Beyond Air, Inc. (XAIR) has experienced an incline of 11.88% in the aftermarket. However, the last trading session closed at $10.61 with a decrease of 4.59%.
Global Regulatory Update for LungFit
On 21st September 2021, XAIR gave an update on the LungFit PH system’s global regulatory clearance process. XAIR has passed the Stage 1 Assessment Audit of its quality system undertaken by the Notified Body for the LungFit PH system. It is required for CE Mark certification (European Union approval). This is the first stage of a two-part inspection and quality assurance audit. In Europe, LungFit® PH is scheduled to acquire CE Mark in the first half of 2022.
Facility inspections needed by the US Food and Drug Administration (FDA) for approval of the LungFit® PH premarket application (PMA) are now underway. LungFit® PH for persistent pulmonary hypertension of the newborn (PPHN) will be commercially available in the United States in the fourth calendar quarter of 2021, according to Beyond Air management.
XAIR announced on 20th August 2021 that Douglas Larson is the Chief Financial Officer, following Douglas Beck, who will retire on September 1, 2021. Mr. Beck will continue to serve as a consultant to the company . He will also collaborate closely with Mr. Larson and the Beyond Air management team to facilitate a smooth transition of CFO duties.
With over 20 years of worldwide and operational finance leadership expertise, Douglas Larson brings a wealth of knowledge to Beyond Air. From 2017 until 2020, he worked for DBV Technologies, Inc. It is a worldwide clinical stage biopharmaceutical business located in France, as Vice President, Finance and Head of Global Controlling. From 2001 until 2015, Mr. Larson worked as the Chief Financial Officer of The Scotts Miracle-Gro Company’s International business in Lyon, France. Mr. Larson has extensive experience in performance management, supply chain finance, forecasting and business modelling, as well as establishing and implementing strategic and financial goals for businesses at various stages of growth over a wide global footprint.
XAIR announced First Quarter Results of Fiscal Year 2022
XAIR reported first quarter results of fiscal year 2022 on 10th August 2021. For the fiscal quarter ending June 30, 2021, revenue was $0, compared to $229,000 for the fiscal quarter ending June 30, 2020. Secondly, research and development costs were $2.7 million, compared to $4.3 million in the previous fiscal quarter.
Thirdly, general, and administrative costs were $3.9 million in the fiscal quarter compared to $2.5 million in the previous fiscal quarter. Lastly, the cash, cash equivalents, and restricted cash totaled $39.6 million as of June 30, 2021.