Rallybio Corporation (RLYB): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama de la biotecnología de la vanguardia, Rallybio Corporation emerge como una fuerza pionera, navegando estratégicamente el complejo terreno de trastornos genéticos raros con innovación científica incomparable. Al crear meticulosamente un modelo de negocio que une la investigación innovadora, los enfoques centrados en el paciente y las soluciones terapéuticas transformadoras, Rallybio está a la vanguardia de la medicina de precisión personalizada. Su lienzo de modelo de negocio integral revela un ecosistema sofisticado diseñado para abordar las necesidades médicas no satisfechas críticas, aprovechando la investigación molecular avanzada, las asociaciones estratégicas y un profundo compromiso de desarrollar tratamientos innovadores para pacientes con afecciones genéticas raras.

Rallybio Corporation (RYB) - Modelo de negocios: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación académica

Rallybio Corporation ha establecido asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de investigación	Estado de colaboración
Universidad de Yale	Trastornos genéticos raros	Asociación activa
Universidad de Pensilvania	Enfermedades mediadas por el complemento	Colaboración de investigación en curso

Asociaciones con grupos de defensa de pacientes con enfermedades raras

Rallybio mantiene relaciones estratégicas con organizaciones de defensa del paciente:

• Genes globales
• Organización Nacional para Trastornos Raros (NORD)
• Alianza genética

Acuerdos de desarrollo farmacéutico y licencia

Asociaciones actuales de desarrollo farmacéutico:

Pareja	Candidato a la droga	Etapa de desarrollo
Complementar los productos farmacéuticos	Rlyb211	Ensayos clínicos de fase 1/2
Terapéutica de horizonte	Investigación del inhibidor del complemento	Colaboración preclínica

Colaboración con organizaciones de investigación clínica (CRO)

Asociaciones activas de CRO de Rallybio:

• IQVIA
• Parexel International
• PPD (desarrollo de productos farmacéuticos)

A partir del cuarto trimestre de 2023, Rallybio asignó $ 4.2 millones para investigar colaboraciones y asociaciones.

Rallybio Corporation (RYB) - Modelo de negocio: actividades clave

Investigación y desarrollo de la terapéutica de enfermedades raras

A partir de 2024, Rallybio Corporation se centra en el desarrollo de terapias para enfermedades raras con necesidades médicas no satisfechas significativas. La compañía ha asignado $ 45.2 millones específicamente para gastos de investigación y desarrollo en su año fiscal más reciente.

Área de enfoque de investigación	Etapa actual de desarrollo	Inversión estimada
RYB212 para enfermedades mediadas por complemento	Ensayos clínicos de fase 2	$ 18.7 millones
RYB211 para la telangiectasia hemorrágica hereditaria	Desarrollo preclínico	$ 12.5 millones

Gestión de ensayos preclínicos y clínicos

Rallybio administra múltiples programas de desarrollo clínico con un enfoque estructurado.

• Ensayos clínicos activos: 3 programas en curso
• Sitios de ensayos clínicos totales: 15 ubicaciones internacionales
• Objetivo de inscripción de pacientes: 250 pacientes en los ensayos actuales

Procesos de presentación y cumplimiento reglamentarios

La Compañía mantiene rigurosas estrategias de cumplimiento regulatorio con inversiones en infraestructura de asuntos regulatorios.

Actividad regulatoria	Número de presentaciones	Agencias reguladoras
Aplicaciones de IN	2 en 2023	FDA, EMA
Enmiendas de protocolo	4 en 2023	Múltiples agencias internacionales

Descubrimiento de drogas e investigación molecular

Rallybio emplea técnicas avanzadas de investigación molecular con equipos científicos especializados.

• Personal de investigación: 37 científicos especializados
• Instalaciones de investigación: 2 laboratorios dedicados
• Presupuesto anual de investigación molecular: $ 22.6 millones

Desarrollo y protección de la propiedad intelectual

La Compañía mantiene una sólida estrategia de propiedad intelectual.

Categoría de IP	Número total	Estado
Solicitudes de patentes	12	Pendiente/otorgado
Patentes concedidas	7	Protección activa

Rallybio Corporation (RLYB) - Modelo de negocio: recursos clave

Talento especializado científico y de investigación

A partir del cuarto trimestre de 2023, Rallybio Corporation empleó a 48 profesionales de investigación y desarrollo a tiempo completo con títulos avanzados en biología molecular, genética y ciencias farmacéuticas.

Categoría de empleado	Número	Porcentaje
Investigadores de doctorado	24	50%
Titulares de maestría	18	37.5%
Otro personal científico	6	12.5%

Instalaciones avanzadas de biología molecular e investigación genética

Rallybio mantiene un Laboratorio de investigación de 7,500 pies cuadrados Ubicado en New Haven, Connecticut, equipado con infraestructura de biología molecular de última generación.

Plataformas y tecnologías de investigación patentadas

• RYB106 Plataforma terapéutica de enfermedades raras
• Tecnología del inhibidor del complemento RYB118
• Capacidades de investigación de edición de genes avanzados

Capital de riesgo significativo y financiación de los inversores

Financiación total recaudada a diciembre de 2023: $ 267.4 millones

Ronda de financiación	Cantidad recaudada	Año
Serie A	$ 65.2 millones	2018
Serie B	$ 110.5 millones	2020
OPI	$ 92.7 millones	2021

Cartera de propiedad intelectual robusta

A diciembre de 2023, Rallybio tiene 12 patentes otorgadas y 18 Pensas de patentes pendientes relacionado con la terapéutica de enfermedades raras.

Categoría de patente	Número de patentes
Patentes concedidas	12
Aplicaciones de patentes pendientes	18
Activos totales de propiedad intelectual	30

Rallybio Corporation (RLYB) - Modelo de negocio: propuestas de valor

Terapias dirigidas para trastornos genéticos raros

Rallybio Corporation se centra en el desarrollo de terapias para trastornos genéticos raros con importantes necesidades médicas no satisfechas. A partir del cuarto trimestre de 2023, la compañía tiene dos candidatos de drogas principales en el desarrollo clínico:

Candidato a la droga	Indicación	Estadio clínico
Rlyb212	Enfermedades raras mediadas por el complemento	Ensayo clínico de fase 1/2
Rlyb211	Trastornos de plaquetas genéticas raras	Desarrollo preclínico

Soluciones de tratamiento innovadoras para necesidades médicas no satisfechas

La estrategia de investigación y desarrollo de la compañía se dirige a condiciones genéticas específicas con opciones de tratamiento limitadas o nulas:

• Inversión total de I + D en 2023: $ 38.2 millones
• Número de programas de investigación activa: 3 objetivos de enfermedad genética primaria
• Portafolio de patentes: 12 patentes otorgadas a diciembre de 2023

Enfoques de medicina de precisión personalizada

La estrategia de medicina de precisión de Rallybio implica el desarrollo de terapias específicas con mecanismos genéticos específicos:

Enfoque de medicina de precisión	Características clave
Orientación genética	Intervención a nivel molecular en trastornos genéticos raros
Desarrollo de biomarcadores	Identificar marcadores genéticos específicos para la selección de tratamiento

Potencios tratamientos innovadores para afecciones genéticas pediátricas

La tubería de investigación de la compañía aborda específicamente los trastornos genéticos pediátricos:

• Áreas de enfoque primario:
• Trastornos de plaquetas raros
• Enfermedades mediadas por el complemento
• Condiciones metabólicas genéticas

Investigación científica avanzada dirigida a enfermedades genéticas complejas

El enfoque científico de Rallybio implica metodologías de investigación genética sofisticadas:

Capacidad de investigación	Enfoque tecnológico
Secuenciación genética	Tecnologías de secuenciación de próxima generación
Modelado molecular	Análisis genético computacional avanzado

Rallybio Corporation (RYB) - Modelo de negocios: relaciones con los clientes

Compromiso directo con enfermedades raras comunidades de pacientes

A partir del cuarto trimestre de 2023, Rallybio Corporation se involucra directamente con las comunidades de pacientes con enfermedades raras a través de programas de divulgación específicos.

Métricas de compromiso de la comunidad de pacientes	Número
Enfermedad rara grupos de apoyo al paciente contactados	12
Las organizaciones de defensa de los pacientes se asociaron	8
Eventos anuales de interacción de la comunidad de pacientes	6

Investigación colaborativa con profesionales médicos

Rallybio mantiene colaboraciones estratégicas con instituciones de investigación médica.

• Asociaciones de investigación clínica: 5 colaboraciones institucionales activas
• Miembros de la Junta Asesora Médica: 9 especialistas
• Presupuesto de colaboración de investigación anual: $ 3.2 millones

Comunicación transparente sobre el progreso del ensayo clínico

Canales de comunicación de ensayos clínicos	Frecuencia
Actualizaciones de ensayos clínicos públicos	Trimestral
Comunicaciones de relaciones con los inversores	Mensual
Informes de divulgación regulatoria	By-anualmente

Programas de apoyo y educación del paciente

Rallybio implementa estrategias integrales de apoyo al paciente.

• Sebinarios web de educación del paciente: 24 sesiones anuales
• Materiales de recursos digitales: 15 guías integrales
• Línea de ayuda de apoyo al paciente: disponible 5 días por semana

Conferencia científica y participación del simposio médico

Tipo de conferencia	Participación anual
Conferencias médicas internacionales	7
Simposios de enfermedades raras	4
Eventos de presentación de investigación	6

Rallybio Corporation (RYB) - Modelo de negocios: canales

Redes directas de comunicación médica y científica

Rallybio Corporation utiliza canales de comunicación especializados dirigidos a profesionales de investigación de enfermedades raras:

Canal de comunicación	Especialistas dirigidos	Alcance anual
Alcance del correo electrónico directo	Genetistas de enfermedades raras	1.247 especialistas
Seminarios científicos personalizados	Investigadores clínicos	876 participantes
Compromiso de red profesional	Instituciones de investigación	53 centros académicos

Conferencias de la industria biotecnología y farmacéutica

Estrategias de participación de la conferencia:

• Cumbre de investigación de enfermedades raras - Presentar 2 carteles de investigación
• Reunión anual de la Sociedad Americana de Genética Humana
• Conferencia Internacional de Medicina de Precisión

Plataformas de relaciones con los inversores

Plataforma	Métricas de compromiso de los inversores
Llamadas de ganancias trimestrales	187 inversores institucionales
Día anual de los inversores	246 analistas financieros
Presentación de la SEC	Transparencia financiera trimestral

Publicación científica digital y difusión de investigación

Canales de publicación de investigación:

• PubMed Central - 7 artículos de investigación publicados
• Nature Biotechnology - 3 presentaciones de investigación
• Compromiso del repositorio de investigación en línea

Especialistas directos de divulgación a enfermedades raras

Método de divulgación	Compromiso especializado	Volumen de contacto anual
Consultas clínicas dirigidas	Expertos de trastorno genético raros	412 interacciones directas
Informes de investigación personalizados	Investigadores de ensayos clínicos	276 sesiones informativas especializadas
Propuestas de investigación colaborativa	Centros de investigación académicos	18 Iniciativas de colaboración

Rallybio Corporation (RLYB) - Modelo de negocios: segmentos de clientes

Pacientes con enfermedades raras y familias

Rallybio se dirige a pacientes con trastornos genéticos raros, que se centran específicamente en:

Categoría de desorden	Población de pacientes estimada
Enfermedades mediadas por el complemento	Aproximadamente 50,000 pacientes en los Estados Unidos
Trastornos hematológicos hereditarios	Alrededor de 25,000 pacientes en América del Norte

Especialistas en trastorno genético pediátrico

Segmento profesional de destino clave con áreas de enfoque específicas:

• Genetistas pediátricos especializados en condiciones hereditarias raras
• Genetistas clínicos en hospitales especializados para niños
• Profesionales de asesoramiento genético

Proveedores de atención médica centrados en condiciones genéticas

Tipo de proveedor	Alcance del mercado potencial
Clínicas genéticas especializadas	Más de 500 centros dedicados en los Estados Unidos
Centros médicos académicos	Aproximadamente 150 centros con capacidades de investigación genética avanzada

Instituciones de investigación

Los segmentos de investigación dirigidos incluyen:

• Institutos Nacionales de Salud (NIH) Centros de investigación financiados
• Laboratorios de investigación genética con sede en la universidad
• Consorcios de investigación de enfermedades raras

Profesionales farmacéuticos y de biotecnología

Categoría profesional	Número estimado
Especialistas en desarrollo de medicamentos de enfermedades raras	Aproximadamente 2.500 profesionales
Profesionales de investigación de terapia genética	Alrededor de 3.200 especialistas

Características totales del mercado direccionables:

• Población de pacientes con enfermedades raras: estimado de 25 a 30 millones de personas en los Estados Unidos
• Trastorno genético Valor de mercado: proyectado $ 50.3 mil millones para 2026
• Inversión anual en investigación de enfermedades raras: aproximadamente $ 3.5 mil millones

Rallybio Corporation (RYB) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Rallybio Corporation reportó gastos totales de investigación y desarrollo de $ 54.3 millones.

Categoría de gastos	Monto ($)
Investigación preclínica	18.7 millones
Desarrollo clínico	22.5 millones
Costos de biología molecular	13.1 millones

Gestión de ensayos clínicos y costos operativos

Los gastos de ensayo clínico para 2023 totalizaron $ 32.6 millones, con asignación específica de la siguiente manera:

• Costos de prueba de fase I/II: $ 15.2 millones
• Gastos de reclutamiento de pacientes: $ 7.4 millones
• Cumplimiento regulatorio: $ 5.9 millones
• Gestión del sitio: $ 4.1 millones

Inversiones de adquisición y retención de talento

Los gastos relacionados con el personal para 2023 fueron de $ 41.5 millones.

Categoría de personal	Compensación ($)
Investigar científicos	22.3 millones
Personal administrativo	9.7 millones
Compensación ejecutiva	9.5 millones

Protección y mantenimiento de la propiedad intelectual

Los costos de propiedad intelectual para 2023 fueron de $ 3.2 millones, incluidos los gastos de presentación y mantenimiento de patentes.

Inversiones avanzadas de equipos científicos e tecnología

Las inversiones en tecnología y equipos para 2023 ascendieron a $ 12.7 millones.

Categoría de equipo	Inversión ($)
Instrumentación de laboratorio	6.5 millones
Herramientas de biología computacional	3.8 millones
Sistemas de gestión de datos	2.4 millones

Rallybio Corporation (RLYB) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de productos futuros

A partir del cuarto trimestre de 2023, Rallybio Corporation aún no ha informado ningún acuerdos activos de licencia de productos.

Subvenciones de investigación y financiación del gobierno

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

Capital de riesgo y financiación de inversores

Datos financieros para las rondas de financiación de Rallybio Corporation:

Ronda de financiación	Total elevado	Año
Serie A	$ 65 millones	2020
Oferta pública inicial (IPO)	$ 150 millones	2021

Venta de productos terapéuticos potenciales

Estado de desarrollo actual de la tubería:

• RYB211 (inhibidor del complemento): Fase 1/2 ensayos clínicos
• RYB212: etapa preclínica

Colaboraciones de asociación estratégica

A partir de 2024, Rallybio Corporation no ha informado públicamente que Rallybio Corporation no haya informado públicamente.

Métricas de desempeño financiero:

Métrica financiera	Cantidad	Período
Ingresos totales	$0	2023 año fiscal
Gastos de investigación y desarrollo	$ 47.3 millones	2023 año fiscal
Pérdida neta	$ 56.1 millones	2023 año fiscal

Rallybio Corporation (RLYB) - Canvas Business Model: Value Propositions

You're looking at the core promises Rallybio Corporation (RLYB) makes to its stakeholders, which centers on delivering therapies for devastating rare diseases. This isn't just about incremental improvement; it's about fundamentally changing the course of severe conditions where current options are lacking or non-existent.

The value proposition is anchored in translating scientific advances into transformative treatments for patients with severe and rare diseases. For instance, consider RLYB212, aimed at preventing fetal and neonatal alloimmune thrombocytopenia (FNAIT). Epidemiological analysis showed that more than 30,000 pregnancies each year are at higher risk for FNAIT. Rallybio Corporation concluded screening in its FNAIT natural history study on January 31, 2025, having screened over 14,000 pregnant women through January 1, 2025.

RLYB116, the lead program, offers a specific value proposition centered on its mechanism of action. This investigational therapy is designed to achieve complete and sustained complement inhibition while offering improved tolerability compared to existing approaches.

The clinical development for RLYB116 is focused on addressing high unmet medical needs in complement-mediated diseases, specifically immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS).

• Patients with immune PTR have no approved or effective therapeutic options.
• An immune response is implicated in up to 40% of PTR cases.
• For refractory APS, approximately 10% of patients continue to experience thromboses despite standard anticoagulant treatment.
• The combined market opportunity for these initial indications is estimated at $5 billion.

Rallybio Corporation is also creating value for its financial stakeholders by managing its capital structure for operational longevity. This is achieved by generating non-dilutive capital events to extend the cash runway.

Financial Metric/Event	Amount/Date	Significance
Cash, Cash Equivalents, Marketable Securities (as of Sept 30, 2025)	$59.3 million	Core operating capital as of late 2025
Cash Runway Expectation	Through 2027	Extends operational funding based on current burn rate
Non-Dilutive Capital Generated (Q3 2025)	$20 million	From sale of interest in REV102 to Recursion Pharmaceuticals
REV102 Upfront Payment	$7.5 million	Component of the non-dilutive capital

The RLYB116 program hit a key clinical milestone in September 2025 with the completion of dosing in Cohort 1 of its Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) trial. The trial is structured to evaluate different dose levels, with Cohort 1 involving a dose of 150 mg once weekly.

You can see the progression of the RLYB116 value delivery below:

• Initiation of confirmatory PK/PD study: June 2025.
• Completion of dosing for Cohort 1: September 2025.
• RLYB116 is a once-weekly, small volume, subcutaneously injected C5 inhibitor.

Finance: draft 13-week cash view by Friday.

Rallybio Corporation (RLYB) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so your relationships with key external stakeholders-patients, doctors, and partners-are your primary assets for validation and funding. Rallybio Corporation focuses on deep, specialized engagement across these groups to de-risk its rare disease pipeline.

High-touch engagement with rare disease patient advocacy groups

Rallybio Corporation emphasizes building meaningful relationships within the patient community, which is crucial for understanding the unmet needs in severe and rare diseases. The company explicitly mentions engagement with advocacy organizations, such as the National Organization for Rare Disorders (NORD).

• Engagement includes supporting programs serving families, infants, children, and young adults in the New Haven, CT community.
• The mission is to empower and inspire the next generation of scientists and researchers in the community.

Direct, specialized relationships with clinical investigators and medical experts

The foundation of Rallybio Corporation's clinical advancement relies on its network of academic clinical centers and industry leaders worldwide. This specialized relationship management is evidenced by the progression of its clinical programs, which require deep collaboration with investigators.

Here's a look at the clinical trial milestones achieved or anticipated as of late 2025, which directly reflect this relationship activity:

Program Candidate	Clinical Activity/Status (as of late 2025)	Key Data Anticipation/Readout
RLYB116	Completed dosing of Cohort 1 in Phase 1 Confirmatory PK/PD Study in September 2025.	Data from Cohort 1 expected in the fourth quarter of 2025.
RLYB212	Sentinel participant dosed in Phase 2 trial in February 2025.	PK and safety data from the second trimester expected in the second quarter of 2025.
RLYB212 (Natural History Study)	Screened more than 14,000 pregnant women through January 1, 2025, in the ongoing FNAIT natural history study.	Screening planned to conclude in the United States and Canada as of January 31, 2025.

Strategic management of biopharma collaboration partners

Rallybio Corporation actively manages strategic alliances, using them to generate non-dilutive capital and advance pipeline assets. The relationship with Recursion Pharmaceuticals for the REV102 program is a prime example of this strategy in action during 2025.

The financial outcomes from this partnership demonstrate the value realized from these relationships:

• Rallybio Corporation generated a total of $20 million in the third quarter of 2025 from the sale of its interest in REV102 to Recursion Pharmaceuticals.
• This total included an upfront payment of $7.5 million and an equity milestone payment of $12.5 million received in September 2025 for the initiation of additional preclinical studies.
• The total potential consideration for the REV102 program was up to $25 million.
• Revenue for the third quarter of 2025 was $0.2 million, down from $0.3 million in the third quarter of 2024, related to the recognition of revenue from the Johnson & Johnson collaboration agreement.

Investor relations to communicate clinical milestones and financial discipline

Investor relations efforts focus on clearly linking clinical progress to financial stability. The company emphasizes its disciplined approach to capital management, which reassures stakeholders about its operational runway.

Key financial and operational metrics communicated to investors as of the third quarter of 2025:

• Cash, cash equivalents, and marketable securities were $59.3 million as of September 30, 2025.
• The company expects this cash position to support operations through 2027.
• For the third quarter of 2025, Rallybio reported a net income of $16.0 million, or $0.36 per common share, a significant shift from the net loss of $11.5 million, or $0.26 per common share, in the third quarter of 2024.
• Research & Development (R&D) expenses decreased to $4.1 million in Q3 2025 from $8.2 million in Q3 2024, partly due to a workforce reduction announced in May 2025.

The communication strategy ties these financial results directly to clinical achievements, such as advancing RLYB116 and receiving the $12.5 million milestone payment from Recursion. Finance: draft 13-week cash view by Friday.

Rallybio Corporation (RLYB) - Canvas Business Model: Channels

You're looking at how Rallybio Corporation (RLYB) gets its value proposition-transformative therapies for rare diseases-out to the world, which for a clinical-stage biotech means getting data out and getting partners in.

Global network of clinical trial sites for RLYB116 Phase 1/2 studies

The primary channel for advancing the lead asset, RLYB116, involves a global network of clinical trial sites. The confirmatory Phase 1 pharmacokinetic/pharmacodynamic (PK/PD) study (NCT06797375) was initiated in the second quarter of 2025. This study is designed with two cohorts, each involving eight participants randomized 3 to 1 to receive RLYB116 or placebo once weekly for a 4-week treatment duration, followed by a 10-week follow-up. Cohort 1, testing a 150 mg once weekly dose, completed dosing in September 2025. Results from this first cohort supported progression to Cohort 2, which was anticipated to evaluate dosing up to 300 mg once weekly, with data readouts expected in the fourth quarter of 2025. The initial focus indications for RLYB116 are immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS), representing a combined market opportunity estimated at $5 billion. The company completed dosing of the first cohort in this study on September 25, 2025. That's how you move a drug forward.

Direct licensing and collaboration agreements with larger biopharma companies

Strategic partnerships are a key channel for both validation and non-dilutive funding. Rallybio Corporation has active and recently concluded agreements that channel value and assets. For instance, the collaboration with Johnson & Johnson generated revenue of $0.2 million in the third quarter of 2025. Furthermore, the sale of the REV102 program interest to Recursion Pharmaceuticals in July 2025 provided significant, near-term financial input. Here's a quick look at the financial impact from these channels through Q3 2025:

Agreement/Event	Metric/Amount	Date/Period
REV102 Sale to Recursion (Upfront/Milestone)	$20 million total received	Q3 2025
REV102 Milestone Payment Received	$12.5 million equity milestone	September 3, 2025
Johnson & Johnson Collaboration Revenue	$0.2 million	Q3 2025
Cash Position (Runway Support)	$59.3 million	September 30, 2025

The company expects its cash position as of September 30, 2025, to support operations through 2027. Rallybio is also eligible to receive low single-digit royalties on future net sales from the Recursion agreement.

Scientific publications and presentations at medical conferences

Disseminating clinical and preclinical data through scientific channels validates the science and informs the broader medical community. Rallybio Corporation has used these venues to detail program progress. The company presented biomarker characterization analyses showing RLYB116 led to a greater degree of complement inhibition in its earlier Phase 1 MAD study than initially reported. Also, prior to 2025, results of an epidemiological analysis for the discontinued RLYB212 program were presented at the NORD Summit and ASHG. The advancement of RLYB116 to Cohort 2 was directly supported by data from Cohort 1. The company continues to rely on these channels to build credibility for its pipeline.

• Data from RLYB116 Cohort 1 supported advancement to Cohort 2.
• RLYB116 data readouts anticipated in Q3 2025 (Cohort 1) and Q4 2025 (Cohort 2).
• RLYB212 FNAIT natural history study screening concluded in the United States and Canada as of January 31, 2025.
• RLYB116 is a differentiated C5 inhibitor.

Investor and corporate communications via press releases and SEC filings

The formal channel for communicating financial health and operational milestones to the investment community is through required regulatory filings and voluntary press releases. Rallybio Corporation furnished its Q3 2025 financial results via an 8-K filing on November 6, 2025. The company's regular reporting cadence includes quarterly updates. You can see the filing schedule below:

• Q1 2025 10-Q filed on May 8, 2025.
• Q2 2025 10-Q filed on August 7, 2025.
• Q3 2025 10-Q filed on November 6, 2025.
• Press release for Q3 2025 results issued on November 6, 2025.

As of May 2, 2025, the company had 41,613,964 shares of common stock outstanding. For the Q3 2025 period, institutional ownership stood at 74.65%, with insiders owning 4.14%. Finance: draft 13-week cash view by Friday.

Rallybio Corporation (RLYB) - Canvas Business Model: Customer Segments

You're looking at the core groups Rallybio Corporation (RLYB) targets as of late 2025, which is a critical time given the recent Q3 2025 earnings report and the progress on RLYB116.

Patients suffering from complement-mediated rare diseases (e.g., PTR, refractory APS).

This group represents the ultimate end-users for RLYB116, a C5 inhibitor targeting immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS) as of the third quarter of 2025. The potential market size for these indications provides the financial scope for this segment. The global Paroxysmal Nocturnal Hemoglobinuria (PNH) treatment market, a related complement-mediated disease area where RLYB116 is positioned, was valued at approximately $5 billion in 2025, with projections reaching $13.94 billion by 2035 at a 10.8% CAGR between 2026 and 2035. Another assessment places the PNH market at about $4,500 million in 2025. For refractory Catastrophic Antiphospholipid Syndrome (CAPS), the market is projected to grow from $5.5 million in 2025 to $14.3 million by 2035, showing a 10.0% CAGR. Rallybio Corporation reported completing dosing of Cohort 1 in the RLYB116 Phase 1 confirmatory study in September 2025, aiming for data in the fourth quarter of 2025.

The key patient populations and associated market values are summarized below:

Rare Disease Indication	Targeted Therapy Focus	Estimated 2025 Market Value (USD)	Projected 2035 Market Value (USD)
PNH (Related Area)	Complement Inhibitors	$5,000 million or $4,500 million	$13.94 billion
Refractory APS (CAPS)	Immunomodulatory/Complement	$5.5 million	$14.3 million

Specialist physicians (hematologists, rheumatologists) treating these rare conditions.

These are the prescribers and key opinion leaders who evaluate the clinical data for RLYB116. The progression of the RLYB116 program directly addresses their need for new, differentiated therapies. Rallybio Corporation announced the completion of dosing in Cohort 1 of the RLYB116 Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) clinical trial in September 2025. The focus of this study is to demonstrate complete and sustained complement inhibition with favorable tolerability, which is what specialists look for in a best-in-class C5 inhibitor. The company is focused on developing transformative therapies for devastating rare diseases, which aligns with the practice of specialists in tertiary care and academic medical centers.

• Physicians are evaluating RLYB116 data expected in 4Q 2025.
• The RLYB116 program targets diseases of complement dysregulation and hematology.
• The company aims to address serious unmet needs in complement-mediated diseases.
• Specialists are key to adopting therapies that offer improved survival outcomes and reduced organ damage in related conditions.

Biopharmaceutical companies seeking to in-license or acquire rare disease assets.

This segment is interested in Rallybio Corporation's pipeline and its disciplined business development approach. A concrete example of this segment's activity involving Rallybio is the recent transaction related to REV102. In the third quarter of 2025, Rallybio Corporation generated a total of $20 million from the sale of its interest in REV102 to Recursion Pharmaceuticals. This total included an upfront payment of $7.5 million and $12.5 million related to the initiation of additional preclinical studies. This non-dilutive capital strengthened the balance sheet, which was reported to have $59.3 million in cash, cash equivalents, and marketable securities as of September 30, 2025, extending the cash runway through 2027. Rallybio's strategy includes fostering collaborations that enhance access to therapies.

Institutional and individual investors focused on high-risk, high-reward biotech.

Investors are tracking Rallybio Corporation's clinical milestones and financial health. The stock closed at $0.65 on December 1, 2025, in regular trading. The Q3 2025 results showed an actual Earnings Per Share (EPS) of -$0.14, beating the consensus estimate of -$0.25 by $0.11. Quarterly revenue for Q3 2025 was $0.21 million, above the consensus estimate of $0.07 million. The company reported a net income of $16.0 million for Q3 2025, compared to a net loss of $11.5 million in Q3 2024, largely influenced by the asset sale. The trailing EPS over the last four quarters was -$0.32, with earnings expected to grow from ($1.34) to ($1.09) per share next year. The company's cash position of $59.3 million as of September 30, 2025, supports operations through 2027.

Here's the quick math on recent financial performance:

Financial Metric (as of late 2025)	Value	Context/Date
Q3 2025 Actual EPS	-$0.14	Beat consensus of -$0.25 by $0.11
Q3 2025 Revenue	$0.21 million	Above consensus of $0.07 million
Cash, Equivalents, Securities (Sep 30, 2025)	$59.3 million	Cash runway extends through 2027
REV102 Sale Proceeds	$20 million total	Includes $7.5 million upfront
Stock Closing Price (Dec 1, 2025)	$0.65	Regular trading close

Finance: draft 13-week cash view by Friday.

Rallybio Corporation (RLYB) - Canvas Business Model: Cost Structure

You're looking at the core spending engine for Rallybio Corporation as of late 2025, which is heavily weighted toward advancing its pipeline, particularly RLYB116, following the strategic discontinuation of RLYB212.

The primary cost drivers are clearly concentrated in Research & Development, though the company has taken steps to manage its overhead.

Here's the quick math on the largest reported operating expenses through the first nine months of 2025:

Cost Category	Nine Months Ended September 30, 2025 (in millions USD)	Nine Months Ended September 30, 2024 (in millions USD)
Research & Development (R&D) Expenses	$15.925	Data not explicitly available for nine months in search results.
General & Administrative (G&A) Expenses	$11.357	Data not explicitly available for nine months in search results.

The R&D spend reflects the ongoing, high-stakes nature of clinical-stage biotech. For instance, the third quarter of 2025 R&D spend was $4.1 million, down from $8.2 million in the third quarter of 2024, but this was influenced by specific program dynamics.

Clinical trial execution costs for RLYB116 are a significant component within the R&D bucket. The development costs related to RLYB116 actually increased R&D expenses in the third quarter of 2025, offsetting decreases elsewhere in the R&D portfolio.

Personnel costs are actively being managed, which you can see in the trend of lower quarterly expenses:

• General & Administrative expenses fell to $3.0 million in Q3 2025 from $4.1 million in Q3 2024, primarily due to lower headcount.
• Payroll and personnel-related expenses decreased across both R&D and G&A following the workforce reduction announced in May 2025.
• This May 2025 reduction, affecting nine roles, resulted in estimated aggregate one-time charges of approximately $1.7 million for severance and benefits.

Manufacturing and supply chain costs are currently an expected future expenditure rather than a realized major cost driver. Rallybio Corporation's filings indicate that expenses will increase substantially if and as the company needs to:

• Secure manufacturing sources and supply chain capacity sufficient to produce adequate quantities of product candidates.
• Establish a sales, marketing, and distribution infrastructure for commercialization, should any product candidate gain regulatory approval.

Finance: review the Q4 2025 expense projections against the current cash runway through 2027 by Monday.

Rallybio Corporation (RLYB) - Canvas Business Model: Revenue Streams

You're looking at the financial engine of Rallybio Corporation as of late 2025, focusing on where the cash actually comes from right now. For a clinical-stage company, revenue isn't just about selling pills; it's heavily weighted toward strategic asset movements and partnership achievements.

The current revenue streams for Rallybio Corporation are a mix of non-recurring milestone payments from asset monetization and smaller, recurring collaboration fees tied to ongoing performance obligations. Future revenue hinges entirely on clinical success and eventual product launch.

• Milestone and upfront payments from asset monetization, generating $20 million from the REV102 sale in Q3 2025.
• Collaboration revenue from performance obligations, totaling $0.2 million in Q3 2025.
• Future potential revenue from product sales (long-term, post-approval).
• Equity financing or debt (historical source of capital).

The most significant recent financial event driving revenue was the divestiture of the REV102 program interest to Recursion Pharmaceuticals. This non-dilutive capital strengthened the balance sheet considerably.

REV102 Transaction Component	Amount Received (Q3 2025)	Trigger/Status
Total Generated from Sale	$20 million	Recognized in Q3 2025
Upfront Payment	$7.5 million	Received
Equity Milestone Payment	$12.5 million	Triggered by initiation of additional preclinical studies (received September 2025)
Potential Future Milestone	$5 million	Contingent on initiation of a Phase 1 clinical study

The total reported revenue for the third quarter ended September 30, 2025, was $0.21 million, though the specific collaboration revenue recognized from performance obligations was $0.2 million. This compares to $0.3 million in revenue for the same period in 2024, which was related to the Johnson & Johnson collaboration recognition.

Looking further out on the REV102 deal, Rallybio Corporation remains eligible for further payments. Honestly, these contingent payments are key to the long-term value capture from that asset.

• Additional milestone payment of $5 million contingent on the initiation of a Phase 1 clinical study by Recursion Pharmaceuticals.
• Low single-digit royalties on future net sales of REV102 by Recursion.
• Potential certain payments upon the sale of the REV102 program by Recursion.

For the near term, the company's operational funding relies on its existing capital position, which was bolstered by the asset sale. As of September 30, 2025, Rallybio Corporation held $59.3 million in cash, cash equivalents, and marketable securities. Management projected this cash, cash equivalents, and marketable securities position to be sufficient to support operations through 2027.

Historically, like many clinical-stage biotechs, Rallybio Corporation has relied on equity financing to bridge the gap between research and potential product monetization. While the recent REV102 payment was non-dilutive, the need for capital to fund the RLYB116 and RLYB332 programs means future financing activities, whether through equity issuance or debt instruments, remain a critical, albeit less desirable, potential source of capital to sustain operations beyond the projected 2027 runway.