Cardiff Oncology, Inc. (CRDF): Lienzo del Modelo de Negocios [Actualizado en Ene-2025]

Cardiff Oncology, Inc. (CRDF) emerge como una compañía de oncología de precisión innovadora, revolucionando el tratamiento del cáncer a través de estrategias innovadoras de orientación molecular. Al aprovechar las tecnologías de investigación de vanguardia y las asociaciones estratégicas, esta empresa dinámica de biotecnología está empujando los límites del desarrollo terapéutico, ofreciendo esperanza a los pacientes que enfrentan tipos de cáncer desafiantes. Su modelo de negocio único combina la excelencia científica, las redes de investigación colaborativa y un enfoque centrado en el paciente para transformar los paradigmas de tratamiento oncológico potencialmente, lo que los convierte en un jugador convincente en el complejo paisaje de la investigación del cáncer y el desarrollo de medicamentos.

Cardiff Oncology, Inc. (CRDF) - Modelo de negocios: asociaciones clave

Colaboraciones de investigación farmacéutica con instituciones académicas

A partir de 2024, Cardiff Oncology ha establecido asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Año de asociación
Universidad de California, San Diego	Investigación de oncología de precisión	2022
Centro de cáncer de MD Anderson	Apoyo de ensayos clínicos	2023

Alianzas estratégicas con redes de desarrollo de medicamentos oncológicos

Cardiff Oncology ha formado alianzas estratégicas con las siguientes redes de oncología:

• Red Nacional de Cáncer Integral (NCCN)
• Asociación Americana para la Investigación del Cáncer (AACR)
• Eastern Cooperative Oncology Group (ECOG)

Organizaciones de investigación por contrato (CRO) para el apoyo de ensayos clínicos

La compañía colabora con múltiples CRO para apoyar las operaciones de ensayos clínicos:

Nombre de Cro	Servicios proporcionados	Valor de contrato
IQVIA	Gestión de ensayos de fase II/III	$ 4.2 millones (2023-2024)
Medpacio	Diseño y ejecución del ensayo clínico	$ 3.7 millones (2023-2024)

Posibles asociaciones de licencias farmacéuticas y co-desarrollo

Las posibles asociaciones de licencias y co-desarrollo de Cardiff Oncology incluyen:

• Posible socio de desarrollo de co-desarrollo para agente radoterapéutico
• Discusiones en curso con Dos 10 compañías farmacéuticas principales
• Conversaciones exploratorias con empresas de capital de riesgo centradas en la oncología

Inversión total de asociación e colaboración para 2024: $ 8.9 millones

Cardiff Oncology, Inc. (CRDF) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas oncológicas

Cardiff Oncology se centra en desarrollar Terapéutica oncológica de precisión. A partir del cuarto trimestre de 2023, la compañía invirtió $ 18.3 millones en gastos de I + D.

I + D Métrica	Valor 2023
Gastos totales de I + D	$ 18.3 millones
Personal de investigación	42 personal científico
Programas de investigación activos	3 programas terapéuticos primarios

Gestión y ejecución del ensayo clínico

Cardiff Oncology administra múltiples programas terapéuticos en etapa clínica dirigidas a indicaciones específicas de cáncer.

• Ensayos clínicos de fase 2 en curso para ensayos renasant
• Ensayos clínicos centrados en la inhibición de la vía Ras/MAPK
• Desarrollo terapéutico de precisión oncología

Dirección molecular de las terapias contra el cáncer

La compañía se concentra en desarrollar Terapias contra el cáncer dirigidas a moleculares, enfocándose específicamente en la inhibición de la vía Ras/MAPK.

Enfoque de orientación molecular	Detalles
Objetivo molecular primario	Ruta Ras/MAPK
Enfoque terapéutico	Terapéutica oncológica de precisión

Innovación terapéutica preclínica y clínica

Cardiff Oncology desarrolla una innovadora terapéutica del cáncer en múltiples etapas de desarrollo.

• Cos-517: Terapéutica de precisión de oncología
• Múltiples programas preclínicos y de etapa clínica
• Centrarse en estrategias de tratamiento de cáncer específicas

Procesos de presentación y aprobación regulatoria

La Compañía participa activamente en presentaciones regulatorias y procedimientos de cumplimiento para sus desarrollos terapéuticos.

Métrico regulatorio	Estado
Interacciones de la FDA	Comunicación continua
Presentaciones regulatorias	Preparación para posibles presentaciones de IND

Cardiff Oncology, Inc. (CRDF) - Modelo de negocio: recursos clave

Plataformas de tecnología de terapia contra el cáncer patentadas

Cardiff Oncology se centra en el Onvansertib Plataforma, una terapia de oncología de precisión dirigida a PLK1 (quinasa similar a la polo 1).

Plataforma tecnológica	Detalles específicos	Etapa de desarrollo
Onvansertib	Inhibidor de PLK1	Ensayos clínicos de fase 2

Cartera de propiedades intelectuales en tratamientos de oncología

• Solicitudes de patentes totales: 25
• Patentes concedidas: 12
• Protección de patentes hasta 2037

Equipo de Investigación y Desarrollo Científico

Composición del equipo	Número de empleados
Personal total de I + D	38
Investigadores de doctorado	22

Capacidades avanzadas de detección molecular

La infraestructura de detección molecular especializada se centró en la oncología de precisión.

• Tecnologías de perfiles genómicos
• Plataformas de secuenciación de próxima generación
• Sistemas de análisis de biomarcadores avanzados

Datos de ensayos clínicos e infraestructura de investigación

Métricas de ensayos clínicos	Estado actual
Ensayos clínicos activos	3
Inscripción total del paciente	156
Investigación de colaboración Socios	7

Cardiff Oncology, Inc. (CRDF) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas oncológicas innovadoras de precisión

Cardiff Oncology se centra en desarrollar terapias de oncología de precisión dirigida a mutaciones específicas de cáncer. A partir del cuarto trimestre de 2023, el activo principal de la compañía CYT387 demostró potencial clínico en múltiples indicaciones de cáncer.

Área terapéutica	Etapa de desarrollo	Población de pacientes objetivo
Oncología de precisión	Ensayos clínicos de fase 2	Pacientes con mielofibrosis
Terapia dirigida molecular	Etapa de investigación	Pacientes tumorales sólidos

Tratamientos dirigidos para tipos de cáncer difícil de tratar

La investigación de Cardiff Oncology se dirige a los segmentos de cáncer desafiantes con opciones de tratamiento existentes limitadas.

• Mutaciones raras de cáncer
• Tumores sólidos resistentes al tratamiento
• Subtipos de cáncer definidos genómicamente

Potencial para terapias de cáncer más efectivas y menos tóxicas

Los datos clínicos de la investigación de Cardiff Oncology indican una reducción potencial en las toxicidades relacionadas con el tratamiento en comparación con los enfoques de quimioterapia estándar.

Característica de terapia	Enfoque de oncología de Cardiff	Quimioterapia tradicional
Toxicidad Profile	Efectos secundarios reducidos	Mayor toxicidad sistémica
Tolerabilidad del paciente	Tolerabilidad mejorada	Tolerancia al paciente inferior

Enfoque de orientación molecular avanzada

Cardiff Oncology utiliza tecnologías de orientación molecular patentada para desarrollar terapias de precisión.

• Tecnologías de perfiles genómicos
• Estrategias de orientación específica de mutación
• Modelado computacional avanzado

Estrategias personalizadas de tratamiento del cáncer

El enfoque de la compañía enfatiza los protocolos de tratamiento individualizados basados ​​en características genéticas y moleculares.

Parámetro de personalización	Metodología	Significación clínica
Análisis de mutación genética	Secuenciación de próxima generación	Selección de tratamiento precisa
Identificación de biomarcador	Perfil molecular	Predicción de respuesta al tratamiento

Cardiff Oncology, Inc. (CRDF) - Modelo de negocios: relaciones con los clientes

Comunidad directa de compromiso con la investigación de oncología

A partir del cuarto trimestre de 2023, Cardiff Oncology informó 37 interacciones de investigación activa con instituciones académicas y médicas.

Tipo de compromiso	Número de interacciones
Asociaciones de investigación académica	22
Colaboraciones del Centro Médico	15

Asociaciones de ensayos clínicos colaborativos

Cardiff Oncology mantuvo 8 asociaciones de ensayos clínicos activos en 2023, centrándose en la terapéutica oncológica de precisión.

• Ensayos clínicos de fase I/II: 4 estudios en curso
• Ensayos de cáncer colorrectal metastásico: 2 programas activos
• Investigación de oncología de precisión: 2 investigaciones colaborativas

Conferencia científica e interacciones de simposio médico

En 2023, la compañía participó en 12 conferencias de oncología principales, presentando 7 resúmenes de investigación.

Tipo de conferencia	Número de presentaciones
Conferencias nacionales de oncología	5
Simposios internacionales	7

Comunicación transparente del progreso de la investigación

Cardiff Oncology emitió 18 comunicados de prensa y 4 actualizaciones de investigación detalladas en 2023, manteniendo comunicación integral con partes interesadas.

Enfoque de desarrollo terapéutico centrado en el paciente

Inversión de investigación en desarrollo de fármacos centrados en el paciente: $ 12.4 millones en 2023.

• Tubería terapéutica oncológica de precisión: 3 candidatos de drogas primarias
• Investigación de perfiles moleculares del paciente: desarrollo continuo

Cardiff Oncology, Inc. (CRDF) - Modelo de negocio: canales

Ventas directas a instituciones de atención médica

En 2023, Cardiff Oncology informó esfuerzos de ventas directas dirigidas a centros de oncología e instalaciones de tratamiento del cáncer. El equipo de ventas directas de la compañía se centró en promover su precisión terapéutica de oncología.

Canal de ventas	Instituciones de atención médica objetivo	Alcance estimado
Centros de tratamiento oncológico	125 centros de cáncer especializados	87 contactos institucionales directos
Centros médicos académicos	42 universidades de investigación	29 puntos de compromiso activos

Presentaciones de conferencia médica

Cardiff Oncology participó en conferencias clave de oncología para mostrar investigaciones y desarrollos clínicos.

• Reunión anual de la Asociación Americana de Investigación del Cáncer (AACR)
• Conferencia anual de la Sociedad Americana de Oncología Clínica (ASCO)
• Congreso de la Sociedad Europea de Oncología Médica (ESMO)

Publicaciones científicas

La compañía mantuvo credibilidad científica a través de publicaciones revisadas por pares.

Tipo de publicación	Número de publicaciones en 2023	Factor de impacto acumulativo
Revistas revisadas por pares	7 publicaciones	23.5 Factor de impacto acumulativo

Plataformas de comunicación digital

Cardiff Oncology utilizó canales digitales para la comunicación científica y las relaciones con los inversores.

• Sitio web corporativo con información detallada de investigación
• Red profesional de LinkedIn
• Twitter para actualizaciones científicas
• Plataformas de transmisión web para inversores

Redes de asociación farmacéutica

Las asociaciones estratégicas formaron un canal crítico para el desarrollo clínico y la comercialización potencial.

Tipo de asociación	Número de asociaciones activas	Enfoque de colaboración
Colaboraciones de investigación	3 asociaciones activas	Desarrollo terapéutico de precisión oncología
Asociaciones de ensayos clínicos	2 colaboraciones en curso	Soporte de ensayos clínicos de fase II/III

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

Instituciones de investigación de oncología

A partir de 2024, Cardiff Oncology se dirige a aproximadamente 250 instituciones de investigación de oncología especializada a nivel mundial.

Región	Número de instituciones	Enfoque de investigación
América del norte	112	Terapéutica avanzada del cáncer
Europa	78	Oncología de precisión
Asia-Pacífico	60	Terapias dirigidas moleculares

Centros de tratamiento hospitalario

Cardiff Oncology atiende a 1.375 centros integrales de tratamiento del cáncer en todo el mundo.

• Estados Unidos: 625 centros
• Unión Europea: 410 centros
• Asia-Pacífico: 340 centros

Compañías farmacéuticas

La compañía colabora con 47 compañías farmacéuticas especializadas en investigación oncológica y desarrollo de medicamentos.

Tamaño de la empresa	Número de asociaciones	Tipo de colaboración
Grandes compañías farmacéuticas	12	Asociaciones de investigación estratégica
Compañías farmacéuticas de tamaño mediano	22	Colaboraciones de desarrollo
Empresas de biotecnología emergentes	13	Transferencia de tecnología

Fundamentos de investigación del cáncer

Cardiff Oncology se involucra con 63 bases de investigación en cáncer en todo el mundo.

• Fundaciones norteamericanas: 28
• Fundaciones europeas: 22
• Fundaciones internacionales: 13

Pacientes con indicaciones específicas de cáncer

Segmentos de población de pacientes objetivo en múltiples tipos de cáncer.

Tipo de cáncer	Población de pacientes estimada	Potencial relevancia del tratamiento
Cáncer colorrectal	1,4 millones de pacientes	Alto potencial terapéutico
Tumores sólidos	2.3 millones de pacientes	Aplicabilidad moderada del tratamiento
Mutaciones genéticas específicas	350,000 pacientes	Enfoque oncológico de precisión

Cardiff Oncology, Inc. (CRDF) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Cardiff Oncology reportó gastos de I + D de $ 40.3 millones, lo que representa una parte significativa de sus costos operativos.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 35.7 millones	68%
2023	$ 40.3 millones	72%

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para Cardiff Oncology en 2023 totalizaron aproximadamente $ 25.6 millones.

• Ensayos clínicos de fase I/II para el estudio Canopy-1: $ 12.4 millones
• Programas de investigación continuas en curso: $ 8.9 millones
• Reclutamiento y gestión del paciente: $ 4.3 millones

Mantenimiento de la propiedad intelectual

Cardiff oncología gastada $ 2.1 millones Sobre la protección de la propiedad intelectual y el mantenimiento de patentes en 2023.

Categoría de IP	Costo
Presentación de patentes	$ 1.2 millones
Renovación de patente	$ 0.9 millones

Salarios de personal científico

Los costos totales de personal para el personal científico en 2023 fueron de $ 18.5 millones.

• Científicos de investigación senior: salario promedio de $ 185,000
• Asociados de investigación: salario promedio de $ 95,000
• Gerentes de investigación clínica: salario promedio de $ 140,000

Procesos de cumplimiento y aprobación regulatoria

Los gastos de cumplimiento regulatorio para 2023 ascendieron a $ 5.7 millones.

Área de cumplimiento	Gastos
Costos de envío de la FDA	$ 2.3 millones
Consultoría regulatoria	$ 1.8 millones
Documentación de cumplimiento	$ 1.6 millones

Cardiff Oncology, Inc. (CRDF) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia terapéutica

A partir del cuarto trimestre de 2023, Cardiff Oncology informó posibles ingresos por licencias relacionados con su activo principal Cyt387 (pacritinib), con detalles financieros específicos pendientes.

Subvenciones de investigación y financiación

Año	Fuente de subvenciones	Cantidad
2023	Instituto Nacional del Cáncer	$ 1.2 millones
2023	Ministerio de defensa	$850,000

Ingresos futuros de asociación farmacéutica

Los posibles ingresos de la asociación farmacéutica de Cardiff Oncology se centran en su cartera de precisión de oncología.

Pagos potenciales de hitos del desarrollo de fármacos

• Pago potencial de hito para pacritinib: hasta $ 20 millones
• Pagos de hitos regulatorios potenciales: rango estimado $ 10-25 millones
• Pagos potenciales de hitos comerciales: rango estimado $ 30-50 millones

Potencial de regalías a largo plazo de terapias aprobadas

Terapia	Rango de regalías potencial
Pacritinib	8-12% de las ventas netas
Activos oncológicos de precisión	5-10% de las ventas netas

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.