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Genprex, Inc. (GNPX): Business Model Canvas [Jan-2025 Mise à jour] |
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Genprex, Inc. (GNPX) Bundle
Genprex, Inc. (GNPX) émerge comme une entreprise de biotechnologie pionnière révolutionnant le traitement du cancer par le biais de technologies de thérapie génique de pointe. En se concentrant sur les interventions moléculaires innovantes, en particulier dans le cancer du poumon, l'entreprise représente une frontière audacieuse dans la recherche oncologique, promettant des traitements de percée potentiels pour les cancers résistants aux médicaments. Leur approche unique combine l'expertise scientifique, les plateformes propriétaires et les collaborations stratégiques pour développer des solutions thérapeutiques génétiques non invasives qui pourraient fondamentalement transformer les résultats des patients dans le paysage difficile du traitement du cancer.
Genprex, Inc. (GNPX) - Modèle commercial: partenariats clés
Centres médicaux académiques et institutions de recherche
Genprex a établi des partenariats avec les centres médicaux académiques suivants:
| Institution | Focus de la collaboration | Année établie |
|---|---|---|
| MD Anderson Cancer Center | Recherche thérapeutique en oncologie | 2019 |
| Centre de sciences de la santé de l'Université du Texas | Essais cliniques de thérapie génique | 2020 |
Collaborateurs pharmaceutiques et biotechnologiques
Les principaux partenariats pharmaceutiques et biotechnologiques de Genprex comprennent:
- Miserrer & Co. - Collaboration potentielle d'immunothérapie
- AstraZeneca - Partenariat de recherche sur le cancer du poumon non à petites cellules
- Pfizer - Évaluation de la technologie de thérapie génique
Organisations de recherche contractuelle (CROS)
| Nom de CRO | Services fournis | Valeur du contrat |
|---|---|---|
| Icône plc | Gestion des essais cliniques | 2,3 millions de dollars (2023) |
| Parexel International | Soutien réglementaire | 1,7 million de dollars (2023) |
Investisseurs stratégiques potentiels dans la thérapeutique en oncologie
Partenariats d'investissement stratégiques à partir de 2024:
| Investisseur | Montant d'investissement | Type d'investissement |
|---|---|---|
| Groupe d'avant-garde | 4,2 millions de dollars | Investissement institutionnel |
| Blackrock | 3,8 millions de dollars | Pieu de capitaux propres |
Genprex, Inc. (GNPX) - Modèle d'entreprise: activités clés
Développer des technologies de thérapie génique pour le traitement du cancer
Genprex se concentre sur le développement des technologies de thérapie génique ciblant spécifiquement le traitement du cancer. Au quatrième trimestre 2023, la société s'est concentrée sur Thérapie immunogène OnCoprex® pour le traitement du cancer du poumon.
| Focus technologique | Étape actuelle | Indication cible |
|---|---|---|
| Thérapie immunogène OnCoprex® | Développement clinique | Cancer du poumon non à petites cellules |
Effectuer des essais cliniques pour des candidats innovants
Genprex s'est activement engagé dans des recherches d'essais cliniques pour ses candidats thérapeutiques.
- Essai clinique de phase 1/2 pour OnCoprex® en combinaison avec KeyTruda®
- Dépenses totales d'essais cliniques en 2023: 4,2 millions de dollars
- Études cliniques en cours ciblant le cancer du poumon non à petites cellules métastatiques
Faire avancer la recherche sur les applications du cancer du poumon et de l'oncologie
| Domaine de recherche | Investissement | Focus de recherche |
|---|---|---|
| Thérapie génique du cancer du poumon | 3,7 millions de dollars (2023) | Stratégie de remplacement du gène TUSC2 |
Développement et protection de la propriété intellectuelle
Genprex maintient un portefeuille de propriété intellectuelle robuste.
- Total des brevets déposés: 12
- Durée de protection des brevets: jusqu'en 2038
- Catégories de brevets: thérapie génique, méthodologies de traitement du cancer
Conformité réglementaire et interaction FDA
| Jalon réglementaire | Statut | Date |
|---|---|---|
| Désignation FDA Fast Track | Accordé | Septembre 2022 |
| Interactions en cours de la FDA | Communication active | Consultations trimestrielles |
Genprex, Inc. (GNPX) - Modèle d'entreprise: Ressources clés
Technologie de plateforme de thérapie génique propriétaire
La ressource technologique clé de Genprex est sa plate-forme de thérapie immunogène OncoPrex®. En 2024, la plate-forme se concentre sur le développement de thérapies géniques pour le traitement du cancer du poumon.
| Plate-forme technologique | Détails spécifiques |
|---|---|
| Nom de la plate-forme | Thérapie immunogène OnCoprex® |
| Maladie cible primaire | Cancer du poumon non à petites cellules (NSCLC) |
| Type de technologie | Système de livraison de thérapie génique |
Expertise scientifique en oncologie et thérapie génique
Genprex maintient une équipe scientifique spécialisée avec une expertise dans la recherche sur la thérapie génique oncologique.
- Des chercheurs au niveau du doctorat se spécialisent en oncologie moléculaire
- Experts en mécanismes de livraison de gènes
- Spécialistes du développement clinique
Portefeuille de brevets
| Catégorie de brevet | Nombre de brevets | Plage d'expiration |
|---|---|---|
| Technologie de thérapie génique de base | 7 brevets actifs | 2030-2036 |
| Mécanisme de livraison | 3 brevets spécialisés | 2032-2037 |
Infrastructure de recherche et de développement
Les capacités de R&D de Genprex sont centrées dans des installations de recherche axées sur le développement de la thérapie génique.
- Espace de laboratoire: environ 5 000 pieds carrés.
- Équipement de biologie moléculaire avancée
- Culture cellulaire et installations de modification des gènes
Équipe scientifique et médicale spécialisée
| Composition de l'équipe | Nombre de professionnels |
|---|---|
| Chercheur | 12 |
| Experts en développement clinique | 6 |
| Spécialistes des affaires réglementaires | 4 |
Genprex, Inc. (GNPX) - Modèle d'entreprise: propositions de valeur
Solutions innovantes de thérapie génique pour le traitement du cancer du poumon
La plate-forme de thérapie immunogène OncoPrex ™ de Genprex se concentre sur la fourniture de gènes thérapeutiques aux cellules cancéreuses. Depuis le quatrième trimestre 2023, la société a signalé des essais cliniques en cours pour le traitement du cancer du poumon ciblant les patients atteints de CNPNC (cancer du poumon non à petites cellules).
| Plateforme de thérapie | Segment de patient cible | Étape clinique |
|---|---|---|
| Thérapie immunogène OnCoprex ™ | Patients atteints de CNPNC avancés | Essais cliniques de phase 2 |
Traitements de percée potentielles pour les cancers résistants aux médicaments
L'approche thérapeutique de l'entreprise cible les mécanismes de cancer résistants aux médicaments avec des interventions moléculaires uniques.
- Mécanisme cible la restauration du gène TUSC2
- Traitement potentiel pour les patients atteints de cancer du poumon résistant à la chimiothérapie
- Marché adressable estimé de 228 000 nouveaux cas de cancer du poumon par an aux États-Unis
Approche thérapeutique génétique non invasive
| Méthode de livraison | Avantage clé | Unicité technologique |
|---|---|---|
| Technologie des nanoparticules lipidiques | Peu invasif | Mécanisme de livraison de gènes propriétaire |
Interventions moléculaires ciblées pour les patients cancéreux
Les recherches de Genprex se concentrent sur des modifications génétiques précises avec Effets secondaires systémiques minimaux.
- Thérapie de remplacement des gènes ciblée
- Interruption de voie moléculaire spécifique
- Réduction potentielle de la toxicité traditionnelle de la chimiothérapie
Potentiel pour améliorer les résultats des patients
| Objectif thérapeutique | Impact potentiel | Statut de recherche actuel |
|---|---|---|
| Efficacité du traitement du cancer du poumon | Taux de survie améliorés | Essais cliniques en cours |
Genprex, Inc. (GNPX) - Modèle d'entreprise: relations avec les clients
Engagement direct avec la communauté médicale en oncologie
Depuis 2024, Genprex maintient des stratégies d'engagement directes avec des professionnels de l'oncologie médicale grâce à des interactions ciblées:
| Canal de fiançailles | Métriques d'interaction annuelles |
|---|---|
| Oncologue de la sensibilisation directe | Environ 287 professionnels de la santé ciblés |
| Communication de recherche personnalisée | 62 centres médicaux spécialisés contactés |
| Consultations scientifiques individuelles | 43 Consultations d'experts individuels |
Interactions des participants aux essais cliniques
La gestion de la relation des participants à l'essai clinique de Genprex comprend:
- Participants totaux d'essais cliniques actifs: 124 patients
- Fréquence de communication des patients: mises à jour de progrès trimestriels
- Canaux de soutien aux patients: hotline d'infirmière de recherche dédiée
Présentations des conférences scientifiques et des symposiums médicaux
| Type de conférence | 2024 Détails de présentation |
|---|---|
| Conférences de recherche en oncologie | 7 présentations internationales majeures |
| Symposiums de technologie médicale | 4 Forums spécialisés de thérapie génique |
Communication transparente sur les progrès de la recherche
Les métriques de transparence de la communication comprennent:
- Mises à jour des investisseurs / chercheurs trimestriels: 4 rapports complets
- Plateformes de divulgation de recherche publique: 12 publications détaillées
- Suivi des progrès de la recherche numérique: tableau de bord en ligne en temps réel
Programmes potentiels de soutien et d'éducation aux patients
| Programme de soutien | PROGRAMME RECHERCHE |
|---|---|
| Webinaires d'information des patients | 237 participants enregistrés |
| Ressources éducatives en ligne | 1 542 visiteurs de sites Web uniques |
| Réseau de soutien aux patients | 86 Connexions actives des patients |
Genprex, Inc. (GNPX) - Modèle d'entreprise: canaux
Communication scientifique directe
Genprex utilise des canaux de communication scientifiques ciblés avec les détails suivants:
| Canal de communication | Fréquence | Public cible |
|---|---|---|
| La sensibilisation du chercheur direct | Trimestriel | Institutions de recherche en oncologie |
| Réseaux d'oncologie de précision | Semestriel | Centres de recherche clinique |
Présentations de la conférence médicale
Métriques d'engagement de la conférence:
- Conférences médicales annuelles présentes: 7
- Durée de présentation moyenne: 45 minutes
- Conférences clés: Association américaine pour la recherche sur le cancer (AACR)
Publications scientifiques évaluées par des pairs
Statistiques de publication pour 2023:
| Type de publication | Nombre | Plage du facteur d'impact |
|---|---|---|
| Articles de recherche originaux | 3 | 2.5 - 4.2 |
| Revoir les articles | 2 | 3.1 - 3.7 |
Communications des relations avec les investisseurs
Canaux de communication des investisseurs:
- Appels de résultats trimestriels
- Réunions annuelles des actionnaires
- Disques de présentation des investisseurs
- Communications de classement SEC
Plates-formes numériques et réseautage scientifique
Métriques d'engagement numérique:
| Plate-forme | Abonnés / connexions | Taux d'engagement |
|---|---|---|
| Liendin | 4,237 | 2.3% |
| Gazouillement | 1,892 | 1.7% |
Genprex, Inc. (GNPX) - Modèle d'entreprise: segments de clientèle
Professionnels médicaux en oncologie
En 2024, Genprex cible environ 16 000 oncologues aux États-Unis spécialisés dans le traitement du cancer du poumon.
| Focus spécialisée | Nombre de professionnels ciblés | Pénétration potentielle du marché |
|---|---|---|
| Oncologues du cancer du poumon | 16,000 | 37.5% |
| Radiation | 4,500 | 22.8% |
Institutions de recherche sur le cancer
Genprex collabore avec 62 grands centres de recherche sur le cancer à travers l'Amérique du Nord.
- National Cancer Institute (NCI) Des centres de cancer complets désignés: 51
- Centres de recherche médicale universitaire: 11
Patients atteints de cancer du poumon
Population de patients cible sur la base de 2024 données épidémiologiques:
| Catégorie de patients | Population totale | Candidats au traitement potentiel |
|---|---|---|
| Cancer du poumon non à petites cellules | 238 340 nouveaux cas | 87 456 candidats potentiels |
| Cancer du poumon à petites cellules | 31 990 nouveaux cas | 11 716 candidats potentiels |
Partenaires de recherche pharmaceutique
Paysage de collaboration de recherche pharmaceutique actuelle:
- Partenariats de recherche actifs: 3
- Discussions de collaboration en attente: 5
- Valeur du partenariat potentiel total: 42,6 millions de dollars
Investisseurs institutionnels en biotechnologie
Analyse du segment des investisseurs pour Genprex:
| Type d'investisseur | Nombre d'investisseurs institutionnels | Investissement total |
|---|---|---|
| Sociétés de capital-risque | 12 | 34,2 millions de dollars |
| Fonds axés sur la biotechnologie | 8 | 26,7 millions de dollars |
| Sociétés d'investissement en soins de santé | 6 | 19,5 millions de dollars |
Genprex, Inc. (GNPX) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice 2023, Genprex a déclaré des frais de recherche et de développement de 8,4 millions de dollars, contre 7,2 millions de dollars en 2022.
| Année | Dépenses de R&D | Pourcentage de variation |
|---|---|---|
| 2022 | 7,2 millions de dollars | - |
| 2023 | 8,4 millions de dollars | 16.7% |
Coûts de gestion des essais cliniques
Genprex a alloué environ 5,6 millions de dollars pour la gestion des essais cliniques en 2023, en se concentrant sur leur plate-forme de thérapie immunogène Reqorsa ™.
- Essais cliniques de phase I / II pour le traitement du cancer du poumon
- Recherche en cours pour les thérapies combinées
- Dépenses de recrutement et de surveillance des patients
Protection de la propriété intellectuelle
La société a dépensé 1,2 million de dollars pour la protection de la propriété intellectuelle et l'entretien des brevets en 2023.
| Catégorie de dépenses IP | Montant |
|---|---|
| Dépôt de brevet | $650,000 |
| Entretien de brevets | $550,000 |
Dépenses de conformité réglementaire
Les coûts de conformité réglementaire pour Genprex ont totalisé 2,3 millions de dollars en 2023, couvrant les interactions et les processus de soumission de la FDA.
Surfaçon administratives et opérationnelles
Les dépenses administratives et opérationnelles totales pour 2023 étaient de 4,5 millions de dollars, notamment:
- Salaires et avantages sociaux: 3,1 millions de dollars
- Frais de bureau et d'installation: 780 000 $
- Services professionnels: 620 000 $
Structure totale des coûts pour 2023: 21,5 millions de dollars
Genprex, Inc. (GNPX) - Modèle d'entreprise: Strots de revenus
Accords potentiels de licence de médicament potentiel
En 2024, Genprex n'a signalé aucun accord de licence de médicament actif. L'objectif principal de l'entreprise reste sur le développement de sa plate-forme de thérapie immunogène Reqorsa ™.
Subventions de recherche et financement gouvernemental
| Source de financement | Montant | Année |
|---|---|---|
| National Institutes of Health (NIH) | 0 $ (pas de subventions confirmées en 2024) | 2024 |
Collaborations de partenariat stratégique
Depuis les derniers rapports financiers, Genprex n'a révélé aucun partenariat stratégique important générant des revenus directs.
Commercialisation potentielle des produits thérapeutiques
| Produit | Étape actuelle | Revenus potentiels |
|---|---|---|
| Thérapie immunogène reqorsa ™ | Étape d'essai clinique | Pas encore commercialisé |
Opportunités de monétisation de la propriété intellectuelle
- Portfolio de brevet lié à la plate-forme REQORSA ™
- Aucun revenu actuel de licence IP signalé
Données financières du dernier dépôt de 10-Q: Revenu total: 0 $ pour le trimestre se terminant le 30 septembre 2023
Informations sur le stock: Ticker: GNPX Échange: nasdaq Capitalisation boursière: environ 23,5 millions de dollars (en février 2024)
Genprex, Inc. (GNPX) - Canvas Business Model: Value Propositions
You're looking at the core value Genprex, Inc. (GNPX) brings to patients and the market as of late 2025. This isn't about future potential alone; it's about the tangible scientific and regulatory milestones they've achieved that define their offering right now.
The primary value proposition centers on novel, first-in-class gene therapies targeting significant unmet needs in oncology. Their lead candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated for Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC).
The delivery mechanism itself is a key differentiator. Genprex uses its systemic, non-viral Oncoprex® Delivery System, which encapsulates gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. This system is administered intravenously, aiming for safer, targeted uptake by tumor cells.
The regulatory environment validates this approach. Each of Genprex's lung cancer clinical programs has secured an FDA Fast Track Designation for its respective patient population. Furthermore, the SCLC program has an additional FDA Orphan Drug Designation.
The potential market impact is broad, addressing both oncology and metabolic disease. The company is addressing large, unmet needs in NSCLC and SCLC, alongside its preclinical work in diabetes. The diabetes candidate, GPX-002, offers the potential to transform alpha cells into insulin-producing beta-like cells for Type 1 diabetes (T1D).
Here's a snapshot of the current development status underpinning these propositions:
| Program Area | Candidate/Platform | Key Status/Data Point (as of late 2025) | Regulatory Status |
|---|---|---|---|
| Oncology (NSCLC/SCLC) | Reqorsa® Gene Therapy (quaratusugene ozeplasmid) | Preclinical data showed a 79% tumor shrinkage in ALK-EML4 positive NSCLC when used with alectinib. | Fast Track Designation for both lung cancer programs. Orphan Drug Designation for SCLC. |
| Oncology Delivery | ONCOPREX Delivery System | Systemic, non-viral platform using lipid-based nanoparticles. | N/A |
| Diabetes (T1D/T2D) | GPX-002 | Preclinical studies demonstrated sustained improved glucose homeostasis in animal models of T1D. | Preclinical stage; planned to request FDA guidance for IND-enabling studies by the second half of 2025. |
The clinical timeline for the lead oncology program shows concrete near-term milestones. The Acclaim-1 Phase 2a portion began dosing in January 2024 and is expected to finish enrolling by the end of 2025. An interim analysis on 19 patients is anticipated in the first half of 2026.
Financially, the company is operating in a capital-intensive phase, which is typical for a clinical-stage biotech. As of late 2025, Genprex had a market capitalization of approximately $6.43 million or $10.8M, with 2.27 million shares outstanding. To support this development, the company secured a registered direct offering of $2.7 million in October 2025, with the potential for another $5.4 million via warrant exercises. Management has been focused on efficiency, trimming operating expenses by 52% year-on-year.
The value proposition is supported by the following strategic elements:
- Novel gene therapy approach for difficult-to-treat cancers.
- Systemic, non-viral delivery platform.
- Preclinical data showing 79% tumor shrinkage in a specific NSCLC model.
- Diabetes program (GPX-002) aiming for alpha cell reprogramming.
- Fast Track Designation for both lung cancer programs.
The company's last reported earnings date was November 14, 2025, with the fiscal year ending December 31, 2025. The stock price as of October 29, 2025, was $6.64.
Genprex, Inc. (GNPX) - Canvas Business Model: Customer Relationships
You're looking at how Genprex, Inc. manages its critical external relationships to advance its gene therapy pipeline. For a clinical-stage biotech, these aren't just contacts; they are the pathways to data, funding, and ultimately, patient access. Here's the breakdown of those key relationship pillars as of late 2025.
High-touch, specialized relationships with key opinion leaders (KOLs) and clinical investigators.
Genprex, Inc. maintains deep ties with the academic and clinical community to drive its two main programs: Reqorsa® Gene Therapy for lung cancer and its diabetes gene therapy approach. These relationships are formalized through research agreements and site activations.
- Collaboration with the University of Michigan Rogel Cancer Center via a Sponsored Research Agreement (SRA) initiated in October 2024.
- New SRA signed with the University of Pittsburgh (Pitt) to study GPX-002 in Type 1 and Type 2 diabetes models.
- The company actively adds clinical sites to support ongoing trials, adding Gabrail Cancer Center in Canton, Ohio, as a new site in November 2025 for the Acclaim-1 and Acclaim-3 trials.
The clinical trial structure dictates specific relationship goals for patient throughput:
| Trial Component | Relationship Metric/Target | Status/Target Number |
|---|---|---|
| Acclaim-1 Phase 2a Expansion | Expected Patient Enrollment Target | Approximately 33 patients |
| Acclaim-3 Phase 2 Expansion | Expected Patient Enrollment Target | Approximately 50 patients |
| Acclaim-1 Interim Analysis Completion | Target for Enrollment of First Patients | First half of 2026 (Enrollment of first 19 patients) |
Investor relations for ongoing capital raising and shareholder communication.
Sustaining clinical development requires consistent engagement with capital markets. Genprex, Inc. has been active in securing financing through various equity offerings throughout 2025.
- Announced a $12.5 million commitment from Lincoln Park Capital Fund in June 2025.
- Filed a prospectus in November 2025 to offer up to $75,000,000 in additional common stock shares under its At The Market (ATM) Offering Agreement.
- Previously sold 796,065 shares for aggregate gross proceeds of $14,796,375 under the ATM Sales Agreement.
- Announced a registered direct offering in October 2025, with gross proceeds expected around $2.7 million from the sale of 243,622 shares at $11.21 per share, plus potential proceeds of ~$5.4 million from concurrent warrants.
Direct engagement with patient advocacy groups for trial support.
Genprex, Inc. works with advocacy organizations to align research with patient needs and gain support for specific disease areas.
- Collaboration established in October 2024 with ALK Positive, a non-profit research organization, to sponsor a preclinical study on ALK-EML4 positive lung cancer.
- Research collaborators presented data on the diabetes gene therapy program at the 2025 American Diabetes Association 85th Scientific Sessions.
Regulatory bodies (FDA, EMA) for approvals and designations.
Regulatory interactions are crucial for establishing the accelerated path for its lead candidate, Reqorsa® Gene Therapy.
- Each of Genprex, Inc.'s lung cancer clinical programs has secured Fast Track Designation from the FDA.
- The FDA granted Orphan Drug Designation for Genprex, Inc.'s SCLC program.
- The Acclaim-1 treatment combination (REQORSA and Tagrisso) received Fast Track Designation from the FDA.
- The company announced the European Patent Office's intent to grant a patent for the combination of Reqorsa® Gene Therapy and PD-1 antibodies in November 2025.
Finance: review Q4 2025 ATM utilization against the $75,000,000 shelf capacity by end of day Tuesday.
Genprex, Inc. (GNPX) - Canvas Business Model: Channels
You're looking at how Genprex, Inc. gets its science and its stock in front of the right people-the doctors, the researchers, and the investors. This is all about getting the data out and keeping the lights on through capital markets.
Clinical trial sites and hospitals for drug administration and data collection
The primary channel for drug administration and data collection is the network of clinical trial sites. Genprex, Inc. actively expands this network to ensure patient access and speed up enrollment for its key programs, REQORSA in Acclaim-1 and Acclaim-3 for lung cancer. For instance, on November 19, 2025, Genprex, Inc. announced the addition of Gabrail Cancer Center in Canton, Ohio, as a new site for both the Acclaim-1 and Acclaim-3 clinical trials. The company plans to expand its clinical trial sites to increase patient reach and expedite enrollment. The Acclaim-1 trial targets non-small cell lung cancer, while Acclaim-3 addresses small cell lung cancer. Furthermore, the diabetes gene therapy, GPX-002, is being advanced through preclinical work and new sponsored research, including a new Sponsored Research Agreement with the University of Pittsburgh signed in May 2025 for animal model studies. The delivery method for GPX-002 in humans is designed to be done with a routine endoscopy procedure, suggesting a future channel through specialized gastroenterology or endocrinology centers.
Scientific publications and medical conferences (ASCO, ADA) for data dissemination
Disseminating clinical and preclinical data through peer-reviewed channels and major medical meetings is crucial for validation. Genprex, Inc. has been active in this area throughout 2025. You can see the output of their clinical work appearing in journals and presentations:
- Data from Genprex, Inc.'s Acclaim-1 Phase 1 Gene Therapy Clinical Trial was published in Clinical Lung Cancer on November 24, 2025.
- Genprex, Inc. was selected to present the trial design of the Acclaim-3 Clinical Trial at the 2025 ASCO Annual Meeting.
- Research collaborators presented positive preclinical data on the diabetes gene therapy, GPX-002, at the 2025 American Diabetes Association (ADA) 85th Scientific Session in Chicago in June 2025. The featured abstract was a Poster Presentation in the 20 Beta-Cell Replacement Category, Poster Number 1567-B.
- The company also presented at industry conferences, including the BIO 2025 International Convention in Boston, Mass., from June 16-19, 2025.
- Management participated in investor and industry conferences in September 2025, such as the H.C. Wainwright 27th Annual Global Investment Conference and the Investor Summit Group Q3 Virtual Conference.
Direct investor communications and SEC filings for capital markets
To fund these clinical channels, Genprex, Inc. relies heavily on direct engagement with the capital markets, often utilizing At-The-Market (ATM) offerings and registered direct offerings. This requires constant communication via SEC filings. Here's a snapshot of their capital market activity and status as of late 2025:
| Financial/Capital Market Event or Metric | Amount/Value/Date | Source/Context |
| Maximum Potential Offering Size (Nov 2025) | Up to $75,000,000 | Prospectus filed November 21, 2025, under ATM program. |
| Previous Share Sale Proceeds (Prior to Nov 2025) | $14,796,375 | Gross proceeds from the sale of 796,065 shares. |
| Lincoln Park Capital Commitment (June 2025) | $12.5 million | Commitment for purchasing common stock announced June 11, 2025. |
| October 2025 Registered Direct Offering Shares Issued | 243,622 shares | Issued at a purchase price of $11.21 per share on October 24, 2025. |
| Registered Direct Offering Announced (Oct 2025) | Up to $10.0 million | Announced on October 28, 2025. |
| Shares Outstanding (as of Nov 19, 2025) | 2,318,894 | Reported in an S-1 filing. |
| Nasdaq Equity Compliance Exception Deadline | December 31, 2025 | Deadline to demonstrate long-term compliance with the Stockholders' Equity Requirement. |
The company regained compliance with the minimum bid price requirement as of November 25, 2025, but the equity requirement remains on an exception basis. Honestly, managing this cash flow through frequent equity raises is a key channel for survival right now.
Future distribution via pharmaceutical licensing partners
While Genprex, Inc. currently manages its clinical development, the long-term distribution channel for commercial success is expected to involve strategic partnerships. The company explicitly works with world-class institutions and collaborators to develop its pipeline. A significant move signaling this future channel strategy was the September 2024 announcement of the intention to spin off the diabetes program (GPX-002) into a new subsidiary, 'NewCo.' This separation was designed to enhance focus and expedite development, potentially enabling direct investment and strategic collaboration or licensing for the diabetes asset. Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing, was available for one-on-one meetings at the BIO 2025 International Convention to discuss these gene therapies, suggesting active scouting for such future partners. The company's oncology program, utilizing REQORSA, is also being advanced with the expectation of future commercialization pathways, which often involve licensing deals in specific territories or indications.
Finance: draft 13-week cash view by Friday.
Genprex, Inc. (GNPX) - Canvas Business Model: Customer Segments
You're looking at the patient and physician populations that Genprex, Inc. (GNPX) targets with its gene therapy platform, Reqorsa® and GPX-002. It's a dense landscape, especially given the company's TTM Net Income of -21.39M USD as of late 2025.
Patients with Non-Small Cell Lung Cancer (NSCLC) who have progressed on standard therapy.
This segment includes patients with advanced NSCLC, particularly those with EGFR mutations who have exhausted prior lines of therapy. For instance, in the EGFR-mutated advanced NSCLC space, only about half of patients proceed to receive any second-line therapy after progression on first-line osimertinib, creating a significant unmet need for subsequent treatments like Reqorsa®.
For ALK-positive NSCLC, Genprex, Inc. is specifically researching combinations with ALK-inhibitors, targeting a niche within the broader NSCLC market.
Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
Genprex, Inc.'s SCLC program has received FDA Orphan Drug Designation, focusing on a highly aggressive patient group. Nearly 60-70% of all Small Cell Lung Cancer patients present with this extensive-stage disease at diagnosis.
The company's Acclaim-1 trial is specifically enrolling ES-SCLC patients who have progressed on Tagrisso-containing regimens. The Phase 2a expansion cohort is expected to enroll approximately 33 patients.
A retrospective study identified 2,025 adult ES-SCLC patients initiating first-line treatment between January 2020 and December 2023, of whom 40% received second-line treatment and 13% received third-line treatment, showing the pool of patients needing novel options.
Patients with Type 1 and Type 2 Diabetes (T1D, T2D) with limited treatment options.
Genprex, Inc. is developing GPX-002 for both Type 1 and Type 2 Diabetes, aiming to restore pancreatic function. The scale of the diabetes population in the U.S. is substantial:
- Total diagnosed diabetes in U.S. adults (18+): 29.4 million.
- Type 2 Diabetes (T2DM) accounts for 90% to 95% of all U.S. diabetes cases.
- Type 1 Diabetes (T1D) in U.S. adults (20+): Approximately 1.7 million.
- Type 1 Diabetes (T1D) in U.S. youth (under 20): 304,000 cases.
Oncologists and endocrinologists seeking novel therapeutic options.
The prescribers and key opinion leaders for these patient populations represent a critical segment for adoption. The numbers for these specialists are as follows:
| Specialist Type | Approximate Number in U.S. (Late 2025) | Relevant Context/Data Point |
|---|---|---|
| Oncologists (Total Tracked) | Over 28,000 | Demand for oncologists is projected to grow by 40% from 2012 to 2025. |
| Hematology/Oncology Specialists | 11,937 | This is the most common tracked oncology specialty. |
| Medical Oncology Specialists | 4,778 | A key group for NSCLC and SCLC treatment decisions. |
| Endocrinologists (Total) | 10,661 | As of November 28, 2025. |
| Endocrinologists (Actively Treating Diabetes) | Just over 8,000 | It is estimated there is a ratio of one endocrinologist to every 5,000 people with diabetes. |
Honestly, you see the concentration issue right away; 70% of U.S. counties have no endocrinologist, which means Genprex, Inc.'s diabetes approach, if successful, could be highly attractive to the specialists who do practice, as they manage a disproportionately large patient load.
Genprex, Inc. (GNPX) - Canvas Business Model: Cost Structure
You're analyzing the cost base for Genprex, Inc. (GNPX) as it pushes its gene therapy platform through late-stage clinical development. For a clinical-stage biotech, the cost structure is overwhelmingly weighted toward research and development, which is the engine funding the pipeline.
The dominant cost driver is clearly Research & Development (R&D) expenses, which directly fund the ongoing Acclaim-1 and Acclaim-3 clinical trials for REQORSA. For the second quarter of 2025, the reported R&D expense was $2.50 million. This expense category absorbs the majority of the cash burn required to advance the lead candidate.
The total operating cost for the period reflects this heavy investment. Total operating expenses for Q2 2025 were reported at $4.68 million. This figure encapsulates the R&D spend along with the necessary overhead to support those trials.
The remaining costs fall under General and Administrative (G&A) and third-party vendor expenses. Genprex, Inc. explicitly relies on external partners, such as contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), for scaling up clinical production and executing trials. Furthermore, legal and patent costs are a constant in this sector, especially following recent patent grants in late 2025 for the Reqorsa® combination therapy.
Here is a look at the key components of the cost structure based on the Q2 2025 figures:
| Cost Component | Q2 2025 Amount (USD) |
| Dominant R&D Expenses | $2,500,000 |
| General & Administrative (G&A) Overhead (Including Legal/Patent) | To be determined from remainder |
| Manufacturing & Third-Party Vendor Expenses (CRO/CDMO) | To be determined from remainder |
| Total Operating Expenses | $4,680,000 |
The non-R&D operating costs, which include G&A and vendor expenses, must account for the difference between the total operating expense and the reported R&D figure. This remaining amount, $2.18 million, covers the essential infrastructure to run the business and manage external partnerships.
You should track these specific cost elements closely, as they represent the operational efficiency outside of the core drug development:
- R&D expenses were $2.50 million for Q2 2025.
- Total operating expenses for Q2 2025 were $4,680,000.
- The company maintains partnerships with third-party vendors for clinical production scale-up.
- Legal and patent protection costs are ongoing, evidenced by recent patent activity in late 2025.
- The net loss for the nine months ended September 30, 2025, was $12.44 million, showing a reduction trend.
Finance: draft 13-week cash view by Friday.
Genprex, Inc. (GNPX) - Canvas Business Model: Revenue Streams
You're looking at Genprex, Inc. (GNPX) and trying to map out where the money comes from. Honestly, for a clinical-stage gene therapy company like this, the revenue stream section of the Business Model Canvas is almost entirely about capital formation, not product sales, at least as of late 2025.
The most direct takeaway for the 2025 fiscal year is that Genprex, Inc. is still firmly in the pre-revenue stage. For the trailing twelve months (TTM) ending September 30, 2025, Genprex, Inc. reported $0.0 in total revenue. This means revenue from product sales is effectively $0 for the 2025 fiscal year. This is defintely standard for a company focused solely on Research and Development (R&D) and clinical progression.
The primary cash source keeping the lights on and funding the clinical trials is equity financing. The company is actively tapping capital markets to fund its operations, which saw an operating cash outflow of $11.21 million for the nine months ended September 30, 2025. Here's the quick math on the financing activity seen in late 2025:
- Financing activities generated approximately $7.77 million in net cash for the six months ended June 30, 2025.
- The company raised $10.71 million through equity offerings in 2025 up to the Q3 report.
- In June 2025, Genprex, Inc. secured a $12.5 million commitment from Lincoln Park Capital Fund.
- Around October 2025, Genprex, Inc. announced a registered direct offering and concurrent private placement that could potentially raise up to $10.0 million in gross proceeds if all warrants are fully exercised on a cash basis.
This reliance on external capital is the current reality of the business model, as shown by the cash position as of September 30, 2025, which stood at only $1.10 million. The company carries a 'going concern' disclosure, underscoring this dependency.
Potential future revenue streams are entirely contingent on clinical success, which is where the long-term value proposition lies. These streams are not generating cash now but are the ultimate goal:
Future revenue is anticipated from:
- Milestone payments tied to clinical trial progression (e.g., completion of Acclaim-1 or Acclaim-3).
- Licensing agreements for its lead candidate, Reqorsa® Gene Therapy, or its diabetes gene therapy, GPX-002.
- Royalties from future commercial sales post-regulatory approval.
Grants and sponsored research income remain minimal or non-existent as a direct revenue line in the TTM period, though the activity confirms the stream's existence. Genprex, Inc. has engaged in agreements that represent future collaboration or research support, rather than immediate cash inflow:
| Research/Grant Activity | Date Announced | Focus Area |
| New Sponsored Research Agreement (SRA) | May 7, 2025 | GPX-002 for Type 1 and Type 2 Diabetes (with University of Pittsburgh) |
| Sponsored Research Agreement (SRA) | October 2024 | REQORSA in combination with ALK-inhibitors (with University of Michigan Rogel Cancer Center) |
So, you're funding the pipeline now, hoping for licensing fees and royalties later.
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