Good afternoon, and welcome to the Beyond Air financial results call for the fiscal quarter ended September 30, 2025. I would now like to turn the call over to Garth Russell from Lifesci Advisors. 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 operational highlights and financial results for Beyond Air's second quarter of fiscal year 2026 ended September 30, 2025. 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 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 the live broadcast, November 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, I'll turn the call over to Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. Steve?

Thanks, Garth, and good afternoon to everyone. With me here today is Doug Larson, our Chief Financial Officer. We continue to receive highly encouraging feedback from hospitals using LungFit PH, reinforcing the clinical value and operational efficiency our technology delivers. Adoption is accelerating meaningfully over the past year, contributing to a 128% year-over-year revenue increase in the fiscal second quarter, reaching $1.8 million, up from $0.8 million for the same period last year. While we are pleased by the strong year-over-year growth, sequential growth was essentially flat compared to the prior quarter, reflecting the timing of hospital purchasing cycles and the natural variability in international shipments. We view this stability as an encouraging baseline from which we expect sequential growth to resume over the coming quarters. We continue to navigate the inherent complexity of hospital sales cycles in the U.S. and internationally. These extended lead times and institutional decision-making processes have led to peaks and valleys in our quarterly sales performance as seen in the September quarter. Importantly, our sales pipeline remains robust, and we see substantial greenfield opportunities across the U.S. as awareness and interest in LungFit PH continue to build. Before getting into further details, let me highlight the changes that have occurred since our last update in August. We have raised $12 million in debt, and we'll file a registration statement for an additional $20 million through an equity line of credit, both with Streeterville Capital, which solidifies our balance sheet. We believe these additional funds will give us the ability to properly address the pace of sales growth with our first-generation system and prepare for the launch of our second-generation system. LungFit PH has been placed in the first hospital outside the United States for commercial use. We have named our Board member, Bob Goodman as Interim Chief Commercial Officer, given the departure of David Webster. We are updating our fiscal year '26 guidance to $8 million to $10 million. We introduced our capital purchase sales model in the United States and had our first hospital purchase of LungFit PH. We collected data from Beyond Cancer's Phase Ia trial with 10 subjects with ultra-high concentration nitric oxide or UNO, which shows median survival has not yet been achieved and currently sits at 22 months. These updates have put us in a very strong position and provide us the financial runway we need to optimize the Gen II launch in late calendar 2026 and drive our international business from the strong foundation we have already built. As you all know, we were awarded a national group purchasing agreement for therapeutic gases with Premier. Coupled with our agreement with Vizient, we now have access to nearly 3,000 hospitals. We are confident that our targeted commercial strategy, supported by the right people now in place and strengthened by our Premier and Vizient GPO contracts will begin to have a meaningful impact on revenue over the coming quarters. Our disciplined approach is allowing us to prioritize the highest value hospital opportunities while deepening relationships across our existing accounts. This focused execution is already translating into broader market engagement and increased visibility of LungFit PH within key hospital systems. At the same time, we are preparing for the next major inflection point with our second-generation LungFit system, which is smaller, lighter and designed for both air and ground transportation, while maintaining all the revolutionary features of the first generation LungFit PH. We believe this next-generation platform will enable us to expand into larger hospitals and health systems, further accelerating adoption and cementing LungFit's position as the standard for nitric oxide delivery. We anticipate commercial launch of the second-generation system in the U.S. market in late calendar year 2026, pending FDA approval. As a significant aside, several of our existing customers have extended their annual contracts with multiyear agreements, while increasing anticipated annual volumes. We see this as a confirmation of the ease of use and the value proposition of LungFit PH, and we expect this trend to continue. During the quarter, we finalized and have since launched a new sales model that complements the traditional industry leasing model. Under this new approach, hospitals may now purchase LungFit PH systems outright while continuing to generate recurring revenue for Beyond Air through disposables and service agreements. Initial system sales occurred subsequent to quarter end, and the early reception has been extremely positive. We are very excited by the flexibility this dual model approach offers and the opportunity it creates to accelerate adoption of LungFit PH. Today, we announced the appointment of Bob Goodman as Interim Chief Commercial Officer, following the departure of David Webster. Bob joined the Beyond Air Board earlier this year and brings deep commercial and operational expertise from leadership roles at BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific and Pfizer. His experience spans public companies, private equity-backed businesses and early-stage ventures, where he has consistently driven innovation, operational scale and commercial success. We have greatly valued his contributions to the Board and look forward to the fresh perspective and leadership he brings as we ramp up commercial activities and, as I just mentioned, prepare for the highly anticipated launch of our second-generation LungFit PH. A key driver of our long-term growth strategy over the past year has focused on the expansion of our global distribution network. During the September quarter, we added new distribution partnerships in Japan, South Korea, Mexico, Costa Rica, Guatemala, Panama and El Salvador. These new agreements significantly broaden our geographic reach and demonstrate growing demand from both mature and emerging health care markets seeking modern, cylinder-free nitric oxide delivery solutions. Importantly, we achieved our first international commercial placement of LungFit PH into hospitals outside the United States this quarter. These initial system sales marked a key validation of our technology's global applicability and confirm that our value proposition, improve safety, reduce logistical burden and long-term cost savings is resonating strongly with hospital administrators and clinicians. We continue to see excellent engagement from our distribution partners who are now actively seeking regulatory approvals or demonstrating LungFit PH in hospitals in their local markets. These latest agreements bring our total international coverage to 35 countries, representing a combined population of approximately 2.8 billion people, and we expect to reach our goal of 60 countries under partnership in calendar 2026. As local distributors begin converting opportunities into active installations and sales, we anticipate international revenue contribution to build steadily through fiscal 2026 with momentum accelerating into fiscal 2027. This growing global footprint positions Beyond Air to capitalize on significant untapped demand for LungFit PH and lays the foundation for broader global adoption following additional regional approvals. To wrap up our remarks around LungFit PH, I have two more positive updates to share. We had a patent allowance for a design patent that covers our second-generation LungFit PH through 2040. And we had data shown by a physician at the Extracorporeal Life Support Organization Conference in September, which show positive results when LungFit was used in the ECMO sweet gas circuit on neonates. I would like to provide an update on the data from Beyond Cancer's Phase Ia study. As a reminder, the study enrolled 10 subjects at doses of 25,000 and 50,000 parts per million nitric oxide gas delivered over 5 minutes intratumorally. These patients all had metastatic disease and were heavily pretreated. The mean number of total prior surgeries, radiation and medications was 10.3 with a minimum of 4 and a maximum of 18. The mean number of all prior medications only was 5.5 with a minimum of 2 and a maximum of 14. All subjects had a life expectancy of less than 12 months when we treated with UNO therapy. The only adverse event which occurred in one patient that was possibly attributable to nitric oxide was a Grade 3 vasovagal response. Otherwise, the safety profile is very clean for this patient population. With respect to overall survival, the median and mean are 22 months and 21.2 months, respectively. These survival numbers will continue to increase, but we have not yet reached the final median survival. Given these impressive data, we are assessing the best path forward for the program at this time. We remain dedicated to pursuing the Phase Ib combination study with anti-PD-1 therapy, and we will communicate more details as we progress. With respect to NeuroNOS, we recently announced that the U.S. FDA granted Orphan Drug Designation to its investigational therapy, BA-101 for the treatment of glioblastoma. The NeuroNOS team is working closely with regulators, investigators, patient groups and the foundations to accelerate development of BA-101 towards a first-in-human study. This program is in addition to the development for BA-102, an investigational therapy for the treatment of Phelan-McDermid syndrome, or PMS syndrome associated with autism. We expect the IND submission for the first-in-human study by the end of calendar 2026. As a reminder, the FDA has also granted orphan drug designation to BA-102 for PMS. I will wrap up by stating how energized we are following the financing, which will support the continued progress of our global commercial activities and help us prepare for the potential launch of the second-generation LungFit PH. The promise of LungFit is apparent, and we are thankful to the team at Streeterville for taking the time to appreciate our vision to provide clinicians and patients around the world with the optimal NO system. Now I will turn it over to our CFO, Doug Larson.

Thanks, Steve, and good afternoon, everyone. Our financial results for the second quarter of fiscal year 2026, which ended September 30, 2025, are as follows: Revenue for the fiscal quarter ended September 30, 2025, increased 128%, to $1.8 million compared with $0.8 million for the fiscal year ended September 30, 2024. We showed 3% growth versus last quarter. Steve mentioned how our revenue is a little chunkier now given an international ramp is never straight up. We are showing a gross loss of $0.3 million for the fiscal second quarter of 2026 compared to a loss of $1.1 million for the same period last year. The improvement was primarily attributed to sales growth. Our margin slipped back negative this quarter due to costs required to upgrade our existing fleet of devices and provisions for excess inventory. Turning to operating expenses. We continue to see cost reduction across the board, in SG&A, R&D and in our supply chain due to cost reduction initiatives we took in the last 12 months. For the second quarter of fiscal 2026, we reduced total operating expenses to just above $7.4 million from $11.7 million for the same period last year. This translates to a 37% reduction year-over-year, and greater than 56% reduction from a high of $17 million at its peak. Going forward, we anticipate R&D expenses will decrease slightly next quarter as the cost related to our Gen II device are mostly behind us. SG&A expenses will only move up in line with our commercial performance to maintain our excellence in service and take advantage of coming opportunities. Research and development expenses were $2.5 million for fiscal quarter 2026 compared to $4.6 million for the same period last year. Half of the decrease of $2.1 million was due to a reduction in development costs for our Gen II device while the other half was mostly attributed to a decrease in salaries and stock-based compensation costs. SG&A expenses for the quarters ended September 30, 2025 and September 30, 2024, were $4.9 million and $7.2 million, respectively. Almost all of the decrease of $2.3 million was from a reduction in salaries and stock-based compensation costs. Only part of the business that saw an increase in SG&A was a NeuroNOS as they start to build a little bit of infrastructure to support the groundbreaking work being done there. Other expense was $0.6 million compared to a $1.2 million expense for the same period a year ago. The decrease in expense of $0.6 million was primarily attributed to the prior period loss associated with the partial extinguishment of debt. Net loss attributed to common stockholders of Beyond Air, Inc. was $7.9 million or a loss of $1.25 per share, basic and diluted. Our net loss for the fiscal quarter ended September 30, 2024, was $13.4 million or a loss of $5.67 per share, basic and diluted. Please note that the per share results for both periods were calculated to reflect the company's 1-for-20 reverse stock split, which became effective on July 14, 2025. Net cash burn for the quarter was $4.7 million, which is a 66% reduction versus a year ago. We believe our overall cash burn will continue to reduce as revenue grows and will only get better until we get approval and start building inventory in preparation for the launch of Gen II. As of September 30, 2025, we reported cash, cash equivalents and marketable securities of $10.7 million. As Steve mentioned earlier, subsequent to the end of the second quarter, we announced closing a strategic financial agreement with Streeterville Capital, LLC. Under the terms of the agreement, we issued a $12 million promissory note bearing a 15% annual interest rate. This note matures in 24 months from the issue date with no payments due for the first 12 months. In addition, we entered into a $20 million equity line of credit agreement with Streeterville Capital dependent on our filing an S-1 resale registration covering resale of the shares Streeterville Capital may receive under the e-lock. This e-lock provides us with the right but not the obligation to sell up to $20 million of newly issued shares of our common stock over a 24-month period, subject to certain limitations. Following these recent financing agreements, we believe that our cash and existing financial vehicles will be sufficient to allow us to support our current operating plans well into calendar 2027 and potentially to profitability, providing we continue to hit our current revenue estimates and continue to control costs at Beyond Air. With that, I'll hand the call back to Steve.

Thanks, Doug. Operator, we'll take questions.

The first question is from Justin Walsh from Jones Trading.

Without going into specific fiscal 2027 guidance, can you comment on the expected growth drivers leading into the potential approval of the second-generation LungFit PH? And then how you're thinking about that trajectory after that second gen product is out?

Thanks, Justin. Appreciate that. So obviously, the trajectory once the second generation is out should be significantly steeper than what we're seeing now. That's our belief. And I think people know the attributes of that system versus the current system and the competition. So we're confident in that. As for the growth drivers prior to that, I assume you're asking for.

Yes.

Yes. We're setting up internationally. We're in 35 countries now with partners. We did just place systems in our first commercial hospital outside the United States. So it takes time to build that. We all wish we'd go a little faster, but it is being built, and our international team is doing a great job. So we've got a lot of seeds planted out there, I guess you could say. And we anticipate that with fiscal '27 coming up, we should be winning a lot of hospitals outside the United States where the competition is a little bit different than it is in the United States. So that's one of the drivers for '27. In the United States, we have introduced a capital purchase model. Our system is now extremely reliable, and we have received interest, including our first hospital making a purchase from us. This will account for a capital equipment purchase, while the filter and other accessories will involve ongoing purchases. Pricing will depend on the annual nitric oxide usage in each hospital per system, but it is very competitive on a per-hour cost basis. We believe this new offering for how hospitals can make payments in the United States has generated interest, and the international market will be a key focus until Gen II is approved.

Got it. And one more question. You mentioned here that you're hoping to commercialize the second-gen LungFit PH around end of calendar 2026, if I heard correctly. I'm just wondering if you can comment on kind of the thinking around this time and whether or not you've noticed any delays in your dealings with the FDA recently.

Yes, I believe the FDA is performing well. The timing we are facing is not primarily due to the FDA but rather our supply chain issues. It's currently challenging for us to obtain the necessary parts, and the global trade disagreements and government shutdown are not helping the situation. We are focused on ensuring our contract manufacturing is ready for inspection. So, it will just take some time for that to happen. While we expect to launch before the end of the year, approval will need to come before December for that to occur. It won't happen immediately after approval; there will be some time required. That reflects our current situation, and while things can change regarding timing, this is how we see it right now.

The next question is from I-Eh Jen from Laidlaw & Company.

Steve, could you just do some comparison between the new model versus the prior ones? So give us a little bit more deep dive in terms of the benefits to the company or maybe for the market penetration? Then I have a follow-up.

Yes, thank you. The main differences are largely related to size. This second-generation machine will be approximately 60% the size of the original model. We anticipate that once we receive FDA approval, it will be permitted for use in both ground and air transportation, which is crucial for us. Additionally, the user interface has been improved based on feedback from our existing and potential future customers who provided input on the Gen II model. We have taken their suggestions into account, and we believe that all functions of the device will be easier and better for users. One other thing is that the maintenance interval will be longer, so the disruption of swapping machines out for high-volume users will be a thing of the past. Hospitals using an exceptional amount of hours per system per year, well above the average, have required fairly regular maintenance. This has caused some disruption for the hospital, and we are working to get Gen II out there so that this issue disappears.

So actually, I try to get a little bit about the new business model and what it can achieve that wasn't fully appreciated by the existing one.

Yes. The market was primarily a leasing market before we joined. We collaborated with hospitals based on their existing practices and received numerous requests from them to purchase the machine. However, we refrained from selling the machine during the first two years because we were still implementing upgrades and improvements, making it impractical to sell a product that was still evolving. Now, we have reached a stage where there are no significant improvements left for the Gen I machine, aside from minor tweaks or software updates. Hospitals that have been inquiring about purchasing the machine have expressed a preference for buying it and acquiring disposables at a lower cost compared to leasing. So we are offering different models for using our system to the hospitals based on their needs. That's all it is, yes. We're not abandoning the leasing model in any way. So we have multiple different types of leases. So we're really just trying to offer the hospitals what they're asking for. So the latest one is the capital purchase model. So we introduced it a few months ago, and we've got hospitals that are taking advantage of it.

Okay, great. I wanted to follow up on the previous question. You have secured a substantial number of international deals, which is a positive development. Given the large market overseas, I assume most of these agreements involve distributors. How should we approach long-term modeling concerning the pricing generated from these deals compared to what we see in the United States, which tends to be somewhat different? Additionally, how does the renewing filter fit into this model?

Yes. The model outside the U.S. involves selling to distributors who then choose how to use the products in their markets, whether through leasing, purchasing equipment, or a combination of these methods. Once they buy the machines as capital equipment, we also provide them with disposables, including the crucial filter. This represents a recurring revenue stream, and I anticipate that this will become more evident in fiscal 2027 as we begin to implement the systems more widely. Once they're placed in hospitals, you see that repeat business, but that's not happening in fiscal '26. It will be a fiscal '27 phenomenon and picking up speed more in fiscal '28 because we're still awaiting regulatory approvals in many countries, and it takes time to get into these hospitals. So it is a long process, but that's the way it goes.

Okay. Great. That's very helpful. And congrats on the fortifying the balance sheet, which you can do a lot of good things. And congrats.

The next question is from Marie Thibault from BTIG.

This is Sam on for Marie. Maybe I can start on the updated guide, the $8 million to $10 million. Steve, would just love your thoughts on the visibility. You have given maybe some of the fluctuations in the hospital sales cycle? And then any thoughts on cadence for the back half of the year?

Thanks, Sam. Appreciate it. Well, look, we've got $3.6 million in the first half. So it's not a large leap to get to the $8 million-plus range. But we have a transition at Chief Commercial Officer. So I'm sure everyone on the call wouldn't expect Bob Goodman to hit the ground running on in week one or two and start ripping sales straight up. I think it will take a little bit of time for Bob to implement his processes here and get things moving in the right direction. So I think that when there's a change like this, there's going to be a little bit of disruption. So that's part of the reason why the $8 million to $10 million is the new guidance.

Okay. Okay. That's helpful. And then maybe I can just follow up here on the pace of contract renewals that are coming up. Are you seeing pretty strong renewal rates? Are customers exiting contracts at all would just love an update there as well?

Yes, the renewals are progressing well. We've seen several contracts extend from one year to three years. While this isn't the case for every contract, it's happening with a significant number. Being on Premier has been very beneficial. We had some hospitals under contract that were not on Premier, and now that they're included, it strengthens our position. We are also hopeful about joining HealthTrust in the future, which would cover the major three GPOs. This is crucial for both acquiring new hospitals and retaining existing ones. Although hospitals can sometimes contract outside their GPO, this is uncommon. Once we are part of a GPO, it becomes very important. We haven't noticed hospitals leaving us; it's a very stable business. I believe this stability is due to our field team, the performance of our machines, and the excellent support from our clinical team at Beyond Air when hospitals need assistance.

At this time, we are showing no further questions in the queue. And this concludes our question-and-answer session. I would now like to turn the call back over to Steve Lisi for any closing remarks.

Thanks, operator. Thanks, everyone, for joining. Look forward to speaking to you in the near future. Thank you.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.