GARDEN CITY, N.Y., Nov. 11, 2020 (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 gaseous NO (gNO) for the treatment of solid tumors, today announced financial results for its second fiscal quarter ended September 30, 2020.

“Over the past few months we have achieved several significant milestones, both regulatory and clinical, across our development pipeline. Most notably, we filed a PMA for the LungFit™ PH system for the treatment of PPHN, which will be subject to the standard 180-day FDA review. If approved, LungFit™ PH will be our first commercially available product from the LungFit™ platform technology that generates nitric oxide from ambient air. I am very proud and humbled by the resilience and execution of the Beyond Air team, as we have faced many pandemic related setbacks. We are now on a clear path towards recognizing the potential of our LungFit™ platform for the treatment of respiratory conditions with the goal of improving the lives of patients,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.

“As the coronavirus pandemic continues to adversely affect everyday life in the United States and around the world, the Beyond Air team has adapted. Site initiation visits are ongoing for the acute viral pneumonia study, which includes patients infected with SARS-CoV-2, and we have overcome significant logistical challenges with our at-home NTM lung infection study, which is expected to begin next month. The team also identified a new opportunity in the development pipeline for ultra-high concentration gNO to treat solid tumors. This program has generated exciting preclinical data demonstrating the conveyance of tumor immunity to the host, which we have presented at three different major medical and scientific conferences this year. We believe this new approach has the potential to elicit a paradigm shift in the standard of care for solid tumors and their metastases, which are responsible for approximately 90% of all cancer-related deaths,” concluded Mr. Lisi.

Fiscal Second Quarter and Recent Highlights

• LungFit™ PH

• Submitted a PMA for LungFit™ PH to the FDA for the treatment of PPHN, which will be subject to the standard 180-day review process

• LungFit™ PRO

• Received all necessary approvals to perform our acute viral pneumonia study in Israel using the LungFit™ PRO at 150 ppm nitric oxide
• Presented promising in vitro data using OC43 human coronavirus infected cells at CHEST, which suggest that the LungFit™ PRO system may be effective for both prevention and treatment of human coronavirus infection with 150-250 ppm nitric oxide intermittent dosing regimens
• Announced positive new efficacy and safety data from the third bronchiolitis pilot study at CHEST that support the development of inhaled NO as a treatment for this unmet medical need
• Published results from a compassionate use patient case study using NO to treat pulmonary Mycobacterium abscessus disease at the National Heart, Lung, and Blood Institute, part of the National Institutes of Health (NIH), in the August edition of Access Microbiology

• Solid Tumor Program

• Announced preclinical data for exogenous high concentration gNO at the AACR Conference on Tumor Immunology and Immunotherapy that suggest direct administration to solid tumors triggers a systemic anti-tumor immune response, which could serve as the basis for an effective immunotherapy
• Presented new in vitro and in vivo preclinical data for the gNO program at the International Association for the Study of Lung Cancer’s (IASLC) North America Conference on Lung Cancer 2020 (NACLC 2020) that suggest high concentration gNO may treat lung cancer locally and its metastases systemically

• Ended the quarter with $22.4 million in cash, cash equivalents and restricted cash

Upcoming Milestones

• LungFit™ PH

• Anticipate receiving FDA approval of the PMA for LungFit™ PH to treat PPHN in the second quarter of calendar year 2021
• LungFit™ PH commercial launch in the United States approximately 4-6 weeks post FDA approval

• LungFit™ PRO

• Expect to announce topline data for the acute viral pneumonia study in the middle of calendar year 2021

• LungFit™ GO

• Expect to initiate the at-home NTM lung infection pilot study in December 2020. This study start has been delayed due to the ongoing COVID-19 pandemic.

Financial results for three months ended September 30, 2020

Revenue for the three months ended September 30, 2020 was $350,000 as compared to $646,000 for the three months ended September 30, 2019, all of which was licensing revenue.

Research and development expenses for the three months ended September 30, 2020 were $3.1 million, compared to $2.8 million for the three months ended September 30, 2019.

General and administrative expenses for the three months ended September 30, 2020 were $2.2 million, compared to $2.1 million for the three months ended September 30, 2019.

For the three months ended September 30, 2020, the Company had a net loss of $5.1 million, or ($0.30) per share, compared to a net loss of $4.1 million, or ($0.38) per share for the three months ended September 30, 2019.

As of September 30, 2020, the Company had cash, cash equivalents and restricted cash of $22.4 million.

About Beyond Air, Inc.

Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System, LungFit™, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. The LungFit™ can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is currently applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary LungFit™ for clinical trials for the treatment of severe lung infections such as SARS-CoV-2 and nontuberculous mycobacteria (NTM). Additionally, Beyond Air is using ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.