Beyond Air Provides Regulatory Update for LungFit

Air Provides Regulatory Update for LungFit PH

CITY, N.Y., Dec. 09, 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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for

the treatment of solid tumors, today announced an update to the expectations for U.S. Food and Drug Administration (FDA) approval of

LungFit PH for the treatment of persistent pulmonary hypertension of the newborn, or PPHN.

upon our ongoing communications with the FDA, the Company no longer believes that the U.S. commercial launch of LungFit

PH will take place prior to December 31, 2021. Beyond Air remains on track to receive CE Mark for LungFit PH in Europe

in the first half of calendar year 2022.

Beyond Air team continues to work towards our goal of bringing LungFit PH, the groundbreaking nitric oxide generator

and delivery system, to NICUs across the United States and the world as soon as possible," commented Steve Lisi, Chairman and CEO

of Beyond Air. "We commend the FDA for their continued commitment to provide us with a comprehensive review of our application.

We shall continue to collaboratively work with the FDA to approve LungFit PH."

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, through its affiliate, Beyond Cancer, 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

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.

press release contains "forward-looking statements" concerning inhaled nitric-oxide and the Company's LungFit

product, including statements with regard to potential regulatory developments and the expected timing thereof, expected product launch

for the Company's LungFit product and the timing thereof, and the potential impact on patients and anticipated

benefits associated with its use. Forward-looking statements include statements about our expectations, beliefs, or intentions regarding

our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking

statements by the words "anticipates," "expects," "intends," "impacts," "plans,"

"projects," "believes," "estimates," "likely," "goal," "assumes,"

"targets" and similar expressions and/or the use of future tense or conditional constructions (such as "will,"

"may," "could," "should" and the like) and by the fact that these statements do not relate strictly

to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or

results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements

are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed

or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date

they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ

materially from the activities and results anticipated in forward-looking statements, including risks related to: the potential that

regulatory authorities, including the FDA and EMA, may not grant or may delay approval for our product candidate; the impact of the COVID-19

pandemic on the FDA's review process; our approach to discover and develop novel drugs, which is unproven and may never lead to

efficacious or marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining

and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our

patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities;

our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development

of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from

others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; our short operating

history and other risks identified and described in more detail in the "Risk Factors" section of the Company's most

recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on our website. We undertake no obligation

to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.

Yonkoski, Head of Investor Relations