Palisade Bio, Inc. (PALI): Canvas del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la biotecnología, Palisade Bio, Inc. (PALI) emerge como una fuerza pionera, revolucionando el manejo de la enfermedad gastrointestinal a través de soluciones terapéuticas basadas en la enzima de vanguardia. Al crear meticulosamente un modelo de negocio innovador que une la investigación científica, las asociaciones estratégicas e intervenciones médicas transformadoras, esta compañía está a la vanguardia de posibles tratamientos innovadores que podrían mejorar drásticamente los resultados de los pacientes y redefinir el enfoque de los complejos trastornos digestivos.

Palisade Bio, Inc. (PALI) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación farmacéutica

Palisade Bio ha establecido asociaciones estratégicas con las siguientes instituciones de investigación:

Institución	Área de enfoque	Detalles de la asociación
Universidad de California, San Diego	Investigación de enfermedades gastrointestinales	Acuerdo de investigación colaborativa para el desarrollo terapéutico LB1148
Clínica de mayonesa	Apoyo de ensayos clínicos	Investigación de colaboración para estrategias terapéuticas de la enfermedad pancreática

Acuerdos de licencia con compañías de biotecnología

Los acuerdos de licencia actuales incluyen:

• Acuerdo de licencia exclusivo con Horizon Therapeutics para la plataforma de tecnología LB1148
• Acuerdo de transferencia de tecnología no exclusiva con Regeneron Pharmaceuticals

Asociaciones de investigación con centros médicos académicos

Centro médico	Enfoque de investigación	Año de asociación
Centro Médico de Stanford	Investigación de inhibidores de la enzima pancreática	2023
Universidad de Johns Hopkins	Desarrollo terapéutico de la enfermedad gastrointestinal	2022

Empresas conjuntas potenciales en terapéutica de enfermedades gastrointestinales

Asociaciones exploratorias continuas:

• Discusiones preliminares con Takeda Pharmaceuticals
• Colaboración potencial con Allergan Pharmaceuticals
• Conversaciones exploratorias con la división de gastroenterología de Pfizer

Inversión total de asociación de investigación: $ 3.2 millones en 2023

Ingresos de asociación proyectados: $ 5.7 millones para 2024

Palisade Bio, Inc. (PALI) - Modelo de negocio: actividades clave

Desarrollo de tratamientos terapéuticos basados ​​en enzimas

La biografía de Palisade se centra en el desarrollo de tratamientos terapéuticos basados ​​en enzimas con énfasis específico en las intervenciones de enfermedades gastrointestinales.

Área de investigación	Estado actual	Etapa de desarrollo
Terapia de reemplazo de enzimas	Desarrollo activo	Ensayos preclínicos/clínicos
Plataforma terapéutica LB1148	Investigación en curso	Ensayos clínicos de fase 2

Realización de ensayos clínicos para intervenciones de enfermedades gastrointestinales

La Compañía realiza activamente ensayos clínicos dirigidos a afecciones gastrointestinales específicas.

• Ensayos clínicos de fase 2 para LB1148 en pancreatitis aguda
• Investigar el tratamiento potencial para complicaciones postoperatorias
• Evaluación de estrategias de modulación enzimática

Investigación de tecnologías de reemplazo de enzimas patentadas

Tecnología	Estado de patente	Inversión de investigación
Plataforma LB1148	Tecnología patentada	$ 3.2 millones (2023)

Persiguiendo procesos de aprobación regulatoria de la FDA

Hitos regulatorios:

• Procesos de solicitud de nueva fármaco de investigación en investigación (IND)
• Compromiso continuo con las pautas regulatorias de la FDA
• Preparación de documentación para posibles aprobaciones terapéuticas

Desarrollar y refinar la tubería de productos biofarmacéuticos

Candidato al producto	Área terapéutica	Etapa de desarrollo
LB1148	Pancreatitis aguda	Ensayos clínicos de fase 2

Gasto de investigación y desarrollo: $ 4.7 millones (año fiscal 2023)

Palisade Bio, Inc. (PALI) - Modelo de negocios: recursos clave

Experiencia de ingeniería enzimática especializada

A partir del cuarto trimestre de 2023, las capacidades de ingeniería enzimática de Palisade Bio se centran en:

• Plataforma farmacéutica LB patentada dirigida al manejo de enfermedades gastrointestinales
• Técnicas avanzadas de modificación de enzimas
• Ingeniería de proteínas terapéuticas dirigidas

Cartera de propiedades intelectuales

Categoría de IP	Número de activos	Estado
Solicitudes de patentes	7	Activo
Patentes emitidos	3	Otorgada
Patentes provisionales	4	Pendiente

Investigaciones y instalaciones de desarrollo

Ubicación: San Diego, California

• Espacio de laboratorio de I + D total: 2.500 pies cuadrados.
• Equipo de biotecnología avanzado
• Infraestructura de investigación enzimática especializada

Equipo de investigación científica

Composición del equipo	Número de profesionales
Investigadores de doctorado	8
Científicos superiores	5
Asociados de investigación	12

Plataformas de biotecnología patentadas

Plataformas clave:

• Plataforma farmacéutica LB para el manejo de enfermedades gastrointestinales
• Tecnología de modificación de enzimas
• Sistema de ingeniería de proteínas dirigido

Financiación para I + D: $ 4.2 millones asignados en 2023 año fiscal

Palisade Bio, Inc. (PALI) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas innovadoras basadas en enzimas

Palisade Bio se centra en el desarrollo de soluciones terapéuticas basadas en enzimas con posicionamiento específico del mercado:

Categoría de productos	Enfoque terapéutico	Etapa de desarrollo
LB1148	Manejo del trastorno gastrointestinal	Estadio clínico
Intervenciones enzimáticas	Condiciones inflamatorias	Tubería de investigación

Tratamientos dirigidos para trastornos gastrointestinales complejos

• Objetivo terapéutico primario: complicaciones gastrointestinales postoperatorias
• Enfoque específico en estrategias de intervención basadas en enzimas
• Tamaño potencial del mercado direccionable: estimado de $ 3.5 mil millones en complicaciones quirúrgicas

Mejoras potenciales en la calidad de vida del paciente

Métricas de desarrollo clínico para LB1148:

Métrico	Valor
Fase II de finalización del ensayo clínico	2023
Reducción estimada del paciente en complicaciones	37%

Enfoque biotecnológico avanzado para el manejo de enfermedades

Investigación y inversión de desarrollo:

• Gasto de I + D (2023): $ 6.2 millones
• Portafolio de patentes: 7 patentes activas relacionadas con la enzima
• Áreas de enfoque de investigación: complicaciones quirúrgicas, afecciones inflamatorias

Estrategias de intervención enzimática únicas

Métricas de diferenciación competitiva:

Estrategia	Característica única
Modulación enzimática	Enfoque de orientación molecular patentada
Mecanismo terapéutico	Intervención enzimática de precisión

Palisade Bio, Inc. (PALI) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir de 2024, Palisade Bio mantiene canales de comunicación directa con profesionales médicos a través de:

Método de compromiso	Frecuencia	Especialistas en el objetivo
Reuniones de la Junta Asesora Médica	Trimestral	Gastroenterólogos, cirujanos
Presentaciones de simposio clínico	2-3 por año	Especialistas quirúrgicos

Programas de apoyo y educación del paciente

Las iniciativas de apoyo al paciente de Palisade Bio incluyen:

• Recursos de información del paciente digital
• Seminarios educativos en línea
• Consultas del programa de asistencia para el paciente

Comunicación de investigación colaborativa

Tipo de colaboración de investigación	Número de asociaciones activas	Instituciones de investigación
Asociaciones de investigación académica	3	Centros médicos universitarios
Colaboraciones de ensayos clínicos	2	Investigar hospitales

Interacciones de los participantes del ensayo clínico

Métricas clave de compromiso de ensayos clínicos:

• Participantes totales de ensayos clínicos activos: 87
• Canales de comunicación del paciente: formularios de informe de casos electrónicos (ECRFS)
• Frecuencia de seguimiento del paciente: trimestralmente

Plataformas de información de salud digital

Plataforma digital	Compromiso de usuario	Tipo de información
Sitio web de la empresa	5.200 visitantes mensuales	Actualizaciones de investigación clínica
Portal de información del paciente	1.800 usuarios registrados	Información sobre el tratamiento

Palisade Bio, Inc. (PALI) - Modelo de negocios: canales

Representantes de ventas médicas directas

A partir de 2024, el equipo de ventas directas de Palisade Bio consta de 7 representantes especializados de ventas médicas dirigidas a los mercados de gastroenterología y especialidad quirúrgica.

Tipo de canal de ventas	Número de representantes	Segmento del mercado objetivo
Ventas médicas directas	7	Especialistas en gastroenterología
Ventas médicas directas	3	Especialistas quirúrgicos

Presentaciones de la conferencia de biotecnología

Palisade Bio participa en 12 principales conferencias de biotecnología anualmente, con un alcance estimado de 3.500 profesionales de la salud.

• Conferencia de la Semana de la Enfermedades Digestivas
• Conferencia de la Asociación Gastroenterológica Americana
• Conferencia de la Organización de Innovación de Biotecnología

Redes de publicación científica

La compañía mantiene la presencia de publicación activa en 6 revistas médicas revisadas por pares, con 14 artículos de investigación publicados en 2023.

Categoría de revista	Número de publicaciones
Revistas de gastroenterología	8
Revistas de investigación de biotecnología	6

Plataformas de investigación médica en línea

Palisade Bio utiliza 4 plataformas de investigación médica en línea primarias con una base de usuarios mensual acumulativa de aproximadamente 125,000 profesionales de la salud.

• PubMed Central
• Investigador
• Ciencia directa
• Escopus

Asociaciones de la industria farmacéutica

La compañía mantiene 3 asociaciones activas de la industria farmacéutica con un valor de investigación colaborativo estimado de $ 4.2 millones en 2024.

Empresa asociada	Tipo de asociación	Valor estimado
Socio confidencial A	Colaboración de investigación	$ 1.7 millones
Socio confidencial b	Desarrollo de productos	$ 1.5 millones
Socio confidencial c	Apoyo de ensayos clínicos	$ 1 millón

Palisade Bio, Inc. (PALI) - Modelo de negocios: segmentos de clientes

Especialistas en gastroenterología

Tamaño del mercado objetivo: aproximadamente 14.500 gastroenterólogos en los Estados Unidos a partir de 2023.

Característica de segmento	Detalles específicos
Enfoque especializado	Manejo de enfermedades gastrointestinales
Potencial de mercado anual	$ 3.2 mil millones en posibles intervenciones de tratamiento

Sistemas hospitalarios

Mercado total direccionable: 6.093 hospitales registrados en los Estados Unidos.

• Grandes centros médicos académicos
• Hospitales comunitarios
• Centros de tratamiento gastrointestinal especializados

Instituciones de investigación

Tipo de institución	Número
Centros de investigación académicos	287 instalaciones especializadas de investigación gastrointestinal
Instituciones financiadas por nih	124 programas de investigación activos

Pacientes con trastornos gastrointestinales específicos

Total de la población de pacientes: 60-70 millones de estadounidenses con enfermedades digestivas.

• Pacientes de enfermedad inflamatoria intestinal: 1.6 millones
• Pacientes de pancreatitis crónica: aproximadamente 100,000
• Pacientes del síndrome de adhesión posquirúrgica: estimado 400,000 anualmente

Investigadores farmacéuticos

Categoría de investigación	Número de investigadores activos
Compañías farmacéuticas	23 empresas principales que realizan investigación gastrointestinal
Equipos de investigación independientes	178 grupos de investigación especializados

Palisade Bio, Inc. (PALI) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finaliza el 31 de diciembre de 2023, Palisade Bio reportó gastos de investigación y desarrollo de $ 8.3 millones.

Año fiscal	Gastos de I + D	Porcentaje de costos operativos totales
2023	$ 8.3 millones	62.4%
2022	$ 6.7 millones	58.9%

Inversiones de ensayos clínicos

Los gastos de ensayos clínicos para programas de desarrollo terapéutico continuos totalizaron $ 4.5 millones en 2023.

• Ensayos clínicos de fase I: $ 2.1 millones
• Ensayos clínicos de fase II: $ 2.4 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio y documentación fueron de $ 1.2 millones en 2023.

Personal y reclutamiento de talento científico

Categoría de personal	Costo anual	Número de empleados
Investigar científicos	$ 3.6 millones	22
Equipo de desarrollo clínico	$ 2.8 millones	15
Personal administrativo	$ 1.5 millones	10

Mantenimiento de la propiedad intelectual

Los costos de mantenimiento de la propiedad intelectual para la presentación de patentes, el enjuiciamiento y la renovación fueron de $ 650,000 en 2023.

• Tarifas de presentación de patentes: $ 350,000
• Costos de enjuiciamiento de patentes: $ 200,000
• Gastos de renovación de patentes: $ 100,000

Palisade Bio, Inc. (PALI) - Modelo de negocios: flujos de ingresos

Venta de productos terapéuticos potenciales

A partir del cuarto trimestre de 2023, Palisade Bio no ha generado importantes ingresos por productos. El enfoque principal de la compañía permanece en desarrollar productos terapéuticos en etapas clínicas.

Subvenciones de investigación

Fuente de subvenciones	Cantidad	Año
Institutos Nacionales de Salud (NIH)	$350,000	2023

Acuerdos de licencia

No se informaron acuerdos de licencia activos en 2023 estados financieros.

Financiación de la investigación colaborativa

• Financiación total de la investigación colaborativa: $ 475,000 en 2023
• Socios de colaboración de investigación primaria: instituciones de investigación académica

Posibles asociaciones farmacéuticas futuras

Etapa de asociación	Ingresos potenciales	Estado
Discusiones exploratorias	No revelado	En curso

Ingresos totales para el año fiscal 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.