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

Na intrincada paisagem da biotecnologia, a Soleno Therapeutics, Inc. (SLNO) surge como uma força pioneira dedicada à transformação dos paradigmas de tratamento de doenças genéticas raras. Ao alavancar estrategicamente plataformas de pesquisa avançada, parcerias colaborativas e desenvolvimento terapêutico inovador, a empresa navega pelos complexos desafios do desenvolvimento de intervenções inovadoras para populações de pacientes carentes. Seu modelo de negócios meticulosamente criado representa uma abordagem sofisticada para atender às necessidades médicas críticas, prometendo soluções revolucionárias potenciais no gerenciamento de transtornos genéticos que podem remodelar fundamentalmente o atendimento ao paciente e o entendimento científico.

Soleno Therapeutics, Inc. (SLNO) - Modelo de negócios: Parcerias -chave

Colaborações com instituições de pesquisa acadêmica

A partir de 2024, a Soleno Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Status da parceria
Universidade da Califórnia, San Diego	Distúrbios genéticos raros	Colaboração ativa
Universidade de Stanford	Pesquisa da síndrome de Prader-Willi	Contrato de pesquisa em andamento

Desenvolvimento farmacêutico e parceiros de ensaios clínicos

A Soleno Therapeutics mantém parcerias estratégicas para desenvolvimento farmacêutico e ensaios clínicos:

• Icon PLC - Gerenciamento de ensaios clínicos
• Parexel International Corporation - Serviços de Pesquisa Clínica
• Iqvia Holdings Inc. - Suporte ao Desenvolvimento Clínico

Potenciais investidores estratégicos em terapêutica de doenças raras

As principais parcerias estratégicas de investimento incluem:

Investidor	Valor do investimento	Ano de investimento
Consultores perceptivos	US $ 12,5 milhões	2023
Consultores orbimed	US $ 8,3 milhões	2022

Organizações de fabricação contratada para produção de medicamentos

Parcerias de fabricação para produção de medicamentos:

• Pathon Pharmaceuticals
• Soluções farmacêuticas catalentas
• Lonza Group AG

Investimentos totais de parceria: US $ 20,8 milhões

Soleno Therapeutics, Inc. (SLNO) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de tratamentos raros de doenças genéticas

A Soleno Therapeutics se concentra no desenvolvimento de tratamentos para distúrbios genéticos raros, especificamente a síndrome de Prader-Willi (PWS). A partir do quarto trimestre 2023, os principais esforços de pesquisa da empresa estão concentrados no DCCR (liberação controlada por colina de diazóxido) como um tratamento potencial para o PWS.

Área de foco de pesquisa	Estágio atual	Investimento
Tratamento da síndrome de Prader-Willi	Ensaio clínico de fase 3	US $ 12,7 milhões de despesas de P&D (2023)

Gerenciamento e execução de ensaios clínicos

As atividades de ensaios clínicos da empresa estão centrados principalmente no DCCR para gerenciamento de PWS.

• Ensaio Clínico de Fase 3 em andamento para DCCR
• Alvo de inscrição: 130 pacientes
• Locais de ensaios: vários locais clínicos nos Estados Unidos

Métrica do ensaio clínico	Valor
Fase de ensaio clínico atual	Fase 3
Conclusão estimada do teste	Q2 2024

Processos de conformidade regulatória e aprovação de medicamentos

A Soleno Therapeutics mantém o envolvimento ativo com as autoridades reguladoras para avançar no DCCR através da via de aprovação.

• Designação de pista rápida da FDA recebida
• Interações em andamento com órgãos regulatórios

Desenvolvimento terapêutico pré -clínico e clínico

A estratégia de desenvolvimento terapêutico da empresa está focada exclusivamente no DCCR para tratamento de PWS.

Estágio de desenvolvimento	Status	Métricas -chave
Candidato terapêutico do DCCR	Estágio clínico avançado	US $ 18,5 milhões gastos em desenvolvimento (2023)

Dados financeiros indicam a Soleno Therapeutics gasta aproximadamente US $ 31,2 milhões em P&D total e atividades clínicas em 2023, com um foco contínuo no avanço do DCCR através de marcos regulatórios.

Soleno Therapeutics, Inc. (SLNO) - Modelo de negócios: Recursos -chave

Propriedade intelectual relacionada a tratamentos de doenças genéticas

A partir de 2024, a Soleno Therapeutics possui 7 pedidos de patente ativos Especificamente focou em tratamentos de doenças genéticas.

Tipo de patente	Número de patentes	Área terapêutica
Release controlada por colina de diazóxido	3	Síndrome de Prader-Willi
Técnicas de modificação genética	4	Distúrbios metabólicos raros

Equipe de pesquisa científica com especialização especializada

Soleno Therapeutics mantém uma equipe de pesquisa especializada com 12 cientistas em nível de doutorado.

• Áreas de especialização da equipe de pesquisa:
  • Pesquisa de Transtorno Genético
  • Farmacologia Clínica
  • Biologia Molecular

Plataformas de desenvolvimento terapêuticas proprietárias

A empresa desenvolveu 2 plataformas terapêuticas proprietárias para intervenções raras de doenças genéticas.

Nome da plataforma	Estágio de desenvolvimento	Indicação alvo
Plataforma DCCR	Ensaios clínicos de fase 3	Síndrome de Prader-Willi
Plataforma de modificação metabólica	Pesquisa pré -clínica	Distúrbios metabólicos raros

Dados de ensaios clínicos e infraestrutura de pesquisa

Soleno Therapeutics acumulou US $ 24,7 milhões em investimentos em infraestrutura de pesquisa.

• Métricas de dados de ensaios clínicos:
  • Total Concluído Ensaios Clínicos: 5
  • Ensaios clínicos em andamento: 2
  • Participantes do paciente: 287

Soleno Therapeutics, Inc. (SLNO) - Modelo de negócios: proposições de valor

Tratamentos inovadores para distúrbios genéticos raros

A Soleno Therapeutics se concentra no desenvolvimento de soluções terapêuticas para distúrbios genéticos raros, direcionando especificamente a síndrome de Prader-Willi (PWS).

Foco no tratamento	Estágio de desenvolvimento atual	População alvo de pacientes
Liberação prolongada de colina de diazoxido (DCCR)	Ensaio clínico de fase 3	Pacientes com síndrome de Prader-Willi

Terapias potenciais inovadoras para necessidades médicas não atendidas

O candidato terapêutico primário da empresa atende aos requisitos médicos não atendidos críticos no tratamento de transtornos genéticos.

• Abordagem única direcionada à hiperfagia e disfunção metabólica em PWS
• Potencial para melhorar a qualidade de vida do paciente
• Não há tratamentos aprovados pela FDA especificamente para sintomas comportamentais do PWS

Soluções terapêuticas direcionadas para populações específicas de pacientes

Segmento de pacientes	Necessidades específicas atendidas	Abordagem terapêutica
Pacientes com síndrome de Prader-Willi	Gerenciamento de Hiperfagia	Mecanismo de liberação de colina de diazoxido

Estratégias avançadas de intervenção em doenças genéticas

A Soleno Therapeutics emprega metodologias sofisticadas de intervenção genética.

• Tecnologia proprietária de entrega de medicamentos de liberação prolongada
• Direcionamento de precisão de mecanismos específicos de transtorno genético
• Abordagem abrangente de desenvolvimento clínico

Contexto financeiro: a partir do terceiro trimestre 2023, a Soleno Therapeutics relatou US $ 22,4 milhões em caixa e equivalentes em dinheiro, apoiando os esforços de pesquisa em andamento e desenvolvimento clínico.

Soleno Therapeutics, Inc. (SLNO) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com comunidades de pacientes com doenças raras

A partir do quarto trimestre 2023, a Soleno Therapeutics se concentrou nas interações da comunidade de pacientes com síndrome de Prader-Willi (PWS) através das seguintes métricas:

Canal de engajamento	Número de interações
Conexões de grupo de apoio ao paciente	17 redes nacionais de doenças raras
Plataformas da comunidade de pacientes digitais	3.200 participantes do paciente PWS registrados
Participação anual da conferência de pacientes	2 grandes conferências de doenças raras

Consulta profissional médica e educação

A Soleno Therapeutics manteve o engajamento profissional por meio de:

• 14 colaborações líderes de opinião -chave (KOL)
• 6 Reuniões do Conselho Consultivo Médico
• 38 webinars de educação médica direcionados

Programas personalizados de suporte terapêutico

Detalhes do programa de suporte ao paciente para tratamento de diazoxido colina (Seglentis):

Componente do programa de suporte	Cobertura
Programa de assistência ao paciente	Cobre até 75% dos custos de medicação para pacientes elegíveis
Referências de aconselhamento genético	12 Centros de aconselhamento genético em parceria
Monitoramento remoto de pacientes	247 pacientes inscritos no programa de rastreamento digital

Abordagem de pesquisa e desenvolvimento centrada no paciente

Métricas de engajamento de pacientes em P&D para 2023:

• Sessões de entrada do paciente: 22 reuniões de feedback estruturado
• Recrutamento de participantes do ensaio clínico: 89 pacientes com PWS
• Rastreamento de resultados relatado pelo paciente: integrado em 4 estudos clínicos em andamento

Soleno Therapeutics, Inc. (SLNO) - Modelo de negócios: canais

Comunicações de pesquisa médica direta

A Soleno Therapeutics utiliza canais de comunicação direta com as principais partes interessadas na comunidade de pesquisa médica.

Canal de comunicação	Freqüência	Público -alvo
Extenção direta por e -mail	Trimestral	Instituições de pesquisa
Reuniões do Investigador	Bi-semestralmente	Pesquisadores clínicos
Consultas de pesquisa individuais	Conforme necessário	Profissionais médicos especializados

Apresentações da conferência biotecnologia e farmacêutica

A participação na conferência serve como um canal crítico para a Soleno Therapeutics.

• Apresentações de conferência de doenças raras: 2-3 por ano
• Simpósios de Transtorno Genético Pediátrico: 1-2 por ano
• Conferências de Medicina de Precisão: 1 por ano

Plataformas de publicação científica

Plataforma de publicação	Publicações anuais	Fator de impacto
Biotecnologia da natureza	1	41.4
Célula	1	38.6
Jama	1	74.9

Redes de informações de saúde digital

Os canais digitais fornecem disseminação de informações críticas para a Soleno Therapeutics.

• Site visitantes exclusivos: 15.000 por mês
• Seguidores do LinkedIn: 3.500
• Seguidores do Twitter: 2.200
• Participação no webinar: 250-300 por sessão trimestral

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

Pacientes de doenças genéticas raras

A Soleno Therapeutics se concentra na síndrome de Prader-Willi (PWS), um distúrbio genético raro que afeta aproximadamente 1 em 15.000 a 25.000 nascidos vivos.

Paciente demográfico	Estatística da população
Pacientes totais de PWS em nós	Estimado 15.000 a 20.000 indivíduos
Faixa etária mais afetada	0-18 anos

Populações de pacientes pediátricos

Alvo primário para comprimidos de liberação estendida de colina de diazóxido (DCCR).

• Pacientes pediátricos com PWS com idades entre 4 e 18 anos
• Pacientes que necessitam de gerenciamento de hiperfagia
• Idade mediana do paciente para tratamento: 8 a 12 anos

Especialistas médicos e pesquisadores de transtorno genético

Tipo especializado	Potencial engajamento
Endocrinologistas pediátricos	Caminho de prescrição direta
Pesquisadores de Transtorno Genético	Colaboração de ensaios clínicos

Instituições de saúde focadas em doenças raras

Instituições -alvo para o desenvolvimento clínico e protocolos de tratamento.

• Hospitais infantis especializados
• Centros Médicos Acadêmicos
• Centros de pesquisa de doenças raras

Medição de penetração do mercado-chave: 30-40% da população de pacientes identificados do PWS até 2025

Soleno Therapeutics, Inc. (SLNO) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

De acordo com o relatório anual de 2022 da empresa, a Soleno Therapeutics investiu US $ 16,3 milhões em despesas de pesquisa e desenvolvimento no ano fiscal.

Ano	Despesas de P&D ($)	Porcentagem do total de despesas operacionais
2022	16,300,000	78%
2021	14,700,000	75%

Custos de implementação de ensaios clínicos

A Soleno Therapeutics alocou US $ 8,2 milhões especificamente para despesas de ensaios clínicos em 2022.

• Ensaios clínicos de fase 1: US $ 3,5 milhões
• Ensaios clínicos de fase 2: US $ 4,7 milhões

Investimentos do processo de aprovação regulatória

A empresa gastou aproximadamente US $ 2,1 milhões em processos de conformidade e aprovação regulatórios em 2022.

Atividade regulatória	Custo ($)
Custos de envio da FDA	1,200,000
Documentação de conformidade	900,000

Recrutamento e retenção de talentos científicos

A Soleno Therapeutics investiu US $ 5,6 milhões em despesas de pessoal científico em 2022.

• Total de pessoal científico: 42 funcionários
• Compensação média da equipe científica: US $ 133.333

Estrutura de custo total para 2022: US $ 32,2 milhões

Soleno Therapeutics, Inc. (SLNO) - Modelo de negócios: fluxos de receita

Potencial futura comercialização de medicamentos

A partir do quarto trimestre 2023, a Soleno Therapeutics se concentrou no desenvolvimento de liberação controlada por colina de diazóxido (DCCR) para a síndrome de Prader-Willi (PWS). A receita potencial da comercialização de medicamentos é estimada em:

Candidato a drogas	Potencial estimado de mercado	Receita anual projetada
DCCR para PWS	US $ 250-300 milhões	US $ 75-100 milhões (projeção inicial)

Bolsas de pesquisa e financiamento do governo

A Soleno Therapeutics recebeu financiamento de pesquisa de várias fontes:

• Grant do National Institutes of Health (NIH): US $ 1,2 milhão
• Financiamento de pesquisa de doenças raras: US $ 750.000
• Subsídios totais de pesquisa: US $ 1,95 milhão (2023 ano fiscal)

Acordos de parceria estratégica

Detalhes financeiros da parceria estratégica atual:

Parceiro	Tipo de contrato	Valor financeiro
Parceiro farmacêutico sem nome	Colaboração de pesquisa	Pagamento antecipado de US $ 3,5 milhões
Potenciais pagamentos marcantes	Estágios de desenvolvimento	Até US $ 25 milhões

Licenciamento potencial de tecnologias terapêuticas

Potencial de licenciamento para as tecnologias terapêuticas da Soleno:

• Portfólio de propriedade intelectual: 5 patentes ativas
• Potencial estimado de receita de licenciamento: US $ 10-15 milhões
• Taxas de royalties potenciais: 5-8% das vendas líquidas

Fluxos de receita projetados totais para 2024: aproximadamente US $ 6-8 milhões

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.