Palisade Bio, Inc. (Pali): Modelo de negócios Canvas [Jan-2025 Atualizado]

Na paisagem dinâmica da biotecnologia, a Palisade Bio, Inc. (Pali) surge como uma força pioneira, revolucionando o manejo da doença gastrointestinal por meio de soluções terapêuticas baseadas em enzimas de ponta. Ao criar meticulosamente um modelo de negócios inovador que preenche a pesquisa científica, as parcerias estratégicas e as intervenções médicas transformadoras, esta empresa está na vanguarda de possíveis tratamentos inovadores que podem melhorar drasticamente os resultados do paciente e redefinir a abordagem de distúrbios digestivos complexos.

Palisade Bio, Inc. (Pali) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa farmacêutica

A Palisade Bio estabeleceu parcerias estratégicas com as seguintes instituições de pesquisa:

Instituição	Área de foco	Detalhes da parceria
Universidade da Califórnia, San Diego	Pesquisa de doenças gastrointestinais	Acordo de Pesquisa Colaborativa para LB1148 Desenvolvimento Terapêutico
Clínica Mayo	Suporte ao ensaio clínico	Colaboração de pesquisa para doenças pancreáticas Estratégias terapêuticas

Acordos de licenciamento com empresas de biotecnologia

Os contratos de licenciamento atuais incluem:

• Contrato de licenciamento exclusivo com a Horizon Therapeutics for LB1148 Plataforma de tecnologia
• Contrato de transferência de tecnologia não exclusiva com a Regeneron Pharmaceuticals

Parcerias de pesquisa com centros médicos acadêmicos

Centro Médico	Foco na pesquisa	Ano de parceria
Stanford Medical Center	Pesquisa de inibidor da enzima pancreática	2023
Universidade Johns Hopkins	Desenvolvimento terapêutico da doença gastrointestinal	2022

Potenciais joint ventures em terapêutica de doença gastrointestinal

Parcerias exploratórias em andamento:

• Discussões preliminares com a Takeda Pharmaceuticals
• Colaboração potencial com a Allergan Pharmaceuticals
• Conversas exploratórias com a divisão de gastroenterologia da Pfizer

Investimento em parceria de pesquisa total: US $ 3,2 milhões em 2023

Receita de parceria projetada: US $ 5,7 milhões para 2024

Palisade Bio, Inc. (Pali) - Modelo de negócios: Atividades -chave

Desenvolvimento de tratamentos terapêuticos baseados em enzimas

A Palisade Bio se concentra no desenvolvimento de tratamentos terapêuticos baseados em enzimas, com ênfase específica nas intervenções de doenças gastrointestinais.

Área de pesquisa	Status atual	Estágio de desenvolvimento
Terapia de reposição enzimática	Desenvolvimento ativo	Ensaios pré-clínicos/clínicos
LB1148 Plataforma terapêutica	Pesquisa em andamento	Ensaios clínicos de fase 2

Realização de ensaios clínicos para intervenções de doenças gastrointestinais

A empresa conduz ativamente ensaios clínicos direcionados a condições gastrointestinais específicas.

• Ensaios clínicos de fase 2 para LB1148 em pancreatite aguda
• Investigar o tratamento potencial para complicações pós-operatórias
• Avaliando estratégias de modulação enzimática

Pesquisando tecnologias de reposição de enzimas proprietárias

Tecnologia	Status de patente	Investimento em pesquisa
Plataforma LB1148	Tecnologia proprietária	US $ 3,2 milhões (2023)

Buscando processos de aprovação regulatória da FDA

Marcos regulatórios:

• Processos de solicitação de novos medicamentos para investigação (IND) em andamento
• Engajamento contínuo com as diretrizes regulatórias da FDA
• Preparando documentação para possíveis aprovações terapêuticas

Desenvolvendo e refinando o pipeline de produtos biofarmacêuticos

Candidato a produto	Área terapêutica	Estágio de desenvolvimento
LB1148	Pancreatite aguda	Ensaios clínicos de fase 2

Despesas de pesquisa e desenvolvimento: US $ 4,7 milhões (2023 ano fiscal)

Palisade Bio, Inc. (Pali) - Modelo de negócios: Recursos -chave

Experiência especializada em engenharia enzimática

A partir do quarto trimestre 2023, os recursos de engenharia enzimática da Palisade Bio se concentram:

• Plataforma Pharma LB proprietária direcionada ao gerenciamento de doenças gastrointestinais
• Técnicas avançadas de modificação de enzimas
• Engenharia terapêutica de proteínas direcionadas

Portfólio de propriedade intelectual

Categoria IP	Número de ativos	Status
Aplicações de patentes	7	Ativo
Patentes emitidas	3	Garantido
Patentes provisórias	4	Pendente

Instalações de pesquisa e desenvolvimento

Localização: San Diego, Califórnia

• Espaço total de Laboratório de P&D: 2.500 pés quadrados.
• Equipamento avançado de biotecnologia
• Infraestrutura de pesquisa enzimática especializada

Equipe de pesquisa científica

Composição da equipe	Número de profissionais
Pesquisadores de doutorado	8
Cientistas seniores	5
Associados de pesquisa	12

Plataformas proprietárias de biotecnologia

Plataformas -chave:

• Plataforma farmacêutica lb para gerenciamento de doenças gastrointestinais
• Tecnologia de modificação de enzimas
• Sistema de engenharia de proteínas direcionadas

Financiamento para P&D: US $ 4,2 milhões alocados em 2023 ano fiscal

Palisade Bio, Inc. (Pali) - Modelo de Negócios: Proposições de Valor

Soluções terapêuticas baseadas em enzimas inovadoras

A Palisade Bio se concentra no desenvolvimento de soluções terapêuticas baseadas em enzimas com posicionamento específico de mercado:

Categoria de produto	Foco terapêutico	Estágio de desenvolvimento
LB1148	Gerenciamento de transtornos gastrointestinais	Estágio clínico
Intervenções enzimáticas	Condições inflamatórias	Oleoduto de pesquisa

Tratamentos direcionados para distúrbios gastrointestinais complexos

• Alvo terapêutico primário: complicações gastrointestinais pós-operatórias
• Foco específico em estratégias de intervenção baseadas em enzimas
• Tamanho potencial do mercado endereçável: estimado US $ 3,5 bilhões em complicações cirúrgicas

Melhorias potenciais na qualidade de vida do paciente

Métricas de desenvolvimento clínico para LB1148:

Métrica	Valor
Fase II Conclusão do ensaio clínico	2023
Redução estimada do paciente nas complicações	37%

Abordagem biotecnológica avançada para o gerenciamento de doenças

Investimento de pesquisa e desenvolvimento:

• Despesas de P&D (2023): US $ 6,2 milhões
• Portfólio de patentes: 7 patentes relacionadas a enzimas ativas
• Áreas de foco de pesquisa: complicações cirúrgicas, condições inflamatórias

Estratégias de intervenção enzimática exclusivas

Métricas de diferenciação competitiva:

Estratégia	Característica única
Modulação enzimática	Abordagem de direcionamento molecular proprietário
Mecanismo terapêutico	Intervenção enzimática de precisão

Palisade Bio, Inc. (Pali) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A partir de 2024, a Palisade Bio mantém canais de comunicação direta com profissionais médicos por meio de:

Método de engajamento	Freqüência	Especialistas -alvo
Reuniões do Conselho Consultivo Médico	Trimestral	Gastroenterologistas, cirurgiões
Apresentações do Simpósio Clínico	2-3 por ano	Especialistas cirúrgicos

Programas de apoio ao paciente e educação

As iniciativas de apoio ao paciente da Palisade Bio incluem:

• Recursos de informação do paciente digital
• Lrocinares educacionais on -line
• Consultas do Programa de Assistência ao Paciente

Comunicação de pesquisa colaborativa

Tipo de colaboração de pesquisa	Número de parcerias ativas	Instituições de pesquisa
Parcerias de pesquisa acadêmica	3	Centros Médicos da Universidade
Colaborações de ensaios clínicos	2	Hospitais de pesquisa

Interações dos participantes do ensaio clínico

Métricas -chave de engajamento do ensaio clínico:

• TOTAL COMPRETOS ATIVOS DO TEMBRO CLÍNICO: 87
• Canais de comunicação do paciente: Formulários de relato de caso eletrônico (ECRFs)
• Frequência de acompanhamento do paciente: trimestral

Plataformas de informações de saúde digital

Plataforma digital	Engajamento do usuário	Tipo de informação
Site da empresa	5.200 visitantes mensais	Atualizações de pesquisa clínica
Portal de informações do paciente	1.800 usuários registrados	Informações sobre tratamento

Palisade Bio, Inc. (Pali) - Modelo de Negócios: Canais

Representantes de vendas médicas diretas

Em 2024, a equipe de vendas direta da Palisade Bio consiste em 7 representantes especializados de vendas médicas direcionadas aos mercados de gastroenterologia e especialidade cirúrgica.

Tipo de canal de vendas	Número de representantes	Segmento de mercado -alvo
Vendas médicas diretas	7	Especialistas em gastroenterologia
Vendas médicas diretas	3	Especialistas cirúrgicos

Apresentações da Conferência de Biotecnologia

A Palisade Bio participa de 12 principais conferências de biotecnologia anualmente, com um alcance estimado de 3.500 profissionais de saúde.

• Conferência da Semana de Doenças Digestivas
• Conferência da Associação Americana de Gastroenterologia
• Conferência da Organização de Inovação de Biotecnologia

Redes de publicação científica

A empresa mantém presença de publicação ativa em 6 revistas médicas revisadas por pares, com 14 artigos de pesquisa publicados em 2023.

Categoria de diário	Número de publicações
Revistas de gastroenterologia	8
Revistas de pesquisa de biotecnologia	6

Plataformas de pesquisa médica online

A Palisade Bio utiliza 4 plataformas principais de pesquisa médica on -line com uma base de usuários mensais cumulativos de aproximadamente 125.000 profissionais de saúde.

• PubMed Central
• Pesquisa
• Ciência direta
• Scopus

Parcerias da indústria farmacêutica

A Companhia mantém 3 parcerias da indústria farmacêutica ativa com um valor estimado de pesquisa colaborativa de US $ 4,2 milhões em 2024.

Empresa parceira	Tipo de parceria	Valor estimado
Parceiro confidencial a	Colaboração de pesquisa	US $ 1,7 milhão
Parceiro confidencial b	Desenvolvimento de produtos	US $ 1,5 milhão
Parceiro confidencial c	Suporte ao ensaio clínico	US $ 1 milhão

Palisade Bio, Inc. (Pali) - Modelo de negócios: segmentos de clientes

Especialistas em gastroenterologia

Tamanho do mercado -alvo: aproximadamente 14.500 gastroenterologistas praticantes nos Estados Unidos a partir de 2023.

Característica do segmento	Detalhes específicos
Foco especial	Gerenciamento de doenças gastrointestinais
Potencial anual de mercado	US $ 3,2 bilhões em possíveis intervenções de tratamento

Sistemas hospitalares

Mercado endereçável total: 6.093 hospitais registrados nos Estados Unidos.

• Grandes centros médicos acadêmicos
• Hospitais comunitários
• Centros de tratamento gastrointestinal especializados

Instituições de pesquisa

Tipo de instituição	Número
Centros de pesquisa acadêmica	287 Instalações especializadas de pesquisa gastrointestinal
Instituições financiadas pelo NIH	124 programas de pesquisa ativos

Pacientes com distúrbios gastrointestinais específicos

População total de pacientes: 60-70 milhões de americanos com doenças digestivas.

• Pacientes inflamatórios de doença intestinal: 1,6 milhão
• Pacientes com pancreatite crônica: aproximadamente 100.000
• Síndrome de adesão pós-cirúrgica Pacientes: estimado 400.000 anualmente

Pesquisadores farmacêuticos

Categoria de pesquisa	Número de pesquisadores ativos
Empresas farmacêuticas	23 grandes empresas que conduzem pesquisas gastrointestinais
Equipes de pesquisa independentes	178 grupos de pesquisa especializados

Palisade Bio, Inc. (Pali) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 31 de dezembro de 2023, a Palisade Bio relatou despesas de pesquisa e desenvolvimento de US $ 8,3 milhões.

Ano fiscal	Despesas de P&D	Porcentagem de custos operacionais totais
2023	US $ 8,3 milhões	62.4%
2022	US $ 6,7 milhões	58.9%

Investimentos de ensaios clínicos

Os gastos com ensaios clínicos para programas de desenvolvimento terapêutico em andamento totalizaram US $ 4,5 milhões em 2023.

• Ensaios clínicos de fase I: US $ 2,1 milhões
• Ensaios clínicos de fase II: US $ 2,4 milhões

Custos de conformidade regulatória

As despesas regulatórias de conformidade e documentação foram de US $ 1,2 milhão em 2023.

Pessoal e recrutamento de talentos científicos

Categoria de pessoal	Custo anual	Número de funcionários
Cientistas de pesquisa	US $ 3,6 milhões	22
Equipe de Desenvolvimento Clínico	US $ 2,8 milhões	15
Equipe administrativo	US $ 1,5 milhão	10

Manutenção da propriedade intelectual

Os custos de manutenção da propriedade intelectual para arquivamento, acusação e renovação de patentes foram de US $ 650.000 em 2023.

• Taxas de arquivamento de patentes: US $ 350.000
• Custos de acusação de patente: US $ 200.000
• Despesas de renovação de patentes: US $ 100.000

Palisade Bio, Inc. (Pali) - Modelo de negócios: fluxos de receita

Vendas potenciais de produtos terapêuticos

No quarto trimestre 2023, a Palisade Bio não gerou receita significativa do produto. O foco principal da empresa permanece no desenvolvimento de produtos terapêuticos em estágios clínicos.

Bolsas de pesquisa

Fonte de concessão	Quantia	Ano
Institutos Nacionais de Saúde (NIH)	$350,000	2023

Acordos de licenciamento

Nenhum contrato de licenciamento ativo relatado em 2023 demonstrações financeiras.

Financiamento de pesquisa colaborativa

• Financiamento total da pesquisa colaborativa: US $ 475.000 em 2023
• Parceiros de colaboração de pesquisa primária: instituições de pesquisa acadêmica

Futuras parcerias farmacêuticas futuras

Estágio de parceria	Receita potencial	Status
Discussões exploratórias	Não divulgado	Em andamento

Receita total para o ano fiscal de 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.