Beyond Air, Inc.

Good afternoon and welcome everyone to the Beyond Air financial results call for the fiscal quarter ended December 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'd like to turn the call over to Corey Davis, 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 third quarter 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 Litigation Reform Act of 1995. Beyond air cautions that these forward-looking statements are subject to risks and uncertainties could cause actual results to differ materially from those indicated. We encourage everyone to review the company's filing 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 the 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, February 12, 2024. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Joining me today on the call are Steve Lisi, Chairman and Chief Executive Officer of and Douglas Larson, Chief Financial Officer. With that, I'll turn it over to Steve Lisi. Go ahead, Steve.

Thanks, Corey, and good afternoon to everyone joining us today. Today, we announced a strong step in the right direction with a greater than 60% increase in revenue this quarter versus last quarter. While this is a small number in absolute terms, there are several factors that give us confidence in hitting our fiscal year 2025 revenue guidance of $12 to $16 million. Filters shipped in fiscal 3Q grew by more than 100% compared with shipments in fiscal 2Q. It's important to note that this growth does not yet reflect the software upgrade received from the FDA in September, as it takes time for such a manufacturing change to result in upgraded systems. Our first new hospital start with the updated system was on February 1st. As this rollout of the new machines has just begun, The financial impact in the March quarter will be a bit muted as compared with the levels of revenue we expect to see in the June quarter. It is important to understand that we will maintain a balance for the next several months between upgrading our existing customer base and adding new customers. The increase in demand for product evaluations has surged since our upgraded system was displayed at the American Academy of Respiratory Care in early November. Since the conference, we have completed, started, or definitively scheduled as many evaluations as we have completed in the previous 10 months. Prior to the upgraded system, we had zero multi-year contracts. I am pleased to announce today that we now have three such engagements with more multi-year requests than single-year requests by a wide margin. For reference, upgrading our software removes all compatibility issues, reduces system noise, improves alarms, and improves sensor accuracy. We have told every hospital that we welcome a head-to-head comparison with any competitor in their hospital. However, not surprisingly, we have had very few instances where a competitor was willing to sit in the same room with us at a hospital to cycle through multiple use cases with our system and their system. While still in its early stages, We have also been pleased with the progress made since securing our innovative technology contract award from Vizient, the nation's largest provider-driven healthcare performance improvement company. We're excited by this opportunity to expand our reach through the Vizient customer network. We also anticipate adding LungFit PH to more group purchasing organization platforms over the course of the next year. To capitalize on this positive growth trajectory, we will continue to build out a field team based on the growth opportunities as they evolve. One last point to make on the US nitric oxide market. Our PMA supplement for the expansion of our label to include cardiac surgery was accepted and is under substantive review by the FDA. Our clinical and regulatory team is to be commended for putting together a strong submission. While there is no firm date for FDA to complete their review, we would expect a decision before the end of calendar 2024. Once approval is received, we anticipate an impact on revenue growth after a few months. Looking outside of the United States, we still expect to receive CE mark in the first half of calendar year 2024. 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 lung fit pH in several countries in the Asia Pacific region, excluding Japan. Moving on to our pipeline, during the quarter, Beyond Cancer announced that its phase one study evaluating ultra-high concentration nitric oxide, or UNO, in advanced relapsed or refractory unresectable primary or metastatic cutaneous and subcutaneous solid tumors has cleared the first cohort of 25,000 parts per million single dose UNO by the safety review committee with no reported dose limiting toxicities. This means that there is an UNO dose of 25,000 parts per million nitric oxide that is safe for human use And given the data shown in November at the CITSE conference, there should be confidence there is an immune response, much like we saw in preclinical studies. As a reminder, this is a first-in-human study that is being conducted in two parts, dose escalation and dose expansion. The dose escalation part will consist of three UNO dose cohorts, 25,000, 50,000, and 100,000 parts per million nitric oxide, or possibly a concentration below 25,000 parts per million. The dose expansion portion of the study will begin once the recommended dose is determined with the primary objective of the trial to assess safety and tolerability of UNO with a secondary objective of assessment of efficacy by immune biomarker response to UNO therapy. One last note is that we anticipate completing the Phase 1A study and presenting the data in the first half of this calendar year and then initiating a Phase 1B study in the back half of the calendar year. which will include combination therapy with anti-PD-1 therapy, given the strong combination data shown to date in the preclinical setting. I encourage all of you to visit Beyond Cancer website to get better educated on this potential transformational therapy for those suffering from solid tumors. Our viral community-acquired pneumonia, or VCAP, studies underway. As a reminder, this randomized, double-blind, placebo-controlled pilot study will treat hospitalized patients with 150 parts per million nitric oxide intermittently for up to seven days. Due to viral pneumonia following seasonal patterns of activity, this is a seasonal study running through the fall and winter months. As a result, we have decided to conduct this study over two seasons. Thus, we expect to announce top-line data by the middle of calendar year 2025 with interim data updates when appropriate. This will not change the timing for a pivotal study in the 25-26 season. Obviously, viral pneumonia is a significant unmet medical need given the times we live in. Turning to our autism program, we are pleased that the program remains on track for human data in 2025. Please recall that this early stage development program is being conducted in partnership with the Hebrew University of Jerusalem, which continues to produce exciting preclinical data. As a reminder, the data thus far have shown that reducing nitric oxide production by inhibiting neuronal nitric oxide synthase, reduces natural state of stress biomarkers in the brain, and reverses the molecular, synaptic, and behavioral autism spectrum disorder associated phenotypes. To be clear, a reversal of behaviors associated with autism was demonstrated in several different genetic mouse models of autism. We believe this program offers tremendous potential and look forward to providing updates as we progress throughout the year. Now I will turn it over to our CFO, Doug Larson. Doug.