Full Press Release Details
Immunic, Inc. Reports Year End 2020 Financial
and Highlights Recent Activity
Phase 3 Program of IMU-838 in Relapsing-Remitting Multiple Sclerosis Expected to Begin in the Second
Reported Positive Top-Line Data From Investigator-Sponsored Phase 2 Proof-of-Concept Clinical Trial of IMU-838 in Primary Sclerosing
Announced Main Analysis of Phase 2 CALVID-1 Trial of IMU-838 Showing Evidence of Clinical Activity in Patients with Moderate COVID-19
Significantly Bolstered Balance Sheet, Raising Approximately $144.4 Million of Cash During 2020 -
With $127.5 Million in Cash and Cash Equivalents, Immunic is Funded Into the Second Half of 2022 -
YORK, February 26, 2021 - Immunic, Inc. (Nasdaq: IMUX), a
clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic
inflammatory and autoimmune diseases, today announced financial results for the year ended December 31, 2020 and highlighted recent
"2020 was a year marked by significant
operational and clinical milestone achievements across our pipeline, culminating most recently in two important data readouts for
our lead asset, selective oral DHODH inhibitor, IMU-838," stated Daniel Vitt, Ph.D., Chief Executive Officer and President
of Immunic. "The main analysis of our phase 2 CALVID-1 trial showed evidence of clinical activity in hospitalized patients
with moderate COVID-19, a highly encouraging result. The trial generated very meaningful clinical data which indicate that IMU-838
may have potential as a more convenient and highly effective therapeutic option for COVID-19. At the same time, we were also pleased
to have just reported positive top-line data from the investigator-sponsored phase 2 proof-of-concept trial of IMU-838 in primary
sclerosing cholangitis (PSC), which was conducted at Mayo Clinic. Achievement of a therapeutic benefit, combined with a statistically
significant decrease in serum alkaline phosphatase in the per-protocol population and the other liver biochemistry parameters showing
a stable pattern, is noteworthy and gives real hope to PSC patients, who currently have no treatment options."
"The strength of these results, including
confirmation of the safety and tolerability of IMU-838, speaks volumes about its broad potential in numerous indications. Following
the excellent efficacy and safety data from our phase 2 EMPhASIS trial in patients with relapsing-remitting multiple sclerosis
(RRMS), which we announced in August and September 2020, respectively, we are on track to file our end-of-phase 2 submissions to
regulatory authorities around the end of the first quarter and expect the outcome of the meetings, including our plans for a phase
3 program which we intend to begin in the second half of 2021, to be available around May of this year. Data from our fully enrolled
60-subject Cohort 2 sub-trial of IMU-838 in RRMS, intended to obtain dose response data in patients receiving 10 mg/day of IMU-838
or placebo for 24 weeks, is anticipated at the end of March or in early April, and should serve to de-risk our phase 3 discussions
with regulatory authorities."
Dr. Vitt continued, "Our ability
to measurably bolster our balance sheet in 2020 reflects investors' belief in the core value of our technology and pipeline
potential, and the approximately $127.5 million in cash and cash equivalents at year-end should fund us through significant clinical
milestones into the second half of 2022. Given our progress and expectations for each of our clinical programs, during the fourth
quarter of 2020, we announced the formation of a Scientific-Medical Advisory Board. The Board's inaugural members include
some of the most highly distinguished authorities in inflammatory and autoimmune diseases, including Drs. Fred D. Lublin, Bruce
E. Sands, Jerrold R. Turner and Paul J. Utz. The experience and guidance of these internationally recognized experts will be invaluable
as we continue to advance our pipeline going forward."
Fourth Quarter 2020 and Subsequent Highlights
Activities Relating to the Preparation of a Phase 3 Program
As previously announced, the full unblinded
clinical data from the company's phase 2 trial of IMU-838 in patients with RRMS showed achievement of all primary and key
secondary endpoints, with high statistical significance. Notably, the 30 and 45 mg/day doses of IMU-838 appear to be equally safe
and efficacious, reducing the number of combined unique active (CUA) magnetic resonance imaging (MRI) lesions up to week 24, as
compared to placebo. Based on established regulatory guidance that the lowest effective dose should be considered for future clinical
trials, Immunic may propose the dose of 30 mg/day of IMU-838 for investigation in a phase 3 program.
Given the relative equal performance of
the two doses tested and to allow for pharmacodynamic modeling of the dose-response relationship, data from a lower dose in the
effective dose range would be beneficial to complete a dose-effect assessment of IMU-838 in RRMS. For this reason, Immunic is conducting
an additional, small Cohort 2 sub-trial to obtain exploratory data on the expanded dose response of IMU-838,
as previously announced. This additional, double-blind assessment, now fully enrolled, includes a cohort of approximately 60 patients
who receive 10 mg/day of IMU-838 or placebo for 24 weeks. The results are not expected to change any conclusions for dosing of
IMU-838 in a future phase 3 program. Rather, the sub-trial is expected to provide additional data to address any potential regulatory
requests in the context of the design of a phase 3 program. An unblinded interim analysis of selected MRI data is planned after
all Cohort 2 patients have completed week 12 MRI assessments. The Company expects this data to be available at the end of March
or in early April 2021. Immunic believes that the foregoing strategy for IMU-838 in RRMS will enable risk reduction for end-of-phase
2 discussions with regulatory agencies.
Immunic intends to submit formal end-of-phase
2 meeting requests to discuss the proposed phase 3 program with major regulatory authorities around the end of the first quarter
of 2021. The outcome of the end-of-phase 2 meetings are expected to be available in or about May 2021. As previously announced,
in parallel to the preparation and execution of the regulatory discussions, Immunic has begun performing formal feasibility activities
for a phase 3 program of IMU-838 in RRMS, including country and site selection, as well as other preparatory activities. Immunic
plans to announce details on the design of the envisaged phase 3 program in RRMS after its end-of-phase 2 meetings with regulatory
authorities. The phase 3 program is expected to start in the second half of 2021.
Additional Anticipated Clinical Milestones
Financial and Operating Results
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. The company is developing three small molecule products: its lead development
program, IMU-838, 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, is currently being developed as a treatment option for multiple sclerosis,
ulcerative colitis, Crohn's disease, COVID-19, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of
the transcription factor ROR t, is targeted for development in psoriasis and Guillain-Barr syndrome. IMU-856, which
targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction.
For further information, please visit: www.imux.com.
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; clinical data for IMU-838; the timing of current and future clinical trials;
the future use of the EIB venture loan; 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, 2020, filed with the SEC on February 26,
2021, 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 reflect events or circumstances
that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not
taken based on any or all the contents of this press release.
Head of Investor Relations and Communications
Rx Communications Group