Beyond Air (XAIR) Corporate presentation summary

Technology and product overview

• LungFit PH generates nitric oxide (NO) from ambient air using patented Plasma Pulse Technology, eliminating the need for tanks or chemicals and enabling continuous, on-demand NO supply.

• FDA- and CE-marked for treating hypoxic respiratory failure in neonates and peri-/post-operative pulmonary hypertension, with a flexible commercial model (monthly fee or capital purchase).

• Second-generation LungFit PH II is lighter, transport-ready, and features improved usability, with a PMA supplement pending at the FDA.

• Over 80 hospitals and 3,500+ patients have used LungFit PH, delivering more than 250,000 hours of inhaled NO therapy.

• Patent portfolio includes over 17 issued patents (expiring up to 2040) and 8+ pending applications, potentially extending protection to 2044.

Market opportunity and competitive positioning

• U.S. market for LungFit PH is estimated at $350M, with a global opportunity of $700M, expected to surpass $1B as the NO therapy market grows.

• 128% year-over-year growth reported for the quarter ending September 2025; distribution partnerships now cover 35 countries and 2.8 billion lives.

• LungFit PH offers significant advantages over cylinder and cassette-based competitors, including unlimited NO supply, faster setup, and lower hospital costs.

• Anticipated significant market share gains following FDA approval of the transport-ready LungFit PH II.

Pipeline and research initiatives

• Focused on expanding inhaled NO applications with investigational devices (LungFit PRO and GO) targeting high-concentration NO therapy for lung infections and at-home use.

• Over 5,000 patients treated with LungFit GO in various clinical settings, with no serious adverse events related to NO.

• Non-LungFit programs include Neuro NOS for neurological disorders (autism, Alzheimer’s, glioblastoma) and Beyond Cancer for ultra-high concentration NO in oncology.

• Orphan drug designations received for BA-101 and BA-102; first-in-human studies targeted for end of 2026.

• Phase 1a completed for UNO in oncology, with median overall survival not yet reached and further trials planned for 2026.