Palisade Bio Q3 2026 loss widens to $14.6M
ASCENTRA-UC’s primary endpoint is Week 12 clinical remission; ASCENTRA-CD’s is Week 12 endoscopic response.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Palisade Bio reported third-quarter 2026 results and clinical progress for PALI-2108. In Phase 2b ASCENTRA-UC, the first patient was dosed October 27, 2026; 29 of 30 planned U.S. sites were active. The study is expected to enroll approximately 204 patients with moderately to severely active ulcerative colitis, comparing once-daily 15 mg and 30 mg doses with placebo. Topline results from its 12-week induction period are expected in Q4 2027. FDA cleared the IND for Phase 2a ASCENTRA-CD on September 22, 2026; enrollment is targeted for Q1 2027, with the primary efficacy readout expected in Q1 2028.
For the three months ended September 30, 2026, research and development expense was $10.579 million versus $1.394 million a year earlier, and general and administrative expense was $5.121 million versus $1.528 million. Net loss was $14.623 million, compared with $2.868 million. For the nine months ended September 30, 2026, net cash used in operating activities was $23.252 million versus $7.703 million.
Cash and cash equivalents were $113.613 million as of September 30, 2026. Palisade said it believes this cash will fund operations through the anticipated ASCENTRA-UC and ASCENTRA-CD primary efficacy readouts.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Minor pointPALI-2108’s Phase 2b ASCENTRA-UC dosed its first patient on October 27, 2026.
- Minor pointFDA cleared the ASCENTRA-CD IND on September 22, 2026.
Negative
- Moderate pointQuarterly net loss was $14.623 million, versus $2.868 million.
- Moderate pointNine-month operating cash used was $23.252 million, versus $7.703 million.
Filing Explained
The balance sheet reports that Palisade Bio’s issued and outstanding common shares increased from 159,444,017 at
8-K Event Classification
Key Figures
Key Terms
Modified Mayo Score medical
histologic-endoscopic mucosal improvement medical
Simple Endoscopic Score for Crohn’s Disease medical
PDE4 inhibitor prodrug medical
IND application regulatory
Earnings Snapshot
The company believes its cash and cash equivalents will fund operations through key Phase 2 clinical milestones, including anticipated primary efficacy readouts for ASCENTRA-UC in the fourth quarter of 2027 and ASCENTRA-CD in the first quarter of 2028.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is PALI’s primary endpoint in ASCENTRA-UC?
What is PALI’s primary endpoint in ASCENTRA-CD?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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): |
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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) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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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 2.02 Results of Operations and Financial Condition.
On November 10, 2026, Palisade Bio, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2026. The press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
The information in Item 2.02 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. The information contained herein shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number |
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Description |
99.1 |
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Palisade Bio, Inc. Press Release issued on November 10, 2026 |
104 |
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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.
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PALISADE BIO, INC. |
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Date: |
November 10, 2026 |
By: |
/s/ J.D. Finley |
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J.D. Finley |
Exhibit 99.1
Palisade Bio Reports Third Quarter 2026 Financial Results and Advances PALI-2108 Phase 2 Clinical Development Programs
First Patient Dosed in Global Phase 2b ASCENTRA-UC Trial; Topline Results Expected in Q4 2027
FDA Clearance Received for Phase 2a ASCENTRA-CD Trial; Initiation of Enrollment Targeted for Q1 2027
New Clinical and Translational Data Presented at ACG and UEG Week 2026 Highlight PALI-2108's Targeted Profile
$113.6 Million in Cash and Cash Equivalents as of September 30, 2026
Denver, CO, November 10, 2026 — Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing oral therapies for immune-mediated and fibrotic diseases, today reported financial results for the third quarter ended September 30, 2026, and provided a business update highlighting continued execution of its Phase 2 clinical development strategy for PALI-2108 across inflammatory bowel disease (“IBD”).
“ASCENTRA-UC is now underway, and our focus is on driving enrollment and executing the study to deliver topline results in the fourth quarter of 2027. With nearly all planned U.S. sites activated, we are expanding our global clinical footprint to build on that progress,” said JD Finley, Chief Executive Officer of Palisade Bio. “In parallel, we are preparing to initiate ASCENTRA-CD, with initiation of enrollment targeted for the first quarter of 2027. Our strong financial position supports execution across both programs as we work to establish PALI-2108’s potential as a differentiated, once-daily oral treatment for patients living with IBD.”
Recent Highlights
Initiated Global Phase 2b ASCENTRA-UC Clinical Trial
Exhibit 99.1
Advanced Phase 2a ASCENTRA-CD Program in Crohn's Disease
Presented New Clinical and Translational Data at ACG and UEG Week 2026
“Now that ASCENTRA-UC is underway, our priority is to maintain enrollment momentum and deliver the clinical data needed to establish PALI-2108’s potential in ulcerative colitis,” said Mitch Jones, M.D., Ph.D., President and Chief Medical Officer of Palisade Bio. “We expect the results to provide a clearer understanding of its ability to induce remission, reduce intestinal inflammation and support sustained disease control. In Crohn’s disease, we are focused on preparing ASCENTRA-CD for initiation of enrollment in the first quarter of 2027. We are pursuing these programs with the goal of developing a treatment that, if approved, could offer patients an effective, well-tolerated treatment that fits into daily life through once-daily oral dosing.”
Exhibit 99.1
Summary of Financial Results
Research and development expenses were $10.6 million for the three months ended September 30, 2026, compared to $1.4 million for the three months ended September 30, 2025. The increase primarily reflects expenses associated with advancing PALI-2108 into Phase 2 clinical development, including clinical trial start-up activities, manufacturing and clinical supply, and supporting preclinical and translational research, as well as higher employee-related expenses, including increased non-cash stock-based compensation expense.
General and administrative expenses were $5.1 million for the three months ended September 30, 2026, compared to $1.5 million for the three months ended September 30, 2025. The year-over-year increase reflects the Company’s expanded operating activities and higher employee-related expenses, including increased non-cash stock-based compensation expense.
Net loss was $14.6 million, or $0.07 per share, for the three months ended September 30, 2026, compared to a net loss of $2.9 million, or $0.38 per share, for the three months ended September 30, 2025.
As of September 30, 2026, the Company had $113.6 million in cash and cash equivalents, which the Company believes will fund operations through key Phase 2 clinical milestones, including the anticipated primary efficacy readouts from ASCENTRA-UC in the fourth quarter of 2027 and ASCENTRA-CD in the first quarter of 2028.
About PALI-2108
PALI-2108 is an investigational, once-daily oral PDE4 inhibitor prodrug designed for localized bioactivation in the terminal ileum and colon. Its active metabolite, PALI-0008, potently inhibits PDE4 isoforms A, B and D, increasing intracellular cAMP to modulate inflammatory signaling. Phase 1 studies have provided evidence of high intestinal exposure, measurable systemic exposure supportive of once-daily dosing, favorable short-term tolerability and early clinical activity, supporting Phase 2 development in UC and Crohn’s disease. PALI-2108 has not been approved for any indication.
About Palisade Bio
Palisade Bio is a clinical-stage biopharmaceutical company developing oral therapies for immune-mediated and fibrotic diseases. Its lead program, PALI-2108, is in Phase 2 development in inflammatory bowel disease. The Company is actively enrolling patients in its Phase 2b ASCENTRA-UC study, while advancing its Phase 2a ASCENTRA-CD study toward commencement.
For more information, please go to www.palisadebio.com.
Forward-Looking Statements
Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “believe,” “designed to,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include but are not limited to: implied or express statements regarding the pharmacological properties, safety, tolerability, clinical response and efficacy, and therapeutic potential of
Exhibit 99.1
PALI-2108, dosing levels and timing of key PALI-2108 development milestones such as regulatory submissions and approvals, trial enrollments and commencements and efficacy readouts; the design, conduct, enrollment and expected timing of results of the ASCENTRA-UC trial, including site activation and the expansion of the trial outside the United States; the potential of PALI-2108 to improve tolerability relative to other PDE4 inhibitors; plans to develop PALI-2108 in Crohn’s disease; and the Company’s expected cash runway. These forward-looking statements are based on the Company’s current expectations.
Forward-looking statements involve risks and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others, the timing of enrollment, commencement and completion of the Company’s clinical trials; the Company’s reliance on PALI-2108, and its early stage of clinical development; the Company’s ability to activate clinical sites on the anticipated timeline; the timing and outcome of regulatory reviews of clinical trial applications outside the United States; the Company’s reliance on third parties, including contract research organizations, clinical sites and contract manufacturers; the risk that prior results, such as signals of safety, clinical response and efficacy, dosing or durability of effect, observed from preclinical or clinical trials with a limited number of patients, will not be replicated or will not continue in ongoing or future studies or clinical trials involving the Company’s product candidates in clinical trials focused on the same or different indications; the risk that safety or tolerability findings emerge in larger, controlled studies; the Company’s need for additional capital to complete its clinical development programs; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2026, and the Quarterly Reports on Form 10-Q, including the Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, or other SEC filings that are filed thereafter. Investors are cautioned not to put undue reliance on these forward-looking statements. 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, except as required by law.
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
908-824-0775
PALI@jtcir.com
Exhibit 99.1
Palisade Bio, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except share and per share amounts)
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September 30, |
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December 31, |
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2026 |
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2025 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
113,613 |
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$ |
133,385 |
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Prepaid expenses and other current assets |
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3,860 |
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836 |
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Total current assets |
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117,473 |
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134,221 |
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Restricted cash |
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55 |
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55 |
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Other noncurrent assets |
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1,017 |
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68 |
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Total assets |
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$ |
118,545 |
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$ |
134,344 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,445 |
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$ |
767 |
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Accrued liabilities |
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3,608 |
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2,187 |
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Accrued compensation and benefits |
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773 |
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1,298 |
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Share liability |
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— |
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313 |
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Insurance financing debt |
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— |
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71 |
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Total current liabilities |
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5,826 |
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4,636 |
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Noncurrent liabilities |
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279 |
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328 |
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Total liabilities |
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6,105 |
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4,964 |
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Commitments and contingencies |
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Stockholders' equity: |
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Series A Convertible Preferred Stock, $0.01 par value, |
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2 |
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2 |
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Common stock, $0.01 par value; 450,000,000 and 300,000,000 shares |
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1,744 |
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1,594 |
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Additional paid-in capital |
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298,216 |
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280,509 |
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Accumulated deficit |
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(187,522 |
) |
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(152,725 |
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Total stockholders' equity |
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112,440 |
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129,380 |
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Total liabilities and stockholders' equity |
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$ |
118,545 |
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$ |
134,344 |
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Exhibit 99.1
Palisade Bio, Inc.
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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License revenue |
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$ |
— |
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$ |
— |
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$ |
500 |
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$ |
— |
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Operating expenses: |
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Research and development |
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10,579 |
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1,394 |
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24,376 |
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4,019 |
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General and administrative |
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5,121 |
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1,528 |
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14,270 |
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4,056 |
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Total operating expenses |
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15,700 |
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2,922 |
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38,646 |
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8,075 |
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Loss from operations |
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(15,700 |
) |
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(2,922 |
) |
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(38,146 |
) |
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(8,075 |
) |
Other (expense) income: |
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Interest expense |
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— |
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(5 |
) |
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(1 |
) |
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(8 |
) |
Other income, net |
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1,077 |
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59 |
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3,350 |
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201 |
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Total other income, net |
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1,077 |
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54 |
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3,349 |
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193 |
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Net loss |
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$ |
(14,623 |
) |
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$ |
(2,868 |
) |
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$ |
(34,797 |
) |
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$ |
(7,882 |
) |
Basic and diluted weighted average shares used in computing basic and diluted net loss per common share |
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212,027,787 |
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7,473,898 |
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211,035,838 |
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5,702,050 |
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Basic and diluted net loss per common share |
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$ |
(0.07 |
) |
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$ |
(0.38 |
) |
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$ |
(0.16 |
) |
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$ |
(1.38 |
) |
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Exhibit 99.1
Palisade Bio, Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands)
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Nine Months Ended September 30, |
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2026 |
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2025 |
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Net loss |
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$ |
(34,797 |
) |
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$ |
(7,882 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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— |
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3 |
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Non-cash operating lease expense |
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— |
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84 |
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Recurring fair value measurements of liabilities |
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1 |
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|
323 |
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Write-off of deferred equity issuance costs |
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— |
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|
75 |
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Stock-based compensation and related charges |
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14,147 |
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|
228 |
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Other |
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(61 |
) |
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Changes in operating assets and liabilities: |
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Prepaid and other current assets and other noncurrent assets |
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(4,223 |
) |
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(537 |
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Accounts payable and accrued liabilities |
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2,145 |
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|
255 |
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Accrued compensation and benefits |
|
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(525 |
) |
|
|
(101 |
) |
Operating lease liabilities |
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— |
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(90 |
) |
Net cash used in operating activities |
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(23,252 |
) |
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(7,703 |
) |
Cash flows from financing activities: |
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Payments on insurance financing debt |
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(71 |
) |
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(180 |
) |
Proceeds from issuance of common stock |
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|
3,450 |
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— |
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Proceeds from the exercise of warrants |
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|
155 |
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|
|
3,909 |
|
Payment of warrant inducement issuance costs |
|
|
— |
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(445 |
) |
Payment of equity issuance costs |
|
|
(74 |
) |
|
|
(178 |
) |
Proceeds from issuance of common stock under Employee Stock Purchase Plan |
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|
20 |
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|
|
3 |
|
Net cash provided by financing activities |
|
|
3,480 |
|
|
|
3,109 |
|
Net decrease in cash, cash equivalents and restricted cash |
|
|
(19,772 |
) |
|
|
(4,594 |
) |
Cash, cash equivalents and restricted cash, beginning of year |
|
|
133,440 |
|
|
|
9,847 |
|
Cash, cash equivalents and restricted cash, end of period |
|
$ |
113,668 |
|
|
$ |
5,253 |
|
Reconciliation of cash, cash equivalents and restricted cash to the balance sheets: |
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|
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|
|
|
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Cash and cash equivalents |
|
$ |
113,613 |
|
|
$ |
5,227 |
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Restricted cash |
|
|
55 |
|
|
|
26 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
113,668 |
|
|
$ |
5,253 |
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|
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|
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