Beyond Air, Inc.

Good afternoon and welcome everyone to the Beyond Air Financial Results Call for the first fiscal quarter of 2022 financial results, ended June 30th, 2021. At this time, participants are in a listen-only mode. A question and answer session will follow the formal presentation. And now, I would like to turn the call over to Maria Jankowski, Head of Investor Relations at Beyond Air. Please go ahead.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us. Today after market close, we issued a press release announcing the first fiscal quarter 2022 operational highlights and financial results. A copy of this press release can be found on the investor relations page of our website. Before we begin, I would like to remind everyone that we will be making comments and various remarks about future expectations, plans, and prospects which constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Beyond their cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. We encourage everyone to review the company's filings with the Securities and Exchange Commission, including without limitation, The companies form 10-K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, www.beyonddare.net. Furthermore, the contents of this conference call contain time-sensitive information that is accurate only as of the date of the live broadcast, August 10, 2021. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Joining me on today's call are Steve Lisi, our Chairman and Chief Executive Officer, Duncan Fatkin, our Chief Commercial Officer, and Douglas Beck, our Chief Financial Officer. With that, I will turn the call over to Steve Lisi, our CEO. Steve?

Thanks, Maria. Good afternoon, everyone, and thank you for joining us today. On today's call, we will provide a brief overview of recent business highlights and preview upcoming milestones across our development pipeline. I will start by providing an update on the company's progress before handing the call over to our Chief Commercial Officer, Duncan Facken, to discuss our commercial launch preparations in greater detail. This will be followed by our Chief Financial Officer, Doug Beck, who will provide a review of our financial results, and then we'll open up the call for your questions. Let me start by saying that the entire BeyondAIR team continues to execute on our strategy, and we remain on track with the timelines that we outlined during our public call on June 10th for the fiscal 2021 results. As you all know, we are awaiting FDA approval of our pending PMA application for the LungFit PH system to treat persistent pulmonary hypertension of the newborn, or PPHN. LungFit PH is designed to offer hospitals a simple, safe, cost-effective, and convenient alternative to products that are currently available. We continue to have a collaborative rapport with FDA and anticipate approval at the end of the third quarter of calendar 2021 with a subsequent commercial launch in the fourth quarter. As we prepare for the potential commercial launch of LungFit PH, we are excited by the opportunity to disrupt this market and create a future of tankless inhaled nitric oxide delivery systems in NICUs across the United States and eventually globally. I will let Duncan discuss the specifics of this commercial planning in a moment. Let me turn to the progress we have made in our other ongoing programs and restate timing expectations, starting with our viral lung infection program, which uses the LungFit Pro system at 150 parts per million nitric oxide to treat acute viral pneumonia in adults and bronchiolitis in children under two years of age. In May, we showed interim data from 19 patients from our acute viral pneumonia pilot study in adults, all of which were COVID-19 patients, at the American Thoracic Society International Conference, or ATS, 2021. We reported that 150 parts per million NO administered using LungFit Pro were safe and well tolerated. We also observed positive efficacy trends for clinically meaningful endpoints, including a two-day mean reduction in oxygen support in NO treated patients versus control, a 26-hour reduction in mean duration of hospital stay between the NO treatment group and control, and only 22% of subjects in the NO treated group required oxygen support beyond their hospitalization, compared to 40% of control subjects. This mid-study review was encouraging. especially since the trends echoed the results of the three previous bronchiolitis pilot trials we conducted. Today, trial sites remain open for this study. We plan on submitting additional detailed study results at a future scientific meeting. Once this pilot trial is complete, our plan is to submit the entirety of the data at 150 to 160 parts per million NO in both hospitalized adult and infant viral pneumonia patient populations. as one comprehensive data package to the FDA. We would like to move to a pivotal all-comer trial for LungFit Pro in patients hospitalized with acute viral pneumonia and anticipate starting this study in the fourth quarter of calendar year 2022, the timing of which is due to the seasonality of most respiratory viruses. Moving on to our ongoing nontuberculous mycobacteria, or NTM, pilot study. We began screening patients for our LungFit Go program and NTM in December 2020, and are on track to report interim data at a conference in the fall of 2021, with top-line results coming later in the second quarter of calendar year 2022. We are pleased with the performance of LungFit Go, especially since this is the first device designed for self-treatment by patients in a home setting in this indication. And this is the first study that is using up to 250 parts per million nitric oxide to treat patients with bacterial lung infections. Enrollment is going well and we anticipate completion in fourth quarter of calendar 2021. As a reminder, patients receive four 40-minute treatments per day for two weeks and then two 40-minute treatments for 10 weeks with more than 11 weeks of self-administration at home. There is a 12-week observation period after treatment is completed. If this trial is successful, we believe our LungFit Go system will be a game changer for the home setting. We could potentially target chronic, severe lung infections with various underlying conditions, such as cystic fibrosis, bronchiectasis, and of course, COPD. Turning now to our Solid Tumor Program. Recall, this program exists outside of the LungFit platform due to the ultra-high concentrations of nitric oxide that are necessary to achieve anti-tumor effects. As I stated in June, we are rapidly approaching a submission to regulatory authorities to enter human studies. Our goal is to receive regulatory approval to move it to humans on the end of calendar year 2021, and subsequently begin recruiting patients the first quarter of calendar year 2022. We have presented data at several conferences in 2020, and it is available on our website. I encourage all of you to take the time to review these data, but if you can't, I'll provide you with the key cliff notes. Nitric oxide as a monotherapy can be tumor immunity to the host after a single five-minute local administration of 50,000 parts per million using BeyondAir's proprietary delivery system in 11 of 11 mice. Though we are highly encouraged by the results from the Solid Tumor Program, our LungFit platform remains the focus of BeyondAir. The resources needed to bring a Solid Tumor Program to a first in human study are not impacting our LungFit programs. We will constantly assess this balance to ensure that we are taking the best path forward for investor return while maintaining our focus on patient benefit. I will now turn the call over to our Chief Commercial Officer, Duncan Facken, for the review of our commercial plan. Duncan?