Full Press Release Details
Air Reports Financial Results
Second Quarter of Fiscal Year 2024
fiscal year 2025 revenue guidance of $12 - $16 million
pilot trial of LungFit PRO to treat viral community acquired pneumonia (VCAP) underway with data expected mid-calendar 2024
Cancer presents positive first-in-human data for intratumoral administration of ultra-high concentration nitric oxide (UNO) therapy demonstrating
safety and evidence of immune system activation at the Society for Immunotherapy Conference (SITC)
PMA supplement to FDA for the expansion of LungFit PH label to include cardiac surgery; approval anticipated in second half calendar
PH granted Innovative Technology contract from Vizient, Inc., the nation's largest provider-driven health care performance improvement
into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region
call scheduled for 4:30 p.m. ET today, November 13th
City, NY, November 13, 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 its financial results for the fiscal quarter ended September 30,
Beyond Air and Beyond Cancer teams continue to execute. In the last three months, we have made significant strides in the US hospital
market with LungFit PH, licensed LungFit PH in certain Asian markets, submitted a PMA supplement to the FDA for cardiac surgery, presented
preclinical and human data for treatment of solid tumors with UNO and began the United States VCAP study," said Steve Lisi, Chairman
and Chief Executive Officer of Beyond Air. "Market confidence in our superior LungFit PH technology continues to grow along with
our market penetration and opportunities. I am proud of our progress and want to thank our customers who gave us the opportunity to succeed
over the past year. At the American Academy of Respiratory Care (AARC) last week there was great enthusiasm around our enhanced LungFit
PH system which gives us confidence in our fiscal 2025 revenue guidance as well as our belief that LungFit PH will become the dominant
product in the market".
Highlights and Upcoming Milestones
| Provided revenue guidance of $12 - $16 million for the fiscal year ending March 31, 2025 | ||
| Entered into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region, paving the way for an ex-U.S. launch | ||
| Received an Innovative Technology contract from Vizient Inc. based on recommendations by hospital experts who serve on Vizient's customer-led councils | ||
| CE Mark anticipated to be received in first half calendar 2024 | ||
| Submitted a PMA supplement to the FDA for a cardiac surgery label expansion; approval anticipated in calendar year 2024 |
| Initiated the process for opening sites for a U.S. pilot trial for patients hospitalized with viral community-acquired pneumonia (VCAP) | ||
| Randomized, double-blind, placebo-controlled trial in 50 patients at 10 sites | ||
| Top line data expected mid-year 2024 from VCAP study |
| Plan to initiate a U.S. trial for patients with nontuberculous mycobacteria (NTM) in calendar year 2025, pending discussion with the FDA | ||
| COPD pilot trial on hold due to strategic prioritization |
| First-in-human data presented at the Society for Immunotherapy Conference (SITC) in November 2023 show that a single intratumoral injection of UNO therapy for 5 minutes was safe and well tolerated in patients and showed upregulation of cytotoxic T-cells, T-central memory cells, M1 macrophages, and dendritic cells while downregulating T-regulatory cells and mononuclear-myeloid-derived suppressor cells (M-MDSC) | ||
| Published pre-clinical data demonstrating that UNO therapy combined with anti-mPD-1 has a synergistic immune response resulting in a significant improvement in tumor regression rates and survival in mice | ||
| Pooled data analysis of combination studies with 50,000 or 100,000 ppm UNO and anti-mPD-1 demonstrated more than a doubling in survival versus anti-mPD-1 alone, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics |
| Announced pre-clinical data demonstrating a therapeutic effect for at least 10 days after a single subcutaneous injection of an extended-release selective neuronal nitric oxide synthase (nNOS) inhibitor | ||
| Plan to initiate a first-in-human study for treatment of ASD in 2025 |
Results for the Fiscal Quarter Ended September 30, 2023
for the three months ended September 30, 2023 were $0.24 million compared to zero for the quarter ended September 30, 2022. Cost of revenue
of $0.4 million was recognized for the three months ended September 30, 2023, compared to $0.2 million for the three months ended September
and development expenses for the three months ended September 30, 2023 were $7.1 million as compared to $4.5 million for the three months
ended September 30, 2022. The additional $2.7 million was due primarily to an increase in stock-based compensation, salaries, and development
costs associated with the pipeline.
and administrative expenses for the three months ended September 30, 2023 and September 30, 2022 were $10.2 million and $8.0 million,
respectively. The $2.2m increase was mainly due to stock based compensation, professional fees and salaries.
loss attributed to common stockholders for the three months ended September 30, 2023, was ($16.2) million or a loss of ($0.51) per share,
basic and diluted. The Company's net loss attributed to common stockholders for the three months ended September 30, 2022 was ($12.0)
million or a loss of ($0.40) per share, basic and diluted.
cash burn in the quarter ended September 30, 2023, was $16.5 million, including $6.4 million in one-time payments which had previously
been disclosed and accrued. Aside from these one-time payments, cash burn in the quarter was $10.1 million which is in line with our
guidance of approximately $10 million per quarter.
of September 30, 2023, the Company had cash, restricted cash, cash equivalents and marketable securities of $43.9 million.
November 13th @ 4:30 PM ET
can use Guest dial-in #s above and be answered by an operator OR click the Call me link for instant telephone access to the event.
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 (ASD) 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