Avenue Therapeutics, Inc. · OTC:ATXI

Avenue Therapeutics — Investor Presentation (December 2016)

15 slides from Avenue Therapeutics's investor presentation, December 2016

  1. Slide 1: Avenue Therapeutics, Inc.

    Avenue Therapeutics, Inc. December 2016

  2. Slide 2: Forward Looking Statements

    Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward‐looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. We have attempted to identify forward‐looking statements

  3. Slide 3: Avenue and its Value Proposition

    Avenue and its Value Proposition What We Do and Why  We focus on pharmaceuticals for the  U.S. hospital market is concentrated acute/intensive care hospital setting and requires a small sales force  Our lead asset is intravenous (IV)  Trend on “multimodal” treatment for tramadol pain favors new

  4. Slide 4: U.S. Post-Op Pain Market

    U.S. Post‐Op Pain Market  IV analgesics sells ~$1 billon (~300 million units)/yr  IV acetaminophen sells ~$250MM ‐ ~25% of total dollar market with approximately 3% of the volume  Room for Improvement Available Classes Pain Levels Common Limitations & Contraindications IV narcotics Moderate to se

  5. Slide 5: What is Tramadol

    What is Tramadol Centrally acting analgesic with dual mechanisms of action  Weak opioid agonist  Inhibitor of monoamine neurotransmitter reuptake Effective and safe  Labeled for “moderate to moderately severe pain”  Analgesic effect similar to other opioid therapies  Differentiated safety pro

  6. Slide 6: IV Tramadol

    IV Tramadol Summary Indication Moderate to moderately severe pain Regulatory pathway 505b(2) Stage of development Phase III to begin in 2017 Clinical efficacy* • Parenteral tramadol has been tested in several randomized, double‐ blind, parallel‐group, comparative studies. • It effectively relieved m

  7. Slide 7: New Restrictions on Opioids

    New Restrictions on Opioids • New guidelines from CDC to physicians attempts to limit opioid prescribing • Many states have passed laws restricting opioid prescriptions • The U.S. DEA has reduced the amount of almost every Schedule II opioid medication that may be produced in the U.S. in 2017 by 25

  8. Slide 8: IV Tramadol Opportunity

    IV Tramadol Opportunity  IV tramadol may be used in all types of inpatient and outpatient surgeries and as part of a multimodal analgesic plan for major surgery  It may be an improved option for patients  With poor cardiopulmonary function  Elderly patients at risk for respiratory depression  O

  9. Slide 9: Results from a Survey of U.S. Anesthesiologists

    Results from a Survey of 30 U.S. Anesthesiologists* Patients taking Switch to IV tramadol Add IV tramadol IV morphine 40% 41% IV NSAIDS 26% 37% IV acetaminophen 24% 35% *Survey conducted through LEERINK and available upon request 9

  10. Slide 10: Key Feature

    Key Feature Phase 3 ready Our IV tramadol dosing regimen provides a similar PK profile (Cmax and AUC) to that of oral Ultram 100 mg Q6h at steady state.  Obtained through PK modeling and confirmed in a PK study 10

  11. Slide 11: Phase 3 Program

    Phase 3 Program* Study Goals Design Orthopedic model 1. To demonstrate safety and 405 patients, 3‐arm (IV tramadol (Bunionectomy) efficacy of IV tramadol (50 50 mg, 25 mg, or placebo), 1:1:1 mg dose) versus placebo randomized, and double‐blind 2. To understand dose study response Soft tissue model 1

  12. Slide 12: Executive Team and Key Advisor

    Executive Team and Key Advisor  Lindsay Rosenwald, MD, Executive Chairman  Chairman and CEO of Fortress Biotech, Inc.  Prolific and successful investor in the life sciences industry for over 20 years  Co‐founder and Co‐Portfolio Manager of Opus Point Partners  Lucy Lu, MD, Interim President & C

  13. Slide 13: Scientific Advisory Board

    Scientific Advisory Board Robert Dworkin, PhD  Director of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Harold Minkowitz, MD  Assistant Professor of Anesthesiology at the University of Texas Health Science Center at Hous

  14. Slide 14: Upcoming Milestones

    Upcoming Milestones  Commence Phase 3 program in 2017  Phase 3 Data 2018  NDA filing 2019  ~$30 million to complete Phase 3 Program 14

  15. Slide 15: Avenue Therapeutics, Inc.

    Avenue Therapeutics, Inc. Contact: Lucy Lu, M.D. 2 Gansevoort St., 9th Floor New York, NY 10014 Tel: 781‐652‐4511 Email: llu@avenuetx.com 15

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