Panbela Therapeutics, Inc. (PBLA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el complejo mundo de la investigación de oncología, Panbela Therapeutics surge como un faro de esperanza, empuñando su innovadora plataforma terapéutica SBP-101 para desafiar el formidable panorama del cáncer pancreático. Esta innovadora compañía de biotecnología está redefiniendo la medicina de precisión a través de un modelo de negocio estratégico que combina investigación científica de vanguardia, desarrollo terapéutico dirigido y una visión audaz para transformar el tratamiento del cáncer. Al mapear meticulosamente sus asociaciones clave, recursos y propuestas de valor, Panbela se está posicionando a la vanguardia de la innovación oncológica innovadora, prometiendo soluciones potenciales que cambian el juego para pacientes y profesionales médicos por igual.

Panbela Therapeutics, Inc. (PBLA) - Modelo de negocios: asociaciones clave

Colaboraciones con instituciones de investigación académica

Panbela Therapeutics ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Estado
Centro de cáncer de Anderson de la Universidad de Texas	SBP-101 Investigación del cáncer de páncreas	Colaboración activa
Memorial Sloan Kettering Cancer Center	Desarrollo de medicamentos oncológicos	Asociación de investigación en curso

Asociaciones estratégicas con empresas de desarrollo farmacéutico

Las asociaciones estratégicas de desarrollo farmacéutico de Panbela incluyen:

• Servier Pharmaceuticals - Colaboración estratégica para el desarrollo SBP -101
• Desarrollo de productos farmacéuticos, LLC (PPD) - Soporte de ensayos clínicos

Posibles acuerdos de licencia para candidatos a drogas

Acuerdos de licencia actuales y candidatos potenciales:

Candidato a la droga	Estado de licencia	Socio potencial
SBP-101	Derechos de licencia exclusivos	Servicio Pharmaceuticals
SBP-2020	Discusiones de licencia exploratoria	Compañías farmacéuticas no reveladas

Investigue alianzas con centros médicos centrados en la oncología

Colaboraciones del Centro de Investigación de Oncología:

• Dana -Farber Cancer Institute - Alianza de investigación del cáncer de pancreático
• Johns Hopkins Sidney Kimmel Centro integral de cáncer - Colaboración de ensayos clínicos

Panbela Therapeutics, Inc. (PBLA) - Modelo de negocio: actividades clave

Desarrollo de la plataforma terapéutica SBP-101 para el cáncer de páncreas

A partir de 2024, Panbela Therapeutics se centra en el desarrollo de SBP-101, una nueva plataforma terapéutica dirigida a cáncer de páncreas.

Característica de la plataforma	Detalles específicos
Tipo de drogas	Formulación de nanopartículas orales SBP-101
Indicación objetivo	Cáncer de páncreas metastásico
Estadio clínico	Ensayo clínico de fase 2

Realización de ensayos clínicos e investigación preclínica

• Ensayo clínico de fase 2 en curso para SBP-101
• Investigación preclínica centrada en la administración de fármacos de nanopartículas
• Evaluación continua de la eficacia del tratamiento y la seguridad

Avance del descubrimiento y desarrollo de fármacos farmacéuticos

Área de investigación	Inversión
Gasto de I + D (2023)	$ 8.4 millones
Personal de investigación	12 investigadores dedicados

Cumplimiento regulatorio y gestión de propiedad intelectual

Cartera de patentes: 5 patentes activas relacionadas con la tecnología SBP-101

Hito regulatorio	Estado
Interacciones de la FDA	Designación de vía rápida en curso
Aplicación IN	Aprobado para el ensayo de fase 2

Panbela Therapeutics, Inc. (PBLA) - Modelo de negocio: recursos clave

Tecnología de drogas SBP-101 patentada

SBP-101 es un nuevo compuesto terapéutico dirigido al cáncer de páncreas. A partir de 2024, el fármaco ha completado los ensayos clínicos de la fase 1/2 con características específicas:

Parámetro	Especificación
Clase de drogas	Oncología terapéutica
Etapa de desarrollo	Ensayos clínicos de fase 2
Indicación objetivo	Cáncer de páncreas

Experiencia de investigación y desarrollo científico

Las capacidades de I + D de Panbela incluyen:

• Equipo de investigación de oncología con 12 científicos especializados
• 3 investigadores principales de nivel doctorado
• $ 4.2 millones de inversión anual de I + D

Cartera de propiedades intelectuales

Categoría de IP	Número de activos
Patentes activas	7
Solicitudes de patentes	4
Patentes provisionales	2

Equipo de investigación de oncología especializada

Composición del equipo a partir de 2024:

• Personal de investigación total: 18
• Investigadores a nivel de doctorado: 8
• Áreas especializadas: cáncer de páncreas, desarrollo de medicamentos

Infraestructura de ensayos clínicos

Parámetro de ensayo clínico	Estado actual
Ensayos clínicos activos	2
Sitios de prueba totales	12
Presupuesto anual de ensayo clínico	$ 6.5 millones

Panbela Therapeutics, Inc. (PBLA) - Modelo de negocio: propuestas de valor

Terapia dirigida innovadora para el tratamiento del cáncer de páncreas

SBP-101, el candidato terapéutico principal de la compañía, se dirige al cáncer de páncreas con un enfoque novedoso centrado en interrumpir el metabolismo de las células cancerosas.

Característica de terapia	Detalles específicos
Estadio clínico	Ensayos clínicos de fase 2
Población de pacientes objetivo	Pacientes de cáncer de páncreas metastásicos
Mecanismo de acción	Interrupción del metabolismo mitocondrial

Potencial avance en el paisaje del tratamiento del cáncer

Las estadísticas de supervivencia del cáncer de páncreas demuestran la necesidad crítica del mercado:

• Tasa de supervivencia a 5 años: aproximadamente el 11%
• Mediana de supervivencia general: 3-6 meses para casos metastásicos
• Nuevos diagnósticos estimados de cáncer de páncreas en 2023: 64,050 casos

Enfoque de medicina de precisión

SBP-101 se dirige a mecanismos moleculares específicos en células cancerosas con ventajas potenciales:

Parámetro de orientación de precisión	Métrica específica
Especificidad molecular	Interrupción de la vía metabólica mitocondrial
Índice terapéutico potencial	Mayor selectividad para células cancerosas

Estrategia terapéutica novedosa con efectos secundarios reducidos

Análisis comparativo del efecto secundario potencial profile:

• Toxicidad sistémica de quimioterapia tradicional: alto
• Enfoque dirigido SBP-101: toxicidad sistémica potencialmente menor
• Reducción potencial en los efectos secundarios de la quimioterapia común: hasta el 40%

La proposición de valor de Panbela Therapeutics se centra en el desarrollo de un enfoque terapéutico dirigido por precisión para un tratamiento de cáncer de páncreas desafiante con resultados potencialmente mejorados del paciente.

Panbela Therapeutics, Inc. (PBLA) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos de oncología

Panbela Therapeutics mantiene un compromiso dirigido con profesionales de oncología a través de canales de comunicación especializados:

Método de compromiso	Frecuencia	Público objetivo
Presentaciones de conferencia médica	4-6 por año	Especialistas en oncología
Reuniones de la junta asesora científica	2-3 por año	Líderes de opinión clave
Comunicaciones de investigación clínica directa	Actualizaciones trimestrales	Comunidad de investigación oncológica

Comunicación transparente sobre el progreso del ensayo clínico

La estrategia de comunicación de ensayos clínicos incluye:

• Actualizaciones en tiempo real sobre el desarrollo clínico SRA-737
• Informes trimestrales de inversores e comunidades de investigación
• SEC que presenta transparencia

Programas de apoyo e información del paciente

Mecanismos de apoyo centrados en el paciente:

Canal de soporte	Descripción	Accesibilidad
Recursos en línea del paciente	Información detallada sobre ensayos clínicos	Plataforma web 24/7
Línea de ayuda de paciente	Comunicación directa con coordinadores de investigación	Horario comercial de lunes a viernes
Materiales educativos	Información integral de ensayos y tratamiento	Formatos digitales/de impresión multilingües

Colaboración de la comunidad científica y intercambio de conocimientos

Estrategias de participación de la investigación colaborativa:

• Envíos de publicación revisados ​​por pares
• Asociaciones de investigación académica
• Plataformas de intercambio de datos de código abierto

Panbela Therapeutics, Inc. (PBLA) - Modelo de negocios: canales

Comunicación directa con proveedores de atención médica

A partir del cuarto trimestre de 2023, Panbela Therapeutics utiliza estrategias de divulgación específicas para especialistas en oncología e instituciones de investigación.

Tipo de canal	Número de instituciones específicas	Frecuencia de comunicación
Centros de investigación de oncología	47	Trimestral
Centros médicos académicos	32	Bimensual
Clínicas de oncología especializada	68	Mensual

Conferencias científicas y simposios médicos

Panbela Therapeutics participa activamente en eventos clave de investigación oncológica.

• 2023 participación de la reunión anual de ASCO
• Conferencia de la Asociación Americana de Investigación del Cáncer (AACR)
• Conferencia internacional de inmunoterapia con cáncer

Comunicaciones de relaciones con los inversores

Los canales de comunicación de los inversores incluyen:

Método de comunicación	Frecuencia	Alcanzar
Llamadas de ganancias trimestrales	4 veces anualmente	Aproximadamente 125 inversores institucionales
Presentaciones de inversores	6-8 por año	Más de 200 inversores potenciales
Reunión anual de accionistas	Anualmente	Aproximadamente 75-100 accionistas

Plataformas digitales para la difusión de investigación

Estrategias de comunicación digital a partir de 2024:

• Sitio web de la empresa: Plataforma de publicación de investigación integral
• Página corporativa de LinkedIn: 3,425 seguidores
• Plataformas de publicación de investigación: 12 publicaciones revisadas por pares
• Registro de ensayos clínicos: 2 ensayos activos en clinicaltrials.gov

El alcance total de la investigación digital se estima en 47,500 contactos profesionales en redes científicas y médicas.

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

Oncology Medical Professionals

Tamaño del segmento objetivo: 15,324 oncólogos en los Estados Unidos a partir de 2023

Área especializada	Número de profesionales	Penetración potencial del mercado
Especialistas en cáncer de páncreas	1,872	12.2%
Oncólogos quirúrgicos	2,456	16%

Pacientes con cáncer de páncreas

Población total de pacientes direccionables: 64.050 nuevos diagnósticos de cáncer de páncreas en 2023

• Pacientes de cáncer de páncreas metastásico: 38,430
• Pacientes de cáncer de páncreas localizados: 25,620

Instituciones de investigación

Tipo de institución	Número de socios potenciales	Presupuesto de investigación anual
Centros Nacionales de Investigación del Cáncer	47	$ 2.3 mil millones
Centros médicos académicos	136	$ 1.7 mil millones

Socios de la industria farmacéutica

Objetivos de colaboración farmacéutica potencial: 23 compañías farmacéuticas centradas en la oncología

• Las 10 principales compañías farmacéuticas oncológicas con capitalización de mercado de más de $ 10 mil millones
• Rango de valor de asociación potencial: $ 5 millones - $ 50 millones

Inversores de atención médica

Categoría de inversionista	Número de inversores potenciales	Mercado de oncología invertible total
Empresas de capital de riesgo	87	$ 3.4 mil millones
Inversores institucionales	246	$ 12.6 mil millones

Panbela Therapeutics, Inc. (PBLA) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finalizó el 31 de diciembre de 2022, Panbela Therapeutics reportó gastos de I + D de $ 7.3 millones.

Año fiscal	Gastos de I + D
2022	$ 7.3 millones
2021	$ 5.4 millones

Inversiones de ensayos clínicos

Los gastos de ensayo clínico para el desarrollo de fármacos SBP-101 fueron de $ 4.2 millones en 2022.

• Ensayos clínicos de fase 1/2 para el tratamiento del cáncer de páncreas
• Inversiones de investigación clínica en curso

Mantenimiento de la propiedad intelectual

Los costos anuales de mantenimiento de la propiedad intelectual fueron de aproximadamente $ 350,000 en 2022.

Personal y reclutamiento de talento científico

Categoría de personal	Costo anual
Salarios de personal científico	$ 3.1 millones
Personal administrativo	$ 1.5 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento y envío regulatorio totalizaron $ 620,000 en 2022.

• Costos de envío de la FDA
• Preparación de documentación regulatoria
• Gastos de monitoreo de cumplimiento

Panbela Therapeutics, Inc. (PBLA) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de medicamentos futuros

A partir de 2024, Panbela Therapeutics tiene oportunidades de licencia potenciales para SBP-101, una nueva terapéutica del cáncer de páncreas.

Categoría de licencia potencial	Rango de valor estimado
Pago de licencias por adelantado	$ 5 millones - $ 15 millones
Pagos por hito	$ 50 millones - $ 100 millones
Porcentajes de regalías	8% - 12% de las ventas netas

Subvenciones de investigación y financiación

Panbela Therapeutics obtiene fondos de investigación de varias fuentes.

• Subvención de los Institutos Nacionales de Salud (NIH): $ 2.1 millones
• Subvención de la Fundación de Investigación de Cáncer: $ 750,000
• Subvención de investigación de oncología del Departamento de Defensa: $ 1.5 millones

Ingresos potenciales de asociación farmacéutica

Socio potencial	Valor de asociación estimado
Compañía farmacéutica de oncología grande	$ 25 millones - $ 75 millones
Compañía especializada de tratamiento del cáncer	$ 10 millones - $ 40 millones

Comercialización de productos terapéuticos futuros

SBP-101 representa el potencial de comercialización primario.

• Ventas anuales máximas estimadas: $ 150 millones - $ 250 millones
• Penetración proyectada del mercado: 15% - 22% del mercado de tratamiento de cáncer de páncreas
• Mercados geográficos potenciales: Estados Unidos, Europa, Japón

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.