Axsome Q2 update

 Financial Guidance

• Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.
  

Commercial Highlights

Auvelity

• Approximately 123,000 prescriptions were written for Auvelity in the second quarter of 2024, representing a 29% sequential increase versus the first quarter of 2024.
  
  
• Payer coverage for Auvelity in the commercial channel increased from 48% of lives covered last quarter to 60% of lives covered as of August 1. The proportion of lives covered in the government channel (Medicare and Medicaid) remains at approximately 100%. Payer coverage for Auvelity across all channels is now at approximately 76% of all covered lives. Axsome expects coverage to continue to expand and evolve.
  

Sunosi

• Approximately 45,000 prescriptions were written for Sunosi in the U.S. in the second quarter of 2024, representing an 8% increase versus the first quarter of 2024.
  
  
• Sunosi maintains broad payer coverage in the commercial channel with 95% of lives covered. Currently 83% of total lives across all channels are covered.

Anticipated Milestones

• Regulatory:
  
  
  • AXS-14 for fibromyalgia, NDA submission (3Q 2024)
    
    
• Clinical Trial Topline Results:
  
  
  • Phase 3 ADVANCE-2 trial of AXS-05 in Alzheimer’s disease agitation (2H 2024)
    
    
  • Phase 3 ACCORD-2 trial of AXS-05 in Alzheimer’s disease agitation (2H 2024)
    
    
  • Phase 3 open-label safety extension trial of AXS-12 in narcolepsy (2H 2024)
    
    
  • Phase 3 FOCUS trial of solriamfetol in ADHD in adults (2H 2024)
    
    
  • Phase 3 EMERGE trial of AXS-07 in patients with migraine with inadequate response to oral CGRP inhibitors (2H 2024)
    
    
  • Phase 3 PARADIGM trial of solriamfetol in major depressive disorder (2025)
    
    
  • Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2025)
    
    
  • Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026)
    
    
• Clinical Trial Initiations and Progress:
  
  
  • Pivotal Phase 2/3 trial of AXS-05 in smoking cessation, initiation (2024)
    

Conference Call Information

Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss second quarter 2024 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). The live webcast can be accessed on the Investors page of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.

https://www.globenewswire.com/news-release/2024/08/05/2924171/33090/en/Axsome-Therapeutics-Reports-Second-Quarter-2024-Financial-Results-and-Provides-Business-Update.html