Palisade Bio Files 2023 10-K, Details Warrant Activity

TL;DR

PALISADE BIO (PALI) filed 2023 10-K. Lots of warrant activity and a UC license deal in Oct 2023.

AI Summary

Palisade Bio, Inc. filed its 2023 10-K on March 26, 2024, reporting on its fiscal year ending December 31, 2023. The company, formerly known as Seneca Biopharma, Inc., is focused on biological products. Key events during the reporting period and subsequent to year-end include various warrant issuances and a license agreement with The Regents of the University of California on October 20, 2023.

Why It Matters

This filing provides investors with a comprehensive overview of Palisade Bio's financial health and operational activities for the past fiscal year, including significant financing events.

Risk Assessment

Risk Level: medium — As a biopharmaceutical company, Palisade Bio faces inherent risks related to drug development, regulatory approvals, and market competition.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period covered by the 10-K)
• 2024-03-26 — Filing Date (Date the 10-K was submitted to the SEC)

Key Players & Entities

• PALISADE BIO, INC. (company) — Filer
• Seneca Biopharma, Inc. (company) — Former company name
• Neuralstem, Inc. (company) — Former company name
• The Regents of the University of California (company) — Licensor in agreement
• 2023-12-31 (date) — Fiscal year end
• 2024-03-26 (date) — Filing date
• 2023-10-20 (date) — Date of license agreement

FAQ

Key Financial Figures

• $0.01 — nge on which registered Common Stock, $0.01 par value PALI Nasdaq Capital Marke
• $1.00 — rket based on our Bid Price being under $1.00 for thirty (30) consecutive trading day

Filing Documents

• pali-20231231.htm (10-K) — 3247KB
• pali-ex23_1.htm (EX-23.1) — 4KB
• pali-ex31_1.htm (EX-31.1) — 16KB
• pali-ex31_2.htm (EX-31.2) — 16KB
• pali-ex32_1.htm (EX-32.1) — 8KB
• pali-ex97_1.htm (EX-97.1) — 42KB
• img60995965_0.jpg (GRAPHIC) — 20KB
• img60995965_1.jpg (GRAPHIC) — 389KB
• img60995965_2.jpg (GRAPHIC) — 93KB
• img60995965_3.jpg (GRAPHIC) — 42KB
• 0000950170-24-036402.txt ( ) — 11907KB
• pali-20231231.xsd (EX-101.SCH) — 1579KB
• pali-20231231_htm.xml (XML) — 1425KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 31 Item 1B. Unresolved Staff Comments 50 Item 1C. Cybersecurity 50 Item 2.

Properties

Properties 50 Item 3.

Legal Proceedings

Legal Proceedings 51 Item 4. Mine Safety Disclosures 51 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 52 Item 6. Reserved 52 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 53 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 63 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 64 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 101 Item 9A.

Controls and Procedures

Controls and Procedures 101 Item 9B. Other Information 102 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 102 PART III Item 10. Directors, Executive Officers and Corporate Governance 103 Item 11.

Executive Compensation

Executive Compensation 109 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 123 Item 13. Certain Relationships and Related Transactions, and Director Independence 126 Item 14. Principal Accounting Fees and Services 130 PART IV Item 15. Exhibits, Financial Statement Schedules 132 Item 16. Form 10-K Summary 139 i Cautionary Note Regarding Forward-Looking Statements and Risk Factor Summary This Annual Report on Form 10-K, including "Management's Discussion and Analysis of Financial Condition and Results of Operations," contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Some of these factors are more fully discussed in section 1A of this Annual Report on Form 10-K entitled "Risk Factors" and elsewhere herein .

Forward-looking statements may include, but are not limited to, statements about

Forward-looking statements may include, but are not limited to, statements about: 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; 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 successfully develop our licensed technologies; our ability to compete effectively in a competitive industry; our ability to identify and qualify additional manufacturers to provide active pharmaceutical ingredients ("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, capital requirements and needs for additional financing; our ability to obtain funding for our operations and the development of our product candidates; our ability to attract collaborators and partners; and the impact of pandemic, foreign or domestic conflicts, or other global disruptions on our business, our operations, and our supply. In some cases, you can identify forward-looking statements by terms such as "may," "will," "intend," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "potential" and similar expressions intended to identify forward-looking statements. There can be no assurance that any of the events anticipated by forward-looking statements will occur or, if any of them do occur, what impact they will have on our business, results of operations and financial condition. You should not rely on forward-looking statements as predictions of future events. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, assu

Business

Item 1. Business. Overview On September 1, 2023, we entered into a research collaboration and license agreement for substantially all of Giiant Pharma, Inc.'s ("Giiant") current and future proposed products ("Giiant License Agreement"). Under the terms of the Giiant License Agreement, we obtained the rights to develop, manufacture, and commercialize all compounds from Giiant, existing now and in the future, and any product containing or delivering any licensed compound, in any formulation or dosage for all human and non-human therapeutic uses for any and all indications worldwide, including those technologies that are the basis of our lead product candidate, PALI-2108 ("Giiant Licensed Assets"). Pursuant to the terms of the Giiant License Agreement, pre-clinical development PALI-2108 will be jointly undertaken by Giiant and us with a portion of development costs being paid by Giiant's current grants. Upon the first approval of either an investigational new drug application ("IND") or a Canadian Clinical Trial Application ("CTA"), we will assume all development, manufacturing, regulatory and commercialization costs. On August 9, 2023, we announced topline data from our U.S Phase 2 PROFILE study demonstrating that our previous lead product candidate, LB1148, did not meet its primary endpoint. The randomized patients in the trial also experienced 228 adverse events ("AEs") reported with 131 reported in patients treated with LB1148 verses 97 treated with placebo. Additionally, there were a total of three serious adverse events ("SAEs") related to LB1148 versus one related to placebo. Based on the efficacy and safety value results of the U.S. Phase 2 PROFILE study, we terminated the development of LB1148. Following entering into the Giiant Licensing Agreement, we have significantly reshaped the business into a pre-clinical stage biotechnology company focused on developing and advancing novel therapies for patients living with autoimmune, inflammatory, and fibroti

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View this 10-K filing on SEC EDGAR