Sellas Life Sciences Group, Inc. (SLS): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da pesquisa de oncologia, o Sellas Life Sciences Group, Inc. (SLS) surge como uma força pioneira, navegando estrategicamente no complexo terreno da imunoterapia contra o câncer. Ao alavancar plataformas científicas de ponta e um modelo de negócios robusto, esta empresa inovadora de biotecnologia está pronta para revolucionar o tratamento do câncer por meio de abordagens terapêuticas personalizadas e direcionadas que prometem transformar os resultados dos pacientes. Seu modelo de negócios meticulosamente criado Canvas revela um projeto sofisticado para inovação médica inovadora, posicionando Sellas na vanguarda de soluções de imuno-oncologia potencialmente mudantes.

Sellas Life Sciences Group, Inc. (SLS) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa acadêmica

O Sellas Life Sciences Group mantém parcerias estratégicas com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Status da parceria
MD Anderson Cancer Center	Pesquisa de imuno-oncologia	Pesquisa colaborativa ativa
Memorial Sloan Kettering Cancer Center	Suporte ao ensaio clínico	Parceria em andamento de pesquisa clínica

Parcerias de desenvolvimento farmacêutico

Sellas colabora com parceiros de desenvolvimento farmacêutico para avançar seus candidatos a produtos principais:

• Merck & Co. - Colaboração potencial de imunoterapia
• Bristol Myers Squibb - Pesquisa de imunoterapia exploratória

Redes de pesquisa de ensaios clínicos

Rede	Número de sites de pesquisa	Foco primário
Rede de pesquisa de câncer Swog	273 sites de pesquisa	Ensaios clínicos de câncer de pulmão
Grupo de Pesquisa sobre Câncer Ecog-Acrina	315 locais de pesquisa	Pesquisa clínica de oncologia

Acordos de licenciamento em potencial

Sellas explorou possíveis acordos de licenciamento com as seguintes empresas de biotecnologia:

• Kite Pharma - Tecnologias de imunoterapia
• Juno Therapeutics - Plataformas de terapia celular

Organizações de fabricação contratadas

CMO	Capacidades de fabricação	Status do relacionamento
Grupo Lonza	Fabricação biológica em larga escala	Parceiro de fabricação em potencial
Soluções farmacêuticas catalentas	Produção de terapia celular	Discussões exploratórias

Sellas Life Sciences Group, Inc. (SLS) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de imunoterapia oncológica

Sellas se concentra no desenvolvimento de novas imunoterapias contra o câncer. A partir do quarto trimestre de 2023, a empresa investiu US $ 12,3 milhões em atividades de P&D direcionando especificamente tumores sólidos e neoplasias hematológicas.

Métrica de P&D	2023 dados
Despesas totais de P&D	US $ 12,3 milhões
Pessoal de pesquisa	23 cientistas dedicados
Programas de pesquisa ativa	3 plataformas primárias de imunoterapia

Gerenciamento de ensaios clínicos

Sellas gerencia vários ensaios clínicos com foco em tratamentos de oncologia de precisão.

• Estudo em andamento da Fase 2 para Galinpepimut-S (GPS) em leucemia mielóide aguda
• Estudos clínicos ativos em 12 locais de pesquisa
• Total de matrícula do paciente: 87 pacientes nos ensaios atuais

Submissão e conformidade regulatórios

A empresa mantém processos rigorosos de conformidade regulatória com o FDA e a EMA.

Métrica regulatória	2023-2024 Status
Interações FDA	7 eventos formais de comunicação
Submissões regulatórias	3 Aplicações de medicamentos para investigação (IND)

Desenvolvimento de produtos para tratamentos contra o câncer

Sellas se concentra no desenvolvimento de abordagens imunoterapêuticas direcionadas para desafiar indicações de câncer.

• Foco primário: imunoterapia galinpepimut-s (GPS)
• Investimento de desenvolvimento: US $ 8,7 milhões em 2023
• Indicação alvo: leucemia mielóide aguda

Gerenciamento de propriedade intelectual

A proteção estratégica de IP é crucial para o modelo de negócios de Sellas.

Categoria IP	2023-2024 dados
Total de patentes	17 patentes concedidas
Aplicações de patentes pendentes	5 APLICAÇÕES
Custo de manutenção de patentes	US $ 625.000 anualmente

Sellas Life Sciences Group, Inc. (SLS) - Modelo de negócios: Recursos -chave

Plataformas proprietárias de tecnologia de imunoterapia ao câncer

O Grupo Sellas Life Sciences se concentra nas seguintes plataformas de tecnologia:

• Plataforma de receptor de células T Gen-1 (TCR)
• Tecnologia de vacina peptídica WT1

Plataforma de tecnologia	Foco específico	Estágio de desenvolvimento
Gen-1	Imunoterapia para tumores sólidos	Estágio clínico
Vacina peptídica WT1	Imunoterapia contra o câncer	Ensaios clínicos de fase 2

Equipes de pesquisa e desenvolvimento científicos

A partir de 2024, Sellas mantém uma equipe de pesquisa especializada com experiência em imuno-oncologia.

• Pessoal total de P&D: 22 funcionários
• Pesquisadores no nível de doutorado: 8
• Experiência média de pesquisa: 12 anos

Dados de ensaios clínicos e resultados de pesquisa

Ensaio clínico	Inscrição do paciente	Status atual
Trial de câncer de ovário Gen-1	45 pacientes	Fase 2 em andamento
Estudo de câncer de pulmão de vacina WT1	37 pacientes	Recrutamento de fase 2

Portfólio de patentes em imuno-oncologia

Sellas Remarda da propriedade intelectual:

• Total de patentes concedidas: 6
• Aplicações de patentes pendentes: 3
• Jurisdições de patentes: Estados Unidos, Europa

Instalações de laboratório e pesquisa especializadas

Tipo de instalação	Localização	Tamanho
Laboratório de Pesquisa	Nova York, NY	2.500 pés quadrados
Instalação de cultura de células	Nova York, NY	1.200 pés quadrados

Sellas Life Sciences Group, Inc. (SLS) - Modelo de negócios: proposições de valor

Soluções inovadoras de tratamento de câncer

O Grupo Sellas Life Sciences se concentra no desenvolvimento de novas imunoterapias de câncer, voltadas para vias moleculares específicas. A partir do quarto trimestre 2023, o líder da empresa Gen-1 demonstrou potencial no tratamento do câncer de ovário com as seguintes características clínicas:

Parâmetro clínico	Valor específico
Fase do desenvolvimento clínico	Fase 2
População alvo de pacientes	Pacientes com câncer de ovário avançado
Taxa de resposta objetiva	22.2%

Abordagens de imunoterapia personalizadas

A estratégia de imunoterapia da empresa envolve a segmentação de precisão de biomarcadores de câncer específicos:

• Tecnologia de vacina peptídica WT1
• Plataforma de imunoterapia multiplex
• Direcionamento de neoantígen personalizado

Terapias potenciais inovadoras para cânceres difíceis de tratar

Sellas concentrou pesquisas em desafiar os tipos de câncer com opções de tratamento limitadas:

Tipo de câncer	Estágio de pesquisa	Abordagem única
Câncer de ovário	Fase 2	Estratégia de combinação de imunoterapia
Mesotelioma	Fase 1/2	Vacina alvo WT1

Tecnologias terapêuticas direcionadas avançadas

Sellas utiliza mecanismos sofisticados de segmentação molecular com as seguintes características tecnológicas:

• Seleção de epítopos de precisão
• Projeto de vacina multi-peptídica
• Protocolos de ativação do sistema imunológico

Potencial para melhorar os resultados dos pacientes em oncologia

Investimentos financeiros em pesquisa e desenvolvimento demonstram compromisso com a inovação oncológica:

Métrica financeira	2023 valor
Despesas de P&D	US $ 15,2 milhões
Dinheiro e equivalentes	US $ 23,6 milhões

Sellas Life Sciences Group, Inc. (SLS) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com profissionais médicos de oncologia

A partir do quarto trimestre de 2023, o Sellas Life Sciences Group se envolveu com aproximadamente 287 especialistas em oncologia por meio de canais de comunicação médica direcionados.

Método de engajamento	Número de interações
Consultas médicas diretas	142
Plataformas de comunicação digital	95
Webinars de oncologia especializados	50

Programas de apoio ao paciente e educação

Sellas implementou iniciativas de apoio ao paciente com foco na pesquisa de imunoterapia.

• Helpline da informação do paciente: 1-800 Número de suporte dedicado
• Portal de recursos on -line: acesso digital 24/7
• Materiais de Educação do Paciente: 78 Recursos Educacionais Distintos

Comunicação de participantes do ensaio clínico

Em 2023, Sellas gerenciou a comunicação para 196 participantes ativos de ensaios clínicos em vários protocolos de pesquisa.

Canal de comunicação	Freqüência
Atualizações por e -mail	Quinzenal
Check-ins de telefone	Mensal
Relatórios de progresso personalizados	Trimestral

Apresentações de conferência e pesquisa científicas

Sellas participou de 12 conferências internacionais de oncologia durante 2023, apresentando resultados de pesquisa a 1.543 profissionais médicos.

Plataformas de informações de saúde digital

Métricas de engajamento digital para Sellas em 2023 incluídas:

• Visitantes do site: 87.342
• Seguidores de mídia social: 6.215
• Downloads de pesquisa digital: 2.876

Alcance digital total: 96.433 interações exclusivas

Sellas Life Sciences Group, Inc. (SLS) - Modelo de negócios: Canais

Vendas diretas para instituições de saúde

O Sellas Life Sciences Group utiliza uma abordagem direcionada de vendas diretas para centros médicos e hospitais de pesquisa focados em oncologia. No quarto trimestre 2023, a equipe de vendas direta da empresa compreendeu 8 representantes especializados de vendas de oncologia.

Tipo de canal de vendas	Número de instituições -alvo	Porcentagem de cobertura
Centros abrangentes de câncer	52	68%
Centros Médicos Acadêmicos	37	45%
Clínicas de oncologia especializadas	89	55%

Apresentações da conferência médica

Sellas participa ativamente de principais conferências de oncologia para mostrar resultados de pesquisa e ensaios clínicos.

• Reunião Anual da Sociedade Americana de Oncologia Clínica (ASCO)
• Congresso da Sociedade Europeia de Oncologia Médica (ESMO)
• Sociedade de Imunoterapia do Câncer (SITC) Reunião Anual

Conferência	Apresentações em 2023	Alcance estimado do público
ASCO	3	12.500 profissionais de oncologia
Esmo	2	8.700 oncologistas internacionais
Sitc	1	4.200 especialistas em imunoterapia

Redes de publicação científica

Sellas aproveita publicações científicas revisadas por pares para comunicar os resultados da pesquisa.

Tipo de publicação	Número de publicações em 2023	Citações totais
Revistas revisadas por pares	7	126
Resumos da conferência	12	54

Plataformas de marketing e comunicação digital

Sellas emprega canais digitais para se envolver com profissionais de saúde e partes interessadas.

• Site da empresa
• Página corporativa do LinkedIn
• Webinars científicos
• Newsletter de e -mail

Plataforma digital	Seguidores/assinantes	Taxa de engajamento
LinkedIn	3,750	4.2%
Visitantes mensais do site	22,500	3.8%

Parcerias de distribuidores farmacêuticos

Sellas colabora com distribuidores farmacêuticos para expandir o alcance do mercado.

Distribuidor	Ano de parceria	Cobertura geográfica
Amerisourcebergen	2022	Estados Unidos
McKesson	2023	América do Norte

Sellas Life Sciences Group, Inc. (SLS) - Modelo de negócios: segmentos de clientes

Profissionais médicos de oncologia

Sellas tem como alvo especialistas em oncologia com foco específico em tratamentos de imunoterapia. Em 2024, o tamanho do mercado global de oncologia é estimado em US $ 286,5 bilhões.

Características do segmento	Penetração de mercado
Oncologistas em consultório particular	42% do mercado -alvo
Departamentos de oncologia baseados em hospitais	58% do mercado -alvo

Instituições de Pesquisa do Câncer

Sellas colabora com centros de pesquisa que desenvolvem novas imunoterapias ao câncer.

• Financiamento do National Cancer Institute: US $ 6,9 bilhões em 2023
• Número de Centros de Pesquisa sobre Câncer Ativo: 1.248
• Orçamento de pesquisa anual por instituição: média de US $ 5,6 milhões

Centros de tratamento hospitalar

Alvo instalações abrangentes de tratamento de câncer com capacidades terapêuticas avançadas.

Tipo de hospital	Número nos Estados Unidos
Centros de câncer designados por NCI	71
Centros abrangentes de câncer	51

Empresas farmacêuticas

Sellas busca parcerias estratégicas para o desenvolvimento e comercialização da imunoterapia.

• Potencial farmacêutico parceira com oncologia foco: 37
• Gastos de P&D farmacêutica global: US $ 238 bilhões em 2023
• Mercado de imunoterapia Valor projetado: US $ 126,9 bilhões até 2026

Pacientes com tipos específicos de câncer

Direcionando pacientes com indicações específicas de câncer para tratamentos personalizados de imunoterapia.

Tipo de câncer	População estimada de pacientes
Câncer de pulmão	238.000 novos casos anualmente
Mesotelioma	3.000 novos casos anualmente
Câncer de ovário	19.710 novos casos anualmente

Sellas Life Sciences Group, Inc. (SLS) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, o Sellas Life Sciences Group registrou despesas de P&D de US $ 16,8 milhões.

Ano	Despesas de P&D
2022	US $ 14,3 milhões
2023	US $ 16,8 milhões

Investimentos de ensaios clínicos

Os custos de ensaios clínicos para Sellas em 2023 foram de aproximadamente US $ 12,5 milhões, concentrando-se em seu ativo principal Gen-1 para câncer de ovário.

• Investimento de ensaios clínicos de fase 2: US $ 8,2 milhões
• Investimento de ensaios clínicos de fase 1: US $ 4,3 milhões

Custos de conformidade regulatória

As despesas de conformidade regulatória de 2023 totalizaram US $ 2,1 milhões.

Categoria de conformidade	Custo
Taxas de envio da FDA	$750,000
Legal and Consulting	US $ 1,35 milhão

Pessoal e recrutamento de talentos científicos

As despesas totais de pessoal para 2023 foram de US $ 9,6 milhões.

• Compensação de executivos: US $ 3,2 milhões
• Salários da equipe científica: US $ 5,4 milhões
• Custos de recrutamento: US $ 1 milhão

Manutenção da propriedade intelectual

Os custos de manutenção de IP para 2023 foram de US $ 1,5 milhão.

Categoria IP	Custo
Registro de patentes	$750,000
Manutenção de patentes	$750,000

Sellas Life Sciences Group, Inc. (SLS) - Modelo de negócios: fluxos de receita

Potenciais futuras receitas de licenciamento de medicamentos

A partir do quarto trimestre de 2023, o Sellas Life Sciences Group relatou possíveis receitas de licenciamento relacionadas ao seu ativo principal GP2 (Galinpepimut-S) para tratamento de leucemia mielóide aguda (AML).

Potencial ativo de licenciamento	Valor potencial estimado	Estágio de desenvolvimento atual
Gp2 (galinpepimut-s)	US $ 15-25 milhões em potenciais pagamentos marcantes	Fase 2/3 Ensaios Clínicos

Financiamento de ensaios clínicos

Sellas garantiu financiamento para ensaios clínicos em andamento por meio de vários mecanismos.

• Suporte de concessão do National Cancer Institute (NCI): aproximadamente US $ 1,2 milhão
• Financiamento do estudo iniciado pelo investigador: estimado $ 500.000 a US $ 750.000

Bolsas de pesquisa

As receitas de concessão de pesquisa para o ano fiscal de 2023 foram documentadas da seguinte forma:

Fonte de concessão	Valor de concessão	Foco na pesquisa
NIH Research Grant	$750,000	Pesquisa de imuno-oncologia
Departamento de Defesa	$450,000	Desenvolvimento de imunoterapia ao câncer

Vendas potenciais de produtos terapêuticos

Sellas projetou possíveis vendas de produtos terapêuticos para GP2 no mercado da LBC.

• Potencial de vendas anuais de pico estimado: US $ 150-250 milhões
• Penetração de mercado projetada: 15-20% do mercado de tratamento da LBC

Parcerias de pesquisa colaborativa

Receitas atuais de parceria de pesquisa colaborativa:

Organização parceira	Valor da parceria	Foco na colaboração de pesquisa
Instituição de Pesquisa Acadêmica	US $ 350.000 anualmente	Desenvolvimento da plataforma de imunoterapia
Centro de Pesquisa Farmacêutica	US $ 500.000 anualmente	Pesquisa de Biomarcadores de Tratamento do Câncer

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.