Medical Device Company Beyond Air Has Cut 20% of its Workforce This Year

Beyond Air, a commercial stage medical device and biopharmaceutical company focused on patients suffering from respiratory illnesses, neurological disorders and solid tumors, announced its financial results for the fiscal fourth quarter and year ended March 31, 2024, and provided a corporate update.

Recent Highlights and Upcoming Milestones

• LungFit PH
  • Commercial demand continues to increase for LungFit PH, as evidenced by:
    • To date, LungFit PH devices have been used in more than 50 hospitals
    • To date, over 1,100 patients have been treated with LungFit PH, accounting for more than 75,000 hours of treatment
    • Current customers extend across 10 states in the U.S.
  • Appointed David Webster as new Chief Commercial Officer to lead commercial operations
  • FDA decision expected in the fourth quarter of CY 2024 for the pending PMA supplement for cardiac surgery
  • Awaiting updates on timing for CE Mark for LungFit PH in Europe
  • Updated revenue guidance to greater than $10 million for FY 2025, from the previous guidance of $12 million to $16 million

• Beyond Cancer – Solid Tumor Program
  • Ultra high concentration Nitric Oxide (UNO) therapy is in an ongoing Phase 1a trial evaluating advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors
    • The ongoing Phase 1a trial reported encouraging first-in-class clinical data demonstrating evidence of immune system activation via biomarker response in a heavily pretreated population. These data were presented at the American Society of Clinical Oncology Key Opinion Leader Event held in conjunction with the 2024 Annual Meeting
    • Upon regulatory approval, a Phase 1b trial will enroll up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease (12 weeks) on single agent anti-PD-1 without radiographic evidence of continued tumor reduction. Subjects enrolled in the Phase 1b trial will be treated with UNO + anti-PD-1 combination upon completion of the Phase 1a trial prior to the end of this year

• Capital Conservation Strategy
  • The company implemented a capital conservation strategy that will extend its cash runway and focus its resources on ramping up the commercial program for LungFit PH and maintain the timeline for the second generation LungFit PH
    • Reduced headcount by over 20% since January 1, 2024
    • Study of LungFit PRO to treat viral community-acquired pneumonia (VCAP) has been placed on hold due to strategic prioritization
    • The trials evaluating LungFit GO for the treatment of nontuberculous mycobacteria (NTM) and COPD have been placed on hold due to strategic prioritization; and the design and development of the LungFit GO device will be performed in-house and LungFit GO will be ready for clinical studies in calendar year 2026
    • Beyond Cancer subsidiary – planned Phase 1b clinical trial of UNO in combination with anti-PD1 will begin enrollment by the end of calendar 2024
    • NeuroNOS subsidiary – plan to initiate first-in-human autism spectrum disorder (ASD) study in 2025, pending available funding
  • Net cash burn rate is expected to be less than $30 million in FY 2025, which assumes the Company hits certain revenue targets. The quarter ended June 30, 2024 will include initial costs associated with implementing the capital preservation strategy. Net cash burn is expected to continue to decline in FY 2026 with an expectation that the Company will achieve cash flow breakeven in the fourth fiscal quarter of 2026.