Beyond Air, Inc. (NASDAQ: XAIR) reported Q1 EPS of ($0.67), $0.39 worse than the analyst estimate of ($0.28). Revenue for the quarter came in at $627.47 thousand versus the consensus estimate of $1.06 million.

Key Highlights

• Remains on track to file a Premarket Approval (PMA) submission with the FDA for the treatment of persistent pulmonary hypertension of the newborn (PPHN) with our LungFit™* PH system in the third quarter of calendar 2019.
• Anticipates obtaining CE Mark for LungFit™* PH for the treatment of PPHN and for the treatment of pulmonary hypertension associated with heart surgery in the first half of calendar 2020.
• Preparing to initiate a 12-week, self-administered, at-home study in nontuberculous mycobacteria (NTM) patients in the second quarter of calendar 2020.
• Preparing to initiate a pilot bronchiolitis study in Israel in the fourth quarter of calendar 2019.
• Completed dosing in a 30-day rat study (in both male and female rats) with our LungFit™* system in which 3 doses were studied, 150 ppm, 250 ppm and 400 ppm, compared to placebo, each for 80 minutes twice daily. Initial results showed no deaths, normal weight gain in all groups, and normal clinical exams including normal gross pathology at necropsy. The company awaits confirmation of the results via clinical pathology and histopathology. These data will support both the bronchiolitis and NTM programs.
• Began trading under new ticker symbol, XAIR, on the NASDAQ stock exchange on July 15, 2019.
• Ended the quarter with $11.7 million in cash and cash equivalents after completing a private investment in public equity (PIPE) financing with gross proceeds of $7.96 million in June 2019.

“We continue to make steady progress towards achieving our goal of submitting our Premarket Approval (PMA) for the LungFit PH system in this current quarter,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “With the completion of a PIPE transaction last June, we have the financial resources to execute and achieve our goals over the next 14 months. This includes gaining FDA approval and CE Mark for our LungFit PH system; completing a pilot study in bronchiolitis; and initiating an at-home study in patients suffering from NTM lung infection. I am confident in our ability to execute on all three of our programs as the Beyond Air team has done an exceptional job over the past 2 years.”

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