Palisade Bio, Inc. reported a net loss of $14.4 million for the year ended December 31, 2024, compared to a net loss of $12.3 million in 2023. Operating expenses totaled $14.9 million in 2024, comprising research and development expenses of $9.1 million and general and administrative expenses of $5.8 million. The company generated no license revenue in 2024, a decrease from the $0.3 million recognized in 2023. The increase in research and development expenses was primarily due to increased joint development expenses related to PALI-2108 and higher drug manufacturing costs, partially offset by a decrease in clinical trial-related expenses for LB1148, which the company ceased developing in August 2023.
The company completed several financings during 2024, including a public offering that yielded net proceeds of $4.1 million, a private placement generating $3.5 million in net proceeds, and a warrant inducement transaction resulting in $2.2 million in net proceeds. These funds are intended for working capital and general corporate purposes, including the development of PALI-2108. As of December 31, 2024, the company held $9.8 million in cash, cash equivalents, and restricted cash, which management believes is sufficient to fund operations through the fourth quarter of 2025. However, the company acknowledges substantial doubt about its ability to continue as a going concern for the next year.
A key strategic development was the September 1, 2023, research collaboration and license agreement with Giiant Pharma Inc., granting Palisade Bio the rights to develop and commercialize Giiant's compounds, including PALI-2108. This agreement involved joint preclinical development, with Palisade Bio assuming all development costs after achieving Proof of Concept in October 2024. An amendment to this agreement in August 2024 adjusted joint development cost reimbursements and milestone payments. As of December 31, 2024, Palisade Bio had eight full-time employees.
Operationally, Palisade Bio initiated a Phase 1 clinical trial of PALI-2108 for ulcerative colitis in Canada on November 7, 2024, following Health Canada's approval on October 9, 2024. The company anticipates releasing topline data from this trial in the second quarter of 2025 and plans to initiate a Phase 1b/2a study in the first quarter of 2026, pending successful results. The company also intends to submit an Investigational New Drug Application to the FDA in 2025 to commence U.S. clinical trials in the first quarter of 2026. The company's market analysis projects significant growth in the ulcerative colitis and fibrostenotic Crohn's disease treatment markets.
The company's 10-K filing highlights several risk factors, including the uncertainties inherent in drug development, dependence on third-party collaborations, the need for substantial additional funding, potential product liability, and the volatility of its common stock price. The filing also discusses regulatory risks associated with obtaining and maintaining approvals in both Canada and the U.S., as well as the potential impact of healthcare reform initiatives on pricing and reimbursement. The company's outlook is contingent upon the successful completion of clinical trials and securing additional funding to support its operations and development pipeline.
About PALISADE BIO, INC.
About 10-K Filings
A 10-K form is a comprehensive annual report that public companies in the United States must file with the SEC, providing a detailed overview of the company's financial condition, performance, and business strategies.
Key points about the 10-K:
- Frequency: Filed annually, typically within 60 to 90 days after the end of the company's fiscal year.
-
Content: It includes:
- Detailed financial statements audited by an independent accounting firm
- Management's Discussion and Analysis (MD&A) of financial condition and results
- Description of the company's business, properties, and legal proceedings
- Risk factors and market risks
- Executive compensation and corporate governance information
- Importance: Considered the most comprehensive and important document a public company files with the SEC.
- Length: Often exceeds 100 pages due to its extensive and detailed nature.
Our Methodology
AssetRoom is committed to providing timely summaries of news from public companies. We use AI to generate these summaries quickly, but they are not reviewed by human experts.
Our method:
- Data Collection: We continuously monitor for new filings (currently limited to US-listed stocks).
- AI-Powered Analysis: Our advanced AI system processes each filing, identifying key information and extracting relevant data.
- Summary Generation: The AI creates a concise, easy-to-understand summary of the filing, highlighting the most important points.
- Publication: The summary is immediately published on our platform, allowing users instant access to the latest information.
- Email users: We distribute round-up emails according to our users preferences, keeping them in the loop with the companies they follow.
Feedback & Corrections
Spot an error or have a suggestion? Contact us.