Beyond Air, Inc. · NASDAQ:XAIR
Beyond Air — Investor Presentation (May 2020)
50 slides from Beyond Air's investor presentation, May 5, 2020
Slide 1: Corporate Presentation May 2020
Corporate Presentation 6& Beyond Air- May 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 LungFit generator and delivery system overview
Air ns and a proprietary delivery Beyond Air’s LungFit™ generator and delivery system generates NO from ambient air, eliminating the need for expensive and cumbersome cylinders Beyond Air's system provides significant advantages over approved NO cylinder based systems currently used in hospitals aro
Slide 4: Program milestones
ProgramPr 1H20 2H20 2H21 LungFit™ PH Pulmonary Hypertension (PPHN & Heart Submit PMA to US FDA Continue to launch globally Surgery?) LungFit™ 9 COVID-19 e eede e LungFit™ Report data from pilot Pivotal study initiation Begin pivotal study in Bronchiolitis study in Israel delayed due to COVID-19 the
Slide 5: Nitric Oxide is Naturally Occurring in the Human Body
Nitric Oxide (NO) is Naturally Occurring in the Human Body”) Antimicrobial Apoptosis Cell proliferation Angiogenesis Immune response Neurotransmission Cardiovascular homeostasis ba Beyond Air (1) Bian K & Murad F. Nitric Oxide, (2014) | Bodgan C. Trends in Immunol, (2015) The Magic of Breathing
Slide 6: NO Already Plays a Major Role in the Human Immune System
NO Already Plays a Major Role in the Human Immune Syste Functions of NO in the immune system Source of NO (cell type) Category Effector function Macrophages, microglia, neutrophils, eosinophils, fibroblasts, endothelial cells, epithelial cells Antimicrobial activity Killing or reduced replication of
Slide 7: LungFit: The Magic of Breathing
LungFit™: The Magic of Breathing Nitric Oxide (NO) Pree os ba Beyond Air hing
Slide 8: Beyond Air: Active Pipeline
Beyond Air: Active Pipeline Worldwide ee Development ; US Sales Indication Key Dates ae Sales Status Potential® = 12) Potential LungFit™ PH In-Hospital use Final preparations PMA filing late (Pulmonary for PPHN and for PMA summer 2020 >$300 million >$600 million Hypertension) cardiac surgery submiss
Slide 9: LungFit PH
LungFit’ PH Cylinder Free NO Delivery for Persistent Pulmonary Hypertension of the Newborn (PPHN) Beyond Air
Slide 10: First Indication: Pulmonary Hypertension Overview
First Indication: Pulmonary Hypertension (PH) Overview NO is an established therapeutic option for patients suffering from Pulmonary Hypertension worldwide Pulmonary Hypertension Overview Effects of Pulmonary Hypertension” = Life-threatening condition from increased pulmonary vascular resistance res
Slide 11: NO is an established therapeutic option for Pulmonary Hypertension
NO is an established therapeutic option for patients suffering from Pulmonary Hypertension >$500M revenue market) ~8% CAGR 2014-2019 () ~5 systems per hospital “) ry (\ ga 1% competitor entered market Q4 2019 ~800 hospitals use NO () Potential label expansion to include cardiovascular patients
Slide 12: LungFit PH: Versus Hospital Standard of Care
LungFit™ PH : Versus Hospital Standard of Care (SOC) ivery system. Both the LungFit™ system and filter are smaller, safer and more practical. The LungFit™ filter is the consummate “razor blade” for NO delivery. hs Cylinder Smart Filter Height 45" 1.25" ey = Width 75" 2.63" Depth NA 1.88" es Weight 4
Slide 13: LungFit PH: Next generation NO care for patients worldwide
LungFit™ PH: Next generation NO care for patients worldwide LungFit PH Cylinder Free Nitric Oxide Therapeutic Platform * Designed for the treatment of pulmonary hypertension for certain ventilated patients, dependent on approvals in each country, in the hospital setting(1) ° Width: ~24 inches ° Dept
Slide 14: LungFit PH: Next generation NO care for patients worldwide
LungFit™ PH: Next generation NO care for patients worldwide * Don’t want the cart? NO problem! * Detachable Unit (weight ~32 Ibs) LungFit PH ALARMS. FRTERTIME: 109 3 MARSPORI. BATT DOM 02% | NO2(ppm) | NO(ppm) | “ER” 22 0.5 20 18 100 30 15 25 User Interface ba ele Air TF ‘caution - Lunges an investi
Slide 15: Losing the High-Pressure Cylinder is a significant gain
Losing the High-Pressure Cylinder is a significant gain Hospitals will have ant cost, safety & logis Improved operating No burdensome inventory economics for the hospital and storage requirements No significant capital investment required for hospitals new to NO Our device will have significant cost
Slide 16: Slide 16
Slide 17: High Concentration NO Delivery Has a Demonstrated Safety Record
High Concentration NO Delivery Has a Demonstrated Safety Record in People and Animals with XAIR Technology . Rats: 30 days of intermittent treatments with LungFit™ at 400 ppm NO showed no macroscopic or microscopic findings . Rats: 12 weeks of intermittent treatments with LungFit™ at 250 ppm NO show
Slide 18: Nitric Oxide Mechanism of Action
Nitric Oxide Mechanism of Action (MOA) ¢ Nitric Oxide has multiple MOA‘s — Pulmonary vasodilator — Anti-inflammatory — Antiviral ¢ Anti-Inflammatory: —Immunoregulatory functions Inhibition of T and B cell proliferation, leukocyte recruitment (adhesion, extravasation, chemotaxis), Antibody production
Slide 19: NO Inhibits the Replication Cycle of SARS Coronavirus
NO Inhibits the Replication Cycle of Severe Ac Respiratory Syndrome (SARS) Coronavirus JOURNAL OF VIROLOGY, Feb. 2005, p. 1966-1969 Vol. 79, No. 3 0022-538X/05/S08.00+0 doi:10.1128/JVI.79.3.1966-1969.2005 Copyright © 2005, American Society for Microbiology. All Rights Reserved. Nitric Oxide Inhibits
Slide 20: LungFit: A Practical Solution for COVID-19
LungFit™: A Practical Solution for COVID-19 Generated from Ambient Air, use it anywhere! ° Easy to Use: * Programmable by filter * Convenient for all ¢ Use with any electrical outlet LungFit BRO \ * Pormabie \ ° Width 11 inches, Depth 16 inches, Height 10 inches, Weight ~20 Ibs * One system can trea
Slide 21: COVID-19: What is Beyond Air Doing Now?
COVID-19: What is Beyond Air Doing Now? * Inthe lab * BSL level 3 in Israel at Beyond Air facility * Testing other types of human coronavirus * Exploring opportunities to test SARS-CoV-2 either in the Beyond Air lab or in 3"? party labs ¢ In humans * We have been approved by FDA for a pilot study in
Slide 22: LungFit BRO
LungFit BRO High Concentration Nitric Oxide Delivery for Bronchiolitis
Slide 23: Bronchiolitis Overview & Market Dynamics
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 drugs approved for the treatment of BRO patients * Standard of care in the hospital is oxygen and
Slide 24: Bronchiolitis Overview
Bronchiolitis Overview A leading cause of global child mortality Bronchiolitis overview * Bronchiolitis is an acute inflammatory injury of the bronchioles usually caused by a viral infection. BRONCHITIS. + Bronchiolitis usually affect children younger than 2 years“, ana anne with a peak in infants a
Slide 25: LungFit BRO Profile
LungFit™ BRO Profile * Simple, Safe, Practical | * 150ppm concentration * 4 daily treatments each 40 minutes spaced 4-5 hours apart LungFit BRO + Intuitive interface * Simple system ¢ Breathing circuit * Sample line * NO, Filter * Portable: Width 11 inches, Depth 16 inches, Height 10 inches, ; Weigh
Slide 26: Completed Two Pilot Bronchiolitis Trials
Completed Two Pilot Bronchiolitis Trials 2018 Trial Design and Baseline Characteristics Data Presented at the September 2018 * Randomized 67 subjects at 6 sites in Israel with a 1:1 European Respiratory Society (ERS) randomization between 160 ppm NO + supportive care (O2 + hydration) and supportive
Slide 27: Pilot trials demonstrated a reduction in length of stay
Data from both Pilot Bronchio! is trials demonstrated a significant reduction in LOS Hospital length of Stay 23.0 hours 1004 = 82.2hr = Ww o 7 59.2hr S S 50 = = a 2 {eo} ol std std+NO * Primary endpoint of Length of stay (LOS) from enrollment to time of hospital discharge. + Welch's t-test: p=0.085.
Slide 28: Pivotal LungFit BRO: Bronchiolitis Study
Pivotal LungFit™ BRO: Bronchiolitis Study Protocol Summary uble blind randomized placebo controlled pivotal study - Approximately 265 subjects < 12 months of age hospitalized with acute bronchiolitis — Potential for a reduction in # of subject dependent on results from ongoing study in Israel (data
Slide 29: LungFit NTM
LungFit' NTM High Concentration Nitric Oxide Delivery for Nontuberculous Mycobacteria (NTM) =
Slide 30: LungFit: Let's Bring it HOME!
LungFit™: Let's Bring it HOME! Simple, Safe, Small & Superior LungFit NTM Plug It In nity [x] , Ny, ” , Ses _ Press Go SE 92 TunitOn —»> Place Mask on Face Insert Filter BA Beyond Air cesten- snes ex esier Oe inte eter ttt 9 an mest se 30 ‘The Magic of Breathing
Slide 31: LungFit: Let's Bring it ANYWHERE!
LungFit™: Let's Bring it ANYWHERE! | All You Need is a Standard Electrical Outlet Cale b& Beyond Air ET ‘The Magic of Breath
Slide 32: Home Market: Nontuberculous Mycobacteria (NTM)
Home Market: Nontuberculous Mycobacteria (NTM) NTM is an FDA disease area of focus with limited options. Patients can die within a few years(1) NTM Market Dynamics? Over 180k NTM cases were estimated for 2014 in the United States There are a limited number of players in NTM Beyond Air is targeting N
Slide 33: Pulmonary Infections: Nontuberculous Mycobacteria (NTM)
Pulmonary Infections: e.g. Nontuberculous Mycobacteria (NTM) ig effect on mult Dose Response (M. abscessus B1 fia ponse ( us B1) * Exogenous Nitric Oxide demonstrates a dose response effect = 10% ‘ against M. abscessus in vitro. Significant bacterial killing (>3-log FA © Control (air) alll Q 10 redu
Slide 34: Pulmonary Infections: Nontuberculous Mycobacteria (NTM)
Pulmonary Infections: . Nontuberculous Mycobacteria (NTM) istant M. abscessus in NO synergistic effect seen with clofazimine (CLO) and amikacin (AMI): Each drug in combination with 3hr continuous exposure of NO demonstrates significant bactericidal activity against clinical isolates of M. abscessus.
Slide 35: Home Market: Nontuberculous Mycobacteria (NTM)
Home Market: Nontuberculous Mycobacteria (NTM) a single arm pilot NTM study with 160 PPM Mean change in 6MW Distance (meters) from Baseline Mean change in FEV1 from Baseline 2 iNO Therapy Off Therapy 2 iNO Therapy Off Therapy a5 FE Sx s= eR ra} en — 3 = = Po os £ ® 2 >2 @ 4 5 D §& o a es Ss os @ x -
Slide 36: 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 Mabs (Mycobacterium abscessus co
Slide 37: LungFit for COPD Exacerbations
LungFit' NTM High Concentration Nitric Oxide Delivery for COPD Exacerbations
Slide 38: How Big is the HOME Market for Severe Lung Infections?
How Big is the HOME Market for Severe Lung Infections? + nis the largest at-risk population for opportunistic lung infections + There are an estimated 30m people in the US suffering from COPD" with 10% considered severe®) 6& Beyond Air The Magic of Breathing Data from 2010 Show? + 1,075,575 estimate
Slide 39: Antiviral effect of continuous nitric oxide
1.010". - : 10x10" 1.0108 1.010% 1.010% CFU\mL CFU\mL 1.010% 1.0«10" 1.010%. ‘ r 0.0 Continuous nitric oxide 40ppm and 80ppm Continuous nitric oxide160ppm and 800ppm 150 x0 Control -® contol ag “*— 40ppm NO Laid —t— 160ppm NO PFU'sim! = 80ppm NO ence —¥= 800ppm NO 200 400 40 400 50 3 or 0 . 7 2 3s @
Slide 40: COPD Exacerbations Due to opportunistic infections
COPD Exacerbations Due to opportunistic infections from a variety of pathogens # Pathogen Percentage of patients Ref. 1 Haemophilus influenzae 13%-50% (11, (2 2 Moraxella catarrhalis 9-21% [2] 3 Streptococcus pneumoniae 7-26% (11, (2 4 Rhinovirus 4-29% (11. Bl 5 Influenza virus 16% (1 6 Staphylococc
Slide 41: Gaseous Nitric Oxide for Solid Tumors
Gaseous Nitric Oxide for Solid Tumors
Slide 42: NO is a Powerful Anti-Cancer Agent, But How Powerful?
NO is a Powerful Anti-Cancer Agent, But How Powerful? ¢ NO has been reported to show anticancer properties at high concentrations ¢ At high concentrations, NO induces DNA damage, and as a result, p53 is upregulated, leading to cell growth arrest and apoptosis * Tumor regression * Oxidative and nitro
Slide 43: The effect of gaseous NO on different cancer cell lines in-vitro
The effect of gaseous NO on different cancer cell lines in-vitro Data to be presented at the American Association for Cancer Research (AACR) April 24-29 POSTPONED DUE TO COVID-19 PANDEMIC TO JUNE 22, 2020 VIA VIRTUAL AACR >70 mice studied
Slide 44: Can Safety Be Maintained for Patients and Caregivers?
Can Safety Be Maintained for Patients and Caregivers? e Miniature Cylinder for single dose ¢ Small amount maintains safety in case of premature NO release ° Easy to handle ° Easy to transport ° Proprietary delivery systems developed * Optimization of system ongoing ° Patents filed 6A Beyond Air 44
Slide 45: Additional Information
Additional Information 6A Beyond Air
Slide 46: Financial and Patent Information
Financial and Patent Information Ticker XAIR Exchange NASDAQ. : S737 Sh Pi ae (as of April 30, 2020) Shares At Outstanding 16.2 million Cash & Marketable $25 million Securities Debt $5 million | $1M-1.1M Expected Monthly Burn excluding clinical trials is approximately 6& Beyond Air ‘The Magic of Bre
Slide 47: Highly experienced and successful team of industry experts
Highly experienced and successful team of industry experts 18 years experience as a Healthcare investor DEERFIELD 3 years as SVP Head of Strategy and BD at Avadel (AVDL) = Previously worked in HC investments at SAC Capital, Millennium Management, and wy Avadel was a partner at Deerfield 15 years of
Slide 48: Board of Directors with vast industry experience
Board of Directors with vast industry experience 18 years experience as a Healthcare investor 3 years as SVP Head of Strategy and BD at Avadel (AVDL) DEERFIELD Previously worked in HC investments at SAC Capital, Millennium a Management, and was a partner at Deerfield » Avadel 15 years of executive-l
Slide 49: Beyond Air LungFit generator and delivery system overview
Air ns and a proprietary delivery Beyond Air’s LungFit™ generator and delivery system generates NO from ambient air, eliminating the need for expensive and cumbersome cylinders Beyond Air's system provides significant advantages over approved NO cylinder based systems currently used in hospitals aro
Slide 50: For more information
For more information 6a Beyond Air’ cance The Magic of Breathing Investor Relations IR@beyondair.net www.beyondair.net baBeyond Air Weta