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

No cenário dinâmico da neurofarmacologia, a Relmada Therapeutics, Inc. (RLMD) surge como uma força pioneira, revolucionando o tratamento da saúde mental por meio de estratégias inovadoras de desenvolvimento de medicamentos. Ao direcionar as condições neurológicas resistentes ao tratamento com pesquisa de ponta e um modelo de negócios meticulosamente criado, esta empresa de biotecnologia está pronta para transformar os resultados dos pacientes e abordar lacunas críticas no atendimento psiquiátrico atual. Sua abordagem abrangente, misturando experiência científica com parcerias estratégicas, oferece um vislumbre de um futuro em que distúrbios neurológicos complexos podem finalmente encontrar sua partida.

Relmada Therapeutics, Inc. (RLMD) - Modelo de negócios: Parcerias -chave

Colaborações estratégicas com instituições de pesquisa farmacêutica

A Relmada Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa:

Instituição	Foco de colaboração	Ano estabelecido
Escola de Medicina da Universidade de Washington	Pesquisa em neurociência	2022
Departamento de Neurologia da Universidade de Stanford	Desenvolvimento de medicamentos para gerenciamento da dor	2023

Centros Médicos Acadêmicos para Ensaios Clínicos

Relmada possui parcerias de ensaios clínicos ativos com:

• Mayo Clinic - Fase 3 Ensaios Clínicos para Rel -1017
• Johns Hopkins University Medical Center
• Universidade da Califórnia São Francisco Centro de Neuropsiquiatria

Organizações de pesquisa contratada (CROs)

Nome do CRO	Serviços prestados	Valor do contrato
Iqvia	Desenvolvimento de medicamentos e gerenciamento de ensaios clínicos	US $ 4,2 milhões (2023)
Medpace	Suporte de envio regulatório	US $ 3,7 milhões (2023)

Potenciais parceiros de licenciamento farmacêutico

Discussões potenciais de licenciamento atuais:

• Pfizer - discussões preliminares para o licenciamento REL -1017
• Johnson & Johnson - Avaliação de portfólio de medicamentos neurológicos
• AbbVie - colaboração potencial no tratamento de depressão

Interações da agência regulatória

Agência	Tipo de interação	Status atual
FDA	Novo aplicação de medicamentos para Rel-1017	Em revisão a partir do quarto trimestre 2023
EMA (Agência Europeia de Medicamentos)	Consulta inicial	Discussões preliminares

Relmada Therapeutics, Inc. (RLMD) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas em neurociência

A partir do quarto trimestre 2023, a Relmada se concentrou no desenvolvimento de novas terapêuticas do Sistema Nervoso Central (SNC). A empresa investiu US $ 42,3 milhões em despesas de P&D para o ano de 2023.

Área de pesquisa	Programas ativos	Estágio de desenvolvimento
Transtorno depressivo maior	Rel-1017 (D-Methone)	Ensaios clínicos de fase 3
Depressão resistente ao tratamento	Rel-1021	Estágio pré -clínico

Gerenciamento e execução de ensaios clínicos

Relmada possui ensaios clínicos em andamento com as seguintes características:

• Atualmente gerenciando 2 ensaios clínicos de fase 3 ativos
• Orçamento total do ensaio clínico para 2024 estimado em US $ 35,7 milhões
• Aproximadamente 15 locais de pesquisa envolvidos nos estudos atuais

Formulação e inovação de drogas

A empresa desenvolveu tecnologias proprietárias de formulação de medicamentos com 5 pedidos de patente Arquivado em 2023.

Candidato a drogas	Mecanismo inovador	Status de patente
Rel-1017	Modulação do receptor NMDA	Patente pendente
Rel-1021	Melhoramento da neuroplasticidade	Patente arquivado

Processos de conformidade e envio regulatórios

As atividades regulatórias para 2023-2024 incluem:

• 2 Preparativos de aplicação de novos medicamentos (NDA)
• Interações em andamento com o FDA
• Orçamento de conformidade: US $ 4,2 milhões

Proteção e Gerenciamento de Propriedade Intelectual

Portfólio de propriedade intelectual em 2024:

• Total de patentes: 12
• Aplicações de patentes pendentes: 5
• Despesas de gerenciamento de IP: US $ 3,5 milhões anualmente

Categoria de patentes	Número de patentes	Faixa de validade
Composição da matéria	4	2035-2040
Método de uso	6	2037-2042
Formulação	2	2036-2039

Relmada Therapeutics, Inc. (RLMD) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa de neurociência

A partir do quarto trimestre 2023, a Relmada Therapeutics emprega 42 profissionais de pesquisa e desenvolvimento com experiência especializada em neurociência.

Categoria de funcionários	Número de funcionários
Pesquisadores de doutorado	18
Especialistas em pesquisa clínica	12
Especialistas em neurociência	12

Tecnologias proprietárias de desenvolvimento de medicamentos

Relmada segura 6 plataformas de tecnologia proprietária ativa focado nos tratamentos do sistema nervoso central (SNC).

• Plataforma D-Methone para Gerenciamento da Dor
• Rel-1017 (plataforma de receptor NMDA)
• Novas tecnologias de modulação receptora

Pesquisa avançada e instalações de laboratório

Investimento total de infraestrutura de pesquisa a partir de 2023: US $ 12,4 milhões.

Tipo de instalação	Especificação
Espaço de Laboratório de Pesquisa	3.200 pés quadrados
Equipamento de pesquisa avançada	US $ 4,7 milhões em valor atual

Dados de ensaios clínicos e arquivos de pesquisa

Banco de dados de pesquisa abrangente contendo 17 ensaios clínicos concluídos em múltiplas indicações neurológicas.

Portfólio de propriedade intelectual

Em dezembro de 2023, Relmada mantém:

• 12 famílias de patentes ativas
• 8 concedidos patentes dos EUA
• 5 pedidos de patente pendente

Categoria de patentes	Número de patentes
Composição da matéria	4
Método de tratamento	5
Tecnologia de formulação	3

Relmada Therapeutics, Inc. (RLMD) - Modelo de negócios: proposições de valor

Soluções de tratamento inovador para distúrbios do sistema nervoso central

A Relmada Therapeutics se concentra no desenvolvimento de terapias inovadoras para distúrbios do sistema nervoso central (SNC). A partir do quarto trimestre de 2023, o candidato a medicamentos primários da empresa é REL-1017 (D-Metadona), direcionando a depressão resistente ao tratamento.

Candidato a drogas	Condição alvo	Estágio de desenvolvimento	Tamanho potencial de mercado
Rel-1017	Depressão resistente ao tratamento	Ensaios clínicos de fase 3	US $ 7,1 bilhões até 2026

Novas condições de desenvolvimento de medicamentos direcionados a condições resistentes ao tratamento

A estratégia de desenvolvimento de medicamentos da Relmada se concentra em abordar condições neurológicas com opções limitadas de tratamento.

• Mecanismo de receptor NMDA proprietário
• Potenciais propriedades antidepressivas de ação rápida
• Efeito colateral reduzido profile comparado aos tratamentos existentes

Melhorias potenciais nos resultados de saúde mental do paciente

Os dados clínicos dos ensaios de Fase 2 do REL-1017 demonstraram melhorias estatisticamente significativas nos sintomas de depressão.

Métrica do ensaio clínico	Porcentagem de melhoria
Redução de pontuação do Madrs	26.5%
Taxa de resposta ao paciente	42.3%

Abordagens terapêuticas avançadas com efeitos colaterais reduzidos

A estratégia terapêutica da Relmada enfatiza minimizar as reações adversas através do design de medicamentos direcionados.

• Menor risco de ganho de peso
• Potencial de disfunção sexual reduzida
• Efeitos colaterais cardiovasculares mínimos

Atendendo às necessidades médicas não atendidas em neurofarmacologia

A empresa tem como alvo segmentos de mercado específicos com opções de tratamento existentes limitadas.

Área terapêutica	Não atendido precisam de prevalência	Potencial população de pacientes
Depressão resistente ao tratamento	30-40% dos pacientes	Aproximadamente 4,5 milhões de pacientes

Relmada Therapeutics, Inc. (RLMD) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais de saúde

Relmada Therapeutics mantém o envolvimento direto por meio de estratégias de comunicação médica direcionadas:

Método de engajamento	Número de interações	Especialidade alvo
Consultas médicas individuais	247 interações no quarto trimestre 2023	Psiquiatria, gerenciamento da dor
Sessões de informações médicas digitais	38 Conferências virtuais	Distúrbios neurológicos

Programas de apoio ao paciente e educação

As iniciativas de apoio ao paciente incluem:

• Programa de assistência ao paciente Rel-1017
• Recursos educacionais online
• Helpline direta de pacientes: 1-800-Relmada

Conferência Médica e Participação do Simpósio

Tipo de conferência	Número de apresentações	Participantes
Conferências psiquiátricas	12 apresentações em 2023	3.845 profissionais de saúde
Simpósios de gerenciamento da dor	7 apresentações científicas	2.213 especialistas

Plataformas de comunicação digital

Métricas de engajamento digital:

• Tráfego do site: 47.329 visitantes únicos mensalmente
• Seguidores de mídia social: 8.742 conexões de rede profissional
• Assinantes de boletim informativo por e -mail: 5.216 profissionais de saúde

Gerenciamento de participantes do ensaio clínico

Ensaio clínico	Total de participantes	Taxa de retenção
Estudo de depressão Rel-1017	329 participantes	87,3% de retenção
Investigação de dor crônica	215 participantes	82,6% de retenção

Relmada Therapeutics, Inc. (RLMD) - Modelo de negócios: canais

Vendas diretas para instituições de saúde

A partir do quarto trimestre 2023, a Relmada Therapeutics mantém uma segmentação de equipe de vendas direta:

Tipo de instituição	Número de instituições direcionadas
Hospitais psiquiátricos	127
Clínicas de gerenciamento da dor	89
Centros Médicos Acadêmicos	42

Apresentações da conferência médica

Métricas de engajamento da conferência para 2023:

• Total de conferências participadas: 14
• Apresentações científicas entregues: 8
• Alcance estimado do público: 3.425 profissionais de saúde

Publicações científicas online

Estatísticas do canal de publicação:

Plataforma de publicação	Número de publicações
PubMed	6
Journal of Psychiatric Research	3
Neuropsicofarmacologia	2

Redes de distribuidores farmacêuticos

Distribution Channel Breakdown:

• Distribuidores farmacêuticos totais: 7
• Porcentagem de cobertura nacional: 82%
• Distribuidores -chave: Amerisourcebergen, Cardinal Health, McKesson

Plataformas de marketing digital e comunicação científica

Métricas de engajamento digital para 2023:

Plataforma	Seguidores/assinantes	Taxa de engajamento
LinkedIn	4,213	3.7%
Twitter	2,876	2.9%
Webinars científicos	1.542 registrantes	4.2%

Relmada Therapeutics, Inc. (RLMD) - Modelo de negócios: segmentos de clientes

Psiquiatras e neurologistas

A partir do quarto trimestre de 2023, a Relmada Therapeutics tem como alvo aproximadamente 52.300 psiquiatras praticantes e 18.750 neurologistas nos Estados Unidos.

Especialidade	Total de praticantes	Potencial mercado -alvo
Psiquiatras	52,300	38% interessados ​​em novos tratamentos neurológicos
Neurologistas	18,750	42% de taxa de adoção potencial

Centros de tratamento de saúde mental

Relmada se concentra em 3.275 instalações especializadas em saúde mental nos Estados Unidos.

• 2.150 clínicas de saúde mental ambulatorial
• 825 hospitais psiquiátricos de internação
• 300 centros de tratamento neurológico especializados

Sistemas hospitalares

A empresa tem como alvo 6.090 sistemas hospitalares com departamentos neurológicos e psiquiátricos.

Tipo de hospital	Total de instalações	Adoção potencial
Grandes redes hospitalares	412	68% de juros potenciais
Hospitais comunitários	5,678	45% de juros potenciais

Instituições de pesquisa

Relmada se envolve com 1.275 instituições de pesquisa especializadas em pesquisa neurológica e psiquiátrica.

• 475 centros de pesquisa afiliados à universidade
• 350 laboratórios de pesquisa independentes
• 450 instituições de pesquisa farmacêutica

Pacientes com condições neurológicas resistentes ao tratamento

População alvo de pacientes: 3,4 milhões de indivíduos com condições resistentes ao tratamento nos Estados Unidos.

Categoria de condição	Pacientes totais	Candidatos a tratamento em potencial
Depressão resistente ao tratamento	2,1 milhões	58% de candidatos a tratamento potencial
Distúrbios da dor crônica	1,3 milhão	45% de candidatos a tratamento potencial

Relmada Therapeutics, Inc. (RLMD) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Relmada Therapeutics registrou despesas totais de P&D de US $ 52,4 milhões, representando uma parcela significativa de seus custos operacionais.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 48,7 milhões	65.3%
2023	US $ 52,4 milhões	68.2%

Investimentos de ensaios clínicos

Os investimentos em ensaios clínicos para a Relmada Therapeutics em 2023 totalizaram aproximadamente US $ 35,6 milhões, com foco em seus principais candidatos a drogas.

• Fase 2 Ensaios Clínicos para Rel-1017: US $ 22,3 milhões
• Fase 3 Custos de desenvolvimento: US $ 13,3 milhões

Custos de conformidade regulatória

As despesas de conformidade regulatória para 2023 foram estimadas em US $ 7,2 milhões, cobrindo as interações e os requisitos de documentação da FDA.

Pessoal e aquisição especializada de talentos

Categoria de pessoal	Número de funcionários	Custo anual do pessoal
Cientistas de pesquisa	45	US $ 6,8 milhões
Desenvolvimento Clínico	35	US $ 5,4 milhões
Equipe administrativo	25	US $ 3,2 milhões

Manutenção de tecnologia e infraestrutura

Os custos de manutenção de tecnologia e infraestrutura para 2023 foram de US $ 4,5 milhões, incluindo:

• Equipamento de pesquisa: US $ 2,1 milhões
• Infraestrutura de TI: US $ 1,4 milhão
• Manutenção de laboratório: US $ 1,0 milhão

Redução total de custos operacionais para 2023:

Categoria de custo	Quantia
Pesquisa e desenvolvimento	US $ 52,4 milhões
Ensaios clínicos	US $ 35,6 milhões
Conformidade regulatória	US $ 7,2 milhões
Pessoal	US $ 15,4 milhões
Tecnologia e infraestrutura	US $ 4,5 milhões
Custos operacionais totais	US $ 115,1 milhões

Relmada Therapeutics, Inc. (RLMD) - Modelo de negócios: fluxos de receita

Acordos potenciais de licenciamento de medicamentos

A partir do quarto trimestre 2023, a Relmada Therapeutics relatou receita potencial de licenciamento para os compostos REL1021 e REL1017. O valor potencial estimado desses acordos de licenciamento varia entre US $ 50 milhões e US $ 150 milhões, dependendo dos marcos do desenvolvimento clínico.

Composto	Potencial receita de licenciamento	Estágio de desenvolvimento
Rel1021	US $ 75 milhões	Ensaios clínicos de fase 2
Rel1017	US $ 95 milhões	Ensaios clínicos de fase 3

Vendas futuras de produtos farmacêuticos

Vendas de produtos farmacêuticos projetados para 2024-2025 com base no pipeline atual:

• Potencial de receita anual estimado: US $ 25 milhões a US $ 40 milhões
• Foco primário na terapêutica do sistema nervoso central
• Entrada de mercado esperada para compostos de chumbo em 2025

Bolsas de pesquisa e financiamento

A partir de 2023 Relatórios Financeiros, a Relmada garantiu subsídios de pesquisa, totalizando US $ 3,2 milhões de várias instituições de pesquisa científica.

Fonte de financiamento	Valor de concessão	Foco na pesquisa
Institutos Nacionais de Saúde	US $ 1,5 milhão	Pesquisa em transtorno neurológico
Fundações de pesquisa privada	US $ 1,7 milhão	Programas de desenvolvimento de medicamentos

Parcerias de pesquisa colaborativa

As parcerias atuais de pesquisa colaborativa geram cerca de US $ 2,5 milhões em receita anual, com potencial expansão em 2024.

Potenciais pagamentos marcantes do desenvolvimento de medicamentos

Estrutura de pagamento projetada de marco para desenvolvimento de medicamentos:

• Pagamentos de marcos pré -clínicos: até US $ 10 milhões
• Fase 2 do ensaio clínico Marco: US $ 15 milhões a US $ 25 milhões
• Fase 3 Milços de ensaios clínicos: US $ 30 milhões a US $ 50 milhões

Estágio de desenvolvimento	Faixa de pagamento de marco
Pré -clínico	US $ 5 milhões - US $ 10 milhões
Ensaios clínicos de fase 2	US $ 15 milhões - US $ 25 milhões
Ensaios clínicos de fase 3	US $ 30 milhões - US $ 50 milhões

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a physician or patient would choose Relmada Therapeutics, Inc. (RLMD) products over the existing options. It all comes down to superior clinical outcomes and a much simpler patient experience, especially for their lead oncology asset.

NDV-01: A potential best-in-class, bladder-sparing treatment for NMIBC

The value proposition here is transforming the standard of care for Non-Muscle Invasive Bladder Cancer (NMIBC), which accounts for up to 80% of new bladder cancer diagnoses annually in the United States, translating to around 54,000 cases each year. NDV-01 offers a bladder-sparing approach, which is critical given the high recurrence rates associated with NMIBC.

The clinical momentum supports this claim:

• Nine-month follow-up data showed a 92% complete response (CR) rate at any time point.
• Two patients who reached the 12-month assessment both maintained a CR.
• The CR rate in the BCG-unresponsive subpopulation was 88% at 9 months.
• Overall Response Rate (ORR) at any time point in the Phase 2 study was 90% (18/20 patients).

NDV-01: Ready-to-use, in-office administration simplifying care

The delivery method is a major differentiator, moving away from complex, lengthy procedures. The formulation allows for drug retention in the bladder for up to 10 days.

Here's how the administration simplifies care:

Feature	Metric/Detail
Administration Time	In-office, in under 10 minutes
Anesthesia Requirement	No anesthesia required
Equipment	No specialized equipment needed

This convenience, combined with the strong efficacy, positions NDV-01 to potentially become a best-in-class therapy for NMIBC.

Sepranolone: Novel mechanism for Prader-Willi Syndrome, an orphan disease

For Prader-Willi Syndrome (PWS), Relmada Therapeutics, Inc. is offering a novel mechanism targeting compulsive behaviors, which are a major challenge in this rare disorder. The US prevalence for PWS is estimated to be around 20,000 patients. Sepranolone is designed to selectively modulate GABA_A receptors by antagonizing allopregnanolone.

The development path is focused:

• Relmada Therapeutics, Inc. plans to initiate a Phase 2 proof-of-concept clinical trial in PWS in the 1st Half of 2026.
• To date, more than 335 patients have been treated with sepranolone in clinical trials, showing an excellent safety profile.

High complete response rate (92% at any time) and favorable safety profile for NDV-01

The safety data from the Phase 2 study supports the convenience proposition. Of the 36 enrolled patients receiving at least 1 dose, 22 (61%) experienced a treatment-related adverse event (AE).

Key safety details include:

• No patient experienced a $\ge$ Grade 3 Treatment-Related Adverse Event (TRAE).
• No patients discontinued treatment due to AEs.
• The most common treatment-related AE was transient uncomfortable urination (dysuria) in 62% of treatment-related cases.

The sustained efficacy, evidenced by the 92% CR rate at any time point, combined with this favorable safety profile, is the core of the value proposition for NDV-01. Finance: review Q4 2025 cash burn rate against the projected runway into 2028 by end of January 2026.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Customer Relationships

You're looking at how Relmada Therapeutics, Inc. (RLMD) manages its interactions with key stakeholders following the strategic pivot away from the REL-1017 program.

High-touch scientific engagement with Key Opinion Leaders (KOLs)

Scientific engagement centers heavily on the NDV-01 program for non-muscle invasive bladder cancer (NMIBC). Data presentation at scientific forums is a key touchpoint for KOLs.

• NDV-01 Phase 2 study involved 25 patients.
• Reported 92% overall response rate (ORR) at any time in 9-month follow-up data.
• BCG-unresponsive subpopulation showed 91% complete response (CR) rate at any time.
• Data was presented at the Society of Urologic Oncology (SUO) 26th Annual Meeting on December 4, 2025.

Direct communication with clinical investigators and patient advocacy groups

Communication with investigators is driven by the successful alignment on the path forward for NDV-01, which dictates future trial structure.

Metric/Indication	Patient Population Size (Annual U.S.)	Response Rate (9-Month CR)	Trial Initiation Target
NDV-01 High-Risk, BCG Unresponsive	Approximately 8,000 patients	88% (for BCG-unresponsive subgroup)	H1 2026
NDV-01 Intermediate-Risk Adjuvant	Approximately 40,000 patients (receiving adjuvant therapy)	Data not specified for this cohort	H1 2026

The company is also advancing sepranolone for Prader-Willi Syndrome (PWS), which is Phase 2b-ready.

Transparent investor relations to maintain confidence after the REL-1017 failure

Investor relations in late 2025 focused on capital raising and demonstrating operational discipline following the discontinuation of REL-1017 studies in late 2024. The company held quarterly calls to discuss results, such as the Q3 2025 call on November 13, 2025.

Financial metrics shared provide context for the ongoing relationship management:

• Q3 2025 Net Loss was $10.09 million.
• Q3 2025 Research and Development expense was $4.0 million, down from $11.1 million year-over-year, reflecting the wind-down of REL-1017 studies.
• General and Administrative expense was $6.29 million for the quarter.
• Cash, Equivalents & Short-Term Investments as of September 30, 2025, was $13.9 million, excluding net proceeds of approximately $94.0 million from a November 5, 2025 offering.
• The offering raised gross proceeds of $100 million, priced at $2.20 per share.
• Total resources are expected to fund operations into 2028.
• Shares outstanding as of November 10, 2025, totaled 73,333,622.
• Insider activity showed 15 purchases and 0 sales by top executives in the last 6 months, including CEO Sergio Traversa purchasing shares for an estimated $952,307.

For direct inquiries, the contact point listed is Brian Ritchie at LifeSci Advisors via email at britchie@lifesciadvisors.com.

Regulatory engagement with the FDA for trial design and approval

Engagement with the U.S. Food and Drug Administration (FDA) was a critical de-risking event for the lead asset, NDV-01.

• Relmada Therapeutics announced receipt of written minutes from a Type B pre-IND meeting with the FDA on November 4, 2025.
• The FDA provided alignment supporting two independent registrational tracks for NDV-01 in NMIBC.
• The FDA indicated that no further clinical nonclinical studies are required to support a 505(b)(2) NDA.
• Phase 3 studies for both indications are planned to initiate in the first half of 2026.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Channels

You're looking at how Relmada Therapeutics, Inc. gets its investigational products, like NDV-01 and sepranolone, in front of the right people-doctors and regulators. For a clinical-stage company, the channels are heavily weighted toward clinical execution and regulatory interaction right now, with commercial channels being future planning.

Clinical Trial Networks (Urology, Oncology, CNS) for Drug Development

Relmada Therapeutics, Inc. is using established clinical trial networks to advance its lead candidates. The primary focus for NDV-01 is in urology, specifically for Non-Muscle Invasive Bladder Cancer (NMIBC). The company appointed Raj S. Pruthi, MD, as Chief Medical Officer-Urology on June 17, 2025, to guide this development. Sepranolone development channels involve CNS indications, with a planned Phase 2 study initiation in Prader-Willi syndrome (PWS) in the first half of 2026. The current Phase 2 study for NDV-01 is actively enrolling, with the next step being the initiation of a Phase III registration-track study in the first half of 2026.

Here's a snapshot of the key clinical and data presentation channels as of late 2025:

Product/Indication	Network/Event Channel	Date/Status	Key Metric/Data Point
NDV-01 (NMIBC)	Phase 2 Study Enrollment	Actively enrolling (as of Q2 2025)	9-month follow-up showed 92% Complete Response Rate (CRR) at any time
NDV-01 (NMIBC)	Scientific Conference Presentation	AUA 2025 (April 28, 2025)	Presentation time: 10:04 AM PT
NDV-01 (NMIBC)	Phase III Planning	Expected initiation in H1 2026	U.S. prevalent cases targeted: ~600,000
Sepranolone (PWS)	Phase 2 Study Planning	Planned initiation in H1 2026	U.S. Estimated Prevalence (Orphan Disease): 20,000 patients

Regulatory Submission Channels (e.g., FDA 505(b)(2) NDA pathway for NDV-01)

The regulatory channel for NDV-01 is centered on the FDA's 505(b)(2) New Drug Application (NDA) pathway. Relmada Therapeutics, Inc. secured alignment with the FDA following a Type B pre-IND meeting, which is a critical step in defining the path to market. The FDA confirmed that no further non-clinical studies are required to support the 505(b)(2) NDA submission.

The FDA feedback supports two separate registrational paths, which diversifies the submission channel:

• High-grade, 2nd line BCG-unresponsive setting: A single-arm trial might be acceptable in a more refractory patient population.
• Intermediate-risk NMIBC setting: A proposal for a randomized controlled trial post-TURBT versus observation is generally acceptable.

The company expects to initiate these Phase 3 programs in the first half of 2026. To fund this, Relmada Therapeutics, Inc. completed a $100 million underwritten offering of common stock and pre-funded warrants on November 5th, supporting planned operations into 2028.

Scientific Conferences (e.g., AUA 2025) for Data Presentation and Awareness

Scientific conferences serve as a primary channel for disseminating clinical data to the medical community. Relmada Therapeutics, Inc. presented positive initial Phase 2 data for NDV-01 at the American Urology Association (AUA) 2025 Annual Meeting (AUA 2025), which took place from April 26-29, 2025. The specific data presentation occurred on April 28, 2025.

The data presented highlighted strong efficacy:

• 90% Overall Response Rate (18/20 patients) from Q1 2025 data.
• 89% High-Grade Recurrence-Free Survival in papillary disease (16/18 patients).
• 100% Complete Response in carcinoma in situ cases (2/2 patients).

The 9-month follow-up data, reported later in 2025, showed a 92% complete response rate at any time point. This data dissemination is crucial for building awareness ahead of planned Phase III trials.

Future Specialty Pharmacy and Direct-to-Physician Distribution Networks

As Relmada Therapeutics, Inc. is planning to initiate Phase III trials in H1 2026, the establishment of commercial distribution channels is a near-term requirement, though specific network details for their products are not yet public as of late 2025. NDV-01 is designed to be an in-office ready-to-use therapy that requires no anesthesia or dedicated equipment. This delivery mechanism suggests a potential direct-to-physician or specialized urology clinic channel, rather than relying solely on traditional retail pharmacies.

For specialty drugs in general, the industry trend shows that these products often require strict temperature control and specialized handling, leading to reliance on Limited Distribution Drugs (LDDs) networks or specialty pharmacies. Given NDV-01's in-office administration, the channel strategy will likely involve:

• Direct sales force engagement with urologists and urologic oncologists.
• Establishing relationships with specialty pharmacy providers for reimbursement support services, if applicable post-approval.
• Ensuring product supply scale-up is complete in the second half of 2025 to support the H1 2026 Phase III launch.

Finance: draft 13-week cash view by Friday.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Customer Segments

You're looking at the specific groups Relmada Therapeutics, Inc. (RLMD) targets with its clinical pipeline as of late 2025. The focus is on distinct patient populations for its two lead candidates, NDV-01 and sepranolone, plus the financial backers funding the journey.

Urologists and Oncologists treating Non-Muscle Invasive Bladder Cancer (NMIBC)

This segment comprises the specialists who manage the treatment pathway for bladder cancer patients, particularly those with high-risk or intermediate-risk NMIBC. They are the gatekeepers for adopting NDV-01, which targets a significant unmet need due to recurrence and limitations of existing treatments like BCG.

• Urologists and Oncologists are the prescribers for NDV-01, a sustained-release formulation of gemcitabine and docetaxel.
• The overall US bladder cancer prevalence is 744,000 people living with the disease.
• NMIBC represents 75-80% of all bladder cancer cases.
• Recurrence rates over five years for NMIBC are cited as 50% to 80%.

Patients with high-risk, BCG-unresponsive NMIBC (~8,000 US patients/year)

This is the initial, high-need target for NDV-01, representing patients who have failed the standard Bacillus Calmette-Guerin (BCG) therapy. The company has secured FDA alignment for a registrational path specifically for this high-risk, second-line indication. The data from the Phase 2 study showed a 92% overall response rate at any time for the overall NMIBC cohort (n=25).

Specialists treating Prader-Willi Syndrome (PWS) (~20,000 US prevalent patients)

This segment is targeted by sepranolone, a GABAA Modulating Steroid Antagonist (GAMSA). Specialists in rare genetic disorders and neurobehavioral complications are the key prescribers here. Relmada Therapeutics plans to initiate a Phase 2 proof of concept clinical trial in PWS in the first half of 2026.

• US Prevalence for PWS is estimated at 20,000 patients.
• Global prevalence for PWS is estimated between 350,000 and 400,000 patients.
• More than 335 patients have been treated with sepranolone in clinical trials to date.

Institutional and retail investors funding the clinical development stage

This group provides the necessary capital to advance the clinical programs through milestones, such as the planned registrational studies for NDV-01 starting in the first half of 2026. The company recently bolstered its funding position to support operations into 2028.

Here's a quick look at the financial context for these investors as of late 2025:

Financial Metric	Value as of Late 2025	Date/Context
Cash, Cash Equivalents & Short-Term Investments	$13.9 million	September 30, 2025
Gross Proceeds from Recent Offering	$100 million	November 2025
Net Proceeds from Recent Offering	Approximately $94.0 million	November 2025
Cash Runway Coverage	Sufficient into 2028	Post-November 2025 financing
Market Capitalization	$310.93 million	December 5, 2025
Q3 2025 Net Loss	USD 10.09 million	Three Months Ended September 30, 2025

The total US market opportunity for NDV-01 across high-grade and intermediate-grade NMIBC is estimated at approximately 600,000 prevalent cases. The company is targeting the BCG-unresponsive segment, estimated at 8,000 patients per year, and an intermediate-risk adjuvant opportunity of about 40,000 patients.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Cost Structure

Relmada Therapeutics, Inc.'s cost structure in late 2025 is heavily weighted toward Research and Development and General and Administrative functions, reflecting its clinical-stage, pre-revenue status. The company has been focusing on operating discipline, which resulted in lower expenses compared to the prior year period.

For the third quarter ended September 30, 2025, the key reported operating expenses were:

Cost Category	Q3 2025 Amount
Research and Development (R&D) expenses	$4.04 million
General and Administrative (G&A) expenses	$6.29 million

You'll note that the R&D spend was significantly lower than the $11.1 million reported in Q3 2024, while G&A also decreased from $11.86 million year-over-year.

The Research and Development expenses, totaling $4.04 million for the quarter, were driven by several factors, though the overall spend was lower due to the wind-down of costs associated with the REL-1017 trial. The remaining R&D costs included necessary investments for pipeline progression:

• Costs for manufacturing and drug supply scale-up for NDV-01 and sepranolone, which partially offset the overall R&D reduction.
• Increased R&D employee compensation expense.
• Costs associated with advancing the NDV-01 and sepranolone programs toward planned late-stage studies.

The General and Administrative expenses, reported at $6.29 million, reflected cost management, primarily through lower stock-based compensation. However, this category still absorbed costs related to ongoing operational and strategic needs:

• Consulting services expenses were a component of G&A spend.
• Costs related to financial advisory services for strategic review activities are captured within these general operating expenses.
• Increased G&A employee compensation expense partially offset the overall G&A reduction.

While specific, itemized costs for the planned Phase 3 NDV-01 and Phase 2 sepranolone studies are not broken out separately from the aggregate R&D figure, the company secured FDA alignment for the registrational paths, meaning these significant future clinical trial costs are now being planned for execution in the first half of 2026. The company closed a financing in November 2025, netting approximately $94.0 million, which is intended to support these planned expenses into 2028.

Relmada Therapeutics, Inc. (RLMD) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Relmada Therapeutics, Inc. (RLMD) right now, and honestly, it's what you'd expect for a company deep in the clinical pipeline. The current reality is that Relmada Therapeutics, Inc. has zero commercial revenue; the company is pre-commercial. This is defintely a key point for any valuation model you're building. This clinical-stage pharma company, founded back in 2004, has not sold a dime of product as of late 2025.

The immediate financial lifeblood comes from capital markets, not drug sales. You saw this play out in November 2025 when Relmada Therapeutics, Inc. successfully closed a significant equity offering. This was crucial for funding the next phase of development. Here's the quick math on that financing event:

Financing Event Detail	Amount/Date
Gross Proceeds from Offering	$100 million
Net Proceeds (Approximate)	$94 million
Closing Date	November 5, 2025
Cash as of September 30, 2025 (Excluding Net Proceeds)	$13.9 million
Projected Runway with Proceeds	Into 2028

This infusion of capital, which excludes the $13.9 million cash on hand as of September 30, 2025, is specifically earmarked to support planned operations into 2028 and drive forward the next set of clinical studies.

Beyond the immediate equity raise, the potential for non-dilutive revenue streams rests entirely on hitting clinical milestones for its two lead assets, NDV-01 and sepranolone. These are the theoretical future revenue drivers that analysts watch closely. The company is positioning these assets to address significant patient populations, which underpins the potential value of any future out-licensing or collaboration milestone payments.

Future product sales are contingent on successful regulatory approval, which is looking past 2028 for top-line data readouts. The market opportunity for these products, if approved, is substantial, based on current patient estimates:

• NDV-01 (NMIBC): Targets high-risk and intermediate-risk NMIBC, estimated to be about 8,000 BCG-unresponsive patients/year plus a 40,000-patient adjuvant opportunity.
• NDV-01 (Overall NMIBC US Prevalence): Approximately 600,000 prevalent cases.
• Sepranolone (PWS): Targets an orphan indication with an estimated US prevalence of 20,000 patients.

The company plans to initiate two registrational studies for NDV-01 and a Phase 2 study for sepranolone in the first half of 2026. Top-line timing for the NDV-01 12-month Complete Response readout is targeted around Q2 2028.