Beyond Air, Inc. · NASDAQ:XAIR
Beyond Air — Investor Presentation (September 2019)
34 slides from Beyond Air's investor presentation, Sep 6, 2019
Slide 1: Transforming the lives of patients with respiratory conditions
Transforming the lives of patients with respiratory conditions Transformational Therapies to Treat Serious Lung Infections & Pulmonary Hypertension Corporate Presentation September 2019 ba Beyond Air” The Magle of Breathing
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation is for confidential and informational purposes only. This presentation 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 b
Slide 3: Risk Factors
Risk Factors ks associated with our business include but are not limited to the following: + Investing in our common stock involves a high degree of risk. You should consider carefully the risks described below, together with the other information included or incorporated by reference in this Annual
Slide 4: LungFit, a Nitric Oxide generator
LungFit™, a i itric Oxide generator 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 a
Slide 5: Beyond Air: Revolutionizing the Delivery of Nitric Oxide (NO)
Beyond Air: Revolutionizing the Delivery of Nitric Oxide (NO) Beyond A ated eline for Pipe Progress and Co ercializatio alenda Program 4Q19 1H20 2H20 1H21 2H21 XAIR-PH Submit PMA to | Anticipate US Commercial Continue to Continue to Pulmonary FDA and FDA launch in the US | launch globally launch glo
Slide 6: Nitric Oxide (NO) is Naturally Occurring in the Human Body
Nitric Oxide (NO) is Naturally Occurring in the Human Body* Antibacterial Apoptosis Cell proliferation = Nitric Oxide Angiogenesis — ==" te Immune response Neurotransmission Cardiovascular hemostasis ; 6& Beyond Air The Magic of Bremhing * Bian K & Murad F. Nitie Oxide, (2014) | Bodgan C. Trends in
Slide 7: First Indication: Pulmonary Hypertension (PH) Overview
First Indication: Pulmonary Hypertension (PH) Overview NO is an established therapeu worldwide Pulmonary Hypertension Overview = Life-threatening condition from increased pulmonary vascular resistance resulting in decreased pulmonary blood flow = Generally not diagnosed until multi-organ system func
Slide 8: Nitric Oxide US market
Nitric Oxide US market TYPICAL NO CYLINDER PROFILE IN THE US: Approved indication: persistent pulmonary Height 45”, Diameter 7.5”, Weight ~45 Ibs (Weight hypertension of the newborn (PPHN) for 2 cylinders on cart w/delivery system is ~175, FY 2018 Mallinckrodt reported INOmax ibs) sales >$500m' and
Slide 9: LungFit PH: Next generation NO care for patients worldwide
LungFit™ PH’: Next generation NO care for patients worldwide User Interface L un g F i t ™ P H Cylinder Free Nitric Oxide Therapeutic Platform Ventilator ‘Connections Backup Switch The next generation phasic flow - ventilator compatible nitric oxide Detachable Unit 7 delivery system. The cylinder fr
Slide 10: Want the cart? NO problem!
Vt want the cart? NO problem! LungFit™ PH Detachable Unit Provides flexibility i in various hospital settings Cylinder Free Nitric Oxide Therapeutic Platform User Interface For illustration purposes only For investigational use only * LungFit PH may not be the final commercial product name; LungFit
Slide 11: Losing the High-Pressure Cylinder is a Significant Gain
Losing the High-Pressure Cylinder is a Significant Gain Hospitals will have significant cost & logistics advantages Improved operating No significant capital No burdensome NO supplied as a No purging economics for the investment required —_ inventory and storage non-hypoxic gas procedures or hospita
Slide 12: A Transforming Partnership — Transaction Details
A Transforming Partnership — Transaction Details = In January 2019 Beyond Air licensed commercial rights to its ventilator compatible NO Generator and Delivery System (LungFit™ PH*) to Circassia Pharmaceuticals for the United States and China markets = Specifically for all indications in the hospita
Slide 13: Circassia: world-class specialty biopharma company
Circassia: world-class specialty biopharma ote company, backed by Astra Zeneca see CIRCASSIA Circassia Pharmaceuticals plc Status: Public company traded on AIM: CIR | Stock Price (08/30/2019): £0.1865 About: Specialty pharmaceutical company founded in 2006. Focused on respiratory diseases based out
Slide 14: High Concentration NO Delivery Opportunities for Bronchiolitis & NTM
High Concentration NO Delivery Opportunities ” for Bronchiolitis & : Nontuberculous Mycobacteria (NTM) 6& Beyond Air The Maglc of Breathing
Slide 15: Safety First
Safety First NO Delivery fo! Our Nitric Oxide Delivery System Has a Demonstrated Safety Record at a concentration of 160 ppm NO 2,100+ 85+ 8 0 Treatments patients Different clinical Serious Adverse administered settings Events (SAEs) related to NO. Date Study Indication Primary Results 2011 Phase 1
Slide 16: Second Indication: Bronchiolitis (BRO) Overview
Second Indication: Bronchiolitis (BRO) Overview Bronchiolitis is the leading cause of hospitalization for Bronchiolitis Overview & Market Dynamics = ~150,000 infant hospitalizations per year in the US@) = Significant impact on the elderly from equivalent viral infections with 177,000 hospitalization
Slide 17: Completed Two Pilot Bronchiolitis Trials
Completed Two Pilot Bronchiolitis Trials Is demonstrated a sig hospital stay (LOS) 2014 Trial Design and Highlights Published in the December 2017 Pediatric 1 = Randomized, Prospective, Double-blind Pulmonology Journal) = 43 patients (age: 2-12 months) with acute bronchiolitis ent nei | ane ne (most
Slide 18: Completed Two Pilot Bronchiolitis Trials
Completed Two Pilot Bronchiolitis Trials Data from both Pilot Bronchiolitis trials demonstrated a significant reduction in LOS 2018 Trial Design and Baseline Characteristics DATA PRESENTED AT THE SEPTEMBER = Randomized 67 subjects at 6 sites in Israel with a 2018 EUROPEAN RESPIRATORY SOCIETY 1:1 ran
Slide 19: Completed Two Pilot Bronchiolitis Trials
Completed Two Pilot Bronchiolitis Trials Data from both Pilot Bronchiolitis trials demonstrated a significant reduction in LOS 2018 Trial Results Presented at ERS 2018 Length of Stay (Per-protocol) $p02292% (Per-protocol) 20.828.9 hr 26.7212.7 br ee + Secondary endpoint of (p=0.04) ~ « time to oxyge
Slide 20: Losing the High-Pressure Cylinder Makes Home Use a Technical Reality
Losing the High-Pressure Cylinder Makes Home Use a Technical Reality Losing the high pressure cylinder makes NO accessible in a number of settings Our system is simple to use and patients can self-administer 4 simple i Plug in any standard | Insert Beyond i Position mask steps: electrical outlet & f
Slide 21: Third Indication: Nontuberculous Mycobacteria (NTM)
Third Indication: Nontuberculous Mycobacteria (NTM) NTM is an FDA disease area of focus with limited options. Patients can die within a few years") NTM Market Dynamics? There are a limited number of players in human studies for NTM Beyond Air is initially targeting NTI i ~@ Over 180k NTM cases were
Slide 22: Pulmonary Infections: Nontuberculous Mycobacteria (NTM)
Pulmonary Infections: Nontuberculous Mycobacteria (NTM) Proprietary NO formulation yielded positive clinical results in humans in its single arm pilot M study 6MW Distance (meters) fi Baseline Mean change = o o SS) 2 ge in FEV1 from Basel 2 iNO Therapy _Off Therapy 2 : iNO Therapy Off Therapy Sa te
Slide 23: Pulmonary Infections: e.g. Non Tuberculous Mycobacteria (NTM)
Pulmonary Infections: e.g. Non Tuberculous Mycobacteria (NTM) NO has direct killing effect on multi-drug resistant M. abscessus in Dose Response (M. abscessus B1) 10% © Control (air) 10° “= NO (160ppm) 10! = NO (250ppm) ~* NO (00pm) 10% = NO (400ppm) Log,, CFU/ml (mean:SEM) Time (hr) M. abscessus Cl
Slide 24: Pulmonary Infections: Non Tuberculous Mycobacteria (NTM)
Pulmonary Infections: Non Tuberculous Mycobacteria (NTM) NO shows synergy . abscessus in vitro clofazimine and amikacin against drug-resistant M, abscessus B1 M. abscessus BS 107 - wo, Meabscessus BB 10' Ex a = Cont (air) 5 10 2 E =~ NO.25099 5 2 z “= 1x010 (ei 10 car Q4 = 5xCLO (ein) _ . 3 aos 72 “
Slide 25: Pulmonary Infections: Nontuberculous Mycobacteria (NTM)
Pulmonary Infections: Nontuberculous Mycobacteria (NTM) jate a pivotal United States Beyond Air Plans for Approval FDA Guidance() = FDAis asking for “evidence of efficacy for a clinically meaningful outcome evaluated in adequate and well controlled trials” = Based on discussions with FDA, Beyond Air
Slide 26: Beyond Air Active Pipeline & Market Size
Beyond Air Active Pipeline & Market Size Developmen a }Proauct | naemon | Orsazne” “ _ FDA PMA filing In-Hospital use Heute XAIR-PH for PPHN and Commercial >$300m (Pulmonary cardiac surgery system in soa >$600m Hypertension) (country development Partner specific) GE Maric halt’ | SeciRCASSIA 2020 =
Slide 27: Beyond Air Inactive Pipeline & Status
Beyond Air Inactive* Pipeline & Status Worldwide Sales Poaa * Product Indication Development Status’ Potential** Pilot study initiation XAIR-SLI Various bacterial infections anticipated in 2021 for pseudomonas aeruginosa oe envi Fe anes by any Proof of concept initiation ‘ type ; anticipated in 2021
Slide 28: Issued and Pending Patents
>20 ssued Patents and >10 Pending Patents Across Major Globa) — *| Air ‘The Magic of Brasthing
Slide 29: As of June
As of June Corporate HQ in New York R&D Engineering Facility in Madison, Wisconsin PPHN FDA regulatory filing anticipated in 4Q2019 with launch in 3Q2020 Positive NTM data presented at ATS and World Bronchiectasis 2018 Positive BRO data presented at ERS 2018 $20-21m in milestones associated with PPH
Slide 30: Management Team
Management Team 2 hey ge ee! ve Steve Lisi Chairman and CEO Amir Avniel | President & COO Duncan Fatkin cco Douglas Beck CFO Frederick Montgomery VP, Medical Syste: Rhona Shanker VP, Regulatory Affairs Ali Ardakai & SVP, Device & BD Highly experienced and successful team of industry experts 18 years
Slide 31: Board of Directors
Board of Directors Board of Directors with vast industry experience Steve Lisi = 18 years experience as a Healthcare investor Ch ad = 3years as SVP Head of Strategy and BD at Avadel (AVDL) DEERFIELD elananar = Previously worked in HC investments at SAC Capital, Millennium Avadel CEO Management, and
Slide 32: Scientific Advisory Board comprised of world renowned thought leaders
Scientific Advisory Board comprised of world renowned thought leaders Stanford @ TORONTO Boston SY) Childrens 24 Hospital Ben Gurion University of the Negev ALABAMA ve CIHR [RSC . we x incinnat @ Children's Boston 2) Childrens Hospital HARVARD 7 r Air’ ‘The Magic ef Brasthing
Slide 33: LungFit, a Nitric Oxide generator
LungFit™, a i itric Oxide generator 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 a
Slide 34: Transforming the lives of patients with respiratory conditions
Transforming the lives of patients with respiratory conditions For more information contact: Steve Lisi, CEO +1-516-665-8200 Ps slisi@beyondair.net B d A ™ www.beyondair.net ba eyo n | r The Magle of Breathing