Beyond Air, Inc.

Good afternoon and welcome everyone to the Beyond Air financial results call for the fiscal quarter ended March 31st, 2024. 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 Garth Russell, LifeSci Advisors. Please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today, after the market closed, we issued a press release announcing the fiscal year 2024 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 purposes of the safe harbor provisions under the Private Securities Allegation Form Act of 1995. Beyond Error 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 limitations, 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 the live broadcast, June 24, 2024. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. I would also like to mention, considering the corporate update being provided to you today, in a relatively short period of time until the company is going to announce its Q1 fiscal year 2025 financial results, management has decided to forego hosting a standalone conference call next month. The company's results will still be thoroughly communicated via press release and 10Q filing with the SEC. With that, I'll now turn the call over to Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. Steve?

Thanks, Garth, and good afternoon to everyone joining us today. Joining me on the call is Doug Larson, Chief Financial Officer, and we're both happy to be here today. I'm excited to report that we closed out our fiscal year 2024 with positive momentum, as revenues for the fiscal fourth quarter grew more than 20% sequentially, and we reported several positive metrics across our growing lineup of existing customers and sales pipeline, which I will touch on in a moment. I would like to offer a short review of the road we've taken to get to this point. We launched LungFit PH following FDA PMA approval in the fall of calendar year 2022. Immediately after FDA approval in mid-22, our engineers worked diligently to expand the device's compatibility with additional ventilators already installed in the market and made certain other improvements that addressed the feedback we received from real-world use and customer input. In the spring of 2023, we had received all we needed from FDA to make our system what we believe is the best on the market, with two notable exceptions, compatibility with an important ventilator and improved nitric oxide sensors, both of which were tied to a pending software approval. Then in the fall of calendar 2023, which is the third quarter of our fiscal 2024, the FDA gave approval for this update. Thus, we are now in the market with a more optimized product. As you all know, with a PMA-approved Class 3 medical device, the implementation of this software change required more than simply uploading files from a thumb drive. We spent several months ensuring perfection, working with our existing customers to be certain the updated system worked perfectly. Once we had that performance indication, we upgraded the devices at all of our existing customer locations. and brought on new customers as well. This took a little longer than expected, but we believe that the quality of the system we now have is paramount for medium and long-term success. Overall, we believe LungFit is well positioned for rapid gains as we expect that it meets all the existing market needs. Now let's talk about our confidence for the next several quarters and beyond. Over the past few months, since the updated LungFit PH system has been available, we have seen a steady flow of high-quality engagements with potential new customers and extremely positive feedback from existing customers. The level of satisfaction among our existing customers is important as word-of-mouth referrals and reference checks are sometimes the most effective form of marketing to hospitals. Momentum is building, and we are ready to seize the moment. We are confident that our newly appointed Chief Commercial Officer, David Webster, who begins on July 8th, will build upon this newly cemented foundation and on our success to date. Now I will fill you in on some quick statistics. More than 50 hospitals in the United States have used LungFit PH to treat patients. These hospitals collectively have now treated over 1,100 patients. This translates to over 75,000 hours of therapy with LungFit PH. Clearly, LungFit PH works in multiple settings while being used with various ventilators, and hospital staff are pleased with LungFit's benefits. Also, it's worth noting that most of these hours were done with LungFit PH prior to the recent updates, so just imagine how much more satisfying it is for hospital staff to work with the upgraded system. Perhaps most telling, continuing on our discussion of engagements from our last earnings call, every hospital that uses LungFit PH that had their contract conclude has renewed with us. And the number of multi-year contracts has increased by over 100% since our last conference call, with such requests becoming more frequent. We are proud of our continuing performance and the quality of LungFit PH. And to be crystal clear to all of our potential customers, we welcome all head-to-head comparisons with any competitor's NO device under any circumstance. Now, a few things about our new chief commercial officer, David Webster, and why we believe he is absolutely the right person to lead the commercial team. We were fortunate to have had several very capable candidates participate in the extensive vetting process for the job. While all the candidates were extraordinary, David's record of success and demonstration of leadership qualities led us to believe that he will drive the success of LungFit PH. He has extensive experience bringing products to market in the hospital setting, and working within small to medium-sized companies. He also has built commercial teams from the stage where we currently are, with customers in 10 states to full-sized, well-oiled machines covering the entire United States. I look forward to having David hit the ground running in two weeks. In addition to having a well-qualified chief commercial officer at the helm, we also have a couple of other upcoming events that should further drive growth. Remember that our PMA supplement for the expansion of the LungFit pH label to include cardiac surgery was accepted and is under review by the FDA. While there is no firm date for FDA to complete its review and timelines may change, based on our interactions with the agency to date, we expect a decision in the fourth quarter of calendar 2024. Recall that there are no nitric oxide products presently approved for cardiac surgery in the United States. Looking outside of the U.S., CE mark for lung fit pH remains pending, and we continue to work collaboratively with regulators. While we don't presently have clarity on updated timing, we have learned to be patient given the overhaul of the EU medical device regulations that occurred a few years ago and the learning curve of the European notified bodies as everyone navigates the new rules. As we have mentioned previously, in addition to opening up doors in Europe for our system, receiving this CE mark will trigger a milestone payment from our partner, Getz Healthcare. which has signed an agreement with us to commercialize the LungFit pH in several countries in the Asia Pacific region, excluding Japan. As I look ahead, while we continue to make significant strides forward, delays in reaching our milestones have left us slightly behind our previous near-term targets. Due to this, we are revising our fiscal year 2025 revenue guidance to greater than 10 million, down from 12 to 16 million. I will now address our cash burn. Preserving capital is critical for us at this juncture in our evolution in this current market. We began our analysis in January of how we could most effectively preserve capital and give our new chief commercial officer a runway to succeed. Since then, we have reduced our headcount by over 20% with most of the moves occurring in the June quarter. Most of the associated costs, including severance payments, will be recognized in the June quarter. the first quarter of our fiscal year, resulting in what we expect to be the largest cash burn of fiscal year 2025. Conceivably, the decrease in our bank balance in the June quarter may end up being more than the other three quarters combined. To reiterate what was in the press release earlier today, the impacted R&D projects include the LungFit Pro program, which is on hold, and LungFit Go, where all engineering has been brought in-house, which resulted in a delay until 2026 for the next clinical study start. The LungFit PH transport-ready system is on track for FDA submission on or about December 31st, 2024. Beyond Cancer's UNO program is nearing the end of Phase 1A and is targeting initiation of a Phase 1B combination study with anti-PD-1 therapy prior to the end of calendar 2024. Neuronos, Beyond Air's subsidiary focused on autism spectrum disorder, is still moving towards a first-in-human study in 2025. Beyond Cancer and Neuronos are focused solely on their respective human studies and in alignment with Beyond Air's focus on careful cash management. Now an update on Beyond Cancer. Data were recently announced from its phase 1A study evaluating ultra-high concentration nitric oxide, or UNO, in subjects with advanced relapsed or refractory unresectable primary or metastatic cutaneous and subcutaneous solid tumors. These encouraging first-in-class clinical data show UNO demonstrated evidence of immune system activation by a biomarker response in a heavily pretreated population. These data were presented at the American Society of Clinical Oncology key opinion leader event held in conjunction with the 2024 annual meeting in Chicago. In addition, Beyond Cancer presented the design of the Phase 1B trial, which will enroll up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease on single-agent anti-PD-1 without radiographic evidence of continued tumor reductions. subject enrolled in the Phase 1B trial, will be treated with the UNO plus anti-PD-1 combination upon completion of the Phase 1A trial and regulatory approval. I encourage all of you to visit the Beyond Cancer website to get better educated on this potential transformational therapy for those suffering from solid tumors. Now we'll turn it over to our CFO, Doug Larson. Thanks, Steve, and good afternoon, everyone.