Q4 2023 Beyond Air Inc. Earnings Call
[music].
Good afternoon, and welcome everyone to the beyond their financial results call for the fiscal year ended March 31 2023.
At this time participants are in a listen only mode.
<unk> and answer session will follow the formal presentation.
And now I would like to turn the call over to Edward partner 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.
Copy of this press release can be found on our website www dot beyond their dot net under the news and events section.
Before we begin I would like to remind everyone that we will be making comments and various remarks about future expectations plans and prospects, which constitute forward looking statements for 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 identify specific factors that may cause actual results or events to differ materially from those described in the forward looking statements.
Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website www dot beyond their dot 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 22023.
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 Bakken, 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 two of our commercial launch.
This is an exciting time for us as we have visibility into what the P. P. H N 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.
Lung fifth ph has been well received in the market, 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 back and we'll have more on this in a few minutes.
Outside of lung fifth th commercial operations, we have been very busy and I am proud of what the beyond air and beyond cancer teams have accomplished.
Lungfish ph cardiac label expansion application will be submitted before the end of this calendar year to F. D. A.
This is later than we had hoped but we wanted to be certain that the application is high quality and well satisfy FAA requirements.
We also expect CE mark in the EU for lung for ph late next quarter.
We anticipate lung fit pro will be used in a community acquired viral pneumonia study in the United States This coming winter.
Lung Pico is scheduled for an at home COPD study start in 'twenty 'twenty, four and N P. M in 2025.
Beyond cancer anticipates phase one a data this fall as announced last week, we now have another N O related program autism.
Please refer to our announcement last week for details.
Our portfolio consists of programs, where <unk> was approved to treat acute pulmonary hypertension newborns is in human studies by 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 pre eminent N O company with the investments we have made into in our research and development.
We believe that we have only scratched the surface of the impact and I'll place 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 lung for ph and our other programs.
In addition, I believe that securing this capital from a well known health care 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 backing for an update on our lung could ph commercial launch okay.
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 <unk> continues to be extremely positive and we would like to thank all of 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 lung <unk> ph to a select group of hospitals to use inhaled nitric oxide on a regular basis.
During this first phase we received positive feedback from a variety of different hospitals on a logistics customer service and the clinical performance of the device.
As a result, several hospitals have signed contracts for lung fifth ph.
These accounts, that's an important foundation from which the team will build upon.
In regard to our sales pipeline, we're excited by the interest in <unk> 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 lung <unk> 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 in 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 hospital supporting this amazing new technology.
We 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 to we're establishing will support the future launch of long trip proud 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'll start with lung fit 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 yearend.
We continue to execute on our regulatory strategy and 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 recap 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 stunning that we would expect to lead to a pivotal study.
As for lung could go we look to initiate a pivotal study in the first half of 2025 pending discussion with the F D. A.
A N T M.
We hope to initiate a pilot study in the second half of 'twenty 'twenty four 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 be on cancer I would just like to emphasize that to date, we have completed multiple studies and several clinical settings, where 150 parts per million to 250 parts per million nitric oxide has been delivered to the lungs and more than 145 patients.
4500 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 lung fit 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 N O or Uno is effective in treating solid tumors as a single agent and in combination with checkpoint inhibitors, such as anti PD, one and anti <unk> four.
To be more specific the data shown in mice, where in a very aggressive triple negative breast cancer model called 41, and Uno therapy in combination with both anti PD, one and anti C. T O four 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 one a human clinical study, which is expected to have topline 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 <unk> inhibitors, I would like to thank Dr. <unk> 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 en masse 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, but 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 what's the compensation costs from scaling up operations and beyond cancer.
We also further increased staff and beyond Air's R&D team recognize 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 lung fit for P. P. H N.
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 and structural investments and 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 surpass yet 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 from our non product related legal matter that was previously partially reserved for and result 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.
<unk> 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.
We believe that this amount in addition to the $17 $5 billion 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 it beyond there.
Operator, let's go to Q&A.
Thank you, ladies and gentlemen at this time well be conducting a question and answer session.
If you'd like to ask a question you May press star one on your telephone keypad.
A confirmation tone will indicate your line is in the question queue.
You May press Star two if you would like to remove your question from the Q4 participants using speaker equipment. It may be necessary to pick up your handset before pressing the star key.
Our first question comes from the line of Marine I bought with BTG. Please proceed with your question.
Hi, Thank you for taking the questions. This evening.
I'm very glad to hear that we will be seeing revenue. This next coming quarter would love to hear a little bit about how the fiscal fourth quarter went and the timing of some of these contracts that you describe this as signing and what you can tell us about you know what's taken place commercially in the last couple of months here as we are as you've shifted to phase two.
No.
Thanks, Marie appreciate that I'm going to turn this over to.
Duncan our chief commercial officer to comment on that.
Thanks, Larry for the question so.
The contracts typically there's a quite a few that start in the first quarter. Our first month of a quarter and so you get that kind of effect and so we fought to get some of these to start a little bit earlier.
The timing of the negotiations and the way that kind of fell just pushed us a little bit.
Further, but certainly nothing that's put us off a long term schedule.
From a lending point of view, we continue to get really good clinical feedback.
Training is going really well and we've refined the way we train and go to the hospitals and we've certainly made some improvements to the software to make the system work, even better than it has been.
It is certainly fair to say that we're a little bit behind where we wanted it to be some of the supply chain challenges from.
Earlier in the fiscal year kind of flowed through and we've taken our time to work with our team and they've done an amazing job actually to make sure. We can stay close to where we need to be and going forward. We are focusing on expanding and as you can see from the prepared remarks, we are going to increase the the team now because we feel like.
We're ready to support that expansion is something that we were a little bit more cautious about earlier on 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, but what do you think is the right number for this phase and you know how quickly either folks getting hired and then as a second part of that question for Doug maybe.
Look at the SG&A this quarter and exclude the $9 million or so that was investment 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 the next fiscal year.
Yeah.
Hey, Maury, so Steve I'll take the sales force expansion so.
It's.
It's an expansion to what we would believe it would be our peak size and I think we've said that number would be somewhere in <unk>.
70 to 80 total people that wouldn't just be sales reps that would be everybody clinical specialists in operations marketing and so forth.
So that will probably take US you know the next 18 to 24 months to bring those people on in an orderly manner get demand 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.
And one big failed swoop like maybe a much larger company might do so.
This is <unk>.
18 to 24 month exercise that we've begun to go from a sub 20 number and multiply that by four to five X.
Is that does that answer your question Murray.
That does that does I wonder if you could comment on the you know the 25 million of them spend this quarter and what it might look like going forward.
And so $25 million is the annual annual number if you pull out a cancer so that was.
The 9 million is an increase versus last year. So it's not the absolute number that we're looking at right. We did have three months of cancer last year.
We've got we've got 12 this year keep in mind that we are going to continue to consolidate cancer into our numbers as well.
So.
I don't know if youre trying to pull those numbers apart.
It might be a little bit tricky, we could maybe follow up on that one.
If that works.
Okay. 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, Yeah, thanks for taking the questions.
Just staying with the bond said ph I guess now that you completed phase one of the launch can you tell us a little bit more about what you accomplished in phase one.
Specifically, maybe some more detail around the number of contracts.
And then with that what you should what we should look for as you as you know launching to into the second phase of the.
Other commercial program here.
So Matt I'm going to let Don can 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 had been signed.
I would say that the the number as we sit here today is less than 10. So we're looking at single digit number of contracts.
And you know going forward, obviously, we expect that number to increase.
Now quite dramatically over the next four to six quarters I mean, as we bring more people on and we.
We're able to handle more volume of customers. So it's going to increase significantly and that's.
That was always the plan with our three states step process towards this launch is as we've had it in our slides for the past 18 months and we've been stating on every quarterly conference call. It phase one would be where we.
Yes.
Learn.
And make sure everything we have is up to speed ready to go to expand and now we're in phase two where we're going to expand our team and and starts it takes some serious market share.
So that's how I look at it but Duncan do you want to comment on what we've learned in phase one yeah. Thanks for the question, Matt. So I mean, our focus has been on making sure that the logistics are smooth the clinical performance is as we'd expected in the training and everything associated with that.
<unk> continues to go well, which we definitely feel good about that.
Suddenly the feedback continues to be the system is very simple to use and it doesn't take too long to to do the training we've been refining some of our programs because in the <unk>.
Simplicity and the 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 through 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's 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 would call it much more confidence.
Okay, and I guess with that how should we think about the contracts converting into.
Revenues.
Overtime.
So Matt you know.
Most of these contracts are going to be annual so you know if we.
If we sign up.
No.
601000, it's going to be 50000 a month.
Or or 150, a quarter. So as you sign them they start to build upon themselves right. So that's how they are going to translate we.
Yeah.
We don't get the cash upfront, we don't book the revenues upfront alright. So this is an annual contract that spread it over four quarters.
So as we we got a bunch of this last quarter, we will get a bunch of the 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.
More volume.
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.
Just shifting gears to the beyond cancer.
You mentioned that you're going to have a phase one 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 and that that Donaldson beyond cancer. Later this year.
Yes, so I don't know exactly how many patients will be will be showing but.
It's going to be.
I don't know.
Give or take 10 patients maybe a few less maybe a few more it'll it'll depend on the cutoff.
You know and I said in the prepared remarks that.
It's the immune biomarkers that debt from an efficacy standpoint, as you know Matt There's a safety study so we'll be looking for safety.
And that's the most important thing at this stage, but we do want to understand what's happening to the to the immune system. So I mentioned in prepared remarks that.
What we saw on the in mice, which we've shown several studies in mice.
And you can see on the <unk> website, what would what the immune.
Markers have done going in the direction that we expect them to go and buy arming the immune system against these tumors.
We're seeing similar activity in the immune Biomarkers currently in the patients that we have data on so far.
So I think that's what you want to look for safety and these these immune biomarkers to see if we're able to.
Predict efficacy going forward.
So we're pretty excited about it I can't I can't wait to show it but you know we'll have to wait until we complete a few more patients can we get the data in house and we get our statisticians to to.
Put that data together, so we can we can share it with you.
Okay. Okay.
And then last question and I'll jump back in the Q1 set a pro you mentioned in your prepared remarks that the next study that you plan to launch.
We'll 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 end the final pneumonia study.
So I think we.
The purpose of this pilot study is too.
Give comfort.
Two F D a and to some of the sites we've spoken to that.
The safety is there and that they feel very comfortable treating their patients and since this is not really a <unk>.
The study that we can go in and the literature and see these types of endpoints that we're looking at this study will also give us the ability to.
To optimize our stats package for the primary endpoint that we're targeting so I think it's twofold. There and then if you could give a little more comfort on the safety side.
Not for US, we're very comfortable on the safety side as you see from all the data that we've shown publicly.
But it will help inform us on.
The primary endpoint and give us a little bit more.
Confidence in sizing study.
Okay. That's great. Thanks, Thanks, Steve.
Thanks, Matt.
Our next question comes from the line of Yale Jen with Laidlaw <unk> Company. Please proceed with your question.
Good afternoon, and thanks for taking the question.
For the lung.
Cole.
Got it.
T H.
You mentioned that you will have.
A number of the contract.
So should we anticipate that you will report that.
Sure.
Group later on in the next earning call or are you or should we anticipate that you will provide some update between this call and the next call in terms of like you'd get.
Several contracts being signed.
Thanks Yale.
Since the start of fiscal year end or at the end of almost at the end of June and we are going to report early in August it's about six weeks' difference between now and then.
So I don't know how much update there will be.
You would anticipate that base.
Based on.
The number of contracts we have.
We've signed where they'll probably be a few more by by do we get there August but it's not going to be.
A material difference in six weeks so.
But again, we will be making progress I think that you know.
There should be a material difference when we report in November for sure. Just these are very tight our fiscal year end and fiscal first quarter.
Understood that's helpful and one other thing in terms of.
Okay.
Are you expecting a CE Mark later this year and the question is that beforehand.
There is a discussion in terms of partnering.
Ex U S.
Any updates on that front that's up now.
Yeah, 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 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 our talks will heat up and we will probably see some kind of a partnership and in short order. After we get the CE Mark in hand so.
We're pretty.
Pretty comfortable with.
The profile of the product I think there are potential partners have seen this profile of the product, they're pretty happy with it so.
You know things are moving along well.
Yeah.
I mean does it doesn't worry 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 is no product tissue, it's all about.
Yes.
Timing, coinciding with CE Mark availability.
Okay, maybe just last question here, which is the window into cancer.
I just want to confirm that all.
All of the studies.
Studies so far.
Is there any combo in other words.
Plus the kept one inhibitor is that correct or.
Are there any is the single agent study.
For the full Oh.
PK and other aspects.
Well, yeah, I mean, theres no PK, obviously, because it's not just it's not a systemic therapy, but yes, I mean, we've done multiple studies with mono therapy and even the combination studies that we reported on all head monotherapy arms as well so there's plenty of monotherapy data.
Of course, the first in human study as monotherapy.
So I mean, you can go to beyond cancer website, and see all of that data and so 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 yeah theres a lot of monotherapy data and it's obviously very positive.
Right right I'm, just talking about the human studies that are currently still.
It is indeed.
Oh, we can harvest so.
That's very helpful and well thanks, a lot I really appreciate that and congrats on the progress and looking for you to see the figures.
Not too long from now.
Thanks, Yeah I appreciate it.
As a reminder, it is star one to ask a question. Our next question comes from the line of Suraj Kalia with Oppenheimer. Please proceed with your question.
Steve can you hear me all right.
Yes, yes, I can suraj.
Good afternoon, everyone.
So a couple of questions one for Duncan and one for you Steve So Duncan let me start out with you.
Appreciate some of the color yellow provided on a contract maybe if you could.
Spend on it a little a little bit more like what does the contract really mean in terms of exclusivity.
Average revenues utilization is 600000, the right bogey to think about.
The subpart of that question Duncan would be 150 demos for pitch.
Consensus estimate.
For the next Euro as is $19 million from what I see is the right way to think about it.
The bogey you need as a key let's say 35 to 40 sites.
Yes, Suraj I used 600000 as an example, that's got nothing to do with anything I could have said 300, I could've said.
20010, 10000, a month I mean that was just a simple math exercise I wouldn't read into that number at all in any way shape or form.
And hospital contracts of course mean exclusivity we have the contract with the hospital, we're the only one there and our competitors where they have their contracts. They are the only player with nitric oxide in those hospitals.
The game this.
There is no supply in the nitric oxide market you don't have to separate machines in the same hospital, it's quite unique in the medical device arena.
So and as for size of contracts, we've said in the past that.
With this market you've got about <unk>.
Hospital is Lebanon or hospitals, or so it's a $354 million market and you can do the average contract per hospital, if you really want to do the math so.
That's the best way to look at it I mean, we.
Been pretty clear on number of hospitals size of the market you can back into and average contract size. So please don't take the numbers I gave you in any way to mean that.
So Duncan did you want to comment on any of the other point I think that the so Steve obviously explained the dynamics, but from a.
Sort of contractual point of view, specifically I think we said earlier, it's going to be.
Spread over the annual.
Unclear right, it's going to be at 12% of the contracts and the contracts are going to very much depend on the size of the hospital. So unfortunately, it's kind of you've seen one hospital and you've seen one hospital. So it really depends on how they land it's hard to predict what the average for us will be because so many variables in each specific hospital, but the good news is.
Once you get them.
It's a little bit like an annuity kind of like builds on itself and.
You don't have to kind of a repeat until the contract's up so as.
As we grow that growth will start to compound.
And so right and I'll comment on you got your consensus question, if you if you'd like.
I don't think consensus has $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 there in their models.
So.
We're not going to control.
What you want to put into your model in any way shape or form.
<unk>.
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, when we build and we build and we build and as we build and get more people it starts to ask.
To accelerate.
Later on you know, maybe 468 quarters from now Youll see a pretty big acceleration. This is what we've been saying consistently saying it so.
No there's somebody out there with a number that's close to 20 million for fiscal 'twenty four.
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 final question I'll just bunch.
Couple of them together. So you in your prepared remarks, you talked about the sites.
And then maybe I'm paraphrasing here the knowledge gained from these sites about Uno.
To understand what was the incremental gap youll identified as you'll get into phase II of commercial launch.
Specifically steep of a broader question or rather a high level question.
Multiple programs going on right and we appreciate the color on the progress.
On all of these how do you you and your vantage point right sit then decide on the R y.
On the commercial launch of our P etch versus.
S D versus you know other programs just kind of walk us through how you are thinking about it.
From your vantage point, what makes more sense from an ROI perspective, gentlemen, thank you for taking my questions.
Sure. Thanks Suraj so.
You know I'll I'll address your first question, there's no gap in our knowledge about nitric oxide. When we launched this program. It was more of where we are a company that's putting together.
Our own.
Customer service, which is 24, 7%.
Logistics no one's ever had a product like this so it's brand new to any logistics provider.
Putting together a team that hasnt been together before highly intelligent highly experienced nitric oxide people would they still need to gel as a team our machine while coming through FDA has approved and working great. There are always tweaks you can make there are always modifications to ventilators would need to be compatible and we couldnt do that while we were going through FDA because.
The design is frozen and we need to work with FDA on what we've given them you don't make changes until later when you can try to adapt and work with ventilators. I mean this is normal this is classic for the medical device space and especially for a PMA product. So those are the things that we were learning and honing in on the <unk>.
Way we contract.
Listening to the customer and adapting to their needs really couldn't talk to them until we got approved so this is pretty standard.
I don't think we did anything different than other companies would do except maybe.
Massive company might've been a little faster than us.
The infrastructure, but it's pretty standard and that's why we needed that six to nine months of that first phase, where we were learning.
As for how we do our ROI boy, there's a lot of different ways to our OE. I mean, you can you can approach it in many different ways.
So there's a lot going on in nitric oxide, it's an untapped.
Part of of Medicine in my opinion and the opinion of.
Most if not everyone it beyond there.
There's a lot going on with nitric oxide as you can see in the neuro space now with autism.
This is not something in our opinion that takes away from the focus on the launch of the product that is our number one focus is our commercial launch by far.
And for beyond cancer, there number one focuses cancers, that's why we.
We spun that.
That program out into its own company, because we didn't want to have.
There'll be an impact on our.
Beyond air activities. So that's why it was separately funded and Thats why Theres, a whole management team and group of people. They are doing an amazing job.
So really I guess autism as the new Kid on the block so to speak that is different than what beyond their proper is doing with lung <unk> ph lung quid pro amongst it go and this is obviously very early stage it was a great opportunity with.
We love what Doctor amount to Hebrew University is done.
Very unique and really we hope that when we get into humans, it's going to bear itself out as it did in the mice. If it does we can really make an impact and make a difference so.
This is not a very expensive program at this point it doesn't take a lot of our people at this point as we go forward over the next two.
<unk> months to 18 months there'll be a little bit more expense, which we talked about last week. When we told everyone. About this program and you can refer to that presentation.
And it's still not that much of an incremental hit to the people on our team, especially on the commercial side, It's got nothing to do with the commercial team at all.
And the people who support the commercial team they have nothing to do the ones, who work with autism, we have statisticians and pharmacologists and so forth and scientists, they're not doing anything for the commercial launch so yeah, it's a little bit maybe extra for me, but you know I like to work 100 hours a week so.
Not a big deal for me I've got to fill my time somehow.
So this is a big.
Program, but it's early stage.
Perhaps in 12 to 18 months or 18 to 24 months when we're in a human study and we're getting results then it might take on a little bit more of a need and more focus and that's when the ROI really needs to be discussed.
I don't want to take away from the other programs, but we'll see when we get there we'll see how this program progresses.
So that's kind of how we look at it cancer, we realized was too big for our bridges and at that time, and we moved it over.
Have a great team run it who people who are cancer experts in this situation I don't think autism has risen to the point, where we need so called autism experts or neurological expertise, although I would like to point out that our new Chief Medical Officer certainly.
We've done a lot of work and nitric oxide actually do ph D thesis and nitric oxide way back in the day. When he was younger and has done work in neurological space with respect to matrix M has done work in other newer areas that are non nitric related show.
That we have on our team. So again, that's kind of how we look at it and if there's something that's going to impact our commercial launch we just defer we don't we don't take it we don't bring it in house is not worthy.
I appreciate the color.
Sure.
There are no further questions in the queue I'd like to hand, the call back to you Steve Lindsey for closing remarks.
I'd like to thank everybody for joining us today. Thanks.
Thanks for keeping track of us and we hope to.
Give us 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.