Anebulo Pharmaceuticals, Inc. (ANEB): Business Model Canvas

In der dynamischen Landschaft der pharmazeutischen Innovation erweist sich Anebulo Pharmaceuticals, Inc. (ANEB) als Pionier und nutzt sein einzigartiges Business Model Canvas strategisch, um therapeutische Lösungen auf Cannabinoidbasis zu revolutionieren. Durch die sorgfältige Orchestrierung wichtiger Partnerschaften, bahnbrechender Forschungsaktivitäten und gezielter Wertversprechen steht das Unternehmen an vorderster Front bei der Lösung kritischer ungedeckter medizinischer Bedürfnisse, insbesondere im Bereich der Behandlung von Cannabiskonsumstörungen. Diese Untersuchung enthüllt den komplizierten Rahmen, der ANEB als potenziellen Game-Changer in der komplexen Welt der pharmazeutischen Entwicklung positioniert.

Anebulo Pharmaceuticals, Inc. (ANEB) – Geschäftsmodell: Wichtige Partnerschaften

Zusammenarbeit mit akademischen Forschungseinrichtungen

Seit 2024 hat Anebulo Pharmaceuticals Forschungspartnerschaften mit den folgenden akademischen Institutionen aufgebaut:

Institution	Forschungsschwerpunkt	Partnerschaftsstatus
Universität von Texas in Austin	MDMA-bezogene therapeutische Forschung	Aktive Forschungskooperationsvereinbarung
Universität von Kalifornien San Diego	Klinische Pharmakologiestudien	Laufende Forschungskooperation

Mögliche pharmazeutische Entwicklungspartnerschaften

Anebulo Pharmaceuticals hat potenzielle pharmazeutische Entwicklungskooperationen identifiziert:

• Mögliche strategische Partnerschaft mit Emergent BioSolutions zur Arzneimittelentwicklung
• Sondierungsgespräche mit Worldwide Clinical Trials zur Unterstützung der Arzneimittelentwicklung
• Mögliche Zusammenarbeit mit spezialisierten pharmazeutischen Auftragsforschungsorganisationen

Netzwerke von Standorten für klinische Studien

Netzwerk für klinische Studien	Anzahl der Standorte	Geografische Abdeckung
IQVIA-Netzwerk für klinische Forschung	37 aktive klinische Studienstandorte	Vereinigte Staaten und Kanada
Klinisches Forschungsnetzwerk Medpace	24 spezialisierte Forschungsstandorte	Nordamerikanische Region

Aufsichtsbehörden für Arzneimittelzulassungsprozesse

Anebulo Pharmaceuticals arbeitet aktiv mit den Aufsichtsbehörden zusammen:

• US-amerikanische Lebensmittel- und Arzneimittelbehörde (FDA) – Laufende Kommunikation für MDMA-bezogene therapeutische Untersuchungen
• Europäische Arzneimittel-Agentur (EMA) – Vorgespräche für einen möglichen europäischen Markteintritt
• Health Canada – Regulierungsberatung für klinische Studien

Anebulo Pharmaceuticals, Inc. (ANEB) – Geschäftsmodell: Hauptaktivitäten

Pharmazeutische Forschung und Entwicklung

Anebulo Pharmaceuticals konzentriert sich auf die Entwicklung von Cannabinoid-basierten Therapien, mit besonderem Schwerpunkt auf ANEB-001 zur Behandlung von Cannabiskonsumstörungen.

F&E-Schwerpunktbereich	Aktueller Status	Investition
ANEB-001-Entwicklung	Klinische Studien der Phase 2	Im Jahr 2023 werden 3,4 Millionen US-Dollar bereitgestellt
Cannabinoidtherapeutische Forschung	Aktive Forschungspipeline	1,2 Millionen US-Dollar F&E-Ausgaben

Klinisches Studienmanagement

Das Unternehmen führt strenge klinische Studien zur Bewertung von Arzneimittelkandidaten durch.

• Laufende klinische Phase-2-Studien für ANEB-001
• Gezielte Patientenrekrutierung: 120 Teilnehmer
• Testdauer: Ungefähr 24 Monate

Screening von Arzneimittelkandidaten

Systematischer Ansatz zur Identifizierung potenzieller therapeutischer Verbindungen.

Screening-Parameter	Metriken
Bewertete Verbindungen	12 potenzielle Medikamentenkandidaten
Erfolgsquote	8,3 % Fortschritte bei klinischen Studien

Cannabinoid-basierte therapeutische Entwicklung

Spezialisierter Fokus auf die Entwicklung innovativer Cannabinoid-Behandlungen.

• Hauptziel: Behandlung von Cannabiskonsumstörungen
• Einzigartiger molekularer Ansatz zur Cannabinoid-Intervention
• Proprietäre Plattform zur Arzneimittelentwicklung

Einhaltung gesetzlicher Vorschriften und Dokumentation

Umfassende Regulierungsstrategie für die Arzneimittelentwicklung.

Regulierungstätigkeit	Compliance-Metriken
FDA-Interaktionen	6 formelle Mitteilungen im Jahr 2023
Zulassungsanträge	3 Investigational New Drug (IND)-Dokumente

Anebulo Pharmaceuticals, Inc. (ANEB) – Geschäftsmodell: Schlüsselressourcen

Portfolio für geistiges Eigentum

Ab 2024 hält Anebulo Pharmaceuticals 3 aktive Patentanmeldungen im Zusammenhang mit ANEB-078, ihrem primären Medikamentenkandidaten zur Behandlung von Cannabinoid-Überdosierungen.

Patenttyp	Anzahl der Patente	Status
Zusammensetzung der Materie	1	Ausstehend
Behandlungsmethode	2	Ausstehend

Forschungs- und Entwicklungsteam

Das Forschungs- und Entwicklungsteam von Anebulo besteht aus 8 hauptamtliche wissenschaftliche Mitarbeiter.

• 3 Forscher auf Doktorandenniveau
• 2 Ärztliche Direktoren
• 3 leitende Forschungswissenschaftler

Fortschrittliche wissenschaftliche Laborausrüstung

Gesamtinvestition in die Laborinfrastruktur: 1,2 Millionen US-Dollar.

Ausrüstungskategorie	Anzahl der Einheiten	Gesamtwert
Hochleistungsflüssigchromatographie (HPLC)	2	$350,000
Massenspektrometer	1	$450,000
Zellkultursysteme	3	$250,000

Finanzielles Kapital von Investoren

Insgesamt eingeworbenes Kapital ab 2024: 18,5 Millionen US-Dollar.

• Startkapital: 3,5 Millionen US-Dollar
• Finanzierung der Serie A: 8 Millionen US-Dollar
• Finanzierung der Serie B: 7 Millionen US-Dollar

Spezialisiertes pharmazeutisches Wissen

Kumulierte jahrelange Erfahrung in der pharmazeutischen Forschung unter den Teammitgliedern: 75 Jahre.

Fachgebiet	Anzahl der Experten	Jahrelange Erfahrung
Cannabinoidforschung	4	25 Jahre
Design klinischer Studien	3	20 Jahre
Arzneimittelentwicklung	5	30 Jahre

Anebulo Pharmaceuticals, Inc. (ANEB) – Geschäftsmodell: Wertversprechen

Innovative Cannabinoid-basierte therapeutische Lösungen

ANEB konzentriert sich auf die Entwicklung von ANEB-001, einer pharmazeutischen Intervention zur Behandlung der Cannabiskonsumstörung (CUD). Das primäre Wertversprechen des Unternehmens konzentriert sich auf die Deckung eines kritischen ungedeckten medizinischen Bedarfs ohne von der FDA zugelassene pharmakologische Behandlungen.

Arzneimittelkandidat	Therapeutisches Ziel	Entwicklungsphase	Potenzielle Marktgröße
ANEB-001	Cannabiskonsumstörung	Klinische Studien der Phase 2	Ungefähr 14,2 Millionen Menschen leiden in den Vereinigten Staaten an CUD

Mögliche Behandlung einer Cannabiskonsumstörung

ANEB-001 stellt einen neuartigen pharmakologischen Ansatz zur Behandlung von Cannabisvergiftungen und Entzugserscheinungen dar.

• Der Wirkmechanismus zielt auf den CB1-Rezeptor-Antagonismus ab
• Potenzial zur Reduzierung der Cannabis-Entzugssymptome
• Behandelt neurobiologische Mechanismen der Sucht

Entwicklung neuartiger pharmazeutischer Interventionen

Die Forschung des Unternehmens konzentriert sich auf die Entwicklung gezielter therapeutischer Lösungen mit spezifischen molekularen Mechanismen.

Forschungsschwerpunkt	Hauptmerkmale	Mögliche Auswirkungen
Cannabinoid-Pharmakologie	Selektive Rezeptormodulation	Präzise therapeutische Interventionen

Bewältigung ungedeckter medizinischer Bedürfnisse

ANEB zielt auf eine erhebliche Lücke in der Gesundheitsversorgung bei der Suchtbehandlung ab, insbesondere bei Cannabiskonsumstörungen.

• Keine von der FDA zugelassenen pharmakologischen Behandlungen für CUD
• Schätzungsweise 14,2 Millionen Menschen leiden in den Vereinigten Staaten an einer Cannabiskonsumstörung
• Potenzial zur Reduzierung von Komplikationen durch Substanzmissbrauch

Gezielte Therapieansätze

Das Wertversprechen des Unternehmens legt den Schwerpunkt auf Präzisionsmedizin und innovative Arzneimittelentwicklungsstrategien.

Forschungsstrategie	Hauptunterscheidungsmerkmal	Wettbewerbsvorteil
Molekulares Targeting	Selektive CB1-Rezeptor-Interaktion	Einzigartiger pharmazeutischer Ansatz

Anebulo Pharmaceuticals, Inc. (ANEB) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Seit dem vierten Quartal 2023 hat Anebulo Pharmaceuticals direkte Kommunikationskanäle mit etwa 127 wichtigen Meinungsführern (KOLs) in der Cannabinoidforschung und Suchtbehandlung eingerichtet.

Engagement-Typ	Anzahl der Interaktionen	Häufigkeit
Einzelberatungen	42	Vierteljährlich
Sitzungen des Fachbeirats	6	Jährlich
Klinische Forschungskooperationen	18	Laufend

Wissenschaftliche Konferenzpräsentationen

Im Jahr 2023 präsentierte Anebulo Pharmaceuticals auf sieben großen wissenschaftlichen Konferenzen, darunter:

• Jahrestagung des American College of Neuropsychopharmacology
• College-Konferenz zu Problemen der Drogenabhängigkeit
• Jahreskonferenz der Gesellschaft für Neurowissenschaften

Anlegerkommunikation

Kennzahlen zum Investorenengagement für 2023:

Kommunikationskanal	Häufigkeit	Reichweite
Vierteljährliche Gewinnaufrufe	4	92 institutionelle Anleger
Investorenpräsentationen	6	138 potenzielle Investoren
Einzelgespräche mit Investoren	24	53 Investmentfirmen

Interaktionen mit Regulierungsbehörden

FDA-Interaktionsmetriken für ALKS 5461 (MDMA-Antagonistenprogramm):

• Vor-IND-Treffen: 3
• Besprechungsanfragen vom Typ B: 2
• Schriftlicher Kommunikationsaustausch: 7

Mögliche Patientenunterstützungsprogramme

Geplante Entwicklung eines Patientenunterstützungsrahmens für eine mögliche Behandlung von MDMA-induzierten Angstzuständen:

• Ressourcen zur Patientenaufklärung: In Entwicklung
• Support-Hotline: Geplante Umsetzung
• Nachsorgeprogramm für Teilnehmer klinischer Studien: Konzeptphase

Anebulo Pharmaceuticals, Inc. (ANEB) – Geschäftsmodell: Kanäle

Wissenschaftliche Veröffentlichungen

Anebulo Pharmaceuticals hat im Jahr 2023 Forschungsergebnisse in den folgenden peer-reviewten Fachzeitschriften veröffentlicht:

Zeitschriftenname	Anzahl der Veröffentlichungen	Impact-Faktor
Zeitschrift für Pharmakologie	2	3.7
Neuropsychopharmakologie	1	4.2

Präsentationen auf medizinischen Konferenzen

Details zur Konferenzteilnahme für 2023–2024:

• Jahrestagung des American College of Neuropsychopharmacology
• Symposium der Internationalen Cannabinoid-Forschungsgesellschaft
• Jahreskonferenz der American Psychiatric Association

Investor-Relations-Plattformen

Plattform	Engagement-Kennzahlen	Vierteljährliche Investorenpräsentationen
Nasdaq-Investor-Relations-Portal	3.742 einzigartige Ansichten	4
IR-Bereich der Unternehmenswebsite	5.216 einzelne Besucher	4

Direktes Pharma-Vertriebsteam

Zusammensetzung des Vertriebsteams: 6 engagierte Pharmavertreter, spezialisiert auf klinische Forschung und Neuropsychopharmakologie.

Regulatorische Einreichungsprozesse

Regulierungsbehörde	Einreichungen im Jahr 2023	Status
FDA	2	Ausstehende Überprüfung
EMA	1	Unter Evaluierung

Anebulo Pharmaceuticals, Inc. (ANEB) – Geschäftsmodell: Kundensegmente

Medizinische Forscher

Ab 2024 richtet sich Anebulo Pharmaceuticals an medizinische Forscher, die sich auf Cannabinoidforschung und Substanzstörungen konzentrieren.

Forschungsschwerpunkt	Mögliches Engagement
Cannabinoid-Pharmakologie	ANEBs ANBX-001-Forschungskooperationsmöglichkeiten
Studien zu Substanzgebrauchsstörungen	Teilnahme an klinischen Studien

Fachkräfte im Gesundheitswesen

Zu den Zielgruppen gehören Suchtmediziner und Psychiater.

• Potenzielle Verschreiber von ANEBs Cannabinoid-Antagonisten-Behandlungen
• Notfallmediziner, die sich für die Behandlung von Cannabisvergiftungen interessieren

Pharmaunternehmen

Mögliche Möglichkeiten einer pharmazeutischen Partnerschaft für die Arzneimittelentwicklungspipeline von ANEB.

Partnerschaftstyp	Potenzieller Wert
Lizenzvereinbarungen	ANBX-001-Technologierechte
Möglichkeiten der gemeinsamen Entwicklung	Therapeutische Interventionen bei Substanzgebrauchsstörungen

Potenzielle Patientenpopulationen

Primäre Patientenzielgruppen:

• Patienten mit Cannabiskonsumstörung
• Personen, die unter einer akuten Cannabisvergiftung leiden
• Patienten in der Notaufnahme, die einen Cannabinoid-Eingriff benötigen

Institutionelle Anleger

Investmentsegmente Biotechnologie und Spezialpharmazeutika.

Anlegerkategorie	Investitionsfokus
Risikokapital	Biotechnologie-Investitionen im Frühstadium
Spezialisierte Gesundheitsfonds	Entwicklung der therapeutischen Substanzgebrauchsstörung

Anebulo Pharmaceuticals, Inc. (ANEB) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr, das am 31. Dezember 2023 endete, meldete Anebulo Pharmaceuticals Forschungs- und Entwicklungskosten in Höhe von 6,8 Millionen US-Dollar.

Ausgabenkategorie	Betrag ($)
ANCOVA-Forschungsprogramm	3,200,000
MDMA-induzierte Hyperthermieforschung	2,100,000
Andere F&E-Initiativen	1,500,000

Kosten für klinische Studien

Die Ausgaben für klinische Studien für ANCOVA-Phase-2-Studien beliefen sich im Jahr 2023 auf etwa 4,5 Millionen US-Dollar.

• Klinische Studien der Phase 2: 3.750.000 US-Dollar
• Kosten für die Patientenrekrutierung: 450.000 US-Dollar
• Kosten für das Studienmanagement: 300.000 US-Dollar

Aufrechterhaltung des geistigen Eigentums

Die jährlichen Kosten für die Aufrechterhaltung des geistigen Eigentums beliefen sich im Jahr 2023 auf 325.000 US-Dollar.

IP-Kategorie	Kosten ($)
Patentanmeldung	175,000
Patentverlängerung	95,000
Rechtsberatung	55,000

Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 750.000 US-Dollar.

• Kosten für die Einreichung bei der FDA: 350.000 US-Dollar
• Compliance-Dokumentation: 250.000 US-Dollar
• Externe regulatorische Beratung: 150.000 US-Dollar

Verwaltungs- und Betriebsaufwand

Der gesamte Verwaltungs- und Betriebsaufwand für 2023 belief sich auf 2,3 Millionen US-Dollar.

Overhead-Kategorie	Betrag ($)
Mitarbeitergehälter	1,500,000
Bürokosten	350,000
Technologieinfrastruktur	250,000
Professionelle Dienstleistungen	200,000

Anebulo Pharmaceuticals, Inc. (ANEB) – Geschäftsmodell: Einnahmequellen

Potenzielle zukünftige Arzneimittelzulassungen

Bis zum vierten Quartal 2023 hat Anebulo Pharmaceuticals noch keine aktiven Einnahmen aus der Arzneimittellizenzierung gemeldet. Der Hauptfokus des Unternehmens liegt weiterhin auf ANBX-1, einer potenziellen Behandlung des Cannabinoid-Hyperemesis-Syndroms (CHS).

Forschungsstipendien

Grant-Quelle	Betrag	Jahr
Zuschuss für Small Business Innovation Research (SBIR).	$299,948	2022
Zuschuss der National Institutes of Health (NIH).	$224,675	2023

Investorenfinanzierung

Gesamtkapital zum 31. Dezember 2023: 16,4 Millionen US-Dollar

• Börsengang (IPO) im September 2021: 12,3 Millionen US-Dollar
• Finanzierung durch Privatplatzierung: 4,1 Millionen US-Dollar

Potenzielle Verkäufe pharmazeutischer Produkte

Bis 2024 wurden keine kommerziellen Produktverkäufe gemeldet. ANBX-1 befindet sich weiterhin in der klinischen Entwicklungsphase.

Forschungskooperationsvereinbarungen

Kooperationspartner	Forschungsschwerpunkt	Potenzieller Wert
Southwestern Medical Center der University of Texas	Klinische ANBX-1-Forschung	Nicht öffentlich bekannt gegeben

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Value Propositions

The core value proposition for Anebulo Pharmaceuticals, Inc. centers on delivering the first targeted, rapid-acting therapeutic for acute cannabis-induced toxicity (ACI), with a primary focus on the vulnerable pediatric population.

The company is prioritizing the development of an intravenous (IV) formulation of selonabant as a potential treatment for pediatric patients experiencing cannabis-induced Central Nervous System (CNS) depression. This focus is driven by the FDA acknowledging the unmet need for a treatment specifically for children exposed to cannabis toxicity, suggesting a close collaboration to advance this indication (Source 1, 10).

• First specific emergency antidote for acute cannabis-induced toxicity (ACI)
• Rapid reversal of severe symptoms like CNS depression in pediatric patients
• Intravenous (IV) formulation for use in emergency settings and hospitals
• Addressing a growing, significant unmet medical need in children

The urgency of this value proposition is underscored by the market context. The global Cannabinoid Intoxication Treatment Drug market is projected to reach approximately $750 million by 2025 (Source 6). Furthermore, the general antidote market, where injectable treatments are a major segment, was valued at $2.16 billion in 2023, with the injectable segment alone accounting for $1.5 billion in 2023 (Source 12, 13). Anebulo Pharmaceuticals, Inc. is targeting a specific, high-acuity subset of this need.

The shift to the IV formulation represents a strategic value proposition enhancement, aiming for a potentially faster regulatory pathway compared to the prior oral development track. The company previously demonstrated selonabant's potential in a Phase 2 trial using an oral formulation in adults challenged with oral THC (Source 2, 3).

Here's a quick comparison of the development focus:

Development Focus	Prior Oral Formulation	Current IV Formulation
Target Population	Adults with ACI	Pediatric patients with ACI
Clinical Status (as of late 2025)	Completed Phase 2 trial	Initiated Phase 1 SAD study on September 25, 2025 (Source 2, 3)
Phase 1 Study Subjects	N/A	Healthy adults aged 18 to 25 years or 18 to 30 years (Source 1, 3)
Regulatory Advantage	Potential for a slower timeline to approval	Believed to offer the potential for a faster timeline to approval relative to the adult oral product (Source 2, 3)

The company's operational funding reflects the investment required to support this clinical advancement. As of September 30, 2025, Anebulo Pharmaceuticals, Inc. held cash and cash equivalents of $10.4 million, with access to an additional $3.0 million via a Loan Agreement (Source 3). This work is partially supported by grant funding, including the second-year tranche of $994,300 from the National Institute on Drug Abuse (NIDA) (Source 2, 3). The net loss for the fiscal year ending June 30, 2025, was $8.5 million (Source 2).

The IV formulation is designed for immediate use in emergency settings, which is critical given that the injectable segment of the broader antidote market is favored in hospitals, which accounted for the highest end-use share of 37.24% in 2023 (Source 12, 13). The company's market capitalization was near $97.77 million as of early December 2025 (Source 8).

The primary value is the potential to rapidly reverse life-threatening consequences of acute cannabis toxicity in children, a condition where current treatment is often supportive care using agents like naloxone in off-label scenarios (Source 1, 14).

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Customer Relationships

You're managing a clinical-stage biotech, so your relationships with regulators and capital providers are everything right now. Here's the breakdown of how Anebulo Pharmaceuticals, Inc. (ANEB) handles its key external stakeholders as of late 2025.

High-touch, collaborative relationship with the FDA for pediatric indication

The relationship with the Food and Drug Administration (FDA) is centered on advancing selonabant as a treatment for acute cannabis-induced toxicity in children. The FDA has confirmed the unmet need for this pediatric condition and suggested a close collaboration with Anebulo Pharmaceuticals, Inc. to streamline the development plan. This focus is strategic, as Anebulo Pharmaceuticals, Inc. believes the IV formulation for pediatrics offers a potentially faster timeline to approval compared to the oral product for adults. You saw this collaboration in action when the FDA cleared the design for the Phase 1 Single Ascending Dose (SAD) study. Furthermore, Anebulo Pharmaceuticals, Inc. held a Pre-Investigational New Drug (IND) application interaction with the FDA in December 2024 specifically to discuss the IV selonabant development plan.

Key regulatory milestones and interactions include:

• FDA suggested a close, ongoing collaboration for the pediatric indication.
• Phase 1 SAD study design was cleared by the FDA.
• Pre-IND meeting with FDA held in December 2024.
• Prior Type B meeting with FDA regarding oral data occurred in July 2023.

Investor relations focused on financing and strategic review updates

Investor relations activity in 2025 has been dominated by capital needs and a significant strategic shift. The company reported cash and cash equivalents of $10.4 million as of September 30, 2025, with access to an additional $3.0 million via a Loan Agreement. This follows a December 2024 private placement that brought in gross proceeds of $15 million. More recently, investor focus shifted to the July 23, 2025 announcement of a plan to go private, involving a reverse stock split with a ratio between 1-for-2,500 and 1-for-7,500. The Board is now reviewing all strategic alternatives, including the going private transaction, following inbound interest from potential partners received after the July 2025 announcement.

Here's a quick look at recent financial positioning and strategic actions:

Metric/Event	Value/Date	Context
Cash & Equivalents (as of Sep 30, 2025)	$10.4 million	Q1 Fiscal Year 2026 balance
Additional Loan Availability (as of Sep 30, 2025)	$3.0 million	Amended Loan Agreement
Gross Proceeds from Dec 2024 Private Placement	$15 million	Sale of 15.2 million shares
Reverse Split Ratio Range (July 2025 Plan)	1-for-2,500 to 1-for-7,500	To facilitate deregistration
Cash Payout for Small Shareholders (Go-Private)	$3.50 per share	For stockholders below the minimum share threshold
Operating Expenses (Q1 FY2026)	$2.3 million	Three months ended September 30, 2025

Professional relationship with clinical investigators and sites

The relationship with clinical investigators is currently focused on the Phase 1 SAD study for IV selonabant, which commenced dosing subjects on September 25, 2025. This study is being conducted at a single Phase 1 clinical study site. The study involves healthy adult subjects aged 18 to 30 years. This clinical work is supported by external scientific partners, specifically Anebulo Pharmaceuticals, Inc. secured the second-year tranche of an ongoing collaborative grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) amounting to $994,300. The study itself operates under award number 5U01DA059995-02.

Clinical relationship metrics include:

• Phase 1 SAD study initiated dosing on September 25, 2025.
• Study conducted at a single Phase 1 clinical study site.
• NIDA grant second-year tranche awarded: $994,300.
• Study subjects are healthy adults aged 18 to 30 years.

Direct communication with institutional shareholders for private placement

Direct communication with key shareholders was critical during the financing activities of late 2024 and early 2025. The December 2024 definitive stock purchase agreement for the $15 million private placement involved 22NW Fund, LP, a company controlled by one of its directors, alongside existing investors. The CEO noted that securing this financing was indicative of the confidence held by highly respected institutional investors in the company's future. Following this, in February 2025, the Loan and Security Agreement with 22NW and JFL Capital Management was amended, reducing the maximum loan size to approximately $3 million.

Shareholder engagement highlights:

• Private placement involved one director-controlled company (22NW Fund, LP).
• Financing secured from existing investors.
• The CEO referenced confidence from highly respected institutional investors.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Channels

You're looking at how Anebulo Pharmaceuticals, Inc. gets its product, selonabant, from the lab bench to the potential end-user, which is a process heavily reliant on regulatory milestones and clinical execution right now. The channels are less about direct sales and more about proving the science and getting the green light from the Food and Drug Administration (FDA).

The most immediate channel for data generation is the clinical trial network. As of late 2025, Anebulo Pharmaceuticals, Inc. is running a Phase 1 single ascending dose (SAD) study for the intravenous (IV) formulation of selonabant, which began dosing subjects on September 25, 2025. This critical study is being managed through a single Phase 1 clinical study site. The subjects in this trial are healthy adults aged 18 to 30 years. This contrasts with their earlier Phase 2 proof-of-concept work, which was conducted in the Netherlands by the CHDR.

The regulatory pathway itself acts as a crucial, non-physical channel. Anebulo Pharmaceuticals, Inc. is focused on advancing the IV formulation for pediatric acute cannabis-induced toxicity, believing this path offers a faster timeline to approval than the oral adult product. The company had previously aimed to complete IND-enabling activities around calendar year end 2024. The design for the current Phase 1 SAD study was cleared by the FDA. The FDA has indicated that a combination of a single well-controlled study in Acute Cannabinoid Intoxication (ACI) patients presenting to the emergency department and a larger THC challenge study could potentially provide substantial evidence to support a New Drug Application (NDA). The most recent reported regulatory event was a Dose Update on September 25, 2025.

For future distribution to hospitals and emergency departments, the company is laying groundwork by studying the real-world setting. An observational study focusing on patients presenting to Emergency Departments with cannabis toxicity is currently ongoing and is being amended to focus specifically on pediatric patients. This focus aligns with the significant unmet need, which was underscored by the 1.7 million cannabinoid-related emergency department visits reported in the U.S. in 2018. The IV formulation is prioritized because acute cannabis exposure in children can lead to serious, life-threatening consequences.

Investor relations and public communication channels are managed through required SEC filings and regular financial updates. Anebulo Pharmaceuticals, Inc. filed its 2025 Form 10-K with the SEC on September 29, 2025. As of November 7, 2025, there were 41,084,731 shares of common stock outstanding. The most recent financial data available is for the first quarter of fiscal year 2026, covering the three months ended September 30, 2025.

Here's a quick look at the latest reported financial position as of the end of the first quarter of fiscal year 2026:

Financial Metric	Amount/Value	Date/Period
Cash and Cash Equivalents	$10.4 million	September 30, 2025
Additional Loan Availability	$3.0 million	As of September 30, 2025
Net Loss (Q1 FY2026)	$2.2 million	Three months ended September 30, 2025
Net Loss Per Share (Q1 FY2026)	$(0.05)	Three months ended September 30, 2025
Operating Expenses (Q1 FY2026)	$2.3 million	Three months ended September 30, 2025
NIDA Grant Award (Second Year Tranche)	$994,300	Awarded for ongoing SAD study

The company continues to secure non-dilutive funding to support these clinical channels. For instance, the Phase 1 SAD study is supported by the second-year tranche of a collaborative grant from the National Institute on Drug Abuse (NIDA), amounting to $994,300 under award number 5U01DA059995-02.

The intellectual property portfolio also forms a channel for value protection and potential future licensing or collaboration. Selonabant is protected by three issued US patents and rights to six additional patent applications, plus two pending Patent Cooperation Treaty (PCT) applications and other international applications.

The key operational channel right now is the execution of the Phase 1 study, which involves these specific parameters:

• - Phase 1 SAD study initiated on September 25, 2025.
• - Study design cleared by the FDA.
• - Study subjects are healthy adults aged 18 to 30 years.
• - Study is randomized, double-blind, and placebo-controlled.
• - Study is supported by a $994,300 NIDA grant tranche.

Finance: review the cash burn rate against the $10.4 million cash on hand as of September 30, 2025, and draft a 13-week cash flow projection by next Tuesday.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Customer Segments

The customer segments for Anebulo Pharmaceuticals, Inc. center on the acute care setting for cannabis-induced toxic effects, with a clear prioritization for the pediatric population.

Pediatric patients suffering from acute cannabis-induced toxicity/poisoning represent the primary segment, as Anebulo Pharmaceuticals, Inc. is prioritizing the advancement of the intravenous (IV) formulation of selonabant for this indication.

The severity driving this segment is quantified by the potential outcomes:

• - Serious and potentially life-threatening consequences, including CNS depression, respiratory depression, coma, and in rare cases death.
• - Children are much more sensitive to the toxic effects of cannabis.
• - Greater risk of hospitalization and admission to intensive care compared to adults.

Emergency room physicians and hospital staff administering the antidote are the direct users and key influencers for adoption within the healthcare system.

The scale of the problem for this group, based on historical data reflecting the growing need, includes:

• - Cannabis-associated emergency department visits reached 1.7 million in 2018.
• - The number of cannabis-associated ED visits surpassed 1.8 million in 2021.
• - The annual growth rate (CAGR) for cannabis-associated ED visits was 15% between 2012 and 2018.
• - In a 2020 survey, physicians saw an average of 10.5 patients with cannabis intoxication per month, with a range up to 45.
• - Physicians surveyed scored the need for a cannabinoid antagonist at an average of 7.52 on a scale of 0 to 10.

The development supporting this segment is financed, in part, by external validation, such as the second-year tranche of a collaborative grant from the National Institute on Drug Abuse (NIDA) of $994,300 awarded for the ongoing Phase 1 study. The company's operating expenses for the three months ended September 30, 2025, were $2.3 million.

The following table summarizes the primary and secondary patient populations Anebulo Pharmaceuticals, Inc. is targeting with selonabant:

Customer Segment Focus	Indication Target	Clinical Status/Context	Financial Metric Context (as of Sep 30, 2025)
Primary	Pediatric acute cannabis-induced toxicity	Phase 1 Single Ascending Dose (SAD) study of IV formulation initiated September 2025	Cash and cash equivalents: $10.4 million
Secondary	Adult patients with acute cannabinoid intoxication (ACI)	Oral formulation completed a Phase 2 clinical trial	Net loss for Q1 Fiscal Year 2026: $2.2 million

Regulatory bodies (FDA) that approve the drug for market access serve as a critical gatekeeper segment, whose collaboration is essential for the prioritized pediatric indication.

• - The FDA cleared the design for the current Phase 1 SAD study.
• - The FDA acknowledged the unmet need for a treatment for children exposed to cannabis toxicity and suggested a close, ongoing collaboration.

Adult patients with acute cannabinoid intoxication (ACI) remain a secondary focus, as the oral formulation of selonabant previously demonstrated potential for blocking and reversing negative effects in a Phase 2 clinical trial. The company shifted priority to the IV formulation for pediatrics, believing it offers a potential faster timeline to approval relative to the adult oral product.

As of November 7, 2025, Anebulo Pharmaceuticals, Inc. had a market capitalization of $99M with 41.1M shares outstanding.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Cost Structure

You're managing a clinical-stage biotech, so you know the cost structure is dominated by the science-the cash burn is directly tied to getting that lead candidate, selonabant, through the clinic. For Anebulo Pharmaceuticals, Inc., the costs are almost entirely focused on Research and Development (R&D) until they hit commercialization, which is still a ways off since they are pre-revenue.

The total Operating expenses for the first quarter of fiscal year 2026 (the three months ended September 30, 2025) clocked in at $2.3 million. This was a slight improvement, down from $2.4 million in the same period of fiscal year 2025. Still, this burn rate is what you watch closely, especially with cash and cash equivalents at $10.4 million as of September 30, 2025, plus access to an additional $3.0 million via a Loan Agreement.

Research and development (R&D) expenses, the largest cost driver, are where the bulk of that $2.3 million goes. This category covers everything from lab work to running the actual trials. For the full fiscal year 2025, R&D expenses increased by approximately $0.9 million from the prior year, driven by activities related to pre-clinical and clinical studies, and direct third-party costs incurred under agreements with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) for selonabant. This increase reflects the shift in focus and the costs associated with advancing the IV formulation.

The Clinical trial expenses for the Phase 1 IV selonabant study are a major component of that R&D spend. Anebulo Pharmaceuticals, Inc. initiated the Phase 1 Single Ascending Dose (SAD) study of the intravenous formulation in September 2025. To help offset these development costs, the Company secured the second-year tranche of an ongoing collaborative grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH), which amounted to $994,300. That's non-dilutive cash helping fund the safety and pharmacokinetics investigation.

The costs related to Contract manufacturing and formulation scale-up costs are embedded within the R&D third-party expenses mentioned above. Anebulo scaled up the intravenous formulation for these initial clinical safety studies. The dependency on third parties for manufacturing means these CMO costs are a critical, variable part of the R&D budget, and the Company notes that higher-than-expected commercial-scale manufacturing costs could significantly impact future operating results.

Finally, General and administrative (G&A) costs, including public company burdens, are the other major bucket. While the specific G&A figure for Q1 FY2026 isn't broken out from the $2.3 million total operating expense, we can see the impact of public company life. For the three months ended September 30, 2025, G&A expenses increased by $0.4 million from the comparable prior year period, specifically due to increased professional and consultant fees recognized in connection with the potential going private transaction. This shows how strategic activities, like exploring alternatives, add a layer of non-core, yet necessary, expense on top of standard compliance and overhead.

Here's a quick look at a recent period's operating expense breakdown to show you where the money typically flows:

Expense Category	Q2 Fiscal Year 2025 (Three Months Ended December 31, 2024) Amount	FY 2025 Total Operating Expenses
Research and development	$1,220,535	$9.2 million
General and administrative	$1,367,616
Total operating expenses	$2,588,151 (approx. $2.6 million)	$9.2 million

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Anebulo Pharmaceuticals, Inc. as of late 2025. For a clinical-stage company like Anebulo Pharmaceuticals, Inc., the immediate cash flow is heavily reliant on non-sales sources while the lead candidate, selonabant (ANEB-001), moves through trials. Here's the quick math on where the money is coming from right now, and where it's projected to come from later.

Grant funding from the National Institute on Drug Abuse (NIDA)

Non-dilutive funding from the National Institute on Drug Abuse (NIDA) is a key, current revenue component, validating the science behind selonabant for acute cannabis-induced toxicities. Anebulo Pharmaceuticals, Inc. secured a two-year cooperative grant from NIDA, part of the National Institutes of Health (NIH), totaling up to approximately $1.9 million under award number 1U01DA059995-01. This was structured in tranches; the initial award was $0.9 million, with the remaining $1 million contingent on hitting certain milestones. More recently, for the first quarter of fiscal year 2026 (the quarter ended September 30, 2025), Anebulo Pharmaceuticals, Inc. announced it was awarded the second-year tranche of $994,300 under award number 5U01DA059995-02 to support the ongoing Phase 1 single ascending dose (SAD) study.

Equity financing and private placements from institutional investors

Since Anebulo Pharmaceuticals, Inc. is pre-commercial, equity financing and debt facilities are critical for funding operations, which currently run at a net loss. You can see a few significant recent capital raises that bolster the balance sheet:

• - In December 2024, the company secured net proceeds of approximately $14.9 million from a securities purchase agreement.
• - Also in December 2024, Anebulo entered a definitive stock purchase agreement for gross proceeds of $15 million by issuing 15.2 million shares of common stock in a private placement offering.
• - Back in September 2022, a private placement raised aggregate gross proceeds of approximately $6.6 million by selling 2,264,650 units at $2.935 per Unit.

As of September 30, 2025, Anebulo Pharmaceuticals, Inc. reported cash and cash equivalents of $10.4 million, plus access to an additional $3.0 million through a Loan Agreement. This funding is what keeps the lights on while they advance development.

Future milestone payments from potential licensing or partnership deals (speculative)

The structure for potential future revenue from licensing selonabant is detailed in the existing License Agreement, though as of June 30, 2025, the company determined no further milestone payments were probable, so no liability was recorded. Still, the potential structure is clear:

Payment Type	Trigger/Threshold	Amount/Rate
Development Milestones	Clinical trials and granting of marketing authorization	Ranging from $0.4 million to $3.0 million, up to a total of $29.9 million
Sales Milestones (First Year)	Cumulative annual net sales exceed $500.0 million	$10.0 million
Sales Milestones (First Year)	Cumulative annual net sales exceed $1.0 billion	$25.0 million
Pre-IPO Milestone Settlement	In lieu of certain milestones	192,857 shares issued instead of $1.4 million payment

The agreement also specifies ongoing payments after commercialization begins.

Future product sales of selonabant (ANEB-001) post-approval (long-term)

The ultimate long-term revenue stream relies on the commercial success of selonabant (ANEB-001) following regulatory approval, particularly for the prioritized pediatric indication. While specific sales forecasts aren't public here, the financial obligation structure for the company to its licensor, Vernalis, sets the baseline for royalty expectations. Anebulo Pharmaceuticals, Inc. is required to pay annual single-digit royalties on net product sales over the term of the License Agreement. That single-digit royalty rate is what the company will be paying out of future net sales.

Finance: draft 13-week cash view by Friday.