Beyond Air, Inc.

Good afternoon and welcome to the Beyond Air Financial Results Call for the second quarter of 2022, ended September 30th, 2021. At this time, all 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 Maria Jankowski, Head of Investor Relations at Beyond Air. 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 second fiscal quarter 2022 operational highlights and financial results. A copy of this press release can be found on the Investor Relations page of our website. 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 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. 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 11, 2021. Beyond Air undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. 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. With that, I will turn the call over to Steve Lisi, our CEO. Steve?

Thank you, Maria, and thanks, everyone, for joining us on the call this afternoon. This quarter has been a busy one, and I am excited to share our recent highlights with you as well as provide some insight on how we think about our active portfolio management strategy. Most significantly, we recently announced the separation of our oncology business into a new independently managed private entity called Beyond Cancer. This decision was made after careful consideration of what would be the best path forward for all stakeholders. I will talk about the future plans for our affiliate in greater detail in a minute. First, I want to give a quick update on our pending PMA application for the LungFit PH system to treat persistent pulmonary hypertension of the newborn, or PPHN. We are very pleased with our ongoing communication and progress with FDA. We will continue to provide FDA with any and all information and support they need to grant approval for our LungFit pH. Our commercial team is prepared to launch in December 2021, consistent with our guidance provided in September. This quarter, we also successfully completed the stage one assessment audit of our quality system for CE-MARC in Europe. We anticipate receiving CE-MARC in the first half of calendar 2022. I would defer to our Chief Commercial Officer, Duncan Fackin, to elaborate on our U.S. launch preparation shortly. Turning now to recent R&D highlights, in mid-October, we released interim data from our ongoing non-tuberculose mycobacteria, or NTM, pilot study using the LungFit Go device. As you may recall, we began screening patients for this trial in December 2020 in Australia. Despite some setbacks due to the difficult COVID-19 lockdown environment in Australia, The Beyond AIR team and our Australian colleagues have been doing an outstanding job navigating these challenges. At the time of data cutoff on September 6th, we had a total of eight refractory NTM patients enrolled, all of whom have been titrated up to the maximum dose of 250 parts per million nitric oxide with no dose reductions, no study discontinuations, and no treatment-related serious adverse events reported. To our knowledge, 250 parts per million is the highest concentration of inhaled nitric oxide that has ever been tested in a clinical trial with patients self-administering treatment in a home setting. These data provide a high level of comfort with respect to the safety of 250 parts per million NO because all subjects remained within the acceptable safety ranges from the hemoglobin levels and NO2 concentrations, below 10% in five parts per million, respectively. We attribute this success to the intermittent dosing regimen which allows for high-concentration NO to be administered without negative effects. Enrollment continues, and we anticipate reporting full safety and efficacy results in 2022. The success of this trial would be a game-changer for the home setting, but we could potentially target other chronic, severe lung infections with various underlying conditions, such as chronic obstructive pulmonary disease, or COPD, with our LungFitGo system. Moving on to our viral lung infection program, which uses the LungFit Pro system at 150 parts per million NO to treat acute viral pneumonia in adults and bronchiolitis in children under two years of age. Our pilot study in adult viral pneumonia, including COVID-19, remains active with trial sites open for enrollment. Our plan is to submit the entirety of the data at 150 to 160 parts per million NO in both hospitalized adult and infant viral pneumonia patient populations as one comprehensive data package to the FDA. We would like to move to a pivotal all-comer trial for LungFit Pro in patients hospitalized with viral pneumonia and anticipate pending agreement with FDA starting this study in the fourth quarter of calendar year 2022, the timing of which is due to the seasonality of most respiratory viruses. As a reminder, we've completed three randomized double-blind controlled studies in infants under the age of 12 months hospitalized with bronchiolitis, and there were consistent positive signals for both safety and efficacy in those trials. A total of 198 infants were enrolled in the three trials, and our third study provided statistical significance when 150 parts per million NO dose four times per day for up to five days was compared to standard of care for 85 parts per million NO for both the primary endpoint of fit to discharge from a hospital and the key secondary endpoint of hospital length of stay. In the adult viral pneumonia trial, to date we have presented data on 19 COVID-19 patients at the 2021 American Thoracic Society meeting in May 2021, and we showed data consistent with what was seen in the bronchiolitis studies. Finally, I will discuss our oncology business and the decision to spin it out into beyond cancer. The oncology program has always existed outside of the LungFit platform through the ultra-high concentrations of nitric oxide that are required to achieve anti-cancer properties. We have developed a proprietary device that, in a single treatment, can deliver up to 200,000 parts per million NO directly to a solid tumor site. We call this UNO therapy for ultra-high concentration nitric oxide. Based on our current preclinical findings, UNO therapy may not only partially ablate or shrink tumors locally, but also can arm the immune system to recognize and attack the same tumor type wherever it may reside in the body. Our preclinical data show that treating a tumor with immunotherapy will cause local cell death, exposing the immune system to tumor antigens, thereby creating a memory immune response. On a patient level, this could mean providing cancer patients and their families with the confidence that their disease will not recur or metastasize. Currently, the standard of care for solid tumors is surgery, cytotoxic chemotherapy, radiotherapy, or a combination of all three. While in recent years immunomodulating therapies have shown promise in improving outcomes for hematological cancers, a significant unmet need remains in the treatment of solid tumors. Solid tumors represent approximately 90% of adult human cancers, and metastatic disease is responsible for 90% of death from solid tumors. This is a huge market with a significant unmet medical need. Checkpoint inhibitors alone accounted for over 25 billion in sales in 2020. We believe that immunotherapy has the potential to improve the condition of patients with certain solid tumors as a monotherapy, but also believe that the effects of chemotherapy, radiation therapy, checkpoint inhibitors, as well as other treatments may be enhanced with NO combination therapy. The ONDAIR board and management team have been highly encouraged by the early results from the solid tumor program. Given this early promise, we recognized that our capital allocation strategy moving forward would change given the resources that would be required to accelerate the oncology program. Our focus is on the transformational LungFit platform technology and bringing it to the clinic as quickly and efficiently as possible. Thus far, resources that we have been investing in our oncology business were not impacting our LungFit programs. However, when evaluating our existing portfolio management strategy, it became clear that this separation of business was imminent and necessary. This will enable BeyondAire to solely focus on existing LungFit programs, as well as allow for investment into other respiratory diseases where we can have a greater impact on our patients. It was time to bring on a management team dedicated to oncology, and I am extremely pleased with the talent that will take on the mission of creating the next generation of immuno-oncology treatments. Beyond Cancer will be led by Chief Executive Officer Selina Chasson, a Stanford-trained physician who brings with her over 25 years of investment management experience from the financial sector, including the last 16 years as Director of Healthcare Investments at Baylor, where a substantial portion of her portfolio was oncology companies. Dr. Hilal Confino, the cancer immunologist who led the efforts at BeyondAire to bring this program to where it is today, has joined Beyond Cancer as Chief Scientific Officer to continue the journey with Dr. Chasson. It will be a pleasure to watch these two change the way we approach the treatment of solid tumors. Additionally, Beyond Cancer has received commitments from people for a few more key positions, including chief medical officer. Announcements for these hires will be made over the coming months. The Beyond Cancer board of directors will consist of six members, three of whom will be from Beyond Air. I will serve as chairman of the board. Our co-founder, president and chief operating officer, Amir Abniel, will serve as executive director. And Bob Carey, a current Beyond Air board member, will be a director. Lena Chasson will also be a director and will recruit two more members. Announcements on new board members as well as scientific advisory board members will begin shortly. None of this would be possible without a dedicated investor base. Recently, $23.9 million was raised in a private round to fund Beyond Cancer, which is subject to change with the final close occurring in a few weeks, but will not exceed $30 million. If $30 million is achieved, Beyond Air will own 80% of Beyond Cancer. Beyond Air will also benefit from a single-digit royalty payment on all future revenues. In exchange, Beyond Cancer will benefit from Beyond Air's nitric oxide expertise, intellectual property portfolio, preclinical oncology team, regulatory progress, and continued support across many areas, such as regulatory, legal, finance, and clinical, among others. The initial funding will be used to accelerate ongoing preclinical work, including the completion of IND-enabling studies and expansion of preclinical programs for combination studies. as well as completion of a phase one study, optimization of the NO delivery system, and building out the Beyond Cancer team. We truly believe that spinning off the oncology business will create long-term value for all shareholders, and we are excited to monitor the progress. I will now turn the call over to Duncan Fatkin, the Chief Commercial Officer of BeyondAire, to provide additional details on the U.S. commercial launch for LungFit PH.

Thanks, Steve, and good afternoon to our investors. I am pleased to report that we have made rapid progress by expanding our commercial organization, optimizing our customer service model, and refining our go-to-market plan. We are ready to launch LungFit PH domestically as soon as we receive approval. As I have previously stated, we are preparing for a limited release for the first six to nine months post-launch. Our strategy for this first phase will be to target a select number of hospitals that have level three or level four NICUs and staff familiar with inhaled nitric oxide. We will launch with a highly experienced team that will work closely with these hospitals to ensure that we have optimized our logistics, customer service, and product performance in the first limited release phase. Since many hospitals are currently in multi-year contracts with our cylinder-based competitors, we'll be targeting hospitals with less than 12 months left on their existing contracts. And we anticipated taking approximately four years to have an opportunity to convert every hospital that uses nitric oxide in the United States. As a reminder, here are the main areas of immediate focus. Firstly, building the team. We already have our pre-approval launch team in place and have identified candidates for the extended team who we plan to recruit once approval is obtained. We have numerous respiratory therapists on staff and experienced leaders to run our sales, marketing, and ex-U.S. partnership efforts. Secondly, our supply chain preparation is well advanced and going according to plan. In preparation for FDA approval, we'll have all the LungFit pH systems and accessories we need, and our service and support resources are in place. Lastly, we are finalizing our marketing plan. Potential customers continue to reach out to us for information on LungFit pH, and this allows us to refine our marketing materials, messaging, and business model. I have previously mentioned that the first major conference following the expected timeline for FDA approval is the AARC, or American Association for Respiratory Care, which was originally planned to be live in Phoenix. That conference is now virtual in December, and we continue to target that meeting as the first introduction of lung fit pH to the world. Stay tuned, as we will provide more detail of our plans in the coming weeks. Our vision is to harness the power of nitric oxide to unlock access, empower healthcare providers, and transform more lives in more ways. As we learn more about the challenges and opportunities for the PPHN population, we're even more excited to bring the LungFit PH, the groundbreaking all-in-one nitric oxide generator monitoring and delivery system to the U.S. market and the world so we can start to turn that vision into a reality. Thank you. And I'll now turn the call over to Doug for the full financial review. Doug?

Thanks, Duncan. Before I jump into the numbers, I wanted to formally introduce myself to our investor community. I joined Beyond Air a few months ago, and I'm very excited to have the opportunity to join such a strong team as we advance the pipeline and transition to a global commercial stage company. Now turning to the brief review of our financial results for our second fiscal quarter of 2022, which ended on September 30th, 2021. Revenue for the fiscal quarter ended September 30th, 2021 was zero, compared to $0.4 million for the fiscal quarter ended September 30th, 2020, all of which was licensing revenue. Research and development expenses for the fiscal quarter ended September 30th, 2021 were $2.8 million, compared to $3.1 million for the fiscal quarter ended September 30, 2020. General and administrative expenses for the fiscal quarter ended September 30, 2021, were $3.4 million, compared to $2.2 million for the fiscal quarter ended September 30, 2020. Other income and expense for the fiscal quarter ended September 30, 2021, was a loss of $2.5 million, compared to a loss of $0.2 million for the fiscal quarter ended September 30th, 2020. For the fiscal quarter ended September 30th, 2021, the company had a net loss of $8.7 million, or 36 cents per share, compared to a loss of $5.1 million, or 30 cents per share, for the fiscal quarter ended September 30th, 2020. As of September 30th, 2021, the company had cash and cash equivalents of $47.7 million. I would also like to run through a few things that occurred subsequent to the end of the quarter. First, we retired $5 million in debt, which removed all of our outstanding long-term debt. Second, we will need to restrict the use of $7.4 million of cash related to the negative outcome of litigation pending its appeal. Finally, we used our equity line of credit and our at-the-market financing vehicle to raise an additional $14.2 million since September 30th. Taking these items into account, plus all other cash disbursements since September 30th, our cash and cash equivalents as of November 10th was $46.5 million. Note that this does not include any of the cash that we received from the financing of Beyond Cancer Limited that we announced last week. We believe this cash is sufficient to fund operations well beyond the next 12 months, including the commercial launch phase of LungFit PH in the U.S., And with that, I'll hand the call back to Steve.

Thanks, Doug. Before taking your questions, it is important to take a moment to appreciate the efforts of the Beyond Air team that has gotten us to this point. I am very fortunate to be part of this outstanding team, and I am positive that only this team could have accomplished so much in a short period of time. Operator, we're now ready for Q&A.

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. Thank you. Our first question is from Greg Frazier with Truist Securities. Please proceed with your question.

Great. Thanks for taking the questions. First on LungFit PH, have some or all of the pre-approval inspections been completed? Just any color on the inspection process would be helpful. Thanks, Greg.

Yes, they've been completed.

Okay. And then thinking ahead further into commercialization, probably beyond kind of the first phase, based on discussions that you've had with hospitals, do you think that there will be some that are price sensitive and looking for a discount versus IMAX, despite the advantages of the lung fit system?

I think everybody's going to try to get the best price that they can. Of course, it's always... negotiation in every sense of the word, but I'm going to pass this over to Duncan Facken, our Chief Commercial Officer, to elaborate a little bit more.

Thanks for the question, Greg. I mean, as Steve said, clearly there are more entrants in the market, so there's now three players, so there's going to be a little bit of price pressure, but we're not planning to compete on price. We expect to be able to tell the story about how our system is in its own category. It's the only system that uses room air to generate nitric oxide. There's no cassette or cylinder. So there are a lot of benefits to using our system in terms of reducing the cost of logistics, the safety benefits, and certainly monitoring. And so from our perspective, we expect people, and our research tells us and the conversations tells us, that they will value the overall benefits that we're going to bring to market. So we don't expect to be competing on price, despite the fact that there is some pressure out there. We're very aware of that, but that's not going to change our strategy.

Got it. That's very helpful. And then a question on LungFitGo, the study for NTM lung disease. Have you gotten interim data on any of the efficacy measures, such as quality of life or physical functions?

We were unable to gather the efficacy data due to the COVID-19 related lockdowns in Australia. It's very difficult to go into the hospitals and gather these data. So it wasn't available when we put out our interim look. So I think that we won't see any of those data until sometime next year. I think things have loosened up a bit in Australia, but a little bit of a backlog in getting things done, so it's going to take a little bit of time. It's just the way the world works right now. Yeah, understood.

Okay, I'll hop back in the queue, but thanks for taking the questions. Thanks, Greg.

Thank you. Our next question comes from Siraj Khalia with Oppenheimer. Please proceed with your question.

Good afternoon, Steve. Duncan, can you hear me all right? Yes, Siraj. Yep, thanks. Perfect. Hey, so Steve, Duncan, either one of you, you know, you all articulated that the supply chain issues, you'll have managed it well. And as you look forward to commercial launch in a few weeks post-approval, may I ask components of how many systems are on hand, you know, for the, let's say the next two to four quarters, just trying to get a sense of how you'll have managed at least the next four quarters?

Siraj, we're not overly concerned over the next four quarters in terms of supply. I guess that would also kind of dictate how many hospitals we're going to be in at the end of four quarters. So we're not going to provide that kind of information, but we're comfortable with the supply chain. We We believe we certainly have enough material to launch this product during this first focused phase launch. And when we go to that next stage of launch, we'll certainly be ready with our supply. This is assuming things don't get worse, but as things stand now, we're very comfortable with the adjustments that have been made over the past several months to deal with this. Duncan, do you have anything to add?

Yeah, I think, Suraj, thanks for the question. I mean, we've consistently said that we're going to, in this first phase, take between six and nine months to work with a dozen hospitals. And none of the supply chain issues that exist globally are affecting us. It's certainly not going to change the approach and our ability to get to those hospitals. So we certainly don't have any concerns at this time.

Got it. Sorry, I had to try again. Hey, Steve, on the CE mark, remind us of the European opportunity. And just like you all have consistently talked about NICUs and the four-year timeline for U.S. adoption and layout and what your initial sites are and all that, just kind of give us some additional granularity on European sites and how you think about the Europe opportunities.

I mean, it's smaller than the U.S. opportunity, that's for sure, but not that much smaller. It could be about half the size of the U.S. So obviously it's going to get started a little later. Approval is going to come later. And it does take time to get through the process in each country there to get going. Plus we'll be looking for a partner. So I think the European launch is going to lag the U.S. launch by about a year or so. But... I think the adoption curve is going to be fairly similar to the U.S. adoption curve. It's a competitive environment there as well. So I hope that gives you some color on the European opportunity.

Fair enough. Steve, Duncan, I do appreciate it, and we look forward to your approval. It's a long time coming, and I hope you guys hit the ground running. Thank you very much for taking my questions. Thanks, Suresh.

Thank you. Our next question is from Scott Henry with Rolfe Capital. Please proceed with your question.

Thank you, and good afternoon. A couple questions. I guess first, starting with the Beyond Cancer kind of spin-out, assuming you will own 80% of it, will you consolidate that in your financial statement? Is that how we should think about it?

Yeah, thanks, Scott. Yeah, we will be consolidating that. roughly the 80% ownership that we'll have.

Okay. The bigger issue, too, when I saw the press release and the terms, it seems like you're unlocking a lot of value there. If I look at the numbers, $23 million or as much as $30 million for 20% of the company would put a substantial equity value on that entity, which I would doubt was in there currently. I mean, can you talk about that, about how you think it offers the ability to unlock that value that perhaps had been missed prior?

Yeah, thanks, Scott. I mean, look, it's easy to back into the number. $30 million comes in, 20% ownership. That means that Beyond Air would own $120 million of value in the cancer program. So it's nice to see investors coming in and validating the value of the cancer program. And, again, not just investors coming in, but the management team that's come on board. I think many of you know Selena and the team she's building is going to be, you know, I hate to say it, but they're going to do a hell of a better job at managing cancer than I could with the team here, although Amir might be upset about me saying that. But I know he's going to be heavily involved as well as going forward. So, yeah, this is a very important... program. You know, we chose to move cancer along rather than COPD over the past few years. That's how promising it was when we got the first data, and it's even more promising now that we've moved it forward to this point where we're, you know, just a few short months away from beginning to enroll patients in our first human study. So it's very exciting. The people who've come to us as investors, as the management team, as well as some consultants that are working with us. Everybody's very excited about this, and it's a brand-new mechanism. It's never been seen before. So hopefully things work out in phase one, and there'll be even more excitement around this. So I appreciate the question, and I think that, yeah, the value's always been there. It's just I think now people can see it more than before, as it was just a preclinical program behind our three clinical programs. So maybe it was just kind of being missed because it was a preclinical project. But now it's an entity on its own. We'll see what happens.

Congratulations. That's a lot of progress over the past year. The final question, and I don't know how much granularity you want to give on this, but how should we think about the magnitude of marketing spend over the first 12 months post-launch, We're a little closer to that date. I don't know if you could put a range around that or just any sense of the magnitude of spend for the first year. I imagine it's not going to be gigantic, but I just wanted to get a sense.

Thank you. Scott, I'm going to pass this on again, but the only thing I'm going to say before that is this is standard of care in the hospitals that use NO. I mean, there's not much education that needs to be done here from that perspective. and we're certainly not doing DTC advertising, so go ahead, Duncan.

Yeah, no worries. Hi, Scott. Yeah, I think that obviously we're not approved, so we can't promote the product to this point. The good news is there's a very high level of awareness because this marketplace, it's a fairly tightly held community. They're very aware of the presence of our organization, the devices, and we certainly have a fairly consistent incoming calls to learn about the device. And so from that point of view, we certainly don't expect a significant amount of investment. In fact, we already have made a lot of the investments to ensure that we have a really strong now virtual launch when we go to market. We already have our pre-launch team in place, so that's already sort of built into our cost base. And any of the additional costs should be quickly be covered by the progress we make from a revenue generation perspective, especially as we get into that second phase. So obviously there is going to be an increase, but we've already done a lot of the preparation. We don't have to raise that awareness, which is a great place for us to be. Okay, great.

Thank you for the color on that, and thank you for taking the question.

All right. Thank you. Our next question comes from Matt Kaplan with Leidenberg Foundation. Please proceed with your question.

Hi. Thanks for taking my questions. I guess, you know, staying on the commercialization preparation maybe for Duncan, have you ID'd the hospitals that you're going to target in the initial launch section yet of the launch?

Thanks, Matt. There's a couple of components to this. Firstly, as I just mentioned, there are a significant number of hospitals that have already been reaching out to us over the last couple of years, ever since we were last physically able to connect with this community. We certainly know where the key hospitals are, and we'll make choices about which hospitals we go to based on a combination of factors, including geographical location, the specific requirements they have and the expertise they have. And obviously, at times, that will be a difficult decision because we're in that phased launch, but we're certainly looking forward to it and we very much know where the key hospitals are.

Okay, very good. And then, Steve, with respect to the PMA approval, it sounds like you're really kind of at the last steps there now with the pre-approval inspections behind you. Is there kind of one gating factor that's still remaining or how should we think about it?

I can't tell you how to think about it, Matt, because, you know, we're just waiting. I mean, we've done all we can and we're going to keep working with FDA. So, you know, we just kind of are, you know, reacting to them and working with them and we'll get there eventually.

Fair enough. And then, you know, congratulations on the announcement and the formation of your subsidiary Beyond Cancer. Just wanted to focus in on that. And can you paint a picture for us in terms of that program moving through preclinical development and potentially into the clinic and how we should expect kind of news over the next six, 12 months as you move into development?

Yeah, I mean, The preclinical process is, you know, we're obviously almost at the end here. We're saying early next year we'll be enrolling patients in our first in-man study, so pretty excited about that. And as you know, it doesn't end. Obviously the preclinical work will continue in parallel to the human study. So hopefully we will have some more preclinical work to share with you next year, perhaps some combination data with some of the other therapies out there, as well as showing some of that phase one data in the back half of next year. So that's what to expect. We'll definitely have some publications. So it'll be an exciting time. There will be news coming out. I mean, Beyond Air will be press releasing the information, obviously, since we'll be an 80% owner of Beyond Cancer. So the news will get out there, and you'll be able to see everything. Yeah, I know.

Looks like a great way to unlock value from that program. Thanks for the questions.

Thanks, Matt.

Thank you. Our next question will come from Yale Jen with Blade Law & Company. Please proceed with your question.

Okay. Thanks, Steve, and thanks for helping me out for GetConnected. My first question follows what Matt asked a little bit more specifically in terms of the Beyond Cancer, which is that we know that you guys had preclinical data presented earlier this year, Should we anticipate additional presentations to come? What I'm just thinking about is, for instance, the AACR or other of those meetings with a high oncology focus.

Yeah, I mean, look, we're certainly going to be submitting our abstracts for conferences for 2022 so we can show more more data. There's no doubt about that. So pending acceptance into these meetings, you know, we'll be showing more data for sure.

Okay, great. That's helpful. And one question is for the CE mark. What might be the gating factor at this point toward a potential approval in the first half of next year? Any other specific work you guys need to do or simply just responding to the agency's questions and whatnot.

Yeah, so getting a CE mark is a little different than getting FDA approval. So there's a process there, and we're going through that process. As we stated a few months ago, it started up, and that process should end in the first half of next year, and we believe we'll get approval in the first half of next year. So it's just a matter of taking all the work we've done, obviously, to to submit to FDA and work with FDA towards a PMA approval and use that information to get the CE mark. And it's not, you know, just turning around and showing the paperwork. I mean, there are some differences in terms of what is needed for CE mark, but it's not a huge difference. And we've done this work. We're fully ready to work with the notified body in Europe. And again, the process is kind of fluid, so there's no real hey, we have to achieve this goal. I mean, it's just a matter of going back and forth with them and satisfying all the requests. So we're in that process, and we feel very comfortable and confident that we'll get through it. Okay.

Maybe the last question here is probably for Duncan, which is that I understand that you guys are geared up for reaching the different hospitals with the NICUs. I understand also this is not formally approved for any cardiovascular use. But my question is that was there any request for the cardiovascular side of the hospital that about the long-set pH and that type of interest at the moment?

So thanks for the question, Yael. So we're obviously focused on promoting the product post-approval. on PPHM, the indication that we'll get it for. We haven't had any conversation in that pre-approval phase. All we're doing is responding to customers' questions and doing any demos. What we will do is post-approval, shortly afterwards we'll be applying for the cardiac label expansion, and that will allow us to unlock that potential, and that's the way we're going to move forward.

Is that the case that although you guys are formally promoting anything on that site, but they can actively request questions to you guys to ask more information?

Yeah, we can only promote on the label, and if we get any requests, we will have a formal process to respond to those requests.

Okay. Okay. Great. That's very helpful, and congrats to reaching the finish line. Thanks, Shio.

Thank you. There are no further questions at this time. I would like to turn the floor back over to Steve Lisi for any closing comments.

Thanks, everyone, for taking the time this afternoon. Talk to you soon.

This concludes today's conference. You may now disconnect your lines. Thank you for your participation.