Avenue Therapeutics, Inc. · OTC:ATXI
Avenue Therapeutics — Investor Presentation (January 2023)
24 slides from Avenue Therapeutics's investor presentation, January 2023
Slide 1: Corporate Overview
Corporate Overview AVENUE THERAPEUTICS, INC. ⎸ NASDAQ: ATXI ⎸ January 2023
Slide 2: Forward looking statement
Forward looking statement This presentation contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this presentation, including statements that exp
Slide 3: Executive Summary
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 includes two clinical stage programs, both of which we believe have significant market potential: – IV Tr
Slide 4: Our clinical stage assets address large unmet patient and market needs in the CNS
Our clinical stage assets address large unmet patient and market needs in the CNS therapeutic space Pipeline Asset BAER-101 IV Tramadol Epilepsy and Indication Post operative pain acute anxiety Selective GABA-A 2, Opioid agonist & inhibitor Mechanism 3 receptor positive of norepinephrine & allosteri
Slide 5: Our pipeline has potential near-term value inflection points
Our pipeline has potential near-term value inflection points Indication Phase 1 Phase 2 Phase 3 Rights Phase 3 Pain Model Studies Post-operative IV Tramadol Pain U.S. Confirmatory Safety Study Epilepsy Phase 1b Photosensitivity BAER-101 Worldwide Phase 1b Acute Anxiety CO2 Inhalation Phase 1b tr
Slide 6: BAER-101
1 2 3 Acquire CNS Rare BAER-101 IV Tramadol Disease Assets 6
Slide 7: BAER-101 is being developed for epilepsy and acute anxiety
BAER-101 is being developed for epilepsy and acute anxiety BAER-101 Epilepsy Acute Anxiety Conditions Anti-Convulsant Effects (e.g., Panic Disorder) Anxiolytic Effects 7
Slide 8: BAER-101 is a selective GABAα receptor agonist that produces anticonvulsant and anxiolytic activity
BAER-101 is a selective GABAα receptor agonist that produces anticonvulsant and anxiolytic activity GABA receptors are the major inhibitory neurotransmitter receptors in the mammalian brain GABA receptors have three major subunits α β γ, which are organized into a pentameric structure Each sub
Slide 9: BAER-101 may have a more tolerable side effect profile compared to nonselective benzodiazepines
BAER-101 may have a more tolerable side effect profile compared to nonselective benzodiazepines due to greater GABA subtype selectively Predicted effect of targeting GABAα subtypes GABAA subtypes Therapeutic Effect α1 α2 α3 α5 Anti-convulsant ✓✓ ✓✓ ✓✓ Positive Anxiolysis ✓✓ ✓✓ Analgesia ✓✓ ✓ ✓✓ Musc
Slide 10: Epilepsy and acute anxiety patients are prescribed benzodiazepines, but have significant unmet needs
Epilepsy and acute anxiety patients are prescribed benzodiazepines, but have significant unmet needs for therapies with improved safety profiles Epilepsy Acute Anxiety Conditions U.S. Prevalence ~6M patients (~360M patients with any anxiety 3 - 4M patients (~65M patients worldwide) condition worldwi
Slide 11: BAER-101 can target the large market of patients prescribed BZDs
BAER-101 can target the large market of patients prescribed BZDs by targeting drug resistant epilepsy, orphan epilepsy, or acute anxiety Addressable market Patients prescribed benzodiazepines Drug Resistant Epilepsy 800K – 1M prevalent Acute Anxiety patients U.S. 6.8M prevalent patients U.S. Orphan
Slide 12: BAER-101 has a compelling profile to address this market
BAER-101 has a compelling profile to address this market Preclinical High receptor disease model occupancy efficacy Safety Preclinical in humans Selective disease model demonstrated in vitro profile safety and in clinical reduced abuse trials in liability >700 patients BAER-101 was licensed from Ast
Slide 13: AstraZeneca completed clinical studies and demonstrated safety across trials at selected doses
AstraZeneca completed 10 clinical studies and demonstrated safety across trials at selected doses 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
Slide 14: Clinical studies demonstrate positive sedation and cognition effects
Clinical studies demonstrate positive sedation and cognition effects Example: subset analysis from Phase 2 generalized anxiety study Subjects experiencing sleepiness % of subjects (N=36-66) 35 30 Lorazepam 2mg BID 25 BAER-101 15mg BID 20 15 BAER-101 5mg BID 10 Placebo 5 0 3 6 9 12 15 18 21 24 27 30
Slide 15: We plan to initiate two Phase 1b studies
We plan to initiate two Phase 1b studies that have the potential to translate well into later development programs Epilepsy: Photosensitivity Study Acute Anxiety: Hypercapnia CO2 Inhalation Model The epilepsy photosensitivity model is a clinical The CO2 inhalation challenge is a clinical transla
Slide 16: BAER-101 is differentiated from others in the class
BAER-101 is differentiated from others in the class Differentiation vs other selective GABAα therapies Company Asset Selectivity Phase Indications Avenue Therapeutics BAER-101 α2/3-preferring Phase 1 Epilepsy and panic disorder Cerevel (Nasdaq: CERE) darigabat α2/3/5-preferring Phase 2 Epilepsy and
Slide 17: IV Tramadol
1 2 3 Acquire CNS Rare BAER-101 IV Tramadol Disease Assets 17
Slide 18: Tramadol has a unique dual mechanism of action among IV analgesics
Tramadol has a unique dual mechanism of action among IV analgesics Opioid Inhibitor of Norepinephrine Opioid Agonist Efficacy & Serotonin Re-uptake Blocking pain signal transmission with Less at both the spinal and brain levels Abuse Blocking pain signal transmission at the spinal level Potential Sc
Slide 19: Safety and efficacy profiles have been demonstrated in two Phase 3 trials in over 700 patients
Safety and efficacy profiles have been demonstrated in two Phase 3 trials in over 700 patients Both pain relief study models show benefit of Tramadol over placebo Study AVE-901-102 (Bunionectomy) SPID24 Study AVE-901-103 (Abdominoplasty) SPID24 IV Tramadol 50 mg achieved primary endpoint and all key
Slide 20: Regulatory history and now a path forward for IV Tramadol NDA
Regulatory history and now a path forward for IV Tramadol NDA 2019 2021 2022 December 2019: We submitted a New February 2021: We addressed the August 9, 2022: We met with the FDA to Drug Application (“NDA”) for IV manufacturing issue identified in the discuss a study design to address the Tramadol a
Slide 21: Acquire CNS Rare Disease Assets
1 2 3 Acquire CNS Rare BAER-101 IV Tramadol Disease Assets 21
Slide 22: We are searching the world for first-rate CNS / rare disease assets
We are searching the world for first-rate CNS / rare disease assets with these characteristics Imaging and Clinical Stage Biomarker with Human Driven Data Endpoints Feasible Clinical Development Programs with Reasonable Costs 22
Slide 23: We are led by an experienced management team and board of directors
We are led by an experienced management team and board of directors Management Board of Directors Lindsay Rosenwald MD CEO, Fortress Biotech Jay Kranzler MD PhD CEO, Urica Therapeutics Alexandra MacLean MD David Jin Michael Ryan Neil Herskowitz CEO Interim CFO VP Clinical Operations & Founder, ReGen
Slide 24: Executive Summary
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 includes two clinical stage programs, both of which we believe have significant market potential: – IV Tr
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