Full Press Release Details
Air Reports Fiscal First Quarter 2025 Financial Results and Provides Corporate Update
increased 45% compared to the previous quarter ended March 31, 2024
LungFit PH device continues to expand footprint and strengthen customer base
Avniel, Beyond Air Board member and Chief Business Officer, appointed Chief Executive Officer of NeuroNOS, Beyond Air's wholly
owned subsidiary focused on neurological disorders with a lead indication of Autism Spectrum Disorder
revenue guidance of at least $10 million for FY 2025
City, NY, August 6, 2024 - Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"),
a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives
of patients, today announced its financial results for the fiscal first quarter ended June 30, 2024, and provided a corporate update.
team continues to enhance the commercial execution for LungFit PH, which includes strengthening our sales pipeline in targeted markets
across the U.S. We are confident in the long-term growth of our optimized LungFit PH system and have received positive feedback from
new and existing customers as they realize the clinical benefits the system provides by offering on-demand, ambient air-generated NO
compared to legacy cylinder NO systems. Through our consistent efforts and customer engagement, we are seeing an increasing number of
customer engagements for multi-year contracts in the sales pipeline and existing hospital relationships are expanding across affiliate
locations," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "This continued positive momentum is supported
by our capital conservation strategy, which has strengthened our cash runway to focus on LungFit PH's launch, and our new Chief
Commercial Officer, David Webster, who brings a results-driven mentality that is already energizing our commercial operations."
Portfolio Highlights and Upcoming Milestones
| A 45% increase in quarterly revenue compared to the previous quarter ending March 31, 2024 | |||
| More than $5 million in contracted revenue through fiscal year 2027 | |||
| LungFit PH devices have been used in more than 55 hospitals | |||
| Customer base extending across 10 states in the U.S. |
| Currently no FDA approved NO system is labeled for cardiac surgery | |||
| Approval would increase LungFit PH's rate of market penetration and support long-term revenue growth |
| A decision on CE Mark for LungFit PH in Europe expected before year-end 2024 | |||
| Transport ready LungFit PH PMA submission to FDA anticipated by year-end 2024/early 2025 |
Cancer - Solid Tumor Program
| Ongoing Phase 1a trial reported encouraging first-in-class clinical data demonstrating evidence of immune system activation via biomarker response in a heavily pretreated population, which were presented at the American Society of Clinical Oncology Key Opinion Leader Event at the 2024 Annual Meeting | |||
| Upon regulatory clearance, a Phase 1b trial is planned to enroll up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease ( 12 weeks) on single agent anti-PD-1 without radiographic evidence of continued tumor reduction. Subjects enrolled in the Phase 1b trial will be treated with UNO + anti-PD-1 combination |
Air - Enhanced Management Team with New Chief Commercial Officer
| Mr. Webster has made strong progress on strengthening the commercial strategy and execution since joining Beyond Air. | |||
| Mr. Webster brings decades of experience leading innovative programs through clinical development and regulatory submissions and spearheading global commercialization strategies, having previously served in executive roles at Body Vision Medical and Samsung NeuroLogica. |
| Continue to implement previously announced capital conservation strategy | ||
| Reduced the Company's headcount by over 25% since January 1, 2024 | ||
| Extends the Company's cash runway and focus resources on the commercial program for LungFit PH and maintain the timeline for the second generation LungFit PH |
- Appointed CEO of Wholly Owned Subsidiary to Oversee Autism Program
| IND-enabling studies are underway for the treatment of autism spectrum disorder ("ASD") | |||
| Successfully completed genotoxicity studies for the lead nNOS inhibitor under development |
| Nonclinical pharmacokinetic studies indicate multiple routes of administration for the lead nNOS inhibitor are feasible, including oral delivery and subcutaneous injection | |||
| Mr. Avniel is resigning as of August 15, 2024 from the Board of Directors and as Chief Business Officer to focus wholly on his added responsibilities. |
Results for the Fiscal First Quarter Ended June 30, 2024
for the fiscal quarter ended June 30, 2024 were $0.7 million compared to $0.1 million for the fiscal quarter ended June 30, 2023 and
$0.5 million for the previous quarter ended March 31, 2024. Cost of revenue of $1.0 million was recognized for the three months ended
June 30, 2024, compared to $0.3 million for the three months ended June 30, 2023. Cost of revenue exceeded revenue primarily driven by
investments in supply chain infrastructure required to grow revenue in future periods and depreciation of LungFit devices built to be
able to capture future revenue.
and development expenses for the three months ended June 30, 2024, were $6.0 million as compared to $4.7 million for the three months
ended June 30, 2023. The increase of $1.3 million was primarily attributed to an increase in development costs in Beyond Air ($1.1 million)
and NeuroNOS ($0.1 million), an increase in salaries of $0.9 million ($0.3 million for Beyond Air and $0.6 million for Beyond Cancer),
offset by a decrease in stock compensation costs $0.6 million ($0.4 million in Beyond Air and $0.2 million in Beyond Cancer) and a decrease
in development costs in Beyond Cancer research ($0.3 million).
general and administrative expenses for the three months ended June 30, 2024 and June 30, 2023 were $7.2 million and $10.9 million, respectively.
The decrease of $3.7 million was primarily attributed to a decrease in stock-based compensation of $2.2 million ($1.2 million in Beyond
Air and $1.0 million in Beyond Cancer), decreasing salaries of $0.4 million (Beyond Air $0.8 million partially offset by an increase
in Beyond Cancer of $0.4 million), professional fees ($0.7 million), rent ($0.2 million) and travel expenses ($0.1 million).
loss attributed to common stockholders for the three months ended June 30, 2024, was ($12.2) million or a loss of ($0.27) per share,
basic and diluted. The Company's net 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.
burn in the fiscal quarter ended June 30, 2024 was $13.1 million.
of June 30, 2024, the Company reported cash, cash equivalents, and marketable securities of $21.4 million.
Guidance for Fiscal Year 2025
announced during the Company's corporate update on June 24th, due to the short period of time between today's
quarterly report and the Fiscal Year 2024 report, the Beyond Air management team will forgo hosting a conference call.
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 revolutionary 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) among others.
Also, 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. Additionally, 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