Beyond Air Inc Aktie

Thank you. 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 Corey Davis, LifeSci Advisors. Please go ahead.

Thank you, Operator. Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release announcing the operational highlights and financial results for Beyond Air's quarter ended June 30, 2026. 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 to differ materially from those indicated. 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 call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 13, 2020. 26. 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 Robert Goodman, Chief Executive Officer of Beyond Air. Bob, the floor is yours.

Thanks, Corey, and good morning everyone. With me today is Dan Moorhead, our Chief Financial Officer. We just had our last quarterly call a few weeks ago. I'll keep my prepared remarks fairly brief. Over the past few months, we've been focused on positioning BeyondAir for its next phase of growth. We strengthened our balance sheet through an up to $30 million financing, regained compliance with NASDAQ's listing requirements, and continue to expand the commercial foundation supporting 150. at PH. Collectively, these actions have strengthened the company's financial position, increased our commercial reach, and enhanced our ability to execute on what we believe is a significant opportunity ahead of us.

To prepare for the planned commercial launch of our second-generation LungFit PH system, pending FDA approval, our priorities are focused on continuing to expand market access, deepen relationships with hospitals and health systems, grow our commercial pipeline, and execute with financial discipline. We believe these efforts will position Beyond Air to drive broader adoption of the LungFit pH while creating a stronger platform for long-term growth. Turning to the financial results, revenue for the quarter ended June 30, 2026, with $1.8 million, which is effectively flat from the March 26 quarter. While revenue remained relatively consistent, we made meaningful progress advancing the commercial and operational initiatives that we believe will support stronger growth as we move through the remainder of the year and prepare for the planned launch of our second-generation 1-fit pH system. We continue to execute against several initiatives designed to expand market access and increase commercial adoption. During the quarter, we entered into a national group purchasing agreement with a leading U.S. GPO, becoming the third major national GPO to partner with Beyond Air.

Together with our existing agreements with Premier and Vizion, these relationships provide access to a substantial portion of U.S. hospitals and health systems and represent an important component to our commercial strategy. We also continue to expand our global distribution network through new and existing commercial partnerships, further extending OneFitPH's reach into the international markets. Another growth center for the company will be the expansion of our international distribution. We have a number of partnerships already in place that cover more than 40 countries. As a result of our strengthened financial position following the recent equity raise, we're in a better position to support our partners' efforts to bring LungFitPH to market in many of these areas. We look forward to providing updates on these programs as appropriate. relates to the Gen 2 Lung Fit system in the U.S., which remains under review at the FDA, we continue to believe this to be the most important near-term catalyst for the company. We submitted our PMA supplement to the FDA in June of 2025, and based off of our interactions with the FDA to date, we continue to believe we are on track for a potential approval in the second half of this calendar year, although the timing and outcome of the review remain subject to the FDA approval process.

Accordingly, we continue to prepare for a potential commercial launch. We are maintaining a disciplined and focused approach to capital allocation. We continue to dedicate our resources predominantly to OneFitPH. In our press release issued earlier today, we reaffirmed our previously issued revenue guidance of $8 million for calendar 2026, representing approximately 15% growth over calendar year 2025. It is worth noting that we're not including any revenue from the second generation lung fit We also reaffirm our previously issued 2027 revenue guidance of 16 to 18 million, representing more than 110% growth at the midpoint compared with our 2026 guidance. The guidance for 2027 does include revenue from the potential commercial launch for the second generation LungFit pH system subject to FDA approval. Looking forward, Beyond Air is approaching an important inflection point.

With continued international expansion and planned commercial launch of our second-generation lung-fix systems pending approval, we have established a stronger foundation to accelerate commercial execution and drive meaningful revenue over the coming years. With that, I'll turn the call over to Dan for review of our financial results. Dan? Thanks, Bob, and good morning, everyone.

I'll walk through our financial results for the quarter ended June 30th, 2026. Revenue for the quarters ended June 30th, 2026 and 2025 was $1.8 million. Gross margin for the quarter ended June 30th, 2026 was 13% compared with gross margin of 9% for the same period last year. This marks our third consecutive quarter of positive gross profit. Research and development expenses for the quarters ended June 30, 2026 were $2 million compared to $3.1 million for the same period last year. Selling general and administrative expenses for the quarter ended June 30, 2026 were $4.9 million, compared with $4.7 million for the same period last year. Other expense for the quarter ended June 30th, 2026 was $1.5 million compared with $500,000 for the same period last year.

Net loss attributable to common stockholders of Beyond Air for the quarter ended June 30th, 2026 was 7.9 million or a loss of $11 per basic and diluted share compared with a net loss of 7.7 million or $30. than 67 cents per share for the same period last year. As of June 30th, 2026, we reported cash, cash equivalents, restricted cash and marketable securities of 15.2 million. Please note, this cash total does not include our recent financing. As Bob previously mentioned, we recently announced a financing for up to $30 million, which provided $10 million in upfront gross proceeds and the potential for up to an additional $20 million upon the exercise of short and long-term warrants. This financing provides us with the financial flexibility to execute the planned commercial launch of our second generation lung fit pH in the U.S. pending FDA approval as well as the international commercial expansion subject to applicable regulatory approvals. On our last quarterly call, we announced the change in our fiscal year end from March 31st to December 31st. While we are referring to calendar year goals, you may notice our SEC filing will still be on our March 31st fiscal year end.

We will move to calendar year reporting with the SEC subsequent to our December 31st, 2026 filing. Thank you.

With that, we will now open the call for questions. Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions.

Our first question comes from Michael King with Rodman and Renshaw. Please proceed with your question.

Hi everyone, this is Jillian Weiss on the line for Michael Kang from Rodman and Rensselaer. So you mentioned the financing will support the Gen 2 Lung Fit PH bond. and commercial bulls out, can you give us a little more detail on what the capital will actually be used for and where you expect to see the biggest investment over the next several quarters? Thank you.

Sure, I can take that. It really is a lot for operations. So what we have going right now is we have the pilots, which are being built on the Gen 2 device, in the near term and then upon FDA clearance, we'd be building a lot more devices and gaining commercial steam for 2027 and beyond. So it's really an operations function, but a lot of it is on the device. And then we are obviously in a cash burn position right now, so it will absorb some of that burn during that period as well. Okay.

Okay, great. And are things starting to pick up on the contracting side and do you think hospitals may be more willing to spend remaining budgets heading into year end?.

Yes, we've noticed a lot of pickup with contracting. Actually, our commercial functions really picked up a lot of that pace with a number of different new opportunities in front of us. Pipelines actually doubled over the last five or six months. So as you know, long sales cycle there, yet a lot of this has picked up. So, yes. Okay.

Okay, great. Thanks for taking my questions and congrats on the quarter.

Thank you. Our next question comes from Yael Jen with Laidlaw & Co. Please proceed with your question.

Good morning, and thanks for taking the questions. My first question is that any update or in terms of the supplement PMA applications, what I meant is that any interaction with the FDA and any other resources?.

related stuff. Didn't I have a follow-up? Yes, let me take that one, Dan. So yes, we've had a lot of activity and a lot of progress with the PMA supplement. So we've begun to submit paperwork to the FDA. They're already reviewing the paperwork, as Dan touched on. We're doing a couple of things with our contract manufacturer, finishing up our engineering build and our pilot builds of all the different products that will be validated by the FDA. So that's all part of this slew of paperwork that goes to them, and it all kind of lands on... on the performance qualification. It'll be a desk audit that the FDA will eventually be doing with us.

So all the different paperwork that's needed to go to them is getting to them on time. We're getting really good communication back and forth. I think I had mentioned on the last call, but this is a really good team over at the FDA very communicative, they get back to us within minutes or hours, sometimes days if it would typically take weeks, but they're really quick. And we're really positive on the way the process has been going.

So at this point, would that still be things to be submitted or basically everything is pretty much done except waiting for their decisions?.

Now, it's less of the decision piece and more of setting up. The next phase that we're in, and we're in this now, is that it's the audit phase. As they're reviewing the paperwork, they'll decide when the audits take place. There's a few different audits. we're already ready for a couple of those. And once our final pilot builds are done, which are happening now, we're doing that, then that part of the process will be dropped into their audit queue and their teams will come in and do their audits with us. But yes, we're where we should be and they've received pretty much everything they need to receive. There's always a little back and forth, but not a back and forth.

It's setting us back. It's more of a, hey, you know, you you know, can you furnish us this? Oh, yes, that was in, you know, document A. So, yes, everything's where it should be. Okay.

Okay, maybe just follow up on that, which is that given we are already in the midst of the third quarter right now, so should we really expect the potential decision likely be in the fourth quarter?.

Yes, you know, I mean, what we're trying not to do is pinpoint an exact date, and only Yale. The only reason for that, as you know, is it's not like with pharmaceuticals where you have a PDUFA date. Right. it's a medical device, we have to give a range. And yes, to your point, yes, we're now a month into Q3, so likely that would be a Q4 period. We're still in H2, and yes, if you were to, you know, you know, want to try to figure out whether it be in Q3 or Q4, you know, So that's up to the FDA and how they're processing everything. So I guess let me step back and just say it's still going to be in H2, but we're only a month and a half away from Q4.

OK, great. Maybe the last question, which is slightly different from the earlier one, which is that, Given that the guidance you have 8 to 10 million revenues for this year, the calendar 26, so a majority of them will come from the second half, which is starting this quarter. and just curious what are the confidence at this point to say support you feel that the second half will be ever greater revenue growth versus the first half?.

Thanks for taking the question. Yes, so a couple of pieces on that, and Dan can definitely weigh in as well. But no, not in 8 to 10. The guidance was $8 million for this year. And so we're looking – yes, yes. So, I mean, really it's, you know, if we could roll in about 3.7 in H1, that means around 4.3. in H2, and we're very confident that we'll be hitting that number and the reason being is the pipeline that I referred to earlier. We've already started to see winds come in the quarter we're in right now, which will have some impact on the H2 numbers. And then in addition to that, our international is starting to pick up a little bit, which is good. that's immediate revenue recognition, as you know, because those are all being purchased and then under our subscription model where if you grab a million dollars of business, it's not spread out over 12 months, and if we close that deal in November, you're really only getting a couple of hundred thousand dollars, you get the whole million dollars, right? So we have a lot of tenders that we have our hands firmly around.

We have already won a number of opportunities within this quarter that we know will be, you know, you know, seeing that bump up as well. So, yes, so we're reaffirming certainly the 8 million and we're also firmly standing behind our 2027 guidance.

So, yes, I hope that answers that. Okay, great. That's very helpful. I appreciate it. And best of luck going forward. And thanks.

Yes, great. Thanks, Yael. We have reached the end of our question and answer session. I would now like to turn the floor back over to Robert Goodman for closing comments.

I just want to thank everybody for joining the call this morning and for all your support. And we look forward to continuing to bring you more information. provide feedback and updates and look forward to our next call together. Have a great day.

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

This live transcript is auto-generated without human intervention or review.

[Call has ended.]

Good morning, everyone, and welcome to the Beyond Air Financial Results Call for Fiscal Year Ended March 31, 2026. [Operator Instructions] And now I'd like to turn the call over to Garth Russell with LifeSci Advisors.

Thank you, Operator. Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release announcing the operational highlights and financial results for Beyond Air's fiscal year ended March 31, 2026. 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 the 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 identifies 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 26, 2026. 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 now turn the call over to Robert Goodman, Chief Executive Officer of Beyond Air. Bob, the floor is yours.

Thanks, Garth, and good morning to everyone. Also here with me today is Dan Moorhead, our Chief Financial Officer. This is my first earnings call as Chief Executive Officer, and I'm excited to lead Beyond Air during what I believe is a pivotal moment for the company. Over the last several months, I've spent a lot of time with our customers, commercial organization, distribution partners, and board, and those discussions have only strengthened my conviction that LungFit PH represents a significant commercial opportunity to establish Beyond Air as a leader in the nitric oxide market.

As a leadership team, we've become increasingly focused on aligning our commercial strategy, R&D efforts, and operating expenses across our core business. Particularly as we move closer to regulatory approval of our second generation LungFit system. The strategic focus is reflected in what we believe is an important inflection point for the business in the near term. With our Gen 2 system, if approved, we expect to be more competitive and offer a more attractive solution for a broader range of hospital systems with external transport needs. As a result, we see the potential to immediately expand our total addressable market to over $1 billion globally.

Accordingly, our strategy is very straightforward. We are allocating our resources with discipline towards the opportunities we believe can create the greatest near and long-term value, including adoption of our current Commercial LungFit system and preparing for the launch of our Gen 2 system. Fiscal 2026 displayed meaningful progress toward this goal. Revenue increased more than 107% year-over-year to $7.7 million in the currently smaller addressable market, driven by strong retention among our existing customer base and continued new hospital adoption. Importantly, our customer renewal rate was approximately 90%, which reflects the value LungFit PH is delivering in clinical practice and the confidence our customers have in our technology and operational service support.

This high level of customer satisfaction should be directly transferable to the Gen 2 device, and we continue to receive consistent feedback from our potential future customers that they're waiting for our next generation platform to help meet all of their comprehensive INO requirements, including their transport needs. As a reminder, the current label for the LungFit PH does not include transport use outside of the hospital.

If approved, the Gen 2 product is intended to address the limitations through a broader label that would include transport use. We believe this will increase the total U.S. addressable market approximately fourfold to approximately $400 million and expand the worldwide opportunity to more than $1 billion. We've made meaningful progress expanding our commercial reach. We recently announced a national purchasing agreement with one of the top 3 U.S. group purchasing organizations for inhaled nitric oxide therapy. This marks the third major GPO to engage Beyond Air and represents another important milestone in expanding access to LungFit PH across the U.S. Combined with our existing agreements with Premier and Vizient, we now have access to a substantial portion of the U.S. market. We believe these relationships provide an important foundation for continued adoption and growth in the years ahead.

Additionally, we continued to broaden our global distribution network throughout the year and we now have regulatory clearance in over 45 countries. While we remain in the early stages of international commercialization, we believe the growing network provides a significant opportunity for future revenue. As it relates to our Gen 2 LungFit PH system, which is under review at the FDA, we believe this to be the most important near-term catalyst for the company. As many of you know, we submitted our PMA supplement to the FDA in June of 2025 and continue to work through the review process at the expected pace. Based on our interactions with the FDA and the progress of the review process to date, we continue to believe we are on track for potential approval in the second half of the calendar year, although the timing and outcome of the review remains subject to the FDA's discretion.

Accordingly, we continue to prepare for a potential commercial launch by the end of the year 2026. We continue to hear from prospective customers that the anticipated features of the Gen 2 platform, including a smaller footprint, reduced weight, simplified operation, longer service intervals, and ground and air transport availability, may address needs that are not fully met by currently available alternatives.

As a result, we believe the Gen 2 platform could represent an attractive option for certain institutions if approved. In terms of the other programs outside of our core LungFit PH business, we're taking a disciplined and focused approach to capital allocation. Our priority is clear. The Beyond Air team and its resources are focused on the success and growth of the commercial activities around the LungFit PH system, and we will continue to allocate our resources almost exclusively to the LungFit PH system. I believe we're currently operating with a greater focus, stronger commercial momentum, and a clearer path forward. We have expanded market access through leading GPO relationships, strengthened our international footprint, and continue to prepare what will be a transformational Gen 2 launch, if approved.

We believe the strategy I've discussed today establishes a clear road map for continued growth. With fiscal '26 complete, we're transitioning from a March 31 to December 31 year-end and begin operating on a calendar year end. As a result, we're providing revenue guidance for the first time for calendar year 2026 of $8 million. That equates to approximately 15% growth over calendar year 2025. Our first-time guidance for calendar year 2027 is $16 million to $18 million, which would represent over 110% year-over-year growth at the midpoint of that range and assumes FDA approval and commercial launch of the Gen 2 system during 2027 in accordance with our current planning assumptions.

Between expanding market access, growing customer adoption, international expansion, and anticipated launch of Gen 2, we believe the company is entering an important new phase of commercial execution and an imminent inflection point for revenue growth. Before I conclude my prepared remarks, I want to recognize the entire Beyond Air team. Over the past several months, I've had the opportunity to work closely with employees across the organization and have seen firsthand the dedication, expertise, and commitment they bring to the mission. With that, I'll turn the call over to Dan for review of the financial results. Dan?

Thanks, Bob. And good morning, everyone. I'll walk through our full-year financial results for the fiscal year 2026, which ended March 31, 2026. Revenues for the fiscal year ended March 31, 2026 increased 107% to $7.7 million compared with $3.7 million for fiscal year 2025. This growth was driven by increased demand for LungFit PH in both U.S. and international markets. Gross profit for fiscal year 2026 improved $300,000 compared with the loss of $1.7 million in the prior year. This represents a $2 million swing to profitability, which is a meaningful milestone for the company and reflects the operating leverage we are beginning to see as revenue scales.

Turning to operating expenses, R&D expenses for fiscal year 2026 decreased 39% to $10.2 million, compared with $16.9 million for fiscal year 2025. The reduction was primarily driven by decreased employee expenses as a result of prior restructuring activities and lower development costs associated with our Gen 2 device and PMA supplement, which was submitted to the FDA in June 2025. SG&A expenses for fiscal year 2026 were $19.1 million, compared with $26 million for fiscal year 2025, a decrease of 27% or approximately $7 million. The reduction was primarily driven by lower employee-related costs as a result of prior restructuring initiatives.

In total, we reduced our cost structure significantly year-over-year, which in combination with revenue growth drove a 35% or $15.5 million improvement in operating results. Other expense for fiscal year 2026 was $5.3 million, compared with $3.9 million for fiscal year 2025. Net loss attributable to common stockholders of Beyond Air for fiscal year 2026 was $33.2 million, or a loss of $4.01 per basic and diluted share, compared with $46.6 million or $13.77 per share for fiscal year 2025. Net cash burn excluding inflows from financing activities for fiscal year 2026 was $19.1 million, down 56% compared to fiscal year 2025.

As of March 31, 2026, we reported cash, cash equivalents, restricted cash, and marketable securities of $17.3 million. Total long-term debt outstanding was $21.6 million. With that, I'll hand the call back to Bob.

Thanks, Dan. Before we open the call for questions, I want to briefly address our Nasdaq listing. Earlier this month, we announced that the Nasdaq Hearings Panel granted our request to continue listing on the Nasdaq stock market, subject to our regaining compliance with Nasdaq's minimum bid price requirement by July 31, 2026. Following stockholder approval at the special meeting held on June 18, our board approved a 1 for 20 reverse split. As a result, we expect the reverse split positions the company to regain compliance with the bid requirement by July 31 deadline. With that, we now open the call for questions.

[Operator Instructions] Our first question comes from the line of I-Eh Jen with Laidlaw & Company.

Good morning, and thanks for taking the questions. I got 2 here. The first one is in terms of the second-gen supplement PMA application at this point. I know it's on track. Any colors in terms of what level of question has been asked and the responses you already have? And then I have a follow-up.

Yes, sure. Sure. Hello there. Yes. So with the second generation supplement whereas you mentioned, and as we mentioned already, we're completely on track. We've done all types of testing around our software and we did our ventilator testing and cybersecurity EMC testing, bootloader testing, altitude testing. We're doing all this as asked by the FDA as part of this supplement. The supplement, as you know, was put in a year ago, and we're expecting to have our scientific letter, all the I's dotted and T's crossed, momentarily actually we're right finishing that up and then from there the next step is really us getting into additional communication with the FDA. Along the way, they've been incredibly communicative with us. They've gotten back to us really quickly.

They're a great team. So all this information has been kind of passed back and forth, which is helping us know where we stand in the process, and we're looking forward to doing our audits in the upcoming couple of months or so and taking things from there. So, yes, we're really excited about the progress.

Okay, great. One more follow-up here is this. In terms of the $8 million guidance for 2026, would that first include the $1.9 million top line of -- calendar for the first quarter of this year. And if so, would that be the case? And then also, would you call that still fiscal 2026 or something else?

I think I can take that, Bob. It is a little confusing, I agree. But, yes, when we're talking the $8 million for calendar 2026, that would include the $1.9 million we just reported, plus calendar quarters ended 6/30, 9/30, and 12/31. So the $8 million is a pure calendar year end 2026 including the quarter we just reported.

No, no, please, please. Go ahead.

No, so you called the $8 million is also fiscal '26, is that right?

It's not. Again, it's just the 4 calendar quarters within 2026. So the $1.9 million that we just reported for the January through March period plus the 3 remaining quarters in calendar '26. So, again, the $8 million is moderate growth as the Gen 2 launch isn't supposed to happen until late in the year. So we're not counting any Gen 2 revenue in calendar 2026. We expect to see the majority of that coming in beginning in calendar '27.

So the calendar year is aligned or identical to the fiscal year that I guess from that, would that be correct? In other words, if we put into the model, we are just that, or change that, that will be, for example, this quarter, the reported quarter will become also fiscal 1Q '26 quarters, would that be fair?

The quarter we just reported at $1.9 million in revenue would be Q1 '26 calendar. Yes.

[Operator Instructions] Our next question comes from the line of Mike King with Rodman & Renshaw.

A couple of things. In terms of the guidance, first of all, thank you for giving us '27 guidance. But maybe some points on that I'd like to ask about. Number one is what proportion do you think second-gen might be? Second question is in terms of these group purchasing orders, how critical is that to executing against that guidance as opposed to conquering sort of individual accounts. And I'll just stop there and let you answer those.

I can take the first part. I would -- sorry, Bob.

No, no. I was going to suggest that, please.

So if you're talking about 2027 revenue, again, if I was looking at the U.S. portion, because Gen 2 wouldn't be sold internationally to begin with, but if we're talking international, or domestic, sorry, it ends up being about half or maybe a little more than half. We have a lot of business, as Bob mentioned, it's pretty sticky. And so we have good renewal rates. And so we'll have a lot of contracts carrying over year to year. So the Gen 2 stuff that starts coming in '27 makes up around half of the U.S. revenue for 2027.

Okay, great. And then just with regard to sort of a conquest that you need to win in order to make those numbers?

It varies. Again, we're moving from a smaller TAM, so right now, without the transportability, we're dealing with much smaller hospitals and average deal size is on the smaller end. And so we expect that deal size to increase right now. We don't really give out the number of hospitals exactly, but it's going to be less than what we have now, right? So if we're doubling revenue in the U.S., it's going to be probably 50% to 70% more accounts rather than having to double the number of accounts.

Okay, all right, that's helpful. Does the Gen 2, even though despite its smaller footprint, does it have the same capacity as the current generation LungFit?

The capacity difference is, there's a couple of differences here with the 2 products. The Gen 2 was the major differentiator. Outside of both of them, providing unlimited nitric oxide from room air. They both are the fastest as far as speed to treatment. So these products compared to our competitors, you can start them up, you can stop them, you can start them again. And that's very important at the bedside, being able to manage patients and moving them around that way. The major difference between the 2 products once the Gen 2 is approved, as mentioned, not approved now, is that it'll be fully designed for transport. So it'll have the air and ground capability opening up that larger total addressable market. That's the first major one.

That was the part of the market that was being missed and why the addressable market is smaller now. The other major difference is the change and the predictability with how long our duration is between our starts for a device that goes into the field. When we put a device into the field, we don't have to bring it back in for any kind of maintenance. It's like 4 times longer. So that's something that will be a major difference for the cost of goods as well as the customers as far as managing the product so it's really a big difference so much easier to use. It's -- we don't have the storage issues compared to the competitors and it will have that transport capability. So excited about those pieces.

Yes, and if I may, Mike, you did have that one question. It wasn't fully, I didn't get to answer around the GPOs and the criticality of that. Yes, it's going to make a big difference for us. There are some -- in fact, the most recent GPO that we signed, the 1st of April, is up and running with already doing evaluations with us. So part of our contracting, we wanted to make sure that we were able to get in front of some of the flagship hospital systems immediately so we could start doing evaluations. So we start getting product in the hospitals and we can knock the incumbents out. So this is happening now [ lifetime ]. So yes, there's going to be some accounts that are going to be coming on board based off of that.

Bob, do you have a number of the GPOs out there that you think are potential customers and what proportion now that you've penetrated?

Yes, well, so I mean, listen, there's 3 major GPOs in the U.S. that cover roughly around 7,000 hospitals and there's all the different integrated delivery networks that are underneath them. Within those IDNs, those are anywhere from, call it 20 hospitals to 200 hospitals, okay? And with the most recent GPO that we signed up, there's almost a couple of thousand hospitals there. And one of the evaluations that we're working with is responsible for a couple hundred hospitals. Of course, the pilots and the evals that we're doing are with regions within those. So they're groups of 10 and 17 and 22 hospitals within the IDNs. And it just kind of spiderwebs out from there. So we're appropriately approaching the evaluation process with them at the appropriate pace. So it's going great.

Thank you. At this time, we're showing no further questions in the queue, and this concludes our question and answer session. I'd now like to turn the call back over to Robert Goodman for any closing remarks.

We appreciate everybody coming on the call today, and we look forward to providing future guidance and delivering for our shareholders. So everybody have a nice day. Thank you.

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

Good morning, and welcome, everyone, to Beyond Air Financial Results Call for the Fiscal Quarter Ended December 31, 2025.

[Operator Instructions]

And now I'd like to turn the call over to Corey Davis of LifeSci Advisors. Please go ahead.

Thank you, operator. Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release announcing the operational highlights and financial results for Beyond Air's third quarter of fiscal 2026 ended December 31, 2025. A copy of this press release can be found on our website, beyondair.net, under the News & 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 beyondairnet. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 13, 2026. And 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, Chief Executive Officer of Beyond Air. Steve, go ahead.

Thanks, Cory, and good morning to everyone. With me here today is Dan Moorhead, our new Chief Financial Officer. It has been a pleasure working with Dan over the past several months. He brings a proven track record as a proactive CFO with demonstrated success supporting commercial organizations through periods of rapid growth. I also look forward to his active engagement with the investment community as it becomes fully integrated into the role. Also joining us today is Bob Liberman, our Chief Commercial Officer. Bob assumed the role in October after previously joining Beyond Air as a Board member back in June.

Let me start my prepared remarks by saying just how pleased I am to speak with you today and provide an update on what has been a productive and meaningful period for our company. We have achieved several significant milestones, strengthened our balance sheet to support continued commercial execution and made a strategic decision to sell our NeuroNOS subsidiary in exchange for equity in the acquiring company and up to $32.5 million of upfront development and commercial milestone payments. We believe these recent events have strengthened our ability to execute our commercial strategy and create long-term value for our shareholders.

Let me walk you through these updates in greater detail. Starting with our core business. Revenue in the fiscal quarter increased 105% year-over-year to $2.2 million. This represents continued progress as we scale adoption and expand awareness of LungFit PH in clinical settings. We now support more than 45 hospitals across the United States and internationally that have adopted our first-generation LungFit PH system. Our through feedback has been encouraging, with retention exceeding 90% and more than half of customers under multiyear agreements.

We believe this installed base positions us well to support continued revenue growth from our first generation system while preparing for the anticipated FDA decision for our second generation system. Our commercial team continues to refine its targeting strategy, prioritizing hospitals most likely to adopt a lung for PH today and expand usage following approval of the second-generation system, which we expect to receive before the end of calendar 2026, subject to regulatory review and clearance. We are making steady progress building relationships with clinicians, administrators and health care systems.

Our current objective is to continue to expand Gen 1 system utilization through calendar 2026 in the U.S. and internationally, while preparing for the potential launch of our second generation is approved. As previously discussed, Gen 2 system is designed to offer reduced size and weight, simplified operation, extended service intervals, improve backup system functionality and very importantly, compatibility with both air and ground transplant. We believe these enhancements will expand the addressable market relative to Gen 1 and support broader adoption over time.

At this point, I'm going to pass the call over to Bob Goodman who has made excellent progress since taking the reins as Chief Commercial Officer about 4 months ago. Bob?

Thanks, Steve. And let me begin by saying I share Steve's enthusiasm about the opportunities here for Beyond Air as well believe that 15 pH is the best-in-class nitric oxide solution globally. Feedback from U.S. customers and international partners on system performance and customer support have been extremely positive, providing a solid foundation for continuous growth. We have national group purchasing organization agreements with Premier and Vizient, which together provide access to nearly 3,000 hospitals across the United States. As awareness of LungFit PH increases, we expect additional opportunities at the GPO and integrated delivery network level in 2026.

As previously announced, we have been working with TriliMed to support our engagements with the federal health care systems. I'm pleased to announce that together with this valued partner, we completed the first sale of Onfi PH to a VA Medical Center. This initial commercial sale, the VA hospital system establishes an important foothold opening potential pathways for future orders and broader adoption across the system, it provides access to the largest health care network in the United States. Internationally, we continue to see strong engagement from our distribution partners.

Over the past several months, we've expanded our global LungFit PH distribution network with new agreements in Canada, Germany, Brazil, Austria, the Netherlands and Sri Lanka, bringing total international coverage to 40 countries. As we broaden our global footprint, we are laying the groundwork for long-term growth and positioning Beyond Air to serve a significantly larger addressable market. It is important to note that we are live in a few hospitals with 1 pH and have already begun to see repeat orders for accessories from several countries.

Taken together, these commercial, operational and strategic developments give me confidence in the trajectory of the business. What also gives me confidence of the people at Beyond Air, the dedication of this team is second to none that I've been in this business for decades. This includes all the aspects of the team from clinical support, the marketing to customer service, to engineering to finance to regulatory to quality, et cetera. Our people are fully engaged and dedicated to the vision of improving the lives of patients and medical staff with lung at PH.

I also want to emphasize the advantages that Steve mentioned earlier on our second-generation system. From my time spent with customers and potential customers in the United States, I believe the Gen 2 system addresses everything on the wish list from clinicians and hospitals. I'm extremely confident that I, along with the team here, will execute on our vision of becoming the global nitric oxide leader.

Now I'll turn things back over to Steve.

Thanks, Bob. Turning to Beyond Cancer. We recently announced that our abstract was selected for the 2026 AACR Annual Meeting, which is taking place from April 17 to 22 in San Diego, California. As previously announced, the study enrolled 10 subjects at doses of 25,000 and 50,000 parts per million of nitric oxide gas delivered over 5 minutes intratumorally. These patients all had metastatic disease and were heavily pretreated. All subjects had a life expectancy of less than 12 months. We have already reported that the safety profile observed to date is acceptable. The data presented at AACR will include updated overall survival data for which median survival has not yet been reached as of October 1, 2025.

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, our neurology-focused subsidiary, on January 13, 2026, XTL Biopharmaceuticals announced a binding letter of intent to acquire neuromas in exchange for Beyond Air's approximately 85% ownership interest Consideration includes a 19.9% stake in XTL, $1 million in cash and milestone-based contingent payments totaling up to $31.5 million. Following closing, neurons is expected to serve as XL's flagship platform for autism and our oncology development.

We believe this agreement provides the potential to create meaningful value for our shareholders by enabling NeuroNOS' pipeline to advance with dedicated focus and funding through XTL Bio. We will not provide additional commentary beyond public disclosures, while the transaction remains pending.

To conclude, the $5 million financing completed in January 2026, together with the previously announced promissory note and equity line of credit for up to $32 million with Streeterville Capital that we announced in November 2025, provide resources to support commercial execution and readiness for the second-generation lunged system. We remain focused on disciplined execution in delivering advanced nitrogoxide solutions to clinicians and patients around the world.

Now I will turn it over to our CFO, Dan Moorhead.

Thanks, Steve, and good morning, everyone. I'm excited to join my first call since being appointed CFO about 7 weeks ago. I still have a lot to learn but I'm incredibly impressed by what the team has achieved not just over the past year but even within the past few months. The progress has been extraordinary, and I see a bright future ahead as the team continues to execute on our growth strategy.

Our financial results for the third quarter of fiscal year 2026, which ended December 31, 2025, are as follows: Revenue for the fiscal quarter ended December 31, 2025, increased 105% to $2.2 million compared with $1.1 million for the fiscal quarter ended December 31, 2024. On a sequential basis, this represents a 21% increase compared with last quarter. Gross profit increased to $300,000 for fiscal third quarter 2026 compared to a gross loss of $200,000 for the same period last year and a gross loss of $300,000 in the prior quarter.

Turning to operating expenses. We continue to see reductions across SG&A, R&D and in our supply chain as a result of cost reduction initiatives taken in the past 12 months as well as the decrease in R&D costs related to our Gen 2 device, which are mostly behind us since the PMA was filed with the FDA. Total operating expenses for the fiscal third quarter of 2026 will reduce to approximately $6.9 million, which is down from $10.7 million for the same period last year.This translates to a 36% reduction year-over-year and a greater than 60% reduction from the high of $17 million at its peak.

Research and development expenses were $2.4 million for fiscal third quarter of 2026 as compared to $3 million for the same period last year. As I mentioned earlier, the year-over-year decrease was primarily driven by lower development costs associated with our Gen 2 device with the remaining reduction attributable to a decrease in head count and related costs.

SG&A expenses for the quarter ended December 31, 2025, and December 31, 2024, were $4.5 million and $7.7 million, respectively, a decrease of 42% year-over-year. Almost all of the decrease of $3.3 million was from a reduction in employee-related costs. Other expense was $1 million compared to $2.4 million for the same period a year ago. The decrease in expense of $1.5 million was primarily attributed to the prior period loss associated with the extinguishment of debt of $1.9 million.

Net loss attributed to common stockholders of Beyond Air was $7.3 million or a loss of $0.85 and per share basic and diluted compared with $13 million or a loss of $2.96 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 $4.3 million, which is a reduction of over 40% 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 2. As of December 31, 2025, we reported cash, cash equivalents restricted cash and marketable securities of $17.8 million. Subsequent to the end of the third quarter, we completed a $4.5 million equity financing net of issuance costs, and we believe this capital provides us with a cash runway in the calendar year 2027 and potential to profitability provided we continue to hit our current revenue estimates and continue to control costs.

With that, I'll hand the call back to you.

Operator, we'll take questions now.

[Operator Instructions] The first question comes from the line of I-Eh Jen with Rodman & Renshaw.

I have a couple of questions, if you don't mind. I just wonder if you could talk a little bit more about the sales process. I think it's great breakthrough that you've got sales into the VA system or VI Hospital, I should say. But it brings up the topic of the VA system, as you mentioned. How do you penetrate systems rather than a single hospital at a time. What needs to happen in terms of the sales process or the RFPs or things like that, that can see us knocking off more than 1 health care facility at a time.

For the question.

Yes, go ahead, Bob. We take this one. Yes, sure. And then you can definitely provide any color if you like, Steve. Thank you Yes. So Mike, with the VA system, we're on, as you know, and our product is being offered through the ECAT system. So that catalog actually makes it an easier approach for our customers to get to us directly. It's outside of an RFP process but we're still able yes, we're still able to actually compete with other RFPs that come out through -- there's a couple of different ways of the VA contract with vendors. So yes, so we have access that way, so it's great.

Okay. And in your formal comments, you mentioned words to the effect that you're identifying facilities most likely to acquire the system. How do you -- how do you -- or can you say how you identify them? And maybe help us understand how you're targeting those facilities.

Yes. So -- so we've done a really good job standing up our commercial organization, both in the U.S. and internationally. And right now, what we're doing is we're focusing and not to say an overhaul, but more of an exactness with our people and our process and our technology. So different prospecting tools with good intelligence and good CRM regular follow-up with the customers and taking the process of real good demand generation where we're getting top of the funnel looks at our customers and having really good pipeline discipline so we could get in front of the right customers and then to have our people, the people part of it in the right places at the right time with the right coverage.

So we have that right reach and frequency getting in front of these customers and just getting in front of more and more. So we have that touch. So yes, we've been really refining that and the customers are really responding well for our ability to get in front of them.

That's great. Has there been any appreciable change in the length of the sales cycle?

Yes. I mean that pretty much might still remain the same. At the real front end, if you get kind of real lucky based off of the timing of a contract that might be expiring and that customer is really, really organized, and you can knock out a real quick demo in the valuation. You could do that in that 4- or 5-month time frame. But it's really in that right around 6 to 9 months, and it could be longer. But what we're doing is a good job identifying the customers and again, reaching out to them and finding out where they're at with their contract and making sure that they see the value of our product. And with that, we're hoping that, that might restrict is just a bit. But we're really organized and our clinical teams are out there in the field with our sales teams to make sure that we're in front of them as early as possible.

Okay. And I pause 1 more quick one. How do you segment or can you segment the next-gen system so that is this typical of a lot of businesses where a next-generation chip, let's say, is coming out or something in the sales cycle kind of contorta effect where the purchaser may hold off until the nextgen system is available. Is that a concern? Or are you segmenting a different market with the new system?

Yes. So we're focusing right now, as you'd expect, on our first-generation product, and it's been really well received the version 24 of the of Gen 1. So -- and we're focusing on the nontransport systems, okay, and we're being really well received there as there's natural conversations within the market, transportation systems, that's a later on Gen 2 conversation, and we're really kind of breaking away from those conversations but being aware that these are systems that are going to want to be working with us in the future.

The next question is from the line of Marie Teva with BTIG. welcome Bob and Dan. I wanted to quickly just check in on anything, any communications you've been having with the FDA on the Gen 2 process. to speak to your confidence in the time line, I think you said by end of calendar year. And then what will be needed to do post clearance in terms of building inventory kind of a time line we might think about before you can go into a formal launch and ramp.

Okay. Thanks, Marie. Well, I'll comment on the FDA side. So we've been having a fairly constant communication with FDA and we're very happy with the interaction. We don't really see any major hurdles everything that FDA has asked for will provide them. It shouldn't be a problem. And I'm sure there'll be -- the process will continue with the FDA, and we'll continue to answer the questions as we go forward. We still are waiting on the work to be completed with our contract manufacturers, so we can be inspected and that's essentially in our minds, what the gating factor will be from a timing perspective. So we feel highly confident in the time lines that we provided given the state of affairs today. I don't know if I can gave you the answer you need that there's other things you want to ask.

Yes. Yes, that's great to hear.And then I guess I'll ask a quick follow-up here on the international side, I know you've got some great partnerships and some efforts going on there. So any wins or any catalyst to think about on the international side?

Sure. Bob, do you want to take the international question.

Yes, sure. So we have had some recent wins, which is great. I think, as you know, from the the past calls, it was all about setting up and getting our distributors armed with our demo devices, so they get in front of the systems, but then there's the whole part of the process with whether it's Europe or Middle East or Australia, where it's mostly tenders compared to the U.K. or Portugal where there's a national frame or you get that hunting license like Germany and APAC, where you can go direct. So with all those different regions, yes, we've had wins. And on top of having wins, we're now actually seeing customers reorder filter.

So the product is being deployed into hospitals now, which is great, and we're starting to, again, get that stickiness. So it's fantastic.

Our next question is from the line of Justin Walsh with Jones Trading.

Wondering if you can provide any color on what attracted XTL biopharmaceuticals to be interested in the neuro nose opportunity. And then how, I guess, collaboration or working with them will look going forward, given that you still have a stake in that company?

Thanks for the question. So yes, Justin, look, XL was a company looking for an asset, and there were multiple choices for that. I think what excited them about this opportunity is the science. I mean, there's been 2 papers, landmark papers published about the work done by Dr. Amal who's the scientists and the innovator behind this, this approach to treating autism as well as gliolesoma want people to recognize that the functions of metric oxide in the brain or numerous. So I think that's what attracted them to this. There's a clear path to human studies.

I think a lot of the work that's been done by the [indiscernible] has given that clarity to anybody who's taken a look under the hood. So I think it's just a matter of providing the what they require, which is pretty straightforward. It's just a matter of getting that work done. So with XTL coming up with funding, and I'll be able to bring this into humans. So I think the attractiveness was great science, clear path to human trials.

And as everyone on this call probably knows, translating efficacy from rodents to humans is something that's difficult to predict, but we'll find out. And I think that's what attracted and we're going to get there and do that study and figure out if the efficacy translates. And if it does, we're looking at a potential treatment for for autism and glioblastoma at this point. So it's very exciting. Just a little bit early for Beyond Air to maintain and and funds. So this is why a transaction was done, and we're very happy that a lot of this transaction for Beyond Air is us getting a 20% stake in the new entity that's the confidence we have that this is going to be in human trials. And we have confidence on the safety side for sure. And the efficacy side, we'll see what happens.

Next question is from the line of Jason Kolbert with David Boral Capital.

Can we talk a little bit about COGS and how COGS performed in the quarter? And over the next couple of years, what do you think is sustainable COGS is?

Dan, do you want to take that one?

Sure. We tend to see GEN 1. Gain, we think we're in a -- and Steve can help me on this. I'm still pretty new on it. But we expect COGS long term as we get to scale in the 60% range and moving up towards 70% with the Gen 2 product. But in the near term, again, with revenue levels growing, but growing at a more moderate pace until we hit the Gen 2 launch. Again, I think you're going to see it pretty close to that what you saw in Q3 and continue to grow from there. But long term, I think that gives you a little profile. And I'm guessing you guys have possibly talked about that in the past as well.

And just a follow-p if u don't mind. Yes, I think Dan is right in what he says, but I would -- there are a couple of factors and like Dan said, barely 2 months in, there are a couple of factors that we're still trying to figure out with respect to the margin and that will be from a pricing side of the market. So I think that goal of 70% with the Gen 2 is a great goal, that's target. If it's 65 to 65. That's not the end of the world for us. But I think that's our target. And I think we'd like to hit it. And target with Gen 1 would be to get close to 60%. But again, I think an 1 is more of a 50 type thing. But again, it's going to depend on how the price shakes out in the market at the end of the day. And that remains to be seen.

You had a follow-up, Jason?

Very helpful. Can you talk also about SG&A and how sensitive the sales cycle would be to increasing SG&A, hiring additional salespeople how does that impact kind of revenues? What I'm trying to do is get a handle on more capital deployed in SG&A. Does that translate into more revenues?

Well, Jason, I mean [indiscernible]. .

The next question is from the line of Yale Chen with Ladlaw.

Just in the press release, you mentioned that for the Gen 2, that has the potential of extending the service intervals. Could you elaborate a little bit more on that specific aspect.

Your live for a question. Please go ahead.

Please stand by, ladies and gentlemen, we're experiencing tectorial, please our conference resume momentarily.

[Technical Difficulty]

Ladies and gentlemen, on our call will resume momentarily.

Steve, you're now reconnected.

Sure. Steve, I believe in the press release, you mentioned that the second gen will have the potential of extending the maker longer service intervals. Could you elaborate a little bit more specifically on this particular aspect. And then I have a follow-up.

Yes, I appreciate that question. So the current system, the first generation system every 1,000 hours, we need to bring it in for service. So that can be -- that can -- it could be a slight disruption for the hospital if they're using a couple of thousand hours a year per machine, so we might be in there every 6 months rotating machines. So it's a smooth process but it's an expensive process for us, right? So we just come in drop them a new machine and pick that 1 up and bring it in for service.

So it's not very frequent but it's something we'd like to improve upon. So with the second-generation machine, we think that service interval will be pushed out to at least 3,000 hours before we need and potentially longer. So testing is still going on. We haven't reached that juncture yet where the reliability testing that we're doing has stopped. So it's still ongoing. So we're past the 3,000-hour mark at this point, which means it's at least 3x longer before we have to go in. So if we were going in every -- at a hospital, let's say we're going in every 10 months, now we're going in every 30 months on average.

Before we have to swipe out the machine. So that's -- it's certainly better for the hospital from that standpoint, although I don't think the swap outs are really a problem for them because our team does a great job and it runs so smooth. But from a gross margin perspective, I think that's the impact that you heard about earlier on a question when Dan and I were responding to the gross margins between Gen 1 and Gen 2.

Okay. Great. And maybe just a touch on that to this 1 a little bit, which is that would this be needed -- you mentioned you're still testing for maybe even longer integral for the service needed? Would that be required before you submit for the general review? Or that's something that could be the general review without having this particular aspect.

No. This is -- so there is a reliability hurdle with FDA. We've already passed that hurdle. So anything that we get is just more of a guide for us for service with our customers. That's really what it is. So it's not a gating factor for FDA approval.

Okay. Great. Maybe 1 more question. So on the on the oncology side that since you guys already have a little bit more cash in hand, should we think about the Phase II -- Phase Ib study potentially to start later this calendar year and tax.

Well, I don't know when it will start, Yale. We're certainly speaking with people and looking at that -- so I don't want to commit to a time line at this point. While we do have a nice balance sheet at this moment in time, I think we need to focus the balance sheet on the commercial operations at this point. So it would probably not be something that Beyond Air would commit to fully fund the study like that. maybe once we are more comfortable with our path to profitability. That could be a different conversation that we have internally.

Okay. Great. That's very helpful. And congrats on the good quarter in terms of the top line.

Thank you. 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.

Now I'd just like to thank everybody for dialing in today. Bye-bye.

Thanks, everyone, for their time today. You may now disconnect your lines at this time, and have a wonderful day.

Good afternoon, and welcome to the Beyond Air financial results call for the fiscal quarter ended September 30, 2025. [Operator Instructions]

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 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 operations 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. That 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 its 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, 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 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. Promise of LungFit is apparent, and we are thankful to the team at Streeterville, 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%, $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 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 $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 continue to control costs at Beyond Air.

With that, I'll hand the call back to Steve.

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

[Operator Instructions] 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.

The other thing inside the United States, we did introduce a capital purchase model. Our system is now -- and to a point where it's extremely reliable, we've had interest, and we've actually had our first hospital purchase from us. So that will be a capital equipment purchase. And then the filter and the other accessories would be the ongoing purchase. And those prices, I guess it depends on how much nitric oxide use in your hospital per year per system, but this is certainly very competitive from a per hour cost basis for nitric oxide. So I think this new offering in terms of how hospitals can pay in the United States, we've gotten some interest there and the ex U.S. will be the driver prior to Gen II being 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 think FDA is doing a great job. I don't think the timing that we're providing is FDA being a limiting factor. It's more supply chain on our side. I think the environment is difficult to get the parts that we need, certainly doesn't help with all the disagreements, I would say that are happening around the world with trade, government shutdown doesn't help either. So I think just getting things in place for our ability to get our contract manufacturing in shape for inspection is what we're doing. So it's just a matter of time before that occurs. And I did mention -- I mean you did mention we'd be launching before the end of the year. I think approval has to be a little bit earlier than December, obviously, for us to be able to launch by then. We're not going to launch the next day. It's going to take a little bit of time. So -- that's kind of where we are right now, things can change, things can be better or worse in terms of timing. But as we sit here today, that's the feeling that we have.

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. Thanks, I-Eh. I mean the biggest difference -- will, there's a few, but the biggest differences are the size. So this second generation machine will be about 60% the size of the original. It will be what we've applied for. And I believe -- we believe that upon approval, with approval from FDA, it would be approved for use in ground and air transportation. That's critical. I think that's probably the biggest difference maker for us. And the user interface has been upgraded based on feedback from our current customers and some future customers, I guess, who weren't using our Gen I system, but did give us advice on Gen II. So we listen to them and we built this device based on their input. So we think that all of the functions of the device will be a little bit easier and a little bit better for the user.

One other thing that we have is that the maintenance interval will be longer, so that the disruption of swapping machines out for those high-volume users will be a thing of the past, let's say. So when you have hospitals that are using an exceptional amount of hours per system per year, let's say, way above what the average is, we're bringing them in for maintenance fairly regularly. So -- that's a little bit of a disruption of the hospital, and we're working to get Gen II out there. So that disappears.

So actually, I try to get - I'm sorry, try to get a little bit about the new business -- new business model can achieve that wasn't really fully appreciated -- can be appreciated by the existing one?

You mean Gen II versus Gen I, I-Eh?

So -- I mean you mentioned that the new business model, which is to purchase -- machine. So I just want to get a sense of what does that -- what the benefits of that versus the business operation you have done before this and what some additional benefits you can generate from that?

Yes. So look, the market was set up as essentially a leasing market before we enter the market. So we're -- we came in and we worked with hospitals based on what they were used to, and we get requests from hospitals, can we purchase the machine, can we purchase the machine. And we weren't doing a purchase of the machine in the first 2 years because we were still making upgrades and tweaking the machine and it would have been difficult to sell something where you were still upgrading it and improving it. We're at the point now where there really aren't any more improvements to the Gen I machine a little tweak here or there is standard, maybe a software update or something. Those things are not major changes. So for hospitals that have been asking us if we take a purchase again, I don't know on their side, they prefer to purchase and to buy the disposables at a much lower rate than the leasing model would have. Again, that's just their preference. 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. Maybe just a follow-up on the question. Next question is that you've got a lot of international deals signed, which is a great thing to happen. And because of the massive market over there, I assume most of these are distributor -- distributors. So how should we think about modeling over the long term in terms of what sort of pricing that may generate versus the one in the United States, which is slightly different? And how was the filter -- renewing filter fit into that model as well?

Yes. I mean the ex U.S. model for us, where we're selling things to the distributors and then they're using it in whatever model they like in their markets, whether it be a leasing model or a capital equipment purchase model or something else or some combination of that, that's their business. So for us, though, they're purchasing the machines like a capital equipment purchase. And then we're also selling them the disposables, including the filter, which is obviously the most important disposable. So -- that's how you should think about it in terms of modeling. It's more of a -- just a repetitive revenue line, and I think that, that's probably going to happen more in fiscal '27 than now because we're just getting the systems out there. 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 fortify 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% 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 1 or 2 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 going well. We've had a bunch of renewals go from 1 year, they renewed for 3 years. We see that happening not with every contract, but a good number of them. And I think that getting on Premier is very helpful. We had a few hospitals that were premier hospitals that we had contracts with weren't yet on Premier, so now being on Premier solidifies that. That's very helpful. We look forward to hopefully getting on HealthTrust as well at some point, and that would give us the big 3 GPOs. That's very helpful for being able to not only get hospitals, but maintain them. Sometimes they can contract out of their -- outside of their GPO, which is rare. But when we do, when we get on the GPO, it's obviously important. So we haven't really seen hospitals leaving us. It's a very sticky business, I think. And I think it's due to the team in the field, the machine's performance, and my -- the clinical team here at Beyond Air do an excellent job of supporting the hospitals when they need support.

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.