Full Press Release Details
Bio Transforms GI-Focused Pipeline Through Exclusive Worldwide Licensing Agreement with Giiant Pharma, Inc. for Multiple Oral Drug Candidates
Targeting Inflammatory Bowel Disease
Lead program, GT-2108 for the treatment of moderate-to-severe ulcerative colitis advancing toward completion of I ND-enabling studies
with IND filing expected by Q3 2024
Inflammatory bowel disease (IBD) represents a multi-billion dollar market opportunity with current therapies achieving a clinical remission
rate of less than 20% on average
CA - September 6, 2023 - Palisade Bio, Inc. (Nasdaq: PALI) ("Palisade" or the "Company"),
a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced that it has
entered into a licensing agreement with Giiant Pharma, Inc. ("Giiant"). The license provides the Company with the exclusive
worldwide rights to develop, manufacture and commercialize Giiant's proprietary targeted prodrug platform focused on therapies
for the multi-billion dollar IBD market. The licensed technologies include Giiant's precision delivery technology platform and
multiple product candidates, including the lead asset in development, GT-2108, an orally administered, gut-restricted, colon-specific
phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by moderate-to-severe ulcerative colitis. The license
also includes the rights to GT-1908, which is anticipated to be developed by the Company as a second program, targeting fibro stenotic
Crohn's Disease by means of an oral PDE4 compound.
the terms of the license, Palisade obtained the rights to develop, manufacture, and commercialize all compounds from Giiant, existing
now and in the future, and any product containing or delivering any licensed compound, in any formulation or dosage for all human and
non-human therapeutic uses for any and all indications worldwide. Pursuant to the terms of the license, Palisade will pay a portion of
the development costs until the first approval of an IND or CTA (Canadian clinical trial approval), and will thereafter assume all development,
manufacturing, and commercialization costs. Additionally, per the license, Palisade will pay (i) certain milestone payments (in cash
or stock at Palisade's election) and (ii) royalty payments based on sales.
are incredibly pleased to enter into this licensing agreement with Giiant and transform our GI-focused development pipeline. With current
IBD therapies achieving minimal rates of efficacy, there remains a strong need for orally administered, novel solutions that overcome
the limitations of current biological medications. We believe the unique mechanism of lead program GT-2108, which enables it to achieve
highly localized GI activity, coupled with an established regulatory pathway, provides a unique partnering opportunity in the IBD space.
Additionally, this utilizes the capacity of our experienced team, and adds multiple value-driving milestones in the near and long term,"
commented J.D. Finley, Chief Executive Officer of Palisade Bio. "This transaction underscores our commitment to our corporate mission
of improving gastrointestinal health and represents an exciting acceleration in our focus to advance innovative therapeutics for the
by external validation and funding by the US Crohn's and Colitis Foundation, we strongly believe in the potential of our technology
platform and the opportunity to address the unmet medical needs in the treatment of IBD. Palisade Bio has an established GI-focused mission,
experienced leadership team and strong balance sheet representing the perfect synergistic partner to take our technology and oral IBD
assets to the next level. We look forward to working alongside the Palisade Bio team to advance the development of these important programs
and realize their full potential," added Christophe Mellon, Ph.D., Giiant's Chief Executive Officer.
previously announced by Giiant, the development of GT-2108 is supported by a $500,000 grant received from the US Crohn's and Colitis
Foundation, through its IBD Ventures program.
Pharma (www.giiant.com), a preclinical-stage biotech company, designs gut-restricted small molecule, drug therapeutics with various
biological targets in gastroenterology owing to its proprietary Precision Delivery technology platform. Its first lead program GT-2108
is a microbiota-activated PDE4 inhibitor prodrug, with vastly improved drug tolerability and enhanced therapeutic effect.
Bio is a biopharmaceutical company focused on developing therapeutics that protect the integrity of the intestinal barrier. The Company
utilizes over three decades of research and established science that links the role of intestinal barrier biology with human disease
to advance novel therapeutics that target and improve the integrity of the intestinal barrier.
Company believes that addressing the disruption of the intestinal barrier can fundamentally change the way diseases are treated and establish
new standards of patient care. For more information, please go to www.palisadebio.com.
communication contains "forward-looking" statements for purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company's intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other things: the extent of our cash runway; our ability to successfully
develop our licensed technologies; estimates about the size and growth potential of the markets for our product candidates, and our ability
to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes or developments
in the United States (U.S.) and foreign countries and the impact of these changes; our ability to build a commercial infrastructure in
the U.S. and other markets; our ability to compete effectively in a competitive industry; our ability to identify and qualify additional
manufacturers to provide API and manufacture drug product; our ability to enter into commercial supply agreements; the success of competing
technologies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy
of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain
funding for our operations; our ability to attract collaborators and strategic partnerships; and the impact of the COVID-19 pandemic
on our business, and operations, and supply. Any statements contained in this communication that are not statements of historical fact
may be deemed to be forward-looking statements. These forward-looking statements are based upon the Company's current expectations.
Forward-looking statements involve risks and uncertainties. The Company's actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without
limitation, the Company's ability to advance its clinical programs, the uncertain and time-consuming regulatory approval process;
and the Company's ability to achieve additional financing to fund future operations. Additional risks and uncertainties can be
found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange
Commission ("SEC") on March 22, 2023 as well as the Company's Quarterly Report on Form 10-Q, for the six months period
ended June 30, 2023, filed with the SEC on August 10, 2023. These forward-looking statements speak only as of the date hereof and the
Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or
circumstances on which any such statements are based.
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