Anebulo Pharmaceuticals, Inc. · OTC:ANEB
Anebulo Pharmaceuticals — Investor Presentation (October 2024)
21 slides from Anebulo Pharmaceuticals's investor presentation, October 2024
Slide 1: Anebulo Pharmaceuticals
ANEBULO PHARMACEUTICALS Nasdaq: ANEB October 2024
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements Forward-Looking Statements Statements contained in this presentation that are not statements of historical fact are forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities E
Slide 3: Introducing Anebulo Pharmaceuticals
ABOUT US Introducing Anebulo Pharmaceuticals Anebulo was founded with the intention of developing treatments for cannabis-induced toxicities, such as unintentional cannabis poisoning, acute cannabinoid intoxication and the broader landscape of cannabis associated conditions. We understand the burden
Slide 4: Investment Highlights
Investment Highlights Anebulo is a biopharmaceutical company developing treatments for unintentional cannabis poisoning and acute cannabinoid intoxication Mechanism of Action (MOA) Patent Status Selonabant (ANEB-001) is a de-risked asset with a well-understood o Strong IP position with 2 issued US p
Slide 5: Cannabis-induced CNS depression in pediatric patients
Cannabis-induced CNS depression in pediatric patients Poison Center Call Data Annual cannabis-associated ED visits in the U.S., in 2021 (All Ages) Poison Center Calls represent a sampling of actual incidence. In particular, the below increase in calls at the poison centers represent a sampling of ca
Slide 6: Key Drivers to Rising Incidence
Key Drivers to Rising Incidence The numbers In 2022, 61.9 million people (22% of people aged 12 or older) used marijuana1 54% of Americans live in a state where the recreational use of An overwhelming share of U.S. adults (88%) say that marijuana marijuana is legal should be legal for medical and/or
Slide 7: Legalization Drives ED Visits
Legalization Drives ED Visits 4-year study at University of Colorado Hospital Edible Inhalable • Cannabis-related ED visits in adults tripled after Colorado became the first U.S. state to n= allow recreational sales • At one hospital alone, there were 10,000 750 cannabis-related visits, of which mor
Slide 8: Demand for Solution
Demand for Solution An increasing number of incidents in children has generated a demand for solution for acute cannabinoid intoxication FDA Commissioner Robert Califf’s comments on top FDA priorities for 2024 at JPM CERSI: (Cannabis Gummies) “We are having a lot of issues with these. They are barel
Slide 9: Mechanism of Action, Treatment and Clinical POC
Mechanism of Action, Treatment and Clinical POC
Slide 10: CB1 Receptor is More Abundant in the Brains of Children
CB1 Receptor is More Abundant in the Brains of Children Children have a greater risk of serious or life-threatening symptoms from cannabis poisoning due to a greater expression of CB1 earlier in life Levels of CB1 are highest in brains of young children. Abundance of the CB1 receptor declines with a
Slide 11: Currently No Approved or Standard Treatment
Currently No Approved or Standard Treatment Currently no approved or standard treatment for acute cannabis-induced toxicity when patients present to the ED, thus physicians typically monitor and provide supportive care. Pediatric Cannabis Poisoning Patient Journey Initial Presentation for Care & Dia
Slide 12: Intuitive Pharmacology Reduces Risk
Intuitive Pharmacology Reduces Risk Selonabant is a competitive antagonist at the human CB1 receptor with an affinity of 0.6nM THC & CB1 Receptor Mechanism Pharmacological Action of Selonabant Selonabant binds to the same receptor as cannabis and other cannabinoids blocking them from binding and act
Slide 13: Selonabant Clinical Development for ACI
Selonabant Clinical Development for ACI Extensive POC with 154 subjects in Phase 2 Study where selonabant showed rapid reversal effects of THC while being well tolerated across all studies Data Read Outs Part A Part B Part C July March August 2022 2023 2023 -Examined range of THC/selonabant -Part C
Slide 14: Selonabant: Phase 2 Part A Study Design
Selonabant: Phase 2 Part A Study Design Primary Objective: To investigate the ability of selonabant to inhibit the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis. Randomized, double-blind, placebo-controlled study Clinical End Points: Single Oral
Slide 15: Selonabant: Phase 2 Part B Study Design
Selonabant: Phase 2 Part B Study Design Part B Study Six sequential cohorts (N = up to 15; 2:1 active/placebo) to examine effect of higher THC doses, Design lower selonabant doses, timing of selonabant, and food THC Dose Selonabant Dosed with Dosed 1hr Primary Outcomes Cohort (mg) Dose (mg) THC afte
Slide 16: Selonabant: Phase 2 Part C Extension - Higher THC Doses
Selonabant: Phase 2 Part C Extension - Higher THC Doses Primary Objective: Safety and Efficacy of selonabant as a treatment for Intoxicating Effects of Δ9-Tetrahydrocannabinol (THC) in Healthy Adult Volunteers. Open-label Study, Simultaneous Dosing of THC/Selonabant Single Oral Dose, 24-hour assessm
Slide 17: Selonabant: Sustained Reduction of Feeling High
Selonabant: Sustained Reduction of Feeling High Selonabant (ANEB-001) produced sustained and substantial reduction of feeling high during coadministration (p < 0.001) Time Course of VAS Feeling High Following Coadministration of THC and selonabant L S M F e e lin g H ig h w P a r t B s c a le V A21
Slide 18: Delayed Dosing: Rapidly Reversed THC Effect
Delayed Dosing: Rapidly Reversed THC Effect Selonabant (ANEB-001) produced sustained and substantial reduction of feeling high during coadministration (p < 0.001) F e e lin g H ig h lo g (m m ) c le a n Time Course of VAS Feeling High After THC with Delayed DosingFof e eselonabant lin g H ig h lo g
Slide 19: Strategic Summary: Selonabant
Strategic Summary: Selonabant Insights Overview o Selonabant has a well-understood mechanism of action as a potent, small molecule CB1 antagonist with a high Next Steps affinity for the human CB1 receptor o Focus on an IV product for the most serious cases o Established proof-of-concept in a Phase 2
Slide 20: Key Milestones for Intravenous Selonabant
Key Milestones for Intravenous Selonabant Outlined below are projected key target milestones starting in 2024 and providing a roadmap through 1H2025 Current 2H24 1H25 Oral Formulation Developed IV Scaling up IV Initiate SAD Study of IV Established Phase 2 formulation for clinical formulation for pre
Slide 21: Leadership
Leadership Executive Management & Team Richie Cunningham Ken Cundy, PhD Chief Executive Officer Chief Scientific Officer Over 25 years of successful leadership experience spanning pre-IND drug Broad experience in drug discovery, preclinical and clinical development, and discovery, clinical developme
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