Beyond Air Reports Financial Results for the Third Quarter of Fiscal Year 2022 LungFit PH premarket approval (PMA) submission under active review by U.S. FDA; approval and commercial launch anticipated in the first half

Air Reports Financial Results for the Third Quarter of Fiscal Year 2022

PH premarket approval (PMA) submission under active review by U.S. FDA; approval and commercial launch anticipated in the first half

of calendar year 2022 along with European CE Mark

$30 million for oncology affiliate Beyond Cancer , Beyond Air maintained an 80% equity ownership; first in human trial initiation

on track for first half of calendar year 2022

of leadership team with appointment of Dr. Andrew Colin to Chief Medical Officer tasked with leading the strategic efforts for LungFit

PRO and LungFit GO clinical programs

abstracts accepted for presentation at leading scientific conferences for ongoing clinical programs in the first half of calendar year

call scheduled for today, February 10th, at 4:30 p.m. ET

CITY, N.Y., Feb. 10, 2022 (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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for

the treatment of solid tumors, today announced financial results for its third fiscal quarter ended December 31, 2021.

Lisi, Chairman and Chief Executive Officer of Beyond Air, commented, "The Beyond Air team continues to maintain a collaborative

relationship with FDA to work towards the approval of LungFit PH for the treatment of persistent pulmonary hypertension of the newborn,

or PPHN, in the United States. Our goal remains to bring this groundbreaking therapy to the market as soon as possible, which we now

anticipate being in the first half of this year. With our strong cash balance of $54.5 million, exclusive of Beyond Cancer cash, we are

in a favorable position for commercial launch of LungFit PH, pending approval. In Europe, we are on track to receive CE Mark in

the first half of calendar year 2022 as well and will look to partner the program internationally later in the year."

am happy to report progress in our other programs under the leadership of our new Chief Medical Officer, Dr. Andrew Colin," continued

Mr. Lisi. "Notably, we will be presenting additional safety and efficacy data from our community-acquired viral pneumonia (CAVP),

including COVID-19, pilot study at ECCMID in April of this year. Recall, we presented an interim analysis of 19 COVID-19 patients at

ATS 2021 in May, where 150 PPM NO was well tolerated and showed encouraging efficacy signals in adult hospitalized patients. Despite

COVID-related lockdowns in Australia, we expect to present efficacy and safety data from our NTM pilot study using LungFit GO to

deliver up to 250 ppm NO in the home setting at the American Thoracic Society conference in May of this year. Finally, our private oncology

affiliate is on track to begin enrolling patients for a first in human study for UNO therapy in solid tumors in the first half of this

Highlights and Upcoming Milestones

Viral Pneumonia (CAVP) Data (including COVID-19)

results for the fiscal quarter ended December 31, 2021

for the fiscal quarter ended December 31, 2021 was $0 as compared to $0.1 million for the fiscal quarter ended December 31, 2020, all

of which was licensing revenue.

and development expenses for the fiscal quarter ended December 31, 2021 were $2.5 million, compared to $3.3 million for the fiscal quarter

ended December 31, 2020.

and administrative expenses for the fiscal quarter ended December 31, 2021 were $4.9 million, compared to $2.5 million for the fiscal

quarter ended December 31, 2020.

income and expense for the fiscal quarter ended December 31, 2021 was a loss of $0.5 million.

the fiscal quarter ended December 31, 2021, the Company had a net loss of $8.0 million of which $7.7m or ($0.29) per share was attributable

to the shareholders of Beyond Air, compared to a net loss of $5.8 million, or ($0.33) per share for the fiscal quarter ended December

of December 31, 2021, the Company had cash and cash equivalents of $83.5 million.

February 10th @ 4:30 PM ET

https://viavid.webcasts.com/starthere.jsp?ei=1526516&tp_key=78e079398f or the

Events page of the Company's website

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 acute viral pneumonia (including COVID-19) 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 U.S. 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 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.

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.

Community Acquired 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.

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

with high morbidity and mortality. NTM infection is acquired by inhaling aerosolized bacteria from the environment, and can lead to NTM

lung disease, a progressive and chronic condition. According to the Cystic Fibrosis Foundation, 13% of U.S. cystic fibrosis patients

had a positive culture for a NTM species in 2017. NTM is an emerging public health concern worldwide because of its multi-drug antibiotic

resistance. Current treatment guidelines suggest a combination of multiple antibiotics dosed chronically 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 to cause severe adverse events. Beyond Air's system is designed to deliver

150 - 400 ppm NO to the lung, and early data indicate that this range of NO concentrations could have a positive effect on patients infected

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.