NEW YORK and
PLANEGG-MARTINSRIED, Germany,
March 31, 2021 /PRNewswire/
-- 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, and 4SC AG (FSE Prime
Standard: VSC), today announced the signing of an agreement under
which Immunic will settle its remaining obligation of a 4.4%
royalty on net sales of selective oral DHODH inhibitor, IMU-838,
for $17.25 million. The transaction
will be payable 50% in cash and 50% in shares of Immunic's common
stock.
Immunic acquired lead program IMU-838 in September 2016 from 4SC AG through an asset
acquisition, in exchange for a one-time upfront cash payment,
future milestone payments and a royalty on net sales for a certain
period. With completion of this transaction, no further payment
obligations remain between Immunic and 4SC.
"Execution of this agreement with 4SC is key, as it provides us
with 100% of the future sales potential of our lead asset,
IMU-838," stated Daniel Vitt, Ph.D.,
Chief Executive Officer and President of Immunic. "Backed by
exceptionally strong data generated by our phase 2 EMPhASIS trial
in relapsing-remitting multiple sclerosis (RRMS), we are now
planning to initiate a phase 3 trial during the second half of this
year. We are excited to move our pipeline forward and the
acquisition of the royalties will enable us to realize the full
market potential of IMU-838, not only as a treatment for RRMS but
also as a potential new therapeutic option for ulcerative colitis,
Crohn's disease, COVID-19, and primary sclerosing cholangitis,
thereby driving significant future value for our shareholders."
Jason Loveridge, Ph.D., Chief
Executive Officer of 4SC, added, "4SC is very pleased to conclude
this transaction as it provides non-dilutive financing for our own
oncology programs, extending our cash reach well into the second
half of 2022. We are expecting exciting data from some key
domatinostat programs, such as DONIMI in the neoadjuvant space, in
2021 and this transaction will help us move this and other key
studies in Merkel cell carcinoma forward."
About Immunic, Inc.
Immunic, 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 RORγt, is targeted for
development in psoriasis and Guillain-Barré 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.
About 4SC
4SC AG is a clinical-stage biopharmaceutical
company developing small-molecule drugs that can target key
indications in cancer with high unmet medical needs. 4SC's pipeline
is protected by a comprehensive portfolio of patents and currently
comprises two drug candidates in clinical development:
resminostat and domatinostat.
4SC aims to generate future growth and enhance its enterprise
value by entering into partnerships with pharmaceutical and biotech
companies and/or the eventual marketing and sales of approved drugs
in select territories by 4SC itself.
4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 48 employees
as of 31 December 2020 and is listed
on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime
Standard: VSC; ISIN: DE000A14KL72).
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 to safely and effectively target diseases;
clinical data for IMU-838; the timing of current and future
clinical trials; the nature, strategy and focus of the company; and
the development and commercial potential of IMU-838 and other
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.
Contact Information
Immunic, Inc.
Jessica
Breu
Head of Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
Immunic, Inc. US IR Contact
Rx Communications
Group
Paula Schwartz
+1 917 322 2216
immunic@rxir.com
Immunic, Inc. US Media Contact
KOGS
Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com
4SC AG
+49 89 700763 0
ir-pr@4sc.com
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SOURCE Immunic, Inc.