Q2 2022 Beyond Air Inc Earnings Call
[music].
Good afternoon, and welcome to the beyond Air financial results call for the second quarter of 2022.
We ended September 32020.
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 Young Penske.
That's the relationship beyond there please.
Please go ahead.
Okay.
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 dot beyond their dot net. Furthermore, the content of this conference call contains time sensitive information that is accurate only as.
As of the date of the live broadcast November 11th 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 King, Our Chief Commercial Officer, and Douglas Larsen, our new Chief Financial Officer with that I will turn the call over to Steve.
Please see 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'm excited to share our recent highlights with you as well as provide some insights on how we think about our active portfolio management strategy.
Most significantly we recently announced the separation of our oncology business to 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.
And I will talk about the future plans for our affiliate in greater detail in a minute.
First I.
I wanted to give a quick update on our pending PMA application for the lungs with ph system to treat persistent pulmonary hypertension of the newborn or P. PHN.
We are very pleased with our ongoing communication and progress with FDA. We will continue to provide F. D. A with any and all information and support they need to grant approval for our lung fifth th.
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 Mark in Europe.
We anticipate receiving CE mark in the first half of calendar 2022.
I would defer to our chief commercial officer Duncan backing 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 tuberculosis mycobacteria or MTM pallet study using the lungs could go device.
As you May recall, we began screening patients for this trial in December 2020 in Australia.
Quite some setbacks due to the difficult COVID-19, lockdown environment in Australia, the beyond air team at our Australian colleagues have been doing an outstanding job navigating these challenges.
At the time of data cutoff on September six we had a total of eight refractory MTM patients enroll all of whom have been titrated up to the maximum dose of 250 parts per million nitric oxide with no dose reductions.
No study discontinuation and no treatment related serious adverse events reported.
Our knowledge 250 parts per million is the highest concentration of inhaled nitric oxide that is.
Never 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 N O. Because all subjects remained within the acceptable safety ranges from the hemoglobin levels and N O two concentrations below 10% and five parts per million respectively.
Attribute the success to the intermittent dosing regimen, which allows for high concentration and how it can be administered without negative effects.
Enrollment continues and we anticipate reporting full safety and efficacy results in 2022.
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 Longford gas system.
Moving onto our viral lung infection program, which uses a lumpy process at 150 parts per million N O to treat acute viral pneumonia in adults and bronchial Edison children under two years of age.
Our pilot study in adult Brown pneumonia, including COVID-19 remains active with trial sites open for enrollment our planet just submit the entirety of the data at 150 to 160 parts per million in both hospitalized adult and infant viral pneumonia patient populations as one comprehensive data package to the FDA.
We'd like to move to a pivotal all comer trial for lumpy CRO in patients hospitalized with viral pneumonia and anticipate.
Pending agreement with FDA, starting this study in the fourth quarter of calendar year 2022.
<unk> 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 bronchiolitis and they were consistent positive signals for both safety and efficacy in those trials.
A total of 198 infants who enrolled in the three trials in our third study provided statistical significance 150 parts from a dose four times per day for up to five days, which compared to standard of care or $85 million and all about that.
Primary endpoint of fit to discharge from the hospital and the key secondary endpoint of hospital length of stay.
The adult viral pneumonia trial to date, we have presented data on 19, COVID-19 patients.
2021 American thoracic Society meeting in May 2021.
And we showed data consistent with what we're seeing in the bronchiolitis studies.
Finally I.
I will discuss our oncology business and the decision to spin it out into beyond cancer.
Yes College program has always existed outside of the lung fit platform due to the ultra high concentrations of nitric oxide that are required to achieve anti cancer properties.
We have developed a proprietary device that a single treatment can deliver up to 200000 parts per million.
Directly to a solid tumor site.
Called this therapy for ultra high concentration metric oxide.
Based on our current preclinical findings, we move therapy may not own partially oblique or shrink tumors locally.
But also can army immune system to recognize and attack the same tumor type wherever it may reside in the body.
Clinical data show that treating a tumor with immune therapy 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 as surgery cytotoxic chemotherapy radiotherapy or a combination of all three.
In recent years immuno modulating therapies have shown promise and improving outcomes. The hematological cancers, a significant unmet need remains in the treatment of solid tumors.
Solid tumors represent approximately 90% of adult human cancers, and metastatic diseases possible for 90% 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 the 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 <unk> combination therapy.
Beyond their board and management team have been highly encouraged by the early results from our solid tumor program. Given this early promise, we recognize that our capital allocation strategy moving forward would change given the resources that it would be required to accelerate the oncology program.
Our focus is on the transformational lung fit 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 lumpy programs. However, when evaluating our existing portfolio management strategy. It became clear that the separation of business was necessary. This.
This will enable beyond there to solely focus on existing lung fit 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 our 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.
John Cancer will be led by Chief Executive Officer, Shlomi chefs on a Stanford trained physician brings with her over 25 years of investment management experience from the financial sector, including the last 16 years as director of Health care investments at Ballard, We're a substantial portion of our portfolio was oncology companies Dr.
Dr HELOC and phenol cancer Immunologist, who led the efforts beyond air to bring this program to where it is today has joined beyond cancer as Chief Scientific officer to continue the journey with Doctor chassis.
It will be a pleasure to watch these two change the way we approach the treatment of solid tumors. Additionally, young 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.
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, and Neil will serve as executive director and Bob Carey, Our current beyond Air Board member will be a director.
<unk> 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.
It's $30 million was achieved beyond their own 80% of beyond cancer.
Beyond they will also benefit from a single digit royalty payment on all future revenues and exchange beyond cancer will benefit from beyond air 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 <unk> delivery system and building out to 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 <unk> COO.
<unk> commercial officer of beyond Air provide additional details on the U S commercial launch for lung for 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 lung fifth ph domestically as soon as we receive approval.
As I've 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 knickers and 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 multiyear contracts with a cylinder based competitors will.
We will be targeting hospitals with less than 12 months left on their existing contracts.
And we anticipated taken approximately four years to have an opportunity to convert every hospital uses nitric oxide in the United States.
As a reminder, here are the main areas of immediate focus.
Firstly building the team we have.
Already have a pre approval launch team in place and have identified candidates for the extended team and 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 will have all the long trip systems and accessories, we need.
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 lung for ph and this allows us to refine our marketing materials messaging and the business model.
I have previously mentioned that the first major conference. Following the expected timeline for FDA approval is the a C or American Association for respiratory care, which was originally planned to be live in Phoenix.
That conference now virtual in December and we continue to target that maintain as the first introduction of lung fit.
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 PPA turn population, we're even more excited to bring the lung fit 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 our vision into a reality.
<unk>.
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.
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 32021.
Revenue for the fiscal quarter ended September 32021 was zero compared to zero point $4 million for the fiscal quarter ended September 32020, all of which was the licensing revenue.
Research and development expenses for the fiscal quarter ended September 32021 were $2 8 million compared.
Compared to $3 $1 million for the fiscal quarter ended September 32020.
General and administrative expenses for the fiscal quarter ended September 32021 were $3 $4 million compared to $2 $2 million for the fiscal quarter ended September 32020.
Other income and expense for the fiscal quarter ended September 32021 was a loss of $2 $5 million compared to a loss of <unk> 2 million for the fiscal quarter ended September 32020.
For the fiscal quarter ended September 32021, the company had a net loss of $8 7 million or <unk> 36 per share compared to a loss of $5 1 million or <unk> 30 per share for the fiscal quarter ended September 32020.
As of September 32021, 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 appeal.
Finally, we used our equity line of credit and our aftermarket financing vehicle to raise an additional $14 $2 million since September 30.
Taking these items into account plus all other cash disbursements since September 30, 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 the 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 lung <unk> 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 one on your telephone keypad, a confirmation tone will indicate that Youre line is in the question queue.
May press Star two if you would like to remove your question from the queue.
Participants using speaker equipment, it won't 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 Fraser with true Securities. Please proceed with your question.
Great. Thanks for taking the questions.
First on fit.
PAA has some or all of the preapproval inspection has been completed just any color on the assessment process would be helpful.
Thanks, Greg.
Yes, they have been completed.
Okay.
And then thinking ahead further into commercialization probably beyond kind of that first phase based on discussions that you've had in hospitals do you think that there will be.
Some that are price sensitive.
A discount versus Thats first and that's despite the advantages alongside this time.
Yes.
I think everybody's going to try to get the best price that they can of course, it's so.
Negotiation in every sense of the word.
But I'm going to pass this over to <unk>.
Duncan <unk>, 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 is 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.
<unk> to generate nitric oxide, there's no cassette or cylinder. So there are a lot of benefits to us in our system in terms of reducing the cost of logistics.
The safety benefits and certainly monitoring and so from our perspective people. We expect people in our research tells us that conversations tells us that they will value.
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.
That was very aware of that but that's not going to change our strategy.
Got it that's very helpful and then.
A question on amongst that go that study for MTM lung disease, and he got an interim data on any of the efficacy measures such as quality of life for physical function.
We.
We're unable to gather the efficacy data do too.
The COVID-19.
19 related Lockdowns in Australia, it's very difficult to.
To go into the hospitals and <unk>. These these data so wasn't.
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, just it's just the way the world works right now.
Got it understood Okay, I'll hop back in the queue, but thanks for taking the questions.
Thanks, Greg.
Thank you. Our next question comes from Suraj Kalia with Oppenheimer. Please proceed with your question.
Good afternoon, Steve Duncan can you hear me all right.
Yes suraj.
Perfect.
So Steve Duncan either one of you.
Youll articulated that the supply chain issues Youll have managed it well and as you look forward to commercial launch in a few weeks post approval.
Yes components of how many systems are on hand.
Let's say the next two to four quarters, just trying to get a sense of.
Youll have managed at least the next four quarters.
Suraj.
We're not.
Overly concerned over the next four quarters in terms of.
Supply I guess that would also.
Kind of dictate.
Many hospitals, we think we're going to be in the end of the 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 with our supply.
This is assuming things don't get worse, but I.
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 yes, 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 to nine months to work with a dozen hospitals and none of the supply in China issues.
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.
Hey, Steve on the CE, Mark can you remind us of the European opportunity and just like you all.
We have consistently talked about Nick used in the full year timeline.
U S adoption and layout.
What are your initial sites are and all of that.
Kind of give us some additional granularity on European sites, and how you think about the Europe.
The Europe opportunity.
I mean, it's smaller than the U S opportunity and Thats for sure, but not that much smaller you know it could be about half the size of the U S. So we.
<unk>.
Obviously, it's going to get started a little later on the approval is going to come later.
Does take time to get through the process in each country there to get get going plus we will 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.
Hope that gives you some some color on the European opportunity.
Fair enough, Steve Duncan I do appreciate it and we look forward to <unk>.
Approval, it's a long time coming in and.
Hope you guys hit the ground running thank you very much for taking my questions.
Thanks Suraj.
Thank you. Our next question is from Scott Henry with Roth Capital. Please proceed with your question.
Thank you and good afternoon, a couple questions I guess first starting with the beyond cancer.
Pan out.
Assuming you will own 80% of it.
When you consolidate that in your financial statements.
Is that how we should think about it.
Yeah. Thanks, Scott, Yeah, we will be consolidating.
Roughly the 80% ownership that we'll have.
Okay.
I mean, the bigger issue to when I.
<unk> saw the press release and the terms it seems like you're 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.
I 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 do you think it offers the ability to unlock that value that perhaps.
<unk> had been missed in prior.
Yes, Thanks Scott.
Look it's easy to back into the number.
$30 million comes in 20% ownership that means that beyond air would own a $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 <unk>.
Again, not just investors coming in but the management team that's come on board I think many of you know Selina.
And the team she's buildings.
Going to be.
I hate to say it but they're going to do a hell of a better job of managing cancer, then I could with the team here, although EMEA might be upset.
Saying that but I know he is going to be heavily involved as well as going forward. So yes. This is this is a very important program.
We chose to.
Move cancer, along rather than COPD over the past few years that is a 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 just a few short months away from beginning to enroll patients.
And our first human study so it's very exciting.
The people who who.
Come to us as investors as the management team and as well as.
Some consultants that are working with US everybody is very excited about this.
It's a brand new mechanisms never been seen before.
So hopefully things work out in phase, one and there'll be even more excitement around this so I.
And I appreciate the question and I think that the value has always been there. It's just I think now people can see it more than than before as it was just a preclinical program behind our three clinical programs. So maybe it was just kind of be missed goes it was a preclinical.
Project, but now it's.
I'd entity on its own.
Congratulations thats a lot of progress over the past year.
The final question.
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 are a little closer to that date I don't know if he.
Put some.
Range around that or just any sense of the magnitude of spend for the first year matches that can be gigantic, but I just wanted to get a sense. Thank you.
Scott I'm going to pass it to Duncan, but the only thing I'm going to say before that is this is.
This is standard of care in.
In the hospitals that use N O. I mean, there is not much education that needs to be done here from that perspective.
And we're certainly not doing DTC advertising so okay.
Yes, Hi, Scott Yeah.
I think that obviously were not approved so we cant promote the product to this point. The good news is there's a very high level of awareness because this this marketplace. It's fairly tightly held community, they're very aware of the presence of <unk>.
Organization that devices and we certainly have.
Fairly consistent income in.
Kohl's to learn about the device and so from that point of view, we certainly do 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 prelaunch team in place with us already.
So built into our cost base.
And any of the additional costs should be quickly be covered by the progress we make from a.
The revenue generation perspective, especially as we get into that second phase so.
Obviously, there is going to be an increase but we've already.
<unk> 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.
Yeah.
Okay.
Thank you. Our next question comes from Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.
Hi, Thanks for taking my questions.
Staying on the.
Commercialization preparation maybe for.
For Dunkin'.
Have you have you need the hospitals that you are going to target and national launch section yet.
The other lunch.
Yes, Thanks, Matt.
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.
And we will make.
Choices about which hospitals would go to based on a combination of factors, including geographical location.
The.
The specific requirements they have and the expertise they have.
And obviously.
At times, there will be a difficult decision because we are in a phased launch where we're certainly looking forward to him we very much know where the key hospitals.
Okay.
And then Steve.
With respect to the.
PMA approval it sounds like you're really kind of about the last steps there now with the pre approval inspections behind you.
Is there is there a kind of one gating factor that that's still remaining ore or how should we think about it.
I can't tell you how to think about it Matt because.
We're just just waiting I mean.
We've we've done all we can and we're going to keep working with the FDA. So.
We just we just kind of.
<unk>.
Reacting to them and working with them in.
And we'll get there eventually.
Okay Fair enough and then.
Congratulations on the announcement with <unk> and the formation of your subsidiary beyond cancer, just wanted to focus in on that.
And.
So picture for us in terms of.
That program.
Moving through preclinical development and potentially into the clinic in and how we should.
Expect news over over the next 612 months.
Yes.
The preclinical process as you know.
We're obviously.
We're almost at the end here.
We're saying early next year will be.
Enrolling patients in our first in man study so.
Pretty pretty excited about that and as you know it doesn't and 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 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 will be an exciting time so.
Be news coming out I mean beyond there will be press, releasing the information obviously since.
We will be 80% owner.
Beyond cancer. So the news, we'll get out there and you'll be able to see everything.
Okay, Yeah I know.
It looks like a great way to unlock value from that program.
Thanks for taking the questions.
Thanks, Matt.
Thank you. Our next question will come from Yale Jen with Laidlaw <unk> Company. Please proceed with your question.
Okay, Thanks, Steve and thanks for helping me out.
Connecticut.
First question to the follow what the met at Liberum.
A little bit more specifically in terms of the be all cancer, which is that we know that you guys had.
Preclinical data presented at <unk> earlier, this year and should we anticipate additional.
And patients to come up.
I'm just thinking about is poised as the APR.
Or are there those meetings that.
Hi oncology focus.
Yes, I mean look yes, we're certainly going to.
Be submitting our abstracts for conferences for 2022, so we can show more.
More data there is no doubt about that so pending acceptance into these meetings will be showing more data for sure.
Okay, Great that's helpful and.
One question is about 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.
You guys need to do or assembly, just responding to the agencies.
Question, So why not.
And so getting a CE mark is a little different than getting FDA approval. So.
There is there's a process there.
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 too to submit to FDA work with FDA towards the PMA approval and use that information.
<unk>.
To get the CE, Mark and it's not just turning around ensuring the paperwork I mean, there is 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 theres no real pay 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 one Duncan which is that I understand that you guys are.
Reaching the different costs below where the Nick Hughes.
And just and also this is not fully approved.
Normally proof point, Andy cardiovascular to use.
My question is that was there any.
Our request.
For the cardiovascular.
The hospital that about the.
Low ph and.
That type of interest at the moment.
So thanks for the question Yale. So, we're obviously focused on promoting the product post approval on PPI and the indication that we will get it for we haven't had any conversation.
In the pre approval phase we are doing is responding to customers' questions and doing any demos, where we will do is post approval. Shortly afterwards, we will be applying for the cardiac label expansion and that will allow us to unlock that.
That potential.
That's.
The way, we are going to move forward.
Is that the case.
Although you guys care that formally.
Promoting anything on that side.
From Lincoln actively requesting questions.
Two you got requests do you guys go to ask more inflammation.
Yes, we can only promote on the label and if we get any request we will have a formal process to respond to those requests.
Okay, Great that's very helpful and congrats to reaching the finish line.
Thanks, Jeff.
Yes.
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.