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Palisade Bio Strengthens Clinical Leadership Team with Appointment of James Izanec, MD, AGAF as Vice President, Clinical Development

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Palisade Bio (Nasdaq: PALI) appointed James Izanec, MD, AGAF as Vice President, Clinical Development effective Dec 2, 2025. Dr. Izanec is a physician‑scientist with over two decades of clinical and drug‑development leadership across immunology, neuroscience, and gastroenterology.

Key credentials cited: leadership of global Phase 2/3 programs including oversight of a 1,200‑patient Phase 3 Crohn’s program, strategic roles on ozanimod and deucravacitinib development, prior senior roles at Bristol Myers Squibb and Janssen, and principal‑investigator experience on more than 50 clinical trials.

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Positive

  • Appointed VP Clinical Development with 20+ years experience
  • Oversaw a 1,200‑patient Phase 3 Crohn’s program
  • Led pediatric development programs in Crohn’s and MS
  • Strategic clinical ownership for ozanimod and deucravacitinib
  • Principal investigator on > 50 clinical trials

Negative

  • None.

News Market Reaction

-2.14%
20 alerts
-2.14% News Effect
-15.3% Trough in 28 hr 50 min
-$6M Valuation Impact
$279M Market Cap
0.9x Rel. Volume

On the day this news was published, PALI declined 2.14%, reflecting a moderate negative market reaction. Argus tracked a trough of -15.3% from its starting point during tracking. Our momentum scanner triggered 20 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $6M from the company's valuation, bringing the market cap to $279M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase 3 Crohn’s program size: 1,200 patients Principal investigator trials: More than 50 clinical trials Publications and abstracts: More than 100 +5 more
8 metrics
Phase 3 Crohn’s program size 1,200 patients Oversight experience in a global Phase 3 Crohn’s disease trial
Principal investigator trials More than 50 clinical trials Inflammatory bowel disease, hepatology, functional GI and motility disorders
Publications and abstracts More than 100 Peer-reviewed publications and abstracts authored by Dr. Izanec
S-8 registered shares 236,557 shares 2025 Form S-8 for equity incentive and ESPP plans
Equity offering proceeds $138 million Underwritten equity offering closed October 2, 2025 (gross proceeds)
Cash balance $133.3 million Cash and cash equivalents as of October 15, 2025 (8-K)
Shelf-registered block 988,872 shares Block listed in S-3 shelf filed August 15, 2025
Estimated offering expenses $49,000 Total estimated expenses in S-3 shelf registration

Market Reality Check

Price: $1.81 Vol: Volume 8,873,647 is 1.9x ...
high vol
$1.81 Last Close
Volume Volume 8,873,647 is 1.9x the 20-day average of 4,670,209, indicating elevated interest before this announcement. high
Technical Price at $2.20 is trading above the 200-day MA of $1.04, reflecting a pre-existing uptrend.

Peers on Argus

Sector peers showed mixed moves: QNRX up 6.87%, while GRI and ADTX declined 4.35...
1 Up 2 Down

Sector peers showed mixed moves: QNRX up 6.87%, while GRI and ADTX declined 4.35–4.39%. With the target’s direction not specified, this points more to stock-specific dynamics than a unified sector trade.

Historical Context

5 past events · Latest: Dec 02 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Dec 02 Clinical leadership hire Positive -2.1% Appointment of experienced VP Clinical Development to guide late-stage programs.
Nov 25 Conference participation Neutral -5.7% Announcement of investor conference fireside chat and webcast availability.
Oct 28 Operations leadership hire Positive +11.4% Appointment of VP, Global Head of Clinical Operations to support PALI-2108.
Oct 20 Phase 1b dosing start Positive +6.9% First patients dosed in Phase 1b study of PALI-2108 for FSCD.
Oct 13 Patent grant Positive -7.5% Canadian patent granted for PALI-2108 composition with protection to 2041.
Pattern Detected

Recent news shows mixed reactions: operational and IP milestones for PALI-2108 sometimes aligned with positive price moves, while leadership and event announcements have occasionally seen negative reactions, indicating inconsistent trading responses to otherwise constructive updates.

Recent Company History

Over the last few months, Palisade Bio has advanced PALI-2108 through Phase 1b dosing in fibrostenotic Crohn’s disease, added experienced clinical operations leadership, and secured Canadian composition-of-matter patent protection through May 28, 2041. Conference participation and today’s senior clinical hire support the transition toward Phase 2 planning. Price reactions to these milestones have been mixed, with some positive clinical and leadership updates followed by drawdowns, highlighting variable trading responses despite steady strategic progress.

Regulatory & Risk Context

Active S-3 Shelf
Shelf Active
Active S-3 Shelf Registration 2025-08-15

An effective S-3 shelf was filed on August 15, 2025, listing 988,872 shares (noted as 10.24% of disclosed share counts) associated with specific holders. The filing also details estimated offering expenses totaling $49,000, indicating a structured framework for potential future registered transactions under this shelf.

Market Pulse Summary

This announcement adds an experienced VP of Clinical Development with leadership over a 1,200-patien...
Analysis

This announcement adds an experienced VP of Clinical Development with leadership over a 1,200-patient Phase 3 Crohn’s program and principal-investigator roles in more than 50 trials, directly supporting PALI-2108’s progression toward Phase 2. In the past year, Palisade paired positive early-stage data with strengthened cash resources and an S-3 shelf. Investors may watch for upcoming Phase 1b and planned Phase 2 milestones, as well as any further use of the shelf for financing.

Key Terms

PDE4 inhibitor prodrugs, Phase 2, Phase 3, ulcerative colitis, +2 more
6 terms
PDE4 inhibitor prodrugs medical
"advancing next-generation, once daily, oral PDE4 inhibitor prodrugs for patients..."
PDE4 inhibitor prodrugs are inactive chemical versions of drugs designed to become active inhibitors of the PDE4 enzyme once processed in the body; PDE4 controls cellular signals linked to inflammation and other conditions. Think of a prodrug as a sealed package that opens inside the body to release the real medicine. Investors care because prodrugs can improve how well a drug works, reduce side effects, extend patent life or simplify dosing, all of which affect clinical success, regulatory approval and commercial value.
Phase 2 medical
"deep expertise driving global Phase 2/3 programs across immunology..."
Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.
Phase 3 medical
"deep expertise driving global Phase 2/3 programs across immunology..."
Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
ulcerative colitis medical
"programs spanning Crohn’s disease, ulcerative colitis, multiple sclerosis..."
A long-term inflammatory disease that causes repeated sores and irritation in the large intestine, leading to symptoms such as abdominal pain, urgent diarrhea, and fatigue. For investors, it matters because the condition creates a steady need for effective treatments, influences the size of drug and medical-device markets, and makes clinical trial results, regulatory decisions and treatment approvals material to companies’ revenue prospects—like watching for fixes to a recurring leak in an important building system.
Crohn’s disease medical
"programs spanning Crohn’s disease, ulcerative colitis, multiple sclerosis..."
A long-lasting inflammatory condition that can inflame any part of the digestive tract, causing pain, diarrhea, weight loss and fatigue; symptoms often flare up unpredictably and may require lifelong medication or surgery. Investors monitor Crohn’s disease because its chronic, costly nature creates steady demand for treatments, diagnostics and medical services, so new drugs, trial results or approval decisions can materially change sales prospects and company valuations — think of it like a recurring plumbing problem that drives ongoing repair business.
hepatologist medical
"spent a decade as a practicing gastroenterologist and hepatologist..."
A hepatologist is a medical specialist who diagnoses and treats diseases of the liver, gallbladder and bile ducts, similar to how a mechanic focuses on one part of a car. For investors, a hepatologist’s findings, clinical opinions or involvement in drug trials can influence the perceived value and market prospects of therapies and diagnostics related to liver disease, affecting clinical risk, adoption and potential sales.

AI-generated analysis. Not financial advice.

Veteran gastroenterologist and clinical development leader with deep expertise driving global Phase 2/3 programs across immunology, neurology, and gastrointestinal disease

Carlsbad, CA, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company advancing next-generation, once daily, oral PDE4 inhibitor prodrugs for patients with inflammatory and fibrotic diseases, today announced the appointment of James Izanec, MD, AGAF as Vice President, Clinical Development.


Dr. Izanec is a physician–scientist with over two decades of clinical and drug development leadership spanning immunology, neuroscience, and gastroenterology. He brings extensive experience directing registrational Phase 2 and Phase 3 programs, shaping asset-level development strategies, and guiding cross‑functional execution at leading pharmaceutical organizations including Bristol Myers Squibb and Janssen.

Dr. Mitchell Jones, Chief Medical Officer of Palisade Bio, commented, “We are thrilled to welcome Dr. Izanec to Palisade. His leadership of major late‑stage global programs, combined with his deep expertise in gastroenterology and immunology, brings the operational rigor and scientific depth needed as PALI‑2108 advances toward key milestones. His experience running complex, multinational Phase 3 programs spanning Crohn’s disease, ulcerative colitis, multiple sclerosis, Sjögren’s syndrome, and pediatric indications positions him to make an immediate and meaningful impact on our development strategy and execution.”

Prior to joining Palisade Bio, Dr. Izanec served as Senior Medical Director and Clinical Development Lead at Bristol Myers Squibb, where he led global Phase 2/3 development programs across autoimmune and neurological diseases. His responsibilities included oversight of a 1,200‑patient Phase 3 Crohn’s program, leadership of pediatric development programs in Crohn’s disease, ulcerative colitis, and multiple sclerosis, and strategic ownership for the clinical development plans of ozanimod and deucravacitinib.

Previously, he served as Medical Director at Janssen, where he led global Phase 3 and Phase 4 studies in gastroenterology and immunology, contributed to lifecycle and label‑expansion programs for ustekinumab and infliximab, and helped support the successful launch of Stelara in ulcerative colitis, the largest franchise within Johnson & Johnson.

Earlier in his career, Dr. Izanec spent a decade as a practicing gastroenterologist and hepatologist, serving as principal investigator for more than 50 clinical trials across inflammatory bowel disease, hepatology, functional GI disorders, and motility disorders. He has authored more than 100 peer‑reviewed publications and abstracts and has been a frequent invited speaker at global medical congresses including DDW, ECCO, ACG, and UEGW.

Dr. Izanec received his medical degree from Weill Cornell Medical College, completed his internal medicine residency at Temple University Hospital, and his gastroenterology fellowship at Drexel University College of Medicine. He is a Fellow of the American Gastroenterological Association and graduated magna cum laude from Cornell University.

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

Source: Palisade Bio


FAQ

Who is the new VP Clinical Development at Palisade Bio (PALI)?

James Izanec, MD, AGAF was appointed Vice President, Clinical Development on Dec 2, 2025.

What clinical experience does James Izanec bring to PALI?

He has 20+ years of clinical and development leadership across immunology, neuroscience, and gastroenterology.

What major program oversight did Dr. Izanec hold previously relevant to PALI?

He oversaw a 1,200‑patient Phase 3 Crohn’s program at Bristol Myers Squibb.

How many clinical trials has Dr. Izanec served as principal investigator on?

He served as principal investigator on more than 50 clinical trials across IBD, hepatology, and GI disorders.

Which marketed assets did Dr. Izanec support in prior roles?

He contributed to lifecycle and label‑expansion programs for ustekinumab and infliximab and supported the launch of Stelara in ulcerative colitis.
Palisade Bio Inc

NASDAQ:PALI

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PALI Stock Data

284.98M
136.93M
0.24%
5.92%
3.6%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States
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