Beyond Air, Inc.

What they do

Beyond Air develops nitric oxide (NO) generators and delivery systems that produce NO from ambient air, marketed as the LungFit platform. LungFit PH received FDA premarket approval in June 2022 and is indicated to improve oxygenation and reduce the need for ECMO in term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension; U.S. marketing began July 2022. The company also has majority-owned affiliates: Beyond Cancer (80% owned, ultra-high-concentration NO for solid tumors) and NeuroNOS (neurology, targeting autism spectrum disorder).

Revenue drivers

• LungFit PH (U.S. commercial) — The only approved and marketed product, generating essentially all reported revenue; sales are of the device and disposable components for neonatal PPHN use.
• International LungFit PH distribution — CE mark received November 2024 for neonatal hypoxic respiratory failure and peri-/post-operative pulmonary hypertension in patients ages 0-17; distribution network stated as covering more than 45 countries, subject to local approvals.
• Second-generation LungFit PH — A PMA supplement for the next-generation system submitted June 2025 is under FDA review; the company's 2027 guidance of $16-$18 million includes anticipated revenue from this product, pending approval.

Recent performance

For the quarter ended June 30, 2026, revenue was $1.8 million, flat versus $1.8 million a year earlier, with gross profit of $0.2 million (13% gross margin, up from 9%). Research and development expense fell to $2.0 million from $3.1 million, while selling, general and administrative expense rose to $4.9 million from $4.7 million. Net loss attributable to common stockholders was $7.9 million, or $11.00 per basic and diluted share, versus $7.7 million, or $30.67 per share, a year earlier. Other expense increased to $1.5 million from $0.5 million, driven by higher debt and related interest expense. Cash, cash equivalents, restricted cash and marketable securities were $15.2 million as of June 30, 2026, and the company reported cash & equivalents of $5.5 million on that date.

Strategy

Management says it is building commercial infrastructure and customer relationships ahead of an expected second-generation LungFit PH launch. It has expanded U.S. access through a national group purchasing agreement with a third major GPO, which it says adds reach to nearly 2,000 hospitals and health systems, and continues to build international distribution. In July 2026 the company closed a financing of up to $30.1 million, consisting of $10.2 million in upfront gross proceeds and up to $20.0 million from potential warrant exercises, including $10.0 million tied to FDA approval of the second-generation system. It reaffirmed revenue guidance of $8 million for calendar 2026 and $16-$18 million for 2027. Regaining Nasdaq minimum bid price compliance was also cited as a recent milestone.

Risks

• Going concern — The company's auditors included an explanatory paragraph expressing substantial doubt about its ability to continue as a going concern, citing recurring net losses and no positive operating cash flow for the year ended March 31, 2026.
• Dependence on regulatory approval — The anticipated second-generation LungFit PH launch, and the revenue guidance that includes it, depends on FDA approval of a PMA supplement submitted in June 2025 that remains under review.
• Thin gross margins and flat revenue — Quarterly revenue was flat year over year at $1.8 million and gross margin was only 13%, leaving a $6.6 million operating loss for the June 2026 quarter.
• Capital needs and debt — The company reported total liabilities of $30.1 million against $32.9 million of total assets and $2.0 million of shareholder equity at June 30, 2026, and interest expense on outstanding debt rose sharply year over year.

Outlook

Management reaffirmed 2026 revenue guidance of $8 million, which excludes any second-generation LungFit PH revenue, and 2027 guidance of $16-$18 million, described as more than 110% year-over-year growth at the midpoint including the second-generation product. The company expects FDA action on the second-generation PMA supplement in the second half of calendar 2026 and says international submissions remain on track with local partners. A recent financing of up to $30.1 million is intended to support international expansion and the U.S. launch of the second-generation system, pending approval.