00:06 Greetings and welcome to the Beyond Air Third Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded. 00:25 I'll now turn the conference over to host, Maria Yonkoski, Head of Investor Relations. You may begin.

00:33 Thank you, operator. Good afternoon, everyone, and thank you for joining us. Today after market close, we issued a press release announcing the third fiscal quarter of 2022 operational highlights and financial results. A copy of this press release can be found on the Investor Relations page of our website. 00:52 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 the purposes ofthe 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 Form 10-K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. 01:41 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, February 10, 2021. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. 02:11 Joining me on today's call are Steve Lisi, our Chairman and Chief Executive Officer; Duncan Fatkin, our Chief Commercial Officer; and Douglas Larson, our new Chief Financial Officer. 02:22 With that, I will turn the call over to Steve Lisi, our CEO. Steve?

02:28 Thanks, Maria, and good afternoon to everyone joining us on today's call. As always, I would like to start by thanking the Beyond Air team as they continue to embody the mission of our organization and move us forward towards regulatory approvals and R&D pipeline progression and expansion. 02:45 We continue to believe in the potential of LungFit PH to revolutionize the treatment of persistent pulmonary hypertension of the newborn or PPHN, in the United States and cardiac surgeries around the world. Today, our commercial team continues to prepare for a U.S. commercial launch of LungFit PH in anticipation of a regulatory decision in the first half of this calendar year. I will have our Chief Commercial Officer, Duncan Fatkin discuss this preparation in much greater detail shortly. 03:14 Beyond Air continues to work collaboratively with the FDA to bring our device to the market as quickly as possible. I won't be able to comment further on our ongoing interactions with the FDA. Except to assure everyone that the dialogue is productive, and we have provided the agency with all information and support we believe they need to grant approval for LungFit PH. Additionally, we remain on track to receive CE Mark in Europe in the first half of this calendar year. We expect to secure an international commercial partnership for LungFit for ex U.S. Markets following CE Mark, and we will provide more information on our global strategy at a later time. 03:54 Turning now to recent operational highlights. In December of last year we expanded our leadership team and welcome Dr. Andrew Colin, as our new Chief Medical Officer. Dr. Colin has been invaluable contributor to our Scientific Advisory Board since 2013 and his advice has been instrumental to the progress of our ongoing clinical programs to…

10:27 Thanks, Steve, and good afternoon to our investors. As I highlighted last year, the commercial organization is ready to LungFit PH domestically as soon as we receive FDA approval. Our strategy has not changed. As we aim to focus on a limited release for the first 6 to 9 months post launch and target a select number of hospitals that have level 3 or level 4 NICUs and staff experienced with inhaled nitric oxide. 10:57 We continuously refine our marketing plan and work to optimize our customer service model as we draw closer to a decision date from the FDA. Our launch team is securely in place and consists of highly experienced individuals with decades of nitric oxide experience who will work closely with our target hospitals to ensure that we provide the best possible logistics support, customer service and product performance. 11:24 As I’ve said before, since many of our target hospitals are currently in multi-year contracts with cylinder based nitric oxide suppliers, we will be targeting hospitals with fewer than 12 months left on their existing contracts, and we anticipated taken approximately 4 years to have an opportunity to convert every hospital that uses nitric oxide in the United States. 11:50 As a reminder, here are the main areas of immediate focus for the commercial team. First, build in and developing the team. Our pre approval launch team is ready to be deployed immediately following approval. We continue to build on the nitric oxide experience that our team has brought to Beyond Air through our intensive internal training program. 12:13 As I’ve previously mentioned, we have numerous respiratory therapies on staff and experienced leaders to run our sales and marketing efforts. Our launch team is also preparing for the execution of our ex-U.S. partnership plans following CE…

14:27 Thanks, Duncan, and good afternoon to our investors. Before I jump into the financials for the past quarter, I'd like to address a couple of housekeeping items. First of all, it's important to note that our balance sheet, P& L and cash flows now include Beyond Cancer, our private oncology affiliate. Due to our majority ownership position, their financial statements are fully consolidated with those of Beyond Air. The P& L and equity sections in our 10-Q breakout out the amounts attributable to the noncontrolling interest that own 20% of the common stock in Beyond Cancer. 15:01 Second, we had a large number of warrants exercised for common stock in fiscal Q3. Especially our warrants issued in January of 2017 which expired in January of 2022. We issued just over 748,000 shares of common stock upon exercise of warrants in Q3 and brought in almost $1.4 million from those transactions. Balance of the warrants from January of 2017 were exercised in January of 2022, bringing in almost $4.6 million of additional cash, which we call out in our note on subsequent events in our 10-Q. With that, I will now turn to brief review of our financial results for our third fiscal quarter of 2022, which ended on December 31 2021. 15:50 Revenue for the fiscal quarter ended December 31 2021 was 0 as compared to $0.1 million for the fiscal quarter and December 31, 2020, all of which was licensing revenue. Research and development expenses for the fiscal quarter ended December 31, 2021 were $2.5 million compared to $3.4 million for the fiscal quarter ended December 31 2020. 16:17 General and administrative expenses for the fiscal quarter ended December 31, 2021 were $4.9 million compared to $2.5 million for the fiscal quarter ended December 31, 2020. Other income and expense for the fiscal quarter ended December 31, 2021 was a loss of $0.5 million. 16:39 For the fiscal quarter ended December 31, 2021, the company had a net loss of $8 million, of which, $7.7 million or $0.29 per share was attributable to the shareholders of Beyond Air Inc. compared to a net loss of $5.8 million or $0.33 per share for the fiscal quarter ended December 31, 2020. 17:00 For the fiscal quarter ended December 31, 2021, the company used $6.3 million of cash for operating activities. As of December 31, 2021, the company had cash and cash equivalents of $83.5 million, of which $54.5 million is in Beyond Air and $29 million is in Beyond Cancer. And keep in mind, this does not the additional $4.6 million we brought in in January that I mentioned earlier. 17:29 We believe that our cash on hand is sufficient to fund operations well beyond the next 12 months, including through the commercial launch phase of LungFit PH in the U.S. 17:39 And with that, I'll hand the call back to Steve.

17:41 Thanks, Doug. Operator, we are ready for Q&A now.

17:46 Thank you. And at this time we'll be conducting a question-and-answer session. [Operator Instructions] And our first question comes from the line of Gregory Fraser with Truist. Please proceed with your question.

18:21 Thanks folks. On LungFit PH , I appreciate the color on your interactions with the agency. It sounds like there's nothing outstanding from your end. Is there anything specific that you're aware of it giving approval at this plan or you just have to wait to see what the agency comes back with next?

18:39 Yeah. Greg, I wish I could give you something more specific, but we're just -- we are just kind of waiting to see what they come back with at this point.

18:48 Got it. Okay. How far will the transport system be to the broader long strategy when you expand to more hospitals? And can you speak to the timing of approval for a transport system?

19:00 I'll speak to the timing and I'll let Duncan tell you how important it is. The time will be, I would say, within the first 2 years after we launch the product, so maybe sometime in the 15 to 18 month time period or so to speak after we get the approval is probably when you'll see the transport unit.

19:24 Yeah, Greg, Thanks for the question. So the transport system, it's important that there is a transport system that the hospital has access to. The good news for us is that, we have made decision to have a controlled phased launch and in that first period where in the first 6 to 9 months we go to 10 to 12 hospitals. We've previously talked about we don't anticipate there to be any resistance, so there are not being a transport system available. And in fact, based on the feedback we've had from many of the customers that have approached us, they can definitely use our system without a transport system being available for a significant period of time, by which time we will have a transport solution. And we believe it will have some significant differentiation that we'll be welcomed by our customers.

20:15 Got it. Thanks That's very helpful. And then on LungFit Pro, will the additional data from the study that you'll be presenting, these of the same group of patients or will you have data for additional patients including non-COVID folks?

20:29 Yes, there will be more patience for sure.

20:35 Got it. Thank you. Thank for taking the questions.

20:38 Thanks, Greg.

20:40 And our next question comes from the line of Suraj Kalia with Oppenheimer & Company. Please proceed with your question.

20:47 Good afternoon, everyone. Steve, a couple of questions for you and 1 for Duncan. Specifically, Steve, I appreciate your commentary about not giving specifics on the FDa process for PPHN. I was wondering at least if you can give us a flavor, was that any new data provided since the last conference call? And also Steve, the support for you is -- any color you can provide with the ongoing bankruptcy of [indiscernible] and are you seeing any structural changes in the marketplace as you prepare for commercial launch? I'll throw in the question for Duncan also. Duncan, for Beyond Cancer and I'm drawing up blank here in terms of your previous commentary. Maybe you could just kind of highlight for us how -- from a modeling perspective, we should think about Opex or Beyond Cancer flowing through Beyond Air. Gentlemen, thank you for taking my questions.

21:48 All right. Suraj, I'm going to give that last one to Doug on the Beyond Cancer side. That's finance question there. So let's take them -- take them kind of in order. So why you just do me a favor, because we were a little bit shocked when you said question for Duncan and it came out as a cancer question. So just kind of recap your question so we could take them in order please. I apologize. Real quickly, don't say the whole question again. Suraj.

22:25 Hi, Suraj. Is your phone on mute?

22:27 Can you hear me now? Sorry.

22:28 Now I can. Yes.

22:30 Okay. Apologies. So very briefly, any new info provided on PPHN?

22:37 Yeah. The answer of that is, no new information that's been provided.

22:42 Okay. Any structural changes in the marketplace with the ongoing [indiscernible] bankruptcy [indiscernible] commercial launch.

22:52 Yes. I mean, I don't want -- whatever is in the public demand about their bankruptcy is in the public domain, but with respect to the market, I don't think we've seen much change over the past 2 years from -- just prior to their bankruptcy and up until now, it's been -- the competition from [indiscernible] has been there. And I don't think the bankruptcy has really impacted much and now that they're coming out, we don’t really see much difference honestly. 23:23 And Duncan, if you have anything else to add?

23:25 No, I think Steve captured it. It's certainly nothing that changed our strategy.

23:35 And Steve, maybe for Duncan. Just the Beyond Cancer OpEx flow, or should we think about it from a housekeeping perspective? Gentlemen, thank you.

23:48 So the expenses for Beyond Cancer, they'll be consolidated to Beyond Air. We own 80% so we'll consolidate all those expenses and you'll be able to see that broken out, that's 20% that's not owned by Beyond Air will have to be broken out in our financials. And I think Doug you may want to just comment on how it's shown in the 10-Q.

24:14 So right now, we're consolidating 100% of Beyond Cancer into Beyond Air. So, when we had the $30 million investment, the 20% or $6 million flows into noncontrolling interest. And then as we generate in this case losses through the quarter, 20% of the losses also flow into noncontrolling interest. And in future cues and case, we're going to be breaking that out so that you can see the equity bridge from the $30 million original to – sorry, from the $6 million in noncontrolling interest to the ending position for the quarter.

24:56 Thank you.

24:59 And our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

25:05 Hey, thanks for taking the question And congrats on the progress. Just wanted to focus a little bit more on the PMA process ongoing. Can you give us any sense, it seems like you're basically ready to launch any day now. Can you give us a sense in terms of what the next steps are with FDA? Is it just waiting for approval? Are you expecting another turn and more questions from them?

25:34 So, Matt, it's an ongoing process. So we continue to work with FDA to get to this end game of approval. So, I mean, I'm not going to say much more than that or no more than that, let's say. And as for the commercial team, they're ready to go. I mean, if FDA were to give us call tonight and say, you're approved on Monday, Duncan and his team will be ready to launch it on Tuesday. No problem. That's not going to happen. I'm just giving you an example.

26:04 Okay. Fair enough. And maybe just switching to some of your programs that you have in pilot stage of development. LungFit Go, can you give us a sense in terms of the ongoing pilot study in the at home setting? When do you think that study could complete? And then what the next steps are for developing an NTM and kind of map that out for us a little bit. I guess, you did announce you plan to launch an additional work in COPD in the next 12 to 24 months, but focusing on NTM, what are the next steps there?

26:47 So, we're going to have some data at ATS. And the study -- since these are 12 week follow-up, that will complete over the summer, the last patient followed up. And then it'll be a several month process to take all the data and put it into a pre submission to give to FDA. We also have some work being done in the lab. So once we get the final freedom samples from the last patients, we'll be sending it out to a lab for further analysis, which I think is important for everyone to understand and we want to present that to FDA. So we are going to wait for that data to come in, go to them and run through the process and see how that will work out. 27:31 And I think sometime probably in the middle of ‘23 or back half of ’23 we'll embark upon starting a study. And what I mean by that is, we'll embark upon identifying sites and speaking with them and trying to get them up and running with all the process that takes. And as you know, this process can take 6 to 9 months to get sites up and running. So, I would look at that kind of a timeline. Could it be faster? Sure. But I really want to be cautious on this because these things do take time. And it's a new it's new ground for everyone, for FDA, for the physicians, for the patients of what we're doing here. 28:15 And hopefully the data will work out to be very strong and people will catch on quickly, but till that happens I'm going to keep that kind of a rough time line. And LungFit Go, as you mentioned COPD, yes, I mean, we want to do COPD as well because this is also targeting mostly for patients at home. And obviously, we feel confident that our LungFit Pro system, which was used in this pilot study will become our LungFit GO system, it is ready for prime time in the home market or we wouldn't be embarking into COPD. So we're very excited about how the machine -- the system perform, how it held up, how simple it was to use and the feedback we got from the participants, not just the patients, but also the engineers and physicians and medical staff halfway around the world from us, and we were obviously managing this remotely, this study. So the feedback was fantastic. And this is why we're now trying to push for COPD and we can get something started up this year fantastic. We'll do everything we can, but it maybe in 2023. Again, sometimes it's tough to push things really fast when it's so new for the people that you're talking to.

29:32 All right. Okay. Fair enough. And just to be clear, so final data from the pilot study late this year and then embark on potentially a pivotal study starting mid to the second half of next year. That makes sense.

29:48 I think that -- I don't think there'll be any patients enrolled in ’23, Matt. I think that would probably be later on, because again, it does take time to get sites moving, getting them set up, getting through IRB process and so forth. So I would look more towards maybe -- best case end of ’23, more likely at first half of ’24 type of getting into to a study. I think -- and again, I hope it's faster than that, but these things -- they take time. We've surprised a few people with what we've tried to do and we realize not everybody is up to speed on what nitric oxide is and does. But I think people are get catching on based on the progress you've made over the past few years.

30:37 Okay. Good. And then just similarly for LungFit Pro, the pilot study that you have going there. Help us understand kind of the next step there in terms of -- I guess you are going to have some additional data in April, but in terms of wrapping up that study and then moving to the next phase of development.

31:02 That study is wrapping up now. I mean, in this winter we were in I guess the back half of the winter to now. So we're wrapping the study up and we're moving as fast as we can here. And the key for this is seasonal. We need to do a study that all the patients were targeting are enrolled within the same winter season. So we're fighting against the clock here to try to get things done and work with FDA to get this study off the ground so we can get going coming up this November. So we're working on that, stay tuned. If we can get everything done and in time, we'll be doing the study this coming winter.

31:46 Okay. Great. All right. Thanks for taking the questions Steve.

31:51 Thanks, Matt.

31:54 Our next question comes from the line of Yale Jen with Laidlaw & Company. Please proceed with your question.

32:00 Good afternoon, and thanks for taking the questions. I just want to follow-up what Matt had asked and maybe the last one. Which is for the LungFit Pro the study you are talking about, would that be for pediatric or for adult or you have not decided?

32:20 It would be for adult.

32:23 Okay. And 2 quick questions here. First one is, it's a little bit more fun, which is that, have you guys give a formal name for the oncology treatment at this point?

32:40 So, we're UNO using therapy right now for ultra-high nitric oxide. So, we'll see how that goes, but we're calling it UNO therapy at the moment.

32:52 Okay.

32:53 So not like the card game, but we'll see what we can do with it. But that's the name now. And we'll see how that progress as we go forward.

33:06 And last question here is actually for Duncan. I’m just curious in terms for the LungFit PH, as you promote that, do you potentially will go through some of the group purchasing organization or that's purely not irrelevant and just go to each hospital specifically?

33:28 Yes, thanks for question, Yale. Just a reminder, we're definitely not promoting the product right now, obviously [Multiple Speakers]

33:34 I understand. After they are launched.

33:40 For the record. But certainly going forward, of course, we will engage with buying groups as appropriate, because we have a phase launch, the initial phase. That group of hospitals I mentioned there's certainly not going to be any of those kind of arrangements in place, but definitely have been contacts from various groups and a lot of the key hospitals that you would know around the country, there is a lot of interest in our technology. And we will negotiate and discuss that with them accordingly. But reinforcement that we don't expect to be competing on price, we focus very much on the benefits that we provide, both potentially, clinically, logistically and then in terms of patient workflows. So that's a long yes, but not now.

34:31 Understood. And maybe just squeeze one more, in terms of LungFit GO, in terms of the level -- the level of nitric oxide based on PPM, is that the same for the NTM versus COPD or they could be different? Thanks.

34:51 Thanks, Yale. So for NTM we titrate up to 250 parts per million for patients with underlying COPD who have lung infections that cause severe exacerbations. Again, we'd be treating the exacerbation, not the underlying disease of COPD. We haven't decided on where that ultimate high end of the range will be for treatment, but obviously, it will be at least 150 parts per million in minimum. So it could be 200 or 250, we are just not sure yet, but I don't think we can go above 250 parts per million just yet. So that will probably be the highest we possibly would go at this moment in time. It's not machine related, it’s not our device related, it's more of a -- what we've learned so far that we're able to do staying within safety parameters.

35:50 Okay, great. That's very helpful. Again congrats on the progress. We look forward to the launch.

35:56 Thanks, Yale.

36:00 [Operator Instructions] Our next question comes from the line of Scott Henry with ROTH Capital. Please proceed with you question.

36:11 Thank you and good afternoon. Just a couple of questions, most of mine have been answered already. I guess, for Doug a couple of modeling questions. First, G& A was certainly above trend in third quarter. Is there some one-time events in there from the Beyond Cancer transaction or perhaps maybe it should take a step up as you have that entity as well. Just trying to get a sense of how to think of G&A going forward?

36:48 Sure. Yeah. No problem. Thanks for the question. So there were a couple of things that happened in there. Certainly, the setup of the cancer business did generate some legal fees, especially some one-time costs around that creation. You may have noticed we didn't use a bank, but that didn't keep the legal fees down, so we did have those. We also had a restricted share grants in the quarter and the way we account for that. So this is a non-cash item, obviously, but the way we account for that is, we take each tranche and spread it over the life of the tranche. And so, whenever we have grants we have a pickup through the P& L, that's fairly significant. So between those two items, that explains the biggest chunk of the increase.

37:41 Okay, great. And you did mention the warrant transactions, particularly in January. I haven't seen the Q yet, but could you give us a sense of where the real time shares are today?

37:54 You mean how many shares are out [Multiple Speakers]

37:56 Shares outstanding in real time.

38:00 Yes. So we just put up the shelf registration. So the share count is in there, I believe –

38:05 Actually for stage to queue as well, it’s $29.8 million.

38:08 There you go. Yes, I think it's almost the same as what we had in the shelf. Yes.

38:13 Okay. Perfect. Thank you. Final question. I think you've talked about this in the past Steve, but as we get closer to potential launch, how would you kind of categorize the manufacturing capacity, any supply issues or you feel pretty good about that for the considerable future?

38:34 So, I think for the first 6 to 9 months of our focused launch, we're all set. I think there's nothing really that concerns us with respect to supply or manufacturing capacity for that timeframe. But as we go beyond that, we have to manage the supply chain. I don't think our capacity – our actual manufacturing capacity is fine. It's really supply chain, I mean there are still things that are difficult to source out there. I'm sure we're not the only company to say that nor is our the only one to have the problem. I think things are getting a little bit better. And I hate to say it. I mean, I wish we had approval already, but this little bit of a push out has helped us to be able to source some of these things so that we do feel more comfortable going beyond that first 6 to 9 months. So we do feel a little bit better about that, but I don't want to say it's something that isn't in a concern, it has to be a concern given the environment in the world right now. 38:34 So -- but we're certainly comfortable to get through the first phase and to the second phase of our launch. But I don't want to be too bold and say, it's not an issue. But I'm very confident with the team and the things that they put in place to make sure that we're going to do okay in the next 2 or 3 years with supply chain. I'm actually quite impressed with the team. Glad I have them, because they know more than me. So it's good thing.

40:01 Okay, great. Thank you for the color, and thank you for taking the questions.

40:05 Thanks, Scott.

40:09 And we have reached the end of the question-and-answer session. I'll now turn the call over to Steve Lisi for closing remarks.

40:16 Thanks everyone for joining today. Much appreciated. And we look forward to the next time we speak.

40:24 And this concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.