SAN DIEGO, June 21, 2019 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a
clinical-stage biopharmaceutical company focused on
developing potentially best-in-class, oral therapies for the
treatment of chronic inflammatory and autoimmune diseases, today
announced that it has filed an amended Current Report on Form 8-K
containing certain financial statements and pro forma financial
information required to be provided in connection with the
stock-for-stock exchange transaction between Immunic, Inc. (then
known as Vital Therapies, Inc.) and Immunic AG, which was completed
on April 12, 2019. Management also
provided an update on the progress of its key development
programs.
The amended Current Report on Form 8-K contains the audited
consolidated financial statements of Immunic AG as of and for the
years ended December 31, 2018 and
December 31, 2017, and the unaudited
condensed consolidated financial statements as of and for the three
months ended March 31, 2019 and the
corresponding period of the preceding fiscal year. The filing also
includes pro forma combined financial information of Immunic AG and
Vital Therapies, Inc.
Clinical Development Progressing Well
- Although all ongoing phase 2 trials with IMU-838 remain
blinded, the observed safety results from these trials are
consistent with the previously defined reference safety information
and no new safety signals have been observed to date.
- Patient recruitment for the company's phase 2, international,
multicenter, double-blind, placebo-controlled, randomized,
parallel-group trial of IMU-838, in development for the treatment
of relapsing-remitting multiple sclerosis (EMPhASIS), is
progressing faster than anticipated and is expected to be completed
in the first half of 2020. Top-line data is anticipated to be
available during the third quarter of 2020.
- Patient recruitment for the phase 2, multicenter, randomized,
double-blind, placebo-controlled, dose-finding study of IMU-838 in
patients with moderate-to-severe ulcerative colitis (CALDOSE-1) was
updated based on current recruitment rates and the anticipated
impact of supportive measures. Study enrollment is projected to
conclude during the second half of 2020. Top-line data is expected
to be available in the first quarter of 2021.
- Initiation of the phase 2, multicenter, randomized,
double-blind, placebo-controlled, dose-finding trial of IMU-838 for
the treatment of active Crohn's disease (CALDOSE-2) is expected to
occur during the second half of 2019, as per previous guidance. All
preparations are in the advanced stage in anticipation of the
interim dosing analysis of CALDOSE-1 in the third quarter of 2019,
which will inform the dose selection for CALDOSE-2.
- The investigator-sponsored trial of IMU-838 in patients with
primary sclerosing cholangitis, which will be conducted at the Mayo
Clinic, is expected to start enrollment soon.
- Immunic's earlier stage programs are on track. The company
expects to begin its phase 1 double-blind, placebo-controlled,
single and multiple ascending dose trials of IMU-935 during
September 2019. Immunic also plans to
extend these studies in the first half of 2020 to assess
safety and mechanism-related biomarkers in patients with
psoriasis.
- Immunic has started preclinical regulatory safety studies of
IMU-856, a drug candidate targeting the intestinal barrier
function. Initiation of phase 1 clinical trials is expected in the
first half of 2020.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX)
is a clinical-stage biopharmaceutical company developing a
pipeline of selective oral immunology therapies aimed at treating
chronic inflammatory and autoimmune diseases, including ulcerative
colitis, Crohn's disease, relapsing-remitting multiple sclerosis,
and psoriasis. The company is developing three small molecule
products: IMU-838 is a selective immune modulator that inhibits the
intracellular metabolism of activated immune cells by blocking the
enzyme DHODH; IMU-935 is an inverse agonist of RORγt; and IMU-856
targets the restoration of the intestinal barrier function.
Immunic's lead development program, IMU-838, is in phase 2 clinical
development for ulcerative colitis and relapsing-remitting multiple
sclerosis, with an additional phase 2 trial in Crohn's disease
planned for 2019. An investigator-sponsored proof-of-concept
clinical trial for IMU-838 in primary sclerosing cholangitis is
planned to start at the Mayo Clinic. For further information,
please visit: www.immunic-therapeutics.com.
Cautionary 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, 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, IMU-935 and IMU-856 to safely and
effectively target diseases; the timing of future clinical trials;
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, 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. 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.
Contact Information
Immunic, Inc.
Jessica Breu
Manager IR and Communications
+49 89 250 0794 69
jessica.breu@immunic.de
Or
Rx Communications Group
Melody Carey
+1-917-322-2571
immunic@rxir.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/immunic-inc-files-financial-statements-and-pro-forma-financial-information-in-accordance-with-previously-completed-stock-for-stock-exchange-transaction-and-provides-corporate-update-300872633.html
SOURCE Immunic, Inc.