Landos Biopharma, Inc. (NASDAQ: LABP) (“Landos” or the “Company”),
a clinical-stage biopharmaceutical company developing novel, oral
medicines for patients with autoimmune diseases, today announced
the transfer of its LANCL portfolio, including Omilancor, LABP-104
and LABP-111 to Dr. Josep Bassaganya-Riera, Ph.D., the founder of
Landos who previously served as its Chairman, President and CEO,
and certain affiliated individuals and entities.
Under the terms of the transaction, the Company will repurchase
approximately [9.1] million Landos shares previously held by Dr.
Bassaganya-Riera and certain affiliated individuals and entities,
representing approximately 23% of Landos’ outstanding shares, for
$3.0 million in cash and assign exclusive global rights to develop,
manufacture and commercialize the LANCL portfolio, including
Omilancor, LABP-104, and LABP-111 to Dr. Bassaganya-Riera and
certain affiliated individuals and entities. Additionally, the
parties have entered into a royalty agreement whereby Landos will
receive a 6% royalty on future commercial sales from any approved
products developed from the LANCL portfolio and Dr.
Bassaganya-Riera and certain affiliated individuals and entities
will receive a 2% royalty on future sales from NX-13, LABP-73,
LABP-66, and LABP-69, if approved. The parties have also agreed to
a mutual, general release of liabilities and claims.
The transaction follows a comprehensive strategic review of the
Landos portfolio. Based on this review, the Landos leadership team
and Board of Directors believe that the transaction with Dr.
Bassaganya-Riera maximizes long-term value for Landos shareholders,
including:
- Enhanced focus on advancing the
clinical development of NX-13, a novel, oral, gut-selective NLRX1
agonist as a once-daily treatment for Ulcerative Colitis (“UC”),
through a Phase 2 proof-of-concept trial;
- Continued participation in future
upside of the LANCL portfolio through the 6% royalty on future
sales of Omilancor, LABP-104 and LABP-111, if approved;
- Improved capital structure through
the acquisition and retirement of approximately [9.1] million
Landos shares previously held by Dr. Bassaganya-Riera and certain
affiliated individuals and entities, representing approximately 23%
of Landos’ outstanding shares; and
- Mutual, general release of
liabilities and claims.
“This transaction is consistent with the strategic plan we
announced last month to focus our resources on advancing the
clinical development of NX-13,” said Gregory Oakes, President and
Chief Executive Officer of Landos. “We have engaged with potential
partners over the past year and based on the interest received, as
well as Dr. Bassaganya-Riera’s previous role in developing these
assets, we believe this transaction is the best path forward to
maximize the value of the LANCL portfolio. This provides a
potential developmental path for programs that we were not
prioritizing at this time, while delivering compelling value to our
shareholders, including potential future upside tied to the
commercialization of these programs.”
“This transaction further sharpens our focus on advancing NX-13
and we look forward to sharing additional details about our Phase 2
proof-of-concept clinical trial in moderate-to-severe UC patients,
which will be dose-ranging, blinded, placebo-controlled, and
statistically powered. As we noted in January, our goal is to
generate as much meaningful data as possible, as quickly as
possible, to build on our already impressive data foundation. We
are on track for first site activation and patient enrollment next
quarter and look forward to reporting topline data by the fourth
quarter of 2024,” continued Mr. Oakes.
Landos will continue with the exclusive collaboration and
license agreement with LianBio for the development and
commercialization of NX-13 in Greater China, including mainland
China, Hong Kong, Taiwan, and Macau, as well as other select Asian
markets.
Cooley LLP served as legal advisor to Landos in connection with
the transaction. Eilenberg & Krause LLP served as legal advisor
to Dr. Bassaganya-Riera.
Enhanced Focus on NX-13 with Significant Optionality for
Broader Pipeline
Consistent with Landos’ strategic update in January 2023, this
transaction streamlines the Company’s portfolio, enhancing its
focus and resources on advancing NX-13.
Landos previously announced top-line results from its NX-13
Phase 1b trial in UC patients in August 2022. The data showed
favorable safety and tolerability profiles across a range of doses,
as well as signals of clinical improvement as soon as two weeks in
patients’ symptoms and four weeks by endoscopy in exploratory
endpoints. NX-13, with its unique mechanism of action, favorable
safety profile, once-daily dosing, and promising early clinical
data, could potentially transform the current UC treatment
paradigm.
Following this transaction, the Company will have three novel,
pre-clinical programs in its portfolio, including:
LABP-69, a novel PLXCD2 agonist in development for
the treatment of Rheumatoid Arthritis and Diabetic Nephropathy;
LABP-66, a novel NLRX1 agonist in development for
the treatment of Multiple Sclerosis, Alzheimer's Disease, and other
debilitating central nervous system diseases; and
LABP-73, a novel NLRX1 agonist in development for
the treatment of Asthma and Chronic Obstructive Pulmonary
Disease.
About Landos Biopharma
Landos Biopharma is a clinical stage biopharmaceutical company
focused on the development of first-in-class therapeutics for
patients with autoimmune disease. The Company’s mission is to
create safer and more effective 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 therapies targeting eight indications in
the immunology space.
The Company is currently focused on advancing the clinical
development of NX-13 in UC, and is on-track to initiate a Phase 2
proof-of-concept trial in the second quarter of 2023.
For more information, please visit www.landosbiopharma.com.
Cautionary Note on Forward-Looking
Statements
Statements in this press release about future expectations,
plans and prospects for Landos Biopharma, Inc. (the “Company”),
including statements about the Company’s strategy, clinical
development and regulatory plans for its product candidates and
other statements containing the words “anticipate”, “plan”,
“expect”, “may”, “will”, “could”, “believe”, “look forward”,
“potential”, the negatives thereof, variations thereon and similar
expressions, or any discussions of strategy constitute
forward-looking statements. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors, including: the uncertainties inherent
in the initiation and enrollment of future clinical trials,
including the planned Phase 2 trial of NX-13, availability and
timing of data from ongoing clinical trials, expectations for
regulatory approvals, other matters that could affect the
availability or commercial potential of the Company’s product
candidates, the ability of Dr. Bassaganya-Riera and certain
affiliated individuals and entities to successfully develop and
commercialize the LANCL platform in order for Landos to receive
royalties on sales of such products, and other similar risks. Risks
regarding the Company’s business are described in detail in its
Securities and Exchange Commission (“SEC”) filings, including in
its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q,
which are available on the SEC’s website at www.sec.gov. Additional
information will be made available in other filings that the
Company makes from time to time with the SEC. Such risks may be
amplified by the impacts of the COVID-19 pandemic. In addition, the
forward-looking statements included in this press release represent
the Company’s views only as of the date hereof. The Company
anticipates that subsequent events and developments will cause the
Company’s views to change. However, while the Company may elect to
update these forward-looking statements at some point in the
future, the Company specifically disclaims any obligation to do so,
except as may be required by law. These forward-looking statements
should not be relied upon as representing the Company’s views as of
any date subsequent to the date hereof.
Investor ContactPatrick Truesdell, Principal
Accounting OfficerLandos Biopharmair@landosbiopharma.com
Media ContactTanner Kaufman / Kara SperryJoele
Frank, Wilkinson Brimmer Katcher212-355-4449
Landos Biopharma (NASDAQ:LABP)
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