Palisade Bio Successfully Demonstrates Bioactivation of PALI-2108 In Ex-Vivo Study of Normal Healthy and Ulcerative Colitis Patients’ Stool

Palisade Bio Successfully Demonstrates Bioactivation of PALI-2108 In Ex-Vivo Study of Normal Healthy and Ulcerative Colitis Patients’ Stool

April 16, 2024

Investors  /  All Press Releases

Company continues advancing ongoing development of targeted therapies for ulcerative colitis (UC)

Carlsbad, CA, April 16, 2024 — Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, announced today the successful completion of its analysis evaluating ex-vivo bioactivation of PALI-2108, an orally administered, locally acting colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug in development for patients affected by UC.

These findings demonstrated that PALI-2108 exhibited efficient ex-vivo conversion into its active PDE4 inhibitor form in stool samples from both normal healthy volunteers and patients with UC. The enzymatic activity in stool samples was assessed using LC-MS analysis with all stool samples meeting the target conversion rate within a 24-hour period. The assessment showed PALI-2108 was converted into its active PDE4 inhibitor form at a mean rate of 90.1% with conversion steadily increasing over time. The study was conducted in collaboration with Altasciences based in Montreal, QC.

“The results from this study underscore our confidence in PALI-2108 as a targeted treatment for moderate-to-severe UC,” said Dr. Mitch Jones, CMO at Palisade Bio. “The successful bioactivation of prodrug PALI-2108 into its active PDE4 inhibitor form at consistently high conversion rates over a 24-hour period in stool samples highlights its promise as an innovative therapeutic approach for managing UC.”

About Palisade Bio

Palisade Bio is a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com.

Forward Looking Statements

This 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 maintain the Nasdaq listing of our securities; 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 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 or any global event 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 nonclinical and clinical programs, the uncertain and time-consuming regulatory approval process; and the Company’s ability to secure additional financing to fund future operations and development of its product candidates. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024. 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.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
833-475-8247
PALI@jtcir.com


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