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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): September 15, 2022 (September 9, 2022)

 

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 5200    
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 2.05. Costs Associated with Exit or Disposal Activities.

 

On September 9, 2022, Palisade Bio, Inc. (the “Company”), in order to better utilize the Company’s resources on the implementation of its refocused clinical programs and corporate strategy, committed to a cost-reduction plan. This cost-reduction plan included a reduction in force to better align the Company’s resources on its clinical studies, including its lead asset, LB1148.

 

As a result of the reduction in force, the Company estimates that it will pay an aggregate of $ $380,148 in cash pursuant to the Company’s normal payroll practices, consisting of (i) $ $307,588 in severance payments and benefits pursuant to employment agreements, (ii) $72,560 in severance payments and benefits pursuant to the potential execution of severance and release agreements. The Company anticipates that the reduction in force will result in annual cost savings of approximately $773,000 after payment of the foregoing severance benefits. The Company expects to substantially complete the payment of the employee severance and benefits incurred by the end of the first quarter of 2023.

 

In additional to the reduction in force, the Company’s initiative also identified certain other cost cutting opportunities that may result in additional annual savings of up to $800,000 without impacting its clinical programs.

 

Item 7.01 Regulation FD Disclosure.

 

On September 15, 2022, we announced the reduction in force and cost reduction plan via a press release. A copy of the press release is attached to this report as Exhibit 99.01.

 

The information contained in this Item 7.01 to this Current Report on Form 8-K and the exhibit attached hereto pertaining to this item shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information or such exhibits be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. The information set forth in the exhibits to this Form 8-K relating to this item 7.01 shall not be deemed an admission as to the materiality of any information in this report that is required to be disclosed solely to satisfy the requirements of Regulation FD.

 

Item 9.01. Financial Statements and Exhibits.

 

Exhibit

No.

   Description
99.01   Press Release dated September 15, 2022
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 to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Palisade Bio, Inc.
     
  By: /s/ Thomas M. Hallam
  Name: Thomas M. Hallam
  Title: Chief Executive Officer

 

Date: September 15, 2022

 

 

 

 

INDEX OF EXHIBITS

 

Exhibit

No.

   Description
99.01   Press Release dated September 15, 2022
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

Exhibit 99.01

 

 

Palisade Bio Streamlines Operations and Identifies Capital Efficiencies to Focus All Resources on Advancement of Lead Clinical Program, LB1148

 


Carlsbad, CA – September 15, 2022 /GlobeNewswire/ — Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced that following an internal strategic review, the Management Team and Board have implemented initiatives to streamline the organization, reduce operating expenses and preserve capital, with the goal of maximizing the advancement of its lead clinical program, LB1148.

 

“In light of current financial market conditions and our need to advance our lead clinical program, LB1148, it was imperative that we conduct a strategic review to ensure we have sufficient capital to extend our runway as long as possible. In partnership with our Board of Directors we took a serious look internally evaluating all aspects of our business. As a result of this process, we identified efficiencies and took cost-saving measures of over $1.5 million per annum to streamline our business, including a 20% reduction in our workforce,” commented Tom Hallam, Ph.D., Chief Executive Officer of Palisade Bio. “Through these necessary actions, I believe our company is now in a much stronger position financially. As we push forward, we remain steadfast in our commitment to advance LB1148 through our pivotal Phase 3 study for accelerating the return of postoperative bowel function and our Phase 2 study for the prevention of post-surgical abdominal adhesions through the finish line, where we believe we will be able to unlock significant shareholder value.”

 

The company recently announced the commencement of patient enrollment and dosing in its pivotal Phase 3 study evaluating LB1148 for postoperative return of bowel function. Completion of patient enrollment in the Phase 3 clinical trial is targeted to take place within 18-24 months. Additionally, the company is conducting an ongoing randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 2 clinical trial of LB1148 in up to 200 patients undergoing elective bowel resection surgery in the United States.

 

About Palisade Bio

 

Palisade Bio is a late-stage 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 which acts to neutralize digestive enzymes, potentially reducing intestinal damage. In multiple clinical studies, LB1148 has demonstrated positive results in accelerating the time to return of postoperative bowel function, and the Company recently presented analysis that LB1148 reduced the incidence and severity of post-surgical abdominal adhesions. LB1148 is currently being evaluated in a pivotal Phase 3 clinical study for accelerating the return of postoperative bowel function and in a Phase 2 study for the prevention of post-surgical abdominal adhesions.

 

 

 

 

The Company believes that addressing the disruption of the intestinal barrier has the potential to fundamentally change the way diseases are treated and to 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 Palisade’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential to fundamentally change the way diseases are treated, the completion of enrollment for the Phase 3 study, the potential for the statistically significant Phase 3 data to allow for NDA approval, and the potential for LB1148 to establish the standard of care, if approved. 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 Palisade’s current expectations. Forward-looking statements involve risks and uncertainties. Palisade’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 clinical development and the company’s ability to comply with the continued listing requirements for Nasdaq. Additional risks and uncertainties can be found in Palisade Bio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022. Palisade 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 Palisade’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