Immunic, Inc. Announces First Patients Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of IMU-838 in Combination with Oseltamivir for the Treatment of Patients with Moderate-to-Severe COVID-19 - Study Being Con

Immunic, Inc. Announces

First Patients Enrolled in Investigator-Sponsored Phase 2 Clinical Trial of IMU-838 in Combination with Oseltamivir for the Treatment

of Patients with Moderate-to-Severe COVID-19

Study Being Conducted in Collaboration with University Hospitals Coventry and Warwickshire NHS Trust -

YORK, July 27, 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 enrollment of the first patients in an investigator-sponsored phase 2 clinical trial of

the company's selective oral DHODH inhibitor, IMU-838, for the treatment of patients with coronavirus disease 2019 (COVID-19).

The IONIC trial is a prospective, randomized, parallel-group, open-label phase 2b study, designed to evaluate efficacy and safety

of IMU-838 in combination with the neuraminidase inhibitor, Oseltamivir (Tamiflu ),

in approximately 120 adult patients with moderate-to-severe COVID-19.

has been set up with the support of the in-house Trial Management Unit (TMU) of the sponsor and lead site, University Hospitals

Coventry and Warwickshire (UHCW) NHS Trust. The IONIC trial has commenced recruitment at the lead site and the TMU is actively

engaging with other NHS trusts interested in participating in the trial to facilitate recruitment.

"The healthcare community has

never faced a more urgent need for new therapies than the unprecedented situation we currently face with the COVID-19

pandemic," commented Prof. Ramesh Arasaradnam, Gastroenterology Consultant at UHCW NHS Trust, Chair of the British

Society of Gastroenterology (BSG) Research Committee and Chief Investigator of the IONIC trial. "Recent third-party

research has highlighted the powerful synergy between direct antiviral drugs and DHODH inhibitors in preclinical models. We believe that the

combination of Oseltamivir, which is a licensed drug in the United Kingdom, and IMU-838, may offer a promising approach for

the treatment of severe viral infections, including mid-to-late-stage COVID-19 patients."

has successfully demonstrated preclinical activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Specifically,

IMU-838 was observed to inhibit replication of clinical isolates of SARS-CoV-2 associated with COVID-19. In cellular assays, IMU-838

demonstrated this antiviral activity at concentrations which are well below the blood concentrations associated with IMU-838 dosing

regimens studied in ongoing and previous clinical trials. In addition, IMU-838 has an attractive pharmacokinetic, safety and tolerability

profile and, to date, has already been tested in about 650 individuals.

IONIC trial, for which Immunic is providing the study medication, is expected to enroll approximately 120 hospitalized patients,

60 in each treatment arm, with moderate-to-severe COVID-19 who will receive IMU-838 plus Oseltamivir, or Oseltamivir alone, for

14 consecutive days. All patients are also eligible to receive standard-of-care therapy throughout the duration of the study. Inclusion

criteria are adult patients with a confirmed or suspected SARS-CoV-2 infection fulfilling clinical status category 3 to 5, as assessed

with the seven-point ordinal scale proposed by the World Health Organization (WHO) master protocol.

are honored to be collaborating with the UHCW NHS Trust on this important clinical trial, in order to find a new treatment option

for COVID-19 patients," noted Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Due to its unique

host-based mode of action, which avoids dependence on specific viral proteins and, therefore, offers broad-spectrum antiviral

activity, as well as the attractive pharmacokinetic, safety and tolerability profile, we believe that IMU-838 is particularly

suitable for combination with other antiviral drugs such as Oseltamivir. We also believe that this trial can provide valuable

insights as to whether the host cell-based antiviral mechanism of IMU-838 has a synergistic effect with a direct antiviral drug

in order to provide a combination treatment approach for COVID-19."

of the IONIC trial, the UHCW NHS Trust has received funding from the medical research charity LifeArc through its COVID-19

drug repurposing initiative. LifeArc CEO Dr Melanie Lee said, "LifeArc is pleased to be able to support the IONIC trial,

as part of our 10 million initiative to find new therapeutics against COVID-19. We believe repurposing already available

medicines or those at a late stage of development, like those being studied in the IONIC trial, offers the fastest route to

bring benefit to patients during this pandemic."

orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells

by blocking the enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on activated T and B cells while leaving other immune

cells largely unaffected and allows the immune system to stay functioning, e.g. in fighting infections. In previous trials, IMU-838

did not show an increased rate of infections compared to placebo. In addition, DHODH inhibitors, such as IMU-838, are known to

possess a host-based antiviral effect, which is independent with respect to specific virus proteins and their structure. Therefore,

DHODH inhibition may be broadly applicable against multiple viruses. IMU-838 was successfully tested in two phase 1 clinical trials

in 2017 and is currently being tested in phase 2 trials in patients with COVID-19, relapsing-remitting multiple sclerosis, where top-line data is expected in the first half of August 2020, and ulcerative

colitis. Furthermore, Immunic's collaboration partner, the Mayo Clinic, has started an investigator-sponsored proof-of-concept

clinical trial testing IMU-838 activity in patients with primary sclerosing cholangitis. To date, IMU-838 has already been tested

in about 650 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile.

Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed

at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis,

Crohn's disease, and psoriasis. The company is developing three small molecule products: lead development program, IMU-838,

is 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; IMU-935 is an inverse agonist of ROR t; and IMU-856 targets the restoration

of the intestinal barrier function. IMU-838 is in phase 2 clinical development for COVID-19, relapsing-remitting multiple sclerosis

and ulcerative colitis, with an additional phase 2 trial considered in Crohn's disease. An investigator-sponsored proof-of-concept

clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the Mayo Clinic. For further information, please visit:

About UHCW NHS Trust

University Hospitals Coventry and Warwickshire (UHCW)

NHS Trust is one of the largest acute teaching Trusts in the UK, comprising University Hospital in Coventry and the Hospital of

St Cross in Rugby and working in partnership with Warwick University Medical School and Coventry University.

over 9,000 staff and delivers services across the West Midlands region. This includes hosting region-wide services such as the

Coventry and Warwickshire Pathology Network and the North West and Midlands Bowel Cancer Screening hub. The Trust works closely

with its partners in health and social care in Coventry/Warwickshire to develop patient-focused services that meet the needs of

Research and Development Department at the Trust supports and delivers a wide range of high quality health research for the benefit

of its patients. In 2019-20, the department recruited 4,295 patients into research projects - demonstrating the Trust's commitment

to improving the quality of care and contributing to wider health improvement.

team recruited more COVID-19 patients per head of population than the national average, supporting the World Health Organisation

ISARIC' trial and the National Institute for Health Research Recovery' study which demonstrated the efficacy

of low dose Dexamethasone as an effective treatment for COVID-19.

Statement Regarding Forward-Looking Statements

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 IMU-838 to safely and effectively target diseases; preclinical and clinical data for IMU-838; the timing of

current and future clinical trials; the potential for IMU-838 as a treatment for severe acute respiratory syndrome coronavirus

2 (SARS-CoV-2) infections associated with coronavirus disease 2019 (COVID-19) and any clinical trials, collaborations and approvals

relating to such potential treatment; the nature, strategy and focus of the company; and the development and commercial potential

of any product candidates of the company. 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 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 resources to meet business

objectives and operational requirements, the fact that the results of earlier studies and 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, 2019, filed with the

SEC on March 16, 2020, the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the

SEC on May 8, 2020, 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 in this release speaks

only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to