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Beyond Air Reports Financial Results for Third Quarter of Fiscal Year 2024 Commercial demand for LungFit PH increasing; manufacturing of upgraded devices is ramping up to meet growing demand PMA supplement for the expans

Key Takeaway: Beyond Air, Inc. reported strong financial results for Q3 2024, showcasing over 60% sequential revenue growth driven by rising demand for its LungFit PH device. The company received FDA acceptance for a PMA supplement to expand LungFit PH's label for cardiac surgeries and is progressing with a pilot trial for LungFit PRO in treating viral community-acquired pneumonia. Despite the positive commercial traction, Beyond Air faced a net loss of $16.2 million during the quarter due to heightened operating and development costs. The fiscal year 2025 revenue guidance has been reaffirmed at $12 - $16 million.

Market Sentiment Analysis

POSITIVE FACTORS

  • Increasing demand for LungFit PH indicates strong market acceptance.
  • Successful acceptance of PMA supplement for cardiac surgery applications by the FDA.
  • Projected revenue growth guidance of $12 million to $16 million for FY 2025.

CONCERNS & RISKS

  • The company reported a significant net loss attributed to common stockholders of $16.2 million in Q3 2024.
  • Increased development costs associated with the pipeline, totaling $6.8 million for Q3 2024.

Full Press Release Details

Air Reports Financial Results
Third Quarter of Fiscal Year 2024
demand for LungFit PH increasing; manufacturing of upgraded devices is ramping up to meet growing demand
supplement for the expansion of LungFit PH label to include cardiac surgery accepted for filing and under substantive review by the FDA
pilot trial of LungFit PRO to treat viral community acquired pneumonia (VCAP) underway; trial will extend over two seasons; the
pivotal study remains on track for Winter 2025/26
1 Study evaluating Beyond Cancer's ultra-high concentration nitric oxide (UNO) in advanced, R/R unresectable, primary or metastatic
cutaneous and subcutaneous solid tumors cleared the first cohort with no reported dose limiting toxicities
FY 2025 revenue guidance of $12 million to $16 million
call scheduled for 4:30 p.m. ET today, February 12th
CITY, N.Y., Feb. 12, 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 quarter ended December 31, 2023.
the third quarter of fiscal year 2024, we reported solid sequential revenue growth of more than 60% compared with the second quarter.
This increasing demand for our current LungFit PH system was seen even as we prepared to launch a key software update. As our inventory
of upgraded LungFit PH grows, we expect to be able to meet accelerating demand over the next several quarters. This positive commercial
traction gives us even more confidence in hitting our fiscal year 2025 sales guidance of $12 to $16 million," said Steve Lisi,
Chairman and Chief Executive Officer of Beyond Air. "The PMA supplement for the expansion of the LungFit PH label to include cardiac
surgery was accepted for filing by the FDA in late-December and is currently under substantive review. FDA approval for this application
should generate even broader use of LungFit PH in U.S. hospitals."
Highlights and Upcoming Milestones
CE Mark is expected to be received in first half calendar 2024
PMA supplement for a cardiac surgery label expansion accepted for filing and under substantive review by the FDA
Revenue guidance of $12 - $16 million reiterated for the fiscal year ending March 31, 2025
Randomized, double-blind, placebo-controlled trial in 50 patients at up to 10 sites
Top line data expected mid-year 2025 from VCAP study as trial is expected to extend over two seasons
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
Enrollment is underway for the 50,000 ppm cohort of the Phase 1 Study
Preparations are being made to enter the Phase Ib portion of the study where UNO is anticipated to be dosed in combination with anti-PD1
Plan to initiate a first-in-human study for treatment of ASD in 2025
Published pre-clinical data by Hebrew University of Jerusalem (HUJI) in the scientific journal Nitric Oxide in September 2023 which show that the partial inhibition of nNOS reversed the manifestations of ASD phenotype, and reversed nitrosative stress.
Results for the Fiscal Quarter Ended December 31, 2023
for the three months ended December 31, 2023 were $0.4 million compared to zero for the quarter ended December 31, 2022. Cost of revenue
of $0.7 million was recognized for the three months ended December 31, 2023, compared to $0.1 million for the three months ended December
and development expenses for the three months ended December 31, 2023 were $6.8 million as compared to $5.0 million for the three months
ended December 31, 2022. The increase of $1.8 million was due primarily to an increase in development costs associated with the pipeline.
and administrative expenses for the three months ended December 31, 2023 and December 31, 2022 were $9.8 million and $8.9 million, respectively.
The $0.9 million increase was mainly due to increases in stock based compensation, headcount and salary inflation.
loss attributed to common stockholders for the three months ended December 31, 2023, was ($16.2) million or a loss of ($0.50) per share,
basic and diluted. The Company's net loss attributed to common stockholders for the three months ended December 31, 2022 was ($12.7)
million or a loss of ($0.43) per share, basic and diluted.
cash burn in the quarter ended December 31, 2023, was $12.7 million, with payments required towards our VCAP study, development of our
Gen 2 device, continued in-human trials in Beyond Cancer and advances in our Autism program. The Company raised $5.5 million on its
ATM to partially offset the planned cash burn.
of December 31, 2023, the Company had cash, cash equivalents, marketable securities of $31.4 million as well as $5.2 million held on
deposit by our contract manufacturer.
February 12th @ 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 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.
majority of hospital admissions of infants with bronchiolitis are caused by respiratory syncytial virus (RSV). RSV is a common and highly

Frequently Asked Questions

What is the fiscal year 2025 revenue guidance for Beyond Air?

The revenue guidance for FY 2025 is set between $12 million and $16 million.

What recent FDA submission is Beyond Air awaiting approval for?

Beyond Air has submitted a PMA supplement for expanding the LungFit PH label to include cardiac surgery.

What trial is currently ongoing for LungFit PRO?

A pilot trial to treat viral community-acquired pneumonia (VCAP) is currently underway.

What progress has been made on the LungFit PH system?

Demand for LungFit PH is increasing, and upgraded device manufacturing is ramping up.

Last updated: Feb 12, 2024