Corporate Presentation
March 2024
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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The Company files annual, quarterly and other reports with the Securities and Exchange Commission (the "SEC") including its Annual Report on Form 10-K for the year ended March 31, 2023 (the "Form 10-K") which was filed on June 22, 2023. You may get these documents for free by visiting EDGAR on the SEC's website at www.sec.gov. For a more complete discussion of the risk factors affecting our business, please refer to the Form 10-K.
Our public communications, including this presentation, and SEC filings, may contain statements related to future, not past, events. These forward-looking statements are based upon current beliefs and expectations of Beyond Air's management and are subject to significant risks and uncertainties. These forward-looking statements often, but not always, may be identified by the use of words such as "believes," "estimates," "anticipates," "targets," "expects," "plans," "projects," "intends," "predicts," "may," "could," "might," "will," "should," "approximately," potential" or, in each case, their negative or other variations thereon or comparable terminology, although not all forward- looking statements contain these words. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
These forward-looking statements appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the patient market size and market adoption of our products by physicians and patients, the timing and cost of clinical trials for our products or whether such trials will be conducted at all, completion and receiving favorable results of clinical trials for our products, the development and approval of the use of nitric oxide for additional indications, FDA approval of, or other regulatory action with respect to, the timing, cost or other aspects of the commercial launch of our products and the commercial launch and future sales of our products or any other future products or product candidates. The extent to which the COVID-19 pandemic and global efforts to contain its spread will impact our operations, including the ability to conduct our preclinical studies and clinical trials or rely on our third-party manufacturing and supply chain, will depend on future developments, which are highly uncertain and cannot be predicted at this time, and include the duration, severity and scope of the pandemic and the actions taken to contain or treat the COVID-19 pandemic.
By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated or not at all. Although we believe that we have a reasonable basis for each forward-looking statement contained in this presentation, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward looking statements contained in this presentation.
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Nitric Oxide: A Simple, Yet Complex Molecule
We are the Nitric Oxide Company
- Nitric Oxide (NO) is the combination of nitrogen and oxygen in a specific manner
- NO is a free radical gas that the human body synthesizes from L-arginine via the enzyme nitric oxide synthase (NOS)
- Modulation of NO in the human body can have significant benefits
- Endogenous and exogenous NO are 100% structurally identical and physiologically indistinguishable in the human body
- In nature a lightning strike forms NO
Nitric oxide synthase (NOS) exists in 3 isoforms in the
human body and has multiple functions.
Type | Location | Mechanism | Therapeutic Target | |||
Endothelial | Vascular | Vasodilation | Hypoxic respiratory | |||
Vasoprotection | ||||||
(eNOS) | endothelial | failure: Right ventricular | ||||
Atherosclerosis | ||||||
cells | dysfunction | |||||
prevention | ||||||
Non-specific immune | ||||||
Inducible | defense | Respiratory infection; | ||||
Macrophages | Mediation of | |||||
(iNOS) | Solid tumors | |||||
inflammation | ||||||
Septic shock | ||||||
Neuronal | Neuronal | Neuronal function | Autism | |||
(nNOS) | tissue | |||||
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Our Mission: Harness the Power of Nitric Oxide
We are developing the ability to transition between the ICU, whole hospital and the untapped home market
Beyond Air's robust active pipeline of products targets the following conditions:
- Hypoxic respiratory failure Right ventricular dysfunction
Respiratory infection | Cancer | Autism spectrum disorder |
Beyond Air Is The World's Leading Nitric Oxide Company
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Nasdaq Listed: XAIR
Headquarters: Garden City, NY
Introducing the LungFit PH with our Patented
Ionizer Technology
The LungFit® PH is the first and only FDA approved system with patented Ionizer technology that
generates nitric oxide using room air, enabling the delivery of unlimited, on-demandnitric oxide | |||
regardless of dose or flow. | Oxygen | ||
60 Watts | Nitric Oxide | ||
NO2 Smart
Filter
Nitrogen | Electrode | Nitrogen | ||
Main and Backup Ionizers | For illustrative purposes. | Dioxide | ||
5 |
Innovative 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 to patients to treat a | |
and other systems in use worldwide | |
variety of lung diseases | |
Hospital Setting | Hospital NICU Setting | At-Home Treatment | ||||||
High concentration nitric oxide to treat viral | Low concentration nitric oxide for the | High concentration nitric oxide for the | ||||||
community acquired pneumonia (including | treatment of term and near-term neonates | treatment of NTM and lung infections in | ||||||
COVID-19) and bronchiolitis+ | with hypoxic respiratory failure* | patients with underlying COPD+ | ||||||
6 >+Caution: LungFit< ® PRO and LungFit® GO are≤investigational devices, limited by federal (or United States) law to investigational use. High concentration iNO is defined as 80 ppm to 400 ppm. Low concentration is 80 ppm.*Commonly referred to as persistent pulmonary hypertension of the newborn or PPHN.
Robust, Active LungFit® Pipeline
Device Therapeutic Area | Preclinical |
Pilot
Pivotal
PMA
Commercial
Next Milestone* | Partners1 |
Hospital NICU Setting | ||
Low-concentration iNO ( | 80 | |
ppm) for pulmonary | treatments | |
≤ |
Hospital Setting High-concentration iNO (150 to 400 ppm) for antimicrobial treatments
At-Home Treatment High-concentrationiNO (80 to 400 ppm) for antimicrobial treatments
Persistent pulmonary hypertension of the newborn (PPHN)
Cardiac surgery
Viral Community- Acquired Pneumonia (VCAP) including COVID-19; Bronchiolitis
Nontuberculous mycobacteria
(NTM) lung infection; Severe exacerbations due to lung infections in COPD patients
US FDA approved CE Mark - 1H 2024
PMA approval 2H 2024
US VCAP pilot study ongoing with pivotal study planned for 2025/2026 winter
Discuss pivotal trial design w/ FDA in 2024
COPD pilot TBD based on strategic priorities
- All dates are calendar year, and based on projections and appropriate financing, anticipated first launch on a global basis pending appropriate regulatory approvals
- Getz Healthcare is our commercial partner in 10 Asian countries (not including Japan) and is recognized as the leading distributor of medical equipment, devices, and consumables, in Asia Pacific The Cystic Fibrosis Foundation provided us with a grant of up to $2.17 million to help fund the completed trial of LungFit GO to treat NTM pulmonary disease in Australia
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Drug NO Candidates
Drug Therapeutic Area | Preclinical | Ph 1 | Ph 2 | Ph 3 | NDA | Commercial | Next Milestone(*) | ||||||||||||||||||||||
nNOS Inhibitor | Autism spectrum disorder (ASD) | First-in-human data | |||||||||||||||||||||||||||
anticipated in 2025 | |||||||||||||||||||||||||||||
(neuronal nitric oxide | Other nNOS related neurological | ||||||||||||||||||||||||||||
synthase inhibitor) | |||||||||||||||||||||||||||||
disorders | |||||||||||||||||||||||||||||
Ultrahigh concentration NO >10,000 ppm to treat multiple types of solid tumors. | |||||||||||||||||||||||||||||
For more information, visit beyondcancer.com | |||||||||||||||||||||||||||||
Drug Therapeutic Area | Preclinical | Ph 1 | Ph 2 | Commercial | Next Milestone(*) | ||||||||||||||||||||||||
Monotherapy | Ph 3 | NDA | |||||||||||||||||||||||||||
UNO | Cutaneous/ near cutaneous | Phase 1a full dataset mid 2024 | |||||||||||||||||||||||||||
tumors | |||||||||||||||||||||||||||||
UNO | Multiple solid tumors | ||||||||||||||||||||||||||||
Combination Therapy | |||||||||||||||||||||||||||||
UNO + anti-PD-1 | Multiple solid tumors | ||||||||||||||||||||||||||||
UNO + anti-CTLA-4 | |||||||||||||||||||||||||||||
Multiple solid tumors |
8 (*) All dates are calendar year, and based on projections and appropriate financing, anticipated first launch on a global basis pending appropriate regulatory approvals
Large Market Opportunities
PPHN Opportunity: | Annual Viral Pneumonia | Annual Bronchiolitis | Total Refractory NTM |
Hospitalizations: | Hospitalizations: | Patient Populations: | |
7.5k cases in US1 | 350k US2 | 120K US4 | 15K US6 |
4k EU57 | |||
ex-US Includes PPHN & | 16M ex-US3 | 3.2M ex-US4,5 | |
Cardiac Patients | 15k Japan8 |
>$350M | >$1.5B | >$500M | >$1B |
>$700M | >$3B | >$1.2B | >$2.5B |
- Lakshminrusimha et al. Neoreviews. 2015;16(12):e680-92.
- NCHS, National Hospital Ambulatory Medical Care Survey, 2017. CDC.
- Rudan et al. WHO Child Health Epidemiology Reference Group. Bull World Health Organ. 2004 Dec;82(12):895-903.
- Hall et al. . N Engl J Med. 2009;360(6):588-598.
- UNICEF
- Winthrop et al. Ann Am Thorac Soc, 17 (2020), pp. 178-185
- Ringshausen et al. . Emerg Infect Dis. 2016;22(6):1102-1105. doi:10.3201/eid2206.151642
- Izumi et al. Ann Am Thorac Soc. 2019 Mar;16(3):341-347. doi: 10.1513/AnnalsATS.201806-366OC. PMID: 30339468.
- Jinjuvadia, Chetna et al. . COPD. 2017;14(1):72-79.
9 10) Company Presentations and Regulatory Filings from Bristol-Myers Squibb , Merck , Roche, AstraZeneca, Pfizer, Regeneron ; Sanofi 2011-2020.
11) Leigh JP et al., J. Autism Dev.Disord., 2015
Programs not
using LungFit >>>
- US$ Sales Potential
- WW$ Sales Potential
Solid Tumor
Program
>$37 Billion Global
Checkpoint Inhibitor
Market in 2022 and
Growing10
The cost of caring for Americans with ASD is expected to be >$460b by 202511
Autism Spectrum
Disorder (ASD)
Financial and Patent Information
Financial Overview
TickerXAIR
Exchange | NASDAQ | ||
Share Price | $1.87 (as of Feb. 9, 2024) | ||
Shares | 36 million | ||
Outstanding | |||
As of December 31, 2023
Cash, Cash
Equivalents & $31.3 million
Restricted Cash
Debt | $17.5 million |
Expected quarterly burn approximately $10M
Revenue Guidance for fiscal year 2025
$12 - $16 million
>15 issued patents expiring through 2040
>10 pending patent applications, if issued, may extend expiration through 2044
Patent portfolio is strong and broad, including but not limited to…..
- The NO generator
- The breathing circuit
- NO delivery system
- NO2 filter (utility and design)
- NO concentration
- NO action in the body
- NO dosing
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Disclaimer
Beyond Air Inc. published this content on 13 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 March 2024 14:17:09 UTC.