US company Beyond Air has announced cash-saving measures including a 20% reduction in workforce and a pause of clinical trials, as part of year-end guidance for the fiscal year ended 31 March 2024.
The decision was made despite the company reporting revenues of $1.2m, an improvement from the zero revenue generated in the previous fiscal year. Beyond Air also downgraded revenue expectations for its only commercial product, LungFit PH, to more than $10m for the fiscal year 2025, from the previous guidance of $12m–16m.
Following the release of year-end guidance, Beyond Air’s stock fell more than 16% in premarket trading, compared with market close on the previous day. The company reported cash reserves of $34.5m as of 31 March 2024.
LungFit PH was approved as the treatment of hypoxic respiratory failure in term and near-term neonates by the US Food and Drug Administration (FDA) in 2022. The device makes nitric oxide from room air and delivers it into a ventilator breathing circuit to support better oxygenation of blood.
“Two upcoming milestones that are expected to drive additional revenue growth include the pending FDA decision on the cardiac surgery indication and development of a second-generation LungFit PH system,” said Steve Lisi, chairman and chief executive officer of Beyond Air.
The company is awaiting the US FDA’s decision on using LungFit PH in cardiac surgery to stabilise the pH and treat pulmonary hypertension. Beyond Air is also awaiting a decision on a European CE mark for the device.
As part of the cash-saving measures, Beyond Air has paused a clinical trial evaluating LungFit PRO to treat viral community-acquired pneumonia (VCAP). It has also paused the development of its LungFit Go device and the subsequent trials evaluating the device for treating nontuberculous mycobacteria (NTM) and chronic obstructive pulmonary disease (COPD). Beyond Air expects the LungFit GO device to be ready for clinical trials in 2026.
The company’s other pipeline programmes include an ultra-high concentration nitric oxide (UNO) therapy and a treatment for autism spectrum disorder. The UNO therapy is currently being investigated as a combination treatment with an immune checkpoint programmed cell death protein 1 (PD-1) therapy in a Phase Ia trial.
Beyond Air plans to enrol up to 20 patients in the Phase Ib study with advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumours. The company is awaiting regulatory clearance and expects to start enrolment by the end of the year. Beyond Air also plans to start trials of its autism spectrum disorder treatment in 2025, pending available funding.
