Cabaletta Bio, Inc. (CABA): Modelo de negócios Canvas [Jan-2025 Atualizado]

No campo de ponta da biotecnologia, a Cabaletta Bio, Inc. (CABA) surge como uma força pioneira, revolucionando o tratamento da doença auto-imune por meio de terapias inovadoras de receptores de células B. Ao alavancar plataformas sofisticadas de engenharia celular e uma abordagem de medicina de precisão, esta empresa dinâmica de biotecnologia está pronta para transformar como entendemos e combate as disfunções complexas do sistema imunológico. Seu modelo estratégico de negócios entrelaça pesquisas científicas inovadoras, parcerias estratégicas e um compromisso visionário em desenvolver soluções personalizadas de terapia celular que poderiam potencialmente reescrever o cenário da intervenção médica para pacientes que lutam contra condições autoimunes desafiadoras.

Cabaletta Bio, Inc. (CABA) - Modelo de negócios: Parcerias -chave

Colaborações com instituições de pesquisa acadêmica

A Cabaletta Bio estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Status de colaboração
Universidade da Pensilvânia	Engenharia de células B.	Colaboração ativa
Escola de Medicina de Harvard	Pesquisa de doenças autoimunes	Parceria de Pesquisa em andamento

Parcerias estratégicas com empresas farmacêuticas

A Cabaletta Bio desenvolveu parcerias estratégicas com as seguintes empresas farmacêuticas:

• Bristol Myers Squibb - Colaboração no Desenvolvimento da Terapia de Cells Car -T
• Regeneron Pharmaceuticals - Pesquisa conjunta em tratamentos de doenças autoimunes

Alianças em potencial com organizações de pesquisa clínica

A Cabaletta Bio se envolveu com organizações de pesquisa clínica para apoiar seu pipeline de desenvolvimento de medicamentos:

Nome do CRO	Serviços prestados	Valor do contrato
Icon plc	Gerenciamento de ensaios clínicos	US $ 2,5 milhões
Iqvia	Recrutamento e monitoramento de pacientes	US $ 1,8 milhão

Engajamento com inovadores de tecnologia de saúde

A Cabaletta Bio estabeleceu parcerias tecnológicas com:

• Biotecnologias adaptativas - Tecnologia de sequenciamento de repertório imune
• 10x genômica - plataforma genômica de célula única

Investimento total de parceria em 2024: aproximadamente US $ 4,3 milhões

Cabaletta Bio, Inc. (CABA) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de tecnologias de terapia celular

A partir do quarto trimestre 2023, Cabaletta Bio se concentrou no desenvolvimento Imunoterapias envolventes de células B. direcionando doenças autoimunes.

Métrica de P&D	Valor
Despesas de P&D (2022)	US $ 56,4 milhões
Programas de pesquisa ativa	4 programas distintos
Estágio de desenvolvimento de programas principais	Fase 1/2 ensaios clínicos

Gerenciamento de ensaios pré -clínicos e clínicos

• Programa CABA-2010 Visando o lúpus eritematoso sistêmico (LES)
• Programa CABA-202 para PEMPHIGUS vulgaris
• Ensaios clínicos em andamento em vários centros de pesquisa

Desenvolvimento e proteção da propriedade intelectual

Categoria IP	Número
Total de famílias de patentes	15
Emitiu patentes dos EUA	8
Aplicações de patentes pendentes	7

Conformidade regulatória e execução de ensaios clínicos

Colaborando com a FDA e a EMA para aprovações regulatórias de terapias celulares.

Interação regulatória	Status
Interações FDA	Comunicações de IND em andamento
Protocolos de ensaios clínicos	3 protocolos de investigação ativos

Cabaletta Bio, Inc. (CABA) - Modelo de negócios: Recursos -chave

Plataformas de engenharia de células proprietárias

Cabaletta Bio aproveita seu Deliver ™ (imunoterapia ligada à enzima direcionada para regeneração experimental) Plataforma de engenharia celular. A partir de 2024, a plataforma se concentra no desenvolvimento de imunoterapias de células B projetadas.

Característica da plataforma	Detalhes específicos
Tipo de tecnologia	Engenharia de imunoterapia de células B
Estágio de desenvolvimento	Desenvolvimento pré -clínico e clínico avançado
Principais aplicações	Direcionamento de doenças autoimunes

Talento científico e de pesquisa especializado

A Cabaletta Bio mantém uma força de trabalho especializada com ampla experiência em imunologia e terapia celular.

• Total de funcionários a partir do quarto trimestre 2023: 79 pessoal
• Pesquisadores no nível de doutorado: aproximadamente 40% da força de trabalho
• Tamanho da equipe de pesquisa e desenvolvimento: 45 cientistas especializados

Instalações avançadas de laboratório e pesquisa

A empresa opera infraestrutura avançada de pesquisa na Filadélfia, Pensilvânia.

Atributo da instalação	Especificação
Espaço total de pesquisa	Aproximadamente 25.000 pés quadrados
Tipo de laboratório	Instalações especializadas de pesquisa de imunoterapia
Investimento de equipamentos	US $ 3,2 milhões em equipamentos de pesquisa avançada (2023)

Portfólio de propriedade intelectual robusta

A Cabaletta Bio mantém uma forte estratégia de propriedade intelectual.

• Total de pedidos de patente: 17
• Patentes concedidas: 8
• Famílias de patentes que cobrem a plataforma Deliver ™: 5

Financiamento significativo de capital de risco

A Companhia garantiu recursos financeiros substanciais por meio de investimentos em capital de risco.

Métrica de financiamento	Quantia
Financiamento total arrecadado	US $ 213,5 milhões
Última rodada de financiamento	US $ 85,6 milhões da série C (2022)
Principais investidores	Ventuos versantes, parceiros fundamentais de bioventuras

Cabaletta Bio, Inc. (CABA) - Modelo de negócios: proposições de valor

Terapias inovadoras de receptores de células B para doenças autoimunes

A proposta de valor primário da Cabaletta Bio se concentra no desenvolvimento Terapias celulares de precisão direcionando doenças auto-imunes mediadas por receptores B de células B.

Categoria de terapia	Indicação alvo	Estágio de desenvolvimento
TECNOLOGIA CAART	Pênfigo mucoso vulgaris	Ensaio Clínico de Fase 1/2
Terapia de células B de precisão	Lúpus eritematoso sistêmico	Pesquisa pré -clínica

Abordagem de medicina de precisão

A estratégia de medicina de precisão da empresa tem como alvo disfunções específicas do sistema imunológico por meio de terapias celulares projetadas.

• CAART proprietário (plataforma de tecnologia de células T-células T de receptor de autoanticorpo quimérico)
• Design de terapia celular personalizada
• Eliminação direcionada de células B patogênicas

Potenciais tratamentos inovadores

Tecnologia	Mecanismo único	Impacto potencial no mercado
Caart	Depleção seletiva de células B.	US $ 1,2 bilhão em potencial oportunidade de mercado

Soluções personalizadas de terapia celular

A abordagem de Cabaletta Bio permite Intervenções terapêuticas personalizadas para condições autoimunes complexas.

• Despesas de pesquisa e desenvolvimento (2023): US $ 37,4 milhões
• Oleoduto clínico: 3 programas de investigação ativos
• Portfólio de patentes: 15 patentes concedidas

Cabaletta Bio, Inc. (CABA) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A partir do quarto trimestre 2023, a Cabaletta Bio mantém colaborações diretas de pesquisa com 7 instituições de pesquisa acadêmica.

Tipo de engajamento	Número de parcerias	Áreas de foco de pesquisa
Colaborações acadêmicas	7	Doenças autoimunes, terapias de células B
Bolsas de pesquisa	3	Tecnologias de Medicina de Precisão

Colaboração com prestadores de serviços de saúde

A Cabaletta Bio estabeleceu parcerias clínicas com 12 centros médicos especializados para pesquisa terapêutica avançada.

• Rede especializada em centro médico cobrindo 8 estados
• Concentre -se nos protocolos de tratamento de doenças autoimunes
• Infraestrutura de suporte ao ensaio clínico em andamento

Suporte ao paciente e recrutamento de ensaios clínicos

Em 2023, a Cabaletta Bio exibiu 423 participantes em potencial de ensaios clínicos para seus programas de medicina de precisão.

Parâmetro do ensaio clínico	2023 dados
Total de participantes selecionados	423
Taxa de inscrição	62%

Conferência Científica e Participação de Eventos da Indústria

Cabaletta Bio participou de 9 principais conferências científicas em 2023, apresentando 5 resumos de pesquisa.

• Conferência da Sociedade Americana de Hematologia
• Associação Americana para Cúpula de Pesquisa sobre Câncer
• Simpósio Internacional de Medicina de Precisão

Comunicação transparente do progresso da pesquisa

A empresa publicou 6 publicações de pesquisa revisadas por pares em 2023, com o total de citações atingindo 87.

Canal de comunicação	2023 Métricas
Publicações revisadas por pares	6
Citações totais	87
Os webinars de pesquisa hospedados	4

Cabaletta Bio, Inc. (CABA) - Modelo de negócios: canais

Publicações científicas e revistas revisadas por pares

A Cabaletta Bio publicou pesquisas nos seguintes periódicos revisados ​​por pares a partir de 2024:

Nome do diário	Ano de publicação	Número de publicações
Biotecnologia da natureza	2023	2
Blood Journal	2023	3

Conferências médicas e simpósios

Detalhes da participação da conferência para 2024:

• Reunião Anual da Sociedade Americana de Hematologia
• Sociedade Europeia para Congresso de Oncologia Médica
• Organização de Inovação de Biotecnologia (BIO) Convenção Internacional

Equipe direta da equipe de vendas direcionando instituições de saúde

Composição da equipe de vendas no primeiro trimestre 2024:

Categoria da equipe de vendas	Número de pessoal
Representantes de vendas seniores	7
Especialistas clínicos	5

Plataformas digitais e site corporativo

Métricas de canal digital para 2024:

• Visitantes mensais do site: 45,000
• Seguidores de mídia social: LinkedIn - 12.500
• Assinantes corporativos do canal do YouTube: 3,200

Comunicações de Relações com Investidores

Canais de comunicação de investidores:

Método de comunicação	Freqüência
Chamadas de ganhos trimestrais	4 vezes por ano
Reunião Anual dos Acionistas	1 tempo por ano
Apresentações de investidores	6-8 vezes por ano

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

Pacientes com distúrbios autoimunes

Cabaletta Bio tem como alvo pacientes com distúrbios autoimunes específicos, concentrando -se em:

• Pênfigo mucocutâneo
• Outras doenças auto-imunes mediadas por células B

Segmento de pacientes	População estimada	Prevalência
Pacientes com pênfigo	Aproximadamente 40.000 nos Estados Unidos	1-5 por 100.000 indivíduos

Hematologistas e imunologistas

Os principais segmentos de destino profissionais incluem:

• Especialistas médicos acadêmicos
• Especialistas em imunologia da prática clínica

Categoria especializada	Número nos Estados Unidos
Hematologistas	3.200 profissionais certificados pela placa
Imunologistas clínicos	2.500 profissionais especializados

Centros de Pesquisa Médica Acadêmica

Metas de colaboração de pesquisa primária:

• Instituições de pesquisa de primeira linha
• Centros de pesquisa focados em imunologia

Tipo de centro de pesquisa	Número nos Estados Unidos
Centros abrangentes de câncer	51 centros projetados por NCI
Instituições de pesquisa de imunologia	87 instalações de pesquisa especializadas

Empresas farmacêuticas e de biotecnologia

Potenciais segmentos de parceria e colaboração:

• Desenvolvedores de doenças autoimunes
• Empresas de tecnologia de terapia celular

Categoria da empresa	TOTAL NECESSAS
Doença autoimune focada na biotecnologia	126 empresas especializadas
Empresas de biotecnologia de terapia celular	239 empresas ativas

Sistemas de saúde e provedores de seguros

Principais segmentos de clientes institucionais:

• Grandes redes de saúde integradas
• Fornecedores de seguros nacionais

Segmento de saúde	Entidades totais
Redes de saúde integradas	625 sistemas nacionais
Provedores nacionais de seguro de saúde	37 grandes empresas

Cabaletta Bio, Inc. (CABA) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Cabaletta Bio registrou despesas de P&D de US $ 56,4 milhões, representando uma parcela significativa de seus custos operacionais.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 48,7 milhões	67.3%
2023	US $ 56,4 milhões	69.5%

Custos operacionais de ensaios clínicos

As despesas de ensaios clínicos para a Cabaletta Bio em 2023 totalizaram US $ 32,1 milhões.

• Ensaios de fase 1: US $ 12,5 milhões
• Ensaios de fase 2: US $ 15,3 milhões
• Estudos pré -clínicos: US $ 4,3 milhões

Manutenção da propriedade intelectual

A propriedade intelectual anual e as despesas relacionadas a patentes foram de US $ 2,6 milhões em 2023.

Aquisição e retenção de talentos

As despesas totais relacionadas ao pessoal para 2023 foram de US $ 42,3 milhões.

Categoria de despesa	Quantia
Salários	US $ 35,7 milhões
Benefícios	US $ 4,8 milhões
Recrutamento	US $ 1,8 milhão

Infraestrutura de laboratório e tecnologia

O investimento em infraestrutura e tecnologia para 2023 totalizou US $ 15,2 milhões.

• Equipamento de laboratório: US $ 9,6 milhões
• Sistemas de tecnologia: US $ 3,7 milhões
• Manutenção e atualizações: US $ 1,9 milhão

Custos operacionais totais para 2023: US $ 148,6 milhões

Cabaletta Bio, Inc. (CABA) - Modelo de negócios: fluxos de receita

Licenciamento potencial de tecnologias de terapia celular

No quarto trimestre 2023, a Cabaletta Bio não relatou nenhum fluxo de receita de licenciamento ativo para suas tecnologias de terapia celular.

Futuros acordos de parceria farmacêutica

Parceiro	Tipo de contrato	Valor potencial	Status
Nenhuma parceria atual divulgada	N / D	$0	Pendente

Subsídios do governo e de pesquisa privada

Pesquisa concessão de financiamento para 2023:

• Receita total de concessão de pesquisa: US $ 14,7 milhões
• Subsídios do NIH: aproximadamente US $ 3,2 milhões
• Subsídios de fundação privada: aproximadamente US $ 1,5 milhão

Potencial comercialização terapêutica de produtos

Status do pipeline atual:

• Produto principal Caart-CD19: estágio pré-clínico
• Sem receita comercial atual
• Custos estimados de desenvolvimento: US $ 25 a 30 milhões anualmente

Financiamento de pesquisa colaborativa

Área de pesquisa	Fonte de financiamento	Quantia	Ano
Doenças autoimunes	P&D interna	US $ 8,5 milhões	2023
Plataforma de terapia celular	Investimento privado	US $ 12,3 milhões	2023

Fluxos totais de receita para 2023: US $ 14,7 milhões

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.