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Beyond Air Reports Financial Results for First Quarter of Fiscal Year 2021 and Provides Business Update U.S. COVID-19 study showing positive safety profile for patients enrolled to date PMA for LungFit TM PH to treat per

Key Takeaway: Air Reports Financial Results for First Quarter of Fiscal Year 2021 and Provides Business Update COVID-19 study showing positive safety profile for patients enrolled to date for LungFitTM PH to treat persistent pulmonary hypertension of the newborn (PPHN) expected to be submitt

Full Press Release Details

Air Reports Financial Results for First Quarter of Fiscal Year 2021 and Provides Business Update
COVID-19 study showing positive safety profile for patients enrolled to date
for LungFitTM PH to treat persistent pulmonary hypertension of the newborn (PPHN) expected to be submitted
to the FDA at the end of September 2020
HOME nontuberculous mycobacteria (NTM) lung infection pilot study expected to start by the end of calendar 2020
supply agreement executed for LungFitTM and LungFitTM PH
call scheduled for today, Thursday, August 6th at 8:30 am ET
CITY, N.Y., Aug. 06, 2020 (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 for the treatment of solid tumors, today announced financial results
for its fiscal first quarter ended June 30, 2020.
the quarter ended June 30th, the entire Beyond Air team continued to show their exceptional capabilities as we initiated
our U.S. COVID-19 study, released positive data in bronchiolitis showing vastly improved benefit with the 150 ppm nitric oxide
compared to the 85 ppm nitric oxide and control arms and revealed our potentially ground-breaking data in solid tumors. This positive
momentum is set to continue over the next few quarters with a planned submission of the PMA for the LungFitTM PH to
treat persistent pulmonary hypertension of the newborn (PPHN), continued enrollment in the U.S. study of the LungFit in COVID-19
patients, initiation of our AT-Home NTM study using the LungFitTM HOME system and progress in our solid tumor program,"
said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.
believe that nitric oxide can be an effective treatment for mild-to-moderate COVID-19 patients, and the LungFitTM is
by far the optimal system to deliver the 150 parts per million concentration needed in order for nitric oxide to be effective
against SARS-CoV-2. Given the progress we are making, we anticipate the opportunity this fall to evaluate the efficacy of nitric
oxide delivered by LungFitTM to COVID-19 patients," concluded Mr. Lisi.
First Quarter and Recent Highlights
Initiated U.S. clinical study using the LungFit system to treat COVID-19 patients with NO therapy.
Completed a commercial supply agreement with Spartronics, formerly Sparton, for the manufacture of LungFit TM and LungFit TM PH.
Announced positive top-line results from the third pilot study in bronchiolitis patients that showed high concentration NO (150 ppm) plus standard supportive therapy (SST) was statistically significant compared to both low concentration nitric oxide (85 ppm) plus SST and to SST alone on both the primary endpoint of fit-to-discharge and the key secondary endpoint of hospital length of stay with no serious adverse events related to NO reported. The company's bronchiolitis program is currently on hold, but is expected to resume once the pandemic subsides.
Published a peer-reviewed paper in the journal Scientific Reports that showed encouraging results from our second bronchiolitis study, indicating that NO is safe and efficacious in hospitalized infants with bronchiolitis.
Presented preclinical data in solid tumors showing NO, at concentrations of 25,000 to 200,000 ppm, eliminates colon and breast cancer cells in vitro and conveys anti-tumor immunity in vivo in a colon cancer model.
Ended the quarter with $24.4 million in cash and cash equivalents.
Expect to submit a PMA for the LungFit PH to treat persistent pulmonary hypertension of the newborn (PPHN) to the FDA at the end of September 2020. This filing has been delayed due to the ongoing COVID-19 pandemic.
Expect to initiate the At-Home nontuberculous mycobacteria (NTM) lung infection pilot study using the LungFit HOME by the end of 2020. This study start has been delayed due to the ongoing COVID-19 pandemic.
Updates expected over the coming months for the U.S. clinical program using the LungFit system to treat COVID-19 patients with NO.
Announce additional preclinical data this fall for high concentration NO as a potential treatment for ablating solid tumors and inducing an anti-tumor immune response.
results for three months ended June 30, 2020
for the three months ended June 30, 2020 was $229,161 as compared to $627,469 for the three month ended June 30, 2019, all of
which was licensing revenue.
and development expenses for the three months ended June 30, 2020 were $4.3 million, compared to $2.3 million for the three month
ended June 30, 2019.
and administrative expenses for the three months ended June 30, 2020 were $2.5 million, compared to $2.2 million for the three
month period ended June 30, 2019.
the three months ended June 30, 2020, the Company had a net loss of $6.7 million, or ($0.40) per share, compared to a net loss
of $6.2 million, or ($0.67) per share for the three months ended June 30, 2019.
of June 30, 2020, the Company had cash, cash equivalents and restricted cash of $24.4 million.
Conference Call & Webcast
Thursday, August 6 th @ 8:30 am ET
Domestic: 888-220-8474
International: 323-794-2590
Passcode: 7088663
Webcast: http://public.viavid.com/index.php?id=140846
Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery
System, the LungFit , that uses NO generated from ambient air to deliver precise amounts of NO to the lungs of ventilated
and non-ventilated patients 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 in clinical trials for the
treatment of severe lung infections such as SARS-CoV-2, bronchiolitis and nontuberculous mycobacteria (NTM). Additionally, Beyond
Air is using ultra-high concentrations of NO with a proprietary delivery system, separate from the LungFit , 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 resistant strains.
the LungFit NO Generator and Delivery System*
Air's LungFit NO Generator and Delivery System is a cylinder-free, phasic flow nitric oxide delivery system and has
been designated as a medical device by the US 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
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 nor 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.
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 over 80 ppm NO, for which preliminary
studies indicate may eliminate bacteria, viruses, fungi and other microbes from the lungs.
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.
(coronavirus disease 2019) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
COVID-19 first emerged in Wuhan, China in December of 2019. Those affected develop fever, cough, shortness of breath and/or difficulty
breathing. While the majority of cases result in mild symptoms, some can progress to pneumonia and multi-organ failure. Older
adults and people who have serious chronic medical conditions are at an increased risk of developing severe complications from
COVID-19. There is no specific treatment approved for COVID-19 and patients are managed with supportive care. 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 process1,2,3. As of August 5, 2020, more than 18 million confirmed cases of COVID-19 and more than 690,000
deaths have been reported globally.
Tripathi et al, FEMS Immunology and Medical Microbiology, December 2017
Saura, M., et al., An antiviral mechanism of nitric oxide: inhibition of a viral protease. Immunity, 1999. 10(1): p. 21-8.
Akerstr m S et al. Nitric oxide inhibits the replication cycle of severe acute respiratory syndrome coronavirus. J Virol.
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
Last updated: Aug 6, 2020