Beyond Air Submits Investigational Device Exemption (IDE) to the United States Food and Drug Administration (FDA) for the Treatment of COVID-19 Patients LungFit BRO system to be used in proposed study to treat COVID-19 p

Air Submits Investigational Device Exemption (IDE) to the United States Food and Drug Administration (FDA) for the Treatment of

BRO system to be used in proposed study to treat COVID-19 patients

applications have been submitted to the Biomedical Advance Research and Development Authority (BARDA), a division of Health

and Human Services (HHS)

trial design being vetted to investigate use in patients exposed to severe acute respiratory syndrome 2 (SARS-CoV-2), but not

to host a conference call today at 8:30 am ET to discuss these developments

City, NY, and Rehovot, Israel, March 16, 2020 - 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 for the

treatment of solid tumors, today announced submission of an Investigational Device Exemption (IDE) to the U.S. Food and

Drug Administration (FDA) for use of its LungFitTM BRO system in the treatment of COVID-19 patients.

Typically, the FDA responds within 30 days of an IDE submission.

is a mounting body of evidence that inhaled NO, including NO generated and delivered by our LungFitTM BRO

system, is safe and well-tolerated in animals and in human subjects at concentrations of 150 ppm and higher. In vitro evidence1

points to inhibition of viral replication in a variety of viruses, including coronaviruses, as well as anti-inflammatory

properties of nitric oxide," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "We believe that

our LungFitTM BRO system may, given the three completed pilot clinical studies in bronchiolitis, be a

significant tool in the battle against this coronavirus that has reached global pandemic status. In response to the unprecedented

nature of the COVID-19 situation, Beyond Air is taking all necessary steps to make this potential solution available as quickly

as possible to ensure that clinicians have access to NO therapy as a treatment option."

oxide therapy at high concentrations is an innovative and potentially ground breaking treatment option against COVID-19. The LungFitTM

BRO system is a practical and effective mode of delivery of nitric oxide for both patients and medical teams,"

added Andrew Colin, M.D., Batchelor Family Professor of Cystic Fibrosis and Pediatric Pulmonology Director, Division of Pediatric

Pulmonology Miller School of Medicine University of Miami. "Combatting this pandemic is of crucial importance

and having the LungFitTM BRO system tested and available as expeditiously as possible should be a priority

Tripathi et al, FEMS Immunology and Medical Microbiology, December 2017: Saura, M., et al., An antiviral mechanism of nitric

oxide: inhibition of a viral protease. Immunity, 1999. 10(1): p. 21-8: Akerstr m S et al. Nitric oxide inhibits the replication

cycle of severe acute respiratory syndrome coronavirus. J Virol. 2005; 79(3):1966-9.

trial design highlights

to FDA approval of our IDE, the Company plans to test the LungFitTM BRO for use in the treatment of patients

suffering from COVID-19 in an open-label study of 75 patients between the ages of 22 and 75 years confirmed with COVID-19 that

require hospitalization. Subjects would be randomized 2:1 and treated with 150 ppm NO administered over 40 minutes, 4 times per

day, in addition to standard of care (SOC) or SOC alone. The primary endpoint is time to clinical improvement based on key parameters

such as fever and oxygen support. Other endpoints include reduction in viral load, fever resolution, oxygen support, hospital

length of stay, requirement of mechanical ventilation, mortality, and various biomarkers. Final trial design is subject to FDA

approval of our IDE.

protocols targeting people exposed to SARS-CoV-2, the virus that causes COVID-19, are being designed to show that treatment with

NO may prevent infection. This can potentially result in a significant decline in the current standard quarantine time of 14 days,

protect medical staff treating those with COVID-19 or allow flexibility for the military. Beyond Air will evaluate the path forward

for these potential trial designs after completion of the first IDE study.

Air has already generated relevant data in humans, as shown at its Analyst Day held on March 5, 2020 (replay available at www.beyondair.net).

Specifically, in a bronchiolitis study from 2014, 4 out of 43 patients in the study tested positive for coronavirus. The trial

was a randomized, double blind, placebo-controlled study designed to compare NO therapy plus SOC versus SOC alone. The study looked

at hospital length of stay (LOS) as its primary endpoint. Of the four non-COVID-19 coronavirus patients, two were in the control

arm and two were in the treatment arm, allowing for a post-hoc comparison of the results. The LOS for the 2 patients in the control

arm was 60 hours compared to a LOS of 30 hours for the 2 patients in the treatment arm. We believe these results represent a clinically

meaningful reduction in LOS. Additionally, Beyond Air has reported efficacy data from two bronchiolitis studies, and anticipates

reporting data from a third study in approximately 8 weeks. The data reported to date show an approximate one day reduction in

LOS. All infants suffering from bronchiolitis have viral infections.

data from the bronchiolitis studies mentioned above, coupled with other high concentration NO studies, show no NO related serious

adverse events (SAEs) with more than 2,000 NO administrations to more than 100 patients. Additionally, Beyond Air has completed

three studies in rats and one in dogs. There were no macroscopic or microscopic observations in any of these studies. Two studies

lasted 12 weeks and the animals were treated with 250 ppm NO intermittently on a daily basis. One study lasted 30 days with the

top NO concentration of 400 ppm dosed intermittently on a daily basis. The fourth study provided a clean report for genotoxicity.

LungFitTM BRO system weighs 20 lbs and is easy to transport. All that is required to power the unit is

an electrical outlet. The system is designed to handle up to 240 volts. Since NO is generated from ambient air, there is an unlimited

supply. For patients who may need supplemental oxygen, the system is designed to accommodate this with a port in the rear of the

device. Beyond Air Nitrogen dioxide (NO2) filters are needed for the system to generate and deliver NO for safety reasons.

Toxic levels of NO2 can be a consequence of high concentration NO without proper filtration. The filters also program

the system. We believe this provides flexibility for NO administration. The Company is confident that patients can easily be trained

to self-administer or if multiple patients are treated in the same facility, one respiratory therapist (RT) can manage at least

10 systems at the same time and each system could treat 4 patients per day. Each patient would receive 4 administrations of NO

per day each lasting 40 minutes separated by 4 hours. Alarms monitor system performance. Filters are single-use and there are

no special requirements for disposal. Each patient would use their own breathing circuit to avoid contamination.

Air has ample LungFit BRO systems, filters and other equipment necessary to perform the study included in

our IDE as well as the second protocol described above.

management team will host a conference call for investors today, March 16 at 8:30 am ET to answer any questions. Conference call

details are as follows:

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 lower respiratory tract infections that are not effectively addressed with current standards of care. Beyond

Air is currently advancing its revolutionary LungFit in clinical trials for the treatment of bronchiolitis and severe lung

infections such as 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.

Oxide (NO) is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, NO

targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs and is used in adult respiratory

distress syndrome and persistent pulmonary hypertension of the newborn. Additionally, NO is believed to play a key role in the

innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria,

including both gram-positive and gram-negative, but also against other diverse organisms, including mycobacteria, viruses, fungi,

yeast and parasites, and has the potential to eliminate multi-drug resistant strains.

the LungFit NO Generator and Delivery System*

Air's NO Generator and Delivery System is a cylinder-free, phasic flow Nitric Oxide delivery system and has been designated

as a medical device by the US Food and Drug Administration (FDA). The ventilator compatible version of the device can generate

NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 part per million (ppm) to 80 ppm. The

LungFit could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting,

including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging

steps, and other benefits. The LungFit can also deliver NO at concentrations above 80 ppm for which intended treatments

are: bronchiolitis in the hospital setting, and chronic, refractory lung infections in the home setting. For the first time, Beyond

Air intends to offer NO treatment in the home setting with the elimination of cylinders.

Beyond Air's LungFit is not approved for commercial use and Beyond Air is not suggesting use over 80 ppm or use at

home. Beyond Air's LungFit is for investigational purposes only.

(coronavirus disease 2019) is an infectious disease caused by the severe acute respiratory syndrome coronavirus

2 (SARS-CoV-2). COVID-19 first emerged in Wuhan, China in December of 2019. Those affected develop fever,

cough, shortness of breath and/or difficulty breathing. While the majority of cases result in mild symptoms, some can progress

to pneumonia and multi-organ failure. The fatality rate is currently estimated at between 1% and 3%. Older

adults and people who have serious chronic medical conditions are at an increased risk of developing severe complications from