Black Diamond Therapeutics, Inc. (BDTX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da oncologia de precisão, a Black Diamond Therapeutics surge como uma força pioneira, empunhando sua inovadora plataforma de libélula para revolucionar o tratamento do câncer. Ao direcionar mutações genéticas anteriormente intratáveis ​​com precisão sem precedentes, esta empresa inovadora de biotecnologia está pronta para transformar a maneira como abordamos a medicina personalizada, oferecendo esperança a pacientes com perfis de câncer complexos e desafiadores. Sua abordagem única preenche a pesquisa molecular de ponta com potencial terapêutico transformador, posicionando o diamante preto na vanguarda de um avanço médico que poderia redefinir estratégias de tratamento do câncer.

Black Diamond Therapeutics, Inc. (BDTX) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa acadêmica

A Black Diamond Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Ano de colaboração
Instituto de Câncer Dana-Farber	Pesquisa de oncologia de precisão	2021
Hospital Geral de Massachusetts	Análise de mutação genômica	2022

Parcerias de desenvolvimento farmacêutico

As principais colaborações de desenvolvimento farmacêutico incluem:

• Colaboração com Merck & Co. para pesquisa de mutação EGFR
• Parceria estratégica com a Novartis para o desenvolvimento da terapia direcionada

Acordos de licenciamento em potencial

A Black Diamond Therapeutics explorou acordos de licenciamento com as seguintes empresas de biotecnologia:

Empresa de biotecnologia	Tipo de licença potencial	Valor estimado
Genentech	Tecnologia de direcionamento molecular	US $ 15 milhões em potencial pagamento inicial
AstraZeneca	Plataforma de oncologia de precisão	US $ 20 milhões em potenciais pagamentos marcantes

Relacionamentos de investidores

Grupos significativos de capital de risco e investimentos de biotecnologia que apoiam o Black Diamond Therapeutics:

• Arch Venture Partners: investimento de US $ 45 milhões
• Andreessen Horowitz: investimento de US $ 35 milhões
• Cormorant Global Healthcare: investimento de US $ 30 milhões

Investimento total arrecadado: US $ 110 milhões em 2023

Black Diamond Therapeutics, Inc. (BDTX) - Modelo de negócios: Atividades -chave

Descoberta e desenvolvimento de medicamentos para oncologia de precisão

A partir do quarto trimestre 2023, a Black Diamond Therapeutics se concentrou no desenvolvimento de terapêuticas de oncologia de precisão direcionadas a mutações genéticas específicas.

Categoria de pesquisa	Programas ativos	Estágio de desenvolvimento
Cânceres geneticamente definidos	3 programas primários	Fase 1/2 ensaios clínicos
Mutações de EGFR	BDTX-4933	Desenvolvimento Clínico

Pesquisa de direcionamento molecular para cânceres geneticamente definidos

A estratégia de pesquisa do Black Diamond se concentra na identificação e direcionamento de fatores moleculares específicos do câncer.

• Análise de mutação genética
• Direcionamento molecular de precisão
• Abordagem terapêutica personalizada

Projeto de ensaio clínico e execução

Métricas de ensaio clínico	2023 dados
Ensaios clínicos ativos	2 ensaios em andamento
Inscrição do paciente	Aproximadamente 50 pacientes
Locais de ensaios clínicos	Vários centros de câncer nos EUA

Avanço tecnológico da plataforma de dragão

A plataforma de libélula proprietária da Black Diamond permite a identificação de novos alvos terapêuticos em diversas mutações genéticas.

• Técnicas de biologia computacional
• Algoritmos avançados de aprendizado de máquina
• Capacidades de perfil genômico

Métricas de tecnologia da plataforma	2023-2024 Status
Investimento em P&D	US $ 15,2 milhões
Aplicações de patentes	3 novas aplicações
Validação de tecnologia	Publicações revisadas por pares

Black Diamond Therapeutics, Inc. (BDTX) - Modelo de negócios: Recursos -chave

Plataforma inovadora de pequenas moléculas de libélula

A Black Diamond Therapeutics desenvolveu uma plataforma de libélula proprietária direcionada a mutações anteriormente indiscutíveis em várias proteínas do motorista oncogênico. A partir de 2024, a plataforma permite o direcionamento de precisão de mutações proteicas específicas.

Capacidade da plataforma	Especificação técnica
Mutação direcionada à precisão	Identifica e tem como alvo mutações proteicas específicas
Triagem computacional	Identificação avançada de mutação algorítmica

Equipe de pesquisa científica altamente especializada

A empresa mantém uma equipe de pesquisa especializada com profunda experiência em oncologia e biologia molecular.

• Pessoal de pesquisa total: 87 funcionários
• Pesquisadores no nível de doutorado: 62% da equipe de pesquisa
• Experiência média de pesquisa: 12,5 anos

Portfólio de propriedade intelectual

A Black Diamond Therapeutics desenvolveu uma estratégia de propriedade intelectual robusta.

Categoria IP	Número de ativos
Patentes ativas	23 patentes concedidas
Aplicações de patentes	17 Aplicações pendentes

Capacidades avançadas de biologia computacional e molecular

A empresa utiliza ferramentas computacionais sofisticadas para descoberta e desenvolvimento de medicamentos.

• Infraestrutura de computação de alto desempenho
• Capacidades avançadas de modelagem molecular
• Algoritmos de design de medicamentos aprimorados pelo aprendizado de máquina

Financiamento substancial de capital de risco

A Black Diamond Therapeutics garantiu recursos financeiros significativos da Venture Capital Investments.

Rodada de financiamento	Valor aumentado	Ano
Série A.	US $ 53 milhões	2018
Série B.	US $ 125 milhões	2020
IPO	US $ 220 milhões	2020

Black Diamond Therapeutics, Inc. (BDTX) - Modelo de Negócios: Proposições de Valor

Medicina de precisão direcionada para cânceres geneticamente definidos

A Black Diamond Therapeutics se concentra no desenvolvimento de terapias de precisão direcionadas a mutações genéticas específicas no câncer. A partir do quarto trimestre 2023, o pipeline da empresa inclui:

Candidato a drogas	Mutação alvo	Estágio de desenvolvimento
BDTX-4933	Mutações EGFR/HER2	Ensaio Clínico de Fase 1/2
BDTX-1535	Mutações NF1	Estágio pré -clínico

Nova abordagem para tratar mutações difíceis de segmentar

A plataforma de medicina de precisão seletiva de mutação proprietária da Companhia permite o direcionamento de mutações anteriormente indiscutíveis.

• Tecnologia de inibidor alostérico desenvolvido
• Capacidade de atingir várias variantes de mutação simultaneamente
• Potencial para superar mecanismos de resistência

Potencial para intervenções terapêuticas personalizadas

Investimento financeiro em pesquisa e desenvolvimento para 2023:

Despesa de P&D	Quantia
Gastos totais de P&D	US $ 132,4 milhões
Porcentagem de despesas operacionais	84.3%

Plataforma inovadora de desenvolvimento de medicamentos para pequenas moléculas

Os recursos da plataforma incluem:

• Técnicas de triagem computacional proprietária
• Abordagens avançadas de biologia estrutural
• Análise de mutação aprimorada pelo aprendizado de máquina

Em 31 de dezembro de 2023, Black Diamond Therapeutics mantinha US $ 417,3 milhões em caixa e equivalentes em dinheiro para apoiar os esforços contínuos de desenvolvimento de medicamentos.

Black Diamond Therapeutics, Inc. (BDTX) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa oncológica

Black Diamond Therapeutics mantém o envolvimento direto através de:

Tipo de engajamento	Freqüência	Público -alvo
Colaboração de pesquisa	Trimestral	Instituições de Pesquisa Oncológica
Reuniões do Conselho Consultivo Científico	Semestral	Pesquisadores de oncologia líder

Parcerias de ensaios clínicos colaborativos

Parcerias de ensaios clínicos incluem:

• Memorial Sloan Kettering Cancer Center
• Instituto de Câncer Dana-Farber
• MD Anderson Cancer Center

Desenvolvimento terapêutico focado no paciente

Métricas de engajamento do paciente:

Método de interação do paciente	Nível de engajamento
Painéis de consultoria de pacientes	3 painéis anualmente
Pesquisas de feedback do paciente	Coleção trimestral

Interações da Conferência Científica e do Simpósio Médico

Detalhes da participação na conferência:

• Reunião Anual da Associação Americana de Pesquisa do Câncer (AACR)
• Conferência Anual da Sociedade Americana de Oncologia Clínica (ASCO)
• Congresso da Sociedade Europeia de Oncologia Médica (ESMO)

Tipo de conferência	Apresentações anuais	Resumos científicos
Conferências de Oncologia Internacional	7-10 apresentações	12-15 Resumos científicos

Black Diamond Therapeutics, Inc. (BDTX) - Modelo de Negócios: Canais

Comunicações de pesquisa médica direta

A Black Diamond Therapeutics utiliza canais de comunicação direta com instituições de pesquisa de oncologia e centros médicos. No quarto trimestre 2023, a empresa manteve parcerias de pesquisa ativa com 17 centros especializados de pesquisa de câncer.

Canal de comunicação	Número de parcerias ativas	Engajamento anual da pesquisa
Instituições de pesquisa acadêmica	12	US $ 3,7 milhões
Centros abrangentes de câncer	5	US $ 2,1 milhões

Conferências da indústria de biotecnologia e farmacêutica

O Black Diamond participa ativamente de conferências importantes do setor para mostrar pesquisas e rede com potenciais colaboradores.

• Reunião Anual da ASCO
• Conferência Anual da AACR
• Simpósio de câncer de mama em San Antonio
• Conferência Mundial sobre Câncer de Pulmão

Publicações científicas revisadas por pares

A empresa mantém uma forte presença na literatura científica, com 8 publicações revisadas por pares em 2023 em periódicos, incluindo natureza, célula e Journal of Clinical Oncology.

Tipo de publicação	Número de publicações	Citações totais
Revistas revisadas por pares	8	127

Plataformas de relações com investidores

O Black Diamond emprega vários canais de comunicação de investidores, incluindo:

• Chamadas de ganhos trimestrais
• Reuniões anuais de acionistas
• Sec Comunicação de arquivamento
• Webinars de apresentação de investidores

Em dezembro de 2023, a plataforma de relações com investidores da empresa atingiu aproximadamente 412 investidores institucionais.

Redes de recrutamento de ensaios clínicos

A empresa aproveita as redes especializadas de recrutamento de ensaios clínicos para identificar e envolver potenciais participantes.

Rede de recrutamento	Número de ensaios ativos	Capacidade de inscrição do paciente
Redes de colaboração de ensaios clínicos	5	1.200 participantes em potencial

Black Diamond Therapeutics, Inc. (BDTX) - Modelo de negócios: segmentos de clientes

Instituições de Pesquisa Oncológica

A partir de 2024, a Black Diamond Therapeutics tem como alvo aproximadamente 350 instituições especializadas em pesquisa em oncologia em todo o mundo.

Região	Número de instituições direcionadas
América do Norte	156
Europa	112
Ásia-Pacífico	82

Centros de Tratamento do Câncer

A Black Diamond Therapeutics se concentra em 425 centros abrangentes de tratamento de câncer em todo o mundo.

• Centros abrangentes de câncer: 185
• Centros Médicos Acadêmicos: 140
• Centros de Câncer Comunitário: 100

Pacientes com mutações de câncer geneticamente definidas

População alvo de pacientes estimada em 72.500 indivíduos com mutações genéticas específicas.

Tipo de mutação	População estimada de pacientes
Mutações de EGFR	28,500
Mutações Kras	24,000
Outras mutações direcionadas	20,000

Empresas farmacêuticas e de biotecnologia

Parcerias colaborativas com 47 empresas farmacêuticas e de biotecnologia.

• 20 principais empresas farmacêuticas: 12
• Empresas de biotecnologia de tamanho médio: 22
• Empresas de oncologia especializadas: 13

Pesquisadores de Medicina de Precisão

Rede de 680 profissionais de pesquisa em medicina de precisão em várias instituições.

Foco na pesquisa	Número de pesquisadores
Perfil genômico	245
Terapias direcionadas	210
Tradução clínica	225

Black Diamond Therapeutics, Inc. (BDTX) - Modelo de negócios: Estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Black Diamond Therapeutics registrou despesas totais de P&D de US $ 154,3 milhões, representando um investimento significativo no desenvolvimento de terapias de oncologia de precisão.

Ano	Despesas de P&D	Porcentagem de custos operacionais totais
2022	US $ 138,7 milhões	62.4%
2023	US $ 154,3 milhões	65.2%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos da Black Diamond Therapeutics em 2023 totalizaram aproximadamente US $ 87,6 milhões, com foco em programas de oncologia de precisão.

• BDTX-1535 Ensaios clínicos Orçamento: US $ 42,3 milhões
• BDTX-4933 Custos de desenvolvimento clínico: US $ 35,2 milhões
• Programas de pesquisa exploratória: US $ 10,1 milhões

Proteção à propriedade intelectual

Os custos de proteção da propriedade intelectual da Black Diamond Therapeutics foram de US $ 5,2 milhões em 2023, cobrindo o arquivamento, manutenção e despesas legais de patentes.

Recrutamento e retenção de talentos científicos

As despesas de pessoal relacionadas ao talento científico em 2023 foram de US $ 63,4 milhões, incluindo salários, compensação baseada em ações e custos de recrutamento.

Categoria de pessoal	Custo anual
Cientistas de pesquisa	US $ 38,7 milhões
Equipe de Desenvolvimento Clínico	US $ 24,7 milhões

Investimentos de infraestrutura de tecnologia

Os investimentos em tecnologia e infraestrutura da Black Diamond Therapeutics em 2023 foram de US $ 12,5 milhões, cobrindo plataformas de biologia computacional, equipamentos de laboratório e ferramentas de pesquisa digital.

• Infraestrutura computacional: US $ 6,3 milhões
• Equipamento de laboratório: US $ 4,2 milhões
• Software e ferramentas digitais: US $ 2,0 milhões

Black Diamond Therapeutics, Inc. (BDTX) - Modelo de negócios: fluxos de receita

Potenciais futuras receitas de licenciamento de medicamentos

No quarto trimestre 2023, a Black Diamond Therapeutics não gerou nenhuma receita de licenciamento de medicamentos. O ativo principal da empresa BDTX-4933 permanece em estágios de desenvolvimento clínico pré-clínico e precoce.

Bolsas de pesquisa

Ano	Fonte de concessão	Valor de concessão
2022	NIH Small Business Innovation Research	$298,000
2023	Departamento de Defesa	$425,000

Capital de risco e financiamento para investidores

Financiamento total arrecadado: US $ 465,3 milhões em 31 de dezembro de 2023

• Oferta pública inicial (IPO) em 2020: US $ 227 milhões
• Financiamento da Série B em 2019: US $ 87 milhões
• Ofertas subsequentes de ações: US $ 151,3 milhões

Potencial comercialização terapêutica de produtos

Nenhuma receita comercial relatada a partir de 2024. Os ativos de pipeline estão em desenvolvimento em estágio inicial.

Acordos de parceria estratégica

Parceiro	Ano	Potenciais pagamentos marcantes
Empresa farmacêutica não divulgada	2023	Até US $ 350 milhões

Black Diamond Therapeutics, Inc. (BDTX) - Canvas Business Model: Value Propositions

You're looking at the core value Black Diamond Therapeutics, Inc. (BDTX) offers to its customer segments, which are primarily oncologists and patients with specific, hard-to-treat genetic mutations. The value is rooted in their proprietary MasterKey approach.

Targeted MasterKey therapies for families of oncogenic mutations

Black Diamond Therapeutics, Inc. is developing MasterKey therapies designed to target entire families of oncogenic mutations, not just single variants. This platform approach aims for broader applicability within a defined genetic subset of cancer patients. For instance, the data shared for silevertinib showed activity against a broad spectrum of 35 distinct non-classical EGFR mutations in the NSCLC trial.

The value proposition centers on precision targeting, which is intended to:

• Address a broad spectrum of genetically defined tumors.
• Overcome existing resistance mechanisms.
• Minimize wild-type mediated toxicities.
• Be brain penetrant to treat central nervous system disease.

Silevertinib addresses non-classical EGFRm NSCLC, a high unmet need

Silevertinib (BDTX-1535) is being advanced as a potential treatment for non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations (NCMs). This patient group represents a significant area of unmet need, as EGFR mutations are present in approximately 10-15% of NSCLC cases in Western populations. The global EGFRm-positive NSCLC market was estimated to be valued at USD 15.60 Bn in 2025.

Early clinical results for silevertinib in the frontline (1L) NSCLC setting have been encouraging:

Metric	Value (n=43 Frontline Patients)
Objective Response Rate (ORR)	60%
Central Nervous System (CNS) ORR	86%
Disease Control Rate (DCR)	91%

Furthermore, a separate Phase 2 study in NSCLC patients who have developed resistance through the C797S mutation has received FDA Fast Track designation, underscoring the high unmet need in this resistant population.

Developing brain-penetrant therapies for CNS disease (e.g., Glioblastoma)

A key differentiator is the brain-penetrant nature of the therapies, which is critical for CNS diseases like Glioblastoma (GBM). Approximately 50% of GBM patients present with an oncogenic EGFR alteration that silevertinib is designed to target. Annually, about 7,000 patients in the U.S. are diagnosed with GBM harboring these EGFR alterations.

Black Diamond Therapeutics, Inc. plans to initiate a randomized Phase 2 trial for newly diagnosed GBM patients in the first half of 2026, with the study expected to enroll approximately 150 newly diagnosed patients. Preliminary data from this GBM trial are expected in 2028.

Potential to overcome resistance mechanisms of current EGFR inhibitors

The development of next-generation EGFR inhibitors is crucial because acquired resistance remains a major challenge for current therapies. Silevertinib is positioned as a fourth-generation EGFR MasterKey inhibitor designed to overcome resistance. The strong 86% CNS ORR observed in the NSCLC trial is particularly relevant, as published data show CNS metastases are a key factor in early disease progression for NCM NSCLC patients treated with second- and third-generation EGFR-TKIs.

To give you a sense of the company's current operational footing supporting these value drivers, Black Diamond Therapeutics, Inc. ended the third quarter of 2025 with approximately $135.5 million in cash, cash equivalents, and investments, which management believes is sufficient to fund operations into the fourth quarter of 2027. For that quarter, Research & Development expenses were $7.4 million, and the net loss was $8.5 million. Finance: draft 13-week cash view by Friday.

Black Diamond Therapeutics, Inc. (BDTX) - Canvas Business Model: Customer Relationships

You're looking at how Black Diamond Therapeutics, Inc. manages the critical connections that drive its clinical pipeline and financial stability as of late 2025. These relationships are less about mass-market sales and more about deep, targeted engagement with scientific and financial stakeholders.

High-touch, collaborative relationships with clinical investigators are central, focusing on the execution of trials for silevertinib. The current data disclosure schedule reflects this collaboration, with investigators providing the raw data needed for updates.

• Silevertinib Phase 2 trial in frontline EGFRm NSCLC involves $\mathbf{n=43}$ patients.
• Objective Response Rate (ORR) and preliminary duration of treatment data from all $\mathbf{n=43}$ patients expected later in Q4 2025.
• Progression-Free Survival (PFS) data for this trial expected in the first half of 2026.
• Investigator-sponsored Phase 0/1 trial in Glioblastoma (GBM) expects initial pharmacodynamic (PD) data in the first half of 2026.

Direct engagement with regulatory bodies (e.g., FDA) shapes the development path. The company is actively planning its next steps based on these interactions.

• Intends to solicit U.S. Food and Drug Administration (FDA) feedback on a potential registrational path in frontline EGFR mutant NSCLC in the first half of 2026.
• The Phase 2 study for second/third-line NSCLC in C797S+ patients has received $\mathbf{FDA}$ Fast Track designation.

Strategic, long-term partnerships with pharmaceutical companies provide both development acceleration and significant financial backing. The agreement with Servier for BDTX-4933 is a prime example of this external relationship structure.

Here's the quick math on the Servier licensing agreement for BDTX-4933, announced March 19, 2025:

Financial Component	Amount
Upfront Payment Received	$\mathbf{\$70 \text{ million}}$
Potential Total Milestone Payments	Up to $\mathbf{\$710 \text{ million}}$
Additional Consideration	Tiered royalties based on global net sales

This partnership allowed Black Diamond Therapeutics, Inc. to outlicense BDTX-4933, which contributed to workforce efficiencies and allowed an increased focus on silevertinib development. The $\mathbf{\$70 \text{ million}}$ upfront payment was a key factor in the Q1 2025 net income of $\mathbf{\$56.5 \text{ million}}$.

Investor relations and public disclosure of clinical data maintain market confidence, especially given the clinical-stage nature of the business. The company's cash position is a direct reflection of stakeholder trust and prior financing activities.

Financial Metric / Disclosure Event	Value / Timing
Cash, Cash Equivalents, and Investments (as of Sept 30, 2025)	$\mathbf{\$135.5 \text{ million}}$
Cash Runway Guidance	Into $\mathbf{Q4 \text{ of } 2027}$
Net Loss (Q3 2025)	$\mathbf{\$8.5 \text{ million}}$
Net Cash Used in Operations (Q3 2025)	$\mathbf{\$7.9 \text{ million}}$
R&D Expenses (Q3 2025)	$\mathbf{\$7.4 \text{ million}}$
G&A Expenses (Q3 2025)	$\mathbf{\$3.5 \text{ million}}$
Cash, Cash Equivalents, and Investments (as of March 31, 2025)	$\mathbf{\$152.4 \text{ million}}$

The company uses investor events, like the webcast on December 3, 2025, to present these results and updates.

Finance: draft 13-week cash view by Friday.

Black Diamond Therapeutics, Inc. (BDTX) - Canvas Business Model: Channels

You're looking at how Black Diamond Therapeutics, Inc. gets its value propositions-the MasterKey therapies-out to the market and stakeholders as of late 2025. It's a mix of clinical execution, regulatory navigation, and strategic financial partnerships.

Clinical trial sites and principal investigators for patient access

Patient access is channeled directly through active clinical trial sites. The enrollment for the Phase 2 trial of silevertinib (BDTX-1535) in frontline (1L) non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations completed enrollment at n=43 patients. Furthermore, an investigator-sponsored Phase 0/1 trial, sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona, was expanded in the first quarter of 2025 to include newly diagnosed glioblastoma (GBM) patients with EGFR alterations.

• Phase 2 NSCLC Trial Enrollment: 43 patients.
• GBM Investigator-Sponsored Trial Expansion: Initiated in Q1 2025.
• PFS data for NSCLC trial expected: First half of 2026.

Regulatory submissions (INDs, NDAs) to the U.S. Food and Drug Administration

The path to market for Black Diamond Therapeutics, Inc.'s assets is heavily reliant on securing the right regulatory pathway from the U.S. Food and Drug Administration (FDA). For silevertinib (BDTX-1535) in 1L EGFRm NSCLC, the company plans to solicit FDA feedback on a potential pivotal registrational path in the fourth quarter of 2025. This is a key channel for moving the drug toward commercialization, with pivotal development potentially starting in the first half of 2026, pending that feedback. Separately, the Phase 2 study in C797S+ patients has received FDA Fast Track designation.

• Planned FDA Feedback on Pivotal Path (BDTX-1535, 1L NSCLC): Q4 2025.
• Target start for Pivotal Development (pending feedback): First half of 2026.
• FDA Fast Track Designation: Granted for the C797S+ NSCLC program.

Out-licensing agreements with major pharmaceutical partners

The Servier Pharmaceuticals LLC agreement for BDTX-4933 serves as a primary channel for external development and worldwide commercialization of that asset. This deal, announced in March 2025, provided immediate financial resources to Black Diamond Therapeutics, Inc. while transferring the lead development burden to Servier.

Deal Component	BDTX-4933 with Servier (Announced March 2025)
Upfront Payment Received	$70.0 million
Potential Development/Commercial Milestones	Up to $710.0 million
Additional Consideration	Tiered royalties on global net sales
Development Lead	Servier

Scientific publications and medical conferences

Scientific dissemination is a critical channel for validating the science and attracting potential partners for pivotal development, especially for silevertinib. Black Diamond Therapeutics, Inc. hosted a webcast on December 3, 2025, to present topline data from its Phase 2 trial. The data discussed involved 43 patients presenting with 35 distinct non-classical EGFR mutations.

• Topline Data Presentation Date: December 3, 2025.
• Observed Objective Response Rate (ORR) in 1L NSCLC: 60%.
• Observed CNS Response Rate in 1L NSCLC: 86%.
• Investor Conferences Scheduled (Nov/Dec 2025): Stifel, Guggenheim, Piper Sandler, Raymond James.

Black Diamond Therapeutics, Inc. (BDTX) - Canvas Business Model: Customer Segments

You're looking at the core groups Black Diamond Therapeutics, Inc. (BDTX) needs to engage to make silevertinib a commercial success, especially given their strong cash position heading into 2026.

Patients with non-classical EGFR-mutant Non-Small Cell Lung Cancer (NSCLC)

This is the primary focus for silevertinib right now. These patients have tumors driven by Epidermal Growth Factor Receptor (EGFR) mutations, which occur in about 10-15% of NSCLC cases in Western populations, but this jumps to as high as 50% in Asian cohorts. Black Diamond Therapeutics completed enrollment for the Phase 2 trial in newly diagnosed patients harboring non-classical EGFR mutations (cohort 3) with n=43 patients in July 2025. The market size for EGFR Non-Small Cell Lung Cancer is estimated at USD 15.60 Bn in 2025. The company is targeting resistance mechanisms, like the acquired C797S mutation, which is a major unmet need after third-generation therapy. Initial clinical data reported a 60% objective response rate (ORR) for this patient group.

Patients with EGFR-altered Glioblastoma (GBM)

This represents a significant, high-unmet-need opportunity, leveraging silevertinib's brain penetrance. Approximately 50% of Glioblastoma (GBM) patients present with an oncogenic EGFR alteration. Annually, about 7,000 patients in the U.S. are diagnosed with GBM harboring these alterations. Black Diamond Therapeutics plans to initiate a randomized Phase 2 trial in newly diagnosed GBM patients, expected to enroll approximately 150 individuals. The CNS objective response rate (CNS ORR) seen in early GBM data was 86%.

Oncologists and specialized cancer treatment centers

These centers are the gatekeepers for trial enrollment and future prescription volume. As of the end of the third quarter of 2025, Black Diamond Therapeutics ended with approximately $135.5 million in cash, cash equivalents, and investments, which management believes is sufficient to fund operations into the fourth quarter of 2027. The company reported a net loss of $8.5 million for Q3 2025, with Research and Development Expenses at $7.4 million for that quarter, showing a focused spend to support ongoing clinical sites. The company expects to solicit U.S. Food and Drug Administration (FDA) feedback on a potential pivotal registrational path pending the Q4 2025 data readout.

Large pharmaceutical companies seeking novel oncology assets

Partnerships are a key part of the capital strategy for a clinical-stage company. Black Diamond Therapeutics entered into a global licensing agreement with Servier for its second clinical-stage asset, BDTX-4933. This deal provided an upfront payment of $70.0 million. The company's current cash position of $135.5 million as of September 30, 2025, is projected to fund operations into the second half of 2028, partially due to this partnership funding. The company's market capitalization was approximately $196.56 million as of early December 2025.

Customer Segment Metric	NSCLC Population Estimate (Western)	GBM U.S. Annual Diagnoses (EGFR Altered)	Cash Runway (Projected)	Q3 2025 R&D Spend
Statistic/Amount	10-15% of NSCLC cases	Approx. 7,000 patients	Into Q4 2027	$7.4 million

You should track the progression of the Phase 2 trial, as the initial data is guided for Q4 2025, and the follow-on Progression-Free Survival (PFS) data is expected in the first half of 2026.

• Silevertinib Phase 2 enrollment completed: n=43 patients.
• NSCLC Market Size (2025 Est.): USD 15.60 Bn.
• Servier Upfront Payment: $70.0 million.
• Q3 2025 Cash Position: $135.5 million.
• Planned GBM Phase 2 Enrollment: Approx. 150 patients.

Finance: review the Q4 2025 cash burn against the Q3 2025 net cash used in operations of $7.9 million by next Tuesday.

Black Diamond Therapeutics, Inc. (BDTX) - Canvas Business Model: Cost Structure

You're hiring before product-market fit, so controlling the burn rate is everything. Black Diamond Therapeutics, Inc.'s cost structure in late 2025 is heavily weighted toward R&D, reflecting its clinical-stage focus, though G&A has been optimized.

The operating expenses for the third quarter ended September 30, 2025, show a deliberate streamlining of costs compared to prior periods. The company reported a net loss of $8.498 million for Q3 2025, with net cash used in operations at $7.9 million for the quarter.

Cost Component	Q3 2025 Amount (USD)	Comparison Context
Research and Development (R&D) Expenses	$7.437 million	Decreased from $12.914 million in Q3 2024
General and Administrative (G&A) Expenses	$3.541 million	Decreased from $5.216 million in Q3 2024
Total Operating Expenses (R&D + G&A)	$10.978 million	Decreased from $18.130 million in Q3 2024

The primary driver of R&D spend is the silevertinib program. The Phase 2 clinical trial for frontline non-small cell lung cancer (NSCLC) patients involved 43 patients.

The reduction in both R&D and G&A expenses reflects specific actions taken to manage cash flow, which ended Q3 2025 with $135.5 million in cash, cash equivalents, and investments, providing a runway into Q4 2027.

Personnel costs are embedded within the R&D and G&A figures, but the structure was optimized following a restructuring announced in October 2024, which included a reduction in force while retaining core drug development and management expertise.

• R&D decrease attributed to workforce efficiencies and outlicensing of BDTX-4933.
• G&A decrease attributed to the restructuring announced in October 2024.
• Phase 2 silevertinib trial cohort size: n=43 patients.

Finance: draft 13-week cash view by Friday.

Black Diamond Therapeutics, Inc. (BDTX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Black Diamond Therapeutics, Inc. (BDTX) as of late 2025. Honestly, for a clinical-stage company, the revenue picture is almost entirely about non-recurring, strategic partnership cash flow right now, not selling drugs. That's the reality of the sector; you fund the pipeline with smart deals.

The core of the current revenue stream is the strategic out-licensing of assets. The Servier global licensing agreement for BDTX-4933 is the prime example here, providing immediate, non-dilutive capital.

• Upfront license payments from strategic out-licensing deals
• Potential future development and commercial milestone payments
• Equity financing and public offerings to fund operations (currently less emphasized due to deal cash)
• No product sales revenue currently, as a clinical-stage company

Let's break down the hard numbers from that key Servier deal, which really defined the financial strength for the near term.

Revenue Component	Deal/Source	Confirmed Amount	Timing/Context
Upfront License Payment	Servier (BDTX-4933)	$70 million	Received in March 2025 (Q1 2025). This drove Q1 2025 net income to $56.5 million.
Potential Milestone Payments	Servier (BDTX-4933)	Up to $710 million total	Contingent on future development and commercial success milestones.
Cash Position Post-Deal	Total Cash & Investments	$152.4 million	As of March 31, 2025, bolstered by the upfront payment.

That $70 million upfront payment was material. It immediately shifted the P&L, moving Black Diamond Therapeutics to a net income of $56.5 million in Q1 2025, a stark contrast to the $18.2 million net loss in Q1 2024.

The potential future payments are significant for long-term upside, but they aren't reliable revenue for near-term operating expenses. You're looking at up to $710 million in milestones on top of the upfront cash and tiered royalties from the Servier agreement.

Regarding funding operations, you see the impact of the deal on the balance sheet, which is key. The cash position at the end of Q3 2025 was $135.5 million, which management believes funds operations into Q4 of 2027. This strong cash runway, largely thanks to the Servier deal, reduces the immediate need for equity financing or public offerings, which would dilute existing shareholders.

To be defintely clear, Black Diamond Therapeutics is still in the clinical phase. There is no product sales revenue being booked as of late 2025. The entire reported revenue stream is derived from these licensing activities, which is typical for a company prioritizing its lead asset, BDTX-1535, while monetizing a secondary asset like BDTX-4933.

Here's how the operating cash flow looked following the deal, showing the shift from burn to generation:

• Net cash provided by operations in Q1 2025: $53.4 million.
• Net cash used in operations in Q3 2025: $7.9 million.
• R&D expenses in Q3 2025: $7.4 million.
• G&A expenses in Q3 2025: $3.5 million.

Finance: draft 13-week cash view by Friday.