• 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

Carlsbad, CA – September 5, 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.

Under 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.

“We 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, provide 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 Palisade Bio 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 treatment of IBD.”

“Supported 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.

As 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.