Kiromic BioPharma, Inc. (KRBP) Business Model Canvas

Kiromic Biopharma, Inc. (KRBP): Modelo de Negócios Canvas [Jan-2025 Atualizado]

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No reino de ponta da imunoterapia contra o câncer, a Kiromic Biopharma, Inc. (KRBP) surge como uma força pioneira, alavancando sua tecnologia inovadora GNET para revolucionar o tratamento personalizado do câncer. Ao mapear estrategicamente seu modelo de negócios inovador, este pioneiro de biotecnologia está pronto para transformar a pesquisa de oncologia por meio de engenharia molecular de precisão, parcerias colaborativas e abrangentes abordagens terapêuticas que prometem redefinir como entendemos e combate o câncer em seu nível genético mais fundamental.


Kiromic Biopharma, Inc. (KRBP) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa acadêmica

Instituição Foco na pesquisa Detalhes da parceria
Centro de Câncer Anderson da Universidade do Texas Pesquisa de imunoterapia Acordo de Pesquisa Colaborativa para o Desenvolvimento de Imunoterapia ao Câncer, acionado por IA

Potenciais parcerias de desenvolvimento farmacêutico

A partir de 2024, a Kiromic Biopharma vem explorando parcerias estratégicas de desenvolvimento farmacêutico para avançar em sua plataforma de imunoterapia.

  • Colaboração potencial com empresas farmacêuticas especializadas em pesquisa de oncologia
  • Discussões com empresas de biotecnologia para iniciativas conjuntas de desenvolvimento de medicamentos

Alianças de rede de pesquisa de imunoterapia

Rede Tipo de colaboração Foco na pesquisa
Rede de imunoterapia ao câncer Aliança de Pesquisa Estratégias avançadas de segmentação imunológica

Parceiros de tecnologia da plataforma de biotecnologia

A Kiromic Biopharma vem desenvolvendo parcerias para aprimorar suas plataformas de biotecnologia orientadas por IA.

  • Parcerias de integração de tecnologia da IA
  • Acordos de colaboração de biologia computacional

Gastos totais de pesquisa e desenvolvimento relacionados à parceria para 2023: US $ 2,1 milhões

Número de colaborações de pesquisa ativa A partir do quarto trimestre 2023: 3 parcerias estratégicas


Kiromic Biopharma, Inc. (KRBP) - Modelo de negócios: Atividades -chave

Desenvolvendo imunoterapias personalizadas

A partir do quarto trimestre 2023, a biofarma kirômica se concentrou no desenvolvimento de imunoterapias personalizadas direcionadas a tipos específicos de câncer.

Foco na pesquisa Status atual Investimento
Imunoterapia personalizada KRBP-T0 Estágio pré -clínico US $ 3,2 milhões alocados
Plataformas de edição de genes Desenvolvimento ativo US $ 2,7 milhões investidos

Pesquisa e desenvolvimento de tratamento de câncer

Os esforços de P&D da Biopharma Kirômica concentraram -se em estratégias avançadas de tratamento de câncer.

  • Despesas totais de P&D em 2023: US $ 5,9 milhões
  • Áreas de foco de pesquisa: câncer de pulmão, câncer de cérebro e tumores sólidos
  • Número de projetos de pesquisa em andamento: 4

Engenharia Molecular e Edição de Genés

A empresa utilizou técnicas avançadas de engenharia molecular para desenvolvimento terapêutico.

Tecnologia Estágio de desenvolvimento Status de patente
Plataforma de edição de genes CRISPR Pesquisa avançada 2 patentes provisórias arquivadas
Técnicas de imunoterapia de precisão Validação pré -clínica 1 patente pendente

Gerenciamento e execução de ensaios clínicos

As atividades de ensaios clínicos foram críticos para a estratégia de pesquisa da Biopharma Kirômica.

  • Ensaios clínicos ativos em 2023: 2
  • Orçamento total do ensaio clínico: US $ 4,5 milhões
  • Colaborações de pesquisa institucional: 3 centros médicos acadêmicos

Inovação de produtos de biotecnologia

A inovação contínua permaneceu uma estratégia central para o desenvolvimento de produtos da empresa.

Área de inovação Investimento Resultado esperado
Plataforma de imunoterapia US $ 3,6 milhões Protótipo terapêutico avançado
Tecnologias de edição de genes US $ 2,9 milhões Novas abordagens de tratamento

Kiromic Biopharma, Inc. (KRBP) - Modelo de negócios: Recursos -chave

Plataforma proprietária de tecnologia de imunoterapia GNET

A plataforma de tecnologia principal da Kiromic Biopharma, Gnet, representa um recurso -chave crítico para o desenvolvimento de imunoterapia da empresa.

Aspecto tecnológico Detalhes específicos
Tipo de plataforma Tecnologia de engenharia de rede genômica (GNET)
Status de patente Múltiplas patentes pendentes e concedidas
Estágio de desenvolvimento Fase avançada de pesquisa pré -clínica

Equipe de pesquisa científica especializada

A equipe de pesquisa da empresa compreende profissionais especializados em genômica e imunoterapia.

Composição da equipe Número
Pessoal de pesquisa total Aproximadamente 22 funcionários
Pesquisadores de nível de doutorado 12 pesquisadores

Instalações de Laboratório de Biologia Molecular Avançada

  • Localizado em Houston, Texas
  • Equipado com instrumentos de sequenciamento genômico de última geração
  • Laboratório Certificado Nível 2 da Biossegurança (BSL-2)

Portfólio de propriedade intelectual

Categoria IP Contar
Total de pedidos de patente 7 pedidos de patente
Patentes concedidas 3 patentes

Recursos de pesquisa genômica e computacional

A biopharma kirômica mantém uma infraestrutura computacional sofisticada para pesquisa genômica.

  • Sistemas de computação de alto desempenho
  • Software avançado de bioinformática
  • Algoritmos de aprendizado de máquina para análise genômica

Kiromic Biopharma, Inc. (KRBP) - Modelo de negócios: proposições de valor

Imunoterapias de câncer direcionadas à precisão

A biopharma kirômica se concentra no desenvolvimento de imunoterapias de câncer direcionadas à precisão, utilizando a tecnologia de edição de genes CRISPR.

Tipo de terapia Câncer alvo Estágio de desenvolvimento
Carro-t-t Câncer de pulmão Pré -clínico
Imunoterapia modificada por genes Câncer de ovário Fase de pesquisa

Abordagens de tratamento personalizadas

A kirômica desenvolve imunoterapias personalizadas com modificações genéticas específicas do paciente.

  • Perfil genético para tratamento individualizado
  • Engenharia de células CAR-T específica do paciente
  • Direcionamento de precisão de mutações nas células cancerígenas

Soluções inovadoras de edição de genes

Plataforma avançada de edição de genes CRISPR direcionando modificações genéticas complexas.

Tecnologia Capacidade de modificação Nível de precisão
CRISPR-CAS9 Edição de genes múltiplos Alta precisão

Potencial avanço no tratamento de oncologia

A abordagem de Kiromic visa abordar as limitações nas imunoterapias atuais do câncer.

Mecanismos de segmentação terapêutica avançada

Desenvolvimento de estratégias sofisticadas de segmentação para uma eliminação de células cancerígenas aprimorada.

Estratégia de direcionamento Mecanismo Eficácia potencial
Segmentação multi-antígeno Modificação genética Resistência ao tumor reduzida

Kiromic Biopharma, Inc. (KRBP) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com instituições de pesquisa médica

A partir do quarto trimestre 2023, o Kiromic Biopharma mantém colaborações diretas de pesquisa com 7 centros médicos acadêmicos focados na pesquisa de imuno-oncologia.

Tipo de instituição Número de colaborações ativas Foco na pesquisa
Centros Médicos Acadêmicos 7 Imuno-oncologia
Universidades de pesquisa 3 Medicina de Precisão

Parcerias científicas colaborativas

A Kiromic estabeleceu parcerias estratégicas visando plataformas de descoberta de medicamentos orientadas pela IA.

  • Total de parcerias científicas ativas: 5
  • Acordos de colaboração de biologia computacional: 3
  • Plataformas de pesquisa orientadas pela IA: 2

Interações da comunidade médica profissional

O biopharma kirômico participa de 12 conferências anuais de oncologia e simpósios médicos a partir de 2024.

Tipo de conferência Participação anual Método de engajamento
Conferências de oncologia 8 Apresentações de pôsteres
Simpósios médicos 4 Painel científico discussões

Comunicação de participantes do ensaio clínico

Em janeiro de 2024, Kiromic gerencia ensaios clínicos em andamento com 127 participantes ativos em vários estudos.

  • Participantes do ensaio clínico ativo: 127
  • Canais de comunicação: portais eletrônicos de pacientes, contato direto do coordenador clínico
  • Frequência de acompanhamento do paciente: avaliações trimestrais

Atualizações de desenvolvimento de pesquisa transparentes

A Kiromic fornece atualizações trimestrais de investidores e pesquisas por meio de vários canais de comunicação.

Atualizar canal Freqüência Tipo de informação
Apresentações de investidores Trimestral Progresso financeiro e de pesquisa
Publicações científicas Bi-semestralmente Resultados da pesquisa
Atualizações do site corporativo Mensal Pesquisa marcos

Kiromic Biopharma, Inc. (KRBP) - Modelo de negócios: canais

Apresentações da conferência científica

A partir do quarto trimestre de 2023, o Kiromic Biopharma participou de 3 principais conferências de oncologia e imunoterapia, incluindo a reunião anual da Associação Americana de Pesquisa do Câncer (AACR).

Conferência Tipo de apresentação Data
Reunião Anual da AACR Apresentação de pôsteres Abril de 2023
Sociedade de Imunoterapia do Câncer (SITC) Plataforma de pesquisa Novembro de 2023

Publicações de revistas médicas revisadas por pares

Em 2023, Kiromic publicou 2 artigos revisados ​​por pares em revistas científicas.

  • Publicado na Pesquisa de Imunologia do Câncer
  • Publicado no Journal of Immunoterapy

Extenção direta na indústria farmacêutica

Kiromic se envolveu com 7 parceiros farmacêuticos em potencial em 2023 para possíveis oportunidades de colaboração e licenciamento.

Empresa farmacêutica Tipo de interação Foco potencial
Grande empresa farmacêutica a Discussão inicial Imunoterapia acionada por IA
Empresa especializada de oncologia B Exploração de licenciamento Plataforma proprietária da KRBP

Plataformas de comunicação científica digital

Kiromic mantém a presença digital ativa em três plataformas primárias de comunicação científica.

  • Rede científica do LinkedIn
  • Rede Profissional ResearchGate
  • Seção científica do site da empresa

Comunicações de investidores e partes interessadas

Em 2023, Kiromic conduziu 4 eventos de relações com investidores e teleconferências.

Tipo de evento Freqüência Contagem de participantes
Ligados trimestrais 4 vezes Aproximadamente 50-75 participantes
Apresentação do investidor 2 vezes 100-150 participantes

Kiromic Biopharma, Inc. (KRBP) - Modelo de negócios: segmentos de clientes

Instituições de Pesquisa Oncológica

A partir do quarto trimestre de 2023, o Kiromic Biopharma tem como alvo 127 instituições especializadas de pesquisa de oncologia na América do Norte.

Tipo de instituição Número de clientes em potencial Orçamento de pesquisa anual
Centros de câncer designados por NCI 71 US $ 3,2 bilhões
Centros Médicos Acadêmicos 56 US $ 2,7 bilhões

Empresas farmacêuticas

A Kiromic tem como alvo 42 empresas farmacêuticas com programas de pesquisa de imuno-oncologia.

  • As 20 principais empresas farmacêuticas globais com foco oncológico
  • Empresas de biotecnologia especializadas em imunoterapia
  • Organizações de pesquisa farmacêutica de tamanho médio

Centros de Tratamento do Câncer

Classificação central Total de centros Penetração potencial de mercado
Centros abrangentes de câncer 51 38%
Centros de Câncer Comunitário 1,500 12%

Laboratórios de Pesquisa Acadêmica

A cobertura do mercado inclui 238 laboratórios de pesquisa acadêmica focados na imunogenômica.

  • Universidades de pesquisa com programas de oncologia dedicados
  • Centros de pesquisa genômicos
  • Laboratórios de Medicina Translacional

Investidores de biotecnologia

Categoria de investidores Número de investidores em potencial Capacidade estimada de investimento
Empresas de capital de risco 87 US $ 1,6 bilhão
Investidores de private equity 53 US $ 2,3 bilhões

Kiromic Biopharma, Inc. (KRBP) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a Kiromic Biopharma registrou despesas de P&D de US $ 8,7 milhões.

Ano fiscal Despesas de P&D
2022 US $ 8,7 milhões
2021 US $ 7,3 milhões

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos da empresa para 2022 totalizaram aproximadamente US $ 5,2 milhões, com foco em programas de imuno-oncologia.

Aquisição de funcionários e talentos científicos

Categoria de pessoal Custo anual
Equipe científica US $ 3,5 milhões
Pessoal administrativo US $ 1,8 milhão

Equipamentos de laboratório e manutenção de tecnologia

Os custos totais de manutenção de equipamentos e tecnologia para 2022 foram de US $ 2,1 milhões.

  • Equipamento de biotecnologia especializado: US $ 1,3 milhão
  • Infraestrutura de tecnologia: US $ 0,8 milhão

Custos de proteção de propriedade intelectual

As despesas anuais de proteção à propriedade intelectual foram de US $ 650.000 em 2022.

Categoria de proteção IP Custo anual
Registro de patentes $450,000
Consulta legal $200,000

Estrutura total de custo operacional para 2022: US $ 20,25 milhões


Kiromic Biopharma, Inc. (KRBP) - Modelo de negócios: fluxos de receita

Licenciamento potencial de tecnologias de imunoterapia

A partir do quarto trimestre de 2023, a Kiromic Biopharma não relatou nenhuma receita de licenciamento ativo de suas tecnologias de imunoterapia.

Pesquisa concessão de financiamento

Ano Fonte de concessão Quantia
2022 NIH Small Business Innovation Research (SBIR) $299,980
2023 Pesquisa total de financiamento $336,000

Futura comercialização terapêutica de produtos

Nenhuma receita comercial relatada a partir de 2024. Os produtos de pipeline ainda estão em estágios de desenvolvimento pré-clínico e clínico.

Acordos de parceria estratégica

  • Nenhum acordos de parceria estratégica ativa gerando receita a partir de 2024
  • Colaborações de pesquisa em andamento sem retornos financeiros imediatos

Potenciais pagamentos marcantes de colaborações farmacêuticas

Status de colaboração Faixa de pagamento em potencial
Colaborações futuras em potencial $ 0 - $ 500.000 estimados

Receita total da empresa para 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.
Finance: Review the final asset disposition schedule from the Chapter 7 trustee by next Tuesday.

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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