Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2023

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, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced financial results for its second fiscal quarter ended September 30, 2022.

“Our commercial team continues to successfully execute the initial phase of the LungFit PH launch following FDA approval in late-June 2022. Over the past few months, the demand for product evaluations and demonstrations have exceeded expectations. We are pleased to report that participating hospital staff have provided a steady flow of positive feedback,” commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “In addition, we are planning to submit a PMA supplement for an expanded cardiac label for the LungFit^® PH system to the FDA.”

“During the quarter, we presented positive data that support the development programs for the LungFit system using high dose NO as a potential treatment for several indications. At the CHEST Annual Meeting 2022 we presented favorable safety, tolerability, and efficany data for our LungFit GO pilot at-home study of patients with severe, treatment refractory, NTM lung disease, which further support development of intermittent high dose NO for the treatment of NTM as well as other chronic respiratory infections. We believe this study breaks new ground in the development of NO therapy by successfully showing the ability of our at-home NO generator-based system to be used safely and consistently by this patient population in a real-world setting.”

“Additionally, we are excited to announce that Beyond Cancer’s first-in-human Phase 1 study of UNO for the treatment of solid tumors designed to assess safety and efficacy is moving along after the first patient was treated in August 2022. We expect to announce topline data from the Phase 1 study in the first half of 2023,” concluded Mr. Lisi.

Recent Highlights and Upcoming Milestones

• LungFit^® PH
  • Continue progress with limited release phase of commercial launch, making it the first and only nitric oxide generator, delivery and monitoring system available in the U.S., following FDA approval on June 28, 2022 to treat term and near-term neonates with hypoxic respiratory failure
  • CE Mark anticipated to be received at the end of calendar year 2022, which is expected to be followed by an international commercial partnership
  • Expect to submit a PMA supplement for a cardiac label expansion for LungFit^® PH to the FDA prior to year-end 2022

• LungFit^® PRO
  • Presented positive data from the LungFit^® PRO pilot study of high-concentration inhaled NO in Viral Community-Acquired Pneumonia (VCAP), including COVID-19, which show a strong safety profile and statistically significant results on key efficacy endpoints in the iNO treatment group compared to standard supportive treatment (SST)
  • The Annals of the American Thoracic Society published a detailed review of a third pilot study of inhaled NO in bronchiolitis patients under the age of 12 months, including an overview of the study design and previously announced results (click here)
  • Plan to initiate a U.S. trial for patients hospitalized with VCAP, including COVID-19, in the fourth quarter of calendar year 2023, pending discussion with the FDA

• LungFit^® GO
  • Presented positive safety, tolerability, and efficacy data from the LungFit GO pilot at-home study of patients with severe, treatment refractory, NTM lung disease at the American College of Chest Physicians (CHEST) Annual Meeting 2022
  • Expect to initiate a pilot study in the fourth quarter of calendar 2023 in COPD patients who are hospitalized due to an exacerbation
• Beyond Cancer’s Solid Tumor Program
  • Pre-clinical data for ultra-high concentration nitric oxide therapy to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 10, 2022 which show benefits of NO therapy in combination with anti-PD1 over anti-PD1 monotherapy with respect to tumor regression and survival
  • Beyond Air received a notice of allowance for its patent titled “System and Method for Delivery or Gas to a Tissue”, which is the first patent covering Beyond Cancer’s UNO therapy

Financial Results for the fiscal quarter ended September 30, 2022

Research and development expenses for the fiscal quarter ended September 30, 2022 were $4.5 million, compared with $2.8 million for the fiscal quarter ended September 30, 2021. The increase is primarily attributable to increased spending on UNO.

General and administrative expenses for the fiscal quarter ended September 30, 2022 increased to $8 million, compared with $3.4 million for the fiscal quarter ended September 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 September 30, 2022 was a loss of $0.2 million, compared with a loss of $2.5 million for the fiscal quarter ended September 30, 2021.

For the fiscal quarter ended September 30, 2022, Beyond Air, Inc. (the “Company”) had a net loss of $12.8 million, of which $12.0 million, or ($0.40) per share, was attributable to the shareholders of Beyond Air, compared with a net loss of $8.7 million, or ($0.36) per share, for the fiscal quarter ended September 30, 2021.

As of September 30, 2022, the Company reported cash and cash equivalents, marketable securities, and restricted cash of $72.5 million.

Total cash burn in the quarter ended September 30, 2022 was $10.4 million, just above the quarterly cash burn guidance of $8.0 – 10.0 million, and includes a $2.5 million non-recurring payment. The Company expects to see the quarterly average cash burn during the fiscal year 2023 to fall within this range. Through first half of our fiscal year ended September 30, 2022, total cash burn was $17.9 million.