Axsome Therapeutics, Inc. · NASDAQ:AXSM

Axsome Therapeutics — American Headache Society Virtual Annual Scientific Meeting 2021

11 slides from Axsome Therapeutics's conference presentation, June 2021

  1. Slide 1: Efficacy and Safety of AXS-07 in the Acute Treatment of Migraine: INTERCEPT Phase 3

    American Headache Society: Virtual Annual Scientific Meeting, June 3-6, 2021 Efficacy and Safety of AXS-07 (MoSEIC™ Meloxicam/Rizatriptan) in the Acute Treatment of Migraine: Results from the INTERCEPT Phase 3 Trial Amanda Jones3, Cedric O’Gorman3, Stewart J. Tepper1, Richard B. Lipton2, Herriot Tab

  2. Slide 2: Disclosures

    INTERCEPT Disclosures Amanda Jones, Cedric O’Gorman, and Herriot Tabuteau are full-time employees of Axsome Therapeutics. Stewart J. Tepper and Richard B. Lipton are consultants to Axsome Therapeutics. © Axsome Therapeutics, Inc. 2

  3. Slide 3: Learning Objectives

    INTERCEPT Learning Objectives 1. Appreciate the seriousness of migraine and the continued unmet need in the acute treatment of migraine 2. Be able to describe the efficacy and safety results from INTERCEPT, a Phase 3 randomized, double- blind, placebo-controlled trial of AXS-07 in the acute treatmen

  4. Slide 4: INTERCEPT Phase 3 Trial: Design Summary

    INTERCEPT INTERCEPT Phase 3 Trial: Design Summary INTERCEPT: INiTiating EaRly Control of MigrainE Pain & Associated SympToms Phase 3 trial of AXS-07 for the acute treatment of migraine Screening Single dose Inclusion Criteria Taken at earliest onset of migraine pain • Male or female, 18 to 65 years

  5. Slide 5: AXS-07 Achieved Co-Primary Endpoints: Freedom from Pain and MBS at 2 Hours

    INTERCEPT AXS-07 Achieved Co-Primary Endpoints: Freedom from Pain and MBS at 2 Hours P=0.002 P=0.003 50% 35% 32.6% 43.9% 30% 40% 25% Percent of Patients 30% 26.7% 20% 16.3% AXS-07 15% 20% Placebo 10% 10% 5% 0% 0% Pain Freedom at Hour 2 Resolution of MBS at Hour 2 Difference P-Value Co- Primary Endpo

  6. Slide 6: Rapid and Durable Freedom from Migraine Pain

    INTERCEPT Rapid and Durable Freedom from Migraine Pain: Migraine Pain Freedom over Time 80% P<0.001 Percent of Patients Achieving Pain Freedom P<0.001 70% P<0.001 60% P<0.001 50% 40% P<0.001 30% 20% AXS-07 Placebo 10% 0% 0 2 4 6 8 10 12 14 16 18 20 22 24 Hour • AXS-07 rapidly eliminated migraine sym

  7. Slide 7: Sustained Pain Freedom and Prevention of Pain Progression

    INTERCEPT Sustained Pain Freedom and Prevention of Pain Progression 24-Hour Sustained Pain Freedom 24-Hour Freedom from Pain Progression P=0.030 P<0.001 25% 80% 22.7% 73.5% 70% Free from Migraine Pain Progression 20% 60% Percentage of Patients Percent of Patients 50% 47.4% 15% 12.6% 40% AXS-07 10% P

  8. Slide 8: Significant Reduction in Rescue Medication Use with AXS-07

    INTERCEPT Significant Reduction in Rescue Medication Use with AXS-07 50% P<0.001 P<0.001 42% P<0.001 40% 39% 36% Using Rescue Medications Percent of Patients P<0.001 30% 24% 20% 14% 15% 13% 9% 10% 5% 4% 0% Hour 2 Hour 4 Hour 12 Hour 16 Hour 24 AXS-07 Placebo • Rescue medication was used by 15.3% of

  9. Slide 9: Significant Functional and Global Improvement with AXS-07

    INTERCEPT Significant Functional and Global Improvement with AXS-07 P<0.001 60% P<0.001 80% 73.5% 52.4% 70% 50% 60% Percentage of Patients Percentage of Patients 40% 50% 47.4% 30% 27.7% AXS-07 40% AXS-07 Placebo Placebo 30% 20% 20% 10% 10% 0% 0% No Functional Disability at Hour 24 "Very Much Improve

  10. Slide 10: Safety of AXS-07: Adverse Events Occurring in ≥2% of Subjects

    INTERCEPT Safety of AXS-07: Adverse Events Occurring in ≥2% of Subjects AXS-07 Placebo (N = 140) (N = 143) Any Treatment-Emergent AE 25 (17.9%) 11 (7.7%) Somnolence 6 (4.3%) 3 (2.1%) Dizziness 4 (2.9%) 2 (1.4%) Paraesthesia 3 (2.1%) 0 Data presented as number of subjects (% of subjects) • There were

  11. Slide 11: INTERCEPT Phase 3 Trial Results: Summary

    INTERCEPT INTERCEPT Phase 3 Trial Results: Summary • AXS-07 achieved the two co-primary endpoints of pain freedom and freedom from most bothersome symptoms at 2 hours, compared to placebo • AXS-07 resulted in rapid, substantial and sustained pain relief compared to placebo in patients who treated a

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