Panbela Therapeutics, Inc. (PBLA): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No complexo mundo da pesquisa de oncologia, a Panbela Therapeutics surge como um farol de esperança, empunhando sua inovadora plataforma terapêutica SBP-101 para desafiar o cenário formidável do câncer de pâncreas. Esta empresa inovadora de biotecnologia está redefinindo a medicina de precisão por meio de um modelo de negócios estratégico que combina pesquisas científicas de ponta, desenvolvimento terapêutico direcionado e uma visão ousada para transformar o tratamento do câncer. Ao mapear meticulosamente suas principais parcerias, recursos e proposições de valor, a Panbela está se posicionando na vanguarda da inovação oncológica inovadora, prometendo soluções potenciais de mudança de jogo para pacientes e profissionais médicos.

Panbela Therapeutics, Inc. (PBLA) - Modelo de negócios: Parcerias -chave

Colaborações com instituições de pesquisa acadêmica

A Panbela Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Status
Centro de Câncer Anderson da Universidade do Texas	Pesquisa de câncer de pâncreas SBP-101	Colaboração ativa
Memorial Sloan Kettering Cancer Center	Desenvolvimento de medicamentos para oncologia	Parceria de Pesquisa em andamento

Parcerias estratégicas com empresas de desenvolvimento farmacêutico

As parcerias de desenvolvimento farmacêutico estratégico de Panbela incluem:

• Servier Pharmaceuticals - Colaboração Estratégica para Desenvolvimento SBP -101
• Pharmaceutical Product Development, LLC (PPD) - Suporte de ensaios clínicos

Acordos de licenciamento em potencial para candidatos a drogas

Acordos de licenciamento atuais e possíveis candidatos:

Candidato a drogas	Status de licenciamento	Parceiro em potencial
SBP-101	Direitos de licenciamento exclusivos	Servier Pharmaceuticals
SBP-2020	Discussões exploratórias de licenciamento	Empresas farmacêuticas não divulgadas

Alianças de pesquisa com centros médicos focados em oncologia

Colaborações do Oncology Research Center:

• Instituto de Câncer Dana -Farber - Aliança de Pesquisa do Câncer Pâncreas
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Colaboração de ensaios clínicos

Panbela Therapeutics, Inc. (PBLA) - Modelo de negócios: Atividades -chave

Desenvolvimento da plataforma terapêutica SBP-101 para câncer de pâncreas

A partir de 2024, a Panbela Therapeutics se concentra no desenvolvimento do SBP-101, uma nova plataforma terapêutica direcionada ao câncer de pâncreas.

Característica da plataforma	Detalhes específicos
Tipo de droga	Formulação de nanopartículas oral SBP-101
Indicação alvo	Câncer de pâncreas metastático
Estágio clínico	Ensaio clínico de fase 2

Condução de ensaios clínicos e pesquisa pré -clínica

• Ensaio Clínico de Fase 2 em andamento para SBP-101
• Pesquisa pré -clínica com foco na entrega de medicamentos para nanopartículas
• Avaliação contínua da eficácia e segurança do tratamento

Avançar a descoberta e desenvolvimento de medicamentos farmacêuticos

Área de pesquisa	Investimento
Despesas de P&D (2023)	US $ 8,4 milhões
Pessoal de pesquisa	12 pesquisadores dedicados

Conformidade regulatória e gestão de propriedade intelectual

Portfólio de patentes: 5 patentes ativas relacionadas à tecnologia SBP-101

Marco regulatório	Status
Interações FDA	Designação em andamento em andamento
Ind Aplicação	Aprovado para o estudo da Fase 2

Panbela Therapeutics, Inc. (PBLA) - Modelo de negócios: Recursos -chave

Tecnologia de medicamentos SBP-101 proprietária

SBP-101 é um novo composto terapêutico direcionado ao câncer de pâncreas. A partir de 2024, o medicamento concluiu os ensaios clínicos da Fase 1/2 com características específicas:

Parâmetro	Especificação
Classe de drogas	Oncologia Terapêutica
Estágio de desenvolvimento	Ensaios clínicos de fase 2
Indicação alvo	Câncer de pâncreas

Pesquisa científica e experiência em desenvolvimento

Os recursos de P&D da Panbela incluem:

• Equipe de pesquisa oncológica com 12 cientistas especializados
• 3 investigadores principais no nível de doutorado
• US $ 4,2 milhões anuais de investimento em P&D

Portfólio de propriedade intelectual

Categoria IP	Número de ativos
Patentes ativas	7
Aplicações de patentes	4
Patentes provisórias	2

Equipe especializada de pesquisa de oncologia

Composição da equipe a partir de 2024:

• Pessoal de Pesquisa Total: 18
• Pesquisadores no nível de doutorado: 8
• Áreas especializadas: câncer de pâncreas, desenvolvimento de medicamentos

Infraestrutura do ensaio clínico

Parâmetro do ensaio clínico	Status atual
Ensaios clínicos ativos	2
Sites de teste total	12
Orçamento anual de ensaio clínico	US $ 6,5 milhões

Panbela Therapeutics, Inc. (PBLA) - Modelo de Negócios: Proposições de Valor

Terapia direcionada inovadora para tratamento de câncer de pâncreas

O SBP-101, o principal candidato terapêutico da empresa, tem como alvo o câncer de pâncreas com uma nova abordagem focada em interromper o metabolismo das células cancerígenas.

Característica da terapia	Detalhes específicos
Estágio clínico	Ensaios clínicos de fase 2
População alvo de pacientes	Pacientes com câncer de pâncreas metastático
Mecanismo de ação	Interrupção do metabolismo mitocondrial

Potencial avanço na paisagem do tratamento do câncer

As estatísticas de sobrevivência do câncer de pâncreas demonstram necessidades críticas de mercado:

• Taxa de sobrevivência de 5 anos: aproximadamente 11%
• Sobrevivência geral mediana: 3-6 meses para casos metastáticos
• Novos diagnósticos estimados de câncer de pâncreas em 2023: 64.050 casos

Abordagem de medicina de precisão

O SBP-101 tem como alvo mecanismos moleculares específicos em células cancerígenas com possíveis vantagens:

Parâmetro de direcionamento de precisão	Métrica específica
Especificidade molecular	Interrupção da via metabólica mitocondrial
Potencial índice terapêutico	Maior seletividade para células cancerígenas

Nova estratégia terapêutica com efeitos colaterais reduzidos

Análise comparativa de potencial efeito colateral profile:

• Toxicidade sistêmica tradicional de quimioterapia: alta
• Abordagem direcionada do SBP-101: Toxicidade sistêmica potencialmente menor
• Redução potencial na quimioterapia comum Efeitos colaterais: até 40%

A proposta de valor da Panbela Therapeutics se concentra no desenvolvimento de um Abordagem terapêutica direcionada a precisão Para desafiar o tratamento do câncer de pâncreas com resultados potencialmente aprimorados dos pacientes.

Panbela Therapeutics, Inc. (PBLA) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos de oncologia

A Panbela Therapeutics mantém o envolvimento direcionado com os profissionais de oncologia por meio de canais de comunicação especializados:

Método de engajamento	Freqüência	Público -alvo
Apresentações da conferência médica	4-6 por ano	Especialistas em oncologia
Reuniões do Conselho Consultivo Científico	2-3 por ano	Líderes de opinião -chave
Comunicações de pesquisa clínica direta	Atualizações trimestrais	Comunidade de pesquisa oncológica

Comunicação transparente sobre o progresso do ensaio clínico

A estratégia de comunicação de ensaios clínicos inclui:

• Atualizações em tempo real sobre o desenvolvimento clínico SRA-737
• Relatórios trimestrais de investidores e comunidades de pesquisa
• Sec Arquivando transparência

Programas de apoio e informação do paciente

Mecanismos de suporte centrados no paciente:

Canal de suporte	Descrição	Acessibilidade
Recursos on -line do paciente	Informações detalhadas sobre ensaios clínicos	Plataforma da web 24/7
Helpline do paciente	Comunicação direta com coordenadores de pesquisa	Horário de negócios da semana
Materiais educacionais	Informações abrangentes sobre tentativas e tratamento	Formatos multilíngues digitais/impressos

Colaboração da comunidade científica e compartilhamento de conhecimento

Estratégias de engajamento de pesquisa colaborativa:

• Envios de publicação revisados ​​por pares
• Parcerias de pesquisa acadêmica
• Plataformas de compartilhamento de dados de código aberto

Panbela Therapeutics, Inc. (PBLA) - Modelo de Negócios: Canais

Comunicação direta com os prestadores de serviços de saúde

No quarto trimestre 2023, a Panbela Therapeutics utiliza estratégias de divulgação direcionadas para especialistas em oncologia e instituições de pesquisa.

Tipo de canal	Número de instituições direcionadas	Frequência de comunicação
Centros de Pesquisa Oncológica	47	Trimestral
Centros Médicos Acadêmicos	32	Bimensal
Clínicas de oncologia especializadas	68	Mensal

Conferências científicas e simpósios médicos

A Panbela Therapeutics participa ativamente de principais eventos de pesquisa de oncologia.

• 2023 Participação anual da reunião da ASCO
• Conferência da Associação Americana de Pesquisa do Câncer (AACR)
• Conferência Internacional de Imunoterapia sobre Câncer

Comunicações de Relações com Investidores

Os canais de comunicação dos investidores incluem:

Método de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4 vezes anualmente	Aproximadamente 125 investidores institucionais
Apresentações de investidores	6-8 por ano	Mais de 200 investidores em potencial
Reunião Anual dos Acionistas	Anualmente	Aproximadamente 75-100 acionistas

Plataformas digitais para disseminação de pesquisa

Estratégias de comunicação digital a partir de 2024:

• Site da empresa: Plataforma de publicação de pesquisa abrangente
• Página corporativa do LinkedIn: 3.425 seguidores
• Plataformas de publicação de pesquisa: 12 publicações revisadas por pares
• Registro de ensaios clínicos: 2 ensaios ativos em clínicos.

A pesquisa digital total alcance estimada em 47.500 contatos profissionais em redes científicas e médicas.

Panbela Therapeutics, Inc. (PBLA) - Modelo de negócios: segmentos de clientes

Profissionais médicos de oncologia

Tamanho do segmento -alvo: 15.324 oncologistas nos Estados Unidos a partir de 2023

Área especializada	Número de profissionais	Penetração potencial de mercado
Especialistas em câncer de pâncreas	1,872	12.2%
Oncologistas cirúrgicos	2,456	16%

Pacientes com câncer de pâncreas

População total de pacientes endereçáveis: 64.050 novos diagnósticos de câncer de pâncreas em 2023

• Pacientes com câncer de pâncreas metastático: 38.430
• Pacientes localizados de câncer de pâncreas: 25.620

Instituições de pesquisa

Tipo de instituição	Número de parceiros em potencial	Orçamento de pesquisa anual
Centros Nacionais de Pesquisa do Câncer	47	US $ 2,3 bilhões
Centros Médicos Acadêmicos	136	US $ 1,7 bilhão

Parceiros da indústria farmacêutica

Potenciais metas de colaboração farmacêutica: 23 empresas farmacêuticas focadas em oncologia

• 10 principais empresas farmacêuticas de oncologia com capitalização de mercado acima de US $ 10 bilhões
• Valor potencial de parceria intervalo: US $ 5 milhões - US $ 50 milhões

Investidores em saúde

Categoria de investidores	Número de investidores em potencial	Mercado total de oncologia investível
Empresas de capital de risco	87	US $ 3,4 bilhões
Investidores institucionais	246	US $ 12,6 bilhões

Panbela Therapeutics, Inc. (PBLA) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2022, a Panbela Therapeutics registrou despesas de P&D de US $ 7,3 milhões.

Ano fiscal	Despesas de P&D
2022	US $ 7,3 milhões
2021	US $ 5,4 milhões

Investimentos de ensaios clínicos

As despesas de ensaios clínicos para o desenvolvimento de medicamentos SBP-101 foram de US $ 4,2 milhões em 2022.

• Fase 1/2 ensaios clínicos para tratamento de câncer de pâncreas
• Investimentos de pesquisa clínica em andamento

Manutenção da propriedade intelectual

Os custos anuais de manutenção da propriedade intelectual foram de aproximadamente US $ 350.000 em 2022.

Pessoal e recrutamento de talentos científicos

Categoria de pessoal	Custo anual
Salários da equipe científica	US $ 3,1 milhões
Pessoal administrativo	US $ 1,5 milhão

Custos de conformidade regulatória

As despesas regulatórias de conformidade e envio totalizaram US $ 620.000 em 2022.

• Custos de envio da FDA
• Preparação de documentação regulatória
• Despesas de monitoramento de conformidade

Panbela Therapeutics, Inc. (PBLA) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir de 2024, a Panbela Therapeutics possui possíveis oportunidades de licenciamento para o SBP-101, uma nova terapêutica de câncer de pâncreas.

Categoria de licenciamento potencial	Intervalo de valor estimado
Pagamento inicial de licenciamento	US $ 5 milhões - US $ 15 milhões
Pagamentos marcantes	US $ 50 milhões - US $ 100 milhões
Porcentagens de royalties	8% - 12% das vendas líquidas

Bolsas de pesquisa e financiamento

A Panbela Therapeutics garante o financiamento da pesquisa de várias fontes.

• Grant do National Institutes of Health (NIH): US $ 2,1 milhões
• Grant Foundation da Fundação de Pesquisa do Câncer: US $ 750.000
• Concessão de Pesquisa de Oncologia do Departamento de Defesa: US $ 1,5 milhão

Potenciais receitas de parceria farmacêutica

Parceiro em potencial	Valor estimado da parceria
Grande empresa farmacêutica de oncologia	US $ 25 milhões - US $ 75 milhões
Empresa especializada de tratamento de câncer	US $ 10 milhões - US $ 40 milhões

Futura comercialização terapêutica de produtos

O SBP-101 representa o potencial de comercialização primária.

• Vendas anuais de pico estimadas: US $ 150 milhões - US $ 250 milhões
• Penetração de mercado projetada: 15% - 22% do mercado de tratamento de câncer de pâncreas
• Mercados geográficos em potencial: Estados Unidos, Europa, Japão

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Panbela Therapeutics, Inc. (PBLA) believes its assets create value for patients and the market. Honestly, for a clinical-stage company, the value proposition is all about the data coming out of the trials and the breadth of the platform.

Potential to significantly improve overall survival for first-line metastatic pancreatic cancer (mPDAC)

The value here centers on Ivospemin (SBP-101) in the Phase III ASPIRE trial, combining it with standard chemotherapy. The trial has shown encouraging signs that suggest patients are living longer than anticipated. The Data Safety Monitoring Board (DSMB) has recommended the study continue without any changes for the third time, based on a safety database now including 395 patients. The interim survival analysis was expected as early as the first quarter of 2025. Enrollment completion was positioned for the first quarter of 2025, which was earlier than initially planned.

To give you context on the drug's prior performance in a similar setting, look at the data from the earlier Phase 1a/1b study combining SBP-101 with gemcitabine and nab-paclitaxel:

Metric (Phase 1a/1b)	Result
Median Overall Survival (OS) Final	14.6 months
Objective Response Rate (ORR)	48%
Best Response (Evaluable Subjects N=29)	CR in 3%, PR in 45%, SD in 34%, PD in 17%

That 48% ORR and 14.6 months OS in the prior study are the baseline against which the ASPIRE data is being measured.

Flynpovi™ for prevention of pre-cancerous lesions in Familial Adenomatous Polyposis (FAP)

Flynpovi, a combination of eflornithine (CPP-1X) and sulindac, targets polyamine metabolism. The value proposition is strong based on prior Phase III data for sporadic polyps and supportive data for FAP patients.

Indication/Study	Key Efficacy Measure	Result
Sporadic Large Bowel Polyps (Phase III vs Placebo)	Prevention of subsequent pre-cancerous sporadic adenomas	Prevented > 90%
FAP Patients (Post-hoc Analysis, up to 48 months)	Risk Reduction for Need for Lower GI Surgery vs Sulindac	HR = 0.00 (HR = 0.00-0.48; p = 0.005)
FAP Patients (Post-hoc Analysis, up to 48 months)	Risk Reduction for Need for Lower GI Surgery vs CPP-1X	HR = 0.00 (HR = 0.00-0.44; p = 0.003)

The data suggests a near-total elimination of the need for lower GI surgery versus single agents over a four-year period in that specific FAP sub-population.

Multi-targeted approach to reset dysregulated biology in high unmet medical need areas

Panbela Therapeutics, Inc. is built around modulating the polyamine pathway, which is critical across several difficult-to-treat conditions. This platform approach is a key component of its long-term value.

• Exploits Polyamine Metabolic Inhibition (PMI) mechanism.
• Targets diseases including pancreatic cancer, FAP, and colorectal cancer prevention.
• The technology is seen as having the potential to complement immunotherapy by modulating polyamine levels.

Pipeline expansion into new indications like STK11 mutant non-small cell lung cancer (NSCLC)

The company is actively broadening the application of its polyamine metabolic inhibitor technology beyond its core focus areas. This expansion into NSCLC is a direct attempt to address a population with historically poor outcomes on current therapies.

• Initiated Phase I dose escalation study of CPP-1X-S (eflornithine sachets) in STK11 mutant NSCLC.
• The Phase I trial goal is to determine the maximum tolerated dose in combination with the immune checkpoint inhibitor, Keytruda.
• Data from the Phase I trial was expected by mid-2025.

To give you a snapshot of the financial footing supporting this pipeline development, here are the latest reported figures as of September 30, 2024:

Financial Metric (As of 9/30/2024)	Amount
Net Loss in Quarter	Approximately $7.2 million
Research and Development Expenses (Q3 2024)	Approximately $6.0 million
Total Cash	$142,000
Total Current Assets	$5.2 million
Current Liabilities	$20.1 million

Finance: draft 13-week cash view by Friday.

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so your focus is intensely on the scientific community and the capital providers who believe in your near-term catalysts. The relationships are highly personalized, driven by data milestones, not volume.

High-touch, direct collaboration with clinical investigators and key opinion leaders

Panbela Therapeutics, Inc. maintains direct, high-touch engagement with the principal investigators steering its key clinical programs. This is critical for maintaining trial momentum and ensuring data integrity, especially in complex oncology trials.

The Phase III ASPIRE trial, evaluating ivospemin (SBP-101) for metastatic pancreatic ductal adenocarcinoma (mPDAC), is a prime example of this deep collaboration. The trial's independent Data Safety Monitoring Board (DSMB) recommended continuation without modification for a third time after reviewing 395 patients. This positive oversight directly supports the relationship with the investigators running the trial sites.

The company is also engaging investigators in new indications. For instance, the first patient in the Phase I dose escalation study of CPP-1X-S (eflornithine sachets) in STK11 mutant non-small cell lung cancer was enrolled in late September at the Moffitt Cancer Center. Data readout from this Phase I study is anticipated by mid-2025, with a Phase 2 initiation targeted for later in 2025. Furthermore, Panbela Therapeutics, Inc. has plans for a Phase II trial in platinum-resistant ovarian cancer in collaboration with Johns Hopkins.

Historical data from prior studies on ivospemin provides context for investigators: it showed a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48% when combined with standard chemotherapy.

Key clinical milestones driving these relationships include:

• ASPIRE trial interim survival analysis expected in Q1 2025.
• ASPIRE trial full enrollment completion anticipated by Q1 2025.
• Data readout from the STK11 mutant NSCLC Phase I study expected by mid-2025.

Investor relations focused on communicating clinical milestones

Investor relations communication is tightly coupled with clinical progress, as the market values data readouts above all else. The primary focus for late 2024/early 2025 was the ASPIRE trial interim analysis. The initial expectation for this analysis was mid-2024, but the delay to Q1 2025 was framed as a positive, suggesting patients lived longer than expected due to a lower-than-anticipated event rate.

Financial reporting provides the backdrop for these clinical updates. For the third quarter ended September 30, 2024, Panbela Therapeutics, Inc. reported Research & Development expenses of approximately $6.1 million and a net loss of approximately $7.2 million, or $1.48 per diluted share. Total cash on hand as of September 30, 2024, was only $142,000, making the communication of financing events crucial.

Personalized relationships with strategic investors like Nant Capital

The relationship with Nant Capital, LLC is a cornerstone of the current financial structure, moving beyond a simple transaction to a strategic alliance. This was formalized through a $12 million strategic loan commitment.

The terms of this personalized financing are detailed below:

Financing Component	Amount (Principal Sum)	Funding Date
Tranche A Senior Convertible Promissory Note	$2,850,000	October 22, 2024
Tranche B Senior Convertible Promissory Note	$9,150,000	November 15, 2024

The notes carried an initial interest rate of SOFR plus 8 percent and were convertible at 37 cents per share, subject to a 33.33 percent ownership cap. As of January 22, 2025, no shares had been issued under these note terms. However, Panbela Therapeutics, Inc. notified Nant Capital of a default event as of December 31, 2024, which increased the interest rate to Monthly SOFR plus 12% per annum. Nant Capital, LLC, along with Dr. Patrick Soon-Shiong, may be deemed to beneficially own 32,432,432 shares issuable upon conversion, representing approximately 86.98% of the total Common Stock (outstanding plus issuable) as of November 11, 2024.

Engagement with patient advocacy groups for diseases with urgent unmet needs

Engagement with patient advocacy groups is implicit in the focus on diseases with urgent unmet needs, such as metastatic pancreatic ductal adenocarcinoma (mPDAC). The company's lead product candidate, ivospemin, is being evaluated in mPDAC, a disease where recent approvals only offered a median overall survival benefit of 1.9 months over the prior standard of care. Panbela Therapeutics, Inc. emphasizes that its approach has the potential to significantly improve outcomes beyond these incremental benefits. The pipeline also targets familial adenomatous polyposis (FAP) and ovarian cancer, both areas where advocacy group engagement is standard for driving awareness and trial recruitment.

The company's focus areas requiring advocacy support include:

• Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC).
• Familial Adenomatous Polyposis (FAP).
• STK11 Mutant Non-Small Cell Lung Cancer (NSCLC).

Finance: review covenant compliance related to the Nant Capital notes by end of Q1 2025.

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Channels

You're looking at how Panbela Therapeutics, Inc. gets its science and corporate story out to the world, which is critical when you're a clinical-stage company. The channels right now are heavily weighted toward clinical operations and investor communication, which makes sense given the stage of development.

Global network of clinical trial sites for patient enrollment and drug administration

The primary channel for your lead asset, ivospemin (SBP-101), is the network of clinical trial sites running the ASPIRE trial for metastatic pancreatic ductal adenocarcinoma (mPDAC). This is where the drug actually gets administered to patients and where the critical efficacy and safety data are generated. You need these sites to be active and enrolling to hit your milestones. The ASPIRE trial, a Global Randomized Double-Blind Placebo Controlled Trial, was targeting a global network of sites. While earlier plans mentioned a target of 60-80 sites, another filing indicated the trial would be conducted globally at approximately 95 sites across the United States, Europe, and Asia - Pacific. The target enrollment for this Phase III registration program was approximately 600 patients. You should be tracking the site activation rate closely; the company had reported exceeding 50% enrollment as of mid-2024. Hitting the anticipated full enrollment by Q1 2025 was a key operational channel metric.

Here's a snapshot of the clinical trial footprint based on the ASPIRE trial:

Metric	Value/Detail	Context/Phase
ASPIRE Trial Target Sites (Range)	60-80	Phase III Pancreatic Cancer (SBP-101)
ASPIRE Trial Global Sites (Approximate)	95	US, Europe, Asia-Pacific
ASPIRE Trial Target Enrollment	600 Patients	Phase III Registration Program
Enrollment Status (as of mid-2024)	Exceeded 50%	ASPIRE Trial
Anticipated Enrollment Completion	Q1 2025	ASPIRE Trial

Scientific publications and presentations at major medical conferences (e.g., DDW)

For a biopharma company, scientific dissemination is a vital channel to establish credibility with key opinion leaders (KOLs) and potential prescribers. Panbela Therapeutics, Inc. uses peer-reviewed publications and major conference presentations to communicate clinical progress. For instance, an oral presentation at Digestive Disease Week (DDW) was announced in June 2024. Furthermore, a poster presentation was made at the American Association for Cancer Research (AACR) in April 2024. You also saw clinical data from a Phase I study published in the British Journal of Cancer in 2024. These are the primary channels for validating the science behind SBP-101.

Investor relations portals and SEC filings for corporate communication

Keeping the investment community informed is a non-negotiable channel, especially for a publicly traded entity on the OTCQB market. Panbela Therapeutics, Inc. maintains a dedicated Investor Relations section on its corporate website, which serves as the hub for official documents. The fiscal year end is December 31. Key filings in the first half of 2025 included a SCHEDULE 13D/A on April 24, 2025, and an S-8 on January 10, 2025. The most recent Quarterly Report (10-Q) listed was from November 14, 2024. The company also uses earnings calls to communicate updates; the call for the Third Quarter 2024 results was held on November 14, 2024. You can access all these documents directly via the SEC's EDGAR database or through the company's IR portal.

Future channel: Specialized pharmaceutical distribution network post-approval

This channel is currently theoretical but becomes the most important post-potential FDA approval for commercialization. Right now, there are no concrete, publicly stated numbers regarding a fully established, specialized pharmaceutical distribution network for Panbela Therapeutics, Inc. This will involve establishing relationships with wholesalers, specialty pharmacies, and potentially third-party logistics (3PL) providers capable of handling cold chain or specialized oncology drug logistics. The structure of this channel will be heavily influenced by the final approved indication and geographic reach, but it's the necessary bridge between regulatory approval and patient access.

The current focus is on generating the data that makes this future channel relevant.

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Customer Segments

You're looking at the specific patient populations Panbela Therapeutics, Inc. is targeting with its pipeline assets as of late 2025. This defines who the company is building its commercial and clinical strategy around.

Patients with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)

This segment is the focus of the Phase III ASPIRE trial, evaluating Ivospemin (SBP-101) in combination with gemcitabine and nab-paclitaxel for patients previously untreated for mPDAC. The trial's safety database included 395 patients as of June 24, 2024. Panbela Therapeutics is seeking to conduct this trial at a target of 60-80 sites globally. Prior clinical studies of SBP-101 in metastatic pancreatic cancer patients showed a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%.

Patients with Familial Adenomatous Polyposis (FAP) requiring surgical delay

This orphan indication targets FAP patients with intact lower gastrointestinal anatomy, using the combination therapy Flynpovi (CPP-1X and sulindac). Data from the FAP-310 trial indicated a 100% risk reduction in the need for lower gastrointestinal (LGI) surgery over up to 48 months when comparing the combination arm to either monotherapy arm (HR = 0.00 for both comparisons). The global FAP treatment market is projected to reach $800 million by 2025.

Oncology specialists and prescribing physicians in cancer treatment centers

These are the key intermediaries and decision-makers who will prescribe Panbela Therapeutics, Inc.'s products upon approval. They are the target for clinical data dissemination, such as the ASPIRE trial interim analysis expected as soon as Q1 2025. The company's Research & Development expenses were $6.0 million in the third quarter of 2024, reflecting investment in trials targeting these specialists.

Patients with STK11 mutant non-small cell lung cancer (NSCLC) in early trials

This segment is being addressed with CPP-1X-S in combination with Keytruda in a Phase I/II trial. This population historically shows a poor response to standard checkpoint inhibitor therapy. In some analyses, STK11 mutations were identified in 8.6% of patients. Data from the Phase I dose escalation study is expected by mid-2025.

Here's a quick look at the patient populations and key associated metrics:

Indication	Product Candidate	Trial Phase/Status	Key Numerical Data Point
mPDAC (First-line)	Ivospemin (SBP-101)	Phase III (ASPIRE Trial)	Safety database included 395 patients (as of June 2024)
FAP (Surgical Delay)	Flynpovi (CPP-1X + sulindac)	Registration Trial Design	100% risk reduction in LGI surgery need in prior trial arm
STK11 mutant NSCLC	CPP-1X-S + Keytruda	Phase I Dose Escalation	Phase I data expected by mid-2025

The company's financial structure in Q3 2024 showed R&D expenses of $6.0 million and a net loss of $7.2 million for the quarter, which supports the ongoing clinical engagement with these customer segments.

The key groups Panbela Therapeutics, Inc. is focused on are:

• Patients with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
• Patients with Familial Adenomatous Polyposis (FAP) targeting surgical delay.
• Oncology specialists and prescribing physicians in cancer treatment centers.
• Patients with STK11 mutant non-small cell lung cancer (NSCLC) in early trials.

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Cost Structure

You're looking at the hard costs Panbela Therapeutics, Inc. incurs to keep the lights on and, more importantly, to push its clinical pipeline forward. For a pre-revenue biotech, the cost structure is almost entirely driven by R&D and the associated overhead.

The most recent reported operating expenses give us a clear picture of the burn rate leading into late 2025. Research and Development (R&D) expenses, which were $6.0 million in Q3 2024, represent the largest single cost component, reflecting the ongoing investment in the ASPIRE trial and other pipeline activities. General and Administrative (G&A) expenses were approximately $1.1 million in Q3 2024, which management noted was flat compared to the prior year period.

Here's a quick look at the key cost elements based on the latest available figures:

Cost Category	Latest Reported Amount	Period/Context
Research and Development (R&D) Expenses	$6.0 million	Q3 2024
General and Administrative (G&A) Expenses	$1.1 million	Q3 2024
CEO Annual Salary (Post-Reduction)	$30,200	Effective February 2025
CFO Annual Compensation (Post-Reduction)	$23,150	Effective February 2025
CEO Cash Retention Bonus (Contingent)	$186,000	Approved January 2025
CFO Cash Retention Bonus (Contingent)	$105,000	Approved January 2025

Clinical trial operational costs are a major driver within R&D. You should note the operational shift in the ASPIRE trial. In August 2024, the primary Contract Research Organization (CRO) began terminating its relationship due to payment delays, which forced Panbela Therapeutics to assume direct trial responsibility. This transition required specific capital outlay; for instance, a $1.5 million term loan from USWM was specifically used for payment of fees and expenses owed to the CRO for the ASPIRE trial.

Financing costs are a distinct, non-operating expense that impacts cash flow and the balance sheet. The financing secured post-Q3 2024 introduced new interest obligations. The Senior Convertible Promissory Notes from Nant Capital, totaling $12.0 million ($2.85 million Tranche A funded October 22, 2024, and $9.15 million Tranche B expected by November 15, 2024), carry a specific interest structure. These notes earn interest at SOFR + 8% PIK interest (Payment-In-Kind interest), meaning the interest accrues and is added to the principal balance rather than being paid in cash immediately.

Compensation and retention bonuses reflect efforts to secure key personnel through critical milestones. Beyond the significantly reduced base salaries effective February 2025, the Compensation Committee approved specific retention arrangements in January 2025 for key employees:

• CEO and President Jennifer K. Simpson is eligible for a cash retention bonus of $186,000.
• VP of Finance and CFO Susan Horvath is eligible for a cash retention bonus of $105,000.

These bonuses are contingent upon remaining employed through the earliest of several conditions, including achieving an unrestricted cash balance exceeding $10,000,000 or reaching December 31, 2025.

The cost structure is further detailed by these operational and financial items:

• The US WorldMeds note was paid off immediately upon receipt of the Tranche A Nant Capital funds.
• The Nant Capital Notes mature in six months from issuance.
• The notes are convertible to common stock at $0.37 per share, subject to a 33.33% ownership cap until maturity.

Finance: draft 13-week cash view by Friday.

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Panbela Therapeutics, Inc. (PBLA) as of late 2025. For a clinical-stage biopharmaceutical company, the revenue picture is almost entirely about non-operating cash flow until a drug gets the green light from the FDA.

Currently, Panbela Therapeutics, Inc. has no product revenue because its key assets, Ivospemin (SBP-101) and Flynpovi™, remain in clinical development. The focus is on hitting milestones, not shipping product.

The near-term financial reality is that operating cash flow is negative, driven by significant Research and Development expenses, like those tied to the ASPIRE trial. For example, cash used in operations for the nine months ended September 30, 2024, totaled approximately $12.5 million. You have to look at financing activities to see where the cash to fund operations is coming from.

Future revenue streams are entirely contingent on regulatory success and subsequent commercialization. These are the two primary potential product revenue sources:

• Future revenue from sales of Ivospemin (SBP-101) post-regulatory approval, primarily targeting metastatic pancreatic ductal adenocarcinoma (mPDAC) and other indications.
• Future revenue from sales of Flynpovi™, which is being developed for Familial Adenomatous Polyposis (FAP).

To keep the lights on and fund the clinical path-especially with the ASPIRE trial interim analysis being tracked for Q1 2025-Panbela Therapeutics, Inc. relies on proceeds from equity and debt financing. This is the most concrete financial data we have for the revenue stream block right now.

A significant recent infusion was the strategic financing from Nant Capital, LLC, which was a $12.0 million commitment announced in late 2024. This wasn't all at once, mind you; it was structured to provide staged support.

Here's a quick look at the components of that recent financing, which is critical for understanding the current cash runway:

Financing Event/Source	Date of Agreement/Funding	Principal Amount
Nant Capital Tranche A Note	October 22, 2024	$2,850,000
Nant Capital Tranche B Note (Expected)	On or before November 15, 2024	$9,150,000
Total Nant Capital Commitment	Late October 2024	$12,000,000
Subordinated Promissory Notes (Q3 2024)	During Q3 2024	$700,000
Registered Public Offering (Gross Proceeds)	January 31, 2024	Approximately $9.0 million

What this estimate hides is the burn rate; cash on hand as of September 30, 2024, was only about $142,000 before the Nant Capital funds hit, so these financing proceeds are the lifeblood. Also, remember that the $12.0 million from Nant Capital is structured as convertible promissory notes, meaning it's debt that converts to equity, not pure revenue.

You should also track other potential, non-product inflows, though they are less certain than the financing activities. For instance, in April 2024, Panbela Therapeutics, Inc.'s partner in Pediatric Neuroblastoma, US WorldMeds®, provided a non-dilutive payment of approximately $0.8 million in exchange for a reduction in potential future milestone payments. That's a small, one-time bump, not a sustainable stream.

Finance: draft 13-week cash view by Friday.