XAIR on Nasdaq

Beyond Air, Inc.

Beyond Air, Inc. is an American surgical and medical instruments and apparatus company.2 It is headquartered in Garden City, United States.2 Its shares trade on Nasdaq under the symbol XAIR.2

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Last updated Oct 21, 2026.

Overview

$7.7MRevenue, fiscal 20263
-$33.2MNet income, fiscal 20263

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  • TickerXAIR on Nasdaq2
  • IndustrySurgical & Medical Instruments & Apparatus2
  • HeadquartersGarden City, United States2
  • Incorporated inDE4
  • Business address900 Stewart Avenue, Suite 301, Garden City, Ny 115304
  • Filer categoryNon-accelerated filer, Smaller reporting company4
  • Legal formCorporation2
  • LEI549300GFTTTXX57283602
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O INCORP SERVICES, INC., 19713 Newark, United States2
  • Registered withDivision of Corporations, Department of State, 57367642

November 2024, the Company received European CE mark approval of the LungFit PH® system for the following:6 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2026

3.3%Gross margin3
-378.2%Operating margin3
-433.0%Net margin3
107.3%Revenue growth, 20263
-542.8%Return on equity3
-$19.2MFree cash flow3

Where the money goes

Where each dollar of revenue went, fiscal 2026

  • Cost of revenue20¢$7.4M
  • Research and development28¢$10.2M
  • Selling, general and admin52¢$19.1M

Out of $7.7M in revenue.3 The company lost money this year.

Financial statements

Revenue789103$7.7M in 2026−1% since 2019
0$2.0M$4.0M$6.0M$8.0M2019: $7.7M$7.7M20192020: $1.4M$1.4M2020−82%2021: $873.0K$873.0K2021−37%2024: $1.2M$1.2M2024+33%2025: $3.7M$3.7M2025+220%2026: $7.7M$7.7M2026+107%
Gross profit11103$252.0K in 2026
-$2.0M-$1.5M-$1.0M-$500.0K0$500.0K2023: -$555.0K-$555.0K20232024: -$1.3M-$1.3M2024+135%2025: -$1.7M-$1.7M2025+27%2026: $252.0K$252.0K2026
Operating income7891211103-$29.0M in 2026+850% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$3.1M-$3.1M20192020: -$18.1M-$18.1M2020+493%2021: -$22.2M-$22.2M2021+22%2022: -$40.7M-$40.7M2022+83%2023: -$52.1M-$52.1M2023+28%2024: -$63.0M-$63.0M2024+21%2025: -$44.5M-$44.5M2025−29%2026: -$29.0M-$29.0M2026−35%
Net income7891211103-$33.2M in 2026+407% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$6.6M-$6.6M20192020: -$19.9M-$19.9M2020+204%2021: -$22.9M-$22.9M2021+15%2022: -$43.2M-$43.2M2022+89%2023: -$55.8M-$55.8M2023+29%2024: -$60.2M-$60.2M2024+8%2025: -$46.6M-$46.6M2025−23%2026: -$33.2M-$33.2M2026−29%

Every line of the income statement as filed: the last 2 fiscal years, latest first.3

Period ending2026-03-312025-03-31
Revenues$7.7M$3.7M
Cost of revenues$7.4M$5.4M
Gross profit (loss)$252.0K-$1.7M
Research and development$10.2M$16.9M
Selling, general and administrative$19.1M$26.0M
Total operating expenses$29.3M$42.9M
Loss from operations-$29.0M-$44.5M
Dividend/investment income$303.0K$705.0K
Interest and finance expense-$3.5M-$3.0M
Change in fair value of warrant liability$35.0K$237.0K
Change in fair value of derivative liability-$1.4M$1.3M
Foreign exchange loss-$108.0K-$3.0K
Loss on extinguishment of debt-$165.0K-$2.4M
Loss on disposal/impairment of fixed assets-$431.0K-$738.0K
Other income/(expense)-$14.0K$9.0K
Total other income/(expense)-$5.3M-$3.9M
Loss before income taxes-$34.3M-$48.5M
Net loss-$34.3M-$48.5M
Less: net loss attributable to non-controlling interest-$1.1M-$1.9M
Net loss attributable to Beyond Air, Inc.-$33.2M-$46.6M
Foreign currency translation adjustment$194.0K-$45.0K
Comprehensive loss attributable to Beyond Air, Inc.-$33.1M-$46.7M
Net basic loss per share attributable to Beyond Air, Inc.-$4.01-$13.77
Net diluted loss per share attributable to Beyond Air, Inc.-$4.01-$13.77
Weighted average number of shares of common stock outstanding - basic8.3M shares3.4M shares
Weighted average number of shares of common stock outstanding - diluted8.3M shares3.4M shares

Compare Beyond Air, Inc. with another company

Corporate structure

Beyond Air, Inc. sits at the top of its group. 9 entities, 5 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Beyond Air, Inc.

  • Yi-Chien Lin Filed SCHEDULE 13G/A on Beyond Air, Inc., latest Oct 2, 2026 (3 filings since Jul 14, 2026)
  • BALYASNY ASSET MANAGEMENT L.P. Filed SCHEDULE 13G/A on Beyond Air, Inc., latest Aug 14, 2026 (7 filings since Feb 14, 2025)
  • Alyeska Investment Group, L.P. Filed SCHEDULE 13G/A on Beyond Air, Inc., latest May 15, 2026 (3 filings since Feb 14, 2025)
  • Avenue Venture Opportunities Fund, L.P. Filed SCHEDULE 13G/A on Beyond Air, Inc., latest Feb 4, 2025 (3 filings since Oct 3, 2024)
  • BlackRock Filed SC 13G on Beyond Air, Inc., latest Mar 7, 2024 (2 filings since Jan 29, 2024)
  • Marlio Charles Mosseri Filed SC 13G/A on Beyond Air, Inc., latest Feb 14, 2024 (3 filings since Feb 9, 2022)
  • James E. Flynn Filed SC 13G/A on Beyond Air, Inc., latest Feb 11, 2022
  • Beyond Air, Inc. Garden City, New York, United States
    • Beyond Air Australia Pty. Ltd. Subsidiary · Australia
    • Beyond Air Ireland Limited Subsidiary · Ireland
    • Beyond Cancer Bermuda Limited Subsidiary · Bermuda
    • Beyond Cancer U.S., Inc. Subsidiary · Delaware, United States
    • NeuroNos Israel Limited Subsidiary · Israel
    • NeuroNos Limited Subsidiary · Ireland
    • NeuroNos US Inc Subsidiary · Delaware, United States
    • XAIR Israel Ltd Subsidiary · Israel

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Beyond Air, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$15.9M3 Mar 31, 2026$16.5M3 Mar 31, 2025−3.7%
Accumulated depreciation$7.7M3 Mar 31, 2026$5.5M3 Mar 31, 2025+39.3%
Property and equipment, net$8.2M3 Mar 31, 2026$11.0M3 Mar 31, 2025−25.1%
Operating-lease assets (leased space)$1.2M3 Mar 31, 2026$1.7M3 Mar 31, 2025−30.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$6.7M3 Mar 31, 2026$4.7M3 Mar 31, 2025+44.5%
Marketable securities, current$4.9M3 Mar 31, 2026$2.3M3 Mar 31, 2025+117.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, net$1.0M3 Mar 31, 2026$1.2M10 Mar 31, 2025−16.7%
Licenses, net$1.0M3 Mar 31, 2026$1.2M3 Mar 31, 2025−16.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$1.4M3 Mar 31, 2026$2.4M3 Mar 31, 2025−41.8%

Properties, in its own words

As of June 18, 2026, the Company leased facilities for corporate and R&D purposes at locations throughout the United States and in various locations outside of the United States. Our executive office is located at 900 Stewart Avenue, Suite 310, Garden City, NY 11530, and is under a lease that expires in June 2031. We have an office in Dublin, Ireland under a lease that expires in September 2026. The Company has a research and development facility in Madison, Wisconsin under a lease that expires in May 2029. The Company believes the existing facilities which are used by all reportable segments of the Company and are in good operating condition and are suitable for the conduct of its business.

Item 2 of the 10-K filed Jun 26, 2026.6

Leadership

Who has led Beyond Air, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (13)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Chief Medical OfficerJeff Lynn Myers named Jun 28, 202336
  • DirectorRobert A. Carey named Jul 9, 2024 to Oct 11, 202437
  • DirectorRobert Lynn Carey named Jun 28, 202336

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Beyond Air Australia Pty. Ltd. Australia5
  • Beyond Air Ireland Limited Ireland5
  • Beyond Air Ltd. Israel5
  • Beyond Cancer Bermuda Limited Bermuda5
  • Beyond Cancer U.S., Inc. Delaware5
  • NeuroNos Israel Limited Israel5
  • NeuroNos Limited Ireland5
  • NeuroNos US Inc Delaware5
  • XAIR Israel Ltd Israel5

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • AIT Therapeutics, Inc.Jan 20, 2017 to Jun 18, 20194
  • KokiCare, Inc.May 8, 2015 to Dec 16, 20164

Timeline

  1. Oct 8, 20268-K Results of operations; Regulation FD disclosure38
  2. Sep 24, 20268-K Entered a material agreement; Executive or director change39
  3. Aug 18, 20268-K Results of operations; Regulation FD disclosure40
  4. Aug 6, 20268-K Other events41
  5. Jul 31, 2026New chief executive Robert Scott Goodman becomes CEO16
  6. Jul 31, 20268-K Entered a material agreement; Unregistered sale of shares; Other events42
  7. Jul 9, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed43
  8. Jun 26, 20268-K Results of operations; Bylaws or fiscal year changed; Regulation FD disclosure44
  9. Jun 22, 20268-K Shareholder vote; Other events45
  10. Jun 1, 20268-K Other events46
  11. Apr 15, 20268-K Other events47
  12. Apr 10, 20268-K Listing notice or transfer48
  13. Apr 1, 20268-K Entered a material agreement; Executive or director change; Regulation FD disclosure49
  14. Apr 26, 2018New chief executive Steven A. Lisi becomes CEO17
  15. Apr 19, 2017New chief executive Amir Avniel becomes CEO18
  16. Apr 28, 2015Founded Beyond Air, Inc. is founded2

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/202650

When it reported results

  1. Oct 8, 2026Reported quarterly or annual results38
  2. Aug 18, 2026Reported quarterly or annual results40
  3. Jun 26, 2026Reported quarterly or annual results44
  4. Feb 13, 2026Reported quarterly or annual results51
  5. Nov 14, 2025Reported quarterly or annual results52
  6. Aug 18, 2025Reported quarterly or annual results53
  7. Jun 18, 2025Reported quarterly or annual results54
  8. Feb 14, 2025Reported quarterly or annual results55

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

306 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 71 major events, 123 insider forms, 22 large holders, 3 private raises, 67 other. The latest 20:

  1. Oct 14, 20264 PRIMARY DOCUMENT EDGAR
  2. Oct 8, 20268-K EDGAR
  3. Oct 2, 20264 PRIMARY DOCUMENT EDGAR
  4. Oct 2, 20263 PRIMARY DOCUMENT EDGAR
  5. Oct 2, 2026SCHEDULE 13G/A EDGAR
  6. Sep 24, 20268-K EDGAR
  7. Aug 24, 2026EFFECT EDGAR
  8. Aug 24, 2026424B3 EDGAR
  9. Aug 18, 20268-K EDGAR
  10. Aug 17, 2026S-3 EDGAR
  11. Aug 14, 2026SCHEDULE 13G/A EDGAR
  12. Aug 13, 202610-Q EDGAR
  13. Aug 6, 20268-K EDGAR
  14. Jul 31, 20264 EDGAR
  15. Jul 31, 20264 EDGAR
  16. Jul 31, 20268-K EDGAR
  17. Jul 16, 2026SCHEDULE 13G/A EDGAR
  18. Jul 14, 2026SCHEDULE 13G EDGAR
  19. Jul 9, 20268-K EDGAR
  20. Jun 26, 20268-K EDGAR

The 306 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

60 open-market trades by officers, directors and large owners since October 2021: 52 buys and 8 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 29, 2026Goodman Robert ScottChief Executive OfficerBuy34,722$5.76$200.0KForm 4
Jul 29, 2026MOORHEAD DANIEL JChief Financial OfficerBuy4,340$5.76$25.0KForm 4
Jul 21, 2025Lisi Steven A.CEO and Chairman of the BoardBuy6,000$3.25$19.5KForm 4
Mar 14, 2025Carey RobertDirectorBuy1,000,000$0.25$250.1KForm 4
Feb 19, 2025Gaul Michael A.Chief Operating OfficerBuy6,000$0.38$2.3KForm 4
Sep 26, 2024Carey RobertDirectorBuy1,476,626$0.50$738.3KForm 4
Sep 26, 2024Lisi Steven A.CEO and Chairman of the BoardBuy1,476,626$0.50$738.3KForm 4
Aug 15, 2024Lisi Steven A.CEO and Chairman of the BoardBuy50,000$0.37$18.5KForm 4
Aug 14, 2024Lucera ErickDirectorBuy39,266$0.40$15.7KForm 4
Aug 14, 2024Lisi Steven A.CEO and Chairman of the BoardBuy100,000$0.39$39.0KForm 4
Aug 14, 2024Carey RobertDirectorBuy100,000$0.40$40.0KForm 4
Dec 28, 2023Avniel AmirChief Business OfficerSale25,000$2.05$51.4KForm 4
Dec 27, 2023Myers Jeff LynnChief Medical OfficerSale3,423$2.21$7.6KForm 4
Dec 18, 2023Lisi Steven A.CEO and Chairman of the BoardBuy77,775$1.63$126.8KForm 4
Dec 18, 2023Carey RobertDirectorBuy1,200,000$1.64$2.0MForm 4
Nov 16, 2023Gaul Michael A.Chief Operating OfficerBuy10,000$1.77$17.7KForm 4
Aug 28, 2023Carey RobertDirectorBuy250,000$2.70$675.0KForm 4
Aug 21, 2023Carey RobertDirectorBuy75,050$2.76$207.1KForm 4
Aug 18, 2023Carey RobertDirectorBuy13,614$2.64$35.9KForm 4
Jun 30, 2023Gaul Michael A.Chief Operating OfficerBuy5,000$4.51$22.6KForm 4

All 60 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$22.1M 2023–2024
Money received by yearMoney received by year, 2023–2024: $22.1M in all. Private raises (Form D) $22.1M.$0$10M$20M$30M2023 · Private raises (Form D): $1.4M20232024 · Private raises (Form D): $20.7M2024
Figures by year
YearPrivate raises (Form D)Total
2024$20.7M$20.7M
2023$1.4M$1.4M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Sep 26, 2024Raised $20.6 million in a private offering of equity37 Form D: 15 investors so far Form D
  2. Jun 24, 2024Raised $128,000 in a private offering of equity63 Form D: 2 investors so far Form D
  3. Jun 15, 2023Raised $1.4 million in a private offering of equity36 Form D: 2 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
SBI Securities Co., Ltd.15$70.0%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Beyond Air, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARBeyond Air, Inc.1
  • CIK0001641631
  • Employer ID (EIN)47-38124566
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsMarch 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address900 Stewart Avenue, Suite 301, Garden City, NY 115301
  • Phone516-665-82001
  • Shares outstanding957,631 as of Aug 12, 202615
  • Public float$15.5M as of Sep 30, 20256
  • AuditorWithumSmith+Brown, PC, East Brunswick, New Jersey PCAOB ID 100; no auditor attestation of internal control over financial reporting6
  • On EDGAR sinceMay 8, 20151
  • Filings626 in all: 4 (206), 8-K (140), 10-Q (31), 424B3 (28), CORRESP (25), EFFECT (20), UPLOAD (20), 3 (19)1
    All 38 form types

    SC 13G/A (12), 10-K (11), S-3 (11), SCHEDULE 13G/A (11), DEF 14A (9), 424B5 (8), D (8), S-1/A (8), S-1 (7), SC 13G (7), S-8 (6), 4/A (4), DEFA14A (4), PRE 14A (4), S-3/A (4), CT ORDER (3), SCHEDULE 13G (3), 144 (2), 5 (2), 8-K/A (2), POS AM (2), 10-K/A (1), 10-KT (1), 3/A (1), 8-A12B (1), 8-A12G (1), CERT (1), NT 10-K (1), NT 10-Q (1), PRER14A (1)

  • Latest filingsAnnual report (10-K) Jun 26, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) May 5, 2026
    Latest 8-K (8-K) Oct 8, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareXAIRNasdaq

From the cover page of the 10-K filed Jun 26, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks Beyond Air, Inc. names in Item 1A of its 10-K filed Jun 26, 2026: 71 risks under these headings, as written.6

  • Risks Related to Our Financial Position and Capital Requirements
  • Our independent registered public accounting firm’s report contains an explanatory paragraph that expresses substantial doubt about our ability to continue as a “going concern.”
  • Numerous factors, including the incurring of significant losses, are relevant to our financial success and any or all such factors could have a disproportionate impact on our bottom line.
  • We will need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult to obtain, and could dilute current stockholders’ ownership interests.
  • Our failure to comply with the covenants or other terms of the Loan Agreement, including as a result of events beyond our control, could result in a default under the Loan Agreement that could materially and adversely affect the ongoing viability of our business.
  • Our Loan Agreement contains restrictions that limit our flexibility in operating our business.
  • Risks Related to Commercialization of Our Approved Product or Product Candidates
  • If the market opportunities for our approved product or product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
  • The insurance coverage and reimbursement status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
  • We face intense competition and rapid technological change and the possibility that our competitors may discover, develop or commercialize therapies that are similar, more advanced or more effective than ours, which may adversely affect our financial condition and our ability to successfully commercialize LungFit® PH and our product candidates.
  • The commercial success of LungFit® PH and any current or future product candidate will depend upon the degree of market acceptance by physicians, patients, third-party payors and others in the medical community.
  • If we fail to properly manage our anticipated growth, our business could suffer.
The other 61 risks
  • Pricing pressure from our competitors and our customers may impact our ability to sell our products at prices necessary to support our current business strategies.
  • Cybersecurity risks and the failure to maintain the confidentiality, integrity, and availability of our computer hardware, software, and Internet applications and related tools and functions could result in harm to our business and/or subject us to costs, fines or lawsuits.
  • Healthcare legislative or regulatory reform measures, including government restrictions on pricing and reimbursement, may have a negative impact on our business and results of operations.
  • We are subject to additional federal and state laws and regulations relating to our business, and our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions.
  • If we fail to comply with applicable privacy, data protection and data security laws and regulations, we could face substantial penalties, liability and adverse publicity and our business, operations and financial condition could be adversely affected.
  • If we or our suppliers fail to comply with ongoing FDA or other foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.
  • Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA or comparable foreign regulatory authorities, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or comparable foreign regulatory authorities, could have a negative impact on us.
  • Our approved product or product candidates may in the future be subject to product recalls that could harm our reputation, business and financial results.
  • We may be subject to regulatory or enforcement actions if we engage in improper marketing or promotion of our approved product or product candidates.
  • We face extensive, ongoing regulatory requirements and review, and our products may face future development and regulatory difficulties.
  • Risks Related to the Discovery and Development of Our Product Candidates
  • We are heavily dependent on the success of our product candidates, which are in various stages of clinical development. We cannot give any assurance that any of our product candidates will receive certification or regulatory approval, which is necessary before they can be commercialized.
  • The success of our business may also depend upon our ability to identify, license or discover additional product candidates.
  • The certification or regulatory approval processes of the FDA and comparable foreign regulatory authorities and notified bodies are lengthy, time-consuming and inherently unpredictable. If we are ultimately unable to obtain certification or regulatory approval for our product candidates, our business will be substantially harmed.
  • Our business and sale of our approved product and product candidates are subject to extensive regulatory requirements, including compliance with labelling, manufacturing and reporting controls. If we fail or are unable to timely obtain the necessary 510(k) clearances, de-novo authorizations, or PMA approvals for new products, or equivalent steps in third countries including the EEA, our ability to generate revenue could be materially harmed.
  • Once commercialized, modifications to our marketed products may require new 510(k) clearances or approval of PMA supplements, or equivalent steps in other countries or regions including the EEA, or may require us to cease marketing or recall the modified products until certification, clearances or regulatory approvals are obtained.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.
  • Legislative or regulatory reforms may make it more difficult and costly for us to obtain certification, regulatory clearance or approval of any future products and to manufacture, market and distribute our products after certification, clearance or approval is obtained.
  • We are working on NTM lung infection which is very rare.
  • We are working on bronchiolitis that usually is caused by the RSV virus and any related trials we conduct are dependent on a number of factors outside of our control, which may lead to varied trial results and possibly delays in our plans.
  • Our subsidiaries are exploring novel therapeutic processes with NO and once they put forth product candidates, those product candidates are likely to be classified as pharmaceutical drugs by the FDA; pharmaceutical regulation is more stringent than the standards to which our current approved product is subject, and as such, as our subsidiaries’ research and results expand, the Company’s regulatory and related costs will increase, which may affect our financial results, in particular, to the extent that these therapies remain investigative and do not lead to the outcomes anticipated.
  • Clinical trials are necessary to support our future product submissions to the FDA and such trials involve regulatory complexity, are lengthy, iterative and involve working with third parties, including CROs and patients for enrollment. These and other factors may affect our ability to complete clinical trials and may lead to delays or failures that would affect our business and financial prospects.
  • We may experience delays in obtaining a CE mark in the EEA for our approved product due to possible EU MDR regulatory classification that differs from the FDA’s regulatory paradigm.
  • We may find it difficult to enroll patients in our clinical trials. Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates.
  • We may encounter substantial delays in our clinical trials, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
  • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their certification or regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.
  • Risks Related to our Reliance on Third Parties
  • We rely on third parties to conduct our preclinical studies and clinical trials and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain certification or regulatory approval for or commercialize our approved product or product candidates and our business could be substantially harmed.
  • We rely on third parties to manufacture our NO generator and delivery system. Our business could be harmed if those third parties fail to provide us with sufficient quantities of our needed supplies, or fail to do so at acceptable quality levels or prices.
  • We and our collaborators and contract manufacturers are subject to significant regulation with respect to manufacturing our approved product or product candidates. The manufacturing facilities on which we rely may not continue to meet regulatory requirements and have limited capacity.
  • If we encounter issues with our contract manufacturers or suppliers, we may need to qualify alternative manufacturers or suppliers, which could impair our ability to sufficiently and timely manufacture and supply LungFit® PH.
  • We depend on third-party manufacturers, including sole source suppliers, to manufacture LungFit® PH and our product candidates and the materials we require for our clinical trials. We may not be able to maintain these relationships and could experience supply disruptions outside of our control.
  • Our reliance on third parties may require us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain effective patent rights for LungFit® PH, our product candidates or any future product candidates, we may not be able to compete effectively in our markets.
  • Intellectual property rights of third parties could adversely affect our ability to commercialize our approved product or product candidates, and we might be required to litigate or obtain licenses from third parties in order to develop or market our approved product or product candidates. Such litigation or licenses could be costly or not available on commercially reasonable terms.
  • Patent terms are limited and we may not be able to effectively protect our products and business.
  • Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • If we are unable to maintain effective proprietary rights for our approved product, product candidates or any future product candidates, we may not be able to compete effectively in our markets.
  • Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
  • We may not be successful in obtaining or maintaining necessary rights to our approved product or product candidates through acquisitions and in-licenses.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • We may be involved in lawsuits or post-grant proceedings to protect or enforce our patents or the patents of our licensor, which could be expensive, time-consuming and unsuccessful.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Our Business Operations
  • We manage our business through a small number of employees and key consultants.
  • We may need to expand our organization and we may experience difficulties in recruiting needed additional employees and consultants, which could disrupt our operations.
  • Our international operations and plans to expand such operations present challenges and risks related to doing business internationally.
  • Conditions in Israel may materially and adversely affect the Company’s business.
  • The use of any of our products could result in product liability or similar claims that could be expensive, damage our reputation and harm our business.
  • Natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events could disrupt the supply, delivery or demand of products, which could negatively affect our operations and performance.
  • We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage.
  • Risks Related to the Ownership of our Common Stock
  • We are currently listed on The Nasdaq Capital Market. Our failure to maintain our compliance with Nasdaq’s continued listing standards or other requirements could result in our common stock being delisted from Nasdaq, which could adversely affect our liquidity and the trading volume and market price of our common stock and decrease or eliminate your investment.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Trading in our common stock has been volatile and may continue to be volatile in the future.
  • Anti-takeover provisions in our amended and restated certificate of incorporation and our amended and restated bylaws, as well as provisions of Delaware law, might discourage, delay or prevent a change in control of the Company or changes in our Board of Directors or management and, therefore, depress the trading price of our common stock.
  • Risks Related to Employee Matters
  • Our business could suffer if we lose the services of key members of our senior management, key advisors or personnel.
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • We are subject to applicable fraud and abuse laws, including anti-kickback and false claims, transparency, health information privacy and security and other healthcare laws. Failure to comply with such laws may result in substantial penalties.
  • Employee litigation and unfavorable publicity could negatively affect our future business.
  • Under applicable employment laws, such as in Israel, we may not be able to enforce covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees.
  • General Risk Factors
  • The increasing use of social media platforms presents new risks and challenges.

Legal proceedings

From time to time, the Company is involved in various legal matters arising in the normal course of business. Litigation and other disputes are inherently unpredictable and subject to substantial uncertainties and unfavorable resolutions could occur. At the same time, the Company does not expect the outcome of such proceedings, either individually or in aggregate, to have a material effect on its financial position, cash flows or results of operations.

The opening of Item 3, Legal Proceedings.6

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