Beyond Air, Inc.

Good afternoon and welcome everyone to the Beyond Air Financial Results Call for the fiscal quarter ended December 31st, 2024. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. And now, I'd like to turn the call over to Corey Davis, LifeSci Advisors. Thank you. You may begin.

Thank you, Operator. Good afternoon, everyone. Thank you for joining us. Today, after the market closed, we issued a press release announcing the operational highlights and financial results for Beyond Air's third quarter of fiscal 2025, ended December 31, 2024. A copy of this press release can be found on our website, 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 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 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 live broadcast, February 10, 2025. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. With that, let me turn the call over to Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. Go ahead, Steve.

Thanks, Corey. Good afternoon to everyone joining us. With me here today is Doug Larson, our Chief Financial Officer. Let's start today's call by stating how pleased we are with the sequential quarterly revenue growth we are seeing as our commercial team continues to make significant progress. This has been driven by a steady stream of new hospital signings and going through the onboarding process to begin using our LungFit PH system in their institutions. During the quarter, we saw six new hospital starts and two hospitals renew their contracts, one of them for three years. There's only been about nine months since our upgraded Longfoot PH began shipping and seven months since our new chief commercial officer joined us, which has brought new energy to the entire Beyond Air team. We expect this momentum will continue and drive sequential quarterly revenue growth throughout this year. A key factor of our ongoing success is that the Beyond Air team has done a tremendous job of strengthening each stage of the customer engagement process. to ensure we are offering the best possible experience for hospital administrators, nurses, physicians, staff, and of course, respiratory therapists. Most importantly, our existing customers are providing overwhelmingly positive feedback on the LungFit PH device, which translates to great references for potential new engagements. Building on our robust customer engagement pipeline, we now have several partnerships in place supplementing our direct sales team. including Healthcare Links, a renowned healthcare advisory and contracting firm that works with GPOs and IDNs, and Trilomet to help us engage with and distribute to the military and veterans administration hospitals. Additionally, our marketing efforts have been upgraded significantly, which has provided a meaningful boost to our sales efforts. In addition, our presence and activities at all respiratory conferences are much improved, which you can see if you take a look at all of our social media postings. Turning to the PMA supplement for the LungFit pH label expansion to include cardiac surgery, the interactive discussion with FDA continues. We will continue to provide FDA with the information that they request and provide updates to investors each quarter. As a reminder, no nitric oxide products are currently approved for cardiac surgery in the United States. One last point about the U.S. market. We expect our PMA supplement for our next-generation LungFit pH transport-capable system to be ready shortly for submission to FDA. Recall that in November, we demonstrated this next-generation system at the AARC Annual Meeting, and the feedback was quite strong, with the most common question being, when can I get this version of LungFit PH in my hospital? We will provide further details on this system on next quarter's earnings call. Outside the U.S., we announced in December that LungFit PH received the long-awaited CE mark approval. This approval allows us to market LungFit PH in the European Union as well as other countries that recognize this certification. The indications covered under CE-MARC certification are the treatment of infants with greater than 34 weeks gestation with hypoxic respiratory failure and the treatment of peri- and post-operative pulmonary hypertension in adults and children in conjunction with heart surgery. Receiving CE Mark triggered a $1 million milestone payment from Getz Healthcare, our Asia-Pacific distribution partner, which we will receive in the March quarter. Along with royalty payments, we will receive based on length of PHS. Getz is already ahead of schedule securing market authorization in Australia less than two months after receiving CE Mark. To accelerate ex-US sales, we have teamed up with business Asia consultants to provide lung fit pH to hospitals throughout Europe, South America, the Asia Pacific region, and the Middle East. We've already seen progress with extremely high distributor interest. And in fact, we already have two new contracts signed in the Middle East. As a reminder, The fact that LungFit pH generates nitric oxide from room air opens up enormous opportunity in areas around the world where hospitals are unable to obtain nitric oxide supply or do not use nitric oxide due to the logistical difficulties associated with cumbersome cylinder-based systems. Overall, we believe that the updated LungFit pH on the U.S. market since the spring of 2024 is poised to start taking significant market share in the U.S. and globally. The inflection point is happening now in the U.S. thanks to the system performance and our new and improved commercial infrastructure. Globally, we expect to see shipments starting in the next few months, which will make an impact on our revenues in the back half of fiscal 2026 and beyond. We will be providing revenue guidance for fiscal 2026 on our fiscal 2025 year-end conference call, which will be held in June. Turning to Beyond Cancer, as previous reported, they received regulatory approval to begin a Phase 1b trial for low-volume, ultra-high concentration nitric oxide, or UNO, in combination with anti-PD-1 therapy in late-stage cancer patients who have failed anti-PD-1 therapy, which remains an area of high unmet patient need. Top-line data from this Phase 1B study are anticipated around the end of calendar 2025. The UNO dose will be 25,000 parts per million. We call it low-volume now because our original human study utilized one liter of gas. while this Phase 1b study will utilize less than 100 milliliters of gas, a reduction of over 90%. As everyone knows, the global anti-PD-1 therapy market is in the tens of billions of dollars. I encourage all of you to visit the Beyond Cancer website for more information, as we believe this year should be transformational for this potentially groundbreaking therapy for those suffering from solid tumors. I am also pleased with the advances that Neuronauts, a subsidiary focused on therapies for autism spectrum disorders, is making. During the December quarter, Neuronauts announced the appointment of Professor Roger Kornberg to its Scientific Advisory Board. Dr. Kornberg is a renowned leader in the field of eukaryotic gene transcription and was awarded the Nobel Prize in Chemistry in 2006 for his groundbreaking work in molecular biology. Neuronauts will meet with FDA later this year to get an idea of the path to human studies, which we expect to begin in calendar 2026. The Neuronauts website offers a more complete understanding of what is to come over the first in human data anticipated later in 2026. I hope you all see the great progress made recently and how these leading indicators paint a bright future for LungFit PH and for nitric oxide as a revolutionary therapy across multiple indications. Beyond Air team will continue to be diligent on this path to profitability and improve the lives of patients in the need of the benefits of nitric oxide. Now I will turn it over to our CFO, Doug Larson.