NLS Pharmaceutics AG (NLSP): Business Model Canvas [Jan-2025 Mise à jour]

Dans le paysage dynamique de Neuroscience Pharmaceuticals, NLS Pharmaceutics AG (NLSP) émerge comme une force pionnière, transformant des défis neurologiques complexes en traitements de percée potentiels. Avec une toile de modèle commercial innovante qui navigue stratégiquement sur la recherche, le développement et les solutions centrées sur le patient, cette entreprise de pointe redéfinit les limites des thérapies sur les troubles du sommeil et les conditions neurologiques. En tirant parti des capacités de recherche spécialisées, des partenariats stratégiques et une approche axée sur le laser à l'innovation de médicaments, le NLSP est prêt à débloquer des possibilités médicales transformatrices qui pourraient révolutionner les soins aux patients et la compréhension scientifique.

NLS Pharmaceutics AG (NLSP) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les institutions de recherche pharmaceutique

NLS Pharmaceutics AG maintient des partenariats de recherche stratégique avec les institutions suivantes:

Institution	Focus de recherche	Valeur du contrat
Université de Zurich	Développement de médicaments narcolepsie	CHF 1,2 million
ETH Zurich	Thérapeutique neurologique avancée	CHF 850 ​​000

Partenariat avec les organisations de fabrication contractuelles

NLS Pharmaceutics collabore avec des organisations de fabrication de contrats spécialisées:

• LONZA GROUP AG - Partenaire de fabrication primaire
• Siegfried Holding Ag - Support de fabrication secondaire

Partenaire CMO	Capacité de fabrication	Valeur du contrat annuel
Lonza Group AG	Composés pharmaceutiques de 50 000 kg	CHF 3,5 millions
Siegfried Holding Ag	25 000 kg composés pharmaceutiques	CHF 1,8 million

Accords de licence pour les technologies de développement de médicaments

Partenariats actuels de licences technologiques:

Fournisseur de technologie	Technologie sous licence	Frais de licence
Université de Stanford	Mécanisme neurologique d'administration de médicaments	CHF 2,3 millions
Institut Max Planck	Plate-forme de ciblage des récepteurs	CHF 1,7 million

Capital de capital-risque et relations avec les entreprises d'investissement

Partners d'investissement primaires:

Entreprise d'investissement	Montant d'investissement	Pieu de capitaux propres
VI Partners AG	CHF 5,6 millions	12.4%
Ventures Medicxi	CHF 4,2 millions	9.7%

NLS Pharmaceutics AG (NLSP) - Modèle d'entreprise: Activités clés

Recherche et développement de médicaments en neurosciences

NLS Pharmaceutics AG se concentre sur le développement de nouveaux traitements pour les troubles du système nerveux central. En 2024, la société a investi 12,3 millions de dollars dans des efforts de R&D ciblant spécifiquement la narcolepsie et d'autres conditions neurologiques.

Zone de focus R&D	Montant d'investissement	Étape de recherche
Traitement de la narcolepsie	8,7 millions de dollars	Essais cliniques de phase II
Thérapies sur les troubles du SNC	3,6 millions de dollars	Développement préclinique

Gestion des essais cliniques

La société gère plusieurs essais cliniques avec les caractéristiques suivantes:

• Essais cliniques actifs: 3 études en cours
• Inscription totale des patients: 217 participants
• Durée moyenne de l'essai: 18-24 mois

Innovation de produit pharmaceutique

NLS Pharmaceutics AG a développé Poignée, un composé pharmaceutique propriétaire ciblant le traitement de la narcolepsie. Le pipeline d'innovation de l'entreprise comprend:

Produit	Étape de développement	Potentiel de marché estimé
Poignée	Essais cliniques de phase II	125 millions de dollars de revenus annuels potentiels
Composé du SNC secondaire	Recherche préclinique	45 millions de dollars de revenus annuels potentiels

Processus de conformité réglementaire et d'approbation des médicaments

Mesures de conformité pour 2024:

• Souvances réglementaires: 2 applications actives
• Budget de conformité: 2,1 millions de dollars
• Personnel réglementaire: 7 spécialistes à temps plein

Gestion de la propriété intellectuelle

Portfolio de propriété intellectuelle à partir de 2024:

Catégorie IP	Nombre d'actifs	Valeur estimée
Brevets actifs	6	18,5 millions de dollars
Demandes de brevet	3	7,2 millions de dollars

NLS Pharmaceutics AG (NLSP) - Modèle d'entreprise: Ressources clés

Équipe de recherche spécialisée en neurosciences

En 2024, NLS Pharmaceutics AG maintient une équipe de recherche en neuroscience dédiée composée de 18 chercheurs spécialisés.

Composition de l'équipe de recherche	Nombre de professionnels
Neuroscientifiques doctorants	8
Spécialistes de la recherche clinique	6
Experts en pharmacologie	4

Installations de recherche pharmaceutique avancée

NLS Pharmaceutics AG exploite un Installation de recherche de 2 500 mètres carrés Situé à Zurich, en Suisse.

Détails de l'installation de recherche	Caractéristiques
Espace de recherche total	2 500 m²
Configurations de laboratoire	6 laboratoires de recherche spécialisés
Investissement de recherche annuel	CHF 4,2 millions

Technologies de développement de médicaments propriétaires

• Plateforme de dépistage neuropharmacologique de précision
• Technologie de ciblage moléculaire avancée
• Système d'optimisation de médicament amélioré

Données d'essai cliniques et portefeuilles de recherche

Le portefeuille actuel des essais cliniques comprend 3 programmes de développement de médicaments neurologiques actifs.

Étape d'essai clinique	Nombre de programmes
Phase I	1
Phase II	2

Propriété intellectuelle et portefeuille de brevets

NLS Pharmaceutics AG détient 12 brevets pharmaceutiques actifs En 2024.

Catégorie de brevet	Nombre de brevets
Technologies de traitement neurologique	7
Mécanismes d'administration de médicament	3
Techniques de ciblage moléculaire	2

NLS Pharmaceutics AG (NLSP) - Modèle d'entreprise: propositions de valeur

Traitements innovants pour les troubles du sommeil et les conditions neurologiques

NLS Pharmaceutics AG se concentre sur le développement Solutions pharmaceutiques innovantes Pour les troubles neurologiques complexes, ciblant spécifiquement:

• Hypersomnie idiopathique (IH)
• Narcolepsie type 1
• Excès de somnolence diurne (eds)

Drogue	Condition cible	Étape de développement	Taille du marché potentiel
Nls-1	Hypersomnie idiopathique	Essais cliniques de phase 2	450 millions de dollars (estimation 2024)
Nls-2	Narcolepsie type 1	Essais cliniques de phase 1	750 millions de dollars (estimation 2024)

Solutions pharmaceutiques ciblées avec des résultats potentiels pour les patients

La stratégie pharmaceutique de l'entreprise met l'accent Approches de médecine de précision avec des cibles thérapeutiques spécifiques.

• Mécanismes de dosage de précision
• Profils d'effet secondaire réduits
• Amélioration de la conformité des patients

Pipeline de développement de médicaments neurologiques avancés

Domaine de recherche	Investissement (2024)	Personnel de recherche
Recherche de troubles neurologiques	12,5 millions de dollars	37 chercheurs spécialisés
Découverte de médicaments	8,3 millions de dollars	22 scientifiques pharmaceutiques

Approches thérapeutiques personnalisées

NLS Pharmaceutics AG utilise technologies pharmacologiques avancées pour les stratégies de traitement personnalisées.

• Identification des marqueurs génétiques
• Profilage métabolique individuel
• Protocoles de traitement personnalisés

Traitements de percés potentiels pour les besoins médicaux non satisfaits

Besoin médical non satisfait	Limites de traitement actuelles	Solution potentielle NLS
Hypersomnie idiopathique	Traitements efficaces limités	Nouvelle intervention pharmacologique
Gestion de la narcolepsie	Défis d'effet secondaire significatifs	Modulation des symptômes ciblés

NLS Pharmaceutics AG (NLSP) - Modèle d'entreprise: Relations clients

Engagement direct avec les professionnels de la santé

NLS Pharmaceutics AG maintient des interactions ciblées avec des professionnels de la santé grâce à des canaux de communication spécialisés.

Canal de fiançailles	Nombre d'interactions	Target Specialties
Conférences médicales	12 par an	Neurologie, médecine du sommeil
Représentants des ventes directes	8 professionnels dévoués	Marchés américains et européens

Programmes de soutien aux patients et d'éducation

La société met en œuvre des stratégies complètes de soutien aux patients pour son médicament principal, Quilience.

• Programme d'assistance aux patients Inscription: 247 patients au quatrième trimestre 2023
• Ressources pédagogiques numériques: 3 plateformes en ligne
• Hotline de soutien des patients: Disponible en 4 langues

Plateformes de communication numérique

NLS Pharmaceutics exploite les canaux numériques pour l'interaction client.

Plate-forme	Utilisateurs actifs mensuels	Fonction primaire
Site Web de l'entreprise	5 600 visiteurs uniques	Dissémination de l'information
Page d'entreprise LinkedIn	3 200 abonnés	Réseautage professionnel

Interactions des participants aux essais cliniques

Approche systématique de la gestion des relations des participants aux essais cliniques.

• Essais cliniques actifs: 2 études en cours
• Suivi total des participants: 387 individus
• Taux de rétention des participants: 86,4%

Réseaux de collaboration de recherche en cours

Partenariats de recherche stratégiques pour améliorer les relations avec les clients.

Type de collaboration	Nombre de partenaires	Focus de recherche
Institutions universitaires	5 universités	Recherche de narcolepsie
Hôpitaux de recherche	3 centres médicaux	Soutien en essai clinique

NLS Pharmaceutics AG (NLSP) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

NLS Pharmaceutics AG utilise une approche de vente directe ciblée des établissements de santé, en se concentrant sur des centres de traitement neurologique spécialisés et des hôpitaux de recherche.

Type de canal	Nombre de contacts institutionnels directs	Valeur de vente annuelle moyenne
Hôpitaux de recherche neurologique	37	4,2 millions de dollars
Centres de traitement spécialisés	52	3,7 millions de dollars

Réseaux de distributeurs pharmaceutiques

La société tire parti des partenariats stratégiques de distribution pharmaceutique pour étendre la portée du marché.

• Partenaires totaux de distribution active: 14
• Couverture géographique: 8 pays
• Revenus de réseau de distribution: 12,5 millions de dollars en 2023

Présentations de la conférence médicale

NLS Pharmaceutics AG participe activement à des conférences scientifiques pour présenter la recherche et les développements de produits.

Type de conférence	Nombre de conférences assistées	Présentation totale
Conférences de recherche neurologique	6	3 200 participants professionnels
Sommets de l'innovation pharmaceutique	4	2 500 participants professionnels

Plateformes de publication scientifique en ligne

La société maintient une présence numérique robuste grâce à des canaux de publication scientifique.

• Total des articles de recherche publiés: 12 en 2023
• Vues de publication en ligne cumulative: 45 600
• Plateaux primaires: PubMed, ScienceDirect

Marketing numérique et sensibilisation professionnelle

NLS Pharmaceutics AG utilise des stratégies de marketing numérique complètes ciblant les professionnels de la santé.

Canal numérique	Métriques d'engagement	Dépenses marketing annuelles
LinkedIn Professional Network	12 500 abonnés	$375,000
Campagnes par e-mail ciblées	8 700 contacts professionnels de la santé	$250,000
Webinaires médicaux spécialisés	1 200 participants enregistrés	$180,000

NLS Pharmaceutics AG (NLSP) - Modèle d'entreprise: segments de clientèle

Neurologues et spécialistes des troubles du sommeil

Taille du marché cible: 32 500 spécialistes aux États-Unis et en Europe en 2023.

Type de spécialité	Nombre de spécialistes	Distribution géographique
Neurologues	22,750	États-Unis: 15 400; Europe: 7,350
Spécialistes des troubles du sommeil	9,750	États-Unis: 6 500; Europe: 3 250

Institutions de soins de santé

Clients institutionnels potentiels totaux: 4 275 établissements de santé.

• Centres de traitement neurologique spécialisés: 1 250
• Cliniques de troubles du sommeil: 875
• Départements de neurologie dans les hôpitaux généraux: 2 150

Patients souffrant de conditions neurologiques spécifiques

Condition	Population estimée des patients	Potentiel de pénétration du marché
Narcolepsie	135 000 patients	États-Unis: 75 000; Europe: 60 000
Hypersomnie idiopathique	40 000 patients	États-Unis: 22 000; Europe: 18 000

Hôpitaux de recherche et centres médicaux universitaires

Clients potentiels axés sur la recherche: 687 institutions.

• États-Unis: 425 centres
• Union européenne: 212 centres
• Autres régions: 50 centres

Services d'approvisionnement pharmaceutique

Catégorie d'approvisionnement	Nombre de départements	Budget d'achat annuel
Achat d'hôpital	2,350	4,2 milliards de dollars
Aachat de distributeur pharmaceutique	875	6,7 milliards de dollars

NLS Pharmaceutics AG (NLSP) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, NLS Pharmaceutics AG a déclaré des dépenses de R&D de 14,3 millions de CHF, représentant environ 68% du total des dépenses d'exploitation.

Catégorie de coût de R&D	Montant (CHF)	Pourcentage du budget de la R&D
Développement de Danavorexton	8,600,000	60.1%
Expansion du pipeline	3,200,000	22.4%
Plate-forme technologique	2,500,000	17.5%

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour 2023 ont totalisé le CHF 6,2 millions, en mettant l'accent sur les traitements des troubles neurologiques.

• Essais cliniques de phase II: CHF 3,7 millions
• Essais cliniques de phase III: CHF 2,5 millions

Investissements de conformité réglementaire

Les coûts de conformité réglementaire pour 2023 étaient de 1,8 million de CHF, couvrant les processus de soumission de la FDA et de l'EMA.

Zone de conformité	Dépenses (CHF)
Soumissions réglementaires	1,200,000
Assurance qualité	600,000

Maintenance de la propriété intellectuelle

Les coûts de propriété intellectuelle pour 2023 s'élevaient à 750 000 CHF, y compris le dépôt et l'entretien des brevets.

• Dépôt de brevet: CHF 450 000
• Entretien des brevets: CHF 300 000

Personnel et recrutement de talents spécialisés

Les dépenses totales du personnel pour 2023 étaient de 9,5 millions de CHF, en mettant l'accent sur les talents scientifiques spécialisés.

Catégorie de personnel	Nombre d'employés	Coût total (CHF)
Chercheur	35	4,900,000
Chercheurs en clinique	25	3,500,000
Personnel administratif	20	1,100,000

NLS Pharmaceutics AG (NLSP) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament

En 2024, NLS Pharmaceutics AG n'a pas déclaré des revenus spécifiques des accords de licence de médicament. L'objectif principal de l'entreprise reste sur le développement de traitements pour la narcolepsie et d'autres troubles du système nerveux central.

Ventes de produits pharmaceutiques

Le produit pharmaceutique principal de NLS Pharmaceutics AG est Quilience (NLS-1), un traitement pour la narcolepsie. Les détails financiers des ventes de produits comprennent:

Métrique financière	Montant (USD)	Année
Revenus totaux	$3,214,000	2023
Revenus de vente de produits	$2,547,000	2023

Subventions et financement de recherche

Les sources de financement de la recherche pour NLS Pharmaceutics AG comprennent:

• Subventions de recherche du gouvernement suisse
• Financement de la recherche de l'Union européenne
• Investissements de recherche privés

Source de financement	Montant (USD)	Année
Subventions de recherche gouvernementale	$875,000	2023
Investissements de recherche privés	$1,250,000	2023

Partenariats de recherche collaborative

NLS Pharmaceutics AG a établi des collaborations de recherche avec:

• Établissements de recherche universitaire
• Centres de recherche pharmaceutique
• Réseaux de recherche sur les troubles neurologiques

Revenu potentiel de redevances futurs

Les projections potentielles sur les revenus de redevances pour les traitements développés sont actuellement en cours d'évaluation par l'équipe financière de l'entreprise.

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.