Beyond Air Reports Financial Results for Fiscal Fourth Quarter and Year-End 2020 Reported positive clinical data for third bronchiolitis study using high concentration nitric oxide, achieving primary and key secondary en

Air Reports Financial Results for Fiscal Fourth Quarter and Year-End 2020

positive clinical data for third bronchiolitis study using high concentration nitric oxide, achieving primary and key secondary

first patient in the U.S. COVID-19 study using the LungFit system

positive pre-clinical data validating high concentration nitric oxide as a potential treatment for ablating solid tumors

and inducing an anti-tumor immune response

for the LungFit PH to treat persistent pulmonary hypertension of the newborn (PPHN) expected to be submitted

to the FDA in the second half of 2020

HOME nontuberculous mycobacteria (NTM) lung infection pilot study expected to start by the end of 2020

call scheduled for today, Monday, June 22nd at 4:30 pm ET

CITY, N.Y., June 22, 2020 (GLOBE NEWSWIRE) - Beyond Air, Inc. (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 financial results

for its fourth quarter and fiscal year ended March 31, 2020.

Highlights and Upcoming Milestones

is an exciting time for Beyond Air as we continue to make progress in our development pipeline. We have several opportunities

to drive long-term shareholder value, with a number of significant milestones expected to occur in the second half of this year

and into 2021, most notably our LungFit PH PMA submission and, subsequent anticipated FDA approval," said Steve Lisi,

Chairman and Chief Executive Officer of Beyond Air. "During the past three months, we rapidly responded to the ongoing pandemic

environment and launched a U.S. COVID-19 study using our LungFit system, also receiving approval to begin a similar study

in Canada. Considering the data compiled to date with high concentration NO, most notably the three completed pilot clinical studies

in bronchiolitis where infants were hospitalized due to viral infections, we believe that this system could be a significant tool

in the battle against this coronavirus. As such, we look forward to announcing the data from the U.S. and Canadian COVID-19 studies.

The rapid response to the pandemic of developing this program is quite an impressive accomplishment by a very special team here

results for three months ended March 31, 2020

for the three months ended March 31, 2020 was ($200,000) as compared to $7.7 million for the three month ended March 31, 2019,

all of which was licensing revenue.

and development expenses for the three months ended March 31, 2020 were $2.9 million, compared to $1.6 million for the three month

ended March 31, 2019.

and administrative expenses for the three months ended March 31, 2020 were $2.2 million, compared to $2.6 million for the three

month period ended March 31, 2019.

the three months ended March 31, 2020, the Company had a net loss of $5.3 million, or ($0.36) per share, compared to a net loss

of $100,000, or ($0.01) per share for the three months ended March 31, 2019.

results for fiscal year ended March 31, 2020

for the fiscal year ended March 31, 2020 was $1.4 million as compared to $7.7 million for fiscal the year ended March 31, 2019,

all of which was licensing revenue.

and development expenses for the fiscal year ended March 31, 2020 were $10.6 million, compared to $3.9 million for the fiscal

year ended March 31, 2019.

and administrative expenses for the fiscal year ended March 31, 2020 were $8.9 million, compared to $6.9 million for the fiscal

year March 31, 2019.

the fiscal year ended March 31, 2020, the Company had a net loss attributed to common shareholders of $20.5 million, or ($1.78)

per share, compared to a net loss of $6.6 million, or ($0.77) per share for the fiscal year ended March 31, 2019.

of March 31, 2020, the Company had cash, cash equivalents and restricted cash of $25.5 million.

Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery

System, the LungFit , that uses NO generated from ambient air to deliver precise amounts of NO to the lungs of ventilated

and non-ventilated patients 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 in clinical trials for the

treatment of severe lung infections such as SARS-CoV-2, bronchiolitis and nontuberculous mycobacteria (NTM). Additionally, Beyond

Air is using ultra-high concentrations of NO with a proprietary delivery system, separate from the LungFit , 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 resistant strains.

the LungFit NO Generator and Delivery System*

Air's LungFit 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 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. The 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

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.

pulmonary hypertension of the newborn (PPHN) is a lethal condition and secondary to failure of normal circulatory transition at

birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased

pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1000 live births (0.4-6.8/1000

live births) with mortality rate ranging between 4-33%. This syndrome complicates the course of about 10% of infants with

respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a vasodilator, is approved in dozens

of countries to improve oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO) in term and near-term

(>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary

hypertension in conjunction with ventilator support and other appropriate agents.

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 over 80 ppm NO, for which preliminary

studies indicate may eliminate bacteria, viruses, fungi and other microbes from the lungs.

mycobacteria (NTM) is a rare and serious bacterial infection in the lungs causing debilitating pulmonary disease associated with

increased morbidity and mortality. NTM infection is acquired by breathing in aerosolized bacteria from the environment, and if

ignored can lead to NTM lung disease, a progressive and chronic condition. NTM is an emerging public health concern worldwide

because of its multi-drug antibiotic resistance. Current treatment guidelines suggest a combination of multiple antibiotics delivered

continually for as long as two years. These complex, expensive and invasive regimens have a poor record in the treatment of Mycobacterium

abscessus complex (MABSC) and refractory Mycobacterium avium complex (MAC) and have the potential for causing severe adverse events.

Beyond Air's system is designed to effectively deliver 150 - 400 ppm NO to the lung, and early data indicate that this range

of NO concentration may have a positive effect on patients infected with NTM.

(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. 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 for COVID-19 and patients are managed with supportive care. NO may prove to

be a treatment as the impact on the lung should result in bronchodilation, reduction in inflammation and inhibition of the viral