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Beyond Air, Inc.
6/22/2023
Good afternoon and welcome everyone to the Beyond Air financial results call for the fiscal year ended March 31st, 2023. At this time, participants are on 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 Edward Barger, 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 fiscal fourth quarter and full year 2023 operational highlights and financial results. A copy of this press release can be found on our website, www.beyondair.net, under the news and events section. 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 Air 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 SEC, including, without limitation, the company's most recent Form 10-K and Form 10-Q, which identify specific factors that may cause actual results for 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 the live broadcast, June 22nd, 2023. 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 the call are Steve Lisi, Chairman and Chief Executive Officer, Duncan Facken, Chief Commercial Officer, and Douglas Larson, Chief Financial Officer. And with that, I'll turn the call over to Steve Lisi. Steve?
Thanks, Ed, and good afternoon to everyone joining us. Welcome to phase two of our commercial launch. This is an exciting time for us as we have visibility into what the PPHN market will look like over the next several years. With our initial limited launch completed, we are highly confident that we have gained the knowledge required to satisfy the needs of hospitals using nitric oxide. LungFit PH has been well received in the market. We believe that our ability to support and service most hospitals has been established. Now is the time to increase the size of our commercial team and increase our market share. Our chief commercial officer, Duncan Fatkin, will have more on this in a few minutes. Outside of LungFit PH commercial operations, we have been very busy, and I am proud of what the Beyond Air and Beyond Cancer teams have accomplished. LungFit PH cardiac label expansion application will be submitted before the end of this calendar year to FDA. This is later than we had hoped. but we want to be certain that the application is high quality and will satisfy FDA requirements. We also expect CE mark in the EU for LungFit pH late next quarter. We anticipate LungFit Pro will be used in a community-acquired viral pneumonia study in the United States this coming winter. LungFit Go is scheduled for an at-home COPD study start in 2024 and NTM in 2025. Beyond Cancer anticipates Phase 1A data this fall. As announced last week, we now have another NO-related program, autism. Please refer to our announcement last week for details. Our portfolio consists of programs where NO is approved to treat acute pulmonary hypertension in newborns, is in human studies for hypoxemia associated with viral lung infection, chronic refractory persistent lung infection, and solid tumors, and in preclinical development for autism. We can consider ourselves the preeminent NO company with the investments we have made into NO research and development. We believe that we have only scratched the surface of the impact NO plays in human health. We recently secured debt financing of up to $40 million from funds managed by Avenue Capital Group. We believe this additional capital strengthens our position to execute on our strategy for Longfoot PH and our other programs. In addition, I believe that securing this capital from a well-known healthcare investment firm with a history of investing in nitric oxide, speaks volumes about our programs and the progress we're making. Now, I will turn the call over to our Chief Commercial Officer, Duncan Facken, for an update on the LungFit PH commercial launch. Duncan?
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