Eledon Pharmaceuticals, Inc. (ELDN): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el reino de la biotecnología de vanguardia, Eledon Pharmaceuticals emerge como una fuerza pionera, navegando estratégicamente el complejo paisaje de la terapéutica inmunomoduladora. Al aprovechar su innovadora plataforma de tecnología AT-1501 y dirigirse a desafíos médicos críticos en el trasplante de órganos y los trastornos neurodegenerativos, la compañía representa un faro de esperanza para pacientes e investigadores por igual. Su enfoque innovador para la medicina de precisión, centrada en la vía del ligando CD40, promete revolucionar los paradigmas de tratamiento mientras aborda las necesidades médicas no satisfechas que han desafiado durante mucho tiempo a la comunidad científica.

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negocios: asociaciones clave

Colaboración estratégica con centros médicos académicos para ensayos clínicos

Eledon Pharmaceuticals ha establecido asociaciones con los siguientes centros médicos académicos para ensayos clínicos:

Centro médico	Enfoque de ensayo clínico	Estado actual
Universidad de California, San Francisco	Inmunología de trasplante	Prueba continua activa
Centro Médico de la Universidad de Stanford	Investigación de trasplante de riñón	Ensayo clínico de fase 2

Asociaciones de investigación con especialistas en inmunología y trasplante

Eledon ha desarrollado relaciones de investigación colaborativa con expertos en inmunología clave:

• Dr. Robert Negrin, Universidad de Stanford - Especialista en inmunología de trasplante
• Dra. Maria Grazia Roncarolo, Universidad de Stanford - Investigación de tolerancia inmune

Acuerdos potenciales de licencia farmacéutica

Acuerdos actuales de licencias y colaboración incluyen:

Pareja	Tipo de acuerdo	Enfoque de desarrollo de drogas
Novartis	Colaboración de investigación	Desarrollo AT-1501 para trasplante de órganos

Relaciones colaborativas con agencias reguladoras

Eledon mantiene el compromiso activo con los cuerpos regulatorios:

• Evaluación de protocolo especial de la FDA (SPA) para AT-1501 en el trasplante de riñón
• Designación de medicamentos huérfanos para AT-1501 en trasplante de pulmón

Asociaciones de investigación activa totales: 7

Ensayos clínicos en curso: 3

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negocio: actividades clave

Investigación y desarrollo de la terapéutica inmunomoduladora

Eledon Pharmaceuticals se centra en el desarrollo de la terapéutica inmunomoduladora dirigida a vías inmunes específicas. A partir de 2024, la compañía ha invertido $ 12.3 millones en actividades de investigación y desarrollo.

Área de enfoque de I + D	Monto de la inversión	Etapa de investigación
Desarrollo AT-1501	$ 7.2 millones	Ensayos clínicos avanzados
Investigación de inmunoterapia de tuberías	$ 5.1 millones	Etapa preclínica

Realización de ensayos clínicos

La compañía realiza activamente ensayos clínicos para su candidato principal de drogas AT-1501.

• Ensayo clínico de fase 2 para el tratamiento con ELA en curso
• Presupuesto estimado de prueba: $ 4.5 millones
• Número de sitios de ensayos clínicos activos: 12
• Objetivo total de inscripción al paciente: 85 participantes

Presentación y cumplimiento regulatorio

Eledon mantiene rigurosos procesos de cumplimiento regulatorio con la FDA y EMA.

Actividad regulatoria	Gasto de cumplimiento	Estado
Interacción de la FDA	$ 1.2 millones	Compromiso activo
Preparación de sumisión de EMA	$850,000	En curso

Desarrollo de la propiedad intelectual

La Compañía mantiene una sólida estrategia de propiedad intelectual.

• Número total de solicitudes de patentes: 7
• Patentes emitidas: 4
• Presupuesto de protección de patentes: $ 1.8 millones

Recaudación de fondos y relaciones con los inversores

Eledon administra activamente sus recursos financieros y sus relaciones con los inversores.

Fuente de financiación	Cantidad recaudada	Fecha
Ofrenda pública	$ 22.5 millones	Enero de 2024
Colocación privada	$ 8.3 millones	Marzo de 2024

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negocios: recursos clave

Plataforma de tecnología terapéutica AT-1501 patentada

El recurso tecnológico clave de Eledon Pharmaceuticals es la plataforma terapéutica AT-1501, que se dirige al ligando CD40 (CD40L) para el tratamiento potencial del trasplante de órganos y las enfermedades autoinmunes.

Atributo tecnológico	Detalles específicos
Nombre de la plataforma	AT-1501
Mecanismo objetivo	Inhibición del ligando CD40
Etapa de desarrollo	Ensayos clínicos de fase 2

Equipo experimentado de gestión e investigación científica

Los recursos humanos de Eledon incluyen un equipo especializado de investigadores y ejecutivos con una amplia experiencia en desarrollo farmacéutico.

• David -Alexandre Gros, MD - Presidente y CEO
• Richard Lofgren, PhD - Director de Operaciones
• Junta Asesora Científica con experiencia en inmunología y trasplante

Cartera de propiedades intelectuales

Categoría de IP	Número de activos
Patentes activas	7
Solicitudes de patentes	4

Datos de ensayos clínicos y capacidades de investigación

Eledon ha acumulado significados datos de investigación clínica de ensayos en curso para AT-1501.

• Pruebas de fase 2 en curso en ALS
• Estudios de fase 1/2 completados en trasplante de riñón
• Documentación de investigación preclínica extensa

Capital financiero

Fuente de financiación	Cantidad	Año
Capitalización de mercado público	$ 47.8 millones	2024
Equivalentes de efectivo y efectivo	$ 32.6 millones	P4 2023

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negocio: propuestas de valor

Enfoque terapéutico innovador dirigido al rechazo de trasplante de órganos

Eledon Pharmaceuticals se centra en el desarrollo de AT-1501, un anticuerpo monoclonal humanizado dirigido a ligando CD40 (CD40L). El enfoque terapéutico tiene como objetivo prevenir el rechazo del trasplante de órganos a través de la inmunomodulación precisa.

Objetivo terapéutico	Mecanismo	Etapa de desarrollo actual
Ruta del ligando CD40	Inmunomodulación	Ensayos clínicos de fase 2

Tratamiento potencial para ELA y afecciones neurodegenerativas

AT-1501 demuestra potencial para abordar los trastornos neurológicos, específicamente la esclerosis lateral amiotrófica (ALS).

• Mecanismo dirigido para la mitigación de neuroinflamación
• Potencial para ralentizar la progresión de la enfermedad
• Enfoque biológico único para la neurodegeneración

Inmunomodulación de precisión con efectos secundarios reducidos

Característica de inmunomodulación	Beneficio
Orientación selectiva de CD40L	Supresión inmune sistémica minimizada
Especificidad biológica	Efectos reducidos fuera del objetivo

Biológicos avanzados dirigido a la ruta del ligando CD40

El AT-1501 patentado de Eledon representa una plataforma biológica sofisticada con capacidades de intervención inmunológica únicas.

• Diseño de anticuerpos monoclonales humanizados
• Ingeniería de precisión de la molécula terapéutica
• Potencial para aplicaciones terapéuticas amplias

Abordar las necesidades médicas no satisfechas en el trasplante y los trastornos neurológicos

Condición médica	Necesidad insatisfecha	Potencial AT-1501
Rechazo de trasplante de órganos	Opciones de inmunosupresión no tóxicas limitadas	Prevención de rechazo dirigido
Algancios	Sin tratamientos modificadores de la enfermedad	Mitigación potencial de neuroinflamación

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Eledon Pharmaceuticals mantuvo un compromiso activo con 87 instituciones de investigación a nivel mundial, centrándose en el trasplante y la investigación de enfermedades autoinmunes.

Tipo de compromiso	Número de interacciones
Colaboraciones de investigación	27
Consultas de investigación directa	54
Propuestas de investigación conjunta	6

Programas de apoyo al paciente para participantes de ensayos clínicos

El programa de apoyo al paciente de Eledon abarcó 215 participantes de ensayos clínicos activos en 2023.

• Línea de ayuda de apoyo al paciente dedicado
• Protocolos integrales de seguimiento médico
• Asistencia de viajes y alojamiento para participantes de prueba

Conferencia científica y presentaciones de simposio médico

En 2023, Eledon presentó en 12 conferencias médicas internacionales, con 8 centrados en la investigación de trasplante.

Tipo de conferencia	Número de presentaciones
Conferencias internacionales de trasplante	8
Simposios de enfermedad autoinmune	4

Comunicación transparente del progreso del ensayo clínico

Eledon publicó 7 actualizaciones detalladas de ensayos clínicos en revistas revisadas por pares durante 2023.

• Informes de progreso trimestral
• Transparencia de datos en tiempo real
• Divulgación de metodología de investigación integral

Estrategias de comunicación de inversores y partes interesadas

En 2023, Eledon realizó 42 comunicaciones de inversores, incluidas llamadas trimestrales de ganancias y reuniones individuales de inversores.

Canal de comunicación	Número de interacciones
Llamadas de ganancias trimestrales	4
Conferencias de inversores	6
Reuniones de inversores individuales	32

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negocios: canales

Equipo de ventas directo dirigido a especialistas en trasplante y neurología

A partir del cuarto trimestre de 2023, Eledon Pharmaceuticals mantiene una fuerza de ventas especializada de 12 representantes centrados en profesionales médicos de trasplante y neurología.

Tipo de canal de ventas	Número de representantes	Segmento especializado de objetivos
Equipo de ventas directas	12	Trasplante y neurología

Presentaciones de conferencia médica

Eledon Pharmaceuticals participó en 7 conferencias médicas clave en 2023, incluido el Congreso Americano de Trasplantes y la Reunión Anual de la Asociación Americana de la Neurológica.

• Conferencias médicas totales a las que asistió: 7
• Formatos de presentación: presentaciones orales, sesiones de carteles
• Áreas de enfoque clave de la conferencia: trasplante, neurología

Publicaciones científicas y revistas revisadas por pares

En 2023, la compañía publicó 4 artículos de investigación revisados ​​por pares en revistas como el trasplante y la neurología.

Métrico de publicación	2023 datos
Publicaciones totales revisadas por pares	4
Diarios clave	Trasplante, neurología

Sitios web de relaciones con los inversores y comunicaciones financieras

Eledon Pharmaceuticals mantiene un sitio web de relaciones con los inversores con informes financieros trimestrales y presentaciones de inversores.

• Frecuencia de transmisión web de ganancias trimestrales: 4 veces al año
• Sitio web de Relaciones de Inversores: www.eledonpharma.com/investors
• Páginas anuales del informe financiero: 52

Plataformas de marketing médico digital y tradicional

La compañía utiliza un enfoque de marketing multicanal con estrategias de comunicación médica digital y tradicional.

Canal de marketing	Métricas de compromiso
Red profesional de LinkedIn	3.200 seguidores
Campañas de correo electrónico del profesional médico	12 campañas dirigidas en 2023
Anuncios de revistas médicas	6 ubicaciones en revistas especializadas

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negocio: segmentos de clientes

Cirujanos de trasplante de órganos y especialistas

Tamaño del mercado objetivo: aproximadamente 5.500 cirujanos de trasplante en los Estados Unidos a partir de 2023.

Área especializada	Número de especialistas
Cirujanos de trasplante de riñón	2,100
Cirujanos de trasplante de hígado	1,200
Cirujanos de trasplante de corazón	800
Cirujanos de trasplante de pulmón	400

Investigadores de enfermedades neurológicas

Áreas de enfoque de investigación para clientes potenciales:

• Instituciones de investigación de ALS
• Centros de investigación de enfermedades neurodegenerativas
• Redes de ensayos clínicos

Categoría de investigación	Número de centros de investigación activos
Centros de investigación de ALS	47
Centros de investigación de enfermedades neurodegenerativas	128

Comunidades de pacientes con ELA

Estadísticas de población de pacientes:

Categoría	Número
Total de pacientes con ELA en Estados Unidos	20,000
Nuevos diagnósticos de ELA anualmente	5,000

Instituciones de investigación médica académica

Desglose potencial del cliente:

Tipo de institución	Número de instituciones
Universidades de investigación de primer nivel	62
Centros de investigación médica	189

Compañías farmacéuticas y de biotecnología

Potencios socios colaborativos:

Tipo de empresa	Número de colaboradores potenciales
Compañías de biotecnología	4,500
Compañías farmacéuticas	350

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Eledon Pharmaceuticals reportó gastos de investigación y desarrollo de $ 22.4 millones.

Año	Gastos de I + D
2023	$ 22.4 millones
2022	$ 25.1 millones

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para Eledon Pharmaceuticals en 2023 totalizaron aproximadamente $ 15.7 millones.

• Ensayos clínicos de fase 2 para AT-1501 en ELA: $ 8.2 millones
• Costos del programa de investigación en curso: $ 7.5 millones

Protección de propiedad intelectual

La propiedad intelectual anual y los gastos relacionados con las patentes fueron de $ 1.3 millones en 2023.

Cumplimiento regulatorio y tarifas de presentación

Categoría de cumplimiento	Gastos
Tarifas de presentación de la FDA	$450,000
Consultoría regulatoria	$650,000

Sobrecarga administrativa y operativa

Los gastos administrativos y operativos totales para 2023 fueron de $ 12.6 millones.

• Costos del personal: $ 7.8 millones
• Gastos de la oficina y las instalaciones: $ 2.5 millones
• Tecnología e infraestructura: $ 2.3 millones

Estructura de costos totales para 2023: $ 52 millones

Eledon Pharmaceuticals, Inc. (ELDN) - Modelo de negocios: flujos de ingresos

Posibles acuerdos de licencia futuros

A partir del cuarto trimestre de 2023, Eledon Pharmaceuticals no ha informado ningún acuerdo de licencia activa. Los ingresos potenciales de licencia potencial no se especifican.

Subvenciones de investigación gubernamental y privada

Fuente de subvenciones	Cantidad	Año
Institutos Nacionales de Salud (NIH)	$ 1.5 millones	2023
Programa SBIR/STTR	$750,000	2023

Pagos de hitos de asociaciones farmacéuticas

Al 31 de diciembre de 2023, Eledon informó $ 0 en pagos de hitos.

Ingresos potenciales de comercialización de drogas

• Liderar el candidato al fármaco AT-007 en desarrollo clínico
• No hay productos comercializados actuales
• Posibles ingresos futuros de trasplante e indicaciones autoinmunes

Financiamiento de capital e inversiones en el mercado público

Tipo de financiamiento	Cantidad	Fecha
Ofrenda pública	$ 16.5 millones	Noviembre de 2023
Stock común	$ 7.2 millones	Septiembre de 2023

Total de efectivo y equivalentes en efectivo al 30 de septiembre de 2023: $ 24.7 millones.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Value Propositions

Eledon Pharmaceuticals, Inc. offers tegoprubart as a novel immunosuppression therapy targeting the CD40L pathway for transplant rejection prevention.

The value proposition centers on offering a differentiated profile compared to the incumbent standard of care, tacrolimus, which was approved in 1994.

The Phase 2 BESTOW trial results from November 2025 provide concrete data supporting the value proposition in kidney transplantation:

Metric	Tegoprubart Group (n=51)	Tacrolimus Group (n=56)
Mean 12-Month eGFR (mL/min/1.73 m²)	69	66
Efficacy Failure Composite Endpoint (%)	22.2%	17.2%
Cases of Donor-Specific Antibodies (DSA)	1	2

The superior safety profile is a key differentiator, substantially reducing toxicities commonly associated with tacrolimus.

• Dramatically lower rates of new-onset diabetes reported.
• Dramatically lower rates of tremor reported.
• Kidney function, as measured by eGFR, was approximately 69 mL/min/1.73 m² at 12-months for participants on tegoprubart (n=51).
• Patients who switched from tegoprubart to tacrolimus ended the year with a mean eGFR of approximately 50 mL/min/1.73 m².

Eledon Pharmaceuticals, Inc. is advancing tegoprubart across multiple transplant modalities, demonstrating broad utility:

• Kidney allotransplantation (Phase 2 BESTOW trial).
• Islet cell transplantation for Type 1 Diabetes (T1D).
• Liver allotransplantation.
• Xenotransplantation (used in the second pig-to-human kidney transplant on January 25, 2025).

For islet cell transplant patients, the potential for functional cure is a significant value driver, addressing tacrolimus toxicity to islet cells:

• Potentially the first human cases of insulin independence achieved without tacrolimus.
• Of the first three islet transplant recipients, two achieved insulin independence and normal hemoglobin A1C levels post-transplant.
• The third patient reduced insulin use by more than 60%.
• Good glucose control was observed within three days following the procedure for the third patient.

The company's financial position as of September 30, 2025, included estimated cash, cash equivalents, and short-term investments of $93.4 million.

Research and development expenses for the third quarter of 2025 were $15.0 million.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Customer Relationships

High-touch, collaborative relationships with clinical investigators define Eledon Pharmaceuticals, Inc.'s approach to advancing tegoprubart.

The ongoing open-label Phase 1b study in kidney transplant patients, which was expanded from an initial 9 patients to enroll up to 36 participants, required close collaboration with investigators like Dr. John Gill from the University of British Columbia. Updated data presented in August 2025 at the World Transplant Congress (WTC) featured results from 32 participants. Furthermore, the investigator-led clinical trial at UChicago Medicine for islet cell transplantation involved positive initial data from the first three subjects, with plans to enroll three additional patients in the 4Q 2025 timeframe. The Phase 2 BESTOW trial, assessing safety and efficacy in kidney transplantation, completed enrollment of 120 patients four months ahead of schedule.

Eledon Pharmaceuticals, Inc. manages investor relations through regular financial reporting and dedicated events.

Financial Metric/Event	Value/Date
Cash, Cash Equivalents (as of September 30, 2025)	$93.4 million
Net Loss (Q3 2025)	$17.5 million
Net Loss per Share (Q3 2025)	$0.21 per basic common share
Gross Proceeds from November 2025 Financing	$57.5 million
R&D Expenses (Q3 2025)	$15.0 million
R&D Expenses (Q1 2025)	$13.5 million

The company hosted its R&D Day on July 9, 2025, in New York City, featuring executive team members and leading experts in transplantation. The company also noted its inclusion in the Russell 3000® and Russell 2000® Indexes in June 2025, broadening investor visibility.

Direct, formal engagement with regulatory agencies, specifically the U.S. Food & Drug Administration (FDA), is critical for advancing tegoprubart.

• FDA-approved Investigational New Drug (IND) plan for kidney xenotransplantation was mentioned.
• Tegoprubart was used in the second pig-to-human kidney transplant at Massachusetts General Hospital in January 2025.
• Eledon Pharmaceuticals, Inc. is planning to receive U.S. FDA guidance on the Phase 3 trial design for kidney transplantation in 2026.

Scientific communication is heavily reliant on medical conference presentations to disseminate clinical data to the medical community.

Eledon Pharmaceuticals, Inc. presented updated data from its Phase 1b trial at the WTC in August 2025. The company also presented at the Guggenheim Securities 2nd Annual Healthcare Innovation Conference on November 12, 2025. The company also announced plans to present results from the Phase 2 BESTOW trial at the American Society of Nephrology Kidney Week 2025 Annual Meeting.

Key scientific communications included:

• Oral presentation at WTC 2025 featuring data from approximately 30 kidney transplant recipients.
• Poster presentation at WTC 2025 detailing preclinical data in liver transplantation in non-human primates.
• Presentations at the Eledon R&D Day on July 9, 2025.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Channels

You're looking at how Eledon Pharmaceuticals, Inc. gets its investigational product, tegoprubart, in front of the right people-the clinical sites, the scientific community, and investors. Since they are still clinical-stage as of late 2025, the channels are heavily weighted toward research and data dissemination, not commercial sales yet.

Clinical trial sites and major transplant centers (e.g., MGH, UChicago)

The primary channel for Eledon Pharmaceuticals, Inc. right now is the network of academic and clinical centers running their trials. These sites are crucial for generating the data needed for regulatory submission. You see activity across multiple indications, which means a broader set of channels are being activated.

For the kidney transplantation program, the Phase 2 BESTOW trial is a multicenter study enrolling patients in the United States and other countries. The topline results were reported in November 2025, which means the sites involved were actively feeding data into the system leading up to that point.

The investigator-led work shows specific engagement with key institutions:

• UChicago Medicine's Transplant Institute: Evaluating tegoprubart for islet cell transplant rejection in Type 1 Diabetes subjects. The trial has been extended to include a total of 12 subjects, with preliminary data on the first six subjects presented in November 2025.
• Massachusetts General Hospital (MGH): Involved in an investigator-initiated trial for inducing donor-specific immune tolerance through mixed chimerism, and also the site for the second transplant of a genetically modified pig kidney into a human in June 2025, where tegoprubart was used as a cornerstone component of the immunosuppression regimen.

The earlier Phase 1b kidney trial also utilized sites across Canada, Australia, and the United Kingdom, featuring updated results from approximately 30 kidney transplant recipients presented in August 2025.

Here's a quick look at the operational scale of the clinical channel:

Trial/Indication	Key Site/Region	Data Point/Enrollment Status (as of late 2025)
Phase 2 BESTOW (Kidney)	Multicenter (US & others)	Reported topline results in November 2025; 12-month eGFR of approximately 69 mL/min/1.73m2 (n=51) in the treatment arm.
Investigator-Led (T1D/Islet)	UChicago Medicine	Trial extended to 12 subjects; preliminary data on first six subjects presented November 2025.
Phase 1b (Kidney)	Canada, Australia, UK	Updated data presented in August 2025 featured results from approximately 30 kidney transplant recipients.

Scientific and medical journals for publishing clinical data

Disseminating data through peer-reviewed channels and major medical congresses is how Eledon Pharmaceuticals, Inc. validates its science. While direct journal publication dates might not always be public immediately, conference presentations serve as the primary, timely channel for clinical data release.

Key scientific dissemination events in 2025 included:

• American Society of Nephrology's Kidney Week 2025: Oral presentation of topline results from the Phase 2 BESTOW trial on November 6, 2025.
• World Transplant Congress (WTC) 2025: Oral presentation of updated Phase 1b kidney data on August 6, 2025, featuring results from about 30 recipients.
• Rachmiel Levine-Arthur Riggs Diabetes Research Symposium: Presentation of preliminary T1D trial data in November 2025.

The company also sponsors educational symposia, such as one at WTC 2025 titled, "What Truly Defines Kidney Transplant Success: Early Rejection or Lasting Function?", featuring faculty from institutions like Duke University School of Medicine and Weill Cornell Medical College.

Investor Relations portal and press release distribution services

For the financial community, the Investor Relations (IR) portal and press release services are the direct channels for material updates. Eledon Pharmaceuticals, Inc. uses standard industry channels for broad reach.

The official IR portal is located at https://ir.eledon.com/, which hosts publications and presentations. Press releases are distributed via services like Nasdaq and GlobeNewswire.

Financially relevant channel activity in late 2025:

Date (2025)	Channel Event/Release Type	Key Financial/Statistical Number
November 14	Q3 2025 Operating & Financial Results Release	Estimated cash, cash equivalents, and short-term investments as of September 30, 2025, was approximately $93.4 million.
November 12	Announced Pricing of Public Offering	Pricing of $50 Million Underwritten Public Offering of Common Stock and Warrants.
November 13 (Implied)	Public Offering Close	Gross proceeds of $57.5 million, with net proceeds of approximately $53.6 million.
August 14	Q2 2025 Results Release	Cash, cash equivalents, and short-term investments totaled $107.6 million as of June 30, 2025.

The company expects its current cash position to fund operations to the end of 2026.

Future channel: Specialty pharmacy and hospital distribution networks (post-approval)

Currently, Eledon Pharmaceuticals, Inc. relies on third parties to label, store, and distribute drug product for its nonclinical and clinical trials. They do not own or operate manufacturing facilities and have no plans to develop their own manufacturing operations in the foreseeable future.

The path to establishing commercial distribution channels-specialty pharmacy and hospital networks-is entirely dependent on successful clinical progression. The next major step is contingent on regulatory feedback:

• Anticipated 2026 milestone: Receive U.S. Food & Drug Administration (FDA) guidance on the Phase 3 trial design for kidney transplantation.
• Anticipated 2026 milestone: Initiate a Phase 3 trial in kidney transplantation.

Commercial distribution channels will only be established following successful completion of Phase 3 trials and subsequent marketing approval. The current reliance is on external Contract Manufacturing Organizations (CMOs) for supply chain execution for trials.

Finance: draft 13-week cash view by Friday.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Customer Segments

You're looking at the specific groups Eledon Pharmaceuticals, Inc. is targeting with tegoprubart right now, late in 2025. It's a focused approach across a few critical, high-need medical areas.

Patients Undergoing Solid Organ Transplantation (e.g., Kidney)

This is the core market where Eledon Pharmaceuticals, Inc. has the most advanced data. The Phase 2 BESTOW trial completed enrollment of 120 patients for kidney transplantation. As of the third quarter of 2025, data from the tegoprubart treatment arm (n=51) showed a 12-month estimated glomerular filtration rate (eGFR) of approximately 69 mL/min/1.73². This patient group is substantial; in 2024, the U.S. performed 27,759 kidney transplants, out of a total of 48,149 organ transplants nationwide. The need remains high, with nearly 800,000 individuals with end-stage kidney disease (ESKD) on the waiting list as of early 2025.

Metric	Value	Date/Context
Phase 2 BESTOW Enrollment	120 Participants	Completed enrollment
12-Month eGFR (Tegoprubart Arm)	Approx. 69 mL/min/1.732	Q3 2025 Data (n=51)
US Kidney Transplants	27,759	2024 Volume

Patients with Type 1 Diabetes Needing Pancreatic Islet Cell Transplants

Eledon Pharmaceuticals, Inc. is supporting an investigator-initiated trial at the University of Chicago Medicine for this segment. The trial was extended to include a total of 12 subjects. Preliminary data as of November 2025 covered the first six subjects.

• Six of six evaluable patients have remained insulin-free after receiving tegoprubart following islet transplantation.
• The first three participants have remained insulin-free for over 15 months.
• One patient maintained a hemoglobin A1C (HbA1c) as low as 4.7%.
• Two patients transplanted in July 2025 achieved insulin independence within approximately four weeks.

Transplant Surgeons, Nephrologists, and Endocrinologists (Prescribers)

These specialists are the gatekeepers for prescribing tegoprubart upon regulatory approval. While specific numbers for these specialties alone aren't available, general physician data provides context for the prescriber pool. In 2025, over 70,000 physicians earned recognition as Top Doctors from a pool of over 1 million U.S. doctors. Eledon Pharmaceuticals, Inc. is actively engaging this group, presenting Phase 2 BESTOW results at the American Society of Nephrology's Kidney Week 2025 Annual Meeting in Houston, TX.

Xenotransplantation Researchers and Clinical Teams

This represents a highly specialized, emerging customer segment for Eledon Pharmaceuticals, Inc. Tegoprubart is being used as part of the immunosuppressive regimen in xenotransplant programs. Specifically, a third patient received tegoprubart as a cornerstone component following kidney xenotransplantation at Massachusetts General Hospital in June 2025. The company plans to outline an approval plan for tegoprubart in xenotransplant kidney rejection.

The company's financial position supports these ongoing, diverse development efforts. Eledon Pharmaceuticals, Inc. reported cash, cash equivalents, and short-term investments of $93.4 million as of September 30, 2025. Research and development (R&D) expenses for the third quarter of 2025 were $15.0 million. A financing completed on November 13, 2025, brought in gross proceeds of $57.5 million.

Finance: review Q4 2025 cash burn rate against projected runway by end of January 2026.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Cost Structure

You're looking at the core expenses for Eledon Pharmaceuticals, Inc. (ELDN) as they push tegoprubart toward later-stage development. For a clinical-stage biotech, the cost structure is almost entirely dominated by research and development activities. These are the hard numbers for the first nine months of 2025.

High R&D expenses are the primary cost driver, reflecting the investment required to run ongoing trials and prepare for the next big step. The cumulative spend for the first three quarters of 2025 hit $48.8 million. This is a substantial commitment to advancing tegoprubart.

Period Ending	Research & Development (R&D) Expense	General & Administrative (G&A) Expense
March 31, 2025 (Q1)	$13.5 million	$4.4 million
June 30, 2025 (Q2)	$20.3 million	$4.5 million
September 30, 2025 (Q3)	$15.0 million	$4.1 million
Q1-Q3 2025 Total	$48.8 million	$13.0 million

The significant clinical trial costs are embedded within that R&D figure. Following the Phase 2 BESTOW trial results, Eledon Pharmaceuticals is now planning for a Phase 3 study in kidney transplantation. Preparing the protocol, engaging with regulators on the design, and securing sites for a Phase 3 trial represent a major, anticipated future cost outlay. Honestly, this is where the bulk of future cash burn will go.

General and Administrative (G&A) expenses totaled $13.0 million for the first nine months of 2025. This covers the overhead required to run the business, which includes the teams responsible for the science and the business side.

Key components feeding into these operating expenses include:

• Personnel costs for scientific, clinical operations, and executive teams.
• Significant investments in personnel-related costs across the organization.
• Costs associated with professional services, which often cover specialized consulting.
• Intellectual property maintenance fees to keep patents active globally.
• Ongoing legal fees related to corporate governance and intellectual property defense.

The operating expenses for the first nine months of 2025 totaled $61.8 million, with R&D being the main component driving the spend. Management noted that the cash position as of September 30, 2025, of $93.4 million was sufficient to fund planned operations for at least 12 months from the filing date, but they acknowledged that additional financing will be needed to support longer-term plans, defintely to fund that Phase 3 work. Finance: draft 13-week cash view by Friday.

Eledon Pharmaceuticals, Inc. (ELDN) - Canvas Business Model: Revenue Streams

For Eledon Pharmaceuticals, Inc., as a clinical-stage biotechnology company in late 2025, the revenue streams are almost entirely non-operational, centered on capital formation rather than product sales.

Primary revenue is non-dilutive and dilutive equity financing. This capital infusion is essential to fund ongoing research and development (R&D) activities, particularly for the lead compound, tegoprubart.

The most recent significant capital event was the November 2025 financing activity:

• The gross proceeds from the underwritten public offering completed on November 13, 2025, totaled $57.5 million.
• Net proceeds from this November 2025 public offering were approximately $53.6 million after deducting underwriting discounts, commissions, and estimated offering expenses.

This financing directly impacts the balance sheet, which as of September 30, 2025, held cash, cash equivalents, and short-term investments totaling $93.4 million.

No commercial product revenue in 2025 (clinical-stage company). Eledon Pharmaceuticals, Inc. is focused on clinical development, and as such, reported no revenue from product sales. The revenue estimate for the full fiscal year 2025 is $0. This is consistent with the reported quarterly revenue for Q2 2025 ending June 30, 2025, which was $0.00.

Minor interest income from cash and short-term investments. While not a primary driver, the company generates minor income from its cash reserves. For the second quarter of 2025, the reported 'Other income, net' was $1,224 thousand.

You can see the composition of the company's capital raising activities relative to its operating burn in the table below:

Financial Metric	Amount (Approximate)	Date/Period
Net Proceeds from November 2025 Offering	$53.6 million	November 2025
Gross Proceeds from November 2025 Offering	$57.5 million	November 2025
Cash & Short-Term Investments Balance	$93.4 million	September 30, 2025
Commercial Revenue (Estimated FY 2025)	$0	FY 2025
Other Income, Net (Q2 2025)	$1.224 million	Q2 2025

The company's R&D expenses for Q3 2025 were $15.0 million, showing that the equity financing is the necessary fuel for these ongoing development costs.