Beyond Air Reports Financial Results for the First Quarter of Fiscal Year 2022 U.S. FDA reviewing premarket approval (PMA) submission for LungFit PH to treat persistent pulmonary hypertension of the newborn (PPHN); On tr

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

FDA reviewing premarket approval (PMA) submission for LungFit PH to treat persistent pulmonary hypertension of the newborn

(PPHN); On track for commercial launch in the fourth quarter of calendar year 2021

reporting interim results from the LungFit GO Nontuberculous Mycobacteria (NTM) lung infection at-home pilot study (self-administration)

data presented at American Thoracic Society in May 2021 from acute viral pneumonia (including COVID-19) study using LungFit

tumor program expected to receive regulatory clearance to initiate first in human studies by the end of calendar year 2021

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

CITY, N.Y., Aug. 10, 2021 (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 first fiscal quarter ended June 30, 2021.

commercial team is ready to introduce the LungFit PH system to hospitals across the United States, with FDA approval

anticipated to be received at the end of next month. I am confident in our ability to successfully bring to market what will be the first-ever

FDA approved generator and delivery system that produces NO from ambient air. LungFit PH is designed to offer a simple,

safe, cost effective and convenient alternative to the NO delivery systems that are currently available to treat PPHN," said Steve

Lisi, Chairman and Chief Executive Officer of Beyond Air. "We are making progress in our other programs and anticipate reporting

interim data from our at-home NTM pilot study using LungFit GO in the fall. Our LungFit PRO acute viral

pneumonia study in adults, which includes COVID-19 patients, remains open and we expect to discuss our progress with FDA this fall in

order to plan next steps. We also expect to receive regulatory clearance to start human studies in our solid tumor program using ultra-high

concentration gNO around the end of calendar year 2021 and begin enrolling patients in early 2022."

Fatkin, Chief Commercial Officer of Beyond Air, stated, "Our initial commercial launch team is in place with experienced leaders

to head our sales and marketing efforts in the US, and our partnership efforts internationally. We established our supply chain well

in advance and are now in the process of finalizing our marketing plan. As we get closer to the anticipated approval date, we are increasingly

excited to fulfill Beyond Air's vision of harnessing the power of nitric oxide to transform the lives of patients."

Highlights and Upcoming Milestones

Viral Pneumonia Data

Study (pending discussions with FDA in Fall 2021)

results for the fiscal quarter ended June 30, 2021

for the fiscal quarter ended June 30, 2021 was $0 as compared to $229,000 for the fiscal quarter ended June 30, 2020, all of which was

and development expenses for the fiscal quarter ended June 30, 2021 were $2.7 million, compared to $4.3 million for the fiscal quarter

ended June 30, 2020.

and administrative expenses for the fiscal quarter ended June 30, 2021 were $3.9 million, compared to $2.5 million for the fiscal quarter

ended June 30, 2020.

the fiscal quarter ended June 30, 2021, the Company had a net loss of $6.7 million, or ($0.31) per share, compared to a net loss of $6.7

million, or ($0.41) per share for the fiscal quarter ended June 30, 2020.

of June 30, 2021, the Company had cash, cash equivalents and restricted cash of $39.6 million.

August 10th @ 4:30 PM ET

http://public.viavid.com/index.php?id=145783 or the Events page of the Company's

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.

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.

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.

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.

is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths.

Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Nitric oxide at ultra-high

concentrations has been reported to show anticancer properties and to serve as a chemosensitizer and radiotherapy enhancer. Based on

its current findings, Beyond Air is developing treatment protocols using ultra-high nitric oxide concentrations to ablate primary tumors