Full Press Release Details
Air Reports Financial Results
the Third Quarter of Fiscal Year 2023
commercial launch continues for LungFit PH for the treatment of term and near-term neonates with hypoxic respiratory failure
positive in vivo combination data with anti-PD1 that support the potential of the Company's novel gaseous ultra-high concentration
nitric oxide (UNO) therapy to treat various types of solid tumors at the Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting
pre-clinical data in the peer-reviewed journal Cancer Cell International ("CCI") on the Company's patented tumor ablation
method utilizing UNO
call scheduled for 4:30 p.m. ET today, February 9th
City, NY, February 9, 2023 - Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company")
a commercial 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, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced financial results for its
third fiscal quarter ended December 31, 2022.
are successfully executing on our planned limited launch of LungFit PH in the United States. Demand among targeted hospitals for demonstrations
and evaluations continues to grow, and we look forward to recording our first sales during the March quarter," said Steve Lisi,
Chairman and Chief Executive Officer of Beyond Air.
the past few years, we have presented data which have demonstrated the safety of inhaled nitric oxide at high concentrations, administered
intermittently, in more than 12 clinical settings with over 170 patients treated and more than 5,000 treatments administered with no
serious adverse reactions related to nitric oxide. Strong efficacy signals were also demonstrated, especially in viral respiratory infections.
We believe high concentration NO delivery with our LungFit PRO generator and delivery system can be a powerful tool against any type
of pneumonia, regardless of the type of virus, including SARS-CoV2, and our company is dedicated to bringing this important therapy to
market as soon as possible."
the year, the team at Beyond Cancer has made incredible progress," continued Mr. Lisi. "The pre-clinical results presented
during the Society for Immunotherapy of Cancer (SITC) 2022 annual meeting in November offer an encouraging first look at the potential
synergistic effect of UNO therapy when combined with anti-PD-1 therapy. We are pleased to have also published our early pre-clinical
work in the peer-reviewed journal Cancer Cell International ("CCI") in December. These impressive data support our understanding
of UNO as an immunomodulating therapeutic option for the treatment of solid tumors and prevention of metastases and we look forward to
further elucidating the powerful effects of UNO in human trials."
Recent Highlights and Upcoming Milestones
| Ongoing progress with limited release phase of commercial launch, making it the first and only nitric oxide generator, delivery, and monitoring system available in the United States | ||
| CE Mark anticipated to be received in the first half of fiscal year 2024, which is expected to be followed by an international commercial partnership | ||
| Expect to submit a PMA supplement for a cardiac label expansion for LungFit PH to the FDA in the first half of calendar year 2023 |
| ID Week 2022 - the Company presented positive data showing a strong safety profile and statistically significant results on key endpoints in patients hospitalized with viral respiratory infections, including SARS-CoV2 | ||
| Plan to initiate a U.S. trial for patients hospitalized with viral community-acquired pneumonia (VCAP), including COVID-19, in the fourth quarter of calendar year 2023, pending discussion with the FDA |
| American College of Chest Physicians (CHEST) Annual Meeting 2022 - the Company presented positive safety, tolerability, and efficacy data from the LungFit GO pilot at-home study of patients with severe, treatment refractory, NTM lung disease | ||
| Plan to initiate a U.S. trial for patients with NTM in the second half of fiscal year 2025, pending discussion with the FDA | ||
| Plan to initiate a U.S. pilot trial in COPD patients who are hospitalized due to a exacerbation in the fourth quarter of calendar 2024, pending discussion with FDA |
| Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022 - presented promising new data in mice for UNO therapy, which showed a doubling of survival when UNO was combined with anti-PD1 compared with anti-PD1 alone | ||
| Published pre-clinical data in Cancer Cell International (CCI) on December 13, 2022, which demonstrated that the company's tumor ablation method results in a potent systemic immune response to the specific tumor type treated. Treated mice were immune to a re-introduction or tumor challenge resulting in a significant improvement in survival for UNO treated mice compared to control mice | ||
| Received a notice of allowance for its patent titled, "System and Method for Delivery or Gas to a Tissue", which is the first patent covering Beyond Cancer's UNO therapy | ||
| Announced a sponsored research agreement with Stanford University, and the expansion of Beyond Cancer's Scientific Advisory Board (SAB) |
Results for the Fiscal Quarter Ended December 31, 2022
and development expenses for the fiscal quarter ended December 31, 2022 were $5.0 million, compared with $2.5 million for the fiscal
quarter ended December 31, 2021. The increase was driven mainly by compensation costs from scaling up operations in Beyond Cancer as
well as from increased investments in pre-clinical work being done across the Group in our targeted therapeutic areas.
and administrative expenses for the fiscal quarter ended December 31, 2022 increased to $8.9 million, compared with $4.9 million for
the fiscal quarter ended December 31, 2021. The increase includes $3.0 million of planned structural investments in Beyond Cancer and
$1.0 million attributable to continued investments in people and systems necessary to support the commercial launch of LungFit PH
income and expense was a $0.2 million gain for the fiscal quarter ended December 31, 2022, compared with a $0.5 million loss for the
fiscal quarter ended December 31, 2021. The two main drivers in this year-over-year improvement were gains made from the Company's
investment in marketable securities as well as favorable foreign exchange movements.
the fiscal quarter ended December 31, 2022, the Company had a GAAP net loss of $13.8 million, of which $12.7 million, or ($0.43) per
share, was attributable to the shareholders of Beyond Air, Inc., compared with a net loss of $7.7 million, or ($0.29) per share, for
the fiscal quarter ended December 31, 2021.
of December 31, 2022, the Company reported cash and cash equivalents, marketable securities, and restricted cash of $63.2 million.
cash burn in the quarter ended December 31, 2022, was $9.3 million, which is in line with the Company's quarterly cash burn guidance
of $8.0 - 10.0 million per quarter. Through the first nine months of the Company's fiscal year 2023, total cash burn was
$27.0 million which includes $2.5 million in non-recurring expense.
February 9th @ 4:30 PM ET
| Domestic: | 1-844-825-9789 | |
| International: | 1-412-317-5180 | |
| Passcode: | 2849570 | |
| Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1593840&tp_key=dccf15938e | |
| or the Events page of the Company's website ( click here ) |
Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide through its
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 has received FDA approval for its first system, LungFit PH for persistent pulmonary hypertension of the newborn. Beyond Air is
currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral
community-acquired pneumonia (including COVID-19), nontuberculous mycobacteria (NTM) and severe lung infections in other settings. Additionally,
Beyond Cancer, 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. 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 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.
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 considered an emerging public health concern worldwide because of its multi-drug