Avenue Therapeutics, Inc. · OTC:ATXI

Avenue Therapeutics — Investor Presentation (August 2016)

12 slides from Avenue Therapeutics's investor presentation, August 2016

  1. Slide 1: Avenue Therapeutics, Inc.

    Avenue Therapeutics, Inc. August 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: 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

  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  Trend: Multi‐modal management to avoid strong/addictive narcotics (Schedule II drugs) Available Classes Pain Levels C

  5. Slide 5: IV Tramadol Opportunity

    IV Tramadol Opportunity Trend on “multimodal” treatment for pain favors new products Tramadol is an opioid without the typical side effects of narcotics  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 ma

  6. Slide 6: 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 6

  7. Slide 7: 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 7

  8. Slide 8: 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

  9. Slide 9: 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

  10. Slide 10: 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

  11. Slide 11: Upcoming Milestones

    Upcoming Milestones  Commence Phase 3 program in 2017  Phase 3 Data 2017  ~$30 million to complete Phase 3 Program 11

  12. Slide 12: 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 12

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