Full Press Release Details
Air Reports Financial Results for Fourth Fiscal Quarter and Year-End 2021
first premarket approval (PMA) application in the Company's history to FDA for LungFit
PH to treat persistent pulmonary
hypertension of the newborn (PPHN); Company preparing for commercial launch in the fourth quarter of calendar year 2021
the commercial and business development teams by appointing executives with extensive nitric oxide (NO) experience
positive data for 150 - 160 ppm NO from LungFit
PRO programs in hospitalized
patients (adults and infants) with viral lung infections at CHEST 2020 and at ATS 2021
grant from the Cystic Fibrosis Foundation (CFF) for ongoing nontuberculous mycobacteria (NTM) at-home pilot study delivering up to 250
ppm NO via LungFit GO
positive preclinical data for the solid tumor program at three scientific conferences; data suggest exogenous ultra-high concentration
gaseous NO (gNO) can trigger anti-tumor immunity
call scheduled for today, Thursday, June 10th, at 4:30 p.m. ET
City, NY, June 10, 2021 - 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 (gNO) for the treatment of solid tumors, today announced financial results for its fourth
quarter and fiscal year ended March 31, 2021.
submission of the first PMA application to the FDA in our Company's history has placed us on a clear path for the transformative
year ahead. I am confident that when approved to treat PPHN, LungFit PH will revolutionize the market as the first and only commercially
available system that is capable of generating NO from ambient air. In preparation for commercial launch, our organization has grown
considerably over the past twelve months, recruiting unparalleled talent with extensive experience in the NO market. I believe our team
is more than prepared to bring our first NO generator and delivery system to NICUs across the United States later this year," said
Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.
beyond PPHN, we have made progress in our other potential indications for the LungFit platform, which have much larger underserved
patient populations. We recently presented positive data at ATS 2021 for high concentration NO in patients hospitalized with acute viral
pneumonia, including COVID-19. We believe the entirety of data that we have presented at 150 - 160 ppm NO in both adult and infant
patient populations supports further development of LungFit PRO. Given the seasonality of viral pneumonia, we anticipate completing
a pivotal study at the end of the 2022-23 pneumonia season in the United States. Additionally, our at-home NTM pilot study using LungFit
GO is progressing nicely, and we are pleased with the performance of our device. We expect to present interim results from this study
at a medical or scientific conference in the Fall of 2021. Success in NTM will further validate the safety and efficacy of LungFit
GO and allow us to move high concentration NO into the large, untapped home market for lung infections. Finally, we expect to receive
regulatory clearance to start human studies in our solid tumor program using ultra-high concentration gNO around the end of calendar
Year 2021 and Recent Highlights
| - | Submitted a PMA application to the U.S. FDA in November 2020 for the treatment of PPHN | |
| - | Appointed NO industry veterans to the roles of Head of Sales, Head of Marketing, and Director of Business Development to support the commercial launch, as well as lead partnership efforts outside of the U.S. | |
| - | Completed the rigorous task of implementing our global supply chain through the Company's subsidiary in Ireland |
Viral Pneumonia Data
| - | Presented interim analysis from the ongoing pilot study for acute viral pneumonia, including COVID-19 patients, at the American Thoracic Society (ATS) International Conference in May 2021; results showed that 150 ppm NO was well-tolerated with no treatment-related adverse events, and showed encouraging efficacy signals for hospital length of stay and duration of oxygen supplementation | |
| - | Initiated a pilot study for acute viral pneumonia, including COVID-19 patients, in Israel using LungFit PRO at 150 ppm NO; patient enrollment began in November 2020 | |
| - | Presented in vitro data on NO-treated OC43 human coronavirus at the CHEST Annual Meeting in October 2020; data suggested that 150 - 250 ppm NO delivered intermittently via LungFit PRO may be effective for both prevention and treatment of human coronavirus infection |
| - | Presented further analysis of three previously reported pilot studies in bronchiolitis at the American Thoracic Society (ATS) International Conference in May 2021; results show that 150 - 160 ppm NO demonstrated a favorable safety profile and consistent efficacy across multiple endpoints, as well as statistical significance on multiple efficacy endpoints of 150 ppm compared to 85 ppm in a head-to-head study | |
| - | Announced detailed positive efficacy and safety data from the third bronchiolitis pilot study at the CHEST Annual Meeting in October 2020, supporting the development of 150 ppm inhaled NO as a treatment for this unmet medical need | |
| - | 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 infants hospitalized with bronchiolitis |
| - | Received a grant for up to $2.17 million from the CFF to advance the clinical development of inhaled NO to treat NTM lung disease by helping fund the ongoing pilot study | |
| - | Initiated an at-home pilot study in Australia using LungFit GO for self-administration of up to 250 ppm NO for the treatment of refractory NTM lung disease in adult patients; patient screening began December 2020 | |
| - | Published the results from a compassionate use patient case study using NO to treat pulmonary Mycobacterium abscessus infection at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, in a scientific article in the August 2020 edition of Access Microbiology |
| - | Presented in vivo preclinical data for exogenous ultra-high concentration gNO at the American Association for Cancer Research (AACR) Conference on Tumor Immunology and Immunotherapy in October 2020. 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 | |
| - | Presented in vitro and in vivo preclinical data at the International Association for the Study of Lung Cancer's (IASLC) North America Conference on Lung Cancer 2020 (NACLC 2020) in October 2020, that suggest ultra-high concentration gNO may treat lung cancer locally and its metastases systemically | |
| - | Presented in vivo and in vitro preclinical data in solid tumors at the AACR Virtual Annual Meeting II in June 2020. The data showed that gNO, 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 |
| - | Anticipate receiving FDA approval to treat PPHN late in the third quarter of calendar year 2021 | |
| - | Commercial launch in the United States planned for the fourth quarter of calendar year 2021 | |
| - | Expect to secure ex-U.S. commercial partnership in 2022 after obtaining CE Mark in the European Union around the end of calendar year 2021 |
results for the fiscal year ended March 31, 2021
for the fiscal year ended March 31, 2021 was $873 thousand as compared to $1.4 million for the fiscal year ended March 31, 2020, all
of which was licensing revenue.
and development expenses for the fiscal year ended March 31, 2021 were $12.6 million, compared to $10.6 million for the fiscal year ended
and administrative expenses for the fiscal year ended March 31, 2021 were $10.5 million, compared to $8.9 million for the fiscal year
ended March 31, 2020.
the fiscal year ended March 31, 2021, the Company had a net loss of $22.9 million, or ($1.27) per share, compared to a net loss of $20.5
million, or ($1.78) per share for the fiscal year ended March 31, 2020.
May 2021, the Company reached a settlement agreement with former LungFit PH commercial licensee, Circassia Group plc ("Circassia").
Under the terms of the agreement, Beyond Air retains global commercialization rights to LungFit PH for payment of $10.5 million,
along with future royalty payments capped at $6.0 million. Beyond Air will begin making payments only after receiving U.S. FDA approval
for LungFit PH in accordance with the following schedule: $2.5 million upon FDA approval, $3.5 million one year after FDA approval,
and $4.5 million two years after FDA approval. Beginning in year three post-approval, Circassia will receive a quarterly royalty payment
equal to 5% of LungFit PH net sales in the U.S. This royalty will terminate once the aggregate payment reaches $6.0 million.
of March 31, 2021, the Company had cash, cash equivalents and restricted cash of $35.3 million. Additionally, as previously reported,
the Company had cash, cash equivalents, and restricted cash of $34.9 million as of April 30, 2021.
June 10th @ 4:30 pm ET
http://public.viavid.com/index.php?id=145098 or the Events page of the Company's website
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 acute viral pneumonia (including
COVID-19) 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.
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 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.
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.
Acute 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) is a rare and serious bacterial infection in the lungs causing debilitating pulmonary disease associated with increased