Beyond Air, Inc. Company Summary

Business Overview

• Type: Medical device and biopharmaceutical company
• Focus: Developing and commercializing nitric oxide (NO) generators and delivery systems, known as the LungFit platform.
• Core Technology:
  • Can generate NO from ambient air via plasma pulse technology.
  • NO is delivered directly to patients' lungs, either via ventilator circuits or masks.
• Key Advantages of LungFit System:
  • Generates NO without the need for high-pressure cylinders.
  • Capable of delivering NO at concentrations from 0.5 ppm up to 400 ppm.
  • Continuous monitoring and control of NO, NO₂, and oxygen levels.
  • Portable and user-friendly design.

Approved Product

• LungFit PH System:
  • Received:
    • FDA Premarket Approval (PMA) in June 2022
    • CE Mark approval in November 2024
  • Indication:
    • Treatment of Persistent Pulmonary Hypertension of the Newborn (PPHN) in infants >34 weeks gestation.
    • Reduces need for extracorporeal membrane oxygenation (ECMO).
    • Also approved for peri- and post-operative pulmonary hypertension in children and adults in conjunction with heart surgery.
  • Commercialization:
    • Launched in the U.S. since July 2022.
    • Regulatory approvals obtained in Australia, New Zealand, Hong Kong, Thailand.
    • Distribution agreements in France, Italy, Turkey, India, Saudi Arabia, Morocco, and others.
  • Market Potential:
    • U.S. sales potential estimated at approximately $350 million.
    • Worldwide sales potential estimated at over $700 million.

Product Pipeline & Development

• LungFit PRO: For viral lung infections, including COVID-19.
  • Completed pilot clinical trials showing safety and efficacy.
  • Clinical trial in the U.S. initiated in 2023, paused pending funding.
• LungFit GO: For Nontuberculous Mycobacteria (NTM) lung infection.
  • Completed clinical trials demonstrating safety, tolerability, and potential effectiveness.
  • Following positive results, a pivotal trial is planned for 2026.
• Other Indications Under Development:
  • Severe lung infections, COPD, and microbial infections.
  • Additional programs targeting solid tumors via a high-concentration NO delivery system (UNO) through the subsidiary Beyond Cancer.
  • Neurological conditions (e.g., Autism Spectrum Disorder) via neuronal NO synthase inhibitors in collaboration with Hebrew University, managed by the private affiliate NeuroNOS.

Key Financial & Operational Data

• Employees: 61 full-time employees as of March 31, 2025.
• Revenue: Not explicitly provided.
• Net Loss:
  • For the fiscal year ended March 31, 2025: $48.5 million
  • For the previous year (ended March 31, 2024): $64.3 million
• Accumulated Deficit: Approximately $286.3 million as of March 31, 2025.
• Market Capitalization (as of September 30, 2024):
  • Approximate market value of voting stock held by non-affiliates: $24.9 million
• Shares Outstanding: 92,794,777 as of June 19, 2025.

Business Strategy

• Focus on building a leading company in respiratory and infectious disease treatment via patent-protected NO delivery systems.
• Expand commercialization, pursue regulatory approval for pipeline products, and develop new indications.
• Partner internationally for distribution and sales outside the U.S.
• Investigate and develop high-concentration NO applications for antimicrobial and oncological uses.

Key Notes

• Market/Customer Base: Hospitals, neonatal intensive care units, ventilator-dependent patients, and potentially immunotherapy for cancer.
• Competitive Advantages: No need for high-pressure cylinders, high NO concentration delivery capabilities, real-time monitoring, and portable design.
• Research & Development: Extensive preclinical and clinical trials demonstrating safety, tolerability, and efficacy in multiple respiratory conditions.