Beyond Air Files 2024 10-K

TL;DR

Beyond Air filed its annual 10-K. Check financials.

AI Summary

Beyond Air, Inc. filed its 10-K for the fiscal year ending March 31, 2024. The company, formerly known as AIT Therapeutics, Inc. and KokiCare, Inc., is involved in the surgical and medical instruments and apparatus industry. The filing covers financial data and business operations for the period.

Why It Matters

This 10-K filing provides a comprehensive overview of Beyond Air's financial health and business strategy for the past fiscal year, crucial for investors and stakeholders.

Risk Assessment

Risk Level: medium — As a publicly traded company in the medical device sector, Beyond Air faces inherent risks related to regulatory approvals, market competition, and financial performance.

Key Players & Entities

• Beyond Air, Inc. (company) — Filer
• AIT Therapeutics, Inc. (company) — Former Company Name
• KokiCare, Inc. (company) — Former Company Name
• March 31, 2024 (date) — Fiscal Year End
• Garden City, NY (location) — Business Address

FAQ

Key Financial Figures

• $0.0001 — h registered: Common Stock, par value $0.0001 per share XAIR The Nasdaq Stock Mar
• $268 billion — g for Americans with autism had reached $268 billion in 2015 and would rise to $461 billion
• $461 billion — $268 billion in 2015 and would rise to $461 billion by 2025 in the absence of more-effectiv
• $298.2 million — cals ("Mallinckrodt"), sales of NO were $298.2 million in 20

Filing Documents

• form10-k.htm (10-K) — 3226KB
• ex10-31.htm (EX-10.31) — 106KB
• ex21-1.htm (EX-21.1) — 8KB
• ex23-1.htm (EX-23.1) — 4KB
• ex31-1.htm (EX-31.1) — 17KB
• ex31-2.htm (EX-31.2) — 17KB
• ex32-1.htm (EX-32.1) — 7KB
• ex32-2.htm (EX-32.2) — 7KB
• ex97.htm (EX-97.1) — 58KB
• form10-k_001.jpg (GRAPHIC) — 99KB
• form10-k_002.jpg (GRAPHIC) — 126KB
• form10-k_003.jpg (GRAPHIC) — 122KB
• 0001493152-24-025000.txt ( ) — 13593KB
• xair-20240331.xsd (EX-101.SCH) — 73KB
• xair-20240331_cal.xml (EX-101.CAL) — 104KB
• xair-20240331_def.xml (EX-101.DEF) — 329KB
• xair-20240331_lab.xml (EX-101.LAB) — 610KB
• xair-20240331_pre.xml (EX-101.PRE) — 505KB
• form10-k_htm.xml (XML) — 2205KB

Business

Business 6 Item 1A. Risk Factors 31 Item 1B. Unresolved Staff Comments 74 Item 1C. Cybersecurity 74 Item 2.

Properties

Properties 75 Item 3. Legal Proceedings 75 Item 4. Mine Safety Disclosures 75 PART II 76 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 76 Item 6. (Reserved) 76 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 77 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 83 Item 8. Financial 83 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 83 Item 9A. Controls and Procedures 84 Item 9B. Other Information 84 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspection 84 PART III 85 Item 10. Directors, Executive Officers and Corporate Governance 85 Item 11. Executive Compensation 92 Item 12. Security 96 Item 13. Certain Relationships and Related Transactions, and Director Independence 98 Item 14. Principal Accounting Fees and Services 99 PART IV 100 Item 15. Exhibits and Financial Statement Schedules 100 Item 16. Form 10-K Summary 104

SIGNATURES

SIGNATURES 105 2 References in this Annual Report on Form 10-K (this "Annual Report") to the "Company," "Beyond Air," "we," "our," or "us" mean Beyond Air, Inc. and its subsidiaries except where the context otherwise requires. FORWARD-LOOKING This Annual Report contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933 (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934 (the "Exchange Act"). All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, approved product and product candidates, certifications or approvals, timing of our clinical development activities, research and development costs, our commercialization plans and the expected timing thereof, timing and likelihood of success, and the plans and objectives of management for future operations and future results of anticipated products are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "expect," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential," or "continue" or the negative of these terms or other similar conditional expressions. The forward-looking and projections about future

Risk Factors

Risk Factors The increasing use and relevance of social media platforms may present new risks. Our business may be affected by unfavorable global or U.S. economic conditions. 5 PART I ITEM 1. BUSINESS

Business

Business Overview We are a commercial-stage medical device and biopharmaceutical company developing a platform of nitric oxide ("NO") generators and delivery systems (the "LungFit platform") capable of generating NO from ambient air. Our first device, LungFit PH received premarket approval ("PMA") from the 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. In July 2022, we commenced marketing LungFit PH in the United States for PPHN as a medical device. 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. Furthermore, 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. Our current areas of focus with LungFit are PPHN, viral community-acquired pneumonia ("VCAP") including COVID-19, bronchiolitis ("BRO"), nontuberculous mycobacteria ("NTM") lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease ("COPD"). Our current product candidates will be subject to premarket reviews and approvals by the FDA, certification thro

View Full Filing

View this 10-K filing on SEC EDGAR