Full Press Release Details
Beyond Air Reports Financial Results
for Third Quarter of Fiscal Year 2021 and Provides Business Update
reviewing premarket approval (PMA) submission for LungFitTM PH to treat persistent pulmonary hypertension of the newborn
(PPHN), as Company prepares for commercialization
results from the acute viral pneumonia (including SARS-CoV-2) pilot study using 150 ppm nitric oxide (NO) with LungFitTM
PRO expected in Spring 2021
results expected mid-calendar year 2021 for Nontuberculous Mycobacteria (NTM) lung infection at-home pilot study where NO is self-administered
at concentrations up to 250 ppm nitric oxide with LungFitTM GO
Conference call scheduled for today, February
9th, at 4:30 p.m. ET
Garden City, NY, February 9, 2021 -
Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric
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 third fiscal quarter ended December
"Over the past several months, Beyond
Air has made significant clinical and regulatory progress across several indications, led by the filing of our PMA for LungFitTM
PH to treat PPHN. This PMA is currently undergoing the 180-day review process at FDA, and if approved, LungFitTM PH
will be the first and only commercially available product able to generate NO from ambient air. Commercial preparations are underway
for a launch this summer," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.
"The Beyond Air team has continued to
deliver on the R&D front throughout 2020 and into 2021, with interim data expected from two additional pilot trials over the
next six months: the acute viral pneumonia (including COVID-19) study using LungFitTM PRO, and the at-home NTM study
with LungFitTM GO. Success in these indications will further validate the safety and efficacy of the broader LungFitTM
platform technology and allow us to move to high concentration NO in hospitals as well as the large, untapped home market where
we can help patients with other severe lung infections with various underlying conditions such as COPD. We also continue to make
progress in our solid tumor program using ultra-high concentration gNO, with the goal of starting human studies by the end of 2021.
Finally, the bronchiolitis program remains on hold with the start date of the pivotal study relying heavily on the state of the
Fiscal Third Quarter and Recent Highlights
| LungFit PH | ||
| FDA review of the PMA to treat PPHN is ongoing; It was submitted in November 2020 and is subject to the 180-day review process |
| LungFit PRO | ||
| Initiated an acute viral pneumonia (including COVID-19) pilot study in Israel using LungFit PRO at 150 ppm NO | ||
| In vitro data with NO-treated OC43 human coronavirus infected cells presented at the CHEST Annual Meeting 2020; data suggested that the LungFit PRO system may be effective for both prevention and treatment of human coronavirus infection with 150-250 ppm NO intermittent dosing regimen | ||
| Announced positive efficacy and safety data from the third bronchiolitis pilot study at the CHEST Annual Meeting 2020 supporting the development of inhaled NO as a treatment for this unmet medical need; the program is currently on hold due to the COVID-19 pandemic | ||
| LungFit GO | ||
| Initiated an at-home pilot study in Australia using LungFit TM GO for self-administration of up to 250 ppm NO for the treatment of refractory Nontuberculous Mycobacteria (NTM) lung disease in adult patients | ||
| Solid Tumor Program | ||
| Presented preclinical data for exogenous high concentration gNO at the AACR Conference on Tumor Immunology and Immunotherapy. These data suggest that direct administration of gNO to solid tumors triggers a systemic anti-tumor immune response, which could serve as the basis for an effective immunotherapy | ||
| In vitro and in vivo preclinical data presented at the International Association for the Study of Lung Cancer's (IASLC) North America Conference on Lung Cancer 2020 (NACLC 2020) suggest that high concentration gNO may treat lung cancer locally and its metastases systemically | ||
| Upcoming Milestones | ||
| LungFit PH | ||
| Anticipate receiving FDA approval to treat PPHN in the second quarter of calendar year 2021 | ||
| Commercial launch in the United States planned for approximately 4-6 weeks after FDA approval | ||
| LungFit PRO | ||
| Planning to report interim data for the acute viral pneumonia study in Spring 2021 | ||
| LungFit GO | ||
| Expect to report interim data for the at-home NTM lung infection pilot study in the middle of calendar year 2021 | ||
| Solid Tumor Program | ||
| Anticipate initiation of human studies by the end of calendar year 2021 |
Financial results for three months ended
Revenue for the three months ended December
31, 2020 was $149,000 as compared to $314,000 for the three months ended December 31, 2019, all of which was licensing revenue.
Research and development expenses for the three
months ended December 31, 2020 were $3.3 million, compared to $2.6 million for the three months ended December 31, 2019.
General and administrative expenses for the
three months ended December 31, 2020 were $2.5 million, compared to $2.5 million for the three months ended December 31, 2019.
For the three months ended December 31, 2020,
the Company had a net loss of $5.8 million, or ($0.33) per share, compared to a net loss of $4.9 million, or ($0.43) per share
for the three months ended December 31, 2019.
As of December 31, 2020, the Company had cash,
cash equivalents and restricted cash of $22.7 million.
Conference Call & Webcast
Tuesday, February 9th @ 4:30 pm ET
Domestic: 877-407-0784
International: 201-689-8560
Beyond 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 SARS-CoV-2 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.
About Nitric Oxide (NO)
Nitric 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.
Beyond 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 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 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.
Persistent 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.
About Acute Viral Pneumonia
In 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.
COVID-19 (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