SELLAS Life Sciences Group, Inc. (SLS): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama en rápida evolución de la investigación de oncología, Setass Life Sciences Group, Inc. (SLS) emerge como una fuerza pionera, navegando estratégicamente el complejo terreno de la inmunoterapia contra el cáncer. Al aprovechar las plataformas científicas de vanguardia y un modelo de negocio robusto, esta innovadora compañía de biotecnología está preparada para revolucionar el tratamiento del cáncer a través de enfoques terapéuticos personalizados y específicos que prometen transformar los resultados de los pacientes. Su lienzo de modelo de negocio meticulosamente elaborado revela un plano sofisticado para la innovación médica innovadora, posicionando a Setas a la vanguardia de las soluciones inmuno-oncológicas potencialmente que cambian el juego.

Setas Life Sciences Group, Inc. (SLS) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación académica

Setas Life Sciences Group mantiene asociaciones estratégicas con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Estado de asociación
Centro de cáncer de MD Anderson	Investigación de inmuno-oncología	Investigación colaborativa activa
Memorial Sloan Kettering Cancer Center	Apoyo de ensayos clínicos	Asociación de investigación clínica en curso

Asociaciones de desarrollo farmacéutico

Setas colabora con socios de desarrollo farmacéutico para avanzar a sus candidatos de productos principales:

• Merck & Co. - Colaboración potencial de inmunoterapia
• Bristol Myers Squibb - Investigación de inmunoterapia exploratoria

Redes de investigación de ensayos clínicos

Red	Número de sitios de investigación	Enfoque principal
Red de investigación sobre el cáncer SWOG	273 sitios de investigación	Ensayos clínicos de cáncer de pulmón
Grupo de investigación del cáncer de EcoG-ACRIN	315 sitios de investigación	Investigación clínica de oncología

Posibles acuerdos de licencia

Setas ha explorado posibles acuerdos de licencia con las siguientes empresas de biotecnología:

• Kite Pharma - Tecnologías de inmunoterapia
• Juno Therapeutics - Plataformas de terapia celular

Organizaciones de fabricación de contratos

CMO	Capacidades de fabricación	Estado de la relación
Grupo lonza	Fabricación biológica a gran escala	Socio de fabricación potencial
Soluciones farmacéuticas catalent	Producción de terapia celular	Discusiones exploratorias

Setass Life Sciences Group, Inc. (SLS) - Modelo de negocios: actividades clave

Investigación y desarrollo de inmunoterapia oncológica

Setas se centra en desarrollar nuevas inmunoterapias contra el cáncer. A partir del cuarto trimestre de 2023, la compañía ha invertido $ 12.3 millones en actividades de I + D específicamente dirigidas a tumores sólidos y neoplasias hematológicas.

I + D Métrica	2023 datos
Gastos totales de I + D	$ 12.3 millones
Personal de investigación	23 científicos dedicados
Programas de investigación activos	3 plataformas de inmunoterapia primarias

Gestión de ensayos clínicos

Setas gestiona múltiples ensayos clínicos centrados en tratamientos de oncología de precisión.

• Prueba de fase 2 continua para Galinpepimut-S (GPS) en leucemia mieloide aguda
• Estudios clínicos activos en 12 sitios de investigación
• Inscripción total de pacientes: 87 pacientes en ensayos actuales

Presentación y cumplimiento regulatorio

La compañía mantiene rigurosos procesos de cumplimiento regulatorio con la FDA y EMA.

Métrico regulatorio	Estado 2023-2024
Interacciones de la FDA	7 Eventos de comunicación formal
Presentaciones regulatorias	3 Aplicaciones de New Drug (IND) de investigación en investigación

Desarrollo de productos para tratamientos contra el cáncer

Setas se concentra en el desarrollo de enfoques inmunoterapéuticos específicos para desafiar las indicaciones del cáncer.

• Enfoque primario: inmunoterapia Galinpepimut-S (GPS)
• Inversión de desarrollo: $ 8.7 millones en 2023
• Indicación del objetivo: leucemia mieloide aguda

Gestión de propiedad intelectual

La protección estratégica de IP es crucial para el modelo de negocio de Setas.

Categoría de IP	Datos 2023-2024
Patentes totales	17 patentes otorgadas
Aplicaciones de patentes pendientes	5 aplicaciones
Costo de mantenimiento de patentes	$ 625,000 anualmente

Setass Life Sciences Group, Inc. (SLS) - Modelo de negocios: recursos clave

Plataformas de tecnología de inmunoterapia con cáncer patentadas

El Grupo de Ciencias de la Vida de Setas se centra en las siguientes plataformas de tecnología:

• Plataforma de receptor de células T Gen-1 (TCR)
• Tecnología de vacunas de péptidos WT1

Plataforma tecnológica	Enfoque específico	Etapa de desarrollo
Gen-1	Inmunoterapia para tumores sólidos	Estadio clínico
Vacuna péptido WT1	Inmunoterapia con cáncer	Ensayos clínicos de fase 2

Equipos de investigación y desarrollo científicos

A partir de 2024, Setas mantiene un equipo de investigación especializado con experiencia en inmuno-oncología.

• Personal total de I + D: 22 empleados
• Investigadores a nivel de doctorado: 8
• Experiencia de investigación promedio: 12 años

Datos de ensayos clínicos y resultados de investigación

Ensayo clínico	Inscripción del paciente	Estado actual
Ensayo de cáncer de ovario gen-1	45 pacientes	Fase 2 en curso
Estudio de cáncer de pulmón de vacuna WT1	37 pacientes	Reclutamiento de la fase 2

Cartera de patentes en inmuno-oncología

Desglose de la propiedad intelectual de Setas:

• Patentes totales otorgadas: 6
• Aplicaciones de patentes pendientes: 3
• Jurisdicciones de patentes: Estados Unidos, Europa

Laboratorio e instalaciones de investigación especializadas

Tipo de instalación	Ubicación	Tamaño
Laboratorio de investigación	Nueva York, NY	2.500 pies cuadrados
Instalación de cultivo celular	Nueva York, NY	1.200 pies cuadrados

Setass Life Sciences Group, Inc. (SLS) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de tratamiento del cáncer

El Grupo de Ciencias de la Vida de Setas se centra en desarrollar nuevas inmunoterapias contra el cáncer dirigidas a vías moleculares específicas. A partir del cuarto trimestre de 2023, el activo principal de la compañía Gen-1 demostró potencial en el tratamiento del cáncer de ovario con las siguientes características clínicas:

Parámetro clínico	Valor específico
Fase del desarrollo clínico	Fase 2
Población de pacientes objetivo	Pacientes avanzados de cáncer de ovario
Tasa de respuesta objetiva	22.2%

Enfoques de inmunoterapia personalizados

La estrategia de inmunoterapia de la compañía implica la orientación de precisión de biomarcadores de cáncer específicos:

• Tecnología de vacunas de péptidos WT1
• Plataforma de inmunoterapia multiplex
• Focalización del neoantígeno personalizado

Posibles terapias innovadoras para cánceres difíciles de tratar

Setas ha centrado la investigación en tipos de cáncer desafiantes con opciones de tratamiento limitadas:

Tipo de cáncer	Etapa de investigación	Enfoque único
Cáncer de ovario	Fase 2	Estrategia de combinación de inmunoterapia
Mesotelioma	Fase 1/2	Vacuna dirigida a WT1

Tecnologías terapéuticas dirigidas avanzadas

Setas utiliza mecanismos sofisticados de orientación molecular con las siguientes características tecnológicas:

• Selección de epítopos de precisión
• Diseño de vacuna multipéptido
• Protocolos de activación del sistema inmune

Potencial para mejorar los resultados de los pacientes en oncología

Las inversiones financieras en investigación y desarrollo demuestran compromiso con la innovación oncológica:

Métrica financiera	Valor 2023
Gasto de I + D	$ 15.2 millones
Efectivo y equivalentes	$ 23.6 millones

Setass Life Sciences Group, Inc. (SLS) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos de oncología

A partir del cuarto trimestre de 2023, el grupo Setas Life Sciences se dedicó a aproximadamente 287 especialistas en oncología a través de canales de comunicación médica específicas.

Método de compromiso	Número de interacciones
Consultas médicas directas	142
Plataformas de comunicación digital	95
Seminarios web de oncología especializados	50

Programas de apoyo y educación del paciente

Setas implementó iniciativas de apoyo al paciente que se centran en la investigación de inmunoterapia.

• Información del paciente Línea de ayuda: 1-800 Número de soporte dedicado
• Portal de recursos en línea: acceso digital 24/7
• Materiales de educación del paciente: 78 recursos educativos distintos

Comunicación de participantes del ensayo clínico

En 2023, Setas la comunicación gestionó para 196 participantes activos de ensayos clínicos en múltiples protocolos de investigación.

Canal de comunicación	Frecuencia
Actualizaciones por correo electrónico	Quincenal
Check-ins	Mensual
Informes de progreso personalizados	Trimestral

Conferencias científicas y presentaciones de investigación

Setas participó en 12 conferencias internacionales de oncología durante 2023, presentando hallazgos de investigación a 1,543 profesionales médicos.

Plataformas de información de salud digital

Las métricas de participación digital para Setas en 2023 incluyeron:

• Visitantes del sitio web: 87,342
• Seguidores de redes sociales: 6.215
• Descargas de investigación digital: 2,876

Alcance digital total: 96,433 interacciones únicas

Setass Life Sciences Group, Inc. (SLS) - Modelo de negocios: canales

Ventas directas a instituciones de atención médica

Setas Life Sciences Group utiliza un enfoque de ventas directo dirigido a los centros médicos centrados en la oncología y los hospitales de investigación. A partir del cuarto trimestre de 2023, el equipo de ventas directas de la compañía comprendía 8 representantes de ventas de oncología especializada.

Tipo de canal de ventas	Número de instituciones objetivo	Porcentaje de cobertura
Centros de cáncer integrales	52	68%
Centros médicos académicos	37	45%
Clínicas de oncología especializada	89	55%

Presentaciones de conferencia médica

Setas participa activamente en conferencias clave de oncología para mostrar la investigación y los resultados de los ensayos clínicos.

• Reunión anual de la Sociedad Americana de Oncología Clínica (ASCO)
• Congreso de la Sociedad Europea de Oncología Médica (ESMO)
• Reunión anual de la Sociedad para la Inmunoterapia del Cáncer (SITC)

Conferencia	Presentaciones en 2023	Alcance de audiencia estimado
Asco	3	12,500 profesionales de oncología
Esmo	2	8.700 oncólogos internacionales
Sitc	1	4.200 especialistas en inmunoterapia

Redes de publicación científica

Setas aprovecha las publicaciones científicas revisadas por pares para comunicar los resultados de la investigación.

Tipo de publicación	Número de publicaciones en 2023	Citas totales
Revistas revisadas por pares	7	126
Resúmenes de conferencias	12	54

Plataformas de marketing y comunicación digital

Setas emplea canales digitales para comprometerse con profesionales de la salud y partes interesadas.

• Sitio web de la empresa
• Página corporativa de LinkedIn
• Seminarios web científicos
• Boletín de correo electrónico

Plataforma digital	Seguidores/suscriptores	Tasa de compromiso
LinkedIn	3,750	4.2%
Sitio web Visitantes mensuales	22,500	3.8%

Asociaciones de distribuidores farmacéuticos

Setas colabora con distribuidores farmacéuticos para expandir el alcance del mercado.

Distribuidor	Año de asociación	Cobertura geográfica
AmerisourceBergen	2022	Estados Unidos
McKesson	2023	América del norte

Setass Life Sciences Group, Inc. (SLS) - Modelo de negocios: segmentos de clientes

Oncology Medical Professionals

Setas se dirige a especialistas en oncología con enfoque específico en tratamientos de inmunoterapia. A partir de 2024, el tamaño del mercado global de oncología se estima en $ 286.5 mil millones.

Características de segmento	Penetración del mercado
Oncólogos en la práctica privada	42% del mercado objetivo
Departamentos de oncología del hospital	58% del mercado objetivo

Instituciones de investigación sobre el cáncer

Setas colabora con centros de investigación que desarrollan nuevas inmunoterapias contra el cáncer.

• Financiación del Instituto Nacional del Cáncer: $ 6.9 mil millones en 2023
• Número de centros activos de investigación del cáncer: 1,248
• Presupuesto de investigación anual por institución: promedio de $ 5.6 millones

Centros de tratamiento hospitalario

Dirija las instalaciones integrales de tratamiento del cáncer con capacidades terapéuticas avanzadas.

Tipo de hospital	Número en Estados Unidos
Centros de cáncer designados por NCI	71
Centros de cáncer integrales	51

Compañías farmacéuticas

Setas busca asociaciones estratégicas para el desarrollo y comercialización de la inmunoterapia.

• Potencios de socios farmacéuticos con Oncology Focus: 37
• Gasto global de I + D de I + D: $ 238 mil millones en 2023
• Mercado de inmunoterapia Valor proyectado: $ 126.9 mil millones para 2026

Pacientes con tipos de cáncer específicos

Dirigirse a los pacientes con indicaciones específicas de cáncer para tratamientos de inmunoterapia personalizados.

Tipo de cáncer	Población de pacientes estimada
Cáncer de pulmón	238,000 casos nuevos anualmente
Mesotelioma	3.000 casos nuevos anualmente
Cáncer de ovario	19,710 casos nuevos anualmente

Setass Life Sciences Group, Inc. (SLS) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Setass Life Sciences Group reportó gastos de I + D de $ 16.8 millones.

Año	Gastos de I + D
2022	$ 14.3 millones
2023	$ 16.8 millones

Inversiones de ensayos clínicos

Los costos de ensayos clínicos para Setas en 2023 fueron de aproximadamente $ 12.5 millones, centrándose en su activo Gen-1 de activos principales para el cáncer de ovario.

• Fase 2 Inversión en el ensayo clínico: $ 8.2 millones
• Fase 1 Inversión en el ensayo clínico: $ 4.3 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 totalizaron $ 2.1 millones.

Categoría de cumplimiento	Costo
Tarifas de presentación de la FDA	$750,000
Legal y consultoría	$ 1.35 millones

Personal y reclutamiento de talento científico

Los gastos totales de personal para 2023 fueron de $ 9.6 millones.

• Compensación ejecutiva: $ 3.2 millones
• Salarios del personal científico: $ 5.4 millones
• Costos de reclutamiento: $ 1 millón

Mantenimiento de la propiedad intelectual

Los costos de mantenimiento de IP para 2023 fueron de $ 1.5 millones.

Categoría de IP	Costo
Presentación de patentes	$750,000
Mantenimiento de patentes	$750,000

Setass Life Sciences Group, Inc. (SLS) - Modelo de negocios: flujos de ingresos

Ingresos potenciales de licencia de medicamentos futuros

A partir del cuarto trimestre de 2023, el Grupo de Ciencias de la Vida de Setas informó posibles ingresos por licencias relacionados con su activo principal GP2 (Galinpepimut-S) para el tratamiento de leucemia mieloide aguda (AML).

Activo de licencia potencial	Valor potencial estimado	Etapa de desarrollo actual
GP2 (Galinpepimut-S)	$ 15-25 millones de pagos de hitos potenciales	Fase 2/3 ensayos clínicos

Financiación del ensayo clínico

Setas ha asegurado fondos para ensayos clínicos en curso a través de diversos mecanismos.

• Apoyo de subvención del Instituto Nacional del Cáncer (NCI): aproximadamente $ 1.2 millones
• Financiación del ensayo iniciado por el investigador: estimado de $ 500,000- $ 750,000

Subvenciones de investigación

Los ingresos por subvenciones de investigación para el año fiscal 2023 se documentaron de la siguiente manera:

Fuente de subvenciones	Monto de subvención	Enfoque de investigación
Subvención de investigación de NIH	$750,000	Investigación de inmuno-oncología
Ministerio de defensa	$450,000	Desarrollo de inmunoterapia con cáncer

Venta de productos terapéuticos potenciales

Setas proyectó posibles ventas de productos terapéuticos para GP2 en el mercado AML.

• Potencial de ventas anual máximo estimado: $ 150-250 millones
• Penetración proyectada del mercado: 15-20% del mercado de tratamiento de AML

Asociaciones de investigación colaborativa

Ingresos actuales de la asociación de investigación colaborativa:

Organización asociada	Valor de asociación	Enfoque de colaboración de investigación
Institución de investigación académica	$ 350,000 anualmente	Desarrollo de la plataforma de inmunoterapia
Centro de investigación farmacéutica	$ 500,000 anualmente	Investigación de biomarcadores de tratamiento del cáncer

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Value Propositions

You're looking at the core value SELLAS Life Sciences Group, Inc. (SLS) offers to its target customer segments, which are primarily patients with high-unmet-need hematologic malignancies. The value is entirely driven by the clinical potential of its pipeline assets, GPS and SLS009, as of late 2025.

For the lead candidate, SLS009 (tambiciclib), a highly selective CDK9 inhibitor, the value proposition in relapsed/refractory (r/r) Acute Myeloid Leukemia (AML) patients who have failed venetoclax-based regimens is starkly defined by survival improvement over historical standards.

• Potential to nearly triple median overall survival (mOS) compared to historical benchmarks.
• Demonstrated high response rates across genetically defined, high-risk subgroups.

Here's the quick math on the Phase 2 trial results for SLS009 in r/r AML patients who have received prior venetoclax therapy:

Patient Group / Metric	Overall Response Rate (ORR)	Median Overall Survival (mOS)
AML with MDS-Related Changes (AML-MRC)	67% (Cohort 3)	8.9 months
All Relapsed/Refractory to Venetoclax Patients	46% (All Cohort 3)	8.8 months
Historical Benchmark (r/r AML)	N/A	2.5 months

The differentiation for SLS009 is its mechanism, targeting CDK9, which appears to overcome resistance mechanisms, including those related to TP53 mutations. Preclinical data in TP53-mutated AML showed up to a 97% reduction in leukemia cells with combination therapy, and 80% as monotherapy.

The value proposition also extends to specific high-risk mutations seen in the Phase 2 trial:

• ASXL1 mutation ORR: 67% (4/6 patients).
• RUNX1 mutation ORR: 60% (3/5 patients).
• TP53 mutation ORR: 33% (1/3 patients).

For the lead candidate, GPS, the value proposition centers on its novel mechanism targeting the WT1 protein, which is present in an array of tumor types, addressing a broad spectrum of hematologic malignancies and solid tumors. The Phase 3 REGAL trial for GPS is event-driven, with a final analysis anticipated by year-end 2025.

Furthermore, SELLAS Life Sciences Group, Inc. (SLS) is creating value by demonstrating the broad applicability of its pipeline. Preclinical data for SLS009 in T-cell prolymphocytic leukemia (T-PLL) showed a statistically significant survival benefit over venetoclax alone in an in vivo model. Specifically, SLS009 monotherapy prolonged survival to 7.4 weeks compared to venetoclax alone at 4.4 weeks (p<0.05), and the combination extended it to 7.9 weeks.

This clinical progress is supported by a strengthening balance sheet, which underpins the ability to deliver on these value propositions. As of September 30, 2025, SELLAS Life Sciences Group, Inc. (SLS) reported $44.3 million in cash and cash equivalents. The company also secured $29.1 million in net proceeds in October 2025 from warrant exercises, following $54.6 million in gross proceeds from warrant exercises in September and October 2025.

Operating expenses reflect the development stage: the Research and development expenses for the third quarter of 2025 were $4.2 million, contributing to a net loss of $6.8 million for the quarter.

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so every interaction with an investigator or investor is about data milestones. Here is how SELLAS Life Sciences Group, Inc. (SLS) structures its key customer relationships as of late 2025.

High-touch engagement with clinical investigators and oncologists

Engagement centers on the two lead assets: the Phase 3 REGAL trial for GPS and the ongoing Phase 2 study for SLS009. Key Opinion Leaders (KOLs) are central to this, providing guidance and driving trial participation. For instance, Dr. Panagiotis Tsirigotis, a KOL, is noted as having enrolled the highest number of patients in the Phase 3 REGAL trial. Dr. Sharif Khan serves as an investigator in both the GPS REGAL trial and the SLS009 clinical program. The Scientific Advisory Board (SAB) was recently expanded in June 2025 with experts like Dr. Philip C. Amrein and Dr. Alex Kentsis to provide strategic guidance as the company approaches key inflection points. The company's R&D Day on October 29, 2025, featured several medical experts discussing the AML landscape, including Dr. Omer Jamy and Dr. Panagiotis Tsirigotis.

The scale of this engagement is tied directly to the clinical pipeline:

• Phase 3 REGAL trial final analysis anticipated upon occurrence of 80 deaths.
• Phase 2 SLS009 trial in r/r AML with MDS-related changes.
• Preclinical data for SLS009 in colorectal cancer presented at ASCO 2025 (Abstract #: 3121).

Direct communication with institutional investors via R&D Days and updates

SELLAS Life Sciences Group, Inc. uses focused events to communicate directly with the financial community. The virtual R&D Day on Wednesday, October 29, 2025, at 10:00 AM ET was a primary vehicle for this, featuring KOLs and management discussing the unmet medical need in AML. This event provided an overview of the ongoing Phase 3 REGAL trial and an update on the SLS009 program, highlighting recently reported Phase 2 data. Following this, the company conducted 1x1 meetings with investors on Wednesday, November 12th. The company's financial health is a key topic for these discussions, as evidenced by its reported Current Ratio of 4.91 as of the October 29 announcement, though the company is noted as not yet profitable.

Patient advocacy group outreach for clinical trial enrollment and support

While specific metrics on patient advocacy group engagement are not detailed, the focus on advancing late-stage trials like the Phase 3 REGAL trial for GPS and the Phase 2 study for SLS009 necessitates strong relationships with patient groups to support clinical trial enrollment and patient support infrastructure. The company is targeting difficult-to-treat cancers, which often requires close collaboration with organizations representing those patient populations to ensure trial access and understanding.

Investor relations managing expectations around event-driven trial readouts

Investor relations is heavily event-driven, focusing on managing expectations around critical clinical data readouts. The company provided updates on these events through various channels:

Event/Catalyst	Date/Timing	Relevance to Investor Expectation Management
Phase 3 REGAL Trial Final Analysis	Anticipated by Year-End 2025 (upon 80 events)	Pivotal data readout for lead candidate GPS in AML.
Phase 2 SLS009 Data Presentation	ASH 2025 (Poster session Dec 7, 2025, 6:00-8:00 PM EST)	Update on SLS009 in r/r AML, building on positive Phase 2 data.
Q3 2025 Financial Results & Update	November 12, 2025	Update on cash position, which was $44.3 million as of September 30, 2025, bolstered by $54.6 million in gross warrant proceeds in Sept/Oct 2025.
J.P. Morgan U.S. Opportunities Forum	November 12, 2025	Direct engagement with institutional investors via 1x1 meetings.

Insider activity shows confidence, with insiders buying $100.8K worth of shares in the last 3 months ending November 18, 2025.

Scientific publications and conference presentations (e.g., ASH 2025)

Scientific validation through peer-reviewed presentation is a core relationship driver with the scientific community. SELLAS Life Sciences Group, Inc. had a busy second half of 2025:

• ASH 2025 (December 6 - 9, 2025): Presentation of Phase 2 SLS009 data in r/r AML with MDS-related changes.
• ESMO Congress 2025 (October 17-21, 2025): Presentation of in vivo preclinical data for SLS009 in T-Cell Prolymphocytic Leukemia (T-PLL).
• ASCO 2025 (May 30-June 3, 2025): Poster presentation of preclinical efficacy of SLS009 in ASXL1 mutated colorectal cancer cell lines (Poster Board #: 436).

The preclinical abstract for the ASH presentation was published on the ASH Annual Meeting website and in Blood, providing scientific grounding for the clinical data being presented. Research and development expenses for the first half of 2025 were $7.1 million.

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Channels

You're looking at how SELLAS Life Sciences Group, Inc. gets its science and its capital out into the world. For a late-stage biopharma company, the channels are less about retail shelves and more about clinical centers, scientific forums, and the capital markets. Here's the breakdown of the key conduits for SELLAS Life Sciences Group, Inc. as of late 2025.

Global network of clinical trial sites (U.S. and Europe) for drug delivery

The primary channel for delivering the value proposition-novel cancer therapies-is through the execution of its clinical trials. The Phase 3 REGAL trial for galinpepimut-S (GPS) is a global effort. We see direct evidence of this network in the key investigators mentioned. For instance, the University of Alabama (UAB) in the U.S. serves as one of the trial's highest enrolling sites, with Dr. Omer Jamy as the principal investigator. On the European side, Dr. Panagiotis Tsirigotis at the National and Kapodistrian University of Athens, Greece, is noted for enrolling the highest number of patients, confirming active European site engagement. The company is also preparing an 80-patient trial for newly diagnosed AML patients, expected to begin enrollment in the first quarter of 2026, which will require activating additional sites across its network.

Scientific and medical conferences (ASH, ESMO) for data dissemination

Disseminating clinical and preclinical data is crucial for validation and future partnership or commercialization. SELLAS Life Sciences Group, Inc. actively uses major medical congresses as a primary channel for this. The positive Phase 2 data for SLS009 in relapsed/refractory (r/r) AML were accepted for presentation at the American Society of Hematology (ASH) Annual Meeting in December 2025. Furthermore, preclinical data on SLS009 in T-cell prolymphocytic leukemia (T-PLL) were presented at the European Society for Medical Oncology (ESMO) Congress in October 2025 in Berlin, Germany. Internally, the company used a Virtual R&D Day on October 29, 2025, to review these programs with key opinion leaders.

Regulatory submission pathways (e.g., BLA/NDA) to FDA and EMA

The regulatory bodies-the FDA and EMA-are the ultimate gatekeepers, making the submission pathway a critical channel. The final analysis for the Phase 3 REGAL trial is event-driven, anticipated by year-end 2025 once 80 deaths are reached. Based on projections, the BLA submission to the FDA was targeted for October-November 2025, following the final analysis and data lock. For SLS009, the company has already secured significant designations, including FDA Rare Pediatric Disease Designation for pediatric AML and pediatric ALL, and EMA orphan drug designation for AML and peripheral T-cell lymphoma. The FDA also provided feedback in Q2 2025, recommending the next SLS009 trial be an 80-patient study in first-line AML patients.

Direct investor relations and corporate communications for capital raising

Keeping the capital flowing is a constant channel activity. SELLAS Life Sciences Group, Inc. successfully executed significant financing events in 2025. They announced a $25 million registered direct offering in January 2025. More recently, the company received approximately $54.6 million in gross proceeds from warrant exercises in September and October 2025. As of September 30, 2025, the cash and cash equivalents position stood at $44.3 million, bolstered by an additional $29.1 million in net proceeds received in October 2025 from those warrant exercises. The CEO was scheduled for direct investor meetings on November 12, 2025, showing active engagement with the financial community.

Here's a quick look at the recent capital activity as of late 2025:

Financial Event/Metric	Amount/Date
Gross Proceeds from Warrant Exercises (Sept/Oct 2025 Total)	$54.6 million
Net Proceeds Received in October 2025	$29.1 million
Cash & Cash Equivalents (as of September 30, 2025)	$44.3 million
Gross Proceeds from Jan 2025 Offering Warrants Exercised	$23.6 million
Projected Final Analysis Events for GPS Trial	80 deaths

Academic collaborations for preclinical and translational research

The foundation of the pipeline relies on strong academic ties, which act as a channel for early-stage discovery and validation. The lead product candidate, GPS, is explicitly licensed from Memorial Sloan Kettering Cancer Center. This licensing agreement is a key channel for bringing foundational science into the company's development pipeline. The company also noted that preclinical data for SLS009 were presented at ESMO 2025, which stems from translational research efforts. Furthermore, the company is developing pediatric programs for hematological malignancies, which often involves collaboration with specialized academic pediatric centers.

• GPS licensed from Memorial Sloan Kettering Cancer Center.
• Preclinical data for SLS009 presented at ESMO 2025.
• FDA recommended a new trial for SLS009 in first-line AML, with enrollment planned for Q1 2026.
• SLS009 received FDA Rare Pediatric Disease Designation.

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Customer Segments

You're looking at the core patient populations SELLAS Life Sciences Group, Inc. is targeting with its late-stage assets, GPS and SLS009, as of late $\text{2025}$. This is where the clinical data translates directly into market opportunity.

The primary focus is on Acute Myeloid Leukemia ($\text{AML}$), a disease with an estimated $\text{22,010}$ new diagnoses in the $\text{US}$ for $\text{2025}$. $\text{AML}$ represents about $\text{1}$ out of $\text{3}$ leukemias in adults.

Acute Myeloid Leukemia (AML) patients in complete remission (CR2)

This segment is the target for the Galinpepimut-S ($\text{GPS}$) Phase 3 $\text{REGAL}$ trial, which is event-driven with a final analysis anticipated by year-end $\text{2025}$ once $\text{80}$ deaths are reached.

• The $\text{REGAL}$ trial involves $\text{126}$ patients achieving $\text{CR2}$ (second complete remission).
• Phase 2 data for $\text{GPS}$ in $\text{CR2}$ patients showed a median survival of $\text{21}$ months versus $\text{5.4}$ months for the comparator, with a $\text{p-value}$ of $\text{0.02}$.

Relapsed/refractory (r/r) AML patients, especially venetoclax-resistant

This segment is the focus for the $\text{SLS009}$ program, which has shown efficacy in patients who have failed prior standard-of-care regimens, including those resistant to venetoclax-based therapy.

Patient Subgroup	SLS009 Median Overall Survival (mOS)	Historical Benchmark mOS
All $\text{r/r}$ to Venetoclax-Based Regimens	$\text{8.8}$ months	Not explicitly stated for this group
$\text{AML}$ Myelodysplasia-Related Changes ($\text{AML-MR}$)	$\text{8.9}$ months	$\sim\text{2.4}$ months

The Overall Response Rate ($\text{ORR}$) for $\text{SLS009}$ in this population was also encouraging:

• $\text{ORR}$ of $\text{33}\%$ in all patients ($\text{n=54}$).
• $\text{ORR}$ of $\text{44}\%$ in $\text{AML-MR}$ patients.
• $\text{ORR}$ of $\text{50}\%$ in $\text{AML-MR}$ with Myelomonocytic/Myelomonoblastic ($\text{M4/M5}$) subtype.

Oncologists and hematologists specializing in blood cancers

These are the treating physicians who prescribe $\text{GPS}$ and $\text{SLS009}$. Their segment is defined by the patient populations they serve, which include the $\text{22,010}$ estimated new $\text{AML}$ cases in $\text{2025}$, with the average patient age being about $\text{69}$ years.

Potential large pharmaceutical/biotech companies for commercial licensing

These entities represent potential strategic partners or acquirers, incentivized by regulatory advantages tied to $\text{SLS}$'s pipeline assets.

• $\text{FDA}$ Rare Pediatric Disease Designation ($\text{RPDD}$) for $\text{GPS}$ in pediatric $\text{AML}$ makes $\text{SLS}$ eligible for a Priority Review Voucher ($\text{PRV}$) upon approval.
• Recent sales valuations for $\text{PRV}$s have been around $\text{\$100}$ million.
• $\text{SLS}$ reported $\text{\$44.3}$ million in cash and cash equivalents as of September $\text{30, 2025}$, supplemented by $\text{\$29.1}$ million in net proceeds from warrant exercises in October $\text{2025}$.

Pediatric AML and ALL patient populations (via RPDD designations)

Both $\text{GPS}$ and $\text{SLS009}$ have secured $\text{RPDD}$ from the $\text{FDA}$ for pediatric $\text{AML}$. $\text{SLS009}$ also holds $\text{RPDD}$ for pediatric $\text{ALL}$.

• The $\text{RPDD}$ for $\text{SLS009}$ in pediatric $\text{AML}$ supports an $\text{80}$-patient trial planned to begin in $\text{Q1 2026}$.
• The designation is for serious or life-threatening diseases affecting fewer than $\text{200,000}$ people in the $\text{US}$, primarily individuals under $\text{18}$.

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for SELLAS Life Sciences Group, Inc. as of late 2025. For a late-stage clinical company, the cost structure is heavily weighted toward research and development, which is where the bulk of your capital goes before a product is commercialized.

Here's a quick look at the primary operating expenses reported for the third quarter ending September 30, 2025:

Cost Category	Q3 2025 Amount (USD Millions)	Nine Months Ended Sept 30, 2025 Amount (USD Millions)
Research and Development (R&D) Expense	$4.22 million	$11.3 million
General and Administrative (G&A) Expense	$2.87 million	$8.7 million
Total Operating Expenses (Approximate Sum)	$7.09 million	$20.0 million

The R&D spend is definitely the dominant cost driver, as you'd expect. It's important to note that the R&D expense for the nine months ending September 30, 2025, at $11.3 million, was down from $14.7 million for the same period in 2024. That reduction points directly to specific activities winding down.

The decrease in R&D spend year-over-year was primarily driven by lower costs associated with the clinical programs. Here are the key components that make up that R&D expenditure:

• Clinical trial execution and monitoring costs for the REGAL Phase 3 trial.
• Decreased clinical trial expenses for the SLS009 program.
• Lower manufacturing costs and clinical drug supply purchases.
• Reduced clinical and regulatory consulting costs.

For G&A, the Q3 2025 figure of $2.87 million compared to $3.0 million in Q3 2024. That slight dip was mainly due to lower professional fees, though it was partially offset by higher personnel-related expenses, including non-cash stock-based compensation.

Finally, you have the costs tied to your core assets. The lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center (MSKCC). While specific ongoing licensing fees aren't broken out in the main expense lines, the initial licensing agreement is a fixed part of the cost structure that supports the development of GPS.

SELLAS Life Sciences Group, Inc. (SLS) - Canvas Business Model: Revenue Streams

You're looking at the financial engine of SELLAS Life Sciences Group, Inc. as of late 2025. For a late-stage clinical biotech like SELLAS Life Sciences Group, Inc., the revenue stream isn't about selling pills yet; it's about funding the journey to get there. Right now, the books reflect this reality.

Currently no product revenue; typical for a late-stage clinical biotech. As of the second quarter of 2025, SELLAS Life Sciences Group, Inc. reported $0.0 in revenue, which is exactly what you'd expect when the focus is entirely on advancing clinical trials for novel cancer therapies like GPS and SLS009, not commercial sales. This lack of sales revenue is the cost of doing late-stage development.

The immediate, tangible revenue stream comes from financing the pipeline. SELLAS Life Sciences Group, Inc. successfully tapped investor commitment through warrant exercises in the recent past. This is crucial cash flow to keep the lights on and the trials running.

Here's a breakdown of the capital infusion from warrant exercises in late 2025:

Financing Event Period	Gross Proceeds Amount	Source Warrants Issued
September and October 2025 Total	$54.6 million	Various (Including Jan 2025, Mar/Aug 2024)
October 2025 Exercise (Specific)	$31.0 million	March and August 2024
September 2025 Exercise (Specific)	$23.6 million	January 2025

This total of $54.6 million in gross proceeds from warrant exercises in September and October 2025 provided significant liquidity. For context, the company reported $44.3 million in cash and cash equivalents as of September 30, 2025, with an additional $29.1 million in net proceeds received in October 2025 from these exercises.

Beyond the current financing activities, the future revenue potential is tied directly to clinical success and strategic deal-making. These are the expected, but not yet realized, revenue sources:

• Potential future milestone payments from commercialization partnerships.
• Potential future product sales or licensing royalties post-regulatory approval.

The company is actively working to secure non-dilutive funding, which is essentially grant money that doesn't require giving up equity or future royalties. This is a key strategic move to offset cash burn.

• Non-dilutive grant funding for specific development programs (applied for). SELLAS Life Sciences Group, Inc. applied for such funding to expand SLS009 development into the frontline setting in Acute Myeloid Leukemia (AML).

Finance: draft 13-week cash view by Friday.