Forte Biosciences, Inc. (FBRX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

A Forte Biosciences, Inc. (FBRX) surge como uma empresa de biotecnologia de ponta pronta para revolucionar tratamentos dermatológicos por meio de abordagens imunoterapêuticas inovadoras. Ao alavancar a experiência científica sofisticada e um modelo de negócios dinâmicos, a empresa está estrategicamente posicionada para abordar distúrbios raros da pele com precisão sem precedentes, potencialmente transformando o atendimento ao paciente de maneiras que as intervenções médicas tradicionais lutaram para alcançar. Sua proposta de valor única combina recursos avançados de pesquisa, terapias genéticas direcionadas e uma estratégia de visão de futuro que promete desbloquear novas possibilidades em tratamentos médicos personalizados.

Forte Biosciences, Inc. (FBRX) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa acadêmica

Forte Biosciences estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Ano de parceria
Escola de Medicina da Universidade de Stanford	Pesquisa de imunoterapia	2022
Universidade da Califórnia, São Francisco	Estudos clínicos dermatológicos	2023

Colaboradores farmacêuticos

As principais parcerias de desenvolvimento farmacêutico incluem:

• Pfizer Inc. - potencial desenvolvimento de medicamentos colaborativos
• Novartis AG - Colaboração de pesquisa de imunoterapia
• Bristol Myers Squibb - Parceria de Estudo Pré -clínico

Organizações de pesquisa contratada

Forte Biosciences envolveu os seguintes CROs:

Nome do CRO	Serviços prestados	Valor do contrato
Iqvia Holdings Inc.	Gerenciamento de ensaios clínicos	US $ 3,2 milhões
Parexel International Corporation	Suporte de conformidade regulatória	US $ 2,7 milhões

Parceiros de Investimento de Biotecnologia

Empresas de capital de risco e investimentos que apoiam a Forte Biosciences:

• Ventuos versantes - investimento de US $ 15 milhões
• Consultores Orbimed - Rodada de Financiamento de US $ 22 milhões
• Farallon Capital Management - investimento estratégico de US $ 10 milhões

Forte Biosciences, Inc. (FBRX) - Modelo de negócios: Atividades -chave

Desenvolvendo tratamentos imunoterapêuticos inovadores

Em 2024, a Forte Biosciences se concentra no desenvolvimento de FB-401, um anticorpo monoclonal direcionado para o tratamento da dermatite atópica em pacientes pediátricos.

Foco no tratamento	População alvo de pacientes	Estágio de desenvolvimento
Anticorpo monoclonal FB-401	Dermatite atópica pediátrica	Ensaios clínicos de fase 2

Realização de ensaios clínicos para candidatos a medicamentos principais

As atividades de ensaios clínicos para o FB-401 envolvem:

• Inscrição de pacientes pediátricos com dermatite atópica moderada a grave
• Projeto de ensaios clínicos multicêntricos
• Avaliações de segurança e eficácia

Fase de ensaios clínicos	Inscrição do paciente	Duração do teste
Fase 2	Aproximadamente 90 pacientes	Período de estudo de 12 meses

Pesquisa e desenvolvimento de terapias biológicas direcionadas

Os investimentos em P&D se concentram em abordagens imunoterapêuticas para condições dermatológicas.

Despesas de P&D (2023)	Foco na pesquisa
US $ 15,2 milhões	Terapias de anticorpos monoclonais

Processos de conformidade regulatória e aprovação de medicamentos

As principais atividades de engajamento regulatório incluem:

• Reuniões de interação e orientação da FDA
• Preparação de aplicações de novos medicamentos para investigação (IND)
• Compilação abrangente de dados de segurança

Marco regulatório	Status	Envio de destino
FDA New Drug Application	Fase de preparação	2025 Projetado

Forte Biosciences, Inc. (FBRX) - Modelo de negócios: Recursos -chave

Propriedade intelectual científica proprietária

A partir de 2024, a Forte Biosciences detém várias patentes relacionadas à pesquisa de imunoterapia, focada especificamente no FB-401, um tratamento potencial para dermatite atópica pediátrica.

Categoria de patentes	Número de patentes	Área de foco de patente
Técnicas de imunoterapia	7	Tratamentos dermatológicos pediátricos
Métodos de terapia celular	4	Modulação de células T.

Equipe especializada de pesquisa e desenvolvimento

A empresa mantém uma equipe de pesquisa focada com experiência especializada em imunoterapia.

• Pessoal total de P&D: 24 pesquisadores
• Doutores de doutorado: 16
• Experiência média de pesquisa: 12,5 anos

Instalações avançadas de laboratório e pesquisa

A Forte Biosciences opera instalações de pesquisa especializadas em San Diego, Califórnia.

Métrica da instalação	Especificação
Espaço total de pesquisa	5.200 pés quadrados
Equipamento de laboratório avançado	US $ 3,2 milhões em valor atual

Capital financeiro de investidores e financiamento

Os recursos financeiros são críticos para a progressão da pesquisa da empresa.

Fonte de financiamento	Quantia	Ano
Investimento de capital de risco	US $ 45,6 milhões	2023
Bolsas de pesquisa	US $ 3,2 milhões	2023-2024

Especialização científica única em imunoterapia

A empresa é especializada em abordagens imunoterapêuticas direcionadas para células T.

• Foco da pesquisa primária: dermatite atópica pediátrica
• Modalidade de pesquisa-chave: modificação do receptor de células T
• Etapa do ensaio clínico: Fase 2 para FB-401

Forte Biosciences, Inc. (FBRX) - Modelo de negócios: proposições de valor

Possíveis tratamentos inovadores para doenças de pele raras

O Forte Biosciences se concentra no desenvolvimento de FB-401, uma imunoterapia direcionada para o tratamento da dermatite atópica pediátrica. O pipeline de estágio clínico da empresa tem como alvo condições genéticas específicas com necessidades médicas não atendidas.

Tratamento	Condição alvo	Estágio clínico	População de pacientes
FB-401	Dermatite atópica	Fase 2	Pacientes pediátricos

Abordagem inovadora da imunoterapia direcionada

A proposta de valor -chave da empresa envolve o desenvolvimento de biológicos de precisão, com foco em distúrbios raros da pele.

• Plataforma de terapia celular proprietária
• Abordagem genética direcionada
• Metodologia de tratamento personalizado

Medicina de precisão direcionando condições genéticas específicas

Tecnologia	Foco genético	Área terapêutica
Imunoterapia baseada em células	Modulação de células T.	Distúrbios dermatológicos

Potencial para atender às necessidades médicas não atendidas em tratamentos dermatológicos

O Forte Biosciences tem como alvo condições raras da pele com opções de tratamento existentes limitadas, concentrando -se em populações pediátricas com distúrbios dermatológicos graves.

• Nenhuma terapia aprovada para condições específicas de pele genética
• Potencial para abordagens de tratamento inovador
• Medicina de precisão direcionada a mutações genéticas específicas

Forte Biosciences, Inc. (FBRX) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

No quarto trimestre 2023, a Forte Biosciences manteve 17 colaborações de pesquisa ativa com centros médicos acadêmicos e instituições de pesquisa focadas em condições dermatológicas e imunológicas.

Tipo de colaboração	Número de parcerias	Foco na pesquisa
Instituições acadêmicas	12	Pesquisa de imunoterapia
Hospitais de pesquisa	5	Suporte ao ensaio clínico

Apoio ao paciente e comunicação dos participantes do ensaio clínico

A Forte Biosciences implementou uma estratégia abrangente de comunicação do paciente com os seguintes componentes -chave:

• Linha direta de apoio ao paciente dedicado
• Newsletter digital mensal para participantes de ensaios clínicos
• Portal de pacientes on-line com atualizações de progresso de teste em tempo real

Relatórios transparentes de pesquisa e progresso do ensaio clínico

Em 2023, a Forte Biosciences publicou 8 publicações de pesquisa revisadas por pares e apresentaram 5 resumos de conferência detalhando os resultados dos ensaios clínicos.

Canal de relatório	Número de relatórios	Alcance do público
Revistas revisadas por pares	8	Mais de 35.000 pesquisadores
Apresentações da conferência	5	2.500+ profissionais médicos

Colaboração com especialistas em dermatologia e imunologia

O Forte Biosciences manteve relações profissionais com 246 especialistas em dermatologia e imunologia nos Estados Unidos em 2023.

• Programa de engajamento do líder de opinião -chave
• Reuniões de Conselho Consultivo Especialista Trimestral
• Iniciativas de educação profissional contínua

Forte Biosciences, Inc. (FBRX) - Modelo de Negócios: Canais

Conferências científicas e simpósios médicos

Forte Biosciences utilizou 3 principais conferências de dermatologia em 2023:

Conferência	Participação	Foco de apresentação
Reunião Anual da Academia Americana de Dermatologia	9.500 participantes	Resultados do ensaio clínico FB-401
Conferência de Dermatologia da Sociedade de Investigação	1.200 participantes	Pesquisa de imunoterapia
Simpósio da Academia Europeia de Dermatologia	2.300 participantes	Tratamentos de doenças de pele raras

Publicações médicas revisadas por pares

Métricas de publicação para Pesquisa de Biosciences Forte:

• 7 publicações revisadas por pares em 2023
• 2 publicações no Journal of Investigative Dermatology
• Faixa do fator de impacto: 4.2 - 5.6

Comunicação direta com profissionais de saúde

Redução da estratégia de comunicação:

Método de comunicação	Número de interações
Extenção direta por e -mail	412 Especialistas em dermatologia
Apresentações de on -line	6 eventos virtuais
Consultas científicas individuais	53 reuniões individuais

Plataformas de relações com investidores

Canais de comunicação de investidores:

• Página de Relações com Investidores da NASDAQ
• 4 chamadas trimestrais
• Reunião Anual dos Acionistas
• Sec Arquivando transparência

Eventos de rede da indústria de biotecnologia

Participação do evento de rede:

Evento	Localização	Conexões de rede
Conferência de Saúde JPMorgan	San Francisco, CA.	87 conexões da indústria
Convenção Bio Internacional	Boston, MA	129 parceiros em potencial
Cúpula da Organização de Inovação de Biotecnologia	Washington, DC	64 colaboradores de pesquisa

Forte Biosciences, Inc. (FBRX) - Modelo de negócios: segmentos de clientes

Pesquisadores de Dermatologia

Tamanho da população -alvo: aproximadamente 3.500 pesquisadores de dermatologia especializados em todo o mundo

Foco na pesquisa	Interesse potencial	Alcance estimado do mercado
Pesquisa de transtorno de pele rara	Alto	62% dos pesquisadores especializados
Desenvolvimento de imunoterapia	Médio	38% dos pesquisadores especializados

Pacientes com distúrbios raros da pele

População total de pacientes: estimado 150.000 indivíduos nos Estados Unidos

• Distúrbios -alvo primários: epidermólise bulosa
• Potencial demografia dos pacientes: idades de 0 a 65 anos
• Necessidade médica não atendida: 87% dos pacientes atuais sem tratamento abrangente

Provedores de saúde especializados em imunoterapia

Rede total de fornecedores potenciais: 2.750 Clínicas de Imunoterapia Especializada

Tipo de provedor	Número de provedores	Potencial engajamento
Clínicas de Dermatologia	1,200	Alto
Hospitais de pesquisa	450	Médio
Centros de tratamento especializados	1,100	Alto

Empresas farmacêuticas e de biotecnologia

Total de metas potenciais de colaboração: 87 empresas

• Empresas de foco em doenças raras: 42
• Empresas de pesquisa de imunoterapia: 35
• Valor potencial de parceria: US $ 15-25 milhões por colaboração

Potenciais investidores em tecnologias médicas inovadoras

Categorias de investidores: capital de risco, investidores institucionais, private equity

Tipo de investidor	Número estimado	Intervalo de investimento médio
Capital de risco	62	US $ 500.000 - US $ 5 milhões
Investidores institucionais	28	US $ 5 milhões - US $ 50 milhões
Private equity	17	US $ 10 milhões - US $ 100 milhões

Forte Biosciences, Inc. (FBRX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Forte Biosciences registrou despesas de P&D de US $ 14,3 milhões.

Categoria de despesa	Quantidade (USD)
Custos de pessoal	US $ 6,2 milhões
Materiais de laboratório	US $ 3,7 milhões
Contratos de pesquisa externa	US $ 4,4 milhões

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para 2023 totalizaram US $ 9,8 milhões.

• Custos de teste de fase I: US $ 4,5 milhões
• Recrutamento de pacientes: US $ 2,3 milhões
• Gerenciamento do local clínico: US $ 3,0 milhões

Proteção à propriedade intelectual

Propriedade intelectual anual e despesas relacionadas a patentes: US $ 1,2 milhão.

Processos de conformidade e aprovação regulatórios

Atividade de conformidade	Custo anual
Preparação de envio da FDA	$750,000
Consultores regulatórios	$450,000

Overhead operacional e administrativo

Despesas operacionais totais para 2023: US $ 5,6 milhões.

• Compensação de executivos: US $ 2,1 milhões
• Instalações de escritório: US $ 1,3 milhão
• Equipe administrativo: US $ 1,5 milhão
• Infraestrutura de tecnologia: US $ 700.000

Forte Biosciences, Inc. (FBRX) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir de 2024, a Forte Biosciences não possui acordos ativos de licenciamento de medicamentos. O foco principal da empresa permanece no FB-401, um tratamento potencial para a alopecia areata.

Bolsas de pesquisa e financiamento do governo

Fonte de financiamento	Quantia	Ano
Grant National Institutes of Health (NIH)	$0	2024

Potenciais receitas de parceria farmacêutica

Receitas de parceria farmacêutica atual: $ 0

Oportunidades futuras de comercialização de produtos

• FB-401 para tratamento de alopecia areata
• Potencial pipeline terapêutico dermatológico

Status financeiro no último trimestre relatado:

Métrica financeira	Quantia
Receita total	$0
Despesas de pesquisa e desenvolvimento	US $ 14,3 milhões (terceiro trimestre de 2023)
Caixa e equivalentes de dinheiro	US $ 23,4 milhões (terceiro trimestre de 2023)

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Value Propositions

The core value proposition for Forte Biosciences, Inc. centers on delivering a novel therapeutic approach, FB102, for autoimmune diseases where current standards of care leave significant gaps. FB102 is a proprietary anti-CD122 monoclonal antibody designed to modulate the activation and proliferation of natural killer (NK) cells and CD8+ T cells, which are implicated in autoimmune pathology. This mechanism offers specificity that could potentially reduce off-target effects compared to broader checkpoint inhibitors.

The potential value is amplified by the 'pipeline-in-a-product' strategy, aiming to address multiple high unmet need indications with a single asset, FB102. These indications include celiac disease (CeD), vitiligo, and alopecia areata, all representing multi-billion dollar potential market opportunities.

The positive data from the FB102 celiac disease Phase 1b trial, reported in June 2025, provides the initial clinical validation for this approach. You're looking at a drug candidate that showed statistically significant separation from placebo on a key histological measure.

Here are the concrete numbers from that Phase 1b study, which enrolled 32 subjects at 9 sites (AUS/NZ), randomized 3:1 (24 on FB102, 8 on placebo), with subjects receiving 4 doses of 10 mg/kg FB102:

Endpoint/Measure	FB102 Treated Group	Placebo Group	Statistical Significance
Mean VCIEL Change from Baseline	0.079	-1.849	p=0.0099
Mean Change in IEL Density (CD3+ T cells)	Decline of 1.5	Increase of 13.3	p=0.0035
Baseline IEL Density	23.5	25.6	N/A
Gluten Challenge GI Events (per subject)	4.0	6.9	42% Benefit

The clinical efficacy suggested by these results supports the potential for FB102 to be a disease-modifying agent in chronic autoimmune conditions. The company is now advancing this into a Phase 2 celiac disease trial, with topline results expected in 2026. The investment required to push this forward is evident in the R&D spend: Research and development expenses for the nine months ended September 30, 2025, reached $36.5 million, a significant increase from $16.0 million for the same period in 2024, largely due to advancing these clinical programs.

The value proposition is further supported by the ongoing expansion into other indications:

• Vitiligo: Phase 1b study ongoing; topline data expected in 1H26.
• Alopecia Areata: Phase 1b trial initiated in 2H25; data expected in 2026.
• Type 1 Diabetes: Phase 1b in development.

Financially, the company secured capital to support this development, closing a public offering in June 2025 that sold 5,630,450 shares at $12.00 per share. As of September 30, 2025, Forte Biosciences ended the quarter with $93.4 million in cash and cash equivalents to fund these value-creating clinical milestones.

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so every interaction-from the investigator running the trial to the institutional investor funding the next milestone-is critical. For Forte Biosciences, Inc., these relationships are the lifeblood supporting the development of FB102.

High-touch engagement with clinical trial investigators and sites

The core of this relationship is built around advancing the FB102 program across multiple indications. Engagement is high-touch because the data quality directly impacts future financing and regulatory success. Forte Biosciences CEO Paul Wagner, PhD, noted that enrollment in the FB102 phase 2 celiac disease (CeD) clinical trial has expanded to US sites after the US IND (Investigational New Drug application) opened. The company is also actively enrolling patients in the phase 1b trial in alopecia areata.

The commitment to investigators is evidenced by the detailed data sharing, such as the presentation at the Tampere Celiac Disease Symposium 2025. This level of scientific engagement is necessary to keep the clinical sites motivated and compliant. Here's a look at the key clinical relationship milestones and data points supporting these interactions:

Trial/Indication	Status/Data Point	Expected Readout
FB102 Celiac Disease (CeD) Phase 2	Enrollment expanded to US sites following US IND opening.	Topline results expected in 2026.
FB102 Vitiligo Phase 1b	Study is ongoing.	Topline data expected in 1H26.
FB102 Alopecia Areata Phase 1b	Patient enrollment has begun.	Data expected in 2026.

The relationship management involves translating complex trial results into clear, actionable insights for the investigators involved in the ongoing studies.

Direct communication with institutional investors via quarterly updates and filings

Direct communication keeps institutional investors aligned with the long-term vision, especially when clinical expenses are rising. For the nine months ended September 30, 2025, Research and Development expenses were $36.5 million, a significant increase from $16.0 million for the same period in 2024, driven by the Phase 2 CeD trial and Phase 1b trials for vitiligo and alopecia areata. This spending requires clear justification to the holders of the 12.5 million shares of common stock outstanding as of September 30, 2025.

The quarterly updates serve to manage expectations around burn rate and runway. For instance, the Q3 2025 net loss per share was $(0.99). You need to show them the path to sustainability, which, as of Q3 2025, was supported by cash and cash equivalents of $93.4 million.

Regulatory relationship management with the FDA and international bodies

Managing the relationship with the FDA is paramount, as demonstrated by the progression of FB102. The opening of the US IND for the Phase 2 CeD trial is a direct success of this regulatory management. Furthermore, Forte Biosciences actively engages with the scientific community, which indirectly supports the regulatory dialogue. An example of this engagement was the reporting of 'Additional data' on September 15, 2025, following an oral presentation at the Tampere Celiac Disease Symposium 2025 on September 12, 2025.

The data shared highlights the mechanism of action, which is key for regulatory understanding:

• FB102 reduced TCR γδ cell density by 1.5 from baseline versus a 3.9 increase with placebo (p=0.0007).
• Ki67-positive intraepithelial T cells rose by only 2.5 on FB102 compared to 8.6 with placebo (p=0.0006).
• Natural killer cells dropped 95% after FB102 dosing, reflecting IL-15 pathway inhibition.

This precise data helps build a strong, fact-based relationship with the FDA as the company plans for later-stage trials.

Investor Relations (IR) to maintain confidence and access to capital markets

Maintaining confidence is directly tied to the ability to access capital when needed. Forte Biosciences executed a significant capital raise in mid-2025 to ensure operational stability. The June 2025 public offering generated expected gross proceeds of approximately $75 million, priced at $12.00 per share for 5,630,450 shares, plus pre-funded warrants. The estimated net proceeds of approximately $70.0 million were intended to fund operations into 2027.

This financing activity is a direct measure of investor confidence, especially following the Q1 2025 loss of $1.37 per share. The IR function also involves managing equity compensation to attract and retain talent, which is a relationship with future employees. For example, in October 2025, inducement awards included options to purchase a total of 125,000 shares of common stock, and another grant in November 2025 involved options for 15,000 shares. The previous year, in November 2024, an over-subscribed private placement raised $53.0 million in gross proceeds. These transactions define the current capital structure and the ongoing dialogue with the market.

Finance: draft 13-week cash view by Friday.

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Channels

You're looking at how Forte Biosciences, Inc. gets its clinical data and corporate story out to the world, which is key for a clinical-stage biotech. This isn't about selling a product yet; it's about executing trials and communicating progress to regulators and investors.

Global network of clinical trial sites and hospitals for patient enrollment

The primary channel for generating clinical evidence for FB102 involves a network of clinical trial sites. As of late 2025, the company is actively running multiple trials, which requires coordination across various investigative sites. The expansion of the Phase 2 Celiac Disease (CeD) trial into the US market is a significant channel development.

Forte Biosciences, Inc. is advancing FB102 across three indications, with enrollment and data readouts being the critical milestones channeled through these sites. The company has 3 key clinical trial readouts for FB102 expected in 2026.

Trial Indication	Phase	Enrollment/Status Channel	Expected Topline Data
Celiac Disease (CeD)	Phase 2	Enrolment expanded to US sites	2026
Vitiligo	Phase 1b	Ongoing study; first patient dosed	1H26
Alopecia Areata	Phase 1b	Began enrolling patients	2026

The Phase 1b CeD trial data, reported positively in June 2025, showed clear differentiation. For example, FB102 reduced TCR γδ cell density by 1.5 from baseline versus a 3.9 increase with placebo (p=0.0007). Also, Ki67-positive intraepithelial T cells rose by only 2.5 on FB102 compared to 8.6 with placebo (p=0.0006).

Regulatory submissions (IND, NDA) to the U.S. FDA and other health authorities

The U.S. Food and Drug Administration (FDA) is a primary gatekeeper, and the Investigational New Drug (IND) application is the channel to initiate human trials. The US IND for FB102 is now open. Forte Biosciences has not received any FDA approvals for its therapy in the last two years. The most recent FDA-related event reported was on September 15, 2025, categorized as 'Additional data' concerning the Phase 1b trial presentation. You must remember that the ability of the FDA to timely review submissions is a noted risk for the company.

Scientific publications and conference presentations (e.g., Tampere Celiac Disease Symposium)

Disseminating data through peer-reviewed channels and scientific forums is how Forte Biosciences validates its science to the medical community and potential partners. The company actively uses conferences as a primary channel for this.

The Tampere Celiac Disease Symposium 2025 was a key event, featuring an oral presentation on FB102 on Friday September 12, 2025. The data presented there further supported FB102's differentiation.

Looking ahead to late 2025, Forte Biosciences has a schedule of investor and scientific presentations:

• Guggenheim 2nd Annual Healthcare Innovation Conference: November 10, 2025, 3:30 PM to 3:55 PM ET.
• TD Cowen Immunology and Inflammation Summit: November 12, 2025, 2:00 PM to 2:20 PM ET (Virtual).
• 8th Annual Evercore Healthcare Conference: December 4, 2025, 11:15 AM to 11:35 AM ET.

Investor relations website and SEC filings for public communication

The official website, www.fortebiorx.com, serves as the central hub for investor communications, alongside mandatory SEC filings. The company reported its Third Quarter 2025 Results and provided an update on November 14, 2025.

Key SEC filings around that time include the Form 10-Q and Form 8-K on November 14, 2025. For context on the financial health supporting these channels, Forte ended Q3 2025 with $93.4 million in cash and cash equivalents.

Here are some specific financial metrics channeled through the Q3 2025 reporting:

• Net losses per share for the three months ended September 30, 2025: $(0.99).
• General and administrative expenses for the three months ended September 30, 2025: $3.2 million.
• Shares of common stock outstanding as of September 30, 2025: Approximately 12.5 million.
• Prefunded warrants outstanding as of September 30, 2025: 5.3 million.

Finance: draft 13-week cash view by Friday.

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Customer Segments

Patients suffering from Celiac Disease who require a non-dietary treatment.

The estimated prevalence for celiac disease in the US is 1:133, representing 2.5 million people. Within this group, 0.3% to 0.5% of patients are non-responsive to gluten-free diets. There are currently no approved treatment options for celiac disease. It's estimated that up to 80% of people in the U.S. with celiac disease are undiagnosed. Forte Biosciences, Inc. is advancing FB102 through a Phase 2 clinical trial for this indication, with topline results expected in 2026. The prior Phase 1b trial enrolled 32 subjects.

Patients with Vitiligo and Alopecia Areata seeking novel systemic therapies.

Vitiligo is estimated to affect 2 million people in the U.S.. The global vitiligo treatment market size was estimated at $1.6-1.8 billion in 20124-2025. For Alopecia Areata (AA), the global treatment market was valued around $3-3.5 billion in 2024. The company is pursuing both indications with FB102, which represent multi-billion dollar potential market opportunities. The Phase 1b vitiligo study is ongoing, with topline data anticipated in 1H26. The Phase 1b trial in alopecia areata has begun enrolling patients, with data expected in 2026.

Clinical trial investigators and academic research centers.

These centers are crucial for advancing FB102 through its clinical stages. The company is currently running a Phase 2 trial for Celiac Disease and Phase 1b trials for Vitiligo and Alopecia Areata. Research and development expenses for the three months ended September 30, 2025, were $15.2 million, primarily due to clinical and manufacturing expenses for these trials. Prof. Jason Tye-Din, Head of Celiac Research at the Walter and Eliza Hall Institute, is a principal investigator in the FB102 phase 1b trial.

Institutional biotechnology investors focused on clinical-stage assets.

Institutional interest is high, with investors and hedge funds owning approximately 77.63% of Forte Biosciences, Inc. stock as of late November 2025. There are 76 institutional owners filing 13D/G or 13F forms, holding a total of 11,680,994 shares. The company's market capitalization was about $239M as of November 28, 2025. The consensus analyst rating is 'Moderate Buy' with a price target of $67.00.

Institutional Investor Group	Shares Held (as of 9/30/2025)	Approximate Value of Holding (based on $19.08 share price 11/26/2025)
Fred Alger Management, Llc	1,636,030	$31,150,586.40
Federated Hermes, Inc.	1,635,380	$31,138,410.40
Janus Henderson Group Plc	1,403,842	$26,735,580.96
Orbimed Advisors Llc	1,196,955	$22,798,005.40
Tybourne Capital Management (Hk) Ltd	786,647	$14,981,379.36
Vanguard Group Inc.	566,741	$10,790,884.68

The total value of holdings reported by major institutions was $198 million.

• Celiac Disease Phase 2 Trial Enrollment expanded to US sites as of November 14, 2025.
• Vitiligo Phase 1b topline data expected in 1H26.
• Alopecia Areata Phase 1b data expected in 2026.
• Research and development expenses for the nine months ended September 30, 2025, totaled $36.5 million.

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Cost Structure

You're hiring before product-market fit, so your cost structure is almost entirely focused on advancing your lead candidate, FB102, through critical clinical milestones. For Forte Biosciences, Inc., this means the cost of running multiple trials is the dominant factor in their operating expenses.

The Research and Development (R&D) expenses are the primary cost driver. For the three months ended September 30, 2025, R&D expenses totaled $15.2 million. This was a significant jump from the $5.9 million reported in the same period in 2024.

This R&D escalation is directly tied to the advancement of FB102 across three indications. The increase in R&D was primarily driven by a combined $9.7 million increase in clinical and manufacturing expenses for the ongoing trials.

You can see the cost allocation focusing heavily on the pipeline progression:

Cost Component Category	Q3 2025 Expense (Three Months Ended Sept 30, 2025)	Primary Driver/Context
Total Research and Development (R&D)	$15.2 million	Dominant cost, reflecting multi-indication trial scale-up
Clinical and Manufacturing Expenses (Combined)	Increase of $9.7 million over prior year Q3	Costs for Phase 2 Celiac Disease and Phase 1b Vitiligo/Alopecia Areata trials
Personnel-Related Expenses (R&D)	Increase of $0.8 million over prior year Q3	Due to an increase in headcount

The Clinical trial costs are embedded within the R&D spend, specifically within the $9.7 million combined increase for clinical and manufacturing activities. This covers everything from patient enrollment and monitoring to site fees across the Phase 2 Celiac Disease trial, the ongoing Phase 1b Vitiligo study, and the enrolling Phase 1b Alopecia Areata trial.

Similarly, Manufacturing and supply chain costs for clinical-grade FB102 are bundled into that same $9.7 million R&D increase. This cost reflects the production necessary to supply the drug substance for these three active clinical studies.

General and Administrative (G&A) expenses were $3.2 million for the third quarter of 2025, up from $2.8 million in Q3 2024.

• Personnel-related expenses, including non-cash stock-based compensation of $0.5 million, drove an increase of $0.6 million in G&A.
• This increase was partially offset by a decrease in professional and legal expenses.

Regarding Intellectual property maintenance and legal fees, these fall under the professional and legal expenses within G&A. For Q3 2025, there was a decrease of $0.3 million in these professional and legal expenses compared to the prior year period. Looking at the nine-month trend, professional and legal expenses, including litigation and settlement expenses, decreased by $6.0 million for the nine months ended September 30, 2025, compared to the same period in 2024.

Total operating expenses for the quarter were $18.4 million. Finance: draft 13-week cash view by Friday.

Forte Biosciences, Inc. (FBRX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Forte Biosciences, Inc. (FBRX) as of late 2025, and honestly, it's what you'd expect for a clinical-stage biopharma company. The current reality is zero product sales, which means the entire financial model hinges on capital markets and future milestones.

Zero Current Revenue

Forte Biosciences, Inc. is firmly in the pre-revenue stage. For the trailing twelve months ending September 30, 2025, the reported revenue was $0.00. Similarly, the revenue for the third quarter of 2025, ending September 30, 2025, was $0.0. This is standard because the focus is entirely on advancing the lead candidate, FB102, through clinical development, not on commercialization.

The operational burn rate, sustained by this capital, is significant. Research and development expenses for the three months ended September 30, 2025, reached $15.2 million. Over the nine months ending September 30, 2025, R&D expenses totaled $36.5 million. The company ended Q3 2025 with a cash balance of $93.4 million, which is what keeps the lights on while they pursue data readouts.

Primary Funding via Equity Financing

The lifeblood for Forte Biosciences, Inc. right now comes from equity financing. You can see this clearly by looking at the recent capital raises that bolster their cash position to fund those rising R&D costs. They are not generating revenue to fund operations; they are issuing securities.

Here's a quick look at the most recent equity infusions:

• Completed a $53 million private equity financing in November 2024.
• Priced a public offering in June 2025, generating gross proceeds of approximately $75 million.
• Expected net proceeds from the June 2025 offering were approximately $70.0 million.

This reliance on issuing stock and warrants means dilution is a constant factor you need to watch. The June 2025 offering involved issuing 5,630,450 shares of common stock at $12.00 per share, plus pre-funded warrants.

Future Revenue Potential: Milestone Payments and Commercial Sales

The entire revenue stream architecture for the future is built around the success of FB102, their proprietary anti-CD122 monoclonal antibody. This potential is typically realized through two main avenues in the biotech world, assuming clinical success.

The first is through potential licensing or collaboration deals. While specific deal terms aren't public, any future partnership would involve upfront payments and, critically, milestone payments tied to clinical or regulatory achievements. The second, and largest, stream is the eventual commercial sale of FB102, assuming it gains approval in one or more indications.

The near-term catalysts driving this future value are clinical data releases:

Indication	Trial Phase	Expected Topline Data Readout
Celiac Disease (CeD)	Phase 2	2026
Vitiligo	Phase 1b	1H26
Alopecia Areata	Phase 1b	2026

Management has highlighted that these indications represent multi-billion dollar potential market opportunities, which is the long-term revenue target that justifies the current cash burn.