NEW
YORK, Jan. 5, 2024 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX) ("Immunic" or the "Company"), a
biotechnology company developing a clinical pipeline of orally
administered, small molecule therapies for chronic inflammatory and
autoimmune diseases, today announced it has entered into a
securities purchase agreement with select accredited investors to
purchase shares of common stock (or pre-funded warrants in lieu
thereof) in a three-tranche offering.
The first tranche is an upfront payment of $80 million at $1.43 per share, which is expected to close on
January 8, 2024, subject to customary
closing conditions. The second tranche is a mandatory purchase of
an additional $80 million of shares
of common stock (or pre-funded warrants) at $1.716 per share, representing 120% of the first
tranche purchase price and is conditioned on the announcement of
phase 2b topline data for the
Company's vidofludimus calcium (IMU-838) progressive multiple
sclerosis clinical trial, volume weighted average share price
levels, and minimum trading volumes. A third tranche, to occur no
later than three years after the second tranche, provides for the
issuance of $80 million of shares of
common stock (or pre-funded warrants in lieu thereof) at the same
price per share as the second tranche, but permits investors to
fund their purchase obligations on a "cashless" or net settlement
basis, which would reduce the proceeds to be raised in the
financing. The third tranche is conditioned on the same volume
weighted average share price levels and minimum trading volumes as
the second tranche. Assuming that the second tranche is exercised,
and depending on the extent to which the investors elect to fund
the third tranche through a net settlement basis, total gross
proceeds from the offering to the Company would be between
$160 and $240
million.
The financing is being led by BVF Partners L.P., and includes
participation from new and existing investors, including Avidity
Partners, Janus Henderson Investors, Soleus Capital, RTW
Investments and Adage Capital Partners LP.
The Company is obligated to register for resale by the investors
all of the shares of common stock issued in the offering and the
shares of common stock issuable on exercise of the pre-funded
warrants.
Leerink Partners is acting as the lead placement agent and
Ladenburg Thalmann is acting as a placement agent in connection
with the financing. Piper Sandler,
B. Riley Securities and Brookline Capital Markets, a division of
Arcadia Securities, LLC, are acting as capital markets advisors to
the Company.
The Company intends to use the net proceeds from the private
placement to fund the ongoing clinical development of its three
lead product candidates, vidofludimus calcium (IMU-838), IMU-856
and IMU-381, and for other general corporate purposes. The proceeds
from the first tranche of this private placement, combined with
current cash, cash equivalents and marketable securities, is
expected to fund operating and capital expenditures into the third
quarter of 2025.
The securities to be sold in this offering, including the shares
of common stock issuable on exercise of the pre-funded warrants,
have not been registered under the Securities Act of 1933, as
amended (the "Securities Act"), or the securities laws of any state
or other jurisdiction and may not be offered or sold in
the United States absent
registration or an applicable exemption from the registration
requirements of the Securities Act and applicable state or other
jurisdictions' securities laws. Immunic has agreed to file a
registration statement with the U.S. Securities and Exchange
Commission registering the resale of the securities issued in the
private placement. Any offering of the securities under the resale
registration statement will only be made by means of a
prospectus.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy, nor will there be any sales of
these securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of such jurisdiction.
About Immunic, Inc.
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, for which 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.
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 expected future
events, including the closing of each tranche of the Company's
private placement financing, the timely funding to the Company by
each investor in the private placement, strategy, future
operations, future financial position, future revenue, projected
expenses, sufficiency of cash, expected timing 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 expected timing and
funding to the Company from the private placement, Immunic's
development programs and the targeted diseases; the potential for
Immunic's development programs to safely and effectively target
diseases; interpretation of preclinical and clinical data for
Immunic's development programs and potential effects; 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, impacts of the Ukraine – Russia conflict and the conflict in the
Middle East on clinical trials,
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
financial and other resources to meet business objectives and
operational requirements, the fact that the results of earlier
preclinical studies and clinical 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, 2022, filed with
the SEC on February 23, 2023, and in
the company's subsequent filings with the SEC. 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
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com
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SOURCE Immunic, Inc.