Anebulo Pharmaceuticals, Inc. · OTC:ANEB
Anebulo Pharmaceuticals — Investor Presentation (January 2023)
33 slides from Anebulo Pharmaceuticals's investor presentation, Jan 9, 2023
Slide 1: Anebulo Pharmaceuticals Corporate Presentation
ANEBULO PHARMACEUTICALS Nasdaq: ANEB Corporate Presentation January 2023
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements Forward-Looking Statements This presentation contains forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21€ of the Securities Exchange Act of 1934, as amended. These forward-looking stateme
Slide 3: Anebulo company overview
ANEBULO * Biopharmaceutical company developing novel antidote for acute cannabinoid intoxication and, longer term, other indications related to abuse and addiction * In clinical trials, ANEB-O001 rapidly reversed the key negative effects of acute cannabinoid intoxication - Potent, small molecule CB1
Slide 4: Investment highlights
Investment highlights ® ANEBULO Addressing unmet medical need to treat acute cannabinoid intoxication, a large and growing market * No FDA approved treatment for ACI and no treatments further along in clinical testing * In 2019, ~1.7 million cannabinoid-related emergency department (ED) visits in th
Slide 5: Leadership
Leadership ® ANEBULO Executive Management Simon Allen Rex Merchant, CFA Ken Cundy, PhD Started in the lab at Gilead before spending over JFL Capital Management, Broad experience in drug discovery, preclinical two decades in sell-side business development and Western Investment, Benchmark Plus and cl
Slide 6: ANEB-001 for Acute Cannabinoid Intoxication
® ANEBULO ANEB-001 for Acute Cannabinoid Intoxication
Slide 7: Cannabis use and acute cannabinoid intoxication
ANEBULO Over 140 million people use cannabis worldwide In U.S., decriminalization of marijuana by states has led to an increase in reports to poison control centers and in cannabis-related ED visits - Catalyzed by excessive use in adults and inadvertent ingestions in small children - Synthetic canna
Slide 8: Annual cannabis-associated ED visits in the U.S.
ted ED visits is large with ween li er of cannabis-assoc accelerated growth Annual cannabis-associated ED visits in the U.S., 2006-2019 Cannabis Related Emergency Department Visits Growth of cannabis- 1,800,000 associated emergency department visits has 2,000,000 enanead WB outside of NEDS (estimate
Slide 9: Significant unmet medical need
Significant unmet medical need ® ANEBULO woe “Have had several pediatric Company-sponsored survey of 27 U.S. emergency room physicians patients require intubation (November 2020) secondary to cannabis overdose and would make a large impact on their care.” (| , On average, each physician saw 10.5 pat
Slide 10: Marijuana legalization is increasing
Marijuana legalization is increasing ® ANEBULO Legalization in the U.S. Laws on recreational and medical marijuana use in the United States @ Legal recreational & medical use M® Medical use only ES ret of As of Nov 9, 2022. Some states not highlighted allow limited medical marijuana access. Sources:
Slide 11: Legalization drives ED visits
Legalization drives ED visits 4-year study at University of Colorado Hospital * Marijuana-related ED visits tripled after Colorado became the first U.S. state to allow recreational sales * 2-3 patients per day presented with severe vomiting, anxiety and psychosis * More than 2,000 visits at this hos
Slide 12: Potency of edibles tends to be deceiving
Potency of edibles tends to be deceiving ® AES O 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 more
Slide 13: Synthetic cannabinoids: a growing, serious problem
Synthetic cannabinoids: a growing, serious problem ® Synthetic cannabinoids (commonly referred to as “spice” or “K2”) are the fastest-growing class of psychoactive drug worldwide e@ These drugs have serious potential side effects including seizure, renal failure and death, and were responsible for a
Slide 14: ANEB-001 market opportunity & commercial plan
ANEB-001 market opportunity & commercial plan ® ANEBULO + Longer-term vision to pursue multiple markets * — Significant opportunity to expand the market at a lower ASP * OUS upside 59 million cannabis past-year users in North America (2019)+ + Users seeking treatment to manage adverse side effects *
Slide 15: ANEB-001
ANEB-001 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-001 is believed to rapidly reverse the signs and symptoms of acut
Slide 16: ANEB-001 mechanism at the CB1 receptor
Cell membrane Feeling high Anxiety Psychosis/hallucinations Sedation Tachycardia Effects Decrease in feeling high Decreased anxiety Decrease in psychosis/hallucinations Normalization of heartbeat ® ANEBULO ANEB-001 is a competitive antagonist at the human CB1 receptor with an affinity of 0.6nM Good
Slide 17: ANEB-001 Clinical Development for ACI - Update
ANEB-001 Clinical Development for ACI - Update ® ANE EULO Phase 2 Study in Healthy Volunteers Challenged with THC: * Positive Part A topline data released July 2022 for co-administered THC/ANEB-001 * Robust reduction in THC effects on feeling high, alertness, body sway * Part B: Variation in THC/ANE
Slide 18: Delayed Dosing of ANEB-001 Rapidly Reversed THC Effect
Delayed Dosing of ANEB-001 Rapidly Reversed THC Effect? . Time Course of VAS Feeling h After 30 mg THC with Delayed Dosing of ANEB-001 Feeling High log(mm) —®- THC 30 mg + PBO (1 hr) (N= 5) —S— THC 30 mg + ANEB-001 10 mg (1 hr) (N= 10) 3/5 placebo subjects were too intoxicated to complete the VAS as
Slide 19: Phase 2 Study in Healthy Subjects Challenged with THC
® Phase 2 Study in Healthy Subjects Challenged with THC4%!244° Randomized, double-blind, placebo-controlled study in 2 parts Part A: Three parallel treatment arms (N = 20/arm) * Oral THC (10.5 mg) with single dose ANEB-001 (50 mg or 100 mg) or placebo Part B: Six cohorts with 2 treatment arms (up to
Slide 20: Phase 2 Part A — Coadministration with THC
Phase 2 Part A — Coadministration with THC ® ANTES 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-ho
Slide 21: Phase 2 Part B — Variation in Dose and Timing
Phase 2 Part B — Variation in Dose and Timing Cohort THC (m 1 2 21 3) 20 4 40 5 30 6 30* Cohorts 1-3 used THC tablets (Namisol®). Cohorts 4-6 used THC capsules (Marinol®) *Following a high fat meal 10 10 10 10 10 21 x Dose ANEB-001 Dose Dosed Dosed 1 hr ig) (mg) with THC after THC 21 30 xX >< Been O
Slide 22: ANEB-001 Produced a Sustained Reduction of Feeling High
ANEB-001 Produced a Sustained Reduction of Feeling High VAS Feeling High logimm) 2.0 Time Course of VAS Feeling High Following Coadministration of THC and ANEB-001 10.5 mg THC (Part A) (N = 20/arm) © THC 10.5 mg/Placebo THC 10.5 mg/ANEB-001 50 mg THC 10.5 mg/ANEB-001 100 mg VAS Feeling High logimm)
Slide 23: Time Course of VAS Feeling High After Delayed Dosing
Time Course of VAS Feeling High After THC with Delayed Dosing of ANEB-001 21 mg THC (Part B) 30 mg THC (Part B) © THE 30mg + P80 (N=5) Feeling High logimm) 20 18 1.0 05 oot —®- THC 21 mg + PaO (N=5) THC 21 + ANEB-001 10 mg (1 hr) (N = 8) B+ THO 80 mg + ANEB-001 10 mg (1 he) aie (N= 10) = £ 15 z 10 “
Slide 24: ANEB-001 for ACI - Summary and Next Steps
ANEB-001 for ACI - Summary and Next Steps ® AAO Phase 2 Clinical Study: Dosing of all cohorts completed; key interim data available; rapid reversal of THC effects even with high THC doses and 1 hour delay in administration of 10 mg ANEB-001; final results expected in 1Q2023 First US Clinical Study:
Slide 25: Development plan
Development plan Dosing Completed Proof of-Concept Phase 2 study at single site in Netherlands 134 healthy volunteers THC + various doses of ANEB-001 or placebo Pivotal Program Ongoing meetings with MIDD/FDA Targeting End of Phase 2a meeting in 1H 2023 to finalize U.S. regulatory path New Drug Appli
Slide 26: Unmet need in acute cannabinoid intoxication
Due to a lack of approved therapeutics for acute cannabinoid intoxication, there is a moderate-to- high unmet need which has resulted in an increased burden in US emergency departments (ED). TRIANGLE INSIGHTS GROUP Acute Cannabinoid Intoxication (ACI) and Unmet Need Cannabinoid intoxication results
Slide 27: Approximately 1.8M patients in the US with an ACI
Approximately 1.8M patients in the US with an ACI may need an intervention after being diagnosed and has further contributed to the ongoing ED burden and crisis occurring today. Patient Impact and Volume Acute Cannabinoid Intoxication Affects: Emergency Department Boarding Crisis Nov. 2022, The Amer
Slide 28: ACI patient journey in the ED with ANEB-001
When compared to the standard of care, ANEB-001 potentially can alleviate symptoms significantly more quickly, saving time and money while also enhancing patient care and overall well-being. Current ACI Patient Journey in the ED with ANEB-001 Symptom Assessment GO ry mn Mild -> “Wait & Watch” Severe
Slide 29: ANEB-001 overview as a novel cannabinoid receptor antagonist
ANEB-001, a novel cannabinoid receptor antagonist, offers the potential to address this unmet need by providing an effective, convenient and accessible option for the treatment of ACI. Overview of ANEB-001 Mechanism of Action Potent, small molecule, cannabinoid receptor 1 antagonist with a high affi
Slide 30: Average estimated cost-of-care for ACI patients
As existing ACI expenses range widely from $1,000-$10,000 when treated and released but also exceed $15,000 if the patient is admitted, ANEB-001 can lower cost of ACI treatment up to 10-fold. $16,000 $14,000 $12,000 $10,000 $8,000 $6,000 $4,000 $2,000 $0 Breakdown of Associated Costs Length of Time*
Slide 31: Core value drivers
[core Valuestow Side ING Anebulo’s value proposition and ability to address an unmet need in ACI is corroborated by favorable receptivity among US emergency department specialists and payers in a growing market Growing Disease Prevalence Emergency |_| Department Burden Need for Better Treatment Opti
Slide 32: In summary
In summary ® ANE EO Addressing unmet medical need in a large and growing market, with acute cannabinoid intoxication becoming an increasingly widespread health issue ANEB-001 is a de-risked asset with a well understood mechanism of action as a CB1 antagonist Demonstrated human poof-of-concept in a P
Slide 33: Investor Contacts
Investor Contacts: Scott Anderson-Head of Investor Relations scott@anebulo.com Rex Merchant-CFO rex@anebulo.com 33
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