Beyond Air Reports Financial Results for Fiscal Fourth Quarter and Year-End 2020

Beyond Air, Inc. 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 fourth quarter and fiscal year ended March 31, 2020.

Recent Highlights and Upcoming Milestones

• 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) is statistically significant compared to both low concentration nitric oxide (85 ppm) plus SST and 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
• Published a peer-reviewed paper in the Scientific Reports journal that showed encouraging results from our second bronchiolitis study which indicate NO is safe and efficacious in hospitalized infants with bronchiolitis
• Enrolled the first patient in the U.S. clinical study using the LungFit™ system to treat COVID-19 with NO therapy
• Received approval from Health Canada to use the LungFit™ system for a study in hospitalized patients diagnosed with COVID-19
• The PMA for the LungFit™ PH to treat persistent pulmonary hypertension of the newborn (PPHN) is currently expected to be submitted to the FDA in the second half of 2020. This filing was delayed due to the ongoing COVID-19 pandemic
• The initiation of the At-Home nontuberculous mycobacteria (NTM) lung infection pilot study using the LungFit™ HOME is currently expected to start by the end of 2020. This study start was delayed due to the ongoing COVID-19 pandemic
• Ended the quarter with $25.5 million in cash and cash equivalents

“This is an exciting time for Beyond Air as we continue to make progress in our development pipeline. We have several opportunities to drive long-term shareholder value, with a number of significant milestones expected to occur in the second half of this year and into 2021, most notably our LungFit™ PH PMA submission and, subsequent anticipated FDA approval,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “During the past three months, we rapidly responded to the ongoing pandemic environment and launched a U.S. COVID-19 study using our LungFit™ system, also receiving approval to begin a similar study in Canada. Considering the data compiled to date with high concentration NO, most notably the three completed pilot clinical studies in bronchiolitis where infants were hospitalized due to viral infections, we believe that this system could be a significant tool in the battle against this coronavirus. As such, we look forward to announcing the data from the U.S. and Canadian COVID-19 studies. The rapid response to the pandemic of developing this program is quite an impressive accomplishment by a very special team here at Beyond Air.”

Financial results for three months ended March 31, 2020

Revenue for the three months ended March 31, 2020 was ($200,000) as compared to $7.7 million for the three month ended March 31, 2019, all of which was licensing revenue.  

Research and development expenses for the three months ended March 31, 2020 were $2.9 million, compared to $1.6 million for the three month ended March 31, 2019.

General and administrative expenses for the three months ended March 31, 2020 were $2.2 million, compared to $2.6 million for the three month period ended March 31, 2019.

For the three months ended March 31, 2020, the Company had a net loss of $5.3 million, or ($0.36) per share, compared to a net loss of $100,000, or ($0.01) per share for the three months ended March 31, 2019.

Financial results for fiscal year ended March 31, 2020

Revenue for the fiscal year ended March 31, 2020 was $1.4 million as compared to $7.7 million for fiscal the year ended March 31, 2019, all of which was licensing revenue.   

Research and development expenses for the fiscal year ended March 31, 2020 were $10.6 million, compared to $3.9 million for the fiscal year ended March 31, 2019.

General and administrative expenses for the fiscal year ended March 31, 2020 were $8.9 million, compared to $6.9 million for the fiscal year March 31, 2019.

For the fiscal year ended March 31, 2020, the Company had a net loss attributed to common shareholders of $20.5 million, or ($1.78) per share, compared to a net loss of $6.6 million, or ($0.77) per share for the fiscal year ended March 31, 2019.

As of March 31, 2020, the Company had cash, cash equivalents and restricted cash of $25.5 million. 

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About Beyond Air, Inc.
Beyond 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.

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.

About the LungFit™ NO Generator and Delivery System*
Beyond 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 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.

About PPHN
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 Bronchiolitis
The 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.

About NTM
Nontuberculous 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.

About Solid Tumors
Cancer 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 high concentrations has been reported to show anticancer properties and to serve as a chemosensitizer and radiotherapy enhancer. Based on its current findings, Beyond Air is developing treatment protocols using ultra-high nitric oxide concentrations to ablate primary tumors and treat metastatic disease.

CONTACTS:
Steven Lisi, Chief Executive Officer
Beyond Air, Inc.
Slisi@beyondair.net

Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com