NLS Pharmaceutics AG (NLSP): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico dos produtos farmacêuticos de neurociência, a NLS Pharmaceutics AG (NLSP) surge como uma força pioneira, transformando desafios neurológicos complexos em possíveis tratamentos inovadores. Com um modelo inovador de modelo de negócios que navega estrategicamente em pesquisas, desenvolvimento e soluções centradas no paciente, esta empresa de ponta está redefinindo os limites do distúrbio do sono e das terapias de condição neurológica. Ao alavancar recursos de pesquisa especializados, parcerias estratégicas e uma abordagem focada em laser para a inovação de drogas, o NLSP está preparado para desbloquear possibilidades médicas transformadoras que podem revolucionar o atendimento ao paciente e o entendimento científico.

NLS Pharmaceutics AG (NLSP) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa farmacêutica

A NLS Pharmaceutics AG mantém parcerias estratégicas de pesquisa com as seguintes instituições:

Instituição	Foco na pesquisa	Valor do contrato
Universidade de Zurique	Desenvolvimento de medicamentos para narcolepsia	CHF 1,2 milhão
Eth Zurique	Terapêutica neurológica avançada	CHF 850.000

Parceria com organizações de fabricação de contratos

A NLS Pharmaceutics colabora com organizações de fabricação de contratos especializadas:

• Lonza Group AG - Parceiro de fabricação primária
• Siegfried Holding AG - Suporte secundário de fabricação

Parceiro da CMO	Capacidade de fabricação	Valor anual do contrato
Lonza Group AG	50.000 kg compostos farmacêuticos	CHF 3,5 milhões
Siegfried Holding AG	25.000 kg compostos farmacêuticos	CHF 1,8 milhão

Acordos de licenciamento para tecnologias de desenvolvimento de medicamentos

Parcerias de licenciamento de tecnologia atuais:

Provedor de tecnologia	Tecnologia licenciada	Taxa de licenciamento
Universidade de Stanford	Mecanismo de entrega de medicamentos neurológicos	CHF 2,3 milhões
Instituto Max Planck	Plataforma de segmentação do receptor	CHF 1,7 milhão

Relacionamentos de capital de risco e empresa de investimentos

Parceiros de investimento primário:

Empresa de investimentos	Valor do investimento	Participação em ações
Vi Partners AG	CHF 5,6 milhões	12.4%
Medicxi Ventures	CHF 4,2 milhões	9.7%

NLS Pharmaceutics AG (NLSP) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de drogas em neurociência

O NLS Pharmaceutics AG se concentra no desenvolvimento de novos tratamentos para distúrbios do sistema nervoso central. A partir de 2024, a empresa investiu US $ 12,3 milhões em esforços de P&D direcionados especificamente à narcolepsia e outras condições neurológicas.

Área de foco em P&D	Valor do investimento	Estágio de pesquisa
Tratamento de narcolepsia	US $ 8,7 milhões	Ensaios clínicos de fase II
Terapias de transtorno do CNS	US $ 3,6 milhões	Desenvolvimento pré -clínico

Gerenciamento de ensaios clínicos

A empresa gerencia vários ensaios clínicos com as seguintes características:

• Ensaios clínicos ativos: 3 estudos em andamento
• Total de matrícula de pacientes: 217 participantes
• Duração média do estudo: 18-24 meses

Inovação de produtos farmacêuticos

NLS Pharmaceutics AG desenvolveu Quilience, um composto farmacêutico proprietário direcionado ao tratamento de narcolepsia. O pipeline de inovação da empresa inclui:

Produto	Estágio de desenvolvimento	Potencial estimado de mercado
Quilience	Ensaios clínicos de fase II	Receita anual potencial de US $ 125 milhões
Composto secundário do CNS	Pesquisa pré -clínica	Receita anual potencial de US $ 45 milhões

Processos de conformidade regulatória e aprovação de medicamentos

Métricas de conformidade para 2024:

• Submissões regulatórias: 2 aplicativos ativos
• Orçamento de conformidade: US $ 2,1 milhões
• Pessoal regulatório: 7 especialistas em tempo integral

Gerenciamento de propriedade intelectual

Portfólio de propriedade intelectual em 2024:

Categoria IP	Número de ativos	Valor estimado
Patentes ativas	6	US $ 18,5 milhões
Aplicações de patentes	3	US $ 7,2 milhões

NLS Pharmaceutics AG (NLSP) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa de neurociência

A partir de 2024, a NLS Pharmaceutics AG mantém uma equipe dedicada de pesquisa de neurociência composta por 18 pesquisadores especializados.

Composição da equipe de pesquisa	Número de profissionais
Neurocientistas de doutorado	8
Especialistas em pesquisa clínica	6
Especialistas em farmacologia	4

Instalações avançadas de pesquisa farmacêutica

NLS Pharmaceutics AG opera um Instalação de pesquisa de 2.500 metros quadrados Localizado em Zurique, Suíça.

Detalhes da instalação de pesquisa	Especificações
Espaço total de pesquisa	2.500 m²
Configurações de laboratório	6 laboratórios de pesquisa especializados
Investimento anual de pesquisa	CHF 4,2 milhões

Tecnologias proprietárias de desenvolvimento de medicamentos

• Plataforma de triagem neurofarmacológica de precisão
• Tecnologia avançada de segmentação molecular
• Sistema de otimização de medicamentos aprimorados da AI-

Dados de ensaios clínicos e portfólios de pesquisa

O portfólio atual de ensaios clínicos inclui 3 programas ativos de desenvolvimento neurológico de medicamentos.

Estágio do ensaio clínico	Número de programas
Fase I.	1
Fase II	2

Propriedade intelectual e portfólio de patentes

NLS Pharmaceutics AG possui 12 patentes farmacêuticas ativas a partir de 2024.

Categoria de patentes	Número de patentes
Tecnologias de tratamento neurológico	7
Mecanismos de entrega de medicamentos	3
Técnicas de direcionamento molecular	2

NLS Pharmaceutics AG (NLSP) - Modelo de negócios: proposições de valor

Tratamentos inovadores para distúrbios do sono e condições neurológicas

NLS Pharmaceutics AG se concentra no desenvolvimento Soluções farmacêuticas inovadoras Para distúrbios neurológicos complexos, direcionados especificamente:

• Hipersomnia idiopática (IH)
• Narcolepsia tipo 1
• Sonolência diurna excessiva (eds)

Candidato a drogas	Condição alvo	Estágio de desenvolvimento	Tamanho potencial de mercado
NLS-1	Hipersomnia idiopática	Ensaios clínicos de fase 2	US $ 450 milhões (estimativa de 2024)
NLS-2	Narcolepsia tipo 1	Ensaios clínicos de fase 1	US $ 750 milhões (estimativa de 2024)

Soluções farmacêuticas direcionadas com possíveis resultados aprimorados dos pacientes

A estratégia farmacêutica da empresa enfatiza As abordagens de medicina de precisão com alvos terapêuticos específicos.

• Mecanismos de dosagem de precisão
• Perfis de efeito colateral reduzidos
• Conformidade aprimorada do paciente

Oleoduto avançado de desenvolvimento de medicamentos neurológicos

Área de pesquisa	Investimento (2024)	Pessoal de pesquisa
Pesquisa em transtorno neurológico	US $ 12,5 milhões	37 pesquisadores especializados
Descoberta de medicamentos	US $ 8,3 milhões	22 cientistas farmacêuticos

Abordagens terapêuticas personalizadas

NLS Pharmaceutics AG utiliza Tecnologias farmacológicas avançadas para estratégias de tratamento personalizadas.

• Identificação do marcador genético
• Perfil metabólico individual
• Protocolos de tratamento personalizados

Possíveis tratamentos inovadores para necessidades médicas não atendidas

Necessidade médica não atendida	Limitações atuais de tratamento	Solução potencial do NLS
Hipersomnia idiopática	Tratamentos eficazes limitados	Nova intervenção farmacológica
Gerenciamento de narcolepsia	Desafios significativos de efeito colateral	Modulação direcionada dos sintomas

NLS Pharmaceutics AG (NLSP) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A NLS Pharmaceutics AG mantém interações direcionadas com profissionais médicos por meio de canais de comunicação especializados.

Canal de engajamento	Número de interações	Especialidades -alvo
Conferências médicas	12 por ano	Neurologia, medicina do sono
Representantes de vendas diretas	8 profissionais dedicados	Mercados americanos e europeus

Programas de apoio ao paciente e educação

A empresa implementa estratégias abrangentes de apoio ao paciente para seu medicamento primário, Quilience.

• Inscrição do Programa de Assistência ao Paciente: 247 pacientes a partir do quarto trimestre 2023
• Recursos educacionais digitais: 3 plataformas online
• Linha direta de suporte ao paciente: disponível em 4 idiomas

Plataformas de comunicação digital

O NLS Pharmaceutics aproveita os canais digitais para a interação do cliente.

Plataforma	Usuários ativos mensais	Função primária
Site da empresa	5.600 visitantes únicos	Disseminação da informação
Página corporativa do LinkedIn	3.200 seguidores	Networking profissional

Interações dos participantes do ensaio clínico

Abordagem sistemática para gerenciar as relações dos participantes do ensaio clínico.

• Ensaios clínicos ativos: 2 estudos em andamento
• Rastreamento total do participante: 387 indivíduos
• Taxa de retenção dos participantes: 86,4%

Redes de colaboração de pesquisa em andamento

Parcerias de pesquisa estratégica para aprimorar o relacionamento com os clientes.

Tipo de colaboração	Número de parceiros	Foco na pesquisa
Instituições acadêmicas	5 universidades	Pesquisa de narcolepsia
Hospitais de pesquisa	3 centros médicos	Suporte ao ensaio clínico

NLS Pharmaceutics AG (NLSP) - Modelo de Negócios: Canais

Vendas diretas para instituições de saúde

A NLS Pharmaceutics AG utiliza uma abordagem direcionada de vendas diretas para as instituições de saúde, com foco em centros de tratamento neurológico especializados e hospitais de pesquisa.

Tipo de canal	Número de contatos institucionais diretos	Valor médio de vendas anual
Hospitais de pesquisa neurológica	37	US $ 4,2 milhões
Centros de tratamento especializados	52	US $ 3,7 milhões

Redes de distribuidores farmacêuticos

A empresa aproveita as parcerias estratégicas de distribuição farmacêutica para expandir o alcance do mercado.

• Parceiros totais de distribuição ativa: 14
• Cobertura geográfica: 8 países
• Receita da rede de distribuição: US $ 12,5 milhões em 2023

Apresentações da conferência médica

A NLS Pharmaceutics AG participa ativamente de conferências científicas para mostrar pesquisas e desenvolvimentos de produtos.

Tipo de conferência	Número de conferências participou	Alcance total de apresentação
Conferências de pesquisa neurológica	6	3.200 participantes profissionais
Cúpulas de inovação farmacêutica	4	2.500 participantes profissionais

Plataformas de publicação científica online

A empresa mantém uma presença digital robusta através de canais de publicação científica.

• Total de Trabalho de Pesquisa Publicado: 12 em 2023
• Visualizações de publicação online cumulativa: 45.600
• Plataformas primárias: PubMed, ScienceDirect

Marketing digital e divulgação profissional

A NLS Pharmaceutics AG emprega estratégias de marketing digital abrangentes direcionadas aos profissionais de saúde.

Canal digital	Métricas de engajamento	Gastos anuais de marketing
Rede Profissional do LinkedIn	12.500 seguidores	$375,000
Campanhas de e -mail direcionadas	8.700 contatos profissionais de saúde	$250,000
Webinars médicos especializados	1.200 participantes registrados	$180,000

NLS Pharmaceutics AG (NLSP) - Modelo de negócios: segmentos de clientes

Neurologistas e especialistas em transtorno do sono

Tamanho do mercado -alvo: 32.500 especialistas nos Estados Unidos e na Europa a partir de 2023.

Tipo especial	Número de especialistas	Distribuição geográfica
Neurologistas	22,750	EUA: 15.400; Europa: 7.350
Especialistas em transtorno do sono	9,750	EUA: 6.500; Europa: 3.250

Instituições de Saúde

Total de clientes institucionais potenciais: 4.275 instalações de saúde.

• Centros de Tratamento Neurológico Especializado: 1.250
• Clínicas de Transtorno do Sono: 875
• Departamentos de Neurologia em Hospitais Gerais: 2.150

Pacientes com condições neurológicas específicas

Doença	População estimada de pacientes	Potencial de penetração no mercado
Narcolepsia	135.000 pacientes	Nós: 75.000; Europa: 60.000
Hipersomnia idiopática	40.000 pacientes	Nós: 22.000; Europa: 18.000

Hospitais de pesquisa e centros médicos acadêmicos

Total de clientes potenciais focados na pesquisa: 687 instituições.

• Estados Unidos: 425 centros
• União Europeia: 212 centros
• Outras regiões: 50 centros

Departamentos de compras farmacêuticas

Categoria de compras	Número de departamentos	Orçamento anual de compras
Compras hospitalares	2,350	US $ 4,2 bilhões
Compras de distribuidores farmacêuticos	875	US $ 6,7 bilhões

NLS Pharmaceutics AG (NLSP) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a NLS Pharmaceutics AG registrou despesas de P&D de 14,3 milhões de CHF, representando aproximadamente 68% do total de despesas operacionais.

Categoria de custo de P&D	Quantidade (CHF)	Porcentagem de orçamento de P&D
Danavorexton Development	8,600,000	60.1%
Expansão do pipeline	3,200,000	22.4%
Plataforma de tecnologia	2,500,000	17.5%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para 2023 totalizaram CHF 6,2 milhões, com foco nos tratamentos neurológicos do distúrbio.

• Ensaios Clínicos de Fase II: CHF 3,7 milhões
• Ensaios clínicos da Fase III: CHF 2,5 milhões

Investimentos de conformidade regulatória

Os custos de conformidade regulatória para 2023 foram de CHF 1,8 milhão, cobrindo os processos de envio da FDA e da EMA.

Área de conformidade	Despesas (CHF)
Submissões regulatórias	1,200,000
Garantia de qualidade	600,000

Manutenção da propriedade intelectual

Os custos de propriedade intelectual de 2023 totalizaram 750.000 CHF, incluindo arquivamento e manutenção de patentes.

• Arquivamento de patentes: CHF 450.000
• Manutenção de patentes: CHF 300.000

Pessoal e recrutamento especializado de talentos

As despesas totais de pessoal para 2023 foram de 9,5 milhões de CHF, com foco em talentos científicos especializados.

Categoria de pessoal	Número de funcionários	Custo total (CHF)
Cientistas de pesquisa	35	4,900,000
Pesquisadores clínicos	25	3,500,000
Equipe administrativo	20	1,100,000

NLS Pharmaceutics AG (NLSP) - Modelo de negócios: fluxos de receita

Acordos potenciais de licenciamento de medicamentos

A partir de 2024, a NLS Pharmaceutics AG não relatou receita específica de acordos de licenciamento de medicamentos. O foco principal da empresa permanece no desenvolvimento de tratamentos para narcolepsia e outros distúrbios do sistema nervoso central.

Vendas farmacêuticas de produtos

O produto farmacêutico primário da NLS Pharmaceutics AG é a quiliência (NLS-1), um tratamento para narcolepsia. Os detalhes financeiros das vendas de produtos incluem:

Métrica financeira	Quantidade (USD)	Ano
Receita total	$3,214,000	2023
Receita de vendas de produtos	$2,547,000	2023

Bolsas de pesquisa e financiamento

As fontes de financiamento de pesquisa para o NLS Pharmaceutics AG incluem:

• Subsídios de pesquisa do governo suíço
• Financiamento de pesquisa da União Europeia
• Investimentos de pesquisa privada

Fonte de financiamento	Quantidade (USD)	Ano
Subsídios de pesquisa do governo	$875,000	2023
Investimentos de pesquisa privada	$1,250,000	2023

Parcerias de pesquisa colaborativa

A NLS Pharmaceutics AG estabeleceu colaborações de pesquisa com:

• Instituições de pesquisa acadêmica
• Centros de pesquisa farmacêutica
• Redes de pesquisa de transtornos neurológicos

Potencial renda futura de royalties

As projeções potenciais de renda de royalties para tratamentos desenvolvidos estão atualmente em avaliação pela equipe financeira da Companhia.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Value Propositions

You're looking at the value NLS Pharmaceutics AG brought to the table before the October 30, 2025, merger that created NewcelX Ltd. The core value was centered on differentiated CNS treatments and a strategic expansion into cell therapy, which is reflected in the combined entity's structure where Kadimastem shareholders now hold 84.4% and NLS shareholders hold 15.6% of the new company's issued share capital.

Quilience: A non-amphetamine, Schedule IV treatment for narcolepsy with a favorable safety profile.

The value proposition for Quilience, the controlled-release formulation of mazindol (mazindol CR), rests on its mechanism and regulatory status for narcolepsy. It is positioned as a non-amphetamine option. You should note that Mazindol CR functions as a partial orexin 2 receptor agonist, which targets the underlying cause of the disorder, unlike some stimulants.

• Quilience has Orphan Drug Designations in both the U.S. and Europe for narcolepsy.
• The lead asset leverages repurposing of a known compound, aiming to accelerate development timelines.

Addressing underlying disease cause via partial orexin 2 receptor agonism.

This mechanism is key; Mazindol is a triple monoamine reuptake inhibitor and, critically, a partial orexin receptor 2 agonist. This mechanism is what sets it apart in the sleep disorder space. The company completed a Phase 2 study in the U.S. evaluating mazindol CR in adult subjects with ADHD, where it met all primary and secondary endpoints and was well-tolerated.

Expanded pipeline targeting high-unmet-need CNS disorders like ADHD and addiction.

The value extended beyond narcolepsy into other CNS areas, leveraging the same core compound. For instance, preclinical data on Mazindol ER regarding its dual efficacy in Fentanyl reward and withdrawal was presented at the 2025 ASCP Annual Meeting between May 27, 2025, and May 30, 2025.

To give you a sense of the legacy NLS Pharmaceutics AG financial footing leading into this transaction, consider the H1 2025 results. The net loss for the half year ended June 30, 2025, was USD 2.22 million, up from USD 2.04 million the prior year. The basic loss per share from continuing operations was USD 1.05 for H1 2025.

Novel cell therapies for neurodegenerative diseases and diabetes (post-merger).

The merger brought in significant new value through Kadimastem's pipeline, which is now part of the combined NewcelX entity. This is a major shift from NLS's prior focus. The combined company is advancing these cell-based therapies.

Here's a quick look at the combined portfolio's development status as of the merger close on October 30, 2025:

Product Candidate	Indication	Development Stage (Post-Merger)	Legacy Company
Quilience (Mazindol CR)	Narcolepsy	Orphan Drug Designation (US/EU)	NLS
Mazindol ER	ADHD	Completed U.S. Phase 2 Study	NLS
AstroRx®	Amyotrophic Lateral Sclerosis (ALS)	Phase 2a Clinical Trial (U.S.)	Kadimastem
IsletRx	Type 1 Diabetes	Pre-IND submission targeted for Q1 2025 (prior to merger close)	Kadimastem

Repurposing known compounds to accelerate development timelines.

This strategy is a foundational element of the original NLS value proposition, aiming to reduce the time and risk associated with novel chemical entities. The lead asset, Mazindol CR, is a prime example of this approach. As of the last active trading day for NLSP on October 30, 2025, the stock price was $0.76 / share, with a reported Market Cap of $31.64 million and 4.15 million shares outstanding.

The operational cash flow for the last 12 months prior to the merger was negative at -$4.81 million, which is typical for a clinical-stage company focused on R&D. This cash burn was offset by the strategic value created through the merger, which brought in the cell therapy platform.

• The merger was structured so that Kadimastem shareholders received 0.706 NewcelX common shares for each Kadimastem ordinary share.
• The transaction involved a 1-for-10 reverse share split implemented by NewcelX in connection with the merger.
• Following the close, NewcelX had approximately 4,558,378 common shares outstanding.

The value proposition is now a dual one: de-risked CNS assets moving toward potential commercialization and a novel cell therapy platform targeting severe, high-unmet-need diseases like ALS and diabetes. That's a defintely broader value set than before.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Customer Relationships

You're looking at the relationship strategy for NLS Pharmaceutics AG, especially now, post-merger with Kadimastem, which closed around October 29, 2025. The focus here is building deep, credible ties with the scientific and financial communities to support their CNS pipeline.

High-touch engagement with Key Opinion Leaders (KOLs) and sleep specialists remains central to validating their science. This isn't just about shaking hands; it's about scientific exchange. For instance, NLS Pharmaceutics announced the submission of Three Research Abstracts to the 2025 ASCP Annual Meeting, which took place from May 27, 2025, to May 30, 2025. These presentations covered critical areas like Mazindol ER for fentanyl dependence and dual orexin receptor agonists for narcolepsy. Furthermore, the company hosted a Virtual Key Opinion Leader (KOL) Event to review top-line results from its Phase 2a clinical trial evaluating Quilience® (Mazindol ER) in narcolepsy. This high-touch approach is designed to get expert buy-in early.

For direct communication with patient advocacy groups for rare CNS disorders, the strategy centers on alignment with their core mission, though specific quantitative metrics on group engagement aren't always public. What is public is the network of high-level scientific collaboration, including partnerships with institutions like Universität Zürich and ETH Zürich. These relationships signal a commitment to rigorous, patient-focused research, which advocacy groups value highly.

Your investor relations and public disclosures section reflects the volatile journey of a clinical-stage company. For the half-year ended June 30, 2025, NLS Pharmaceutics reported a net loss of USD 2.22 million, up from USD 2.04 million the prior year, with a basic loss per share from continuing operations of USD 1.05. The market reacted to capital structure changes; around September 30, 2025, the company filed to sell 5 million common shares, which naturally sparked concerns over potential dilution. Following the merger completion, the fully diluted share split was estimated to result in Kadimastem shareholders holding approximately 85% and former NLS shareholders holding about 15%. The stock, NLSP, traded its last day on October 30, 2025, at 0.7620 USD before delisting.

The credibility-building through scientific presentations at major conferences is quantifiable through their submission volume. The Three Research Abstracts submitted to ASCP 2025 were key relationship touchpoints with the broader sleep specialist community. These presentations focused on data for Mazindol ER, AEX-41, and AEX-2. Honestly, for a company at this stage, these scientific milestones are the primary currency for building trust with prescribers and future partners.

Here's a quick look at some of the key figures shaping these customer relationships as of late 2025:

Metric Category	Specific Data Point	Value/Amount	Reporting Period/Date
Financial Performance (H1 2025)	Net Loss	USD 2.22 million	Half Year Ended June 30, 2025
Investor Relations Activity	Common Shares Filed for Sale	5 million	Reported near September 30, 2025
Scientific Engagement	Abstracts Submitted to ASCP 2025	Three	January 2025
Post-Merger Governance	Estimated Former NLS Shareholder Split	15%	Post-Merger Closing (Oct 2025)
Market Data	Last Traded Price (NLSP)	0.7620 USD	October 30, 2025

The company's engagement strategy is heavily weighted toward scientific validation, which is typical when you're trying to establish a novel mechanism of action, like with Mazindol ER. You defintely see the focus on peer-reviewed credibility over broad marketing spend at this juncture.

Finance: draft 13-week cash view by Friday.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Channels

You're looking at how NLS Pharmaceutics AG, now operating as NewCelX Ltd. post-merger closing on October 30, 2025, gets its value proposition to the market, which is heavily weighted toward clinical data generation and future commercial partnerships.

Clinical trial sites (US and global) for drug development and data generation

The channel for data generation relies on a network of clinical investigators and sites. As of late 2025, NLS Pharmaceutics AG (now NewCelX Ltd.) had 4 total clinical trials where it acted as the Lead Sponsor, with 1 trial in Phase 3 and 3 trials in Phase 2, involving a total enrollment across these trials of 251 participants in the past. The pipeline advancement channel is now focused on the combined entity's assets, including the AstroRx® program, which is slated for a Phase 2a multi-site clinical trial in the U.S.. The Phase 3 study for Quilience (NLS-2) in Narcolepsy Type 1 (NCT05914194) involved 48 participants and was completed on Jul 30, 2025.

The reliance on external academic and clinical partners for data generation is evident through past collaborations, including partnerships with Universität Zürich, ETH Zürich, Centre Hospitalier Universitaire Vaudois CHUV, Université de Lausanne, and Assistance Publique Hôpitaux de Paris.

Direct sales force (future, post-approval) targeting specialized prescribers

A dedicated direct sales force is a future channel, post-approval for candidates like Quilience (for narcolepsy) or Nolazol (for ADHD). Currently, the company's operational focus, as reflected in its H1 2025 net loss of USD 2.22 million and forecasted 2025 EBIT of -22MM, is on R&D and merger integration, not on commercial infrastructure build-out. The post-merger entity will also integrate Kadimastem's cell therapy pipeline, which includes AstroRx® for ALS and IsletRx for diabetes, which will require specialized sales channels targeting neurologists and endocrinologists, respectively, upon potential approval.

Licensing and commercialization agreements with larger pharmaceutical partners

This channel is critical for NLS Pharmaceutics AG, as evidenced by past and current structures. The company has a strategic licensing agreement with Aexon Labs for its DOXA portfolio. Historically, NLS Pharmaceutics entered into an agreement with Novartis Pharma AG. Financially, to support the merger and pipeline, the company secured a $25 million committed equity facility agreement in March 2025. The company reported 0MM in forecasted annual revenue for the period ending 2025-12-31, indicating pre-commercialization status.

Here are some key figures related to the company's financial and structural channels as of late 2025:

Metric	Value	Context/Date
Committed Equity Facility	$25 million	March 2025 financing agreement
H1 2025 Net Loss	USD 2.22 million	Half year ended June 30, 2025
Forecasted Annual Revenue (2025)	0MM	Forecasted for 2025-12-31
Shares Outstanding	4.15 million	As of late 2025
Net Cash Position	$3.07 million	As of late 2025

Scientific publications and medical education platforms

Dissemination of data through scientific channels is a primary activity for a clinical-stage company. NLS Pharmaceutics AG submitted three research abstracts to the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP), held from May 27 to May 30, 2025, in Scottsdale, Arizona.

The specific data presented via these publication channels included:

• Evaluating Mazindol ER for fentanyl dependence (Study KO-943).
• Preliminary results of AEX-41 and AEX-2 in a mouse model of narcolepsy.
• A comprehensive multitarget strategy for managing Diabetes-Associated Neurological and Sleep Disorders (DANS).

The presentation of preclinical data on Mazindol ER at the ASCP meeting on May 29, 2025, highlighted its effect at a 0.5 mg/kg dose in neutralizing fentanyl reward effects in mice.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Customer Segments

You're looking at the core groups NLS Pharmaceutics AG targets with its specialized CNS therapies, particularly for narcolepsy. Honestly, in this niche, the customer segments are tightly defined, blending patient needs with the prescribing physician base and the capital markets that fund the journey.

The primary patient base is defined by rare and complex Central Nervous System (CNS) disorders. NLS Pharmaceutics AG is focused on patients diagnosed with Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2). These are not broad markets; they are specific patient populations requiring targeted intervention for conditions like Excessive Daytime Sleepiness (EDS) and Cataplexy. The narcolepsy with cataplexy segment, for instance, dominated the market share in 2024, accounting for 37% of the narcolepsy therapeutics market by treatment type.

To give you a sense of the scale in key markets, DelveInsight estimated around 360,000 diagnosed prevalent cases of narcolepsy across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan in 2024. Specifically in the US, the 2024 estimate pointed to approximately 95,000 female and 90,000 male patients with narcolepsy. The overall global narcolepsy therapeutics market size was valued at USD 4.12 billion in 2025.

Here's a quick breakdown of how the patient segment is often segmented in the market analysis, which directly informs NLS Pharmaceutics AG's focus:

• Narcolepsy Type 1 (with Cataplexy) held 61.63% of the market share in 2024.
• Narcolepsy Type 2 (without Cataplexy) is projected for an 11.24% CAGR through 2030.
• The Narcolepsy Without Cataplexy segment is anticipated to grow at a notable CAGR of 9.7% during the projected period.

The second key segment involves the healthcare professionals who manage these patients. These are the gatekeepers for NLS Pharmaceutics AG's product, Mazindol ER (Quilience), which promotes wakefulness and reduces cataplexy. You are targeting:

• Neurologists specializing in sleep disorders.
• Sleep medicine specialists who use diagnostic tools like nocturnal polysomnography (PSG) and Multiple Sleep Latency Tests.
• Clinicians who are aware of the neurobiological root of the disorder, focusing on agents that target the orexin system or have partial OX2R agonist activity.

The third, and perhaps most volatile, segment is the financial community. As a clinical-stage biopharmaceutical company, NLS Pharmaceutics AG relies on capital to advance its pipeline, including the development of Quilience. This segment includes:

• Investors and institutional funds focused on the biotech sector and CNS therapeutics.
• Shareholders who track milestones like the proposed merger with Kadimastem Ltd..
• Analysts covering companies with products aiming to restore wakefulness regulation.

For the investor segment, here are some concrete financial markers as of late 2025. Note that stock performance can shift rapidly in this sector, so these figures are snapshots:

Metric	Value (as of Dec 03, 2025)	Value (as of Oct 30, 2025)
Stock Price	$0.762	$7.62
Market Capitalization	$1.169M	$3.97M
Shares Outstanding	N/A	521K

The company has actively engaged this investor segment through financing. In the first quarter of 2025, NLS Pharmaceutics AG closed two equity financing transactions, bringing in aggregate gross proceeds of $2.5 million. Furthermore, the company signed a $25 million equity facility commitment to support its clinical programs and the pending merger. BVF Partners is listed as an institutional investor. Finance: draft 13-week cash view by Friday.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Cost Structure

You're looking at the cost side of NLS Pharmaceutics AG's business model right before its transition into NewcelX Ltd. For a clinical-stage biotech, costs are heavily weighted toward development and compliance, especially when nearing major corporate events like a merger.

High R&D expenses are a constant in this industry, historically driven by the costs of advancing Quilience through its clinical program, particularly the Phase 3 trial costs. While the trailing twelve months (TTM) ending June 30, 2025, showed a lower reported Research & Development figure, this is a key area of expenditure that dictates future value.

General and administrative (G&A) costs cover the necessary overhead to keep the lights on and the company compliant with public market rules. This includes legal fees and the ongoing costs associated with maintaining NASDAQ compliance, which can be substantial for a smaller entity.

The cost structure is heavily influenced by the small team size. Employee compensation is a fixed cost tied to a highly specialized group. As reported in earlier filings, the team was small, which helps keep the personnel burn rate relatively low compared to larger pharma operations.

The financial results for the first half of 2025 reflect these ongoing operational costs. The net loss for the half year ended June 30, 2025, was USD 2.22 million. This compares to a net loss of USD 2.04 million for the same period a year prior, showing an increase in the loss rate for the first half of the year.

Finally, significant, non-recurring costs are associated with the corporate restructuring. The finalization of the reverse merger with Kadimastem, which resulted in the formation of NewcelX Ltd. and trading under the ticker 'NCEL' starting October 31, 2025, involved substantial legal and advisory fees. The financial statements for the period ending June 30, 2025, capture some of these transition expenses.

Here's a look at the key expense components from the financial data available for the period ending June 30, 2025 (TTM figures in millions USD):

Cost Category	Amount (Millions USD)	Notes
Selling, General & Admin (G&A)	3.07	Covers overhead, legal, and compliance costs.
Research & Development (R&D)	0.29	Clinical trial and drug development spending.
Operating Expenses (Total)	3.36	Sum of R&D and G&A plus other operating costs.
Merger & Restructuring Charges	-1.16	Charge recognized in TTM ending Jun '25, related to the transition.

You should also note the personnel structure, which is a critical component of the operating cost base:

• Reported team size: 7 employees.
• Employee count in 2021 was 6 full-time and 1 part-time.
• The company's core team is small and specialized.

Finance: draft 13-week cash view by Friday.

NLS Pharmaceutics AG (NLSP) - Canvas Business Model: Revenue Streams

You're looking at the current financial reality for NLS Pharmaceutics AG as of late 2025. Honestly, the story here is all about runway funding because, as expected for a company at this stage, the top line from product sales is still a future event.

Currently pre-revenue; primary stream is equity financing and capital raises.

The immediate financial lifeblood for NLS Pharmaceutics AG comes from securing capital through the equity markets. This is how you fund the clinical development and regulatory path for Quilience. Since the last reported earnings for the half year ended June 30, 2025, showed a net loss of USD 2.22 million, these capital raises are critical to bridge the gap to commercialization. The company has been actively executing on financing agreements throughout 2025.

Here's a quick look at the recent capital activity that defines the current revenue stream:

• Secured an equity facility for gross proceeds of $25,000,000 announced in June 2025.
• Completed a $3 million equity financing round in mid-2025.
• The final closing of a tranche on June 27, 2025, brought in $1 million.
• Another transaction in June 2025 involved securing $1 million via preferred participation certificates.
• The company reported cash on hand of $3.07 million in its latest financial snapshot.

This activity is best summarized by mapping the key financing events that have occurred leading up to the end of 2025, which is your current revenue stream:

Financing Event Date (Announced/Closed)	Gross Proceeds (USD)	Instrument Type	Implied Share Price (If Applicable)
June 17, 2025	$25,000,000	Equity Facility	N/A
June 27, 2025 (Final Closing)	$1,000,000	Preferred Participation Certificates/Warrants	Executed at $1.65 per share equivalent
March 28, 2025 (Post IPO)	$3,000,000	Post IPO Financing	N/A
January 7, 2025 (Post IPO)	$500,000	Post IPO Financing	N/A

The operating cash flow for the last 12 months was negative at -$4.81 million, reinforcing that equity financing is the only current revenue source offsetting operational burn.

Future revenue from commercial sales of Quilience, post-FDA approval (expected late 2026/early 2027).

The true, sustainable revenue stream for NLS Pharmaceutics AG hinges entirely on the successful commercial launch of Quilience, their lead asset for narcolepsy and ADHD. The expectation right now is that this will begin generating sales sometime in late 2026 or early 2027, assuming the necessary FDA approvals clear on schedule. Until then, this stream remains theoretical, but it is the primary driver of the company's valuation.

Potential milestone payments from future licensing or partnership deals.

Beyond direct product sales, NLS Pharmaceutics AG has the potential to book non-recurring revenue through strategic agreements. These are typically milestone payments tied to achieving certain development or regulatory goals for their assets, or upfront payments upon licensing a compound to a larger pharmaceutical partner for specific territories or indications. While no specific dollar amounts are public for these potential payments as of late 2025, these are a standard component of a biotech revenue model.

Future revenue from Nolazol and the new cell therapy pipeline assets.

Following the merger completion with Kadimastem Ltd. in October 2025, the revenue outlook expands to include the combined pipeline. This means future revenue potential is also tied to the commercial success of assets like Nolazol, which targets different CNS indications, and the cell therapy assets now integrated into the portfolio. These assets represent diversification away from Quilience, adding secondary potential revenue streams once they advance through clinical stages and reach the market.