Palisade Bio Provides Corporate Update and Reiterates Guidance
Palisade Bio, Inc. announces a strategic streamlining of the Board to align with current clinical development and corporate vision. The company is advancing PALI-2108 for the treatment of moderate-to-severe ulcerative colitis towards a Phase 1 clinical study, with significant progress in various areas.
Positive
Formation of Clinical Advisory Board with renowned Key Opinion Leaders
Exercise of common stock warrants generating $2.5 million
Positive preclinical data presentation of lead asset, PALI-2108
Receipt of milestone payment from joint development partner, Giiant Pharma, Inc.
The recent corporate update from Palisade Bio, Inc. indicates a strategic realignment of its Board of Directors and progress in the development of PALI-2108, a treatment for ulcerative colitis. The streamlining of the board from 8 to 4 members, while maintaining diversity, is a move typically aimed at improving decision-making efficiency and reducing overhead costs. This change, coupled with the company's focus on a precision medicine approach, may be seen as a positive signal by investors.
The financial implications of the exercised common stock warrants, resulting in $2.5 million in gross proceeds, provide the company with additional capital. This capital inflow is crucial for funding ongoing research and development activities, particularly as the company approaches significant milestones such as the submission of an IND/CTA and the initiation of Phase 1 clinical studies. These developments are likely to be closely monitored by investors as they can significantly affect the company's valuation and future funding requirements.
PALI-2108's advancement towards Phase 1 clinical study represents a critical step in Palisade Bio's pipeline. As a locally acting colon-specific PDE4B inhibitor prodrug, PALI-2108 could offer a novel therapeutic option for patients with moderate-to-severe ulcerative colitis. The emphasis on a precision medicine approach suggests that the treatment may be tailored to individual patient profiles, potentially improving efficacy and safety outcomes.
The positive preclinical data presented at the Crohn's & Colitis Congress provides preliminary validation of the drug's potential, which is essential for attracting further investment and partnerships. The receipt of a milestone payment from the US Crohn's and Colitis Foundation through its IBD Ventures program also reflects external confidence in the drug's development and may help mitigate some of the financial risks associated with the drug's R&D.
The strategic changes within Palisade Bio's board and the progress of their lead asset PALI-2108 could have a considerable impact on the company's market positioning. The biopharmaceutical sector, especially within the GI disease domain, is highly competitive and the ability to streamline operations can provide a significant advantage. The focus on a precision medicine approach aligns with current industry trends towards personalized healthcare solutions, which could increase the marketability of PALI-2108 if successful.
Investors and competitors will be interested in the upcoming milestones, as the transition from preclinical to clinical stages often serves as a significant valuation inflection point for biotech companies. The anticipation of these milestones could influence the company's stock volatility as the market responds to each development. Additionally, the strategic appointments of Key Opinion Leaders Bruce Sands, MD, MS and Floria Rieder, MD, to the Clinical Advisory Board could enhance credibility and attract attention from stakeholders within the medical community.
02/13/2024 - 08:35 AM
– Company announces strategic streamlining of Board to align with the current state of clinical development and corporate vision
– Advancement of PALI-2108 for the treatment of moderate-to-severe ulcerative colitis (UC) toward Phase 1 clinical study; first in human study on track to commence before year end
Carlsbad, CA, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc.
Recent Highlights
The formation of the Company’s Clinical Advisory Board and the appointments of preeminent Key Opinion Leaders, Bruce Sands, MD, MS and Floria Rieder, MD; The exercise of outstanding common stock warrants resulting in gross proceeds of $2.5 million ; Presentation of positive preclinical data of lead asset, PALI-2108, at the 2024 Crohn’s & Colitis Congress; and Receipt of the second milestone payment to our joint development partner, Giiant Pharma, Inc., from the US Crohn’s and Colitis Foundation, through its Inflammatory Bowel Disease (IBD) Ventures program. “We continue to make significant development progress with PALI-2108, our lead program. The program is providing us with a growing body of data that we find encouraging, including support for a precision medicine approach,” commented J.D. Finley, Chief Executive Officer of Palisade. “On the corporate front, we recently completed a strategic realignment of our Board of Directors by reducing its size from 8 to 4 which better positions us with companies in our peer group. Although smaller, we believe the reconstituted board better matches our stage of development while retaining ethnic and gender diversity. We are extremely grateful to each resigning Director for their contributions to Palisade over the years.”
Corporate Update
As part of the Company’s ongoing efforts to streamline its operations and align its leadership with the Company’s current business initiatives, Directors Stephanie Diaz, Cristina Csimma, PharmD, MHP, Robert Trenschel, DO and James Neal, Chairman of the Board, resigned from the Company’s Board. Donald Williams has been appointed as the Company’s Chairman of the Board.
PALI-2108 Development Program
The Company continues to advance its lead program, PALI-2108, for the treatment of moderate-to-severe ulcerative colitis (UC) toward a Phase 1 clinical study. PALI-2108 is an orally administered, locally acting colon-specific phosphodiesterase-4B (PDE4B) inhibitor prodrug in development for patients affected by UC.
Upcoming Milestones
Ongoing IND/CTA-enabling tox studies; Complete nonclinical IND/CTA-enabling activities by the end of the third quarter of 2024; Submit initial IND/CTA prior to the end of 2024; and Initiate Phase 1a/b before the end of 2024. 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, LLCPALI@jtcir.com
Source: Palisade Bio
What is Palisade Bio, Inc. announcing regarding its Board?
Palisade Bio, Inc. is streamlining its Board to align with current clinical development and corporate vision.
What is the lead program being advanced by Palisade Bio, Inc.?
Palisade Bio, Inc. is advancing PALI-2108 for the treatment of moderate-to-severe ulcerative colitis.
What are some recent highlights mentioned in the press release?
Recent highlights include the formation of a Clinical Advisory Board, exercise of common stock warrants, positive preclinical data presentation of PALI-2108, and receipt of a milestone payment from Giiant Pharma, Inc.
Who has been appointed as the Chairman of the Board at Palisade Bio, Inc.?
Donald Williams has been appointed as the Chairman of the Board at Palisade Bio, Inc.
What is the upcoming milestone related to PALI-2108 development program?
Upcoming milestones include completing nonclinical activities by the end of the third quarter of 2024, submitting initial IND/CTA before the end of 2024, and initiating Phase 1a/b before the end of 2024.
