Beyond Air, Inc. · NASDAQ:XAIR
Beyond Air — Investor Presentation (November 2020)
43 slides from Beyond Air's investor presentation, Nov 13, 2020
Slide 1: Corporate Presentation
Corporate Presentation 6& Beyond Air’ November 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 for
Slide 4: Late Stage, Active Pipeline
Late Stage, Active Pipeline Preclinical lot Trials otal PMA Commercial Next stone (1) LungFit™ PH ventilator compatible PMA pending CE Mark 2H21? LungFit™ PRO Acute viral pneumonia (including Ongoing pilot study, COVID-19) data mid-2021 wi gee Pivotal study start 4Q21 Bronchiolitis (pandemic itting)
Slide 5: Potential Market Size
Potential Market Size ie Worldwide Indication US Sales Potential® - Sales Potential® In-hospital use for PPHN and cardiac >$300 million >$600 million it™ i i surge! LungFit™ PH ventilator compatible gery Beyond Air to commercialize Acute viral pneumonia (including >$1.5 billion >$3 billion COVID-19)
Slide 6: Antimicrobial Apoptosis
Antimicrobial Apoptosis 6& Beyond Air The Magic of Breathing { Cell proliferation to Angiogenesis Immune response Neurotransmission Cardiovascular homeostasis The role of nitric oxide Nitric oxide market is currently > $500M in the US! 1.MNK company reports 2.Image source: Bian K & Murad F. Nitric O
Slide 7: 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
Slide 8: 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 9: NO Plays a Major Role in the Immune System
NO Plays a Major Role in the Immune System Source of NO (cell type) Categoi Macrophages, microglia, neutrophils, eosinophils, fibroblasts, endothelial cells, epithelial cells Antimicrobial activity Effector function Killing or reduced replication of infectious agents (viruses, bacteria, protozoa, fu
Slide 10: LungFit — Multiple Devices
6& Beyond Air’ The Magic of Breathing LungFit PRO LungFit™ — Multiple Devices Nitric oxide generation from ambient air sO
Slide 11: 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 12: Nitric Oxide for PPHN and Cardiac Surgery
Nitric Oxide for PPHN and Cardiac Surgery Inhaled NO (iNO) causes smooth muscle PPHN — Persistent Pulmonary : 2 « relaxation, increasing blood flow to the Hypertension of the Neonate‘ % | cu aepletion : hye lungs and decreasing right ventricular Ree workload) iNO reversal of i. ae pulmonary hyperten
Slide 13: 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 14: Significant Advantages in the Hospital — Pulmonary Hypertension
Significant Advantages in the Hospital — Pulmonary Hypertension Current SOC uses large, bulky, and heavy cylinders Cylinder LungFi PH LungFit™ PH On Gat LungFit™ PH generates NO from ambient air Height ~60" 1 60" Width ~20" 18” 24" Depth OT" 14” 28" Weight 175 Ibs 32 Ibs 65 Ibs User Interface Simple
Slide 15: Beyond Air Smart Filter vs. Cylinder
Beyond Air Smart Filter vs. Cylinder Consummate “razor blade” financial model for NO Delivery 45 pounds 2.5 Oz Proprietary smart filter removes toxic nitrogen dioxide (NO,) gas Filters are a fraction of the cylinder size ik s * No disposal requirements oN » Easy to store, handle, and manage inventor
Slide 16: 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 | A NO supplied as a non-hypoxic gas mixture No purging procedures or additional safety measures due to nitrogen dioxide (NO3) buildup i No signifi
Slide 17: LungFit PH 2Q21 US Launch Anticipated
LungFit™ PH 2Q21 US Launch Anticipated Beyond Air is prepared to launch in the United States Key launch elements in place * Commercial scale manufacturing in place for both LungFit™ PH and Smart Filter * Accessory kit complete * Calibration gas supply secured * Commercial leadership, quality systems
Slide 18: LungFit — Multiple Devices
6& Beyond Air’ The Magic of Breathing LungFit PRO LungFit™ — Multiple Devices Nitric oxide generation from ambient air sO
Slide 19: LungFit: For Treating Lung Infections
LungFit™: For Treating Lung Infections LungFit PRO Monitor acter enn aie eso ow Paton 20000 Oi — 6A Beyond Air Simple, safe, and convenient + 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 a
Slide 20: 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 2,900+ 140+ 9 0 Treatments . Different Serious Adverse Events ad
Slide 21: 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 Clinical NTM Pilot Study —- 160 PPM NO . : % Methemoglobin (MetHb) - well known bioma
Slide 22: Acute Viral Pneumonia (including COVID-19)
6& Beyond Air The Magic of Breathing Acute Viral Pheumonia (including COVID-19) Nitric oxide has demonstrated antiviral activity
Slide 23: Nitric Oxide Inhibits SARS Coronavirus Replication Cycle
Nitric Oxide Inhibits SARS Coronavirus Replication Cycle JOURNAL OF VinoLOGY, Feb. 2015, p. 1966-1969 (0022-S38X/05/S08. 00-0 doi:0.1128/3V1.79.3.1966-1960,2005 Copyright © 2005, American Society for Microbiology. All Rights Reserved. Nitric Oxide Inhibits the Replication Cycle of Severe Acute Respi
Slide 24: Acute Viral Pneumonia (COVID-19) Pilot Study
ute Viral Pheumonia (COVID-19) Pilot Study In Vitro Data Presented at CHEST 2020 Support Anti-Coronavirus Activity of Nitric Oxide that Acts Within Hours (1) A single 2-hour exposure to 250 ppm NO prior to infection reduces OC43 infectivity and improves host cell viability (2) Treatment of C43 coron
Slide 25: Bronchiolitis
X 6& Beyond Air The Magic of Breathing Bronchiolitis Three successful pilot studies completed in infants
Slide 26: Bronchiolitis Disease Overview
Bronchiolitis Disease Overview A leading cause of child mortality globally Bronchitis is different from bronchiolitis® The disease Bronchitis , . . : Inflammation and swelling of the + Acute inflammatory injury of the bronchioles usually caused by viral infection bronchi * Usually affects children <
Slide 27: 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 « No
Slide 28: Two Completed and Published Pilot Bronchiolitis Trials
Two Completed and Published Pilot Bronchiolitis Trials First two pilot bronchiolitis trials demonstrate reduction in hospital LOS sy [PEDIATRIC| PULMONOLO ORIGINAL ARTICLE: RESPIRATORY INFECTIONS: Nitric oxide inhalations in bronchiolitis: A pilot, randomized, double-blinded, controlled trial Asher
Slide 29: Bronchiolitis Pilot Study Results
PO 150 ppm vs. 85 ppm 150 ppm vs. SST 85 ppm vs. SST Time to Fit-to-Discharge (FTD) Hazard Ratio 241 2.32 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 Pivot
Slide 30: 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 31: 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 possible
Slide 32: Pilot Study in NTM infected CF Patients Demonstrates Safety and Efficacy
Pilot Study in NTM infected CF Patients Demonstrates Safety and Efficacy Single arm study with 160 ppm NO showed a reduction in bacterial load and improvements in quality of life Data Published in the Journal of Cystic Fibrosis (Bentur et al., 2019) Mean change in 6MW Distance (meters) from Baseline
Slide 33: 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 34: 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 data suggest immunostimulatory activity
Slide 35: Nitric Oxide is an Anti-Cancer Agent
Nitric Oxide is an Anti-Cancer Agent » NO has shown anticancer properties at high concentrations by activating innate and adaptive responses of the immune system * Our data suggest that our innovative gaseous NO-based treatment may treat solid tumors locally and their distant metastases systemically
Slide 36: Previous Data
Previous Data In vivo results showed that lung tumor-bearing mice treated with 50,000 ppm gNO for 10 minutes were resistant to a second Findings from In Vivo Murine Lung Cancer Model Are Consistent with LLC1 cancer cell inoculation ~Day -10 DayO Up to Day +14 Follow-up Tumor Induction NO Treatment C
Slide 37: High-Concentration gNO Inhibits Colon and Breast Cancer Cell Line Viability
High-Concentration gNO Inhibits Colon and Breast Cancer Cell Line Viability In Vitro and Challenge Tumor Take In Vivo Data presented at the AACR Conference on Tumor Immunology and Immunotherapy, October 16, 2020 Colon and breast tumor-bearing mice (CT26 and 4T1) received a single treatment with high
Slide 38: 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 39: Upcoming Milestones
Upcoming Milestones Estimated timelines for pipeline progress and commercialization™ Program LungFit™ PH Pulmonary Hypertension (PPHN & Heart Surgery) 1H21 PMA submission to FDA delayed due to COVID-19 pandemic 2H20 Submit PMA to US FDA ACHIEVED 1H21 US FDA approval anticipated: Commercial launch in
Slide 40: 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 41: Management Team
Management Team Highly experienced and successful team of industry experts Steve Lisi Chairman and CEO Amir Avniel President & COO Duncan Fatkin cco Douglas Beck cFO Frederick Montgomery VP, Medical Systems Rhona Shanker VP, Regulatory Affairs Mike Gaul SVP, Operations bABeyond Air 18 years experien
Slide 42: Board of Directors
Board of Directors Board of Directors with vast industry experience Steve Lisi Chairman and CEO Amir Avniel President & COO. Ron Bentsur Director Erick Lucera Director Yoori Lee Director Bill Forbes Director Robert F. Carey Director 6& Beyond Air 18 years experience as a Healthcare investor 3 years
Slide 43: For more information contact
For more information contact: ba Beyo nd Ai r° Investor Relations IR@beyondair.net www.beyondair.net The Magic of Breathing