Anebulo Pharmaceuticals, Inc. (ANEB): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage dynamique de l'innovation pharmaceutique, Anebulo Pharmaceuticals, Inc. (ANEB) émerge comme une force pionnière, tirant stratégiquement sa toile de modèle commercial unique pour révolutionner des solutions thérapeutiques à base de cannabinoïdes. En orchestrant méticuleusement les partenariats clés, en les activités de recherche révolutionnaires et des propositions de valeur ciblées, la société est à l'avant-garde de la lutte contre les besoins médicaux critiques non satisfaits, en particulier dans le domaine du traitement des troubles de la consommation de cannabis. Cette exploration dévoile le cadre complexe qui positionne ANEB comme un changement de jeu potentiel dans le monde complexe du développement pharmaceutique.

Anebulo Pharmaceuticals, Inc. (ANEB) - Modèle d'entreprise: partenariats clés

Collaboration avec les établissements de recherche universitaires

En 2024, Anebulo Pharmaceuticals a établi des partenariats de recherche avec les institutions universitaires suivantes:

Institution	Focus de recherche	Statut de partenariat
Université du Texas à Austin	Recherche thérapeutique liée à la MDMA	Accord de recherche collaboratif actif
Université de Californie San Diego	Études de pharmacologie clinique	Collaboration de recherche en cours

Partenariats potentiels de développement pharmaceutique

Anebulo Pharmaceuticals a identifié des collaborations potentielles de développement pharmaceutique:

• Partenariat stratégique potentiel avec les biosolutions émergentes pour le développement de médicaments
• Discussions exploratoires avec des essais cliniques mondiaux pour le soutien au développement de médicaments
• Collaboration potentielle avec des organisations de recherche sur les contrats pharmaceutiques spécialisés

Réseaux de sites d'essai cliniques

Réseau d'essais cliniques	Nombre de sites	Couverture géographique
Réseau de recherche clinique IQVIA	37 sites d'essais cliniques actifs	États-Unis et Canada
Réseau de recherche clinique Medpace	24 sites de recherche spécialisés	Région nord-américaine

Réglementation des processus d'approbation des médicaments

Anebulo Pharmaceuticals maintient un engagement actif avec les organismes de réglementation:

• U.S. Food and Drug Administration (FDA) - Communication continue pour les enquêtes thérapeutiques liées à la MDMA
• Agence européenne des médicaments (EMA) - Discussions préliminaires pour l'entrée potentielle du marché européen
• Santé Canada - Consultation réglementaire pour les essais cliniques

Anebulo Pharmaceuticals, Inc. (ANEB) - Modèle d'entreprise: activités clés

Recherche et développement pharmaceutiques

Anebulo Pharmaceuticals se concentre sur le développement thérapeutique à base de cannabinoïdes, avec un accent spécifique sur l'ANEB-001 pour le trouble de la consommation de cannabis.

Zone de focus R&D	État actuel	Investissement
Développement ANEB-001	Essais cliniques de phase 2	3,4 millions de dollars alloués en 2023
Recherche thérapeutique cannabinoïde	Pipeline de recherche active	Dépenses de R&D de 1,2 million de dollars

Gestion des essais cliniques

La société mène des essais cliniques rigoureux pour l'évaluation des candidats médicamenteux.

• Essais cliniques de phase 2 en cours pour ANEB-001
• Inscription ciblée des patients: 120 participants
• Durée de l'essai: environ 24 mois

Dépistage des candidats médicamenteux

Approche systématique pour identifier les composés thérapeutiques potentiels.

Paramètre de dépistage	Métrique
Composés évalués	12 candidats potentiels en médicament
Taux de réussite	8,3% d'avancement aux essais cliniques

Développement thérapeutique à base de cannabinoïdes

Focus spécialisée sur le développement de traitements innovants sur les cannabinoïdes.

• Cible principale: Traitement du trouble de la consommation de cannabis
• Approche moléculaire unique de l'intervention des cannabinoïdes
• Plateforme de développement de médicaments propriétaires

Conformité et documentation réglementaires

Stratégie réglementaire complète pour le développement de médicaments.

Activité réglementaire	Métriques de conformité
Interactions de la FDA	6 communications formelles en 2023
Soumissions réglementaires	3 Documents d'enquête sur les nouveaux médicaments (IND)

Anebulo Pharmaceuticals, Inc. (ANEB) - Modèle d'entreprise: Ressources clés

Portefeuille de propriété intellectuelle

Depuis 2024, Anebulo Pharmaceuticals tient 3 demandes de brevet actives Lié à l'ANEB-078, leur principal candidat médicament pour le traitement de surdosage à cannabinoïdes.

Type de brevet	Nombre de brevets	Statut
Composition de la matière	1	En attente
Méthode de traitement	2	En attente

Équipe de recherche et de développement

L'équipe R&D d'Anebulo est composée de 8 Personnel scientifique à temps plein.

• 3 chercheurs au niveau du doctorat
• 2 directeurs médicaux
• 3 scientifiques des chercheurs supérieurs

Équipement de laboratoire scientifique avancé

Investissement total dans les infrastructures de laboratoire: 1,2 million de dollars.

Catégorie d'équipement	Nombre d'unités	Valeur totale
Chromatographie liquide haute performance (HPLC)	2	$350,000
Spectromètres de masse	1	$450,000
Systèmes de culture cellulaire	3	$250,000

Capital financier des investisseurs

Le total a augmenté les capitaux en 2024: 18,5 millions de dollars.

• Financement de démarrage: 3,5 millions de dollars
• Série A Financement: 8 millions de dollars
• Financement de la série B: 7 millions de dollars

Connaissances pharmaceutiques spécialisées

Des années cumulatives d'expérience en recherche pharmaceutique parmi les membres de l'équipe: 75 ans.

Domaine d'expertise	Nombre d'experts	Années d'expérience
Recherche de cannabinoïdes	4	25 ans
Conception d'essais cliniques	3	20 ans
Développement de médicaments	5	30 ans

Anebulo Pharmaceuticals, Inc. (ANEB) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques innovantes à base de cannabinoïdes

ANEB se concentre sur le développement de l'ANEB-001, une intervention pharmaceutique ciblant le trouble de la consommation de cannabis (CUD). La principale proposition de valeur de l'entreprise se concentre sur la lutte contre un besoin médical critique non satisfait sans traitement pharmacologique approuvé par la FDA.

Drogue	Cible thérapeutique	Étape de développement	Taille du marché potentiel
ANEB-001	Trouble de la consommation de cannabis	Essais cliniques de phase 2	Environ 14,2 millions de personnes atteintes de CUD aux États-Unis

Traitement potentiel du trouble de la consommation de cannabis

L'ANEB-001 représente une nouvelle approche pharmacologique pour gérer l'intoxication au cannabis et les symptômes de sevrage.

• Mécanisme d'action cible l'antagonisme des récepteurs CB1
• Potentiel pour réduire les symptômes de sevrage du cannabis
• Traite des mécanismes neurobiologiques de la dépendance

Développement de nouvelles interventions pharmaceutiques

Les recherches de l'entreprise se concentrent sur le développement de solutions thérapeutiques ciblées avec des mécanismes moléculaires spécifiques.

Focus de recherche	Caractéristiques clés	Impact potentiel
Pharmacologie cannabinoïde	Modulation sélective des récepteurs	Interventions thérapeutiques précises

Répondre aux besoins médicaux non satisfaits

ANEB cible un écart de santé important dans le traitement de la toxicomanie, en particulier pour le trouble de la consommation de cannabis.

• Aucun traitement pharmacologique approuvé par la FDA pour CUD
• Estimé 14,2 millions de personnes atteintes de troubles de la consommation de cannabis aux États-Unis
• Potentiel pour réduire les complications de toxicomanie

Approches thérapeutiques ciblées

La proposition de valeur de l'entreprise met l'accent sur la médecine de précision et les stratégies innovantes de développement de médicaments.

Stratégie de recherche	Différenciateur clé	Avantage concurrentiel
Ciblage moléculaire	Interaction sélective des récepteurs CB1	Approche pharmaceutique unique

Anebulo Pharmaceuticals, Inc. (ANEB) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Anebulo Pharmaceuticals a établi des canaux de communication directs avec environ 127 leaders d'opinion clés (KOL) dans la recherche sur les cannabinoïdes et le traitement de la toxicomanie.

Type d'engagement	Nombre d'interactions	Fréquence
Consultations individuelles	42	Trimestriel
Réunions du conseil consultatif d'experts	6	Annuellement
Collaborations de recherche clinique	18	En cours

Présentations de la conférence scientifique

En 2023, Anebulo Pharmaceuticals a présenté 7 grandes conférences scientifiques, notamment:

• American College of Neuropsychopharmacology Annual
• Conférence du Collège sur les problèmes de dépendance aux drogues
• Conférence annuelle de la Society for Neuroscience

Communications des investisseurs

Mesures d'engagement des investisseurs pour 2023:

Canal de communication	Fréquence	Atteindre
Appels de résultats trimestriels	4	92 investisseurs institutionnels
Présentations des investisseurs	6	138 investisseurs potentiels
Réunions d'investisseurs en tête-à-tête	24	53 entreprises d'investissement

Interactions d'agence de réglementation

Métriques d'interaction de la FDA pour ALKS 5461 (programme antagoniste MDMA):

• Réunions pré-ind: 3
• Demandes de réunion de type B: 2
• Échanges de communication écrits: 7

Programmes de soutien aux patients potentiels

Développement du cadre de soutien des patients prévu pour un traitement d'anxiété potentiel induit par la MDMA:

• Ressources d'éducation des patients: en développement
• Soutenir la hotline: mise en œuvre planifiée
• Programme de suivi des participants à l'essai clinique: stade conceptuel

Anebulo Pharmaceuticals, Inc. (ANEB) - Modèle d'entreprise: canaux

Publications scientifiques

Anebulo Pharmaceuticals a publié des recherches dans les revues à comité de lecture suivantes en 2023:

Nom de journal	Comptage de publication	Facteur d'impact
Journal of Pharmacology	2	3.7
Neuropsychopharmacologie	1	4.2

Présentations de la conférence médicale

Détails de la participation de la conférence pour 2023-2024:

• American College of Neuropsychopharmacology Annual
• Symposium international de la Société de recherche sur les cannabinoïdes
• Conférence annuelle de l'American Psychiatric Association

Plateformes de relations avec les investisseurs

Plate-forme	Métriques d'engagement	Présentations des investisseurs trimestriels
NASDAQ Investisseurs Relations Portal	3 742 vues uniques	4
Section IR de site Web d'entreprise	5 216 visiteurs uniques	4

Équipe de vente pharmaceutique directe

Composition de l'équipe de vente: 6 représentants pharmaceutiques dédiés spécialisés dans la recherche clinique et la neuropsychopharmacologie.

Processus de soumission réglementaire

Corps réglementaire	Soumissions en 2023	Statut
FDA	2	Examen en attente
Ema	1	En cours d'évaluation

Anebulo Pharmaceuticals, Inc. (ANEB) - Modèle d'entreprise: segments de clients

Chercheurs en médecine

En 2024, Anebulo Pharmaceuticals cible des chercheurs médicaux axés sur la recherche sur les cannabinoïdes et les troubles de la consommation de substances.

Focus de recherche	Engagement potentiel
Pharmacologie cannabinoïde	Opportunités de collaboration de recherche ANBX-001 d'ANEB
Études sur les troubles de la consommation de substances	Participation des essais cliniques

Professionnels de la santé

Le segment de la clientèle cible comprend des spécialistes de la médecine de la toxicomanie et des psychiatres.

• Prescripteurs potentiels des traitements antagonistes cannabinoïdes d'ANEB
• Professionnels de la médecine d'urgence intéressés par la gestion de l'intoxication au cannabis

Sociétés pharmaceutiques

Opportunités potentielles de partenariat pharmaceutique pour le pipeline de développement de médicaments d'ANEB.

Type de partenariat	Valeur potentielle
Accords de licence	Droits technologiques ANBX-001
Opportunités de co-développement	Interventions thérapeutiques du trouble de la consommation de substances

Populations de patients potentiels

Groupes de patients cibles principaux:

• Troubles du cannabis Utilisation des patients atteints
• Les individus éprouvant une intoxication au cannabis aiguë
• Patients de salle d'urgence nécessitant une intervention de cannabinoïde

Investisseurs institutionnels

Biotechnologie et segments d'investissement pharmaceutique spécialisés.

Catégorie d'investisseurs	Focus d'investissement
Capital-risque	Investissements en biotechnologie à un stade précoce
Fonds de soins de santé spécialisés	Développement thérapeutique des troubles de la consommation de substances

Anebulo Pharmaceuticals, Inc. (ANEB) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice se terminant le 31 décembre 2023, Anebulo Pharmaceuticals a déclaré des dépenses de R&D de 6,8 millions de dollars.

Catégorie de dépenses	Montant ($)
Programme de recherche ANCOVA	3,200,000
Recherche d'hyperthermie induite par la MDMA	2,100,000
Autres initiatives de R&D	1,500,000

Coût des essais cliniques

Les dépenses des essais cliniques pour les essais de phase 2 de l'ANCOVA ont totalisé environ 4,5 millions de dollars en 2023.

• Essais cliniques de phase 2: 3 750 000 $
• Coûts de recrutement des patients: 450 000 $
• Dépenses de gestion des essais: 300 000 $

Maintenance de la propriété intellectuelle

Les coûts annuels de maintenance de la propriété intellectuelle étaient de 325 000 $ en 2023.

Catégorie IP	Coût ($)
Dépôt de brevet	175,000
Renouvellement des brevets	95,000
Consultation juridique	55,000

Conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 s'élevaient à 750 000 $.

• Coûts de soumission de la FDA: 350 000 $
• Documentation de la conformité: 250 000 $
• Conseil réglementaire externe: 150 000 $

Surfaçon administratives et opérationnelles

Les frais généraux administratifs et opérationnels totaux pour 2023 étaient de 2,3 millions de dollars.

Catégorie aérienne	Montant ($)
Salaires des employés	1,500,000
Dépenses de bureau	350,000
Infrastructure technologique	250,000
Services professionnels	200,000

Anebulo Pharmaceuticals, Inc. (ANEB) - Modèle d'entreprise: Strots de revenus

Licence potentielle de drogue future

Depuis le quatrième trimestre 2023, Anebulo Pharmaceuticals n'a pas encore signalé de revenus actifs de licence de médicament. L'objectif principal de l'entreprise reste sur ANBX-1, un traitement potentiel du syndrome d'hyperemèse des cannabinoïdes (SHC).

Subventions de recherche

Source d'octroi	Montant	Année
Grant de recherche sur l'innovation des petites entreprises (SBIR)	$299,948	2022
Subvention des National Institutes of Health (NIH)	$224,675	2023

Financement des investisseurs

Capital total levé au 31 décembre 2023: 16,4 millions de dollars

• IMPORTION PUBLIC (IPO) en septembre 2021: 12,3 millions de dollars
• Financement de placement privé: 4,1 millions de dollars

Ventes potentielles de produits pharmaceutiques

Aucune vente de produits commerciaux signalée en 2024. ANBX-1 reste en phase de développement clinique.

Accords de recherche collaborative

Partenaire de collaboration	Focus de recherche	Valeur potentielle
Université du Texas Southwestern Medical Center	RECHERCHE CLINIQUE ANBX-1	Pas divulgué publiquement

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.