Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Investor Presentation (September 2020)
21 slides from Axsome Therapeutics's investor presentation, Sep 16, 2020
Slide 1: Corporate Presentation September 2020
NASDAQ: AXSM Corporate Presentation September 2020 © Axsome Therapeutics, Inc.
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 accelerates the invention and adoption of life-changing medicines
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 2034-2036, worldwide rights for most product candidates Product Candidate / MOA Phase 1 Phase 2 Phase 3 NDA AXS-05 NMDA receptor antagonist with multimodal activity AXS-07 MoSEIC™ COX-2 p
Slide 5: Late-stage portfolio with positive data in conditions affecting >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 Major Depressive Disorder Migraine Alzheimer’s Disease Agitation Narcolepsy Fibromyalgia NDA Submission 4Q 2020 NDA Submission 4Q 2020
Slide 6: Late-Stage Indications with Potential Total U.S. Peak Sales of Up to $9B
6 Late-Stage Indications with Potential Total U.S. Peak Sales of Up to $9B Corporate Program/ MOA Indication Launch Year Est. Est. Peak U.S. Sales Key Highlights AXS-05 NMDA receptor antagonist with multimodal activity MDD 2021 $1B - $3B • Novel, oral, NMDA receptor antagonist • Rapid and substantia
Slide 7: AXS-05: Depression Overview
7 AXS-05: Depression Overview © Axsome Therapeutics, Inc. AXS-05 1. National Survey on Drug Use and Health (NSDUH). (2017). 2. Rush AJ, et al. Am J Psychiatry 2006;163:1905-1917. 17.3M patients in the U.S.1 Product Candidate Preclinical Phase 1 Phase 2 Phase 3 AXS-05 (DM + BUP) Abbreviations: DM = D
Slide 8: AXS-05 Depression Franchise Completed Trials
8 AXS-05 Depression Franchise Completed Trials © Axsome Therapeutics, Inc. Depression MDD NDA-Enabling Efficacy Studies: 1:1 Status: 1:1 inadequate responders Bupropion Positive results Bupropion AXS-05 Met key secondary endpoints TRD Efficacy Study: Placebo AXS-05 Bupropion AXS-05 Positive re
Slide 9: AXS-05 Depression Franchise Ongoing Trials
9 AXS-05 Depression Franchise Ongoing Trials © Axsome Therapeutics, Inc. Depression COMET (N~900) Completion Expected: 1:1 AXS-05 Placebo AXS-05 • 4Q 2020 AXS-05 6 months, N=300 1 year, N = 100 1 1 COMET-TRD (N~70) MERIT (TRD) (N~50) 1 AXS-05 COMET-AU (N~150) 1 AXS-05 COMET-SI (N~30) 1 Abbreviations
Slide 10: AXS-05: Alzheimer's Disease Agitation Overview
10 AXS-05: Alzheimer’s Disease Agitation Overview © Axsome Therapeutics, Inc. AXS-05 4M patients in the U.S.1,2 Product Candidate Preclinical Phase 1 Phase 2 Phase 3 AXS-05 (DM + BUP) Agitation in Alzheimer’s Disease: Breakthrough Therapy Designation Abbreviations: DM = Dextromethorphan; BUP = Bupro
Slide 11: AXS-05 Alzheimer's Disease Agitation
11 AXS-05 Alzheimer’s Disease Agitation © Axsome Therapeutics, Inc. AD Agitation Status: ADVANCE-2 (N=TBD) NDA-Enabling Efficacy Studies: ADVANCE-1 (N=366) Randomization Bupropion AXS-05 Placebo Positive results • Initiation 4Q 2020 1:1 AXS-05 Placebo AXS-05 1
Slide 12: AXS-05: Smoking Cessation Overview
12 AXS-05: Smoking Cessation Overview © Axsome Therapeutics, Inc. AXS-05 • Smoking is single largest cause of preventable death in the U.S.1 • 70% of smokers want to quit and only 3-5% who attempt to quit without assistance are successful for 6-12 months.2 • Positive Phase 2 trial results (Duke Univ
Slide 13: AXS-07: MoSEIC Meloxicam + Rizatriptan for Migraine
13 AXS-07: MoSEIC™ Meloxicam + Rizatriptan for Migraine © Axsome Therapeutics, Inc. AXS-07 • AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine • Positive results in Phase 3 MOMENTUM trial in patients with history of inadequate r
Slide 14: AXS-07 Migraine Program
1:1 14 AXS-07 Migraine Program © Axsome Therapeutics, Inc. Migraine NDA-Enabling Efficacy Studies: Status: Placebo AXS-07 Rizatriptan AXS-07 2:2:2:1 Placebo MoSEIC™ Meloxicam Positive results Positive results Open Label Trial: MOVEMENT • Completion expected 3Q 2020 6 months, N=300 1 year, N = 10
Slide 15: AXS-12 (reboxetine): Narcolepsy Overview
Product Candidate Preclinical Phase 1 Phase 2 Phase 3 AXS-12 (Reboxetine) Narcolepsy; Orphan & Breakthrough Therapy Designation • Debilitating sleep disorder characterized by excessive daytime sleepiness (EDS) and cataplexy • Limited treatment options – Only one approved agent for cataplexy – Most c
Slide 16: AXS-14 (esreboxetine): Fibromyalgia Overview
16 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: – Cur
Slide 17: Key Financial Information
17 Key Financial Information © Axsome Therapeutics, Inc. Corporate • Financial guidance: Cash anticipated to fund operating requirements for at least two years. As June 30, 2020 Cash: $190.7 Million Debt (Face Value): $20.0 Million Common Shares Outstanding: 37.3 Million Options, RSUs, and Warrants
Slide 18: Our Team
18 Our Team © Axsome Therapeutics, Inc. Corporate Management Herriot Tabuteau, MD Founder & CEO Nick Pizzie, CPA, MBA Chief Financial Officer Dave Marek Chief Commercial Officer Mark Jacobson, MA Chief Operating Officer Cedric O’Gorman, MD, MBA SVP, Clinical Development & Medical Affairs Board of Di
Slide 19: Barriers to Entry
MoSEIC™ Meloxicam (AXS-07) AXS-05 19 Barriers to Entry © Axsome Therapeutics, Inc. Corporate 37 Issued U.S. Patents 8 Issued O-U.S. Patents Claims extending to 2034 >45 pending Proprietary Manufacturing Drug Product Formulation 41 issued U.S. Patents 3 issued O-U.S. Patent Claims extending to 2036 >
Slide 20: Our Clinical and Regulatory Milestones
20 Our Clinical and Regulatory Milestones Corporate Product Candidate Indication Milestone AXS-05 NMDA receptor antagonist with multimodal activity MDD ✓ STRIDE-1 topline results ✓ Pre-NDA meeting ● COMET completion (4Q 2020) ● COMET-AU / SI / TRD sub-study results (4Q 2020) ● MERIT results (1H 2021
Slide 21: 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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