Full Press Release Details
Air Reports Financial Results
Fourth Quarter and Fiscal Year-End 2023
completed phase 1 of U.S. commercial launch, with multiple hospitals contracted, and have initiated phase 2 of launch for LungFit
PH for the treatment of term and near-term neonates with hypoxic respiratory failure
positive preclinical data for ultra-high concentration nitric oxide (UNO) therapy in solid tumors during the American Association for
Cancer Research (AACR) 2023 annual meeting
commercial rights to selective neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of autism spectrum disorder and other
indications from Hebrew University of Jerusalem
up to $40 million debt financing
call scheduled for 4:30 p.m. ET today, June 22nd
City, NY, June 22, 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.), today announced financial results for its fiscal fourth quarter and year ended March 31, 2023.
successfully completed our phase 1 limited commercial launch of LungFit PH in the United States signing multiple hospitals to contracts.
We are pleased with the hard work and dedication demonstrated by our commercial team, and as planned, we have shifted into phase two
where we are making significant progress in our efforts to expand the team and our geographic reach." said Steve Lisi, Chairman
and Chief Executive Officer of Beyond Air.
are the leader in nitric oxide research as evidenced from our robust pipeline of revolutionary LungFit systems, the development of ultra-high
concentration NO to treat solid tumors, and now the development of nNOS inhibitors to treat autism and potentially other neurological
conditions," continued Mr. Lisi.
Highlights and Upcoming Milestones
| Term length: Four years (interest only for up to 36 months) | ||
| Coupon: Greater of 12.00% or WSJ Prime plus 3.75% | ||
| $17.5 million funded at closing (Tranche 1 of a potential 3) | ||
| 233,843 warrants issued to purchase shares of Borrower's common stock at a price of $5.88 |
| Successfully completed phase 1 (limited release phase) of commercial launch and shifted into phase 2 with the initiation of the expansion of our commercial team in the United States | ||
| CE Mark anticipated to be received before the end of calendar year 2023 | ||
| Expect to submit a PMA supplement for a cardiac label expansion for LungFit PH to the FDA before the end of calendar year 2023 |
| Plan to initiate a U.S. trial for patients with nontuberculous mycobacteria (NTM) in the first half of fiscal year 2025, pending discussion with the FDA | ||
| Plan to initiate a pilot trial in COPD patients who have been discharged from the hospital after being hospitalized due to exacerbation in the fourth quarter of calendar 2024, pending discussion with regulatory authorities |
| Presented promising new in vivo and in vitro data at AACR (American Association for Cancer Research) that support the potential of the company's novel UNO therapy to treat various types of solid tumors as a single agent and in combination with checkpoint inhibitors (anti-PD1 and anti-CTLA4) | ||
| 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 | ||
| Continue to see a similar immune profile in our phase 1a human study (UNO monotherapy) as seen in pre-clinical studies in mice | ||
| Phase 1a data expected to be released before year end 2023 |
Results for the Fiscal Year Ended March 31, 2023
and development expenses for the fiscal year ended March 31, 2023 were $16.8 million, compared with $11.8 million for the fiscal year
ended March 31, 2022. The increase of $5.0 million was attributed primarily to an increase in development costs in Cancer, Autism and
preparing for the approval of PPHN, partially offset in a decrease in spend on NTM and bronchiolitis (BRO).
general and administrative expenses for the fiscal year ended March 31, 2023, increased to $34.7 million, compared with $18.4 million
for the fiscal year ended March 31, 2022. The increase was due to a $9.2 million structural investment in Beyond Cancer, with the remaining
$7.1 million driven primarily by the US commercial launch of LungFit PH.
operating expenses for the fiscal year ended March 31, 2023, were zero, compared with $10.5 million which were entirely related to the
contingent liability for the Circassia settlement from May of 2021. As a reminder, the Company paid $2.5 million to Circassia in the
2nd fiscal quarter of 2023, we have another $3.5 million to pay in the 2nd fiscal quarter of 2024 with the final $4.5 million not due
until the 2nd quarter of fiscal 2025.
income and expense was a $7.3 million loss for the fiscal year ended March 31, 2023, compared with a $3.4 million loss for the fiscal
year ended March 31, 2022. The increase of $3.9 million was primarily due to a non-product related legal matter that was resolved in
the fourth fiscal quarter of 2023.
the fiscal year ending March 31, 2023, the Company had a GAAP net loss of $59.4 million, of which $55.8 million, or ($1.86) per share,
was attributable to the shareholders of Beyond Air, Inc., compared with a net loss of $43.2 million, or ($1.68) per share, for the fiscal
year ended March 31, 2022.
of March 31, 2023, the Company reported cash, cash equivalents, and marketable securities of $45.9 million. Additionally, the Company
recently secured $17.5 million, before fees, through an agreement with Avenue Capital, increasing its cash balance.
June 22nd @ 4:30 PM ET
| Domestic: | 1-877-407-0784 |
| International: | 1-201-689-8560 |
| Passcode: | 13738837 |
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), 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.
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