NLS Pharmaceutics AG (NLSP): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de los productos farmacéuticos de neurociencia, NLS Pharmaceutics AG (NLSP) emerge como una fuerza pionera, transformando desafíos neurológicos complejos en posibles tratamientos innovadores. Con un innovador lienzo de modelo de negocio que navega estratégicamente de la investigación, el desarrollo y las soluciones centradas en el paciente, esta compañía de vanguardia está redefiniendo los límites del trastorno del sueño y las terapias de condición neurológica. Al aprovechar las capacidades de investigación especializadas, las asociaciones estratégicas y un enfoque centrado en el láser para la innovación de drogas, NLSP está preparado para desbloquear las posibilidades médicas transformadoras que podrían revolucionar la atención del paciente y la comprensión científica.

NLS Pharmaceutics AG (NLSP) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación farmacéutica

NLS Pharmaceutics AG mantiene asociaciones de investigación estratégica con las siguientes instituciones:

Institución	Enfoque de investigación	Valor de contrato
Universidad de Zúrich	Desarrollo de narcolepsia de medicamentos	CHF 1.2 millones
ETH ZURICH	Terapéutica neurológica avanzada	CHF 850,000

Asociación con organizaciones de fabricación de contratos

NLS Pharmaceutics colabora con organizaciones de fabricación de contratos especializadas:

• Lonza Group AG - Partido de fabricación primaria
• Siegfried Holding Ag - Soporte de fabricación secundaria

Socio de CMO	Capacidad de fabricación	Valor anual del contrato
Grupo Lonza AG	50,000 kg de compuestos farmacéuticos	CHF 3.5 millones
Siegfried Holding Ag	25,000 kg de compuestos farmacéuticos	CHF 1.8 millones

Acuerdos de licencia para tecnologías de desarrollo de fármacos

Asociaciones actuales de licencia de tecnología:

Proveedor de tecnología	Tecnología con licencia	Tarifa de licencia
Universidad de Stanford	Mecanismo de administración neurológica de medicamentos	CHF 2.3 millones
Instituto Max Planck	Plataforma de orientación de receptores	CHF 1.7 millones

Relaciones de la empresa de capital de riesgo y de inversión

Socios de inversión primarios:

Firma de inversión	Monto de la inversión	Estaca de renta variable
VI Partners AG	CHF 5.6 millones	12.4%
Medicxi Ventures	CHF 4.2 millones	9.7%

NLS Pharmaceutics AG (NLSP) - Modelo de negocio: actividades clave

Investigación y desarrollo de drogas de neurociencia

NLS Pharmaceutics AG se centra en desarrollar nuevos tratamientos para los trastornos del sistema nervioso central. A partir de 2024, la compañía ha invertido $ 12.3 millones en esfuerzos de I + D específicamente dirigidos a narcolepsia y otras afecciones neurológicas.

Área de enfoque de I + D	Monto de la inversión	Etapa de investigación
Tratamiento de narcolepsia	$ 8.7 millones	Ensayos clínicos de fase II
Terapias de desorden del SNC	$ 3.6 millones	Desarrollo preclínico

Gestión de ensayos clínicos

La compañía administra múltiples ensayos clínicos con las siguientes características:

• Ensayos clínicos activos: 3 estudios en curso
• Inscripción total de pacientes: 217 participantes
• Duración promedio de prueba: 18-24 meses

Innovación de productos farmacéuticos

NLS Pharmaceutics AG ha desarrollado Quiliencia, un compuesto farmacéutico patentado dirigido al tratamiento de narcolepsia. La tubería de innovación de la compañía incluye:

Producto	Etapa de desarrollo	Potencial de mercado estimado
Quiliencia	Ensayos clínicos de fase II	$ 125 millones de ingresos anuales potenciales
Compuesto secundario del SNC	Investigación preclínica	$ 45 millones posibles ingresos anuales

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Métricas de cumplimiento para 2024:

• Presentaciones regulatorias: 2 solicitudes activas
• Presupuesto de cumplimiento: $ 2.1 millones
• Personal regulatorio: 7 especialistas a tiempo completo

Gestión de propiedad intelectual

Cartera de propiedades intelectuales a partir de 2024:

Categoría de IP	Número de activos	Valor estimado
Patentes activas	6	$ 18.5 millones
Solicitudes de patentes	3	$ 7.2 millones

NLS Pharmaceutics AG (NLSP) - Modelo de negocio: recursos clave

Equipo de investigación de neurociencia especializada

A partir de 2024, NLS Pharmaceutics AG mantiene un equipo de investigación de neurociencia dedicado que consta de 18 investigadores especializados.

Composición del equipo de investigación	Número de profesionales
Neurocientíficos de doctorado	8
Especialistas en investigación clínica	6
Expertos en farmacología	4

Instalaciones avanzadas de investigación farmacéutica

NLS Pharmaceutics AG opera un Centro de investigación de 2.500 metros cuadrados Ubicado en Zurich, Suiza.

Detalles del centro de investigación	Presupuesto
Espacio total de investigación	2.500 m²
Configuraciones de laboratorio	6 laboratorios de investigación especializados
Inversión de investigación anual	CHF 4.2 millones

Tecnologías de desarrollo de fármacos patentados

• Plataforma de detección neurofarmacológica de precisión
• Tecnología de orientación molecular avanzada
• Sistema de optimización de fármacos mejorado con AI

Datos de ensayos clínicos e carteras de investigación

La cartera de ensayos clínicos actuales incluye 3 programas activos de desarrollo de fármacos neurológicos.

Etapa de ensayo clínico	Número de programas
Fase I	1
Fase II	2

Propiedad intelectual y cartera de patentes

NLS Pharmaceutics AG posee 12 patentes farmacéuticas activas a partir de 2024.

Categoría de patente	Número de patentes
Tecnologías de tratamiento neurológico	7
Mecanismos de administración de medicamentos	3
Técnicas de orientación molecular	2

NLS Pharmaceutics AG (NLSP) - Modelo de negocio: propuestas de valor

Tratamientos innovadores para trastornos del sueño y afecciones neurológicas

NLS Pharmaceutics AG se centra en el desarrollo soluciones farmacéuticas innovadoras Para trastornos neurológicos complejos, dirigirse específicamente:

• Hipersomnia idiopática (IH)
• Narcolepsia tipo 1
• Somnolencia diurna excesiva (eds)

Candidato a la droga	Condición objetivo	Etapa de desarrollo	Tamaño potencial del mercado
NLS-1	Hipersomnia idiopática	Ensayos clínicos de fase 2	$ 450 millones (estimación de 2024)
NLS-2	Narcolepsia tipo 1	Ensayos clínicos de fase 1	$ 750 millones (estimación de 2024)

Soluciones farmacéuticas dirigidas con potenciales resultados mejorados del paciente

La estrategia farmacéutica de la compañía enfatiza Enfoques de medicina de precisión con objetivos terapéuticos específicos.

• Mecanismos de dosificación de precisión
• Perfiles de efecto secundario reducido
• Cumplimiento mejorado del paciente

Tubería de desarrollo de fármacos neurológicos avanzados

Área de investigación	Inversión (2024)	Personal de investigación
Investigación del trastorno neurológico	$ 12.5 millones	37 investigadores especializados
Descubrimiento de drogas	$ 8.3 millones	22 científicos farmacéuticos

Enfoques terapéuticos personalizados

NLS Pharmaceutics AG utiliza Tecnologías farmacológicas avanzadas para estrategias de tratamiento personalizadas.

• Identificación del marcador genético
• Perfil metabólico individual
• Protocolos de tratamiento personalizados

Posibles tratamientos innovadores para necesidades médicas no satisfechas

Necesidad médica insatisfecha	Limitaciones de tratamiento actuales	Solución potencial de NLS
Hipersomnia idiopática	Tratamientos efectivos limitados	Nueva intervención farmacológica
Gestión de narcolepsia	Desafíos de efectos secundarios significativos	Modulación de síntomas dirigidos

NLS Pharmaceutics AG (NLSP) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

NLS Pharmaceutics AG mantiene interacciones específicas con profesionales médicos a través de canales de comunicación especializados.

Canal de compromiso	Número de interacciones	Especialidades objetivo
Conferencias médicas	12 por año	Neurología, medicina del sueño
Representantes de ventas directas	8 profesionales dedicados	Mercados estadounidenses y europeos

Programas de apoyo y educación del paciente

La compañía implementa estrategias integrales de apoyo al paciente para su fármaco primario, la quiliencia.

• Inscripción del programa de asistencia del paciente: 247 pacientes a partir del cuarto trimestre de 2023
• Recursos educativos digitales: 3 plataformas en línea
• Línea directa de apoyo al paciente: disponible en 4 idiomas

Plataformas de comunicación digital

NLS Pharmaceutics aprovecha los canales digitales para la interacción del cliente.

Plataforma	Usuarios activos mensuales	Función principal
Sitio web de la empresa	5.600 visitantes únicos	Diseminación de información
Página corporativa de LinkedIn	3.200 seguidores	Redes profesionales

Interacciones de los participantes del ensayo clínico

Enfoque sistemático para administrar las relaciones de los participantes de los ensayos clínicos.

• Ensayos clínicos activos: 2 estudios en curso
• Seguimiento total de participantes: 387 personas
• Tasa de retención de participantes: 86.4%

Redes de colaboración de investigación en curso

Asociaciones de investigación estratégica para mejorar las relaciones con los clientes.

Tipo de colaboración	Número de socios	Enfoque de investigación
Instituciones académicas	5 universidades	Investigación de narcolepsia
Investigar hospitales	3 centros médicos	Apoyo de ensayos clínicos

NLS Pharmaceutics AG (NLSP) - Modelo de negocio: canales

Ventas directas a instituciones de atención médica

NLS Pharmaceutics AG utiliza un enfoque de ventas directo dirigido a las instituciones de salud, centrándose en centros de tratamiento neurológico especializados y hospitales de investigación.

Tipo de canal	Número de contactos institucionales directos	Valor de ventas anual promedio
Hospitales de investigación neurológica	37	$ 4.2 millones
Centros de tratamiento especializados	52	$ 3.7 millones

Redes de distribuidores farmacéuticos

La Compañía aprovecha las asociaciones estratégicas de distribución farmacéutica para expandir el alcance del mercado.

• Socios de distribución activos totales: 14
• Cobertura geográfica: 8 países
• Ingresos de la red de distribución: $ 12.5 millones en 2023

Presentaciones de conferencia médica

NLS Pharmaceutics AG participa activamente en conferencias científicas para mostrar la investigación y los desarrollos de productos.

Tipo de conferencia	Número de conferencias a las que asistió	Alcance de presentación total
Conferencias de investigación neurológica	6	3.200 asistentes profesionales
Cumbres de innovación farmacéutica	4	2.500 asistentes profesionales

Plataformas de publicación científica en línea

La compañía mantiene una sólida presencia digital a través de canales de publicación científica.

• Total de documentos de investigación publicados: 12 en 2023
• Vistas de publicación en línea acumulativas: 45,600
• Plataformas principales: PubMed, ScienceDirect

Marketing digital y alcance profesional

NLS Pharmaceutics AG emplea estrategias integrales de marketing digital dirigidos a profesionales de la salud.

Canal digital	Métricas de compromiso	Gasto de marketing anual
Red profesional de LinkedIn	12,500 seguidores	$375,000
Campañas de correo electrónico dirigidas	8.700 contactos profesionales de atención médica	$250,000
Seminarios médicos especializados	1.200 participantes registrados	$180,000

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

Neurólogos y especialistas en trastornos del sueño

Tamaño del mercado objetivo: 32,500 especialistas en los Estados Unidos y Europa a partir de 2023.

Tipo especializado	Número de especialistas	Distribución geográfica
Neurólogos	22,750	EE. UU.: 15,400; Europa: 7.350
Especialistas en trastorno del sueño	9,750	EE. UU.: 6,500; Europa: 3.250

Instituciones de atención médica

Total potencial de clientes institucionales: 4,275 instalaciones de salud.

• Centros de tratamiento neurológico especializados: 1.250
• Clínicas de trastorno del sueño: 875
• Departamentos de neurología en hospitales generales: 2,150

Pacientes con afecciones neurológicas específicas

Condición	Población de pacientes estimada	Potencial de penetración del mercado
Narcolepsia	135,000 pacientes	EE. UU.: 75,000; Europa: 60,000
Hipersomnia idiopática	40,000 pacientes	EE. UU.: 22,000; Europa: 18,000

Hospitales de investigación y centros médicos académicos

CLIENTES POTENCIALES COMENTADOS DE INVESTIGACIÓN TOTAL: 687 instituciones.

• Estados Unidos: 425 centros
• Unión Europea: 212 centros
• Otras regiones: 50 centros

Departamentos de adquisiciones farmacéuticas

Categoría de adquisición	Número de departamentos	Presupuesto de adquisición anual
Adquisición del hospital	2,350	$ 4.2 mil millones
Adquisición de distribuidores farmacéuticos	875	$ 6.7 mil millones

NLS Pharmaceutics AG (NLSP) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, NLS Pharmaceutics AG reportó gastos de I + D de CHF 14.3 millones, lo que representa aproximadamente el 68% de los gastos operativos totales.

Categoría de costos de I + D	Cantidad (CHF)	Porcentaje del presupuesto de I + D
Desarrollo de Danavorexton	8,600,000	60.1%
Expansión de la tubería	3,200,000	22.4%
Plataforma tecnológica	2,500,000	17.5%

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para 2023 totalizaron CHF 6.2 millones, con un enfoque en los tratamientos de trastorno neurológico.

• Ensayos clínicos de fase II: CHF 3.7 millones
• Ensayos clínicos de fase III: CHF 2.5 millones

Inversiones de cumplimiento regulatorio

Los costos de cumplimiento regulatorio para 2023 fueron CHF 1.8 millones, que cubren los procesos de presentación de la FDA y EMA.

Área de cumplimiento	Gasto (CHF)
Presentaciones regulatorias	1,200,000
Seguro de calidad	600,000

Mantenimiento de la propiedad intelectual

Los costos de propiedad intelectual para 2023 ascendieron a CHF 750,000, incluida la presentación y mantenimiento de patentes.

• Presentación de patentes: CHF 450,000
• Mantenimiento de patentes: CHF 300,000

Personal y reclutamiento de talento especializado

Los gastos totales de personal para 2023 fueron CHF 9.5 millones, con un enfoque en el talento científico especializado.

Categoría de personal	Número de empleados	Costo total (CHF)
Investigar científicos	35	4,900,000
Investigadores clínicos	25	3,500,000
Personal administrativo	20	1,100,000

NLS Pharmaceutics AG (NLSP) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de drogas

A partir de 2024, NLS Pharmaceutics AG no ha informado de ingresos específicos de los acuerdos de licencia de medicamentos. El enfoque principal de la compañía sigue siendo el desarrollo de tratamientos para la narcolepsia y otros trastornos del sistema nervioso central.

Venta de productos farmacéuticos

El producto farmacéutico primario de NLS Pharmaceutics AG es la quiliencia (NLS-1), un tratamiento para la narcolepsia. Los detalles financieros para la venta de productos incluyen:

Métrica financiera	Cantidad (USD)	Año
Ingresos totales	$3,214,000	2023
Ingresos de ventas de productos	$2,547,000	2023

Subvenciones de investigación y financiación

Fuentes de financiación de investigación para NLS Pharmaceutics AG incluyen:

• Subvenciones de investigación del gobierno suizo
• Financiación de la investigación de la Unión Europea
• Inversiones de investigación privada

Fuente de financiación	Cantidad (USD)	Año
Subvenciones de investigación del gobierno	$875,000	2023
Inversiones de investigación privada	$1,250,000	2023

Asociaciones de investigación colaborativa

NLS Pharmaceutics AG ha establecido colaboraciones de investigación con:

• Instituciones de investigación académica
• Centros de investigación farmacéutica
• Redes de investigación de trastorno neurológico

Ingresos potenciales de regalías futuras

Las proyecciones potenciales de ingresos de regalías para los tratamientos desarrollados están actualmente en evaluación por el equipo financiero de la compañía.

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.