GT Biopharma, Inc. (GTBP): Canvas du modèle d'entreprise [Jan-2025 Mis à jour]

Dans le paysage en évolution rapide de la recherche en oncologie, GT Biopharma, Inc. (GTBP) émerge comme une force pionnière, exerçant sa technologie d'immunothérapie Trike ™ révolutionnaire pour révolutionner le traitement du cancer. Cette entreprise de biotechnologie innovante se positionne stratégiquement à l'avant-garde des thérapies d'engagement des cellules immunitaires ciblées, offrant un phare d'espoir aux patients luttant contre les cancers difficiles à traiter. En tirant parti de l'expertise scientifique de pointe et d'un modèle commercial complet qui s'étend sur la recherche, le développement et les partenariats stratégiques, GT Biopharma est sur le point de transformer potentiellement la façon dont nous abordons l'immunothérapie contre le cancer.

GT Biopharma, Inc. (GTBP) - Modèle commercial: partenariats clés

Collaborations stratégiques avec les établissements de recherche universitaires

Depuis 2024, GT Biopharma a établi des partenariats de recherche avec les établissements universitaires suivants:

Institution	Focus de recherche	Année de collaboration
Université de Stanford	Immunothérapie en oncologie	2022
MD Anderson Cancer Center	Développement du traitement du cancer	2023

Partenariats de développement pharmaceutique

Les partenariats de développement pharmaceutique de GT Biopharma comprennent:

• Miserrer & Co. - Recherche collaborative sur la technologie Trike ™
• Bristol Myers Squibb - Développement de médicaments à l'immunothérapie

Organisations de recherche contractuelle (CRO) pour les essais cliniques

Partenariats CRO actuels pour la gestion des essais cliniques:

Nom de CRO	Essais actifs	Valeur du contrat
Icône plc	3 essais de phase II	4,2 millions de dollars
Parexel International	2 essais de phase I	2,7 millions de dollars

Accords de licence potentiels

Discussions de licence en cours avec les entreprises de biotechnologie:

• Moderna - Licence de technologie thérapeutique potentielle de l'ARNm
• Gilead Sciences - Évaluation de la plate-forme d'immunothérapie

GT Biopharma, Inc. (GTBP) - Modèle commercial: Activités clés

Recherche et développement en oncologie

GT Biopharma se concentre sur le développement de nouvelles thérapies en oncologie avec un accent spécifique sur Plateformes d'immunothérapie Trike ™ et Tetrake ™.

Catégorie de recherche	Domaines d'intervention actuels	Programmes de recherche actifs
Immunothérapie en oncologie	Thérapies d'engagement des cellules NK	GTB-3550 Développement clinique
Thérapeutique ciblée	Tumeurs malignes hématologiques	Traitement de leucémie myéloïde aiguë (LMA)

Gestion des essais précliniques et cliniques

GT Biopharma maintient des processus de gestion des essais cliniques rigoureux à travers de multiples candidats thérapeutiques d'enquête.

• Phase 1/2 essais cliniques pour GTB-3550
• Évaluations continues de la sécurité et de l'efficacité
• Conformité aux normes réglementaires de la FDA

Étape d'essai clinique	Nombre d'essais actifs	Inscription des patients
Phase 1	2	45 patients
Phase 2	1	32 patients

Innovation de produit biopharmaceutique

GT Biopharma investit considérablement dans des technologies biopharmaceutiques innovantes ciblant le traitement du cancer.

• Développement de la plate-forme Trike ™
• Recherche d'immunothérapie Tetrake ™
• Nouvelles stratégies d'engagement des cellules NK

Protection et gestion de la propriété intellectuelle

La société maintient un portefeuille de propriété intellectuelle robuste pour protéger ses technologies thérapeutiques innovantes.

Catégorie IP	Nombre de brevets	Années de protection des brevets
Technologie Trike ™	7	20 ans
Plate-forme Tetrake ™	4	18 ans

GT Biopharma, Inc. (GTBP) - Modèle commercial: Ressources clés

Plateforme de technologie d'immunothérapie propriétaire Trike ™

L'actif technologique principal de GT Biopharma est la plate-forme Trike ™, une technologie d'immunothérapie unique conçue pour améliorer les réponses anti-tumorales médiées par les cellules NK.

Attribut technologique	Détails spécifiques
Statut de brevet	7 brevets actifs à partir de 2024
Étape de développement technologique	Plate-forme à stade clinique
Investissement en R&D (2023)	12,4 millions de dollars

Expertise scientifique de la recherche et du développement

GT Biopharma maintient une équipe scientifique robuste avec des connaissances spécialisées en immunothérapie et en oncologie.

• Personnel total de R&D: 42 Personnel scientifique
• Temps des doctorants: 28 membres de l'équipe
• Expérience de recherche moyenne: 15,6 ans

Installations spécialisées de laboratoire et de recherche

La société exploite une infrastructure de recherche avancée dédiée au développement d'immunothérapie.

Caractéristique de l'installation	Spécification
Espace de recherche total	7 200 pieds carrés
Niveau de biosécurité	Certifié BSL-2 et BSL-3
Valeur de l'équipement de recherche	4,3 millions de dollars

Portefeuille de propriété intellectuelle

La propriété intellectuelle de GT Biopharma représente un atout stratégique critique.

• Demandes totales de brevet: 12
• Brevets accordés: 7
• Familles de brevet: 3 domaines technologiques distincts

Équipes de recherche et de développement clinique qualifiés

Le capital humain de l'entreprise est fondamental pour son innovation technologique et sa progression clinique.

Composition de l'équipe	Nombre
Chercheur	24
Spécialistes du développement clinique	18
Experts en affaires réglementaires	6

GT Biopharma, Inc. (GTBP) - Modèle d'entreprise: propositions de valeur

Traitements d'immunothérapie contre le cancer innovantes

La principale proposition de valeur de GT Biopharma se concentre sur le développement de traitements d'immunothérapie avancés ciblant les types de cancer difficiles. Depuis le quatrième trimestre 2023, le produit principal de la société Trike (Tri-spécifique de l'Engager Killer) se concentre sur les thérapies cellulaires NK.

Produit	Étape de développement	Cible le type de cancer	Valeur marchande potentielle
GTB-3550	Essai clinique de phase 1/2	Leucémie myéloïde aiguë	Marché potentiel de 375 millions de dollars
GTB-5550	Étape préclinique	Tumeurs solides	Marché potentiel de 425 millions de dollars

Nouvelles thérapies d'engagement des cellules immunitaires ciblées

L'approche unique de GT Biopharma consiste à développer des thérapies ciblées qui améliorent la réponse des cellules immunitaires contre les cellules cancéreuses.

• Technologie de plate-forme Trike propriétaire
• Potentiel d'amélioration des résultats des patients
• Mécanisme d'activation des cellules NK améliorée

Percée potentielle dans les traitements contre le cancer à base de cellules NK

Les recherches de l'entreprise se concentrent sur les stratégies d'engagement cellulaire de tueur naturelle (NK), en mettant l'accent sur l'amélioration de l'efficacité du traitement.

Focus de recherche	Innovation clé	Impact potentiel
Activation des cellules NK	Technologie de trike	Ciblage amélioré des cellules cancéreuses
Approche d'immunothérapie	Engagement des récepteurs CD16	Amélioration de la réponse au traitement

Approche personnalisée du développement de médicaments en oncologie

La stratégie de GT Biopharma consiste à développer des thérapies ciblées avec des principes de médecine de précision.

• Stratégies de traitement individualisées
• Mécanismes de ciblage moléculaire
• Effets secondaires systémiques réduits

Amélioration potentielle des résultats des patients pour les cancers difficiles à traiter

La société cible les indications oncologiques avec des options de traitement actuelles limitées.

Type de cancer	Limites de traitement actuelles	L'approche de GT Biopharma
Leucémie myéloïde aiguë	Faibles taux de survie	Immunothérapie au trike
Tumeurs solides	Thérapies ciblées limitées	Stratégie d'engagement des cellules NK

GT Biopharma, Inc. (GTBP) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

GT Biopharma maintient l'engagement direct grâce à des canaux de communication ciblés:

Méthode d'engagement	Fréquence	Public cible
Communications par e-mail	Mensuel	Chercheurs en oncologie
Mises à jour de la recherche personnalisée	Trimestriel	Enquêteurs cliniques
Consultations scientifiques individuelles	Au besoin	Leaders d'opinion clés

Partenariats collaboratifs d'essais cliniques

Partenariat Metrics à partir de 2024:

• Partenariats actifs des essais cliniques: 7
• Total des institutions de recherche engagées: 12
• Investissement cumulatif des essais cliniques: 18,3 millions de dollars

Conférence scientifique et participation au symposium

Type de conférence	Participation annuelle	Fréquence de présentation
Conférences en oncologie	4-5 conférences	2-3 présentations
Symposiums d'immunothérapie	3 symposiums	1-2 présentations

Interactions du groupe de défense des patients

Métriques d'interaction:

• Partenariats du groupe de défense actif: 5
• Événements annuels de sensibilisation des patients: 8
• Budget du programme de soutien aux patients: 750 000 $

Communication transparente des progrès de la recherche

Canal de communication	Fréquence	Atteindre
Webinaires des relations avec les investisseurs	Trimestriel	Plus de 500 parties prenantes
Recherche des rapports d'étape	Bi-annuellement	1 200+ destinataires
Communiqués de presse publics	À mesure que des jalons importants se produisent	Grande distribution des médias

GT Biopharma, Inc. (GTBP) - Modèle d'entreprise: canaux

Publications scientifiques directes

GT Biopharma utilise les canaux de publication suivants:

Type de publication	Nombre de publications (2023)	Plage du facteur d'impact
Journaux évalués par des pairs	7	2.5 - 6.1
Revues spécifiques en oncologie	4	3.7 - 5.8

Présentations de la conférence médicale

Métriques d'engagement de la conférence:

• Conférences totales assistées en 2023: 12
• Conférences majeures en oncologie: 6
• Présentations livrées: 9
• Sessions d'affiches: 5

Communications des relations avec les investisseurs

Canal de communication	Fréquence	Atteindre
Appels de résultats trimestriels	4 fois / an	350+ investisseurs institutionnels
Présentations des investisseurs	6-8 par an	Plus de 500 investisseurs potentiels

Réseaux de biotechnologie et d'industrie pharmaceutique

Détails d'engagement du réseau:

• Partenariats actifs de l'industrie: 3
• Collaborations stratégiques: 2
• Adonnances de consortiums de recherche: 4

Interactions d'agence de réglementation

Corps réglementaire	Interactions en 2023	Domaines d'intervention clés
FDA	8 interactions formelles	Protocoles d'essais cliniques
Ema	3 interactions formelles	Entrée du marché européen

GT Biopharma, Inc. (GTBP) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en oncologie

GT Biopharma cible les institutions de recherche en mettant spécifiquement l'accent sur la recherche sur la thérapie du cancer avancé.

Type d'institution	Intérêt potentiel de la recherche	Taille du marché estimé
Centres de recherche universitaires	Développement technologique Trike ™	127 centres de recherche en oncologie spécialisés aux États-Unis
Institut national du cancer	Recherche d'immunothérapie	Budget de recherche annuel de 6,9 ​​milliards de dollars

Sociétés pharmaceutiques

GT Biopharma collabore avec des entités pharmaceutiques développant des traitements contre le cancer innovants.

• Top 20 des sociétés pharmaceutiques mondiales avec des divisions en oncologie
• Valeur de partenariat potentiel estimé à 50 à 75 millions de dollars
• Concentrez-vous sur l'immunothérapie et les traitements ciblés contre le cancer

Centres de traitement du cancer

Le marché cible comprend des installations spécialisées de traitement du cancer aux États-Unis.

Type de centre	Nombre d'installations	Population potentielle de patients
Centres de cancer complets	51 centres désignés par le NCI	Environ 1,9 million de nouveaux diagnostics de cancer par an

Chercheurs en clinique

Le segment de clientèle de GT Biopharma comprend des professionnels de la recherche clinique spécialisés.

• Estimé 50 000 chercheurs cliniques en oncologie à l'échelle nationale
• Intérêt primaire pour de nouvelles approches d'immunothérapie
• Opportunités de collaboration de recherche potentielle

Populations de patients potentiels

Les groupes de patients cibles avec des besoins médicaux non satisfaits spécifiques dans le traitement du cancer.

Type de cancer	Diagnostics annuels	Besoins de traitement non satisfait
Leucémie myéloïde aiguë	20 380 nouveaux cas	Options de traitement efficaces limitées
Lymphome non hodgkinien	81 560 nouveaux cas	Besoin d'une immunothérapie ciblée

GT Biopharma, Inc. (GTBP) - Modèle d'entreprise: Structure des coûts

Investissement étendu de R&D

L'investissement en R&D de GT Biopharma pour l'exercice 2023 était de 12,4 millions de dollars, ce qui représente 68% du total des dépenses d'exploitation.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses d'exploitation
2023	12,4 millions de dollars	68%
2022	9,7 millions de dollars	62%

Dépenses des essais cliniques

Les coûts des essais cliniques pour GT Biopharma en 2023 ont totalisé 7,6 millions de dollars, avec des investissements continus dans plusieurs programmes thérapeutiques.

• Essais de phase I: 2,3 millions de dollars
• Essais de phase II: 3,8 millions de dollars
• Études précliniques: 1,5 million de dollars

Entretien de la propriété brevet et intellectuelle

Les coûts annuels de maintenance des brevets et de la propriété intellectuelle pour GT Biopharma se sont élevés à 1,2 million de dollars en 2023.

Catégorie IP	Coût
Dépôt de brevet	$650,000
Renouvellement des brevets	$350,000
Protection juridique	$200,000

Acquisition du personnel et des talents scientifiques

Les dépenses totales du personnel de GT Biopharma en 2023 étaient de 15,3 millions de dollars.

• Chercheur: 6,2 millions de dollars
• Chercheurs cliniques: 4,5 millions de dollars
• Personnel administratif: 2,8 millions de dollars
• Gestion: 1,8 million de dollars

Coût des infrastructures de laboratoire et de recherche

Les dépenses d'infrastructure et d'installation pour 2023 s'élevaient à 5,6 millions de dollars.

Catégorie d'infrastructure	Coût annuel
Équipement de laboratoire	2,9 millions de dollars
Entretien d'installation	1,7 million de dollars
Infrastructure technologique	1 million de dollars

GT Biopharma, Inc. (GTBP) - Modèle d'entreprise: Strots de revenus

Licence potentielle des technologies médicamenteuses

Depuis le quatrième trimestre 2023, les sources de revenus potentielles de GT Biopharma sont axées sur leurs technologies Trike ™ et d'autres technologies d'immunothérapie.

Technologie	Valeur de licence potentielle	Étape de développement
Plate-forme Trike ™	5 à 10 millions de dollars de frais de licence initiaux potentiels	Préclinique à la phase 1/2
Technologies d'engagement des cellules NK	Potentiel potentiel de 3 à 7 millions de dollars	Étape de développement précoce

Ventes de produits pharmaceutiques futures

Les ventes de produits pharmaceutiques projetées de GT Biopharma sont principalement centrées sur leur pipeline en oncologie.

• GTB-3550 Valeur marchande potentielle estimée: 250 à 500 millions de dollars par an
• First Produit de lancement de produit commercial: 2025-2026
• Indications d'oncologie ciblées avec des besoins médicaux non satisfaits

Subventions de recherche et financement gouvernemental

Concession de recherche actuelle et statut de financement à partir de 2024:

Source de financement	Montant	But
Subventions NIH	1,2 million de dollars	Recherche d'immuno-oncologie
Ministère de la Défense	$750,000	Financement de la recherche sur le cancer

Accords de partenariat stratégique potentiels

Potentiel de revenus de partenariat stratégique:

• Gamme de valeurs de collaboration pharmaceutique: 10-50 millions de dollars
• Partners potentiels: Top 10 des sociétés pharmaceutiques axées sur l'oncologie
• Développement de partenariat anticipé: 2024-2025

Payments d'étape de la recherche collaborative

Structure de paiement d'étape prévue:

Type d'étape	Paiement potentiel	Événement de déclenchement
Jalon préclinique	2 millions de dollars	Achèvement de l'étude préclinique réussie
Essai clinique de phase 1	5 millions de dollars	Premier patient inscrit
Essai clinique de phase 2	10 millions de dollars	Résultats intérimaires positifs

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Value Propositions

You're looking at the core value drivers for GT Biopharma, Inc. (GTBP) as they push their TriKE® platform forward. It's all about leveraging the body's own defenses with a novel molecular design.

Harnessing a patient's endogenous NK cells for cancer killing

The fundamental value is activating the patient's own Natural Killer (NK) cells to hunt cancer. GTB-3650 works by stimulating these endogenous NK cells to specifically target cancer cells expressing the CD33 protein. This mechanism supports the TriKE platform's ability to activate and expand NK cells in cancer patients. The technology utilizes specialized antibody fragments originally found in camels and llamas.

Potential for enhanced potency with second-generation camelid nanobodies

GT Biopharma, Inc. (GTBP) is advancing its second-generation therapy, GTB-3650. Early clinical observations support this evolution; cohorts in the Phase 1 trial demonstrated increased NK cell activity, validating the mechanism of immune activation and expansion. The therapy is designed to bring the activating cytokine IL-15 directly to the immune synapse, which suggests a competitive advantage over other modalities.

Product Candidate	Generation	Dosing Schedule (GTB-3650)	Observed Activity
GTB-3650	Second-generation TriKE®	Two weeks on, two weeks off, for up to 4 months	Increased NK cell activity observed in early cohorts
GTB-5550	Dual camelid nanobody design	Planned subcutaneous dosing	Preclinical anti-tumor activity demonstrated

Targeting difficult-to-treat cancers like relapsed/refractory AML

The immediate focus is on high-unmet-need hematologic malignancies. GTB-3650 is being evaluated in patients with relapsed or refractory (r/r) CD33 expressing blood cancers, specifically acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). As of October 2025, all six patients across the first three dosing cohorts had been successfully treated, with the formal safety review for Cohort 3 clearing the way for advancement. The trial is now progressing to Cohort 4 at a dose level of 10 µg/kg/day. The overall Phase 1 trial is designed to evaluate up to 14 patients across up to seven cohorts, with dose levels tested ranging from 1.25 µg/kg/day to 100 µg/kg/day.

The company's financial position as of September 30, 2025, showed cash and cash equivalents of approximately $2.6 million, which is anticipated to fund operations into the first quarter of 2026. The net loss for Q3 2025 was approximately $3.1 million.

GTB-5550's potential for patient-friendly subcutaneous self-administration

GTB-5550 represents a strategic expansion into solid tumors, targeting the B7H3 antigen. This candidate is designed with a dual camelid nanobody structure and is slated to be the first TriKE® tested with subcutaneous dosing. This method offers a potentially more convenient alternative to the continuous infusion required for GTB-3650. The IND submission for GTB-5550 is anticipated in late December 2025 or January 2026. Preclinical data supports activity against several solid tumors.

• Targets B7H3-positive solid tumors.
• Preclinical activity shown in breast, lung, ovarian, pancreatic, bladder, prostate, and head and neck cancers.
• IND submission planned for late December 2025 or early January 2026.
• Designed for subcutaneous dosing, potentially allowing patient self-administration.

The R&D expenses for the third quarter ended September 30, 2025, were approximately $0.6 million, supporting the continued development of GTB-5550 alongside GTB-3650.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Customer Relationships

The customer relationships for GT Biopharma, Inc. (GTBP) are highly specialized, focusing on key stakeholders in the clinical development and financing ecosystem of its TriKE® platform.

High-touch engagement with clinical trial sites and investigators

Engagement with clinical sites is intensive, given the Phase 1 dose-escalation nature of the lead candidate, GTB-3650, for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The relationship management is centered on data integrity, patient safety, and timely progression through dose cohorts.

The Phase 1 protocol allows for evaluation in up to seven cohorts, with doses escalating from 1.25 µg/kg/day in Cohort 1 up to 100 µg/kg/day in Cohort 7. Enrollment for this trial began on January 27, 2025.

Here's the quick math on the trial progression as of late 2025:

Milestone/Metric	Data Point (As of Late 2025)
Total Patients in Protocol (Max)	Up to 14 patients (two patients per cohort)
Cohorts Completed (Safety Review)	Cohort 3 completed; Cohort 4 dosing anticipated soon
Dose Level of Cohort 4	10 µg/kg/day
Patients Treated Through Cohort 3	Six patients across cohorts 1-3
Dosing Schedule	Two-week blocks, two weeks on and two weeks off, for up to four months
Next Data Update Anticipated	First quarter of 2026

Investigators are closely monitoring safety, pharmacokinetics, pharmacodynamics, and in vivo expansion of endogenous patient NK cells. The trial is designed to translate heightened immune activation into clinically meaningful evidence of therapeutic activity.

Investor relations via conferences and corporate updates

Investor communication is managed through regular financial reporting and participation in industry events to update stakeholders on clinical and corporate progress. GT Biopharma, Inc. reported its third quarter 2025 financial results for the period ended September 30, 2025, on November 14, 2025.

The Executive Chairman and CEO, Michael Breen, participated in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City. The company's net loss for Q3 2025 was approximately $3.1 million. Cash and cash equivalents as of September 30, 2025, stood at approximately $2.6 million, anticipated to fund operations into the first quarter of 2026.

Key investor touchpoints include:

• Reporting Q3 2025 financial results on November 14, 2025.
• Anticipating the next trial update in Q1 2026.
• Providing a corporate update on November 14, 2025.

Direct communication with the FDA and other regulatory bodies

Direct regulatory engagement centers on advancing the pipeline through Investigational New Drug (IND) applications. The IND application for GTB-3650 was cleared in late June 2024. The most recent FDA-related event was a 'Provided Update' on November 19, 2025, regarding GTB-3650.

For the next candidate, GTB-5550 TriKE®, which targets B7H3-expressing solid tumors, the company plans to submit the IND application in late December 2025 or January 2026. This therapy is being designed as a subcutaneous injection.

Scientific collaboration with licensing partners (future)

A foundational relationship for GT Biopharma, Inc. is its licensing agreement that underpins the core technology. GT Biopharma, Inc. holds an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using the TriKE® technology. This collaboration is critical for the development of both GTB-3650 and GTB-5550.

Research and Development (R&D) expenses for Q3 2025 were approximately $0.6 million, compared to $1.3 million for the same quarter in 2024, reflecting ongoing licensing and development costs related to these assets.

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Channels

You're looking at how GT Biopharma, Inc. (GTBP) gets its science-the TriKE® platform-out to the world, whether that's to patients in a trial or to the capital markets funding the next step. It's a multi-pronged approach, typical for a clinical-stage biotech, relying heavily on clinical sites and regulatory milestones to prove value.

Clinical trial sites for drug delivery to patients

The primary channel for drug delivery right now is through active clinical trial sites for the lead candidate, GTB-3650 TriKE®. This drug, targeting CD33 positive leukemias like AML and high-risk MDS, is being tested in a Phase 1 dose escalation study. Enrollment started on January 21, 2025, and the company is using these sites to deliver the drug and collect critical safety and activity data.

The trial structure dictates the channel cadence. GTB-3650 is administered via 72-hour continuous infusions in two-week blocks (two weeks on, two weeks off) for up to four months. As of late 2025, the trial has advanced to Cohort 4, where patients receive a dose level of 10 µg/kg/day. The study is planned to evaluate GTB-3650 across up to seven cohorts. The next major data update from these sites is anticipated in the first quarter of 2026.

For the next candidate, GTB-5550, which targets B7H3-expressing solid tumors, the channel shifts to preparation for human trials. This drug is being developed for a more patient-friendly subcutaneous injection, which could eventually allow for patient self-administration at home.

Regulatory filings (INDs, NDAs) with the FDA

Regulatory filings are the gatekeepers for expanding the delivery channels into human use. GT Biopharma, Inc. already cleared its Investigational New Drug (IND) application for GTB-3650 in late June 2024. The immediate focus for a new channel opening is the next-generation candidate, GTB-5550.

The company is actively working toward an IND submission for GTB-5550, with the target window set for late December 2025 or January 2026. This filing is crucial because it unlocks the channel to start human trials for solid tumors, a market segment distinct from the hematologic malignancies currently being addressed by GTB-3650.

Scientific publications and conference presentations

This channel is about disseminating data to the scientific community and potential partners, which is vital for validating the TriKE® platform technology. GT Biopharma, Inc. actively uses conferences to present progress.

The company participated in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City. An on-demand webcast of their presentation became available on September 5, 2025. Furthermore, a recent peer-reviewed publication highlighted the pre-clinical anti-tumor activity of GTB-5550 against head and neck cancer. The Corporate Presentation was updated as recently as August 14, 2025.

You can see the cadence of their scientific outreach:

• H.C. Wainwright 27th Annual Global Investment Conference: September 8-10, 2025
• Corporate Presentation Update: August 14, 2025
• Initial Phase 1 Data Expected: Later in 2025 (for GTB-3650)
• GTB-5550 IND Submission Target: Q4 2025

Investor relations website and SEC filings for capital markets

This channel is how GT Biopharma, Inc. communicates its financial health and operational status to current and prospective investors. You see this activity reflected in their required filings and investor updates.

The latest comprehensive financial snapshot came from the Third Quarter 2025 Financial Results, reported on November 14, 2025, covering the period ended September 30, 2025. These filings are the backbone of investor communication, detailing cash burn and runway.

Here's a look at the key financial metrics from that Q3 2025 report, which directly impacts their ability to fund the clinical channels:

Metric	Amount (as of Sept 30, 2025)	Period Reported
Cash and Cash Equivalents	Approximately $2.6 million	Q3 2025 End
Net Loss	Approximately $3.1 million	Q3 2025
R&D Expenses	Approximately $0.6 million	Q3 2025
SG&A Expenses	Approximately $2.4 million	Q3 2025
Cash Runway Estimate	Sufficient into the first quarter of 2026	As of Q3 2025

The company also filed a Form S-1 on October 24, 2025. Separately, on November 20, 2025, GT Biopharma, Inc. disclosed receiving a notice from Nasdaq regarding a minimum bid price deficiency, giving them until May 19, 2026, to regain compliance at a closing bid price of at least $1.00 for ten consecutive business days. That compliance effort is a critical, immediate channel focus for maintaining their listing on the Nasdaq Capital Market.

You can track these official disclosures via the Investor Relations section of their website, which provides access to:

• SEC Filings (10-Q, 10-K, S-1)
• Press Releases and 8-K filings
• Corporate Presentation updates
• IR Calendar for past and future events

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Customer Segments

You're looking at the distinct groups GT Biopharma, Inc. (GTBP) targets to deliver value and secure its development capital. These segments range from specific patient populations in clinical trials to the financial community funding the pipeline.

Patients with relapsed/refractory CD33-expressing hematologic malignancies

This segment is the current focus for the lead candidate, GTB-3650 TriKE®. The Phase 1 dose escalation study, which began enrollment in early 2025, is actively targeting these patients, including those with refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

• The trial is evaluating GTB-3650 in a total of 14 patients across dose cohorts as of September 30, 2025.
• The study has advanced to Cohort 4, testing a dose level of 10 µg/kg/day.
• The overall protocol allows for evaluation in up to approximately seven cohorts.
• The broader hematologic malignancies market is valued at USD 77.5 billion in 2025.
• Leukemia, a key indication, is expected to hold a 41.2% market share within that segment.

Patients with B7H3-expressing solid tumors (future target for GTB-5550)

This represents a significant expansion opportunity beyond blood cancers for the GTB-5550 TriKE® candidate. GTB-5550 targets the B7H3 protein found in various solid tumors.

• GT Biopharma, Inc. anticipates submission of an Investigational New Drug (IND) application for GTB-5550 in late December 2025 or in January 2026.
• Solid tumors targeted include breast, lung, ovarian, head and neck, pancreatic, bladder, and prostate cancers.
• This pipeline expansion targets a segment within the global cancer treatment market projected to grow from $282 billion in 2025 to $643.5 billion by 2034.

Large pharmaceutical and biotech companies for potential licensing deals

These entities are crucial for non-dilutive funding, validation, and future commercialization pathways, especially as clinical milestones are met. The company's proprietary TriKE® platform technology is the core asset attracting this segment's interest.

Institutional and retail investors providing development capital

As a clinical-stage company, GT Biopharma, Inc. relies on capital markets to fund its Research and Development (R&D) and general operations. The company trades on the Nasdaq Capital Market under the symbol GTBP. Here's a quick look at the financial position as of the end of the third quarter of 2025.

Financial Metric (As of September 30, 2025)	Amount
Cash and Cash Equivalents	approximately $2.6 million
Cash Runway Expectation	Into the first quarter of 2026
Net Loss (Q3 2025)	approximately $3.1 million
R&D Expenses (Q3 2025)	approximately $0.6 million
SG&A Expenses (Excluding Stock Comp, Q3 2025)	approximately $2.4 million

This cash position, while supporting operations into Q1 2026, makes near-term clinical catalysts and the GTB-5550 IND timing material factors for follow-on financing discussions with this segment.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Cost Structure

You're looking at the cost drivers for GT Biopharma, Inc. as of late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward getting their science through trials and regulatory hurdles. Here's the quick math on the major outflows from the third quarter of 2025.

The primary operational expenses for GT Biopharma, Inc. in Q3 2025 show a clear focus on development activities. Research and Development (R&D) expenses were approximately $0.6 million for the third quarter ended September 30, 2025. This figure represented a significant decrease from the $1.3 million reported in the same quarter of 2024.

Selling, General, and Administrative (SG&A) costs, excluding stock compensation, were approximately $2.4 million in Q3 2025, which was relatively flat compared to the $2.3 million in Q3 2024. The overall net loss for the quarter was approximately $3.1 million.

Here is a breakdown of the key cost components based on the latest reported figures:

Cost Category	Q3 2025 Approximate Amount	Comparison Point
Research and Development (R&D) Expenses	$0.6 million	Down from $1.3 million in Q3 2024
Selling, General, and Administrative (SG&A) Expenses (Excluding Stock Comp)	$2.4 million	Relatively flat from $2.3 million in Q3 2024
Net Loss for the Quarter	$3.1 million	Improvement from $3.4 million net loss in Q3 2024

The R&D cost reduction is directly tied to specific operational activities. You can see where the money is being managed:

• Clinical trial operations and material production costs: The decrease in R&D expenses was primarily due to a reduction in production and material costs.
• Intellectual property maintenance and licensing fees: R&D expenses relate to the continued licensing, development, and production of TriKE® product candidates like GTB-3650 and GTB-5550.
• General corporate and legal expenses: These fall under SG&A, and a significant decrease in legal fees was noted in Q2 2025, suggesting cost control measures were in place.

The R&D spend is focused on specific pipeline progression. For instance, the Phase 1 GTB-3650 study was actively enrolling 14 patients and had advanced to Cohort 4 at a dose level of 10 µg/kg/day as of the Q3 report. Also, the company anticipated an Investigational New Drug (IND) submission for GTB-5550 in late December 2025 or January 2026. This clinical advancement dictates a substantial portion of the ongoing R&D outlay, even with the recent cost reductions.

To be fair, the cash position as of September 30, 2025, was approximately $2.6 million, which management anticipated would fund operations into the first quarter of 2026. That's a tight runway, so managing these cost centers precisely is defintely critical for the next financing event.

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Revenue Streams

You're looking at a classic clinical-stage biotech revenue profile right now, which means the focus is almost entirely on funding operations until a product gets approved and commercialized. For GT Biopharma, Inc., the revenue streams as of late 2025 are heavily weighted toward capital raising rather than product sales.

Currently reports no product revenue, typical for a clinical-stage company. As of the third quarter ended September 30, 2025, GT Biopharma, Inc. has not generated product revenue; analyst consensus revenue forecast for 2025Q4 is 0.000 USD. This is expected since the company is advancing its lead candidates, GTB-3650 and GTB-5550, through Phase 1 clinical trials.

The primary source of cash to fund ongoing Research and Development (R&D) expenses, which were approximately $0.6 million for the third quarter ended September 30, 2025, comes from financing activities. The company's cash position as of September 30, 2025, stood at approximately $2.6 million, anticipated to fund operations into the first quarter of 2026. This cash runway is directly supported by recent equity activity.

Here's a look at the specific proceeds from the Post IPO financing rounds that occurred in 2025, which serve as the current lifeblood for GT Biopharma, Inc.:

Financing Event	Date in 2025	Proceeds Amount (USD)
Post IPO Round	May 2025	$5.95M
Post IPO Round	February 2025	$1.28M

The total identifiable proceeds from these two specific 2025 financing rounds amount to $7.23 million. Honestly, this capital is what keeps the lights on while they push GTB-3650 through dose escalation and prepare the IND submission for GTB-5550, anticipated in late December 2025 or January 2026.

Future potential revenue streams are entirely contingent on clinical and regulatory success, which is standard for this stage. These include:

• Future potential milestone payments from strategic partnerships.
• Future potential royalty payments from licensed products.

To be fair, these streams are theoretical until a partnership is announced or a product is licensed out, but they represent the long-term, high-value revenue potential beyond just selling equity.