GARDEN CITY, N.Y. - Beyond Air, Inc. (NASDAQ: NASDAQ:XAIR), a medical device and biopharmaceutical company, has seen a surge in commercial demand for its LungFit PH system, with shipments of filters doubling quarter over quarter. The company is increasing production to meet this demand and has reiterated its revenue guidance for fiscal year 2025 at $12 million to $16 million.
The LungFit PH system, which received a key software update approved by the FDA in September 2023, is also expected to gain broader usage with the potential FDA approval for its use in cardiac surgery. The PMA supplement for this label expansion was accepted for filing by the FDA in late December and is currently under review.
Beyond Air's LungFit PRO is undergoing a U.S. pilot trial for the treatment of viral community-acquired pneumonia (VCAP), with top-line data expected in mid-year 2025. The trial will span two seasons, with a pivotal study planned for the 2025/2026 pneumonia season.
For the fiscal quarter ended December 31, 2023, Beyond Air reported revenues of $0.4 million, a significant increase from zero revenue in the same quarter the previous year. However, the company also reported a net loss of $16.2 million, or a loss of $0.50 per share.
The company's cash position remains strong, with $31.3 million in cash, cash equivalents, and marketable securities, and an additional $5.0 million held on deposit by their contract manufacturer as of December 31, 2023. This financial update, along with other company highlights and upcoming milestones, will be discussed in a conference call scheduled for today at 4:30 p.m. ET.
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