- Landos' lead asset, NX-13, is a first-in-class, oral NLRX1
agonist in Phase 2 for the treatment of ulcerative colitis
(UC)
NORTH CHICAGO, Ill. and
NEW YORK, March 25, 2024 /PRNewswire/ -- AbbVie Inc. (NYSE:
ABBV) ("AbbVie") and Landos Biopharma, Inc. (NASDAQ: LABP)
("Landos") today announced a definitive agreement under which
AbbVie will acquire Landos, a clinical stage biopharmaceutical
company focused on the development of novel, oral therapeutics for
patients with autoimmune diseases. Landos' lead investigational
asset is NX-13, a first-in-class, oral NLRX1 agonist (a member of
the NOD-like receptor family) with a bimodal mechanism of action
(MOA), which is anti-inflammatory and facilitates epithelial
repair.
"With this acquisition, we aim to advance the clinical
development of NX-13, a differentiated, first-in-class, oral asset
with the potential to make a difference in the lives of people
living with ulcerative colitis and Crohn's disease," said
Roopal Thakkar, M.D., senior vice
president, chief medical officer, global therapeutics, AbbVie.
"This announcement is a testament to Landos' talented team and
their commitment to our mission of creating oral treatments that
can address a therapeutic gap," said Gregory Oakes, president and chief executive
officer, Landos. "NX-13 and its bimodal MOA have the potential to
provide a novel approach to the treatment of ulcerative colitis and
Crohn's disease. With AbbVie's therapeutic area leadership and
expertise in global development, they are the right company to
further advance NX-13."
NLRX1 regulates immunometabolism and inflammation, and its
activation impacts multiple mechanisms of inflammatory bowel
disease (IBD) pathogenesis. The randomized controlled Phase 2
NEXUS clinical trial evaluating NX-13 in UC is currently enrolling
patients in the United States and
Europe (NCT05785715).
Under the terms of the agreement, AbbVie will acquire Landos at
a price of $20.42 per share in cash
upon closing, or approximately $137.5
million in the aggregate, plus one non-tradable contingent
value right per share with a value of up to $11.14 per share, or approximately an additional
$75 million in the aggregate, subject
to the achievement of a clinical development milestone. The
proposed transaction is expected to close in the second calendar
quarter of 2024, subject to customary closing conditions, including
approval by Landos' stockholders.
About the NEXUS Study
NEXUS is a Phase 2 proof-of-concept clinical trial evaluating
NX-13 in patients with moderate to severe UC. NEXUS is a
randomized, multicenter, double-blind, placebo-controlled, multiple
dose, 12-week induction study evaluating 80 patients with moderate
to severe UC with a long-term extension (LTE) period. All subjects
will be randomized to receive either 250 mg or 750 mg immediate
release NX-13, or placebo. The primary objective of the trial will
be to evaluate the clinical efficacy, safety and pharmacokinetics
of oral NX-13 versus placebo (NCT05785715 ClinicalTrials.gov).
Advisors
AbbVie's legal advisor is Paul, Weiss, Rifkind, Wharton &
Garrison LLP. Landos' financial advisor is Jefferies LLC
and Cooley LLP is serving as legal advisor.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions that solve serious health issues today and address
the medical challenges of tomorrow. AbbVie strives to have a
remarkable impact on people's lives across several key therapeutic
areas – immunology, oncology, neuroscience, and eye care – and
products and services in AbbVie's Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X
(formerly Twitter), and YouTube.
About Landos Biopharma
Landos Biopharma is a clinical stage biopharmaceutical company
focused on the development of first-in-class, oral therapeutics for
patients with autoimmune diseases. Its mission is to create safe
and effective oral treatments that address the therapeutic gap in
the current treatment paradigm.
Landos has a portfolio of novel targets anchoring two libraries
of immunometabolic modulation pathways, including four potentially
first-in-class, once-daily, oral therapies targeting multiple
indications in the immunology space.
Landos is currently focused on advancing the clinical
development of NX-13 in UC. Landos initiated the NEXUS Phase 2
proof-of-concept trial (NCT05785715) in the second quarter of 2023
and plans to report topline results in the fourth quarter of
2024.
For more information, please
visit www.landosbiopharma.com.
No Offer or Solicitation
This press release is for information purposes only and is not
intended to and does not constitute, or form part of, an offer,
invitation or the solicitation of an offer or invitation to
purchase, otherwise acquire, subscribe for, sell or otherwise
dispose of any securities, or the solicitation of any vote or
approval in any jurisdiction, pursuant to the proposed transaction
or otherwise, nor shall there be any sale, issuance or transfer of
securities in any jurisdiction in contravention of applicable
law.
Forward-Looking Statements
Some statements in this news release, and documents
referred to in this news release, are, or may be
considered, forward-looking statements for purposes of the Private
Securities Litigation Reform Act of 1995. The words "believe,"
"expect," "anticipate," "project" and similar expressions and uses
of future or conditional verbs, generally identify forward-looking
statements. AbbVie and Landos caution that these forward-looking
statements are subject to risks and uncertainties that may cause
actual results to differ materially from those expressed or implied
in the forward-looking statements. Such risks and uncertainties
include: (i) the risk that the proposed transaction may not
be completed in a timely manner or at all, (ii) the satisfaction
(or waiver) of the conditions to the consummation of the proposed
transaction, including with respect to the adoption of the
definitive agreement by the stockholders of Landos and required
regulatory approvals, (iii) potential delays in consummating the
proposed transaction, (iv) the occurrence of any event, change or
other circumstance that could give rise to the termination of the
definitive agreement, (v) the effect of the announcement or
pendency of the proposed transaction on Landos' business
relationships, operating results, and business generally, (vi)
risks that the proposed transaction disrupts current plans and
operations of the parties and potential difficulties in Landos'
employee retention as a result of the proposed transaction, (vii)
risks related to diverting management's attention from Landos'
ongoing business operations, (viii) the outcome of any legal
proceedings that may be instituted against the parties or their
respective directors or officers related to the proposed
transaction, (ix) challenges to intellectual property, (x)
competition from other products, (xi) difficulties inherent in the
research and development process, (xii) adverse litigation or
government action, and (xiii) changes to laws and regulations
applicable to the industries of the parties. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's and Landos' operations is
set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual
Report on Form 10-K which has been filed with the Securities and
Exchange Commission, as updated by its subsequent Quarterly Reports
on Form 10-Q and Item 1A, "Risk Factors," of Landos' 2023 Annual
Report on Form 10-K, which has been filed with the Securities and
Exchange Commission, as updated by its subsequent Quarterly Reports
on Form 10-Q. Such filings identify and address other
important risks and uncertainties that could cause actual events
and results to differ materially from those contained in the
forward-looking statements. Forward-looking statements speak only
as of the date they are made. Readers are cautioned not to put
undue reliance on forward-looking statements, and neither
AbbVie nor Landos undertakes any obligation, and each specifically
declines, to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
Additional Information and Where to Find It
In connection with the proposed transaction, Landos will be
filing relevant documents with the SEC, including preliminary and
definitive proxy statements on Schedule 14A relating to the
proposed transaction. The definitive proxy statement will be sent
to Landos' stockholders in connection with the proposed
transaction. This news release is not a substitute for the proxy
statement or any other document that may be filed by Landos with
the SEC. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND
SECURITY HOLDERS ARE URGED TO READ THE PRELIMINARY AND DEFINITIVE
PROXY STATEMENTS AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC
IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY
REFERENCE IN THE PROXY STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTION. Any vote in respect of resolutions to be proposed
at Landos' special stockholder meeting to approve the proposed
transaction or other responses in relation to the proposed
transaction should be made only on the basis of the information
contained in Landos' proxy statement. Investors and security
holders will be able to obtain free copies of these documents (when
they are available) and other related documents filed with the SEC
at the SEC's web site at www.sec.gov, on Landos' website at
https://ir.landosbiopharma.com, or by contacting Landos at
ir@landosbiopharma.com.
Participants in the Solicitation
Landos and certain of its directors, executive officers and
employees and other persons may be deemed to be participants in
soliciting proxies from its stockholders in connection with the
proposed acquisition. Information regarding the interests of
Landos' directors and executive officers and their ownership of
Landos' stock is set forth in Landos' proxy statement on Schedule
14A for its 2023 Annual Meeting of Stockholders, which was filed
with the SEC on April 19, 2023.
Additional information regarding the persons who may, under the
rules of the SEC, be considered to be participants in the
solicitation of Landos' shareholders in connection with the
proposed acquisition and any direct or indirect interests
they may have in the proposed acquisition will be set
forth in Landos' definitive proxy statement for its special
shareholder meeting when it is filed with the SEC. To the
extent that Landos' directors and executive officers and their
respective affiliates have acquired or disposed of security
holdings since the "as of" date indicated in the 2023 Proxy
Statement, such transactions have been or will be reflected on
Statements of Change in Ownership on Form 4 or amendments to
beneficial ownership reports on Schedule 13D filed with the
SEC.
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SOURCE AbbVie