Clinical Trial Failure Risk: The success of LungFit NO depends on positive outcomes from ongoing and future clinical trials for various indications (e.g., bronchiolitis, NTM). Failure to meet primary or secondary endpoints in these trials would severely impact the company's prospects.

Regulatory Approval Uncertainty Risk: Even with successful clinical trials, obtaining regulatory approvals from agencies like the FDA is complex, costly, and not guaranteed. Delays or outright rejections could significantly postpone or prevent commercialization.

Funding and Liquidity Risk: As a clinical-stage company, Beyond Air continues to incur substantial operating losses. The company relies on its ability to raise additional capital through equity offerings or debt financing, which may not be available on favorable terms or at all, leading to potential liquidity issues.