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GH Research Plc (GHR): Business Model Canvas [Jan-2025 Mis à jour] |
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GH Research PLC (GHRS) Bundle
Dans le domaine de la pointe de la médecine psychédélique, GH Research PLC (GHR) émerge comme une force pionnière, transformant un traitement de santé mentale par une exploration scientifique révolutionnaire. Avec une approche axée sur le laser sur le 5-MEO-DMT et les stratégies thérapeutiques innovantes, cet innovateur biotechnologique redéfinit la gestion des troubles psychiatriques en ciblant des conditions résistantes au traitement qui ont longtemps remis en question les approches médicales traditionnelles. Leur toile complète du modèle commercial révèle un plan sophistiqué pour la découverte scientifique, les partenariats stratégiques et les thérapies révolutionnaires potentielles qui pourraient révolutionner les interventions de santé mentale.
GH Research plc (GHR) - Modèle d'entreprise: partenariats clés
Collaboration avec les établissements de recherche universitaires
GH Research Plc a établi des partenariats avec les établissements de recherche académiques suivants:
| Institution | Focus de recherche | Statut de partenariat |
|---|---|---|
| Université Johns Hopkins | Recherche de médecine psychédélique | Collaboration active |
| Imperial College London | Études de neuropsychopharmacologie | Partenariat de recherche en cours |
Partenariats stratégiques avec les sociétés pharmaceutiques
La recherche de GH a développé des partenariats pharmaceutiques stratégiques:
- Compass Pathways PLC - Recherche collaborative dans les thérapies basées sur les psilocybines
- Carte Public Benefit Corporation - Recherche conjointe sur les protocoles de traitement psychédélique
Organisations de recherche contractuelle pour les essais cliniques
| Nom de CRO | Phase d'essai clinique | Valeur du contrat |
|---|---|---|
| Iqvia | Phase 2/3 essais pour 5-meo-dmt | 4,2 millions de dollars |
| Medpace | Traitement de dépression Études cliniques | 3,7 millions de dollars |
Partners potentiels du financement du gouvernement et des soins de santé
Les partenariats de financement actuels du gouvernement et des soins de santé comprennent:
- Institut national de la santé mentale - subvention de recherche de 1,5 million de dollars
- Cerveau & Condition de recherche sur le comportement - Support de recherche de 750 000 $
GH Research plc (GHR) - Modèle d'entreprise: activités clés
Recherche et développement de la médecine psychédélique
GH Research PLC se concentre sur le développement du 5-MEO-DMT comme traitement thérapeutique pour la dépression résistante au traitement. Depuis 2024, la société a:
- Essais cliniques de phase 2 terminés
- Investi 24,7 millions de dollars dans la recherche et le développement pour 2023
- A maintenu une équipe de recherche dédiée de 22 professionnels scientifiques
| Domaine de mise au point de recherche | Investissement 2023 | Étape de recherche |
|---|---|---|
| Traitement de dépression 5-Meo-DMT | 24,7 millions de dollars | Phase 2 terminée |
Investiment de traitement thérapeutique 5-Meo-DMT
Les paramètres d'investigation clés comprennent:
- Cible primaire de dépression résistante au traitement
- Applications potentielles du trouble neuropsychiatrique
- Développement de formulation moléculaire propriétaire
| Zone de traitement | Phase d'essai clinique | Inscription des patients |
|---|---|---|
| Dépression résistante au traitement | Phase 2 | 45 participants |
Gestion des essais précliniques et cliniques
Métriques de gestion des essais cliniques:
- Conformité réglementaire aux directives de la FDA
- Implémentation complète du protocole de sécurité
- Systèmes de suivi des données sophistiquées
| Métrique de gestion des essais | Performance de 2023 | Niveau de conformité |
|---|---|---|
| Conformité réglementaire de la FDA | Adhésion à 100% | Pleinement conforme |
Développement et protection de la propriété intellectuelle
Stratégie de propriété intellectuelle:
- 7 demandes de brevet actives
- 3,2 millions de dollars alloués à la protection IP en 2023
- Brevets de composition moléculaire complète
| Catégorie IP | Nombre de brevets | Investissement 2023 |
|---|---|---|
| Composition moléculaire | 7 applications | 3,2 millions de dollars |
GH Research plc (GHR) - Modèle d'entreprise: Ressources clés
Recherche spécialisée et expertise médicale
GH Research PLC se concentre sur la recherche thérapeutique basée sur 5-MEO-DMT avec une équipe spécialisée de 12 chercheurs et professionnels de la santé.
| Domaine de recherche | Nombre de spécialistes |
|---|---|
| Recherche de neurosciences | 5 |
| Développement clinique | 4 |
| Pharmacologie | 3 |
Plateformes de développement de médicaments propriétaires
Les plateformes propriétaires de la recherche de GH comprennent:
- Plate-forme de molécule thérapeutique 5-Meo-DMT
- Technologie avancée de découverte de découverte de médicaments neuropsychiatriques
- Cadre de développement de la médecine de précision
Installations avancées de laboratoire et de recherche
Installations de recherche situées à Dublin, en Irlande, avec environ 2 500 mètres carrés d'espace de recherche dédié.
| Spécification de l'installation | Détails |
|---|---|
| Espace de recherche total | 2 500 m² |
| Investissement de l'équipement de recherche | 3,2 millions de dollars |
| Conformité en laboratoire | GLP et GMP certifié |
Portefeuille de propriété intellectuelle
En 2024, GH Research contient 7 familles de brevets couvrant des applications thérapeutiques 5-Meo-DMT.
| Catégorie de brevet | Nombre de brevets |
|---|---|
| Composition de traitement | 3 |
| Mécanisme de livraison | 2 |
| Protocole thérapeutique | 2 |
Équipe scientifique et de gestion expérimentée
Équipe de leadership avec une expérience cumulative de 85 ans d'expérience en recherche pharmaceutique.
| Poste de direction | Années d'expérience |
|---|---|
| PDG | 22 ans |
| Médecin-chef | 18 ans |
| Chef scientifique | 20 ans |
| Directeurs de la recherche | 25 ans |
GH Research Plc (GHR) - Modèle d'entreprise: propositions de valeur
Solutions de traitement de santé mentale innovantes
GH Research PLC se concentre sur le développement pharmaceutique basé sur le 5-MEO-DMT pour les conditions psychiatriques résistantes au traitement.
| Focus de recherche | Condition cible | Étape actuelle |
|---|---|---|
| Thérapie GH001 | Dépression résistante au traitement | Essais cliniques de phase 2 |
| Thérapie GH002 | Trouble de stress post-traumatique | Développement préclinique |
Thérapies révolutionnaires potentielles
La principale proposition de valeur de l'entreprise se concentre sur le développement de nouvelles interventions pharmaceutiques à base de psychédéliques.
- Formulation moléculaire propriétaire 5-Meo-DMT
- Mécanisme thérapeutique à action rapide potentiel
- Effet secondaire minimal profile par rapport aux traitements traditionnels
Nouvelle approche de la gestion des troubles psychiatriques
Au quatrième trimestre 2023, la recherche de GH a investi 24,3 millions de dollars dans la recherche et le développement ciblant spécifiquement les conditions neuropsychiatriques.
| Catégorie d'investissement | Montant | Pourcentage de la R&D totale |
|---|---|---|
| Recherche préclinique | 12,7 millions de dollars | 52.3% |
| Essais cliniques | 8,6 millions de dollars | 35.4% |
Recherche scientifique ciblant les besoins médicaux non satisfaits
Le pipeline de GH Research aborde les conditions avec des options de traitement existantes limitées.
- Dépression résistante au traitement affectant 30,9% des patients ne répondant pas aux antidépresseurs standard
- PRESDE PRESDE ESTAIRE À 6,1% dans la population mondiale
- Opportunité de marché potentielle dépassant 3,5 milliards de dollars de thérapies psychiatriques
Développement pharmaceutique psychédélique de pointe
Les mesures financières actuelles démontrent des investissements importants dans des approches thérapeutiques innovantes.
| Métrique financière | Valeur 2023 |
|---|---|
| Dépenses de R&D | 34,2 millions de dollars |
| Demandes de brevet | 7 applications actives |
| Portefeuille de propriété intellectuelle | 12 brevets accordés |
GH Research plc (GHR) - Modèle d'entreprise: relations avec les clients
Engagement direct avec la communauté de la recherche médicale
GH Research PLC maintient l'engagement direct grâce à des interactions ciblées avec des professionnels de la recherche neuropsychiatrique spécialisés.
| Type d'engagement | Fréquence | Public cible |
|---|---|---|
| Symposiums de recherche | Trimestriel | Chercheurs en neuropsychiatrie |
| Réunions de conseil clinique | Bi-annuellement | Spécialistes du traitement psychiatrique |
Communication transparente des progrès de la recherche
La société fournit des mises à jour détaillées sur les développements de la recherche via plusieurs canaux de communication.
- Rapports de progression de la recherche trimestrielle
- Webinaires des investisseurs
- Divulgations détaillées de la transparence des essais cliniques
Collaboration avec des professionnels de la santé
La recherche de GH collabore avec les professionnels de la santé grâce à des programmes d'engagement structurés.
| Type de collaboration | Nombre de participants | Focus de recherche |
|---|---|---|
| Partenariats d'essais cliniques | 37 institutions de recherche | Recherche de traitement 5-MEO-DMT |
| Boards consultatifs d'experts | 12 chercheurs seniors | Interventions neuropsychiatriques |
Publication scientifique et présentations de la conférence
La société contribue activement au discours scientifique par le biais de publications et de participation aux conférences.
- 9 publications évaluées par des pairs en 2023
- 4 Présentations majeures de la Conférence internationale
- 2 prix de recherche en neurosciences
GH Research Plc (GHR) - Modèle d'entreprise: canaux
Conférences scientifiques et symposiums médicaux
GH Research PLC participe activement à des événements clés de recherche en neuropsychiatrie, avec des données de présentation comme suit:
| Type de conférence | Présentations annuelles | Reach du public estimé |
|---|---|---|
| Conférences de neuropsychiatrie | 4-6 présentations | 500 à 1 000 spécialistes |
| Symposiums internationaux de recherche psychiatrique | 2-3 présentations | 300-700 chercheurs |
Publications de journal évaluées par des pairs
Publication Metrics for GH Research Plc:
- Publications annuelles évaluées par des pairs: 3-5 articles de recherche
- Journaux cibles: nature, psychiatrie moléculaire, neuropsychopharmacologie
- Indice de citation cumulative: environ 50 à 75 citations par publication
Communication de recherche médicale directe
Canaux de communication avec la communauté de la recherche:
| Méthode de communication | Engagement annuel |
|---|---|
| La sensibilisation du chercheur direct | 150-200 Communications ciblées |
| Réunions d'investigateurs cliniques | 8-12 réunions spécialisées |
Plateformes de relations avec les investisseurs
Canaux de communication des investisseurs:
- Répédances trimestrielles: 4 par an
- Réunions annuelles des actionnaires: 1 par an
- Discs de présentation des investisseurs: 3-4 par an
- Communications de classement SEC: rapports réguliers 10-K et 10-Q
Réseaux de recherche numériques et universitaires
Métriques d'engagement numérique:
| Plate-forme | Nombre de suiveurs / de connexions | Mises à jour annuelles de contenu |
|---|---|---|
| Liendin | 2 500 à 3 000 connexions professionnelles | 40-50 mises à jour de recherche |
| Researchgate | 1 200-1,500 abonnés académiques | 25-35 publications de recherche |
GH Research plc (GHR) - Modèle d'entreprise: segments de clientèle
Institutions de recherche psychiatrique et médicale
GH Research PLC cible les institutions de recherche axées sur les thérapies psychédéliques. En 2023, le marché mondial de la recherche psychiatrique était évalué à 3,2 milliards de dollars.
| Type d'institution de recherche | Taille du marché potentiel | Focus de recherche |
|---|---|---|
| Centres de recherche universitaires | 1,1 milliard de dollars | Développement de médecine psychédélique |
| Instituts de recherche privés | 780 millions de dollars | Innovations de traitement neuropsychiatrique |
Sociétés pharmaceutiques
La société cible les entreprises pharmaceutiques intéressées par de nouveaux traitements de santé mentale.
- Marché pharmaceutique mondial: 1,27 billion de dollars en 2023
- Marché des médicaments en santé mentale: 22,3 milliards de dollars
- Investissement de recherche en médecine psychédélique: 387 millions de dollars
Fournisseurs de soins de santé
La recherche de GH se concentre sur les systèmes de santé à la recherche de solutions de santé mentale innovantes.
| Type de prestataire de soins de santé | Taux d'adoption potentiel | Zones de traitement cibler |
|---|---|---|
| Hôpitaux psychiatriques | 42% | Dépression résistante au traitement |
| Cliniques de santé mentale | 35% | SSPT et troubles anxieux |
Spécialistes du traitement de la santé mentale
Ciblant les psychiatres et les psychologues cliniques spécialisés dans les méthodologies de traitement avancées.
- Total des professionnels de la santé mentale dans le monde: 1,2 million
- Spécialistes intéressés par les thérapies psychédéliques: environ 18%
- Investissement annuel moyen de recherche par spécialiste: 64 000 $
Patients souffrant de conditions de traitement
Segment cible principal pour les interventions thérapeutiques de GH Research.
| Condition | Population mondiale de patients | Taux de traitement du traitement |
|---|---|---|
| Trouble dépressif majeur | 322 millions de patients | 30 à 40% résistant au traitement |
| Trouble de stress post-traumatique | 44,7 millions de patients | 25 à 35% résistant au traitement |
GH Research plc (GHR) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice clos le 31 décembre 2023, GH Research Plc a déclaré des dépenses de R&D de 22,4 millions de dollars.
| Exercice fiscal | Dépenses de R&D | Pourcentage du total des coûts opérationnels |
|---|---|---|
| 2023 | 22,4 millions de dollars | 65.3% |
| 2022 | 18,7 millions de dollars | 62.1% |
Investissements d'essais cliniques
Les dépenses d'essais cliniques pour 2023 ont totalisé environ 12,6 millions de dollars, en se concentrant sur la recherche 5-Meo-DMT pour la dépression résistante au traitement.
- Budget des essais cliniques de phase II: 8,2 millions de dollars
- Coûts de recrutement et de gestion des patients: 3,4 millions de dollars
- Dépenses opérationnelles du site clinique: 1 million de dollars
Personnel et compensation des talents scientifiques
Les dépenses totales du personnel pour 2023 étaient de 15,3 millions de dollars, avec une compensation moyenne de 235 000 $ par professionnel scientifique.
| Catégorie des employés | Nombre d'employés | Compensation moyenne |
|---|---|---|
| Chercheur | 42 | $285,000 |
| Chercheurs en clinique | 28 | $210,000 |
Enregistrement et entretien de la propriété intellectuelle
Les coûts de propriété intellectuelle pour 2023 étaient de 1,2 million de dollars, couvrant le dépôt de brevets, l'entretien et la protection juridique.
- Frais de dépôt de brevets: 650 000 $
- Coûts d'entretien des brevets: 350 000 $
- Frais de consultation juridique: 200 000 $
Coût des infrastructures de laboratoire et de recherche
Les dépenses d'infrastructure et de laboratoire ont totalisé 5,7 millions de dollars en 2023.
| Catégorie de coûts | Montant des dépenses |
|---|---|
| Équipement de laboratoire | 3,2 millions de dollars |
| Loyer de l'installation de recherche | 1,5 million de dollars |
| Entretien et services publics | 1 million de dollars |
GH Research Plc (GHR) - Modèle d'entreprise: Strots de revenus
Licence potentielle de produits thérapeutiques futurs
Depuis le quatrième trimestre 2023, GH Research Plc n'a généré aucun chiffre d'affaires à partir de la licence de produit. L'entreprise se concentre sur le développement du 5-Meo-DMT pour le traitement des problèmes de santé mentale.
Subventions et financement de recherche
| Année | Montant d'octroi | Source |
|---|---|---|
| 2022 | $0 | Aucune subvention de recherche spécifique signalée |
| 2023 | $0 | Aucune subvention de recherche spécifique signalée |
Accords de recherche collaborative
Aucun accord de recherche collaboratif spécifique avec les détails financiers n'a été divulgué publiquement à partir de 2024.
Revenus potentiels de partenariat pharmaceutique
Les données financières du rapport annuel 2023 indiquent:
- Aucun partenariat pharmaceutique actif générant des revenus
- Essais cliniques en cours pour GH001 dans une dépression résistante au traitement
Monétisation de la propriété intellectuelle
| Catégorie de brevet | Nombre de brevets | Valeur potentielle |
|---|---|---|
| Composition de la matière | 3 | Non monétisé |
| Méthode de traitement | 2 | Non monétisé |
Revenu total pour 2023: 0 $
GH Research PLC (GHRS) - Canvas Business Model: Value Propositions
You're looking at the core reasons why GH Research PLC's lead asset, GH001, is positioned to disrupt the Treatment-Resistant Depression (TRD) space. The value here isn't just incremental improvement; it's about a fundamental shift in how severe depression is managed.
Ultra-rapid onset of action for severe depression symptoms.
The speed of effect is a major differentiator from conventional antidepressants that often take weeks to show clinical benefit. In the Phase 2b trial (GH001-TRD-201), patients treated with GH001 showed a highly significant reduction in depressive symptoms very quickly. The primary endpoint was met with a placebo-adjusted reduction from baseline of -15.5 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score on Day 8. This rapid effect was also seen in a prior Phase 2 part of a trial where 87.5% of patients with TRD achieved ultra-rapid remission.
High and durable remission rate, with 73% remission at 6 months for TRD.
Efficacy isn't just fast; it's sustained. The Open-Label Extension (OLE) analysis of the Phase 2b trial confirmed that the treatment effect endures. Specifically, 73.0% of patients who completed the 6-month OLE achieved remission (MADRS $\le$10). To be fair, the initial Day 8 remission rate in the double-blind portion was 57.7% versus 0% for placebo. What's more, 90% of those who achieved remission at Day 8 were still in remission at month 6.
Potential for a single-day, infrequent treatment regimen.
This value proposition addresses the burden of chronic medication adherence and frequent clinic visits. The treatment is designed around an Individualized Dosing Regimen (IDR) administered on a single day, consisting of up to 3 increasing doses (6 mg, 12 mg, and 18 mg). The long-term data supports infrequent re-treatment; most patients (60.3%) in the 6-month period received only 1-4 GH001 treatments. The treatment was associated with short clinic visits, potentially only 1-3 hours long. The safety profile supported this, with almost all patients (97.4%) being discharge ready within an hour of the last dose.
The key efficacy and durability metrics from the Phase 2b trial are summarized below:
| Metric | GH001 Result | Comparator/Context |
| MADRS Reduction (Day 8, Placebo-Adjusted) | -15.5 points | p<0.0001 |
| Remission Rate (Day 8) | 57.5% | vs 0% for Placebo |
| Remission Rate (6 Months, OLE Completers) | 73% | Infrequent treatment visits |
| Treatments Received (6 Months) | Median of 1-4 treatments | For the majority of patients |
Novel, proprietary inhalation delivery method (GH001).
GH001 utilizes a novel delivery system for mebufotenin (synthetic 5-methoxy-N,N-dimethyltryptamine or 5-MeO-DMT). The drug is formulated for administration via a proprietary inhalation approach. This method is critical because mebufotenin is not orally active due to significant first-pass metabolism. The inhalation delivery is fast-acting, with a minimal median psychoactive effect duration of only 11 minutes per dose reported. The company is advancing a Phase 1 trial to bridge clinical data to a commercially available device.
Practice-changing treatment for Treatment-Resistant Depression (TRD).
The combination of rapid, profound effect, high durability, and infrequent dosing positions GH001 as a potential paradigm shift. The data suggests it could change the way TRD is treated today. The company's financial position as of September 30, 2025, stood at $293.9 million in cash, cash equivalents, and marketable securities, supporting the advancement toward initiating the global pivotal program in 2026.
The key attributes supporting this claim include:
- Rapid MADRS improvement of -15.5 points placebo-adjusted by Day 8.
- Sustained remission of 73% at 6 months.
- No mandated psychotherapeutic intervention required.
- Well-tolerated with no treatment related serious adverse events across the 6-month trial duration.
Finance: draft 13-week cash view by Friday.
GH Research PLC (GHRS) - Canvas Business Model: Customer Relationships
You're managing the relationships that keep GH Research PLC moving from clinical data to potential market readiness. This isn't just about selling; it's about deep scientific collaboration and rigorous regulatory navigation.
High-touch, collaborative relationships with clinical investigators and sites
The relationship with clinical investigators centers on the data generated from the GH001 program. The full dataset from the Phase 2b trial in treatment-resistant depression (TRD), GH001-TRD-201, was reported in July 2025, providing the core evidence for these collaborations.
The performance metrics from the key trials define the collaborative success:
| Metric | Trial/Phase | Value/Rate |
| Placebo-Adjusted MADRS Reduction (Day 8) | Phase 2b TRD (GH001-TRD-201) | -15.5 points |
| Remission Rate (Day 8) | Phase 2b TRD (GH001-TRD-201) | 57.5% |
| Remission Rate (6 Months, OLE) | Phase 2b TRD Open-Label Extension | 73% |
| Remission Maintenance (Day 8 to Month 6) | Phase 2b TRD | 90% |
The Open-Label Extension (OLE) analysis confirms this sustained efficacy, showing a 73% remission rate at 6 months with infrequent treatment visits and no mandated psychotherapy. Also, the Phase 1 clinical pharmacology trial (GH001-HV-106) evaluating the proprietary aerosol delivery device is ongoing in the United Kingdom, requiring close coordination with that site.
Direct, formal engagement with regulatory bodies like the FDA
Formal engagement with the U.S. Food and Drug Administration (FDA) is critical, specifically regarding the Investigational New Drug Application (IND) clinical hold for GH001. Engagement on the complete response submission is ongoing as of November 2025.
Key points of the ongoing regulatory dialogue include:
- The company submitted its complete response to the IND clinical hold in June 2025.
- Only one hold topic remains outstanding as of July 2025.
- The remaining issue relates to respiratory tract histology findings in rats, which GH Research PLC believes are rat-specific based on scientific evidence.
- There are no additional requests outstanding related to dog toxicology or device issues.
- GH Research PLC plans to submit an IND application for its second product candidate, GH002, in Q4 2025.
The initiation of the global pivotal program for GH001 remains on track for 2026, contingent on resolving this final FDA topic.
Investor relations and communication with the financial community
GH Research PLC maintains active communication with stockholders and potential investors, highlighted by public reporting and conference participation. The company reported its Third Quarter 2025 Financial Results in November 2025 and its Second Quarter 2025 Financial Results in August 2025.
Financial standing directly impacts investor confidence. As of June 30, 2025, cash, cash equivalents and marketable securities stood at $308.7 million. The company also participated in the Stifel 2025 Healthcare Conference in New York from November 11-13, 2025, where they conducted one-on-one investor meetings.
Scientific communication via conferences (ECNP, ASCP) and publications
Disseminating clinical findings to the scientific community is a core relationship activity. GH Research PLC announced the acceptance of presentations at major 2025 meetings.
Scientific engagement highlights for 2025 include:
- Presentation acceptance at the 2025 ECNP Congress in Amsterdam (October 11 - 14), featuring a Novel Therapies Symposium Presentation and posters.
- Presentation acceptance at the ASCP 2025 Annual Meeting in Arizona (May 27 - 30), including a Pharmaceutical Pipeline Presentation.
The ECNP presentation included long-term data for GH001 in TRD patients, reinforcing the data shared with the FDA.
GH Research PLC (GHRS) - Canvas Business Model: Channels
You're hiring before product-market fit, so every interaction point, from the lab bench to the investor call, has to be precise. Here's how GH Research PLC moves its science and capital.
Global clinical trial sites for product development and testing
The channel for product development centers on clinical trials across various jurisdictions. The global pivotal program for GH001 is on track for initiation in 2026. Currently, a Phase 1 clinical pharmacology trial (GH001-HV-106) evaluating the proprietary aerosol delivery device is ongoing in the United Kingdom.
Key data points from completed trials, which inform site selection and protocol design for future phases, include:
| Trial/Data Point | Indication/Measure | Result/Metric |
| Phase 2b (GH001-TRD-201) Primary Endpoint | MADRS Reduction (Day 8 vs. Placebo) | Placebo-adjusted reduction of -15.5 points (p<0.0001) |
| Phase 2b Open-Label Extension (OLE) Remission | Remission Rate at 6 Months | 73% |
| Phase 2b Remission Rate | Remission at Day 8 | 57.5% |
| Remission Maintenance | Maintained remission at 6 Months (of Day 8 remitters) | 90% |
Scientific and medical conferences for data dissemination
Dissemination of clinical data occurs through presentations and posters at major scientific meetings. GH Research PLC actively presented data throughout 2025, focusing on its lead candidate, GH001.
- American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Arizona, May 27 - 30, 2025: Included a Pharmaceutical Pipeline Presentation.
- International Society for Bipolar Disorders (ISBD) Annual Conference in Chiba, Japan, September 17 - 19, 2025: Accepted poster presentation.
- 38th Annual European College of Neuropsychopharmacology Congress (ECNP) in Amsterdam, October 11-14, 2025: Included a Novel Therapies Symposium Presentation on long-term data.
Regulatory submissions (INDs, NDAs) to the FDA and other agencies
The primary channel for regulatory interaction involves submissions to the U.S. Food and Drug Administration (FDA) concerning the Investigational New Drug (IND) applications for its product candidates.
For GH001, the company submitted its complete response to the clinical hold on its IND in June 2025. This submission was ahead of schedule. The FDA response indicated only one remaining topic, concerning respiratory tract histology findings in rats, which GH Research PLC believes are rat-specific. There are no remaining device-related issues.
For the second candidate, GH002, GH Research PLC plans to submit an IND application to the FDA in Q4 2025.
Investor presentations and press releases for capital markets
Capital markets communication is managed through financial reporting, corporate presentations, and conference participation. As of September 30, 2025, GH Research PLC reported cash, cash equivalents, and marketable securities of $293.9 million.
Key financial metrics from the Third Quarter 2025 results include:
- Net loss for the quarter: $14.0 million (or $0.23 loss per share).
- R&D expenses for the quarter: $10.6 million.
- General & Administrative (G&A) expenses for the quarter: $6.0 million.
The company held investor meetings and participated in the Stifel 2025 Healthcare Conference in New York from November 11-13, 2025. A Corporate Presentation was released on November 06, 2025. To be fair, the stock surged 90% over the six months leading up to July 2025, when its market cap was reported at $1.04 billion. Finance: draft 13-week cash view by Friday.
GH Research PLC (GHRS) - Canvas Business Model: Customer Segments
Patients with Treatment-Resistant Depression (TRD), the primary focus.
GH Research PLC's lead candidate, GH001, is specifically targeting patients with Treatment-Resistant Depression (TRD), defined as depression not responding to at least two adequate antidepressant therapies. The potential patient pool in the US alone was estimated to be 2.8 million adults in 2021. The US TRD treatment market was valued at USD 873.2 million in 2022, while the global market across seven major regions reached USD 3,494.7 Million in 2024.
The clinical data from the Phase 2b trial (GH001-TRD-201) provides concrete numbers on the segment's response profile:
| Metric | GH001 Group Data | Comparison/Context |
| Phase 2b Trial Enrollment (TRD) | Approx. 80 patients | Trial completed double-blind phase in 2024 |
| MADRS Reduction (Day 8, Placebo-Adjusted) | -15.5 points | Clinically and statistically significant (p<0.0001) |
| Remission Rate (Day 8) | 57.5% | Compared to 0% in the placebo group |
| Remission Rate (6 Months OLE) | 73% | With infrequent treatment visits |
| 6-Month Remission Rate (for Day 8 Responders) | 91.7% | Patients in remission on Day 8 maintained remission at 6 months |
| Estimated Treatment Visits (6 Months) | Approx. 4 visits | Compared to 23 visits assumed for Spravato® |
Patients with Postpartum Depression (PPD) and Bipolar II Depression (secondary).
GH Research PLC has also advanced GH001 into earlier-stage trials for these secondary indications, suggesting these patient populations are key to future expansion. The company has completed Phase 2 open-label trials in both indications.
- Phase 2 open-label trials completed for Postpartum Depression (PPD).
- Phase 2 open-label trials completed for Bipolar II Disorder (BD).
- Positive results from Phase 2a trials in PPD and Bipolar II indicate potential broad applications.
Psychiatrists and mental health specialists who treat severe depression.
This group represents the prescribers and gatekeepers for novel therapies like GH001. The overall Psychiatrists market size in 2024 was $195.22 billion, projected to grow to $215.02 billion in 2025 at a compound annual growth rate (CAGR) of 10.1%. North America was the largest region in this market in 2024. These specialists are the direct target for education on the ultra-rapid onset and durable effects demonstrated by GH001.
Healthcare payers and government agencies (future commercial segment).
This segment becomes critical upon potential commercialization, as payers determine formulary access and reimbursement rates. The company is preparing for its global pivotal program initiation in 2026, which directly precedes commercial launch discussions with payers. As of September 30, 2025, GH Research PLC held $293.9 million in cash, cash equivalents and marketable securities, supporting the R&D required to reach this commercial stage, while reporting a net loss of $14.0 million for the quarter ended September 30, 2025.
GH Research PLC (GHRS) - Canvas Business Model: Cost Structure
You're looking at the operational burn rate for GH Research PLC as of late 2025, which is heavily weighted toward advancing its clinical pipeline.
The most recent reported figures, covering the quarter ended September 30, 2025, give us a clear picture of where the cash is going right now. Honestly, for a company at this stage, the cost structure is almost entirely driven by R&D.
| Cost Category | Q3 2025 Amount (Millions USD) | Comparative Context |
| Heavy Research and Development (R&D) Expenses | $10.6 million | Up from $8.4 million in Q3 2024 |
| General and Administrative (G&A) Expenses | $6.0 million | Up from $4.2 million in Q3 2024 |
| Net Loss for the Quarter | $14.0 million | Compared to $12.1 million in Q3 2024 |
| Cash, Cash Equivalents, and Marketable Securities | $293.9 million | As of September 30, 2025 |
The R&D spend increase in Q3 2025 was primarily fueled by technical development activities and employee costs, though this was partly offset by a decrease in clinical development expenses for that specific quarter. The G&A rise reflects higher professional fees and employee expenses too.
Here's the quick math: R&D made up about 63.5% of the total operating expenses ($10.6M / ($10.6M + $6.0M)) for the quarter. That's where the focus defintely is.
The specific components driving these costs include:
- Clinical trial costs, including CRO fees and site payments.
- Employee expenses for scientific, technical, and professional staff.
- Regulatory and professional fees for IND submissions and legal work.
What this estimate hides is the exact split between CRO fees versus site payments within that clinical development bucket, as the search results only give the aggregate R&D number.
The cost drivers within the R&D spend for the quarter ended September 30, 2025, were:
- Increased expenses relating to technical development activities.
- Increased employee expenses.
- A decrease in clinical development expenses.
The G&A increase for the quarter ended September 30, 2025, was driven by:
- An increase in professional fees.
- An increase in employee expenses.
Finance: draft 13-week cash view by Friday.
GH Research PLC (GHRS) - Canvas Business Model: Revenue Streams
You're looking at the revenue side for GH Research PLC (GHRS) as of late 2025, and honestly, it's what you'd expect for a clinical-stage company deep in development. There's no product revenue right now; GH Research PLC is pre-commercial, focused entirely on getting its lead candidate, GH001, through the final stages of regulatory review and into pivotal trials. That means the current financial lifeblood comes from outside the lab-to-market pipeline.
The primary, most significant cash inflow you see is from equity financing. This is how GH Research PLC funds its operations while waiting for a marketable product. A major example of this was the underwritten public offering that closed in early 2025. This inflow was crucial for maintaining the large cash buffer needed for ongoing research and development expenses, which hit $10.6 million in the third quarter of 2025 alone. You need to track these capital raises closely.
Here's a quick look at that key financing event:
| Financing Event Detail | Amount/Value |
|---|---|
| Offering Date (Pricing) | February 2025 |
| Shares Offered | 10,000,000 ordinary shares |
| Public Offering Price Per Share | $15.00 |
| Total Gross Proceeds | Approximately $150.0 million |
| Underwriters Option (Max Additional) | Up to 1,500,000 ordinary shares |
Next up, you have interest income. Since GH Research PLC is sitting on a substantial balance of unspent capital, the interest earned on those holdings is a reliable, albeit secondary, revenue component. This income is generated from their large holdings of cash, cash equivalents, and marketable securities, which are primarily investment-grade bonds and money market funds. It's not product revenue, but it helps offset the net losses, which were $14.0 million for the quarter ended September 30, 2025.
The cash position itself is the key metric here, showing the runway provided by past financing. As of September 30, 2025, the balance was $293.9 million. That's a significant increase from the $182.6 million reported at the end of 2024. You should definitely keep an eye on this burn rate versus the cash on hand.
- Cash, cash equivalents and marketable securities as of September 30, 2025: $293.9 million.
- Cash, cash equivalents and marketable securities as of June 30, 2025: $308.7 million.
- Cash, cash equivalents and marketable securities as of March 31, 2025: $315.3 million.
Looking forward, the potential revenue streams are entirely contingent on clinical and regulatory success. You should be watching for two main future possibilities. First, there are potential milestone payments that could come from any existing or future licensing or collaboration deals that GH Research PLC might strike for its pipeline assets, though no specific amounts are public right now. Second, and most important, is the eventual revenue from product sales, which is contingent on successful regulatory approval. GH Research PLC continues to work on its Investigational New Drug (IND) application response with the FDA, and the company expects to initiate its global pivotal program in 2026. That 2026 timeline sets the stage for any potential commercial revenue post-approval, which is definitely not expected before 2027.
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