Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 13, 2024 (February 8, 2024)

PALISADE BIO, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-33672

52-2007292

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

7750 El Camino Real

Suite 2A

Carlsbad, California

92009

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (858) 704-4900

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.01 per share		PALI		Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 5.02 Departure of Director or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

Between February 8, 2024 and February 9, 2024, James Neal, Stephanie Diaz, Dr. Cristina Csimma, and Dr. Robert Trenschel (collectively, the “Resigning Directors”), informed the board of directors (“Board”) of Palisade Bio, Inc. (the “Company”) that each is resigning as a member of the Board effective immediately. Each of the resignations of the Resigning Directors did not result from any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.

Item 8.01 Other Events

On February 13, 2024, the Company issued a press release announcing a corporate update, including the information contained in Item 5.02 above. A copy of the press release is attached to this report as Exhibit 99.01.

Item 9.01 Financial Statement and Exhibits.

Exhibit No.		Description
99.01		Press Release Dated February 13, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.

Date: February 13, 2024	Palisade Bio, Inc.

		/s/ J.D. Finley
	By:	J.D. Finley
		Chief Executive Officer

Exhibit 99.01

Palisade Bio Provides Corporate Update and Reiterates Guidance

– 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 – February 13, 2024 – Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today provided a corporate update and reiterated upcoming milestones.

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, LLC

Jenene Thomas

833-475-8247

PALI@jtcir.com

Source: Palisade Bio

Cover	Feb. 13, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 13, 2024
Entity File Number	001-33672
Entity Registrant Name	PALISADE BIO, INC.
Entity Central Index Key	0001357459
Entity Tax Identification Number	52-2007292
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	7750 El Camino Real
Entity Address, Address Line Two	Suite 2A
Entity Address, City or Town	Carlsbad
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92009
City Area Code	(858)
Local Phone Number	704-4900
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	PALI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false