Full Press Release Details
Air Reports Financial Results
the Second Quarter of Fiscal Year 2023
launch underway for LungFit PH for the treatment of term and near-term neonates with hypoxic respiratory failure, which received
FDA approval on June 28, 2022
favorable safety, tolerability, and efficacy results from the pilot study of at-home LungFit GO for nontuberculous mycobacterial
(NTM) lung infection at the American College of Chest Physicians (CHEST)
data showing prolonged survival for ultra-high concentration nitric oxide (UNO) in combination with anti-PD1 to be unveiled at the Society
for Immunotherapy of Cancer (SITC) on November 10, 2022
call scheduled for 4:30 p.m. ET today, November 8th
City, NY, November 8, 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, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment
of solid tumors, today announced financial results for its second fiscal quarter ended September 30, 2022.
commercial team continues to successfully execute the initial phase of the LungFit PH launch following FDA approval in late-June 2022.
Over the past few months, the demand for product evaluations and demonstrations have exceeded expectations. We are pleased to report
that participating hospital staff have provided a steady flow of positive feedback," commented Steve Lisi, Chairman and Chief Executive
Officer of Beyond Air. "In addition, we are planning to submit a PMA supplement for an expanded cardiac label for the LungFit
PH system to the FDA."
the quarter, we presented positive data that support the development programs for the LungFit system using high dose NO as a potential
treatment for several indications. At the CHEST Annual Meeting 2022 we presented favorable safety, tolerability, and efficany data for
our LungFit GO pilot at-home study of patients with severe, treatment refractory, NTM lung disease, which further support development
of intermittent high dose NO for the treatment of NTM as well as other chronic respiratory infections. We believe this study breaks new
ground in the development of NO therapy by successfully showing the ability of our at-home NO generator-based system to be used safely
and consistently by this patient population in a real-world setting."
we are excited to announce that Beyond Cancer's first-in-human Phase 1 study of UNO for the treatment of solid tumors designed
to assess safety and efficacy is moving along after the first patient was treated in August 2022. We expect to announce topline data
from the Phase 1 study in the first half of 2023," concluded Mr. Lisi.
Highlights and Upcoming Milestones
Results for the fiscal quarter ended September 30, 2022
and development expenses for the fiscal quarter ended September 30, 2022 were $4.5 million, compared with $2.8 million for the fiscal
quarter ended September 30, 2021. The increase is primarily attributable to increased spending on UNO.
and administrative expenses for the fiscal quarter ended September 30, 2022 increased to $8 million, compared with $3.4 million for the
fiscal quarter ended September 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 PH in the U.S.
income and expense for the fiscal quarter ended September 30, 2022 was a loss of $0.2 million, compared with a loss of $2.5 million for
the fiscal quarter ended September 30, 2021.
the fiscal quarter ended September 30, 2022, Beyond Air, Inc. (the "Company") had a net loss of $12.8 million, of which $12.0
million, or ($0.40) per share, was attributable to the shareholders of Beyond Air, compared with a net loss of $8.7 million, or ($0.36)
per share, for the fiscal quarter ended September 30, 2021.
of September 30, 2022, the Company reported cash and cash equivalents, marketable securities, and restricted cash of $72.5 million.
cash burn in the quarter ended September 30, 2022 was $10.4 million, just above the quarterly cash burn guidance of $8.0 - 10.0
million, and includes a $2.5 million non-recurring payment. The Company expects to see the quarterly average cash burn during the fiscal
year 2023 to fall within this range. Through first half of our fiscal year ended September 30, 2022, total cash burn was $17.9 million.
November 8th@ 4:30 PM ET
| Domestic: | 1- 844-825-9789 | |
| International: | 1- 412-317-5180 | |
| Passcode: | 10172080 | |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1576040&tp_key=65a361d2ed or the Events page of the Company's website ( click here ) |
Air is a medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide 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 viral community-acquired
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 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.
Air's LungFit is a cylinder-free, phasic flow 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 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 to treat term and near-term neonates
with hypoxic respiratory failure. 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.
Viral Community-Acquired Pneumonia (VCAP)
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. 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 replication process.
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 considered 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 lungs, and early data, including from the pilot study of the LungFit GO, indicate that
this range of NO concentrations could 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