Beyond Air, Inc. · NASDAQ:XAIR
Beyond Air — Investor Presentation (June 2023)
60 slides from Beyond Air's investor presentation, June 2023
Slide 1: Corporate Presentation
Corporate Presentation June 2023
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: Our Mission: Harness the Power of Nitric Oxide
Our Mission Harness the Power of Nitric Oxide Ability to transition between hospital and untapped at-home market Creating Unlimited Access to On-Demand Nitric Oxide from Ambient Air Nasdaq Listed: XAIR Headquarters: Garden City, NY 3
Slide 4: LungFit Platform Elicits Paradigm Shift for Nitric Oxide Therapy
® LungFit Platform Elicits Paradigm Shift for Nitric Oxide Therapy Our revolutionary LungFit® technology The LungFit® Systems are designed platform generates nitric oxide (NO) by the same inventors who developed on-demand from ambient air and the first nitric oxide delivery system safely delivers it
Slide 5: Introducing the Patented Ionizer Technology
Introducing the Patented Ionizer™ Technology The LungFit® PH is the first and only system with patented Ionizer technology that generates nitric oxide using room air, enabling the delivery of unlimited, on-demand nitric oxide regardless of dose or flow. Oxygen 60 Watts Nitric Oxide NO2 Smart Filter
Slide 6: Robust, Active Pipeline with Device and Drug NO Candidates
Robust, Active Pipeline with Device and Drug NO Candidates Device Therapeutic Area Preclinical Pilot Pivotal PMA Commercial Next Milestone(a) Persistent pulmonary hypertension of US FDA Approved the newborn (PPHN) CE Mark – 2H 2023 Hospital NICU Setting Low-concentration iNO (≤80 ppm) for pulmonary
Slide 7: Large Market Opportunities
Large Market Opportunities Annual Acute COPD Annual Viral Pneumonia Annual Bronchiolitis Total Refractory NTM PPHN Opportunity: Exacerbations Related Hospitalizations: Hospitalizations: Patient Populations: Hospitalizations: Solid Tumor 15K US6 Program 7.5k cases in US1 350k US2 120K US4 4k EU57 1M
Slide 8: The Critical Role Endogenous Nitric Oxide Plays in the Human Body
The Critical Role Endogenous Nitric Oxide Plays in the Human Body
Slide 9: Nitric Oxide Has Multiple Mechanisms of Action
Nitric Oxide Has Multiple Mechanisms of Action Pulmonary Antimicrobial Immunomodulation Low NO (<80 PPM) High NO (>80 PPM <400 PPM) Ultra-High NO (>10,000 PPM) Inhaled NO selectively dilates Antiviral the pulmonary vasculature via • Inhibition of viral enzymes2 relaxation of vascular smooth • Blocki
Slide 10: Nitric Oxide Plays a Major Role in the Immune System
Nitric Oxide Plays a Major Role in the Immune System Source of NO (cell type) Category Effector function Macrophages, microglia, neutrophils, eosinophils, Killing or reduced replication of infectious agents Antimicrobial activity fibroblasts, endothelial cells, epithelial cells (viruses, bacteria, p
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: Current Nitric Oxide U.S. Market Dynamics
Current Nitric Oxide U.S. Market Dynamics Established standard of care for 20+ years for pulmonary hypertension in the hospital setting (only PPHN on label) >$350M LTM US Sales1 854 Monopoly Broken in 2019 Level 3 & 4 NICU’s in the US2 LungFit® PH Receives FDA Approval in June 2022 Incidence ~1.9 pe
Slide 14: Current Nitric Oxide U.S. Market Dynamics
Current Nitric Oxide U.S. Market Dynamics 2022 receives FDA approval >$400 M 2021 >$480 M 2020 Beyond Air submits PMA for LungFit® PH >$535 M Market dominated 2019 NOxBOXi and GENOSYL receive FDA approval >$514 M 2022 by cylinder 2018 systems >$ 488 M 2017 >$455 M INOmax approved in EU for HRF in ne
Slide 15: LungFit PH: The Power to Transform iNO Care
LungFit® PH: The Power to Transform iNO Care LungFit® PH is the first and only FDA approved system to generate and deliver unlimited, on-demand, nitric oxide using room air Fast, Precise, Simple Power on, generate, and deliver iNO within 1 minute. All You Need Is AirTM No Cylinders. No handling and
Slide 16: Beyond Air Smart Filter vs. Cylinder
Beyond Air Smart Filter vs. Cylinder LungFit® PH: Revolutionary, Smart Design Standard 45-pound Proprietary smart filter removes toxic nitrogen dioxide (NO2) Cylinder Filters are a fraction of the cylinder size • No disposal requirements • Easy to store, handle, and manage inventory 2.5 oz Smart Fil
Slide 17: Significant Advantages to Hospitals
Significant Advantages to Hospitals Improved operating economics for the hospital Simple No burdensome inventory and storage requirements Reduced training burden NO supplied as a non-hypoxic gas mixture No purging procedures or additional safety measures due to nitrogen dioxide (NO2) buildup Safe Re
Slide 18: Revolutionizing the Delivery of Nitric Oxide
Revolutionizing the Delivery of Nitric Oxide Phase 3: Transformation Full Availability Design Innovation Approximately 20% of US Release to Phase 2 hospitals hospitals use Phase 2: Expansion (25-50% of NO users) NO Expand commercial team International Launch Phase 1: Foundation Establish PPHN clinic
Slide 19: An All-Inclusive Partnership
An All-Inclusive Partnership LungFit PH System & Service Exceeding your expectations with: All-inclusive contract—LungFit® PH Systems, backup systems, and accessories, creating budget certainty Customer 24/7 live customer service and support Excellence Clinical (technical, clinical, commercial) Supp
Slide 20: Harnessing the Power of Nitric Oxide
Harnessing the Power of Nitric Oxide Built on a Legacy of Innovation
Slide 21: 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 22: 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 23: 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 24: 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 25: Viral Lung Disease Overview
Viral Lung Disease Overview Viral Community-Acquired Benefits of Nitric Oxide Bronchiolitis Pneumonia (VCAP) Vaccines are Leading not available Influenza virus is the most common Nitric Oxide has broad-spectrum activity RSV is the most common cause of cause of for all cause of viral pneumonia
Slide 26: Potential Nitric Oxide Market for Viral Respiratory Infections
Potential Nitric Oxide Market for Patients Hospitalized with Viral Respiratory Infections ~450M 13% 27% ~16M Annual global cases of of cases require intensive of pneumonias are caused Annual global viral pneumonia pneumonia1 treatment2 by a viral pathogen3 hospitalizations 1.3M 27% ~350K Annual US p
Slide 27: NO Tested in Three Bronchiolitis Pilot Trials
NO Tested in Three Bronchiolitis Pilot Trials Trial 1 Trial 2 Trial 3 150 ppm NO + SST 160 ppm NO + SST 160 ppm NO + SST Treatment groups 85 ppm NO + SST SST alone (control) SST alone (control) SST alone (control) Next Steps: Total Intent to Treat (ITT) Subjects Enrolled & 43 68 87 Pivotal study on
Slide 28: 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 29: Long-Term Safety Data Supports High Concentration NO in Bronchiolitis
Long-Term Safety Data Supports High Concentration NO in Bronchiolitis 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
Slide 30: 150 PPM NO is Minimum Therapeutic Dose
150 PPM NO is Minimum Therapeutic Dose 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 endpoint: Time to Fit-to-Discharge (FTD) Hazard Ratio 2
Slide 31: 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 32: 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) Demographics SST LungFit- 150 ppm NO+SST All Baseline Characteristics SST L
Slide 33: 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 34: Nontuberculous Mycobacteria
Nontuberculous Mycobacteria Expanding Nitric Oxide into the Home Market for Lung Infections
Slide 35: 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 Fibrosi
Slide 36: 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 37: Current NTM Market Dynamics
Current NTM Market Dynamics Targeting Refractory Mycobacterium avium complex (MAC) & M. abscesses NTM Patients Refractory NTM patients in US1 Refractory NTM patients in the EU52 Refractory NTM patients in Japan3 ~15K ~4K Refractory NTM patients in the EU52 ~15K Refractory NTM patients in Japan3 Refr
Slide 38: 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 39: 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 difficulty, Any AE 15 100 dry mouth, fatigue, headache, paresthesia and hypotension Any AE related to study treatment *
Slide 40: Comparable Lung Function Throughout Treatment
Comparable Lung Function Throughout Treatment Data are not adjusted for the time spent for Total distance walked in 6 minutes Activity Tracker Summary 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 41: 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 42: Improvement in Key Secondary Endpoint Quality of Life
Improvement in Key Secondary Endpoint Quality of Targeting Refractory Life (QoL-B) Mycobacterium avium complex (MAC) & M. abscesses NTM Patients • Overall QoL improvement shown in 100 Percentage of Subjects Improved/Remained Unchanged majority of categories at Day 85*** Unchanged Improved Percentage
Slide 43: How Big is the Home Market for Severe Lung Infections?
How Big is the Home Market for Severe Lung Infections? • …is the largest at-risk • 1,075,575 estimated acute • After hospitalization • In the ECLIPSE5 study (Hurst et al. NEJM 2010), a population for recurrent COPD exacerbation-related varies between 16% and 3 year observation of 1,679 moderate to s
Slide 44: Nitric Oxide for Solid Tumors
Nitric Oxide for Solid Tumors An Affiliate of Beyond Air
Slide 45: Nitric Oxide is a Powerful Anti-Cancer Agent
Nitric Oxide is a Powerful Anti-Cancer Agent NO has shown anticancer properties at ultra-high concentrations by activating the immune system Our data suggest that our innovative gaseous NO-based treatment may treat solid tumors locally and their distant metastases systemically via stimulation of an
Slide 46: Beyond Cancer Pipeline
Beyond Cancer Pipeline Clinical Program Initial Indication Discovery IND-Enabling Next Milestone Development Monotherapy Cutaneous/ near UNO Phase Ia data cutaneous tumors Multiple solid UNO Ongoing development tumors Combination Therapy PD-1 sensitive UNO + PD-1 Ongoing development tumors Multiple
Slide 47: UNO Immunotherapy Targets Solid Tumors
UNO Immunotherapy Targets Solid Tumors Prostate, 268,490 Solid Tumors represent approximately 90% of adult Breast (female), 287,850 human cancers1, accounting for approximately 1.4 million annual new cases of most Estimated Annual Lung (including common cancer types in the New Cases of Bronchus), Mo
Slide 48: UNO Potential to Be a New Modality in Immuno-oncology
UNO has the Potential to be an Entirely New Modality in the Immuno-oncology Market >$37 Billion Checkpoint Inhibitor Market in 2022 and Growing First FDA Percent Company Drug Name 2021 Revenue 2022 Revenue Approval Increase Bristol-Myers Yervoy March 2011 $2.0 Billion $2.1Billion 5% Squibb Merck Key
Slide 49: Effects of UNO on CT26 Challenge Tumors In Vivo
Effects of UNO on CT26 Challenge Tumors In Vivo Showed Evidence of Dose-Dependent Effects on Survival Dose-dependent effects of primary tumor treatment on survival was observed in CT26 tumor-bearing mice treated with 20,000 or 50,000 ppm NO Survival Challenge assay: CT26 study mice were treated with
Slide 50: UNO + Anti-mPD-1 Treatment – Survival Analysis
UNO + Anti-mPD-1 Treatment – Survival Analysis Survival Analysis 1.0 Proportion of subjects Yet to be Euthanized 0.9 0.8 Statistics – Kaplan Meier HR p-value1 [95% CI] Comparison Hazard Ratio, 50,000 0.7 ppm NO 10 min + anti-mPD1 vs 0.41 0.0653 [0.16, 1.06] 0.6 Anti-mPD1 0.5 HR p-value1 [95% CI] 1Ha
Slide 51: Mechanism of Action Summary
Mechanism of Action Summary: Estimated Timeline Day 14+ Approximately 14+ days after treatment the adaptive and innate immune system is activated with increased levels of T- cells and B-cells circulating in the blood stream following ultra-high concentration gNO treatment. Blood B-cells 80 % B cells
Slide 52: Introducing the Role of Nitric Oxide in Autism Spectrum Disorder
Introducing the Role of Nitric Oxide in Autism Spectrum Disorder
Slide 53: 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 54: Autism Spectrum Disorder (ASD)
Autism Spectrum Disorder (ASD) Economic Burden of ASD in the US1 500 $461 450 Cost in $billions 400 350 300 $268 250 200 150 100 50 0 2015 2025 High U.S. prevalence of 1 in 362. Early onset, between 1 - 3 years Strong genetic basis Globally 1 in 1003 children has autism 1. Leigh JP et al., J. Autism
Slide 55: 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 56: 7-NI Reversed ASD Behaviors
7-NI Reversed ASD Behaviors 1. 7-NI leads to an increase of novelty seeking 150 ✱✱✱ and improved memory ✱✱ 1. Time (sec) 100 n s 2. 7-NI improved social behavior in the ASD 50 mouse model 0 Familiar Novel Familiar Novel Familiar Novel 3. 7-NI decreased anxiety like behavior in the WT M2 M2 treated A
Slide 57: Data Summary
Data Summary • In 3 distinct ASD mouse models, treatment with the nNOS inhibitor 7-NI led to decreased nitric oxide levels and to a reversal of the molecular, synaptic, and behavioral ASD-associated phenotypes without evidence of off-target effects • 3 mutations were tested - Shank3, Caspr-2, and Nl
Slide 58: Financial and Patent Information
Financial and Patent Information Financial Overview Over 70 worldwide patents expiring through 2040 Ticker XAIR > 50 pending patent applications, if issued, may extend the last Exchange NASDAQ expiration through 2044 Beyond Air believes that its patent portfolio is strong and broad: Share Price $5.9
Slide 59: Achievements and Upcoming Milestones
Achievements and Upcoming Milestones(1) 2022 1H 2023 2H 2023 1H 2024 2H 2024 2025 Persistent Pulmonary US PMA Approval CE Mark Ex-US Partnership Generation 2 LungFit Hypertension of the Newborn US Commercial US Cardiac PMA and Launch PH FDA approval (PPHN), and cardiac surgery Launch Submission Vira
Slide 60: For more information contact
For more information contact: Investor Relations [email protected] www.beyondair.net