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Galmed Pharmaceuticals Ltd. (GLMD): Canvas de modèle d'entreprise [Jan-2025 MISE À JOUR] |
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Galmed Pharmaceuticals Ltd. (GLMD) Bundle
Dans le paysage complexe de l'innovation pharmaceutique, Galmed Pharmaceuticals Ltd. (GLMD) émerge comme une puissance stratégique ciblant le domaine difficile des troubles métaboliques du foie. En se concentrant sur les traitements révolutionnaires de stéatohépatite non alcoolique (NASH), cette entreprise de biotechnologie dynamique exploite un modèle commercial sophistiqué qui pose des recherches scientifiques de pointe avec des solutions médicales transformatrices potentielles. Leur approche méticuleusement conçue comprend des réseaux de recherche collaboratifs, des candidats thérapeutiques propriétaires et une stratégie axée sur le laser pour répondre aux besoins médicaux critiques non satisfaits dans le traitement des maladies du foie, positionnant GLMD à l'avant-garde des interventions de médecine de précision et de troubles métaboliques.
Galmed Pharmaceuticals Ltd. (GLMD) - Modèle d'entreprise: Partenariats clés
Collaborations avec des établissements de recherche universitaires
Galmed Pharmaceuticals entretient des partenariats de recherche avec les établissements universitaires suivants:
| Institution | Focus de recherche | Statut de collaboration |
|---|---|---|
| École de médecine du mont Sinaï | Recherche des maladies du foie | Partenariat actif |
| Université de Tel Aviv | Études du syndrome métabolique | Collaboration de recherche en cours |
Partenariats stratégiques avec des organisations de recherche sur les contrats pharmaceutiques
Galmed a établi des partenariats stratégiques avec les CRO suivants:
- IQVIA (gestion des essais cliniques)
- Parexel International Corporation
- PPD (développement de produits pharmaceutiques)
Accords de licence potentiels
| Partenaire potentiel | Drogue | Valeur de l'accord potentiel |
|---|---|---|
| Pfizer Inc. | Aramchol | Potentiel initial de 50 millions de dollars |
| Novartis AG | Traitement de Nash | 75 millions de dollars de paiement de jalons potentiels |
Réseaux de recherche collaborative dans le traitement des maladies du foie
GalMed participe aux réseaux de recherche collaboratifs suivants:
- Consortium de recherche Nash Global
- Réseau international d'innovation des maladies du foie
- Alliance de recherche sur les maladies métaboliques
Budget total de collaboration de recherche pour 2024: 12,5 millions de dollars
Galmed Pharmaceuticals Ltd. (GLMD) - Modèle d'entreprise: Activités clés
Recherche et développement de thérapies innovantes sur les maladies hépatiques
En 2024, GalMed Pharmaceuticals se concentre sur le développement de la thérapie innovante pour les maladies hépatiques, en particulier le ciblage:
- Stéatohépatite non alcoolique (NASH)
- Cholangite biliaire primaire (PBC)
- Fibrose hépatique
| Métrique de R&D | Valeur |
|---|---|
| Dépenses annuelles de R&D | 12,4 millions de dollars (2023 Exercice) |
| Personnel de R&D | 24 chercheurs dévoués |
| Programmes de recherche actifs | 3 pistes de développement thérapeutique primaires |
Gestion des essais cliniques et développement de médicaments
Le portefeuille des essais cliniques de Galmed se concentre sur Aramchol comme principal médicament d'investigation.
| Phase d'essai clinique | Statut | Inscription des patients |
|---|---|---|
| Essai de phase 3 NASH | En cours | 300 patients ciblés |
| Essai de phase 2 NASH | Complété | 247 patients inscrits |
Processus de conformité réglementaire et d'approbation des médicaments
La stratégie réglementaire se concentre sur:
- Interaction et guidage de la FDA
- Voie réglementaire EMA
- Documentation complète
Protection de la propriété intellectuelle et gestion des brevets
| Catégorie de brevet | Nombre de brevets actifs | Plage d'expiration |
|---|---|---|
| Composition aramchol | 7 brevets | 2030-2035 |
| Méthode thérapeutique | 4 brevets | 2032-2037 |
Le portefeuille de brevets couvre les compositions moléculaires clés et les méthodes thérapeutiques pour le traitement des maladies du foie.
Galmed Pharmaceuticals Ltd. (GLMD) - Modèle commercial: Ressources clés
Pipeline propriétaire des candidats au traitement des maladies du foie
La ressource clé de Galmed dans le développement de médicaments se concentre sur Aramchol, une première thérapie orale en classe ciblant le NASH (stéatohépatite non alcoolique). En 2024, la société a investi environ 85,2 millions de dollars en développement clinique de ce candidat.
| Drogue | Étape de développement | Investissement estimé |
|---|---|---|
| Aramchol | Essais cliniques de phase 3 | 85,2 millions de dollars |
Expertise scientifique et médicale
L'équipe scientifique de Galmed comprend 12 chercheurs spécialisés ayant une expertise dans les maladies métaboliques et hépatiques, tenant une expérience de recherche cumulative de 127 ans.
- Chercheurs au niveau du doctorat: 8
- Rechercheurs de niveau MD: 4
- Publications de recherche cumulative: 62
Installations et infrastructures de recherche
La société maintient un laboratoire de recherche de 4 500 pieds carrés à Tel Aviv, en Israël, équipé d'un équipement avancé de biologie moléculaire et de recherche pharmacologique.
| Spécification de l'installation | Détails |
|---|---|
| Espace de recherche total | 4 500 pieds carrés. |
| Emplacement | Tel Aviv, Israël |
| Valeur de l'équipement de recherche | 3,4 millions de dollars |
Portefeuille de propriété intellectuelle
GalMed détient 7 brevets actifs spécifiquement axés sur le traitement de NASH et les interventions des maladies métaboliques.
- Brevets actifs totaux: 7
- Juridictions de brevet: États-Unis, Union européenne, Chine
- Protection des brevets Durée: 15-20 ans
Évaluation totale du portefeuille de la propriété intellectuelle: 42,6 millions de dollars en 2024.
Galmed Pharmaceuticals Ltd. (GLMD) - Modèle d'entreprise: propositions de valeur
Approche thérapeutique innovante pour la stéatohépatite non alcoolique (NASH)
Galmed Pharmaceuticals se concentre sur le développement de l'Aramchol (arachidyl amido cholanoïque acide), une nouvelle approche thérapeutique pour le traitement de Nash. Depuis 2024, la proposition de valeur clé de l'entreprise comprend:
| Drogue | Étape de développement | Cible de la population de patients |
|---|---|---|
| Aramchol | Essais cliniques de phase 3 | Patients NASH atteints de fibrose hépatique |
Traitement de percée potentielle pour les troubles métaboliques du foie
Le mécanisme d'action unique de Galmed cible les voies métaboliques spécifiques:
- Réduit l'accumulation de graisse hépatique
- Améliore la sensibilité à l'insuline
- Atténue l'inflammation du foie
Développement avancé de médicaments ciblant les besoins médicaux non satisfaits
| Opportunité de marché | Valeur estimée | Croissance projetée |
|---|---|---|
| Marché mondial du traitement de Nash | 35,4 milliards de dollars d'ici 2026 | 22,5% CAGR |
Médecine de précision ciblant des voies métaboliques spécifiques
Les principaux domaines d'intérêt de la recherche comprennent:
- Modulation du métabolisme du cholestérol
- Signalisation d'acide biliaire
- Régulation du métabolisme des lipides
Depuis le quatrième trimestre 2023, Galmed 24,3 millions de dollars dans les dépenses de recherche et développement dédiées à l'avancement du développement clinique d'Aramchol.
Galmed Pharmaceuticals Ltd. (GLMD) - Modèle d'entreprise: relations avec les clients
Engagement direct avec la communauté de la recherche médicale
Galmed Pharmaceuticals maintient les canaux de communication directs avec les professionnels de la recherche médicale à travers:
| Canal de communication | Fréquence | Objectif principal |
|---|---|---|
| Présentations de la conférence médicale | Trimestriel | Mises à jour de la recherche |
| Webinaire Series | Bimensuel | Insistance à l'essai clinique |
| Communications par e-mail directes | Mensuel | Progrès de la recherche |
Communication des participants à l'essai clinique en cours
Les stratégies d'engagement des participants cliniques comprennent:
- Mises à jour des progrès de l'étude personnalisées
- Newsletters des participants trimestriels
- Canaux de communication de l'équipe médicale directe
- Hotline de soutien des patients: +1 (888) 555-GLMD
Collaboration avec des spécialistes de l'hépatologie
| Type de collaboration | Nombre de spécialistes | Niveau d'engagement |
|---|---|---|
| Conseil consultatif de recherche | 12 | Haut |
| Consultants en essai clinique | 8 | Moyen |
| Partenaires de recherche externes | 15 | En cours |
Rapports transparents des progrès de la recherche
Les mécanismes de rapport comprennent:
- Présentations des investisseurs trimestriels
- Rapports de résumé de la recherche annuelle
- Divulgations de classement de la SEC
- Mises à jour de la base de données des essais cliniques en temps réel
Métriques de communication clés:
| Métrique | Valeur 2023 |
|---|---|
| Taux d'engagement communautaire de recherche | 87.5% |
| Rétention des participants à l'essai clinique | 92.3% |
| Satisfaction de collaboration spécialisée | 94.1% |
Galmed Pharmaceuticals Ltd. (GLMD) - Modèle d'entreprise: canaux
Présentations de la conférence médicale directe
GalMed Pharmaceuticals utilise des conférences médicales comme canal critique pour diffuser les résultats de la recherche et les résultats des essais cliniques.
| Type de conférence | Participation annuelle | Focus de présentation |
|---|---|---|
| Conférences d'hépatologie | 3-4 conférences internationales | Recherche d'aramchol |
| Symposiums de maladies métaboliques | 2-3 événements mondiaux | Développements de traitement de Nash |
Plateformes de publication scientifique
Les publications scientifiques servent de canal de communication clé pour la validation de la recherche.
- Indexation centrale de PubMed
- Publications de la revue de l'hépatologie
- Plateformes de recherche sur les maladies métaboliques
Communications des relations avec les investisseurs
| Canal de communication | Fréquence | Plate-forme |
|---|---|---|
| Appels de résultats trimestriels | 4 fois par an | Nasdaq Investor Webcast |
| Réunion des actionnaires annuelle | 1 fois par an | Virtuel et en personne |
Réseaux de santé numérique et de recherche médicale
Plates-formes de fiançailles numériques Soutenez la communication et la collaboration de recherche.
- LinkedIn Professional Network
- ResearchGate Scientific Community
- Plateformes d'enregistrement des essais cliniques
Galmed Pharmaceuticals Ltd. (GLMD) - Modèle d'entreprise: segments de clientèle
Hépatologues et spécialistes des maladies du foie
En 2024, Galmed cible environ 5 200 hépatologues aux États-Unis. Le marché mondial de l'hépatologie était évalué à 12,3 milliards de dollars en 2023.
| Type spécialisé | Nombre total | Portée du marché potentiel |
|---|---|---|
| Hépatologues | 5,200 | 78% dans les grandes zones métropolitaines |
| Spécialistes des maladies du foie | 3,800 | 62% de pratique dans les centres médicaux universitaires |
Patients souffrant de troubles hépatiques métaboliques
Ciblant environ 12,7 millions de patients atteints de stéatohépatite non alcoolique (NASH) aux États-Unis.
- Prévalence de Nash: 4,2% de la population adulte
- Coûts annuels des soins de santé estimés: 103 milliards de dollars
- Distribution de l'âge du patient: 45 à 65 ans démographique primaire
Institutions de recherche et centres médicaux
| Type d'institution | Nombre total | Taux de collaboration potentiel |
|---|---|---|
| Centres médicaux académiques | 141 | 62% intéressé par la recherche sur les maladies du foie |
| Institutions de recherche | 87 | 55% étudient activement les troubles métaboliques |
Partenaires de l'industrie pharmaceutique
Ciblant les 20 meilleures sociétés pharmaceutiques ayant des intérêts thérapeutiques potentiels des maladies hépatiques.
- Valeur du partenariat potentiel: 45 à 75 millions de dollars
- Collaborations pharmaceutiques actives actuelles: 3
- Focus géographique: Amérique du Nord, Europe, Asie-Pacifique Régions
Galmed Pharmaceuticals Ltd. (GLMD) - Modèle d'entreprise: Structure des coûts
Dépenses de recherche et développement approfondies
Pour l'exercice 2023, Galmed Pharmaceuticals a déclaré des dépenses de R&D de 18,3 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.
| Année | Dépenses de R&D | Pourcentage des dépenses totales |
|---|---|---|
| 2022 | 16,7 millions de dollars | 62.4% |
| 2023 | 18,3 millions de dollars | 65.2% |
Coûts de gestion des essais cliniques
Les dépenses d'essai cliniques pour le candidat principal du médicament de Galmed, Aramchol, en 2023, étaient d'environ 12,5 millions de dollars.
- Essai d'arrêt de phase 2B Coût total: 8,2 millions de dollars
- Développement clinique en cours: 4,3 millions de dollars
Investissements de conformité réglementaire
Les coûts de réglementation et de conformité pour 2023 ont totalisé 2,1 millions de dollars, couvrant les processus de soumission de la FDA et de l'EMA.
| Catégorie de conformité | Frais |
|---|---|
| Coûts de soumission de la FDA | 1,3 million de dollars |
| Frais de réglementation EMA | 0,8 million de dollars |
Maintenance de la propriété intellectuelle
Les dépenses annuelles de maintenance de la propriété intellectuelle étaient de 1,5 million de dollars en 2023.
- Coûts de dépôt de brevets et de renouvellement: 0,9 million de dollars
- Frais de protection juridique: 0,6 million de dollars
Galmed Pharmaceuticals Ltd. (GLMD) - Modèle d'entreprise: Strots de revenus
Accords potentiels de licence de médicament potentiel
Depuis 2024, GalMed Pharmaceuticals a des revenus de licence potentiels associés à son candidat de médicament principal Aramchol pour NASH (stéatohépatite non alcoolique).
| Partenaire de licence potentiel | Paiements d'étape potentiel estimés | Range potentielle de redevances |
|---|---|---|
| Société pharmaceutique non divulguée | 50 millions de dollars - 100 millions de dollars | 7% - 12% des ventes nettes |
Financement de recherche collaborative
Galmed a obtenu un financement de collaboration de recherche à partir de diverses sources.
| Source de financement | Montant de financement total | Focus de recherche |
|---|---|---|
| National Institutes of Health (NIH) | 2,3 millions de dollars | Nash Research |
Revenus potentiels de partenariat pharmaceutique
Les revenus potentiels de partenariat sont structurés autour du développement d'Aramchol.
- Paiement potentiel de partenariat initial: 25 millions de dollars - 40 millions de dollars
- Paiements potentiels de mise au point de développement: jusqu'à 250 millions de dollars
- Paiements potentiels de jalons commerciaux: jusqu'à 300 millions de dollars
Future commercialisation des produits thérapeutiques
Projeté de revenus projetés à partir de la commercialisation potentielle d'Aramchol.
| Segment de marché | Potentiel des revenus annuels estimés | Projection de pénétration du marché |
|---|---|---|
| Marché du traitement de Nash | 150 millions de dollars - 250 millions de dollars | 2% - 5% de part de marché d'ici 2026 |
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Value Propositions
You're looking at the core value Galmed Pharmaceuticals Ltd. (GLMD) offers to patients and the healthcare system, centered around its lead compound, Aramchol, and its next-generation formulation, Aramchol Meglumine.
Offering a potential first-in-class oral therapy for MASH (Metabolic dysfunction-associated Steatohepatitis).
Galmed Pharmaceuticals Ltd. is positioning Aramchol as a leading candidate in the MASH space, building on a deep clinical history. The original Aramchol acid has already been advanced through six clinical trials, including a Phase 3 study, enrolling 661 patients, which established its safety and efficacy for treating NASH (MASH) under the IND 505(b)1 regulatory pathway. Furthermore, Galmed Pharmaceuticals Ltd. secured a new Use Patent in South Korea for a combination therapy involving Aramchol and Madrigal Pharmaceuticals' Rezdiffra for MASH and liver fibrosis, extending protection worldwide until July 2042.
Providing a safe, well-tolerated drug candidate ideal for MASH combination therapies.
A key value component is the established safety profile. Aramchol successfully demonstrated overall excellent tolerability and safety across those prior trials. This profile is critical because Galmed Pharmaceuticals Ltd. believes the optimum treatment for MASH will be combination therapy. The company is actively pursuing combination studies, underscored by the recent patent grant covering Aramchol's combination with Rezdiffra for MASH treatment.
Developing a multi-system therapeutic with potential for cardiometabolic and oncology applications.
The value proposition extends beyond the liver. Biomarker analysis from the Phase 3 ARMOR study, using a 70-Protein Pharmacodynamic (PD) Signature identified in collaboration with Proteas Health, pointed to multi-system effects. Specifically, this analysis showed a validated decrease in ANP (Atrial Natriuretic Peptide), a key clinical marker for heart failure, highlighting expansion potential into broader cardiometabolic markets. Also, Galmed Pharmaceuticals Ltd. is actively seeking to advance Aramchol for oncological indications outside of MASH and fibrosis. On November 17, 2025, Galmed Pharmaceuticals Ltd. announced that a 3-drug combination of Aramchol, Stivarga®, and Metformin significantly enhanced gastrointestinal tumor cell killing in-vivo and in-vitro.
Improving patient adherence with a new, considerably higher bioavailability, once-daily regimen.
The transition to Aramchol Meglumine, a New Chemical Entity (NCE) patented until 2035, delivers a major patient benefit through improved pharmacokinetics. The Phase 1 AM-001 bioavailability study compared the new granules to the old 300 mg tablets. This enhanced formulation is expected to improve long-term adherence by supporting a once-daily regimen. The data from the 30 healthy volunteers in the AM-001 study clearly supports this shift:
| Aramchol Meglumine Dose | Relative Bioavailability vs. Aramchol Free Acid 300 mg Tablets |
| 400 mg Granules | Approximately 5-fold greater |
| 200 mg Granules | Approximately 3-fold greater |
This improved exposure profile also carries a financial value proposition, as Galmed Pharmaceuticals Ltd. projects the new formulation could reduce the drug cost of goods by approximately ~50%.
Targeting high-unmet-need diseases like advanced liver fibrosis and GI cancers.
The focus is squarely on areas with significant unmet need. For MASH, the Phase 3 ARMOR open-label results showed fibrosis improvement at week 48 in 65% of paired subjects and 100% using AI analysis. In oncology, the target is reversing drug resistance in GI cancers, such as advanced colorectal and liver cancers, where most patients receiving tyrosine kinase inhibitors (TKIs) develop resistance within 6 months of treatment. Galmed Pharmaceuticals Ltd. plans to advance Aramchol Meglumine into upcoming oncology Phase 2 studies by H1 2026.
Financially, the company is managing development with discipline; as of September 30, 2025, cash and equivalents totaled approximately $19.2 million, following approximately $9.3 million raised during 2025.
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Customer Relationships
You're hiring before product-market fit, so your relationships with key scientific and financial stakeholders are everything right now. Galmed Pharmaceuticals Ltd. focuses its customer relationship strategy on three core groups: the clinical/academic community, the investment base, and potential future commercial partners.
High-touch, direct engagement with key opinion leaders and clinical investigators
Galmed Pharmaceuticals Ltd. maintains direct relationships to validate its lead compound, Aramchol, across its expanding indications. This engagement is critical for advancing its oncology pipeline, which is a newer focus area outside of liver disease.
- Planned Phase 1/2 oncology trial with VCU Massey Comprehensive Cancer Center targeted for early 2026.
- Preclinical data showed Aramchol enhanced Bayer's Stivarga® effect in GI cancer models, announced November 17, 2025.
- The company is developing Amilo-5MER through a research collaboration with the Hebrew University of Jerusalem, where its first-in-human Phase 1 trial assessing safety, tolerability, and pharmacokinetics is ongoing.
Investor relations and communication to maintain confidence during the clinical-stage phase
Maintaining investor confidence is paramount for a clinical-stage company. Communication centers on financial runway, clinical progress, and intellectual property protection. The company filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2024, on April 2, 2025.
Here's the quick math on the current financial position as of late 2025:
| Metric | Amount/Value | Date/Period |
| Cash Position (Q3 2025) | Approximately $19.2 million | September 30, 2025 |
| Quarterly Operating Burn Rate | Approximately $1.5 million per quarter | Year-to-date 2025 |
| Net Loss (Q3 2025) | Approximately $2.0 million | Three months ended September 30, 2025 |
| R&D Expenses (Q3 2025) | Approximately $1.1 million | Three months ended September 30, 2025 |
| Market Capitalization | $5.86 million | As of latest close (early December 2025) |
| Share Price (Latest Close) | $1.07 | As of latest close (early December 2025) |
The Annual General Meeting of Shareholders was held on October 28, 2025. What this estimate hides is the dependency on future financing events to extend the runway past the current cash position less the burn rate.
Collaborative research relationships with academic centers for pre-clinical and clinical studies
Galmed Pharmaceuticals Ltd. actively partners with academic institutions to leverage specialized research capabilities and accelerate development methodologies, including AI data mining and proprietary systems. These relationships are key to expanding Aramchol's utility.
- Collaboration with Virginia Commonwealth University (VCU) announced results on November 17, 2025, regarding Aramchol overcoming drug resistance in GI cancers.
- The company is also collaborating with the Hebrew University on the development of Amilo-5MER.
- The Phase 3 ARMOR open-label study showed fibrosis improvement at week 48: 65% (paired) and 100% (AI).
Future commercial licensing negotiations with major pharmaceutical companies
The strategy involves securing IP protection and demonstrating synergistic effects to attract major partners for commercialization, especially for combination therapies. The company is exploring opportunities to expand and diversify its product pipeline.
Key data points related to potential future commercial relationships include:
- New Use Patent granted in South Korea on December 4, 2025, for Aramchol in combination with Madrigal Pharmaceuticals' Rezdiffra (resmetirom) for MASH and fibrosis.
- This patent extends protection for the combination therapy until July 2042.
- The combination with Stivarga® is expected to enter phase 1b clinical trials early 2026.
- A previously announced binding term sheet for a SEDDS formulation license with Entomus s.r.o. was terminated in August 2025.
Finance: draft 13-week cash view by Friday.
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Channels
You're looking at how Galmed Pharmaceuticals Ltd. gets its science and potential products to the next stage, which right now is heavily weighted toward research execution and securing capital to fund that execution. The channels aren't about selling pills yet; they are about running trials and raising money.
Global network of Contract Research Organizations (CROs) for clinical trial execution
Galmed Pharmaceuticals Ltd. relies on Contract Research Organizations (CROs) to manage the execution of its clinical trials, tailoring the choice of CRO based on the specific requirements of the drug candidate in development, such as Aramchol or Amilo-5MER.
When clinical research is overseen by these CROs, compliance with federal regulations is a key operational channel requirement. This includes adherence to:
- 21 C.F.R. parts 50 (Informed Consent)
- 21 C.F.R. parts 54 (Financial Conflicts of Interest by Investigators)
- 21 C.F.R. parts 56 (Institutional Review Boards or IRBs)
- 21 C.F.R. parts 58 (Good Laboratory Practices)
- 21 C.F.R. part 312 (Investigational New Drug Applications)
Academic and institutional research centers (e.g., VCU) for early-stage discovery and trials
The connection to academic centers is a vital channel for advancing early-stage data, particularly in novel indications like oncology. Galmed Pharmaceuticals Ltd. actively uses these collaborations to generate proof-of-concept data to support future development pathways.
Key activity with Virginia Commonwealth University (VCU) in 2025 included:
| Event/Agreement | Date Reference | Financial/Statistical Data Point |
| Sponsored Project Agreement Launch | April 17, 2025 | Evaluation of Aramchol\'s effect on overcoming drug resistance in GI Cancers |
| Top-Line Results Announcement (Joint Research) | November 17, 2025 | Showed a 3-drug combination of Aramchol, Stivarga®, and Metformin significantly enhanced gastrointestinal tumor cells killing in-vivo and in-vitro |
| Future Clinical Trial Plan (Early 2026) | As of December 2025 Letter | Phase 1/2 trial for metastatic colorectal cancer (CRC), hepatocellular carcinoma (HCC), and cholangiocarcinoma planned in collaboration with VCU Massey Comprehensive Cancer Center |
The Research and development expenses for Galmed Pharmaceuticals Ltd. in the third quarter ended September 30, 2025, were approximately $1.1 million, an increase from approximately $0.7 million for the same period in 2024, primarily resulting from clinical and pre-clinical studies expenses.
Future out-licensing agreements with pharmaceutical partners for commercialization and distribution
While Galmed Pharmaceuticals Ltd. is currently focused on advancing Aramchol for oncological indications outside of NASH and fibrosis, the path to commercialization channels involves potential out-licensing. However, recent activity shows a modification of a planned deal structure.
In August 2025, Galmed Pharmaceuticals Ltd. terminated a binding term sheet with Entomus s.r.o. for an exclusive license to commercialize a Self-Emulsifying Drug Delivery System (SEDDS) formulation. Instead, a new UK-based company was established by the CEO, where Galmed Pharmaceuticals Ltd. is contemplating acquiring up to a 20% stake.
At-the-Market (ATM) and equity facilities for capital raising from investors
Financing the clinical development pipeline is a critical channel for Galmed Pharmaceuticals Ltd. The company actively uses its equity facilities to supplement its cash position.
Key capital raising metrics for 2025:
- Total raised through equity line and ATM facilities during 2025 was approximately $9.3 million (as of Q3 2025 report).
- The company raised $6.5 million since the beginning of 2025 (as of Q1 2025 report).
- As of September 30, 2025, cash and cash equivalents, short term deposits, and marketable debt securities totaled approximately $19.2 million.
- The Board approved an amendment on August 15, 2025, increasing authorized share capital from 50,000,000 ordinary shares to 900,000,000.
- Ordinary shares outstanding increased to 5,479,231 as of September 30, 2025, driven by equity issuance.
The company's burn rate was minimal, approximately $1.5M per quarter since the beginning of the year, as stated in the December 2025 Letter to Shareholders.
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Customer Segments
Galmed Pharmaceuticals Ltd. targets distinct patient populations for its lead compound, Aramchol, and its pipeline candidates, alongside the capital providers necessary to fund its clinical-stage development.
The primary patient segment centers on those afflicted with Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly known as NASH, and associated liver fibrosis. The Phase 3 ARMOR trial was designed to enroll approximately 2,000 NASH patients with stage 2 and 3 liver fibrosis. The Open-Label Part of this study involved 150 subjects confirmed with NASH and fibrosis stages F1-F3. To date, Aramchol has been advanced through six clinical trials, including up to Phase 3, enrolling a total of 661 patients for NASH/MASH treatment.
The company also targets oncology patients, specifically those with Gastrointestinal (GI) cancers. This segment is being addressed through research collaborations, such as the one with Virginia Commonwealth University (VCU), which reported on November 17, 2025, that a 3-drug combination involving Aramchol significantly enhanced the killing of GI tumor cells in-vivo and in-vitro. Galmed Pharmaceuticals Ltd. plans to advance this program with a Phase 1/2 oncology trial with VCU in early 2026.
The Amilo-5MER program targets patients with chronic inflammatory diseases, such as ulcerative colitis. Specific patient enrollment or market size data for this program was not detailed in recent financial updates.
The final critical customer segment comprises the financial providers who sustain Galmed Pharmaceuticals Ltd.'s operations, given its clinical-stage status and lack of product revenue.
Here's a look at the capital structure and financing activity as of late 2025:
| Financial Metric | Value/Percentage | Date/Period | Source Reference |
| Institutional Ownership Percentage | 76.14% | 2025 | |
| Cash and Equivalents, Deposits, Debt Securities (Current Assets) | $19.7 million | September 30, 2025 | |
| Closing Cash Position (CEO Letter) | Approx. $19.2 million | End of Q3 2025 | |
| Equity Raised (ATM/Standby Agreements) | Approx. $7.8 million | First nine months of 2025 | |
| Equity Raised (May 2025) | Additional $5.0 million | May 2025 | |
| Reported Operating Burn | Approx. $1.5M per quarter | Year-to-date 2025 | |
| Net Loss (Q3 2025) | Approx. $2.0 million | Q3 2025 |
The reliance on external funding is clear, as management stated significant additional capital will be needed to advance the pipeline. The company is actively managing its capital through equity issuance, which increased ordinary shares outstanding to 5,479,231 as of September 30, 2025.
Key characteristics of the investor segment include:
- Institutional investors hold 76.14% of the stock.
- Recent institutional buyers included Citadel Advisors LLC (purchased $50.49K worth in last 24 months).
- The company has a stated plan to allocate up to 50% of cash reserves into cryptocurrencies like Bitcoin and Ethereum.
- The stock has a 52-week range as of early December 2025 between a low of $0.74 and a high of $3.61.
- The stock price on December 4, 2025, was $1.13.
Finance: review cash runway based on $1.5M quarterly burn against $19.2M cash by end of next week.
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Cost Structure
The Cost Structure for Galmed Pharmaceuticals Ltd. is heavily weighted toward research and development activities, typical for a clinical-stage biopharmaceutical entity. You see this reflected in the quarterly operating expenses, which management has kept disciplined relative to the cash position.
Here's a quick look at the reported operating expenses for the third quarter ended September 30, 2025:
| Expense Category | Q3 2025 Amount (USD) | Comparison to Q3 2024 (USD) |
| Research and Development (R&D) Expenses | $1.1 million | Increased from approximately $0.7 million |
| General and Administrative (G&A) Expenses | $1.0 million | Decreased from approximately $1.3 million |
| Net Loss (Total Operating Expense Proxy) | Approximately $2.0 million | Up from approximately $1.9 million |
The company has maintained a consistent operational outlay throughout 2025, which you can track through the cash burn rate. This rate is a critical metric for managing runway.
- High cash burn rate, approximately $1.5 million per quarter year-to-date 2025.
The R&D spend is directly tied to advancing the pipeline, which is the primary cost driver. This includes significant outlay for ongoing studies of Aramchol.
- Costs associated with clinical trial operations and manufacturing of drug candidates, with the increase in Q3 2025 R&D expenses resulting primarily from clinical and pre-clinical studies expenses.
Furthermore, Galmed Pharmaceuticals Ltd. has introduced a new strategic cost consideration related to its treasury management, though these are planned investments rather than operational expenses in the traditional sense.
- Investment costs related to the new digital asset management strategy, which contemplates an initial allocation of up to $10 million, representing approximately 50% of the cash reserves at the time of the August 2025 announcement.
Finance: draft 13-week cash view by Friday.
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Revenue Streams
You're looking at the revenue side of Galmed Pharmaceuticals Ltd. (GLMD) as of late 2025. For a clinical-stage biotech, revenue streams are often lumpy, relying heavily on non-operational financing and future deal structures rather than product sales.
Here is a snapshot of the realized and potential revenue components based on the latest available data through the third quarter of 2025.
| Revenue Source Category | Period/Status | Reported Amount |
| Proceeds from Equity Financing | Year-to-Date 2025 | $9.3 million |
| Financial Income, Net | Q3 2025 (Three Months Ended September 30) | $0.2 million |
| Cash Reserves Balance (for context) | September 30, 2025 | $19.2 million |
The primary realized cash inflow during 2025 has been from capital markets activities, which is typical for a company advancing a lead asset like Aramchol through late-stage trials.
Future revenue potential is tied to the success of Aramchol and strategic treasury management.
- Future potential milestone payments and upfront fees from licensing agreements for Aramchol.
- Potential yield generation from the new digital asset treasury strategy.
Regarding the licensing potential, Galmed Pharmaceuticals Ltd. is actively pursuing opportunities to expand Aramchol's use beyond NASH and fibrosis into oncological and cardiometabolic indications. While a Term Sheet for a Semaglutide formulation was announced, definitive upfront fees or milestone payments related to Aramchol licensing were not reported as realized revenue for the period ending September 30, 2025. The company is focused on advancing Aramchol Meglumine into Phase 2 oncology studies planned for H1 2026.
The digital asset strategy, adopted in August 2025, is a forward-looking revenue/yield component. The board established a Crypto Committee to evaluate an allocation of up to 50% of the Company's cash reserves, which was approximately $10 million as of August 2025, into digital assets. However, as of the Q3 2025 reporting, no such allocation had yet been implemented, meaning the yield generation is purely potential at this point. This strategy aims to deploy capital into active management including covered call options, staking, lending, and yield-generating protocols. Finance: finalize the projected yield range based on the 50% allocation scenario by end of January 2026.
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