Beyond Air, Inc. · NASDAQ:XAIR
Beyond Air — Investor Presentation (September 2020)
42 slides from Beyond Air's investor presentation, Sep 2, 2020
Slide 1: Corporate Presentation – Beyond Air
Corporate Presentation 6& Beyond Air’ September 2020 The Magic of Breathing
Slide 2: Forward Looking Statement
Forward Looking Statement 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: Beyond Air — A Paradigm Shift in Nitric Oxide Therapy
Beyond Air — A Paradigm Shift in Nitric Oxide Therapy LungFit™ devices generate nitric oxide (NO) from ambient air — Allows for unlimited on-site generation of NO vs. fixed supply cylinder systems currently used in hospitals — NO therapy can move safely into the home setting with self-administration
Slide 4: Late Stage, Active Pipeline
Late Stage, Active Pipeline 2c 23 eee Worldwide Indication Development Status Key Dates™ US Sales Potential@ i 102) Sales Potential® In-hospital use for Final preparations for PMA filing 2H 2020 >$300 million >$600 million LungFit™ PH PPHN and cardiac PMA ventilator compatible surgery US launch 1H 2
Slide 5: Antimicrobial Apoptosis
Antimicrobial Apoptosis 6& Beyond Air Tewegcot Greats Cell proliferation => €o Nitric Oxide? —=te —te | B Immune _ response F) \ Neurotransmission Cardiovascular homeostasis Angiogenesis The role of nitric oxide Nitric oxide market is currently > $500M in the US! 1.MNK company reports 2.Image source
Slide 6: Generating NO From Ambient Air - High Barrier to Entry
Generating NO From Ambient Air -— High Barrier to Entry During electric discharge in a lightning storm at 20,000°C, the nitrogen and oxygen in air react to produce nitric oxide LungFit™ safely reproduces the reaction in a proprietary chamber without the extreme heat
Slide 7: Nitric Oxide: Multiple Mechanisms of Action
Nitric Oxide: Multiple Mechanisms of Action Pulmonary vasodilator — Inhaled NO selectively dilates the pulmonary vasculature via relaxation of vascular smooth muscle = Any NO that passes from the pulmonary vascular wall into systemic circulation is rapidly and efficiently scavenged by hemoglobin whi
Slide 8: NO Plays a Major Role in the Immune System
NO Plays a Major Role in the Immune System Source of NO (cell type) Category Macrophages, microglia, neutrophils, eosinophils, fibroblasts, endothelial cells, epithelial cells Antimicrobial activity Effector function Killing or reduced replication of infectious agents (viruses, bacteria, protozoa, f
Slide 9: LungFit — Multiple Devices
6& Beyond Air The Magic of Breathing LungFit BRO Lungeit PH 0830, LungFit™ — Multiple Devices Nitric oxide generation from ambient air baBeyond Air
Slide 10: Significant Advantages in the Hospital — Pulmonary Hypertension
Significant Advantages in the Hospital — Pulmonary Hypertension Current SOC uses large, bulky, and heavy cylinders Gylinder LungFit System PH Height 15 60 Width 18" 24" Depth ~21" 14" 28" Weight 175 Ibs 32 Ibs 65 Ibs Simple, safe, and practical = Ventilator compatible Easy to Use: = Filter timer — s
Slide 11: Beyond Air Smart Filter vs. Cylinder
Beyond Air Smart Filter vs. Cylinder Consummate “razor blade” financial model for NO Delivery 45 pounds Proprietary smart filter removes toxic nitrogen dioxide (NO,) gas Filters are a fraction of the cylinder size + No disposal requirements + Easy to store, handle, and manage inventory Smart filter
Slide 12: LungFit: For Treating Lung Infections
LungFit™: For Treating Lung Infections Simple, safe, and practical + Allows for both home and hospital use = Supplemental oxygen can be utilized through the system Easy to Use * Programmable by RFID on filter ‘ * Convenient for all staff j + Self-administration for home use \ » Use with any electric
Slide 13: High Concentration NO - XAIR Demonstrated Safety in Humans
High Concentration NO - XAIR Demonstrated Safety in Humans * Beyond Air has 9 years of experience with high concentration NO * Concentrations as high as 250 ppm have been tested, with no SAE's * Currently only 20 ppm NO approved by FDA 2,500+ 140+ 9 0 Treatments . Different Serious Adverse Events ad
Slide 14: Intermittent Dosing — Safe Delivery of High Concentration NO
Intermittent Dosing — Safe Delivery of High Concentration NO Demonstrated safety using intermittent dosing in preclinical animal toxicity studies and in humans (predictable methemoglobin) Preclinical Animal Studies Rats: 30 days of intermittent treatments with LungFit™ at 400 ppm NO showed no macros
Slide 15: Persistent pulmonary hypertension of the newborn (PPHN)
6& Beyond Air The Magic of Breathing Persistent pulmonary ° hypertension of the newborn (PPHN) LungFit™ has significant advantages over cylinders
Slide 16: Nitric Oxide for PPHN and Cardiac Surgery
Nitric Oxide for PPHN and Cardiac Surgery Inhaled NO (iNO) causes smooth muscle relaxation, increasing blood flow to the lungs and decreasing right ventricular workload) (Nos) {a t] +4 eno oe ; 2 NO Noe Nos 6a Beyond Air PPHN -— Persistent Pulmonary Hypertension of the Neonate? @ Neconum aspiation c
Slide 17: Current Nitric Oxide Market Dynamics
Current Nitric Oxide Market Dynamics Established as standard of care for >20 years for treating pulmonary hypertension in the hospital setting Approved globally for decades ° Approved in the U.S. by the FDA in 1999 for PPHN « Approved in the EU in 2001 for PPHN and subsequently cardiac surgery US ma
Slide 18: LungFit PH has Significant Advantages for Hospitals
LungFit™ PH has Significant Advantages for Hospitals a a Improved operating economics for the hospital No burdensome inventory and storage requirements NO supplied as a non-hypoxic gas mixture No purging procedures or additional safety measures due to nitrogen dioxide (NO,) buildup ty No significant
Slide 19: COVID-19
6& Beyond Ai The Magic of Breathing COVID-19 Nitric oxide has demonstrated antiviral activity
Slide 20: Nitric Oxide Inhibits SARS Coronavirus Replication Cycle
Nitric Oxide Inhi its SARS Coronavirus Replication Cycle JOURNAL OF VIROLOGY, Feb. 2005, p. 1966-1969 Vol. 79, No. 3 0022-538X/05/$08.00+0 doi:10.1128/JVI1.79.3.1966-1969.2005 Copyright © 2005, American Society for Microbiology. All Rights Reserved. Nitric Oxide Inhibits the Replication Cycle of Sev
Slide 21: COVID-19 Pilot Study: Current Status and Timelines
COVID-19 Pilot Study: Current Status and Timelines Human clinical testing Patient enrollment commenced in US pilot study in June 2020 Expect to enroll 20 patients in the US Goal is to establish safety at 80 ppm Pivotal study will use higher concentration (150 ppm) to demonstrate efficacy Pilot clini
Slide 22: Bronchiolitis
6& Beyond Air The Magic of Breathing Bronchiolitis Three successful pilot studies completed in infants
Slide 23: Bronchiolitis Disease Overview
Bronchiolitis Disease Overview A leading cause of child mortality globally Bronchitis is different from bronchiolitis® The disease Bronchitis ‘ ae . oo. Inflammation and swelling of the * Acute inflammatory injury of the bronchioles usually caused by viral infection bronchi » Usually affects childre
Slide 24: Bronchiolitis Market
Bronchiolitis Market Bronchiolitis is the leading cause of hospitalization for infants worldwide “ Bronchiolitis Overview & Market Dynamics * ~130,000 infant hospitalizations per year in the US®) * Significant impact on the elderly with 177,000 hospitalizations per year in the US®) for RSV alone « N
Slide 25: Two Completed and Published Pilot Bronchiolitis Trials
Two Completed and Publish First two pilot bronchiolitis trials demonstrate reduc 3 PEDIATRIC} PULMONOLOGY ORIGINAL ARTICLE: RESPIRATORY INFECTIONS Nitric oxide inhalations in bronchiolitis: A pilot, randomized, double-blinded, controlled trial Asher Talis, David Greenberg, Yossef Av-Gay, Inbal Golan
Slide 26: Bronchiolitis pilot results: time to fit-to-discharge and length of stay
SSS eee 150 ppm vs. 85 ppm 150 ppm vs. SST 85 ppm vs. SST Time to Fit-to-Discharge (FTD) Hazard Ratio 241 232, 0.90 95% Cl 1.03, 4.31 1.01, 5.33 0.44, 1.81 P-value 0.041 0.049 NS Hospital Length of Stay (LOS) Hazard Ratio 2.01 2.28 0.77 95% Cl 1.01, 3:99 1.03, 5.06 0.40, 1.48 P-value 0.046 0.043 NS
Slide 27: Expanding NO into the home market for lung infections
a Air The Magic of Breathing Expanding NO into the home market for lung infections
Slide 28: Home Market: Nontuberculous Mycobacteria (NTM)
Home Market: Nontuberculous Mycobacteria (NTM) NTM is an FDA disease area of focus with limited treatment options How is NTM acquired? * Acquired by inhalation from the environment * Water thought to be the main source * Warmer climates have higher infection rates * Patient to patient transmission p
Slide 29: Pulmonary Infections: Nontuberculous Mycobacteria (NTM)
Pulmonary Infections: Nontuberculous Mycobacteria (NTM) NO has direct killing effect on multi-drug resistant M. abscessus in vitro as well as common co-infections Dose Response (M. abscessus B1) = © Control (at) an & NO (160ppm) 2 10! = NO (250ppm) = ~® NO (300ppm) é 10 + NO (400ppm) 6 al 5 Time (hr
Slide 30: Pulmonary Infections: Nontuberculous Mycobacteria (NTM)
Pulmonary Infections: Nontuberculous Mycobacteria (NTM) NO synergy with clofazimine and amikacin against M. abscessus in vitro and kills when dosed intermittently NO + CLO (@. abscessus ATCC 19777) NO + AMI (M. abscessus 062600_B1) NO + AMI (M. abscessus 110917_D1) _ Kruskal-Wallis (p=0.0059) & 10°
Slide 31: Pilot Study in NTM infected CF Patients Demonstrates Safety and Efficacy
Pilot Study in NTM infected CF Patients Demonstrates Safety and Efficacy Single arm pilot study with 160 ppm NO showed a reduction in bacterial load and improvements in quality of life Mean change in Mean change in 6MW Distance (meters) from Baseline FEV1 from Baseline iNO Tk Off Th NO Th Off The E
Slide 32: Pilot LungFit NTM Study Protocol Summary
Pilot LungFit™ NTM Study Protocol Summary * Open label pilot study with 12 weeks of treatment and 12 weeks of observation * Approximately 20 subjects >18 years of age with NTM lung infection refractory to antibiotic therapy — Both MAC (Mycobacterium avium complex) and Mycobacterium abscessus will be
Slide 33: Nitric Oxide for Solid Tumors
6& Beyond Air’ The Magic of Breathing Nitric Oxide for Solid Tumors Ultra high concentration nitric oxide has cytotoxic effects and immunostimulatory activity
Slide 34: Nitric Oxide is a Powerful Anti-Cancer Agent
Nitric Oxide is a Powerful Anti-Cancer Agent » NO has shown anticancer properties at high concentrations * Local tumor ablation resulting in tumor antigen release of has been a goal in the fight against solid tumors * Local tumor ablation using NO at concentrations > 10,000 ppm may result in tumor a
Slide 35: Nitric Oxide Shows a Cytotoxic Effect on Colon and Breast Cancer Cells
Nitric Oxide Shows a Cytotoxic Effect on Colon and Breast Cancer Cells Colon Cancer Cells Breast Cancer Cells MOsec M10sec M60sec M180 sec HOsec MNO10sec MNO60sec MNO 180 sec 120% 120% 100% zB = 80% 2 a S 60% & 40% 20% 20% 0% 0% Air 50,000 ppm NO Air 150 ppm NO 4,000 ppm NO 10,000 ppm NO 50,000 ppm
Slide 36: Nitric Oxide Stimulates an Anti-Tumor Immune Response
Nitric Oxide Stimulates an Anti-Tumor Immune Response Nitric oxide mediates 100% prevention of tumor challenge Dayo Day 7-14 Day 11-25 Follow-up 100% ge ; . 20% ’ x 8 5 60% Tumor cell Gaseous NO Challenge Monitoring & Gi inoculation treatment assay challenge tumor & 3 G 20% x 0% — — — Challenge assa
Slide 37: Issued patents expiring through 2033
> 20 issued patents expiring through 2033 > 10 pending patents, if issued, may extend the last expiration through 2037 Beyond Air believes that its patent portfolio is strong and broad The generator The breathing circuit NO concentration NO action in the body NO dosing NO, filter Method of Use Cance
Slide 38: Upcoming Milestones
Upcoming Milestones Estimated timelines for pipeline progress and commercialization™ Program LungFit™ PH Pulmonary Hypertension (PPHN & Heart Surgery2)) 1H20 PMA submission to FDA delayed due to COVID-19 pandemic 2H20 ‘Submit PMA to US FDA 1H21 US FDA approval anticipated: Commercial launch in the U
Slide 39: Beyond Air — A Paradigm Shift in Nitric Oxide Therapy
Beyond Air — A Paradigm Shift in Nitric Oxide Therapy LungFit™ devices generate nitric oxide (NO) from ambient air — Allows for unlimited on-site generation of NO vs. fixed supply cylinder systems currently used in hospitals — NO therapy can move safely into the home setting with self-administration
Slide 40: Management Team
Management Team Highly experienced and successful team of industry experts + 18 years experience as a Healthcare investor + 3 years as SVP Head of Strategy and BD at Avadel (AVDL) y om + Previously worked in HC investments at SAC Capital, Millennium Management, and was a partner at Deerfield DEERFIE
Slide 41: Board of Directors
Board of Directors Board of Directors with vast industry experience + 18 years experience as a Healthcare investor Steve Lisi + 3 years as SVP Head of Strategy and BD at Avadel (AVDL) ig i “SUETTTETDEENSE) + Previously worked in HC investments at SAC Capital, Millennium Management, and was a partner
Slide 42: For more information contact: Beyond Air
For more information contact: ba Beyond Air’ Investor Relations IR@beyondair.net www.beyondair.net The Magic of Breathing