Q4 2021 Navidea Biopharmaceuticals Inc Earnings Call
[music].
Greetings and welcome to the <unk> Biopharmaceuticals fourth quarter earnings Conference call.
At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad and please note that this conference is being recorded.
I'll now turn the conference over to Michael Rosell, Chief Medical Officer. Thank you you may begin.
Thank you and thank you all for joining US today. This call is being webcast live on our website IR dot and the video Dot com and a replay will be made available. Following the prepared remarks, we will be conducting a live Q&A session.
The videos Vice President of Finance and administration, Erika Eves will be joining me on the call today.
During the course of this conference call, we will be making forward looking statements regarding future events and the future performance of the company.
These events relate to our business plans to develop new video is molecular diagnostics and immuno therapeutics, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters as well as the impact of the COVID-19 pandemic on the video business operations.
All of these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions risks and uncertainties and could cause actual results to differ materially we assume no obligation to revise or update forward looking statements, whether as a result of new information future event.
Or otherwise investors should read carefully the risks and uncertainties described within the Safe Harbor section of our website as well as the risk factors included in the company's most recent quarterly and annual filings with the SEC.
So with that let's begin with our update during the fourth quarter of 2021 and since we have continued to work on financing for the company. We are engaged with an investment bank and options are being pursued this is all I can say at the current time, but be assured that the board of directors and senior management are working on this tie.
Leslie we will provide you with updates as we are able to do so overall, we've made excellent progress in our phase two b trial in rheumatoid arthritis or are a comparing imaging the biopsy and begun enrollment into our phase III following dialogue with the FDA.
We continue to advance the therapeutics in imaging applications through collaborative relationships with various well known institutions and investigators across the globe and are growing and diligently maintaining the company's intellectual property.
The team here works extremely hard and efficiently and I'm very proud to be associated with this outstanding group of individuals' senior.
Senior management is working closely with the board of directors and we are United in moving the company forward as we've said in the recent past there are many things we are working on behind the scenes. We will provide you with updates as soon as we are able and as appropriate.
So now I'd like to provide some more detail around clinical updates I'll begin with progress on our rheumatoid arthritis program.
We initiated and have enrolled into our phase III trial and are a titled evaluation of Technetium 99 am till manifest imaging for the early prediction of anti TNF Alpha therapy response in patients with moderate to severe active already.
The indications, we're going for and our a R. One early prediction of treatment response to our new or first time anti TNF alpha therapy and to identify our eh patients with low level of localization, who are less likely to respond to anti TNF Alpha therapy. As we've discussed previously there is a large and.
That need for reliable early predictor of whether or not a therapy is working in a patient with our a because of the drug is not working the patient's disease is not being treated and this can lead to long term consequences, along with unnecessary high drug costs for ineffective therapies that bring with them possible side effects.
Recall that our previously completed phase <unk> study demonstrated that <unk> can provide robust quantitative imaging in healthy controls and in patients with active RA.
That this imaging is reproducible and can define joints with and without our ey involved inflammation and that's humana Sept imaging can provide an early prediction of treatment efficacy of anti TNF Alpha therapy.
And anti TNF alphas are by far the most commonly prescribed second line therapy for those suffering from R. E.
Analysis of that study demonstrated high accuracy at early prediction of treatment effect with a strong predictive value in particular for non responders to anti TNF alpha therapies, even from the baseline scan alone in a defined subset of patients in these patients those who exhibit a low level of <unk> uptake.
Their joints on their initial baseline scan, who likely represent the fibroid subtype of <unk>. There was an almost 90% non response rates to anti TNF Alpha therapy, using a clinical gold standard assessment. This result on its own the ability to use a single time point scan to predict at an anti TNF Alpha third.
It is highly unlikely to work in a particular group of patients would be a powerful tool for rheumatologists to be able to rule out an entire class of therapies from the get go avoiding the high costs possible side effects and possible worsening of disease that could otherwise be the case.
So in combination with the predictive capacity, we saw in the rest of the subjects. The data continue to support our hypotheses. We are preparing to submit the results from the full data set from this trial for presentation at an upcoming international meeting and of course, we plan to write these up for publication in a medical journal.
As we've also discussed previously we had our end of phase II type B meeting with the FDA back in September where we reviewed the phase <unk> data and the proposed phase III plant after that constructive meeting with the FDA and after receipt of the formal meeting minutes to make sure. We remained in alignment we finalized agreed upon.
Modifications to the Phase III protocol design and statistical analysis plan and set those back for comment.
We then initiated the phase III.
Following additional feedback from the FDA, we reorganized and restructured several of the trial objectives. While the trial protocol itself did not change as part of this restructuring we revisited the targets to achieving the trial objectives, and we're able to reduce the trial size from an earlier range of 318 to 720.
Eight patients down to 200 to 672 patients. We then to open up the trial for enrollment.
As of this moment, we have opened up two sites for this phase III with another and process. These are sites that were involved in the phase <unk> study and are well acquainted with the trial design and operations.
We have also completed enrollment into the healthy control study Nab $3 35 to establish what is called enormity of database for <unk> in RA and integral part of our ability to discriminate inflamed joints from those that do not have inflammation is the knowledge of what healthy joints looked like quantitatively we use.
The healthy control data from one of the arms of the completed phase <unk> to start to set these parameters and we're using this study to add to the size of the current normative database. This should enable us to discriminate involve joints from non a non inflamed joints with improved accuracy and should have a positive impact on our <unk>.
<unk> to predict treatment response, so this normative database, establishing the parameters of what a normal joint looks like with <unk> will play in a central part in both the phase III data analysis as well as the commercial product and will serve as one of many barriers to entry for possible competition.
Our comparison study of <unk> imaging to joined biopsy now of $3 32 is in active recruitment.
In this phase <unk> study, we are comparing <unk> imaging to histopathology from the joints of patients with active RA, we aimed to recruit patients with each of the three subtypes of RA to obtain comparative imaging and pathology results in order to establish the correlation between our imaging signal and the number and denser.
City of macrophages in these patients' joints.
As of this call we have 11 subjects, who have completed both imaging and biopsy with an additional four to five subjects in screening.
The trial is designed so that we enroll a minimum of four subjects in each of the three subtypes of RA. So overall trial size is expected to range between 12 and 24.
In terms of recruitment into the trial, we're doing quite well as a guidepost for that when we first approached our UK site expert and world leader in synovial tissue biopsy of the biopsy of the joints of patients with <unk> <unk>.
Estimate was that if we were able to open up 10 sites. He could achieve enrollment of one five subjects per month overall across all of those sites. We have done about as well is that with only three sites opened how we do this as we pick our sites very carefully and make sure we have excellent relationships with what we know are very.
Motivated primary investigators and their staff.
Remember this trial is not required for FDA approval in the initial indications in RA that we are going for in that I just mentioned earlier, but we believe it is critical in order to achieve qualification of <unk> six as a biomarker for <unk> as well as to engage with pharma for its use in trials of new RNA therapeutics.
It will also provide rheumatologists with gold standard information related to our imaging readout and the fundamental biology of a patients already for.
For example results from this study could directly demonstrate that <unk> imaging can be used to determine a patient subtype of <unk> and this would have implications for what class of therapeutics might or might not work on that particular patient. This could therefore, a significant impact on the management of our <unk> patients if approved.
We continue to make very good progress on automating the image quantification as well, which will have significant benefits for the commercial product.
We have signed a letter of intent with the image analysis company MIM software to be the company's commercial partner for image quantification of <unk> imaging in RA.
NIM is a leading medical imaging software company based in Cleveland with a large footprint in the nuclear medicine space. It is a privately held company that sells its products globally to imaging centers hospital specialty clinics research organizations and pharmaceutical companies. They have their software installed in more than half of the.
Nuclear medicine facilities in the U S and have cloud based applications as well.
We've been working on this for a while and we believe NIM is the right partner.
We have completed a pilot study using data from our trials demonstrating that they can develop a fully automated application that can robustly reproduce our quantitative imaging reads using our proprietary algorithm.
This will be important for rollout of a commercial product the ability to perform the quantitative reads rapidly and reproducibility at large scale through automated means it's critical to large scale use of <unk> Ferrara.
This letter of intent is an acknowledgment of their commitment as well as ours to partner to provide for the image analysis image transfer and imaging redistribution for the commercial product, we will work with them over the next several months to finalize terms of the partnership.
On the cardiovascular disease front work is completed on the investigator initiated atherosclerotic plaque imaging study at MGH Mass General Hospital in Boston.
The group there has presented an abstract at an international conference in February the data are promising in terms of localization of tremendous up to sites of plaque and had been in line with what was reported in the pilot study we co published with them previously.
Preclinical studies on gallium 68, <unk> for pet imaging and related next generation manners stepped imaging agents have progressed significantly through internal work in the video and through extra neuro collaborations with researchers at the University of Alabama, Birmingham or Uhm.
Progress includes completion of our NIH funded preclinical studies for evaluating gallium 68, <unk> and various new imaging agent similar to <unk> in a mouse model of atherosclerosis data analysis show significant uptake of gallium <unk> like imaging agent and natural scrubbed.
<unk> in this mouse model.
Another important set of preclinical imaging studies were recently completed with our collaborators at UAB.
These studies evaluated two new imaging technologies in a mouse model of cancer.
The first technology is designed to increase imaging agent localization to target tissues. While the second technology is designed to block off target imaging agent localization to the liver.
Major site of localization when <unk> is administered by intravenous injection.
These studies were highly successful showing that we can dramatically increase localization of our new <unk> like imaging agent to tumors, while simultaneously significantly blocking off target localization to deliver with.
With help from our colleagues at UAB a manuscript describing these results has been prepared for publication will submitted for publication in the next few weeks following intellectual property review by our patent Council.
So the success of these imaging studies greatly expands our imaging knowhow and potentially illuminate our path to a next generation imaging agent <unk>.
Perhaps as importantly, the success of these imaging studies also points to a pathway leading to synthesis of more effective therapeutic drug delivery construct building on this information new drug delivery constructs had been synthesize that carry a variety of payloads that include dexamethasone and doxorubicin.
In addition, other new constructs had been synthesize that carrying new drug payloads that may be more effective than doxorubicin for beneficially altering the immune status of tumor macrophages.
Six of these new contracts had been evaluated in a human macrophage assay system with the first new construct carrying a DOCSIS doxorubicin payload in a second construct carrying a different payload having progressed to evaluation in a mouse model.
Results showed that when administered alone or in combination with another cancer drug the videos therapeutic construct significantly reduce the rate of tumor growth in that model.
The dexamethasone carrying construct will also be evaluated but in the mouse model of inflammation rather than cancer.
This construct could have broad reaching applications in autoimmunity inflammation and in diseases of metabolism.
As these preclinical studies are completed we will update you and announce when and where results will be presented and so our therapeutic pipeline is robust and moving forward.
On the progress of Lymphoseek approval in India as lymphoma aim we were informed last week that the senior regulatory reviewer has accepted our most recent replies to their organizations inquiries and the file has been moved to the administrative department for further processing.
Weren't able to give us a timeline, but this is promising news that things are moving towards approval.
On the intellectual property front, we have submitted two new provisional applications. The first is related to new methods of attaching chemotherapeutic to our <unk> platform and the second relates to maximizing target tissue uptake and off target competitive blocking.
These have important implications for pipeline applications. We also recently held an IP meeting with Cardinal health to make sure. We are aligned on IP strategy as they lead prosecution of certain patents in North America, and we and the rest of the World. This was a very good meeting and we will work closely together going forward.
We have an active IP protection strategy that we believe will provide needed protections and rights to both our current diagnostic and therapeutic agents as well as to our next generation molecules and disease indications I was recently looking back of the company's IP history and with these above items plus the other new provisions.
Based on ideas from the current team here that we have filed in the three years since I arrived and with the signing of the license agreement with Ohio State recently.
Arguably been the most productive three years in the company's history IP wise.
Those are just some of the highlights of the last quarter that I wanted to touch on for this update we remain largely focused on the rheumatoid arthritis pipeline, specifically the phase <unk> imaging the biopsy trial and the phase III, while we continue to support and push for progress on our other diagnostic and therapeutic.
<unk>.
As always I want to thank the team here for their tireless efforts to keep things moving and our network of clinical trial sites and academic research collaborators for all of their hard work.
And with that I'll stop and I will turn the call over to Erica for financial updates Erika take it away. Thanks, Mike.
Total net revenues for the fourth quarter of 2021 were $50000 compared to $219000 for the same period in 2020.
Total net revenues for the full year of 2021.
$532000 compared to $914000 in 2020.
The decrease was primarily due to decreased grant revenue related to small business innovation research grant from the National Institutes of health supporting <unk> development.
And decreased royalty and license revenue from sales of <unk> in Europe .
These decreases were offset by the partial recovery of previously written off and receipt of reimbursement from Cardinal health of certain R&D costs.
Okay.
Research and development expenses for the fourth quarter of 2021 were $1 4 million.
Compared to $1 3 million in the same period in 2020.
R&D expenses for the full year of 2021 were $5 1 million compared to $4 9 million in 2020.
The net increase during the year to date was primarily due to increased regulatory consulting employee compensation travel recruiting and general office expenses, coupled with net increases in drug project expenses, including increased <unk> therapeutic.
TC 99 M <unk> development costs offset by decreased <unk> diagnostic development costs.
Selling general and administrative expenses for the fourth quarter of 2021 were $2 3 million compared to $1 7 million in the same period in 2020.
G&A expenses for the full year of 2021 were $7 5 million compared to $6 7 million in 2020.
Net increase during the year to date was primarily due to separation of our former Chief Executive Officer.
Coupled with increased consulting services related to European distribution of TC 99, and Tim assets.
Director compensation related to additional board members and increased board compensation rates.
Insurance costs losses on the abandonment of certain intellectual property.
Recruiting fees travel and general office expenses.
These increases were offset by decreases in legal and professional services employee compensation Investor relations costs European annual registration fees facility facilities costs and franchise taxes.
We would like to clarify that this morning's press release, you used the word termination to describe the accounting for separation expenses related to the resignation of our former CEO Chad lacking.
Our relationship with Mr. Ken remains amicable.
The video net loss attributable to common stockholders for the fourth quarter of 2021 was $3 7 million or <unk> 12 per share compared to $3 million or <unk> 11 per share for the same period in 2020.
And <unk> net loss attributable to common stockholders for the full year of 2021 was $11 7 million or <unk> 40 per share.
Compared to $11 4 million or <unk> 48 per share in 2020.
And finally in the video ended the fourth quarter of 2021 with $4 $2 million in cash and cash equivalents.
Now I'll turn the call back over to Mike.
Thank you Erica will now begin the Q&A portion of the call.
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One moment, please when we pull for questions.
As a reminder, if you would like to ask a question. Please press star one.
Our first question comes from the line of Mike Private Investor You May proceed with your question.
Good day, Dr Rosell, and Erika How're you guys did a good good I might well.
You're good to go with Q&A now.
Hey, I've got some questions and I. Appreciate you guys can hear you.
Okay.
Yes, I appreciate you guys. Thanks for taking I mean, it's a tough time for everybody.
Dr. Rosol, a couple of questions for you if you don't mind.
On the you.
You were hoping to move into an early or an IMD in the Tampa area sometime in early 2024, and I know youre still doing the preclinical does that reach.
Yeah, Yeah. Thanks, Mike I think it is in reach yes, it's still in line with our projections.
Okay.
Yes.
On the R&D front, there's a lot of people out there are a lot of companies out there trying to do what you're trying to do but not in the kind of the technical and sophisticated way and the videos. They try using blood tests in various type of meaningful like that and they are not FDA approved.
Having any progress with the rheumatologist to demonstrate how much advantaged than you would have with the rheumatologist Dr. Rosen.
Yeah, I don't want to get too much into their business, but.
I can say, we think we have several advantages competitively relates to those assays and maybe there is something to be said for being complementary to them, but what we're doing of course is where we're measuring directly activity directly in the joint so primary at the site of interest where the activity is.
And those peripheral based blood assay.
It kind of assays and examinations.
Have some utility, but because they are downstream you are not really getting where the action is so we think we have advantages there.
We know that the Kols, we speak to are very positive about our modality and our method and our molecule.
Applications in <unk>.
And we'll keep moving forward with them in mind and they've told us that.
If our data keep holding up the way they have been in these trials then there'll be very happy to have something like this out in the field that they can use as part of their toolkit.
Excellent excellent I appreciate that.
On the 523 patients in the $3 33.
Okay.
I noticed that statisticians like about 500 in their test, but I was really happy to hear that Youre down between 200 600 range. Now is that 523 trying to also proves that the negative predictive value as well as the positive predictive value or is that one because I know that's one of your stretch targets.
Yeah, no exactly so it's to cover really it's to encompass the sensitivity specificity as well as the PPV and MTV, so kind of all of the above and $5 23 is kind of.
At the midpoint, it's maybe we're conservative in the sense that it's in the higher zone of where we'd like to be.
As you've noted and as I said are somewhere between 260 72 will be the number we need to achieve our objective statistically if all works out as planned and that really is dependent on the responders and non responders to the anti TNF. So what am I, saying the trial sizes dependent.
On the number of responders and non responders to the drugs they get not just on what our readout says, but we have to have a certain number of people who actually respond to the anti TNF. So we can see if we predicted the response correctly and we have to have a certain number of non responders to see if we predicted non response correctly so that.
Part is out of our hands, how do patients respond to the therapeutics. So thats why there is that big range. If we have about a 50 50 ratio of responders to the anti TNF and non responders, that's where we get to 200 and the trial size and we can look to see if our NPV and PPV and sensitivity and specificity are.
Our significant and achieve our targets, but if there are great. Many more non responders than responders to the drugs then we're going to need a higher number. So $5 23 was it just kind of a conservative number we picked as the midpoint. It's just the way clinical trial Dot Gov. As is set up that they want you to choose a number right.
Well that's it that's an important piece of information and very informative. So I know you probably can't disclose how many patients have been the image jet and the 333, but are you starting to get any early.
213 day major for all of the outcomes, but are you seeing any outcomes yet on any of the patients that have been <unk> 33.
I can't comment on that it's early but stay tuned.
Stay tuned.
I can't brag that one.
You did mention something on 330 to about 11 patients in the Q1 three of each type.
Is it fair to assume that with the revenue had a.
Three three and nine of the three or four four and three how would you break those down in other words, one short one type or not.
I don't know that I can say that either but yes. We are looking at 444 and four and we will let you know as soon as we get it as you know we can't.
We can't tell them.
Two is who walks through the door right and if you look at the literature.
The thinking is the literature suggests there's about a third of each subtype in the general population.
And whether or not we're hitting that.
Can't reveal at this time, but.
Keep that in mind and that should give you an idea of the upper bound.
If things get off balance one way or another that probably isn't a satisfying answer to you, but we are getting good recruitment.
11 at this stage is pretty good we had a little bit of a lag over Christmas and the holidays that happens.
But we have sites that are really ramped it up again and that's why as I said, we have four or five in screening.
At this stage so again stay tuned we'll let you know as soon as we can on that trial.
And one more question for Dr. Rosenberg.
On the that meeting you had with Cardinal that was very timely and informative. So how do you guys decide with Cardinal like where you are advancing or a whose rights there under I mean, how do you how do you do.
Yes, they have the patent prosecution rights for North America for a certain family of patents that that were part of the asset purchase and we of course have developed our own over the over the later of the ensuing years.
And in terms of their patent prosecution right those apply to the U S and ours apply for those same patents elsewhere. So you can imagine things could kind of go.
Every which way, but loose if we weren't working together so at some point not too long ago I realized with my colleague who is managing the IP that we didn't want that to happen because they might not prosecute claims are pushed back against rejections that we think we need. So we had this dialogue with them and we're working quite well together.
Because.
In the at the end of the day.
The more we can get.
Approved it benefits potentially not just us, but possibly cardinal as well okay.
So when they advanced eight eight.
For instance, they modified or improve it it could be on your behalf or it could be on their behalf is that fair.
Well since we have the license rights, we have the irrevocable exclusive license to all of these it would it could input it obviously could affect us. So we wanted to make sure. We have to say we have a voice in what their responses would be to the examiner objections or whatever the case may be and so now we're in a very good place where we're doing just that.
So we.
Take our input we take their input and we're working together quite harmoniously to make sure. There are no gaps right, where they may say Oh, we don't think we need this in and actually we think they do or we do for reasons for our business purposes. Now we've joined with them in terms of this collaboratively and.
We're in a very good place.
Don't think Theres anything significant that's been that's been lost there. It was just there was some complexities and I think now we've smoothed that all those out so it's we're in a really good place.
Okay great.
Maybe this is both for Erica for you Dr. Rosenberg.
On the in.
In the EU.
Have you guys got the supply issue worked out in the EU, where there seemed to be some issue on having the stock of tumor handsets available or is that still an open issue.
Yes, it took a while to get the distribution setup.
And that was a quite a heavy lift for a small company, but I think I'm pretty proud of the team here, Jeff Smith, who is our who moonlights as our BD person is also our VP of operations and he did yeomans work in getting the distribution set up so I think we're in a good place there.
As you know we're looking at possible.
Partners for Europe .
And we will keep you guys posted on that as things progress.
Is there anything you can share on jubilant Mou or is that still.
Yes.
And I think we haven't gotten extremely specific but as everybody has noticed that I think we have said in the past the <unk> hundred 32 study is very important.
Kind of a both sides recognize the importance of this study and so.
They're they're interest remains and it's still the due diligence process and.
<unk> hundred 32 goes.
When does their due diligence and with the 12 patients or what the 'twenty for you can you disclose that.
Yeah, I don't think I can disclose the exact term of it.
Okay. Erika this is probably more for you but have you got any feedback from the FCC on the S. One or is that non disclosed.
We received a letter from the SEC, stating that they do not intend to review and comments on the Athlon at this time.
That's really the only feedback.
Okay very good and his key Keystone converted any of their last tranche to common or is that going to be in the 10-K 10-Q report.
It will be in the 10-K, but no they have not as of now they have not converted any of their remaining series D.
Well, thanks for being so generous with your guys as times and things for working so hard for your shareholders.
Mike I appreciate it. Thank you you've reached a new record and questions, but they're all good.
I I I tried to be really fast.
Okay. Thank.
Thank you.
Yeah.
Thank you as a reminder, if you would like to ask a question. Please press star one.
Next question comes from the line of Edward English a private Investor you May proceed with your question.
Hello, Dr. Roseland Erika this is Eddie English I'm, an individual investor to have a few questions.
My first one relates to some information I think that's one F D. A dot Gov site on the clinical trials with 332, it seems to indicate that we're not recruiting at the Queen Mary location is that accurate and if so any idea when they will commence recruiting there.
Yes, no. Good question no thats actually an error on the side, we actually submitted to correct that I don't know where the air came from but they have been recruiting.
As you know and I think what we said previously they were slower to open because of Covid.
But that was.
That is a just an air kind of a typo in entry error on the site. So we're correcting that they've been recruiting.
Great.
The next question is with your man Dog studies with Kaposi sarcoma and since Doxorubicin is approved by the FDA already.
Well long term clinical studies would be required before submitting an FDA application for a new drug.
Well, that's a great question. So so it does help that the drug is already approved and well known what we think are one of our advantages is we are one of the issues are one of the main concerns with doxorubicin is essentially you have a lifetime maximum dose you can get because things start to happen in other organs of your body.
Typically the heart, so bad things happen with our construct being able to deliver this drug to the areas of interest specifically.
With a very high affinity and and it not going and off target locations are very much. We are we should be able to significantly reduce that.
The risk of the side effects. So we'll have to demonstrate that in preclinical studies.
As well as human studies, but I don't.
We're not going to have to do I think we won't have to do I'm not going to speak for the FDA yet we haven't approached them about this I think there will be some we have the proof points of the core molecule itself till manifesting or medisoft being safe doxorubicin is a well known toxicity profile, we can deliver less of it but more specifically to the area of.
Triste all of this will be taken together as part of the package by the FDA to as they consider the safety and what kinds of long term follow up are needed, but we have one of our main advantages as I said are the main advantages that we can just bring the drug to the area it needs to be and it won't go.
Significantly to areas, where it doesn't need to be so that should help us with our approval process in terms of the trial duration because that makes sense.
Yes. Thank you.
Another question, what's the difference and the work that world care clinical will perform which they are a workflow versus the activities that you.
You signed a letter of intent with the.
MIM software, yes, another great question. So what world care is doing for US is they are imaging contract research organization. So theyre actually the imaging group, that's helping us with all of these clinical trials.
They're fundamentally handling the imaging chain, we call. It so they they oversee in a broad sense of the image acquisition. We also do quite a bit of that ourselves, but in any of that they have all the processes and systems in place to handle these in a secure fashion for regulatory purposes, as well as for data integrity.
For good science, so they do that for US we had we had been working with them and talking to them about possibly being a commercial partner for the imaging readout as well, but we think over time.
And our conversations with NIM that NIM is probably the better partner for us for that specific purpose of the imaging readout for the commercial product cause minimum does this for a living right and they have a literally I think the number is over 100 data scientists, who just work on image analysis and.
One of their big buckets as nuclear medicine images, so they're already doing this and they have their application out there that we could be kind of an add on to they also have a cloud based application where images could just be uploaded to the web and with their automated readout. If you could just can be spit right back at the snap of a finger basically to the nuc med dock on the other end who.
Can make sure that you know it was read an inappropriate fashion, but there is the score so they have the background and the infrastructure and the software in place to do this we think in a way that maybe world care would take some time to ramp up too. So we're still working with world cares our imaging vendor in the trials, but.
<unk>.
Plan is to go with men.
Thank you I was confused on that with the announcement today.
One final question has there been any progress on securing a deal with your NAV 46 94 product.
Yes. So we do currently have a we have a.
Licensed from Astrazeneca in a sub license deal with manure and.
We're always thinking.
Thinking about ways to optimize value for the company and so as we discuss possibilities with with these players will let you guys know.
Alright.
That's all I have thank you very much and congratulations on the progress.
I appreciate it.
Okay.
Thank you at this time, we have reached the end of the question and answer session I will turn the call back over to Michael for any closing remarks.
Perfect. Thank you all I want to thank you again for taking the time today to listen to us and to ask us to your questions.
We appreciate all of you and your investment in the company and your faith in Us and I want to reassure you that we're working all the time on this to bring value to the shareholders and to the patients.
At large out there and we'll keep doing that and we look forward to speaking to you again before too long. Thank you.
This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and have a great day.
Thank you.
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