Beyond Air Presents Data in Hospitalized Patients with Viral Lung Infections (including COVID-19) from LungFit PRO Programs at ATS 2021 Interim analysis from the ongoing, open-label, randomized acute viral pneumonia (inc

Air Presents Data in Hospitalized Patients with Viral Lung Infections (including COVID-19) from LungFit PRO Programs at ATS

analysis from the ongoing, open-label, randomized acute viral pneumonia (including COVID-19) pilot study shows 150 ppm nitric oxide (NO)

administered with LungFit PRO is well-tolerated with no treatment-related adverse events, and demonstrates encouraging efficacy

analysis of 3 previously reported pilot studies in bronchiolitis at 150-160 ppm NO demonstrates a favorable safety profile and consistent

efficacy across multiple endpoints

of data at 150-160 ppm NO in both adult and infant patient populations supports further development of LungFit PRO in patients hospitalized

with viral pneumonia

City, NY, May 13, 2021 - 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 the presentation of data at the American

Thoracic Society (ATS) International Conference 2021, which is being held virtually from May 14 - May 19. The data from both LungFit

PRO programs, acute viral pneumonia (including COVID-19) and bronchiolitis, show a favorable safety profile and encouraging efficacy

trends using high concentration inhaled NO for the treatment of acute viral lung infections in hospitalized patients.

have now demonstrated a consistently favorable safety profile at high concentrations of nitric oxide in both adult and infant populations

with acute viral lung infections," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "The new data from

the acute viral pneumonia pilot trial in adults, taken together with our three previously completed pilot clinical trials in bronchiolitis,

enable Beyond Air to prepare for a pivotal study for high concentration NO in a viral indication."

interim analysis of patients in the acute viral pneumonia (including COVID-19) pilot study shows a favorable safety profile and encouraging

efficacy signals in this adult patient population treated with 150 ppm NO generated and delivered by LungFit PRO," commented

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. "Given these current data, I believe the results support the continued development

of high concentration inhaled NO that can be delivered with ease by LungFit for the treatment of viral pneumonia including COVID-19.

LungFit PRO is a revolutionary device that can allow for the treatment of this diverse patient population on a large scale".

of Interim Results of Acute Viral Pneumonia (including COVID-19) Pilot Trial

ongoing acute viral pneumonia pilot study is a multi-center, open-label, randomized clinical trial in Israel with an emphasis on enrolling

patients infected with SARS-CoV-2. Patients are randomized in a 1:1 ratio to receive inhalations of 150 ppm NO given intermittently for

40 minutes four times per day for up to seven days in addition to standard supportive treatment (NO + SST) or standard supportive treatment

alone (SST, control group). At the time of the cut off for these data, a total of 23 COVID-19 subjects were enrolled. The intent-to-treat

(ITT) analysis population included 19 patients (9 NO + SST vs 10 SST).

on Duration of Hospital Stay

to Treat Population with Exclusion of Extreme Values*

subjects discharged from hospital within 6 hours of study enrollment were excluded from analysis.

on Oxygen Support Requirements

detailed study results will be submitted for presentation at an upcoming scientific meeting.

of Analysis of 3 Completed Bronchiolitis Pilot Trials

date, over 90 patients hospitalized with a viral lung infection have received 150-160 ppm inhaled NO, dosed intermittently, without any

reported treatment-related serious adverse events," said Asher Tal, M.D. Professor Emeritus, Pediatrics, Soroka University Medical

Center; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. "Overall, the data show that 150 ppm

NO given intermittently via inhalation is effective in the treatment of patients with bronchiolitis, while data at the lower concentration

of 85 ppm show no benefits. I look forward to further development of the program using a minimum concentration of 150 ppm NO, noting

that a reduction in time spent in the hospital by these patients would be clinically meaningful."

Air has assessed inhaled NO in three pilot clinical trials in bronchiolitis. 198 infants (43% females; 57% males) participated across

the three programs, with a mean age of 3.9 months (range 0.3 - 11.9 months). Inhaled NO treatments were given intermittently for

30 to 40 minute durations, from 4 to 5 times daily for up to 5 days. Data from patients in the SST group were pooled across the 3 studies

for safety analysis.

Included in the Analysis

statistical significance (p<0.05)

hazard ratio estimate greater than one represents a higher probability of achieving success on each endpoint in the NO group relative

to fit for discharge was not measured in Trial 2

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. 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.

Oxide (NO) is a powerful molecule, naturally synthesized in the human body, 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. Currently,

exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension

of the newborn to treat hypoxemia. 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 pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug

Air's LungFit is a cylinder-free, phasic flow nitric oxide generator and 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. LungFit system 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. LungFit can also

deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g. COVID-19,

bronchiolitis) and chronic, refractory lung infections in the home setting (e.g. NTM). With the elimination of cylinders, Beyond Air

intends to offer NO treatment in the home setting.

Beyond Air's LungFit is not approved for commercial use. Beyond Air's LungFit is for investigational use only.

Beyond Air is not suggesting NO use over 80 ppm or use at home.

majority of hospital admissions of infants with bronchiolitis are caused by respiratory syncytial virus (RSV). RSV is a common and highly

transmissible virus that infects the respiratory tract of most children before their second birthday. While most infants with RSV present

with minor respiratory symptoms, a small percentage develop serious lower airway infections, termed bronchiolitis, which can become life-threatening.

The absence of treatment options for bronchiolitis limits the care of these sick infants to largely supportive measures. Beyond Air's

system is designed to effectively deliver 150 - 400 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses, fungi

and other microbes from the lungs.

Acute Viral Pneumonia

adults, viruses have been identified as the causative agents in approximately 100 million cases of community-acquired pneumonia per year.

While viral pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (RSV) and influenza virus, newly emerging

viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing to the

overall burden of adult viral pneumonia. Patients aged 65 years or older are at particular risk for death from the disease, as are patients

with other underlying health conditions or weakened immune systems. There is no consensus regarding the use of antiviral drugs to treat

viral pneumonia, and specific preventative measures are currently limited to the influenza vaccine. Given that current treatment recommendations

are largely limited to supportive care, there is an unmet medical need for effective treatment options.

(coronavirus disease 2019) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19

first emerged 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. Older adults and people who have serious chronic

medical conditions are at an increased risk of developing severe complications from COVID-19. There is no specific treatment approved