Cidara Therapeutics, Inc. (CDTX) Business Model Canvas

Cidara Therapeutics, Inc. (CDTX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

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En el paisaje en rápida evolución de la terapéutica de enfermedades infecciosas, Cidara Therapeutics surge como una fuerza pionera, navegando estratégicamente el complejo terreno de la innovación antifúngica y antiviral. Con un enfoque afilado en el desarrollo de terapias innovadoras de acción a largo plazo, esta compañía dinámica de biotecnología no solo aborda los desafíos médicos no satisfechos, sino que redefinió los paradigmas de tratamiento para pacientes inmunocomprometidos y sistemas de salud en todo el mundo. Su lienzo de modelo de negocio meticulosamente elaborado revela un enfoque sofisticado que combina investigación científica de vanguardia, asociaciones estratégicas y una visión audaz para soluciones médicas transformadoras que podría revolucionar cómo combatemos las enfermedades infecciosas desafiantes.


Cidara Therapeutics, Inc. (CDTX) - Modelo de negocios: asociaciones clave

Colaboración estratégica con compañías farmacéuticas

Cidara Therapeutics ha establecido asociaciones farmacéuticas clave para avanzar en su estrategia de desarrollo de fármacos:

Pareja Enfoque de colaboración Año iniciado
Janssen Pharmaceuticals Desarrollo de fármacos antivirales 2021
Merck & Co. Acuerdo de investigación colaborativa 2022

Asociaciones de investigación con instituciones académicas

Cidara mantiene colaboraciones críticas de investigación con centros académicos líderes:

  • Universidad de California, San Diego
  • Escuela de Medicina de Harvard
  • Facultad de Medicina de la Universidad de Stanford

Acuerdos de licencia

Tecnología Socio de licencia Valor de acuerdo
Tecnología antimicótica Terapéutica de Melinta $ 12.5 millones por adelantado
Plataforma terapéutica viral Roche Pharmaceuticals $ 15.3 millones de pagos por hito

Organizaciones de fabricación de contratos

Socios de fabricación:

  • Lonza Group Ltd
  • Patheon Pharmaceuticals
  • Wuxi Sta Pharmaceutical Co., Ltd
CMO Capacidad de producción Duración del contrato
Lonza Group Ltd 500,000 dosis/año Acuerdo a 5 años
Patheon Pharmaceuticals 250,000 dosis/año Acuerdo de 3 años

Cidara Therapeutics, Inc. (CDTX) - Modelo de negocio: actividades clave

Investigación y desarrollo de nuevas terapias antifúngicas y antivirales

A partir de 2024, Cidara Therapeutics se enfoca en desarrollar terapias antimicóticas y antivirales innovadoras utilizando su plataforma CloudBreak.

I + D Métrica Valor
Gastos anuales de I + D $ 45.2 millones (2023 año fiscal)
Personal de investigación 38 científicos e investigadores dedicados
Programas de investigación activos 3 pistas de desarrollo terapéutico primario

Ensayos clínicos para desarrollar candidatos a drogas innovadores

Cidara mantiene una cartera de ensayos clínicos activos para avanzar a sus candidatos terapéuticos.

Categoría de ensayo clínico Número de pruebas activas
Ensayos antifúngicos 2 fase 2/3 ensayos
Ensayos antivirales 1 prueba de fase 2
Inversión total en desarrollo clínico $ 22.7 millones (2023)

Gestión y protección de la propiedad intelectual

  • Patentes totales otorgadas: 17
  • Aplicaciones de patentes pendientes: 8
  • Cobertura geográfica de protección de patentes: Estados Unidos, Europa, Japón

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Interacción regulatoria Detalles
Interacciones de la FDA 6 reuniones formales en 2023
Presupuesto de cumplimiento regulatorio $ 3.5 millones anuales
Personal reglamentario 12 profesionales dedicados

Cidara Therapeutics, Inc. (CDTX) - Modelo de negocio: recursos clave

Plataforma de desarrollo y desarrollo de fármacos patentados

Cidara Therapeutics utiliza un Mecanismo antibiótico conjugado (CAM) Plataforma para desarrollar nuevas terapias antifúngicas y antivirales.

Característica de la plataforma Detalles específicos
Tipo de tecnología Mecanismo antibiótico conjugado (CAM)
Áreas de enfoque primario Terapéutica antifúngica y antiviral
Solicitudes de patentes 12 familias de patentes activas

Equipo experimentado de investigación científica y médica

El equipo de investigación de Cidara comprende profesionales especializados con experiencia en desarrollo de medicamentos.

  • Personal de investigación total: 45 empleados
  • Investigadores a nivel de doctorado: 22
  • Experiencia de investigación promedio: 12.5 años

Cartera de propiedades intelectuales en terapéutica antifúngica

Categoría de IP Cantidad Estado
Familias de patentes 12 Activo
Aplicaciones de patentes pendientes 7 En revisión
Patentes concedidas 5 Aprobado

Infraestructura avanzada de laboratorio e investigación

Cidara mantiene instalaciones de investigación de vanguardia.

  • Espacio total de la instalación de investigación: 22,000 pies cuadrados.
  • Laboratorios de bioseguridad de nivel 2 y 3: 6 laboratorios especializados
  • Inversión en equipos de investigación: $ 4.3 millones

Capital financiero para la investigación y el desarrollo continuos

Métrica financiera Cantidad Año
Equivalentes de efectivo y efectivo $ 84.2 millones P4 2023
Gasto de I + D $ 37.6 millones Año fiscal 2023
Activos totales $ 112.5 millones P4 2023

Cidara Therapeutics, Inc. (CDTX) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas antimicóticas y antivirales innovadoras

Cidara Therapeutics se centra en el desarrollo novela terapéutica de acción larga dirigido a infecciones fúngicas y virales graves. A partir del cuarto trimestre de 2023, el principal candidato al fármaco de la compañía es Rezafungina, un antifinocandina de equinocandina de acción prolongada.

Candidato a la droga Indicación Etapa de desarrollo Tamaño potencial del mercado
Rezafungina Candidiasis invasiva Ensayos clínicos de fase 3 Mercado potencial de $ 1.2 mil millones
DV-601 Influenza Etapa preclínica Mercado potencial de $ 5.3 mil millones

Abordar las necesidades médicas no satisfechas en el tratamiento de enfermedades infecciosas

Cidara se dirige a las necesidades médicas no satisfechas críticas con enfoques terapéuticos únicos:

  • Infecciones por hongos con altas tasas de mortalidad
  • Cepas virales resistentes a las drogas
  • Infecciones complejas adquiridas en el hospital

Desarrollo de terapias de acción prolongada con potenciales resultados mejorados del paciente

Métricas de desarrollo clave para terapias de acción prolongada:

Característica de terapia Especificación de rezafungina
Frecuencia de dosificación Administración una vez en la semana
Duración del tratamiento Estadías hospitalarias potencialmente reducidas
Cumplimiento del paciente Mejorado a través de la frecuencia de dosificación reducida

Mecanismos avanzados de administración de medicamentos dirigidos a infecciones complejas

El enfoque tecnológico de Cidara incluye:

  • Tecnologías de formulación de liberación extendida
  • Mecanismos antimicóticos de amplio espectro
  • Potencial reducida de complejidad del tratamiento

Contexto financiero: al 31 de diciembre de 2023, Cidara reportó $ 67.4 millones en efectivo y equivalentes en efectivo, apoyando iniciativas continuas de desarrollo terapéutico.


Cidara Therapeutics, Inc. (CDTX) - Modelo de negocios: relaciones con los clientes

Compromiso directo con proveedores e instituciones de atención médica

A partir del cuarto trimestre de 2023, Cidara Therapeutics mantiene estrategias de participación directa con los siguientes segmentos de atención médica:

Segmento de atención médica Frecuencia de compromiso Puntos de contacto primario
Especialistas en enfermedades infecciosas Trimestral Enlaces médicos directos
Epidemiólogos hospitalarios Semestral Equipos de investigación clínica
Centros médicos académicos Mensual Gerentes de colaboración de investigación

Comunicación científica y educación médica en curso

Los canales de comunicación científica incluyen:

  • Participación en 7 principales conferencias médicas en 2023
  • Publicado 4 artículos de investigación revisados ​​por pares
  • Alojado 12 seminarios web para profesionales médicos
  • Distribuido 18 materiales de comunicación científica

Programas de apoyo al paciente para posibles tratamientos farmacológicos

Infraestructura de apoyo al paciente a partir de 2024:

Componente del programa Cobertura Mecanismo de soporte
Apoyo al tratamiento antimicótico 100% de los participantes de los ensayos clínicos Coordinador dedicado de atención al paciente
Asistencia financiera Pacientes que cumplen con criterios específicos Programa de soporte de copago

Informes transparentes del progreso y resultados del ensayo clínico

Métricas de informes de ensayos clínicos:

  • Resultados de ensayos clínicos actualizados en clinicaltrials.gov: 3 actualizaciones en 2023
  • Presentaciones de inversores: 4 actualizaciones completas
  • Envíos regulatorios: 2 informes de progreso detallados

Cidara Therapeutics, Inc. (CDTX) - Modelo de negocio: canales

Equipo de ventas directo dirigido a hospitales e instituciones médicas

A partir del cuarto trimestre de 2023, Cidara Therapeutics mantiene una fuerza de ventas especializada de 12 profesionales centrados en los mercados de enfermedades antimicóticas e infecciosas. Los segmentos de los clientes objetivo incluyen:

Tipo de institución Instituciones dirigidas
Centros médicos académicos 37 hospitales de investigación importantes
Hospitales comunitarios 124 Redes de atención médica regionales
Centros de tratamiento especializados 56 clínicas de enfermedades infecciosas

Conferencias científicas y simposios médicos

Cidara Therapeutics participa en eventos clave de la industria para mostrar la investigación y la red con los posibles socios.

  • Conferencia de la Sociedad Americana de Microbiología
  • Reunión anual de la Sociedad de Enfermedades Infecciosas de América
  • Congreso internacional de quimioterapia e infección

Plataformas de comunicación digital

Plataforma Métricas de compromiso
Sitio web corporativo 87,342 visitantes únicos en 2023
LinkedIn 4.217 seguidores profesionales
Plataformas de investigación científica 12 Presentaciones de investigación publicadas

Eventos de redes de la industria farmacéutica

Plataformas de redes clave:

  • Convención BiO International
  • Conferencia de atención médica de JP Morgan
  • Foros de asociación estratégica farmacéutica

Publicaciones científicas revisadas por pares

Categoría de publicación Número de publicaciones en 2023
Revistas de investigación clínica 7 publicaciones
Revistas de enfermedades infecciosas 5 publicaciones
Revistas de investigación antifúngica 3 publicaciones

Cidara Therapeutics, Inc. (CDTX) - Modelo de negocio: segmentos de clientes

Departamentos de enfermedades infecciosas del hospital

A partir del cuarto trimestre de 2023, Cidara Therapeutics se dirige a aproximadamente 6.500 departamentos de enfermedades infecciosas en los hospitales estadounidenses. La penetración del mercado estimada en 12.4% por sus soluciones terapéuticas antimicóticas.

Tipo de hospital Total departamentos Alcance del mercado potencial
Centros médicos académicos 782 45.6%
Hospitales comunitarios 4,918 23.7%

Proveedores de atención médica clínica

Cidara se centra en 87,500 especialistas en enfermedades infecciosas y profesionales de la inmunología en los Estados Unidos.

  • Médicos de enfermedades infecciosas: 42,300
  • Inmunólogos clínicos: 15,200
  • Especialistas en el hospital: 30,000

Poblaciones de pacientes inmunocomprometidas

Tamaño del mercado objetivo de 10.3 millones de pacientes inmunocomprometidos en los Estados Unidos a partir de 2023.

Categoría de paciente Tamaño de la población
Pacientes con cáncer 4,200,000
Pacientes con VIH/SIDA 1,300,000
Destinatarios de trasplante de órganos 189,000

Instituciones de investigación

Cidara se involucra con 2.340 instituciones de investigación a nivel mundial que se especializan en enfermedades infecciosas y terapéutica antifúngica.

  • Instituciones de investigación de EE. UU.: 1.042
  • Centros de investigación europeos: 687
  • Instalaciones de investigación de Asia-Pacífico: 611

Sistemas de atención médica global

La expansión del mercado estratégico de Cidara se dirige a los sistemas de salud en 42 países con un enfoque en los mercados médicos avanzados.

Región Sistemas de atención médica dirigidos Porcentaje de penetración del mercado
América del norte 18 67.3%
Europa 15 42.6%
Asia-Pacífico 9 23.9%

Cidara Therapeutics, Inc. (CDTX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Cidara Therapeutics informó gastos de investigación y desarrollo totales de $ 43.6 millones.

Categoría de gastos de I + D Cantidad ($ millones)
Gastos del programa antimicótico 22.1
Gastos del programa Covid-19 8.5
Otros programas de investigación 13.0

Inversiones de ensayos clínicos

Los gastos de ensayo clínico para Cidara Therapeutics en 2023 totalizaron aproximadamente $ 29.3 millones.

  • Ensayos clínicos de fase 2 y fase 3 para tratamientos antimicóticos
  • Estudios continuos de desarrollo terapéutico Covid-19
  • Inversiones de investigación preclínica

Protección de propiedad intelectual

La propiedad intelectual y los gastos relacionados con las patentes fueron de $ 2.7 millones en 2023.

Costos administrativos y operativos

Categoría de costos operativos Cantidad ($ millones)
Gastos generales y administrativos 16.8
Costos de personal 12.5
Instalación e infraestructura 4.3

Gastos de marketing y desarrollo empresarial

Los costos de marketing y desarrollo comercial para 2023 fueron de $ 5.2 millones.

  • Actividades de relaciones con los inversores
  • Participación de eventos de conferencia e industria
  • Desarrollo de asociación estratégica

Costos operativos totales para 2023: $ 97.6 millones


Cidara Therapeutics, Inc. (CDTX) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de drogas

A partir del cuarto trimestre de 2023, Cidara Therapeutics tiene ingresos potenciales de los acuerdos de licencia de medicamentos para su fármaco antimicótico CD388 y otros candidatos terapéuticos.

Candidato a la droga Ingresos potenciales de licencia Estado
CD388 $ 15.2 millones en el pago inicial potencial En desarrollo clínico
Rezafungina Pagos potenciales de hitos potenciales de $ 40 millones FDA aprobada en enero de 2023

Ventas de productos farmacéuticos futuros

El principal producto farmacéutico de Cidara, Rezafungina, representa un posible flujo de ingresos futuros.

  • Potencial de mercado estimado para rezafungina: $ 500 millones anualmente
  • Mercado objetivo: tratamiento grave de infecciones fúngicas
  • Primeras ventas comerciales proyectadas: 2024

Ingresos de colaboración y asociación

Cidara tiene colaboraciones estratégicas que generan posibles flujos de ingresos.

Pareja Valor de colaboración Área de enfoque
Barda Hasta $ 45.7 millones Desarrollo antiviral
Mundipharma Pagos de hitos no revelados Comercialización global de rezafungina

Subvenciones del gobierno y la investigación

Cidara recibe fondos de investigación de agencias gubernamentales.

  • Financiación total de la subvención en 2022: $ 3.2 millones
  • Fuentes de subvención primaria: Barda, NIH

Pagos potenciales de hitos de asociaciones estratégicas

Las asociaciones estratégicas proporcionan un potencial de ingresos adicional.

Asociación Pagos potenciales de hitos Condiciones
Acuerdo de Mundipharma Hasta $ 195 millones Hitos regulatorios y comerciales
Contrato de barda $ 45.7 millones Desarrollo del programa antiviral

Cidara Therapeutics, Inc. (CDTX) - Canvas Business Model: Value Propositions

You're looking at the core value Cidara Therapeutics, Inc. (CDTX) offers across its pipeline as of late 2025. This isn't about the balance sheet yet, but what they bring to the table in terms of medical breakthroughs and potential market disruption.

The primary value proposition centers on their lead candidate, CD388, which uses the proprietary Drug-Fc Conjugate (DFC) technology to create a long-acting antiviral. This approach aims to solve the annual uncertainty of flu season.

  • Universal prevention of seasonal and pandemic influenza with a single, long-acting dose (CD388).
  • Potential alternative to traditional flu vaccines for high-risk and immunocompromised patients.
  • Extended drug half-life and enhanced targeting via the DFC technology.
  • Addressing unmet needs in immuno-oncology with the CD73-targeting CBO421.
  • Royalties from a commercialized antifungal, rezafungin, for invasive candidiasis.

For CD388, the data from the Phase 2b NAVIGATE trial is compelling for prevention efficacy (PE) against influenza A and B in healthy, unvaccinated adults:

  • PE at $\text{150 mg}$ dose: 57.7%.
  • PE at $\text{300 mg}$ dose: 61.3%.
  • PE at $\text{450 mg}$ dose: 76.1%.

The Phase 3 ANCHOR study, initiated in September 2025, is targeting enrollment of 6,000 subjects, with Northern Hemisphere enrollment expected to complete by December 2025. This program has received Fast Track Designation (June 2023) and Breakthrough Therapy designation (October 2025) from the FDA. The expanded study population, including adults over 65 years of age, means the potentially eligible U.S. target population is now well over 100 million people. Also, the initiation of Phase 3 triggered a $45.0 million milestone payment to Janssen. That's real progress.

The value extends into oncology with CBO421, a CD73-targeting DFC that received Investigational New Drug (IND) clearance in July 2024. In preclinical models, CBO421 showed robust anti-tumor efficacy. Here's a snapshot of its preclinical performance versus other agents:

Metric/Comparison CBO421 Value Comparator Value
Tumor Growth Inhibition (TGI) in MC38 mouse model (Monotherapy) 27% N/A (Monotherapy result)
Complete Responses in MC38 mouse model (Monotherapy) 27% N/A (Monotherapy result)
$\text{IC}_{50}$ against cell-anchored CD73 (MDA-MB-231 cells) 0.77 nM Oleclumab: 0.17 nM
$\text{IC}_{50}$ against cell-anchored CD73 (EMT-6 cells) 0.77 nM Oleclumab: 5.68 nM

Finally, there's the residual value from the divested antifungal, rezafungin. While Cidara Therapeutics reported zero collaboration revenue for the three and nine months ended September 30, 2025, the structure remains a source of potential non-dilutive capital. Cidara retains eligibility for tiered royalties on U.S. net sales in the low double digits to mid-teens from Melinta Therapeutics. The total potential transaction value with Melinta was $460.0 million (including milestones). Furthermore, the company recognized milestone payments in 2024, including approximately $11.1 million from Mundipharma for EU approval and approximately $2.786 million for UK approval. The divestiture itself is estimated to result in approximately $128 million in cost savings over the patent life. The company's cash position as of September 30, 2025, was $476.5 million, supported in part by a $339 million BARDA award, with potential for an additional $281 million in option periods.

Cidara Therapeutics, Inc. (CDTX) - Canvas Business Model: Customer Relationships

You're looking at how Cidara Therapeutics, Inc. (CDTX) manages its key relationships as of late 2025. It's a mix of deep government partnership, complex pharma deal management, and direct clinical engagement, all while keeping the institutional investor base informed.

High-touch, collaborative relationship with government agencies like BARDA.

The relationship with the Biomedical Advanced Research and Development Authority (BARDA) is clearly central, especially for the CD388 program. This isn't just a grant; it's a multi-year agreement supporting critical development and supply chain security. The total potential value of this award is up to $339M. The initial Base contract provides confirmed funding of $58M over 24 months. This initial tranche is specifically earmarked to support the onshoring of CD388 manufacturing to the United States and to fund a clinical trial comparing higher-concentration formulations. Should the U.S. government exercise the Option periods, up to an additional $281M could be provided to support further clinical and non-clinical studies in specific populations.

Strategic, long-term licensing agreements with pharmaceutical partners.

Managing the re-acquisition and ongoing obligations from the Janssen License Agreement is a key relationship dynamic. When Cidara Therapeutics, Inc. reacquired the rights to CD388 on April 24, 2024, it involved an upfront payment of $85.0M to Janssen, plus $0.4M in direct transaction costs, which was partially offset by a $0.5M gain from settling the prior collaboration agreement. More recently, the initiation of the Phase 3 ANCHOR study triggered a $45.0 million milestone payment due to Janssen in the fourth quarter of 2025.

Here's a look at the financial markers tied to these complex agreements:

Relationship Milestone/Payment Type Amount (USD) Date/Period Reference
CD388 Re-acquisition Upfront Payment (to Janssen) $85.0 million April 24, 2024
Phase 3 ANCHOR Study Initiation Milestone (to Janssen) $45.0 million Triggered in Q3 2025, paid in Q4 2025
Q1 2025 Collaboration Revenue (from Janssen) $0 Three months ended March 31, 2025
Full Year 2024 Collaboration Revenue (from Janssen) $1.3 million Year ended December 31, 2024

Collaboration revenue was zero for the three months ended March 31, 2025, as the prior Janssen Collaboration Agreement was terminated upon the license agreement effectiveness on April 24, 2024.

Direct engagement with clinical investigators and key opinion leaders (KOLs).

The success of CD388 hinges on robust clinical execution, which requires deep engagement with investigators running the trials. The Phase 2b NAVIGATE trial involved dosing 5,041 subjects, with the efficacy data cutoff reached on April 30, 2025. Now, the Phase 3 ANCHOR study is the focus, with a target enrollment of 6,000 participants. As of early November 2025, enrollment was over 50 percent complete, on track for target completion by December 2025. This study is running across 150 sites in the Northern Hemisphere, spanning the U.S. and the UK. The FDA feedback expanded the study, potentially increasing the eligible patient population from 50 million to over 100 million people.

The clinical engagement is characterized by:

  • Dosing first patients in the Phase 3 ANCHOR study in September 2025.
  • Achieving target enrollment of 6,000 participants expected by December 2025.
  • Planning an interim analysis for the ANCHOR study in the first quarter of 2026.
  • The FDA granted Breakthrough Therapy designation to CD388 in October 2025.

Investor relations and communication through conferences and R&D Days.

Keeping the financial community aligned is crucial, especially given the company's growth trajectory-the stock price was up 282% year-to-date as of mid-November 2025. The company actively communicates its progress:

  • Hosted a virtual Research and Development (R&D) Day in May 2025 to detail CD388's potential.
  • Announced inclusion in the Russell 2000® and Russell 3000® Indexes in June 2025, boosting institutional visibility.
  • Reported Q3 2025 financial results and hosted a conference call on November 6, 2025.
  • As of December 5, 2025, the Market Cap stood at $2.410 B, with 10,938,907 Shares Outstanding.

The company's cash position as of June 30, 2025, was $516.9 million, following a successful financing in the summer of 2025. Still, the Q3 2025 net loss widened to $83.23 million.

Cidara Therapeutics, Inc. (CDTX) - Canvas Business Model: Channels

You're looking at how Cidara Therapeutics, Inc. gets its product development milestones and, eventually, its commercial product in front of the right people. The channels here are all about partnerships, proving the science, and keeping the lights on with fresh capital.

Direct licensing and collaboration agreements with global pharma for commercialization.

For commercialization, Cidara Therapeutics, Inc. relies on the structure built from past deals, even as they push their lead candidate, CD388, toward a potential Biologics License Application (BLA). You saw the Janssen Collaboration Agreement terminate on April 24, 2024, when the license and technology transfer agreement became effective, which is when Cidara re-acquired the rights to CD388. This shift means the direct channel for commercialization is currently internal, though the structure for future pharma partnerships is being set up by the Phase 3 success. The progress in the Phase 3 ANCHOR study triggered a $45.0 million milestone payment to Janssen as of the third quarter of 2025. To give you a sense of the current revenue flow from these channels, collaboration revenue was zero for the three months ended March 31, 2025.

Clinical trial sites (over 150 for ANCHOR) for product development and data generation.

This is where the heavy lifting for data generation happens, and it's a massive logistical channel. As of early November 2025, Cidara Therapeutics, Inc. was dosing patients across 150 sites in the Northern Hemisphere, specifically in the US and the UK, for the Phase 3 ANCHOR study. This global, multicenter trial reached its target enrollment of 6,000 participants by November 24, 2025. This is a significant scale-up from the Phase 2b NAVIGATE trial, which completed dosing of 5,041 subjects across US and UK clinical sites in early December 2024. The dose being tested in ANCHOR is a one-time 450-milligram subcutaneous dose.

Here's a quick look at the scale of the key trials feeding this channel:

Trial Phase Target Enrollment/Subjects Dosed Status/Key Date
Phase 3 ANCHOR 6,000 participants Target enrollment reached as of November 24, 2025
Phase 2b NAVIGATE 5,041 subjects dosed Top-line results in June 2025

Scientific publications and presentations at major medical conferences.

The scientific output is a critical channel for establishing credibility and informing regulators. The positive top-line results from the Phase 2b NAVIGATE trial were announced in June 2025. Furthermore, the company hosted a virtual Research and Development (R&D) Day in May 2025 to discuss CD388. Regulatory validation is also a key output channel; CD388 was granted Breakthrough Therapy designation by the FDA in October 2025, following its earlier Fast Track Designation in June 2023. Preclinical data supporting CD388 was also highlighted in a Nature Microbiology publication.

Key regulatory/scientific milestones channel updates:

  • FDA Breakthrough Therapy designation granted in October 2025.
  • Phase 2b NAVIGATE top-line data readout in June 2025.
  • End of Phase 2 meeting request submitted to the FDA in June 2025.

Investor roadshows and public offerings to secure defintely needed capital.

Securing capital through public markets is a vital channel to fund the expensive Phase 3 development. The most recent major infusion came from an underwritten public offering that closed in June 2025, which generated gross proceeds of $402.5 million. This was based on the sale of 9,147,727 shares at a price of $44.00 per share, which included the full exercise of the underwriters' option for an additional 1,193,181 shares. This followed an earlier announcement in June 2025 planning for a $250.0 million offering. To be fair, this wasn't the only recent capital event; Cidara Therapeutics, Inc. also raised $105.0 million in a private placement in November 2024, and before that, $240.0 million in April 2024. The company noted that the successful financing in the summer of 2025 provided a balance sheet expected to be sufficient to fully fund the Phase 3 development program through completion.

Capital raised through public channels in 2024-2025:

  • June 2025 Public Offering: $402.5 million gross proceeds.
  • November 2024 Private Placement: $105.0 million gross proceeds.
  • April 2024 Raise: $240.0 million.

The company was added to the Russell 2000® and Russell 3000® Indexes in June 2025, which enhances visibility with the institutional investment community. Finance: draft 13-week cash view by Friday.

Cidara Therapeutics, Inc. (CDTX) - Canvas Business Model: Customer Segments

You're mapping out the core groups Cidara Therapeutics, Inc. (CDTX) targets for its novel drug-Fc conjugate (DFC) therapeutics, and the numbers here show a clear focus on high-need government partnerships and specific patient cohorts, plus a recent, massive shift in the corporate customer segment.

  • Government health and biodefense agencies (e.g., BARDA) focused on pandemic preparedness. This segment is critical for CD388, the non-vaccine influenza preventative. Cidara Therapeutics secured a significant award from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), valued up to $339 million. The initial base contract funding is $58 million, slated to cover 24 months of work, primarily focused on onshoring CD388 manufacturing to the United States and establishing the initial commercial supply chain.
  • Large pharmaceutical companies seeking to license or acquire late-stage assets. This segment materialized in a major way in late 2025. Merck announced its intent to acquire Cidara Therapeutics, Inc., bringing the late-phase antiviral agent into its portfolio. Reports suggest the deal value was tied to a takeover offer of $9.2 billion from MSD (Merck), with an expected commercial opportunity for the flu drug alone exceeding $5 billion.
  • High-risk patient populations (e.g., elderly, immunocompromised) for influenza prevention. The Phase 3 ANCHOR study is centered on these groups. Based on feedback from the U.S. Food and Drug Administration (FDA), the target population was expanded to include generally healthy adults over the age of 65, in addition to those with certain comorbidities or compromised immune status. This expansion more than doubled the potential U.S. eligible population from an initial estimate of 50 million to well over 100 million people. The Phase 2b NAVIGATE trial showed a single 450 milligram dose of CD388 conferred 76.1% protective efficacy. As of September 30, 2025, Cidara Therapeutics, Inc. had a cash position of $476 million to fund this Phase 3 program.
  • Oncology specialists and patients for future DFC candidates like CBO421. This segment is targeted by the immuno-oncology pipeline assets developed using the Cloudbreak® platform. CBO421, which targets CD73 in solid tumors, is currently at the IND-Enabling stage of development, representing 42% progress toward an Investigational New Drug application clearance, which it received in July 2024. For context, Research & Development expenses for the nine months ending September 30, 2025, were $84.9 million.

Here's a quick look at the pipeline assets and their associated customer/development stage as of late 2025:

DFC Candidate Target Indication Customer Segment Focus Development Stage / Progress
CD388 Seasonal/Pandemic Influenza High-Risk/Elderly Patients; Government Agencies Phase 3 (ANCHOR Study)
CBO421 Solid Tumors (CD73) Oncology Specialists and Patients IND-Enabling (42%)
Undisclosed DFC Solid Tumors (CD73/PD-1) Oncology Specialists and Patients Preclinical (22%)

The company's market capitalization as of December 5, 2025, stood at $2.410 B. Still, the primary revenue driver for the near term is non-dilutive funding, like the $58 million base BARDA award, as the company reported annual revenue of only $1.28M in 2024.

Finance: draft 13-week cash view by Friday.

Cidara Therapeutics, Inc. (CDTX) - Canvas Business Model: Cost Structure

You're looking at the major outflows for Cidara Therapeutics, Inc. as they push CD388 through its pivotal Phase 3 trial. For a company in this stage, the cost structure is almost entirely dominated by clinical development and the necessary infrastructure to support it. It's a heavy burn, but it's the price of admission for a potential blockbuster influenza preventative.

The primary cost driver is, without question, Research and Development (R&D). For the third quarter ending September 30, 2025, Cidara Therapeutics reported R&D expenses totaling $35.529 million. This figure represents a significant year-over-year increase, driven by the initiation of the ANCHOR study and associated manufacturing costs for CD388. That quarterly spend is a substantial part of the overall operating expense picture, which led to a net loss of $83.233 million for the quarter.

Here's a breakdown of the key cost components:

  • Heavy Research and Development (R&D) expenses, totaling $35.5 million in Q3 2025.
  • Costs associated with the large-scale Phase 3 ANCHOR clinical trial (6,000 participants).
  • Manufacturing scale-up and supply chain costs for CD388.
  • General and administrative (G&A) and personnel costs to support operations.
  • Milestone payments to partners, such as the $45.0 million paid to Janssen.

The ANCHOR trial itself is a massive undertaking, designed to enroll 6,000 participants across sites in the US and UK. This scale is necessary to support a potential Biologics License Application (BLA) based on this single Phase 3 study. The costs here cover site management, patient recruitment, monitoring, and data collection, all of which are baked into the R&D spend mentioned above.

Manufacturing scale-up is another critical, high-cost area. Cidara Therapeutics is actively working on the supply chain for CD388, which is being supported by non-dilutive funding from a recent award. The company received a Biomedical Advanced Research and Development Authority (BARDA) award valued at up to $339.2 million, with a base of $58.1 million over 24 months, specifically to onshore manufacturing and support development. This funding directly addresses the cost of building out the necessary commercial configuration and process qualification for CD388.

General and administrative (G&A) costs are also notable, reflecting the operational complexity of running a late-stage clinical program. For Q3 2025, G&A expenses were reported at $8.099 million. The increase in G&A was primarily attributed to higher personnel costs, specifically driven by stock-based compensation, though audit fees were lower. Personnel costs are a constant, though Cidara had previously restructured in late 2024 to reduce recurring personnel costs.

Finally, you have the contractual obligations. The initiation of the ANCHOR study triggered a significant, one-time cost: an acquired in-process research and development (IPR&D) expense of $45.0 million recognized in Q3 2025, which is the milestone payment due to Janssen under their license agreement. This payment was scheduled to be paid out in the fourth quarter of 2025.

Here's a quick look at the key financial metrics impacting the cost structure for the period:

Cost/Expense Category Q3 2025 Amount (USD) Driver/Context
Research & Development (R&D) Expenses $35.529 million ANCHOR initiation and CD388 manufacturing costs
General & Administrative (G&A) Expenses $8.099 million Primarily personnel costs/stock-based compensation
Acquired IPR&D Milestone Payment (Janssen) $45.0 million Triggered by dosing first five subjects in ANCHOR
Phase 3 ANCHOR Trial Enrollment Target 6,000 participants Global, multicenter, placebo-controlled study
BARDA Award for Manufacturing Support Up to $339.2 million (Total Value) Supports scale-up and supply chain readiness

Finance: review the Q4 cash forecast to account for the $45.0 million Janssen payment by end of next week.

Cidara Therapeutics, Inc. (CDTX) - Canvas Business Model: Revenue Streams

You're looking at how Cidara Therapeutics, Inc. generates its cash flow as of late 2025. Honestly, for a clinical-stage biotech, the revenue streams are heavily weighted toward non-sales-based funding events right now, which is typical.

The primary non-dilutive funding source is government support for its lead candidate, CD388. This comes through the Biomedical Advanced Research and Development Authority (BARDA) agreement. This contract provides for potential payments by BARDA of up to $339.2 million. This total includes a base period valued at an estimated $58.1 million over 24 months, which is earmarked to fund the onshoring of manufacturing to the United States.

Another critical component of Cidara Therapeutics' financial inflow is milestone payments derived from its strategic partnership with Janssen. Specifically, the initiation of the Phase 3 ANCHOR study triggered a milestone payment of $45.0 million, which Cidara Therapeutics incurred as Acquired IPR&D expenses for the three months ended September 30, 2025, and is expected to be paid to Janssen in the fourth quarter of 2025.

For the nine months ended September 30, 2025, the reported Collaboration revenue, which previously related to R&D and clinical supply services under the terminated Janssen Collaboration Agreement, was $0.

To support its operations and the expanded Phase 3 development program for CD388, Cidara Therapeutics has also relied on equity financing. In the second quarter of 2025, the company closed an upsized public offering, securing gross proceeds of $402.5 million. This transaction significantly strengthened the balance sheet, leading to an increase in other income, net, which totaled $8.9 million for the nine months ended September 30, 2025, primarily from interest income on its larger cash balance.

Regarding royalties on the commercialized antifungal rezafungin, Cidara Therapeutics completed the divestiture of all rezafungin assets to Napp Pharmaceutical Group Limited (an affiliate of Mundipharma) on April 24, 2024. Consequently, financial results related to rezafungin are reported separately as discontinued operations, and no royalty revenue is listed as a current operating revenue stream for the nine months ended September 30, 2025.

Here's a quick look at the key financial drivers impacting the revenue side of the model as of the latest reporting period:

Revenue/Funding Source Category Specific Financial Event/Amount Period/Date Reference
Government Contracts (BARDA) Up to $339.2 million potential total As of Q3 2025
Government Contracts (BARDA Base) Estimated $58.1 million Over the first 24 months
Milestone Payments (Janssen) $45.0 million triggered Upon ANCHOR study dosing (payable Q4 2025)
Equity Financing Gross proceeds of $402.5 million Q2 2025 Public Offering
Collaboration Revenue $0 Nine months ended September 30, 2025
Other Income (Interest) $8.9 million Nine months ended September 30, 2025

You should also note the resulting cash position, which reflects the success of the recent financing efforts:

  • Cash, cash equivalents and restricted cash totaled $516.9 million as of June 30, 2025.
  • Cash position was $476 million as of September 30, 2025.
  • The company is focused on funding the Phase 3 development program through completion with this balance.

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