Palisade Bio Announces Strategic Equity Investment from the Crohn’s & Colitis Foundation’s IBD Ventures Program to Advance PALI-2108

Rhea-AI Summary

Palisade Bio (Nasdaq: PALI) announced a strategic equity investment of up to $500,000 from the Crohn’s & Colitis Foundation through its IBD Ventures program to support development of PALI-2108, a gut-microbiota-activated PDE4 inhibitor designed for targeted delivery to the terminal ileum and colon for fibrostenotic Crohn’s disease (FSCD) and moderate to severe ulcerative colitis (UC).

Palisade has completed Phase 1a single- and multiple-ascending dose and food-effect studies, plus a Phase 1b cohort in UC, and is conducting a Phase 1b cohort in FSCD. Data from these studies are expected to support Phase 2 IND submissions to the FDA in 2026.

Positive

• $500,000 strategic equity investment from Crohn’s & Colitis Foundation
• Completed Phase 1a single- and multiple-ascending dose and food-effect studies
• Completed Phase 1b cohort in UC; ongoing Phase 1b cohort in FSCD
• Data expected to support Phase 2 IND submissions in 2026

Negative

• Investment capped at $500,000, a limited near-term capital infusion
• No Phase 2 IND yet; progress depends on upcoming 2026 study data

News Market Reaction

+5.21%

16 alerts

+5.21% News Effect

-18.0% Trough in 25 hr 50 min

+$14M Valuation Impact

$288M Market Cap

0.1x Rel. Volume

On the day this news was published, PALI gained 5.21%, reflecting a notable positive market reaction. Argus tracked a trough of -18.0% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $14M to the company's valuation, bringing the market cap to $288M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

IBD Ventures investment: $500,000 Phase 1a study: Phase 1a Phase 1b UC cohort: Phase 1b +2 more

5 metrics

IBD Ventures investment $500,000 Strategic equity investment from Crohn’s & Colitis Foundation’s IBD Ventures

Phase 1a study Phase 1a Completed SAD, MAD, and food-effect study of PALI-2108

Phase 1b UC cohort Phase 1b Completed cohort study in ulcerative colitis

Phase 1b FSCD cohort Phase 1b Ongoing cohort study in fibrostenotic Crohn’s disease

Planned IND timing 2026 Expected Phase 2 IND submissions to FDA in 2026

Market Reality Check

Price: $1.74 Vol: Volume 3,798,379 is below...

low vol

$1.74 Last Close

Volume Volume 3,798,379 is below the 20-day average of 5,921,979, suggesting no unusual trading activity before this news. low

Technical Shares at $1.92 were trading above the 200-day MA of $1.14 ahead of the announcement.

Peers on Argus

PALI was down 8.57% while close biotech peers showed mixed moves (e.g., GRI +3.4...

1 Down

PALI was down 8.57% while close biotech peers showed mixed moves (e.g., GRI +3.43%, ADTX -7.18%, KTTA -4.42%, SXTP +3.02%, TTNP -3.96%), indicating stock-specific dynamics rather than a broad sector move.

Historical Context

5 past events · Latest: Dec 30 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 30	Patent grant	Positive	-4.8%	Japan patent granted for PALI-2108, extending IP protection into 2041.
Dec 02	Leadership hire	Positive	-2.1%	Appointment of VP Clinical Development with extensive Phase 2/3 experience.
Nov 25	Conference participation	Neutral	-5.7%	Announcement of fireside chat at Piper Sandler healthcare conference.
Oct 28	Leadership hire	Positive	+11.4%	New VP, Global Head of Clinical Operations to support PALI-2108 execution.
Oct 20	Clinical progress	Positive	+6.9%	First patients dosed in Phase 1b FSCD study of PALI-2108 with Q1 2026 data goal.

Pattern Detected

Recent news on strategy, IP, and clinical progress often produced mixed reactions, with some positive operational updates met by negative price moves.

Recent Company History

Over the past few months, Palisade Bio has focused on building the PALI-2108 program and corporate infrastructure. Key steps included first patients dosed in a Phase 1b FSCD study on Oct 20, 2025, a senior clinical operations hire on Oct 28, 2025, and a Japanese composition-of-matter patent with term into 2041. Conference participation and leadership appointments rounded out the story. Today’s strategic equity investment to advance PALI-2108 fits this ongoing clinical and platform-building trajectory.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-08-15

An S-3 shelf filed on Aug 15, 2025 lists 988,872 shares and outlines estimated offering expenses totaling $49,000. The shelf was not yet effective in the provided data but has already seen at least one related 424B4 usage, indicating an established mechanism for potential future equity issuance.

Market Pulse Summary

The stock moved +5.2% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +5.2% in the session following this news. A strong positive reaction aligns with the strategic nature of a foundation-backed equity investment and continued advancement of PALI-2108 through Phase 1b studies. Historical data show prior clinical and leadership updates sometimes produced sizable upside moves. However, investors have a registered S-3 shelf filed on Aug 15, 2025 and prior 424B4 usage to monitor for future equity issuance that could influence sustainability of any sharp gains.

Key Terms

pde4 inhibitor, terminal ileum, ulcerative colitis (uc), fibrostenotic crohn’s disease (fscd), +4 more

8 terms

pde4 inhibitor medical

"PALI-2108 is the first and only PDE4 inhibitor in development"

A PDE4 inhibitor is a drug that blocks an enzyme (PDE4) involved in turning off certain cell signals linked to inflammation and brain activity; blocking it lets those signals persist and can reduce inflammation or alter nerve-cell behavior. Investors care because this drug class underlies treatments for conditions like chronic inflammatory and neurological disorders, so clinical trial results, regulatory decisions, or patent news can strongly affect a company’s drug pipeline value and stock outlook.

terminal ileum medical

"designed for targeted delivery to the terminal ileum and colon"

The terminal ileum is the final segment of the small intestine that connects to the large intestine; think of it as the doorway between two rooms of the digestive tract where nutrients are absorbed and waste moves on. It matters to investors because many gastrointestinal diseases, targeted drugs, diagnostic tests, and surgical procedures focus on this specific site, so outcomes or regulatory news about treatments affecting the terminal ileum can materially influence clinical trial results, approvals, and a company’s financial prospects.

ulcerative colitis (uc) medical

"addressing significant unmet needs in ulcerative colitis (UC)"

A long-lasting inflammatory disease that affects the inner lining of the large intestine, causing symptoms such as abdominal pain, urgent or bloody diarrhea, and fatigue; it is commonly abbreviated UC. For investors, UC matters because it creates predictable demand for medications, diagnostic tools and care services, and clinical trial outcomes or regulatory approvals for new treatments can quickly change a company’s revenue outlook — like a major product launch reshaping a firm’s future sales.

fibrostenotic crohn’s disease (fscd) medical

"and fibrostenotic Crohn’s disease (FSCD)"

Fibrostenotic Crohn’s disease is a form of Crohn’s disease where repeated inflammation leads to scar tissue that narrows parts of the intestine, like a garden hose pinched by buildup. It matters to investors because it creates a clear, high‑impact medical need—patients often require surgeries or long‑term interventions—driving demand for drugs, minimally invasive procedures and devices that can prevent or reverse scarring and reduce healthcare costs.

single-ascending dose medical

"completed a Phase 1a single-ascending dose, multiple-ascending dose"

A single-ascending dose (SAD) study is an early-stage clinical test where small groups of volunteers each receive one single dose of a drug, with each subsequent group getting a higher dose if the previous dose is safe. Think of it like stepping up a staircase one step at a time to check stability; investors watch SAD results because they reveal initial safety, how the body handles the drug, and the safe dose range, all of which affect development risk and timelines.

multiple-ascending dose medical

"single-ascending dose, multiple-ascending dose, and food-effect study"

A multiple-ascending dose study is an early-stage clinical trial where groups of volunteers receive a drug repeatedly at progressively higher dose levels to see how the body handles it and whether repeated dosing causes side effects. Think of it as gradually increasing the weight on a workout machine to find the safe, effective range; for investors, results reveal safety, how the drug behaves over time, and whether the program can move into larger, more costly trials.

investigational new drug (ind) regulatory

"support Phase 2 Investigational New Drug (IND) submissions"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

u.s. food and drug administration (fda) regulatory

"IND submissions to the U.S. Food and Drug Administration (FDA) in 2026"

The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.

AI-generated analysis. Not financial advice.

PALI-2108 is the first and only PDE4 inhibitor in development designed for targeted delivery to the terminal ileum and colon, addressing significant unmet needs in ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD)

Carlsbad, CA, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company developing next-generation, once-daily, oral PDE4 inhibitor prodrugs designed for targeted delivery to the terminal ileum and colon, today announced that the Crohn’s & Colitis Foundation (the “Foundation”), through its IBD Ventures program, has approved a strategic equity investment of up to $500,000 in Palisade. The investment will support the continued clinical and mechanistic development of PALI-2108, the Company’s lead gut-microbiota-activated PDE4 inhibitor, being advanced for fibrostenotic Crohn’s disease (FSCD) and moderate to severe ulcerative colitis (UC).

“We are honored to receive this strategic equity investment from the Crohn’s & Colitis Foundation through its IBD Ventures program,” said J.D. Finley, Chief Executive Officer of Palisade Bio. “This investment represents a strong endorsement of both the scientific rationale underlying PALI-2108 and our targeted, gut-restricted approach to PDE4 inhibition. The Foundation’s support further validates the potential of PALI-2108 to address the significant unmet needs of patients living with UC and FSCD, and we look forward to continuing to advance this program toward the next stages of clinical development.”

“We’re excited to be funding and working with Palisade Bio to address major unmet needs in fibrostenotic Crohn’s disease and ulcerative colitis, where patients still face progression to strictures and surgery and limited treatment options,” said Andrés Hurtado Lorenzo, PhD, Senior Vice President of Translational Research and IBD Ventures at the Crohn’s & Colitis Foundation. “PALI-2108 may help meet this need by directly targeting inflammation and fibrosis in the colon and ileum with limited systemic effects. Through our IBD Ventures program, we invest in promising, differentiated therapies like PALI-2108 to improve patient outcomes and advance innovative approaches for IBD.”

Palisade has completed a Phase 1a single-ascending dose, multiple-ascending dose, and food-effect study of PALI-2108, followed by a Phase 1b cohort study in UC, and is currently evaluating PALI-2108 in an ongoing Phase 1b cohort study in FSCD. Data from these studies are expected to support Phase 2 Investigational New Drug (IND) submissions to the U.S. Food and Drug Administration (FDA) in 2026.

About PALI-2108

PALI-2108 is an orally administered, prodrug engineered for local delivery of phosphodiesterase-4 (PDE4) inhibition to the terminal ileum and colon. The prodrug molecule is gut-restricted and pharmacologically inactive until it reaches the lower intestine, where it is cleaved by bacterial enzymes to release its active PDE4 inhibitor metabolite directly at the site of inflammation and fibrosis. This targeted and slow-release design prevents absorption through the upper gut, achieves sustained local exposure and a longer half-life that enables once-daily dosing, and is engineered to produce a blunted peak plasma concentration to improve the overall therapeutic index. Together, these properties are intended to maximize anti-inflammatory and anti-fibrotic effects while minimizing systemic exposure and reducing class-related tolerability issues, such as nausea and headache, that have limited systemic PDE4 inhibitors.

About the Crohn’s & Colitis Foundation

The Crohn’s & Colitis Foundation is the leading non-profit organization focused on both research and patient support for inflammatory bowel disease (IBD), with the mission of curing Crohn’s disease and ulcerative colitis, and of improving the quality of life of the millions of Americans living with IBD. The Foundation’s work is dramatically accelerating the research process through investment in research initiatives, while also providing extensive educational and support resources for patients and their families, medical professionals, and the public. For more information, visit www.crohnscolitisfoundation.org, call 888-694-8872, or email info@crohnscolitisfoundation.org.

About Palisade Bio

Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”) is a clinical-stage biopharmaceutical company advancing a next generation of, once daily, oral PDE4 inhibitor prodrugs designed to improve pharmacology, tolerability and convenience for patients with inflammatory and fibrotic diseases. Through its differentiated prodrug platform and precision pharmacology strategy, Palisade Bio is committed to transforming proven PDE4 biology into better, safer oral therapies for patients living with chronic inflammatory and fibrotic diseases.

The Company’s lead program, PALI-2108, is a locally-bioactivated PDE4 inhibitor prodrug being developed for moderate-to-severe Ulcerative Colitis (UC) and fibrostenotic Crohn’s Disease (FSCD), two diseases with limited non-immunosuppressive therapy options. In a recently reported Phase 1b trial, PALI-2108 achieved a 100% clinical response in the UC cohort, with no serious adverse events, favorable tolerability and pharmacokinetics consistent with sustained localized activation, low systemic exposure, and controlled release within the GI tract.

Palisade Bio is now advancing towards a Phase 2 clinical study in UC designed to evaluate clinical remission, response and pharmacodynamic biomarkers over 12 weeks, with an extension phase assessing maintenance of remission. In addition, the Company is preparing to initiate studies in FSCD to further characterize PALI-2108’s safety, pharmacology and therapeutic benefit across inflammatory bowel disease indications. 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: statements regarding the timing and results of clinical trials, the potential mechanisms of action and therapeutic benefits of PALI-2108, and plans for regulatory submissions. 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, activity, dosing or durability of effect, observed from preclinical or clinical trials, 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, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2025, 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.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
908-824-0775
PALI@jtcir.com

FAQ

What amount did the Crohn’s & Colitis Foundation invest in Palisade Bio (PALI)?

The Foundation approved a strategic equity investment of up to $500,000 in Palisade Bio.

What is PALI-2108 and which conditions is Palisade advancing it for (PALI)?

PALI-2108 is a gut-microbiota-activated PDE4 inhibitor designed for targeted delivery to the terminal ileum and colon, being advanced for fibrostenotic Crohn’s disease and moderate to severe ulcerative colitis.

What clinical studies of PALI-2108 has Palisade completed (PALI)?

Palisade completed Phase 1a single- and multiple-ascending dose and food-effect studies, plus a Phase 1b cohort study in UC.

Is Palisade conducting any ongoing PALI-2108 trials (PALI)?

Yes. Palisade is currently evaluating PALI-2108 in an ongoing Phase 1b cohort study in FSCD.

When does Palisade expect to file Phase 2 IND submissions for PALI-2108 (PALI)?

Palisade expects study data to support Phase 2 IND submissions to the FDA in 2026.

How does the Foundation describe its rationale for investing in PALI-2108 (PALI)?

The Foundation said it funds PALI-2108 because it may target inflammation and fibrosis in the colon and ileum with limited systemic effects and address unmet needs in FSCD and UC.