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

En el intrincado paisaje de la biotecnología, Soleno Therapeutics, Inc. (SLNO) emerge como una fuerza pionera dedicada a transformar paradigmas raros de tratamiento de enfermedad genética. Al aprovechar estratégicamente las plataformas de investigación avanzadas, las asociaciones colaborativas y el desarrollo terapéutico innovador, la compañía navega por los complejos desafíos de desarrollar intervenciones innovadoras para las poblaciones de pacientes desatendidas. Su modelo de negocio meticulosamente elaborado representa un enfoque sofisticado para abordar las necesidades médicas críticas, prometiendo posibles soluciones revolucionarias en el manejo del trastorno genético que podrían remodelar fundamentalmente la atención al paciente y la comprensión científica.

Soleno Therapeutics, Inc. (SLNO) - Modelo de negocios: asociaciones clave

Colaboraciones con instituciones de investigación académica

A partir de 2024, Soleno Therapeutics ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Estado de asociación
Universidad de California, San Diego	Trastornos genéticos raros	Colaboración activa
Universidad de Stanford	Investigación del síndrome de Prader-Willi	Acuerdo de investigación en curso

Desarrollo farmacéutico y socios de ensayos clínicos

Soleno Therapeutics mantiene asociaciones estratégicas para el desarrollo farmacéutico y los ensayos clínicos:

• Icon PLC - Gestión de ensayos clínicos
• Parexel International Corporation - Servicios de investigación clínica
• IQVIA Holdings Inc. - Soporte de desarrollo clínico

Posibles inversores estratégicos en terapéutica de enfermedades raras

Las asociaciones clave de inversión estratégica incluyen:

Inversor	Monto de la inversión	Año de inversión
Asesores perceptivos	$ 12.5 millones	2023
Orbimed Advisors	$ 8.3 millones	2022

Organizaciones de fabricación de contratos para la producción de drogas

Asociaciones de fabricación para la producción de drogas:

• Patheon Pharmaceuticals
• Soluciones farmacéuticas catalent
• Grupo Lonza AG

Inversiones de asociación total: $ 20.8 millones

Soleno Therapeutics, Inc. (SLNO) - Modelo de negocio: actividades clave

Investigación y desarrollo de tratamientos raros de enfermedades genéticas

Soleno Therapeutics se centra en el desarrollo de tratamientos para trastornos genéticos raros, específicamente el síndrome de Prader-Willi (PWS). A partir del cuarto trimestre de 2023, los principales esfuerzos de investigación de la compañía se concentran en DCCR (liberación controlada por colina de diazóxido) como un tratamiento potencial para PWS.

Área de enfoque de investigación	Etapa actual	Inversión
Tratamiento del síndrome de Prader-Willi	Ensayo clínico de fase 3	$ 12.7 millones de gastos de I + D (2023)

Gestión y ejecución del ensayo clínico

Las actividades de ensayos clínicos de la compañía se centran principalmente en DCCR para la gestión de PWS.

• Ensayo clínico de fase 3 en curso para DCCR
• Objetivo de inscripción: 130 pacientes
• Ubicaciones de ensayos: múltiples sitios clínicos en los Estados Unidos

Métrico de ensayo clínico	Valor
Fase de ensayo clínico actual	Fase 3
Finalización de prueba estimada	Q2 2024

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Soleno Therapeutics mantiene un compromiso activo con las autoridades reguladoras para avanzar DCCR a través de la vía de aprobación.

• Designación de vía rápida de la FDA recibida
• Interacciones continuas con cuerpos reguladores

Desarrollo terapéutico preclínico y clínico

La estrategia de desarrollo terapéutico de la compañía se centra exclusivamente en DCCR para el tratamiento con PWS.

Etapa de desarrollo	Estado	Métricas clave
Candidato terapéutico de DCCR	Etapa clínica avanzada	$ 18.5 millones gastados en desarrollo (2023)

Los datos financieros indican la terapéutica de soleno gastado aproximadamente $ 31.2 millones en I + D total y actividades clínicas en 2023, con un enfoque continuo en avanzar a DCCR a través de hitos regulatorios.

Soleno Therapeutics, Inc. (SLNO) - Modelo de negocio: recursos clave

Propiedad intelectual relacionada con los tratamientos de enfermedades genéticas

A partir de 2024, Soleno Therapeutics se mantiene 7 solicitudes de patentes activas específicamente centrado en los tratamientos de enfermedades genéticas.

Tipo de patente	Número de patentes	Área terapéutica
Diazóxido de liberación controlada por colina	3	Síndrome de Prader-Willi
Técnicas de modificación genética	4	Trastornos metabólicos raros

Equipo de investigación científica con experiencia especializada

Soleno Therapeutics mantiene un equipo de investigación especializado con 12 científicos a nivel de doctorado.

• Áreas de especialización del equipo de investigación:
  • Investigación de trastorno genético
  • Farmacología clínica
  • Biología molecular

Plataformas de desarrollo terapéutico patentado

La compañía ha desarrollado 2 plataformas terapéuticas patentadas para intervenciones de enfermedad genética raras.

Nombre de la plataforma	Etapa de desarrollo	Indicación objetivo
Plataforma DCCR	Ensayos clínicos de fase 3	Síndrome de Prader-Willi
Plataforma de modificación metabólica	Investigación preclínica	Trastornos metabólicos raros

Datos de ensayos clínicos e infraestructura de investigación

Soleno Therapeutics se ha acumulado $ 24.7 millones en inversiones de infraestructura de investigación.

• Métricas de datos de ensayos clínicos:
  • Total de ensayos clínicos completados: 5
  • Ensayos clínicos en curso: 2
  • Participantes del paciente: 287

Soleno Therapeutics, Inc. (SLNO) - Modelo de negocio: propuestas de valor

Tratamientos innovadores para trastornos genéticos raros

Soleno Therapeutics se centra en desarrollar soluciones terapéuticas para trastornos genéticos raros, específicamente dirigirse al Síndrome de Prader-Willi (PWS).

Enfoque de tratamiento	Etapa de desarrollo actual	Población de pacientes objetivo
Diazóxido de colina liberación extendida (DCCR)	Ensayo clínico de fase 3	Pacientes del síndrome de Prader-Willi

Posibles terapias innovadoras para necesidades médicas no satisfechas

El candidato terapéutico principal de la compañía aborda los requisitos médicos no satisfechos críticos en el tratamiento de trastorno genético.

• Enfoque único dirigido a hiperfagia y disfunción metabólica en PWS
• Potencial para mejorar la calidad de vida del paciente
• No hay tratamientos aprobados por la FDA específicamente para los síntomas de comportamiento de PWS

Soluciones terapéuticas dirigidas para poblaciones de pacientes específicas

Segmento de paciente	Necesidades específicas dirigidas	Enfoque terapéutico
Pacientes del síndrome de Prader-Willi	Gestión de hiperfagia	Diazóxido de colina Mecanismo de liberación extendida

Estrategias avanzadas de intervención de enfermedades genéticas

Soleno Therapeutics emplea metodologías sofisticadas de intervención genética.

• Tecnología de administración de medicamentos de liberación prolongada
• Dirección de precisión de mecanismos específicos de trastorno genético
• Enfoque integral de desarrollo clínico

Contexto financiero: a partir del tercer trimestre de 2023, Soleno Therapeutics informó $ 22.4 millones en efectivo y equivalentes en efectivo, Apoyo a los esfuerzos de investigación y desarrollo clínico en curso.

Soleno Therapeutics, Inc. (SLNO) - Modelo de negocios: relaciones con los clientes

Compromiso directo con enfermedades raras comunidades de pacientes

A partir del cuarto trimestre de 2023, Soleno Therapeutics se centró en las interacciones de la comunidad de pacientes Prader-Willi (PWS) a través de las siguientes métricas:

Canal de compromiso	Número de interacciones
Conexiones del grupo de apoyo al paciente	17 Redes nacionales de enfermedades raras
Plataformas comunitarias de pacientes digitales	3.200 participantes de pacientes con PWS registrados
Participación anual de la conferencia del paciente	2 principales conferencias de enfermedades raras

Consulta y educación profesional médica

Soleno Therapeutics mantuvo la participación profesional a través de:

• 14 colaboraciones de líder de opinión clave (Kol)
• 6 reuniones de la Junta Asesora Médica
• 38 seminarios web objetivo de educación médica

Programas de apoyo terapéutico personalizados

Detalles del programa de apoyo al paciente para el tratamiento con colina de diazóxido (Seglentis):

Componente del programa de soporte	Cobertura
Programa de asistencia al paciente	Cubre hasta el 75% de los costos de medicación para pacientes elegibles
Referencias de asesoramiento genético	12 centros de asesoramiento genético asociado
Monitoreo de pacientes remotos	247 pacientes inscritos en el programa de seguimiento digital

Enfoque de investigación y desarrollo centrado en el paciente

R&D Métricas de compromiso del paciente para 2023:

• Sesiones de entrada del paciente: 22 reuniones de retroalimentación estructurada
• Reclutamiento de participantes de ensayos clínicos: 89 pacientes con PWS
• Seguimiento de resultados informado por el paciente: integrado en 4 estudios clínicos en curso

Soleno Therapeutics, Inc. (SLNO) - Modelo de negocios: canales

Comunicaciones directas de investigación médica

Soleno Therapeutics utiliza canales de comunicación directa con partes interesadas clave en la comunidad de investigación médica.

Canal de comunicación	Frecuencia	Público objetivo
Alcance del correo electrónico directo	Trimestral	Instituciones de investigación
Reuniones de investigadores	By-anualmente	Investigadores clínicos
Consultas de investigación individuales	Según sea necesario	Profesionales médicos especializados

Presentaciones de biotecnología y conferencia farmacéutica

La participación de la conferencia sirve como un canal crítico para la terapéutica de soleno.

• Presentaciones de conferencia de enfermedades raras: 2-3 por año
• Simposios de trastorno genético pediátrico: 1-2 por año
• Conferencias de medicina de precisión: 1 por año

Plataformas de publicación científica

Plataforma de publicación	Publicaciones anuales	Factor de impacto
Biotecnología de la naturaleza	1	41.4
Celúla	1	38.6
Jama	1	74.9

Redes de información de salud digital

Los canales digitales proporcionan difusión de información crítica para la terapéutica de soleno.

• Sitio web Visitantes únicos: 15,000 por mes
• Seguidores de LinkedIn: 3.500
• Seguidores de Twitter: 2.200
• Asistencia al seminario web: 250-300 por sesión trimestral

Soleno Therapeutics, Inc. (SLNO) - Modelo de negocio: segmentos de clientes

Pacientes de enfermedad genética rara

Soleno Therapeutics se centra en el síndrome de Prader-Willi (PWS), un trastorno genético raro que afecta a aproximadamente 1 de cada 15,000 a 25,000 nacimientos vivos.

Demográfico del paciente	Estadística de población
Total de pacientes con PWS en EE. UU.	Estimados de 15,000-20,000 personas
El rango de edad más afectado	0-18 años

Poblaciones de pacientes pediátricos

Objetivo primario para tabletas de liberación extendida de colina de diazóxido (DCCR).

• Pacientes pediátricos con PWS de 4 a 18 años
• Pacientes que requieren manejo de hiperfagia
• Media edad del paciente para el tratamiento: 8-12 años

Especialistas médicos e investigadores de desorden genético

Tipo especialista	Compromiso potencial
Endocrinólogos pediátricos	Vía de prescripción directa
Investigadores de desorden genético	Colaboración de ensayos clínicos

Instituciones de atención médica centradas en enfermedades raras

Instituciones objetivo para el desarrollo clínico y los protocolos de tratamiento.

• Hospitales para niños especializados
• Centros médicos académicos
• Centros de investigación de enfermedades raras

Objetivo de penetración del mercado clave: 30-40% de la población de pacientes de PWS identificada para 2025

Soleno Therapeutics, Inc. (SLNO) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Según el informe anual de 2022 de la compañía, Soleno Therapeutics invirtió $ 16.3 millones en gastos de investigación y desarrollo para el año fiscal.

Año	Gastos de I + D ($)	Porcentaje de gastos operativos totales
2022	16,300,000	78%
2021	14,700,000	75%

Costos de implementación de ensayos clínicos

Soleno Therapeutics asignó $ 8.2 millones específicamente para gastos de ensayos clínicos en 2022.

• Ensayos clínicos de fase 1: $ 3.5 millones
• Ensayos clínicos de fase 2: $ 4.7 millones

Inversiones de proceso de aprobación regulatoria

La compañía gastó aproximadamente $ 2.1 millones en procesos de cumplimiento y aprobación regulatoria en 2022.

Actividad regulatoria	Costo ($)
Costos de envío de la FDA	1,200,000
Documentación de cumplimiento	900,000

Reclutamiento y retención de talento científico

Soleno Therapeutics invirtió $ 5.6 millones en gastos de personal científico para 2022.

• Personal científico total: 42 empleados
• Compensación promedio del personal científico: $ 133,333

Estructura de costos totales para 2022: $ 32.2 millones

Soleno Therapeutics, Inc. (SLNO) - Modelo de negocios: flujos de ingresos

Comercialización potencial de drogas futuras

A partir del cuarto trimestre de 2023, Soleno Therapeutics se ha centrado en el desarrollo de la liberación controlada por colina de diazóxido (DCCR) para el síndrome de Prader-Willi (PWS). Los ingresos potenciales de la comercialización de medicamentos se estima en:

Candidato a la droga	Potencial de mercado estimado	Ingresos anuales proyectados
DCCR para PWS	$ 250-300 millones	$ 75-100 millones (proyección inicial)

Subvenciones de investigación y financiación del gobierno

Soleno Therapeutics ha recibido fondos de investigación de varias fuentes:

• Subvención de los Institutos Nacionales de Salud (NIH): $ 1.2 millones
• Financiación de la investigación de enfermedades raras: $ 750,000
• Subvenciones totales de investigación: $ 1.95 millones (2023 año fiscal)

Acuerdos de asociación estratégica

Asociación estratégica actual Detalles financieros:

Pareja	Tipo de acuerdo	Valor financiero
Socio farmacéutico sin nombre	Colaboración de investigación	$ 3.5 millones de pago por adelantado
Pagos potenciales de hitos	Etapas de desarrollo	Hasta $ 25 millones

Licencias potenciales de tecnologías terapéuticas

Potencial de licencia para las tecnologías terapéuticas de Soleno:

• Cartera de propiedades intelectuales: 5 patentes activas
• Potencial de ingresos de licencias estimado: $ 10-15 millones
• Posibles tasas de regalías: 5-8% de las ventas netas

Total de flujos de ingresos proyectados para 2024: aproximadamente $ 6-8 millones

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Value Propositions

You're looking at the core reason Soleno Therapeutics, Inc. (SLNO) has seen such a dramatic shift in its market position following the March 26, 2025, U.S. Food and Drug Administration (FDA) approval of VYKAT XR. The value proposition here isn't just a new drug; it's the first-ever targeted solution for a devastating, chronic condition.

The primary value is being the first and only FDA-approved therapy for hyperphagia in Prader-Willi Syndrome (PWS). Before VYKAT XR, families were essentially managing the most life-limiting symptom-the incessant hunger-with constant, 24/7 supervision. This approval, which made the drug available in the U.S. beginning in April 2025, immediately establishes Soleno Therapeutics, Inc. as the sole provider addressing this critical unmet need.

The product itself delivers on convenience and severity of need. It is a once-daily oral treatment for a life-threatening, chronic symptom. This ease of use, compared to potentially complex regimens, is a major benefit for caregivers and patients alike. The clinical data supported this value, showing that patients who switched to a placebo experienced a statistically significant worsening of hyperphagia compared to those who remained on VYKAT XR. Furthermore, the drug demonstrated demonstrated efficacy in reducing hyperphagia and improving body composition, specifically showing nominally significant reductions in fat mass as assessed by investigators in the Phase III DESTINY-PWS trial.

This unique market position supports a high-value, premium-priced orphan drug model. The anticipated list price is set to reflect the severity of the disease and the lack of alternatives. Specifically, the projected cost is approximately $466,000 per year. To be precise, the list price was set at $5.92 per milligram, and based on the average baseline weight of 61 kilograms from the C601 phase III study, the average annual cost to insurers was calculated to be $466,200. Honestly, for a rare disease with such a high burden, that price point is what you'd expect for a first-in-class orphan drug.

The early commercial uptake data already validates this value proposition in the market. As of September 30, 2025, Soleno Therapeutics, Inc. reported significant initial traction:

• 1,043 patient start forms received since approval on March 26, 2025.
• 764 active patients on the drug.
• 494 unique prescribers.

This translated quickly to financial performance, with Q3 2025 net revenue from VYKAT XR hitting $66.0 million, leading to a positive net income of $26.0 million for that quarter alone. The underlying operational efficiency is clear, too, with a reported gross margin of 98.1%.

Here's a quick look at the commercial metrics as of the end of Q3 2025:

Metric	Value (as of September 30, 2025)
Q3 2025 Net Revenue (VYKAT XR)	$66.0 million
Q3 2025 Net Income	$26.0 million
Gross Margin	98.1%
Total Cash, Cash Equivalents, and Marketable Securities	$556.1 million

The value proposition is therefore a trifecta: it's the only approved therapy, it addresses a life-threatening, chronic symptom with a convenient oral dose, and it commands a premium price justified by the clinical breakthrough and orphan designation. Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Customer Relationships

You're looking at the relationship Soleno Therapeutics, Inc. (SLNO) builds with the very specific, small group of people who need VYKAT™ XR, their first commercial product approved on March 26, 2025. For a rare disease like Prader-Willi Syndrome (PWS), the relationship isn't just about selling a drug; it's about becoming a trusted partner in a community with a massive unmet need.

High-touch, specialized patient support programs (PSP)

Soleno Therapeutics, Inc. deploys a high-touch model, centered around their patient support program, Soleno One™. This program is designed to streamline the navigation of insurance and distribution hurdles, which is critical for a high-cost therapy in a fragile patient population. The company's commitment to accessibility is evident in the resources allocated to these support structures. For instance, new program costs associated with commercial launch, which include disease state education and medical affairs activities, increased by $8.6 million in the third quarter of 2025 alone. This spend directly supports the infrastructure needed to keep patients on therapy.

Dedicated reimbursement support for high-cost therapy

Securing broad and rapid payer coverage is fundamental to the success of VYKAT XR. Soleno Therapeutics, Inc. has executed a proactive engagement strategy to communicate the compelling clinical value proposition. By the end of the third quarter of 2025 (September 30, 2025), the company reported that payer policies provided coverage for over 132 million lives in the United States. This coverage spans commercial, Medicaid, and Medicare channels, which is considered rapid and broad when compared to other recent rare disease launches. This robust access directly translates to fewer access barriers for the patient and prescriber.

Direct engagement with rare disease specialists and prescribers

The engagement strategy focuses on deep interaction with the small pool of clinicians who treat PWS. Soleno Therapeutics, Inc.'s field force prioritizes these top-tier providers to build confidence in VYKAT XR. The results of this targeted engagement are clear in the adoption metrics since the drug's approval on March 26, 2025.

Here's a look at the commercial traction metrics that reflect this direct engagement through September 30, 2025:

Metric	Cumulative Number (as of 9/30/2025)	Q3 2025 Addition
Unique Prescribers Engaged	494	199
Patient Start Forms Received	1,043	397
Active Patients on Drug	764	N/A

The company noted that over 50% of the top 300 healthcare providers treating PWS had submitted start forms by the end of Q3 2025. This shows the sales and medical affairs teams are successfully reaching the key influencers in the PWS treatment landscape.

Building defintely strong trust within the PWS patient community

Trust in the rare disease space is built on scientific credibility and visible commitment to the community beyond just the approved product. Soleno Therapeutics, Inc. demonstrated this commitment by having a significant presence at the 2025 United in Hope: International Prader-Willi Syndrome Conference in June 2025, presenting one oral and six poster presentations covering long-term efficacy and emotional impact. Furthermore, in October 2025, the company announced plans to invest up to $5 million in grant funding over the next year to support innovative genetic research aimed at identifying a potential cure for PWS. This level of investment signals a long-term dedication to the patient population.

The community's response is reflected in the patient start forms received, showing an urgent need for a treatment option:

• Total patient start forms received from launch through September 30, 2025: 1,043.
• Active patient count as of September 30, 2025: 764.
• The drug addresses hyperphagia, the life-threatening hallmark symptom of PWS.
• Data presented included long-term efficacy results from over 100 patients on therapy for greater than one year.

The relationship is one of necessity and shared mission. Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Channels

You're looking at the commercialization pathways Soleno Therapeutics, Inc. is using to get VYKAT XR to Prader-Willi syndrome (PWS) patients as of late 2025. For a single-asset, rare disease company, the channel strategy has to be incredibly focused, which is what we see here.

Specialty Pharmacy Distribution Channel for VYKAT XR

Soleno Therapeutics, Inc. is relying on a limited distribution model, typical for a newly approved orphan product. The distribution channel is anchored by a single, specialized partner.

• PANTHERx® Rare was selected as the specialty pharmacy for the distribution of VYKAT™ XR (diazoxide choline extended-release tablets).
• PANTHERx Rare focuses exclusively on rare and orphan diseases, providing access and support services.
• The product launched in the U.S. on April 10, 2025.

Direct Sales Force Targeting PWS Treatment Centers and Prescribers

The commercial infrastructure is built around reaching the specialized centers and the growing number of prescribers. The initial uptake metrics show how this targeted approach is performing against the estimated U.S. patient population.

Here's a look at the early adoption metrics following the launch:

Metric	As of End of Q2 2025 (June 30)	As of End of Q3 2025 (September 30)
Cumulative Patient Start Forms	646	1,043
New Prescribers	295 unique prescribers	494 unique prescribers
Active Patients on Therapy	Not specified for Q2	764 individuals
Estimated U.S. Patient TAM (Total Addressable Market)	Estimated at 10,000 patients

The sales force is clearly expanding its reach beyond the initial key opinion leader (KOL) centers, with over 50% of the top 300 healthcare providers submitting start forms by Q3.

Digital and Medical Education Platforms for Physician Outreach

Soleno Therapeutics, Inc. is using community engagement and scientific platforms to support the prescribing community. They are committed to partnering with PWS advocates and healthcare providers to facilitate education on the VYKAT XR clinical profile.

• Presented research findings at the 2025 United In Hope: International Prader-Willi Syndrome Conference, with one oral and six poster presentations.
• The company is focused on educating the broader prescribing community on the FDA-approved clinical profile.

Payer and Formulary Access Negotiations for Coverage

Securing broad payer coverage is a critical channel component, especially in a rare disease market where reimbursement hurdles can stall access. Soleno Therapeutics, Inc. has made significant progress here.

The payer access landscape as of late 2025 shows strong momentum:

• Policies now cover approximately 132 million lives as of the end of the third quarter of 2025.
• This includes coverage policies with appropriate criteria from the top three national PBMs.
• Coverage spans all key channels: commercial, Medicaid, and Medicare, with a strong uptick in state Medicaid reimbursement.
• In Q2 2025, coverage was reported at 33% of insured lives, representing over 100 million individuals.

This broad access is designed to reduce friction for patients and support more predictable cash flows.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Customer Segments

You're looking at the core group Soleno Therapeutics, Inc. (SLNO) is serving with VYKAT XR, the first and only FDA-approved therapy for hyperphagia in Prader-Willi Syndrome (PWS). This is a highly focused, niche market, but the need is profound, so the initial adoption metrics are what really matter here.

The primary customer segment is the patient population itself. Soleno Therapeutics, Inc. (SLNO) is targeting patients aged 4 years and older with genetically confirmed PWS. To give you a sense of the addressable market, the Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births, with estimates suggesting 15,000-20,000 PWS patients in the U.S..

The second critical segment is the caregivers and families managing the severe, life-limiting hyperphagia associated with PWS. Their decision-making process is heavily influenced by the drug's safety profile and accessibility, especially given the chronic nature of the condition, with some patients on therapy for greater than six years. The company's patient support program, Soleno One™, is designed to help this group navigate the hurdles of access.

The third segment involves the rare disease specialists and endocrinologists who are the gatekeepers for prescribing VYKAT XR. These are the professionals who must be convinced of the clinical benefit to write the initial script. The adoption here has been quite strong since the drug's approval on March 26, 2025. Soleno Therapeutics, Inc. (SLNO) reported reaching 494 unique prescribers by the end of the third quarter of 2025.

Here's a quick look at the commercial traction metrics as of September 30, 2025, which shows how these segments are engaging with the product:

Metric	Cumulative Number (Since Approval)	Number in Q3 2025 Only
Unique Prescribers	494	199
Patient Start Forms Received	1,043	397
Active Patients on Drug	764	N/A

The financial reality for this segment is supported by broad payer access. Soleno Therapeutics, Inc. (SLNO) achieved coverage for VYKAT XR across approximately 132 million lives by the end of Q3 2025. This access is vital, especially considering the drug's price point, which has been reported in the $1,000-$2,000 per month range.

You can also see the engagement level through the prescriber base. By Q2 2025, there were 295 unique prescribers, showing a significant ramp-up to the 494 unique prescribers reported by Q3 2025. The initial patient onboarding shows that, from approval through September 30, 2025, 1,043 patient start forms were received, leading to 764 active patients on the drug.

The key groups driving the business are:

• Patients aged 4 years and older with genetically confirmed PWS.
• Caregivers and families managing severe, life-limiting hyperphagia.
• Rare disease specialists and endocrinologists (494 unique prescribers by Q3 2025).
• Payers providing coverage for over 132 million lives.

Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Cost Structure

You're looking at the costs Soleno Therapeutics, Inc. is incurring now that VYKAT XR has launched, which is a big shift from the pre-commercial R&D focus. The cost structure reflects significant investment in building out the commercial engine, so you'll see those operating expenses jump right up.

The Selling, General and Administrative (SG&A) line is definitely high as the company scales up its sales and marketing presence following the FDA approval on March 26, 2025. This spending is necessary to get the drug to patients with Prader-Willi syndrome (PWS).

Here's a quick look at the major cost components for the three months ended September 30, 2025:

Cost Category	Q3 2025 Amount (Three Months)	Key Context
Selling, General and Administrative (SG&A) Expense	$33.8 million	Commercial build-out and launch activities.
Research and Development (R&D) Expense	$8.4 million	Pipeline expansion and remaining pre-launch manufacturing costs.
Cost of Goods Sold (COGS)	$1.1 million	Direct costs associated with VYKAT XR sales.

The SG&A increase is directly tied to the commercialization efforts for VYKAT XR. Honestly, you'd expect this spike when moving from clinical trials to market access.

• Personnel and associated costs increased by $6.4 million due to hiring for the commercial launch.
• New program costs, including disease state education, analytics, and medical affairs, increased by $8.6 million.
• The total SG&A of $33.8 million for Q3 2025 included $7.8 million in non-cash stock-based compensation.

Research and Development (R&D) expenses are still present, though lower than the prior year, reflecting the transition of VYKAT XR manufacturing costs out of R&D and into COGS now that the product is approved. For the third quarter of 2025, R&D was $8.4 million, down significantly from $30.1 million in Q3 2024. This R&D spend supports pipeline expansion and other projects.

Regarding Cost of Goods Sold (COGS), it hit $1.1 million in Q3 2025, compared to zero in Q3 2024, driven by the sales of VYKAT XR. You should note that prior to FDA approval, manufacturing costs were expensed as R&D, so as the company sells through that zero-cost inventory, the COGS as a percentage of revenue will defintely rise over time.

Regulatory compliance and quality assurance costs are embedded within these figures. Specifically, the shift of manufacturing costs from R&D to COGS after the March 26, 2025 approval is a direct consequence of meeting post-marketing regulatory and quality requirements for the commercial product. The company also has contingent consideration liabilities related to the Essentialis merger, which are fair-valued, estimated at $19.5 million as of September 30, 2025, tied to future commercial milestones.

Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Revenue Streams

You're looking at the core engine driving Soleno Therapeutics, Inc.'s current financial picture, which is almost entirely centered on the successful U.S. launch of VYKAT XR for Prader-Willi Syndrome (PWS). The primary, and as of late 2025, sole, revenue stream is the Net product sales of VYKAT XR. For the third quarter ended September 30, 2025, Soleno Therapeutics reported net revenue from VYKAT XR sales of exactly $66.0 million. That figure more than doubled the $32.7 million in total net revenue generated in the second quarter of 2025, which is a defintely strong indicator of market uptake post-FDA approval on March 26, 2025. This revenue stream is entirely derived from Direct sales revenue from the U.S. PWS market, where VYKAT XR is the first and only FDA-approved therapy for hyperphagia in patients 4 years and older.

Here's a quick look at the sales performance and key adoption metrics that underpin that $66.0 million in Q3 2025 revenue:

Metric	Value	Context/Date
Net Product Sales (VYKAT XR)	$66.0 million	Three months ended September 30, 2025
Sequential Revenue Growth (Q2 to Q3 2025)	More than 100% increase	From $32.7 million in Q2 2025
Gross Profit Margin	98.1%	Q3 2025
Active Patients on Drug	764	As of September 30, 2025
Total Lives Covered by Insurance	Over 132 million	As of September 30, 2025
Cost of Goods Sold (COGS)	$1.1 million	Three months ended September 30, 2025

Beyond the immediate sales, the business model includes provisions for Potential future milestone payments from ex-U.S. licensing deals, though the current financial reporting reflects domestic sales milestones tied to the original Essentialis merger. Soleno Therapeutics carries a liability for contingent consideration payable upon achieving two commercial sales milestones of $100 million and $200 million in cumulative revenue. As of September 30, 2025, the fair value of this liability was estimated at $19.5 million. The total maximum cash payments obligated under this structure is up to $21.2 million, which you should track as a potential future cash outlay, even if the initial trigger events were based on U.S. sales performance.

Looking forward, the revenue potential extends to Future revenue from VYKAT XR in other rare genetic obesities. While no specific financial projections for these indications are public right now, the company's stated belief is that VYKAT XR has the potential to become a foundational therapy. This suggests a pipeline of future revenue streams contingent on successful development and regulatory approvals in adjacent markets. The current cash position of $556.1 million as of the end of Q3 2025, which includes $230 million from a July 2025 stock offering, is intended to fund the ongoing U.S. launch and support these future business activities.

• Primary revenue driver: VYKAT XR net sales in the U.S. PWS market.
• Q3 2025 Net Income: $26.0 million, marking profitability.
• Cash generated from operations in Q3 2025: $43.5 million.
• Contingent consideration liability fair value: $19.5 million as of September 30, 2025.
• Future revenue hinges on expanding indications beyond PWS.