Beyond Air, Inc.

Good afternoon and welcome everyone to the Beyond Air financial results call for the fiscal quarter and year ended March 31st, 2025. At this time, participants are in a listen only mode. The question and answer session will follow the formal presentation. And now I would like to turn the call over to Corey Davis with LifeSci Advisors. Please go ahead.

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 fourth quarter of fiscal year 2025 ended March 31st, 2025. A copy of this press release can be found on our website, beyondair.net, under the news and events section. Before we begin, I'd 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 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 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, 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 17, 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, I'll turn the call over to Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. Go ahead, Steve.

Thanks, Corey, and good afternoon to everyone. With me here today is Doug Larson, our Chief Financial Officer. We are quite pleased with the progress we've made over the past year. For the fiscal year ended March 31st, 2025, we reported a 220% increase in revenue to $3.7 million, compared with $1.2 million for the same period last year. All of this growth came from U.S. sales, the majority coming from hospitals signed during the back half of the year. As a result, we have tremendous revenue growth built in to kick off fiscal year 2026, along with several new growth drivers, as I will discuss in a moment. With this in mind, we have decided to also announce that we are on track to report revenue of at least $1.7 million for the quarter ending in just two weeks on June 30, 2025, which translates to greater than a 45% sequential quarterly growth and greater than 145% year-over-year growth. In addition, we are providing revenue guidance of $12 to $16 million for the full fiscal year ending March 31, 2026. This level of projected growth moving forward shows how we are overcoming the barriers to entry in the nitric oxide market and are well on our way to making LungFit PH the market leader. The more customers use LungFit PH, the more confidence grows in the product and our ability to provide top tier service. This is an exciting time for our team and our shareholders. Let me now dig a little deeper into the numbers for the fiscal fourth quarter of 2025 and growth drivers for fiscal 2026. The commercial team's efforts have led to a steady flow of new hospital contracts throughout fiscal year 2025. During the fourth quarter, we saw three new hospital starts and three hospitals renew their contracts. As I've mentioned recently, we have established a solid customer base across key target regions in the U.S. We are pleased and thankful that many of these customers have made themselves available as references for LungFit PH over recent months, which has proven to be a valuable tool when establishing new accounts. Further to the customer reference approach, we have partnered with Vanderbilt University Medical Center, naming them as the first luminary site for LungFit PH. Through this program, we will work alongside the Vanderbilt team to further optimize LungFit products and explore new opportunities to enhance hospital-based nitric oxide therapy. In addition, Vanderbilt has made themselves available to better showcase the full utility of LungFit PH technology to respiratory therapists, anesthesiologists, nurses, and other relevant clinicians at hospitals considering adopting our cylinder-free nitric oxide delivery system. This collaboration marks a major milestone in our core mission to redefine tankless nitric oxide delivery and drive continued innovation in respiratory care. Now, I would like to update you on the status of LungFit PH2, our next generation system. As announced yesterday, we have submitted a PMA supplement to FDA. LungFit PH2 is smaller, lighter, and designed for air and ground transportation, while still delivering all the revolutionary features of the current FDA approved system. Additional improvements include a more intuitive user interface, more functional backup system, adjustable alarm volume and significantly less frequent maintenance. All of these improvements were made with extensive input from our customers. We anticipate that the anticipated FDA approval of the second generation system and subsequent introduction to the U.S. market will have a major impact on our market share, total NO volume and logistics within the hospital. Looking outside the U.S., Over the course of just the past six months, we have quickly ramped up our commercial program across Europe, Southeast Asia, and the Middle East. These activities have included securing key regulatory approvals, including CE Mark, as well as signing distribution agreements across more than two dozen countries covering over 2 billion lives. Today, we announced that the team has recently signed several new international distribution partnerships for the following countries, India, Italy, Latvia, Lithuania, Estonia, Ukraine, Kuwait, Kazakhstan, Israel, and Poland. As a reminder, because the LungFit system generates NO from room air, unlike other systems that require NO-filled cylinders, we are opening an enormous new opportunity in geographical 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. I am pleased to report that we have already shipped more than a dozen units of LungFit pH to customers outside the U.S. over the course of just the past few weeks. As a result, we plan to see a meaningful contribution from these activities reflected in our financial results starting the back half of fiscal 2026 and beyond. Turning to Beyond Cancer, as previously reported, they received regulatory approval in Israel to begin a Phase 1B trial for low-volume UNO, or ultra-high-concentration nitric oxide, in combination with anti-PD-1 therapy in late-stage cancer patients who have failed anti-PD-1 therapy. This remains an area of high unmet patient need. Timing for the initiation of this study is under review. Onto Neuronasa, subsidiary focused on therapies for autism spectrum disorders. We were pleased to announce recently that the U.S. FDA granted Orphan Drug designation to our lead investigational therapy, BA102, which is being developed for the treatment of Phelan-McDermid syndrome, a syndrome associated with autism spectrum disorder. As many of you are aware, this designation provides key development incentives, including seven years of market exclusivity upon approval, tax credits for qualified clinical trials, waiver of FDA application fees, and access to FDA protocol assistance. Neuro-NOS will meet with FDA later this year to get an idea of the path to human studies, which we expect to begin late in calendar 2026. The excitement around our autism program goes beyond our walls. This is evident by our ability to recruit leaders in the field to our scientific advisory board. Just recently, we announced the appointment of Nobel Prize Laureate Professor Dan Scheffman to the Neuro-NOS SAB. We believe bringing in Professor Schechtman to join Professor Roger Kornberg from Stanford University on this board brings unparalleled scientific expertise to the Neuronauts team. During the March quarter, Neuronauts published a peer-reviewed journal, article, and translational psychiatry, which presented breakthrough research by its chief scientific officer, Professor Haitham Amal, which shows compelling evidence of a novel mechanism in the early stages of Alzheimer's disease. These new preclinical data further underscore the consistency and power of Neuronus' platform and offers new hope for the development of effective therapies for this devastating condition. Building on the excitement around the data and progress of its programs, Neuronus announced at the end of March that it completed a $2 million equity financing from private investors as part of a larger funding round. This investment will accelerate the preclinical development of Neuronus' small molecule drug designed as an injectable or oral treatment for children with autism. Turning to the corporate side, we're excited to announce today the appointment of Bob Goodman to our Board of Directors, effective June 13, 2025. Bob is a seasoned healthcare executive and board director who brings decades of commercial leadership experience from across the medical technology, pharmaceutical services, and medical device industries. His career has included executive roles at BioTelemetry, Philips Healthcare, CardioCore, Thermo Fisher, and Pfizer. Our board and management team look forward to working with Bob as we continue to build positive momentum across the commercial side of our business. Before I conclude my comments today, I want to mention that our Lung Fit Go program is still moving along. We are dedicated to bringing this therapy to market to improve the lives of patients suffering with lung infections. We plan to meet with FDA prior to year end to discuss the clinical path forward. We continue to make significant progress in executing against the strategies for each of our businesses. Past years show just a glimpse of how LungFit pH will transform the global NO landscape for the better and gives us a solid foundation from which to continue to build. The iDare team will continue to be diligent on its path to profitability and improving the lives of patients in need of the benefits of nitric oxide. Now I will turn it over to our CFO, Doug Larson.