Beyond Air, Inc. (NASDAQ: XAIR) reported Q4 EPS of ($0.36), $0.02 better than the analyst estimate of ($0.38).

Recent Highlights and Upcoming Milestones

• Announced positive top-line results from the third pilot study in bronchiolitis patients that showed high concentration NO (150 ppm) plus standard supportive therapy (SST) is statistically significant compared to both low concentration nitric oxide (85 ppm) plus SST and SST alone on both the primary endpoint of fit-to-discharge and the key secondary endpoint of hospital length of stay with no serious adverse events related to NO reported
• Published a peer-reviewed paper in the Scientific Reports journal that showed encouraging results from our second bronchiolitis study which indicate NO is safe and efficacious in hospitalized infants with bronchiolitis
• Enrolled the first patient in the U.S. clinical study using the LungFit™ system to treat COVID-19 with NO therapy
• Received approval from Health Canada to use the LungFit™ system for a study in hospitalized patients diagnosed with COVID-19
• The PMA for the LungFit™ PH to treat persistent pulmonary hypertension of the newborn (PPHN) is currently expected to be submitted to the FDA in the second half of 2020. This filing was delayed due to the ongoing COVID-19 pandemic
• The initiation of the At-Home nontuberculous mycobacteria (NTM) lung infection pilot study using the LungFit™ HOME is currently expected to start by the end of 2020. This study start was delayed due to the ongoing COVID-19 pandemic
• Ended the quarter with $25.5 million in cash and cash equivalents

“This is an exciting time for Beyond Air as we continue to make progress in our development pipeline. We have several opportunities to drive long-term shareholder value, with a number of significant milestones expected to occur in the second half of this year and into 2021, most notably our LungFit™ PH PMA submission and, subsequent anticipated FDA approval,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “During the past three months, we rapidly responded to the ongoing pandemic environment and launched a U.S. COVID-19 study using our LungFit™ system, also receiving approval to begin a similar study in Canada. Considering the data compiled to date with high concentration NO, most notably the three completed pilot clinical studies in bronchiolitis where infants were hospitalized due to viral infections, we believe that this system could be a significant tool in the battle against this coronavirus. As such, we look forward to announcing the data from the U.S. and Canadian COVID-19 studies. The rapid response to the pandemic of developing this program is quite an impressive accomplishment by a very special team here at Beyond Air.”

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