Avenue Therapeutics, Inc. · OTC:ATXI
Avenue Therapeutics — IPO Roadshow (October 2022)
30 slides from Avenue Therapeutics's IPO roadshow presentation, Oct 6, 2022
Slide 1: Corporate Overview
AVENUE THERAPEUTICS, INC. ⎸ NASDAQ: ATXI ⎸ OCTOBER 2022 Corporate Overview Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333 - 267206 (Preliminary Prospectus dated October 6, 2022)
Slide 2: Notice & Disclaimers
2 Notice & Disclaimers Free Writing Prospectus This free writing prospectus relates to the proposed public offering of securities of Avenue Therapeutics, Inc. (the “Company ”), which is being registered with the U.S. Securities and Exchange Commission (the “SEC”) on a Registration Statement on Form
Slide 3: Offering Summary
3 Offering Summary Issuer Avenue Therapeutics, Inc. Ticker / Exchange NASDAQ / ATXI Securities Offered Common Stock and 100% Warrant Coverage Offering Size $12 million Over - Allotment Option 15% of Offering Use of Proceeds $3 million of the net proceeds from this offering to repurchase all the shar
Slide 4: Executive Summary
4 Executive Summary Avenue Therapeutics is a specialty pharmaceutical company that seeks to develop and commercialize therapies to treat central nervous system (CNS) conditions Our portfolio will soon include two clinical stage programs that we believe each have a significant market potential
Slide 5: Clinical stage assets address large unmet needs in CNS
5 Our clinical stage assets address large unmet patient and market needs in the CNS therapeutic space Note: * Contingent upon closing of the Baergic Bio acquisition; ** Market cap as of 9/8/22 Pipeline Asset BAER - 101* IV Tramadol Indication Epilepsy and acute anxiety Post operative pain Mechanism
Slide 6: Our pipeline has near term value inflection points
6 Our pipeline has near term value inflection points Indication Phase 1 Phase 2 Phase 3 Rights IV Tramadol Post - operative Pain U.S. BAER - 101 Epilepsy Worldwide Acute Anxiety Continue regulatory discussions Completed study Planned study Phase 3 Pain Model Studies Confirmatory Safety Study Phase
Slide 7: IV Tramadol / Acquire CNS / Rare Disease Assets
7 BAER - 101 IV Tramadol Acquire CNS / Rare Disease Assets 1 2 3
Slide 8: Being developed for epilepsy and acute anxiety
8 Epilepsy Anti - Convulsant Effects Acute Anxiety Conditions (e.g., Panic Disorder) Anxiolytic Effects BAER - 101 is being developed for epilepsy and acute anxiety BAER - 101
Slide 9: Selective GABA-A receptor agonist mechanism
9 BAER - 101 is a selective GABA α receptor agonist that produces anticonvulsant and anxiolytic activity Jacob et al., Nature Reviews Neuroscience, 2008 GABA receptors are the major inhibitory neurotransmitter receptors in the mammalian brain GABA receptors have three major subunits α β γ , whic
Slide 10: More tolerable profile than nonselective benzodiazepines
10 BAER - 101 may have a more tolerable side effect profile compared to nonselective benzodiazepines due to greater GABA subtype selectively Therapeutic Effect GABA A subtypes α 1 α 2 α 3 α 5 Positive Anti - convulsant xx xx xx Anxiolysis xx xx Analgesia xx x xx Muscle Relaxation xx xx Negative Seda
Slide 11: Epilepsy patients have unmet needs with benzodiazepines
11 Epilepsy patients are prescribed benzodiazepines to control seizures, but have significant unmet needs for therapies with improved safety profiles Source: CDC.gov; Kalilani L et al. The epidemiology of drug - resistant epilepsy: A systematic review and meta - analysis. Epilepsia . 2018 Dec Diseas
Slide 12: Acute anxiety patients have unmet need
12 Acute anxiety patients also utilize benzodiazepines today and have significant unmet need for therapies with improved safety profiles Disease Panic disorder is a common form of an acute anxiety disorder manifesting as frequent panic attacks unrelated to specific situations Manifests as intens
Slide 13: Large market of patients prescribed benzodiazepines
13 BAER - 101 can target the large market of patients prescribed BZDs by targeting drug resistant epilepsy, orphan epilepsy, or acute anxiety Source: CDC.gov; Grand View Research, Polaris Market Research; Kalilani L et al. The epidemiology of drug - resistant epilepsy: A systematic review and meta -
Slide 14: Compelling profile to address this market
14 BAER - 101 has a compelling profile to address this market Safety in humans demonstrated in clinical trials in >700 patients Preclinical disease model safety and reduced abuse liability Preclinical disease model efficacy Selective in vitro profile High receptor occupancy BAER - 101 was licensed
Slide 15: Preclinical efficacy in multiple epilepsy models
15 Preclinical in vivo studies demonstrate efficacy in multiple epilepsy models Note: BAER - 101 was previously known as AZD7325 when tested in these preclinical models BAER - 101 decreases hyperthermia induced seizures in a mouse model of Dravet syndrome (SCN1A+/) In a mouse model of Dravet syndrom
Slide 16: Preclinical efficacy in multiple anxiety models
16 Preclinical in vivo studies demonstrate efficacy in multiple anxiety models Note: BAER - 101 was previously known as AZD7325 when tested in these preclinical models EXAMPLE: BAER - 101 results in rat punished responding model Punished Un - punished % of Control In the rat punished responding mode
Slide 17: AstraZeneca completed clinical studies and demonstrated safety
17 AstraZeneca completed 10 clinical studies and demonstrated safety across trials BAER - 101/AZD7325 was tested in over 700 subjects (healthy volunteers and patients) Side effects were mild or moderate with the most common side effects being dizziness and somnolence In two Phase 2 studies, BA
Slide 18: Clinical studies show positive sedation and cognition effects
18 Clinical studies demonstrate positive sedation and cognition effects Note: BAER - 101 was previously known as AZD7325 when tested in these preclinical models 0 5 10 15 20 25 30 35 3 6 9 12 15 18 21 24 27 30 Subjects experiencing sleepiness % of subjects (N=36 - 66) Lorazepam 2mg BID BAER101 15mg
Slide 19: Two planned Phase 1b studies
19 We plan to initiate two Phase 1b studies that we expect to translate well into later development programs Epilepsy: Photosensitivity Study Acute Anxiety: Hypercapnia CO2 Inhalation Model The epilepsy photosensitivity model is a clinical translational model that provides proof - of - principle f
Slide 20: Differentiated from others in the class
20 BAER - 101 is differentiated from others in the class Company Asset Selectivity Phase Indications Avenue Therapeutics BAER - 101 α 2/3 - preferring Phase 1 Epilepsy and panic disorder Cerevel (Nasdaq: CERE) darigabat α 2/3/5 - preferring Phase 2 Epilepsy and panic disorder Engrail Therapeutics EN
Slide 21: IV Tramadol / Acquire CNS / Rare Disease Assets
21 BAER - 101 IV Tramadol Acquire CNS / Rare Disease Assets 1 2 3
Slide 22: Tramadol has a unique dual mechanism of action
22 Tramadol has a unique dual mechanism of action among IV analgesics Note: Schedule IV means a low potential for abuse and low risk of dependence. Schedule II drugs have a high potential for abu se, with use potentially leading to severe psychological or physical dependence. Source: https://www.dea
Slide 23: Safety and efficacy shown in two Phase 3 trials
23 Safety and efficacy has been demonstrated in two Phase 3 trials in over 700 patients Both pain relief study models show benefit of Tramadol over placebo Study AVE - 901 - 103 (Abdominoplasty) SPID24 Study AVE - 901 - 102 (Bunionectomy) SPID24 IV Tramadol 50 mg achieved primary endpoint and all ke
Slide 24: Regulatory history and path forward for IV Tramadol NDA
24 Regulatory history and now a path forward for IV Tramadol NDA The Company intends to continue the dialogue with the FDA and submit a detailed protocol to gain alignment on a single safety study – the outcomes of this study could form the basis for resubmission of the NDA for IV tramadol 2022 2019
Slide 25: IV Tramadol / Acquire CNS / Rare Disease Assets
25 BAER - 101 IV Tramadol Acquire CNS / Rare Disease Assets 1 2 3
Slide 26: Searching for first rate CNS / rare disease assets
26 We are searching the world for first rate CNS / rare disease assets with these characteristics Feasible Clinical Development Programs with Reasonable Costs Imaging and Biomarker Driven Endpoints Clinical Stage with Human Data 26 CONFIDENTIAL
Slide 27: Avenue Company Overview
27 27 Avenue Company Overview
Slide 28: Experienced management team and board of directors
28 We are led by an experienced management team and board of directors Lindsay Rosenwald MD CEO, Fortress Biotech Jay Kranzler MD PhD Partner, Jay D Kranzler Consulting Neil Herskowitz Founder, ReGen Capital Curtis Oltmans Chief Legal Officer, Fulcrum Therapeutics Faith Charles Partner, Thompson Hin
Slide 29: IP / Exclusivity
29 IP / Exclusivity BAER - 101 Two issued US patents and related foreign patents in European States (CH, DE, ES, FR, GB, IT and SE), China, Canada and Japan for composition of matter with expiry date of December 2026 – Eligible for patent term extension (expected 5 years) – Potential for Orphan Dr
Slide 30: Executive Summary
30 Executive Summary Avenue Therapeutics is a specialty pharmaceutical company that seeks to develop and commercialize therapies to treat central nervous system (CNS) conditions Our portfolio will soon include two clinical stage programs that we believe each have a significant market potential