S-1: Beyond Air S-1: Streeterville Resale, $20M Capital Potential

Beyond Air, a medical device and biopharmaceutical company, filed an S-1 registration statement for the resale of up to 1.6 million shares by Streeterville Capital, LLC, with the potential to raise up to $20 million for general corporate purposes.

Summary

• Beyond Air, Inc. is a commercial-stage medical device and biopharmaceutical company focused on nitric oxide (NO) generators and delivery systems (the LungFit platform).
• The LungFit PH system received FDA premarket approval in June 2022 and European CE mark approval in November 2024 for hypoxic respiratory failure in neonates (PPHN) and periand post-operative pulmonary hypertension in adults and pediatric patients.
• The company is also developing the LungFit platform for nontuberculous mycobacteria (NTM) lung infection and severe lung infections with underlying chronic obstructive pulmonary disease (COPD).
• Beyond Air has two additional programs: Beyond Cancer (80% owned) for solid tumors using ultra-high concentration gaseous NO (UNO) in Phase 1 clinical trial, and NeuroNOS Limited (88.2% owned) for neurological conditions like autism spectrum disorder (ASD) using nNOS inhibitors, expected to enter Phase 1 by the end of 2026.
• This S-1 filing registers up to 1,600,000 shares of common stock for resale by Streeterville Capital, LLC, which may be issued to Streeterville under an Equity Purchase Agreement dated November 4, 2025.
• Beyond Air will not receive any proceeds from Streeterville's resale of these shares.
• Beyond Air may receive up to $20,000,000 in gross proceeds from selling its common stock to Streeterville under the Purchase Agreement, with estimated net proceeds of approximately $18,000,000 after fees and expenses, assuming the full amount is sold.
• The purchase price for shares sold to Streeterville will be 96% of the lowest daily volume-weighted average price (VWAP) during a four-day period, or 85% of the Nasdaq Minimum Price (subject to a $0.39 floor) if a Secured Promissory Note is outstanding and certain trading conditions are met.
• As of November 20, 2025, there were 8,009,488 shares of common stock outstanding.
• A 1-for-20 reverse stock split became effective on July 14, 2025.

Sentiment

Score: 4

Explanation: The filing indicates significant financial challenges, including expected losses and substantial potential dilution from the capital raise structure. While the company has promising product development and regulatory approvals, the immediate financial outlook and the nature of the capital raise present considerable risks to investors.

Positives

• The LungFit PH system has received FDA premarket approval (June 2022) and European CE mark approval (November 2024) for PPHN and other pulmonary hypertension indications.
• The LungFit platform utilizes patented plasma pulse technology to generate on-demand NO from ambient air, offering competitive advantages over current NO delivery systems by not requiring high-pressure cylinders or cumbersome purging procedures.
• The company is pursuing multiple indications beyond PPHN, including NTM lung infection, severe lung infections with COPD, solid tumors (Beyond Cancer), and neurological conditions like ASD (NeuroNOS).
• The potential to raise up to $20,000,000 in gross proceeds from the Equity Purchase Agreement with Streeterville provides a source of capital for general corporate purposes, including working capital, commercial operations, and R&D.

Negatives

• The company will not receive any proceeds from the resale of shares by Streeterville Capital, LLC, which is the primary purpose of this S-1 filing.
• Sales of common stock to Streeterville under the Purchase Agreement, and subsequent resales by Streeterville, may result in substantial dilution to existing stockholders.
• The company expects to incur losses for the next year.
• The investment involves a high degree of risk, as stated in the filing.
• The purchase price for shares sold to Streeterville is at a discount (96% of lowest VWAP or 85% of Nasdaq Minimum Price with a $0.39 floor), indicating potentially unfavorable terms for the company.

Risks

• A sale of a substantial number of shares of common stock by the Selling Stockholder could cause the price of common stock to decline.
• Such sales may make it more difficult for the company to sell equity or equity-related securities in the future at a reasonable or appropriate time and price.
• The company expects to incur losses for the next year.
• There is a risk that products may contain undetected errors or defects or otherwise not perform as anticipated.
• The company's ability to successfully commercialize its LungFit PH system in the U.S. is a risk.
• Future capital needs and the ability to raise additional funds are significant risks.
• The company's ability to build a pipeline of product candidates and develop and commercialize approved products is uncertain.
• Risks exist regarding the company's ability to enroll patients in clinical trials, timely and successfully complete those trials, and receive necessary certifications or regulatory approvals.
• Maintaining existing or future collaborations or licenses is a risk.
• Protecting and enforcing intellectual property rights is a challenge.
• Federal, state, and foreign regulatory requirements, including FDA regulation, pose risks.
• The ability to obtain and retain key executives and attract and retain qualified personnel is critical.
• Successfully managing growth, including as a commercial-stage company, is a risk.
• Rule 144 for resale of securities is generally not available for former shell companies, though exceptions apply if certain conditions are met.

Future Outlook

The company expects to incur losses for the next year. The NeuroNOS program, targeting autism spectrum disorder and other neurological conditions, is expected to progress from preclinical to a Phase 1 first-in-human clinical trial by the end of 2026. The company aims to successfully commercialize its LungFit PH system in the U.S. and continue developing its product candidates for various severe lung infections.

Management Comments

• "We expect to incur losses for the next year."
• "We believe that there is a high unmet medical need for patients suffering from certain severe lung infections that the LungFit platform can potentially address."
• "We believe the ability of LungFit PH to generate NO from ambient air provides us with many competitive advantages over the current standard of NO delivery systems."
• "We believe that 150 ppm is the minimum therapeutic dose to achieve the desired pulmonary antimicrobial effect of NO."
• "Our management will have broad discretion in the application of the net proceeds [from the Streeterville agreement]."

Industry Context

Beyond Air operates in the medical device and biopharmaceutical sectors, focusing on nitric oxide (NO) therapy. Its LungFit platform addresses a critical need in respiratory care, particularly for conditions like PPHN, where it offers a novel, cylinder-free NO generation system. The company is also expanding into high-unmet-need areas such as severe lung infections (NTM, COPD), oncology (solid tumors with ultra-high NO), and neurological disorders (ASD with nNOS inhibitors). The development of on-demand NO generation from ambient air positions Beyond Air as an innovator against traditional NO delivery methods, potentially reducing logistical burdens in healthcare settings. The pursuit of high-concentration NO for antimicrobial effects represents a differentiated approach in the infectious disease space, while its oncology and neurology programs aim to leverage NO's therapeutic potential in novel applications.

Comparison to Industry Standards

• The LungFit PH system's ability to generate NO from ambient air is a competitive advantage over current standard NO delivery systems in the U.S., EU, Japan, and other markets, which typically require high-pressure cylinders and cumbersome purging procedures.
• Current FDA-approved NO vasodilation treatments deliver low concentrations (<100 ppm), which the company believes would have limited success in treating microbial infections, contrasting with Beyond Air's belief that 150 ppm is the minimum therapeutic dose for pulmonary antimicrobial effect.
• Currently, neither the FDA nor comparable foreign regulatory agencies have approved any NO formulation and/or delivery system for >80 ppm NO, indicating Beyond Air's high-concentration NO approach is novel and not yet standard.
• There are no FDA-approved therapies specifically for the treatment of Autism Spectrum Disorder (ASD), highlighting the significant unmet medical need that NeuroNOS aims to address.

Management Changes

Corporate Governance

Related Party Transactions

• On November 1, 2024, the company issued five-year warrants to purchase up to 757,975 shares of common stock at an exercise price of $7.586 per share in connection with a secured loan to related parties, including the Chief Executive Officer and a director.
• On November 4, 2025, the company entered into a Waiver Agreement, pursuant to which the lenders (related parties) consented to the company's issuance of the Secured Promissory Note to Streeterville in exchange for reducing the exercise price of their existing warrants to $1.95 per share.
• On November 4, 2025, the company issued five-year warrants to a director to purchase up to 512,821 shares of common stock at an exercise price of $1.95 per share as consideration for obtaining a waiver for the Secured Promissory Note.

Stakeholder Impact

• Shareholders face significant potential dilution from the issuance and resale of shares to Streeterville Capital, LLC. The market price of common stock could decline.
• Company operations may benefit from the potential gross proceeds of up to $20 million from the Equity Purchase Agreement with Streeterville, which will be used for general corporate purposes, including working capital, commercial operations, repayment of the promissory note, pre-clinical and clinical activities, and other strategic initiatives.
• Creditors (Streeterville Capital, LLC) will receive shares at a discount and have the right to resell them, potentially recouping their investment or profiting. They also hold a Secured Promissory Note.

Next Steps

• Commercialize the LungFit PH system in the U.S.
• Continue development of the LungFit platform for nontuberculous mycobacteria (NTM) lung infection and severe lung infections with underlying chronic obstructive pulmonary disease (COPD).
• Progress the Beyond Cancer program (solid tumors using UNO) through its Phase 1 human clinical trial.
• Advance the NeuroNOS program (nNOS inhibitors for ASD) from preclinical to a Phase 1 first-in-human clinical trial by the end of 2026.
• Potentially issue and sell additional shares of common stock to Streeterville Capital, LLC under the Equity Purchase Agreement to raise up to $20 million for general corporate purposes.
• File additional registration statements if more than 1,600,000 shares are to be sold to Streeterville.

Key Dates

Recommendation

The company presents a mixed bag of significant potential and substantial risk. On one hand, it has FDA and CE approvals for its LungFit PH system and a pipeline addressing high-unmet-need areas like severe lung infections, oncology, and neurological disorders. This indicates strong long-term growth potential if these programs succeed. On the other hand, the immediate financial outlook includes expected losses and a capital raise structure with Streeterville Capital that involves significant potential dilution for existing shareholders, as shares are sold at a discount and the company does not receive proceeds from the direct resale. The high degree of investment risk and the potential for stock price decline due to dilution warrant a cautious approach. A 'hold' recommendation allows investors to monitor the progress of commercialization and clinical trials while acknowledging the near-term financial pressures and dilution risks.

Keywords

Beyond Air, XAIR, SEC Filing, S-1, Equity Purchase Agreement, Streeterville Capital, Common Stock Resale, Dilution, Capital Raise, Nitric Oxide, LungFit PH, PPHN, Medical Device, Biopharmaceutical, FDA Approval, CE Mark, Pulmonary Hypertension, NTM Lung Infection, COPD, Beyond Cancer, Solid Tumors, NeuroNOS, Autism Spectrum Disorder, ASD, nNOS Inhibitors, Clinical Trials, Risk Factors, Nasdaq Capital Market