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

En el panorama dinámico de la neurofarmacología, Relmada Therapeutics, Inc. (RLMD) surge como una fuerza pionera, revolucionando el tratamiento de salud mental a través de estrategias innovadoras de desarrollo de medicamentos. Al dirigirse a las condiciones neurológicas resistentes al tratamiento con una investigación de vanguardia y un modelo de negocio meticulosamente elaborado, esta compañía de biotecnología está preparada para transformar los resultados de los pacientes y abordar las brechas críticas en la atención psiquiátrica actual. Su enfoque integral, combinando experiencia científica con asociaciones estratégicas, ofrece un vistazo a un futuro donde los trastornos neurológicos complejos finalmente podrían cumplir con su partido.

Relmada Therapeutics, Inc. (RLMD) - Modelo de negocios: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación farmacéutica

Relmada Therapeutics ha establecido asociaciones con las siguientes instituciones de investigación:

Institución	Enfoque de colaboración	Año establecido
Facultad de Medicina de la Universidad de Washington	Investigación de neurociencia	2022
Departamento de Neurología de la Universidad de Stanford	Desarrollo de medicamentos para el manejo del dolor	2023

Centros médicos académicos para ensayos clínicos

Relmada tiene asociaciones de ensayos clínicos activos con:

• Mayo Clinic - Ensayos clínicos de fase 3 para REL -1017
• Centro médico de la Universidad Johns Hopkins
• Centro de Neuropsiquiatría de la Universidad de California en San Francisco

Organizaciones de investigación por contrato (CRO)

Nombre de Cro	Servicios proporcionados	Valor de contrato
IQVIA	Desarrollo de fármacos y gestión de ensayos clínicos	$ 4.2 millones (2023)
Medpacio	Soporte de presentación regulatoria	$ 3.7 millones (2023)

Posentes socios de licencia farmacéutica

Discusiones de licencia potenciales actuales:

• Pfizer - Discusiones preliminares para la licencia REL -1017
• Johnson & Johnson - Evaluación de cartera de drogas neurológicas
• ABBVIE - Colaboración potencial en el tratamiento de depresión

Interacciones de la agencia reguladora

Agencia	Tipo de interacción	Estado actual
FDA	Nueva aplicación de drogas para REL-1017	Bajo revisión a partir del cuarto trimestre 2023
EMA (Agencia Europea de Medicamentos)	Consulta inicial	Discusiones preliminares

Relmada Therapeutics, Inc. (RLMD) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas de neurociencia

A partir del cuarto trimestre de 2023, Relmada se ha centrado en el desarrollo de nuevas terapias del sistema nervioso central (SNC). La compañía ha invertido $ 42.3 millones en gastos de I + D para el año 2023.

Área de investigación	Programas activos	Etapa de desarrollo
Trastorno depresivo mayor	REL-1017 (D-Metadona)	Ensayos clínicos de fase 3
Depresión resistente al tratamiento	REL-1021	Etapa preclínica

Gestión y ejecución del ensayo clínico

Relmada tiene ensayos clínicos continuos con las siguientes características:

• Actualmente gestionando 2 ensayos clínicos activos de fase 3
• Presupuesto total de ensayos clínicos para 2024 estimado en $ 35.7 millones
• Aproximadamente 15 sitios de investigación involucrados en estudios actuales

Formulación e innovación de drogas

La compañía ha desarrollado tecnologías de formulación de drogas patentadas con 5 solicitudes de patentes Archivado en 2023.

Candidato a la droga	Mecanismo innovador	Estado de patente
REL-1017	Modulación del receptor NMDA	Patente pendiente
REL-1021	Mejora de la neuroplasticidad	Patente archivada

Procesos de cumplimiento y presentación regulatoria

Las actividades regulatorias para 2023-2024 incluyen:

• 2 nuevos preparativos de aplicación de drogas (NDA)
• Interacciones continuas con la FDA
• Presupuesto de cumplimiento: $ 4.2 millones

Protección y gestión de la propiedad intelectual

Cartera de propiedades intelectuales a partir de 2024:

• Patentes totales: 12
• Aplicaciones de patentes pendientes: 5
• Gastos de gestión de IP: $ 3.5 millones anuales

Categoría de patente	Número de patentes	Rango de vencimiento
Composición de la materia	4	2035-2040
Método de uso	6	2037-2042
Formulación	2	2036-2039

Relmada Therapeutics, Inc. (RLMD) - Modelo de negocio: recursos clave

Equipo de investigación de neurociencia especializada

A partir del cuarto trimestre de 2023, Relmada Therapeutics emplea a 42 profesionales de investigación y desarrollo con experiencia especializada en neurociencia.

Categoría de empleado	Número de empleados
Investigadores de doctorado	18
Especialistas en investigación clínica	12
Expertos en neurociencia	12

Tecnologías de desarrollo de fármacos patentados

Relmada sostiene 6 plataformas de tecnología patentadas activas centrado en los tratamientos del sistema nervioso central (SNC).

• Plataforma D-Methadone para el manejo del dolor
• REL-1017 (plataforma de receptores NMDA)
• Nuevas tecnologías de modulación de receptores

Investigación avanzada e instalaciones de laboratorio

Inversión total de infraestructura de investigación a partir de 2023: $ 12.4 millones.

Tipo de instalación	Especificación
Espacio de laboratorio de investigación	3,200 pies cuadrados
Equipo de investigación avanzado	$ 4.7 millones en valor actual

Datos de ensayos clínicos y archivos de investigación

Base de datos de investigación integral que contiene 17 ensayos clínicos completados a través de múltiples indicaciones neurológicas.

Cartera de propiedades intelectuales

A diciembre de 2023, Relmada mantiene:

• 12 familias de patentes activas
• 8 Patentes de EE. UU. Concedidas
• 5 solicitudes de patentes pendientes

Categoría de patente	Número de patentes
Composición de la materia	4
Método de tratamiento	5
Tecnología de formulación	3

Relmada Therapeutics, Inc. (RLMD) - Modelo de negocio: propuestas de valor

Soluciones de tratamiento innovadoras para trastornos del sistema nervioso central

Relmada Therapeutics se centra en desarrollar terapias innovadoras para los trastornos del sistema nervioso central (SNC). A partir del cuarto trimestre de 2023, el principal candidato al fármaco de la compañía es REL-1017 (D-Methadona), dirigido a la depresión resistente al tratamiento.

Candidato a la droga	Condición objetivo	Etapa de desarrollo	Tamaño potencial del mercado
REL-1017	Depresión resistente al tratamiento	Ensayos clínicos de fase 3	$ 7.1 mil millones para 2026

Novedoso desarrollo de medicamentos dirigidos a afecciones resistentes al tratamiento

La estrategia de desarrollo de fármacos de Relmada se centra en abordar las condiciones neurológicas con opciones de tratamiento limitadas.

• Mecanismo de receptor NMDA patentado
• Potencios de propiedades antidepresivas de acción rápida
• Efecto secundario reducido profile en comparación con los tratamientos existentes

Mejoras potenciales en los resultados de la salud mental del paciente

Los datos clínicos de los ensayos de fase 2 de REL-1017 demostraron mejoras estadísticamente significativas en los síntomas de depresión.

Métrico de ensayo clínico	Porcentaje de mejora
Reducción de la puntuación de Madrs	26.5%
Tasa de respuesta del paciente	42.3%

Enfoques terapéuticos avanzados con efectos secundarios reducidos

La estrategia terapéutica de Relmada enfatiza la minimización de reacciones adversas a través del diseño de fármacos dirigido.

• Menor riesgo de aumento de peso
• Potencial de disfunción sexual reducida
• Efectos secundarios cardiovasculares mínimos

Abordar las necesidades médicas no satisfechas en neurofarmacología

La Compañía se dirige a segmentos específicos del mercado con opciones de tratamiento existentes limitadas.

Área terapéutica	Necesidad insatisfecha de prevalencia	Potencial de población de pacientes
Depresión resistente al tratamiento	30-40% de los pacientes	Aproximadamente 4.5 millones de pacientes

Relmada Therapeutics, Inc. (RLMD) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales de la salud

Relmada Therapeutics mantiene la participación directa a través de estrategias de comunicación médica específicas:

Método de compromiso	Número de interacciones	Especialidad objetivo
Consultas médicas individuales	247 interacciones en el cuarto trimestre 2023	Psiquiatría, manejo del dolor
Sesiones de información médica digital	38 conferencias virtuales	Trastornos neurológicos

Programas de apoyo y educación del paciente

Las iniciativas de apoyo al paciente incluyen:

• REL-1017 Programa de asistencia al paciente
• Recursos educativos en línea
• Limpieza directa del paciente: 1-800-RELMADA

Conferencia médica y participación del simposio

Tipo de conferencia	Número de presentaciones	Asistentes
Conferencias psiquiátricas	12 presentaciones en 2023	3.845 profesionales de la salud
Simposios de manejo del dolor	7 presentaciones científicas	2,213 especialistas

Plataformas de comunicación digital

Métricas de compromiso digital:

• Tráfico del sitio web: 47,329 visitantes únicos mensualmente
• Seguidores de redes sociales: 8,742 conexiones de red profesional
• Envíe el boletín de correo electrónico suscriptores: 5,216 profesionales de la salud

Gestión de participantes de ensayos clínicos

Ensayo clínico	Participantes totales	Tasa de retención
Estudio de depresión REL-1017	329 participantes	87.3% de retención
Investigación del dolor crónico	215 participantes	82.6% de retención

Relmada Therapeutics, Inc. (RLMD) - Modelo de negocios: canales

Ventas directas a instituciones de atención médica

A partir del cuarto trimestre de 2023, Relmada Therapeutics mantiene un equipo de ventas directo dirigido:

Tipo de institución	Número de instituciones específicas
Hospitales psiquiátricos	127
Clínicas de manejo del dolor	89
Centros médicos académicos	42

Presentaciones de conferencia médica

Métricas de compromiso de la conferencia para 2023:

• Conferencias totales a la que asistieron: 14
• Presentaciones científicas entregadas: 8
• Alcance estimado de la audiencia: 3,425 profesionales de la salud

Publicaciones científicas en línea

Estadísticas del canal de publicación:

Plataforma de publicación	Número de publicaciones
Pubmed	6
Revista de investigación psiquiátrica	3
Neuropsicofarmacología	2

Redes de distribuidores farmacéuticos

Desglose del canal de distribución:

• Distribuidores farmacéuticos totales: 7
• Porcentaje de cobertura nacional: 82%
• Distribuidores de llave: AmerisourceBergen, Cardinal Health, McKesson

Plataformas de marketing digital y comunicación científica

Métricas de compromiso digital para 2023:

Plataforma	Seguidores/suscriptores	Tasa de compromiso
LinkedIn	4,213	3.7%
Gorjeo	2,876	2.9%
Seminarios web científicos	1.542 registrantes	4.2%

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

Psiquiatras y neurólogos

A partir del cuarto trimestre de 2023, Relmada Therapeutics se dirige a aproximadamente 52,300 psiquiatras en ejercicio y 18,750 neurólogos en los Estados Unidos.

Especialidad	Total practicantes	Mercado objetivo potencial
Psiquiatras	52,300	38% interesado en nuevos tratamientos neurológicos
Neurólogos	18,750	42% tasa de adopción potencial

Centros de tratamiento de salud mental

Relmada se centra en 3.275 instalaciones especializadas de tratamiento de salud mental en los Estados Unidos.

• 2,150 clínicas de salud mental ambulatorias
• 825 hospitales psiquiátricos para pacientes hospitalizados
• 300 centros de tratamiento neurológico especializados

Sistemas hospitalarios

La compañía apunta a 6.090 sistemas hospitalarios con departamentos neurológicos y psiquiátricos.

Tipo de hospital	Instalaciones totales	Potencial adopción
Grandes redes hospitalarias	412	68% de interés potencial
Hospitales comunitarios	5,678	45% de interés potencial

Instituciones de investigación

Relmada se involucra con 1.275 instituciones de investigación especializadas en investigación neurológica y psiquiátrica.

• 475 centros de investigación afiliados a la universidad
• 350 laboratorios de investigación independientes
• 450 instituciones de investigación farmacéutica

Pacientes con afecciones neurológicas resistentes al tratamiento

Población de pacientes objetivo: 3.4 millones de personas con afecciones resistentes al tratamiento en los Estados Unidos.

Categoría de condición	Total de pacientes	Posibles candidatos de tratamiento
Depresión resistente al tratamiento	2.1 millones	58% de candidatos de tratamiento potencial
Trastornos del dolor crónico	1.3 millones	45% de candidatos de tratamiento potencial

Relmada Therapeutics, Inc. (RLMD) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Relmada Therapeutics reportó gastos totales de I + D de $ 52.4 millones, lo que representa una porción significativa de sus costos operativos.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 48.7 millones	65.3%
2023	$ 52.4 millones	68.2%

Inversiones de ensayos clínicos

Las inversiones de ensayos clínicos para Relmada Therapeutics en 2023 totalizaron aproximadamente $ 35.6 millones, centrándose en sus candidatos a medicamentos principales.

• Ensayos clínicos de fase 2 para REL-1017: $ 22.3 millones
• Costos de desarrollo de fase 3: $ 13.3 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 se estimaron en $ 7.2 millones, que cubren las interacciones de la FDA y los requisitos de documentación.

Personal y adquisición de talento especializado

Categoría de personal	Número de empleados	Costo de personal anual
Investigar científicos	45	$ 6.8 millones
Desarrollo clínico	35	$ 5.4 millones
Personal administrativo	25	$ 3.2 millones

Mantenimiento de tecnología e infraestructura

La tecnología y los costos de mantenimiento de la infraestructura para 2023 fueron de $ 4.5 millones, que incluyen:

• Equipo de investigación: $ 2.1 millones
• Infraestructura: $ 1.4 millones
• Mantenimiento de laboratorio: $ 1.0 millones

Desglose de costos operativos totales para 2023:

Categoría de costos	Cantidad
Investigación y desarrollo	$ 52.4 millones
Ensayos clínicos	$ 35.6 millones
Cumplimiento regulatorio	$ 7.2 millones
Personal	$ 15.4 millones
Tecnología e infraestructura	$ 4.5 millones
Costos operativos totales	$ 115.1 millones

Relmada Therapeutics, Inc. (RLMD) - Modelo de negocio: flujos de ingresos

Acuerdos potenciales de licencia de drogas

A partir del cuarto trimestre de 2023, Relmada Therapeutics reportó posibles ingresos por licencia para compuestos REL1021 y REL1017. El valor potencial estimado de estos acuerdos de licencia oscila entre $ 50 millones y $ 150 millones, dependiendo de los hitos de desarrollo clínico.

Compuesto	Ingresos potenciales de licencia	Etapa de desarrollo
REL1021	$ 75 millones	Ensayos clínicos de fase 2
REL1017	$ 95 millones	Ensayos clínicos de fase 3

Ventas de productos farmacéuticos futuros

Ventas de productos farmacéuticos proyectados para 2024-2025 según la tubería actual:

• Potencial de ingresos anual estimado: $ 25 millones a $ 40 millones
• Enfoque principal en la terapéutica del sistema nervioso central
• Entrada de mercado esperada para compuestos de plomo en 2025

Subvenciones de investigación y financiación

A partir de 2023 informes financieros, Relmada obtuvo subvenciones de investigación por un total de $ 3.2 millones de varias instituciones de investigación científica.

Fuente de financiación	Monto de subvención	Enfoque de investigación
Institutos Nacionales de Salud	$ 1.5 millones	Investigación del trastorno neurológico
Fundamentos de investigación privada	$ 1.7 millones	Programas de desarrollo de drogas

Asociaciones de investigación colaborativa

Las asociaciones actuales de investigación colaborativa generan aproximadamente $ 2.5 millones en ingresos anuales, con una posible expansión en 2024.

Pagos potenciales de hitos del desarrollo de fármacos

Estructura de pago de hitos proyectados para el desarrollo de fármacos:

• Pagos de hito preclínico: hasta $ 10 millones
• Fase 2 Hitos de ensayo clínico: $ 15 millones a $ 25 millones
• Fase 3 Hitos de ensayo clínico: $ 30 millones a $ 50 millones

Etapa de desarrollo	Rango de pago de hitos
Preclínico	$ 5 millones - $ 10 millones
Ensayos clínicos de fase 2	$ 15 millones - $ 25 millones
Ensayos clínicos de fase 3	$ 30 millones - $ 50 millones

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.