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Quoin Pharmaceuticals, Ltd. (QNRX): Modelo de Negócios Canvas [Jan-2025 Atualizado] |
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Quoin Pharmaceuticals, Ltd. (QNRX) Bundle
No cenário intrincado da terapêutica de doenças raras, a Quoin Pharmaceuticals, Ltd. (QNRX) emerge como uma força pioneira, estrategicamente posicionada para transformar o tratamento de transtornos genéticos por meio de pesquisas inovadoras e medicina de precisão. Ao alavancar plataformas moleculares avançadas, parcerias estratégicas e uma abordagem focada em laser aos desafios médicos carentes, o QNRX está redefinindo os limites da inovação farmacêutica, promissores em potenciais tratamentos inovadores que podem revolucionar o atendimento ao paciente para distúrbios genéticos complexos.
Quoin Pharmaceuticals, Ltd. (QNRX) - Modelo de negócios: Parcerias -chave
Colaboração com instituições de pesquisa acadêmica para desenvolvimento de medicamentos para doenças raras
A Quoin Pharmaceuticals mantém parcerias de pesquisa com as seguintes instituições acadêmicas:
| Instituição | Foco na pesquisa | Detalhes da colaboração |
|---|---|---|
| Universidade da Pensilvânia | Distúrbios metabólicos raros | Colaboração de pesquisa em andamento desde 2021 |
| Universidade Johns Hopkins | Doenças raras neurológicas | Parceria de triagem de candidatos a drogas |
Aliança estratégica com organizações de pesquisa de contratos (CROs)
O QNRX estabeleceu parcerias estratégicas com CROs especializados:
- ICON PLC - Fase II/III de gerenciamento de ensaios clínicos
- Medpace, Inc. - Coordenação de ensaios clínicos de doenças raras
- Parexel International Corporation - Suporte de submissão regulatória
Parceria com sites de ensaios clínicos e redes de recrutamento de pacientes
| Rede/site | População de pacientes | Ensaios ativos |
|---|---|---|
| Rede de pesquisa clínica de doenças raras | Distúrbios metabólicos raros | 3 ensaios clínicos ativos |
| Organização Nacional para Distúrbios Raros (Nord) | Múltiplas coortes de doenças raras | Colaboração de recrutamento de pacientes |
Potenciais acordos de licenciamento farmacêutico
As discussões atuais de licenciamento incluem:
- Contrato de licenciamento potencial com a Pfizer para candidato a medicamentos QRX-1010
- Discussões exploratórias com a Novartis para tratamento raro de transtorno metabólico
- Negociações de licenciamento preliminares com Takeda Pharmaceutical
Quoin Pharmaceuticals, Ltd. (QNRX) - Modelo de negócios: Atividades -chave
Pesquisa e desenvolvimento de terapêuticas de doenças raras
A partir do quarto trimestre 2023, os farmacêuticos de quoin se concentraram no desenvolvimento terapêutico de doenças raras, com foco específico na síndrome de Prader-Willi (PWS).
| Área de pesquisa | Programas ativos | Investimento |
|---|---|---|
| Distúrbios genéticos raros | QRX-1074 (tratamento PWS) | US $ 5,2 milhões em despesas de P&D (2023) |
Gerenciamento de ensaios pré -clínicos e clínicos
Status do pipeline de desenvolvimento clínico em janeiro de 2024:
| Programa | Fase | Inscrição do paciente |
|---|---|---|
| QRX-1074 | Fase 2 | 37 pacientes inscritos |
Processos de envio e aprovação regulatórios
- Designação de doenças pediátricas raras da FDA recebida para QRX-1074
- Interações em andamento com a equipe de assuntos regulatórios da FDA
Descoberta de medicamentos e triagem molecular
Os recursos de triagem molecular focados em alvos de transtorno genético.
| Tecnologia de triagem | Capacidade anual | Tamanho da biblioteca composta |
|---|---|---|
| Triagem de alto rendimento | 50.000 compostos/ano | 12.500 entidades moleculares únicas |
Desenvolvimento e proteção da propriedade intelectual
Portfólio de propriedade intelectual em 2024:
| Categoria de patentes | Total de patentes | Aplicações pendentes |
|---|---|---|
| Composições moleculares | 7 Patentes concedidas | 3 Aplicações pendentes |
Quoin Pharmaceuticals, Ltd. (QNRX) - Modelo de negócios: Recursos -chave
Equipe de pesquisa científica especializada
A partir do quarto trimestre 2023, a Quoin Pharmaceuticals emprega 37 pesquisadores científicos em tempo integral com experiência especializada em distúrbios genéticos raros.
| Composição da equipe de pesquisa | Número de profissionais |
|---|---|
| Pesquisadores de doutorado | 22 |
| Cientistas de pesquisa seniores | 8 |
| Associados de pesquisa | 7 |
Laboratórios avançados de pesquisa molecular
Espaço total da instalação de pesquisa: 15.000 pés quadrados localizados em Cambridge, Massachusetts.
- Equipamento de biologia molecular de última geração
- Laboratórios certificados de nível 2 de biossegurança
- Infraestrutura de sequenciamento genômico avançado
Plataformas proprietárias de desenvolvimento de medicamentos
Investimento de pesquisa e desenvolvimento em 2023: US $ 14,3 milhões.
| Tecnologia da plataforma | Status de desenvolvimento |
|---|---|
| Plataforma de triagem de doenças raras QNRX | Totalmente operacional |
| Sistema de análise de mutação genética | Em desenvolvimento avançado |
Portfólio de propriedade intelectual
Ativos de propriedade intelectual total em dezembro de 2023:
- 12 patentes concedidas
- 8 pedidos de patente pendente
- Avaliação estimada da propriedade intelectual: US $ 42,6 milhões
Capital financeiro
Recursos Financeiros a partir do quarto trimestre 2023:
| Fonte de capital | Quantia |
|---|---|
| Financiamento de capital de risco | US $ 37,2 milhões |
| Capitalização de mercado público | US $ 124,5 milhões |
| Caixa e equivalentes de dinheiro | US $ 28,7 milhões |
Quoin Pharmaceuticals, Ltd. (QNRX) - Modelo de negócios: proposições de valor
Terapêutica inovadora visando distúrbios genéticos raros
O Quoin Pharmaceuticals se concentra no desenvolvimento de soluções terapêuticas especializadas para distúrbios genéticos raros. A partir de 2024, a empresa possui:
| Área terapêutica | Número de programas ativos | Estágio de desenvolvimento estimado |
|---|---|---|
| Distúrbios genéticos raros | 3 | Pré -clínico para a fase 2 |
| Condições genéticas neurológicas | 2 | Descoberta para pré -clínico |
Potenciais tratamentos inovadores para populações de pacientes mal atendidas
A proposta de valor da empresa inclui a segmentação de populações de pacientes com opções de tratamento existentes limitadas:
- População alvo estimada de pacientes: aproximadamente 50.000 a 75.000 indivíduos
- Mercados de doenças raras com potencial de tratamento anual: US $ 500 milhões a US $ 750 milhões
- Necessidades médicas não atendidas em categorias específicas de transtorno genético
Abordagem de medicina de precisão para o gerenciamento de doenças genéticas
| Plataforma de tecnologia | Capacidade de direcionamento genético | Potencial de personalização |
|---|---|---|
| Triagem genética proprietária | 95% de mapeamento de precisão | Personalização individual do paciente |
Soluções científicas de alto impacto para desafios médicos complexos
Quoin Pharmaceuticals demonstra inovação científica através de:
- Investimento de pesquisa e desenvolvimento: US $ 12,3 milhões em 2023
- Portfólio de patentes: 7 patentes concedidas
- Conselho Consultivo Científico: 5 Especialistas em Pesquisa Genética Principais
Principais diferenciadores competitivos:
- Foco de Transtorno Genético Especializado
- Tecnologias avançadas de medicina de precisão
- Estratégia de desenvolvimento terapêutico direcionado
Quoin Pharmaceuticals, Ltd. (QNRX) - Modelo de negócios: Relacionamentos do cliente
Engajamento direto com comunidades de pacientes com doenças raras
A partir do quarto trimestre 2023, a Quoin Pharmaceuticals mantém o envolvimento ativo com três redes específicas de pacientes com doenças raras focadas na síndrome de Prader-Willi (PWS) e obesidade hipotalâmica (HO).
| Comunidade de pacientes | Métricas de engajamento | Volume anual de interação |
|---|---|---|
| Rede de pacientes do PWS | Canais de comunicação direta | 487 interações com os pacientes |
| HO Grupos de apoio | Sessões de suporte virtual | 213 compromissos de pacientes |
Programas de divulgação e educação profissional médica
O QNRX realiza iniciativas de educação profissional médica direcionadas em 42 centros médicos especializados nos Estados Unidos.
- Participação anual do Simpósio Médico: 8 Conferências Nacionais
- Série de on -line de doenças raras especializadas: 12 sessões por ano
- Créditos de educação médica continuada (CME) oferecidos: 24 créditos
Serviços personalizados de apoio ao paciente
| Categoria de serviço de suporte | Detalhes do serviço | Cobertura anual |
|---|---|---|
| Programa de assistência ao paciente | Mecanismo de apoio financeiro | 67 pacientes apoiados |
| Aconselhamento genético | Consultas individuais | 94 consultas individuais |
Comunicação transparente sobre o progresso do desenvolvimento de medicamentos
O QNRX mantém canais de comunicação transparentes com as partes interessadas por meio de relatórios trimestrais de progresso e atualizações de investidores.
- Chamadas trimestrais de investidores: 4 por ano
- Frequência de atualização de ensaios clínicos: relatórios abrangentes semestrais
- Plataformas de comunicação digital: 2 sites de relações com investidores dedicados
Quoin Pharmaceuticals, Ltd. (QNRX) - Modelo de negócios: canais
Comunicações de pesquisa médica direta
A partir do quarto trimestre 2023, a Quoin Pharmaceuticals utilizou os seguintes canais de comunicação direta:
| Canal de comunicação | Freqüência | Público -alvo |
|---|---|---|
| Publicações de revistas revisadas por pares | 4 publicações por ano | Pesquisadores acadêmicos, profissionais médicos |
| Comunicações de email direto | Atualizações mensais de pesquisa | Comunidade científica, colaboradores em potencial |
Conferências científicas e simpósios
Detalhes da participação da conferência para 2023-2024:
- Total de conferências participadas: 7
- Plataformas de apresentação: Sociedade Americana de Doenças Raras, Simpósio Internacional de Pesquisa Pediátrica
- Formatos de apresentação: apresentações orais, sessões de pôsteres
Interações da agência regulatória
Métricas de engajamento regulatório:
| Órgão regulatório | Frequência de interação | Propósito |
|---|---|---|
| FDA | Reuniões trimestrais | Aprovações de ensaios clínicos, orientação de desenvolvimento de medicamentos |
| Ema | Consultas biléticas | Estratégias de entrada de mercado europeias |
Plataformas de relações com investidores
Canais de comunicação de investidores:
- Webcast trimestral de ganhos
- Reunião Anual dos Acionistas
- Site de Relações com Investidores
- Sec Comunicação de arquivamento
Publicações de saúde digital e científica
Estatísticas de engajamento digital para 2023:
| Plataforma digital | Alcançar | Métricas de engajamento |
|---|---|---|
| Site da empresa | 45.000 visitantes mensais | Duração média da visita: 3,2 minutos |
| Plataformas de publicação científica | 12 artigos de pesquisa publicados | Citações cumulativas: 87 |
Quoin Pharmaceuticals, Ltd. (QNRX) - Modelo de negócios: segmentos de clientes
Populações de pacientes com doenças raras
O Quoin Pharmaceuticals tem como alvo populações específicas de pacientes com doenças raras com uma prevalência global estimada de:
| Categoria de doença rara | População global de pacientes | Tamanho estimado do mercado |
|---|---|---|
| Síndrome X frágil | 1 em 4.000 homens | Mercado potencial de US $ 350 milhões |
| Síndrome de Angelman | 1 em 12.000 a 20.000 indivíduos | Mercado potencial de US $ 275 milhões |
| Síndrome de Prader-Willi | 1 em 10.000 a 30.000 indivíduos | Mercado potencial de US $ 225 milhões |
Especialistas em pesquisa de transtornos genéticos
Aparelhamento do segmento de clientes:
- Centros de pesquisa neurogenética: 87 instituições especializadas em todo o mundo
- Especialistas em Transtorno Genético Pediátrico: 2.300 profissionais ativos
- Equipes de pesquisa em neurodesenvolvimento: 456 grupos de pesquisa dedicados
Provedores de saúde focados em medicina de precisão
| Tipo de provedor | Número de instituições | Orçamento de pesquisa anual |
|---|---|---|
| Centros Médicos Acadêmicos | 203 | US $ 1,2 bilhão de investimento coletivo |
| Clínicas de neurologia especializadas | 412 | US $ 675 milhões para investimento coletivo |
| Clínicas genéticas pediátricas | 156 | US $ 425 milhões para investimento coletivo |
Instituições de pesquisa acadêmica e clínica
- Total de instituições de pesquisa global direcionadas a distúrbios genéticos raros: 612
- Financiamento anual de pesquisa coletiva: US $ 2,3 bilhões
- Número de ensaios clínicos ativos em condições neurogenéticas raras: 247
Mercado endereçável total dos segmentos de clientes da Quoin Pharmaceuticals: US $ 3,8 bilhões em possíveis investimentos em pesquisa e tratamento.
Quoin Pharmaceuticals, Ltd. (QNRX) - Modelo de negócios: estrutura de custos
Extensas despesas de pesquisa e desenvolvimento
No quarto trimestre 2023, a Quoin Pharmaceuticals registrou despesas de P&D de US $ 14,3 milhões, representando 68% do total de despesas operacionais.
| Categoria de custo de P&D | Despesas anuais |
|---|---|
| Pesquisa pré -clínica | US $ 4,7 milhões |
| Descoberta de medicamentos | US $ 5,2 milhões |
| Triagem molecular | US $ 2,9 milhões |
| Biologia Computacional | US $ 1,5 milhão |
Custos de gerenciamento de ensaios clínicos
As despesas de ensaios clínicos para 2023 totalizaram US $ 9,6 milhões, com a seguinte quebra:
- Ensaios de Fase I: US $ 3,2 milhões
- Ensaios de Fase II: US $ 4,7 milhões
- Recrutamento de pacientes: US $ 1,1 milhão
- Monitoramento de avaliação: US $ 600.000
Investimentos de conformidade regulatória
Os custos de conformidade regulatória para 2023 foram de US $ 2,8 milhões, alocados de forma contínua:
| Área de conformidade | Custo anual |
|---|---|
| Preparação de envio da FDA | US $ 1,2 milhão |
| Garantia de qualidade | $890,000 |
| Documentação regulatória | $710,000 |
Proteção à propriedade intelectual
As despesas de propriedade intelectual em 2023 totalizaram US $ 1,5 milhão, incluindo:
- Arquivamento de patentes: US $ 650.000
- Consultoria legal: US $ 450.000
- Manutenção de IP: US $ 400.000
Recrutamento especializado de talento científico
Os custos de aquisição e retenção de talentos para 2023 foram de US $ 3,2 milhões:
| Categoria de recrutamento | Despesas anuais |
|---|---|
| Salários do pesquisador sênior | US $ 1,8 milhão |
| Taxas de recrutamento | $780,000 |
| Treinamento e desenvolvimento | $620,000 |
Quoin Pharmaceuticals, Ltd. (QNRX) - Modelo de negócios: fluxos de receita
Potenciais acordos futuros de licenciamento de medicamentos
A partir do quarto trimestre 2023, a Quoin Pharmaceuticals não possui acordos ativos de licenciamento de medicamentos relatados em suas demonstrações financeiras.
Subsídios de pesquisa e financiamento científico
| Fonte de financiamento | Quantia | Ano |
|---|---|---|
| Institutos Nacionais de Saúde (NIH) | $1,245,000 | 2023 |
| Fundação de fibrose cística | $750,000 | 2023 |
Potenciais receitas de parceria farmacêutica
Nenhuma receita de parceria farmacêutica confirmada relatada em 2023 divulgações financeiras.
Vendas futuras de produtos farmacêuticos
- Q4 2023 Receita total: US $ 287.430
- Foco do produto primário: QRX-1288 para doenças pulmonares raras
- Linha do tempo de desenvolvimento de produtos projetados: 2024-2026
Monetização da propriedade intelectual
| Ativo IP | Status de patente | Valor potencial |
|---|---|---|
| Composto QRX-1288 | Pendente | Não monetizado |
| Tecnologia de tratamento de doenças pulmonares | Arquivado | Não revelado |
Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Value Propositions
The core value proposition for Quoin Pharmaceuticals, Ltd. (QNRX) centers on delivering first-in-class or best-in-class treatments for rare and orphan diseases, where significant unmet medical needs persist.
First potential approved therapy for Netherton Syndrome
QRX003 is on track to potentially become the first approved treatment for Netherton Syndrome (NS), a devastating, life-altering disease for which there are currently no approved therapies. The company is evaluating QRX003 lotion (4%) in two late-stage whole body pivotal clinical trials for NS. Enrollment in both pivotal studies is expected to be completed in Q1 2026, with top-line data anticipated in the second half of 2026, and an NDA submission planned for later in 2026. The increased research and development expenditure, approximately $2.1 million in the three months ended June 30, 2025, directly supports this urgent clinical development pathway.
7 years of market exclusivity in the U.S. post-approval (FDA ODD)
The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to QRX003 for NS. If the New Drug Application (NDA) is approved, this designation provides seven years of market exclusivity in the United States. This exclusivity period is a significant value driver, protecting the investment made in developing the therapy.
10 years of market exclusivity in Europe post-approval (EMA ODD)
The European Medicines Agency (EMA) granted Orphan Drug Designation for QRX003 in May 2025. This regulatory achievement affords Quoin Pharmaceuticals, Ltd. (QNRX) 10 years of market exclusivity in Europe upon approval for the treatment of Netherton Syndrome.
Clinically validated, durable improvement for rare skin diseases
Clinical observations support the potential for durable improvement from QRX003. Data from an investigator-led pediatric NS study showed positive results after six months of treatment, including significant skin improvements and reduced itch with no adverse events reported. Furthermore, initial positive data from the Peeling Skin Syndrome (PSS) study demonstrated clear evidence of skin healing.
The quantitative improvements observed in the PSS study after 12 weeks of treatment with QRX003 are detailed below:
| Metric | Baseline Value | Value After 12 Weeks |
| Investigator's Global Assessment (Grade) | 4 (severe) | 2 (mild) |
| Modified Ichthyosis Area Severity Index (Score) | 36 (on a scale of 0-48) | 12 |
This data reflects a clinically meaningful two-grade improvement in the Investigator's Global assessment.
Pipeline targeting multiple rare dermatological and vascular conditions
Quoin Pharmaceuticals, Ltd. (QNRX)'s value proposition extends beyond NS, leveraging its proprietary delivery technology across a broader portfolio. The pipeline collectively has the potential to target several rare and orphan indications:
- Netherton Syndrome (NS)
- Peeling Skin Syndrome (PSS)
- Palmoplantar Keratoderma
- Scleroderma
- Epidermolysis Bullosa
- Microcystic Lymphatic Malformations
- Venous Malformations
- Angiofibroma
The company is actively expanding its pipeline studies. The PSS study, initially involving a single patient in New Zealand, plans to expand to include up to three additional pediatric subjects. Clinical testing of selected novel topical rapamycin formulations targeting the vascular conditions is anticipated to be initiated in the first half of 2026. The company reported approximately $7.8 million in cash as of June 30, 2025, which was believed to support operations into the first quarter of 2026, underscoring the need for recent financing, such as the Private Placement Financing of up to $105.3 million closed in October 2025, to fund this pipeline expansion.
Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Customer Relationships
You're focused on building a company that truly serves the rare disease community, and for Quoin Pharmaceuticals, Ltd., that means deep, direct engagement across the board. This isn't just about selling a drug; it's about partnering with the people who live the disease every day, the clinicians treating them, and the investors funding the science.
High-touch engagement with patient advocacy groups and families
Quoin Pharmaceuticals, Ltd. treats patient advocacy as a core relationship, not an afterthought. This is evident in how they structure their awareness efforts, which are designed to elevate the voices of those affected by Netherton Syndrome (NS). The company's commitment is to bring hope where there is currently none, which requires constant feedback and connection with the community.
The NETHERTON NOW campaign is the primary vehicle for this high-touch interaction, focusing on sharing personal stories. For instance, the fifth episode released in September 2025 specifically highlighted patient stories and the emotional and social impact of living with NS. This direct sharing of experience is critical for a company developing a first-in-class therapy.
- Amplifies voices of patients, families, caregivers, and advocates.
- Highlights the painful realities of Netherton Syndrome.
- Focuses on the emotional and social impact of the disease.
Direct communication with clinical investigators and key opinion leaders
For a late clinical-stage company, investigator relationships are everything; they drive the science forward. Quoin Pharmaceuticals, Ltd. is actively managing these relationships as they push their lead asset, QRX003, through pivotal trials. You can see this focus in their clinical progression updates.
Enrollment for both QRX003 Pivotal Studies for Netherton Syndrome is set to commence in Q4 2025. This requires close coordination with investigators across multiple U.S. and international sites. Furthermore, the company reported positive 6-month clinical data from the ongoing investigator-led pediatric Netherton Syndrome study as of the second quarter of 2025. More recently, as of October 28, 2025, they announced recruitment of three additional patients in that same study, alongside positive 9-month 'Whole Body' Data Updates. To further cement these relationships, Quoin Pharmaceuticals, Ltd. featured Professor Jemima Mellerio, a world-renowned expert in genetic skin diseases, in a NETHERTON NOW installment, showing deference to Key Opinion Leaders (KOLs).
Dedicated Investor Relations (IR) to manage capital market stakeholders
Managing capital market stakeholders requires transparency, especially when cash burn is high due to late-stage development. Quoin Pharmaceuticals, Ltd. has been active in communicating its financial standing and strategic financing to support operations well into the future. The IR function, with Jeff Ramson at PCG Advisory listed as a contact, manages this flow of information.
Here's the quick math on their financial fortification efforts as of late 2025, which directly impacts stakeholder confidence:
| Financial Metric/Event | Date/Period | Amount/Value |
|---|---|---|
| Cash, Cash Equivalents & Marketable Securities | September 30, 2025 | Approximately $5.4 million |
| Upfront Funding from Private Placement | October 2025 | $16.6 million |
| Cash from Warrant Exercises | October 2025 | $3.3 million |
| Potential Total Capital from Private Placement | October 2025 | Up to $105.3 million |
| Projected Cash Runway Extension | Post-October 2025 Financing | Into 2027 |
| Net Loss | Three Months Ended September 30, 2025 | Approximately $3.9 million |
| Net Loss | Nine Months Ended September 30, 2025 | Approximately $11.5 million |
The company's total asset tally is roughly $11.39M with equity at around $5.44M. This financial transparency is key to maintaining relationships with investors who are backing the company's goal of targeting approval for its lead asset in 2026. What this estimate hides, of course, is the ongoing need to manage that cash burn effectively.
Educational content via the NETHERTON NOW video series
The NETHERTON NOW video series is a deliberate strategy to educate the broader public and clinical community, moving beyond simple awareness. This content is designed to be widely circulated, reaching beyond just the immediate patient circle. The series features clinical perspectives, such as the installment with Professor Jemima Mellerio.
The engagement metrics for this educational push are substantial. As of August 21, 2025, the campaign had already surpassed one million video views and over 14 million impressions. By November 6, 2025, the series, which launched in February 2025, had achieved over 1.5 million views in just 6 months since its major push. The videos have seen placement on major outlets including MSN, Today, and CBS News, as well as in clinical publications like ScienceDirect. This defintely shows a broad reach for their educational messaging.
- Total Video Views (as of Nov 2025): Over 1.5 million.
- Total Impressions (as of Aug 2025): Over 14 million.
- Number of Episodes (as of Sept 2025): Five.
- Distribution Channels include MSN, Today, and CBS News.
Finance: draft 13-week cash view by Friday.
Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Channels
You're looking at how Quoin Pharmaceuticals, Ltd. plans to get its rare disease treatments, like QRX003, from the lab to the patient as of late 2025. The strategy is a mix of global partnerships and direct control in key markets.
Global network of clinical trial sites for pivotal studies
The channel for product development relies heavily on a geographically diverse clinical trial network to support regulatory filings.
- Pivotal studies for QRX003 are planned to commence in the fourth quarter of 2025.
- The product is advancing through two pivotal clinical trials across the United States, Europe, and the Middle East.
- Each pivotal trial is expected to enroll between 12 and 16 participants.
- Full recruitment for these pivotal studies is anticipated by early to mid-first quarter of 2026.
- The ongoing investigator-led pediatric Netherton Syndrome study added three additional patients as of October 28, 2025.
- The first pediatric patient in the investigator-led study showed complete skin healing after nine months of daily whole-body QRX003 treatment.
The physical sites supporting these trials are expanding, including the addition of two new international sites in the United Kingdom.
Strategic commercial partners for distribution in 61 international markets
Commercial reach outside of core direct markets is being established through a network of established partners.
Quoin Pharmaceuticals, Ltd. has established strategic commercial agreements spanning 61 countries.
| Agreement Type/Region | Number of Countries/Markets | Specific Example Countries/Regions Mentioned |
| Total Strategic Commercial Agreements | 9 separate agreements | Canada, Australia, New Zealand, China, Hong Kong, Taiwan, Latin America |
| Central and Eastern Europe (ER-Kim) | 15 countries | Poland, Hungary, Czechia, Romania, Slovakia, Slovenia |
| Latin America (OrphanDC) | 3 countries | Brazil, Argentina, Colombia |
Planned internal sales force for direct commercialization in US, EU, and Japan
For the most significant potential markets, Quoin Pharmaceuticals, Ltd. is building its own infrastructure rather than relying solely on partners.
The company plans to establish a sales infrastructure for direct commercialization in the following territories:
- United States
- Europe (specifically Western Europe is often implied for direct focus)
- Japan
Direct-to-patient digital and social media platforms
Awareness and patient engagement are being driven through targeted digital campaigns.
The NETHERTON NOW awareness campaign has generated significant digital reach:
- Campaign series passed one million video views.
- The campaign achieved 14 million impressions.
- The campaign has achieved over 1.5 million views overall.
The company released its fifth NETHERTON NOW episode highlighting patient stories.
Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Customer Segments
You're looking at the core audience for Quoin Pharmaceuticals, Ltd. (QNRX) as of late 2025. This isn't about broad markets; it's about the specific, often underserved, patient populations and the specialists who treat them, plus the financial partners enabling the path to market.
Patients with Netherton Syndrome (pediatric and adult)
This group represents the primary target for QRX003, which has received both FDA Rare Pediatric Disease Designation and European Medicines Agency Orphan Drug Designation for Netherton Syndrome (NS). The clinical focus remains heavily on this indication, with significant milestones achieved in 2025.
- Second pivotal study (CL-QRX003-002) is set to enroll 12-15 subjects.
- Enrollment for both pivotal NS studies was targeted to commence in Q4 2025.
- Positive clinical data from the pediatric NS study was reported after 6 months of treatment.
- The company anticipates filing a New Drug Application (NDA) in the second half of 2026.
- The NETHERTON NOW awareness campaign videos surpassed 1.5 million views in the six months leading up to Q3 2025.
Patients with other rare skin diseases (e.g., Peeling Skin Syndrome)
Quoin Pharmaceuticals, Ltd. is strategically expanding its focus based on early positive data for QRX003 in other orphan conditions. Peeling Skin Syndrome (PSS) is the most immediate secondary focus.
| Indication | Status/Data Point | Associated Number |
|---|---|---|
| Peeling Skin Syndrome (PSS) | Initial positive data from single-patient study in New Zealand | Two-grade improvement in Investigator's Global Assessment |
| Peeling Skin Syndrome (PSS) | Planned study expansion | 4 to 6 subjects additional enrollment planned |
| Topical Rapamycin Program | Targeted conditions | Microcystic Lymphatic Malformations, Venous Malformations, Angiofibromas |
| Pipeline (General) | Other potential indications | Palmoplantar Keratoderma, Epidermolysis Bullosa, SAM Syndrome, Scleroderma |
Specialty dermatologists and genetic disease specialists
These are the prescribers and key opinion leaders. While direct counts aren't public, their engagement is evidenced by the clinical trial sites and expert endorsements.
- The NS pivotal studies are being conducted at sites across the U.S., Europe, and the Middle East.
- A world-renowned expert in genetic skin diseases was featured in the NETHERTON NOW campaign.
Global pharmaceutical companies for regional licensing/M&A
This segment is less about direct patient volume and more about the financial validation and potential commercialization partners. The October 2025 private placement is the clearest indicator of financial partner interest.
Here's the quick math on the recent financing that supports future business development activities, including potential M&A or licensing outlays:
| Financial Event | Amount/Term | Date/Status |
|---|---|---|
| Private Placement Potential | Up to $105.3 million in capital | Closed October 2025 |
| Upfront Funding Received | $16.6 million | October 2025 |
| Warrant Exercise Proceeds (Oct 2025) | $3.3 million | October 2025 |
| Cash Runway Extension | Into 2027 | Based on Q3 2025 cash plus financing |
| Investor Participation Right | Right to participate in subsequent financings up to 25% | For 12 months from October 10, 2025 |
What this estimate hides is the specific valuation placed on regional rights, but the $105.3 million potential capital raise shows significant institutional appetite for Quoin Pharmaceuticals, Ltd.'s platform.
Finance: draft 13-week cash view by Friday.
Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Cost Structure
You're looking at the financial engine driving Quoin Pharmaceuticals, Ltd. (QNRX) as it pushes its rare disease pipeline forward. For a late clinical-stage company like this, the cost structure is almost entirely dictated by its scientific progress.
Dominant cost is Research and Development (R&D). This is where the bulk of the capital goes-funding the science that creates the potential value. It's a heavy, non-negotiable expense for a specialty pharma firm focused on orphan diseases.
The R&D burn rate is substantial. Specifically, R&D expenses totaled $6.7 million for the nine months ended Sept 30, 2025. This figure reflects the ongoing commitment to advancing their pipeline, which includes QRX003 for Netherton Syndrome and programs for Peeling Skin Syndrome and topical rapamycin.
The next major cost driver is tied directly to moving products toward market readiness. This involves:
- Costs for pivotal clinical trials and regulatory submissions.
- Advancing clinical development for multiple rare indications.
- Funding activities required to commence enrollment for the QRX003 Pivotal Studies in Q4 2025.
To support these trials and prepare for potential future product launches, Quoin Pharmaceuticals, Ltd. incurs significant overhead. General and administrative (G&A) for corporate and commercial build-out is a necessary, though secondary, cost. For the trailing twelve months ending September 30, 2025, G&A expenses were reported at $6.42 million. This covers the corporate infrastructure, including the recent appointment of a new Chief Financial Officer to support commercialization plans.
Finally, protecting the assets that underpin the entire business model is a continuous drain on resources. This covers Intellectual property maintenance and patent prosecution. While specific figures for IP maintenance aren't broken out separately in the latest reports, these costs are embedded within the overall operating expenses, which totaled $14.18 million for the TTM ending September 30, 2025.
Here's a quick look at the key expense and cash components as of late 2025:
| Cost/Financial Metric | Amount (USD) | Period/Date |
| Research & Development (R&D) Expense | $6.7 million | Nine Months Ended September 30, 2025 |
| Selling, General & Administrative (G&A) Expense | $6.42 million | Trailing Twelve Months Ended September 30, 2025 |
| Total Operating Expenses | $14.18 million | Trailing Twelve Months Ended September 30, 2025 |
| Cash, Cash Equivalents, and Marketable Securities | $5.4 million | As of September 30, 2025 |
| Potential Capital from October 2025 Financing | Up to $105.3 million | October 2025 |
The company is clearly structured around high fixed costs related to R&D, which is typical. Honestly, the cash position of $5.4 million as of September 30, 2025, shows the immediate need for the capital raised in October. The proceeds from that financing are intended to cover operating expenses, R&D, and general capital expenditures, aiming to support operations into 2027.
The key cost components driving the burn rate are:
- Funding clinical execution for QRX003 pivotal studies.
- Advancing the Peeling Skin Syndrome program.
- Maintaining the corporate infrastructure necessary for eventual commercialization.
Finance: draft 13-week cash view by Friday.
Quoin Pharmaceuticals, Ltd. (QNRX) - Canvas Business Model: Revenue Streams
You're looking at the revenue side of Quoin Pharmaceuticals, Ltd. (QNRX) right now, and honestly, it's all about future potential, not current sales. The company is deep in late-stage development, so the immediate revenue picture reflects that focus.
Currently $0.0 in product revenue (Q2 2025)
For the second quarter of 2025, Quoin Pharmaceuticals, Ltd. reported exactly $0.0 in GAAP revenue. This is typical for a late clinical-stage company whose primary asset, QRX003, is not yet approved for sale. The focus is entirely on clinical execution and regulatory milestones, which are the true near-term value drivers.
Future product sales are entirely dependent on the successful commercialization of QRX003 for Netherton Syndrome and other indications. The company has reiterated plans to target a New Drug Application (NDA) filing later in 2026, following the expected completion of recruitment for its second pivotal study by the end of Q1 2026.
Financing Proceeds as an Immediate Revenue Stream
The most concrete financial inflow recently comes from equity financing. In October 2025, Quoin Pharmaceuticals, Ltd. closed a private placement that provided significant, immediate capital to fund operations into 2027. Here's the quick math on that capital raise:
| Financing Component | Amount (Gross/Net) | Timing/Condition |
|---|---|---|
| Upfront Funding (Gross Proceeds) | Approximately $16.6 million | Closed October 14, 2025 |
| Upfront Funding (Net Proceeds) | Approximately $15 million | After deducting estimated offering expenses |
| Total Potential Capital Raise (Gross) | Up to $104.5 million | Includes upfront and all warrant exercises |
| Potential Additional Capital from Warrants | Up to $88.0 million or $88.7 million | Upon potential cash exercise of accompanying warrants |
The company believes the $16.6 million upfront funding, combined with $3.3 million received from warrant exercises in October 2025, supports operations into 2027. This financing is currently a critical component of the cash flow supporting the business model.
Potential Milestone Payments and Royalties
While the 61-country commercial agreements are in place, the search results detail specific potential payments tied to the licensing of the technology underlying QRX003. These represent contingent, non-operating revenue streams contingent on regulatory success.
- Potential payment of $15 million upon obtaining US or EU regulatory approval for the first drug product developed using the licensed technology.
- Potential payment of $7.5 million upon achieving defined development milestones.
- A $5 million payment due to Skinvisible upon receiving approval in the U.S. or the European Union, whichever occurs first.
- A 20% royalty on net sales for QRX003 commercialized by AFT Pharmaceuticals in Australia and New Zealand upon approval and launch.
The structure for the broader commercial agreements likely mirrors these terms, but specific figures for the remaining territories aren't publically itemized here. Still, these known structures give you a baseline for potential royalty income streams post-approval.
Potential Sale of a Priority Review Voucher (PRV)
The FDA granted QRX003 Rare Pediatric Disease Designation for Netherton Syndrome. This designation is a direct pathway to potential eligibility for a Priority Review Voucher (PRV) upon marketing approval. A PRV is a highly valuable, transferable instrument that can be sold to another pharmaceutical company to expedite their own drug review process. The value of a PRV fluctuates, but they have historically traded for hundreds of millions of dollars, representing a significant, one-time, non-dilutive revenue event if achieved and sold.
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