Full Press Release Details
Air Reports Financial Results for the Second Quarter of Fiscal Year 2022
FDA actively reviewing premarket approval (PMA) submission for LungFit PH to treat persistent pulmonary hypertension
of the newborn (PPHN); Remain on track for commercial launch in the fourth quarter of calendar year 2021
$23.9 million to form a new private, independently managed entity, called Beyond Cancer, Ltd, to advance the development of ultra-high
concentration nitric oxide (UNO) for the treatment of solid tumors
interim results reported from the LungFit GO Nontuberculous Mycobacteria (NTM) lung infection at-home pilot study (self-administration),
with full efficacy and safety data expected in CY2022
call scheduled for today, November 11th, at 4:30 p.m. ET
CITY, N.Y., Nov. 11, 2021 (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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for
the treatment of solid tumors, today announced financial results for its first fiscal quarter ended September 30, 2021.
Lisi, Chairman and Chief Executive Officer of Beyond Air commented, "This has been an exciting quarter for Beyond Air, as the team
continues to deliver both operationally and strategically. On the strategic front, the launch of Beyond Cancer under the new leadership
of CEO Selena Chaisson, M.D. is a special achievement. The separation of the UNO franchise to an independently managed affiliate was
made possible through the support of investors in a $23.9 million ongoing private financing. We believe that the spin-off will accelerate
UNO's path to the clinic and create long-term value for shareholders. Beyond Cancer will leverage our NO expertise, IP portfolio,
preclinical oncology team, regulatory progress, and initially use existing Company infrastructure. The separation enables Beyond Air
to focus on its core business of advancing its LungFit platform for the treatment of respiratory diseases."
Lisi continued, "Consistent with our global regulatory update from September, our PMA for LungFit PH continues
to be under review at FDA. We successfully completed our Stage 1 Assessment Audit for a CE Mark in Europe and anticipate approval during
the first half of calendar year 2022, after which we plan to partner the program internationally. In the United States, we continue to
guide a commercial launch in the fourth quarter of this calendar year. Our commercial team has grown considerably and is ready to bring
the first-ever integrated generator and delivery system that produces NO to hospitals across the country. The Beyond Air team also continues
to execute on the R&D front with the release of interim data from our NTM pilot study using LungFit GO to deliver
up to 250 ppm NO in a home setting. Despite the COVID-19 related lockdowns in Australia, as of September 6th we had 8 patients
successfully enrolled and titrated up to 250 ppm NO, with no study discontinuations and no treatment-related serious adverse events.
The pilot study continues enrolling patients, and we expect to report complete safety and efficacy results in 2022."
Highlights and Upcoming Milestones
| Commercial launch in the United States on track for the fourth quarter of calendar year 2021, pending FDA PMA approval | ||
| Successfully completed Stage 1 Assessment Audit in the CE Mark process; expect to receive CE Mark in 1H CY2022 followed by international commercial partnership |
Viral Pneumonia Data
Study (pending discussion with FDA)
| Reported positive interim data for 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 | ||
| Interim results showed that 250 ppm NO was well-tolerated with no study discontinuations or treatment-related serious adverse events observed in 8 patients, with methemoglobin and NO 2 concentrations remaining within acceptable safety ranges in all subjects | ||
| Expect to report full efficacy and safety data for the at-home NTM lung infection pilot study at a medical or scientific conference in calendar year 2022 | ||
| Published a compassionate use case study called " Non-tuberculous mycobacteria infection treated with intermittently inhaled high-dose nitric oxide " using high concentration NO treatment to treat the Mycobacterium abscessus strain of NTM in The BMJ 1 |
| Secured commitments of $23.9 million in a concurrent private placement of common shares, not to exceed $30 million, to form Beyond Cancer that will leverage Beyond Air's NO experience and accelerate and enhance the solid tumor pipeline | ||
| After this financing, Beyond Air will retain at least 80% equity ownership in Beyond Cancer | ||
| Anticipate beginning enrollment of patients in the first half of calendar year 2022 |
Goldbart A, Gatt D, Golan Tripto I. BMJ Case Rep 2021;14:e243979. doi:10.1136/bcr-2021-243979
results for the fiscal quarter ended September 30, 2021
for the fiscal quarter ended September 30, 2021 was $0 as compared to $350,000 for the fiscal quarter ended September 30, 2020, all of
which was licensing revenue.
and development expenses for the fiscal quarter ended September 30, 2021 were $2.8 million, compared to $3.1 million for the fiscal quarter
ended September 30, 2020.
and administrative expenses for the fiscal quarter ended September 30, 2021 were $3.4 million, compared to $2.2 million for the fiscal
quarter ended September 30, 2020.
income and expense for the fiscal quarter ended September 30, 2021 was a loss of $2.5 million, compared to a loss of $0.2 million for
the fiscal quarter ended September 30, 2020.
the fiscal quarter ended September 30, 2021, the Company had a net loss of $8.7 million, or ($0.36) per share, compared to a net loss
of $5.1 million, or ($0.30) per share for the fiscal quarter ended September 30, 2020.
of September 30, 2021, the Company had cash, cash equivalents and restricted cash of $48.7 million.
November 11th @ 4:30 PM ET
http://public.viavid.com/index.php?id=146470 or the Events page of the Company's
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) 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 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 lung, and early data indicate that this range of NO concentrations could have a positive effect on patients infected
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