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Kiromic Biopharma, Inc. (KRBP): Business Model Canvas [Jan-2025 Mis à jour] |
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Kiromic BioPharma, Inc. (KRBP) Bundle
Dans le domaine de la pointe de l'immunothérapie contre le cancer, Kiromic Biopharma, Inc. (KRBP) émerge comme une force pionnière, tirant parti de sa technologie de GNE révolutionnaire pour révolutionner le traitement personnalisé du cancer. En cartographiant stratégiquement leur modèle commercial innovant, ce pionnier de biotechnologie est sur le point de transformer la recherche en oncologie par le biais de l'ingénierie moléculaire de précision, des partenariats collaboratifs et des approches thérapeutiques révolutionnaires qui promettent de redéfinir notre façon de comprendre et de lutter contre le cancer à son niveau génétique le plus fondamental.
Kiromic Biopharma, Inc. (KRBP) - Modèle commercial: partenariats clés
Collaborations stratégiques avec les établissements de recherche universitaires
| Institution | Focus de recherche | Détails du partenariat |
|---|---|---|
| Université du Texas MD Anderson Cancer Center | Recherche d'immunothérapie | Contrat de recherche collaboratif pour le développement d'immunothérapie contre le cancer basé sur l'IA |
Partenariats potentiels de développement pharmaceutique
En 2024, Kiromic Biopharma a exploré des partenariats stratégiques de développement pharmaceutique pour faire progresser sa plateforme d'immunothérapie.
- Collaboration potentielle avec des sociétés pharmaceutiques spécialisés dans la recherche en oncologie
- Discussions avec les entreprises de biotechnologie pour les initiatives conjointes de développement de médicaments
Alliances du réseau de recherche d'immunothérapie
| Réseau | Type de collaboration | Focus de recherche |
|---|---|---|
| Réseau d'immunothérapie contre le cancer | Alliance de recherche | Stratégies de ciblage immunologique avancées |
Biotechnology Platform Technology Partners
Kiromic Biopharma a développé des partenariats pour améliorer ses plateformes de biotechnologie axées sur l'IA.
- Partenariats d'intégration de la technologie AI
- Accords de collaboration en biologie informatique
Total des dépenses de recherche et développement liées au partenariat pour 2023: 2,1 millions de dollars
Nombre de collaborations de recherche active auprès du trimestre 2023: 3 partenariats stratégiques
Kiromic Biopharma, Inc. (KRBP) - Modèle d'entreprise: activités clés
Développer des immunothérapies personnalisées
Depuis le Q4 2023, Kiromic Biopharma s'est concentré sur le développement d'immunothérapies personnalisées ciblant des types de cancer spécifiques.
| Focus de recherche | État actuel | Investissement |
|---|---|---|
| Immunothérapie personnalisée KRBP-T0 | Étape préclinique | 3,2 millions de dollars alloués |
| Plates-formes d'édition de gènes | Développement actif | 2,7 millions de dollars investis |
Recherche et développement du traitement du cancer
Les efforts de R&D de Kiromic Biopharma se sont concentrés sur les stratégies de traitement du cancer avancé.
- Total des dépenses de R&D en 2023: 5,9 millions de dollars
- Recherchez les domaines de l'information: cancer du poumon, cancer du cerveau et tumeurs solides
- Nombre de projets de recherche en cours: 4
Ingénierie moléculaire et édition de gènes
L'entreprise a utilisé des techniques de génie moléculaire avancées pour le développement thérapeutique.
| Technologie | Étape de développement | Statut de brevet |
|---|---|---|
| Plate-forme d'édition de gène CRISPR | Recherche avancée | 2 brevets provisoires déposés |
| Techniques d'immunothérapie de précision | Validation préclinique | 1 brevet en attente |
Gestion et exécution des essais cliniques
Les activités des essais cliniques étaient essentielles à la stratégie de recherche de Kiromic Biopharma.
- Essais cliniques actifs en 2023: 2
- Budget total des essais cliniques: 4,5 millions de dollars
- Collaborations de recherche institutionnelle: 3 centres médicaux académiques
Innovation de produit biotechnologique
L'innovation continue est restée une stratégie de base pour le développement de produits de l'entreprise.
| Zone d'innovation | Investissement | Résultat attendu |
|---|---|---|
| Plate-forme d'immunothérapie | 3,6 millions de dollars | Prototype thérapeutique avancé |
| Technologies d'édition de gènes | 2,9 millions de dollars | Nouvelles approches de traitement |
Kiromic Biopharma, Inc. (KRBP) - Modèle d'entreprise: Ressources clés
Plateforme de technologie d'immunothérapie GNET propriétaire
La plate-forme technologique principale de Kiromic Biopharma, GNET, représente une ressource clé critique pour le développement d'immunothérapie de l'entreprise.
| Aspect technologique | Détails spécifiques |
|---|---|
| Type de plate-forme | Technologie génomique d'ingénierie du réseau (GNET) |
| Statut de brevet | Multiples brevets en attente et accordés |
| Étape de développement | Phase de recherche préclinique avancée |
Équipe de recherche scientifique spécialisée
L'équipe de recherche de l'entreprise comprend des professionnels spécialisés en génomique et en immunothérapie.
| Composition de l'équipe | Nombre |
|---|---|
| Personnel de recherche total | Environ 22 employés |
| Chercheurs de doctorat | 12 chercheurs |
Installations avancées de laboratoire de biologie moléculaire
- Situé à Houston, Texas
- Équipé d'instruments de séquençage génomique de pointe
- Laboratoire certifié de niveau 2 (BSL-2)
Portefeuille de propriété intellectuelle
| Catégorie IP | Compter |
|---|---|
| Demandes totales de brevets | 7 demandes de brevet |
| Brevets accordés | 3 brevets |
Capacités de recherche génomique et informatique
Kiromic Biopharma maintient une infrastructure informatique sophistiquée pour la recherche génomique.
- Systèmes informatiques hautes performances
- Logiciel de bioinformatique avancé
- Algorithmes d'apprentissage automatique pour l'analyse génomique
Kiromic Biopharma, Inc. (KRBP) - Modèle d'entreprise: propositions de valeur
Immunothérapies contre le cancer ciblé de précision
Kiromic Biopharma se concentre sur le développement d'immunothérapies contre le cancer ciblé de précision en utilisant la technologie d'édition de gènes CRISPR.
| Type de thérapie | Cancer de la cible | Étape de développement |
|---|---|---|
| Car-T-Imanced Crispr | Cancer du poumon | Préclinique |
| Immunothérapie modifiée par le gène | Cancer de l'ovaire | Phase de recherche |
Approches de traitement personnalisées
Kiromic développe des immunothérapies personnalisées avec des modifications génétiques spécifiques au patient.
- Profil génétique pour un traitement individualisé
- Ingénierie de cellules CAR-T spécifique au patient
- Ciblage de précision des mutations des cellules cancéreuses
Solutions d'édition de gènes innovantes
Plate-forme d'édition de gène CRISPR avancée ciblant les modifications génétiques complexes.
| Technologie | Capacité de modification | Niveau de précision |
|---|---|---|
| CRISPR-CAS9 | Édition de gènes multiples | Haute précision |
Percée potentielle dans le traitement en oncologie
L'approche de Kiromic vise à aborder les limites des immunothérapies actuelles sur le cancer.
Mécanismes de ciblage thérapeutique avancés
Développer des stratégies de ciblage sophistiquées pour une élimination accrue des cellules cancéreuses.
| Cibler la stratégie | Mécanisme | Efficacité potentielle |
|---|---|---|
| Ciblage multi-antigènes | Modification génétique | Réduction de la résistance tumorale |
Kiromic Biopharma, Inc. (KRBP) - Modèle d'entreprise: relations avec les clients
Engagement direct avec les institutions de recherche médicale
Depuis le quatrième trimestre 2023, Kiromic Biopharma maintient des collaborations de recherche directes avec 7 centres médicaux universitaires axés sur la recherche sur l'immuno-oncologie.
| Type d'institution | Nombre de collaborations actives | Focus de recherche |
|---|---|---|
| Centres médicaux académiques | 7 | Immuno-oncologie |
| Universités de recherche | 3 | Médecine de précision |
Partenariats scientifiques collaboratifs
Kiromic a établi des partenariats stratégiques ciblant les plateformes de découverte de médicaments dirigés par l'IA.
- Partenariats scientifiques actifs totaux: 5
- Accords de collaboration en biologie informatique: 3
- Plateformes de recherche dirigés par l'IA: 2
Interactions professionnelles de la communauté médicale
Kiromic Biopharma participe à 12 conférences annuelles en oncologie et symposiums médicaux en 2024.
| Type de conférence | Participation annuelle | Méthode d'engagement |
|---|---|---|
| Conférences en oncologie | 8 | Présentations d'affiches |
| Symposium médical | 4 | Traitements scientifiques |
Communication des participants à l'essai clinique
En janvier 2024, Kiromic gère des essais cliniques en cours avec 127 participants actifs dans plusieurs études.
- Participants à l'essai clinique actif: 127
- Canaux de communication: portails de patients électroniques, contact direct du coordinateur clinique
- Fréquence de suivi des patients: évaluations trimestrielles
Mises à jour de développement de la recherche transparente
Kiromic fournit des mises à jour trimestrielles sur les investisseurs et la recherche via plusieurs canaux de communication.
| Mettre à jour le canal | Fréquence | Type d'information |
|---|---|---|
| Présentations des investisseurs | Trimestriel | Progrès financier et de recherche |
| Publications scientifiques | Bi-annuellement | Résultats de la recherche |
| Mises à jour du site Web d'entreprise | Mensuel | Jalons de recherche |
Kiromic Biopharma, Inc. (KRBP) - Modèle d'entreprise: canaux
Présentations de la conférence scientifique
Depuis le quatrième trimestre 2023, Kiromic Biopharma a participé à 3 conférences majeures en oncologie et en immunothérapie, y compris la réunion annuelle de l'American Association for Cancer Research (AACR).
| Conférence | Type de présentation | Date |
|---|---|---|
| Réunion annuelle AACR | Présentation de l'affiche | Avril 2023 |
| Society for Immunotherapy of Cancer (SITC) | Plateforme de recherche | Novembre 2023 |
Publications de revues médicales évaluées par des pairs
En 2023, Kiromic a publié 2 articles évalués par des pairs dans des revues scientifiques.
- Publié dans Cancer Immunology Research
- Publié dans Journal of Immunotherapy
Sensibilisation directe de l'industrie pharmaceutique
Kiromic s'est engagé avec 7 partenaires pharmaceutiques potentiels en 2023 pour des opportunités potentielles de collaboration et de licence.
| Entreprise pharmaceutique | Type d'interaction | Focus potentiel |
|---|---|---|
| Grande entreprise pharmaceutique A | Discussion initiale | Immunothérapie dirigée par l'IA |
| Entreprise spécialisée en oncologie B | Exploration de licence | Plateforme propriétaire de KRBP |
Plateformes de communication scientifique numérique
Kiromic maintient une présence numérique active sur 3 plates-formes de communication scientifiques primaires.
- Réseau scientifique LinkedIn
- ResearchGate Professional Network
- Section scientifique du site Web de l'entreprise
Communications des investisseurs et des parties prenantes
En 2023, Kiromic a organisé 4 événements de relations avec les investisseurs et conférences téléphoniques.
| Type d'événement | Fréquence | Comptage des participants |
|---|---|---|
| Appel de résultats trimestriel | 4 fois | Environ 50 à 75 participants |
| Présentation des investisseurs | 2 fois | 100-150 participants |
Kiromic Biopharma, Inc. (KRBP) - Modèle d'entreprise: segments de clientèle
Institutions de recherche en oncologie
Depuis le quatrième trimestre 2023, Kiromic Biopharma cible 127 institutions de recherche en oncologie spécialisées en Amérique du Nord.
| Type d'institution | Nombre de clients potentiels | Budget de recherche annuel |
|---|---|---|
| Centres de cancer désignés par le NCI | 71 | 3,2 milliards de dollars |
| Centres médicaux académiques | 56 | 2,7 milliards de dollars |
Sociétés pharmaceutiques
Kiromic cible 42 sociétés pharmaceutiques avec des programmes de recherche sur immuno-oncologie.
- Top 20 des sociétés pharmaceutiques mondiales avec une orientation en oncologie
- Biotechnology Cirmols spécialisés dans l'immunothérapie
- Organisations de recherche pharmaceutique de taille moyenne
Centres de traitement du cancer
| Classification du centre | Centres totaux | Pénétration potentielle du marché |
|---|---|---|
| Centres de cancer complets | 51 | 38% |
| Centres de cancer de la communauté | 1,500 | 12% |
Laboratoires de recherche universitaire
La couverture du marché comprend 238 laboratoires de recherche universitaire axés sur l'immunogénomique.
- Recherchez des universités avec des programmes d'oncologie dédiés
- Centres de recherche génomique
- Laboratoires de médecine translationnelle
Investisseurs en biotechnologie
| Catégorie d'investisseurs | Nombre d'investisseurs potentiels | Capacité d'investissement estimée |
|---|---|---|
| Sociétés de capital-risque | 87 | 1,6 milliard de dollars |
| Investisseurs en capital-investissement | 53 | 2,3 milliards de dollars |
Kiromic Biopharma, Inc. (KRBP) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice clos le 31 décembre 2022, Kiromic Biopharma a déclaré des dépenses de R&D de 8,7 millions de dollars.
| Exercice fiscal | Dépenses de R&D |
|---|---|
| 2022 | 8,7 millions de dollars |
| 2021 | 7,3 millions de dollars |
Investissements d'essais cliniques
Les investissements des essais cliniques de la société pour 2022 ont totalisé environ 5,2 millions de dollars, en se concentrant sur les programmes d'immuno-oncologie.
Acquisition du personnel et des talents scientifiques
| Catégorie de personnel | Coût annuel |
|---|---|
| Personnel scientifique | 3,5 millions de dollars |
| Personnel administratif | 1,8 million de dollars |
Équipement de laboratoire et maintenance de la technologie
Les coûts totaux de maintenance de l'équipement et de la technologie pour 2022 étaient de 2,1 millions de dollars.
- Équipement de biotechnologie spécialisé: 1,3 million de dollars
- Infrastructure technologique: 0,8 million de dollars
Coûts de protection de la propriété intellectuelle
Les dépenses annuelles de protection de la propriété intellectuelle étaient de 650 000 $ en 2022.
| Catégorie de protection IP | Coût annuel |
|---|---|
| Dépôt de brevet | $450,000 |
| Consultation juridique | $200,000 |
Structure totale des coûts opérationnels pour 2022: 20,25 millions de dollars
Kiromic Biopharma, Inc. (KRBP) - Modèle d'entreprise: Strots de revenus
Licence potentielle des technologies d'immunothérapie
Depuis le quatrième trimestre 2023, Kiromic Biopharma n'a signalé aucun revenu de licence actif de ses technologies d'immunothérapie.
Financement de la subvention de la recherche
| Année | Source d'octroi | Montant |
|---|---|---|
| 2022 | NIH Small Business Innovation Research (SBIR) | $299,980 |
| 2023 | Financement total de subvention de recherche | $336,000 |
Future commercialisation des produits thérapeutiques
Aucun revenu commercial déclaré en 2024. Les produits de pipeline sont toujours en phase de développement préclinique et clinique.
Accords de partenariat stratégique
- Aucun accord de partenariat stratégique actif générant des revenus à partir de 2024
- Collaborations de recherche en cours sans rendement financier immédiat
Paiements de jalons potentiels provenant de collaborations pharmaceutiques
| Statut de collaboration | Gamme de paiement de jalons potentiel |
|---|---|
| Collaborations futures potentielles | 0 $ - 500 000 $ estimés |
Revenus totaux de l'entreprise pour 2023: $336,000
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Value Propositions
You're looking at the core value Kiromic BioPharma, Inc. is trying to deliver with its platform, especially when you compare it to the established, but cumbersome, autologous (patient-specific) cell therapies. The main draw here is speed and accessibility for serious conditions.
The primary offering is Deltacel™, which is an allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy. This means it's ready to go from the donor, not custom-made for each patient, which directly addresses the 'faster patient access' proposition.
The clinical focus is squarely on solid tumors, an area where CAR-T has historically struggled. Specifically, the initial target is metastatic non-small cell lung cancer (NSCLC), which makes up about 80% to 85% of all lung cancer cases.
This approach gained significant regulatory validation. Kiromic BioPharma secured FDA Fast Track Designation in August 2024 for Deltacel™ when used with low-dose radiation therapy for metastatic NSCLC patients who have already progressed on 2 or more prior lines of standard-of-care treatment.
Here's a quick look at the early clinical data supporting this value, keeping in mind the trial is ongoing with an estimated completion date of January 2027:
- Average Progression-Free Survival (PFS) of 4.8 months (range, 2-8) among 5 evaluable patients from Part 1 data reported on August 9, 2024.
- One patient showed a 32% Decrease in Tumor Volume eight months post-treatment (reported December 12, 2024).
- Another patient reached 10-Month Progression-Free Survival (reported February 18, 2025).
- The trial reported No dose-limiting toxicities for patients completing the full course of therapy.
The engine driving the discovery of these targets is the proprietary DIAMOND® AI 2.0 target discovery engine. While general industry data suggests AI can reduce drug discovery costs by up to 40% and slash timelines to 12-18 months, Kiromic BioPharma is using this to create high-precision immuno-oncology candidates.
The cost and logistics proposition is where the allogeneic nature really shines against the competition. You can see the contrast clearly when you map the known issues of autologous treatments against the intended benefits of Kiromic BioPharma's platform:
| Value Proposition Aspect | Autologous Therapy Challenge | Kiromic BioPharma Deltacel (Allogeneic) Value |
| Manufacturing Cost | Exorbitant production costs, limiting accessibility. | Aims to mitigate high costs through scalable, donor-derived production. |
| Manufacturing Timeline | Long time needed to process patient cells, delaying treatment. | Off-the-shelf availability for faster patient access. |
| Solid Tumor Targeting | Limited efficacy in solid tumors remains a significant challenge. | Designed to exploit natural potency of GDT cells to target solid cancers. |
To give you some context on the investment required to support this development, the clinical trials expenses for Deltacel-01 rose to $8.1 million for the year ended December 31, 2024, contributing to a reported net loss of $26.9 million for that same fiscal year. The company raised $18.4 million through financing activities to support operations, though it noted insufficient cash resources beyond March 2025.
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Customer Relationships
You're looking at the relationships Kiromic BioPharma, Inc. maintained with its key external stakeholders, which, for a clinical-stage biotech, are primarily investigators, regulators, and capital providers. These relationships were critical, especially given the company's financial position leading into 2025.
High-touch, direct collaboration with clinical investigators and sites
The core of the customer relationship, in the clinical sense, involved the investigators and sites running the Deltacel-01 Phase 1 study. This required close, direct interaction to ensure protocol adherence and data integrity. The company was actively working to expand this network, having expected to activate a fifth clinical trial site on August 30, 2024.
The relationship with the medical community was built on the preliminary data generated from the Deltacel therapy in combination with low-dose radiation for metastatic non-small cell lung cancer (NSCLC).
Here's a look at the clinical milestones that underpinned these collaborations:
| Metric | Value/Status | Date Context |
| Product Candidate | Deltacel (KB-GDT-01) | Ongoing Phase 1 |
| Tumor Volume Decrease (Patient 4) | 32% | Eight Months Post-Treatment (Reported Dec 2024) |
| Progression-Free Survival (Patient 4) | 10-Month | Reported Dec 2024 |
| Preliminary Tumor Reduction (First Patient) | 6.6% | Reported March 2024 |
| Total Product Candidates | 3 (Deltacel, Isocel, Procel) | Pre-Bankruptcy |
Dedicated investor relations for capital raising and market communication
For a company operating with substantial doubt about its ability to continue as a going concern, investor relations was a survival function. The focus was squarely on capital raising to fund operations, which were heavily weighted toward clinical expenses. For the year ended December 31, 2024, Kiromic BioPharma, Inc. reported net losses of $26.9 million.
The company actively engaged investors, for instance, by participating in the OTC Markets' Life Science Investor Forum on March 7, 2024. The financial activities show the reliance on external funding sources.
Key financial interactions defining this relationship included:
- Cash provided by financing activities for the nine months ended September 30, 2024: $16,000,000.
- Gross proceeds from a private placement in August 2024: $2,000,000 via a note bearing 25% interest.
- Total financing raised to support operations (as of Feb 2025 filing): $18.4 million.
- Cash and cash equivalents as of September 30, 2024: $3,056,000.
- The company acknowledged that cash resources were insufficient to meet obligations beyond March 2025.
The IR contact listed for the company was Alliance Advisors IR, with Tirth T. Patel as the contact.
Regulatory engagement with the U.S. FDA (e.g., Fast Track process)
Regulatory engagement was a high-stakes relationship, especially following past disclosure issues. A major positive milestone was the U.S. Food and Drug Administration (FDA) granting Fast Track designation to Deltacel in August 2024. This designation is designed to expedite development and review for serious conditions filling an unmet need, allowing for more frequent communication with the FDA.
This positive engagement contrasts with prior regulatory friction. The company settled an SEC investigation in December 2024 related to the non-disclosure of clinical holds placed on IND applications in June 2021. The SEC did not impose a civil penalty due to the company's self-reporting, prompt remediation, and cooperation.
The Fast Track status for Deltacel was specifically for its use in combination with low-dose radiation therapy for metastatic NSCLC patients who progressed on at least two lines of standard of care therapy.
Scientific and medical community outreach via publications and conferences
Outreach to the scientific community centered on presenting clinical data and highlighting the underlying technology platform. The company's proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine was a key asset discussed in these forums.
The scale of the data underpinning this platform was cited as a relationship-building asset with the scientific community.
Key metrics related to scientific outreach and platform development included:
- Data collected into the DIAMOND® platform: Over two billion data points (as of March 2024).
- Clinical Trial Expenses for 2024: $8.1 million.
- Research and development expenses for 2024: $6.9 million.
- The platform supports 3 product candidates: Deltacel, Isocel, and Procel.
The company's management, including the CEO, participated in investor forums to communicate these scientific developments directly to the market.
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Channels
You're looking at the Channels for Kiromic BioPharma, Inc. (KRBP) as of late 2025. Honestly, the reality of the situation dictates the current channel strategy, which is far from a typical commercialization roadmap. The most significant financial and operational event defining this period is the filing of a voluntary petition for relief under Chapter 7 of Title 11 of the United States Code on March 21, 2025, in the United States Bankruptcy Court for the District of Delaware.
Clinical trial sites (e.g., Texas Oncology, Virginia Oncology Associates)
The activation of clinical trial sites, which was an active channel focus in 2023 for the Deltacel (KB-GDT-01) Phase 1 trial in non-small cell lung cancer (NSCLC), is effectively suspended or in the process of being terminated due to the Chapter 7 filing on March 21, 2025. Any remaining site relationships would now be managed through the bankruptcy proceedings for asset disposition or contract wind-down, not patient enrollment.
- Last known trial focus: Phase 1 for Deltacel in NSCLC.
- Operational status: Governed by Chapter 7 proceedings as of March 21, 2025.
Scientific publications and presentations at oncology conferences
For a company in Chapter 7 liquidation, presenting new data is not a near-term channel. However, the scientific community where Kiromic BioPharma, Inc. would have aimed to present its data on Gamma Delta T-cell therapy remains active. For instance, the Society of Hematologic Oncology (SOHO) Annual Meeting in September 2025 was expected to draw more than 3,800 participants. Other relevant forums included the IASLC World Conference on Lung Cancer in September 2025 and the Summit for Novel Therapeutics in Oncology & Precision Medicine in Cancer (STOP Cancer) in late September 2025.
The primary channel for scientific communication shifts from presenting new trial data to managing the scientific record related to their proprietary DIAMOND® AI platform and cell therapy candidates.
Investor relations portal and SEC filings for public communication
The official channel for public and investor communication is now dominated by bankruptcy-related disclosures. The company's CIK identifier is 0000071691. The critical filing was the Form 8-K reporting the Bankruptcy or Receivership on March 21, 2025. Prior to this, the company was filing quarterly reports, such as the 10-Q for the quarter ending March 31, 2025, filed on May 7, 2025. The July 2021 follow-on public offering, which raised $40 million to fund prospective clinical trials, is now a historical financial data point relevant to the company's wind-down.
| Communication Channel Element | Key Identifier/Date/Amount |
| CIK Number | 0000071691 |
| Chapter 7 Filing Date | March 21, 2025 |
| Bankruptcy Court Location | District of Delaware |
| Last Reported Offering Amount (Historical Context) | $40 million (July 2021) |
Direct sales force (future, post-commercialization)
The deployment of a direct sales force for commercialization is not a current or future channel for Kiromic BioPharma, Inc. given the Chapter 7 status as of March 21, 2025. In the biopharma industry generally, successful commercialization requires deploying sales forces supported by Pharma CRM software to manage relationships with healthcare professionals (HCPs). For context, industry benchmarks suggest that successful commercialization must maximize returns during the approximately 7 to 10 years of patent protection remaining after launch, a phase Kiromic BioPharma, Inc. will not reach for its current pipeline assets.
- Post-commercialization sales force: Not applicable due to bankruptcy.
- Industry benchmark for patent life post-launch: 7 to 10 years.
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Customer Segments
You're looking at the core groups Kiromic BioPharma, Inc. (KRBP) needs to satisfy to move its cell therapy pipeline forward, especially as of late 2025.
The most immediate customer segment involves the patients themselves, specifically those with advanced disease who have exhausted other options.
- Patients with stage 4 metastatic or locally-advanced non-small cell lung cancer (NSCLC) failing standard therapies are the target for the Deltacel-01 Phase 1 clinical trial.
The clinical side represents the next layer of customer engagement, where the product is tested and administered.
- The Deltacel-01 trial has involved multiple clinical sites, including Beverly Hills Cancer Center (BHCC), Clinical Research Advisors Koreatown, and Virginia Oncology Associates.
- The University of Arizona Cancer Center was activated as the fifth clinical trial site in September 2024.
Funding this development is critical, making investors a key segment, even if the company has acknowledged substantial doubt about its ability to continue as a going concern beyond March 2025. The company was actively seeking additional financing.
Future pharmaceutical partners are the ultimate commercial customers for licensing or co-development deals, which are essential for market access and revenue generation.
Here's a quick look at the quantifiable data points related to these segments as reported in early 2025 filings and press releases:
| Customer Segment | Key Metric | Reported Value/Amount | Date Context |
|---|---|---|---|
| Patients (Deltacel-01 Trial) | Number of Patients Enrolled/Treated (Minimum) | 9 patients treated/enrolled as of January 21, 2025 | |
| Patients (Deltacel-01 Trial) | Tumor Volume Reduction (Patient 1) | 33.33% reduction at 12-month follow-up | |
| Patients (Deltacel-01 Trial) | Tumor Volume Reduction (Patient 7) | 9.5% reduction at two-month follow-up | |
| Clinical Sites/Investigators | Number of Activated Trial Sites (Minimum) | 5 sites activated as of September 2024 | |
| Institutional Investors | Financing Raised (Convertible Notes) | $18.4 million raised to support operations | |
| Institutional Investors | Reported Institutional Filers (13D/G or 13F) | 1 institutional owner reported | |
| Future Partners | Prior Equity Offering Amount | $40 million raised in a July 2021 offering |
The success of current and future license and collaboration agreements is a stated factor in the company's outlook.
Finance: draft 13-week cash view by Friday.
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Cost Structure
You're looking at the core expenses driving Kiromic BioPharma, Inc.'s operations as they push their cell therapy candidates through clinical stages. For a pre-commercial biotech, the cost structure is almost entirely weighted toward discovery, development, and compliance. The numbers from the fiscal year ended December 31, 2024, paint a clear picture of where the cash burn is concentrated.
The primary cost drivers are heavily skewed toward the science. For FY 2024, Research and Development (R&D) expenses totaled $6.9 million, a slight dip from $7.0 million the prior year, showing a tight focus on their Deltacel product candidate development. However, the real spike is in the clinical execution. Significant clinical trial expenses hit $8.1 million in FY 2024, a substantial increase from $2.7 million the year before, directly tied to activating the Deltacel-01 trial. That's where the money goes when you're testing a therapy in humans; you can't really skimp there.
General and administrative (G&A) costs, which cover the overhead of running the company-salaries, rent, professional fees-were $8.9 million for FY 2024. That's down from $10.3 million previously, suggesting some belt-tightening on the non-R&D side, likely through a reduction in professional and legal fees. Still, the total operating expenses for the year were $23.77 million, leading to a net loss of $26.9 million for the period. That's the cost of keeping the lights on and the trials running.
Here's a quick look at the main operating expense categories for the fiscal year ending December 31, 2024:
| Expense Category | FY 2024 Amount (in millions) |
|---|---|
| Research and Development (R&D) | $6.9 |
| Clinical Trial Expenses | $8.1 |
| General and Administrative (G&A) | $8.9 |
| Total Operating Expenses | $23.77 |
The physical infrastructure supporting this work is also a cost center. Kiromic BioPharma, Inc. maintains its Houston cGMP manufacturing facility. While specific annual maintenance costs aren't itemized in the same way as R&D, the balance sheet shows the investment in the physical plant. As of December 31, 2024, Property, Plant, and Equipment stood at $4.31 million. You have to factor in the depreciation, utilities, and specialized staffing required to keep a current Good Manufacturing Practice (cGMP) site ready for potential future commercial production or advanced clinical supply.
Beyond the direct R&D and G&A spend, there are essential, recurring costs to protect the core assets. These include:
- Patent prosecution expenses to secure new intellectual property.
- Intellectual property maintenance fees to keep existing patents active.
- Costs related to regulatory filings and compliance activities.
- Stock-based compensation, which was $0.60 million for the year.
These fixed costs are non-negotiable for a company whose value is tied to its pipeline exclusivity. Finance: draft 13-week cash view by Friday.
Kiromic BioPharma, Inc. (KRBP) - Canvas Business Model: Revenue Streams
You're looking at the revenue side for Kiromic BioPharma, Inc. as of late 2025. Since this is a clinical-stage company, the current revenue picture is almost entirely non-operational, meaning it comes from capital markets rather than selling a product.
Zero product revenue (pre-commercial stage)
As of the end of fiscal year 2024, Kiromic BioPharma, Inc. has consistently reported zero revenue. This is typical for a company focused on developing its pipeline candidates, like Deltacel™, through clinical trials. The financial data from the annual report filed in February 2025 confirms this pre-commercial status, showing zero revenue for the year ended December 31, 2024. This zero revenue, coupled with widening net losses-which reached $26.9 million for the year ended December 31, 2024-is the financial signature of a company funding its research and development entirely through external capital. The company has reported zero revenue and negative gross profit in each year from 2021 through 2024.
Proceeds from financing activities (e.g., convertible notes, equity offerings)
The primary source of cash inflow for Kiromic BioPharma, Inc. is financing. This capital is essential to fund operations, especially the clinical trials for Deltacel™. The company actively sought and secured funds through debt instruments, primarily convertible notes, to bridge operational gaps. For instance, the nine months ending September 30, 2024, showed Cash provided by financing activities was $16,000,000. Separately, the annual report covering the fiscal year ended December 31, 2024, indicated the company raised $18.4 million through financing activities, mainly from issuing convertible notes to support operations. One specific transaction noted was the completion of a private placement on August 1, 2024, issuing a senior secured convertible promissory note for gross proceeds of $2,000,000, which carried a 25% per annum interest rate and was set to mature on August 1, 2025.
Here's a look at the financing activity reported around the 2024 period:
| Financing Metric/Event | Amount (USD) | Reporting Period/Date |
|---|---|---|
| Cash Provided by Financing Activities | $16,000,000 | Nine months ended September 30, 2024 |
| Total Raised via Financing Activities (Convertible Notes) | $18.4 million | Fiscal Year Ended December 31, 2024 |
| Gross Proceeds from Senior Secured Convertible Note | $2,000,000 | Completed August 1, 2024 |
| Exchange of Senior Convertible Notes into Preferred Stock (Non-cash) | $16,838,000 | Reported in 2024 filings |
The reliance on these activities highlights the ongoing need for capital, as the company faced substantial doubt about its ability to continue as a going concern without additional financing as of late 2024.
Potential future upfront payments from licensing or collaboration deals
As of late 2025, Kiromic BioPharma, Inc. has not publicly announced any realized upfront payments from licensing or collaboration deals for its pipeline assets. The focus has been on advancing Deltacel™ through its Phase 1 clinical trial, which received Fast-Track Designation from the FDA in August 2024. The potential for future revenue streams is tied directly to the success of this clinical advancement. The company's strategy involves developing its allogeneic Gamma Delta T-cell therapy platform, which could attract strategic partners interested in licensing rights for specific indications or geographies once positive data emerges from the ongoing Deltacel-01 trial.
Potential future milestone payments from strategic alliances
Milestone payments are contingent revenues tied to achieving specific development, regulatory, or commercial goals outlined in a partnership agreement. Currently, there are no reported active agreements that specify dollar amounts for future milestone payments. The potential exists for such payments upon:
- Successful completion of the Deltacel-01 Phase 1 trial, especially moving into Phase 2 or Phase 3.
- Achieving specific endpoints, such as progression-free survival targets, which were recently reported for Patient 4 at 10 months as of January 2025.
- Regulatory milestones, such as receiving Investigational New Drug (IND) clearance for other pipeline candidates like Isocel or Procel.
Future product sales of Deltacel™ and other pipeline candidates
Future product sales represent the ultimate, long-term revenue stream for Kiromic BioPharma, Inc., but these are entirely prospective. The company is developing Deltacel™ for stage 4 metastatic non-small cell lung cancer (NSCLC), which represents about 80% to 85% of all lung cancer cases. The realization of sales revenue depends on successfully navigating the remaining clinical trial phases, securing regulatory approval, and establishing manufacturing and commercialization capabilities. No specific sales forecasts or pricing data for Deltacel™ are available as of late 2025, given its status in the Phase 1 trial.
The company's pipeline includes:
- Deltacel™ (KB-GDT-01): Lead candidate, currently in the Deltacel-01 Phase 1 trial.
- Isocel: Another product candidate on the GDT platform.
- Procel: Another product candidate on the GDT platform.
The near-term financial action for you is tracking cash burn against the next financing round needed, as current resources are insufficient to fund operations beyond December 2024, according to a late 2024 filing. Finance: draft 13-week cash view by Friday.
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