0001493152-22-033543.txt : 20221123 0001493152-22-033543.hdr.sgml : 20221123 20221123160535 ACCESSION NUMBER: 0001493152-22-033543 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20221123 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20221123 DATE AS OF CHANGE: 20221123 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PALISADE BIO, INC. CENTRAL INDEX KEY: 0001357459 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 522007292 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33672 FILM NUMBER: 221416366 BUSINESS ADDRESS: STREET 1: 7750 EL CAMINO REAL, SUITE 5200 CITY: CARLSBAD STATE: CA ZIP: 92009 BUSINESS PHONE: (858) 704-4900 MAIL ADDRESS: STREET 1: 7750 EL CAMINO REAL, SUITE 5200 CITY: CARLSBAD STATE: CA ZIP: 92009 FORMER COMPANY: FORMER CONFORMED NAME: Seneca Biopharma, Inc. DATE OF NAME CHANGE: 20200127 FORMER COMPANY: FORMER CONFORMED NAME: Neuralstem, Inc. DATE OF NAME CHANGE: 20060324 8-K 1 form8-k.htm
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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): November 23, 2022 (November 17, 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 5.02. Departure of Director or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

 

Appointment of Dr. Herbert Slade as Chief Medical Officer

 

On November 17, 2022, the Board of Directors of Palisade Bio, Inc. (“Company”) appointed Herbert B. Slade, MD FAAAAI, to serve as the Company’s chief medical officer. Dr. Slade will serve this role as a consultant on a part time basis and will be compensated $240,000 per annum. Dr. Slade has previously been providing consulting services to the Company since May of 2022. The Company anticipates entering into an amended and restated consulting agreement with Dr. Slade. Dr. Slade’s consulting arrangement does not provide for any severance or other termination-based benefits upon termination or resignation.

 

There are no family relationships between Dr. Slade and any of the directors or officers of the Company.

 

Dr. Slade, age 68, has over 25 years of leadership experience in the pharmaceutical and medical device industries, demonstrating execution of regulatory negotiations with the U.S. Food and Drug Administration and European Medicines Agency, and the design, conduct, and reporting of clinical programs. Since 2007, Dr. Slade has been serving as the Adjunct Clinical Assistant Professor of the Department of Pediatrics at the Texas College of Osteopathic Medicine. Since 2018, he has also been serving as the treasurer and member of the Board of Directors of the Wound Healing Society, a 501(c)3 organization. He serves as President and Managing Director of Chisholm Clinical Research Services, a Texas limited liability company, where he provides assistance with the clinical development of promising new products for 6 client companies in the US and EU. From 2012 to 2016, Dr. Slade served as Chief Medical Officer and then Sr. Vice President of Research and Development in the Advanced Wound Management department of Smith and Nephew, plc, where he was responsible for restructuring 3 strategic business R&D departments and two clinical groups into a single worldwide R&D organization. Prior to that, from 2006 to 2012, Dr. Slade served as Chief Medical Officer and Sr. Vice President at DFB Pharmaceuticals, a private Texas company, until it was acquired by Smith & Nephew in 2012. Dr. Slade has additionally served in various chief medical officer and other senior positions of various private and public pharmaceutical companies throughout his career. Dr. Slade received a bachelor’s degree from Hamilton College in Clinton, NY, a Medical Degree from State University of New York in Syracuse, NY, a Pediatrics category PL-1 from State University of New York, a Pediatrics category PL-2 from C.S. Mott Children’s Hospital in Ann Arbor, MI, and a fellowship in Basic and Clinical Immunology from the University of Michigan in Ann Arbor, MI.

 

On November 18, 2022, the Company issued a press release announcing Dr. Slade’s appointment, which is attached to this report as Exhibit 99.01.

 

Item 9.01 Financial Statement and Exhibits.

 

Exhibit

No.

  Description
99.01  

Press Release Dated November 18, 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 on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: November 23, 2022 Palisade Bio, Inc.
       
      /s/ J.D. Finley
    By: J.D. Finley
      Interim Chief Executive Officer

 

 

EX-99.01 2 ex99-01.htm

 

Exhibit 99.01

 

 

Palisade Bio Appoints Herbert B. Slade, MD, FAAAAI as Chief Medical Officer

 

Established academic and corporate executive with proven track record leading large, multinational organizations across the pharmaceutical and medical device industries

 

Well-versed with LB1148 - serving as recent expert clinical advisor to Palisade Bio

 

Carlsbad, CA – November 18, 2022 -- Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the appointment of Herbert B. Slade, MD, FAAAAI as Chief Medical Officer of Palisade Bio.

 

Dr. Slade is a proven medical and regulatory professional with over 25 years of leadership experience in the pharmaceutical and medical device industries. Over the course of his career, he has demonstrated execution of regulatory negotiations with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the design, conduct and reporting of clinical programs.

 

“Over the past six months Dr. Slade has provided important input and guidance in advancing the development of LB1148 as a clinical advisor to the Company. We firmly believe his appointment as Chief Medical Officer will be a natural transition, and we are very pleased to welcome him to the executive leadership team. Throughout his career, he has amassed valuable expertise across the healthcare industry and academia and has developed a deep-rooted, respected skillset in research and development that we believe will be critical as we move our development programs forward. We will continue to leverage Dr. Slade’s perspective and leadership as we work to unlock the full potential of the Company and LB1148 for all stakeholders,” commented JD Finley, interim CEO of Palisade Bio.

 

“There remains a significant unmet need when it comes to addressing acute and chronic gastrointestinal post-surgical complications and the serious risks that come with them. I believe that the demonstrated mechanism to protect intestinal barrier health and the data seen to date well position LB1148 to become a potential standard of care, and I am dedicated to further advancing its development. With the prioritization on the prevention of adhesions program, I believe we have the potential to offer millions of patients an important therapeutic option and provide a much-needed benefit. Having closely worked with the Palisade Bio team as a clinical advisor for LB1148 over the past several months, I am excited to continue building on the progress made and look forward to bringing its development successfully across the finish line,” added Dr. Slade.

 

Dr. Slade currently serves as the Adjunct Clinical Associate Professor, Dept. of Pediatrics, Texas College of Osteopathic Medicine, UNTHSC and as Treasurer and member of the Board of Directors of The Wound Healing Society. He joins Palisade Bio having most recently served as the President and Managing Director of Chisholm Clinical Research Services, LLC (CCRS) where he provided assistance with clinical testing and development of promising new products for 11 client companies in seven countries. Prior to CCRS, Dr. Slade served as Chief Scientific and Medical Officer, Advanced Wound Management of Smith and Nephew plc before transitioning to Sr. Vice President, Research & Development where he was responsible for restructuring three strategic business unit R&D departments and two clinical groups into a single worldwide R&D organization, adding post-marketing surveillance. Prior to that he served as Chief Medical Officer and Senior Vice President at DFB Pharmaceuticals until it was acquired by Smith & Nephew in 2012. Additional career appointments include Chief Medical Officer of 3M Pharmaceuticals where he was responsible for all Medical, Clinical Research, Biometrics, Data Management and Pharmacovigilance personnel worldwide for 12 years. Dr. Slade also was afforded the unique opportunity to work at Rhône-Poulenc Rorer (RPR) with the prestigious Dr. Jonas Salk, as the principal physician and clinical immunologist on the Salk HIV Immunogen project. During that time, he assisted Dr. Salk on a wide range of program issues including the scientific validity of a therapeutic vaccine (now termed Theracines or Pharmacines), and the importance of the Th1/Th2 concept.

 

 

 

 

Dr. Slade has authored or co-authored over 100 publications. He has held academic positions at a number of universities including University of Michigan Medical School, Cornell University Medical College, University of North Texas Health Science Center, and University of Pennsylvania Medical School. Dr. Slade received his undergraduate degree in biology from Hamilton College and his M.D. from State University of New York Upstate Medical University in Syracuse, New York. He completed post doctorate work at S.U.N.Y. Upstate Medical Center and C.S. Mott Children’s Hospital and completed his fellowship at the University of Michigan.

 

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 which acts to neutralize digestive enzymes, potentially reducing intestinal damage. In clinical studies, LB1148 has demonstrated positive results in accelerating the time to return of postoperative bowel function, and reduced the incidence and severity of post-surgical abdominal adhesions. LB1148 is currently being evaluated in a Phase 2 study to evaluate return of gastrointestinal function, post-operative ileus and intra-abdominal adhesions 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

 

 

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