Beyond Air, Inc. is a commercial-stage medical device and biopharmaceutical company that is pioneering the use of nitric oxide (NO) to improve the lives of patients. The company's innovative LungFit platform has the ability to generate and deliver nitric oxide up to 400 parts per million (ppm) for a variety of respiratory and infectious disease indications.
Business Overview and History
Beyond Air was incorporated on April 28, 2015, under Delaware law as AIT Therapeutics, Inc. The company's focus has been on developing a platform of nitric oxide generators and delivery systems capable of producing NO from ambient air. On June 25, 2019, the company changed its name to Beyond Air, Inc. to better reflect its expanded mission and diverse pipeline of nitric oxide-based therapies.
The company's lead product, LungFit PH, received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in June 2022. LungFit PH 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 pulmonary hypertension, commonly referred to as persistent pulmonary hypertension of the newborn (PPHN). Beyond Air commenced the commercial launch of LungFit PH in the United States in July 2022.
In addition to LungFit PH, Beyond Air is exploring the use of its nitric oxide platform for the treatment of various severe lung infections, including nontuberculous mycobacteria (NTM) lung disease and chronic obstructive pulmonary disease (COPD). The company initiated a pilot clinical trial for NTM lung disease in December 2020 and presented positive interim data at the American Thoracic Society International Conference in May 2022.
Beyond Air's pipeline also includes a majority-owned subsidiary, Beyond Cancer, Ltd., which is developing ultra-high concentration nitric oxide (UNO) therapy for the treatment of solid tumors. The UNO therapy has shown promising preclinical results, and Beyond Cancer commenced a phase 1 clinical trial in August 2022, with the first patient treated in this first-in-human study to assess the safety and immune biomarkers of UNO therapy.
Furthermore, Beyond Air has formed a wholly owned subsidiary, NeuroNOS, which is focused on developing therapies that partially inhibit neuronal nitric oxide synthase (nNOS) in the brain to treat neurological conditions, with the first target indication being autism spectrum disorder (ASD). The company expects NeuroNOS to progress from preclinical to a phase 1 first-in-human clinical trial by the end of 2026.
It's worth noting that Beyond Air has faced challenges over the years. In 2019, the company terminated an agreement with Circassia for commercial rights to PPHN and future related indications in the United States and China. In 2021, Beyond Air entered into a settlement agreement with Circassia, resolving all claims between the parties and mutually terminating the prior agreement. Additionally, the regulatory approval process for LungFit PH took several years to obtain PMA from the FDA.
Product Segments
Beyond Air has three main product segments: LungFit PH, LungFit PRO, and LungFit GO.
LungFit PH is the company's first FDA-approved and CE marked system that uses patented plasma pulse technology to generate on-demand nitric oxide from ambient air. It is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. Beyond Air commenced marketing LungFit PH in the United States in July 2022 and received CE mark approval in the European Union in November 2024 for treating infants with hypoxic respiratory failure as well as peri- and post-operative pulmonary hypertension in adults and pediatric patients. The company believes the addressable U.S. market for LungFit PH is approximately $350 million and the worldwide market to be around $700 million. Beyond Air initiated a limited launch phase in July 2022 and is working towards a full commercial launch in the U.S. in 2025 and expanding to the EU and global markets.
LungFit PRO is focused on using the company's NO delivery platform to treat viral community-acquired pneumonia (VCAP), including COVID-19. Beyond Air initiated a pilot clinical trial in 2020 using LungFit PRO at 150 ppm of NO to treat VCAP patients, which showed trends of shortened length of stay and faster time to stable oxygen saturation compared to the control group. The company believes the U.S. market potential for VCAP, excluding the COVID-19 pandemic, is greater than $1.5 billion, and the worldwide market potential is over $3 billion. Beyond Air commenced a larger clinical trial in the U.S. in the second half of 2023 but has decided to pause this study pending future funding.
LungFit GO is targeting the treatment of nontuberculous mycobacteria (NTM) lung infection, a rare and serious pulmonary disease. In December 2020, Beyond Air began a 12-week, multi-center, open-label clinical trial in Australia to evaluate the safety and efficacy of LungFit GO delivering up to 250 ppm of NO for NTM patients. Interim data presented at scientific conferences in 2022 showed that high-dose NO treatment was well-tolerated, and trends were observed in improved quality of life, respiratory function, and reduction of microbial load. The company expects to commence a pivotal clinical trial for LungFit GO in NTM in 2026 following discussions with the FDA. The U.S. sales potential for the NTM indication is believed to be greater than $1 billion, with the worldwide market potential exceeding $2.5 billion.
Financial Overview
For the fiscal year ended March 31, 2024, Beyond Air reported total revenue of $1.16 million. The company's net loss for the same period was $60.24 million. Annual operating cash flow was negative $56.01 million, and annual free cash flow was negative $61.76 million.
For the most recent quarter ended December 31, 2024, Beyond Air reported quarterly revenue of $1.07 million, representing a 174% increase from $0.39 million in the same quarter of the previous year. This increase in revenue was primarily due to the company signing new hospital contracts and customers beginning to use the LungFit PH system. The quarterly net loss for this period was $13.03 million.
Beyond Air reported total revenue of $2.55 million for the nine months ended December 31, 2024, compared to $0.69 million for the same period in the prior year. The company's net loss for the nine months ended December 31, 2024 was $40.42 million, or $0.64 per share, compared to a net loss of $49.74 million, or $1.46 per share, for the nine months ended December 31, 2023.
Liquidity
As of December 31, 2024, Beyond Air had cash and cash equivalents of $4.60 million and restricted cash of $232,000, for a total of $4.83 million. The company's debt-to-equity ratio stood at 0.11, with a current ratio of 3.56 and a quick ratio of 3.12.
Beyond Air has a $11.5 million loan agreement entered into on November 1, 2024 with certain lenders including the CEO and a director. The loan has a 10-year term, 15% interest rate payable in-kind through July 2026, and an 8% royalty on net sales until the loan is repaid.
The company believes its current cash position, along with its plans for increased revenues and decreased expenditures, will enable it to meet its obligations through the spring of 2026.
Risks and Challenges
Beyond Air's success is subject to a number of risks and uncertainties, including:
1. Regulatory Approval: The company's product candidates, including LungFit PH and its other nitric oxide-based therapies, will require premarket review and approval by the FDA, certification through a conformity assessment by a notified body in the European Union, and comparable approvals from foreign regulatory authorities. Delays or failures in obtaining these approvals could significantly impact the company's business.
2. Commercialization Challenges: Even with regulatory approvals, the company may face challenges in successfully commercializing its products, including competition, pricing pressures, and the ability to establish effective sales and marketing infrastructure.
3. Financing Needs: Beyond Air may require additional financing to fund its ongoing research and development activities, as well as the commercialization of its approved products. The company's ability to raise capital on favorable terms, or at all, is critical to its long-term success.
4. Dependence on Key Personnel: The company's success is heavily dependent on its ability to attract and retain key personnel, including its management team and scientific and technical experts.
Outlook and Future Guidance
Beyond Air is well-positioned to capitalize on the growing demand for innovative respiratory and infectious disease treatments. The company's LungFit PH system has demonstrated its potential to improve patient outcomes, and the successful commercialization of this product in the U.S. and global markets will be a key driver of the company's future growth.
Beyond Air expects sequential quarterly revenue growth throughout fiscal year 2025, driven by a steady stream of new hospital signings and the onboarding process for their LungFit PH system. The company believes its updated LungFit PH system is poised to start taking significant market share in the U.S. and globally, with the inflection point happening now in the U.S.
Regarding ex-U.S. markets, Beyond Air expects to see shipments of the LungFit PH starting in the next few months, which will start impacting their revenues in the back half of fiscal year 2026 and beyond. The company plans to provide revenue guidance for fiscal year 2026 on their fiscal year 2025 year-end conference call, which will be held in June.
Additionally, Beyond Air's pipeline of nitric oxide-based therapies, including its efforts in NTM lung disease, COPD, solid tumors, and autism spectrum disorder, represent significant long-term opportunities for the company. As these programs advance through clinical development, they could unlock significant value for shareholders.
While Beyond Air faces a number of risks and challenges, the company's strong intellectual property portfolio, experienced management team, and unique nitric oxide technology platform provide a solid foundation for sustainable growth. As the company continues to execute on its strategic initiatives, it may emerge as a leader in the development and commercialization of nitric oxide-based therapies that can transform the lives of patients worldwide.