On August 12, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a 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, reported financial results for its first fiscal quarter ended June 30, 2022 (Press release, Beyond Air, AUG 12, 2022, View Source [SID1234618266]).
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"Our sales team has quickly ramped up the initial phase of the commercial launch for the LungFit PH, which received FDA approval in late-June. This initial activity includes conducting product demonstrations at numerous U.S. hospitals, which we are pleased to report have generated positive feedback from the participating hospital staff. We are also highly encouraged by the feedback received during the medical conferences our team has attended since approval. The early success of this program and initial feedback received is expected to put us on schedule to equip the first small group of hospitals with LungFit PH systems over the next several months. We look forward to the upcoming American Association for Respiratory Care (AARC) in November and encourage investors to come see us in New Orleans," commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "We continue to expect to receive CE Mark for LungFit PH in Europe during the second half of calendar year 2022. In addition, we are planning to submit a PMA supplement for an expanded cardiac label for the LungFit PH system to the U.S. FDA."
Recent Highlights and Upcoming Milestones
LungFit PH
Received U.S. FDA approval on June 28, 2022 to treat term and near-term neonates with hypoxic respiratory failure
Initiated limited release phase of commercial launch, making it the first and only nitric oxide generator, delivery and monitoring system available in the U.S.; and already conducted numerous on-site demonstrations
CE Mark anticipated to be received in the second half of calendar year 2022, which is expected to be followed by an international commercial partnership
Expect to submit a PMA supplement for an expanded cardiac label for the LungFit PH to the U.S. FDA prior to year-end 2022
LungFit PRO
Planning to initiate a U.S. trial for patients hospitalized with viral community-acquired pneumonia (VCAP), including COVID-19, in the fourth quarter of calendar year 2023, pending discussion with FDA
Will present data in a poster session at an upcoming conference this Fall from the Company’s recently completed VCAP study
LungFit GO
Will present data from the pilot study of at-home LungFit GO for nontuberculous mycobacterial (NTM) lung infection at CHEST 2022 in Nashville on October 17, 2022
Expect to initiate a pilot study in COPD patients who are hospitalized due to an exacerbation in the fourth quarter of calendar 2023
Beyond Cancer’s Solid Tumor Program
Anticipate dosing the first patient in a first-in-human Phase 1 study to assess the safety and efficacy of ultra-high concentration nitric oxide for the treatment of solid tumors in the current quarter
Financial Results for the fiscal quarter ended June 30, 2022
Research and development expenses for the fiscal quarter ended June 30, 2022 were $3.2 million, compared with $2.7 million for the fiscal quarter ended June 30, 2021.
General and administrative expenses for the fiscal quarter ended June 30, 2022 increased to $8.2 million, compared with $3.9 million for the fiscal quarter ended June 30, 2021. The increase is mainly attributable to the staffing and scaling up of Beyond Cancer in both the U.S. and Israel, as well as continued investments necessary to support the commercial launch of LungFit PH in the U.S.
Other income and expense for the fiscal quarter ended June 30, 2022 was a loss of $0.2 million, compared with a loss of $0.2 million for the fiscal quarter ended June 30, 2021.
For the fiscal quarter ended June 30, 2022, the Company had a net loss of $11.7 million, of which $10.9 million, or ($0.37) per share, was attributable to the shareholders of Beyond Air, compared with a net loss of $6.7 million, or ($0.31) per share, for the fiscal quarter ended June 30, 2021.
As of June 30, 2022, the Company reported cash and cash equivalents of $72.8 million.
Net cash used in operations, including Beyond Cancer, was $6.8 million in the fiscal quarter ended June 30, 2022. This is below the quarterly cash burn guidance of $8.0 – 10.0 million. The Company expects to see the quarterly average cash burn during the fiscal year 2023 to fall within this range.