Anebulo Pharmaceuticals, Inc. · OTC:ANEB
Anebulo Pharmaceuticals — Investor Day (September 2022)
53 slides from Anebulo Pharmaceuticals's investor day presentation, Sep 26, 2022
Slide 1: Inaugural R&D Day
ANEBULO PHARMACEUTICALS NASDAQ: ANEB Inaugural R&D Day
Slide 2: Cautionary Note Regarding Forward-Looking Statements
® Cautionary Note Regarding Forward-Looking Statements ANEBULO 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 Se
Slide 3: Agenda
ANEBULO ¢ Introduction: Dr. Joseph Lawler, MD, PhD, Chairman of the Board * Corporate Overview: Simon Allen, Chief Executive Officer * Clinical Program Highlights and Progress Updates: Dr. Ken Cundy, PhD, Chief Scientific Officer * Q&A Session * Concluding Remarks: Simon Allen, Chief Executive Offic
Slide 4: Dr. Joseph Lawler, Founder and Chairman of the Board
ANEBULO Dr. Joseph Lawler, MD, PhD, Founder and Chairman of the Board
Slide 5: Simon Allen, Chief Executive Officer
ANEBULO Simon Allen, Chief Executive Officer
Slide 6: Corporate overview
ANEBULO * Biopharmaceutical company developing novel antidote for acute cannabinoid intoxication and, longer term, other indications related to abuse and addiction ¢ ANEB-001 has the potential to reverse the negative effects of acute cannabinoid intoxication within one hour of administration - Poten
Slide 7: Value highlights
Value highlights Potential to address unmet medical need to treat acute cannabinoid intoxication, a large and growing market * No product is approved for this indication and no other compound is further along in clinical testing * In 2019, 1.7 million cannabinoid-related emergency department (ED) vi
Slide 8: ANEB-001 for Acute Cannabinoid Intoxication
OH ANEBULO ANEB-001 for Acute Cannabinoid Intoxication
Slide 9: Symptoms of Acute Cannabinoid Intoxication
ANEBULO Symptoms of Acute Cannabinoid Intoxication * Over 140 million people use cannabis worldwide ¢ Physiological effects include decreased systemic vascular resistance, elevated heart rate, decreased intraocular pressure, nystagmus, conjunctival injection, lethargy, decreased concentration and ge
Slide 10: Annual cannabis-associated ED visits in the U.S.
ANEBULO Annual cannabis-associated ED visits in the U.S., 2006-2019 Cannabis Related Emergency Department Visits . 2,000,000 Growth of cannabis- (15%) associated emergency 1,600,000 Quiside of NEDS (estimated) ~s department visits has 1,400,000 idaho accelerated to a 15% CAGR 1,200,000 ra since the
Slide 11: Marijuana legalization by state
RR ANEBULO Hi Legalized Hi Medical and Decriminalized | Medical Decriminalized CBD only Fully illegal yy, =, Since 2012, recreational marijuana has gone fro legal in no states to legal in 19 states Marijuana is legal for medical use in 37 states > > https://disa.com/map-of-marijuana-legality-by-stat
Slide 12: Potency of edibles tends to be deceiving
Potency of edibles tends to be deceiving ® ANEBULO Manufactured and packaged as familiar products to consumers, including candy bars or gummy snacks * Consumers often approach cannabis edibles with the same serving size expectations as non-cannabis products * Cannabis candy bar may contain 4x or mor
Slide 13: ANEB-001
ANEB-001 . Promising potential solution for acute cannabinoid intoxication CB1 antagonist. Blocks the effect of THC at the CB1 receptor. Well- understood pharmacology. Oral bioavailability. ANEB-001 is administered as an oral treatment in the form of a pill, capsule or tablet. Rapid absorption. ANEB
Slide 14: ANEB-001 mechanism at the CB1 receptor
eeee @eeee Cell membrane Potential Effects Feeling high Reduction in alertness Body Sway Tachycardia gps. Cell membrane Potential Effects Decrease in feeling high Inhibit reduction in alertness Reduction of body sway Normalization of heartbeat ANEBULO ANEB-001 is a competitive antagonist at the huma
Slide 15: Phase 2 proof-of-concept trial design
Phase 2 proof-of-concept trial design ¢ N=up to 150 subjects Part A included 60 subjects, 20 healthy volunteers (HV) randomized to 50mg and 100mg doses of ANEB-001 or placebo Ongoing Part B expected to include 6 cohorts of 15 healthy subjects (10 active and 5 placebo) evaluating lower doses of ANEB-
Slide 16: ANEB-001: Next Steps
ANEB-001: Next Steps Development * Continue Part B to explore lower ANEB-001 doses and higher THC challenge doses * Discussions ongoing with FDA’s Model-Informed Drug Development team + Preparation for a US observational study in ACI subjects to support PK/PD model development and dose selection Com
Slide 17: Development milestones and lifecycle management
ANEBULO H1 CY22 Readout Lifecycle management Proof of-Concept Pivotal Program New Drug Application Intellectual Property Portfolio Phase 2 study at single * FDA pre-IND meeting * Exploration of * Method of use patent site in Netherlands provided valuable strategic options for - Issued October 2021 U
Slide 18: In summary
In summary ® ANEBULO Addressing unmet medical need in a large and growing market, with acute cannabinoid intoxication becoming an increasingly widespread health issue ANEB-001 has a well-understood mechanism of action as a CB1 antagonist Phase 2 proof-of-concept study continues Part A Complete, Part
Slide 19: Dr. Ken Cundy, Chief Scientific Officer
ANEBULO Dr. Ken Cundy, PhD, Chief Scientific Officer
Slide 20: ANEB-001 Clinical Development for ACI - Update
ANEB-001 Clinical Development for ACI - Update Phase 2 Part A Proof of Concept: New PK data, additional post-hoc efficacy data Ongoing Phase 2 Part B Extension: 2 cohorts completed - interim PK/PD/safety update Plans for Completion of Part B: Cohort 3 initiated — 6 cohorts total for PK/PD modeling R
Slide 21: ANEB-001 Development for ACI: Background
ANEB-001 Development for ACI: Background iN Pharmacology Safety Efficacy * Potent CB1 receptor antagonist * More than 140 subjects have been * Positive proof of concept data in dosed with oral ANEB-001 to date: Phase 2 Part A THC challenge study * Oral bioavailability and half-life 80+ in Phase 1 an
Slide 22: ANEB-001 Phase 2 Proof of Concept Clinical Trial
ANEB-001 Phase 2 Proof of Concept Clinical Trial Study Title: A randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of CB1 antagonist ANEB- 001 in healthy occasional cannabis users Primary Objective: To inv
Slide 23: Clinical Trial Design — Part A Challenge Study
ANEB-001: Clinical Trial Design — Part A Challenge Study Primary Objective: To investigate the ability of ANEB-001 to inhibit the psychotropic effects of A9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis. Randomized, double-blind, placebo-controlled study Single Oral Dose,
Slide 24: Sustained Reduction of Feeling High
ANEB-001: Produced Sustained Reduction of Feeling High Time Course of VAS Feeling High @ ~=THC/Placebo 1.54 ™ THC/50 mg ANEB-001 A THC/100 mg ANEB-001 0.54 VAS Feeling High log(mm) Time (hours) Administration of 10.5 mg oral THC alone produced a substantial increase in the VAS feeling high score Coa
Slide 25: Subjects Feeling High (VAS mm)
ANEB-001: Subjects Feeling High (VAS 20 mm) Proportion of Subjects Reporting Feeling High* Maximum VAS Feeling High Scores (mm) eo) 75% 100 604 40 30% Proportion (%) Max VAS Score (mm) 207 10% - Ss Ss on On nd & — y AS 5 PN 5 © oe x a wx
Slide 26: Subjects Feeling High (VAS >25 mm)
ANEB-001: Subjects Feeling High (VAS >25 mm) Proportion of Subjects Reporting Feeling High* Maximum VAS Feeling High Scores (mm) 80 70% 100 e o ° a ° Proportion (%) Max VAS Score (mm)
Slide 27: ANEB-001 Reduced THC-Induced Body Sway
ANEB-001 Reduced THC-Induced Body Sway | Maximum Change from B e in Body ¢ Administration of 10.5 mg oral THC e400 alone produced an increase in £ body sway over 8 hours s 300 * ANEB-001 showed a significant 3 * * reduction in the maximum change 3 200 from baseline for body sway ° . * The 50 mg dose
Slide 28: ANEB-001 Reduced THC-Induced Heart Rate Increase
ANEB-001 Reduced THC-Induced Heart Rate Increase > in Heart Rate ¢ Administration of 10.5 mg oral THC 20 alone produced an increase in heart rate = a * . ANEB-001 showed a significant reduction in the maximum change from baseline for heart rate * The 50 mg dose of ANEB-001 produced a similar effect
Slide 29: Phase 2 Part B Adaptive Study Design
Phase 2 (Part B) Adaptive Study Design ONC ee Completed THC (21 mg) + ANEB-001 (30 mg) vs THC/Placebo (2:1 active/placebo) Cohort 2* THC (21 mg) + ANEB-001 (10 mg) vs THC/Placebo Completed Cohort 3* THC (21 mg) + ANEB-001 (10 mg) vs THC/Placebo Ongoing 1 hr Separation Cohort 4* THC + ANEB-001 vs THC
Slide 30: Phase 2 and Observational Study Data for PK/PD Modeling
Phase 2 and Observational Study Data for PK/PD Modeling ONC e Completed THC (21 mg) + ANEB-001 (30 mg) vs THC/Placebo (10 active/5 placebo) Cohort 2* THC (21 mg) + ANEB-001 (10 mg) vs THC/Placebo Completed Cohort 3* THC (21 mg) + ANEB-001 (10 mg) vs THC/Placebo Ongoing Part A PK/PD Data 1 hr Separat
Slide 31: Part B Cohort 1 — Study Design
Part B Cohort 1 — Study Design (THC), the main psychoactive constituent of cannabis. Primary Objective: To investigate the ability of ANEB-001 to inhibit the psychotropic effects of A9-Tetrahydrocannabinol Randomized, double-blind, placebo-controlled study Single Oral Dose, 24-hour assessment a el T
Slide 32: Part B Cohort 2 — Study Design
Part B Cohort 2 — Study Design Primary Objective: To investigate the ability of ANEB-001 to inhibit the psychotropic effects of A9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis. Randomized, double-blind, placebo-controlled study Single Oral Dose, 24-hour assessment = > En
Slide 33: Part B Cohorts 1 and 2 - Interim Data Update
Part B Cohorts 1 and 2 - Interim Data Update Available Interim data: * Blinded safety data * Primary PD data (VAS feeling high, VAS alertness, body sway, heart rate) by treatment group with statistical analysis * Placebo data for the first two cohorts (21 mg THC) were pooled for the analysis * PK da
Slide 34: Part B Preliminary Data - Effect on Feeling High
Part B Cohort 1 & 2 Preliminary Data - Effect on Feeling High Time Course of VAS Feeling High 2.0 * Oral administration of 21 mg THC alone —®- THO 21 mg/Placebo produced a substantial increase in the VAS feeling high score —™- THC 21 mg/ANEB-001 10 mg —*— THC 21 mg/ANEB-001 30 mg * Coadministration
Slide 35: Part B Preliminary Data - Effect on Alertness
Part B Cohort 1 & 2 Preliminary Data - Effect on Alertness Time Course of VAS Alertness * Oral administration of 21 mg THC alone produced a substantial decrease in VAS —®- THC 21 mg/Placebo alertness score 60-4 THC 21 mg/ANEB-001 10 mg * Coadministration of THC with 10 mg or THE: 21 Ma/ANEB-001 30 m
Slide 36: Part B Preliminary Data - Effect on Body Sway
Part B Cohort 1 & 2 Preliminary Data - Effect on Body Sway ¢ Administration of 21 mg THC alone 70074 produced an increase in body sway, oe . . THO 21 mg/Placebo and 2 subjects were too dizzy to —™- THC 21 mg/ANEB-001 10 mg soo! perform the test —*— THC 21 mg/ANEB-001 30 mg * Coadministration of THC
Slide 37: Part B Preliminary Data - Effect on Heart Rate
Part B Cohort 1 & 2 Preliminary Data - Effect on Heart Rate Time Course of Heart Rate —®- THC 21 mg/Placebo —™- THC 21 mg/ANEB-001 10 mg ¢ Administration of 21 mg THC alone had only a minor effect on heart rate °° * Coadministration of THC with ANEB- 001 showed a trend towards —k—- THC 21 mg/ANEB-00
Slide 38: Effect of THC Dose on Feeling High
Effect of THC Dose on Feeling High amon 80 * Plot compares PD data from THC Challenge studies: Part A, Part B Cohorts Placebo 1 and 2, and published data for THC 50 mg ANEB-001 challenge at lower doses? 100 mg ANEB-001 Clear dose response for THC/placebo — 10 mg ANEB-001 increased feeling high with
Slide 39: Part A and Part B Interim Data: PK of ANEB-001
Phase 2 Part A and Part B Interim Data: PK of ANEB-001 Pharmacokinetics of ANEB-001 in Plasma of Subjects Challenged with THC’ Linear Scale Log Scale 1200 —s— 10 mg ANEB-001 | —*— 30mg ANEB-001 1000 —*—- 50mg ANEB-001 —*— 100 mg ANEB-001 ANEB-001 Conc. (ng/mL) T T T ) 6 12 18 24 0 6 12 18 24 Time (h
Slide 40: Part A and Part B Interim Data: PK of THC in Plasma
Phase 2 Part A and Part B Interim Data: PK of THC in Plasma Linear Scale Log Scale 20 —*— THC 10.5 mg + PBO —"— THC 10.5 mg + ANEB-001 50 mg —*— THC 10.5 mg + ANEB-001 100 mg 10 a —*— THC 21mg+PBO —*— THC 21 mg + ANEB-001 10 mg —*— THC 21 mg + ANEB-001 30 mg 6 THC Cone. (ng/mL) = THC Conc. (ng/mL) a
Slide 41: Part B Cohorts 1 and 2 - Interim Data Conclusions
Part B Cohorts 1 and 2 - Interim Data Conclusions THC Dose Effect: 21 mg THC produced stronger intoxication effects compared to 10.5 mg in Part A VAS Feeling High: ANEB-001 (10 or 30 mg) produced a sustained reduction in feeling high (p < 0.001) VAS Alertness: ANEB-001 (10 or 30 mg) produced a susta
Slide 42: Part B Cohort 3 - Protocol Amended and Dosing Initiated
Part B Cohort 3 - Protocol Amended and Dosing Initiated * Protocol amended to allow staggered dosing and add additional time points/subjective measures * Cohort 3: staggered single oral doses of 21 mg oral THC and 10 mg ANEB-001 or placebo * THC will be administered 1 hour before ANEB-001/placebo *
Slide 43: Observational Study in ACI Patients
Observational Study in ACI Patients Study Title: Multi-center observational study of plasma concentrations of THC and its metabolites in subjects visiting emergency departments for acute cannabinoid intoxication Primary Objective: To determine plasma concentrations of THC and its metabolites, 11-OH-
Slide 44: Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling
Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling Objective: To develop a PK/PD model to predict the optimal ANEB-001 dose for treating ACI Components: * Historical data for THC PK and PD outcomes in healthy subjects * New PK/PD data for THC and ANEB-001 from Anebulo Phase 2 challenge study * New dat
Slide 45: ANEB-001 Potential Regulatory Path
ANEB-001 Potential Regulatory Path * Previous Pre-IND Meeting held in December 2021 * Discussions ongoing with FDA’s Model-Informed Drug Development team ¢ First Proposed US Study: Multi-center Observational study in ACI subjects * Intended to support PK/PD model development and dose selection for A
Slide 46: ANEB-001: Additional Activities - CMC and Nonclinical
ANEB-001: Additional Activities - CMC and Nonclinical CMC Activities: ¢ Emerging Phase 2 data supportive of a lower ANEB-001 dose than originally projected \" ¢ Drug substance manufacturing already ongoing at “commercial” scale ¢ Drug product manufacturing on track to support clinical and commercial
Slide 47: ANEB-001 Parenteral Product Development Program
ANEB-001 Parenteral Product Development Program Status: Potential for use in ACI subjects unable to swallow oral capsules Preferred route of administration for pediatric subjects * Targeting single dose IV or IM injection to be administered in Emergency Department ¢ Multiple novel prototype parenter
Slide 48: ANEB-001 Clinical Development for ACI - Summary
ANEB-001 Clinical Development for ACI - Summary Phase 2 Part A New Data: Dose related exposure, reductions in body sway/heart rate Ongoing Phase 2 Part B: 2 cohorts completed — 10 mg and 30 mg doses reduced THC-related effects despite a higher THC dose, appears safe and well tolerated Plans for Comp
Slide 49: Q&A Session
Q&A Session
Slide 50: Simon Allen, Chief Executive Officer
ANEBULO Simon Allen, Chief Executive Officer
Slide 51: Development milestones and lifecycle management
ANEBULO H2 CY22 Readout Lifecycle management Proof of-Concept Pivotal Program New Drug Application Intellectual Property Portfolio Phase 2 study at single * FDA pre-IND meeting * Exploration of * Method of use patent site in Netherlands provided valuable strategic options for - Issued October 2021 U
Slide 52: In summary
In summary ® ANEBULO ry Addressing unmet medical need in a large and growing market, with acute cannabinoid intoxication becoming an increasingly widespread health issue antagonist é Phase 2 proof-of-concept study continues (Part A topline data released July 5, 2022; Part B initiated in Q3 2022) (@:
Slide 53: Investor Contacts
Investor Contacts: Scott Anderson-Head of IR and PR scott@anebulo.com Rex Merchant-CFO rex@anebulo.com
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