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Palisade Bio Receives Intention to Grant from European Patent Office for LB1148 Patent

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Palisade Bio, a clinical-stage biopharmaceutical company, announced that the European Patent Office intends to grant a patent for its application titled “Administration of Serine Protease Inhibitors to the Stomach,” expected in H2 2023. This patent supports their lead program, LB1148, which has shown promise in reducing post-surgical abdominal adhesions and improving gastrointestinal function. The company aims to fortify its global intellectual property portfolio with additional patent submissions. Clinical studies for LB1148 are ongoing, with topline data anticipated in the first half of 2023.

Positive
  • Issuance of European Patent Office's intention to grant a patent for LB1148, expected in H2 2023.
  • LB1148 demonstrated positive results in reducing post-surgical abdominal adhesions.
  • Ongoing Phase 2 study of LB1148 expected to report topline data in the first half of 2023.
Negative
  • Regulatory approval process for LB1148 remains uncertain and time-consuming.
  • Risks associated with future clinical program advancements and financing.

Carlsbad, CA, March 01, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (the “Company”), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced that European Patent Office (EPO) has issued a notice of intention to grant for its patent application titled, “Administration of Serine Protease Inhibitors to the Stomach.” Based on the intention to grant notice, the Company expects the EPO to issue a patent in the second half of 2023.

In addition to this European patent, the Company continues to bolster its global intellectual property portfolio surrounding LB1148 with submitted and planned submissions of additional patent applications.

“We are pleased to receive this encouraging feedback from the EPO for our LB1148 patent and look forward to adding a granted patent to our growing IP portfolio. We believe LB1148 represents a global opportunity and are therefore committed to bolstering its global IP protection as we continue to advance the development of LB1148 for treatment in reducing post-surgical abdominal adhesions,” commented J.D. Finley, interim Chief Executive Officer of Palisade Bio.

The patent application, with application number 19209258, for which the EPO has issued an Intention to Grant notice, relates to Palisade Bio’s proprietary compositions for oral administration. The applications contains allowed claims directed to liquid formulations, along with additional claims directed to the use of these formulations in treating shock, a life-threatening complication in situations associated with trauma including burns, surgery, ischemia, sepsis, and other critical care applications.

In clinical studies, the Company’s lead program, LB1148 has demonstrated promising results in reducing the incidence and severity of post-surgical abdominal adhesions and accelerating the time to return of postoperative bowel function. LB1148 is currently being evaluated in a Phase 2 study for its effectiveness in reducing intra-abdominal adhesions, accelerating return of gastrointestinal function, and the prevention of post-operative ileus in subjects undergoing elective bowel resection (PROFILE). Palisade expects to report topline data in the first half of 2023.

About Palisade Bio 
Palisade 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 and human disease to develop novel therapeutics that target and improve the integrity of the intestinal barrier.

The Company’s lead program, LB1148, is a broad-spectrum serine protease inhibitor that acts to neutralize digestive enzymes, potentially reducing intestinal damage. In clinical studies, LB1148 has demonstrated positive results in reducing the incidence and severity of post-surgical abdominal adhesions and potentially accelerating the time to return of postoperative bowel function. LB1148’s current Phase 2 study is evaluating its effectiveness in reducing intra-abdominal adhesions, accelerating return of gastrointestinal function, and the prevention of post-operative ileus in subjects undergoing elective bowel resection (PROFILE).

The 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.

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: progress of studies, including opening additional clinical trial sites, timing of results or data, progress and completion of patient enrollment, including timing thereof and the Company’s co-development partner’s expectation to complete enrollment; regulatory progress and strategy, including potential registration and commercialization of LB1148; the extent of the cash runway; the closing of the underwritten public offering; and expected proceeds from financings. 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; the Company’s ability to achieve additional financing to fund future operations and the Company’s ability to comply with the continued listing requirements for Nasdaq. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed with the SEC on November 14, 2022, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. 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 significance of the patent for Palisade Bio (PALI)?

The European Patent Office's intention to grant a patent for LB1148 strengthens Palisade Bio's intellectual property portfolio, enhancing market opportunities.

When does Palisade Bio expect to report topline data for LB1148?

Palisade Bio expects to report topline data for LB1148 in the first half of 2023.

What are the clinical benefits of LB1148 according to the recent press release?

LB1148 has shown promise in reducing post-surgical abdominal adhesions and accelerating gastrointestinal function return.

What risks did Palisade Bio mention regarding its clinical studies?

Palisade Bio highlighted the uncertain and time-consuming nature of the regulatory approval process as a risk.

What is the application number for the patent related to LB1148?

The application number for the patent related to LB1148 is 19209258.

Palisade Bio, Inc.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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