With a robust active pipeline of products that address respiratory therapeutic areas, cancer, and autism spectrum disorder, Beyond Air is the world’s leading nitric oxide company.

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

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

Persistent pulmonary hypertension of the newborn (PPHN)2

Visit LungFitPH.com

 US FDA approved
CE Mark mid 2024		 Getz Healthcare

Cardiac surgery3

 PMA approval decision 2H 2024  
LungFit PRO Hospital Setting

High-concentration iNO (150 to 400 ppm) for antimicrobial treatments

Viral Community-Acquired Pneumonia (VCAP), including COVID-194,5;
Bronchiolitis6,7

 US VCAP pilot study ongoing with pivotal study planned for 2025/2026 winter  
LungFit GO At-home Treatment

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

Nontuberculous mycobacteria (NTM) lung infection8,9; Severe exacerbations due to lung infections in COPD patients10

Discuss pivotal trial design with FDA in 2H 2024

COPD pilot TBD based on strategic priorities

 Cystic Fibrosis Foundation Logo
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 Drug Therapeutic Area Preclinical Ph1 Ph2 Ph3 NDA Commercial Next Milestone*
Neuro NOS
nNOS Inhibitor

Neuronal nitric oxide synthase inhibitor

Autism Spectrum Disorder (ASD)11

 First-in-human data anticipated in 2025

Other nNOS related neurological disorders
Beyond Cancer

Visit BeyondCancer.com

 Drug Therapeutic Area Preclinical Ph1 Ph2 Ph3 NDA Commercial Next Milestone*
Monotherapy

UNO: Ultrahigh concentration nitric oxide (>10,000 ppm)

Cutaneous / near cutaneous tumors

 Phase 1a full dataset mid 2024

Multiple solid tumors
Combination Therapy

UNO + anti-PD-1

Multiple solid tumors

 Human study initiation 2H24

UNO + anti-CTLA-4

Multiple solid tumors

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

Getz Healthcare is Beyond Air's commercial partner in 10 Asian countries (not including Japan) and is recognized as the leading distributor of medical equipment, devices, and consumables, in Asia Pacific.

The Cystic Fibrosis Foundation provided Beyond Air with a grant of up to $2.17 million to help fund the completed trial of LungFit GO to treat NTM pulmonary disease in Australia.

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
Solid Tumor
Program*
Autism Spectrum Disorder (ASD)*

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

350K US,12 16M ex-US13

120K US,14 3.2M ex-US15,16

15K US,16 4K EU5,17 15K Japan18
LungFit PH LungFit PRO LungFit GO Beyond Cancer
 

US >$350M
WW >$700M

US >$1.5B
WW >$3B

US >$500M
WW >$1.2B

US >$1B
WW >$2.5B

>$37 Billion Global Checkpoint Inhibitor Market in 2022 and Growing19

The cost of caring for Americans with ASD is expected to be >$460B by 202520

* Programs not using LungFit technology

LungFit Technology

See the Products

Corporate Presentation

See Our Advantage

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. Tripathi, M. K., Ojha, S. K., Kartawy, M., Hamoudi, W., Choudhary, A., Stern, S., Aran, A., Amal, H., The NO Answer for Autism Spectrum Disorder. Adv. Sci. 2023, 2205783. https://doi.org/10.1002/advs.202205783. 12. 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 13. 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. 14. 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 15. UNICEF. Global annual results report 2020: goal area 5. https://www.unicef.org/reports/global-annual-results-2020-goal-area-5 16. 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 17. 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 18. 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 19. Company Presentations and Regulatory Filings from Bristol-Myers Squibb, Merck, Roche, AstraZeneca, Pfizer, Regeneron; Sanofi 2011-2020. 20. Leigh JP, Du J. Brief Report: Forecasting the Economic Burden of Autism in 2015 and 2025 in the United States. J Autism Dev Disord. 2015 Dec;45(12):4135-9. doi: 10.1007/s10803-015-2521-7. PMID: 26183723.

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