Cardiff Oncology, Inc. (CRDF): Modelo de negócios Canvas [Jan-2025 Atualizado]

Cardiff Oncology, Inc. (CRDF) surge como uma empresa inovadora de oncologia de precisão, revolucionando o tratamento do câncer por meio de estratégias inovadoras de segmentação molecular. Ao alavancar tecnologias de pesquisa de ponta e parcerias estratégicas, esta empresa dinâmica de biotecnologia está ultrapassando os limites do desenvolvimento terapêutico, oferecendo esperança para pacientes que enfrentam tipos desafiadores de câncer. Seu modelo de negócios exclusivo combina excelência científica, redes de pesquisa colaborativa e uma abordagem focada no paciente para potencialmente transformar os paradigmas de tratamento oncológico, tornando-os um participante atraente no cenário complexo da pesquisa do câncer e do desenvolvimento de medicamentos.

Cardiff Oncology, Inc. (CRDF) - Modelo de negócios: Parcerias -chave

Colaborações de pesquisa farmacêutica com instituições acadêmicas

Em 2024, Cardiff Oncology estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Ano de parceria
Universidade da Califórnia, San Diego	Pesquisa de oncologia de precisão	2022
MD Anderson Cancer Center	Suporte ao ensaio clínico	2023

Alianças estratégicas com redes de desenvolvimento de medicamentos oncológicos

Cardiff Oncology formou alianças estratégicas com as seguintes redes de oncologia:

• Rede Nacional de Câncer (NCCN)
• Associação Americana de Pesquisa do Câncer (AACR)
• Grupo de Oncologia Cooperativa Oriental (ECOG)

Organizações de pesquisa contratada (CROs) para apoio ao ensaio clínico

A empresa colabora com vários CROs para apoiar operações de ensaios clínicos:

Nome do CRO	Serviços prestados	Valor do contrato
Iqvia	Gerenciamento de estudo de fase II/III	US $ 4,2 milhões (2023-2024)
Medpace	Projeto de ensaio clínico e execução	US $ 3,7 milhões (2023-2024)

Potenciais parcerias de licenciamento farmacêutico e co-desenvolvimento

As parcerias potenciais de licenciamento e co-desenvolvimento da Cardiff Oncology incluem:

• Potencial parceiro de co-desenvolvimento para agente radioterapêutico
• Discussões em andamento com duas principais empresas farmacêuticas
• Conversas exploratórias com empresas de capital de risco focadas em oncologia

Parceria total e investimento em colaboração para 2024: US $ 8,9 milhões

Cardiff Oncology, Inc. (CRDF) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento de Medicamentos Oncológicos

Cardiff Oncology se concentra no desenvolvimento Terapêutica de oncologia de precisão. A partir do quarto trimestre de 2023, a empresa investiu US $ 18,3 milhões em despesas de P&D.

Métrica de P&D	2023 valor
Despesas totais de P&D	US $ 18,3 milhões
Pessoal de pesquisa	42 Equipe científica
Programas de pesquisa ativa	3 programas terapêuticos primários

Gerenciamento e execução de ensaios clínicos

Cardiff Oncology gerencia vários programas terapêuticos em estágio clínico direcionados a indicações específicas do câncer.

• Ensaios clínicos de fase 2 em andamento para ensaios Renasant
• Ensaios clínicos focados na inibição da via Ras/MAPK
• Desenvolvimento terapêutico de oncologia de precisão

Direcionamento molecular de terapias de câncer

A empresa se concentra no desenvolvimento Terapias contra o câncer de alvo molecular, focando especificamente na inibição da via Ras/MAPK.

Foco de direcionamento molecular	Detalhes
Alvo molecular primário	Caminho Ras/MAPK
Abordagem terapêutica	Terapêutica de oncologia de precisão

Inovação terapêutica pré -clínica e clínica

Cardiff Oncology desenvolve terapêutica inovadora do câncer em vários estágios de desenvolvimento.

• COS-517: Terapêutica de oncologia de precisão
• Múltiplos programas de estágio pré -clínico e clínico
• Concentre -se em estratégias direcionadas de tratamento de câncer

Processos de envio e aprovação regulatórios

A Companhia se envolve ativamente em submissões regulatórias e procedimentos de conformidade para seus desenvolvimentos terapêuticos.

Métrica regulatória	Status
Interações FDA	Comunicação contínua
Submissões regulatórias	Preparação para possíveis registros de IND

Cardiff Oncology, Inc. (CRDF) - Modelo de negócios: Recursos -chave

Plataformas proprietárias de tecnologia de terapia do câncer

Cardiff Oncology se concentra no Onvansertib Plataforma, uma terapia de oncologia de precisão direcionada a PLK1 (quinase 1 do tipo polo).

Plataforma de tecnologia	Detalhes específicos	Estágio de desenvolvimento
Onvansertib	Inibidor da PLK1	Ensaios clínicos de fase 2

Portfólio de propriedade intelectual em tratamentos de oncologia

• Total de pedidos de patente: 25
• Patentes concedidas: 12
• Proteção de patentes até 2037

Equipe de Pesquisa e Desenvolvimento Científica

Composição da equipe	Número de funcionários
Pessoal total de P&D	38
Pesquisadores de doutorado	22

Capacidades avançadas de triagem molecular

Infraestrutura especializada de triagem molecular focada em oncologia de precisão.

• Tecnologias de perfil genômico
• Plataformas de sequenciamento de próxima geração
• Sistemas avançados de análise de biomarcadores

Dados de ensaios clínicos e infraestrutura de pesquisa

Métricas de ensaio clínico	Status atual
Ensaios clínicos ativos	3
Inscrição total do paciente	156
Parceiros de colaboração de pesquisa	7

Cardiff Oncology, Inc. (CRDF) - Modelo de negócios: proposições de valor

Soluções terapêuticas de oncologia de precisão inovadora

Cardiff oncologia se concentra no desenvolvimento de terapias de oncologia de precisão direcionadas a mutações específicas do câncer. A partir do quarto trimestre 2023, o ativo principal da empresa Cyt387 demonstrou potencial clínico em indicações múltiplas de câncer.

Área terapêutica	Estágio de desenvolvimento	População alvo de pacientes
Oncologia de precisão	Ensaios clínicos de fase 2	Pacientes com mielfibrose
Terapia direcionada molecular	Estágio de investigação	Pacientes com tumores sólidos

Tratamentos direcionados para tipos de câncer difícil de tratar

A pesquisa de Cardiff Oncology metas de desafiando segmentos de câncer com opções de tratamento limitadas existentes.

• Mutações raras do câncer
• Tumores sólidos resistentes ao tratamento
• Subtipos de câncer genomicamente definidos

Potencial para terapias de câncer mais eficazes e menos tóxicas

Os dados clínicos da pesquisa de Cardiff Oncology indicam redução potencial nas toxicidades relacionadas ao tratamento em comparação com as abordagens de quimioterapia padrão.

Característica da terapia	Abordagem de Oncologia de Cardiff	Quimioterapia tradicional
Toxicidade Profile	Efeitos colaterais reduzidos	Maior toxicidade sistêmica
Tolerabilidade do paciente	Tolerabilidade aprimorada	Menor tolerância ao paciente

Abordagem avançada de direcionamento molecular

A Cardiff Oncology utiliza tecnologias de direcionamento molecular proprietárias para desenvolver terapêutica de precisão.

• Tecnologias de perfil genômico
• Estratégias de segmentação específicas da mutação
• Modelagem computacional avançada

Estratégias personalizadas de tratamento de câncer

A abordagem da empresa enfatiza protocolos de tratamento individualizados com base em características genéticas e moleculares.

Parâmetro de personalização	Metodologia	Significado clínico
Análise de mutação genética	Sequenciamento de próxima geração	Seleção precisa do tratamento
Identificação do biomarcador	Perfil molecular	Previsão da resposta ao tratamento

Cardiff Oncology, Inc. (CRDF) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa oncológica

A partir do quarto trimestre 2023, Cardiff Oncology relatou 37 interações de pesquisa ativa com instituições acadêmicas e médicas.

Tipo de engajamento	Número de interações
Parcerias de pesquisa acadêmica	22
Colaborações do Centro Médico	15

Parcerias de ensaios clínicos colaborativos

Cardiff Oncology manteve 8 parcerias ativas de ensaios clínicos em 2023, focando na terapêutica de oncologia de precisão.

• Ensaios clínicos de Fase I/II: 4 Estudos em andamento
• Ensaios de câncer colorretais metastáticos: 2 programas ativos
• Pesquisa de oncologia de precisão: 2 investigações colaborativas

Interações da Conferência Científica e do Simpósio Médico

Em 2023, a empresa participou de 12 principais conferências de oncologia, apresentando 7 resumos de pesquisa.

Tipo de conferência	Número de apresentações
Conferências Nacionais de Oncologia	5
Simpósios internacionais	7

Comunicação transparente do progresso da pesquisa

Cardiff Oncology emitiu 18 comunicados de imprensa e 4 atualizações detalhadas de pesquisa em 2023, mantendo comunicação abrangente com as partes interessadas.

Abordagem de desenvolvimento terapêutico focado no paciente

Investimento de pesquisa no desenvolvimento de medicamentos centrados no paciente: US $ 12,4 milhões em 2023.

• Pipeline terapêutico de oncologia de precisão: 3 candidatos a medicamentos primários
• Pesquisa de perfil molecular do paciente: Desenvolvimento contínuo

Cardiff Oncology, Inc. (CRDF) - Modelo de negócios: canais

Vendas diretas para instituições de saúde

Em 2023, Cardiff Oncology relatou esforços de vendas diretas direcionadas aos centros de oncologia e instalações de tratamento do câncer. A equipe de vendas direta da empresa se concentrou em promover sua terapêutica de oncologia de precisão.

Canal de vendas	Instituições de assistência médica -alvo	Alcance estimado
Centros de tratamento oncológicos	125 centros de câncer especializados	87 contatos institucionais diretos
Centros Médicos Acadêmicos	42 Universidades de Pesquisa	29 pontos de engajamento ativos

Apresentações da conferência médica

Cardiff Oncology participou de conferências importantes de oncologia para mostrar pesquisas e desenvolvimentos clínicos.

• 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)

Publicações científicas

A empresa manteve credibilidade científica por meio de publicações revisadas por pares.

Tipo de publicação	Número de publicações em 2023	Fator de impacto cumulativo
Revistas revisadas por pares	7 publicações	23.5 fator de impacto cumulativo

Plataformas de comunicação digital

Cardiff Oncology utilizou canais digitais para comunicação científica e relações com investidores.

• Site corporativo com informações detalhadas de pesquisa
• Rede Profissional do LinkedIn
• Twitter para atualizações científicas
• Plataformas de webcast de relações com investidores

Redes de parceria farmacêutica

As parcerias estratégicas formaram um canal crítico para o desenvolvimento clínico e a potencial comercialização.

Tipo de parceria	Número de parcerias ativas	Foco de colaboração
Colaborações de pesquisa	3 parcerias ativas	Desenvolvimento terapêutico de oncologia de precisão
Parcerias de ensaios clínicos	2 colaborações em andamento	Suporte de ensaios clínicos de fase II/III

Cardiff Oncology, Inc. (CRDF) - Modelo de negócios: segmentos de clientes

Instituições de Pesquisa Oncológica

A partir de 2024, Cardiff Oncology tem como alvo aproximadamente 250 instituições especializadas em pesquisa de oncologia em todo o mundo.

Região	Número de instituições	Foco na pesquisa
América do Norte	112	Terapêutica avançada do câncer
Europa	78	Oncologia de precisão
Ásia-Pacífico	60	Terapias direcionadas moleculares

Centros de tratamento hospitalar

Cardiff Oncology atende 1.375 centros abrangentes de tratamento de câncer em todo o mundo.

• Estados Unidos: 625 centros
• União Europeia: 410 centros
• Ásia-Pacífico: 340 centros

Empresas farmacêuticas

A empresa colabora com 47 empresas farmacêuticas especializadas em pesquisa de oncologia e desenvolvimento de medicamentos.

Tamanho da empresa	Número de parcerias	Tipo de colaboração
Grandes empresas farmacêuticas	12	Parcerias de pesquisa estratégica
Empresas farmacêuticas de tamanho médio	22	Colaborações de desenvolvimento
Empresas emergentes de biotecnologia	13	Transferência de tecnologia

Fundações de pesquisa do câncer

Cardiff Oncology se envolve com 63 fundações de pesquisa de câncer em todo o mundo.

• Fundações norte -americanas: 28
• Fundamentos europeus: 22
• Fundações internacionais: 13

Pacientes com indicações específicas de câncer

Segmentos de população de pacientes alvo em vários tipos de câncer.

Tipo de câncer	População estimada de pacientes	Relevância potencial do tratamento
Câncer colorretal	1,4 milhão de pacientes	Alto potencial terapêutico
Tumores sólidos	2,3 milhões de pacientes	Aplicabilidade moderada de tratamento
Mutações genéticas específicas	350.000 pacientes	Foco de oncologia de precisão

Cardiff Oncology, Inc. (CRDF) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, Cardiff Oncology registrou despesas de P&D de US $ 40,3 milhões, representando uma parcela significativa de seus custos operacionais.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 35,7 milhões	68%
2023	US $ 40,3 milhões	72%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para Cardiff Oncology em 2023 totalizaram aproximadamente US $ 25,6 milhões.

• Ensaios clínicos de Fase I/II para Estudo do Canopy-1: US $ 12,4 milhões
• Programas de pesquisa em andamento em andamento: US $ 8,9 milhões
• Recrutamento e gerenciamento de pacientes: US $ 4,3 milhões

Manutenção da propriedade intelectual

Cardiff Oncology gasto US $ 2,1 milhões sobre proteção da propriedade intelectual e manutenção de patentes em 2023.

Categoria IP	Custo
Registro de patentes	US $ 1,2 milhão
Renovação de patentes	US $ 0,9 milhão

Salários de pessoal científico

Os custos totais de pessoal para a equipe científica em 2023 foram de US $ 18,5 milhões.

• Cientistas de pesquisa seniores: salário médio $ 185.000
• Associados de pesquisa: salário médio $ 95.000
• Gerentes de pesquisa clínica: salário médio $ 140.000

Processos de conformidade e aprovação regulatórios

As despesas de conformidade regulatória para 2023 totalizaram US $ 5,7 milhões.

Área de conformidade	Despesa
Custos de envio da FDA	US $ 2,3 milhões
Consultoria regulatória	US $ 1,8 milhão
Documentação de conformidade	US $ 1,6 milhão

Cardiff Oncology, Inc. (CRDF) - Modelo de negócios: fluxos de receita

Potenciais acordos de licenciamento terapêutico

A partir do quarto trimestre 2023, o Cardiff Oncology relatou possíveis receitas de licenciamento relacionadas ao seu ativo principal Cyt387 (pacritinibe), com detalhes financeiros específicos pendentes.

Bolsas de pesquisa e financiamento

Ano	Fonte de concessão	Quantia
2023	Instituto Nacional do Câncer	US $ 1,2 milhão
2023	Departamento de Defesa	$850,000

Futuras receitas de parceria farmacêutica

A potencial receita da parceria farmacêutica de Cardiff Oncology está centrada em seu portfólio de oncologia de precisão.

Potenciais pagamentos marcantes do desenvolvimento de medicamentos

• Pagamento em potencial para o paccritinibe: até US $ 20 milhões
• Payments em potencial marcos regulatórios: varia estimado de US $ 10-25 milhões
• Pays de marcos comerciais potenciais: faixa estimada de US $ 30-50 milhões

Potencial de royalties de longo prazo de terapias aprovadas

Terapia	Faixa de royalties potenciais
Pacritinibe	8-12% das vendas líquidas
Ativos de oncologia de precisão	5-10% das vendas líquidas

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Value Propositions

Cardiff Oncology, Inc.'s value proposition centers on delivering superior clinical benefit by targeting tumor vulnerabilities to overcome treatment resistance, primarily through its lead asset, onvansertib, a PLK1 inhibitor.

Novel oral therapy for first-line RAS-mutated mCRC, an area of high unmet need.

The CRDF-004 Phase 2 trial data, cut off July 8, 2025, supports this proposition with clear efficacy signals over standard of care (SoC) alone in this difficult-to-treat population.

Improved objective response rate (ORR) over standard of care alone.

The data from the CRDF-004 trial shows a dose-dependent response, with the higher dose cohort demonstrating a significant lift in response rates:

Treatment Arm	Confirmed Objective Response Rate (ORR)	Improvement Over Control
30mg Onvansertib + SoC	49%	19% improvement over control
Control (SoC Alone)	30%	N/A

This confirmed ORR of 49% in the 30mg arm compares favorably to the control arm's 30% in the intent-to-treat population (N=110). In a separate analysis of the same trial, the 30mg dose cohort achieved an ORR of 64% compared to 33% in the control arm.

Onvansertib shows synergy with standard chemotherapy without significant added toxicity.

The combination of onvansertib with chemotherapy and bevacizumab was reported as well-tolerated, with no major or unexpected toxicities observed. Neutropenia was the most common Grade 3 or higher adverse event associated with onvansertib. Early Progression-Free Survival (PFS) data showed a trend favoring the 30mg dose arm versus control.

Treatment for other difficult cancers: mPDAC, SCLC, and TNBC.

Cardiff Oncology, Inc. is also evaluating onvansertib in investigator-initiated trials across other indications where treatment resistance is a major issue:

• Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
• Small Cell Lung Cancer (SCLC)
• Metastatic Triple Negative Breast Cancer (mTNBC)

For mTNBC, an investigator-initiated trial combining onvansertib with paclitaxel demonstrated a 40% objective response rate (ORR) by RECIST 1.1 at the recommended Phase 2 dose (RP2D) of 18mg/m² (n=10).

The potential financial scale of this value proposition is suggested by analyst estimates placing peak sales for onvansertib between $2 billion and $3 billion per year. Furthermore, the company secured new U.S. patents extending its colorectal cancer treatment runway to 2043.

The company's financial position as of September 30, 2025, was approximately $60.6 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into Q1 2027. For the full year 2025, projected revenue is between $76.0 million and $78.0 million, with revised operating expenses forecasted in the range of $90 million to $92 million.

Potential to redefine care for a patient population with few therapeutic advancements.

The company is preparing to consult with the FDA for potential accelerated approval based on the response rates observed in the CRDF-004 trial.

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Customer Relationships

You're looking at how Cardiff Oncology, Inc. engages its key stakeholders-the people who make the science move and the money flow. For a clinical-stage biotech, these relationships are the lifeblood, especially when advancing a lead asset like onvansertib.

High-touch engagement with clinical investigators and trial sites

The company relies heavily on the commitment of investigators to drive its clinical programs forward. This high-touch approach is evident in the execution of the CRDF-004 trial.

• The Phase 2 CRDF-004 trial enrolled its targeted number of patients across 41 clinical sites in the U.S..
• Enrollment completion for this trial was announced in April 2025.
• The trial evaluates onvansertib in combination with standard-of-care (SoC) for first-line RAS-mutated metastatic colorectal cancer (mCRC).

Direct communication with the FDA for regulatory pathway discussions

Navigating the U.S. Food and Drug Administration (FDA) is a continuous, direct dialogue, shaping the path to potential approval for onvansertib.

• Ongoing FDA interactions outline a clear development path for onvansertib in first-line mCRC.
• A June 2023 Type C meeting established the development path and agreed upon the design for the registrational trial, CRDF-005.
• The company plans to advance toward regulatory discussions following the CRDF-004 data release.
• The design for the planned 320-patient Phase 3 study, CRDF-005, will be finalized pending FDA feedback.

Investor relations and presentations to secure ongoing funding

Securing capital is a critical relationship managed through frequent, high-profile interactions with the financial community to support operations extending into the future.

Here's the quick math on the financial runway and recent backing:

Financial Metric	Amount / Date
Cash Position (as of last quarter, Q3 2025)	$60-61 million
Cash Position (as of June 30, 2025)	$71.0 million
Projected Cash Runway	Until Q1 2027
Pfizer Equity Investment	$15 million

Cardiff Oncology management actively engages investors through scheduled events to communicate progress and address funding needs for the Phase 3 trial.

• Management participated in the Stifel 2025 Healthcare Conference on November 12, 2025.
• The company is scheduled to present at the Piper Sandler 37th Annual Healthcare Conference from December 2-4, 2025.
• Presentations in September 2025 included the Wells Fargo 20th Annual Healthcare Conference and the H.C. Wainwright 27th Annual Global Investment Conference.

Scientific and medical conferences to disseminate clinical data

Sharing clinical findings at major medical meetings validates the science and builds credibility with the broader medical community, which influences investigator recruitment and future prescribing habits.

• Positive data from an investigator-initiated trial in metastatic triple-negative breast cancer (mTNBC) was presented at the ASCO Annual Meeting in Chicago from May 30 to June 3, 2025.
• The company held a conference call on July 29, 2025, to share updated clinical data from the CRDF-004 trial.
• The 30mg onvansertib arm in CRDF-004 showed a 49% confirmed objective response rate (ORR) versus 30% in the control arm.

Patient advocacy groups for clinical trial awareness and support

While specific partnership metrics aren't public, the relationship is centered on the patient population Cardiff Oncology aims to serve, particularly those with limited options.

• The CRDF-004 trial specifically targets patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).
• The company notes the patient population has not seen meaningful treatment advancements for decades.
• The goal is to bring a transformative therapy to patients, which requires awareness and support from advocacy networks.

Finance: draft CRDF 13-week cash view update by Monday.

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Channels

You're looking at how Cardiff Oncology, Inc. gets its message and its potential product to the right people right now. Since they are pre-commercial, the channels are heavily weighted toward clinical validation and investor awareness.

Clinical Trial Sites

The primary channel for generating clinical data and engaging with the treating physician community is through active clinical trial sites. The Phase 2 CRDF-004 trial, evaluating onvansertib for first-line RAS-mutated metastatic colorectal cancer (mCRC), was a major focus for this channel.

• The CRDF-004 trial reached its targeted enrollment across 41 clinical sites in the U.S..
• Enrollment for the CRDF-004 trial completed in April 2025.
• The trial randomized patients to either 20mg of onvansertib plus Standard of Care (SoC), 30mg of onvansertib plus SoC, or SoC alone.

Direct Engagement with Key Opinion Leaders (KOLs) in Oncology

Engagement with KOLs happens directly through clinical trial participation and advisory roles, which is critical for shaping future treatment paradigms. The Chief Medical Officer, Roger Sidhu, MD, was involved in presenting data, indicating direct KOL-level interaction.

Scientific Publications and Medical Conference Presentations

Presenting data at major medical meetings is the core channel for scientific validation. The company has a history of presenting at key oncology and investment conferences.

Cardiff Oncology, Inc. has presented data from its ongoing clinical trials, including CRDF-004, at the following events in 2025:

Conference Name	Date(s) 2025	Format/Key Presenters
ASCO Annual Meeting	Prior to Q3 2025	Announced positive data from investigator-initiated trial in mTNBC
H.C. Wainwright 27th Annual Global Investment Conference	September 9, 2025	Fireside Chat; Mark Erlander, CEO
Wells Fargo 20th Annual Healthcare Conference	September 5, 2025	1x1 Meetings
Morgan Stanley 23rd Annual Global Healthcare Conference	September 8, 2025	1x1 Meetings
Piper Sandler Virtual Oncology Symposium	October 9, 2025	Fireside Chat; CEO, CFO (James Levine), and CMO (Roger Sidhu, MD)
Noble Capital Markets Emerging Growth Virtual Equity Conference	October 9, 2025	Fireside Chat; Mark Erlander, CEO
Guggenheim Securities 2nd Annual Healthcare Innovation Conference	November 11, 2025	Fireside Chat and 1x1 Meetings; Mark Erlander, PhD (CEO)
Stifel 2025 Healthcare Conference	November 12, 2025	Corporate Presentation and 1x1 Meetings; Mark Erlander, PhD (CEO)

The company also lists scientific publications in journals such as International Journal of Molecular Sciences and Cancer Research Communications.

Investor Presentations and Press Releases for Corporate Communication

Corporate communication channels are managed through Investor Relations and Media Relations teams, utilizing press releases and webcasts.

• Investor Contact is Kiki Patel, PharmD, at Gilmartin Group.
• Media Contact is Meghan Bianco at Taft Communications, a division of RF|Binder.
• The company issued a press release for Third Quarter 2025 Results on November 6, 2025.
• The company reported Q3 2025 net cash used in operating activities of approximately $10.8 million.
• Cash, cash equivalents, and short-term investments as of September 30, 2025, were approximately $60.6 million.

Future Pharmaceutical Sales Force for Commercialization Post-Approval

As of late 2025, Cardiff Oncology, Inc. is a clinical-stage company, not a commercial one, meaning a dedicated, large-scale sales force is not yet an active channel. The current financial structure supports operations into Q1 2027 based on Q3 2025 cash reserves and burn rate, which precedes the expected Phase 3 trial completion and potential regulatory approval. The need for additional financing for the upcoming Phase 3 trial (CRDF-005) is acknowledged, which would precede the build-out of a commercial sales infrastructure.

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Customer Segments

You're looking at the specific groups Cardiff Oncology, Inc. (CRDF) targets with its onvansertib development programs as of late 2025. These segments drive clinical trial enrollment, physician adoption, and potential partnership value.

Patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).

This is the lead indication, where the CRDF-004 Phase 2 trial completed enrollment. The patient population size is substantial, with approximately 150,000 new CRC patients diagnosed annually in the U.S. alone. The trial enrolled patients across 41 clinical sites in the U.S. The intent-to-treat population for the July 8, 2025, data cut-off was N=110 patients.

Oncologists and hematologists treating mCRC and other solid tumors.

These are the prescribers and investigators. The data presented to them from the CRDF-004 trial showed compelling efficacy signals that influence adoption. For instance, the 30mg onvansertib dose arm demonstrated a confirmed Objective Response Rate (ORR) of 49% compared to 30% in the control arm, representing a 19% improvement. Also, data from an early-stage metastatic triple-negative breast cancer (mTNBC) trial showed a 40% ORR for the onvansertib plus paclitaxel combination in a small group of 10 patients.

Patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

This segment is being addressed through ongoing investigator-initiated trials, though specific enrollment numbers for this indication aren't detailed in the latest public reports. The company is leveraging its PLK1 inhibition technology here to target tumor vulnerabilities.

Patients with small cell lung cancer (SCLC) and triple-negative breast cancer (TNBC).

Cardiff Oncology, Inc. is exploring onvansertib in these indications via investigator-initiated trials as well. The mTNBC data point, showing a 40% ORR in the early trial, is a key data point for engaging oncologists treating this difficult-to-treat population.

Pharmaceutical companies seeking late-stage oncology assets for licensing.

These entities are potential partners for late-stage development or commercialization. The company's financial stability, with cash and investments of $60.6 million as of September 30, 2025, projects a runway into Q1 2027, which is relevant for partnership timelines. Furthermore, the intellectual property portfolio offers significant protection, with a new USPTO patent covering mCRC treatment extending protection until at least 2043. Pfizer holds an equity investment of $15 million, and a research agreement is in place with Merck & Co. to explore combination studies with pembrolizumab. The Q3 2025 net cash used in operating activities was approximately $10.8 million.

Here's a quick look at the key financial and IP data points relevant to potential partners:

• Cash Runway Projection: Into Q1 2027.
• Cash Position (as of 9/30/2025): $60.6 million.
• Q3 2025 Operating Cash Use: $10.8 million.
• mCRC Patent Expiration (Extended): At least 2043.
• Pfizer Equity Stake: $15 million.

The company definitely needs to secure additional funding for the planned Phase 3 trial, which is a key dependency for this segment.

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Cost Structure

Cardiff Oncology, Inc.'s cost structure is heavily weighted toward the clinical development of its lead asset, onvansertib. Significant Research and Development (R&D) costs for clinical trials are the primary expenditure driver, as evidenced by the Q1 2025 operating expenses of approximately $14.5 million, which was primarily due to costs associated with the CRDF-004 clinical trial and other clinical programs related to onvansertib development.

The full-year 2025 Operating Expenses forecast has been revised to a range between $90 million and $92 million. This projection follows a period of increased spending, with total operating expenses for the three months ended June 30, 2025, reaching approximately $14.9 million.

Here's a look at the recent quarterly operating expense trend:

Period Ending	Total Operating Expenses
March 31, 2025 (Q1 2025)	$14.5 million
June 30, 2025 (Q2 2025)	$14.9 million
September 30, 2025 (Q3 2025)	$12.1 million
Full Year 2024	$49.3 million

The cost base also includes salaries and wages for key hires and general administrative expenses. For the full year 2024, the increase in operating expenses was attributed, in part, to higher salaries and staff costs from increased headcount and stock-based compensation.

The cash burn rate reflects these ongoing costs. Net cash used in operating activities was approximately $10.8 million in Q3 2025. This cash usage is what drives the need to manage the current cash position of approximately $60.6 million as of September 30, 2025, which the Company projects is sufficient to fund operations into Q1 2027.

Manufacturing and supply chain costs for onvansertib, while not detailed in isolation, are part of the overall cost structure, which is currently being impacted by external factors. Specifically, Cardiff Oncology is facing cost pressures due to U.S. tariffs on goods produced in China, which are expected to increase the Surgical Glaucoma segment's cost of goods sold by $1.0 million to $1.5 million over the full year 2025.

Key cost components influencing the structure include:

• Costs associated with the CRDF-004 clinical trial.
• Outside service costs for onvansertib development.
• Salaries and staff costs, including stock-based compensation.
• Tariff-related increases impacting the Surgical Glaucoma segment COGS.

Finance: draft 13-week cash view by Friday.

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for Cardiff Oncology, Inc. (CRDF) as of late 2025, and honestly, it's what you'd expect for a clinical-stage biotech deep into trials. The current revenue picture is quite thin, reflecting the pre-commercial stage.

Minimal current revenue, primarily from royalties on prior licensed technologies. Right now, the money coming in is almost entirely from those prior deals. This isn't a sales-driven business yet; it's about earning from past intellectual property work. For the third quarter ending September 30, 2025, the reported royalty revenues were exactly $0.12 million.

To give you a clearer picture of this core, small revenue stream, here's how the royalty income has looked recently:

Period Ending	Royalty Revenue (in millions USD)	Total Revenue (in millions USD)
September 30, 2025 (Q3 2025)	$0.12	$0.12
June 30, 2025 (Q2 2025)	$0.121	$0.121
March 31, 2025 (Q1 2025)	$0.109	N/A

Interest income from cash, cash equivalents, and investments. While not broken out separately as a major stream, Cardiff Oncology, Inc. maintains a cash balance that generates interest. As of September 30, 2025, the company held approximately $60.6 million in cash, cash equivalents, and short-term investments. That's a decent pile of capital that will be earning something, though it's secondary to the R&D burn.

Q3 2025 Total Revenue was only $0.12 million, typical for a pre-commercial biotech. This figure is the bottom line for revenue in the quarter. For context, the cumulative revenue for the first three quarters of 2025 was reported as $0.35 million. This low number is standard when a company is focused on expensive clinical development rather than product sales.

Future revenue from product sales of onvansertib post-FDA approval. The real financial upside hinges on onvansertib. The company is tracking positive data from the ongoing Phase 2 CRDF-004 trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). If this progresses and gains approval, sales of onvansertib will become the primary revenue driver. The CEO noted that approximately 150,000 new CRC patients are diagnosed annually in the U.S. alone, representing the commercial opportunity.

Potential milestone payments and royalties from future licensing deals. Beyond direct product sales, Cardiff Oncology, Inc. has the potential for non-sales revenue tied to its pipeline progress. This includes:

• Potential milestone payments from existing or future partners based on clinical or regulatory achievements.
• Royalties on net sales of any licensed products, including onvansertib, should they be commercialized by a partner.

The company's focus on advancing onvansertib is designed to hit value-creating milestones that could trigger these payments, helping to extend the current cash runway, which was projected into Q1 2027 based on the $60.6 million cash position.