Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — SVB Leerink Global Healthcare Conference 2021
22 slides from Axsome Therapeutics's conference presentation, Feb 24, 2021
Slide 1: Corporate Presentation – SVB Leerink Global Healthcare Conference
Corporate Presentation SVB Leerink Global Healthcare Conference February 24, 2021 © Axsome Therapeutics, Inc. Exhibit 99.1
Slide 2: Forward-Looking Statements
Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “pl
Slide 3: Axsome mission statement
3 For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. © Axsome Therapeutics, Inc.
Slide 4: Our CNS Candidates and Pipeline Overview
Four differentiated clinical-stage CNS assets targeting significant and growing markets Patent protection to 2034-2040, worldwide rights for most product candidates Migraine Major Depressive Disorder: Breakthrough Therapy Designation Alzheimer’s Disease Agitation: Breakthrough Therapy Designation Sm
Slide 5: Late-stage portfolio affects >60M U.S. patients
4M (~70% of 6M AD patients) 5 Our late-stage portfolio has generated positive data in conditions that affect >60M U.S. patients © Axsome Therapeutics, Inc. Corporate 17M 37M 5M 185K
Slide 6: AXS-05: Novel therapy for MDD, AD agitation, smoking cessation
Novel therapy for CNS disorders: Major Depressive Disorder (MDD) Agitation in Alzheimer’s Disease (AD) Smoking Cessation 6 © Axsome Therapeutics, Inc. (dextromethorphan/bupropion) modulated delivery tablet AXS-05
Slide 7: Major Depressive Disorder: High Unmet Needs
7 Major Depressive Disorder: High Unmet Needs © Axsome Therapeutics, Inc. AXS-05 1) Internal primary market research; 2) Thomas, D., & Wessel, C. (2017). The State of Innovation in Highly Prevalent Chronic Diseases: Volume 1: Depression Therapies, BIO 3) Rush AJ, et al. Am J Psychiatry 2006;163:1905
Slide 8: Prevalence of Depression Symptoms Before and During Pandemic
8 Prevalence of Depression Symptoms Before and During Pandemic © Axsome Therapeutics, Inc. AXS-05 Depression increased more than 3 fold due to pandemic and skewed toward those with more severe symptoms 1) Ettman CK, Abdalla SM, Cohen GH, Sampson L, Vivier PM, Galea S. Prevalence of Depression Sympto
Slide 9: No new oral MOA to treat MDD in over years
9 No new oral MOA to treat MDD in over 60 years © Axsome Therapeutics, Inc. AXS-05 Source: Thomas, D., & Wessel, C. (2017). The State of Innovation in Highly Prevalent Chronic Diseases: Volume 1: Depression Therapies, BIO.
Slide 10: GEMINI Study of AXS-05 in MDD: MADRS Change and Remission
10 GEMINI Study of AXS-05 in MDD: MADRS Change and Remission © Axsome Therapeutics, Inc. AXS-05 Change in MADRS Total Score Achievement of Remission Abbreviations: DM = Dextromethorphan; BUP = Bupropion. Major Depressive Disorder: Breakthrough Therapy Designation
Slide 11: Alzheimer's Disease Agitation: High Unmet Medical Need
11 Alzheimer’s Disease Agitation: High Unmet Medical Need © Axsome Therapeutics, Inc. AXS-05 1Alzheimer’s Association. Alzheimers Dement. 2020;16(3):391+. 2Tractenberg R, et al. J Neuropsychiatry Clin Neurosci. 2002;14:11-18. 3Porsteinsson AP, et al. Expert Opin Pharmacother. 2017; 18:6, 611-620. 4R
Slide 12: AXS-05: Alzheimer's Disease Agitation
12 AXS-05: Alzheimer’s Disease Agitation © Axsome Therapeutics, Inc. AXS-05 Primary endpoint met in ADVANCE-1 pivotal Phase 2/3 trial Second pivotal trial initiated – ACCORD Phase 3, placebo-controlled, randomized withdrawal trial FDA Breakthrough Therapy Designation received Abbreviations: DM = Dex
Slide 13: AXS-07: Novel therapy for Migraine
Novel therapy for: Migraine 13 (MoSEIC™ meloxicam/rizatriptan) AXS-07 © Axsome Therapeutics, Inc.
Slide 14: AXS-07: MoSEIC Meloxicam + Rizatriptan for Migraine
14 AXS-07: MoSEIC™ Meloxicam + Rizatriptan for Migraine © Axsome Therapeutics, Inc. AXS-07 Unmet need for improved efficacy in migraine: disability on par with dementia, quadriplegia, active psychosis1,2 AXS-07: novel, oral, rapidly absorbed, multi-mechanistic Rapid and sustained efficacy as compare
Slide 15: AXS-12: Novel therapy for Narcolepsy
Novel therapy for: Narcolepsy 15 (reboxetine) AXS-12 © Axsome Therapeutics, Inc.
Slide 16: AXS-12 (reboxetine): Narcolepsy
Debilitating sleep disorder characterized by excessive daytime sleepiness and cataplexy Limited treatment options Positive Phase 2 results with AXS-12 Significant reduction in cataplexy attacks and EDS Significant improvement in cognitive function Phase 3 trial initiation anticipated in 2Q 2021 16 A
Slide 17: AXS-14: Novel therapy for Fibromyalgia
Novel therapy for: Fibromyalgia 17 esreboxetine AXS-14 © Axsome Therapeutics, Inc.
Slide 18: AXS-14 (esreboxetine): Fibromyalgia Overview
18 AXS-14 (esreboxetine): Fibromyalgia Overview © Axsome Therapeutics, Inc. AXS-14 Debilitating, chronic, CNS disorder characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment; ~90% affected are women Limited treatment options—only 3 approved agents: Current t
Slide 19: Barriers to Entry
19 Barriers to Entry © Axsome Therapeutics, Inc. Corporate >50 Issued U.S. Patents >40 Issued O-U.S. Patents Claims extending to 2034-40 >40 pending Proprietary Manufacturing Drug Product Formulation >40 issued U.S. Patents >40 issued O-U.S. Patent Claims extending to 2036 >40 pending Proprietary Ma
Slide 20: Our Team
20 Our Team © Axsome Therapeutics, Inc. Corporate Management Herriot Tabuteau, MD Founder & CEO Nick Pizzie, CPA, MBA Chief Financial Officer Mark Jacobson, MA Chief Operating Officer Kevin Laliberte, PharmD EVP, Product Strategy Lori Englebert SVP, Commercial & Business Dev. Amanda Jones, PharmD SV
Slide 21: Our Clinical and Regulatory Milestones
21 Our Clinical and Regulatory Milestones Corporate © Axsome Therapeutics, Inc.
Slide 22: For more information, please contact
For more information, please contact Mark Jacobson Chief Operating Officer 212-332-3243 mjacobson@Axsome.com axsome.com
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