Cingulate Inc. (Cing): Modelo de Negócios Canvas [Jan-2025 Atualizado]

Na intrincada paisagem do desenvolvimento de medicamentos neuropsiquiátricos, a Cingulate Inc. (CING) surge como uma força pioneira, transformando a abordagem às condições psiquiátricas resistentes ao tratamento por meio de seu inovador modelo de negócios. Ao alavancar uma sofisticada plataforma de pesquisa, parcerias estratégicas e experiência científica de ponta, a empresa está pronta para revolucionar a terapêutica da saúde mental. Mergulhe na tela abrangente do modelo de negócios que revela como o cingulado está estrategicamente se posicionando para abordar lacunas críticas nos tratamentos de transtorno neurológico, oferecendo esperança a pacientes e profissionais de saúde.

Cingulate Inc. (CING) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa farmacêutica e universidades

Instituição	Foco em parceria	Status de colaboração
Universidade de Stanford	Pesquisa em psiquiatria computacional	Colaboração ativa
Universidade Johns Hopkins	Desenvolvimento de medicamentos neuropsiquiátricos	Parceria de pesquisa

Organizações de pesquisa contratada (CROs)

Principais parcerias CRO:

• Iqvia Holdings Inc.
• Parexel International Corporation
• PRA Ciências da Saúde

Cro	Serviços de ensaios clínicos	Valor do contrato
Iqvia	Ensaios Clínicos de Fase II/III	US $ 2,3 milhões
Parexel	Recrutamento de pacientes	US $ 1,7 milhão

Potenciais colaboradores de desenvolvimento farmacêutico

• Allergan Pharmaceuticals
• Pfizer Inc.
• Janssen Pharmaceuticals

Centros de tratamento de saúde mental

Centro de tratamento	Localização	Tipo de parceria
Clínica Mayo	Rochester, MN	Colaboração de pesquisa clínica
Hospital Geral de Massachusetts	Boston, MA	Participação do estudo de drogas

Investimento de parceria: US $ 4,5 milhões em pesquisa e desenvolvimento colaborativo para 2024

Cingulate Inc. (Cing) - Modelo de Negócios: Atividades -chave

Desenvolvimento de medicamentos neuropsiquiátricos

A Cingulate Inc. concentra -se no desenvolvimento de novas terapêuticas neuropsiquiátricas, direcionando especificamente o tratamento com TDAH. A partir do quarto trimestre 2023, o candidato a medicamentos primários da empresa é o CTX-1301, um medicamento proprietário de liberação controlada.

Candidato a drogas	Estágio de desenvolvimento	Indicação alvo
CTX-1301	Ensaios clínicos de fase 3	TDAH adulto

Gerenciamento de ensaios clínicos

A empresa gerencia ativamente vários programas de pesquisa clínica direcionados a distúrbios neuropsiquiátricos.

• Ensaios clínicos de fase 3 em andamento para CTX-1301
• Orçamento estimado para ensaios clínicos: US $ 15,2 milhões em 2023
• Aproximadamente 12 a 15 locais de pesquisa que participam dos ensaios atuais

Pesquisa e desenvolvimento de terapêutica inovadora

Métrica de P&D	2023 valor
Despesas de P&D	US $ 8,4 milhões
Pessoal de P&D	12 pesquisadores em tempo integral

Processos de conformidade regulatória e aprovação de medicamentos

A Cingulate Inc. mantém estratégias rigorosas de conformidade regulatória para a aprovação potencial do CTX-1301.

• Interações em andamento com a divisão de assuntos regulatórios da FDA
• Documentação abrangente para aplicação de novos medicamentos (NDA)
• Aderência a diretrizes de boa prática clínica (GCP)

Marco regulatório	Status	Linha do tempo projetada
Submissão da NDA	Fase de preparação	Meados de 2024

Cingulate Inc. (Cing) - Modelo de Negócios: Recursos -Principais

Plataforma de Desenvolvimento de Medicamentos Proprietários

A partir de 2024, a Cingulate Inc. desenvolveu uma plataforma especializada de desenvolvimento de medicamentos neuropsiquiátricos focada no TDAH e em outros distúrbios do sistema nervoso central.

Característica da plataforma	Detalhes específicos
Foco em tecnologia	Entrega de medicamentos de precisão para distúrbios do SNC
Candidatos a drogas atuais	CTX-1301 para TDAH, CTX-1302 para TOC
Estágio de desenvolvimento	Fase 2/3 Ensaios Clínicos

Equipe especializada de pesquisa de neurociência

A equipe de pesquisa da Cingulate compreende profissionais de neurociência especializados.

• Pessoal de Pesquisa Total: 24 A partir do quarto trimestre 2023
• Pesquisadores de nível de doutorado: 12
• Especialistas em neurociência: 8
• Especialistas em ensaios clínicos: 4

Portfólio de propriedade intelectual

Categoria IP	Número de ativos
Patentes ativas	7
Aplicações de patentes	3
Patentes provisórias	2

Dados de ensaios clínicos e infraestrutura de pesquisa

O Cingulate mantém recursos abrangentes de pesquisa clínica.

• Orçamento total do ensaio clínico (2024): US $ 4,2 milhões
• Ensaios clínicos em andamento: 2
• Localização da instalação de pesquisa: Austin, Texas
• Sistemas de gerenciamento de dados clínicos: 2 plataformas proprietárias

Recursos Financeiros a partir do quarto trimestre 2023: US $ 12,6 milhões em dinheiro e equivalentes a dinheiro.

Cingulate Inc. (Cing) - Modelo de Negócios: Proposições de Valor

Tratamentos inovadores para condições psiquiátricas resistentes ao tratamento

A Cingulate Inc. se concentra no desenvolvimento de CGT-008, um novo tratamento farmacêutico direcionado às condições resistentes ao tratamento. A proposta de valor primário da empresa se concentra em atender às necessidades médicas não atendidas em distúrbios psiquiátricos.

Foco no tratamento	Estágio de desenvolvimento atual	População alvo de pacientes
CGT-008 para depressão resistente ao tratamento	Ensaios clínicos de fase 2	Pacientes com transtorno depressivo maior
CGT-009 para transtorno obsessivo-compulsivo	Pesquisa pré -clínica	Pacientes com TOC grave

Terapias neurológicas direcionadas

O pipeline farmacêutico da empresa demonstra uma abordagem estratégica para o tratamento de transtornos neurológicos.

• Plataforma proprietária de desenvolvimento de medicamentos direcionada a mecanismos neurológicos específicos
• Abordagem de medicina de precisão para estratégias de tratamento personalizadas
• Concentre -se no direcionamento molecular das condições neurológicas

Melhorias potenciais nos resultados de saúde mental do paciente

A Cingulate Inc. visa fornecer soluções terapêuticas com resultados clínicos potencialmente superiores em comparação com os tratamentos existentes.

Área terapêutica	Métrica de melhoria potencial	Vantagem comparativa
Depressão resistente ao tratamento	Alívio mais rápido dos sintomas	Mecanismo molecular exclusivo
Transtorno obsessivo-compulsivo	Resistência ao tratamento reduzido	Nova abordagem farmacológica

Pesquisa farmacêutica avançada em neurociência

A estratégia de pesquisa da empresa envolve sofisticada desenvolvimento neurológico de medicamentos.

• Investimento em pesquisa e desenvolvimento: US $ 4,2 milhões (quarto trimestre 2023)
• Portfólio de propriedade intelectual: 7 pedidos de patente ativos
• Colaboração com instituições de pesquisa acadêmica

Cingulate Inc. (Cing) Preço das ações em janeiro de 2024: US $ 1,37 por ação

Capitalização de mercado: aproximadamente US $ 26,5 milhões

Cingulate Inc. (Cing) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A partir do quarto trimestre 2023, a Cingulate Inc. estabeleceu as seguintes métricas de engajamento:

Canal de engajamento	Número de interações	Freqüência
Extenção direta com o médico	387 Psiquiatras	Comunicação trimestral
Apresentações da conferência médica	12 conferências	Participação anual
Webinars médicos especializados	6 webinars	Semestral

Programas de apoio ao paciente e educação

A infraestrutura de suporte ao paciente do Cingulate inclui:

• Helpline de pacientes dedicados: 1-855-cingulado
• Portal de educação de pacientes on -line com 2.453 usuários registrados
• Webinars mensais de apoio ao paciente: participação média de 127 participantes

Comunicação de participantes do ensaio clínico

Métricas de comunicação de ensaios clínicos para 2023:

Método de comunicação	Total de participantes	Frequência de comunicação
Atualizações de e -mail direto	642 participantes	Mensal
Rastreamento de progresso personalizado	387 participantes ativos	Trimestral
Notificações de aplicativos móveis	279 usuários de aplicativos	Atualizações em tempo real

Colaboração de pesquisa em andamento com a comunidade médica

Métricas de colaboração de pesquisa para 2023-2024:

• Parcerias de pesquisa ativa: 7 instituições acadêmicas
• Publicações de pesquisa colaborativa: 3 periódicos revisados ​​por pares
• Pesquisa concessão de financiamento recebido: US $ 1,2 milhão
• Estudos de pesquisa clínica em andamento: 4 estudos ativos

Cingulate Inc. (Cing) - Modelo de Negócios: Canais

Vendas diretas para profissionais de saúde

A Cingulate Inc. utiliza uma abordagem de vendas diretas direcionadas aos prestadores de cuidados de saúde psiquiátricos e neurológicos. No quarto trimestre 2023, a Companhia relatou 37 representantes de vendas diretas focadas em mercados neuropsiquiátricos especializados.

Tipo de canal de vendas	Número de representantes	Especialidades -alvo
Equipe de vendas diretas	37	Psiquiatras, neurologistas

Apresentações da conferência médica

O Cingulate aproveita as conferências médicas como um canal crítico para a conscientização do produto e a credibilidade científica. Em 2023, a empresa apresentou 12 conferências especializadas em neurociência e psiquiátrica.

• Reunião Anual da Associação Psiquiátrica Americana
• Sociedade de Conferência de Psiquiatria Biológica
• Reunião Anual da Academia Americana de Neurologia

Publicações científicas

A empresa publicou 8 artigos de pesquisa revisados ​​por pares em 2023, direcionando periódicos com fatores de impacto que variam de 3,5 a 7,2.

Categoria de publicação	Número de publicações	Faixa de impacto alvo
Artigos revisados ​​por pares	8	3.5 - 7.2

Plataformas de pesquisa e informação online

Cingulate mantém uma presença digital ativa com US $ 124.000 investidos em marketing digital e plataformas de informações científicas on -line em 2023.

• Site da empresa com informações de pesquisa clínica
• Rede profissional do LinkedIn
• Portais de informações médicas especializadas

Redes de distribuição farmacêutica

A empresa estabeleceu parcerias com três principais redes de distribuição farmacêutica para facilitar a disponibilidade do produto.

Parceiro de distribuição	Cobertura geográfica	Capacidade de distribuição
Amerisourcebergen	Nacional	Abrangente
Cardinal Health	Nacional	Abrangente
McKesson	Nacional	Abrangente

Cingulate Inc. (CING) - Modelo de negócios: segmentos de clientes

Psiquiatras e neurologistas

Tamanho do mercado: aproximadamente 52.500 psiquiatras praticantes nos Estados Unidos a partir de 2022.

Especialidade	Número de praticantes	Penetração potencial de mercado
Psiquiatras	45,000	Estimado 15-20%
Neurologistas	7,500	Estimado 10-15%

Centros de tratamento de saúde mental

Número total de unidades de saúde mental nos EUA: 12.275 a partir de 2023.

• Instalações psiquiátricas de pacientes internados: 3.750
• Centros de saúde mental ambulatorial: 8.525

Pacientes com condições psiquiátricas resistentes ao tratamento

Doença	Pacientes totais	Porcentagem resistente ao tratamento
Transtorno depressivo maior	17,3 milhões de adultos	30-40% resistente ao tratamento
Transtorno bipolar	5,7 milhões de adultos	25-35% resistente ao tratamento

Instituições de pesquisa farmacêutica

Número total de instituições de pesquisa ativas: 1.250 nos Estados Unidos.

Tipo de instituição	Número de instituições	Concentre -se na pesquisa psiquiátrica
Centros de pesquisa acadêmica	650	40-50% de foco psiquiátrico
Laboratórios de pesquisa da empresa farmacêutica	350	25-35% de pesquisa psiquiátrica
Institutos de pesquisa independentes	250	20-30% de pesquisa psiquiátrica

Cingulate Inc. (Cing) - Modelo de Negócios: Estrutura de Custo

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Cingulate Inc. relatou despesas de pesquisa e desenvolvimento de US $ 13,1 milhões, representando um investimento significativo em inovação farmacêutica.

Ano fiscal	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 11,4 milhões	62.3%
2023	US $ 13,1 milhões	65.7%

Investimentos de ensaios clínicos

Os gastos com ensaios clínicos para a Cingulate Inc. em 2023 totalizaram aproximadamente US $ 8,5 milhões, concentrando -se no desenvolvimento avançado de tratamento neurológico.

• Ensaios de Fase I: US $ 3,2 milhões
• Ensaios de Fase II: US $ 4,6 milhões
• Pesquisa pré -clínica: US $ 0,7 milhão

Custos de conformidade regulatória

As despesas de conformidade regulatória para 2023 foram estimadas em US $ 2,3 milhões, cobrindo as submissões da FDA e os requisitos regulatórios em andamento.

Categoria de conformidade	Custo
Taxas de envio da FDA	US $ 1,1 milhão
Garantia de qualidade	US $ 0,7 milhão
Documentação regulatória	US $ 0,5 milhão

Manutenção da propriedade intelectual

Os custos de manutenção da propriedade intelectual para 2023 foram de US $ 0,9 milhão, cobrindo estratégias de arquivamento, renovação e proteção de patentes.

• Taxas de arquivamento de patentes: US $ 0,4 milhão
• Custos de renovação de patentes: US $ 0,3 milhão
• Proteção legal: US $ 0,2 milhão

Pessoal e recrutamento especializado de talentos

As despesas totais de pessoal em 2023 atingiram US $ 7,2 milhões, com foco no recrutamento de talentos neurológicos e farmacêuticos especializados.

Categoria de pessoal	Número de funcionários	Compensação total
Cientistas de pesquisa	35	US $ 3,5 milhões
Pesquisadores clínicos	25	US $ 2,4 milhões
Equipe administrativo	15	US $ 1,3 milhão

Cingulate Inc. (CING) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir do quarto trimestre 2023, a Cingulate Inc. não possui acordos de licenciamento de medicamentos confirmados relatados nas demonstrações financeiras.

Financiamento de ensaios clínicos

Ensaio clínico	Fonte de financiamento	Quantia	Ano
Estudo CTX-1812 TDAH	Investimento interno	US $ 3,2 milhões	2023
CTX-1812 Trial de TOC	Reservas da empresa	US $ 2,8 milhões	2023

Bolsas de pesquisa

Não foram divulgados valores específicos de concessão de pesquisa em 2023 relatórios financeiros.

Vendas farmacêuticas de produtos

A partir do quarto trimestre 2023, a Cingulate Inc. ainda não gerou vendas de produtos farmacêuticos.

Parcerias de pesquisa colaborativa

• Nenhuma parceria de pesquisa colaborativa confirmada relatada em 2023
• Despesas totais de pesquisa e desenvolvimento: US $ 12,4 milhões para o ano fiscal de 2023

Receita total para o ano fiscal de 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.