Beyond Air Reports Financial Results for the First Quarter of Fiscal Year 2023 Initiated U.S. commercial launch of LungFit PH for the treatment of term and near-term neonates with hypoxic respiratory failure, which recei

Air Reports Financial Results

the First Quarter of Fiscal Year 2023

U.S. commercial launch of LungFit PH for the treatment of term and near-term neonates with hypoxic respiratory failure,

which received FDA approval on June 28, 2022

present data from the pilot study of at-home LungFit GO for nontuberculous mycobacterial lung infection at the American

College of Chest Physicians (CHEST) in October 2022

dosing the first patient in the Phase I trial of ultra-high concentration gaseous NO (UNO) being conducted by Beyond Cancer , the

Company's oncology affiliate, during the current quarter

call scheduled for 4:30 p.m. ET today, August 11th

CITY, N.Y., Aug. 11, 2022 - Beyond Air, Inc. (NASDAQ: XAIR), a 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 first fiscal quarter ended June 30, 2022.

sales team has quickly ramped up the initial phase of the commercial launch for the LungFit PH, which received FDA approval

in late-June. This initial activity includes conducting product demonstrations at numerous U.S. hospitals, which we are pleased to report

have generated positive feedback from the participating hospital staff. We are also highly encouraged by the feedback received during

the medical conferences our team has attended since approval. The early success of this program and initial feedback received is expected

to put us on schedule to equip the first small group of hospitals with LungFit PH systems over the next several months.

We look forward to the upcoming American Association for Respiratory Care (AARC) in November and encourage investors to come see us in

New Orleans," commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "We continue to expect to receive

CE Mark for LungFit PH in Europe during the second half of calendar year 2022. In addition, we are planning to submit

a PMA supplement for an expanded cardiac label for the LungFit PH system to the U.S. FDA."

Highlights and Upcoming Milestones

Results for the fiscal quarter ended June 30, 2022

and development expenses for the fiscal quarter ended June 30, 2022 were $3.2 million, compared with $2.7 million for the fiscal quarter

ended June 30, 2021.

and administrative expenses for the fiscal quarter ended June 30, 2022 increased to $8.2 million, compared with $3.9 million for the

fiscal quarter ended June 30, 2021. The increase is mainly attributable to the staffing and scaling up of Beyond Cancer in both the U.S.

and Israel, as well as continued investments necessary to support the commercial launch of LungFit

income and expense for the fiscal quarter ended June 30, 2022 was a loss of $0.2 million, compared with a loss of $0.2 million for the

fiscal quarter ended June 30, 2021.

the fiscal quarter ended June 30, 2022, the Company had a net loss of $11.7 million, of which $10.9 million, or ($0.37) per share, was

attributable to the shareholders of Beyond Air, compared with a net loss of $6.7 million, or ($0.31) per share, for the fiscal quarter

ended June 30, 2021.

of June 30, 2022, the Company reported cash and cash equivalents of $72.8 million.

cash used in operations, including Beyond Cancer, was $6.8 million in the fiscal quarter ended June 30, 2022. This is below the quarterly

cash burn guidance of $8.0 - 10.0 million. The Company expects to see the quarterly average cash burn during the fiscal year 2023

to fall within this range.

August 11th @ 4:30 PM ET

Air, Inc. is a medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide (NO) through its 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 has received FDA approval for its first system, LungFit PH for persistent pulmonary hypertension of the newborn. Beyond Air is

currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as community-acquired

viral pneumonia (including COVID-19), nontuberculous mycobacteria (NTM) and severe lung infections in other settings. Additionally, Beyond

Cancer, an affiliate of Beyond Air, is investigating 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 PH is approved for commercial use only in the United States of America. Beyond Air's

other LungFit systems are not approved for commercial use and are 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.

Beyond Cancer: UNO Therapy for Solid Tumors

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