Cabaletta Bio, Inc. (CABA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el reino de la biotecnología de la vanguardia, Cabaletta Bio, Inc. (CABA) emerge como una fuerza pionera, revolucionando el tratamiento de la enfermedad autoinmune a través de terapias innovadoras de receptores de células B. Al aprovechar plataformas sofisticadas de ingeniería celular y un enfoque de medicina de precisión, esta compañía dinámica de biotecnología está preparada para transformar cómo entendemos y combatemos las disfunciones del sistema inmune complejo. Su modelo de negocio estratégico entrelaza una innovadora investigación científica, asociaciones estratégicas y un compromiso visionario para desarrollar soluciones de terapia celular personalizadas que podrían reescribir el panorama de la intervención médica para pacientes que luchan con afecciones autoinmunes desafiantes.

Cabaletta Bio, Inc. (CABA) - Modelo de negocios: asociaciones clave

Colaboraciones con instituciones de investigación académica

Cabaletta Bio ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Estado de colaboración
Universidad de Pensilvania	Ingeniería de células B	Colaboración activa
Escuela de Medicina de Harvard	Investigación de enfermedades autoinmunes	Asociación de investigación en curso

Asociaciones estratégicas con compañías farmacéuticas

Cabaletta Bio ha desarrollado asociaciones estratégicas con las siguientes compañías farmacéuticas:

• Bristol Myers Squibb - Colaboración en el desarrollo de la terapia de células CAR -T
• Regeneron Pharmaceuticals - Investigación articular en tratamientos de enfermedades autoinmunes

Posibles alianzas con organizaciones de investigación clínica

Cabaletta Bio se ha involucrado con organizaciones de investigación clínica para apoyar su tubería de desarrollo de medicamentos:

Nombre de Cro	Servicios proporcionados	Valor de contrato
Ícono plc	Gestión de ensayos clínicos	$ 2.5 millones
IQVIA	Reclutamiento y monitoreo de pacientes	$ 1.8 millones

Compromiso con los innovadores de tecnología de atención médica

Cabaletta Bio ha establecido asociaciones tecnológicas con:

• Biotecnologías adaptativas - Tecnología de secuenciación del repertorio inmune
• Genómica 10x: plataforma de genómica de células individuales

Inversión total de asociación a partir de 2024: aproximadamente $ 4.3 millones

Cabaletta Bio, Inc. (CABA) - Modelo de negocios: actividades clave

Investigación y desarrollo de tecnologías de terapia celular

A partir del cuarto trimestre de 2023, Cabaletta Bio se ha centrado en desarrollar Inmunoterapias de células B dirigido a enfermedades autoinmunes.

I + D Métrica	Valor
Gastos de I + D (2022)	$ 56.4 millones
Programas de investigación activos	4 programas distintos
Etapa de desarrollo del programa principal	Ensayos clínicos de fase 1/2

Gestión de ensayos preclínicos y clínicos

• Programa CABA-2010 dirigido al lupus eritematoso sistémico (LES)
• Programa CABA-202 para Pemphigus vulgaris
• Ensayos clínicos en curso en múltiples centros de investigación

Desarrollo y protección de la propiedad intelectual

Categoría de IP	Número
Familias de patentes totales	15
Patentes de EE. UU. Emitido	8
Aplicaciones de patentes pendientes	7

Cumplimiento regulatorio y ejecución de ensayos clínicos

Colaborando con la FDA y EMA para las aprobaciones regulatorias de las terapias celulares.

Interacción regulatoria	Estado
Interacciones de la FDA	Comunicaciones IND en curso
Protocolos de ensayos clínicos	3 protocolos de investigación activos

Cabaletta Bio, Inc. (CABA) - Modelo de negocios: recursos clave

Plataformas de ingeniería celular patentadas

Cabaletta Bio aprovecha su Entrega ™ (inmunoterapia ligada a enzimas dirigida para la regeneración experimental) Plataforma de ingeniería celular. A partir de 2024, la plataforma se centra en desarrollar inmunoterapias de células B de ingeniería.

Característica de la plataforma	Detalles específicos
Tipo de tecnología	Ingeniería de inmunoterapia de células B
Etapa de desarrollo	Desarrollo preclínico y clínico avanzado
Aplicaciones clave	Dirección de enfermedad autoinmune

Talento especializado científico y de investigación

Cabaletta Bio mantiene una fuerza laboral especializada con amplia experiencia en inmunología y terapia celular.

• Total de empleados a partir del cuarto trimestre 2023: 79 Personal
• Investigadores a nivel de doctorado: aproximadamente el 40% de la fuerza laboral
• Tamaño del equipo de investigación y desarrollo: 45 científicos especializados

Instalaciones avanzadas de laboratorio e investigación

La compañía opera infraestructura de investigación avanzada en Filadelfia, Pensilvania.

Atributo de instalación	Especificación
Espacio total de investigación	Aproximadamente 25,000 pies cuadrados
Tipo de laboratorio	Instalaciones de investigación de inmunoterapia especializada
Inversión en equipos	$ 3.2 millones en equipos de investigación avanzados (2023)

Cartera de propiedad intelectual robusta

Cabaletta Bio mantiene una fuerte estrategia de propiedad intelectual.

• Solicitudes de patentes totales: 17
• Patentes concedidas: 8
• Familias de patentes que cubren la plataforma Deliver ™: 5

Financiación significativa de capital de riesgo

La compañía ha asegurado recursos financieros sustanciales a través de inversiones de capital de riesgo.

Métrico de financiación	Cantidad
Financiación total recaudada	$ 213.5 millones
Última ronda de financiación	Serie C de $ 85.6 millones (2022)
Principales inversores	Versant Ventures, Pivotal Bioventure Partners

Cabaletta Bio, Inc. (CABA) - Modelo de negocio: propuestas de valor

Terapias innovadoras de receptores de células B para enfermedades autoinmunes

La propuesta de valor principal de Cabaletta Bio se centra en el desarrollo Terapias celulares de precisión dirigidas a enfermedades autoinmunes mediadas por receptores de células B.

Categoría de terapia	Indicación objetivo	Etapa de desarrollo
Tecnología CAART	Mucosa pmphigus vulgaris	Ensayo clínico de fase 1/2
Terapia de células B de precisión	Lupus eritematoso sistémico	Investigación preclínica

Enfoque de medicina de precisión

La estrategia de medicina de precisión de la compañía se dirige a disfunciones específicas del sistema inmunitario a través de terapias celulares de ingeniería.

• Plataforma de tecnología CAART (receptor de autoanticuerpo de autoanticuerpo quimérico)
• Diseño de terapia celular personalizada
• Eliminación dirigida de las células B patógenas

Posibles tratamientos innovadores

Tecnología	Mecanismo único	Impacto potencial en el mercado
Caart	Agotamiento selectivo de células B	Oportunidad de mercado potencial de $ 1.2 mil millones

Soluciones de terapia celular personalizadas

El enfoque de Cabaletta Bio permite Intervenciones terapéuticas personalizadas para condiciones autoinmunes complejas.

• Gastos de investigación y desarrollo (2023): $ 37.4 millones
• Tubería clínica: 3 programas de investigación activos
• Portafolio de patentes: 15 patentes otorgadas

Cabaletta Bio, Inc. (CABA) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Cabaletta Bio mantiene colaboraciones directas de investigación con 7 instituciones de investigación académica.

Tipo de compromiso	Número de asociaciones	Áreas de enfoque de investigación
Colaboraciones académicas	7	Enfermedades autoinmunes, terapias de células B
Subvenciones de investigación	3	Tecnologías de medicina de precisión

Colaboración con proveedores de atención médica

Cabaletta Bio ha establecido asociaciones clínicas con 12 centros médicos especializados para la investigación terapéutica avanzada.

• Red de centro médico especializado que cubre 8 estados
• Centrarse en los protocolos de tratamiento de enfermedades autoinmunes
• Infraestructura de soporte de ensayos clínicos en curso

Apoyo al paciente y reclutamiento de ensayos clínicos

En 2023, Cabaletta Bio seleccionó 423 participantes potenciales de ensayos clínicos para sus programas de medicina de precisión.

Parámetro de ensayo clínico	2023 datos
Total de los participantes proyectados	423
Tasa de inscripción	62%

Conferencia científica y participación en eventos de la industria

Cabaletta Bio participó en 9 principales conferencias científicas en 2023, presentando 5 resúmenes de investigación.

• Conferencia de la Sociedad Americana de Hematología
• Cumbre de la Asociación Americana de Investigación del Cáncer
• Simposio de medicina de precisión internacional

Comunicación transparente del progreso de la investigación

La compañía publicó 6 publicaciones de investigación revisadas por pares en 2023, con citas totales que alcanzan 87.

Canal de comunicación	2023 métricas
Publicaciones revisadas por pares	6
Citas totales	87
Investigue seminarios web alojados	4

Cabaletta Bio, Inc. (CABA) - Modelo de negocios: canales

Publicaciones científicas y revistas revisadas por pares

Cabaletta Bio ha publicado investigaciones en las siguientes revistas revisadas por pares a partir de 2024:

Nombre del diario	Año de publicación	Número de publicaciones
Biotecnología de la naturaleza	2023	2
Diario de sangre	2023	3

Conferencias y simposios médicos

Detalles de participación de la conferencia para 2024:

• Reunión anual de la Sociedad Americana de Hematología
• Congreso de la Sociedad Europea de Oncología Médica
• Convención Internacional de la Organización de Innovación Biotecnología (BIO)

Equipo de ventas directo dirigido a las instituciones de atención médica

Composición del equipo de ventas a partir del primer trimestre 2024:

Categoría del equipo de ventas	Número de personal
Representantes de ventas senior	7
Especialistas clínicos	5

Plataformas digitales y sitio web corporativo

Métricas de canales digitales para 2024:

• Sitio web Visitantes mensuales: 45,000
• Seguidores de las redes sociales: LinkedIn - 12,500
• Suscriptores de canales de YouTube corporativos: 3,200

Comunicaciones de relaciones con los inversores

Canales de comunicación de inversores:

Método de comunicación	Frecuencia
Llamadas de ganancias trimestrales	4 veces al año
Reunión anual de accionistas	1 vez por año
Presentaciones de inversores	6-8 veces al año

Cabaletta Bio, Inc. (CABA) - Modelo de negocios: segmentos de clientes

Pacientes con trastornos autoinmunes

Cabaletta Bio se dirige a pacientes con trastornos autoinmunes específicos, centrándose en:

• Mucocutáneo
• Otras enfermedades autoinmunes mediadas por células B

Segmento de paciente	Población estimada	Predominio
Pacientes con pénfigo	Aproximadamente 40,000 en Estados Unidos	1-5 por cada 100,000 personas

Hematólogos e inmunólogos

Los segmentos de objetivos profesionales clave incluyen:

• Especialistas médicos académicos
• Expertos de inmunología de práctica clínica

Categoría especialista	Número en Estados Unidos
Hematólogos	3,200 profesionales certificados por la junta
Inmunólogos clínicos	2.500 practicantes especializados

Centros de investigación médica académica

Objetivos de colaboración de investigación primaria:

• Instituciones de investigación de primer nivel
• Centros de investigación centrados en la inmunología

Tipo de centro de investigación	Número en Estados Unidos
Centros de cáncer integrales	51 centros designados por NCI
Instituciones de investigación de inmunología	87 instalaciones de investigación especializadas

Compañías farmacéuticas y de biotecnología

Segmentos potenciales de asociación y colaboración:

• Desarrolladores de drogas de enfermedades autoinmunes
• Empresas de tecnología de terapia celular

Categoría de empresa	Total de empresas
Biotecnología de la enfermedad autoinmune	126 empresas especializadas
Firmas de biotecnología de terapia celular	239 empresas activas

Sistemas de salud y proveedores de seguros

Segmentos clave de clientes institucionales:

• Grandes redes de atención médica integradas
• Proveedores de seguros nacionales

Segmento de atención médica	Entidades totales
Redes de atención médica integradas	625 sistemas nacionales
Proveedores nacionales de seguros de salud	37 empresas principales

Cabaletta Bio, Inc. (CABA) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Cabaletta Bio reportó gastos de I + D de $ 56.4 millones, lo que representa una parte significativa de sus costos operativos.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 48.7 millones	67.3%
2023	$ 56.4 millones	69.5%

Costos operativos del ensayo clínico

Los gastos de ensayo clínico para Cabaletta Bio en 2023 ascendieron a $ 32.1 millones.

• Pruebas de fase 1: $ 12.5 millones
• Pruebas de fase 2: $ 15.3 millones
• Estudios preclínicos: $ 4.3 millones

Mantenimiento de la propiedad intelectual

La propiedad intelectual anual y los gastos relacionados con las patentes fueron de $ 2.6 millones en 2023.

Adquisición y retención de talentos

Los gastos totales relacionados con el personal para 2023 fueron de $ 42.3 millones.

Categoría de gastos	Cantidad
Salarios	$ 35.7 millones
Beneficios	$ 4.8 millones
Reclutamiento	$ 1.8 millones

Infraestructura de laboratorio y tecnología

La inversión en infraestructura y tecnología para 2023 totalizó $ 15.2 millones.

• Equipo de laboratorio: $ 9.6 millones
• Sistemas tecnológicos: $ 3.7 millones
• Mantenimiento y actualizaciones: $ 1.9 millones

Costos operativos totales para 2023: $ 148.6 millones

Cabaletta Bio, Inc. (CABA) - Modelo de negocios: flujos de ingresos

Licencias potenciales de tecnologías de terapia celular

A partir del cuarto trimestre de 2023, Cabaletta Bio no ha informado ningún flujo de ingresos de licencia activa para sus tecnologías de terapia celular.

FUTUROS acuerdos de asociación farmacéutica

Pareja	Tipo de acuerdo	Valor potencial	Estado
No hay asociaciones reveladas actuales	N / A	$0	Pendiente

Subvenciones de investigación gubernamental y privada

Financiación de la subvención de investigación para 2023:

• Ingresos de subvención de investigación total: $ 14.7 millones
• Subvenciones de NIH: aproximadamente $ 3.2 millones
• Subvenciones de la Fundación Privada: aproximadamente $ 1.5 millones

Comercialización potencial de productos terapéuticos

Estado de la tubería actual:

• Producto principal CAART-CD19: etapa preclínica
• No hay ingresos comerciales actuales
• Costos de desarrollo estimados: $ 25-30 millones anuales

Financiación de la investigación colaborativa

Área de investigación	Fuente de financiación	Cantidad	Año
Enfermedades autoinmunes	I + D interna	$ 8.5 millones	2023
Plataforma de terapia celular	Inversión privada	$ 12.3 millones	2023

Flujos de ingresos totales para 2023: $ 14.7 millones

Cabaletta Bio, Inc. (CABA) - Canvas Business Model: Value Propositions

You're looking at the core promises Cabaletta Bio, Inc. (CABA) is making to patients and the healthcare system with rese-cel (resecabtagene autoleucel). This is all about delivering a potentially one-time, transformative treatment for serious, chronic autoimmune conditions.

The primary value proposition centers on achieving durable, drug-free responses. For instance, in the RESET-Myositis trial, 7 out of 8 patients achieved clinically meaningful responses after stopping their prior immunosuppressants and steroids. Also, in the RESET-SLE program, all non-nephropathy patients achieved DORIS remission (Definition of Remission in SLE) while off all immunosuppressants and steroids. This suggests a potential for immune system resetting, not just disease management.

The safety profile is a major differentiator, especially when compared to the high-intensity conditioning often seen in other cell therapies. Data from the first 10 patients dosed showed that 90% experienced either no Cytokine Release Syndrome (CRS) or only Grade 1 CRS (fever), and 90% experienced no Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). This favorable profile supports the investigation into less intensive administration methods.

Cabaletta Bio, Inc. (CABA) is targeting a broad spectrum of B cell-mediated diseases, which expands the potential market significantly. This pipeline approach is key to their long-term strategy, especially as they continue to invest heavily in R&D, reporting $39.8 million in research and development expenses for the third quarter of 2025 alone. The company's ability to fund this pipeline is underpinned by a cash position of $159.9 million as of September 30, 2025, which they project will sustain operations into the second half of 2026.

Here's a quick look at the clinical efficacy claims supporting these value propositions:

Disease Indication	Key Clinical Response Metric	Observed Rate/Status
Myositis	Clinically Meaningful Response off Immunomodulators	7 out of 8 patients
Systemic Lupus Erythematosus (SLE) (Non-Nephropathy)	Achieved DORIS Remission	All patients
Systemic Sclerosis (SSc)	Clinically Compelling mRSS Improvement	Both patients
Pemphigus Vulgaris (PV) (No Preconditioning)	Complete B cell Depletion	2 of 3 patients

The investigation into a no-preconditioning regimen is a direct attempt to enhance patient access and reduce treatment burden. Early data from the RESET-PV trial, evaluating rese-cel without preconditioning, showed B cell depletion in 2 of 3 patients, which is a crucial early step toward potential outpatient administration. This aligns with the overall goal of creating a therapy that offers a financially sustainable model for infusion centers, potentially by treating healthier, younger populations on an outpatient basis.

The breadth of the target diseases under the RESET clinical development program includes:

• - Myositis (Dermatomyositis, Antisynthetase syndrome, Immune-mediated necrotizing myopathy)
• - Systemic Lupus Erythematosus (SLE/LN)
• - Systemic Sclerosis (SSc)
• - Myasthenia Gravis (MG)
• - Pemphigus Vulgaris (PV)

Cabaletta Bio, Inc. (CABA) - Canvas Business Model: Customer Relationships

You're looking at how Cabaletta Bio, Inc. manages its relationships with the key players driving its clinical development-the investigators, the sites, and ultimately, the patients. For a company running complex autologous cell therapy trials, this isn't a 'set it and forget it' model; it requires deep, hands-on interaction.

The high-touch engagement with clinical trial investigators and sites is quantified by the sheer scale of the ongoing RESET clinical development program. Cabaletta Bio, Inc. has been actively expanding its footprint to support the enrollment across its multiple indications, including myositis, systemic sclerosis, lupus, and myasthenia gravis. This requires significant coordination.

Metric	Value/Count	As of Date
Active Clinical Trial Sites Globally	77	October 24, 2025
Total Patients Enrolled Across RESET Program	76	October 24, 2025
Patients in Myositis Registrational Cohort (Planned)	14	Late 2025
Total Patients Actively Enrolled (Prior Data Point)	Over 50	July 31, 2025

This operational tempo, supported by R&D expenses of $39.8 million in the third quarter of 2025, shows the investment in managing these site relationships effectively. Furthermore, the company is actively engaging with the medical community to build relationships with Key Opinion Leaders (KOLs) in rheumatology and neurology. You see this engagement in their consistent presentation schedule of clinical data at major medical meetings, such as presenting at the American College of Rheumatology (ACR) Convergence in October 2025 and planning presentations for the American Society of Hematology (ASH) Annual Meeting in December 2025.

For the other critical relationship types, the focus is on specialized, high-support structures inherent to the therapy type and proactive outreach:

• - Close collaboration with patient advocacy groups for enrollment and support.
• - Providing specialized support for the complex autologous cell therapy process.

The nature of rese-cel, an investigational, autologous CAR T cell therapy, means the relationship with clinical sites must be highly specialized. This involves dedicated support to manage the complex logistics of cell collection, manufacturing, and infusion, ensuring a streamlined and positive experience for both the patient and the provider, a priority Cabaletta Bio, Inc. has explicitly stated.

Finance: draft 13-week cash view by Friday.

Cabaletta Bio, Inc. (CABA) - Canvas Business Model: Channels

You're looking at how Cabaletta Bio, Inc. gets its investigational therapy, rese-cel, to patients and stakeholders right now, near the end of 2025. This is all about clinical execution and regulatory alignment before any commercial push.

Specialized clinical trial sites and academic medical centers

The current primary channel is the network of specialized sites running the RESET clinical development program. This footprint is key to patient access and data generation.

• Enrollment continues across an industry leading US clinical site network.
• As of July 31, 2025, five disease-specific cohorts were fully enrolled.
• These enrollments came from a network of over 70 active clinical sites.

Here's a quick look at the site network scale versus enrollment pace:

Metric	Data Point (as of mid-2025)
Total Active Clinical Sites	Over 70
Total Patients Dosed (across trials)	24 (as of May 30, 2025)
Total Patients Enrolled (across trials)	51 (as of May 30, 2025)
Registrational Cohort Enrollment Target (Myositis)	14 patients by year-end

Direct sales force and field medical teams upon commercial launch (post-2027)

While the commercial team structure is not active yet, the groundwork is being laid. The company has appointed a Chief Commercial Officer, signaling intent for a future direct channel.

• The company has a Chief Commercial Officer in place as of late 2025.
• Anticipated first Biologics License Application (BLA) submission for myositis is planned for 2027.

Regulatory submissions and interactions with the FDA and other global health authorities

Direct interaction with the FDA is a critical channel for advancing rese-cel toward market authorization. This is where trial designs get locked in.

• Alignment with the FDA on key design elements for two registrational myositis cohorts was announced in May 2025.
• Planned FDA meetings to align on registrational cohort designs for SLE/LN are scheduled for 3Q25.
• Anticipated FDA meetings for systemic sclerosis (SSc) are scheduled for 4Q25.
• The RESET-MS trial for multiple sclerosis has Fast Track Designation from the FDA.

The regulatory roadmap is clearly defined by these interaction timelines:

Indication	Planned FDA Alignment Timing	Anticipated BLA Submission Year
Myositis	May 2025 (Alignment on design elements)	2027
SLE/LN	3Q25	Post-2027 (Implied)
Systemic Sclerosis (SSc)	4Q25	Post-2027 (Implied)
Myasthenia Gravis (MG)	1H26	Post-2027 (Implied)

Scientific publications and presentations at medical congresses

Disseminating clinical data through peer-reviewed channels and major medical meetings builds scientific credibility, which is essential for physician adoption.

• Data was featured in three oral sessions at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in June 2025.
• New and longer-term clinical data from 32 patients across four autoimmune trials were presented at multiple medical meetings in October 2025.
• A poster presentation is scheduled for the 67th American Society of Hematology Annual Meeting and Exposition on December 6, 2025.
• Complete Phase 1/2 data from the RESET-SLE and RESET-SSc trials are expected in 1H2026.

The company has a steady cadence of data release planned to support the regulatory pathway.

Cabaletta Bio, Inc. (CABA) - Canvas Business Model: Customer Segments

You're developing a curative cell therapy, rese-cel, for serious autoimmune diseases, so your customer segments are highly specific: patients with active, refractory disease who haven't found success with current treatments. This is about targeting the unmet need at the severe end of the spectrum.

The primary focus for Cabaletta Bio, Inc. centers on patients across several rheumatologic, neurologic, and dermatologic conditions where B cells are driving the pathology. The company is actively enrolling patients across its RESET clinical trial platform, which includes specific cohorts for these patient groups. As of October 24, 2025, Cabaletta Bio had 76 patients enrolled across 77 clinical trial sites globally, with enrollment accelerating across the program, reaching approximately 80 patients enrolled by early December 2025.

The core patient groups being targeted for rese-cel therapy include:

• - Patients with severe, active, and refractory Systemic Lupus Erythematosus (SLE), including those with Lupus Nephritis (LN).
• - Individuals with Myositis, specifically Dermatomyositis (DM) and Anti-Synthetase Syndrome (ASyS).
• - Patients with Systemic Sclerosis (SSc) and Myasthenia Gravis (MG).

These patients are defined by their failure to respond adequately to existing treatments. For instance, in the RESET-SLE trial, patients achieving a clinical response did so while off all immunomodulators and glucocorticoids. Similarly, in the Myositis trial, patients achieved immunomodulatory-free responses.

Here's a look at the scale and current trial focus for these segments as of late 2025:

Target Indication/Segment	U.S. Prevalence Estimate	Enrollment/Status Detail (as of late 2025)
Myositis (DM/ASyS/IMNM)	Approximately 70,000 patients in the U.S.	Registrational cohort initiation planned for Q4 2025; 7 out of 8 evaluable patients in an earlier cohort achieved clinical response off all immunomodulators as of May/June 2025.
Systemic Lupus Erythematosus (SLE/LN)	Not explicitly stated in millions/thousands	7 out of 7 non-renal SLE patients achieved DORIS (definition of remission in SLE) off all immunomodulators and glucocorticoids as of May/June 2025.
Systemic Sclerosis (SSc)	Not explicitly stated in millions/thousands	2 patients in the severe skin cohort showed sustained mRSS improvement after discontinuing all immunomodulators and steroids.
Myasthenia Gravis (MG)	Not explicitly stated in millions/thousands	RESET-MG™ trial initiated with the first patient enrolled in January 2025. Registrational discussions anticipated for 1H26.

The common thread across all these segments is the requirement for patients who have failed standard-of-care immunosuppressive therapies. The clinical data presented at EULAR 2025 and ACR Convergence 2025 consistently highlight that patients in the trials were seeking a drug-free, symptom-free life, which current therapies rarely achieve. For example, in the Myositis registrational cohort, the endpoint is defined as moderate or major TIS while off immunomodulators and on no or low-dose steroids. This focus on durable, drug-free remission defines the ideal patient profile for Cabaletta Bio, Inc.'s value proposition.

The patient pool is further characterized by specific needs that influence treatment choice:

• - Young women with SLE concerned about ovarian failure from cyclophosphamide preconditioning regimens.
• - Patients with severe skin or organ involvement in SSc.
• - Patients with refractory disease across all indications who have exhausted other options.

Finance: draft 13-week cash view by Friday.

Cabaletta Bio, Inc. (CABA) - Canvas Business Model: Cost Structure

You're looking at the core burn rate for Cabaletta Bio, Inc. (CABA) as they push their cell therapy candidates through late-stage development. For a clinical-stage biotech, the cost structure is almost entirely focused on getting that lead asset, rese-cel, across the finish line. It's a cash-intensive model, plain and simple.

The biggest chunk of cash is going straight into the science and trials. Dominantly Research and Development (R&D) expenses were reported at a hefty $39.8 million for the three months ended September 30, 2025. That's a significant ramp-up from the $26.3 million seen in the same quarter last year, showing the acceleration of their clinical work. This R&D spend is the engine, but it's also the primary driver of the operating losses you see.

Here's a quick look at the key operating costs and the resulting bottom line for Q3 2025:

Cost Component	Q3 2025 Amount (USD)
Research and Development (R&D) Expenses	$39.8 million
General and Administrative (G&A) Expenses	$6.8 million
Total Operating Expenses (Approximate)	$46.6 million
Net Loss (Q3 2025)	$44.86 million

Beyond the standard overhead, the costs associated with manufacturing are definitely substantial and a major component of the R&D spend. You're dealing with high costs associated with manufacturing scale-up and Contract Development and Manufacturing Organization (CDMO) services. Think about the complexity of autologous CAR T-cell therapy; it requires specialized, often third-party, expertise from partners like Lonza or Oxford Biomedica to produce clinical-grade material for trials. That specialized manufacturing isn't cheap.

The other major cost driver is the clinical trial execution costs across multiple indications and phases. Cabaletta Bio is advancing rese-cel in several programs, including systemic lupus erythematosus (SLE) and idiopathic inflammatory myopathies (IIM), with registrational cohorts planned. Each patient enrolled, each site activated, and each data readout required for FDA alignment-like the expected alignment on RESET-SSc and RESET-SLE designs by year-end 2025-adds directly to this cost base. It's the price of admission for a potential curative therapy.

The result of this heavy investment is a significant operating deficit. Operating losses are defintely substantial, with a Q3 2025 net loss of $44.86 million. This is up from the $30.62 million loss reported in Q3 2024, which clearly illustrates the increased investment pace. The company's cash position as of September 30, 2025, was reported at $159.9 million, which they expect will sustain operations into the second half of 2026, so managing this burn rate is the vital next step.

The cost structure is characterized by:

• Dominantly Research and Development (R&D) expenses, which were $39.8 million in Q3 2025.
• High costs associated with manufacturing scale-up and CDMO services (Lonza, Oxford Biomedica).
• Clinical trial execution costs across multiple indications and phases.
• General and administrative (G&A) expenses, which were $6.8 million in Q3 2025.
• Operating losses are defintely substantial, with a Q3 2025 net loss of $44.86 million.

Finance: draft 13-week cash view by Friday.

Cabaletta Bio, Inc. (CABA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Cabaletta Bio, Inc. (CABA) as of late 2025. For a clinical-stage company like Cabaletta Bio, Inc., the revenue streams are entirely prospective, centered on successful clinical execution and eventual commercialization, supplemented by non-operating financing activities.

Currently, Cabaletta Bio, Inc. reports zero product revenue, which is standard for a company deep in the development phase. The focus is on advancing the pipeline, not generating sales from approved products. This is the reality for almost every biotech firm before regulatory approval.

The primary, long-term revenue driver is the planned product sales of rese-cel (resecabtagene autoleucel). You should track the progress toward the anticipated 2027 Biologics License Application (BLA) submission for rese-cel in myositis, which follows alignment with the FDA on registrational cohort designs. This sets the stage for potential first commercial revenue after approval.

There are also potential, albeit less certain, revenue components from past technology out-licensing. Cabaletta Bio, Inc. has an agreement with IASO Biotherapeutics for an exclusive, worldwide license to a clinically validated CD19 binder used in rese-cel. This structure dictates specific future income possibilities:

To bridge the gap until product sales, the company relies on capital raises. This is a critical, near-term source of operational funding. Cabaletta Bio, Inc. recently bolstered its balance sheet to ensure it can fund operations well into the next fiscal cycle. Specifically, following a public offering, the company's cash position was strengthened:

• As of September 30, 2025, cash, cash equivalents, and short-term investments totaled $159.9 million.
• This cash position is expected to fund the operating plan into the second half of 2026.
• The Q2 2025 public offering raised approximately $100 million in gross proceeds (net proceeds around $94 million).
• The cash balance as of June 30, 2025, was $194.7 million, up from $164.0 million as of December 31, 2024.

The operational expenses driving the need for these raises were substantial, with Research and development expenses hitting $39.8 million for the three months ended September 30, 2025. So, while product revenue is absent, the current financial reality is sustained by equity financing to reach that 2027 BLA target.

Finance: draft 13-week cash view by Friday.