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Palisade Bio Announces Receipt of Second Milestone Payment from the US Crohn’s and Colitis Foundation for Development of PALI-2108

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Palisade Bio, Inc. (Nasdaq: PALI) receives second milestone payment for co-development partner Giiant Pharma, Inc. from the US Crohn’s and Colitis Foundation for the treatment of moderate-to-severe ulcerative colitis (UC).
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The funding received by Giiant Pharma from the US Crohn's and Colitis Foundation is a strategic financial catalyst for Palisade Bio's lead program, PALI-2108. The grant not only provides non-dilutive capital, enhancing the company's financial position without impacting shareholder equity, but also serves as an endorsement of the program's potential. Investors should note that such grants can accelerate development timelines, potentially bringing the product to market sooner. However, the actual impact on Palisade's stock will depend on further clinical results and regulatory milestones, such as the IND filing expected by Q3 2024.

From a medical research perspective, the progression of PALI-2108, a PDE4B inhibitor prodrug, is significant for the ulcerative colitis therapeutic market. This class of drugs works by modulating inflammatory pathways, which could offer a novel treatment modality for UC patients. The milestone payment signifies progress in the drug's development pathway, but the efficacy and safety profile will be critical to its success. Potential benefits for patients include improved disease management and quality of life, while risks involve unforeseen adverse effects that could emerge during clinical trials.

Ulcerative colitis is a chronic condition affecting millions globally, representing a substantial market for effective treatments. The advancement of PALI-2108 could meet a significant unmet need in the GI therapeutic space. As the drug moves closer to clinical trials, it will be important to monitor the competitive landscape and payer receptivity to new treatment options. Market adoption will hinge on the drug's comparative effectiveness and cost-effectiveness. The long-term impact on Palisade's market share and revenue will be contingent on these factors, as well as on strategic partnerships and marketing.

- Company’s co-development partner, Giiant Pharma, Inc. (“Giiant”), receives funding as part of previously announced grant from the US Crohn’s and Colitis Foundation

- Lead program, PALI-2108 for the treatment of moderate-to-severe ulcerative colitis (UC) advancing toward completion of IND-enabling studies with IND filing expected by Q3 2024

Carlsbad, CA, Dec. 28, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc.  (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today announced the receipt of the second milestone payment to Giiant from the US Crohn’s and Colitis Foundation, through its Inflammatory Bowel Disease (IBD) Ventures program.

“We are grateful for the continued support of the Foundation and remain steadfast in our commitment to advance the treatment landscape for IBD. We are encouraged by the potential of PALI-2108 and view this milestone payment from the US Crohn’s and Colitis Foundation as further validation of our precision approach for IBD treatment. Our team continues to drive the clinical development of PALI-2108 toward the launch of a Phase 1 clinical study, which is on track for next year,” commented J.D. Finley, Chief Executive Officer of Palisade.

The previously announced US Crohn’s and Colitis Foundation research program funding agreement with Giiant of up to US$ 500,000 will support the development of the Company’s lead program, PALI-2108, an orally administered, locally acting colon-specific phosphodiesterase-4B (PDE4B) inhibitor prodrug in development for patients affected by moderate-to-severely active UC.

About the Crohn's & Colitis Foundation

The Crohn's & Colitis Foundation is the leading non-profit organization focused on both research and patient support for inflammatory bowel disease (IBD), with the mission of curing Crohn's disease and ulcerative colitis, and of improving the quality of life of the millions of Americans living with IBD. The Foundation’s work is dramatically accelerating the research process through investment in research initiatives, while also providing extensive educational and support resources for patients and their families, medical professionals, and the public. For more information, visit www.crohnscolitisfoundation.org, call 888-694-8872, or email info@crohnscolitisfoundation.org.

About Palisade Bio

Palisade Bio is a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal 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, 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 three and nine month periods ended September 30, 2023, filed with the SEC on November 9, 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.

Investor Relations Contact

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

Source: Palisade Bio


FAQ

What is the company name and ticker symbol of the biopharmaceutical company receiving the milestone payment for the treatment of UC?

Palisade Bio, Inc. (Nasdaq: PALI) is the biopharmaceutical company receiving the milestone payment for the treatment of UC.

What is the lead program being developed by Palisade Bio, Inc. for the treatment of UC?

The lead program being developed by Palisade Bio, Inc. for the treatment of UC is PALI-2108, an orally administered, locally acting colon-specific phosphodiesterase-4B (PDE4B) inhibitor prodrug.

What is the funding amount provided by the US Crohn’s and Colitis Foundation to Giiant for the development of PALI-2108?

The US Crohn’s and Colitis Foundation has provided funding of up to US$ 500,000 to Giiant for the development of PALI-2108.

When is the IND filing expected for PALI-2108?

The IND filing for PALI-2108 is expected by Q3 2024.

Who is the Chief Executive Officer of Palisade Bio, Inc.?

J.D. Finley is the Chief Executive Officer of Palisade Bio, Inc.

Palisade Bio, Inc.

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