Beyond Air Files Prospectus Highlighting Over 60% Quarterly Revenue Growth and Innovative Nitric Oxide Therapies Free from Cylinder Dependency

Nitric oxide (NO) is a potent molecule that is naturally synthesized in the human body and has been proven to play a critical role in various biological functions.

In the airways, the target of NO is the vascular smooth muscle cells surrounding the low-resistance pulmonary arterioles. Currently, exogenous inhaled NO is used to treat hypoxemia in acute respiratory distress syndrome, after certain cardiac surgeries, and in persistent pulmonary hypertension of the newborn.

Furthermore, NO is considered to play a critical role in the innate immune system. In vitro studies have demonstrated that NO exhibits antimicrobial activity not only against common bacteria, including both Gram-positive and Gram-negative strains, but also against various other pathogens, such as mycobacteria, viruses, fungi, yeasts, and parasites, with the potential to eradicate multidrug-resistant strains.

Beyond Air is a company dedicated to unlocking the potential of nitric oxide (NO) in the medical field. Established in 2011, this U.S.-based medical device and biopharmaceutical company is committed to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory diseases, neurological disorders, and solid tumors.

LungFit^®The product portfolio is Beyond Air’s R&D focus in the field of therapeutic devices, designed by the inventor who developed the world’s first nitric oxide delivery system.

LungFit ^®The product utilizes patented Ionizer™ technology,In hospital and home settings, nitric oxide can be delivered on demand via indoor air and safely administered to patients for the treatment of various pulmonary diseases.

This technology utilizes a compact ion generator chamber to convert indoor air into inhaled nitric oxide (iNO). During this process, the system consumes power equivalent to that of a 60-watt light bulb to ionize nitrogen and oxygen molecules, which then recombine to form NO. While generating NO, small amounts of NO are also inevitably produced.₂. Regarding this by-product,Ionizer™ technology features a smart filter that eliminates toxic NO within the internal circuitry.₂, ensuring the safe delivery of NO to patients.In addition, the integrated automatic purification function further reduces NO exposure for patients and clinicians.₂Risk of exposure.

Ionizer™ Technology Converts Indoor Air into Inhaled Nitric Oxide

Currently, Beyond Air has deployed compact, easily storable NO devices at the point of care.₂Smart filters and disposable accessories enable healthcare professionals to quickly access these components, enhancing LungFit.^®The product’s practicality and convenience in delivering medical care. Meanwhile, LungFit technology integrates inhaled nitric oxide (iNO) management into hospitals’ point-of-care solutions, enabling timely provision of iNO therapy as needed without reliance on external suppliers, thereby enhancing treatment accessibility and efficiency.

Beyond Air boasts a robust and active product portfolio spanning respiratory therapy, cancer, and autism spectrum disorder.Among them, LungFit^®The system utilizes proprietary plasma pulse technology, with one product currently on the market and two products under development.

LungFit® Product Pipeline

LungFit^®The PH system is designed for use in hospital neonatal intensive care units (NICUs). It delivers low-concentration inhaled nitric oxide at concentrations ≤80 ppm to treat hypoxic respiratory failure (commonly referred to as persistent pulmonary hypertension of the newborn, PPHN) in term and near-term neonates, eliminating the need for traditional gas cylinders.

LungFit^®PRO delivers high-concentration nitric oxide (NO) at 80 to 400 ppm for the treatment of community-acquired viral pneumonia (including COVID-19) and bronchitis. The system is currently undergoing a U.S. VCAP pilot study, with pivotal trials scheduled for the winter of 2025/2026.

LungFit^®GO is specifically designed for home-based treatment, delivering high-concentration nitric oxide (NO) at 80 to 400 ppm to treat pulmonary infections in patients with nontuberculous mycobacteria (NTM) and chronic obstructive pulmonary disease (COPD). Discussions with the FDA on pivotal trial design are scheduled for the second half of 2024.

LungFit® Product Series

All three of the aforementioned products feature performance monitoring and early warning capabilities, and are equipped with disposable NO₂Smart filter, compatible with standard 110V or 220V power outlets. During actual use, Beyond Air provides 24/7 real-time customer service and support covering technical, clinical, and commercial aspects. Its LungFlex Rapid Replacement Program enables emergency delivery within 6 hours and offers customized, comprehensive on-demand on-site training tailored to hospital needs.

To date, Beyond Air has accumulated over 10 years of experience with high-concentration nitric oxide (NO). Its NO therapeutic concentrations, reaching up to 250 ppm, have been tested without any serious adverse events. Currently, the FDA has only approved NO at a concentration of 20 ppm; however, Beyond Air has conducted multiple animal studies across two species, demonstrating that intermittent dosing of NO at levels as high as 400 ppm is safe, with no macroscopic or microscopic abnormalities observed.

Meanwhile, Beyond Air is also exerting efforts in the field of pharmacotherapy, exploring the application potential of nitric oxide (NO) in drug development. Currently, the company is developing neuronal nitric oxide synthase (nNOS) inhibitors for autism spectrum disorder and other nNOS-related neurological diseases, as well as monotherapy and combination therapies for cutaneous/near-cutaneous tumors and multiple solid tumors.

Beyond Air's Pharmaceutical Drug Pipeline

Beyond Air's LungFit^®The PH system, LungFit, has received FDA approval for the treatment of hypoxic respiratory failure in term and near-term neonates.^®The first device on the nitric oxide generator treatment platform, and the company’s first and only FDA-approved patented plasma pulse technology system.

During specific treatment, as a potent vasodilator, nitric oxide reduces pulmonary arterial pressure by dilating pulmonary blood vessels, thereby decreasing right-to-left shunting through a patent foramen ovale (PFO) and a patent ductus arteriosus (PDA), and significantly improving oxygenation.

Specifically, LungFit^®PH products boast three major advantages.

First, quick and easy setup for rapid deployment.LungFit^® The PH product enables rapid initiation of therapy with just three simple steps: power on, make the three necessary connections, and set the therapeutic dose. The entire process can be completed within one minute. This design frees respiratory therapy staff from cumbersome equipment operations, allowing them to devote more time and energy to direct patient care.

Furthermore, traditional iNO therapy requires monitoring of supply sources such as gas cylinders or liquid-filled canisters to ensure that treatment is not interrupted due to depletion of the gas supply. LungFit^®PH eliminates concerns about supply sources, as it draws from indoor air, which is inexhaustible. And LungFit^®The PH filter has a predictable lifespan, maintaining a stable 12-hour service life regardless of dosage or gas flow rate. This allows healthcare personnel to align filter replacement with routine inspections of ventilation equipment, thereby improving work efficiency.

Second, it can accurately deliver the preset dose.LungFit^®PH can precisely control the delivery concentration of NO and regulate gas flow, with an NO delivery range of 0.1–80 ppm and a gas flow rate of 0.5–100 L/min. The system’s primary and backup generators are highly compact, with a size comparable to that of a D-cell battery. In terms of mode, LungFit^®PH offers multiple modes, including primary mode, backup mode, and bag ventilation mode, enabling flexible delivery of iNO through the main jet line and the bagging system to ensure continuous and stable administration under various conditions.

Furthermore, LungFit^®PH employs a validated dual-channel independent delivery and monitoring method to precisely measure ventilator gas flow in real time, ensuring accurate and stable iNO delivery. Its backup battery lasts up to 4 hours, allowing LungFit to operate even without an external power source.^®The backup battery of the pH meter can also support system operation for up to 4 hours.

Third, LungFit^®PH Improves Efficiency by Eliminating the Need for an iNO Source Supply, eliminating the burdens of inventory management, storage space, and safety risks associated with iNO supply. The system has no special storage requirements, does not need to be stored under specific temperature or pressure conditions, contains no hazardous materials, and does not require the use of gas cylinders. This makes LungFit^®PH can avoid the costs and logistical issues associated with treatment using 45-pound high-pressure nitric oxide gas cylinders, improving hospitals’ operational economics. According to Beyond Air, currently, Lunfit^®PH has become the gold standard for hospital NO delivery.

LungFit^®All other components of the PH system are disposable patient accessories, with no reusable parts requiring sterilization. This simplifies operational procedures, reduces the risk of cross-infection, and further lowers maintenance costs and time. The system features an easily replaceable breathing circuit, with each patient using a dedicated circuit to prevent cross-infection. Additionally, a new filter is used for each treatment session to prevent microorganisms and other contaminants from entering the respiratory system, providing patients with a cleaner and safer therapeutic environment.

In terms of operation, the system is designed with user-friendliness in mind, allowing healthcare professionals with limited experience in nitric oxide therapy to easily get started. LungFit^®Each device in the system can treat multiple patients, and one respiratory therapist can operate multiple systems.

On February 12, 2024, Beyond Air announced its financial results for the quarter ended December 31, 2023. In the third quarter of fiscal year 2024, the company reported a robust sequential revenue increase of more than 60% compared to the second quarter.

Meanwhile, LungFit^®PH’s commercial demand continues to grow, with filter shipments increasing by 100% compared to the previous quarter. In September 2023, LungFit^®PH’s software update has received FDA approval, making it likely that this growth trend will continue. Meanwhile, the PMA supplement application for the expansion of the system’s cardiac surgery indications has been accepted by the FDA and is undergoing substantive review. Upon FDA approval of this application, LungFit^®PH will see broader adoption in U.S. hospitals. The company reaffirmed its revenue guidance of $12 million to $16 million for the fiscal year ending March 31, 2025.

Beyond Cancer, a subsidiary of Beyond Air, is conducting a Phase 1 study to evaluate the efficacy of UNO in treating advanced, recurrent, or refractory unresectable primary or metastatic cutaneous and subcutaneous solid tumors. The Safety Review Committee has approved the treatment of the first cohort with a single dose of UNO at 25,000 ppm, and no dose-limiting toxicities have been reported.

Currently, enrollment for the 50,000 ppm cohort in the Phase I study is ongoing. The company is preparing to initiate the Phase Ib study, in which UNO is expected to be administered in combination with an anti-PD-1 agent. First-in-human data presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2023 demonstrated that a single 5-minute intratumoral injection of UNO was safe and well tolerated in patients.

For the three months ended December 31, 2023, Beyond Air’s research and development expenses were $6.8 million, compared with $5.0 million for the three months ended December 31, 2022. The $1.8 million increase was primarily driven by higher pipeline-related development costs. Compared with January 1, 2024, the Company’s annual contract revenue as of April 1, 2024 increased by 40%. The annual contract revenue growth rate as of July 1, 2024 is expected to exceed the 40% growth rate recorded as of April 1, 2024.

Next, Beyond Air will continue to expand the application scope of its nitric oxide therapy technology while actively developing new therapeutic areas, thereby consolidating its market leadership in the development and application of NO.