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Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2022
U.S. FDA actively reviewing premarket approval (PMA) submission for LungFit® PH to treat persistent pulmonary hypertension of the newborn (PPHN); Remain on
About this update from Beyond Air, Inc.
[{"type":"text","content":"U.S. FDA actively reviewing premarket approval (PMA) submission for LungFit® PH to treat persistent pulmonary hypertension of the newborn (PPHN); Remain on track for commercial launch in the fourth quarter of calendar year 2021 Raised $23.9 million to form a new private, independently managed entity, called Beyond Cancer, Ltd, to advance the development of ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors Positive interim results reported from the LungFit® GO Nontuberculous Mycobacteria (NTM) lung infection at-home pilot study (self-administration), with full efficacy and safety data expected in CY2022 Conference call scheduled for today, November 11th, at 4:30 p.m. ET GARDEN CITY, N.Y., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced financial results for its first fiscal quarter ended September 30, 2021. Steve Lisi, Chairman and Chief Executive Officer of Beyond Air commented, “This has been an exciting quarter for Beyond Air, as the team continues to deliver both operationally and strategically. On the strategic front, the launch of Beyond Cancer under the new leadership of CEO Selena Chaisson, M.D. is a special achievement. The separation of the UNO franchise to an independently managed affiliate was made possible through the support of investors in a $23.9 million ongoing private financing. We believe that the spin-off will accelerate UNO’s path to the clinic and create long-term value for shareholders. Beyond Cancer will leverage our NO expertise, IP portfolio, preclinical oncology team, regulatory progress, and initially use existing Company infrastructure. The separation enables Beyond Air to focus on its core business of advancing its LungFit® platform for the treatment of respiratory diseases.” Mr. Lisi continued, “Consistent with our global regulatory update from September, our PMA for LungFit® PH continues to be under review at FDA. We successfully completed our Stage 1 Assessment Audit for a CE Mark in Europe ...