Beyond Air Stock

Beyond Air, Inc., a commercial-stage medical device and biopharmaceutical company, develops a platform of nitric oxide (NO) generators and delivery systems (the ‘LungFit platform’) capable of generating NO from ambient air.

The company’s first device, LungFit PH received premarket approval (PMA) approval from the U.S. Food and Drug Administration (FDA) in June 2022. The NO generated by the LungFit PH System is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation 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 ventilatory support and other appropriate agents. This condition is commonly referred to as persistent pulmonary hypertension of the newborn (PPHN). The LungFit platform can generate NO up to 400 parts per million (ppm) for delivery to a patient’s lungs directly or via a ventilator. LungFit can deliver NO either continuously or for a fixed amount of time at various flow rates and has the ability to either titrate dose on demand or maintain a constant dose. LungFit can be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via delivery through a breathing mask or similar apparatus. The company’s areas of focus with LungFit are PPHN, community-acquired viral pneumonia (CAVP), including COVID-19, bronchiolitis (BRO), nontuberculous mycobacteria (NTM) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (COPD). The company’s product candidates will be subject to premarket reviews and approvals by the FDA, certification through the conduct of a conformity assessment by a notified body in the European Union (EU) for the product to be CE marked, as well as comparable foreign regulatory authorities. The company’s system will be marketed as a medical device in the U.S.

An additional program of Beyond Air targets solid tumors, through the company’s majority-owned affiliate Beyond Cancer, Ltd. (Beyond Cancer). The LungFit platform is not utilized for the solid tumor indication due to need for ultra-high concentrations of gaseous nitric oxide (UNO). This program has advanced to phase 1 as enrollment is underway in the first human study.

LungFit PH is the first FDA approved system using the company’s patented ionizer technology to generate on-demand nitric oxide from ambient air and, regardless of dose or flow, deliver it to a ventilator circuit. The device uses a medical air compressor to drive room air through a plasma chamber in the center of the unit where pulses of electrical discharge are created between two electrodes. The system uses the power equivalent to a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, which then combine as NO with low levels of nitrogen dioxide (NO2) created as a byproduct. The products are then passed through a Smart Filter, which removes the toxic NO2 from the internal circuit. With respect to PPHN, the novel LungFit PH is designed to deliver a dosage of NO to the lungs that is consistent with guidelines for the delivery of 20 ppm NO with a range of 0.5 ppm – 80 ppm (low concentration NO) for ventilated patients.

The company’s novel LungFit platform can also deliver a high concentration (>150 ppm) of NO directly to the lungs, which has the potential to eliminate microbial infections, including bacteria, fungi and viruses, among others.

LungFit PH for the Treatment of Persistent Pulmonary Hypertension of the Newborn (PPHN)

In June 2022, the FDA approved LungFit PH to treat PPHN. LungFit PH is the inaugural device from the LungFit platform of NO generators that use patented ionizer technology and is the first FDA-approved product for Beyond Air.

The company also focuses to receive the CE Mark under the Medical Device Regulation (MDR) in the E.U. in the second half of 2022. The company initiated the first phase of its commercial launch in June 2022 in the U.S. and will continue to work toward a potential launch in the EU and globally in 2022 and beyond.

LungFit PRO for the Treatment of Viral Lung Infections in Hospitalized Patients

Community-Acquired Viral Pneumonia (including COVID-19)

The company initiated a pilot study in late 2020 using its novel LungFit PRO system at 150 ppm to treat patients with community-acquired viral pneumonia (CAVP). The trial is a multi-center, open-label, randomized clinical trial in Israel, including patients infected with COVID-19. Patients are randomized in a 1:1 ratio to receive either inhalations of 150 ppm NO given intermittently for 40 minutes four times per day for up to seven days in addition to standard supportive treatment (NO+SST) or standard supportive treatment alone (SST). Endpoints related to safety (primary endpoint), oxygen saturation and ICU admission, among others, were assessed.

The company reported interim data from this trial at the American Thoracic Society (ATS) International Conference 2021, which was held virtually from May 14, 2021 through May 19, 2021.

Bronchiolitis (BRO)

The company’s BRO program is on hold due to the COVID-19 pandemic. The pivotal study for bronchiolitis was originally set to be performed in the winter of 2020/21 but was delayed due to the pandemic. The company has completed three successful pilot studies for bronchiolitis. A further analysis of the three previously reported pilot studies was presented at the ATS International Conference 2021, which was held virtually from May 14, 2021 through May 19, 2021. Additionally, long-term safety data for high concentration inhaled NO in bronchiolitis was presented at the Pediatric Academic Societies Meeting 2022 (PAS 22), which was held in Denver, Colorado from April 21, 2022 through April 25, 2022.

The company focuses that the entirety of data at 150 ppm - 160 ppm NO in both adult and infant patient populations supports further development of LungFit PRO in a pivotal study for patients hospitalized with CAVP or bronchiolitis.

LungFit GO for the Treatment of Nontuberculous Mycobacteria (NTM)

In December 2020, the company began a 12-week, multi-center, open-label clinical trial in Australia intended to enroll approximately 20 adult patients with chronic refractory nontuberculous mycobacteria (NTM) lung disease. The company received a grant from the Cystic Fibrosis Foundation (CFF) to fund this study and advance the clinical development of inhaled NO to treat NTM pulmonary disease. The trial is enrolling both cystic fibrosis (CF) and non-CF patients infected with Mycobacterium avium complex (MAC), M. abscessus or any strain of NTM. The study consists of a run-in period followed by two treatment phases. The run-in period provides a baseline for the efficacy endpoints. During this phase patients receive NO for 40 minutes, four times per day while methemoglobin (MetHb) levels are monitored. Patients are also trained to use LungFit GO and subsequently discharged to complete the remaining portion of the two-week treatment period at their home at the highest tolerated NO concentration. For the second treatment phase, a 10-week maintenance phase, the administration is twice daily. The study is evaluating safety, quality of life, physical function, and bacterial load among other parameters.

The company reported positive interim results in October 2021. It reported additional positive interim results at the American Thoracic Society International Conference 2022 (ATS 2022), which was held in San Francisco from May 13, 2022 through May 18, 2022. The company’s program in COPD is in the preclinical stage and, subject to obtaining additional financing, is expected to enter clinical trials in 2023.

Ultra-High Concentration NO in Solid Tumors through Majority-owned Affiliate Beyond Cancer, Ltd.

The company has released preclinical data at several medical/scientific conferences showing the promise of delivering NO at concentrations of 20,000 ppm – 200,000 ppm directly to tumors. The company presented new in vivo and in vitro preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2022.

NitricGen License

In 2018, the company entered into a definitive agreement to acquire a global, exclusive, perpetual, transferable license to the eNOGenerator and associated critical assets, including intellectual property, know-how, trade secrets and confidential information (the ‘License’) from NitricGen Inc. (NitricGen). The eNOGenerator is a novel and precise delivery system that uses NO generated from ambient air with a novel NO generator.

The Beyond Air LungFit system, which incorporates the eNOGenerator, has been designated as a medical device by the FDA. The eNOGenerator can generate NO on demand for delivery to the lungs at concentrations ranging from 0.5 to 400 ppm. With the License, the company expects that it will be able to target all conditions requiring NO at any concentration, regardless of the need for intermittent or continuous dosing.

Intellectual Property

The company owns or has exclusively licensed patents, pending patent applications, know-how and trade secrets that relate to its NO generator, NO2 filtration, delivery systems, devices configured for delivering NO to patients by inhalation, the methods of exposing patients to inhalation of NO, and methods for treating subjects in need of NO inhalation.

In particular, the company is party to a global, exclusive, transferable license agreement with NitricGen, Inc. for the eNOGenerator, its components, and all associated patents and know how related thereto. Additionally, the company has an intellectual property portfolio directed to its product candidates and mode of delivery, monitoring parameters and methods of treating specific disease indications. Its intellectual property portfolio consists of issued patents and pending applications, which includes patents it acquired pursuant to the exercise of an option in 2017 granted to it by Pulmonox Technologies Corporation (Pulmonox).

CareFusion Non-Exclusive License Agreement: In 2013, the company entered into a non-exclusive worldwide license agreement with CareFusion Corp. (CareFusion), whereby it licensed seven issued U.S. patents and corresponding foreign counterparts. Its intellectual property licensed from CareFusion, for which the earliest expiring patent term was 2019 and the last to expire is 2025. The term of the agreement extends through the life of the patents and may be terminated by either party with 60 days’ prior written notice in the event of a breach of the agreement, and may be terminated unilaterally by CareFusion with 30 days’ prior written notice in the event that it does not meet certain milestones.

Pulmonox Patents and Assets - Option to Acquire: In 2015, the company entered into an agreement with Pulmonox (the ‘Option Agreement’) whereby the company acquired the option to purchase certain intellectual property assets, including Pulmonox’s rights in 17 issued U.S. patents, including eight patents jointly owned with CareFusion, which are directed to devices and methods for delivering NO formulations to a patient at steady and alternating concentrations (80-400 ppm), including intermittent delivery of NO; a device and methods for the treatment of surface infections; and use of NO as a mucolytic agent and for treatment and disinfection of biofilms.

The company exercised the Option in January 2017, acquiring Pulmonox’s rights in the patents.

Patent Applications: The company has filed over 35 U.S. and foreign patents and patent applications, including Patent Corporation Treaty (PCT) patent applications.

Research and Development

For the year ended March 31, 2022, the company’s research and development expenses were $11.8 million.

Government Regulation

The company’s products have been designated as devices by the FDA. If the company sells its device outside the U.S., it must comply with the Foreign Corrupt Practices Act and local laws of other countries.

The company performs a portion of the clinical studies on certain of its therapeutic candidates in Israel, it is required to obtain authorization from the ethics committee and general manager of each institution in which it intends to conduct its clinical trials, and in most cases, from the Israeli Ministry of Health.

History

The company was formerly known as AIT Therapeutics, Inc. and changed its name to Beyond Air, Inc. in 2019.