Beyond Air Reports Revenue Growth and CE Mark Approval for LungFit® PH System

Beyond Air, Inc. reported its financial results for the three and nine months ended December 31, 2024, revealing a significant increase in revenue compared to the previous fiscal period. The company generated $1.1 million in revenue for the three months ended December 31, 2024, up from $391,000 in the same period last year. For the nine months, revenue rose to $2.6 million from $689,000. Despite this growth, the company incurred a gross loss of $215,000 for the quarter and $1.6 million for the nine months, attributed to increased costs of revenue, which totaled $1.3 million and $4.1 million, respectively.

In terms of operational efficiency, Beyond Air has made notable strides in reducing its operating expenses. For the three months ended December 31, 2024, total operating expenses decreased to $10.7 million from $16.6 million in the prior year, while for the nine months, expenses fell to $35.7 million from $49.6 million. This reduction was primarily driven by lower research and development costs, which decreased from $6.8 million to $3.0 million for the quarter, and from $18.7 million to $13.6 million for the nine months. Selling, general, and administrative expenses also saw a decline, reflecting the company's efforts to streamline operations.

Strategically, Beyond Air has made significant advancements, including the receipt of European CE mark approval for its LungFit® PH system, which is designed to treat hypoxic respiratory failure in neonates. This approval, received on December 2, 2024, expands the device's market potential, particularly in the European Union. The company has also entered into agreements with various partners to enhance its market reach, including collaborations with TrillaMed and Healthcare Links to access Department of Defense hospitals and group purchasing organizations, respectively.

The company’s financial position has been impacted by its liquidity challenges, with cash and cash equivalents decreasing to $4.6 million as of December 31, 2024, down from $11.4 million at the end of the previous fiscal period. Beyond Air has implemented a capital conservation strategy, reducing its workforce by over 30% and placing certain studies on hold to manage expenses. The company anticipates that these measures, along with expected revenue growth from its product offerings, will help stabilize its financial situation.

Looking ahead, Beyond Air remains focused on the commercialization of its LungFit® platform and plans to initiate pivotal clinical trials for its other product candidates, including treatments for viral lung infections and nontuberculous mycobacteria. The company is also preparing for a potential expansion into additional markets, with a goal of becoming a leader in the nitric oxide delivery space. However, management acknowledges that future capital needs will depend on the success of these initiatives and the ability to secure additional funding.