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Beyond Air Reports Financial Results for First Quarter of Fiscal Year 2024 Reported commercial sales for LungFit PH for the treatment of term and near-term neonates with hypoxic respiratory failure Currently have in exce

Key Takeaway: Air Reports Financial Results First Quarter of Fiscal Year 2024 commercial sales for LungFit PH for the treatment of term and near-term neonates with hypoxic respiratory failure have in excess of $1 million in annual commercial LungFit PH contracts up to $40 million in debt f

Full Press Release Details

Air Reports Financial Results
First Quarter of Fiscal Year 2024
commercial sales for LungFit PH for the treatment of term and near-term neonates with hypoxic respiratory failure
have in excess of $1 million in annual commercial LungFit PH contracts
up to $40 million in debt financing from Avenue Capital
agreement with FDA to run a U.S. clinical study in patients hospitalized with viral community acquired pneumonia (VCAP), which will be
performed in the 2023-24 winter season
pipeline with addition of pre-clinical program for selective neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of autism
spectrum disorder and other indications
call scheduled for 4:30 p.m. ET today, August 10th
City, NY, August 10, 2023 - Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"),
a commercial stage medical device and biopharmaceutical company focused on harnessing the power of endogenous and exogenous nitric oxide
(NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate
Beyond Cancer, Ltd. ("Beyond Cancer")), today announced financial results for its fiscal quarter ended June 30, 2023.
concluded the first quarter of our fiscal year 2024 with LungFit PH adopted as the nitric oxide system of choice at several hospitals
in the United States. Our commercial team has implemented training programs and support at each of these hospitals, and report that LungFit
PH has been well received. The initial success of the LungFit PH commercial rollout has allowed our team to hone their sales and support
processes and move into the second phase of the commercial launch which has resulted in annual contracted revenue in excess of $1 million
at this time," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.
addition to our commercial accomplishments, we presented promising preclinical data for our ultra-high concentration nitric oxide (UNO)
program to treat solid tumors, expanded our R&D pipeline to include selective nNOS inhibitors for the treatment of autism spectrum
disorder and came to an agreement with FDA on a VCAP protocol to conduct a clinical study in the U.S. this winter. We believe that each
of these programs are positioning Beyond Air to provide improved treatment options for various patient populations with high unmet medical
needs, while also generating significant value for our investors," continued Mr. Lisi.
Highlights and Upcoming Milestones
LungFit PH
Reported commercial sales from early adopters of LungFit PH for the treatment of term and near-term neonates with hypoxic respiratory failure
Advanced the commercial program for LungFit PH into the planned second phase of the launch, which has resulted in attaining in excess of $1 million in annual contracted revenue
CE Mark anticipated to be received before the end of calendar year 2023
Expect to submit a PMA supplement to the FDA for a cardiac label expansion of LungFit PH before the end of calendar year 2023
LungFit PRO
Plan to initiate a U.S. trial for patients hospitalized with viral community-acquired pneumonia (VCAP) in the fourth quarter of calendar year 2023
LungFit GO
Plan to initiate a U.S. trial for patients with nontuberculous mycobacteria (NTM) in calendar year 2025, pending discussion with the FDA
Plan to initiate a pilot trial during the fourth quarter of calendar 2024 in COPD patients who have been discharged from the hospital after being hospitalized due to exacerbation, pending discussion with regulatory authorities
Beyond Cancer - Solid Tumor Program
Presented promising new in vivo and in vitro data at AACR (American Association for Cancer Research) that support the potential of Beyond Cancer's novel UNO therapy to treat various types of solid tumors as a single agent and in combination with checkpoint inhibitors (anti-PD1 and anti-CTLA4)
Phase 1a human data expected to be released before calendar year end 2023
Autism Spectrum Disorder (ASD) Program
Signed a licensing agreement with Hebrew University of Jerusalem for the commercial rights to selective neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of ASD
Results for the Fiscal Quarter Ended June 30, 2023
for the three months ended June 30, 2023 were $0.1 million compared to zero for the quarter ended June 30, 2022. Cost of revenue of $0.3
million was recognized for the three months ended June 30, 2023, compared to $0 for the three months ended June 30, 2022.
and development expenses for the three months ended June 30, 2023 were $4.7 million as compared to $3.2 million for the three months
ended June 30, 2022. The increase of $1.5 million was attributed primarily to an increase in development costs in cancer research and
autism as well as an increase in stock-based compensation and salaries.
and administrative expenses for the three months ended June 30, 2023 and June 30, 2022 were $10.9 million and $8.2 million, respectively.
The increase of $2.7 million was attributed primarily to an increase in stock-based compensation and salaries.
loss attributed to common stockholders for the three months ended June 30, 2023, was ($14.1) million or a loss of ($0.45) per share,
basic and diluted. The Company's net loss attributed to common stockholders for the three months ended June 30, 2022 was ($10.9)
million or a loss of ($0.37) per share, basic and diluted.
June 2023 up to $40 million in debt financing was provided to the Company from Avenue Capital, of which $17.5 million in gross funds
were drawn. As of June 30, 2023, the Company had cash, cash equivalents and marketable securities of $57.0 million and $2.7 million in
August 10th @ 4:30 PM ET
Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous
nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors. The
Company has received FDA approval for its first system, LungFit PH, for the treatment of term and near-term neonates
with hypoxic respiratory failure. Beyond Air is currently advancing its other LungFit systems in clinical trials for the treatment of
severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM). The Company
has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of autism spectrum
disorder (ADS) and other neurological disorders. Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating 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 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.
Air's LungFit is a cylinder-free, phasic flow 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 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. 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 PH is approved for commercial use only in the United States of America to treat term and near-term neonates
with hypoxic respiratory failure. Beyond Air's other LungFit systems are not approved for commercial use and are 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.
Viral Community-Acquired Pneumonia (VCAP)
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. NO may prove to be a treatment
as the impact on the lung should result in bronchodilation, reduction in inflammation and inhibition of the viral replication process.
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 considered 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 lungs, and early data, including from the pilot study of the LungFit GO, indicate that this range of NO concentrations
could have a positive effect on patients infected with NTM.
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 150 - 400 ppm NO, for which preliminary studies indicate may eliminate bacteria, viruses,
fungi, and other microbes from the lungs.
Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing (UNO via
Last updated: Aug 10, 2023