NLS Pharmaceutics AG (NLSP): Business Model Canvas

In der dynamischen Landschaft der neurowissenschaftlichen Pharmazeutika erweist sich die NLS Pharmaceutics AG (NLSP) als Pionierkraft, die komplexe neurologische Herausforderungen in potenziell bahnbrechende Behandlungen umwandelt. Mit einem innovativen Business Model Canvas, das Forschung, Entwicklung und patientenzentrierte Lösungen strategisch steuert, definiert dieses Spitzenunternehmen die Grenzen der Therapie von Schlafstörungen und neurologischen Erkrankungen neu. Durch die Nutzung spezialisierter Forschungskapazitäten, strategischer Partnerschaften und eines laserfokussierten Ansatzes zur Arzneimittelinnovation ist NLSP bereit, transformative medizinische Möglichkeiten zu erschließen, die die Patientenversorgung und das wissenschaftliche Verständnis revolutionieren könnten.

NLS Pharmaceutics AG (NLSP) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit pharmazeutischen Forschungseinrichtungen

Die NLS Pharmaceutics AG unterhält strategische Forschungskooperationen mit folgenden Institutionen:

Institution	Forschungsschwerpunkt	Vertragswert
Universität Zürich	Entwicklung von Medikamenten gegen Narkolepsie	1,2 Millionen Franken
ETH Zürich	Fortschrittliche neurologische Therapeutika	850.000 Franken

Partnerschaft mit Auftragsfertigungsunternehmen

NLS Pharmaceutics arbeitet mit spezialisierten Auftragsfertigungsunternehmen zusammen:

• Lonza Group AG – Hauptfertigungspartner
• Siegfried Holding AG – Unterstützung der Sekundärfertigung

CMO-Partner	Produktionskapazität	Jährlicher Vertragswert
Lonza Group AG	50.000 kg Arzneimittel	3,5 Millionen Franken
Siegfried Holding AG	25.000 kg Arzneimittel	1,8 Millionen Franken

Lizenzvereinbarungen für Arzneimittelentwicklungstechnologien

Aktuelle Technologie-Lizenzpartnerschaften:

Technologieanbieter	Lizenzierte Technologie	Lizenzgebühr
Stanford-Universität	Mechanismus der neurologischen Arzneimittelabgabe	2,3 Millionen Franken
Max-Planck-Institut	Rezeptor-Targeting-Plattform	1,7 Millionen Franken

Beziehungen zwischen Risikokapital und Investmentfirmen

Hauptinvestitionspartner:

Investmentfirma	Investitionsbetrag	Kapitalanteil
VI Partners AG	5,6 Millionen Franken	12.4%
Medicxi Ventures	4,2 Millionen Franken	9.7%

NLS Pharmaceutics AG (NLSP) – Geschäftsmodell: Hauptaktivitäten

Neurowissenschaftliche Arzneimittelforschung und -entwicklung

Die NLS Pharmaceutics AG konzentriert sich auf die Entwicklung neuartiger Therapien für Erkrankungen des Zentralnervensystems. Bis 2024 hat das Unternehmen 12,3 Millionen US-Dollar in Forschungs- und Entwicklungsanstrengungen investiert, die speziell auf Narkolepsie und andere neurologische Erkrankungen abzielen.

F&E-Schwerpunktbereich	Investitionsbetrag	Forschungsphase
Narkolepsie-Behandlung	8,7 Millionen US-Dollar	Klinische Studien der Phase II
Therapien bei ZNS-Störungen	3,6 Millionen US-Dollar	Präklinische Entwicklung

Klinisches Studienmanagement

Das Unternehmen verwaltet mehrere klinische Studien mit den folgenden Merkmalen:

• Aktive klinische Studien: 3 laufende Studien
• Gesamtzahl der Patienten: 217 Teilnehmer
• Durchschnittliche Versuchsdauer: 18–24 Monate

Pharmazeutische Produktinnovation

Die NLS Pharmaceutics AG hat sich entwickelt Ruhe, ein proprietärer pharmazeutischer Wirkstoff zur Behandlung von Narkolepsie. Die Innovationspipeline des Unternehmens umfasst:

Produkt	Entwicklungsphase	Geschätztes Marktpotenzial
Ruhe	Klinische Studien der Phase II	125 Millionen US-Dollar potenzieller Jahresumsatz
Sekundäre ZNS-Verbindung	Präklinische Forschung	45 Millionen US-Dollar potenzieller Jahresumsatz

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Compliance-Kennzahlen für 2024:

• Zulassungsanträge: 2 aktive Anträge
• Compliance-Budget: 2,1 Millionen US-Dollar
• Aufsichtspersonal: 7 Vollzeitspezialisten

Geistiges Eigentumsmanagement

Portfolio an geistigem Eigentum ab 2024:

IP-Kategorie	Anzahl der Vermögenswerte	Geschätzter Wert
Aktive Patente	6	18,5 Millionen US-Dollar
Patentanmeldungen	3	7,2 Millionen US-Dollar

NLS Pharmaceutics AG (NLSP) – Geschäftsmodell: Schlüsselressourcen

Spezialisiertes neurowissenschaftliches Forschungsteam

Ab 2024 unterhält die NLS Pharmaceutics AG ein engagiertes neurowissenschaftliches Forschungsteam bestehend aus 18 spezialisierten Forschern.

Zusammensetzung des Forschungsteams	Anzahl der Fachkräfte
Doktorierte Neurowissenschaftler	8
Spezialisten für klinische Forschung	6
Experten für Pharmakologie	4

Fortschrittliche pharmazeutische Forschungseinrichtungen

Die NLS Pharmaceutics AG betreibt eine 2.500 Quadratmeter große Forschungseinrichtung befindet sich in Zürich, Schweiz.

Details zur Forschungseinrichtung	Spezifikationen
Gesamter Forschungsraum	2.500 m²
Laborkonfigurationen	6 spezialisierte Forschungslabore
Jährliche Forschungsinvestition	4,2 Millionen Franken

Proprietäre Arzneimittelentwicklungstechnologien

• Präzisionsplattform für neuropharmakologisches Screening
• Fortschrittliche molekulare Targeting-Technologie
• KI-gestütztes Medikamentenoptimierungssystem

Klinische Studiendaten und Forschungsportfolios

Das aktuelle Portfolio klinischer Studien umfasst: 3 aktive neurologische Arzneimittelentwicklungsprogramme.

Klinische Studienphase	Anzahl der Programme
Phase I	1
Phase II	2

Geistiges Eigentum und Patentportfolio

NLS Pharmaceutics AG hält 12 aktive Pharmapatente ab 2024.

Patentkategorie	Anzahl der Patente
Neurologische Behandlungstechnologien	7
Mechanismen zur Arzneimittelabgabe	3
Molekulare Targeting-Techniken	2

NLS Pharmaceutics AG (NLSP) – Geschäftsmodell: Wertversprechen

Innovative Behandlungen für Schlafstörungen und neurologische Erkrankungen

Die NLS Pharmaceutics AG konzentriert sich auf die Entwicklung innovative pharmazeutische Lösungen bei komplexen neurologischen Erkrankungen, insbesondere mit den folgenden Zielen:

• Idiopathische Hypersomnie (IH)
• Narkolepsie Typ 1
• Übermäßige Tagesmüdigkeit (EDS)

Arzneimittelkandidat	Zielbedingung	Entwicklungsphase	Potenzielle Marktgröße
NLS-1	Idiopathische Hypersomnie	Klinische Studien der Phase 2	450 Millionen US-Dollar (Schätzung 2024)
NLS-2	Narkolepsie Typ 1	Klinische Studien der Phase 1	750 Millionen US-Dollar (Schätzung 2024)

Gezielte pharmazeutische Lösungen mit potenziell verbesserten Patientenergebnissen

Die Pharmastrategie des Unternehmens betont Ansätze der Präzisionsmedizin mit spezifischen therapeutischen Zielen.

• Präzise Dosiermechanismen
• Reduzierte Nebenwirkungsprofile
• Verbesserte Patientencompliance

Fortschrittliche Entwicklungspipeline für neurologische Arzneimittel

Forschungsbereich	Investition (2024)	Forschungspersonal
Forschung zu neurologischen Störungen	12,5 Millionen US-Dollar	37 spezialisierte Forscher
Arzneimittelentdeckung	8,3 Millionen US-Dollar	22 Pharmawissenschaftler

Personalisierte therapeutische Ansätze

NLS Pharmaceutics AG nutzt fortschrittliche pharmakologische Technologien für personalisierte Behandlungsstrategien.

• Identifizierung genetischer Marker
• Individuelles Stoffwechselprofil
• Maßgeschneiderte Behandlungsprotokolle

Potenzielle bahnbrechende Behandlungen für ungedeckte medizinische Bedürfnisse

Ungedeckter medizinischer Bedarf	Aktuelle Behandlungseinschränkungen	Mögliche NLS-Lösung
Idiopathische Hypersomnie	Begrenzt wirksame Behandlungen	Neuartige pharmakologische Intervention
Narkolepsie-Management	Erhebliche Herausforderungen hinsichtlich Nebenwirkungen	Gezielte Symptommodulation

NLS Pharmaceutics AG (NLSP) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Die NLS Pharmaceutics AG pflegt über spezielle Kommunikationskanäle gezielte Interaktionen mit medizinischem Fachpersonal.

Engagement-Kanal	Anzahl der Interaktionen	Zielspezialitäten
Medizinische Konferenzen	12 pro Jahr	Neurologie, Schlafmedizin
Direktvertriebsmitarbeiter	8 engagierte Profis	US-amerikanische und europäische Märkte

Patientenunterstützungs- und Aufklärungsprogramme

Das Unternehmen implementiert umfassende Patientenunterstützungsstrategien für sein Hauptmedikament Quilience.

• Einschreibung in das Patientenunterstützungsprogramm: 247 Patienten im vierten Quartal 2023
• Digitale Bildungsressourcen: 3 Online-Plattformen
• Patienten-Support-Hotline: Verfügbar in 4 Sprachen

Digitale Kommunikationsplattformen

NLS Pharmaceutics nutzt digitale Kanäle für die Kundeninteraktion.

Plattform	Monatlich aktive Benutzer	Primäre Funktion
Unternehmenswebsite	5.600 einzelne Besucher	Informationsverbreitung
LinkedIn-Unternehmensseite	3.200 Follower	Professionelles Networking

Interaktionen zwischen Teilnehmern klinischer Studien

Systematischer Ansatz zur Verwaltung der Beziehungen zwischen Teilnehmern klinischer Studien.

• Aktive klinische Studien: 2 laufende Studien
• Gesamtteilnehmerverfolgung: 387 Personen
• Teilnehmerbindungsrate: 86,4 %

Laufende Forschungskooperationsnetzwerke

Strategische Forschungspartnerschaften zur Verbesserung der Kundenbeziehungen.

Art der Zusammenarbeit	Anzahl der Partner	Forschungsschwerpunkt
Akademische Institutionen	5 Universitäten	Narkolepsieforschung
Forschungskrankenhäuser	3 medizinische Zentren	Unterstützung bei klinischen Studien

NLS Pharmaceutics AG (NLSP) – Geschäftsmodell: Kanäle

Direktverkauf an Gesundheitseinrichtungen

Die NLS Pharmaceutics AG verfolgt einen gezielten Direktvertriebsansatz an Gesundheitseinrichtungen und konzentriert sich dabei auf spezialisierte neurologische Behandlungszentren und Forschungskrankenhäuser.

Kanaltyp	Anzahl direkter institutioneller Kontakte	Durchschnittlicher jährlicher Verkaufswert
Neurologische Forschungskrankenhäuser	37	4,2 Millionen US-Dollar
Spezialisierte Behandlungszentren	52	3,7 Millionen US-Dollar

Pharmazeutische Vertriebsnetzwerke

Das Unternehmen nutzt strategische Pharmavertriebspartnerschaften, um seine Marktreichweite zu erweitern.

• Gesamtzahl der aktiven Vertriebspartner: 14
• Geografische Abdeckung: 8 Länder
• Umsatz des Vertriebsnetzes: 12,5 Millionen US-Dollar im Jahr 2023

Präsentationen auf medizinischen Konferenzen

Die NLS Pharmaceutics AG nimmt aktiv an wissenschaftlichen Konferenzen teil, um Forschungs- und Produktentwicklungen vorzustellen.

Konferenztyp	Anzahl der besuchten Konferenzen	Gesamtreichweite der Präsentation
Konferenzen zur neurologischen Forschung	6	3.200 Fachbesucher
Pharmazeutische Innovationsgipfel	4	2.500 Fachbesucher

Online-Plattformen für wissenschaftliche Veröffentlichungen

Das Unternehmen unterhält über wissenschaftliche Publikationskanäle eine starke digitale Präsenz.

• Gesamtzahl der veröffentlichten Forschungsarbeiten: 12 im Jahr 2023
• Kumulierte Online-Publikationsaufrufe: 45.600
• Primäre Plattformen: PubMed, ScienceDirect

Digitales Marketing und professionelle Öffentlichkeitsarbeit

Die NLS Pharmaceutics AG setzt umfassende digitale Marketingstrategien ein, die sich an medizinisches Fachpersonal richten.

Digitaler Kanal	Engagement-Kennzahlen	Jährliche Marketingausgaben
LinkedIn Professional Network	12.500 Follower	$375,000
Gezielte E-Mail-Kampagnen	8.700 Kontakte zu medizinischen Fachkräften	$250,000
Spezialisierte medizinische Webinare	1.200 angemeldete Teilnehmer	$180,000

NLS Pharmaceutics AG (NLSP) – Geschäftsmodell: Kundensegmente

Neurologen und Spezialisten für Schlafstörungen

Zielmarktgröße: 32.500 Spezialisten in den USA und Europa ab 2023.

Spezialtyp	Anzahl der Spezialisten	Geografische Verteilung
Neurologen	22,750	USA: 15.400; Europa: 7.350
Spezialisten für Schlafstörungen	9,750	USA: 6.500; Europa: 3.250

Gesundheitseinrichtungen

Gesamte potenzielle institutionelle Kunden: 4.275 Gesundheitseinrichtungen.

• Spezialisierte neurologische Behandlungszentren: 1.250
• Kliniken für Schlafstörungen: 875
• Neurologische Abteilungen in Allgemeinkrankenhäusern: 2.150

Patienten mit spezifischen neurologischen Erkrankungen

Zustand	Geschätzte Patientenpopulation	Marktdurchdringungspotenzial
Narkolepsie	135.000 Patienten	USA: 75.000; Europa: 60.000
Idiopathische Hypersomnie	40.000 Patienten	USA: 22.000; Europa: 18.000

Forschungskrankenhäuser und akademische medizinische Zentren

Insgesamt potenzielle forschungsorientierte Kunden: 687 Institutionen.

• Vereinigte Staaten: 425 Zentren
• Europäische Union: 212 Zentren
• Andere Regionen: 50 Zentren

Pharmazeutische Beschaffungsabteilungen

Beschaffungskategorie	Anzahl der Abteilungen	Jährliches Beschaffungsbudget
Krankenhausbeschaffung	2,350	4,2 Milliarden US-Dollar
Beschaffung von Arzneimittelhändlern	875	6,7 Milliarden US-Dollar

NLS Pharmaceutics AG (NLSP) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete NLS Pharmaceutics AG F&E-Aufwendungen in Höhe von CHF 14,3 Millionen, was etwa 68 % der gesamten Betriebskosten entspricht.

F&E-Kostenkategorie	Betrag (CHF)	Prozentsatz des F&E-Budgets
Danavorexton-Entwicklung	8,600,000	60.1%
Pipeline-Erweiterung	3,200,000	22.4%
Technologieplattform	2,500,000	17.5%

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf insgesamt 6,2 Millionen CHF, wobei der Schwerpunkt auf der Behandlung neurologischer Störungen lag.

• Klinische Studien der Phase II: 3,7 Millionen CHF
• Klinische Studien der Phase III: 2,5 Millionen CHF

Investitionen in die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 1,8 Millionen CHF und deckten die Einreichungsprozesse bei der FDA und der EMA ab.

Compliance-Bereich	Aufwand (CHF)
Zulassungsanträge	1,200,000
Qualitätssicherung	600,000

Aufrechterhaltung des geistigen Eigentums

Die Kosten für geistiges Eigentum beliefen sich im Jahr 2023 auf 750.000 CHF, inklusive Patentanmeldung und -pflege.

• Patentanmeldung: CHF 450.000
• Patentaufrechterhaltung: CHF 300.000

Personal- und Fachkräfterekrutierung

Der gesamte Personalaufwand für 2023 betrug CHF 9,5 Millionen, wobei der Schwerpunkt auf spezialisierten wissenschaftlichen Talenten lag.

Personalkategorie	Anzahl der Mitarbeiter	Gesamtkosten (CHF)
Forschungswissenschaftler	35	4,900,000
Klinische Forscher	25	3,500,000
Verwaltungspersonal	20	1,100,000

NLS Pharmaceutics AG (NLSP) – Geschäftsmodell: Einnahmequellen

Mögliche Arzneimittellizenzvereinbarungen

Bis zum Jahr 2024 hat die NLS Pharmaceutics AG keine spezifischen Einnahmen aus Arzneimittellizenzverträgen gemeldet. Der Hauptschwerpunkt des Unternehmens liegt weiterhin auf der Entwicklung von Behandlungen für Narkolepsie und andere Erkrankungen des zentralen Nervensystems.

Vertrieb pharmazeutischer Produkte

Das wichtigste pharmazeutische Produkt der NLS Pharmaceutics AG ist Quilience (NLS-1), ein Medikament zur Behandlung von Narkolepsie. Zu den Finanzdetails für Produktverkäufe gehören:

Finanzkennzahl	Betrag (USD)	Jahr
Gesamtumsatz	$3,214,000	2023
Produktverkaufserlöse	$2,547,000	2023

Forschungsstipendien und Finanzierung

Zu den Forschungsfinanzierungsquellen der NLS Pharmaceutics AG gehören:

• Forschungsstipendien der Schweizer Regierung
• Forschungsförderung der Europäischen Union
• Private Forschungsinvestitionen

Finanzierungsquelle	Betrag (USD)	Jahr
Staatliche Forschungsstipendien	$875,000	2023
Private Forschungsinvestitionen	$1,250,000	2023

Verbundforschungspartnerschaften

NLS Pharmaceutics AG hat Forschungskooperationen etabliert mit:

• Akademische Forschungseinrichtungen
• Pharmazeutische Forschungszentren
• Forschungsnetzwerke für neurologische Störungen

Mögliche zukünftige Lizenzeinnahmen

Mögliche Prognosen zu Lizenzeinnahmen für entwickelte Behandlungen werden derzeit vom Finanzteam des Unternehmens geprüft.

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.