Processa Pharmaceuticals, Inc. (PCSA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Sumérgete en el innovador mundo de ProcessA Pharmaceuticals, Inc. (PCSA), una compañía de biotecnología de vanguardia que revoluciona la medicina de precisión y el tratamiento de enfermedades raras. Esta organización dinámica está a la vanguardia de la innovación farmacéutica, mapeando estratégicamente su modelo de negocio para transformar las condiciones médicas desatendidas a través de soluciones terapéuticas específicas. Al aprovechar las capacidades de investigación avanzadas, las asociaciones estratégicas y un enfoque centrado en el paciente, ProcessA está redefiniendo cómo los tratamientos innovadores se conceptualizan, desarrollan y llevan al mercado, prometiendo esperanza para pacientes y avances innovadores en la ciencia médica.

ProcessA Pharmaceuticals, Inc. (PCSA) - Modelo de negocio: asociaciones clave

Colaboraciones estratégicas con centros médicos académicos

A partir de 2024, ProcessA Pharmaceuticals ha establecido asociaciones con los siguientes centros médicos académicos:

Centro médico académico	Enfoque de investigación	Estado de colaboración
Centro Médico de la Universidad de Maryland	PCS499 ensayos clínicos	Asociación activa
Universidad de Johns Hopkins	Investigación del cáncer de páncreas	Colaboración en curso

Asociaciones de investigación con instituciones de investigación farmacéutica

ProcessA Pharmaceuticals ha desarrollado asociaciones estratégicas de investigación con las siguientes instituciones:

• Institutos Nacionales de Salud (NIH)
• Centro de cáncer de MD Anderson
• Memorial Sloan Kettering Cancer Center

Organizaciones de fabricación de contratos para el desarrollo de medicamentos

ProcessA Pharmaceuticals colabora con organizaciones de fabricación de contratos especializadas:

Socio de fabricación	Especialización	Valor actual del contrato
Patheon Pharmaceuticals	Fabricación de medicamentos oncológicos	$ 3.2 millones
Soluciones farmacéuticas catalent	Producción de medicamentos clínicos	$ 2.7 millones

Acuerdos de licencia potenciales con empresas de biotecnología

ProcessA Pharmaceuticals ha explorado acuerdos de licencia con las siguientes empresas de biotecnología:

• Biomarin Pharmaceutical Inc.
• Celgene Corporation
• Merck KGAA

Inversión de asociación total a partir de 2024: $ 8.5 millones

ProcessA Pharmaceuticals, Inc. (PCSA) - Modelo de negocio: actividades clave

Investigación farmacéutica y desarrollo de fármacos

ProcessA Pharmaceuticals se centra en desarrollar tratamientos de medicina de precisión para enfermedades raras. A partir de 2024, la compañía tiene:

• 2 candidatos de drogas principales en desarrollo activo
• $ 14.7 millones asignados para investigación y desarrollo en el año fiscal 2023
• Investigación de tuberías dirigidas a necesidades médicas no satisfechas específicas

Categoría de investigación	Proyectos activos	Inversión
Tratamientos de enfermedades raras	2 candidatos de drogas principales	$ 14.7 millones

Gestión y ejecución del ensayo clínico

La compañía mantiene rigurosos protocolos de ensayos clínicos con las siguientes características:

• Gestionando actualmente 1-2 ensayos clínicos activos
• Presupuesto promedio de ensayo clínico: $ 5-7 millones por ensayo
• Centrado en las poblaciones de pacientes con enfermedades raras

Procesos de cumplimiento regulatorio y de presentación de la FDA

La estrategia regulatoria implica:

• Equipo de asuntos regulatorios dedicado de 4-5 profesionales
• Interacciones continuas con la FDA para las vías de desarrollo de fármacos
• Presupuesto de cumplimiento estimado en $ 1.2 millones anuales

Desarrollo de productos de medicina de precisión

Enfoque del producto	Etapa de desarrollo	Indicación objetivo
PCS499	Ensayos clínicos de fase 2	Trastorno metabólico raro
PCS6422	Desarrollo preclínico	Condición genética rara

Innovación del tratamiento de enfermedades raras

Métricas de innovación para 2024:

• Inversión de I + D: 68% del gasto total de la empresa
• Portafolio de patentes: 7-9 patentes farmacéuticas activas
• Equipo de investigación especializado: 12-15 personal científico

ProcessA Pharmaceuticals, Inc. (PCSA) - Modelo de negocio: recursos clave

Capacidades de investigación farmacéutica especializada

ProcessA Pharmaceuticals se centra en el desarrollo de terapias para poblaciones de pacientes raras y desatendidas. A partir de 2024, la compañía tiene:

Área de enfoque de investigación	Número de programas activos
Trastornos metabólicos raros	3
Terapéutica oncológica	2
Condiciones inflamatorias	1

Cartera de propiedades intelectuales

Los activos de propiedad intelectual de la compañía incluyen:

• Número total de patentes activas: 12
• Solicitudes de patentes pendientes: 5
• Familias de patentes que cubren las tecnologías centrales: 3

Equipo experimentado de investigación científica y médica

Composición del equipo	Número de profesionales
Investigadores de doctorado	18
Médico	7
Especialistas en investigación clínica	12

Infraestructura avanzada de laboratorio e investigación

Detalles de la instalación de investigación:

• Espacio total de la instalación de investigación: 25,000 pies cuadrados
• Número de laboratorios de investigación especializados: 6
• Equipo de detección molecular avanzado: 4 plataformas de alto rendimiento

Experiencia de desarrollo clínico

Fase de ensayo clínico	Número de pruebas en curso
Fase I	2
Fase II	3
Fase III	1

ProcessA Pharmaceuticals, Inc. (PCSA) - Modelo de negocio: propuestas de valor

Soluciones terapéuticas dirigidas para afecciones médicas desatendidas

ProcessA Pharmaceuticals se centra en desarrollar tratamientos para afecciones médicas raras y desatendidas con poblaciones de pacientes específicas.

Área terapéutica	Condición objetivo	Población de pacientes
Trastornos metabólicos raros	Cacéxia de cáncer de próstata	Aproximadamente 90,000 pacientes anualmente
Apoyo oncológico	Condiciones relacionadas con el cáncer	Estimados de 500,000 pacientes potenciales

Enfoques innovadores de medicina de precisión

Estrategia de medicina de precisión dirigida a vías moleculares específicas y perfiles genéticos.

• Desarrollo de fármacos basado en genómico
• Algoritmos de tratamiento personalizados
• Tecnologías de intervención molecular dirigidas

Posibles tratamientos innovadores para enfermedades raras

La tubería de desarrollo se centró en las necesidades médicas no satisfechas con un alto potencial clínico.

Candidato a la droga	Etapa de desarrollo	Potencial de mercado estimado
PCS-499	Ensayos clínicos de fase 2	$ 120 millones de ingresos anuales potenciales
PCS-6422	Investigación preclínica	Oportunidad de mercado potencial de $ 80 millones

Estrategia de desarrollo de medicamentos centrada en el paciente

Enfoque integral priorizar los resultados del paciente y la calidad de vida.

• Métricas de resultados informadas por el paciente
• Diseño integral de ensayos clínicos
• Programas de apoyo al paciente a largo plazo

Tecnologías de intervención médica personalizada

Plataformas tecnológicas avanzadas que permiten intervenciones terapéuticas precisas.

Plataforma tecnológica	Capacidades clave	Diferenciador único
Sistema de orientación molecular	Perfil genético	95% de precisión en la identificación de candidatos de tratamiento
Análisis de biomarcadores	Predicción de respuesta al tratamiento	87% de precisión en resultados clínicos

ProcessA Pharmaceuticals, Inc. (PCSA) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, ProcessA Pharmaceuticals mantiene estrategias de participación directa con profesionales médicos a través de interacciones específicas:

Método de compromiso	Frecuencia	Público objetivo
Presentaciones de conferencia médica	4-6 conferencias anualmente	Especialistas en oncología y enfermedades raras
Reuniones de la Junta Asesora Clínica	2-3 reuniones por año	Top 50 Centros de Investigación de Oncología
Consultas médicas individuales	Aproximadamente 120 por trimestre	Médicos especializados

Programas de apoyo y educación del paciente

ProcessA Pharmaceuticals implementa iniciativas integrales de apoyo al paciente:

• Presupuesto del programa de asistencia para el paciente: $ 1.2 millones en 2023
• Sebinarios web de educación del paciente: 12 sesiones anualmente
• Línea directa directa de soporte de pacientes: operando 8 horas diarias

Asociaciones de investigación colaborativa

Investigación de métricas de colaboración para 2023:

Tipo de asociación	Número de asociaciones	Inversión
Instituciones de investigación académica	7 asociaciones activas	$ 3.5 millones
Organizaciones de investigación clínica	5 colaboraciones activas	$ 2.8 millones

Comunicación transparente sobre desarrollos clínicos

Métricas de transparencia de comunicación:

• Comunicados de prensa de actualización de ensayos clínicos: 8 en 2023
• Informes de inversores/analistas: 4 sesiones trimestrales
• Cumplimiento de divulgación regulatoria: 100% de adherencia

Interacción de la comunidad médica en curso

Estadísticas de participación de la comunidad médica para 2023:

Canal de interacción	Alcanzar	Tasa de compromiso
Publicaciones de la revista médica	3 publicaciones revisadas por pares	Tasa de citas del 72%
Interacciones de plataforma médica digital	1.200 profesionales de la salud registrados	58% de compromiso mensual activo

ProcessA Pharmaceuticals, Inc. (PCSA) - Modelo de negocio: canales

Ventas directas a proveedores de atención médica

A partir del cuarto trimestre de 2023, ProcessA Pharmaceuticals mantiene una focalización especializada de la fuerza de ventas:

Segmento de atención médica objetivo	Número de representantes de ventas directas
Especialistas en oncología	12
Centros de hematología	8
Clínicas de enfermedades raras	6

Presentaciones de conferencia médica

Estadísticas de participación de la conferencia para 2023:

• Conferencias médicas totales a la que asistieron: 22
• Presentaciones científicas entregadas: 15
• Alcance estimado de la audiencia: 3.450 profesionales de la salud

Plataformas de publicación científica

Plataforma de publicación	Número de trabajos de investigación publicados
Pubmed	7
New England Journal of Medicine	2
Revista de oncología clínica	3

Comunicación digital e información basada en la web

Métricas de canal digital para 2023:

• Sitio web de la compañía Visitantes únicos: 85,670
• Seguidores de LinkedIn: 4,230
• Seguidores de Twitter: 2,890
• Suscriptores mensuales de boletín de correo electrónico: 1.750

Eventos de redes de la industria farmacéutica

Tipo de evento	Número de eventos atendidos	Conexiones comerciales potenciales
Conferencias de biotecnología	8	156
Reuniones de inversores farmacéuticos	5	87
Foros de colaboración de investigación	3	45

ProcessA Pharmaceuticals, Inc. (PCSA) - Modelo de negocio: segmentos de clientes

Poblaciones de pacientes con enfermedades raras

ProcessA Pharmaceuticals se centra en pacientes con enfermedades raras específicas, particularmente:

• Pacientes de mielofibrosis ulcerosa: aproximadamente 18,000-20,000 en los Estados Unidos
• Pacientes de cáncer de próstata con mutaciones genéticas específicas
• Pacientes con afecciones complejas de linfedema

Categoría de enfermedades	Población de pacientes estimada	Potencial del mercado objetivo
Mielofibrosis ulcerosa	18,000-20,000 pacientes	$ 450- $ 500 millones de mercado potencial
Linfedema complejo	3-5 millones de pacientes	$ 250- $ 300 millones de mercado potencial

Médicos especializados

Los segmentos de los clientes incluyen:

• Especialistas en hematología
• Centros de tratamiento de enfermedades raras
• Profesionales de asesoramiento genético

Sistemas hospitalarios y centros de tratamiento

Las instituciones de atención médica objetivo incluyen:

• National Cancer Center Network: más de 50 centros especializados
• Centros médicos académicos
• Instalaciones integrales de tratamiento del cáncer

Instituciones de investigación

Tipo de institución de investigación	Número de colaboradores potenciales
Instituciones Afiliadas de los Institutos Nacionales de Salud (NIH)	27 centros de investigación principales
Centros de investigación de enfermedades raras	15-20 instituciones especializadas

Comunidad de investigación farmacéutica

Los segmentos de investigación objetivo incluyen:

• Departamentos de I + D
• Grupos de investigación de biotecnología
• Redes de ensayos clínicos

Investigación de la comunidad segmento	Potencial de colaboración estimado
Compañías farmacéuticas	Las 50 principales empresas farmacéuticas globales
Grupos de investigación de biotecnología	200-250 organizaciones de investigación especializadas

ProcessA Pharmaceuticals, Inc. (PCSA) - Modelo de negocio: Estructura de costos

Inversiones de investigación y desarrollo

A partir del año fiscal 2023, ProcessA Pharmaceuticals reportó gastos de I + D de $ 14.3 millones.

Año	Gasto de I + D	Porcentaje de ingresos
2022	$ 12.7 millones	68.2%
2023	$ 14.3 millones	72.5%

Gastos de ensayo clínico

Los costos de ensayos clínicos para ProcessA Pharmaceuticals en 2023 totalizaron aproximadamente $ 9.6 millones.

• Pruebas de fase I: $ 3.2 millones
• Pruebas de fase II: $ 4.7 millones
• Pruebas de fase III: $ 1.7 millones

Costos de cumplimiento regulatorio

Los gastos anuales de cumplimiento regulatorio fueron de $ 2.1 millones en 2023.

Categoría de cumplimiento	Costo
Tarifas de presentación de la FDA	$650,000
Gestión de cumplimiento interno	$1,450,000

Adquisición de personal y talento científico

Los gastos totales de personal para 2023 fueron de $ 8.5 millones.

• Salarios del personal científico: $ 5.3 millones
• Personal administrativo: $ 2.2 millones
• Reclutamiento y capacitación: $ 1 millón

Mantenimiento de tecnología e infraestructura

Los costos de tecnología e infraestructura para 2023 ascendieron a $ 3.2 millones.

Componente de infraestructura	Costo anual
Equipo de laboratorio	$ 1.8 millones
Sistemas de TI y software	$900,000
Mantenimiento de la instalación	$500,000

ProcessA Pharmaceuticals, Inc. (PCSA) - Modelo de negocio: flujos de ingresos

Venta potencial de productos farmacéuticos

A partir del cuarto trimestre de 2023, ProcessA Pharmaceuticals informó posibles flujos de ingresos de sus principales candidatos a medicamentos:

Candidato a la droga	Mercado potencial	Potencial de ingresos anual estimado
PCS499 (curación de heridas ulcerosas)	Mercado de úlceras para el pie diabético	$ 75-100 millones
PCS6422 (tratamiento del cáncer)	Oncología tumoral sólida	$ 50-85 millones

Subvenciones de investigación y financiación

ProcessA ha obtenido fondos de investigación de múltiples fuentes:

• Subvención de los Institutos Nacionales de Salud (NIH): $ 2.3 millones
• Subvención de investigación del Departamento de Defensa: $ 1.7 millones
• Subvenciones de Investigación de Innovación de Pequeñas Empresas (SBIR): $ 850,000

Licencia de propiedad intelectual

El potencial de licencia de propiedad intelectual incluye:

Activo IP	Ingresos potenciales de licencia	Mercado objetivo
Plataforma de tecnología PCS499	$ 5-10 millones por adelantado	Biotecnología de curación de heridas
Vía molecular del tratamiento del cáncer	$ 3-7 millones por adelantado	Investigación oncológica

Acuerdos de investigación colaborativos

Asociaciones actuales de investigación colaborativa:

• Colaboración del Centro Médico Académico: Financiación anual de $ 1.2 millones
• Asociación de investigación farmacéutica: soporte de investigación de $ 2.5 millones

Oportunidades futuras de comercialización de drogas

Flujos de ingresos de comercialización proyectados:

Candidato a la droga	Año de comercialización proyectado	Ventas anuales máximas estimadas
PCS499	2025	$ 120-150 millones
PCS6422	2026	$ 90-130 millones

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a patient or payer would choose Processa Pharmaceuticals, Inc. (PCSA) over the current standard of care. It's all about making existing, proven cancer drugs better, and tackling rare diseases where options are nonexistent.

Next Generation Cancer (NGC) drugs with improved safety and efficacy over existing chemotherapies.

Processa Pharmaceuticals, Inc. (PCSA) focuses on modifying the metabolism or distribution of established, FDA-approved oncology drugs. The goal here is to maintain the cancer-killing mechanism while delivering a better benefit-risk profile. This strategy is designed to facilitate quicker commercial adoption because the active molecules are already familiar to healthcare professionals.

The company is applying its Regulatory Science Approach, which incorporates principles from the FDA's Project Optimus Oncology initiative, to these NGC drug products.

PCS6422 (NGC-Cap) offering improved tolerability for metastatic breast cancer patients.

The lead asset, PCS6422 combined with capecitabine (NGC-Cap), is in an adaptive Phase 2 trial for advanced or metastatic breast cancer. This trial is specifically looking at patients who aren't candidates for anthracycline- or taxane-containing therapies, or other available options like PD-1 or PARP inhibitors. The value proposition here is built on earlier data showing a better tolerability profile.

Here are some specifics from the earlier clinical work that support this value proposition:

• Phase 1b data demonstrated improved safety compared to standard capecitabine monotherapy.
• Earlier data showed partial responses or stable disease in 66.7% (8 out of 12) evaluable patients.
• Progression-free survival in those patients was approximately 5 to 11 months.

The Phase 2 adaptive design trial is set up to assess the efficacy and safety of NGC-Cap against the standard dose of capecitabine alone.

PCS499 addressing a high unmet need in rare kidney diseases (PGDs) with a potential fast-track path.

For rare kidney diseases, specifically Focal Segmental Glomerulosclerosis (FSGS), the unmet need is urgent; there are currently no FDA-approved therapies specifically indicated for FSGS. PCS499 is positioned to address this gap. It's an analog of a metabolite of pentoxifylline (PTX).

You see the advantage when you compare it to the older agent:

Agent	Dose/Context	Key Outcome/Tolerability
Pentoxifylline (PTX)	0.8-1.2 gm/d in Diabetic Nephropathy (DN) patients	Significantly decreased proteinuria, but 23% of patients withdrew due to side effects.
PCS499	1.2 gm/d in CKD studies	Stable and slightly lower urine albumin-creatinine ratios compared to placebo with minimal side effects.

Processa Pharmaceuticals, Inc. (PCSA) is designing an adaptive Phase 2/3 study for PCS499 to discuss with the FDA, aiming to optimize dosing and accelerate the path toward regulatory approval, which is a key part of the value proposition for an underserved population.

Reduced systemic toxicity via tumor-targeted pro-drug design (PCS11T).

PCS11T is Processa Pharmaceuticals, Inc. (PCSA)'s preclinical oncology asset, which is a tumor-targeted pro-drug of SN-38, the active metabolite of irinotecan. The design explicitly aims to increase the drug concentration within the tumor while simultaneously reducing systemic toxicity, which is a major issue with standard chemotherapy.

Preclinical data suggests a superior delivery mechanism:

• PCS11T (NGC-Iri) delivers more cancer-killing SN-38 molecules to tumor than either irinotecan or Onivyde®.

This targeted approach is a clear value driver, promising better local effect with less off-target exposure. Finance: draft 13-week cash view by Friday.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Customer Relationships

Processa Pharmaceuticals, Inc. manages relationships with key external stakeholders through highly structured, data-driven interactions, reflecting the company's reliance on scientific validation and regulatory navigation.

Strategic, long-term collaboration with licensing partners like Intact Therapeutics is a core relationship component, exemplified by the PCS12852 out-licensing deal announced in June 2025. This partnership is structured to provide Processa Pharmaceuticals, Inc. with non-dilutive funding and continued upside exposure.

Deal Component (PCS12852 with Intact Therapeutics)	Financial/Statistical Value
Total Potential Milestone Payments	$452.5 million (or up to $454 million)
Option Exercise Fee (Near-term payment)	$2.5 million
Development and Regulatory Milestones	Up to $20 million
Commercial Milestone Payments	Over $432.5 million
Royalty Rate on Worldwide Net Sales (Excluding South Korea)	12% (Double-digit royalty)
Equity Stake in Intact Therapeutics Upon Closing	3.5%
Cash Payment Share to Processa's Licensor	60% of cash payments

High-touch engagement with clinical investigators and key opinion leaders underpins the development of the Next Generation Cancer (NGC) pipeline. The company leverages its Oncology Advisory Board, formed in November 2023, which includes Key Opinion Leaders (KOLs) from institutions such as the Mayo Clinic and Rutgers Cancer Institute. The KOL feedback for PCS11T suggests that removing even part of a black box warning would be a game-changer for prescribing physicians.

The Phase 2 study of PCS6422 (NGC-Cap) in metastatic breast cancer is actively enrolling patients, with preliminary analysis data anticipated in the second half of 2025. The company's development team has direct experience supporting this engagement, having been involved with more than 30 drug approvals by the FDA and over 100 FDA meetings throughout their careers.

Direct management of regulatory relationships with the FDA is managed through the company's Regulatory Science Approach. This approach was successfully used to negotiate the Phase 2 study protocol for PCS6422 with the FDA. Dr. David Young, President of Research & Development, has personally met with the FDA over one hundred times and was a key member on more than thirty FDA indication approvals.

Active investor relations via webinars and conference participation is a consistent activity to manage shareholder relationships and seek strategic partnerships. Processa Pharmaceuticals, Inc. management participated in the 2025 BIO CEO & Investor Conference on February 10-11, 2025, and the 2025 BIO International Convention from June 16-19, 2025. An investor webinar with RedChip was held on July 9, 2025. Insider activity in the six months leading up to May 2025 showed 4 purchases and 0 sales of PCSA stock.

• KOLs on Oncology Advisory Board: Members from Henry Ford Cancer Institute, Mayo Clinic, Rutgers Cancer Institute, and TGen Research Institute.
• PCS6422 Phase 2 Trial Enrollment: Remaining patients needed for interim analysis expected to be enrolled in the second half of 2025.
• Investor Meetings Scheduled via BIO Partnering portal for the 2025 BIO International Convention.
• Development Team FDA Experience: Involved in over 30 drug approvals.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Channels

You're looking at how Processa Pharmaceuticals, Inc. (PCSA) gets its drug development and financing efforts out to the world. For a clinical-stage company, the channels are less about direct sales and more about clinical execution, data dissemination, and capital acquisition.

Clinical trial sites and oncology centers for drug development and patient access

The primary channel for advancing the core oncology pipeline involves active clinical sites. Processa Pharmaceuticals, Inc. is actively enrolling patients in its Phase 2 study for its lead asset, NGC-Cap (PCS6422) combined with capecitabine, targeting advanced or metastatic breast cancer.

The company anticipated that the remaining patients required for the pre-planned interim analysis of the Phase 2 trial would be enrolled during the second half of 2025. Furthermore, for its PCS499 program in primary glomerular diseases (PGDs), Processa Pharmaceuticals, Inc. is establishing the design for a new adaptive pivotal Phase III study, with plans to discuss this design with the FDA in the fourth quarter of 2025.

• Lead oncology asset, NGC-Cap, in Phase 2 trial for metastatic breast cancer.
• PCS499 Phase III study design planned for discussion in Q4 2025.

Scientific and medical conferences (e.g., ASCO 2025) to disseminate clinical data

Dissemination of clinical and preclinical data is a critical channel for establishing scientific credibility and attracting potential partners. Processa Pharmaceuticals, Inc. successfully presented data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which took place from May 30 to June 3, 2025.

The company secured acceptance for three abstracts at ASCO 2025, showcasing advancements for drug candidates including PCS6422 and PCS11T. One presentation was a Trials in Progress Poster Presentation, Abstract Number TPS1133, at Poster Board Number 105b on June 2, 2025. The published abstracts carried numbers such as e15152 and e15023.

Processa Pharmaceuticals, Inc. also participated in the 2025 BIO International Convention from June 16-19, 2025, and had a presence at the American Society of Nephrology (ASN) Kidney Week 2025 on November 7, 2025.

Conference/Event	Date Range (2025)	Data Presented/Activity
ASCO Annual Meeting	May 30 - June 3	Three accepted abstracts; Poster Presentation Abstract Number TPS1133
BIO International Convention	June 16 - June 19	Executive leadership engagement with partners and investors
ASN Kidney Week	November 7	Poster Presentation for PCS499

Out-licensing agreements to commercialize non-core assets (PCS12852)

Monetizing non-oncology assets is a key channel for non-dilutive funding and value realization. Processa Pharmaceuticals, Inc. entered into a binding term sheet with Intact Therapeutics for the exclusive option to license PCS12852, a 5-HT4 receptor agonist for gastroparesis.

The financial structure of this channel is substantial, with Processa Pharmaceuticals, Inc. eligible for a $2.5 million option exercise fee. Total potential milestone payments are valued at over $432.5 million, which includes up to $20 million in development and regulatory milestones and over $432.5 million in commercial milestones. Processa Pharmaceuticals, Inc. will also receive double-digit royalties on worldwide net sales, excluding South Korea, and a 3.5% equity stake in Intact Therapeutics.

A crucial term of this channel is that Processa Pharmaceuticals, Inc. must share 60% of any cash payments received with its licensor.

Capital markets (NASDAQ) for raising equity financing

The NASDAQ listing serves as the primary channel for raising necessary equity financing to fund ongoing clinical development. Processa Pharmaceuticals, Inc. executed multiple public offerings in 2025 to bolster its balance sheet.

For the nine months ended September 30, 2025, the company reported raising $10.6 million through public offerings. This includes a completed offering in January 2025 that raised $5 million in gross proceeds, with shares priced at $0.615 for institutional investors and $0.7975 for the CEO and board members. Later, in June 2025, the company announced pricing of a $7 million public offering, involving the sale of 28,000,000 shares at $0.25 per share, alongside warrants.

The July 2025 portfolio update specifically cited a $7M capital infusion as having strengthened the balance sheet.

• $10.6 million raised through public offerings (nine months ended Sep 30, 2025).
• $7 million gross proceeds from June 2025 offering at $0.25 per share.
• $5 million gross proceeds from January 2025 offering.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Customer Segments

Processa Pharmaceuticals, Inc. (PCSA) targets distinct groups whose needs drive the development and financing of its pipeline assets, PCS6422 and PCS499.

Oncology patients with advanced or metastatic breast cancer (PCS6422 target).

• Estimated 170,000 women in the U.S. living with metastatic breast cancer in 2025.
• PCS6422, in combination with capecitabine (NGC-Cap), is in a Phase 2 study for metastatic breast cancer.
• Initial data from the NGC-Cap Phase 2 clinical trial is anticipated in the second half of 2025.
• The broader oncology market exceeds $180 billion.

Patients with rare kidney diseases, specifically Primary Glomerular Diseases (PCS499 target).

• PCS499 is being developed for Focal Segmental Glomerulosclerosis (FSGS), a serious condition with limited treatment options.
• The FDA accepts a surrogate endpoint of albuminuria/proteinuria for Primary Glomerular Diseases (PGDs).
• Processa is designing an adaptive Phase III study for PCS499 in FSGS to discuss with the FDA later in 2025.
• The standardized incidence of primary FSGS was estimated at 1.7 cases per 100,000 patient-years (based on 2010-2021 data).
• The United States has the largest patient pool for FSGS among the top seven major markets analyzed.

Large pharmaceutical and biotech companies for future licensing and M&A.

These entities seek innovative therapies to integrate or acquire, creating strategic monetization opportunities for Processa Pharmaceuticals, Inc. (PCSA).

• Processa is creating value through strategic business development.
• A binding term sheet was signed granting Intact Therapeutics an exclusive option to license PCS12852.
• This licensing deal is structured for Processa to be eligible for up to $454 million in milestone payments.
• The potential return includes a 12% royalty on future sales and a 3.5% equity stake in Intact.

Equity investors providing capital for R&D operations.

This segment provides the necessary capital to advance clinical trials, as reflected in the company's recent financial performance and funding activities.

Financial Metric	Amount/Value	Period/Date
Net Loss	$3.93 million	Q2 2025
Operating Loss	$3.95 million	Q2 2025
Research and Development Expenses	$2.45 million	Q2 2025
Cash and Cash Equivalents	$6.94 million	June 30, 2025
Net Proceeds from Equity Financing	Approximately $10.6 million	Early 2025
Stock Price (Last Traded)	$0.2652	December 4, 2025
52 Week Stock Range	$0.15 to $1.50	2025

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Cost Structure

You're looking at where Processa Pharmaceuticals, Inc. (PCSA) is spending its capital to push the pipeline forward, which is typical for a clinical-stage biopharma company. The costs are heavily weighted toward development activities, as you'd expect since they report no revenue under contract or immediate sales prospects as of late 2025.

The primary cost drivers are clearly Research and Development (R&D) and General and Administrative (G&A) overhead. For the third quarter of 2025, the R&D spend was reported at $1.66 million, which was actually a decrease from the prior year, largely due to lower costs associated with the NGC-Cap clinical trials for that specific quarter. Right alongside that, General and Administrative expenses totaled $1.82 million for Q3 2025, marking a significant increase of approximately $681,000 compared to Q3 2024.

Here's a quick look at those headline quarterly figures:

Cost Category	Period	Amount (USD)
Research and Development (R&D) Expenses	Q3 2025	$1.66 million
General and Administrative (G&A) Expenses	Q3 2025	$1.82 million

Digging into the components, you see how those R&D dollars break down. For instance, looking at the first quarter of 2025, the specific outlay for preclinical, clinical trial, and other related costs was $1,197,035. That number reflects the ongoing nature of the Phase 1B and Phase 2 clinical trials for NGC-Cap.

Salaries, stock-based compensation, and professional fees make up the bulk of the operating expenses outside of direct clinical spend. For R&D specifically, salaries and benefits for the three months ended March 31, 2025, were $391,505. To be fair, G&A costs in the prior year showed a reduction due to lower professional fees and stock-based compensation, suggesting management is watching those discretionary overhead items closely, though G&A rose substantially in Q3 2025.

The costs associated with maintaining intellectual property, like patent filings and legal defense of those assets, are an inherent, though often less granularly reported, part of the R&D and G&A structure for a company like Processa Pharmaceuticals, Inc. These costs are necessary to protect the proprietary Regulatory Science Approach and the pipeline candidates like PCS6422.

The cost structure is further defined by these key operational elements:

• Clinical trial execution and regulatory filing costs for NGC-Cap.
• R&D salaries and benefits, which saw a decrease in Q1 2025 due to voluntary departures.
• General and administrative expenses, which surged in Q3 2025.
• Costs related to ongoing clinical trials for Phase 2 programs.

Finance: draft 13-week cash view by Friday.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Revenue Streams

You're looking at Processa Pharmaceuticals, Inc.'s (PCSA) revenue streams as of late 2025. Honestly, for a clinical-stage company, the revenue picture is all about financing and future potential, not product sales yet. This is typical for the stage they are in.

The most immediate, concrete funding source has been capital markets activity. Throughout the first nine months of 2025, Processa Pharmaceuticals successfully raised net proceeds of $10.6 million through public offerings, selling over 15 million shares of common stock. These funds are earmarked to support ongoing research and development initiatives for NGC-Cap and general corporate purposes.

As for product sales, the reality is that as of Q3 2025, Processa Pharmaceuticals recorded zero revenue under contract or immediate sales prospects. The company is still firmly in the clinical development phase, not commercialization.

The major upside potential comes from non-core asset monetization, specifically the binding term sheet signed with Intact Therapeutics for PCS12852. This deal is structured to bring in significant non-dilutive cash flow if development milestones are hit.

Here's a quick breakdown of the potential deal value:

• Potential milestone payments total up to $454 million.
• Future royalties are set at 12% on net sales of the licensed asset.
• Processa also retains a 3.5% equity stake in Intact Therapeutics.

The structure of the PCS12852 deal is quite detailed, showing how the potential $454 million is segmented. Remember, Processa must share 60% of cash payments with its licensor, excluding the equity stake.

Revenue Component	Detail/Amount	Source of Payment
Equity Financing (9M 2025)	$10.6 million net raised	Public Offerings
PCS12852 Milestones (Total Potential)	Up to $454 million	Intact Therapeutics
PCS12852 Royalty Rate	12% on net sales	Intact Therapeutics
Cryptocurrency Treasury Value	$850,000 held	Digital Assets
Product Sales Revenue (Q3 2025)	$0	Product Sales

Furthermore, Processa Pharmaceuticals is exploring innovative financial strategies. On August 7, 2025, the company announced its exploration of corporate cryptocurrency treasury strategies to diversify its capital base. As of November 3, 2025, the company held $850,000 in digital assets, with plans to further capitalize on this emerging asset class.

The potential income streams can be summarized by their nature:

• Immediate, non-dilutive cash from financing activities.
• Contingent, large-scale payments from licensing milestones.
• Long-term, passive income from future royalties.
• Strategic, liquid asset holdings from treasury diversification.

Finance: draft 13-week cash view by Friday.