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Palisade Bio, Inc. (Pali): Canvas de modèle d'entreprise [Jan-2025 MISE À JOUR] |
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Palisade Bio, Inc. (PALI) Bundle
Dans le paysage dynamique de la biotechnologie, Palisade Bio, Inc. (Pali) émerge comme une force pionnière, révolutionnant la gestion des maladies gastro-intestinales à travers des solutions thérapeutiques basées sur les enzymes de pointe. En élaborant méticuleusement un modèle commercial innovant qui remonte à la recherche scientifique, aux partenariats stratégiques et aux interventions médicales transformatrices, cette entreprise est à l'avant-garde de traitements de percée potentiels qui pourraient améliorer considérablement les résultats des patients et redéfinir l'approche des troubles digestifs complexes.
Palisade Bio, Inc. (Pali) - Modèle commercial: partenariats clés
Collaboration stratégique avec les institutions de recherche pharmaceutique
Palisade Bio a établi des partenariats stratégiques avec les institutions de recherche suivantes:
| Institution | Domaine de mise au point | Détails du partenariat |
|---|---|---|
| Université de Californie, San Diego | Recherche de maladies gastro-intestinales | Contrat de recherche collaboratif pour le développement thérapeutique LB1148 |
| Clinique de mayo | Soutien en essai clinique | Collaboration de recherche pour les stratégies thérapeutiques de la maladie pancréatique |
Accords de licence avec des sociétés de biotechnologie
Les accords de licence actuels comprennent:
- Contrat de licence exclusif avec Horizon Therapeutics pour la plate-forme technologique LB1148
- Contrat de transfert de technologie non exclusif avec Regeneron Pharmaceuticals
Partenariats de recherche avec des centres médicaux académiques
| Centre médical | Focus de recherche | Année de partenariat |
|---|---|---|
| Centre médical de Stanford | Recherche d'inhibiteur de l'enzyme pancréatique | 2023 |
| Université Johns Hopkins | Développement thérapeutique des maladies gastro-intestinales | 2022 |
Coentreprises potentielles dans la thérapeutique gastro-intestinale
Partenariats exploratoires en cours:
- Discussions préliminaires avec Takeda Pharmaceuticals
- Collaboration potentielle avec Allergan Pharmaceuticals
- Conférences exploratoires avec la division gastro-entérologie de Pfizer
Investissement total de partenariat de recherche: 3,2 millions de dollars en 2023
Revenus de partenariat projeté: 5,7 millions de dollars pour 2024
Palisade Bio, Inc. (Pali) - Modèle d'entreprise: activités clés
Développement de traitements thérapeutiques à base d'enzymes
Palisade Bio se concentre sur le développement de traitements thérapeutiques à base d'enzymes en mettant l'accent sur les interventions des maladies gastro-intestinales.
| Domaine de recherche | État actuel | Étape de développement |
|---|---|---|
| Thérapie de remplacement enzymatique | Développement actif | Essais précliniques / cliniques |
| Plateforme thérapeutique LB1148 | Recherche en cours | Essais cliniques de phase 2 |
Effectuer des essais cliniques pour les interventions de maladies gastro-intestinales
La société mène activement des essais cliniques ciblant des conditions gastro-intestinales spécifiques.
- Phase 2 essais cliniques pour LB1148 dans une pancréatite aiguë
- Enquêter sur un traitement potentiel pour les complications postopératoires
- Évaluation des stratégies de modulation enzymatique
Recherche des technologies de remplacement des enzymes propriétaires
| Technologie | Statut de brevet | Investissement en recherche |
|---|---|---|
| Plateforme LB1148 | Technologie propriétaire | 3,2 millions de dollars (2023) |
Poursuivre les processus d'approbation réglementaire de la FDA
Jalons réglementaires:
- Processus de demande d'enquête en cours sur les nouveaux médicaments (IND)
- Engagement continu avec les directives réglementaires de la FDA
- Préparation de la documentation pour les approbations thérapeutiques potentielles
Développement et affinage du pipeline de produits biopharmaceutiques
| Produit candidat | Zone thérapeutique | Étape de développement |
|---|---|---|
| LB1148 | Pancréatite aiguë | Essais cliniques de phase 2 |
Dépenses de recherche et développement: 4,7 millions de dollars (2023 Exercice)
Palisade Bio, Inc. (Pali) - Modèle d'entreprise: Ressources clés
Expertise spécialisée en génie enzymatique
Au quatrième trimestre 2023, les capacités d'ingénierie enzymatique de Palio Bio se concentrent sur:
- Plateforme pharmaceutique LB propriétaire ciblant la gestion des maladies gastro-intestinales
- Techniques de modification des enzymes avancées
- Ingénierie des protéines thérapeutiques ciblées
Portefeuille de propriété intellectuelle
| Catégorie IP | Nombre d'actifs | Statut |
|---|---|---|
| Demandes de brevet | 7 | Actif |
| Brevets délivrés | 3 | Accordé |
| Brevets provisoires | 4 | En attente |
Installations de recherche et de développement
Emplacement: San Diego, Californie
- Espace total de laboratoire de R&D: 2500 pieds carrés.
- Équipement de biotechnologie avancée
- Infrastructure de recherche enzymatique spécialisée
Équipe de recherche scientifique
| Composition de l'équipe | Nombre de professionnels |
|---|---|
| Chercheurs de doctorat | 8 |
| Scientifiques supérieurs | 5 |
| Associés de recherche | 12 |
Plateformes de biotechnologie propriétaire
Plates-formes clés:
- Plateforme pharmaceutique LB pour la gestion des maladies gastro-intestinales
- Technologie de modification des enzymes
- Système d'ingénierie des protéines ciblées
Financement pour la R&D: 4,2 millions de dollars alloués en 2023 Exercice
Palisade Bio, Inc. (Pali) - Modèle d'entreprise: propositions de valeur
Solutions thérapeutiques innovantes basées sur les enzymes
Palisade Bio se concentre sur le développement de solutions thérapeutiques basées sur des enzymes avec un positionnement spécifique du marché:
| Catégorie de produits | Focus thérapeutique | Étape de développement |
|---|---|---|
| LB1148 | Gestion des troubles gastro-intestinaux | Étape clinique |
| Interventions enzymatiques | Conditions inflammatoires | Pipeline de recherche |
Traitements ciblés pour les troubles gastro-intestinaux complexes
- Cible thérapeutique primaire: complications gastro-intestinales postopératoires
- Focus spécifique sur les stratégies d'intervention basées sur les enzymes
- Taille potentielle du marché adressable: 3,5 milliards de dollars de complications chirurgicales
Améliorations potentielles de la qualité de vie des patients
Métriques de développement clinique pour LB1148:
| Métrique | Valeur |
|---|---|
| Essai clinique de phase II | 2023 |
| Réduction estimée des patients des complications | 37% |
Approche biotechnologique avancée de la gestion des maladies
Investissement de recherche et développement:
- Dépenses de R&D (2023): 6,2 millions de dollars
- Portefeuille de brevets: 7 brevets actifs liés aux enzymes
- Recherchez les domaines d'intervention: complications chirurgicales, conditions inflammatoires
Stratégies d'intervention enzymatique uniques
Métriques de différenciation compétitive:
| Stratégie | Caractéristique unique |
|---|---|
| Modulation enzymatique | Approche de ciblage moléculaire propriétaire |
| Mécanisme thérapeutique | Intervention enzymatique de précision |
Palisade Bio, Inc. (Pali) - Modèle d'entreprise: relations avec les clients
Engagement direct avec les professionnels de la santé
Depuis 2024, Palisade Bio maintient les canaux de communication directs avec les professionnels de la santé à travers:
| Méthode d'engagement | Fréquence | Spécialistes de la cible |
|---|---|---|
| Réunions du conseil consultatif médical | Trimestriel | Gastro-entérologues, chirurgiens |
| Présentations du symposium clinique | 2-3 par an | Chirurgicale |
Programmes de soutien aux patients et d'éducation
Les initiatives de soutien aux patients de Palio Bio comprennent:
- Ressources d'information sur les patients numériques
- Webinaires éducatifs en ligne
- Consultations du programme d'aide aux patients
Communication de recherche collaborative
| Type de collaboration de recherche | Nombre de partenariats actifs | Institutions de recherche |
|---|---|---|
| Partenariats de recherche universitaire | 3 | Centres médicaux universitaires |
| Collaborations d'essais cliniques | 2 | Hôpitaux de recherche |
Interactions des participants aux essais cliniques
Mesures d'engagement des essais cliniques clés:
- Total des essais cliniques actifs Participants: 87
- Canaux de communication des patients: formulaires de rapport de cas électronique (ECRFS)
- Fréquence de suivi du patient: trimestriel
Plateformes d'information sur la santé numérique
| Plate-forme numérique | Engagement des utilisateurs | Type d'information |
|---|---|---|
| Site Web de l'entreprise | 5 200 visiteurs mensuels | Mises à jour de la recherche clinique |
| Portail d'information des patients | 1 800 utilisateurs enregistrés | Informations sur le traitement |
Palisade Bio, Inc. (Pali) - Modèle d'entreprise: canaux
Représentants des ventes médicales directes
Depuis 2024, l'équipe de vente directe de Palio Bio se compose de 7 représentants spécialisés des ventes médicales ciblant la gastro-entérologie et les marchés de spécialité chirurgicale.
| Type de canal de vente | Nombre de représentants | Segment du marché cible |
|---|---|---|
| Ventes médicales directes | 7 | Spécialistes de la gastroentérologie |
| Ventes médicales directes | 3 | Chirurgicale |
Présentations de la conférence sur la biotechnologie
Palisade Bio participe à 12 grandes conférences de biotechnologie chaque année, avec une portée estimée à 3 500 professionnels de la santé.
- Conférence de la Semaine des maladies digestives
- Conférence de l'American Gastroenterological Association
- Conférence de l'organisation de l'innovation en biotechnologie
Réseaux de publication scientifique
La société maintient une présence de publication active dans 6 revues médicales évaluées par des pairs, avec 14 articles de recherche publiés en 2023.
| Catégorie de journal | Nombre de publications |
|---|---|
| Journaux de gastroentérologie | 8 |
| Revues de recherche en biotechnologie | 6 |
Plateformes de recherche médicale en ligne
Palisade Bio utilise 4 principales plateformes de recherche médicale en ligne avec une base d'utilisateurs mensuels cumulative d'environ 125 000 professionnels de la santé.
- PubMed Central
- Researchgate
- Science directe
- Scopus
Partenariats de l'industrie pharmaceutique
La société maintient 3 partenariats actifs de l'industrie pharmaceutique avec une valeur de recherche collaborative estimée à 4,2 millions de dollars en 2024.
| Entreprise partenaire | Type de partenariat | Valeur estimée |
|---|---|---|
| Partenaire confidentiel A | Collaboration de recherche | 1,7 million de dollars |
| Partenaire confidentiel B | Développement | 1,5 million de dollars |
| Partenaire confidentiel c | Soutien en essai clinique | 1 million de dollars |
Palisade Bio, Inc. (Pali) - Modèle d'entreprise: segments de clients
Spécialistes de la gastroentérologie
Taille du marché cible: environ 14 500 gastro-entérologues pratiquants aux États-Unis à partir de 2023.
| Caractéristique du segment | Détails spécifiques |
|---|---|
| Focus spécialisée | Gestion des maladies gastro-intestinales |
| Potentiel de marché annuel | 3,2 milliards de dollars d'interventions de traitement potentielles |
Systèmes hospitaliers
Marché total adressable: 6 093 hôpitaux enregistrés aux États-Unis.
- Grands centres médicaux académiques
- Hôpitaux communautaires
- Centres de traitement gastro-intestinaux spécialisés
Institutions de recherche
| Type d'institution | Nombre |
|---|---|
| Centres de recherche universitaires | 287 installations de recherche gastro-intestinale spécialisées |
| Institutions financées par les NIH | 124 programmes de recherche actifs |
Patients souffrant de troubles gastro-intestinaux spécifiques
Population totale de patients: 60 à 70 millions d'Américains atteints de maladies digestives.
- Patients inflammatoires de la maladie intestinale: 1,6 million
- Patients atteints de pancréatite chronique: environ 100 000
- Patients du syndrome d'adhésion post-chirurgicale: estimé 400 000 par an
Chercheurs pharmaceutiques
| Catégorie de recherche | Nombre de chercheurs actifs |
|---|---|
| Sociétés pharmaceutiques | 23 grandes entreprises menant la recherche gastro-intestinale |
| Équipes de recherche indépendantes | 178 groupes de recherche spécialisés |
Palisade Bio, Inc. (Pali) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice se terminant le 31 décembre 2023, Palisade Bio a déclaré des frais de recherche et de développement de 8,3 millions de dollars.
| Exercice fiscal | Dépenses de R&D | Pourcentage du total des coûts opérationnels |
|---|---|---|
| 2023 | 8,3 millions de dollars | 62.4% |
| 2022 | 6,7 millions de dollars | 58.9% |
Investissements d'essais cliniques
Les dépenses d'essais cliniques pour les programmes de développement thérapeutique en cours ont totalisé 4,5 millions de dollars en 2023.
- Essais cliniques de phase I: 2,1 millions de dollars
- Essais cliniques de phase II: 2,4 millions de dollars
Coûts de conformité réglementaire
Les frais de conformité et de documentation réglementaires se sont élevés à 1,2 million de dollars en 2023.
Recrutement du personnel et des talents scientifiques
| Catégorie de personnel | Coût annuel | Nombre d'employés |
|---|---|---|
| Chercheur | 3,6 millions de dollars | 22 |
| Équipe de développement clinique | 2,8 millions de dollars | 15 |
| Personnel administratif | 1,5 million de dollars | 10 |
Maintenance de la propriété intellectuelle
Les coûts de maintenance de la propriété intellectuelle pour le dépôt des brevets, les poursuites et le renouvellement étaient de 650 000 $ en 2023.
- Frais de dépôt de brevets: 350 000 $
- Coûts de poursuite en brevet: 200 000 $
- Dépenses de renouvellement des brevets: 100 000 $
Palisade Bio, Inc. (Pali) - Modèle d'entreprise: sources de revenus
Ventes de produits thérapeutiques potentiels
Depuis le quatrième trimestre 2023, Palisade Bio n'a pas généré de revenus importants sur les produits. L'objectif principal de l'entreprise reste sur le développement de produits thérapeutiques aux stades cliniques.
Subventions de recherche
| Source d'octroi | Montant | Année |
|---|---|---|
| National Institutes of Health (NIH) | $350,000 | 2023 |
Accords de licence
Aucun accord de licence actif signalé dans les états financiers de 2023.
Financement de recherche collaborative
- Financement total de recherche collaborative: 475 000 $ en 2023
- Partners de collaboration de recherche primaire: établissements de recherche universitaires
Partenariats pharmaceutiques potentiels
| Étape de partenariat | Revenus potentiels | Statut |
|---|---|---|
| Discussions exploratoires | Non divulgué | En cours |
Revenus totaux pour l'exercice 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.
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