Good afternoon, and welcome everyone to the Beyond Air Financial Results Call for the Fiscal Year ended March 31, 2023. 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 Edward Barger, 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 fiscal fourth quarter and full year 2023 operational highlights and financial results. A copy of this press release can be found on our website, www.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 the 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 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 22, 2023. 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 the call are Steve Lisi, Chairman and Chief Executive Officer; Duncan Fatkin, Chief Commercial Officer; and Douglas Larson, Chief Financial Officer. And with that, I'll turn the call over to Steve Lisi. Steve?

Thanks, Ed, and good afternoon to everyone joining us. Welcome to phase 2 of our commercial launch. This is an exciting time for us as we have visibility into what the PPHN market will look like over the next several years. With our initial limited launch completed, we are highly confident that we have gained the knowledge required to satisfy the needs of hospitals using nitric oxide. LungFit PH has been well received in the market, and we believe that our ability to support and service most hospitals has been established. Now is the time to increase the size of our commercial team and increase our market share. Our Chief Commercial Officer, Duncan Fatkin, will have more on this in a few minutes. Outside of LungFit PH commercial operations, we have been very busy, and I am proud of what the Beyond Air and Beyond Cancer teams have accomplished. LungFit PH cardiac label expansion application will be submitted before the end of this calendar year to FDA. This is later than we had hoped, but we want to be certain that the application is of high quality and will satisfy FDA requirements. We also expect CE Mark in the EU for LungFit PH late next quarter. We anticipate LungFit PRO will be used in a community-acquired viral pneumonia study in the United States this coming winter. LungFit GO is scheduled for an at-home COPD study start in 2024 and NTM in 2025. Beyond Cancer anticipates phase 1a data this fall. As announced last week, we now have another nitric oxide related program, autism. Please refer to our announcement last week for details. Our portfolio consists of programs where nitric oxide was approved to treat acute pulmonary hypertension in newborns, is in human studies, hypoxemia associated with viral lung infection, chronic refractory persistent lung infection, and solid tumors, and in preclinical development for autism. We can consider ourselves the preeminent nitrogen oxide company with the investments we have made into nitric oxide research and development. We believe that we have only scratched the surface of the impact nitric oxide plays in human health. We recently secured debt financing of up to $40 million from funds managed by Avenue Capital Group. We believe this additional capital strengthens our position to execute on our strategy for LungFit PH and our other programs. In addition, I believe that securing this capital from a well-known healthcare investment firm with a history of investing in nitric oxide speaks volumes about our programs and the progress we're making. Now, I will turn the call over to our Chief Commercial Officer, Duncan Fatkin, for an update on the LungFit PH commercial launch. Duncan?

Thanks, Steve, and good afternoon to our investors. As Steve just mentioned, we've made steady progress with our commercial launch over the past few quarters. The feedback from hospitals regarding LungFit PH continues to be extremely positive, and we would like to thank all the hospitals and clinical staff that have contributed to this first wave of clinical use. As I mentioned on previous calls, our go-to-market strategy is a multi-phased commercial approach. The initial phase represented a measured release of LungFit PH to a select group of hospitals that use inhaled nitric oxide on a regular basis. During this first phase, we received positive feedback from a variety of different hospitals on our logistics, customer service, and the clinical performance of the device. As a result, several hospitals have signed contracts for LungFit PH. These accounts set an important foundation from which the team will build upon. In regard to our sales pipeline, we're excited about the interest in LungFit PH. As one point of reference, we have conducted more than 150 in-person demonstrations that have resulted in positive feedback and helped to optimize the LungFit PH system, our service and support, supply chain, logistics, and back-office operations. Based on our success to date, we moved into the second phase of our commercial program at the beginning of the current quarter. In this phase, we are expanding our commercial team, both field sales and clinical specialists, and expanding our network of reference hospitals and key opinion leaders. We expect that this will lead to market share gains over the next 10 to 12 quarters before we enter the final phase of commercialization. In closing, we continue to be excited by the growing coalition of hospitals supporting this amazing new technology and believe the program has gathered tremendous momentum to drive future growth. We project the annual value of contract signings over the next six months to be measured in the millions. In addition, a key point to remember is that the customer base and commercial function that we're establishing will support the future launch of LungFit PRO for additional indications for the hospital if and when approved. With that, I will turn the call back to Steve for the pipeline review. Steve?

Thanks, Duncan. I will start with LungFit PH. I mentioned earlier that CE Mark is expected near the end of the next quarter and we expect the FDA submission for the cardiac label expansion before year-end. We continue to execute on our regulatory strategy in our interactions with the FDA and other regulatory authorities, prioritizing as needed. We are confident that both milestones will be achieved. With respect to our VCAP program, we are preparing to conduct a study this coming winter in the United States. This study will not be a pivotal study but a small study that we would expect to lead to a pivotal study. As for LungFit GO, we look to initiate a pivotal study in the first half of 2025, pending discussion with the FDA for NTM. We hope to initiate a pilot study in the second half of 2024 for COPD patients released from the hospital after having been hospitalized for an exacerbation. This is an exciting time for the clinical, regulatory, and engineering teams. Before I move on to Beyond Cancer, I would just like to emphasize that, to date, we have completed multiple studies in several clinical settings where 150 parts per million to 250 parts per million nitric oxide has been delivered to the lungs in more than 145 patients and over 4,500 individual administrations with zero serious adverse events directly attributable to nitric oxide. In addition, strong efficacy trends were seen in multiple studies. This portfolio of clinical data, along with our preclinical data, leads us to believe that exogenous nitric oxide generated and delivered by LungFit will improve the lives of patients. Earlier in the current quarter, we presented impressive new in vivo and in vitro data at the American Association of Cancer Research Annual Meeting. These data suggest that ultra-high concentration NO, or UNO, is effective in treating solid tumors as a single agent and in combination with checkpoint inhibitors such as anti-PD1 and anti-CTLA4. To be more specific, the data shown in mice were in a very aggressive triple-negative breast cancer model called 4T1. An UNO therapy in combination with both anti-PD1 and anti-CTLA4 showed improvements in survival against each checkpoint inhibitor alone. Repeated UNO therapy suggests that repeat dosing is safe and effective. We remain very enthusiastic about our ongoing Phase 1a human clinical study, which is expected to have top-line data later this calendar year. I would like to emphasize that thus far the data from the human study are consistent with the preclinical animal studies with respect to immune biomarkers. Turning to our newest program, neuronal nitric oxide synthase, or nNOS, inhibitors. I would like to thank Dr. Haitham Amal and his team at the Hebrew University in Jerusalem for working with us over the past year. We expect big things going forward. The relationship is focused on what nNOS inhibition can do in neurological disorders and, as stated in our recent announcement, is initially focusing on reversing the effects of autism spectrum disorder. Considering we just held the conference call dedicated to the announcement of this particular program last week, I suggest anyone who didn't listen to the live call visit our website and listen to the archive of the call. I will now turn the call over to Doug Larson, our Chief Financial Officer, to provide an overview of our financial results for the fiscal year ended March 31, 2023.

Thanks, Steve, and good afternoon, everyone. Our financial results for the fiscal year ended March 31, 2023, are as follows: Revenue for the fiscal year ended March 31, 2023, was zero as compared with zero for the fiscal year ended March 31, 2022. I'm very happy to say that this will be the last time you hear me say that revenues are zero. On a GAAP basis, research and development expenses for the fiscal year ended March 31, 2023, were $16.8 million compared with $11.8 million for the fiscal year ended March 31, 2022. The main driver of the $5 million increase was compensation costs from scaling up operations in Beyond Cancer. We also further increased staff in Beyond Air's R&D team, recognized some of the initial work with autism, and had generated costs early in the fiscal year for the final push to get approval for the LungFit for PPHN. Selling, general and administrative expenses for the fiscal year ended March 31, 2023, increased to $34.7 million from $18.4 million for the fiscal year ended March 31, 2022, mainly due to $9.2 million in structural investments in Beyond Cancer, with the remaining $7.1 million mainly driven by the U.S. commercial launch. Other operating expenses for the fiscal year ended March 31, 2023, were zero compared with $10.5 million, which were entirely related to the contingent liability for the Circassia settlement from May of 2021. As a reminder, we paid $2.5 million to Circassia in the second fiscal quarter of 2023, we have another $3.5 million to pay in the second fiscal quarter of 2024, with the final $4.5 million not due until the second quarter of fiscal 2025. Other income and expense for the fiscal year ended March 31, 2023, was a net loss of $7.3 million compared with $3.4 million for the fiscal year ended March 31, 2022. The $3.9 million increase is from a non-product-related legal matter that was previously partially reserved for and resolved in the fiscal fourth quarter. For the fiscal year ended March 31, 2023, the company had a GAAP net loss of $59.4 million, of which $55.8 million or $1.86 per share was attributable to the shareholders of Beyond Air, Inc., compared with a net loss of $43.2 million or $1.68 per share for the fiscal year ended March 31, 2022. Net cash used by the company, including Beyond Cancer, was $37.9 million during the fiscal year ended March 31, 2023. We forecast our average quarterly cash burn to be approximately $10 million per quarter as we head into fiscal 2024. As of March 31, 2023, the company had cash and cash equivalents of $45.9 million. We believe that this amount, in addition to the $17.5 million secured through our agreement with Avenue Capital, is sufficient to fund operations for at least the next 12 months. And with that, I'll hand the call back to Steve.

Thanks, Doug. Hope everyone is as pleased as I am with the execution and progress at Beyond Air. Operator, let's go to Q&A.

Thank you. Our first question comes from Marie Thibault with BTIG. Please proceed with your question.

Hi. Thank you for taking the questions this evening. Very glad to hear that we will be seeing revenue this next coming quarter. We'd love to hear a little bit about how the fiscal fourth quarter went, the timing of some of these contracts that you described us as signing, and what you can tell us about what's taking place commercially in the last couple of months here as you've shifted to phase 2?

Thanks, Marie. Appreciate that. I'm going to turn this over to Duncan, our Chief Commercial Officer, to comment on that.

Thank you, Marie, for the question. The contracts usually have several starting in the first month of a quarter, which creates a specific impact. This allows us to begin some of them slightly earlier. However, the timing of the negotiations did delay us a bit. Nevertheless, this hasn't affected our long-term schedule. From the perspective of learnings, we're receiving excellent clinical feedback. The training has progressed well, and we've improved our training methods and our approach to hospitals. We've also enhanced the software to optimize system performance. While it's fair to say we're somewhat behind our initial targets, some earlier supply chain issues did carry over. We've taken the necessary time to collaborate with our team, who have done an impressive job to keep us on track. Moving forward, we're concentrating on expansion. As noted in the prepared remarks, we plan to grow our team now, as we feel ready to support that expansion, which we were more cautious about earlier in the year.

Okay. That's really helpful, Duncan. Maybe I can ask as a follow-up. How should we think about that commercial sales force expansion? What do you think is the right number for this phase? And how quickly are those folks getting hired? And then, as a second part of that question for Doug maybe, if I look at the SG&A this quarter and exclude the $9 million or so that was invested in Beyond Cancer, I'm getting to about $25 million. Is that the right level that you would have us look at for SG&A here in this next fiscal year?

Hey, Marie. So, it's Steve. I'll take the sales force expansion. So, it's an expansion to what we would believe would be our peak size. And I think we've said that number would be somewhere around 70 to 80 total people. That wouldn't just be sales reps, that would be everybody, clinical specialists and operations, marketing, and so forth. So that will probably take us the next 18 to 24 months to bring those people on in an orderly manner, get them on, train them, deploy them, and go back and bring more people on. So that's how it will happen. We're not in any rush to bring the people on in one big fail swoop like maybe a much larger company might do. So this is a good 18 to 24 month exercise that we've begun to go from a sub-20 number and multiply that by 4x to 5x. I don't know, does that answer your question, Marie?

That does. I wonder if Doug could comment on the $25 million in spend this quarter and what it might look like going forward.

The annual figure is $25 million if we exclude Cancer. The $9 million represents an increase compared to last year. It's not just the absolute number we should focus on. Last year, we had three months of Cancer, but this year we have 12 months. It's important to note that we will keep integrating Cancer into our overall numbers. I’m not sure if you’re trying to separate those figures, as it could be a bit complex. We can discuss that further if you'd like.

Okay. Certainly. Happy to follow-up later. Thanks for taking the questions.

Thanks, Marie.

Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Hi. Thanks for taking the questions. Just staying with the LungFit PH, I guess, now that you've completed phase 1 of the launch, can you tell us a little bit more about what you accomplished in phase 1, specifically maybe some more detail around the number of contracts? And then, with that, what we should look for as you now launch into the second phase of the commercial program here?

So, Matt, I'm going to let Duncan talk about what we've learned and what's going to help us going forward. But with respect to the number of contracts, I mean, we did state that we had multiple contracts that have been signed. I would say that the number as we see here today is less than 10. So, we're looking at a single-digit number of contracts. And going forward, obviously, we expect that number to increase quite dramatically over the next four to six quarters. I mean, as we bring more people on and we are able to handle more volume of customers, it is going to increase significantly. And that was always the plan with our three-step process towards this launch as we've had in our slides for the past 18 months and we've been stating on every quarterly conference call that phase 1 would be where we learn and make sure everything we have is up to speed, ready to go to expand. And now we're in phase 2 where we're going to expand our team and start to take some serious market share. It's how I look at it. But Duncan, do you want to comment on what we've learned in phase 1?

Yes. Thanks for the question, Matt. So, I mean, our focus has been on making sure that the logistics smooth, the clinical performance is as we'd expected, and the training and everything associated with that continues to go well, which we definitely feel good about that. Certainly, the feedback continues to be that our system is very simple to use and it doesn't take too long to do the training. We've been refining some of our programs because in the simplicity and ease, sometimes actually a lot of the clinicians using the device don't spend as much time as we'd like them to. And so, we kind of do some remedial work. And so, we refine our program. We certainly also understood better the profile of the hospitals that we need to go to, to make sure that we pick the ideal locations and the ideal partners, which is why we took our time to go to a variety of different types of hospitals. So from our perspective, that probably the main learnings, nothing that has been shocking to us, and definitely some optimization that we've done with the device. So, we're pleased with what we've learned and now we can really start to expand with, I'll call it, much more confidence.

Okay. And I guess with that, how should we think about the contracts converting into revenues over time as you add?

So, Matt, most of these contracts are going to be annual. So, if we sign up $600,000, it's going to be $50,000 a month or $150,000 a quarter. So, as you sign them, they start to build upon themselves, right? So that's how they're going to translate. We don't get the cash upfront, we don't book the revenues upfront, right? So this is an annual contract that's spread over four quarters. So, as we got a bunch this last quarter, we'll get a bunch next quarter, so they'll build on each other and then the next quarter and it'll just keep piling on top. And the more we expand our team, the more people we get trained and out there, the more volume we can have. So every quarter should get better and better from the previous quarter in terms of not just the number of contracts but the size of those contracts we're able to handle larger hospitals as well as we get bigger.

Okay. And just shifting gears to Beyond Cancer. You mentioned that you're going to have a phase 1 data later this year. Can you give us some more detail in terms of how many patients and what we should be looking for in that data from Beyond Cancer later this year?

Yes. I don't have the exact number of patients we'll be showing, but it's likely around 10, give or take a few depending on the cutoff. As I mentioned earlier, this is a safety study, so our main focus will be on safety, which is the priority at this stage. However, we also want to understand the effects on the immune system. In previous studies with mice, we've observed positive outcomes in immune markers, which you can find on the Beyond Cancer website. We're seeing similar activity in the immune biomarkers from the patients we have data on so far. Therefore, the key indicators to monitor will be safety and these immune biomarkers to help predict efficacy in the future. We're quite excited about the progress and eager to showcase the results, but we need to complete a few more patient assessments and consolidate the data with our statisticians before we can share it.

Okay. Very good. And then last question and then I'll jump back in the queue. LungFit PRO, you mentioned in your prepared remarks that the next study that you plan to launch will be a pilot study. What do you hope to learn from this pilot study prior to moving into a pivotal study with the program in the viral pneumonia setting?

The purpose of this pilot study is to provide reassurance to the FDA and some of the sites we have engaged with regarding safety, ensuring they feel comfortable treating their patients. Since there is limited literature on the specific endpoints we are examining, this study will also allow us to refine our statistical package for the primary endpoint we are targeting. Essentially, this serves a dual purpose: enhancing safety confidence—not that we lack it; we are quite assured in safety based on our publicly shared data—and helping us gain insights into the primary endpoint, thus boosting our confidence in determining the appropriate size for our study.

Okay. That's great. Thanks, Steve.

Thanks, Matt.

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

Good afternoon, and thanks for taking the questions. For the LungFit PRO, I'm sorry, LungFit PH, you mentioned that you have a number of contracts. So, should we anticipate that you report that as the group later on in the next earnings call, or should we anticipate that you will provide some update between this call and the next call in terms of several contracts being signed?

Thank you, Yale. Since the start of the fiscal year at the end of June, and with our report coming early in August, there's about a six-week gap. I'm not sure how much of an update there will be during that time. Based on the number of contracts we've signed, we may see a few more by August, but it won't be a significant change in such a short period. However, we will be making progress, and I expect a more substantial difference when we report in November. This period is just very close to the fiscal year end and the beginning of the first quarter.

Understood. That's helpful. I have one more question regarding your expectation for a CE Mark later this year. Is there any update on potential partnerships outside the U.S. as of now?

Yes, I mean, we're getting close to CE Mark. So the conversations are certainly progressing with ex U.S. partners now that we kind of see the light with CE Mark. But again, we don't have it in hand. So I think we will have it in hand in September, maybe October timeframe. So I think that our talks will heat up and we'll probably see some kind of a partnership in short order after we get the CE Mark in hand. So, we're pretty comfortable with the profile of the product. I think that our potential partners have seen this profile of the product. They're pretty happy with it. So things are moving along. I mean, Duncan is with me as well, I don't know if he has anything else to add, but...

No, I think that the timing obviously is associated with the CE Mark and there's really nothing that should slow us down. So from my point of view, there's no product issue. It's all about this timing coinciding with CE Mark availability.

Okay. I have just one last question regarding the UNO in cancer. I want to confirm that all the studies conducted so far are in combination, specifically the UNO plus the checkpoint inhibitor. Is that correct? Or are there any single-agent studies for pharmacokinetics and other aspects?

Well, yes, I mean, there's no PK obviously because it's not a systemic therapy. But yes, I mean we've done multiple studies with monotherapy and even the combination studies that we reported on all had monotherapy arms as well. So, there's plenty of monotherapy data. And of course, the first in human study is monotherapy. So I mean, you can go to the Beyond Cancer website and see all that data. It's all there. It's all out in the open and public. And I encourage you to call the CEO of Beyond Cancer and have a chat with her, and she can walk you through everything. But, yes, there's a lot of monotherapy data, and it's obviously very positive.

Right. The human study is currently focused on the single agent scenario.

That's very helpful. Thank you so much. I really appreciate it and congratulations on the progress. I look forward to seeing the figures soon.

Thank you. Our next question comes from Suraj Kalia with Oppenheimer. Please go ahead with your question.

Steve, can you hear me all right?

Yes, I can, Suraj.

Perfect. Good afternoon, everyone. So couple of questions, one for Duncan and one for you, Steve. So, Duncan, let me start out with you. So appreciate some of the color you all have provided on a contract. Maybe if you could expand on it a little bit more? Like, what does the contract really mean in terms of exclusivity, average revenues, utilization? Is $600,000 the right bogey to think about? And the sub part of that question, Duncan, would be 150 demos for PH, consensus estimate for the next year is $19 million from what I see, is that the right way to think about it? The bogey you need is at least, let's say, 35 to 40 sites.

Yes, Suraj. I used $600,000 as an example, but that figure is arbitrary. I could have mentioned different amounts like $300,000 or $120,000, and it was just a simple calculation. Don't read too much into that number. Regarding hospital contracts, they imply exclusivity since we have the contract with the hospital and are the only provider there. Our competitors hold contracts in their respective hospitals where they are the exclusive supplier of nitric oxide. This market doesn't allow for dual supply, meaning a hospital won't have two separate machines for nitric oxide. It's a unique situation in the medical device sector. As for the size of contracts, we've previously mentioned that the market consists of around 1,000 to 1,100 hospitals, representing a market value of approximately $350 million to $400 million. You can determine the average contract per hospital if you want to calculate it. We've been transparent about the number of hospitals and the market size, allowing you to estimate an average contract size. So, please don't interpret the numbers I provided in any specific way. Duncan, do you have anything to add regarding the other points?

Yes. Steve explained the dynamics, but from a contractual perspective, we mentioned earlier that the revenue will be distributed over the annual monthly rate, which will be one-twelfth of the contracts. The contracts will vary based on the size of the hospitals. Unfortunately, each hospital is unique, making it difficult to predict our averages due to the many variables involved. However, the positive aspect is that once we secure these contracts, they tend to build on themselves, similar to an annuity, and we won't need to renew until the contract ends. As we expand, that growth will begin to compound.

And Suraj, I'll comment on your consensus question if you'd like. I don't think consensus is $24 million or whatever you said. But yes, we've given guidance as best we can in conversations with analysts about how our business works, and they make their own decisions on what they're going to put in their models. So we're not going to control what you want to put into your model in any way, shape, or form. But we have certainly not intimated in any way that this is going to be a massive launch of any size that this is more of a slow build every quarter we add hospitals and we build and we build and we build. And as we build and get more people, it starts to accelerate later on. Maybe four, six, eight quarters from now you'll see a pretty big acceleration. This is what we've been saying. We are consistently saying it. So I know there's somebody out there with a number that's close to $20 million for fiscal '24. I don't know why anybody would consider that a rational or reasonable number based on what we've been saying prelaunch and since the launch. But again, everybody's got their own way of analyzing the market.

Got it. Steve, for my final question, I’ll combine a couple of them. In your prepared remarks, you mentioned the insights gained from the sites regarding nitric oxide. I would like to know what additional gap you identified as you move into phase 2 of the commercial launch. Also, Steve, looking at the bigger picture, with multiple programs happening, how do you assess the return on investment for the commercial launch of PH compared to ASD and other programs? Please walk us through your thought process and what you believe offers the best ROI.

Sure. Thanks, Suraj. I'll address your first question. We had a complete understanding of nitric oxide when we launched this program. What we were building was our own customer service model, which operates around the clock. This type of product is unprecedented, making it new territory for any logistics provider. We assembled a highly intelligent and experienced team specializing in nitric oxide, but they still need to develop their teamwork. Our machine is currently approved by the FDA and functioning well. There are always adjustments to be made, particularly to ensure compatibility with ventilators. However, we couldn't implement those changes during the FDA review process since the design was finalized, and we have to collaborate closely with the FDA regarding what we submitted. Modifications typically occur later when we can adapt our approach based on feedback from ventilator manufacturers. This is standard practice in the medical device industry, especially for a PMA product. We were in a learning and refinement stage, including how we manage contracts and respond to customer feedback. Until we received FDA approval, conversations with customers were limited. Our approach mirrors that of other companies in the sector, though larger corporations may move slightly quicker due to their extensive infrastructure. The initial six to nine months were crucial for our learning process. Regarding our approach to ROI, there are numerous methodologies we can employ. In my view, nitric oxide represents an untapped area in medicine, a sentiment shared by most at Beyond Air. There are considerable developments occurring within nitric oxide, particularly in neuro-related fields like autism. This focus does not detract from our primary goal, which is the commercial launch of our product. Beyond Cancer remains focused on its cancer program; that's why we established it as a separate entity to minimize its impact on Beyond Air. We wanted to ensure dedicated management for that initiative. Autism represents a new area for us, distinct from our primary offerings of LungFit PH, LungFit PRO, and LungFit GO, and it is still in the early stages. We appreciate Dr. Amal's work at Hebrew University, which is quite unique. We hope that once we initiate human trials, we can achieve results similar to those seen in animal studies. Currently, the program is not costly and doesn't require significant personnel commitment. As we progress over the next 12 to 18 months, expenses may increase, as discussed in our recent presentation. This increase will not significantly burden our commercial team or those who support them, as the autism team involves statisticians, pharmacologists, and scientists who are not participating in the commercial launch. Personally, I'm dedicated and willing to allocate extensive hours to this initiative. While it's a large program, it remains in its early phases. In about 12 to 24 months, as we move forward with human studies and start obtaining results, it may demand more attention and focus, at which point the ROI will be crucial because we don't want it to interfere with our other projects. We’ll assess the progress as we go. We recognized that cancer was a substantial undertaking at that time, so we transitioned it to a dedicated team of cancer specialists. Currently, I don't believe autism has reached a level that necessitates specialized expertise in that area. However, our new Chief Medical Officer has significant experience in nitric oxide, having completed his PhD thesis on the topic and worked in various neurological spaces, contributing additional support to Dr. Amal and his lab, along with other team members. This is how we envision the program moving forward. If any project threatens our commercial launch, we will prioritize and defer any conflicting efforts.

Appreciate the color.

Sure.

There are no further questions in the queue. I'd like to hand the call back to Steve Lisi for closing remarks.

I'd like to thank everybody for joining us today. Thanks for keeping track of us, and we hope to give you some more good news as we go forward. Thank you.

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.