population represents another key milestone for what could potentially be a

first-in-class Nurr1 activator for PMS," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Serum

NfL responses were consistently observed for vidofludimus calcium across progressive MS disease as well as all subpopulations and even

in non-active SPMS, a population where the medical need for new therapies is particularly high. We believe that the data set provides

biomarker evidence that vidofludimus calcium's activity extends beyond the previously observed anti-inflammatory effects, further

reinforcing its neuroprotective potential and bolstering our view that it may be associated with the reduced disability-worsening events

we already observed in multiple sclerosis (MS) patients."

"Assuming that the top-line CALLIPER data,

which we plan to report in April 2025, continues to show a neuroprotective effect, we may be able to position vidofludimus calcium as

the first oral treatment for non-active secondary progressive MS. We also think that the drug's potential first-in-class ability

to activate Nurr1 may meaningfully benefit our ongoing phase 3 ENSURE program in relapsing MS (RMS). To that end, we continue to enroll

patients in our twin phase 3 ENSURE trials and currently expect to report an interim futility analysis in late 2024, with the read-out

of the first of the ENSURE trials expected at the end of 2025. If ultimately approved, we continue to believe that vidofludimus calcium,

with combined neuroprotective, anti-inflammatory, and antiviral effects, could potentially offer a unique treatment option targeted to

the complex pathophysiology of MS."

Vitt continued, "In October and November, respectively, we presented the previously reported positive results from our phase 1b

clinical trial of our second key program, IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6

(Sirtuin 6), in patients with celiac disease, at two prestigious medical conferences. The results, gathered during periods of gluten-free

diet and gluten challenge, demonstrated positive effects for IMU-856 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.

IMU-856 was also observed to be safe and well-tolerated in this trial. We believe that this highly encouraging data provides initial clinical

proof-of-concept for a potential new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture.

That said, we are currently preparing for clinical phase 2 testing of IMU-856 in ongoing active celiac disease (OACD), while also considering

further potential clinical applications in other gastrointestinal disorders."

Third Quarter 2023 and Subsequent Highlights

Anticipated Clinical Milestones

Financial and Operating Results

For the nine months ended September

30, 2023, R&D expenses were $63.9 million, as compared to $50.5 million for the same period ended September 30, 2022. The $13.4 million

increase reflects (i) a $10.1 million increase in external development costs related to the phase 3 clinical program of vidofludimus calcium

in RMS, (ii) a $2.9 million increase in external development costs related to the phase 2 clinical trial of vidofludimus calcium in PMS,

(iii) a $2.3 million increase in drug supply costs for vidofludimus calcium to support our ongoing trials, (iv) a $1.8 million increase

in external development costs related to the phase 1 clinical trial of IMU-856, (v) a $1.6 million increase in personnel expense in R&D

related to an increase in headcount, $0.2 million of which was due to non-cash stock based compensation and (vi) a $0.5 million increase

in related costs across numerous categories. The increases were partially offset by (i) a decrease of $4.0 million resulting from deprioritizing

the izumerogant program in psoriasis and castration-resistant prostate cancer and (ii) a decrease of $1.8 million in external development

costs related to the phase 2 clinical trial of vidofludimus calcium in UC.

For the nine months ended September

30, 2023, G&A expenses were $11.9 million, as compared to $11.6 million for the same period ended September 30, 2022. The $0.3 million

increase was primarily due to (i) a $0.2 million increase in travel expense, (ii) a $0.2 million increase in legal and consultancy expense

and (iii) a $0.5 million increase across numerous categories. The increases were partially offset by a decrease of $0.6 million in personnel

expenses in G&A, which was primarily due to non-cash stock-based compensation decrease.

For the nine months ended September

30, 2023, other income was $3.8 million, as compared to ($1.8 million) for the same period ended September 30, 2022. The $5.6 million

increase was primarily attributable to (i) a $2.2 million increase in interest income as a result of higher interest rates, (ii) a $3.2

million decrease in foreign exchange losses and (iii) a $1.1 million research allowance attributable to tax year 2021 from the German

Federal Ministry of Finance. The increase was partially offset by a $0.9 million decrease in R&D tax incentives for clinical trials

in Australia as a result of decreased spending on clinical trials in Australia.

Net loss for the nine months ended

September 30, 2023, was approximately $72.0 million, or $1.63 per basic and diluted share, based on 44,227,264 weighted average common

shares outstanding, compared to a net loss of approximately $63.9 million, or $2.16 per basic and diluted share, based on 29,655,946 weighted

average common shares outstanding for the same period ended September 30, 2022.

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_AxIAE0pCQ12oMZIiehNKDg

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, where 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

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 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; 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 and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability