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Beyond Air Reports Financial Results for Fourth Fiscal Quarter and Year-End 2022 LungFit PH received FDA approval for the treatment of term and near-term neonates with hypoxic respiratory failure on

Key Takeaway: Air Reports Financial Results for Fourth Fiscal Quarter and Year-End 2022 PH received FDA approval for the treatment of term and near-term neonates with hypoxic respiratory failure on June 28, 2022 and the first phase of U.S. commercial launch has begun positive data for high-

Full Press Release Details

Air Reports Financial Results for Fourth Fiscal Quarter and Year-End 2022
PH received FDA approval for the treatment of term and near-term neonates with hypoxic respiratory failure on June 28, 2022 and
the first phase of U.S. commercial launch has begun
positive data for high-concentration nitric oxide (NO) with LungFit PRO in hospitalized patients with community-acquired
viral pneumonia, including covid-19, at ECCMID 2022
positive long-term safety data for high-concentration NO at PAS 2022 in infants hospitalized with bronchiolitis
positive updated interim data from the ongoing at-home LungFit GO pilot study for nontuberculous mycobacterial lung disease
screening has begun for the Phase I trial of ultra-high concentration gaseous NO (UNO) being conducted by the Company's oncology
affiliate, Beyond Cancer
call scheduled for 4:30 p.m. ET today, June 28th
City, NY, June 28, 2022 - 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 fiscal fourth quarter and year ended March 31, 2022.
hard work and dedication, we have achieved the goal of FDA approval for our first LungFit system," commented Steve
Lisi, Chairman and Chief Executive Officer of Beyond Air. "We believe the introduction of this groundbreaking system, LungFit PH,
will transform the way nitric oxide is used by hospital staff and provide numerous benefits related to safety and cost. In addition,
we are on track to receive CE Mark for LungFit PH in Europe during the second half of calendar year 2022. Looking beyond LungFit PH,
we believe receiving this initial regulatory approval in the U.S. validates our patented Ionizer technology and creates a path
forward for the other devices in the LungFit platform, including LungFit PRO and LungFit GO, to address other respiratory indications
with even larger patient populations with unmet medical needs."
Lisi added, "Over the past few months we have taken significant strides in our other clinical programs, presenting new data at
four medical conferences. This includes positive safety and efficacy data for high-concentration NO with LungFit PRO in patients hospitalized
with community-acquired viral pneumonia at ECCMID 2022 and positive long-term safety data in infants hospitalized with bronchiolitis
at PAS 2022, strengthening our previously reported strong data. Additionally, at the ATS 2022 conference we presented positive interim
data from our NTM pilot study using the LungFit GO to deliver up to 250 ppm NO in the home setting.
at AACR 2022 our oncology affiliate, Beyond Cancer, presented positive new preclinical data for its ultra-high concentration gaseous
NO (UNO) therapy for solid tumors. Beyond Cancer's Phase I first-in-human study for UNO therapy in solid tumors is open for enrollment.
We continue to be excited by the progress this talented team is making as they advance the development of UNO therapy to treat solid
tumors," concluded Mr. Lisi.
Highlights and Upcoming Milestones
Received U.S. FDA approval on June 28, 2022 for PPHN
Initial limited release phase for commercial launch underway, making it the first and only nitric oxide generator and delivery system available in the U.S.
CE Mark approval anticipated to be received in the second half of calendar year 2022, which is expected to be followed by international commercial partnership
Viral Pneumonia (CAVP) Data (including COVID-19)
Presented data from an updated interim analysis from the ongoing pilot study for 250 PPM NO self-administered by refractory NTM lung infection patients in the home-setting at the American Thoracic Society (ATS) 2022 International Conference in May 2022; these data showed that 250 ppm inhaled NO was well tolerated following a total of 2,323 inhalations self-administered in the home setting with no treatment related discontinuations reported and overall high treatment compliance among the 15 subjects enrolled per the data cut-off date
A pilot study in COPD patients who are hospitalized due to an exacerbation is expected to begin in the second half of calendar 2023 with treatment both in-hospital and at-home
Presented positive in vivo and in vitro data at the American Association for Cancer Research (AACR) Annual Meeting in April 2022; these data suggested that ultra-high concentration gaseous NO (UNO) induced both innate and adaptive immune cell populations, and a decline in immune suppressor cells, which are indicative of an anti-tumor immune response
Patient screening in the Phase 1 human study has begun
Amir Avniel, co-founder, president and chief operating officer will now serve as president and chief business officer of Beyond Air
Mike Gaul, SVP operations, will now serve as chief operating officer of Beyond Air
Jedidiah Monson appointed as chief medical officer at Beyond Cancer
Susan Jones appointed as chief financial officer at Beyond Cancer
results for the fiscal year ended March 31, 2022
for the fiscal year ended March 31, 2022 was $0 as compared to $0.9 million for the fiscal year ended March 31, 2021, all of which was
and development expenses for the fiscal year ended March 31, 2022 were $11.8 million, compared to $12.6 million for the fiscal year ended
and administrative expenses for the fiscal year ended March 31, 2022 increased to $18.4 million, from $10.5 million for the fiscal year
ended March 31, 2021, mainly due to the structural investments required to prepare the Company for commercial launch in the U.S.
operating expenses for the fiscal year ended March 31, 2022 were $10.5 million, entirely related to the contingent liability in the settlement
agreement with Circassia which was recognized in the fourth quarter of fiscal 2022 in accordance with GAAP. $2.5 million of this liability
is due within the next 12 months.
income and expense for the fiscal year ended March 31, 2022 was a loss of $3.4 million compared to $0.7 million for the fiscal year ended
March 31, 2021. In the fiscal year ended March 31, 2022, the Company recorded an estimated liability for contingent loss related to a
lawsuit for $2.4 million.
the fiscal year ended March 31, 2022, the Company had a net loss of $44.1 million of which $43.2m or ($1.68) per share was attributable
to the shareholders of Beyond Air, compared to a net loss of $22.9 million, or ($1.27) per share for the fiscal year ended March 31,
of March 31, 2022, the Company had cash and cash equivalents of $80.2 million.
June 28th @ 4:30 PM ET
Events page of the Company's website (click here)
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.
Community Acquired 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
Last updated: Jun 28, 2022