Beyond Air Expands iNO Therapy into Global $10B+ Pneumonia Market with On-Demand Nitric Oxide Platform

Recently, Beyond Air, a U.S. medical device and biopharmaceutical company, announced clinical trial progress for its new product, LungFit PRO, in the treatment of viral community-acquired pneumonia (VCAP). The study enrolled 40 patients hospitalized with VCAP, 39 of whom had COVID-19. The data demonstrated that inhaled nitric oxide (iNO) delivered by LungFit PRO was generally well tolerated.

Beyond Air focuses on inhaled nitric oxide (iNO) for the treatment of respiratory diseases and pulmonary arterial hypertension. The company had its initial public offering on NASDAQ in June 2019,Current market capitalization is approximately $203 million.. Its subsidiary Beyond Cancer developsUltra-High Concentration Nitric Oxide Therapy (UNO) for the Treatment of Solid Tumors.

On June 28, 2022, Beyond Air’s first product, LungFit PH, received FDA approval for the treatment of persistent pulmonary hypertension of the newborn (PPHN). Currently, Beyond Air is working to expand the LungFit system,to accommodate a wider range of severe pulmonary infections,such as community-acquired viral pneumonia and severe pulmonary infections in other settings.

LungFit PH is Beyond Air’s first FDA-approved product for the treatment of term and late-preterm neonates with hypoxic respiratory failure.It is estimated that LungFit PH has a U.S. market worth over $400 million and a global market exceeding $700 million.

Through Beyond Air's patented Ionizer technology,LungFit PH can generate nitric oxide (NO) on demand from ambient air.This system draws indoor air into a compact ion generator chamber to produce inhaled nitric oxide (iNO), which is then delivered into the ventilator circuit to administer a precise dose of NO to the patient’s lungs. This enables hospitals to eliminate their reliance on high-pressure iNO gas cylinders, thereby avoiding logistics and storage-related issues.Operating costs have been significantly reduced.

This device uses a low-power unit (with power consumption comparable to that of a 60-watt light bulb) to ionize nitrogen and oxygen molecules, forming nitric oxide while simultaneously generating small amounts of nitrogen dioxide (NO₂). The gas will then enter the smart filter, where toxic NO is removed by the internal circuitry.₂. Each smart filter can operate continuously for 12 hours, and replacement takes only a few seconds. Additionally, the integrated automatic purge function saves clinicians’ time while reducing the risk of patient exposure to excessive NO.

LungFit PH also includes a gas monitoring system and a backup NO system, respectively used for real-time measurement of NO and NO in the breathing circuit.₂and O₂concentration, and provide a fixed concentration of NO. They enable the LungFit PH system to maintain accurate and stable iNO delivery, ensuring comprehensive patient safety.

LungFit 

Image source: Beyond Air official website

Neonatal hypoxic respiratory failure can be caused by various factors, with persistent pulmonary hypertension of the newborn (PPHN) being the most common. This is a life-threatening condition characterized by elevated pulmonary vascular resistance (PVR). It has been reported that in the United States, PPHN affects an average of 1.9 per 1,000 newborns, with a mortality rate reaching up to 33%.

For over two decades, low-concentration inhaled nitric oxide (iNO) therapy has been the standard of care in the United States for treating persistent pulmonary hypertension of the newborn (PPHN), helping to improve oxygen levels in the blood of neonates with respiratory failure. Studies have shown that infants receiving iNO therapy have a lower likelihood of requiring extracorporeal membrane oxygenation (ECMO) compared to those who do not receive NO therapy.

On October 16, 2022, Beyond Air presented the pilot study results of LungFit GO at the 2022 American College of Chest Physicians (CHEST) Annual Meeting. The data demonstrated that LungFit GO exhibited favorable performance in terms of safety, tolerability, and efficacy in patients with severe, refractory, non-tuberculous mycobacterial (NTM) lung disease. These results not only support the company’s further development of intermittent high-dose nitric oxide (NO) therapy for the treatment of NTM but also highlightThe Potential for Safe and Continuous Nitric Oxide Therapy at Home, paving the way for new advancements in the development of nitric oxide (NO) therapy.

Nontuberculous Mycobacteria (NTM) infection is a rare and serious pulmonary bacterial infection that can lead to debilitating lung diseases, such as chronic obstructive pulmonary disease (COPD), which are associated with high morbidity and mortality rates. In the United States, 1.1 million COPD patients are hospitalized annually due to exacerbations, with a three-month post-discharge mortality rate of 16% to 19%. Common treatment regimens involve the combined use of multiple antibiotics. However, this approach requires administration for up to two years, is costly, and may cause severe adverse reactions.

LungFit GO is designed to deliver 150–400 ppm of NO to the lungs. Data suggest that this range of NO concentration may have a positive impact on patients with NTM infections. It is estimated thatThe U.S. NTM treatment market is valued at over $1 billion, with the global market exceeding $2.5 billion; the U.S. COPD treatment market is valued at over $2.5 billion, with the global market surpassing $6 billion.

On October 24, 2022, Beyond Air announced the success of its clinical trial evaluating LungFit PRO for the treatment of viral community-acquired pneumonia (VCAP), primarily COVID-19. This may enable Beyond AirEnter the global market for viral pneumonia treatment, valued at over $3 billion.

“High-concentration NO delivered by LungFit PRO can combat any type of pneumonia, especially COVID-19. We now hope to bring this therapy to market as soon as possible,” said Steve Lisi, Chairman and CEO of Beyond Air.

R&D Pipeline

Source: Beyond Air Official Website

Steve Lisi has served as Chairman of the Board and Chief Executive Officer of Beyond Air since 2017. Previously, Mr. Lisi held the position of Senior Vice President of Business and Corporate Development at Flamel Technologies’ Irish subsidiary. During his tenure, he helped the company raise $121 million in equity financing and realigned its business development focus and product pipeline.Increase its enterprise value from $100 million to $1 billion within three years. Prior to joining Flamel, Lisi spent 18 years working in global healthcare investments at firms including Deerfield Management, Millennium Management, and SAC Capital.

Steve Lisi

Image source: Beyond Air official website

On May 7, 2019, Beyond Air’s common stock began trading on the Nasdaq. In June 2019, the Company entered into agreements with investors to issue 1,394,997 shares of common stock at a price of $5.00 per share, and issued 188,746 shares of common stock to insiders at a price of $5.15 per share.

On December 12, 2019, Beyond Air announced the completion of an underwritten public offering of 2,620,199 shares of common stock at a price of $3.66 per share. Concurrently, the company sold 532,786 shares of common stock to certain existing investors in a private placement. The total gross proceeds from this public offering and private placement amounted to approximately $11.5 million. The net proceeds were allocated for working capital and clinical research.

On February 10, 2021, Beyond Air received a $2.17 million grant from the Cystic Fibrosis Foundation (CFF) to advance the clinical development of high-concentration nitric oxide (NO) therapy for pulmonary diseases caused by nontuberculous mycobacteria (NTM).

On February 4, 2022, Beyond Air entered into a new at-the-market equity offering sales agreement with Truist Securities and Oppenheimer (the “2022 ATM”). Under the agreement, Beyond Air may offer and sell shares of its stock,The total gross proceeds from the sale of its common shares amounted to US$50 million.

As of June 30, 2022, the company had $72.8 million in cash and cash equivalents and $10.0 million in restricted cash.

Beyond Air received FDA approval for LungFit PH in June 2022 and is expected to begin generating revenue in fiscal year 2023. Its operational performance after the fourth quarter of fiscal 2024 will largely depend on the commercial success of LungFit PH. Analysts predict,Beyond Air is projected to achieve a compound annual growth rate (CAGR) of 57.9% in revenue and 67.6% in profit over the next three years, outpacing the U.S. medical device market’s average annual revenue growth of 7.1% and profit growth of 13.4%.

Beyond Air: 3-Year Growth Forecast

Image source: VCBeat

Beyond Air’s subsidiary, Beyond Cancer, has developed an exclusive ultra-high concentration nitric oxide therapy (UNO) that delivers ultra-high concentration gaseous nitric oxide (gNO) directly into solid tumors. In vitro murine data demonstrate that UNO can not only locally ablate primary tumors but also identify and attack metastatic tumor cells by stimulating anti-tumor immune responses. Furthermore, this therapyEach treatment takes only five minutes, with limited toxicity or off-target effects.

Solid tumors account for 90% of adult cancers, and tumor metastasis is responsible for 90% of cancer-related deaths. Therefore, preventing and inhibiting tumor metastasis is key to prolonging patient survival. Over the past few decades, numerous immunomodulatory drugs have emerged that leverage the body’s own immune system to prevent, control, and eliminate cancer. Although these therapies are effective, many cancer immunotherapies targeting single-molecule mutations or specific cancer pathways lead to drug resistance.

Nitric oxide (NO) has been proven to play a critical role in both innate and adaptive immune responses. In vitro studies have demonstrated that NO possesses broad-spectrum antimicrobial activity and anticancer properties. “Coupled with the known ability of NO to activate the immune system, the data we presented this year at the AACR (American Association for Cancer Research) indicate thatgNO may be effective in treating various types of tumors.“said Hila Confino, Chief Scientific Officer of Beyond Cancer.”

On August 23, 2022, Beyond Cancer announced that the first patient would be treated in its inaugural Phase I human clinical trial to evaluate the safety and immune biomarkers of UNO therapy. Preliminary clinical data from the trial are expected to be released in early 2023. Prior to this, Beyond Cancer will present preclinical data on UNO at the 2022 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held from November 8 to 12.