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November 11 , 2021 Beyond Air The Magic of Breathing Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2022 U.S. FDA actively reviewing premarket approval ( PMA ) submission for LungFiⓇ 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 LungFi 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 Lung Fit® PH continues to be under review at FDA . We successfully completed our Stage 1 Assessment Audit for a CE Mark in Europe and anticipate approval during the first half of calendar year 2022 , after which we plan to partner the program internationally . In the United States , we continue to guide a commercial launch in the fourth quarter of this calendar year . Our commercial team has grown considerably and is ready to bring the first - ever integrated generator and delivery system that produces NO to hospitals across the country . The Beyond Air team also continues to execute on the R & D front with the release of interim data