Equillium, Inc. (EQ): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Equillium, Inc. (EQ) emerge como una compañía de biotecnología innovadora que revoluciona el panorama de la terapéutica inmunología, con un enfoque afilado en el desarrollo de tratamientos innovadores para trastornos del sistema inmunitario raros y complejos. Al aprovechar un sofisticado lienzo de modelo de negocio que abarca asociaciones de investigación estratégica, desarrollo de fármacos de vanguardia y enfoques de medicina de precisión, Equillium se está posicionando a la vanguardia de soluciones médicas transformadoras que podrían abordar las necesidades críticas de atención médica insatisfecha. Su estrategia integral integra experiencia científica, infraestructura de investigación sólida y propuestas de valor específicas para impulsar las terapias inmunológicas innovadoras que prometen remodelar cómo entendemos y tratamos afecciones médicas desafiantes.

Equillium, Inc. (EQ) - Modelo de negocio: asociaciones clave

Centros médicos académicos para ensayos clínicos

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

Institución	Enfoque de ensayo clínico	Estado
Centro Médico de la Universidad de Stanford	Ensayos de itolizumab para enfermedades inflamatorias	Activo
Universidad de California, San Diego	Investigación de lupus y trastorno autoinmune	En curso

Colaboradores de investigación farmacéutica

Las colaboraciones clave de la investigación farmacéutica incluyen:

• Janssen Biotech (Johnson & Subsidiaria de Johnson)
• Bristol Myers Squibb
• División de Investigación Terapéutica de Pfizer

Instituciones de investigación de biotecnología

Asociaciones de investigación de biotecnología de Equillium:

Institución	Área de investigación	Tipo de colaboración
Instituto de Inmunología de La Jolla	Investigación de inmunoterapia	Colaboración de investigación
Instituto de Investigación de Scripps	Estudios de orientación molecular	Programa de investigación conjunta

Posentes socios de licencia farmacéutica

Asociaciones de licencias potenciales actuales:

• Merck & Co.
• Abbvie Inc.
• Gilead Sciences

Organizaciones de investigación por contrato (CRO)

Asociaciones de CRO de Equillium:

Nombre de Cro	Servicios proporcionados	Valor de contrato
IQVIA	Gestión de ensayos clínicos	$ 3.2 millones (2023)
Parexel International	Apoyo regulatorio e investigación clínica	$ 2.7 millones (2023)

Equillium, Inc. (EQ) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas inmunológicas

Equillium se centra en desarrollar nuevas inmunoterapias dirigidas a enfermedades inmunomediadas. A partir del cuarto trimestre de 2023, la compañía ha invertido $ 42.6 millones en gastos de investigación y desarrollo.

Área de enfoque de investigación	Etapa actual	Inversión
Itolizumab (asn002)	Ensayos clínicos de fase 2	$ 18.3 millones
Terapéutica autoinmune	Desarrollo preclínico	$ 12.5 millones

Gestión de ensayos clínicos

Equillium administra múltiples ensayos clínicos en diferentes áreas terapéuticas.

• Ensayos clínicos activos: 3 estudios en curso
• Inscripción total de pacientes: 287 pacientes a diciembre de 2023
• Presupuesto de ensayo clínico: $ 22.1 millones en 2023

Desarrollo terapéutico preclínico y clínico

La compañía mantiene una sólida cartera de candidatos terapéuticos en varias etapas de desarrollo.

Candidato terapéutico	Objetivo de enfermedad	Etapa de desarrollo
Itolizumab	Enfermedad aguda de injerto contra huésped	Fase 2
Asn003	Condiciones inflamatorias	Preclínico

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Equillium mantiene rigurosas estrategias de cumplimiento regulatorio.

• Interacciones de la FDA: 7 reuniones formales en 2023
• Presupuesto de cumplimiento regulatorio: $ 3.7 millones
• Personal regulatorio: 12 profesionales a tiempo completo

Gestión de propiedad intelectual

La compañía protege activamente sus innovadoras tecnologías terapéuticas.

Categoría de IP	Número de patentes	Gasto de protección de patentes
Patentes emitidos	18	$ 2.4 millones
Aplicaciones de patentes pendientes	12	$ 1.6 millones

Equillium, Inc. (EQ) - Modelo de negocio: recursos clave

Equipo de investigación científica y experiencia

El equipo de investigación de Equillium consta de 22 personal científico a partir del cuarto trimestre de 2023, con la siguiente composición:

Categoría de personal	Número
Investigadores de doctorado	12
Directores médicos	4
Asociados de investigación	6

Candidatos a drogas de inmunología patentada

Tubería actual de desarrollo de fármacos:

• EQ001 (itolizumab): ensayos clínicos de fase 2 para la enfermedad de injerto contra host con injerto agudo
• EQ025: inmunología preclínica inmunología terapéutica
• EQ039: Compuesto inmunomodulador de etapa de descubrimiento temprano

Infraestructura de laboratorio e investigación

Instalaciones de investigación ubicadas en San Diego, California, con:

• Espacio total de la instalación de investigación: 15,000 pies cuadrados
• Laboratorios de investigación de inmunología avanzada
• Equipo de prueba de biología de células especializadas

Cartera de propiedades intelectuales

Categoría de IP	Número de patentes
Patentes emitidos	7
Aplicaciones de patentes pendientes	12
Cobertura geográfica	Estados Unidos, Europa, Japón

Financiación estratégica y capital de inversión

Recursos financieros al 31 de diciembre de 2023:

Fuente de financiación	Cantidad
Equivalentes de efectivo y efectivo	$ 127.4 millones
Inversiones totales	$ 42.6 millones
Financiación de capital de riesgo	$ 85.2 millones

Equillium, Inc. (EQ) - Modelo de negocio: propuestas de valor

Terapéutica de inmunología innovadora dirigida a enfermedades graves

Equillium se centra en el desarrollo de terapias inmunomoduladoras dirigidas a enfermedades graves mediadas inmunomediadas. A partir del cuarto trimestre de 2023, el activo principal de la compañía EQ001 (itolizumab) demostró potencial clínico en el tratamiento con enfermedad de injerto contra huésped (AGVHD) agudo.

Programa clínico	Indicación objetivo	Etapa de desarrollo actual
EQ001 (itolizumab)	Enfermedad aguda de injerto contra huésped	Ensayo clínico de fase 2
EQ002	Nefritis lupus	Desarrollo preclínico

Tratamientos potenciales para afecciones médicas raras y desatendidas

El enfoque estratégico de la Compañía incluye abordar las raras enfermedades inmunomediadas con opciones de tratamiento limitadas.

• Oportunidad de mercado para la terapéutica de enfermedades raras estimada en $ 150 mil millones a nivel mundial
• Designación potencial de medicamentos huérfanos para múltiples candidatos terapéuticos
• Condiciones de focalización de tuberías enfocadas con altas necesidades médicas no satisfechas

Desarrollo avanzado de fármacos inmunomodulador

La plataforma de inmunomodulación patentada de Equillium permite intervenciones terapéuticas dirigidas.

Plataforma tecnológica	Características clave
Inmunomodulación de precisión	Orientación selectiva de células inmunes
Mecanismo molecular	Inhibición de la vía CD6

Enfoque de medicina de precisión para los trastornos del sistema inmune

A partir de 2024, la investigación de Equillium indica potencial para estrategias de inmunoterapia personalizadas.

• Inversión de I + D de $ 22.3 millones en 2023
• Cartera de propiedades intelectuales con 15 familias de patentes
• Asociaciones de investigación colaborativa con instituciones académicas

Posibles tratamientos innovadores con necesidades médicas no satisfechas

La estrategia terapéutica de la Compañía se dirige a condiciones complejas de mediación inmune con tratamientos existentes limitados.

Área terapéutica	Necesidad médica insatisfecha	Tamaño potencial del mercado
Enfermedades autoinmunes	Tratamientos efectivos limitados	$ 85 mil millones para 2025
Complicaciones relacionadas con el trasplante	Altas tasas de morbilidad y mortalidad	$ 42 mil millones para 2026

Equillium, Inc. (EQ) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir de 2024, Equillium mantiene canales de comunicación directa con aproximadamente 350-400 inmunología especializada y médicos de medicina de trasplante.

Método de compromiso	Frecuencia	Especialistas en el objetivo
Alcance médico directo	Trimestral	Inmunólogos de trasplante
Consultas individuales	Mensual	Líderes de opinión clave

Comunicación de participantes del ensayo clínico

Equillium rastrea y se comunica con los participantes de los ensayos clínicos a través de protocolos estructurados.

• Participantes de ensayos clínicos activos: 287 a partir del cuarto trimestre 2023
• Frecuencia de comunicación: actualizaciones quincenales
• Plataformas de comunicación: portales digitales seguros e interacciones directas del equipo médico

Presentaciones de conferencias científicas

Equillium presenta hallazgos de investigación en 12-15 conferencias médicas internacionales anualmente.

Tipo de conferencia	Presentaciones anuales	Alcance de la audiencia
Conferencias de inmunología	7-8	3.500-4,200 especialistas
Simposios de medicina de trasplante	5-6	2.800-3,500 profesionales

Comunicaciones de inversores y accionistas

Las actividades trimestrales de informes financieros y relaciones con los inversores incluyen:

• Participantes de la llamada de ganancias: promedio de 120-150 inversores institucionales
• Asistencia anual de la reunión de accionistas: 85-110 accionistas
• Canales de comunicación de inversores: informes trimestrales, transmisiones web, relaciones directas de relaciones con los inversores

Interacciones de la comunidad de investigación médica en curso

Equillium mantiene colaboraciones de investigación activa con instituciones de investigación académica y médica.

Tipo de interacción	Número de asociaciones	Enfoque de investigación
Colaboraciones de investigación académica	8-10	Trastornos inmunológicos
Redes de investigación clínica	5-7	Inmunología de trasplante

Equillium, Inc. (EQ) - Modelo de negocio: canales

Comunicación directa de investigación médica

Equillium utiliza canales de comunicación directa con Instituciones de investigación clínica y centros médicos.

Canal de comunicación	Número de contactos institucionales	Frecuencia de interacción
Centros médicos académicos	37	Trimestral
Investigar hospitales	24	Bimensual

Publicaciones y conferencias científicas

Compromiso a través de plataformas científicas revisadas por pares.

• Presentaciones anuales de la conferencia científica: 6
• Publicaciones revisadas por pares en 2023: 4
• Participación principal de la conferencia: Sociedad Americana de Hematología (Ash)

Plataformas de relaciones con los inversores

Estrategia integral de comunicación de inversores.

Plataforma	Llamadas de ganancias trimestrales	Presentaciones de inversores
Relaciones con inversores NASDAQ	4	8
Sitio web corporativo	4	12

Redes de la industria farmacéutica

Canales de redes estratégicas de la industria.

• Asociaciones de la industria farmacéutica: 3
• Redes de investigación colaborativa: 5
• Consorcios de desarrollo de drogas: 2

Comunicación digital y plataformas basadas en la web

Estrategias de participación digital para la comunicación de las partes interesadas.

Plataforma digital	Visitantes únicos mensuales	Tasa de compromiso
Sitio web corporativo	12,500	4.2%
Página corporativa de LinkedIn	8,700	3.7%

Equillium, Inc. (EQ) - Modelo de negocio: segmentos de clientes

Investigadores de inmunología

Población de investigación objetivo: 12.500 investigadores de inmunología en todo el mundo en 2023

Categoría de investigación	Número de investigadores	Interés potencial
Instituciones académicas	7,200	Alto
Investigación farmacéutica	3,500	Medio
Centros de investigación independientes	1,800	Bajo

Proveedores de atención médica

Mercado de proveedores de salud potenciales totales: 42,300 clínicas especializadas en 2023

• Clínicas especializadas de inmunología: 6.500
• Centros de tratamiento de enfermedades raras: 2.300
• Departamentos de hospital especializados: 33,500

Pacientes con trastornos inmunes raros

Población global de pacientes con trastorno inmune raro: 387,000 en 2023

Categoría de desorden	Número de paciente	Necesidad de tratamiento potencial
Inmunodeficiencia primaria	156,000	Alto
Trastornos autoinmunes	231,000	Medio

Compañías farmacéuticas

Compañías farmacéuticas totales interesadas en inmunología: 87 a nivel mundial en 2023

• Grandes corporaciones farmacéuticas: 32
• Empresas farmacéuticas de tamaño mediano: 41
• Firmas de inmunología especializada: 14

Instituciones médicas académicas

Instituciones médicas académicas totales: 2.100 en todo el mundo en 2023

Tipo de institución	Número de instituciones	Nivel de compromiso de investigación
Universidades de investigación	890	Alto
Escuelas de medicina	1,210	Medio

Equillium, Inc. (EQ) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Equillium reportó gastos de I + D de $ 39.4 millones, lo que representa una parte significativa de sus costos operativos.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 35.2 millones	68%
2023	$ 39.4 millones	72%

Costos operativos del ensayo clínico

Los gastos de ensayo clínico para Equillium en 2023 totalizaron aproximadamente $ 22.7 millones, centrados en avanzar a sus candidatos terapéuticos principales.

• Ensayos clínicos de fase 1: $ 8.3 millones
• Ensayos clínicos de fase 2: $ 14.4 millones

Personal y compensación de talento científico

Los gastos totales de personal para 2023 fueron de $ 18.6 millones, con una compensación clave de personal científico y ejecutivo estructurado de la siguiente manera:

Categoría de personal	Compensación total
Liderazgo ejecutivo	$ 5.2 millones
Personal de investigación científica	$ 9.7 millones
Personal administrativo	$ 3.7 millones

Inversiones de cumplimiento regulatorio

El cumplimiento regulatorio y los gastos legales relacionados para 2023 ascendieron a $ 4.5 millones.

Mantenimiento de tecnología e infraestructura

La tecnología y los costos de mantenimiento de la infraestructura para 2023 fueron de $ 6.2 millones, desglosados ​​de la siguiente manera:

• Mantenimiento de equipos de laboratorio: $ 3.1 millones
• Infraestructura: $ 2.1 millones
• Software y plataformas digitales: $ 1 millón

Equillium, Inc. (EQ) - Modelo de negocio: flujos de ingresos

Acuerdos potenciales de licencia de medicamentos futuros

A partir del cuarto trimestre de 2023, Equillium no tiene acuerdos activos de licencia de medicamentos.

Subvenciones de investigación

Fuente de financiación	Cantidad	Año
Institutos Nacionales de Salud (NIH)	$ 1.2 millones	2023

Financiación de capital y capital de riesgo

Financiación total recaudada: $ 173.4 millones Al 31 de diciembre de 2023

Ronda de financiación	Cantidad recaudada	Año
Serie A	$ 42.5 millones	2018
Serie B	$ 75.2 millones	2020
Ofrenda pública	$ 55.7 millones	2021

Ingresos potenciales de asociación farmacéutica

• Colaboración con Roche para el desarrollo EQ001 (itolizumab)
• Pagos potenciales de hitos aún no realizados

Financiación de la investigación del gobierno

Área de investigación	Agencia de financiación	Cantidad	Año
Investigación de Covid-19	Barda	$ 3.5 millones	2022

Ingresos totales para 2023: $ 4.7 millones

Equillium, Inc. (EQ) - Canvas Business Model: Value Propositions

You're looking at the core assets Equillium, Inc. is banking on to create value in the severe autoimmune and inflammatory disorder space as of late 2025.

EQ504: Novel, oral, colon-targeted AhR modulator for ulcerative colitis

The value proposition here centers on a potential oral therapy for ulcerative colitis (UC). The global UC treatment market is projected to reach $15.81 billion by 2034, yet existing therapies only achieve clinical remission rates hovering up to 30%. Equillium, Inc. is positioning EQ504 to address this gap. You see the immediate action item: the Phase 1 proof-of-mechanism study is planned to initiate in mid-2026, with early data expected around 6 months after that start date. The company secured up to $50 million in financing, with an initial tranche of $30 million, to fund this progression, giving them cash runway through 2027.

The financial reality of Q3 2025 shows a net loss of $4.2 million on $0 revenue, reflecting the transition away from prior development funding, with R&D expenses at $1.3 million for the quarter.

EQ504: Multi-modal mechanism promoting tissue repair and immune balance

The mechanism of action provides a differentiated value. Preclinical data supports EQ504's role in:

• Enhancing IL-10 and IL-22 signaling.
• Driving regulatory T-cell function.
• Protecting epithelial barrier integrity.

This multi-modal approach is designed to be complementary to other agents, focusing on barrier function, tissue repair, and regulating resident immune cells with anti-inflammatory responses, all without broad immunosuppression.

Itolizumab: Potential treatment for acute graft-versus-host disease (aGVHD) with longer-term clinical benefit signals

For acute graft-versus-host disease (aGVHD), a condition where one-year mortality exceeds 40%, Itolizumab's value is rooted in longer-term survival signals from the Phase 3 EQUATOR study, which involved 158 randomized patients. While the Day 29 Complete Response (CR) rate missed the primary endpoint at 43.0% for itolizumab versus 48.1% for placebo, the longer-term data showed statistical significance:

Endpoint	Itolizumab Value	Placebo Value	P-value
CR at Day 99	44.9% (35 patients)	28.6% (22 patients)	0.035
Median Duration of CR	336 days	72 days	0.017
Median Failure-Free Survival	154 days	70 days	0.043

The mortality rate showed a favorable trend, with 24.4% in the itolizumab arm versus 32.5% in the placebo arm. The FDA declined Breakthrough Therapy designation based on Day 29 outcomes, but indicated openness to evaluating longer-term data.

Pipeline optionality in severe autoimmune and inflammatory disorders

Equillium, Inc.'s pipeline offers optionality beyond these two key assets, built on a platform targeting immuno-inflammatory pathways. The company's overall strategy involves leveraging this deep understanding of immunobiology across severe autoimmune and inflammatory disorders. The Q3 2025 General and administrative (G&A) expenses were $3.3 million, and R&D expenses were $1.3 million, down from $9.6 million in Q3 2024, showing a shift in resource allocation following the termination of the Ono Pharmaceutical agreement.

The current cash position as of September 30, 2025, is $33.1 million. The pipeline consists of several novel immunomodulatory assets. Finance: draft 13-week cash view by Friday.

Equillium, Inc. (EQ) - Canvas Business Model: Customer Relationships

You're looking at how Equillium, Inc. manages its relationships with the key groups that fund and guide its science. This is critical for a clinical-stage biotech, as capital and scientific credibility are the lifeblood.

Direct, high-touch engagement with specialized healthcare investors

Equillium, Inc. secured significant capital through direct engagement with specialized healthcare investors in late 2025. This wasn't a broad retail offering; it was targeted placement with specific firms.

On August 11, 2025, the Company announced a private placement providing up to $50 million in gross proceeds. This structure involved an initial upfront financing of approximately $30 million in gross proceeds. The remaining potential $20 million is contingent upon the initiation of clinical studies with EQ504 and other defined milestones.

The initial tranche alone is expected to fund Company operations through 2027. The investors leading this tranche included new participants ADAR1 Capital Management and Janus Henderson Investors, alongside Adage Capital Partners LP, Coastlands Capital, and Woodline Partners LP.

Financing Component	Amount (Gross Proceeds)	Trigger/Condition
Initial Upfront Financing	$30 million	Closed August 11, 2025
Contingent Tranche	Up to $20 million	Initiation of EQ504 clinical studies and other milestones
Total Potential Financing	Up to $50 million	N/A

Investor relations for public market communication and financing updates

Investor relations activity ramps up around key corporate milestones, like financing announcements and upcoming data readouts. The focus is on communicating runway and strategic pivots.

As of September 30, 2025, cash, cash equivalents and short-term investments totaled $33.1 million. This improved significantly from $22.6 million as of December 31, 2024, directly reflecting the August 2025 financing. General and administrative (G&A) expenses for the third quarter of 2025 were $3.3 million, flat compared to the same period in 2024, showing cost discipline.

Management actively engaged with the public market through conference participation in late 2025.

• Piper Sandler 37th Annual Healthcare Conference: Fireside Chat & 1x1 Meetings on Tuesday, December 2, 2025, at 11:30 AM EST.
• Evercore ISI 8th Annual Healthcare Conference: Fireside Chat & 1x1 Meetings on Wednesday, December 3, 2025, at 3:50 PM EST.

Scientific advisory board and KOL engagement for pipeline validation

Validation from Key Opinion Leaders (KOLs) is essential, especially when pivoting focus to a new asset like EQ504. Equillium, Inc. used targeted events to secure this buy-in.

The Company hosted a virtual KOL investor event on November 5, 2025. This event specifically highlighted the potential clinical utility of EQ504, the novel oral Aryl Hydrocarbon Receptor (AhR) modulator, for ulcerative colitis (UC). The event featured experts discussing the unmet medical need and the science behind AhR modulation.

The scientific engagement included specific external experts:

• Dr. Francisco J. Quintana, PhD (Harvard Medical School).
• Dr. Brian Feagan, MD, FRCPC (Western Ontario).

The goal was to support the planned initiation of the EQ504 Phase 1 clinical study expected in mid-2026.

Regulatory dialogue with the FDA for clinical development path

The relationship with the U.S. Food and Drug Administration (FDA) directly dictates the path and timeline for clinical assets. Equillium, Inc. had a significant interaction regarding itolizumab in early 2025.

On April 24, 2025, Equillium, Inc. announced feedback from its Type D meeting with the FDA concerning itolizumab for first-line treatment of acute graft-versus-host disease (aGVHD). The FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway based on the EQUATOR study data, specifically highlighting attention to response outcomes at Day 29.

The FDA did indicate openness to evaluating other endpoints, including longer term outcomes, provided independent data supports their validity. Prior to this feedback, cash, cash equivalents as of March 31, 2025, totaled $14.5 million, which the Company believed was capable of funding operations into the third quarter of 2025.

The company is now advancing EQ504 toward a Phase 1 study initiation planned for mid-2026. The termination of the collaboration and license agreement with Biocon relating to itolizumab was effective September 30, 2025. Finance: draft 13-week cash view by Friday.

Equillium, Inc. (EQ) - Canvas Business Model: Channels

You're looking at how Equillium, Inc. gets its data and its cash out to the world, which is critical for a clinical-stage company like this. The channels here are less about direct sales and more about validation, funding, and future partnerships.

Private Placement Agents for Capital Raising

The primary channel for immediate, large-scale funding as of late 2025 involved direct engagement with specialized healthcare investors, facilitated by placement agents. Equillium, Inc. secured a definitive securities purchase agreement on August 11, 2025, targeting up to $50 million in gross proceeds to push EQ504 development. This financing is structured to provide a cash runway through 2027 based on the initial closing proceeds. Leerink Partners served as the lead placement agent, with LifeSci Capital acting as the co-placement agent for this transaction.

Here's the quick math on that August 2025 private placement:

Financing Component	Gross Proceeds Target	Shares/Warrants Issued (Initial)	Price Per Share/Warrant
Initial Upfront Closing	$30 million	Approx. 52.6 million	$0.57 / $0.5699
Milestone Closing Potential	Up to $20 million	Up to Approx. 35.1 million	Contingent on milestones

As of September 30, 2025, the balance sheet reflected cash, cash equivalents, and short-term investments totaling $33.1 million. Honestly, that initial $30 million tranche was the lifeline to get to the next stage.

Scientific Publications and Conferences for Data Dissemination

Disseminating clinical and translational data is a key channel for building credibility with future partners and investors. Equillium, Inc. management actively engaged in this process throughout late 2025. For instance, management participated in a fireside chat at the Cantor Global Healthcare Conference 2025 on September 5, 2025, at 7:55 am ET. Furthermore, the company hosted a virtual Key Opinion Leader (KOL) event on November 5, 2025, focusing on EQ504 and the unmet need in ulcerative colitis. Looking ahead, the plan included showcasing the pipeline at two major December 2025 investor conferences:

• Piper Sandler 37th Annual Healthcare Conference: December 2, 2025.
• Evercore ISI 8th Annual Healthcare Conference: December 3, 2025.

The company's R&D expenses for Q3 2025 were $1.3 million, showing the investment supporting the data being presented through these channels.

Clinical Trial Sites and Contract Research Organizations (CROs)

The execution of clinical development relies on external site networks and specialized Contract Research Organizations (CROs). While specific CRO partners for the upcoming EQ504 program aren't detailed, past trials provide context. The Phase 2 study for itolizumab in Ulcerative Colitis was conducted at multiple clinical trial sites in India. The next major operational milestone is the planned initiation of the EQ504 Phase 1 study in mid-2026, with data anticipated approximately six months after initiation. This timeline dictates the immediate need for CRO and site contracting channels to be fully activated.

The broader industry context shows the importance of these partners; the global CRO market was projected to reach $139.42 billion by 2029 from an estimated $82 billion in 2024, underscoring the competitive landscape for securing top-tier CRO support.

Future Out-licensing Agreements for Commercialization Access

The strategic channel for future commercialization access is currently being redefined following a major pipeline change. Equillium, Inc. made the definitive move to cease development of itolizumab, terminating its collaboration and license agreement with Biocon on September 30, 2025. This termination signals a sharp focus on EQ504. The current financing, up to $50 million, is intended to fund EQ504 development through 2027, which sets a target window for securing a future out-licensing or commercial partnership for EQ504 before that cash runway ends. The initial private placement included a potential $20 million tranche contingent on clinical study initiation, which is a de-risking step often required before major out-licensing discussions can finalize terms.

Equillium, Inc. (EQ) - Canvas Business Model: Customer Segments

You're looking at the customer base for Equillium, Inc. (EQ) as of late 2025. The company has made a sharp pivot, so the segments reflect where they are now focusing their development efforts, primarily with EQ504, after concluding the itolizumab program.

Specialized healthcare institutional investors

This segment provided the capital to fund the strategic shift. They are sophisticated entities focused on clinical-stage biotech with high-unmet-need assets. You can see their commitment in the recent financing activity.

• Secured up to $50 million in gross proceeds via a private placement announced August 11th, 2025.
• The initial tranche provided approximately $30 million in gross proceeds.
• The upfront financing involved issuing approximately 52.6 million shares or pre-funded warrants at $0.57 per share.
• This initial funding is projected to fund Company operations through 2027.
• Key participants in this syndicate include ADAR1 Capital Management, Janus Henderson Investors, Adage Capital Partners, Coastlands Capital, and Woodline Partners LP.

Honestly, the cash position as of September 30, 2025, was $33.1 million in cash, cash equivalents, and short-term investments, which is up from $22.6 million at the end of 2024.

Patients with severe inflammatory diseases, primarily Ulcerative Colitis

This is the primary target for the lead investigational asset, EQ504, an AhR modulator. While the previous drug, itolizumab, was studied here, the focus is now on the oral, colon-targeted EQ504. The market need is clear, as evidenced by prior trial data.

For context on the disease space, the prior Phase 2 study for itolizumab in moderate to severe Ulcerative Colitis (UC) showed:

Endpoint (12 Weeks)	Itolizumab	Adalimumab (Active Control)	Placebo
Clinical Remission Rate	23.3%	20.0%	10.0%
Endoscopic Remission Rate	16.7%	16.7%	6.7%

Equillium, Inc. expects to initiate the Phase 1 clinical study for EQ504 in mid-2026, with the potential to add UC patient cohorts following the SAD/MAD (Single Ascending Dose/Multiple Ascending Dose) portion.

Patients with acute graft-versus-host disease (aGVHD)

This segment was the focus of the Phase 3 EQUATOR study for itolizumab. Although the collaboration with Biocon for itolizumab was terminated on September 30, 2025, the data generated here is important for understanding the drug's profile and the high-unmet-need population.

The aGVHD patient population faces high mortality, cited as in excess of 40%. The Phase 3 EQUATOR study, despite missing the Day 29 primary endpoint, showed statistically significant longer-term benefits for itolizumab:

• Failure-free survival median: 154 days versus 70 days (p-value 0.043).
• Complete Response (CR) at Day 99: 44.9% (35 patients) versus 28.6% (22 patients) (p-value 0.035).

The company had submitted for Breakthrough Therapy designation, expecting FDA feedback during May 2025, which would have set the course for this program.

Large pharmaceutical and biotech companies (potential strategic partners)

This segment is crucial for future commercialization or development funding for the new lead asset, EQ504. The prior relationship with a major player concluded recently, resetting the partnership landscape.

The exclusive partnership with Ono Pharmaceutical Co., Ltd. for itolizumab rights in the US, Canada, Australia, and New Zealand officially terminated on September 30, 2025. Equillium, Inc. now maintains all commercial rights to itolizumab.

The focus for new partnerships shifts to EQ504, which is designed to be complementary to other inflammation and immunology agents. The company's Q3 2025 revenue was $0, down from $12.2 million in Q3 2024 (which was entirely from itolizumab development funding and amortization), underscoring the need for a new partnership or successful internal development of EQ504 to generate future revenue streams.

Finance: draft 13-week cash view by Friday.

Equillium, Inc. (EQ) - Canvas Business Model: Cost Structure

You're looking at the core expenses Equillium, Inc. is managing as it pivots its focus entirely to EQ504. The cost structure reflects a significant streamlining following the termination of the itolizumab program funding.

The third quarter of 2025 showed a major reduction in operating costs compared to the prior year, driven by strategic decisions made earlier in 2025.

Cost Category	Q3 2025 Amount	Comparison/Context
Research and Development (R&D) Expenses	$1.3 million	Significantly reduced from $9.6 million in Q3 2024.
General and Administrative (G&A) Expenses	$3.3 million	Held flat from $3.3 million in Q3 2024.
Revenue (Offsetting Costs)	$0	Compared to $12.2 million in Q3 2024, reflecting the end of the Ono Pharmaceutical funding.

The reduction in Research and Development expenses to $1.3 million in Q3 2025 was a direct result of the shift in pipeline priority. This lower spend level is intended to conserve cash, with the initial tranche of recent financing expected to fund operations through 2027.

The major drivers for the reduced R&D spend include:

• Lower clinical development expenses.
• Lower Chemistry, Manufacturing and Controls (CMC) activities.
• Lower consulting expenses related to the wind down of the EQUATOR study.
• Lower employee compensation and benefits due to lower headcount.

Clinical trial expenses are now primarily future-facing, centered on the next asset. The focus is on preparing for the EQ504 Phase 1 clinical study initiation planned for mid-2026. This contrasts sharply with the costs associated with the wind down of prior programs, specifically the itolizumab Phase 3 EQUATOR study, which was a major component of earlier R&D spending.

General and Administrative costs remained stable at $3.3 million for the third quarter of 2025. This category encompasses the ongoing fixed costs of running the organization, which includes:

• Personnel costs for essential, non-R&D staff.
• Legal expenses necessary for corporate governance.
• Intellectual property maintenance costs to secure the platform.

The overall net loss for Q3 2025 was $4.2 million, which was an increase from the near breakeven net loss in Q3 2024, primarily due to the lower revenue, partially offset by the lower operating expenses.

Equillium, Inc. (EQ) - Canvas Business Model: Revenue Streams

You're looking at Equillium, Inc.'s revenue picture as of late 2025, and honestly, it's a story of transition, heavily reliant on recent financing rather than product sales right now. The prior revenue stream, which was tied to the itolizumab Asset Purchase Agreement with Ono Pharmaceutical, has run its course; that agreement was terminated in October 2024.

For the third quarter ended September 30, 2025, the reported revenue was exactly $0, which makes sense given the end of that Ono-related funding which comprised all revenue in 2024. So, the immediate cash flow is coming from the capital markets, not product milestones or sales.

Here's the quick math on the new financing that is funding operations through 2027; this is your primary near-term revenue driver:

Revenue Component	Amount (Gross Proceeds)	Trigger/Timing
Q3 2025 Revenue	$0	Following end of Ono-related funding
Private Placement - Upfront Tranche	Approximately $30 million	Initial closing in August 2025
Private Placement - Contingent Milestones	Up to an additional $20 million	Initiation of clinical studies with EQ504 and other specified milestones

The August 2025 private placement was structured to give Equillium, Inc. immediate runway. The initial upfront financing brought in approximately $30 million in gross proceeds. To be defintely precise on that initial cash infusion, one filing detailed the initial closing proceeds as approximately $29,996,918.3595.

The potential upside from that same deal is significant, but conditional. You can potentially see up to an additional $20 million if the company hits certain performance markers. These milestones are tied directly to advancing the pipeline, specifically the initiation of the EQ504 Phase 1 clinical study, which is planned for mid-2026.

Regarding itolizumab, while Equillium, Inc. retains the rights to the asset, the revenue stream from development funding and amortization of the upfront payment from Ono Pharmaceutical has ceased. Any future revenue from itolizumab would need to come from a new deal or, much further out, product sales, but no concrete figures for new licensing fees or milestones were announced as of late 2025.

The long-term view for Equillium, Inc.'s revenue streams rests on commercial success, which is standard for a clinical-stage biotech. This involves:

• Potential future licensing fees and milestone payments for itolizumab, should a new partnership materialize.
• Future product sales for either itolizumab or EQ504, post-approval.

Finance: draft 13-week cash view by Friday.