Advancing a potentially best-in-class once-daily oral, locally-activated PDE4 inhibitor prodrug specifically engineered for the treatment of inflammatory bowel disease (IBD)
Enrollment of first patient for Phase 2 ASCENTRA-UC trial of PALI-2108 expected in the second half of 2026; primary efficacy results expected in the second half of 2027
IND for Phase 2 ASCENTRA-CD trial of PALI-2108 for the treatment of Crohn’s disease expected in the second half of 2026
Strong balance sheet expected to support execution through key Phase 2 clinical readouts
Key Takeaways from the Phase 1 Clinical Trial
- Across the Phase 1 clinical trial, PALI-2108 demonstrated favorable safety and tolerability, sustained exposure of the active metabolite above the IC90 threshold, targeted distribution in the ileum and colon, and pharmacodynamic (PD) activity across key inflammatory and fibrotic pathways.
- The Phase 1 clinical trial included five patients with UC and five patients with fibrostenotic Crohn’s disease (FSCD).
- In the UC cohort, 5 out of 5 patients achieved clinical response and 2 out of 5 achieved clinical remission based on Modified
Mayo Score . - In the FSCD cohort, PALI-2108 reduced mean SES-CD score by approximately 47.5% (a 3.8-point improvement), with 2 out of 5 patients achieving both endoscopic response and remission based on SES-CD.
Together, these findings provide a strong foundation for the planned commencement of the Phase 2 ASCENTRA-UC trial in the second half of 2026. The Company also intends to submit an investigational new drug (IND) application to the
“The second quarter marked a decisive transition for
Recent Highlights
- Strengthened the Board of Directors with the appointments of biopharmaceutical industry veterans
Robert Baltera andJordan Zwick , adding expertise across biotechnology leadership, strategic transactions and capital markets as the Company advances PALI-2108 into Phase 2 development.
Scientific Presentations
- Presented Phase 1 translational findings for PALI-2108 at Digestive Disease Week (DDW) 2026, highlighting rapid clinical, histologic and biomarker improvements.
- Showcased PALI-2108’s targeted PDE4 inhibition strategy in fibrostenotic Crohn’s disease at the 4th Annual Precision Medicine in IBD Summit.
- Discussed the role of intestinal fibrosis and PALI-2108’s therapeutic potential at a
New York Academy of Sciences symposium. - Additional PALI-2108 data to be presented at the
American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting and United European Gastroenterology (UEG) Week 2026.
Advancing PALI-2108 Into Phase 2 Development
Phase 2 ASCENTRA-UC
- Received FDA clearance of the IND application for PALI-2108
- Phase 2 UC clinical trial expected to commence in 2H 2026
- Primary efficacy readout expected 2H 2027
Phase 2 ASCENTRA-CD
- IND submission for the Phase 2 CD trial expected 2H 2026
- Phase 2 CD clinical trial commencement targeted for 1Q 2027
- Primary efficacy readout expected in early 2028
Summary of Financial Results
Research and development expenses were
General and administrative expenses were
The Company recognized license revenue of
Net loss was
As of
About Palisade Bio
Palisade Bio, Inc. (Nasdaq: PALI) is a clinical-stage biopharmaceutical company developing prodrugs for patients living with inflammatory and fibrotic diseases.
The Company’s lead clinical product candidate, PALI-2108, is being advanced into Phase 2 clinical trials as a treatment for patients living with inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD). Despite the availability of multiple biologic and small-molecule therapies, many patients with UC and CD do not achieve durable remission, lose response over time, or discontinue treatment because of safety or tolerability limitations. The Company believes PALI-2108 has the potential to address these limitations through once-daily oral dosing, targeted lower-intestinal bioactivation and broad PDE4-mediated anti-inflammatory activity.
Palisade Bio is now advancing into Phase 2 development for UC and CD. 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. 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 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, 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 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; 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 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
Palisade Bio, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except share and per share amounts)
| 2026 | 2025 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 125,172 | $ | 133,385 | ||||
| Accounts receivable | 500 | — | ||||||
| Prepaid expenses and other current assets | 1,588 | 836 | ||||||
| Total current assets | 127,260 | 134,221 | ||||||
| Restricted cash | 55 | 55 | ||||||
| Other noncurrent assets | — | 68 | ||||||
| Total assets | $ | 127,315 | $ | 134,344 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,835 | $ | 767 | ||||
| Accrued liabilities | 3,136 | 2,187 | ||||||
| Accrued compensation and benefits | 275 | 1,298 | ||||||
| Share liability | — | 313 | ||||||
| Insurance financing debt | — | 71 | ||||||
| Total current liabilities | 5,246 | 4,636 | ||||||
| Derivative liability | 62 | 62 | ||||||
| Contingent consideration obligation | 259 | 266 | ||||||
| Total liabilities | 5,567 | 4,964 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Series A Convertible Preferred Stock, 7,000,000 shares authorized; 200,000 issued and outstanding at | 2 | 2 | ||||||
| Common stock, authorized; 173,595,201 and 159,444,017 shares issued and outstanding at | 1,735 | 1,594 | ||||||
| Additional paid-in capital | 292,910 | 280,509 | ||||||
| Accumulated deficit | (172,899 | ) | (152,725 | ) | ||||
| Total stockholders' equity | 121,748 | 129,380 | ||||||
| Total liabilities and stockholders' equity | $ | 127,315 | $ | 134,344 | ||||
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share amounts)
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| License revenue | $ | 500 | $ | — | $ | 500 | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,400 | 1,675 | 13,797 | 2,625 | ||||||||||||
| General and administrative | 4,798 | 1,168 | 9,149 | 2,528 | ||||||||||||
| Total operating expenses | 12,198 | 2,843 | 22,946 | 5,153 | ||||||||||||
| Loss from operations | (11,698 | ) | (2,843 | ) | (22,446 | ) | (5,153 | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest expense | — | (2 | ) | (1 | ) | (3 | ) | |||||||||
| Other income, net | 1,124 | 61 | 2,273 | 142 | ||||||||||||
| Total other income, net | 1,124 | 59 | 2,272 | 139 | ||||||||||||
| Net loss | $ | (10,574 | ) | $ | (2,784 | ) | $ | (20,174 | ) | $ | (5,014 | ) | ||||
| Basic and diluted weighted average shares used in computing basic and diluted net loss per common share | 211,381,969 | 4,797,196 | 210,528,231 | 4,796,434 | ||||||||||||
| Basic and diluted net loss per common share | $ | (0.05 | ) | $ | (0.58 | ) | $ | (0.10 | ) | $ | (1.05 | ) | ||||
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands)
| Six Months Ended | ||||||||
| 2026 | 2025 | |||||||
| Net loss | $ | (20,174 | ) | $ | (5,014 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | — | 2 | ||||||
| Non-cash operating lease expense | — | 62 | ||||||
| Recurring fair value measurements of liabilities | (7 | ) | (9 | ) | ||||
| Write-off of deferred equity issuance costs | — | 75 | ||||||
| Stock-based compensation and related charges | 9,082 | 138 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (500 | ) | — | |||||
| Prepaid and other current assets and other noncurrent assets | (915 | ) | (18 | ) | ||||
| Accounts payable and accrued liabilities | 2,044 | 1,210 | ||||||
| Accrued compensation and benefits | (1,023 | ) | (530 | ) | ||||
| Operating lease liabilities | — | (66 | ) | |||||
| Net cash used in operating activities | (11,493 | ) | (4,150 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Payments on insurance financing debt | (71 | ) | (80 | ) | ||||
| Proceeds from issuance of common stock | 3,250 | — | ||||||
| Proceeds from the exercise of warrants | 155 | 1 | ||||||
| Payment of equity issuance costs | (74 | ) | (178 | ) | ||||
| Proceeds from issuance of common stock under Employee Stock Purchase Plan | 20 | 3 | ||||||
| Net cash provided by (used in) financing activities | 3,280 | (254 | ) | |||||
| Net decrease in cash, cash equivalents and restricted cash | (8,213 | ) | (4,404 | ) | ||||
| Cash, cash equivalents and restricted cash, beginning of year | 133,440 | 9,847 | ||||||
| Cash, cash equivalents and restricted cash, end of period | $ | 125,227 | $ | 5,443 | ||||
| Reconciliation of cash, cash equivalents and restricted cash to the balance sheets: | ||||||||
| Cash and cash equivalents | $ | 125,172 | $ | 5,417 | ||||
| Restricted cash | 55 | 26 | ||||||
| Total cash, cash equivalents and restricted cash | $ | 125,227 | $ | 5,443 | ||||
