Forte Biosciences, Inc. (FBRX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Forte Biosciences, Inc. (FBRX) emerge como una compañía de biotecnología de vanguardia listada para revolucionar los tratamientos dermatológicos a través de enfoques inmunoterapéuticos innovadores. Al aprovechar la experiencia científica sofisticada y un modelo de negocio dinámico, la compañía está estratégicamente posicionada para abordar los trastornos de la piel raros con precisión sin precedentes, potencialmente transformando la atención del paciente de manera que las intervenciones médicas tradicionales han luchado por lograr. Su propuesta de valor única combina capacidades de investigación avanzadas, terapias genéticas dirigidas y una estrategia a futuro que promete desbloquear nuevas posibilidades en tratamientos médicos personalizados.

Forte Biosciences, Inc. (FBRX) - Modelo de negocio: asociaciones clave

Instituciones de investigación académica

Forte Biosciences ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Año de asociación
Facultad de Medicina de la Universidad de Stanford	Investigación de inmunoterapia	2022
Universidad de California, San Francisco	Estudios clínicos dermatológicos	2023

Colaboradores farmacéuticos

Las asociaciones clave de desarrollo farmacéutico incluyen:

• Pfizer Inc. - Desarrollo de fármacos colaborativos potenciales
• Novartis AG - Colaboración de investigación de inmunoterapia
• Bristol Myers Squibb - Asociación de estudio preclínico

Organizaciones de investigación por contrato

Forte Biosciences ha contratado a los siguientes CRO:

Nombre de Cro	Servicios proporcionados	Valor de contrato
IQVIA Holdings Inc.	Gestión de ensayos clínicos	$ 3.2 millones
Parexel International Corporation	Apoyo de cumplimiento regulatorio	$ 2.7 millones

Socios de inversión biotecnología

Capital de riesgo e empresas de inversión que apoyan biosciencias de Forte:

• Versant Ventures - Inversión de $ 15 millones
• Orbimed Advisors - Ronda de financiación de $ 22 millones
• Farallon Capital Management - $ 10 millones de inversión estratégica

Forte Biosciences, Inc. (FBRX) - Modelo de negocio: actividades clave

Desarrollo de tratamientos inmunoterapéuticos innovadores

A partir de 2024, Forte Biosciences se centra en el desarrollo de FB-401, un anticuerpo monoclonal dirigido para el tratamiento de la dermatitis atópica en pacientes pediátricos.

Enfoque de tratamiento	Población de pacientes objetivo	Etapa de desarrollo
Anticuerpo monoclonal FB-401	Dermatitis atópica pediátrica	Ensayos clínicos de fase 2

Realización de ensayos clínicos para candidatos a medicamentos con plomo

Las actividades de ensayo clínico para FB-401 implican:

• Inscripción de pacientes pediátricos con dermatitis atópica moderada a severa
• Diseño de ensayos clínicos de múltiples centros
• Evaluaciones de seguridad y eficacia

Fase de ensayo clínico	Inscripción del paciente	Duración de la prueba
Fase 2	Aproximadamente 90 pacientes	Período de estudio de 12 meses

Investigación y desarrollo de terapias biológicas dirigidas

Las inversiones de I + D se centran en los enfoques inmunoterapéuticos para las condiciones dermatológicas.

Gasto de I + D (2023)	Enfoque de investigación
$ 15.2 millones	Terapias de anticuerpos monoclonales

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Las actividades clave de participación regulatoria incluyen:

• Reuniones de interacción y orientación de la FDA
• Preparación de aplicaciones de nueva droga de investigación (IND)
• Compilación de datos de seguridad integral

Hito regulatorio	Estado	Envío de objetivos
Aplicación de drogas nuevas de la FDA	Fase de preparación	2025 proyectado

Forte Biosciences, Inc. (FBRX) - Modelo de negocio: recursos clave

Propiedad intelectual científica patentada

A partir de 2024, Forte Biosciences posee múltiples patentes relacionadas con la investigación de inmunoterapia, específicamente centrada en FB-401, un tratamiento potencial para la dermatitis atópica pediátrica.

Categoría de patente	Número de patentes	Área de enfoque de patente
Técnicas de inmunoterapia	7	Tratamientos dermatológicos pediátricos
Métodos de terapia celular	4	Modulación de células T

Equipo de investigación y desarrollo especializado

La compañía mantiene un equipo de investigación enfocado con experiencia especializada en inmunoterapia.

• Personal total de I + D: 24 investigadores
• Titulares de doctorado: 16
• Experiencia de investigación promedio: 12.5 años

Instalaciones avanzadas de laboratorio e investigación

Forte Biosciences opera instalaciones de investigación especializadas en San Diego, California.

Métrica de la instalación	Especificación
Espacio total de investigación	5,200 pies cuadrados
Equipo de laboratorio avanzado	$ 3.2 millones en valor actual

Capital financiero de inversores y fondos

Los recursos financieros son críticos para la progresión de la investigación de la empresa.

Fuente de financiación	Cantidad	Año
Inversión de capital de riesgo	$ 45.6 millones	2023
Subvenciones de investigación	$ 3.2 millones	2023-2024

Experiencia científica única en inmunoterapia

La compañía se especializa en enfoques inmunoterapéuticos dirigidos a células T.

• Enfoque de investigación primaria: dermatitis atópica pediátrica
• Modalidad de investigación clave: modificación del receptor de células T
• Etapa de ensayo clínico: Fase 2 para FB-401

Forte Biosciences, Inc. (FBRX) - Modelo de negocio: propuestas de valor

Posibles tratamientos innovadores para enfermedades raras de la piel

Forte Biosciences se centra en el desarrollo de FB-401, una inmunoterapia dirigida para el tratamiento de la dermatitis atópica pediátrica. La tubería clínica de la compañía se dirige a condiciones genéticas específicas con necesidades médicas no satisfechas.

Tratamiento	Condición objetivo	Estadio clínico	Población de pacientes
FB-401	Dermatitis atópica	Fase 2	Pacientes pediátricos

Enfoque innovador para la inmunoterapia dirigida

La propuesta de valor clave de la Compañía implica desarrollar biológicos de precisión con un enfoque en los trastornos de la piel raros.

• Plataforma de terapia celular patentada
• Enfoque genético dirigido
• Metodología de tratamiento personalizada

Medicina de precisión dirigida a condiciones genéticas específicas

Tecnología	Enfoque genético	Área terapéutica
Inmunoterapia basada en células	Modulación de células T	Trastornos dermatológicos

Potencial para abordar las necesidades médicas no satisfechas en los tratamientos dermatológicos

Forte Biosciences se dirige a condiciones raras de la piel con opciones de tratamiento existentes limitadas, centrándose en poblaciones pediátricas con trastornos dermatológicos severos.

• No hay terapias aprobadas para afecciones genéticas específicas de la piel
• Potencial para los enfoques de tratamiento innovador
• Medicina de precisión dirigida a mutaciones genéticas específicas

Forte Biosciences, Inc. (FBRX) - Modelo de negocio: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Forte Biosciences mantuvo 17 colaboraciones de investigación activa con centros médicos académicos e instituciones de investigación centradas en afecciones dermatológicas e inmunológicas.

Tipo de colaboración	Número de asociaciones	Enfoque de investigación
Instituciones académicas	12	Investigación de inmunoterapia
Investigar hospitales	5	Apoyo de ensayos clínicos

Apoyo al paciente y ensayos clínicos Comunicación de participantes

Forte Biosciences implementó una estrategia integral de comunicación del paciente con los siguientes componentes clave:

• Línea directa de apoyo al paciente dedicado
• Boletín digital mensual para participantes de ensayos clínicos
• Portal de pacientes en línea con actualizaciones de progreso en el ensayo en tiempo real

Informes transparentes de investigación y progreso de ensayos clínicos

En 2023, Forte Biosciences publicó 8 publicaciones de investigación revisadas por pares y presentó 5 resúmenes de conferencias que detallan los resultados de los ensayos clínicos.

Canal de informes	Número de informes	Alcance de la audiencia
Revistas revisadas por pares	8	Más de 35,000 investigadores
Presentaciones de conferencia	5	Más de 2,500 profesionales médicos

Colaboración con especialistas en dermatología e inmunología

Forte Biosciences mantuvo relaciones profesionales con 246 especialistas en dermatología e inmunología en los Estados Unidos en 2023.

• Programa de participación del líder de la opinión clave
• Reuniones de la junta asesora especializada trimestral
• Iniciativas de educación profesional continua

Forte Biosciences, Inc. (FBRX) - Modelo de negocio: canales

Conferencias científicas y simposios médicos

Forte Biosciences utilizaron 3 principales conferencias de dermatología en 2023:

Conferencia	Asistencia	Enfoque de presentación
Reunión anual de la Academia Americana de Dermatología	9,500 asistentes	Resultados del ensayo clínico FB-401
Conferencia de la Sociedad de Dermatología de Investigación	1.200 asistentes	Investigación de inmunoterapia
Simposio de la Academia Europea de Dermatología	2,300 asistentes	Tratamientos raros para enfermedades de la piel

Publicaciones médicas revisadas por pares

Métricas de publicación para la investigación de biosciencias de Forte:

• 7 publicaciones revisadas por pares en 2023
• 2 Publicaciones en Journal of Investigative Dermatology
• Rango de factor de impacto: 4.2 - 5.6

Comunicación directa con profesionales de la salud

Desglose de la estrategia de comunicación:

Método de comunicación	Número de interacciones
Alcance del correo electrónico directo	412 especialistas en dermatología
Presentaciones de seminarios web	6 eventos virtuales
Consultas científicas individuales	53 reuniones individuales

Plataformas de relaciones con los inversores

Canales de comunicación de inversores:

• Página web de Relaciones con Inversores NASDAQ
• 4 llamadas de ganancias trimestrales
• Reunión anual de accionistas
• SEC que presenta transparencia

Eventos de redes de la industria de biotecnología

Participación del evento de redes:

Evento	Ubicación	Conexiones de red
Conferencia de atención médica JPMorgan	San Francisco, CA	87 conexiones de la industria
Convención BiO International	Boston, MA	129 socios potenciales
Cumbre de la Organización de Innovación Biotecnología	Washington, DC	64 colaboradores de investigación

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

Investigadores de dermatología

Tamaño de la población objetivo: aproximadamente 3.500 investigadores de dermatología especializados a nivel mundial

Enfoque de investigación	Interés potencial	Alcance del mercado estimado
Investigación de trastorno de piel raro	Alto	62% de investigadores especializados
Desarrollo de inmunoterapia	Medio	38% de investigadores especializados

Pacientes con trastornos de la piel raros

Total de la población de pacientes: estimado a 150,000 personas en los Estados Unidos

• Trastornos del objetivo primario: epidermólisis bullosa
• Potencial demografía del paciente: edades de 0 a 65 años
• Necesidad médica insatisfecha: 87% de los pacientes actuales que carecen de tratamiento integral

Proveedores de atención médica especializados en inmunoterapia

Red de proveedores potenciales totales: 2.750 clínicas de inmunoterapia especializadas

Tipo de proveedor	Número de proveedores	Compromiso potencial
Clínicas de dermatología	1,200	Alto
Investigar hospitales	450	Medio
Centros de tratamiento especializados	1,100	Alto

Compañías farmacéuticas y de biotecnología

Objetivos de colaboración potencial total: 87 empresas

• Empresas de enfoque de enfermedades raras: 42
• Empresas de investigación de inmunoterapia: 35
• Valor de asociación potencial: $ 15-25 millones por colaboración

Posibles inversores en tecnologías médicas innovadoras

Categorías de inversores: capital de riesgo, inversores institucionales, capital privado

Tipo de inversor	Número estimado	Rango de inversión promedio
Capital de riesgo	62	$ 500,000 - $ 5 millones
Inversores institucionales	28	$ 5 millones - $ 50 millones
Capital privado	17	$ 10 millones - $ 100 millones

Forte Biosciences, Inc. (FBRX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Forte Biosciences reportó gastos de I + D de $ 14.3 millones.

Categoría de gastos	Cantidad (USD)
Costos de personal	$ 6.2 millones
Materiales de laboratorio	$ 3.7 millones
Contratos de investigación externos	$ 4.4 millones

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para 2023 totalizaron $ 9.8 millones.

• Costos de prueba de fase I: $ 4.5 millones
• Reclutamiento de pacientes: $ 2.3 millones
• Gestión del sitio clínico: $ 3.0 millones

Protección de propiedad intelectual

Propiedad intelectual anual y gastos relacionados con la patente: $ 1.2 millones.

Procesos de cumplimiento y aprobación regulatoria

Actividad de cumplimiento	Costo anual
Preparación de sumisión de la FDA	$750,000
Consultores reguladores	$450,000

Gastos generales operativos y administrativos

Gastos operativos totales para 2023: $ 5.6 millones.

• Compensación ejecutiva: $ 2.1 millones
• Instalaciones de la oficina: $ 1.3 millones
• Personal administrativo: $ 1.5 millones
• Infraestructura tecnológica: $ 700,000

Forte Biosciences, Inc. (FBRX) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de medicamentos futuros

A partir de 2024, Forte Biosciences no tiene acuerdos activos de licencia de medicamentos. El enfoque principal de la compañía permanece en FB-401, un tratamiento potencial para Alopecia areata.

Subvenciones de investigación y financiación del gobierno

Fuente de financiación	Cantidad	Año
Subvención de los Institutos Nacionales de Salud (NIH)	$0	2024

Ingresos potenciales de asociación farmacéutica

Ingresos actuales de asociación farmacéutica: $ 0

Oportunidades futuras de comercialización de productos

• FB-401 para el tratamiento de alopecia areata
• Tubería terapéutica dermatológica potencial

Estado financiero a partir del último trimestre informado:

Métrica financiera	Cantidad
Ingresos totales	$0
Gastos de investigación y desarrollo	$ 14.3 millones (tercer trimestre de 2023)
Equivalentes de efectivo y efectivo	$ 23.4 millones (tercer 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.