Palisade Bio Announces Granting of Japanese Patent Covering Composition of Matter for Lead Product Candidate, PALI-2108

Rhea-AI Summary

Palisade Bio (NASDAQ: PALI) announced the Japan Patent Office granted a composition-of-matter patent for PALI-2108, a gut-microbiota-activated PDE4 B/D inhibitor targeting fibrostenotic Crohn’s disease (FSCD) and moderate-to-severe ulcerative colitis (UC).

The base patent term extends into 2041 and is eligible for patent term extension based on regulatory review timelines. PALI-2108 has completed Phase 1a SAD/MAD and FE studies, a Phase 1b cohort in UC, and is in an ongoing Phase 1b cohort in FSCD. Data are expected to support a Phase 2 IND submission in H1 2026. The patent expands the company’s global IP estate for its locally-acting PDE4 prodrug platform.

Positive

• Japan composition patent granted for PALI-2108
• Base patent term extends into 2041
• Phase 1a SAD/MAD and FE completed for PALI-2108
• Phase 1b cohort in UC completed and FSCD cohort ongoing
• Phase 2 IND submission planned H1 2026

Negative

• Clinical-stage company with no approved PALI-2108 products
• Patent term extension is only eligible and not guaranteed

News Market Reaction – PALI

-4.84%

16 alerts

-4.84% News Effect

+5.0% Peak Tracked

-13.0% Trough Tracked

-$19M Valuation Impact

$370M Market Cap

0.2x Rel. Volume

On the day this news was published, PALI declined 4.84%, reflecting a moderate negative market reaction. Argus tracked a peak move of +5.0% during that session. Argus tracked a trough of -13.0% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $19M from the company's valuation, bringing the market cap to $370M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Japanese patent term: to 2041 Phase 2 IND timing: H1 2026 Cash balance: $133.3M +5 more

8 metrics

Japanese patent term to 2041 Composition-of-matter protection for PALI-2108 in Japan

Phase 2 IND timing H1 2026 Planned IND submissions for FSCD and UC

Cash balance $133.3M Cash and cash equivalents as of Oct 15, 2025 (8-K)

Equity offering $138M Gross proceeds from underwritten offering closed Oct 2, 2025

Q3 2025 net loss $2.9M Quarter ended Sept 30, 2025 (10-Q)

Cash & equivalents $5.2M Balance at Sept 30, 2025 before October financing

Pre-funded warrants 73,271,424 Pre-funded warrants outstanding as of Oct 15, 2025 (8-K)

S-3 registered shares 988,872 shares Shares listed in S-3 shelf registration filed Aug 15, 2025

Market Reality Check

Price: $1.85 Vol: Volume 13,586,595 is abou...

high vol

$1.85 Last Close

Volume Volume 13,586,595 is about 2.35x the 20-day average of 5,793,719, signaling elevated interest ahead of this patent update. high

Technical Price at $2.48 is trading above the 200-day MA of $1.11 and sits 4.25% below the 52-week high of $2.59.

Peers on Argus

PALI gained 15.35% with strong volume, while key peers in biotechnology were mix...

1 Up

PALI gained 15.35% with strong volume, while key peers in biotechnology were mixed: GRI showed an intraday scanner move of +18.68%, but other high-affinity peers like SXTP (-23.93%) and ADTX (-6.36%) were down, indicating a company-specific reaction rather than a broad sector move.

Historical Context

5 past events · Latest: Dec 02 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 02	Leadership appointment	Positive	-2.1%	Hired VP Clinical Development with broad immunology and IBD trial experience.
Nov 25	Conference participation	Positive	-5.7%	Announced fireside chat and investor meetings at healthcare conference.
Oct 28	Operations leadership hire	Positive	+11.4%	Appointed VP, Global Head of Clinical Operations to support PALI-2108 programs.
Oct 20	Phase 1b dosing start	Positive	+6.9%	Dosed first patients in Phase 1b FSCD study for PALI-2108.
Oct 13	Canadian patent grant	Positive	-7.5%	Canadian composition-of-matter patent granted for PALI-2108 through 2041.

Pattern Detected

Recent news reactions are mixed: operational and IP milestones sometimes sold off, while development updates for PALI-2108 more often aligned positively with price moves.

Recent Company History

Over the last few months, Palisade Bio has focused on building its inflammatory bowel disease franchise around PALI-2108. Key steps included Canadian composition-of-matter protection through 2041, initiation of a Phase 1b FSCD study with topline data targeted for Q1 2026, and senior clinical operations hires to support Phase 2 IND submissions planned for H1 2026. Today’s Japanese patent grant extends that IP-building trend, reinforcing global coverage around the same lead asset.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-08-15

An effective shelf registration on Form S-3 was filed on August 15, 2025, listing 988,872 shares tied to specific holders and disclosing estimated offering expenses totaling $49,000. The shelf is noted as not yet effective and shows 1 usage via a 424B4 prospectus supplement dated October 2, 2025.

Market Pulse Summary

This announcement adds Japanese composition-of-matter protection for PALI-2108, extending patent cov...

Analysis

This announcement adds Japanese composition-of-matter protection for PALI-2108, extending patent coverage into 2041 and complementing earlier Canadian IP. The update fits an ongoing strategy to advance PALI-2108 through Phase 1b and toward Phase 2 IND submissions planned for H1 2026. Recent filings highlight strengthened liquidity from a $138M offering and cash of $133.3M, while the existing S-3 registration and substantial warrants remain structural factors to monitor.

Key Terms

PDE4 inhibitor, ulcerative colitis (UC), fibrostenotic Crohn’s disease (FSCD), composition-of-matter, +4 more

8 terms

PDE4 inhibitor medical

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

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.

ulcerative colitis (UC) medical

"for treatment of ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD)"

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

"for treatment of ulcerative colitis (UC) 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.

composition-of-matter regulatory

"The patent ... provides composition-of-matter protection for PALI-2108 in Japan."

A composition-of-matter is a legal description of a specific chemical or biological substance or mixture—think of it as the exact recipe and ingredients that make up a drug, material, or chemical product. For investors, ownership of a composition-of-matter patent can act like a locked recipe that keeps competitors out, protecting future sales and profit margins and reducing the risk that a product will be easily copied.

gut-microbiota-activated medical

"the Company’s lead, gut-microbiota-activated PDE4 B/D inhibitor being advanced for FSCD"

A compound described as "gut-microbiota-activated" is one that only becomes effective after bacteria in the intestines chemically change it, much like a locked package that is opened by a specific key inside the gut. For investors, this matters because patient-to-patient differences in gut bacteria can affect how well the product works, its safety profile, dosing predictability, regulatory review, and the need for companion tests or targeted marketing to the right patient groups.

prodrug medical

"Palisade Bio ... developing ... oral PDE4 inhibitor prodrugs designed for targeted delivery"

A prodrug is an inactive or less-active compound that is designed to be converted into an active drug inside the body, like a packaged meal that needs heating before it's ready to eat. For investors, prodrugs matter because this design can improve how a medicine is absorbed, reduce side effects, extend patent protection, or enable new dosing forms — all factors that can affect a drug's regulatory path, marketability, and commercial value.

Phase 1b medical

"and FE, followed by a Phase 1b cohort study in UC and is currently being evaluated"

"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.

Investigational New Drug (IND) regulatory

"Data from these studies are expected to 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.

AI-generated analysis. Not financial advice.

PALI-2108 is the first and only PDE4 inhibitor in development targeting
the terminal ileum and colon for treatment of ulcerative colitis (UC) and fibrostenotic Crohn’s disease (FSCD) to address significant unmet medical needs

Ongoing development of PALI-2108 across FSCD and UC, with Phase 2 IND submission planned for H1 2026

Carlsbad, CA, Dec. 30, 2025 (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 Japan Patent Office (JPO) has granted a key patent covering PALI-2108, the Company’s lead, gut-microbiota-activated PDE4 B/D inhibitor being advanced for fibrostenotic Crohn’s disease (FSCD) and moderate to severe ulcerative colitis (UC).

The patent, titled “Gut Microbiota-Activated PDE4 Inhibitor Prodrug,” provides composition-of-matter protection for PALI-2108 in Japan. The base patent term extends into 2041 and is eligible for patent term extension based on regulatory review timelines. This issuance expands Palisade Bio’s growing global intellectual property estate supporting PALI-2108 and its broader platform of locally activated PDE4 inhibitor prodrugs.

“Securing this Japanese patent for PALI-2108 is an important milestone as we continue to strengthen the IP foundation for our IBD portfolio,” said J.D. Finley, Chief Executive Officer of Palisade Bio. “Japan represents one of the world’s largest and most commercially significant markets for inflammatory bowel disease, and patients with UC and FSCD continue to face limited targeted treatment options. This patent not only reinforces the global reach of our technology but also supports the long-term opportunity of PALI-2108 as a differentiated, locally-acting therapy. We believe PALI-2108 has the potential to meaningfully improve outcomes for IBD patients in Japan and worldwide.”

PALI-2108 has recently completed a Phase 1a SAD/MAD and FE, followed by a Phase 1b cohort study in UC and is currently being evaluated 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 the first half of 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 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 did Palisade Bio announce about PALI-2108 on December 30, 2025?

The company announced the Japan Patent Office granted a composition-of-matter patent for PALI-2108, with a base term into 2041.

How does the Japan patent affect PALI (NASDAQ: PALI) commercialization in Japan?

The patent provides composition-of-matter protection for PALI-2108 in Japan, supporting the drug's long-term IP position in that market.

What is the clinical status of PALI-2108 and the expected regulatory timeline for PALI (NASDAQ: PALI)?

PALI-2108 completed Phase 1a SAD/MAD and FE, completed a Phase 1b cohort in UC, has an ongoing Phase 1b in FSCD, and plans a Phase 2 IND submission in H1 2026.

Does the Japan patent for PALI-2108 expire in 2041 for PALI (NASDAQ: PALI)?

The base patent term extends into 2041, and it is eligible for patent term extension based on regulatory timelines.

Will the Japan patent guarantee commercial success for PALI-2108 (PALI)?

The patent strengthens IP protection in Japan but does not guarantee regulatory approval or commercial success for PALI-2108.

What next clinical milestone should investors in PALI (NASDAQ: PALI) watch for?

Investors should watch for clinical data releases and the planned Phase 2 IND submission in H1 2026.