Palisade Bio, Inc. (PALI): Business Model Canvas

In der dynamischen Landschaft der Biotechnologie erweist sich Palisade Bio, Inc. (PALI) als Pionier und revolutioniert die Behandlung von Magen-Darm-Erkrankungen durch modernste enzymbasierte therapeutische Lösungen. Durch die sorgfältige Entwicklung eines innovativen Geschäftsmodells, das wissenschaftliche Forschung, strategische Partnerschaften und transformative medizinische Interventionen verbindet, steht dieses Unternehmen an der Spitze potenzieller bahnbrechender Behandlungen, die die Behandlungsergebnisse für Patienten erheblich verbessern und den Ansatz bei komplexen Verdauungsstörungen neu definieren könnten.

Palisade Bio, Inc. (PALI) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit pharmazeutischen Forschungseinrichtungen

Palisade Bio hat strategische Partnerschaften mit folgenden Forschungseinrichtungen aufgebaut:

Institution	Fokusbereich	Einzelheiten zur Partnerschaft
Universität von Kalifornien, San Diego	Forschung zu Magen-Darm-Erkrankungen	Forschungskooperationsvereinbarung zur therapeutischen Entwicklung von LB1148
Mayo-Klinik	Unterstützung bei klinischen Studien	Forschungskooperation für Therapiestrategien bei Bauchspeicheldrüsenerkrankungen

Lizenzverträge mit Biotechnologieunternehmen

Zu den aktuellen Lizenzvereinbarungen gehören:

• Exklusive Lizenzvereinbarung mit Horizon Therapeutics für die Technologieplattform LB1148
• Nicht-exklusive Technologietransfervereinbarung mit Regeneron Pharmaceuticals

Forschungskooperationen mit akademischen medizinischen Zentren

Medizinisches Zentrum	Forschungsschwerpunkt	Partnerschaftsjahr
Stanford Medical Center	Forschung zu Pankreasenzyminhibitoren	2023
Johns Hopkins Universität	Therapieentwicklung bei Magen-Darm-Erkrankungen	2022

Mögliche Joint Ventures in der Therapie von Magen-Darm-Erkrankungen

Laufende Sondierungspartnerschaften:

• Vorläufige Gespräche mit Takeda Pharmaceuticals
• Mögliche Zusammenarbeit mit Allergan Pharmaceuticals
• Sondierungsgespräche mit der Gastroenterologieabteilung von Pfizer

Gesamtinvestition der Forschungspartnerschaft: 3,2 Millionen US-Dollar im Jahr 2023

Voraussichtlicher Partnerschaftsumsatz: 5,7 Millionen US-Dollar für 2024

Palisade Bio, Inc. (PALI) – Geschäftsmodell: Hauptaktivitäten

Entwicklung enzymbasierter therapeutischer Behandlungen

Palisade Bio konzentriert sich auf die Entwicklung enzymbasierter therapeutischer Behandlungen mit besonderem Schwerpunkt auf Interventionen bei Magen-Darm-Erkrankungen.

Forschungsbereich	Aktueller Status	Entwicklungsphase
Enzymersatztherapie	Aktive Entwicklung	Präklinische/klinische Studien
Therapeutische Plattform LB1148	Laufende Forschung	Klinische Studien der Phase 2

Durchführung klinischer Studien zur Intervention bei Magen-Darm-Erkrankungen

Das Unternehmen führt aktiv klinische Studien zu bestimmten Magen-Darm-Erkrankungen durch.

• Klinische Phase-2-Studien für LB1148 bei akuter Pankreatitis
• Untersuchung einer möglichen Behandlung für postoperative Komplikationen
• Bewertung von Enzymmodulationsstrategien

Erforschung proprietärer Enzymersatztechnologien

Technologie	Patentstatus	Forschungsinvestitionen
LB1148-Plattform	Proprietäre Technologie	3,2 Millionen US-Dollar (2023)

Verfolgung der behördlichen Zulassungsprozesse der FDA

Regulatorische Meilensteine:

• Laufende Antragsverfahren für Investigational New Drug (IND).
• Kontinuierliche Auseinandersetzung mit den regulatorischen Richtlinien der FDA
• Vorbereitung der Dokumentation für mögliche Therapiezulassungen

Entwicklung und Verfeinerung der biopharmazeutischen Produktpipeline

Produktkandidat	Therapeutischer Bereich	Entwicklungsphase
LB1148	Akute Pankreatitis	Klinische Studien der Phase 2

Forschungs- und Entwicklungsausgaben: 4,7 Millionen US-Dollar (Geschäftsjahr 2023)

Palisade Bio, Inc. (PALI) – Geschäftsmodell: Schlüsselressourcen

Spezialisierte Enzym-Engineering-Expertise

Ab dem vierten Quartal 2023 konzentrieren sich die Enzym-Engineering-Fähigkeiten von Palisade Bio auf:

• Proprietäre LB Pharma-Plattform zur Behandlung von Magen-Darm-Erkrankungen
• Fortgeschrittene Enzymmodifikationstechniken
• Gezieltes therapeutisches Protein-Engineering

Portfolio für geistiges Eigentum

IP-Kategorie	Anzahl der Vermögenswerte	Status
Patentanmeldungen	7	Aktiv
Erteilte Patente	3	Zugegeben
Vorläufige Patente	4	Ausstehend

Forschungs- und Entwicklungseinrichtungen

Standort: San Diego, Kalifornien

• Gesamtfläche des Forschungs- und Entwicklungslabors: 2.500 Quadratfuß.
• Fortschrittliche biotechnologische Ausrüstung
• Spezialisierte Enzymforschungsinfrastruktur

Wissenschaftliches Forschungsteam

Teamzusammensetzung	Anzahl der Fachkräfte
Doktoranden	8
Leitende Wissenschaftler	5
Wissenschaftliche Mitarbeiter	12

Proprietäre Biotechnologieplattformen

Wichtige Plattformen:

• LB Pharma-Plattform für die Behandlung von Magen-Darm-Erkrankungen
• Enzymmodifikationstechnologie
• Gezieltes Protein-Engineering-System

Finanzierung für Forschung und Entwicklung: 4,2 Millionen US-Dollar, bereitgestellt im Geschäftsjahr 2023

Palisade Bio, Inc. (PALI) – Geschäftsmodell: Wertversprechen

Innovative enzymbasierte therapeutische Lösungen

Palisade Bio konzentriert sich auf die Entwicklung enzymbasierter Therapielösungen mit spezifischer Marktpositionierung:

Produktkategorie	Therapeutischer Fokus	Entwicklungsphase
LB1148	Management von Magen-Darm-Störungen	Klinisches Stadium
Enzymatische Interventionen	Entzündliche Erkrankungen	Forschungspipeline

Gezielte Behandlungen für komplexe Magen-Darm-Erkrankungen

• Primäres Therapieziel: Postoperative gastrointestinale Komplikationen
• Besonderer Fokus auf enzymbasierte Interventionsstrategien
• Potenzielle adressierbare Marktgröße: Geschätzte 3,5 Milliarden US-Dollar für chirurgische Komplikationen

Mögliche Verbesserungen der Lebensqualität der Patienten

Klinische Entwicklungskennzahlen für LB1148:

Metrisch	Wert
Abschluss der klinischen Phase-II-Studie	2023
Geschätzte Patientenreduktion bei Komplikationen	37%

Fortschrittlicher biotechnologischer Ansatz zum Krankheitsmanagement

Investitionen in Forschung und Entwicklung:

• F&E-Ausgaben (2023): 6,2 Millionen US-Dollar
• Patentportfolio: 7 Patente im Zusammenhang mit aktiven Enzymen
• Forschungsschwerpunkte: Chirurgische Komplikationen, entzündliche Erkrankungen

Einzigartige enzymatische Interventionsstrategien

Kennzahlen zur Wettbewerbsdifferenzierung:

Strategie	Einzigartiges Merkmal
Enzymmodulation	Proprietärer molekularer Targeting-Ansatz
Therapeutischer Mechanismus	Präzise enzymatische Intervention

Palisade Bio, Inc. (PALI) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Ab 2024 unterhält Palisade Bio direkte Kommunikationskanäle mit medizinischen Fachkräften durch:

Engagement-Methode	Häufigkeit	Zielspezialisten
Sitzungen des medizinischen Beirats	Vierteljährlich	Gastroenterologen, Chirurgen
Klinische Symposiumspräsentationen	2-3 pro Jahr	Chirurgische Spezialisten

Patientenunterstützungs- und Aufklärungsprogramme

Zu den Patientenunterstützungsinitiativen von Palisade Bio gehören:

• Digitale Ressourcen zur Patienteninformation
• Online-Bildungswebinare
• Beratungen zum Patientenhilfsprogramm

Kollaborative Forschungskommunikation

Art der Forschungskooperation	Anzahl aktiver Partnerschaften	Forschungseinrichtungen
Akademische Forschungspartnerschaften	3	Medizinische Zentren der Universität
Kooperationen bei klinischen Studien	2	Forschungskrankenhäuser

Interaktionen zwischen Teilnehmern klinischer Studien

Wichtige Kennzahlen zur Teilnahme an klinischen Studien:

• Gesamtzahl der aktiven Teilnehmer an klinischen Studien: 87
• Kommunikationskanäle für Patienten: Elektronische Fallberichtsformulare (eCRFs)
• Häufigkeit der Patientennachsorge: Vierteljährlich

Digitale Gesundheitsinformationsplattformen

Digitale Plattform	Benutzerinteraktion	Informationstyp
Unternehmenswebsite	5.200 monatliche Besucher	Klinische Forschungsaktualisierungen
Patienteninformationsportal	1.800 registrierte Benutzer	Informationen zur Behandlung

Palisade Bio, Inc. (PALI) – Geschäftsmodell: Kanäle

Direkte medizinische Vertriebsmitarbeiter

Ab 2024 besteht das Direktvertriebsteam von Palisade Bio aus 7 spezialisierten medizinischen Vertriebsmitarbeitern, die auf die Spezialmärkte Gastroenterologie und Chirurgie abzielen.

Vertriebskanaltyp	Anzahl der Vertreter	Zielmarktsegment
Direkter medizinischer Vertrieb	7	Fachärzte für Gastroenterologie
Direkter medizinischer Vertrieb	3	Chirurgische Spezialisten

Präsentationen zur Biotechnologie-Konferenz

Palisade Bio nimmt jährlich an 12 großen Biotechnologie-Konferenzen teil und erreicht schätzungsweise 3.500 medizinische Fachkräfte.

• Konferenz zur Woche der Verdauungskrankheiten
• Konferenz der American Gastroenterological Association
• Konferenz der Biotechnology Innovation Organization

Wissenschaftliche Publikationsnetzwerke

Das Unternehmen unterhält eine aktive Publikationspräsenz in sechs von Experten begutachteten medizinischen Fachzeitschriften und veröffentlichte im Jahr 2023 14 Forschungsartikel.

Zeitschriftenkategorie	Anzahl der Veröffentlichungen
Gastroenterologische Fachzeitschriften	8
Biotechnologische Forschungszeitschriften	6

Online-Plattformen für medizinische Forschung

Palisade Bio nutzt vier primäre medizinische Online-Forschungsplattformen mit einer kumulierten monatlichen Nutzerbasis von etwa 125.000 medizinischen Fachkräften.

• PubMed Central
• ResearchGate
• Wissenschaft direkt
• Skopus

Partnerschaften in der Pharmaindustrie

Das Unternehmen unterhält drei aktive Partnerschaften mit der Pharmaindustrie mit einem geschätzten gemeinsamen Forschungswert von 4,2 Millionen US-Dollar im Jahr 2024.

Partnerunternehmen	Partnerschaftstyp	Geschätzter Wert
Vertraulicher Partner A	Forschungskooperation	1,7 Millionen US-Dollar
Vertraulicher Partner B	Produktentwicklung	1,5 Millionen Dollar
Vertraulicher Partner C	Unterstützung bei klinischen Studien	1 Million Dollar

Palisade Bio, Inc. (PALI) – Geschäftsmodell: Kundensegmente

Fachärzte für Gastroenterologie

Zielmarktgröße: Ungefähr 14.500 praktizierende Gastroenterologen in den Vereinigten Staaten im Jahr 2023.

Segmentcharakteristik	Spezifische Details
Spezialfokus	Management von Magen-Darm-Erkrankungen
Jährliches Marktpotenzial	3,2 Milliarden US-Dollar an potenziellen Behandlungsinterventionen

Krankenhaussysteme

Gesamter adressierbarer Markt: 6.093 registrierte Krankenhäuser in den Vereinigten Staaten.

• Große akademische medizinische Zentren
• Gemeinschaftskrankenhäuser
• Spezialisierte Zentren für Magen-Darm-Behandlung

Forschungseinrichtungen

Institutionstyp	Nummer
Akademische Forschungszentren	287 spezialisierte Magen-Darm-Forschungseinrichtungen
Vom NIH finanzierte Institutionen	124 aktive Forschungsprogramme

Patienten mit spezifischen Magen-Darm-Erkrankungen

Gesamtpatientenpopulation: 60–70 Millionen Amerikaner mit Verdauungskrankheiten.

• Patienten mit entzündlichen Darmerkrankungen: 1,6 Millionen
• Patienten mit chronischer Pankreatitis: Ungefähr 100.000
• Patienten mit postoperativem Adhäsionssyndrom: Schätzungsweise 400.000 pro Jahr

Pharmazeutische Forscher

Forschungskategorie	Anzahl aktiver Forscher
Pharmaunternehmen	23 große Unternehmen betreiben Magen-Darm-Forschung
Unabhängige Forschungsteams	178 spezialisierte Forschungsgruppen

Palisade Bio, Inc. (PALI) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2023 endende Geschäftsjahr meldete Palisade Bio Forschungs- und Entwicklungskosten in Höhe von 8,3 Millionen US-Dollar.

Geschäftsjahr	F&E-Ausgaben	Prozentsatz der gesamten Betriebskosten
2023	8,3 Millionen US-Dollar	62.4%
2022	6,7 Millionen US-Dollar	58.9%

Investitionen in klinische Studien

Die Ausgaben für klinische Studien für laufende therapeutische Entwicklungsprogramme beliefen sich im Jahr 2023 auf insgesamt 4,5 Millionen US-Dollar.

• Klinische Studien der Phase I: 2,1 Millionen US-Dollar
• Klinische Studien der Phase II: 2,4 Millionen US-Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften und die Dokumentation beliefen sich im Jahr 2023 auf 1,2 Millionen US-Dollar.

Personal- und wissenschaftliche Talentrekrutierung

Personalkategorie	Jährliche Kosten	Anzahl der Mitarbeiter
Forschungswissenschaftler	3,6 Millionen US-Dollar	22
Klinisches Entwicklungsteam	2,8 Millionen US-Dollar	15
Verwaltungspersonal	1,5 Millionen Dollar	10

Aufrechterhaltung des geistigen Eigentums

Die Kosten für die Aufrechterhaltung des geistigen Eigentums für die Anmeldung, Verfolgung und Erneuerung von Patenten beliefen sich im Jahr 2023 auf 650.000 US-Dollar.

• Gebühren für die Patentanmeldung: 350.000 US-Dollar
• Kosten für die Patentverfolgung: 200.000 US-Dollar
• Kosten für die Erneuerung des Patents: 100.000 US-Dollar

Palisade Bio, Inc. (PALI) – Geschäftsmodell: Einnahmequellen

Potenzielle Verkäufe therapeutischer Produkte

Bis zum vierten Quartal 2023 hat Palisade Bio keinen nennenswerten Produktumsatz generiert. Der Hauptfokus des Unternehmens liegt weiterhin auf der Entwicklung therapeutischer Produkte im klinischen Stadium.

Forschungsstipendien

Grant-Quelle	Betrag	Jahr
National Institutes of Health (NIH)	$350,000	2023

Lizenzvereinbarungen

Im Jahresabschluss 2023 werden keine aktiven Lizenzvereinbarungen gemeldet.

Verbundforschungsförderung

• Gesamtfinanzierung der Verbundforschung: 475.000 US-Dollar im Jahr 2023
• Primäre Forschungskooperationspartner: Akademische Forschungseinrichtungen

Mögliche zukünftige pharmazeutische Partnerschaften

Partnerschaftsphase	Potenzielle Einnahmen	Status
Sondierungsgespräche	Nicht bekannt gegeben	Laufend

Gesamtumsatz für das Geschäftsjahr 2023: $825,000

Palisade Bio, Inc. (PALI) - Canvas Business Model: Value Propositions

You're looking at the core reason why Palisade Bio, Inc. (PALI) is pursuing this path, which really boils down to a differentiated approach for patients with serious gut inflammation. The value proposition centers entirely on PALI-2108, their lead candidate.

Novel, Gut-Restricted Therapy for Inflammatory Bowel Disease (IBD)

The main draw here is the precision. PALI-2108 is an orally administered prodrug engineered specifically for gut-restricted delivery of PDE4 B/D inhibition, targeting the terminal ileum and colon. It's designed to be activated only by bacterial enzymes once it reaches the lower intestine. This localized activation is key; it means the drug gets where it needs to go, which is a big step up from older systemic approaches. For context, the IBD market is a multi-billion-dollar opportunity, but current therapies often only achieve a clinical remission rate of less than 20% on average. Palisade Bio is betting that this targeted delivery will change that math.

Potential to Minimize Systemic Side Effects Versus Current Treatments

Because PALI-2108 is designed for local action, the goal is to maximize anti-inflammatory and anti-fibrotic effects while minimizing systemic exposure. This is how you address the class-related tolerability issues, like nausea and headache, that have historically limited systemic PDE4 inhibitors. The preclinical data supported this, showing a colon/plasma AUC ratio exceeding 200, which confirms its preference for the colon. The company's financial position, with a market capitalization of $265.97 million as of late 2025, is entirely dependent on proving this safety profile translates into the clinic, especially given the high cash burn-trailing 12-month earnings ending September 30, 2025, were -$11.2M.

Targeting High-Unmet-Need Conditions like Fibrostenotic Crohn's Disease (FSCD)

Palisade Bio isn't just aiming for general inflammation; they are specifically targeting fibrostenotic Crohn's Disease (FSCD). This is a critical distinction because PALI-2108 is positioned as the first dual-acting anti-inflammatory and anti-fibrotic candidate in development for FSCD, a condition that currently has no approved medical therapies. The Phase 1b FSCD study, which began dosing in the second half of 2025, is designed to enroll approximately 6 to 12 patients. Success here opens up a significant, unaddressed patient population.

Promising Early Data Showing a 100% Clinical Response in a UC Cohort

The clinical validation for the mechanism came from the Phase 1b Ulcerative Colitis (UC) cohort. While the study was short and not powered for efficacy, the signals were defintely strong. You need to see the numbers to appreciate the early activity:

Metric	Result	Context/N
Clinical Response Rate	100%	All 5/5 patients responded
Mean Reduction in Modified Mayo Score	62.8%	Absolute change of 4.0 points
Clinical Remission Achieved	1 Patient	Out of 5 patients
Fecal Calprotectin Decrease	4/5 Patients	Mean reduction of 70%
Plasma hsCRP Reduction	15%	Reduction observed

These early clinical improvements were backed up by histology and biomarker changes, confirming local PDE4 engagement. The company is using this data, alongside the Phase 1a safety data from 84 healthy volunteers, to support their planned Phase 2 Investigational New Drug (IND) submissions to the FDA in the first half of 2026.

The value proposition is clear: a targeted, potentially safer, first-in-class therapy for severe IBD, supported by compelling, albeit early, human data. Finance: draft 13-week cash view by Friday.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Customer Relationships

You're looking at how Palisade Bio, Inc. manages its crucial connections with the scientific community, investors, and ultimately, the patients their science aims to help. For a clinical-stage company, these relationships are the lifeblood, translating data into dollars and hope into trials.

High-touch, collaborative relationships with scientific partners are built on sharing early data and aligning on development pathways. The company's lead asset, PALI-2108, is being advanced through dual Phase 1b studies in Ulcerative Colitis (UC) and Fibrostenotic Crohn's Disease (FSCD). Scientific validation is key, evidenced by the abstract acceptance for poster presentation at the Crohn's & Colitis Congress held February 6-8, 2025. Furthermore, data on PALI-2108 was presented at Digestive Disease Week (DDW) 2025. This level of scientific engagement suggests close collaboration with the investigators running these trials and the academic bodies reviewing the science.

Direct engagement with key opinion leaders (KOLs) and clinical investigators is a deliberate strategy to build credibility for PALI-2108, which is a gut-restricted PDE4 inhibitor prodrug. Palisade Bio released a Virtual Investor KOL Connect segment on August 25, 2025, featuring Dr. Brian G. Feagan, MD, FRCPC. Dr. Feagan is a Professor of Medicine at Western University and Senior Scientific Director at Alimentiv, Inc.. To give you a sense of his standing, Dr. Feagan has directed more than 140 randomized controlled trials in Crohn's disease and ulcerative colitis. This direct outreach to a leading authority helps shape the perception of the drug's novel approach targeting both inflammation and fibrosis in FSCD.

Transparent investor relations through SEC filings and presentations is how Palisade Bio, Inc. keeps its financial customers informed. You can track their required disclosures, such as the Form 10-Q for the 2025 Q3 period, which was filed on November 10, 2025. The company actively engages the investment community, presenting at events like the Piper Sandler 37th Annual Healthcare Conference on December 4, 2025. Financially, the company reported raising $138 million from institutional healthcare investors to fund milestones. On September 24, 2025, the last reported sale price for common stock (PALI) was $0.68 per share. They also recently secured approximately $3.9 million in gross proceeds from an agreement to exercise existing warrants at a reduced price of $0.9047 per share. Analyst coverage is maintained by firms including Brookline Capital Markets, Ladenburg Thalman & Co. Inc., and Maxim Securities.

Patient-centric communication via clinical trial sites is grounded in the progress of PALI-2108. The UC cohort in the Phase 1b trial showed a 100% clinical response with no serious adverse events reported. The company announced dosing the first patients in the FSCD Phase 1b study on October 20, 2025. This trial is exploring safety, PK (pharmacokinetics), and PD (pharmacodynamics) endpoints. The company is currently conducting this Phase 1 clinical trial of PALI-2108 in Canada. The next major step for the UC indication is the expected start of Phase 2 in 2026.

Here's a quick look at the recent investor-facing structural changes and key personnel updates:

• Stockholders approved increasing authorized common shares from 280,000,000 to 300,000,000 on December 3, 2025.
• As of the October 17, 2025 record date, there were 148,964,572 shares of common stock outstanding.
• The company appointed James Izanec, MD, AGAF, as Vice President, Clinical Development on December 2, 2025.
• Sharon Skare was appointed Vice President, Global Head of Clinical Operations on October 28, 2025.

The relationship with the financial community is further detailed by the recent capital raise activity:

Transaction Type	Gross Proceeds / Shares Involved	Key Price Point	Date Context
Institutional Funding (Prior)	Raised $138 million	N/A	Prior to late 2025
Warrant Exercise Agreement	Approximately $3.9 million gross proceeds	$0.9047 per share exercise price	July 2025
Stock Price (Reported)	N/A	$0.68 per share	September 24, 2025
Stockholder Vote on Shares	Authorized shares increased from 280,000,000 to 300,000,000	N/A	December 2025

The clinical investigators and sites are directly engaged in the PALI-2108 program, which is described as the only PDE4 inhibitor prodrug in development for terminal ileum and colon.

• PALI-2108 is a locally-bioactivated PDE4 inhibitor prodrug.
• UC Phase 1b achieved 100% clinical response.
• FSCD Phase 1b study is ongoing, with first subject dosed expected in Q4 2025.
• Phase 2 IND clearance for UC is a key upcoming milestone for 2026.

Finance: review the impact of the December 3rd authorized share increase on the current share count for the next 10-Q filing due in February 2026.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Channels

You're building a clinical-stage biopharma company, so your channels for data dissemination, site activation, and future commercial reach are critical. For Palisade Bio, Inc. (PALI) as of late 2025, these channels are heavily weighted toward the scientific and investment communities while clinical operations ramp up.

Clinical trial sites and contract research organizations (CROs)

Executing clinical development requires a network of external partners to manage the actual patient interactions. Palisade Bio, Inc. relies on outside consultants, Contract Research Organizations ('CROs'), clinical sites, contract manufacturing organizations ("CMOs") and research laboratories for its pre-clinical, process development, manufacturing, clinical development, and regulatory activities.

The company is actively managing multiple trials, which dictates channel activity:

• Phase 1b/2 Proof-of-Concept (POC) trial in Ulcerative Colitis (UC) patients was planned to initiate in the second half of 2025.
• An open-label Phase Ib study of PALI-2108 for fibrostenotic Crohn's disease (FSCD) received a no-objection letter from Health Canada, with subject dosing scheduled to commence in the latter half of 2025.
• One subject had completed the screening and dosing portion of the Phase 1b UC patient cohort study as of April 2025.

This clinical channel is the primary conduit for generating the safety, pharmacokinetic (PK), and pharmacodynamic (PD) data needed for the next stage of development.

Scientific publications and medical conferences (e.g., DDW 2025)

Presenting at key medical forums is how Palisade Bio, Inc. validates its science to peers and potential partners. The Digestive Disease Week (DDW) 2025 was a major channel for PALI-2108 data presentation, held May 3-6 in San Diego, California.

The specific engagements at DDW 2025 included:

Presentation Type	Session Date & Time	Focus Area
Poster Presentation	May 4, 2025 from 12:30 PM to 1:30 PM PDT	Bioinformatic approach to PALI-2108 treatment in Ulcerative Colitis, revealing potential anti-fibrotic efficacy.
Poster of Distinction	May 5, 2025 from 12:30 PM to 1:30 PM PDT	PALI-2108 bioactivation in a mouse model of colitis, showing dose-dependent reduction of PDE4B.

Also, the company used investor conferences to communicate progress. Palisade Bio, Inc. leadership participated in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Thursday, December 4th at 10:30 AM ET.

Furthermore, clinical leadership brings established scientific channels. The newly appointed Vice President of Clinical Development, Dr. James Izanec, has authored over 100 peer-reviewed publications and abstracts and is a frequent invited speaker at global medical congresses including DDW, ECCO, ACG, and UEGW.

Investor relations platforms (NASDAQ, press releases, webcasts)

The primary channel for financial and corporate updates is the public market disclosure system. Palisade Bio, Inc. is listed on NASDAQ under the ticker PALI.

Key investor communication channels utilized in late 2025 include:

• Press Releases (GLOBE NEWSWIRE): Used for major announcements like leadership appointments (e.g., James Izanec on Dec 2, 2025) and clinical milestones (e.g., First Patients Dosed in FSCD study on Oct 20, 2025).
• SEC Filings: The source for official financial data, including 10-K and 10-Q reports. The 10-K for fiscal year ended December 31, 2024, was filed on March 24, 2025.
• Conference Webcasts: Live webcasts are used for investor conferences, such as the Piper Sandler event on December 4, 2025, at 10:30 AM ET.
• Financing Activities: Capital raising is a direct channel to investors, evidenced by the closing of an upsized $138 Million Public Offering on October 2, 2025.

Analyst coverage is another key channel, with firms like Brookline Capital Markets, Ladenburg Thalman & Co. Inc., and Maxim Securities following the stock as of mid-2025.

Future channel: Global pharmaceutical licensing partners for commercialization

While Palisade Bio, Inc. currently holds the rights to its pipeline, the ultimate commercialization channel will likely involve strategic partnerships. The company already has a foundational agreement in place that defines this future path.

This is established through the exclusive worldwide licensing agreement with Giiant Pharma, Inc., announced in September 2023, which grants Palisade the rights to develop, manufacture, and commercialize the proprietary targeted prodrug platform for all indications worldwide.

The structure of this existing agreement dictates the future licensing terms:

• Palisade assumes all development, manufacturing, and commercialization costs after the first IND or CTA approval.
• Palisade will pay Giiant royalty payments based on sales.
• Palisade will pay certain milestone payments (in cash or stock at Palisade's election).

The next major milestone that will inform future licensing discussions is the planned US Food and Drug Administration (FDA) Phase II Investigational New Drug (IND) submission, anticipated in the first half of 2026, following the completion of the FSCD trial.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Customer Segments

You're looking at the core groups Palisade Bio, Inc. (PALI) targets to validate its science and fund its journey through clinical development. For a clinical-stage company like Palisade Bio, these segments are the lifeblood, driving both clinical proof and capital formation.

Patients with moderate-to-severe Ulcerative Colitis (UC)

This group represents the initial, most immediate patient population for PALI-2108, the company's lead candidate. The data from the early clinical work is what speaks loudest here, showing the potential for a differentiated, locally-acting therapy.

The Phase 1b Ulcerative Colitis (UC) cohort, though small, provided compelling early signals for PALI-2108:

• 5 patients were in the Phase 1b UC cohort.
• 100% clinical response rate was observed.
• 40% (or 2 out of 5) patients achieved remission after just seven days.
• The treatment resulted in a 62.8% mean reduction in modified Mayo score.
• Biomarker analysis showed an approximate 70% reduction in fecal calprotectin.

Palisade Bio is now advancing towards a Phase 2 clinical study in UC designed to evaluate clinical remission and response over 12 weeks.

Patients with Fibrostenotic Crohn's Disease (FSCD)

This segment is critical because it addresses a significant unmet need-a condition where few non-surgical options exist. PALI-2108's potential anti-fibrotic activity, suggested by biomarker data from the UC study, makes this a high-value target segment.

Here's what the timeline shows for this patient group:

• PALI-2108 is being developed for FSCD, a condition with no current approved medical therapies.
• The Phase 1b exploratory study for FSCD was designed to enroll approximately 6 to 12 patients.
• Patient dosing for the Phase 1b FSCD study was planned to begin in the second half of 2025 (2H 2025).
• Topline data for the FSCD study is anticipated in the first quarter of 2026 (Q1 2026).

The company is using data from both UC and FSCD studies to inform its planned Phase 2 IND submissions, anticipated in the first half of 2026 (1H 2026).

Biopharmaceutical companies seeking to license late-stage assets

While Palisade Bio, Inc. is currently focused on advancing PALI-2108 internally, the successful navigation of clinical milestones positions the company as a potential partner or acquisition target. The interest from the investment community underscores the perceived value of their late-stage asset.

The financial validation from the October 2025 offering suggests external confidence in the asset's progression:

Financing Event	Date	Gross Proceeds
Upsized Public Offering	October 2, 2025	Approximately $138 million
Warrant Inducement Agreement	July 2025	Approximately $3.9 million

These capital events are directly tied to the perceived value of PALI-2108 progressing toward Phase 2, which is a key inflection point for potential licensing discussions.

Institutional and retail investors funding clinical development

This segment provides the necessary runway for Palisade Bio, Inc. to execute its development plan. The company relies on capital markets to bridge the gap between research and potential commercialization, especially given its current operating losses.

The investor base and recent capital activity are concrete metrics for this segment:

• Palisade Bio has total 3 institutional investors, including the HHS, which made its first investment in 2017.
• The October 2025 public offering was led by B Group Capital and Columbia Threadneedle Investments, with participation from firms like Adage Capital Partners LP and Perceptive Advisors.
• The offering price for the October 2025 raise was $0.70 per share.
• For the trailing 12 months ending September 30, 2025, the company reported earnings of -$11.2 million.
• The net loss for Q3 2025 was $2.86 million, an improvement from $3.48 million in Q3 2024.

Individual investors were noted as the biggest owners after a market cap rise in November 2025. Honestly, for a company burning cash, the confidence shown by institutional participation in a $138 million raise is a major vote of confidence in the management's strategy.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Cost Structure

You're looking at the cost side of Palisade Bio, Inc. (PALI) as they push PALI-2108 through critical clinical stages. Honestly, for a company like this, the cost structure is almost entirely dictated by the science and the regulatory hurdles ahead.

The business is heavily driven by Research and Development (R&D) expenses. This is where the bulk of your cash burn is going, funding the science that might become a future revenue stream. To give you a sense of scale, R&D expenses for the full year ending December 31, 2024, were $9,063 thousand. Then, looking at the most recent quarter, Q3 2025 R&D spend was $1.39 million, which was actually a decrease from $2.13 million in Q3 2024, reflecting a shift in focus from earlier preclinical work to active clinical trials.

The next big ticket item is the significant clinical trial costs for PALI-2108 Phase 2. You can see the capital need directly reflected in their financing activities. Palisade Bio closed a public offering in October 2025, bringing in approximately $138 million in gross proceeds, with the explicit goal of funding the Phase 2 clinical development of PALI-2108 for Ulcerative Colitis. Plus, earlier in 2025, they received CAD$1.39 million in non-dilutive funding from Canada's SR&ED program to reimburse prior pre-clinical costs for the same candidate. These are the direct costs of proving the drug works safely in humans.

Then there's the General and Administrative (G&A) overhead you have to cover just to keep the lights on and the lawyers busy. For the year ended December 31, 2024, Sales, General and Admin expenses totaled $5,796 thousand. In Q3 2025, the narrative noted that G&A saw a minor increase due to rising employee-related costs and, definitely, high legal fees, which is standard when managing clinical programs and corporate financing activities.

You also have to account for licensing fees and intellectual property maintenance costs. While I don't have the exact 2025 figures for IP maintenance, the structure relies on maintaining exclusivity for PALI-2108, which involves ongoing legal and filing expenses to protect those assets. Remember, they have a co-development agreement with Giiant Pharma, Inc., which implies ongoing contractual obligations that factor into the cost base.

All these expenditures lead to the bottom line. The forecasted 2025 net loss is around -$158.6 million, based on the average analyst consensus estimate of -$158,569,216 for the full year. That number is the net result of zero expected revenue and the heavy operational spending detailed above.

Here's a quick look at some of those key cost components:

Cost Category	Period	Amount (USD)
Forecasted Net Loss (Consensus)	FY 2025 Estimate	-$158,569,216
Research & Development (R&D)	Year Ended 12/31/2024	$9,063 thousand
Sales, General & Admin (G&A)	Year Ended 12/31/2024	$5,796 thousand
Research & Development (R&D)	Q3 2025	$1.39 million
Total Operating Expenses	Q3 2025	$2.92 million
Capital Raised for Phase 2 Funding	October 2025 Offering	$138 million
Pre-clinical Cost Reimbursement (PALI-2108)	February 2025	CAD$1.39 million

The main cost drivers you need to track are:

• Funding the PALI-2108 Phase 2 clinical program.
• Managing G&A, especially legal and employee-related costs.
• Maintaining the intellectual property estate.
• Covering ongoing operational burn rate until potential financing events.

Finance: draft 13-week cash view by Friday.

Palisade Bio, Inc. (PALI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Palisade Bio, Inc. (PALI) as of late 2025. For a clinical-stage company like this, revenue streams are often less about selling products and more about fueling the clinical engine through capital markets and strategic non-dilutive sources. Honestly, the current picture is entirely focused on financing the development of PALI-2108.

The forecast for the current fiscal year is clear: $0 in product revenue is projected for the 2025 fiscal year. On average, 5 Wall Street analysts forecast PALI's revenue for 2025 to be $0. This is typical for a company deep in clinical trials, where the focus is on data milestones, not sales.

The primary stream keeping the lights on and funding the Phase 2 program is equity financing. This is where you see the big, lumpy cash infusions. Most recently, Palisade Bio, Inc. closed an upsized underwritten public offering in October 2025, raising approximately $138 million in gross proceeds before fees, which included the full exercise of the underwriter's over-allotment option. This financing validates the science, but it definitely dilutes existing shareholders.

Here's a quick look at the major capital raises identified through late 2025 filings:

Financing Event	Date Announced/Closed	Gross Proceeds (USD)	Purpose
Public Offering (Closing)	October 2025	Approx. $138 million	Support Phase 2 clinical development for PALI-2108
Warrant Exercise	July 2025	Approx. $3.9 million	Working capital and general corporate purposes
Initial Public Offering Pricing	October 2025	Approx. $120 million (Initial Target)	Support clinical trial and R&D efforts

Also contributing to the cash runway is non-dilutive funding. This is the good stuff because it doesn't require selling more shares. Palisade Bio, Inc. secured a notable amount from Canadian tax incentives related to prior work on PALI-2108.

These non-dilutive sources include:

• Receipt of CAD$1.39 million in Scientific Research and Experimental Development (SR&ED) tax credits from Canada in February 2025.
• Reimbursement for prior pre-clinical costs associated with PALI-2108 incurred under the joint development plan with Giiant Pharma, Inc.

The future potential revenue streams are tied directly to the success of PALI-2108 in the clinic. If the drug candidate proves effective in its ongoing Phase 1b and upcoming Phase 2 studies for Ulcerative Colitis and Fibrostenotic Crohn's Disease, the company will look to strategic out-licensing partnerships. These deals are structured to bring in immediate, non-dilutive cash via upfront payments, followed by potential milestone payments upon hitting specific clinical or regulatory achievements, plus eventual royalties on future net sales. Right now, those are just potential figures on a term sheet, but they represent the next logical step in the revenue model post-Phase 2 data.

Finance: draft 13-week cash view by Friday.