Full Press Release Details
Air Reports Fiscal Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
industry veteran, David Webster, as new Chief Commercial Officer
upgraded LungFit PH device expands customer base; revenue growth expected to accelerate each quarter going forward
2025 revenue guidance revised to greater than $10 million
capital conservation strategy to reduce cash burn
call scheduled for 4:30 p.m. ET today, June 24th
CITY, N.Y., June 24, 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 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 fourth quarter and year ended March 31, 2024,
and provided a corporate update.
am proud of the Beyond Air team's accomplishments throughout our fiscal year (FY) 2024, which positions the Company for growth
over the coming year and beyond," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "Throughout the past
year, we successfully navigated challenges during the initial soft launch of LungFit PH and emerged with a stronger solution and commercial
infrastructure. These improvements have positively impacted our sales pipeline and existing customer engagements, which are expected
to be reflected in our topline performance over the coming quarters. Two upcoming milestones that are expected to drive additional revenue
growth include the pending FDA decision on the cardiac surgery indication and development of a second generation LungFit PH system."
the past few months, we implemented a strategy to conserve capital as we continue building momentum around the commercial launch of LungFit
PH. This will significantly reduce our quarterly spend going forward. The impacted R&D projects include our VCAP program, which was
placed on hold, and our LungFit GO home-based device for NTM and other lung infections, which we are now bringing in-house for design
and development, resulting in a modest delay. We continue to target initiation of the next clinical study for the NTM program during
calendar year 2026. Separately, our cancer and autism programs are anticipated to be self-funded. Given these adjustments, we expect
our operations to be funded through at least July 2025," stated Mr. Lisi.
Highlights and Upcoming Milestones
| To date, LungFit PH devices have been used in more than 50 hospitals | ||
| To date, over 1,100 patients have been treated with LungFit PH, accounting for more than 75,000 hours of treatment | ||
| Current customers extend across 10 states in the U.S. |
| Appointed David Webster as new Chief Commercial Officer to lead commercial operations | ||
| FDA decision expected in the fourth quarter of CY 2024 for the pending PMA supplement for cardiac surgery | ||
| Awaiting updates on timing for CE Mark for LungFit PH in Europe | ||
| Updated revenue guidance to greater than $10 million for FY 2025, from the previous guidance of $12 million to $16 million |
| The 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. These data were presented at the American Society of Clinical Oncology Key Opinion Leader Event held in conjunction with the 2024 Annual Meeting | ||
| Upon regulatory approval, a Phase 1b trial will 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 upon completion of the Phase 1a trial prior to the end of this year |
| Reduced headcount by over 20% since January 1, 2024 | ||
| Study of LungFit PRO to treat viral community-acquired pneumonia (VCAP) has been placed on hold due to strategic prioritization | ||
| The trials evaluating LungFit GO for the treatment of nontuberculous mycobacteria (NTM) and COPD have been placed on hold due to strategic prioritization; and the design and development of the LungFit GO device will be performed in-house and LungFit GO will be ready for clinical studies in calendar year 2026 | ||
| Beyond Cancer subsidiary - planned Phase 1b clinical trial of UNO in combination with anti-PD1 will begin enrollment by the end of calendar 2024 | ||
| NeuroNOS subsidiary - plan to initiate first-in-human autism spectrum disorder (ASD) study in 2025, pending available funding |
Results for the Fiscal Year Ended March 31, 2024
for the fiscal year ended March 31, 2024 were $1.2 million compared to zero for the fiscal year ended March 31, 2023. Cost of revenue
of $2.5 million was recognized for the fiscal year ended March 31, 2024, compared to $0.6 million for the three months ended March 31,
and development expenses for the fiscal year ended March 31, 2024 were $24.4 million compared to $16.8 million for the fiscal year ended
March 31, 2023. The increase of $7.6 million was due primarily to an increase in development costs associated with the pipeline.
and administrative expenses for the fiscal years ended March 31, 2024 and March 31, 2023 were $37.3 million and $34.7 million, respectively.
The $2.6 million increase was mainly due to increases in stock-based compensation, headcount and salary inflation.
loss attributed to common stockholders for the fiscal year ended March 31, 2024, was ($60.2) million or a loss of ($1.82) per share,
basic and diluted. The Company's net loss attributed to common stockholders for the fiscal year ended March 31, 2023 was ($55.8)
million or a loss of ($1.86) per share, basic and diluted.
cash burn in the fiscal year ended March 31, 2024 was $46.2 million, which excludes $6.6 million non-recurring items for payments of
non-product related litigation and $2.5 million of additional funds requested by our third-party manufacturer to secure long lead-time
the course of the fiscal year, the Company received net proceeds of $13.4 million from its ATM, $15.8 million in net debt, and $14.6
million from the sale of securities through a securities purchase agreement to partially offset the Company's cash burn.
of March 31, 2024, the Company reported cash, cash equivalents, and marketable securities of $34.5 million.
June 24th @ 4:30 PM ET
| Domestic: | 1-877-407-0784 |
| International: | 1-201-689-8560 |
| Conference ID: | 13746892 |
| Webcast: | A webcast of the live conference call can be accessed by visiting the Events section of the Company's website (click here) or directly (click here). An online replay will be available on the Company's website or via the direct link an hour after the 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
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.
Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing (UNO via
a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has