Rallybio Corporation (RLYB): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Na paisagem de ponta da biotecnologia, a Rallybio Corporation surge como uma força pioneira, navegando estrategicamente no complexo terreno de raros distúrbios genéticos com inovação científica incomparável. Ao criar meticulosamente um modelo de negócios que preenche pesquisas inovadoras, abordagens centradas no paciente e soluções terapêuticas transformadoras, o Rallybio fica na vanguarda da medicina de precisão personalizada. Seu modelo abrangente de negócios de negócios revela um ecossistema sofisticado projetado para atender às necessidades médicas críticas não atendidas, alavancando pesquisas moleculares avançadas, parcerias estratégicas e um profundo compromisso em desenvolver tratamentos inovadores para pacientes com condições genéticas raras.

Rallybio Corporation (RLYB) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa acadêmica

A Rallybio Corporation estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco na pesquisa	Status de colaboração
Universidade de Yale	Distúrbios genéticos raros	Parceria ativa
Universidade da Pensilvânia	Doenças mediadas por complemento	Colaboração de pesquisa em andamento

Parcerias com grupos de defesa de pacientes com doenças raras

Rallybio mantém relações estratégicas com organizações de defesa de pacientes:

• Genes globais
• Organização Nacional para Distúrbios Raros (Nord)
• Aliança genética

Acordos de desenvolvimento farmacêutico e licenciamento

Parcerias atuais de desenvolvimento farmacêutico:

Parceiro	Candidato a drogas	Estágio de desenvolvimento
Complemento farmacêuticos	RLYB211	Fase 1/2 ensaios clínicos
Horizon Therapeutics	Pesquisa de inibidores do complemento	Colaboração pré -clínica

Colaboração com organizações de pesquisa clínica (CROs)

RALLYBIO ATIVO CRO Partnerships:

• Iqvia
• Parexel International
• PPD (Desenvolvimento de Produtos Farmacêuticos)

A partir do quarto trimestre 2023, o Rallybio alocado US $ 4,2 milhões Para pesquisar colaborações e parcerias.

Rallybio Corporation (RLYB) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de terapêuticas de doenças raras

A partir de 2024, a Rallybio Corporation se concentra no desenvolvimento de terapias para doenças raras com necessidades médicas não atendidas significativas. A empresa alocou US $ 45,2 milhões especificamente para despesas de pesquisa e desenvolvimento em seu mais recente ano fiscal.

Área de foco de pesquisa	Estágio atual de desenvolvimento	Investimento estimado
RLYB212 para doenças mediadas por complemento	Ensaios clínicos de fase 2	US $ 18,7 milhões
RLYB211 para tenngiectasia hemorrágica hereditária	Desenvolvimento pré -clínico	US $ 12,5 milhões

Gerenciamento de ensaios pré -clínicos e clínicos

Rallybio gerencia vários programas de desenvolvimento clínico com uma abordagem estruturada.

• Ensaios clínicos ativos: 3 programas em andamento
• Sites de ensaios clínicos totais: 15 locais internacionais
• Alvo de inscrição do paciente: 250 pacientes nos ensaios atuais

Processos de submissão e conformidade regulatórios

A Companhia mantém estratégias rigorosas de conformidade regulatória com investimentos em infraestrutura de assuntos regulatórios.

Atividade regulatória	Número de envios	Agências regulatórias
Aplicações IND	2 em 2023	FDA, Ema
Emendas de protocolo	4 em 2023	Várias agências internacionais

Descoberta de drogas e pesquisa molecular

A Rallybio emprega técnicas avançadas de pesquisa molecular com equipes científicas especializadas.

• Pessoal de pesquisa: 37 cientistas especializados
• Instalações de pesquisa: 2 laboratórios dedicados
• Orçamento anual de pesquisa molecular: US $ 22,6 milhões

Desenvolvimento e proteção da propriedade intelectual

A empresa mantém uma estratégia de propriedade intelectual robusta.

Categoria IP	Número total	Status
Aplicações de patentes	12	Pendente/concedido
Patentes concedidas	7	Proteção ativa

Rallybio Corporation (RLYB) - Modelo de negócios: Recursos -chave

Talento científico e de pesquisa especializado

A partir do quarto trimestre 2023, a Rallybio Corporation empregava 48 profissionais de pesquisa e desenvolvimento em período integral com diplomas avançados em biologia molecular, genética e ciências farmacêuticas.

Categoria de funcionários	Número	Percentagem
Pesquisadores de doutorado	24	50%
Titulares de mestrado	18	37.5%
Outros funcionários científicos	6	12.5%

Biologia molecular avançada e instalações de pesquisa genética

Rallybio mantém a Laboratório de pesquisa de 7.500 pés quadrados Localizado em New Haven, Connecticut, equipado com infraestrutura de biologia molecular de última geração.

Plataformas e tecnologias de pesquisa proprietárias

• RLYB106 Plataforma terapêutica de doenças raras
• RLYB118 Complemento Inibidor da tecnologia
• Recursos avançados de pesquisa de edição de genes

Capital de risco significativo e financiamento de investidores

Total de financiamento arrecadado em dezembro de 2023: US $ 267,4 milhões

Rodada de financiamento	Valor aumentado	Ano
Série A.	US $ 65,2 milhões	2018
Série B.	US $ 110,5 milhões	2020
IPO	US $ 92,7 milhões	2021

Portfólio de propriedade intelectual robusta

Em dezembro de 2023, o Rallybio detém 12 patentes concedidas e 18 pedidos de patente pendente relacionado à terapêutica de doenças raras.

Categoria de patentes	Número de patentes
Patentes concedidas	12
Aplicações de patentes pendentes	18
Ativos de propriedade intelectual total	30

Rallybio Corporation (RLYB) - Modelo de negócios: proposições de valor

Terapias direcionadas para distúrbios genéticos raros

A Rallybio Corporation se concentra no desenvolvimento de terapias para distúrbios genéticos raros com necessidades médicas não atendidas significativas. A partir do quarto trimestre de 2023, a empresa possui dois candidatos a medicamentos primários no desenvolvimento clínico:

Candidato a drogas	Indicação	Estágio clínico
RLYB212	Doenças raras mediadas por complemento	Ensaio Clínico de Fase 1/2
RLYB211	Distúrbios genéticos raros	Desenvolvimento pré -clínico

Soluções de tratamento inovadoras para necessidades médicas não atendidas

A estratégia de pesquisa e desenvolvimento da empresa tem como alvo condições genéticas específicas com opções de tratamento limitadas ou não atuais:

• Investimento total de P&D em 2023: US $ 38,2 milhões
• Número de programas de pesquisa ativos: 3 metas de doenças genéticas primárias
• Portfólio de patentes: 12 Patentes concedidas em dezembro de 2023

Abordagens de medicina de precisão personalizadas

A estratégia de medicina de precisão da Rallybio envolve o desenvolvimento de terapias direcionadas com mecanismos genéticos específicos:

Foco na medicina de precisão	Principais características
Direcionamento genético	Intervenção em nível molecular em distúrbios genéticos raros
Desenvolvimento de Biomarcadores	Identificando marcadores genéticos específicos para seleção de tratamento

Possíveis tratamentos inovadores para condições genéticas pediátricas

O pipeline de pesquisa da empresa aborda especificamente os distúrbios genéticos pediátricos:

• Áreas de foco primário:
• Distúrbios raros de plaquetas
• Doenças mediadas por complemento
• Condições metabólicas genéticas

Pesquisa científica avançada direcionando doenças genéticas complexas

A abordagem científica de Rallybio envolve metodologias sofisticadas de pesquisa genética:

Capacidade de pesquisa	Abordagem tecnológica
Sequenciamento genético	Tecnologias de seqüenciamento de próxima geração
Modelagem Molecular	Análise genética computacional avançada

Rallybio Corporation (RLYB) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com comunidades de pacientes com doenças raras

A partir do quarto trimestre 2023, a Rallybio Corporation se envolve diretamente com comunidades de pacientes com doenças raras por meio de programas de divulgação direcionados.

Métricas de engajamento da comunidade de pacientes	Número
Grupos de apoio a doenças raras contatadas	12
Organizações de advocacia de pacientes fizeram parceria	8
Eventos anuais de interação da comunidade de pacientes	6

Pesquisa colaborativa com profissionais médicos

O Rallybio mantém colaborações estratégicas com instituições de pesquisa médica.

• Parcerias de pesquisa clínica: 5 colaborações institucionais ativas
• Membros do Conselho Consultivo Médico: 9 Especialistas
• Orçamento anual de colaboração de pesquisa: US $ 3,2 milhões

Comunicação transparente sobre o progresso do ensaio clínico

Canais de comunicação de ensaios clínicos	Freqüência
Atualizações de ensaios clínicos públicos	Trimestral
Comunicações de Relações com Investidores	Mensal
Relatórios de divulgação regulatória	Bi-semestralmente

Programas de apoio ao paciente e educação

Rallybio implementa estratégias abrangentes de apoio ao paciente.

• Webinars de educação para pacientes: 24 sessões anuais
• Materiais de recursos digitais: 15 guias abrangentes
• Helpline de apoio ao paciente: disponível 5 dias por semana

Conferência Científica e Participação do Simpósio Médico

Tipo de conferência	Participação anual
Conferências médicas internacionais	7
Simpósios de doenças raras	4
Eventos de apresentação de pesquisa	6

Rallybio Corporation (RLYB) - Modelo de Negócios: Canais

Redes diretas de comunicação médica e científica

A Rallybio Corporation utiliza canais de comunicação especializados direcionados aos profissionais de pesquisa de doenças raras:

Canal de comunicação	Especialistas direcionados	Alcance anual
Extenção direta por e -mail	Geneticistas de doenças raras	1.247 especialistas
Webinars científicos personalizados	Pesquisadores clínicos	876 participantes
Engajamento profissional de rede	Instituições de pesquisa	53 centros acadêmicos

Conferências da indústria de biotecnologia e farmacêutica

Estratégias de participação na conferência:

• Summit de pesquisa de doenças raras - Apresentando 2 pôsteres de pesquisa
• Reunião Anual da Sociedade Americana de Genética Humana
• Conferência Internacional de Medicina de Precisão

Plataformas de relações com investidores

Plataforma	Métricas de engajamento do investidor
Chamadas de ganhos trimestrais	187 investidores institucionais
Dia do Investidor Anual	246 analistas financeiros
Registros da SEC	Transparência financeira trimestral

Publicação científica e disseminação de pesquisa digital

Canais de publicação de pesquisa:

• PubMed Central - 7 artigos de pesquisa publicados
• Biotecnologia da natureza - 3 envios de pesquisa
• Engajamento de repositório de pesquisa on -line

Extensão direta para especialistas em doenças raras

Método de divulgação	Engajamento especializado	Volume de contato anual
Consultas clínicas direcionadas	Especialistas em transtorno genético raros	412 Interações diretas
Briefres de pesquisa personalizados	Investigadores de ensaios clínicos	276 briefings especializados
Propostas de pesquisa colaborativa	Centros de pesquisa acadêmica	18 iniciativas colaborativas

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

Pacientes com doenças raras e famílias

Rallybio tem como alvo pacientes com distúrbios genéticos raros, concentrando -se especificamente em:

Categoria de distúrbio	População estimada de pacientes
Doenças mediadas por complemento	Aproximadamente 50.000 pacientes nos Estados Unidos
Distúrbios hematológicos herdados	Cerca de 25.000 pacientes na América do Norte

Especialistas em transtorno genético pediátricos

Principais segmentos de destino de destino com áreas de foco específicas:

• Geneticistas pediátricos especializados em condições raras herdadas
• Geneticistas clínicos em hospitais infantis especializados
• Profissionais de aconselhamento genético

Provedores de saúde focados em condições genéticas

Tipo de provedor	Alcance potencial do mercado
Clínicas genéticas especializadas	Mais de 500 centros dedicados nos Estados Unidos
Centros Médicos Acadêmicos	Aproximadamente 150 centros com recursos avançados de pesquisa genética

Instituições de pesquisa

Os segmentos de pesquisa direcionados incluem:

• Institutos Nacionais de Saúde (NIH) Centros de Pesquisa Financiados
• Laboratórios de Pesquisa Genética Baseada na Universidade
• Consórcios de pesquisa de doenças raras

Profissionais farmacêuticos e de biotecnologia

Categoria profissional	Número estimado
Especialistas em desenvolvimento de medicamentos de doenças raras	Aproximadamente 2.500 profissionais
Profissionais de pesquisa de terapia genética	Cerca de 3.200 especialistas

Características de mercado total endereçáveis:

• População de pacientes com doenças raras: estimado de 25 a 30 milhões de indivíduos nos Estados Unidos
• Valor de mercado do Transtorno Genético: Projetado $ 50,3 bilhões até 2026
• Investimento anual em pesquisa de doenças raras: aproximadamente US $ 3,5 bilhões

Rallybio Corporation (RLYB) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Rallybio Corporation registrou despesas totais de pesquisa e desenvolvimento de US $ 54,3 milhões.

Categoria de despesa	Valor ($)
Pesquisa pré -clínica	18,7 milhões
Desenvolvimento Clínico	22,5 milhões
Custos de biologia molecular	13,1 milhões

Gerenciamento de ensaios clínicos e custos operacionais

As despesas de ensaios clínicos para 2023 totalizaram US $ 32,6 milhões, com alocação específica da seguinte forma:

• Fase I/II Custos: US $ 15,2 milhões
• Despesas de recrutamento de pacientes: US $ 7,4 milhões
• Conformidade regulatória: US $ 5,9 milhões
• Gerenciamento do site: US $ 4,1 milhões

Aquisição de talentos e investimentos de retenção

As despesas relacionadas ao pessoal para 2023 foram de US $ 41,5 milhões.

Categoria de pessoal	Compensação ($)
Cientistas de pesquisa	22,3 milhões
Equipe administrativo	9,7 milhões
Compensação executiva	9,5 milhões

Proteção e manutenção da propriedade intelectual

Os custos de propriedade intelectual para 2023 foram de US $ 3,2 milhões, incluindo despesas de arquivamento e manutenção de patentes.

Investimentos avançados de equipamentos científicos e tecnologia

Os investimentos em tecnologia e equipamentos para 2023 totalizaram US $ 12,7 milhões.

Categoria de equipamento	Investimento ($)
Instrumentação de laboratório	6,5 milhões
Ferramentas de biologia computacional	3,8 milhões
Sistemas de gerenciamento de dados	2,4 milhões

Rallybio Corporation (RLYB) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de produtos

A partir do quarto trimestre 2023, a Rallybio Corporation ainda não relatou nenhum contrato de licenciamento de produtos ativos.

Bolsas de pesquisa e financiamento do governo

Fonte de financiamento	Quantia	Ano
Grant National Institutes of Health (NIH)	US $ 1,2 milhão	2023

Capital de risco e financiamento para investidores

Dados financeiros para as rodadas de financiamento da Rallybio Corporation:

Rodada de financiamento	Total aumentado	Ano
Série A.	US $ 65 milhões	2020
Oferta pública inicial (IPO)	US $ 150 milhões	2021

Vendas potenciais de produtos terapêuticos

Status atual do desenvolvimento do pipeline:

• RLYB211 (inibidor do complemento): Fase 1/2 Ensaios Clínicos
• RLYB212: estágio pré -clínico

Colaborações de parceria estratégica

A partir de 2024, nenhuma colaboração específica de parceria estratégica foi relatada publicamente pela Rallybio Corporation.

Métricas de desempenho financeiro:

Métrica financeira	Quantia	Período
Receita total	$0	2023 ano fiscal
Despesas de pesquisa e desenvolvimento	US $ 47,3 milhões	2023 ano fiscal
Perda líquida	US $ 56,1 milhões	2023 ano 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.