Beyond Air, Inc. · NASDAQ:XAIR
Beyond Air — Investor Presentation (May 2024)
42 slides from Beyond Air's investor presentation, May 2024
Slide 1: Corporate Presentation May 2024
Corporate Presentation May 2024
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation is for informational purposes only and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities of Beyond Air, Inc. (the “Company”) nor shall there be any sale of securities in any
Slide 3: Nitric Oxide: A Simple, Yet Complex Molecule
Nitric Oxide: A Simple, Yet Complex Molecule We are the Nitric Oxide Company Nitric oxide synthase (NOS) exists in 3 isoforms in the human body and has multiple functions. • Nitric Oxide (NO) is the combination of nitrogen Type Location Mechanism Therapeutic Target and oxygen in a specific manner •
Slide 4: Our Mission: Harness the Power of Nitric Oxide
Our Mission: Harness the Power of Nitric Oxide We are developing the ability to transition between the ICU, whole hospital and the untapped home market Beyond Air’s robust active pipeline of products targets the following conditions: Hypoxic respiratory failure Right ventricular dysfunction Re
Slide 5: Financial and Patent Information
Financial and Patent Information Financial Overview Revenue Guidance of $12 - $16 million for FY ending March 31, 2025 Ticker XAIR >15 issued patents expiring up to 2040 Exchange NASDAQ >10 pending patent applications, if Share Price issued, may extend expiration $1.29 (as of 5/16/24) through 2044 S
Slide 6: Introducing the LungFit PH with our Patented Plasma Pulse Technology
Introducing the LungFit PH with our Patented Plasma Pulse Technology The LungFit® PH is the first and only FDA approved system with patented Plasma Pulse Technology to generate continuous, unlimited iNO at the point of care from room air. Oxygen 60 Watts Nitric Oxide NO2 Smart Filter Nitrogen Electr
Slide 7: Innovative LungFit Platform Elicits Paradigm Shift for Nitric Oxide Therapy
® Innovative LungFit Platform Elicits Paradigm Shift for Nitric Oxide Therapy Hospital Setting At-Home Treatment High concentration nitric oxide to treat viral High concentration nitric oxide for the community acquired pneumonia and treatment of NTM and lung infections in bronchiolitis+ patients wit
Slide 8: Robust LungFit Pipeline
® Robust LungFit Pipeline Device Therapeutic Area Preclinical Pilot Pivotal PMA Commercial Next Milestone* Partners1 Persistent pulmonary hypertension US FDA approved of the newborn (PPHN) CE Mark mid 2024 Hospital NICU Setting Low-concentration iNO (≤80 PMA approval ppm) for pulmonary treatments Ca
Slide 9: Drug NO Candidates
Drug NO Candidates Drug Therapeutic Area Preclinical Ph 1 Ph 2 Ph 3 NDA Commercial Next Milestone(*) First-in-human data Autism spectrum disorder (ASD) anticipated in 2025 nNOS Inhibitor Other nNOS related neurological (neuronal nitric oxide disorders synthase inhibitor) For more information, visit
Slide 10: Large Market Opportunities
Large Market Opportunities Annual Viral Pneumonia Annual Bronchiolitis Total Refractory NTM PPHN Opportunity: Hospitalizations: Hospitalizations: Patient Populations: 15K US6 Solid Tumor 7.5k cases in US1 350k US2 120K US4 Program Programs not 4k EU57 ex-US Includes PPHN & 16M ex-US3 3.2M ex-US4,5 u
Slide 11: Persistent Pulmonary Hypertension of the Newborn (PPHN)
Persistent Pulmonary Hypertension of the Newborn (PPHN)* LungFit® PH offers significant advantages to hospitals *PPHN is commonly used to refer to the condition treated with NO. The actual labelled indication is to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in te
Slide 12: Nitric Oxide for PPHN and Cardiac Surgery
Nitric Oxide for PPHN and Cardiac Surgery PPHN – Persistent Pulmonary Artery Hypertension of the Neonate2 Inhaled NO (iNO) causes smooth muscle relaxation, In PPHN NO reversal of pulmonary hypertension Red Blood increasing blood flow to the decreases right-to-left shunt Cell lungs and decreasing rig
Slide 13: Evolution of Nitric Oxide
Evolution of Nitric Oxide DSIR Plus Vero enters market MNK EVOLVE and Approved with non-cylinder offer Airgas Ulspira approved Beyond Air to NO molecule of submit PMA to FDA NO Approved the year… with for transport-ready in Europe for Nobel prize finally LungFit PH II PPHN awarded in 1998 1992 1999
Slide 14: LungFit PH: All You Need Is Air
LungFit® PH: All You Need Is Air LungFit® PH uses patented Plasma Pulse Technology to generate nitric oxide within seconds from ambient room air, eliminating the need for inhaled nitric oxide (iNO) source supplies like cylinders or cassettes. Confidently deliver the set dose and initiate iNO thera
Slide 15: LungFit PH Market Position as of Today
LungFit PH Market Position as of Today Today LungFit PH is the Gold Standard for NO delivery in the hospital • This Gold Standard status required a software update, as the adoption of our first approved system had limitations Limitations Prior to Software Update Position in the Market Today Compatib
Slide 16: Nitric Oxide to treat Lung Infections
Nitric Oxide to treat Lung Infections
Slide 17: LungFit For Treating Lung Infections
LungFit® For Treating Lung Infections Simple, safe and convenient • Allows for both home and hospital use • Supplemental oxygen can be utilized through the system (hospital only) Easy to Use • Programmable by RFID on filter • Convenient for all staff • Self-administration for home use • Usable with
Slide 18: High Concentration NO – Demonstrated Safety in Humans
High Concentration NO – Beyond Air Demonstrated Safety in Humans 5,000+ 170+ 12 0 Serious Adverse Treatments Patients Different Events Related to NO Administered Treated Clinical Settings • Beyond Air has 10+ years of experience with high concentration NO • Concentrations as high as 250 ppm have bee
Slide 19: Intermittent Dosing Key to Safe Administration of High Concentration NO
Intermittent Dosing Key to Safe Administration of High Concentration NO • Methemoglobin (MetHb) is a well-known biomarker for NTM Compassionate Use – 160 PPM NO safety of NO; with the acceptable safety threshold <10% • Methemoglobinemia is a condition where higher-than- normal levels of MetHb are fo
Slide 20: Viral Community-Acquired Pneumonia in Hospitalized Patients
Viral Community- Acquired Pneumonia in Hospitalized Patients Nitric oxide has demonstrated antiviral and broad-spectrum antimicrobial activity
Slide 21: Viral Lung Disease Overview
Viral Lung Disease Overview Viral Community-Acquired Benefits of Nitric Oxide Bronchiolitis Pneumonia (VCAP) Vaccines are not available Influenza virus is the most common Nitric Oxide has broad-spectrum RSV is the most common cause of Leading activity cause of for all cause of viral pneumonia
Slide 22: VCAP US Pilot Study Design
Viral Community-Acquired Pneumonia (VCAP) US Pilot Study Design Pilot Clinical Trial in the United States (FDA IDE approved) • Multicenter, randomized, double blind, placebo-controlled study of adult patients hospitalized with VCAP, including COVID-19 • Primary endpoint is safety • Exploratory effic
Slide 23: VCAP Pilot Study Design
Viral Community-Acquired Pneumonia (VCAP) Pilot Study Design Pilot Clinical Trial in Israel Commenced enrollment in November 2020 Interim data presented at ATS 2021 Additional data presented at ECCMID 2022 ̶ Multicenter open label study of adult patients hospitalized with VCAP, including COVID
Slide 24: 150 PPM NO Evaluated in VCAP Pilot Study
150 PPM NO Evaluated in VCAP (including COVID-19) Pilot Study Results Presented at the European Congress of Clinical Microbiology & Infectious Diseases in 2022 Intent to Treat Population: 35 subjects (16 iNO + SST vs 19 SST) Adverse Events SST LungFit- 150 ppm NO+SST Any AE 9 (47%) 13 (81%) Any AE d
Slide 25: VCAP (including Covid-19) Efficacy Data
VCAP (including Covid-19) Efficacy Data Efficacy Data show Strong Trends in Favor of NO (97% of subjects were Covid-19) Intent to Treat Population: 35 subjects (16 iNO + SST vs 19 SST) Duration of hospital stay (days) Time to reach SpO2 ≥ 93% (days) Duration of O2 support (days) HR [95% CI] 1.8 [0.7
Slide 26: NO Safe & Well Tolerated in Bronchiolitis Studies
NO Safe & Well Tolerated in Bronchiolitis Studies Pooled Safety Results Presented at American Thoracic Society International Conference 2021 85 ppm NO + SST 150 ppm NO + SST 160 ppm NO + SST SST (N=82) All (N=198) (N=32) (N=29) (N=55) N % N % N % N % N % Any AE 45 54.9% 20 62.5% 18 62.1% 25 45.5% 10
Slide 27: Long-Term Safety Data Supports High Concentration NO
Long-Term Safety Data Supports High Concentration NO Long-Term Safety Results Presented at Pediatric Academic Societies 2022 Meeting Subjects re-hospitalized for bronchiolitis related outcomes Treatment/ Control Subjects Re- Patient Exposure Total Subjects (N) Incidence Rate (95% Cl)% Rate per 100 P
Slide 28: 150 PPM NO is Minimum Therapeutic Dose
150 PPM NO is Minimum Therapeutic Dose for Patients Hospitalized due to Viral Infection Data Presented at CHEST 2020 – Statistical Significance on both the Primary & Secondary Endpoint at 150 PPM Third Bronchiolitis Pilot Study Results 150 ppm vs. 85 ppm 150 ppm vs. SST 85 ppm vs. SST Primary endpoi
Slide 29: Nontuberculous Mycobacteria
Nontuberculous Mycobacteria Expanding Nitric Oxide into the Home Market for Lung Infections
Slide 30: Nontuberculous Mycobacteria (NTM) Overview
Nontuberculous Mycobacteria (NTM) Overview Who is at risk? How is NTM acquired? Immunocompromised people are at a greater risk for NTM NTM is commonly found in water sources, with warmer climates having higher infection rates • Underlying lung disease and/or genetic predisposition • Cystic Fibrosis
Slide 31: Home Market: NTM Market Dynamics
Home Market: NTM Market Dynamics There are a limited number of Significant undiagnosed NTM players in NTM patient population Beyond Air is targeting Mycobacterium abscessus, the most aggressive and difficult to Median survival for MAC is treat form of NTM and NTM costs estimated at $1.7 13 years whi
Slide 32: Pilot LungFit NTM Study Protocol Summary
Pilot LungFit® NTM Study Protocol Summary • Pilot Clinical Trial In Australia Baseline Demographics Received grant for up to $2.17 million from the Cystic Fibrosis N 15 Foundation to help fund pilot study Age (yrs.) Mean 62.1 (15) Data presented at the CHEST Conference on October 17, 2022 Gender
Slide 33: High Compliance Rate with No SAEs that led to Discontinuation
High Compliance Rate with No SAEs that led to Discontinuation of Treatment Total N (Intent-to-treat Population) = 15 N % • Related AEs included: Hemoptysis (SAE), vomiting, balance Any AE 15 100 difficulty, dry mouth, fatigue, headache, paresthesia and Any AE related to study treatment * 9 60.0 hypo
Slide 34: Comparable Lung Function Throughout Treatment
Comparable Lung Function Throughout Treatment Data are not adjusted Total distance walked in 6 minutes Activity Tracker Summary for the time spent for treatment administration 60000 40 700 Mean Weekly distance (Km) Mean Weekly steps 50000 600 30 40000 Distance (meters) 500 30000 20 400 20000 300 10
Slide 35: Improvement in Key Secondary Endpoint
Improvement in Key Secondary Endpoint Quality of Targeting Refractory Life (QoL-B) Mycobacterium avium complex (MAC) & M. abscessesPivotal Study Endpoint NTM Patients • Overall QoL improvement shown in 100 Percentage of Subjects Improved/Remained Unchanged majority of categories at Day 85*** Unchang
Slide 36: Reduction in Microbial Load
Reduction in Microbial Load • The changes reach statistical significance at study day 113/114, and a trend in favor of a decrease in mycobacterial load was observed at other time points. Mean change from baseline on the • One subject achieved culture conversion with 3 consecutive negative cultures s
Slide 37: Introducing the Role of Nitric Oxide in Autism Spectrum Disorder
Introducing the Role of Nitric Oxide in Autism Spectrum Disorder For more information, visit www.Neuro-NOS.com
Slide 38: Beyond Air Partners with Hebrew University
Beyond Air Partners with Hebrew University Beyond Air has acquired exclusive global commercial rights to several compounds that partially inhibit the activity of neuronal nitric oxide synthase (nNOS) • Nitric Oxide (NO) has been linked to autism spectrum disorder (ASD) in humans • More specifically,
Slide 39: Nitric Oxide and Autism
Nitric Oxide and Autism • NO plays a major role in neuronal function and synaptic transmission1 • NO was found to be involved in a human mutation-based mouse models for ASD • Nitrosative stress, marked by high levels of NO, is associated with a number of neurological disorders • Recently, the Amal l
Slide 40: nNOS Inhibition Reversed ASD Behaviors
nNOS Inhibition Reversed ASD Behaviors In the ASD mouse model, the nNOS inhibitor leads to: 150 ✱✱✱ ✱✱ 1. increased novelty seeking and improved memory 1. Time (sec) 100 n s 2. improved social behavior 50 3. decreased anxiety-like behavior 0 Familiar Novel Familiar Novel Familiar Novel WT M2 M2 trea
Slide 41: Achievements and Upcoming Milestones
Achievements and Upcoming Milestones1 2022 1H 2023 2H 2023 1H 2024 2H 2024 2025 US PMA US cardiac surgery CE Mark Persistent Pulmonary approval PMA submission US cardiac surg LungFit PH II FDA Hypertension of the Newborn PMA approval approval (PPHN), and cardiac surgery US commercial Asia-Pacific la
Slide 42: For more information contact
For more information contact: Investor Relations IR@beyondair.net www.beyondair.net