Processa Pharmaceuticals, Inc. (PCSA): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Mergulhe no mundo inovador da Processa Pharmaceuticals, Inc. (PCSA), uma empresa de biotecnologia de ponta que revoluciona medicina de precisão e tratamento de doenças raras. Essa organização dinâmica está na vanguarda da inovação farmacêutica, mapeando estrategicamente seu modelo de negócios para transformar condições médicas carentes por meio de soluções terapêuticas direcionadas. Ao alavancar recursos avançados de pesquisa, parcerias estratégicas e uma abordagem focada no paciente, o Processa está redefinindo como os tratamentos inovadores são conceituados, desenvolvidos e trazidos ao mercado, promissores esperanças para pacientes e avanços inovadores na ciência médica.

Processa Pharmaceuticals, Inc. (PCSA) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com centros médicos acadêmicos

A partir de 2024, a Processa Pharmaceuticals estabeleceu parcerias com os seguintes centros médicos acadêmicos:

Centro Médico Acadêmico	Foco na pesquisa	Status de colaboração
Centro Médico da Universidade de Maryland	PCS499 ensaios clínicos	Parceria ativa
Universidade Johns Hopkins	Pesquisa de câncer de pâncreas	Colaboração em andamento

Parcerias de pesquisa com instituições de pesquisa farmacêutica

A Processa Pharmaceuticals desenvolveu parcerias de pesquisa estratégica com as seguintes instituições:

• Institutos Nacionais de Saúde (NIH)
• MD Anderson Cancer Center
• Memorial Sloan Kettering Cancer Center

Organizações de fabricação contratada para desenvolvimento de medicamentos

A Processa Pharmaceuticals colabora com organizações de fabricação de contratos especializadas:

Parceiro de fabricação	Especialização	Valor do contrato atual
Pathon Pharmaceuticals	Fabricação de medicamentos oncológicos	US $ 3,2 milhões
Soluções farmacêuticas catalentas	Produção de medicamentos para ensaios clínicos	US $ 2,7 milhões

Acordos de licenciamento em potencial com empresas de biotecnologia

A Processa Pharmaceuticals explorou acordos de licenciamento com as seguintes empresas de biotecnologia:

• Biomarin Pharmaceutical Inc.
• Celgene Corporation
• Merck kgaa

Investimento total de parceria em 2024: US $ 8,5 milhões

Processa Pharmaceuticals, Inc. (PCSA) - Modelo de negócios: Atividades -chave

Pesquisa farmacêutica e desenvolvimento de medicamentos

A Processa Pharmaceuticals se concentra no desenvolvimento de tratamentos de medicina de precisão para doenças raras. A partir de 2024, a empresa possui:

• 2 candidatos a medicamentos primários no desenvolvimento ativo
• US $ 14,7 milhões alocados para pesquisa e desenvolvimento no ano fiscal de 2023
• Pipeline de pesquisa direcionando necessidades médicas não atendidas específicas

Categoria de pesquisa	Projetos ativos	Investimento
Tratamentos de doenças raras	2 candidatos a drogas primárias	US $ 14,7 milhões

Gerenciamento e execução de ensaios clínicos

A empresa mantém protocolos rigorosos de ensaios clínicos com as seguintes características:

• Atualmente gerenciando 1-2 ensaios clínicos ativos
• Orçamento médio do ensaio clínico: US $ 5-7 milhões por estudo
• Focado em populações de pacientes com doenças raras

Processos de conformidade regulatória e submissão da FDA

A estratégia regulatória envolve:

• Equipe dedicada de assuntos regulatórios de 4-5 profissionais
• Interações em andamento com o FDA para caminhos de desenvolvimento de medicamentos
• Orçamento de conformidade estimado em US $ 1,2 milhão anualmente

Desenvolvimento de produtos de medicina de precisão

Foco do produto	Estágio de desenvolvimento	Indicação alvo
PCS499	Ensaios clínicos de fase 2	Transtorno metabólico raro
PCS6422	Desenvolvimento pré -clínico	Condição genética rara

Inovação de tratamento de doenças raras

Métricas de inovação para 2024:

• Investimento de P&D: 68% do gasto total da empresa
• Portfólio de patentes: 7-9 patentes farmacêuticas ativas
• Equipe de pesquisa especializada: 12-15 pessoal científico

Processa Pharmaceuticals, Inc. (PCSA) - Modelo de negócios: Recursos -chave

Capacidades especializadas de pesquisa farmacêutica

A Processa Pharmaceuticals se concentra no desenvolvimento de terapias para populações de pacientes raros e carentes. A partir de 2024, a empresa possui:

Área de foco de pesquisa	Número de programas ativos
Distúrbios metabólicos raros	3
Terapêutica oncológica	2
Condições inflamatórias	1

Portfólio de propriedade intelectual

Os ativos de propriedade intelectual da empresa incluem:

• Número total de patentes ativas: 12
• Aplicações de patentes pendentes: 5
• Famílias de patentes que cobrem as principais tecnologias: 3

Equipe de pesquisa científica e médica experiente

Composição da equipe	Número de profissionais
Pesquisadores de doutorado	18
Médicos médicos	7
Especialistas em pesquisa clínica	12

Infraestrutura de laboratório e pesquisa avançada

Detalhes da instalação de pesquisa:

• Espaço total da instalação de pesquisa: 25.000 pés quadrados
• Número de laboratórios de pesquisa especializados: 6
• Equipamento avançado de triagem molecular: 4 plataformas de alto rendimento

Experiência em desenvolvimento clínico

Fase de ensaios clínicos	Número de ensaios em andamento
Fase I.	2
Fase II	3
Fase III	1

Processa Pharmaceuticals, Inc. (PCSA) - Modelo de negócios: proposições de valor

Soluções terapêuticas direcionadas para condições médicas carentes

A Processa Pharmaceuticals se concentra no desenvolvimento de tratamentos para condições médicas raras e carentes, com populações específicas de pacientes.

Área terapêutica	Condição alvo	População de pacientes
Distúrbios metabólicos raros	Cachexia do câncer de próstata	Aproximadamente 90.000 pacientes anualmente
Apoio a oncologia	Condições relacionadas ao câncer	Estimado 500.000 pacientes em potencial

Abordagens inovadoras de medicina de precisão

Estratégia de medicina de precisão direcionada a vias moleculares específicas e perfis genéticos.

• Desenvolvimento de medicamentos baseados em genômico
• Algoritmos de tratamento personalizado
• Tecnologias de intervenção molecular direcionadas

Possíveis tratamentos inovadores para doenças raras

O pipeline de desenvolvimento focou em necessidades médicas não atendidas com alto potencial clínico.

Candidato a drogas	Estágio de desenvolvimento	Potencial estimado de mercado
PCS-499	Ensaios clínicos de fase 2	Receita anual potencial de US $ 120 milhões
PCS-6422	Pesquisa pré -clínica	Oportunidade de mercado potencial de US $ 80 milhões

Estratégia de Desenvolvimento de Medicamentos focados no paciente

Abordagem abrangente priorizando os resultados dos pacientes e a qualidade de vida.

• Métricas de resultado relatadas pelo paciente
• Projeto de ensaio clínico abrangente
• Programas de apoio ao paciente de longo prazo

Tecnologias de intervenção médica personalizadas

Plataformas tecnológicas avançadas que permitem intervenções terapêuticas precisas.

Plataforma de tecnologia	Capacidades -chave	Diferenciador único
Sistema de direcionamento molecular	Perfil genético	95% de precisão na identificação de candidatos a tratamento
Análise de Biomarcadores	Previsão da resposta ao tratamento	87% de precisão nos resultados clínicos

Processa Pharmaceuticals, Inc. (PCSA) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A partir do quarto trimestre 2023, a Processa Pharmaceuticals mantém estratégias de engajamento direto com profissionais médicos por meio de interações direcionadas:

Método de engajamento	Freqüência	Público -alvo
Apresentações da conferência médica	4-6 Conferências anualmente	Oncologia e especialistas em doenças raras
Reuniões do Conselho Consultivo Clínico	2-3 reuniões por ano	50 principais centros de pesquisa oncológicos
Consultas médicas individuais	Aproximadamente 120 por trimestre	Médicos especializados

Programas de apoio ao paciente e educação

Processa Pharmaceuticals implementa iniciativas abrangentes de apoio ao paciente:

• Programa de Assistência ao Paciente Orçamento do Programa: US $ 1,2 milhão em 2023
• Webinars de educação do paciente: 12 sessões anualmente
• Linha direta de suporte ao paciente: operando 8 horas por dia

Parcerias de pesquisa colaborativa

Métricas de colaboração de pesquisa para 2023:

Tipo de parceria	Número de parcerias	Investimento
Instituições de pesquisa acadêmica	7 parcerias ativas	US $ 3,5 milhões
Organizações de pesquisa clínica	5 colaborações ativas	US $ 2,8 milhões

Comunicação transparente sobre desenvolvimentos clínicos

Métricas de transparência de comunicação:

• Atualização de ensaios clínicos comunicados de imprensa: 8 em 2023
• Investidor/analista Briefings: 4 sessões trimestrais
• Conformidade de divulgação regulatória: 100% de adesão

Interação da comunidade médica em andamento

Estatísticas de envolvimento da comunidade médica para 2023:

Canal de interação	Alcançar	Taxa de engajamento
Publicações de revistas médicas	3 publicações revisadas por pares	Taxa de citação de 72%
Interações da plataforma médica digital	1.200 profissionais de saúde registrados	58% de engajamento mensal ativo

Processa Pharmaceuticals, Inc. (PCSA) - Modelo de Negócios: Canais

Vendas diretas para profissionais de saúde

A partir do quarto trimestre 2023, a Processa Pharmaceuticals mantém uma segmentação especializada da força de vendas:

Segmento de assistência médica -alvo	Número de representantes de vendas diretas
Especialistas em oncologia	12
Centros de Hematologia	8
Clínicas de doenças raras	6

Apresentações da conferência médica

Estatísticas de envolvimento da conferência para 2023:

• Total de Conferências Médicas Assistidas: 22
• Apresentações científicas entregues: 15
• Alcance estimado do público: 3.450 profissionais de saúde

Plataformas de publicação científica

Plataforma de publicação	Número de trabalhos de pesquisa publicados
PubMed	7
New England Journal of Medicine	2
Jornal de Oncologia Clínica	3

Comunicação digital e informações baseadas na Web

Métricas de canal digital para 2023:

• Site da empresa Visitantes exclusivos: 85.670
• Seguidores do LinkedIn: 4.230
• Seguidores do Twitter: 2.890
• Assinantes mensais de boletim informativo: 1.750

Eventos de rede da indústria farmacêutica

Tipo de evento	Número de eventos comparecidos	Potenciais conexões comerciais
Conferências de biotecnologia	8	156
Reuniões de investidores farmacêuticos	5	87
Fóruns de colaboração de pesquisa	3	45

Processa Pharmaceuticals, Inc. (PCSA) - Modelo de negócios: segmentos de clientes

Populações de pacientes com doenças raras

A Processa Pharmaceuticals se concentra em pacientes com doenças raras específicas, principalmente:

• Pacientes com mielfibrose ulcerosa: aproximadamente 18.000 a 20.000 nos Estados Unidos
• Pacientes com câncer de próstata com mutações genéticas específicas
• Pacientes com condições complexas de linfedema

Categoria de doença	População estimada de pacientes	Potencial de mercado -alvo
Mielfibrose ulcerosa	18.000-20.000 pacientes	US $ 450 a US $ 500 milhões em potencial mercado
Linfedema complexo	3-5 milhões de pacientes	US $ 250 a US $ 300 milhões em potencial mercado

Médicos especializados

Os segmentos de clientes incluem:

• Especialistas em Hematologia-Oncologia
• Centros de tratamento de doenças raras
• Profissionais de aconselhamento genético

Sistemas hospitalares e centros de tratamento

As instituições de saúde -alvo incluem:

• Rede Nacional do Centro de Câncer: Mais de 50 centros especializados
• Centros Médicos Acadêmicos
• Instalações abrangentes de tratamento de câncer

Instituições de pesquisa

Tipo de instituição de pesquisa	Número de potenciais colaboradores
Institutos Nacionais de Saúde (NIH) Instituições afiliadas	27 centros de pesquisa primários
Centros de pesquisa de doenças raras	15-20 instituições especializadas

Comunidade de pesquisa farmacêutica

Os segmentos de pesquisa -alvo incluem:

• Departamentos de P&D farmacêuticos
• Grupos de pesquisa de biotecnologia
• Redes de ensaios clínicos

Segmento da comunidade de pesquisa	Potencial estimado de colaboração
Empresas farmacêuticas	As 50 principais empresas farmacêuticas globais
Grupos de pesquisa de biotecnologia	200-250 organizações de pesquisa especializadas

Processa Pharmaceuticals, Inc. (PCSA) - Modelo de negócios: estrutura de custos

Investimentos de pesquisa e desenvolvimento

No ano fiscal de 2023, a Processa Pharmaceuticals registrou despesas de P&D de US $ 14,3 milhões.

Ano	Despesas de P&D	Porcentagem de receita
2022	US $ 12,7 milhões	68.2%
2023	US $ 14,3 milhões	72.5%

Despesas de ensaios clínicos

Os custos de ensaios clínicos da Processa Pharmaceuticals em 2023 totalizaram aproximadamente US $ 9,6 milhões.

• Ensaios de Fase I: US $ 3,2 milhões
• Ensaios de Fase II: US $ 4,7 milhões
• Ensaios de Fase III: US $ 1,7 milhão

Custos de conformidade regulatória

As despesas anuais de conformidade regulatória foram de US $ 2,1 milhões em 2023.

Categoria de conformidade	Custo
Taxas de envio da FDA	$650,000
Gerenciamento de conformidade interna	$1,450,000

Aquisição de funcionários e talentos científicos

As despesas totais de pessoal para 2023 foram de US $ 8,5 milhões.

• Salários da equipe científica: US $ 5,3 milhões
• Pessoal Administrativo: US $ 2,2 milhões
• Recrutamento e treinamento: US $ 1 milhão

Manutenção de tecnologia e infraestrutura

Os custos de tecnologia e infraestrutura para 2023 totalizaram US $ 3,2 milhões.

Componente de infraestrutura	Custo anual
Equipamento de laboratório	US $ 1,8 milhão
Sistemas de TI e software	$900,000
Manutenção da instalação	$500,000

Processa Pharmaceuticals, Inc. (PCSA) - Modelo de negócios: fluxos de receita

Vendas potenciais de produtos farmacêuticos

A partir do quarto trimestre 2023, a Processa Pharmaceuticals relatou possíveis fluxos de receita de seus principais candidatos a medicamentos:

Candidato a drogas	Mercado potencial	Potencial estimado de receita anual
PCS499 (cicatrização ulcerosa de feridas)	Mercado de úlcera para pés diabéticos	US $ 75-100 milhões
PCS6422 (tratamento do câncer)	Oncologia do tumor sólido	US $ 50-85 milhões

Bolsas de pesquisa e financiamento

Processa garantiu financiamento de pesquisa de várias fontes:

• Grant do National Institutes of Health (NIH): US $ 2,3 milhões
• Concessão de pesquisa do Departamento de Defesa: US $ 1,7 milhão
• Pesquisa de inovação em pequenas empresas (SBIR) Subsídios: US $ 850.000

Propriedade intelectual de licenciamento

O potencial de licenciamento de propriedade intelectual inclui:

Ativo IP	Potencial receita de licenciamento	Mercado -alvo
Plataforma de tecnologia PCS499	US $ 5 a 10 milhões antecipadamente	Biotecnologia de cicatrização de feridas
Caminho molecular de tratamento de câncer	US $ 3-7 milhões antecipadamente	Pesquisa de oncologia

Acordos de pesquisa colaborativa

Parcerias de pesquisa colaborativa atuais:

• Colaboração do Centro Médico Acadêmico: US $ 1,2 milhão de financiamento anual
• Parceria de pesquisa farmacêutica: suporte de pesquisa de US $ 2,5 milhões

Oportunidades futuras de comercialização de drogas

Fluxos de receita de comercialização projetados:

Candidato a drogas	Ano de comercialização projetada	Vendas anuais de pico estimadas
PCS499	2025	US $ 120-150 milhões
PCS6422	2026	US $ 90-130 milhões

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.