Beyond Air is harnessing nitric oxide’s pulmonary, antimicrobial, anti-inflammatory, and immunomodulatory mechanisms of action to deliver global access to more treatment options from hospital to home.

With a robust active pipeline of products that generate and deliver low, high, and ultrahigh concentrations of nitric oxide, Beyond Air continues to make progress toward validation and approval.

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Therapeutic Area Preclinical Pilot Pivotal PMA Commercial Next Milestone*
LungFit PH Hospital NICU Setting

Low-concentration iNO (≤80 ppm) for pulmonary treatments1

Neonates with hypoxic respiratory failure2

Visit LungFitPH.com

US FDA approved
CE Mark 2H22

Cardiac surgery3

US submission 2H22
LungFit PRO Hospital Setting

High-concentration iNO (80 to 400 ppm) for antimicrobial treatments

Community-acquired viral pneumonia (CAVP), including COVID-194,5

Initiate US study in 2H23; pending discussion with FDA

Bronchiolitis6,7

LungFit GO At-home Treatment

High-concentration iNO (80 to 400 ppm) for antimicrobial treatments

Nontuberculous mycobacteria (NTM) lung infection8,9

Full dataset in 2H22 (home self-administration)

Severe exacerbations due to lung infections in COPD patients10

Pilot study starts 2023
Beyond Cancer

Ultrahigh concentration nitric oxide (>10,000 ppm) for immunomodulatory treatments

Multiple solid tumors

Visit BeyondCancer.com

First in-human trial ongoing

Demonstrated Safety with
High Concentration Nitric Oxide

Icon Treatments Administered
5,000+ Treatments Administered
Icon Patients Treated
170+ Patients Treated
Icon Clinical Settings
12+ Clinical Settings
Icon Adverse Reactions
0 Serious Adverse Reactions Related to Nitric Oxide

Beyond Air has 10+ years of experience with high concentration NO, as high as 250 ppm have been tested with no SAEs. Currently, only 20 ppm NO is approved by FDA. Beyond Air has conducted multiple animal studies in 2 species that show intermittent dosing up to 400 ppm NO to be safe with no macroscopic or microscopic findings.

Significant Market Opportunity Exists
to Treat More Patients With Nitric Oxide

PPHN
Opportunity
Annual Viral Pneumonia Hospitalizations
Annual Bronchiolitis Hospitalizations
Total Refractory NTM Patient Population
Annual Acute COPD Exacerbation-Related Hospitalizations
Solid Tumor
Program

7.5K cases in the United States2
Ex-US includes PPHN and cardiac patients

350K US,11 16M ex-US12

120K US,13 3.2M ex-US13,14

15K US,15 4K EU5,16 15K Japan17

1M US18

LungFit PH LungFit PRO LungFit GO Beyond Cancer
 

US >$400M
WW >$700M

US >$1.5B
WW >$3B

US >$500M
WW >$1.2B

US >$1B
WW >$2.5B

US >$2.5B
WW >$6B

>$30B global checkpoint inhibitor market in 2021 and growing19

LungFit Technology

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Corporate Presentation

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References: 1. Tripathi P, Tripathi P, Kashyap L, Singh V. The role of nitric oxide in inflammatory reactions [retracted in: FEMS Immunol Med Microbiol. 2012;66(3):449]. FEMS Immunol Med Microbiol. 2007;51(3):443-452. doi:10.1111/j.1574-695X.2007.00329.x 2. Lakshminrusimha S, Keszler M. Persistent pulmonary hypertension of the newborn. Neoreviews. 2015;16(12):e680-e692. doi:10.1542/neo.16-12-e680 3. Rosenkranz S, Gibbs JS, Wachter R, De Marco T, Vonk-Noordegraaf A, Vachiéry JL. Left ventricular heart failure and pulmonary hypertension. Eur Heart J. 2016;37(12):942-954. doi:10.1093/eurheartj/ehv512 4. Wolak T, Dicker D, Kalaora R, et al. Inhaled nitric oxide for the treatment of COVID-19 and other viral pneumonias in adults. Presented at: American Thoracic Society (ATS) 2021 International Conference; May 14-19, 2021. Accessed May 13, 2022. https://d1io3yog0oux5.cloudfront.net/beyondairinc/files/docs/2021.05.13+ATS2021-AVP-Final.mp4 5. Wolak T, Dicker D, Shifer Y, Hatan M, Tal A, et al. Treatment of COVID-19 with inhaled nitric oxide using a novel nitric oxide generator. Presented at: 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2022; April 23-26, 2022; Lisbon, Portugal. Accessed May 13, 2022. 6. Tal A, Kalaora R, Hatan M, et al. Efficacy and safety of inhaled nitric oxide for the treatment of acute bronchiolitis: an evaluation of three trials. Presented at: American Thoracic Society (ATS) 2021 International Conference; May 14-19, 2021. Accessed May 13, 2022. 7. Goldbart A, Lavie M, Lubetzky R, et al. Evaluation of two doses of nitric oxide (NO) given intermittently via inhalation to subjects with bronchiolitis – a multi-center double blind study. Poster presented at: CHEST Annual Meeting; October 16-19, 2020; Nashville, Tennessee. Accessed May 13, 2022. 8. Goldbart A, Gatt D, Golan Tripto I. Non-tuberculous mycobacteria infection treated with intermittently inhaled high-dose nitric oxide. BMJ Case Rep. 2021;14(10):e243979. doi:10.1136/bcr-2021-243979 9. Chau T, da Silva J, Ghaffari A, Zelazny A, Olivier KN. Synergistic effect of nitric oxide with antibiotics against mycobacterium abscessus in vitro. Am J Respir Crit Care Med. 2019;199:A2656. https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2019.199.1_MeetingAbstracts.A2656 10. McMullin BB, Chittock DR, Roscoe DL, Garcha H, Wang L, Miller CC. The antimicrobial effect of nitric oxide on the bacteria that cause nosocomial pneumonia in mechanically ventilated patients in the intensive care unit. Respir Care. 2005;50(11):1451-1456. 11. Rui P, Kang K. National Hospital Ambulatory Medical Care Survey: 2017 emergency department summary tables. National Center for Health Statistics. https://www.cdc.gov/nchs/data/nhamcs/web_tables/2017_ed_web_tables-508.pdf 12. Rudan I, Tomaskovic L, Boschi-Pinto C, Campbell H; WHO Child Health Epidemiology Reference Group. Global estimate of the incidence of clinical pneumonia among children under five years of age. Bull World Health Organ. 2004;82(12):895-903. 13. Hall CB, Weinberg GA, Iwane MK, et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009;360(6):588-598. doi:10.1056/NEJMoa0804877 14. UNICEF. Global annual results report 2020: goal area 5. https://www.unicef.org/reports/global-annual-results-2020-goal-area-5 15. Winthrop KL, Marras TK, Adjemian J, Zhang H, Wang P, Zhang Q. Incidence and prevalence of nontuberculous mycobacterial lung disease in a large U.S. managed care health plan, 2008-2015. Ann Am Thorac Soc. 2020;17(2):178-185. doi:10.1513/AnnalsATS.201804-236OC 16. Ringshausen FC, Wagner D, de Roux A, et al. Prevalence of nontuberculous mycobacterial pulmonary disease, Germany, 2009-2014. Emerg Infect Dis. 2016;22(6):1102-1105. doi:10.3201/eid2206.151642 17. Izumi K, Morimoto K, Hasegawa N, et al. Epidemiology of adults and children treated for nontuberculous mycobacterial pulmonary disease in Japan. Ann Am Thorac Soc. 2019;16(3):341-347. doi:10.1513/AnnalsATS.201806-366OC 18. Jinjuvadia C, Jinjuvadia R, Mandapakala C, Durairajan N, Liangpunsakul S, Soubani AO. Trends in outcomes, financial burden, and mortality for acute exacerbation of chronic obstructive pulmonary disease (COPD) in the United States from 2002 to 2010. COPD. 2017;14(1):72-79. doi:10.1080/15412555.2016.1199669 19. Company Presentations and Regulatory Filings from Bristol-Myers Squibb, Merck, Roche, AstraZeneca, Pfizer, Regeneron; Sanofi 2011-2020.

*All dates are based on projections and appropriate financing, and anticipated first launch on a global basis pending appropriate regulatory approvals.

Label expected to include cardiac surgery and PPHN.

Caution: LungFit®PRO and LungFit®GO are investigational devices, limited by federal (or United States) law to investigational use.