Beyond Air, Inc.

Good afternoon, and welcome to the Beyond Air second quarter 2023 earnings call. All participants will be in a listen-only mode. Should you need any assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note that this event is being recorded today. I would now like to turn the conference over to Ed Barger. Please go ahead, sir.

Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today, after market close, we issued a press release announcing the second quarter of fiscal year 2023 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 the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Beyond their cautions that these forward-looking statements are subjects 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 company's most recent Form 10-K and Form 10-Q, which identify 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.beyondair.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this broadcast, November 8, 2022. 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, Chairman and Chief Executive Officer, Duncan Fackin, Chief Commercial Officer, and Douglas Larson, Chief Financial Officer. With that, I will turn the call over to Steve Lisi. Steve?

Thanks, Ed, and good afternoon to everyone joining us. I'd like to take a moment to welcome Ed Barger to the Beyond Air team. Ed is our new head of investor relations, and we're very fortunate to have someone with Ed's experience, which includes some time on Wall Street and the last eight years on the investor relations teams at Teva and Organon. Turning to our review of the business, on today's call, I'll begin by providing an update across our portfolio, including Beyond Cancer, before turning it over to our Chief Commercial Officer, Duncan Fatkin, for an update on the LungFit PH commercial launch. This will be followed by an overview of our financial results for the quarter by our Chief Financial Officer, Douglas Larson, and then we will open the call up for questions. Let me start by stating that we continue to successfully execute our strategy across our pipelines. which is a testament to the quality of our team and our LungFit therapeutic platform of nitric oxide generators targeting pulmonary diseases. Leading the way is our commercial program for LungFit PH that received FDA approval in late June. As a reminder, this is our first commercial product, and we believe it has the potential to revolutionize the treatment of persistent pulmonary hypertension of the newborn, or PPHN, and cardiac surgeries around the world. The sales and marketing teams have been working hard over the past few months, implementing the initial phase of the commercial launch. I am very pleased with their progress thus far. Perhaps most important is that the feedback from hospitals remains very positive. As we look ahead, the team is on track with the commercial timeline we have in place, and we anticipate being able to progress to phase two of our launch in the second quarter of calendar year 2023. We also anticipate launching internationally through a partner next year, given our current expectation of receiving CE mark in Europe by the end of 2022. We will provide more information on our global strategy as these matters unfold. Turning now to our development pipeline, which has delivered several data announcements at recent scientific conferences. We're excited to present favorable safety, tolerability, and efficacy data from the LungFitGo at-home study of patients with severe treatment refractory nontuberculous mycobacteria or NTM lung disease during a rapid oral session at the CHEST annual meeting last month. These data show that high concentration inhaled nitric oxide was well tolerated following a total of 2,492 inhalations self-administered at home with no treatment-related discontinuations reported. and an overall high treatment compliance rate above 90%. Respiratory function and physical function were maintained during treatment and the 12-week follow-up period. Key efficacy endpoints of quality of life and bacterial load reduction showed strong results with improvements seen in the majority of quality of life domains and a statistical reduction in bacterial load four months after NO treatment began or one month after cessation of NO therapy. It is important to note that according to the FDA's most recent guidance for an NTM pivotal study, a patient reported outcome or quality of life questionnaire is the required primary endpoint with bacterial load as a secondary endpoint. In addition to further supporting the development of intermittent high-dose NO for the treatment of NTM, this study breaks new ground by successfully showing the ability of our at-home NO generator-based system to be used safely and consistently by this patient population in a real-world setting. We believe there is an enormous home market opportunity for the LungFit Go in treating NTM, as well as other respiratory conditions, if approved. To expand the landscape for both LungFit Pro and Go, we are currently planning to initiate a pilot study in late 2023 that will evaluate the LungFit Go treating severe exacerbations due to lung infections in COPD patients. This, of course, is pending discussions with FDA. Moving on to our viral lung infection program, which uses the LungFit Pro system at 150 parts per million NO to treat viral community-acquired pneumonia, or what we call VCAP, in adults and bronchiolitis in children under two years of age. Last month, we presented positive incremental data from the completed LungFit Pro pilot study of high-concentration inhaled NO in VCAP, including COVID-19, in a poster presentation at Infectious Disease Week 2022. These data show that NO treatment with the LungFit Pro was well tolerated overall with no treatment-related serious adverse events and improved efficacy on multiple parameters compared to standard supportive treatment. Our next milestone for this indication will be a discussion with the FDA over the next few months on a U.S. trial design with the intention of starting such a study in the fourth quarter of calendar year 2023. As a reminder, under this program, we've already conducted a total of four studies with NO concentrations of 150 parts per million or more in hospitalized subjects suffering from viral respiratory infections. All of these studies have shown a strong safety profile with consistently positive results on efficacy. Considering these data, we believe high concentration NO delivery with LungFit Pro can be a powerful tool against any type of pneumonia, especially COVID-19, and we remain dedicated to bringing this important therapy to market as soon as possible. And to conclude our highlights for the pipeline, we'd like to remind everyone that we have now completed an adult pneumonia study, three bronchiolitis studies, two NTM studies, along with several other studies, to give us an excess of 5,000 NO administrations at 150 parts per million to 250 parts per million to over 170 patients with an excellent safety profile. Moving to our private affiliate, Beyond Cancer. In late August, we announced that the first patient was treated in the phase one clinical trial to evaluate the maximum tolerated dose safety and efficacy of our UNO therapy, or ultra high concentration nitric oxide, for patients with cutaneous solid tumors in the refractory setting. We are excited to announce that we've already seen evidence of an immune response at the low dose of 25,000 parts per million nitric oxide. While still early, this is extremely encouraging. We anticipate announcing initial data from the study in the first half of 2023. Beyond Cancer will present preclinical in vivo data at the CITC conference this Thursday, which will show that the combination of UNO therapy with anti-PD-1 achieved higher tumor regression rates and prolonged survival in CT26 tumor-bearing mice compared with anti-PD-1 alone. Based on this study, we believe there is a strong possibility that high concentration NO assists the immune system in overcoming anti-PD-1 resistance. As a result, we believe the combination of high concentration NO and immune checkpoint inhibitors, such as anti-PD-1, could be a potential breakthrough therapy with important clinical implications. I encourage everyone to review the full data set on Thursday. One last point to make on Beyond Cancer is that we very recently received a notice of allowance from the U.S. Patent Office for our first patent, an important milestone. Now it is with great pleasure that I hand the call over to Duncan Fatkin, the Chief Commercial Officer of Beyond Air, to speak about the first few months of the U.S. commercial launch for the FDA-approved LungFit PH. Duncan?