I have been following Beyond Air (XAIR) for a few months now and am using recent weakness to rebuild a position that I had reduced into strength. Beyond Air is a clinical-stage biotechnology company that uses medical-grade nitric oxide (NO) to treat lung conditions. The LungFit system uses proprietary technology to generate NO from ambient air. A separate unique delivery system allows for the administration of ultra-high NO concentrations directly to solid tumors. LungFit PH allows NO to be administered to ventilated patients in the hospital without using cumbersome cylinder systems and is administered at home.
XAIR is waiting for the FDA to grant premarket approval (PMA) of its application for LungFit PH to treat persistent pulmonary hypertension in newborn infants (PPHN). The company expects a decision in the fourth quarter. The decision was expected in the third quarter but has been pushed back. The company has completed the necessary Stage 1 Assessment and now the FDA is undergoing inspection of the manufacturing process.
Nitros Oxide is already well known to be an effective treatment for a variety of conditions. What XAIR is offering is a much more convenient and effective delivery process. The hurdle for FDA approval is much lower than if this was a new drug.
XAIR also expects two other milestones before the end of the year. Preliminary results from the LungFit GO Nontuberculous Mycobacteria (NTM) lung infection at-home pilot study are expected, and the company's solid tumor program should receive regulatory clearance for human trials by year's end.
There was over $2 million in insider buying earlier in the year so management appears to be optimistic. In addition, XAIR has coverage from four analysts in the last three months and all four have 'buy' recommendations. Matthew Kaplan of Ladenburg has a $17 target and recently stated: "We remain confident that Beyond Air has set itself up to execute its timeline for commercial launch and label expansion. We believe the upcoming milestones could serve as significant potential catalysts for the stock."
The stock recently topped out on September 21 when management announced that FDA approval had been pushed back. Approval could come at any time and management has made it clear that it expects it to hit this quarter.
I've added to my position today and will be looking for further entry points.