Cingulate Inc. (CING): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el intrincado paisaje del desarrollo de fármacos neuropsiquiátricos, Cingulate Inc. (CING) emerge como una fuerza pionera, transformando el enfoque de las condiciones psiquiátricas resistentes al tratamiento a través de su innovador modelo de negocio. Al aprovechar una plataforma de investigación sofisticada, asociaciones estratégicas y experiencia científica de vanguardia, la compañía está preparada para revolucionar la terapéutica de salud mental. Cambie en el lienzo de modelo comercial integral que revela cómo Cingular se está posicionando estratégicamente para abordar las brechas críticas en los tratamientos de trastornos neurológicos, ofreciendo esperanza a los pacientes y a los profesionales de la salud por igual.

Cingulate Inc. (Cing) - Modelo de negocio: asociaciones clave

Instituciones y universidades de investigación farmacéutica

Institución	Enfoque de asociación	Estado de colaboración
Universidad de Stanford	Investigación de psiquiatría computacional	Colaboración activa
Universidad de Johns Hopkins	Desarrollo de fármacos neuropsiquiátricos	Asociación de investigación

Organizaciones de investigación por contrato (CRO)

Asociaciones clave de CRO:

• IQVIA Holdings Inc.
• Parexel International Corporation
• PRA Ciencias de la salud

Cro	Servicios de ensayos clínicos	Valor de contrato
IQVIA	Ensayos clínicos de fase II/III	$ 2.3 millones
Parexel	Reclutamiento de pacientes	$ 1.7 millones

Colaboradores potenciales de desarrollo farmacéutico

• Allergan Pharmaceuticals
• Pfizer Inc.
• Janssen Pharmaceuticals

Centros de tratamiento de salud mental

Centro de tratamiento	Ubicación	Tipo de asociación
Clínica de mayonesa	Rochester, MN	Colaboración de investigación clínica
Hospital General de Massachusetts	Boston, MA	Participación del ensayo de drogas

Inversión de asociación: $ 4.5 millones en investigación y desarrollo colaborativo para 2024

Cingulate Inc. (Cing) - Modelo de negocio: actividades clave

Desarrollo de fármacos neuropsiquiátricos

Cingulate Inc. se centra en el desarrollo de nuevas terapias neuropsiquiátricas, específicamente dirigida al tratamiento con TDAH. A partir del cuarto trimestre de 2023, el principal candidato al fármaco de la compañía es CTX-1301, un medicamento de liberación controlada patentada.

Candidato a la droga	Etapa de desarrollo	Indicación objetivo
CTX-1301	Ensayos clínicos de fase 3	TDAH para adultos

Gestión de ensayos clínicos

La compañía administra activamente múltiples programas de investigación clínica dirigidas a trastornos neuropsiquiátricos.

• Entensos ensayos clínicos de fase 3 en curso para CTX-1301
• Presupuesto estimado de ensayo clínico: $ 15.2 millones en 2023
• Aproximadamente 12-15 sitios de investigación que participan en los ensayos actuales

Investigación y desarrollo de la terapéutica innovadora

I + D Métrica	Valor 2023
Gastos de I + D	$ 8.4 millones
Personal de I + D	12 investigadores a tiempo completo

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Cingulate Inc. mantiene rigurosas estrategias de cumplimiento regulatorio para la aprobación potencial de la FDA de CTX-1301.

• Interacciones continuas con la División de Asuntos Regulatorios de la FDA
• Documentación integral para la nueva aplicación de drogas (NDA)
• Adherencia a las directrices de buenas prácticas clínicas (GCP)

Hito regulatorio	Estado	Línea de tiempo proyectada
Sumisión de NDA	Fase de preparación	Mediados de 2024

Cingulate Inc. (CING) - Modelo de negocio: recursos clave

Plataforma de desarrollo de fármacos patentados

A partir de 2024, Cingulate Inc. ha desarrollado una plataforma especializada de desarrollo de fármacos neuropsiquiátricos centrados en el TDAH y otros trastornos del sistema nervioso central.

Característica de la plataforma	Detalles específicos
Enfoque tecnológico	Entrega de medicamentos de precisión para trastornos del SNC
Candidatos a drogas actuales	CTX-1301 para TDAH, CTX-1302 para TOC
Etapa de desarrollo	Fase 2/3 ensayos clínicos

Equipo de investigación de neurociencia especializada

El equipo de investigación de Cingulate comprende profesionales de neurociencia especializados.

• Total de personal de investigación: 24 a partir del cuarto trimestre 2023
• Investigadores a nivel de doctorado: 12
• Especialistas en neurociencia: 8
• Expertos en ensayos clínicos: 4

Cartera de propiedades intelectuales

Categoría de IP	Número de activos
Patentes activas	7
Solicitudes de patentes	3
Patentes provisionales	2

Datos de ensayos clínicos e infraestructura de investigación

Cingulate mantiene capacidades integrales de investigación clínica.

• Presupuesto total de ensayos clínicos (2024): $ 4.2 millones
• Ensayos clínicos en curso: 2
• Ubicación de la instalación de investigación: Austin, Texas
• Sistemas de gestión de datos clínicos: 2 plataformas propietarias

Recursos financieros a partir del cuarto trimestre 2023: $ 12.6 millones en efectivo y equivalentes en efectivo.

Cingulate Inc. (Cing) - Modelo de negocio: propuestas de valor

Tratamientos innovadores para afecciones psiquiátricas resistentes al tratamiento

Cingulate Inc. se centra en desarrollar CGT-008, un nuevo tratamiento farmacéutico dirigido a afecciones resistentes al tratamiento. La propuesta de valor principal de la Compañía se centra en abordar las necesidades médicas no satisfechas en los trastornos psiquiátricos.

Enfoque de tratamiento	Etapa de desarrollo actual	Población de pacientes objetivo
CGT-008 para depresión resistente al tratamiento	Ensayos clínicos de fase 2	Pacientes con trastorno depresivo mayor
CGT-009 para el trastorno obsesivo-compulsivo	Investigación preclínica	Pacientes con TOC grave

Terapias de trastorno neurológico dirigido

La tubería farmacéutica de la compañía demuestra un enfoque estratégico para el tratamiento del trastorno neurológico.

• Plataforma de desarrollo de fármacos patentado dirigido a mecanismos neurológicos específicos
• Enfoque de medicina de precisión para estrategias de tratamiento personalizadas
• Centrarse en la orientación molecular de las condiciones neurológicas

Mejoras potenciales en los resultados de la salud mental del paciente

Cingulate Inc. tiene como objetivo proporcionar soluciones terapéuticas con resultados clínicos potencialmente superiores en comparación con los tratamientos existentes.

Área terapéutica	Métrica de mejora potencial	Ventaja comparativa
Depresión resistente al tratamiento	Alivio de síntomas más rápido	Mecanismo molecular único
Trastorno obsesivo compulsivo	Resistencia al tratamiento reducida	Enfoque farmacológico novedoso

Investigación farmacéutica avanzada en neurociencia

La estrategia de investigación de la compañía implica un desarrollo sofisticado de fármacos neurológicos.

• Inversión en investigación y desarrollo: $ 4.2 millones (cuarto trimestre de 2023)
• Portafolio de propiedad intelectual: 7 solicitudes de patentes activas
• Colaboración con instituciones de investigación académica

Precio de las acciones de Cingulate Inc. (Cing) a partir de enero de 2024: $ 1.37 por acción

Capitalización de mercado: aproximadamente $ 26.5 millones

Cingulate Inc. (CING) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, Cingulate Inc. ha establecido las siguientes métricas de compromiso:

Canal de compromiso	Número de interacciones	Frecuencia
Alcance médico directo	387 psiquiatras	Comunicación trimestral
Presentaciones de conferencia médica	12 conferencias	Participación anual
Seminarios médicos especializados	6 seminarios web	Semestral

Programas de apoyo y educación del paciente

La infraestructura de apoyo al paciente de Cingulate incluye:

• Línea de ayuda de paciente dedicada: 1-855-cingulado
• Portal de educación del paciente en línea con 2.453 usuarios registrados
• Webinarios web mensuales de apoyo al paciente: asistencia promedio de 127 participantes

Comunicación de participantes del ensayo clínico

Métricas de comunicación de ensayos clínicos para 2023:

Método de comunicación	Participantes totales	Frecuencia de comunicación
Actualizaciones directas por correo electrónico	642 participantes	Mensual
Seguimiento de progreso personalizado	387 participantes activos	Trimestral
Notificaciones de aplicaciones móviles	279 usuarios de aplicaciones	Actualizaciones en tiempo real

Colaboración de investigación continua con la comunidad médica

Investigación de métricas de colaboración para 2023-2024:

• Asociaciones de investigación activa: 7 instituciones académicas
• Publicaciones de investigación colaborativa: 3 revistas revisadas por pares
• Financiación de la subvención de investigación recibida: $ 1.2 millones
• Estudios de investigación clínica en curso: 4 estudios activos

Cingulate Inc. (Cing) - Modelo de negocio: canales

Ventas directas a proveedores de atención médica

Cingulate Inc. utiliza un enfoque de ventas directo dirigido a los proveedores de atención médica psiquiátrica y neurológica. A partir del cuarto trimestre de 2023, la compañía reportó 37 representantes de ventas directas centrados en mercados neuropsiquiátricos especializados.

Tipo de canal de ventas	Número de representantes	Especialidades objetivo
Equipo de ventas directas	37	Psiquiatras, neurólogos

Presentaciones de conferencia médica

Cingular aprovecha las conferencias médicas como un canal crítico para la conciencia del producto y la credibilidad científica. En 2023, la compañía presentó en 12 conferencias especializadas de neurociencia y psiquiátrica.

• Reunión anual de la Asociación Americana de Asociación Psiquiátrica
• Conferencia de la Sociedad de Psiquiatría Biológica
• Reunión anual de la Academia Americana de Neurología

Publicaciones científicas

La compañía publicó 8 artículos de investigación revisados ​​por pares en 2023, dirigidos a revistas con factores de impacto que van de 3.5 a 7.2.

Categoría de publicación	Número de publicaciones	Rango de impacto del objetivo
Artículos revisados ​​por pares	8	3.5 - 7.2

Plataformas de investigación e información en línea

Cingulado mantiene una presencia digital activa con $ 124,000 invertidos en marketing digital y plataformas de información científica en línea en 2023.

• Sitio web de la empresa con información de investigación clínica
• Networking profesional de LinkedIn
• Portales de información médica especializada

Redes de distribución farmacéutica

La compañía ha establecido asociaciones con 3 principales redes de distribución farmacéutica para facilitar la disponibilidad de productos.

Socio de distribución	Cobertura geográfica	Capacidad de distribución
AmerisourceBergen	Nacional	Integral
Salud cardinal	Nacional	Integral
McKesson	Nacional	Integral

Cingulate Inc. (Cing) - Modelo de negocio: segmentos de clientes

Psiquiatras y neurólogos

Tamaño del mercado: aproximadamente 52,500 psiquiatras en ejercicio en los Estados Unidos a partir de 2022.

Especialidad	Número de practicantes	Penetración potencial del mercado
Psiquiatras	45,000	Estimado del 15-20%
Neurólogos	7,500	Estimado del 10-15%

Centros de tratamiento de salud mental

Número total de instalaciones de salud mental en los EE. UU.: 12,275 a partir de 2023.

• Instalaciones psiquiátricas para pacientes hospitalizados: 3.750
• Centros de salud mental ambulatorios: 8,525

Pacientes con afecciones psiquiátricas resistentes al tratamiento

Condición	Total de pacientes	Porcentaje resistente al tratamiento
Trastorno depresivo mayor	17.3 millones de adultos	30-40% resistente al tratamiento
Trastorno bipolar	5.7 millones de adultos	25-35% resistente al tratamiento

Instituciones de investigación farmacéutica

Número total de instituciones de investigación activa: 1.250 en los Estados Unidos.

Tipo de institución	Número de instituciones	Centrarse en la investigación psiquiátrica
Centros de investigación académicos	650	40-50% de enfoque psiquiátrico
Laboratorio de investigación de la compañía farmacéutica	350	25-35% de investigación psiquiátrica
Institutos de investigación independientes	250	20-30% de investigación psiquiátrica

Cingulate Inc. (Cing) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Cingulate Inc. reportó gastos de investigación y desarrollo de $ 13.1 millones, lo que representa una inversión significativa en innovación farmacéutica.

Año fiscal	Gastos de I + D	Porcentaje de gastos totales
2022	$ 11.4 millones	62.3%
2023	$ 13.1 millones	65.7%

Inversiones de ensayos clínicos

Los gastos de ensayos clínicos para Cingulate Inc. en 2023 totalizaron aproximadamente $ 8,5 millones, centrándose en el desarrollo avanzado del tratamiento neurológico.

• Pruebas de fase I: $ 3.2 millones
• Pruebas de fase II: $ 4.6 millones
• Investigación preclínica: $ 0.7 millones

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 se estimaron en $ 2.3 millones, que cubren las presentaciones de la FDA y los requisitos regulatorios continuos.

Categoría de cumplimiento	Costo
Tarifas de presentación de la FDA	$ 1.1 millones
Seguro de calidad	$ 0.7 millones
Documentación regulatoria	$ 0.5 millones

Mantenimiento de la propiedad intelectual

Los costos de mantenimiento de la propiedad intelectual para 2023 fueron de $ 0.9 millones, que cubren la presentación de patentes, la renovación y las estrategias de protección.

• Tarifas de presentación de patentes: $ 0.4 millones
• Costos de renovación de patentes: $ 0.3 millones
• Protección legal: $ 0.2 millones

Personal y reclutamiento de talento especializado

Los gastos totales de personal para 2023 alcanzaron $ 7.2 millones, con un enfoque en reclutar talento neurológico y farmacéutico especializado.

Categoría de personal	Número de empleados	Compensación total
Investigar científicos	35	$ 3.5 millones
Investigadores clínicos	25	$ 2.4 millones
Personal administrativo	15	$ 1.3 millones

Cingulate Inc. (Cing) - Modelo de negocio: flujos de ingresos

Acuerdos potenciales de licencia de medicamentos futuros

A partir del cuarto trimestre de 2023, Cingulate Inc. no tiene acuerdos de licencia de medicamentos confirmados reportados en los estados financieros.

Financiación del ensayo clínico

Ensayo clínico	Fuente de financiación	Cantidad	Año
Prueba de TDAH-1812 TDAH	Inversión interna	$ 3.2 millones	2023
Prueba de TOC CTX-1812	Reservas de la compañía	$ 2.8 millones	2023

Subvenciones de investigación

No se revelaron públicamente los montos de subvenciones de investigación específicos en los informes financieros de 2023.

Venta de productos farmacéuticos

A partir del cuarto trimestre de 2023, Cingulate Inc. aún no ha generado ventas de productos farmacéuticos.

Asociaciones de investigación colaborativa

• No se informaron asociaciones de investigación de colaboración confirmadas en 2023
• Gastos totales de investigación y desarrollo: $ 12.4 millones para el año fiscal 2023

Ingresos totales para el año fiscal 2023: $ 0

Cingulate Inc. (CING) - Canvas Business Model: Value Propositions

You're looking at the core value Cingulate Inc. delivers, which is built entirely around their Precision Timed Release™ (PTR™) technology. This platform is the engine creating the differentiated product profiles for both ADHD and anxiety candidates.

True once-daily dosing for entire active-day symptom control in ADHD

For the lead ADHD asset, CTx-1301 (dexmethylphenidate), the value proposition is delivering symptom control across the entire active day from a single dose. Phase 3 clinical trial results, presented at the AACAP Annual Meeting, demonstrated this capability. Specifically, the 37.5mg dose showed the largest effect size in symptom reduction on the ADHD ratings scale and Clinical Global Impression-Severity scales. Raul Silva, Chief Science Officer, stated that CTx-1301 can deliver reliable symptom control for the entire active-day in one pill. This is achieved by the PTR platform delivering three precisely timed releases of medication throughout the day. The market Cingulate is targeting for its ADHD candidates, including CTx-1301 and CTx-1302, is approximately $18 billion annually in the U.S.

Rapid onset of action with a smooth pharmacokinetic profile

The Phase 3 trial data for CTx-1301 also confirmed a rapid onset of effect with sustained efficacy through evening hours. This contrasts with many existing extended-release formulations that may require a midday booster dose. The technology is designed to provide control of drug release at precise, pre-defined times using a proprietary Erosion Barrier Layer (EBL). The safety profile of CTx-1301 has remained consistent over the course of nine clinical trials as of March 2025.

Flexibility of dosing without regard to food intake

A key convenience factor is the lack of restriction on meal timing. A food effect study conducted in healthy adults using a single 50 mg dose of CTx-1301 reported that the primary endpoint was met, demonstrating that CTx-1301 can be taken with or without food. This flexibility simplifies the patient's daily routine significantly.

Improved patient adherence by eliminating multiple daily doses

The core benefit here is simplifying the regimen. For CTx-1301, this means moving from potentially multiple daily doses to just one. For the anxiety candidate, CTx-2103 (buspirone), the value is even more pronounced against the standard of care. Buspirone is typically taken two to three times a day (BID or TID) due to its short half-life. Cingulate Inc. is developing CTx-2103 to be a once-daily formulation, which should inherently boost adherence in the $5.5 billion US anxiety market.

The following table summarizes the key financial context and product-specific metrics underpinning these value propositions as of late 2025.

Metric Category	Product/Metric	Value/Data Point	Date/Context
Financial Health	Cash and Cash Equivalents	$6.1 million	September 30, 2025
Financial Health	Cash Runway Expectation	Into the second quarter of 2026	Current business plan
Financial Health	Q3 2025 Net Loss	$7.3 million	Three months ended September 30, 2025
Financial Health	Estimated Capital Needed	Approximately $7.0 million	To advance commercialization efforts through May 31, 2026 PDUFA date
CTx-1301 (ADHD)	FDA PDUFA Target Action Date	May 31, 2026	NDA accepted
CTx-1301 (ADHD)	FDA Fee Waiver Value	Approximately $4.3 million saved	July 2025
CTx-1301 (ADHD)	Dose Showing Largest Effect Size	37.5mg	Phase 3 trial
CTx-2103 (Anxiety)	Grant Funding Secured	$3 million	Non-dilutive grant
CTx-2103 (Anxiety)	Maximum Cumulative Royalty	$3.5 million	To the foundation providing the grant
CTx-2103 (Anxiety)	US Market Size (Buspirone)	$5.5 billion	Annual US market

Novel, non-benzodiazepine treatment option for anxiety (CTx-2103)

CTx-2103 uses buspirone, which is an azapirone derivative and a 5-hydroxytryptamine receptor 1A (5-HT1A) partial agonist, offering an alternative to benzodiazepines and their associated withdrawal and dependency issues. The development of CTx-2103 is being accelerated by a $3 million non-dilutive grant, paid in three $1 million installments. The foundation providing this funding will receive future royalties capped at a cumulative $3.5 million. An early-phase study showed the 30 mg CTx-2103 tablet delivered buspirone spread across three peaks, supporting the once-daily goal. The company expects this grant will cover development costs through mid-2026, aligning with the targeted Investigational New Drug Application (IND) timing.

The company's Q3 2025 operating costs reflect this development push, with Research and Development Expenses at $2.8 million and General and Administrative Expenses at $3.1 million for that quarter. The market capitalization for Cingulate Inc. stood at $21 million as of late October 2025.

Cingulate Inc. (CING) - Canvas Business Model: Customer Relationships

You're preparing to launch a novel, once-daily ADHD treatment, CTx-1301, pending FDA approval, so your customer relationship strategy is focused heavily on pre-launch readiness and commercial infrastructure build-out as of late 2025. This means leveraging external expertise and managing capital carefully while communicating key regulatory progress to the market.

Dedicated medical affairs and sales force engagement with key prescribers

Cingulate Inc. has significantly advanced its commercial leadership structure to prepare for the potential launch of CTx-1301. Industry veteran Bryan Downey was appointed Chief Commercial Officer on November 3, 2025, specifically to lead launch preparation and oversee the execution of the Indegene partnership, which includes field deployment. This signals a shift in focus toward direct prescriber engagement. While current field deployment numbers aren't public for late 2025, historical planning from 2022 suggested a need for a combined sales force of 250 to 300 professionals to effectively cover high-volume neurology, psychiatry, and primary care prescribers upon launch. The General and Administrative (G&A) Expenses for the third quarter ending September 30, 2025, were $3.1 million, an increase of 69.7% compared to the same period in 2024, driven in part by commercial costs incurred in preparation for a potential mid-2026 launch.

Omnichannel digital marketing and medical communications (via Indegene)

Cingulate Inc. relies on a comprehensive joint commercialization agreement with Indegene, Inc. for its go-to-market strategy. This partnership covers cross-functional services, including medical communications and omnichannel marketing, designed to optimize prescriber reach. The agreement spans services like sales, medical affairs, and marketing, and is designed to continue for three years post-launch of CTx-1301. The G&A expenses for Q3 2025 included commercial costs related to this contract.

High-touch support for payers regarding formulary inclusion and reimbursement

The Indegene agreement explicitly includes support for Pricing, Reimbursement, and Market Access (PRMA). You are actively engaging payers now, as early payer research indicates strong formulary receptivity for the differentiated profile of once-daily CTx-1301. This high-touch support is crucial given the need to secure favorable placement ahead of the potential May 31, 2026, Prescription Drug User Fee Act (PDUFA) target action date.

Patient support programs to drive adherence post-launch

The commercialization plan with Indegene incorporates patient support elements. Since CTx-1301 is engineered to address adherence challenges through its true once-daily dosing, the support programs are designed to reinforce this benefit post-launch. Specific enrollment numbers for these programs are not yet public, as the product awaits FDA approval.

Investor relations to communicate regulatory and financial milestones

Investor Relations has been highly active communicating the transition from a development-stage to a commercial-stage company. Key milestones communicated in late 2025 include:

• FDA acceptance of the CTx-1301 New Drug Application (NDA) in October 2025.
• Setting the PDUFA target action date for May 31, 2026.
• Receiving a small-business PDUFA fee waiver, saving approximately $4.3 million.
• Completing a $6 million financing transaction on November 3, 2025, structured as a non-convertible, unsecured promissory note accruing interest at 9% per annum.
• As of September 30, 2025, cash on hand was $6.1 million, with working capital at $1.6 million.
• The company estimates needing to raise approximately $7.0 million of additional capital to fund commercialization efforts through the PDUFA date.

You can reach the VP of Corporate Communications, Thomas Dalton, at (913) 942-2301, or the investor relations firm, Darrow Associates, at (214) 597-8200.

Here's a quick look at the financial context supporting these commercial relationship investments as of the end of Q3 2025:

Metric	Value (as of 9/30/2025 or latest reported)	Context
Cash and Cash Equivalents	$6.1 million	As of September 30, 2025.
Working Capital	$1.6 million	As of September 30, 2025.
Q3 2025 G&A Expenses	$3.1 million	Increased by 69.7% year-over-year, includes commercial costs.
Q3 2025 R&D Expenses	$2.8 million	Increased by 99.5% year-over-year, includes regulatory costs.
Additional Capital Needed (Estimate)	Approx. $7.0 million	Needed to advance commercialization efforts through PDUFA date.
PDUFA Target Action Date	May 31, 2026	Set by the FDA for CTx-1301 review.

The appointment of Bryan Downey as CCO, coupled with the Indegene contract, shows you are prioritizing commercial execution readiness. Finance: draft 13-week cash view by Friday.

Cingulate Inc. (CING) - Canvas Business Model: Channels

You're looking at how Cingulate Inc. plans to get its product, CTx-1301, from the manufacturer to the patient, especially since the New Drug Application (NDA) was accepted in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. This is all pre-launch, so the channels are set up via agreements and personnel hiring.

The core of the physical supply chain relies on established pharmaceutical infrastructure. Cingulate Inc. executed a commercial supply agreement with Bend Bio Sciences in September 2025, naming them the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, subject to FDA approval. This agreement dictates that Cingulate Inc. commits to purchasing 100% of its overall U.S. commercial supply from Bend Bio Sciences.

For getting the product into the market, the company has leaned on external expertise. Cingulate Inc. partnered with Indegene, Inc. to support the commercialization of CTx-1301 in the U.S., leveraging Indegene's infrastructure. General and Administrative Expenses for the third quarter ending September 30, 2025, included commercial costs related to this contract, totaling $3.1 million for the three months ended September 30, 2025.

The structure for direct physician engagement is being built out now. In November 2025, Cingulate Inc. appointed Bryan Downey as Chief Commercial Officer to lead these commercial activities for the potential launch. While the actual 2025 sales force size isn't reported, planning data from 2022 suggested a need for a combined force of 250-300 sales professionals to cover high-volume neurology, psychiatry, and primary care prescribers at launch.

The planned channel strategy involves leveraging the existing network for broad access, which is standard for a new CNS product launch. The company anticipates needing approximately $7.0 million to $9 million of additional capital to advance these commercialization efforts through the PDUFA date and into the potential launch phase.

Here is a summary of the key channel-related operational and financial data as of late 2025:

Channel Component	Metric/Partner	Value/Date/Detail
Commercialization Support	Partner Company	Indegene, Inc.
Exclusive Manufacturer	Partner Company	Bend Bio Sciences
Sales Force Planning (Historical Basis)	Targeted Sales Professionals	250-300 (Initial Launch Estimate)
Commercial Leadership Hired	Chief Commercial Officer	Bryan Downey (November 2025)
Q3 2025 G&A Expenses (Includes Commercial Costs)	Amount	$3.1 million
Commercial Supply Agreement Term	Duration	Through 2028, subject to FDA approval
Total Employees (As of 9/30/2025)	Headcount	22

The intended reach for the product, once approved, is structured as follows:

• Pharmaceutical wholesalers and national distributors: Access secured via the commercial supply agreement with Bend Bio Sciences.
• Retail pharmacy chains and independent pharmacies: Target access point for CTx-1301 distribution.
• Specialty pharmacies for complex reimbursement cases: Strategy to be executed post-launch, supported by the new commercial team.
• Direct-to-physician marketing and sales force detailing: Led by the newly appointed Chief Commercial Officer, Bryan Downey.

Cingulate Inc. (CING) - Canvas Business Model: Customer Segments

You're looking at Cingulate Inc.'s customer base as they push toward a potential 2026 launch for CTx-1301. Honestly, understanding these segments is key because their success hinges on adoption by patients, prescribers, and the payers who control access.

The primary patient groups Cingulate Inc. targets are those living with Attention Deficit Hyperactivity Disorder (ADHD) in the U.S. As of their first quarter 2025 report on March 31, 2025, the total U.S. patient pool was reported to be over 20 million individuals diagnosed with ADHD. This massive population is split across two core segments that Cingulate Inc. is addressing with its once-daily stimulant candidate, CTx-1301.

For the pediatric and adolescent segment, Cingulate Inc. is targeting the over 8 million patients under the age of 17 as of March 31, 2025. This group is highly familiar with stimulant treatment, but the promise of a 'true, once-daily' formulation is what aims to capture their attention and improve compliance. In the broader context, U.S. children aged 5 to 17 have a lifetime diagnosis prevalence where boys show a rate of 14.5% versus girls at 8.0%.

The adult segment is equally, if not more, critical. Cingulate Inc. reported 12 million adults diagnosed with ADHD as of March 31, 2025. Current market trends suggest this adult prevalence is larger and growing faster than the child and adolescent segments combined. This segment is specifically looking for improved once-daily efficacy to manage symptoms throughout their entire active day, which is what CTx-1301 is designed to deliver. By 2024, the adults segment already held the highest market share within the U.S. ADHD market, and it is forecast to expand at an 8.23% CAGR through 2030.

The market opportunity for Cingulate Inc. is substantial, given that stimulant medications, which CTx-1301 is a part of, anchor the majority of prescriptions. Here's a quick look at the market context Cingulate Inc. is preparing to enter:

Metric	Value (Late 2025/2024 Data)
U.S. ADHD Market Value (2025 Estimate)	USD 17.60 billion
U.S. ADHD Market Forecast (2030)	USD 23.03 billion
Stimulant Market Share (2024)	68.54%
Adult Segment Market Share (2024)	Highest Share
Retail Pharmacy Channel Share (2024)	54.78%

The next set of customers are the healthcare professionals who write the scripts. These are the psychiatrists, pediatricians, and primary care physicians who prescribe stimulants. Cingulate Inc. is focused on convincing these prescribers that CTx-1301 offers a superior duration profile over existing options. It's important to note that in 2023, nurse practitioners prescribed more than 75% of all stimulant prescriptions, making them a key specialty to target alongside MDs. Cingulate Inc. definitely signaled its intent to reach this group by appointing Bryan Downey as Chief Commercial Officer in November 2025 to lead launch preparation.

Finally, you have the gatekeepers: managed care organizations and Pharmacy Benefit Managers (PBMs). These entities determine formulary placement and patient access, which directly impacts prescription volume. Cingulate Inc. is preparing for this by executing commercial strategies; for instance, they announced a commercial supply agreement with Bend Bio Sciences in the third quarter of 2025. Their ability to secure favorable coverage will be tied to the clinical differentiation of CTx-1301, especially against established, often generic, stimulant therapies. The company expects its current cash position to satisfy capital needs into the second quarter of 2026, but advancing commercialization efforts through the May 31, 2026, Prescription Drug User Fee Act (PDUFA) date will require raising approximately $7.0 million of additional capital.

• Cingulate Inc. completed its Pre-NDA meeting with the FDA on April 2, 2025.
• The New Drug Application (NDA) for CTx-1301 was accepted by the FDA in October 2025.
• The PDUFA target action date is set for May 31, 2026.
• CTx-1301 utilizes dexmethylphenidate HCl, an already FDA-approved compound.

Cingulate Inc. (CING) - Canvas Business Model: Cost Structure

You're looking at the cash burn Cingulate Inc. faces while pushing CTx-1301 toward its May 31, 2026, PDUFA date. The cost structure is heavily weighted toward getting the drug approved and ready for market.

Research and development (R&D) expenses for the three months ended September 30, 2025, totaled $2.8 million. This was a significant jump, up 99.5% compared to the same period in the prior year.

General and administrative (G&A) costs for the third quarter of 2025 were $3.1 million. This represented a 69.7% increase year-over-year, primarily driven by personnel costs, including contingent bonus plan accruals upon the CTx-1301 New Drug Application (NDA) submission in Q3 2025, plus other general overhead.

Here's a quick look at the main operating expenses for the third quarter of 2025:

Cost Category	Amount (Q3 2025)
Research and Development (R&D) Expenses	$2.8 million
General and Administrative (G&A) Expenses	$3.1 million
Net Loss (Q3 2025)	$7.3 million

Manufacturing and supply chain costs for CTx-1301 production saw an increase during 2025. This rise was specifically tied to the significant manufacturing costs related to preparing the process validation batches for CTx-1301. Cingulate Inc. also entered a commercial supply agreement with Bend Bio Sciences, which signals future commitment to production scale-up.

Pre-commercialization and sales force build-out expenses are ramping up as the company prepares for a potential mid-2026 launch. The hiring of Bryan Downey as Chief Commercial Officer on November 3, 2025, is a clear indicator of this shift in spending focus. To manage this transition and cover costs through the May 31, 2026, PDUFA date, Cingulate Inc. stated it will need to raise approximately $7.0 million of additional capital.

Financing costs include interest expense from recent debt. On November 3, 2025, Cingulate Inc. completed a financing structured as a $6,570,000 non-convertible, unsecured promissory note. This note accrues interest at 9% per annum and matures 18 months from issuance. This debt structure adds a fixed financing cost to the structure.

The company's cost structure is currently dominated by R&D and G&A, which contributed to a net loss of $7.3 million for the third quarter of 2025. Finance: draft 13-week cash view by Friday.

Cingulate Inc. (CING) - Canvas Business Model: Revenue Streams

You're looking at Cingulate Inc.'s near-term financial scaffolding, which is heavily reliant on near-term financing and regulatory success as of late 2025. The primary long-term revenue driver hinges on the success of CTx-1301, but the immediate cash flow is being supplemented by non-dilutive funding and debt instruments.

The most significant potential revenue stream is the future commercialization of CTx-1301 (dexmethylphenidate HCl). Following the NDA acceptance in October 2025, the Prescription Drug User Fee Act (PDUFA) target action date is set for May 31, 2026. Cingulate Inc. has projected that CTx-1301 could generate peak sales of US$1.6 billion by 2035. This is set against the backdrop of the U.S. ADHD market, estimated to be valued at more than US$20 billion.

The company has also secured non-dilutive funding, which is crucial as it doesn't dilute existing shareholder equity. This includes a $3 million grant from a private foundation to accelerate CTx-2103 development.

• The $3 million grant is paid in three installments of $1 million each.
• The foundation receives a future royalty on CTx-2103 commercialization of $500,000 per quarter, capped at a maximum cumulative royalty of $3.5 million.
• The grant is projected to cover CTx-2103 development costs through mid-2026.

To bridge the gap to potential launch revenue, Cingulate Inc. executed a financing transaction in November 2025. This debt financing provided immediate liquidity for working capital and general corporate purposes.

Financing Component	Amount/Term
Net Proceeds Received	$6 million
Promissory Note Principal	$6,570,000
Interest Rate	9% per annum
Maturity Term	18 months
Cash Runway Extension	Into the second quarter of 2026

Furthermore, Cingulate Inc. realized a significant, one-time financial benefit through a regulatory fee waiver. This saved immediate cash outlay as they prepared the CTx-1301 New Drug Application (NDA).

The company is also looking at future, less certain revenue streams tied to its core technology, the Precision Timed Release (PTR) platform. Exploring out-licensing opportunities for the platform is part of the strategy to diversify beyond single-asset risk.

• The first projected loss of exclusivity for the PTR platform intellectual property is 2035.
• Milestone payments from out-licensing are a potential, though not yet quantified, revenue source.

Finally, the immediate financial impact of the PDUFA fee waiver is a direct boost to the balance sheet, preserving capital that would otherwise have been spent on regulatory filing fees.

The fiscal year 2025 PDUFA fee waiver from the FDA, granted under the small business provision, saved Cingulate Inc. approximately $4.3 million. This is a direct, realized saving that strengthens the cash position ahead of the PDUFA date. Finance: review the projected capital need of $7.0 million against the current cash position of $6.1 million as of September 30, 2025.