Q4 2020 Navidea Biopharmaceuticals Inc Earnings Call
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Greetings and welcome to the non video bio Pharmaceuticals, Q4, 'twenty 'twenty earnings 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. Please note. This conference is being recorded.
I will now turn the conference over to your host Jed Black N C E O of Nvidia. Thank you you may begin.
Thank you Hillary.
First of all from I'll start by saying this call is being webcast live on our website and a replay will be made available. Following prepared remarks, we will be conducting a question and answer segment and the video as Chief Medical Officer, Dr. Rosol, and the company's Chief business offer business Officer, Joel Kaufman will be joining me on the call today as well.
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 plan to develop the videos molecular diagnostics 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 events or otherwise.
Investors should read carefully the risks and uncertainties described in 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.
The fourth quarter and beginning of the year marked several key moment for the company, we were able to successfully complete enrollment and complete all the imaging in the phase III study. This was something that I thought we wouldn't be able to do given the situation with COVID-19 around the country, but I would like to thank the various sites for keeping the recruiting open and getting all the patients in the door and image.
<unk> successfully.
Our discussions in Europe are progressing well and in the meantime, we will be distributing the product with the assistance of a company that has excellent distribution capabilities throughout Europe.
Want to thank my transition team for continuing to push forward with what has been a very difficult transition given the COVID-19 restrictions.
<unk> been quite the task just set up a network of distribution without being able to do any face to face meetings or market. The product any new partners. We have had quite a few meetings with potential partners and are working through some potential arrangements to find the right partner to agree with to distribute and sell the product. It's important that we bide, our time and make an agreement.
Will benefit the company and its shareholders for the long term.
The European market is much different than the U S. One and our previous partner was not skilled and radiopharmaceutical product distribution, which has created some unique challenges in finding another partner.
And this past quarter, we completed a 5 million dollar placement with our largest shareholder Mr. Scott and continued to receive inflows from Keystone as they work towards completing a $50 million commitment under the series D preferred.
Our discussions with jubilant continue and we have turned our focus towards the data that we will generate over the next several quarters in the 332 trial. The biopsy data that we hope to generate as we start to enroll patients will be invaluable towards increasing the value of the raw product, we feel strongly that positive correlation resolved in this trial will enhance the label the product.
Right from the get go.
I'm happy that we're able to start enrolling in north of at northwestern and hopefully the lockdown on U K will end soon so that we can start enrolling over there as well it's unfortunate that the COVID-19 lockdowns inhibited us from starting the trial on time, but the second we got the Green light in Illinois. The paperwork had all been filed and we were ready to roll. We are also ready to run.
All of the U K as soon as the surgery centers reopened for elective procedures.
We expect the next quarter to be very busy as we continue the dialogue with the FDA and get ready for the launch of the phase III for RA.
We made the decision to finish as many of you aren't free patients as we could before submitting the briefing book and I believe that was the right thing to do in order to give the FDA as much data as possible as we move towards the phase III launch.
Before I turn things over to Dr. Rosol I want to once again, thank my entire team for all their tireless hours of work and it's most difficult environment. I also want to thank our European consultants that have been invaluable in helping us move the European partnership forward since we have been unable to travel over there to do the necessary face to face partnering meetings that would normally.
On a deal done.
Now I would like to turn the call over to Dr. Rosol, who will cover on the clinical portion of the call Mike.
Thank you Jed and Hello, everyone as always I'm happy to participate in today's call and provide you with updates from the clinical side I'll begin with the progress on our phase two B trial, now $3 31, and our a I am pleased to announce that we have had the last patient last visit event in this trial, meaning all of the patient related events are completed including.
Imaging and clinical assessments I'd like to thank the clinical team as well as well as all of the pies and personnel at the various sites for their tireless efforts to complete this trial during particularly difficult times final data monitoring validation and analysis are ongoing as you know this trial on the data we have analyzed from it thus far.
Our critical to moving us forward and already as a reminder, this space to be is a three arm trial on arms, one and two we have been evaluating the repeatability reproducibility on stability of our <unk> imaging readout in both healthy subjects and in patients with active all right and then the third arm, we are mirroring the upcoming phase III <unk>.
To obtain data to help with sample sizing for the phase III as well as day have a first look at the ability of <unk> imaging to serve as an early predictor of treatment efficacy and as a monitoring tool.
As we have discussed and presented in the past the interim results to date on all three arms were very positive we have data demonstrating that technetium 99 M. <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 <unk>.
Balder inflammation and that the tremendous apt imaging readout can provide an early prediction of treatment efficacy of anti TNF Alpha therapy in some specific cases, using the baseline scan alone.
In November we presented the positive interim analysis results of arm three at the American College of Rheumatology annual meeting and we provided an update on the positive interim news on our last shareholder call.
We have also submitted our briefing package containing interim results from this study as well as the proposed phase III design and analysis plan to the FDA and the FDA is currently reviewing these formal briefing documents. This was a large undertaking with the final package of information containing over 800 pages covering our complete already.
<unk> program with an emphasis on the data from Nab $3 31, as you May know this is a regulated or regulated process with guidance is recommending specific timelines for material submission as well as FDA responses based on the guidance, we expect to hear back from the FDA. Shortly keep in mind. However that these our guidance is.
The only and so the response to our materials might take longer than expected. Once we receive the response there might be clarifications or responses requested and we will work diligently to respond in a timely fashion to any and all questions. So that we can initiate the phase III as soon as possible and we are preparing for that currently.
You should also know that while the strategy we pursued as an aggressive one we believe we're doing it smartly usually this type of FDA meeting would occur after completion of a phase two or phase two b. Following full analysis of the data with the phase III discussed in beginning thereafter.
In conjunction with the positive interim data from the current trial, we've sought guidance from the FDA and have aligned development of our <unk> program with the agencies suggestions in so doing we have integrated the earlier suggestions into the proposed design of the phase III because of this we believe we have presented a strong data package in support of the study design and indication.
This strategy will enable us to begin the phase III with confidence earlier than might otherwise be the case our goal in seeking feedback from the FDA. At this time is to ensure we maintain alignment and that they agreed that our proposed plan if successful could be used to make the case for approval of <unk> in our E.
So when you will see on the clinical trials Dot Gov site that we will have opened up by healthy control study to establish what is called a normative database for Atlanta stepped in or a an integral part of our ability to discriminate already 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 arm one of the phase to be to start to set these parameters and we will use this study to add to the size of the current normative database. This should enable us to discriminate already involve joints from non already involved joined with improved accuracy and should have a positive impact on our ability to predict treatment <unk>.
Bonds and.
An additional objective of this trial will be to evaluate spec C T and a number of healthy subjects at already involved patients in order to establish the feasibility and possible utility of spect imaging for these purposes. There are some potential advantages to using spec Cte for this type of imaging and this pilot arm should put us on a good position.
Looking ahead to the application of the spec C. T for til Medisoft imaging at all or a this trial should open for enrollment next month and will run in parallel with the phase III as well as the biopsy study.
And speaking of the biopsy study.
As Jud mentioned, we have opened up enrolment at northwestern University into this phase to be comparative study of <unk> imaging to histology from the joints of patients with all or a in this study we aimed to recruit patients with each of the three known subtypes of already in order to obtain comparative imaging and pathology results.
<unk> from biopsies of their already inflamed joints. In addition to northwestern we're working to open up our first UK site and we are scheduling a remote site initiation visit to occur in the coming weeks.
As you heard from Jed there were a couple of rounds of Covid related delays in opening up the UK site, but as of this moment things appear to be on track for opening up the site on recruitment into the trial.
The reason we have selected this UK site you might recall is that our lead principal investigator for the trial is located there and he is the world's leading physician enjoined biopsy of patients with all array and he maintains a laboratory specializing in the examination of the pathology pathological results from these biopsies remember that this trial.
Is not required for FDA approval in the initial indications in RA that we are going for but we believe it is critical in order to achieve qualification of CD to a six as a biomarker for our a as well as to engage with pharma for use in clinical trials of new already therapeutics.
We'll also provide rheumatologists with gold standard information related to our imaging readout and the fundamental biology of a patient's rheumatoid arthritis. For example results from this study could directly demonstrates that <unk> imaging can be used to determine a patient subtype of <unk> and this would have implications for what class of therapies.
Might or might not work on that particular patient. This could therefore have immediate impact on the management of our RA patients on the cardiovascular disease front work is continuing on the investigator initiated atherosclerotic plaque imaging study at MGH in Boston. They are very close to achieving full enrollment after a slow down due to COVID-19 restrictions.
<unk> the data, we havent seen thus far have been promising in terms of localization of telematics app to sites of atherosclerotic plaque and have been in line with what was reported in the pilot study we co published with them previously.
Preclinical studies of gallium 68, <unk> imaging for our NIH funded project with the University of Alabama, Birmingham are also on going.
We have also made important strides forward on the therapeutic front I will just touch upon a couple of these here four indications in oncology. We have performed preclinical studies that demonstrate macrophage phenotype changed from an immuno suppressive to a pro inflammatory state and a synergistic effect on tumor growth reduction in <unk>.
Animal models, using our doxorubicin containing construct with an approved checkpoint inhibitor therapy put more simply the tumors grow as significantly reduce rate with our molecule combined with an approved drug compared to the approved drug alone. We've now seen this in different tumor models and combined with different therapies.
These are important mechanism of action and proof of concept studies that need to be done in order to move forward and we are excited by these results. Thus far we plan to present. These results at an upcoming conference as well as in manuscript form in a journal currently we are preparing to initiate a preclinical dosing schedule study.
At different starting points for therapy and are looking to run a toxicology study this year with an eye towards first in human studies.
We also have promising preclinical results related to increasing the delivery of our molecule whether it be labeled as a radiopharmaceutical or with a drug for a therapeutic to areas of interest versus off target localization this bit of far reaching positive implications for our compounds related to efficacy and safety we continue.
To make significant strides towards producing the next generation of our molecule that we think will improve performance in both diagnostic as well as therapeutic applications as well.
We believe we have also improved the methods of synthesis for both diagnostic and therapeutic construct and are currently working on and intend to file another provisional patent application covering our new synthesis protocol.
We've also had positive developments on the IP front, we received a notice of patent grant from the U S. PTO for application entitled compositions for targeting macrophages and other CD to a six high expressing cells and methods of treating a diagnosis. The main IP here relates to the linker is we use that deliver our drug payload.
Whatever that payload might be to the cells that express CD tour. Six this was an important and fundamental protection for our therapeutics pipeline. We have also received a notice of allowance from the U S. PTO for the patent application titled compounds and methods for diagnosis and treatment of viral infections. This relates to pause.
<unk> therapies for a variety of viral diseases, including dengue yellow fever, and other diseases caused by flavor viruses I can assure you that 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 nextgen molecules in disease.
Indications.
Those are just some of the highlights of the last quarter that we wanted to touch on for this update we remain largely focused on the <unk> pipeline, specifically preparation for the phase III enrollment into the currently open biopsy study and opening of the normative database study. While we also continue to support and push for progress on our other diagnostic.
And therapeutic indications some of which I've touched upon today 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 I wanted to keep these remarks relatively brief today I'm not sure that I did but please feel free to ask question.
During the Q&A and thank you Ah now I will turn the call back over to Jeff.
Thank you Mike I think one of the points that I do want to update you on that Michael discussed was that IP I think that it might have gotten lost since it occurred around the time when I know many of you we're tuned into the trial in December but that IP is really key and that's something that we had been negotiating with the individuals that OSU for many many.
Years that was something that at one point in time look like would never happen due to some issues in the past, but we were able to successfully navigate around those issues and get those patents, which really cover us and protect us out to 2035, and that's something that is very very important as a <unk>.
Step towards making some of the therapeutics a reality obviously in the future we will talk more about it a lot of the foundational work is being done now since it wasn't done in the past and it is being done now so it's something that we are taking those necessary first steps to really make this a reality and it will become a.
An increasing focus for us with that I, just want to turn it over to Joel to give some of the financial update.
And discuss some of the detailed financials from the from the K.
Joel.
Thank you Jed here on the financial updates from the fourth quarter and full year 2020 total net revenue for the fourth quarter 2020 were $219000 compared to $119000 for the same period in 2019 total net revenue for the full year 2020 were two 900 and.
Compared to 651000 for 2019 the increase in revenues were primarily due to the increase in revenue related to innovation research grants from the NIH supporting the matter set platform are coupled with increased license revenue from net translation net sales in Europe.
R&D expense for the fourth quarter of 2020 was $1 3 million compared to $1 7 million in the same period 2019 R&D expense for the full year 2020 was $4 9 million compared to $5 3 million in the same period 2019. The decreases were primarily due to net decreases in drug project expenses.
Including decrease from Anisette therapeutic development costs decreased Madison and and decreased matter. There's a diagnostic development costs. The net decreases also included decreased regulatory consulting and travel expenses offset by increased employee compensation.
Okay from the fourth quarter 2020 was $1 7 million compared to 1.2 million period in 2019 SG&A expenses for the full year 2020 was $6 7 million compared to $6 3 million in 2019. The net increase was primarily due to increased legal and professional services.
Employee compensation European Medicine agency fees for Lymphoseek and franchise taxes, offset by decreased travel depreciation and amortization losses on disposals of assets insurance and investor relation services. The videos net loss attributed attributable to common stockholders from the fourth quarter 2020 was.
$3 million or <unk> 11 per share compared to $2 8 million or <unk> 15 per share for the same period in 2019, the videos net loss attributable to common stockholders for the full year 2020 was $11 4 million.
<unk> per share compared to $10 9 million or 76% 76 cents per share for 2019. The video ended the fourth quarter of 2020 with $2 7 million in cash and cash equivalents.
Since December 31, 2020 the D.
Point of cash related to the series D and series E preferred stock funding transactions to date. The company has received over $14 million of proceeds from the a b C D and.
The series E preferred stock I'll now turn it back over to Judd for closing remarks.
Yeah.
Thank you Joel are actually with that we will open up the Q&A and will lead to give a little bit of time to fill the the queue. Hilary. Please let us know when the questions are already.
At this time.
A question and answer session I would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is on the question queue. You May Press Star two if you would like.
Your questions on the queue from participants.
It may be necessary to pick up your handset before pressing the star team.
One moment, please while we poll for question.
Yeah.
One.
Our first question comes from Jason Mccarthy of Maxim Group.
Please state your question.
Yeah.
Hey, guys. Thanks for taking the question. This is Mike look you know it's on a lot on for Jason.
Thank you Hello, Michael how are you.
I'm doing well.
So I'd like to ask what additional analyses, we should expect to see from the full dataset for an a b III 31.
Gonna be it on all of the larger set or are there any additional data points in there and then for NAV 332 should we expect to see any interim reads from that study and if so when should we expect those.
Yeah. So this is Mike rosol, so good questions for now $3 31.
For the in the main this will be the complete data set that we'll be analyzing we will and we are we.
Main diligent in looking for different ways to look at the data to make sure that we're not missing something so it's possible that there were there will be a readouts that are you know amplifies or takes us gives us something that increases our ability to.
On to predict response earlier, but in the main we're doing what we're doing now is just analyzing the full dataset, but you know what day emphasis on the adjusted there because we're looking at things on any number of ways at all times.
And that'll take some time you know it takes two.
These things are fully in the correct way. It takes several months typically we're hard at work at it and we will we will continue to be as we go for.
<unk> hundred 32, its an adaptive study in the sense that.
As you heard me mentioned, we're looking to enroll patients with all three different subtypes of <unk> and what we're doing is Oh, we can't predict those in advance we're hoping to get a certain number of each subtype and once we do that we will then do an interim analysis to look at the data once we have a minimal.
Number of each subtype and that number is four so four subjects with each of the three subtypes will then do an interim look see.
See how those day to look and determine if we need to go further in the study or if we want to we might've learned something that would give us reason to go forward.
On a positive way and we'll let you folks know then in terms of the timeline.
You know its interesting I I don't want to make a promise I can't keep so I won't we.
Right now.
The main sites that we are the site the northwestern that has opened in the U K sites that we expect to open shortly.
You know they they would predict and they have predicted maybe a patient or two a month, we've been known to exceed our you know in concert with our sites the enrollment projections at those sites have had sometimes we you know they they they want to meet them right. So it's hard to predict so I will take some months.
To get to that number we will be working with those sites and the Pea is actively to try to get those recruitment numbers high there's always a kind of a hurdle. When you first open a trial to recruit patients kind of logistics need to be worked out in the site.
The local site staff need to figure things out and so there's oftentimes a slow open but then things will pick up we'll keep you apprised of these but it's going to take some time to to get to those four four and four subjects, but we will do our best to make it happen sooner rather than later so.
Thank you Mike and then I'd also like to ask if you could talk a bit more about the phase two in atherosclerotic plaques how does the Tc til.
And already there's a pretty clear path you are monitoring a response objective imaging and phenotyping for Mac macrophage activation, but how would it be applicable to atherosclerosis and one can we expect to see any data would be the next step for development.
Yeah. So also a great question. So fundamentally of course, the one of the key components of the atherosclerotic plaque is the macrophage and what our previous work and what the data are showing to date in this in this trial are that we are tremendous up localize us to these atherosclerotic plaques at least in the areas we've looked at.
And it looks like and localize more to larger class right. So.
We're still discussing with our kols.
What what best indications might be but in a general sense. The one idea would be that if we can.
Detect plaques that may have a more of a propensity to rupture right the so-called vulnerable plaques and maybe we then might have a risk predictor right in and so what what might be done if cardiologists sees.
This kind of plaque light up and they're in their patient well you might use this as a kind of determinants of should the patient be put on a more aggressive treatment regime or regimen right. So like high dose statin.
Versus not being on statin, right or or maybe there needs to be an interventional procedure done to roto rooter out a clear out the pathway, where there is a so called vulnerable plaque.
Terms of those who would be imaged, we we might imagine a kind of a medium risk cohort at first.
As folks were.
There may be some evidence already that they might they might need to be put on some therapeutic regimen that theyre not currently.
But not just a general screening of the general populace as a whole so and they're also not high risk already where they're already put on a high dose statin.
Still though even in those patients we could possibly bring some value because we might be able to determine if the if the high dose statin is working and or if theres any particular area of interest that needs to have an intervention procedure. So broadly speaking it would be as a as a biomarker for risk right. So <unk>.
<unk> have a cardiovascular event and there is a need for those are the the field is littered with molecular imaging agents.
That have had this potential I can tell you that in our clinical as well as in some of the preclinical work we're doing.
The kind of leader in the molecular imaging domain as FDG pet imaging, a our results look to be superior to that and by a lot. So that that's very promising but again, we need to think about this carefully what the indications would be and what patients are population, we would think about screening but with cardiovascular.
Fuller events being the number one.
Cause of death overall, we think there's an opportunity here to bring something to the market that could benefit a lot of people, but we will be meeting and we have been and will continue to meet with kols to refine the strategy.
We have some next steps plan I don't want to talk.
Talk all day here on this but but we are we are thinking about this I think strategically.
That's a good answer.
Yeah and just.
When do you expect to see data from the phase two it's I know, it's investigator initiated to you Mike.
Have that.
Yeah. So we've they've been really great about sharing the data with us and we just had a relatively recent couple of months ago, we had an update from them.
And are they are they actually I don't want to reveal too much of their inner workings, but they they expect it to be done by now, but there were a couple of enrollment issues and there shouldn't be done very soon and they have assured us where on the short list of the first folks they will share the data with in the first outside of their actual group [laughter]. So we should see results.
We will see results I think in the next couple of months and there will be ongoing analysis of those results of course and as we make any decisions. We will keep you guys are priced.
Alright, Thank you very much for taking my questions excellent. Thank you Michael.
Next question.
Our next question is from Vernon Bernardino with H C. Wainwright. Please state your question.
Thank you and good afternoon, guys. Thanks for taking my question my.
My question relates to the the type B meeting with the F D. A.
I know you can't give a timeline because it is the F D a.
But just wondering because this is something I've been surveying oh from all the companies I cover as well as I'm, just sort of talk to and the due diligence and that is what has been your experience and your interactions so far.
I think generally.
Timely a very quick in replying to you know.
Questions that could be easily answered or you know when they are involved though or they I'm, taking a little bit of a more extra time that you may have experienced in the past then I have a follow up question yeah. Great. So this is Mike Rosol answer and good question. So our experience on our interactions with this.
<unk> FDA group has been has been great they've been very responsive they actually thus far.
Has held to the timelines for the most part there was the response I think in April of 2019 that came a little later than we thought but there were extenuating circumstances, the government shutdown, namely that that caused that I think more than anything they've been very responsive are very engaged with us and so far in this type B meeting.
<unk> process they have exceeded the guidelines in terms of rapidity of response. So we'll see I think all of that is is very promising.
Along the lines of what you are you've experienced maybe with other groups as we've I was speaking with our colleague from another company, who said they put in a meeting request for a face to face or a zoom style meeting and they were told this was two months ago and they were told we can schedule the meeting in August.
I think we did a we took a more strategic approach and did a written response only and those are usually you're able to hold to stricter timelines because you don't have together a whole bunch of people in the room. It in a room at the same time and because of Covid. Many of those formal face to face meetings have really.
Dragged on and been put off so theres a backlog. So our response is going to be in writing, which we think is the smart way to go given the circumstances okay.
Terrific.
My follow up is related so along those lines there or.
<unk>.
You you you don't have studies activities related to our egg on that studies, Dovetailing, Oh, and a specific time point, but there are.
A lot of things are going on in parallel at the same time and somewhere down the road is the initiation of the phase III.
You could provide any.
Detail as far as any feedback you have received and.
This is something they may or may not want to or have provided as far as the email or redness is concerned what has been their feedback regarding how a lot of these piece parts as far as the clinical trials are concerned our R. R. Dovetailing.
Necessarily.
And to one time point, but in which there's going to be a lot of pieces that they need to consider at some point and I know you gave the book, but I'm just wondering if you could describe though hum what's their mindset.
Sure. So all of this has been done and and alignment with them all along the way so they knew of our plans to.
To run these trials in this fashion and in the sequence.
And remember as well that the naphtha <unk> 32, as I said isn't part of the critical path, but it is critical we think for development in our a and will provide a great.
Enhancement as Jud put it to the to the commercial product that physicians Rheumatologists in particular are really excited about but back back to the FDA, we'd been in alignment with them.
And in fact in the design of the I've mentioned this before the design of the phase III, we've taken their comments to heart.
And crafted the primary objectives.
Essentially exactly the way they suggested we might.
So I think we're we're in a good place with them they've they've understood our our path on our our strategic way of approaching this and the fact that will at any one time might have a few.
A few plates in the air but we're working on our best to make sure those land at the same time or their cost at the same time and we are and we can do this in a in a smart, but expeditious fashion. So we've been in in tandem with them is the short version of all of that.
Perfect got it sounds like you've got a lot of things in place and that you've the approach you've taken or the strategy of you taken seems to be.
For the most part the low maintenance you just need to hear their feedback and then you know hum step on the gas again.
Thanks for taking my question.
Youre welcome. Thank you Vernon. Thank you I appreciate it.
Next question.
Our next question from Matt.
Jacob.
Please state your question.
Yeah, Hi, guys. So first of all I've been a very patient investing for a long time with the video.
Last year at this time, there was a clear mentioned that Mastiff Hay group was gonna be planning on buying the they were guaranteed to be buying a million shares at $5 a share.
From looking at the balance sheet seems pretty darn clear that didn't happen can you explain this please.
We entered an agreement with them in August of our.
2020, and are they guaranteed a funding of $5 million at $5 a share and to date they have not funded now.
Is there any plans to do anything about that I know, it's hard to go after a hedge fund or anything like that you probably don't want to but is there any plans or are we just feel like that slide.
We're currently in discussions with the board as to what our options are in terms of dealing with them and are they.
They have acknowledged that they are still obligated to provide that $5 million.
And I have said that they intend to find at some point in time. So we are still in discussions with them and the board to evaluate our options with related with in relation to the master funding.
Okay.
Secondly.
I think it was about this time last year that we entered the agreement with jubilant. It might've been Argus that might be mixed up on my time schedule here.
Did we first.
On the M a y or when did you Blink first time MLA with us.
The Mou was signed in on.
The Mou was signed in August of August 25, 2020.
We've been waiting for that because it was at the time discussed as being a permanent the partnership how.
How much longer do you think we should be patient as.
The owners of the videos are.
Shareholders on the video before we expect some sort of either sign or don't sign final agreement.
We continue our discussions with them and I think the discussions have been fruitful.
Fruitful I think from our side as a company we are comfortable to see more data from the trials as I said in my remarks, I think that as we generate data from $3 32, a that will allow us to increase our what we could expect in any.
And any final signing of the deal with jubilant Ah as we continue the discussions I think that it's important.
That as we generate more data we firmly believe here at the company and I think jubilant actually agrees with us that the product increases in value are the biopsy data from $3 32.
I'll set a bar as I discussed on our remarks that will establish what we feel is an enhancement to the initial label, which would allow an immediate diversion from the standard of care, which is the anti TNF.
And potentially allow for doctors to move from that tier one, which the insurance companies don't like to do but if we prove.
Within what we've seen in the arm three of the phase <unk> as well as what we hope to see and $3 32 that there is a certain percentage of the population where a greater than 80% plus part of the time the anti TNF just won't work if they have a particular phenotype.
And that gives us a very potent weapon as part of the label.
That also makes it a very convincing argument to start using our imaging agent right away. If we know that we can eliminate say, 35% to 40% of the population from using Ah and anti TNF for any period of time since anti TNF come with a lot of side effects and they don't work all the time.
And if we have and we have seen this in the arm on three and this is something to lead back to the question that Michael had asked earlier.
We see that there is a population and it's a big portion of the population that just won't respond to anti TNF.
And once we get that data from 332, I think that's going to be something that is very key into the completion of the final deal with jubilant, which should also.
Lead to some increased consideration as well.
Okay, and then one last thing we talked about funding last year and that we had enough funding to get us through I believe the phase III trials do you still feel it that way with where we stand right now with our cash balance.
Yes, we're getting the money from Mr. Scott as you pointed out assets has made a commitment and to date has not funded we got terms that we thought were attractive we're very attractive from Mr. Scott, especially given that.
He is a continuing and supportive shareholder.
He is eliminate he obviously can't go above 33% ownership. So there are those restrictions and his ability to convert on the series a preferred that he subscribe to but he did fund that upfront. So that money is there Keystone continues to fund and and so from taking into consideration the funding from both of them.
Those sources, whether we get the massive money or not our phase III trial is fully funded.
Okay.
Alright, that's it from me from them.
Thank you Jacob I appreciate it thank you.
Next question.
Our next question is from Mike.
Yeah.
Please state your cranky Alley.
We finally got it right last time, Rocky Ali Hey, we're getting we're getting there I do appreciate it. Thanks for taking my questions you know on.
I have several of them. So I appreciate it thank you.
More on to what I believe Jacob just on the funding. So do you still believe that.
We have funding for the full two years as you stated last conference calls here.
I think that we have a very good runway from here that should allow for a completion of substantially all of the phase III, yes.
Okay and that on the yet so.
Yes, Uh huh.
Keystone on track then to finish their conversion funding by geography.
They have until the beginning of June to do that and.
And we have had discussions with them and yes. They are.
And so just my comment it looks like they normally do.
On some place between $5 million, so anyway, I don't know, if that's correct or not but it's just my observation.
Is there a milestone payment from Cardinal for.
So the North America, right and reach you know they will.
We continue to hear the number of imaging.
Is there a milestone payment and reach or not you can you share that.
So I have not gotten the last year's data we got.
I mean, so we should get it on June 30th the data for the full year.
I mean, it's it's a possibility prior to Covid, we had seen renewed growth in lymphoseek and so there is a possibility that down the road there could be that milestone payment and once it passes $100 million a year in sales.
Right.
Yeah.
Alright, so there's something there was a possibility, but not a probability is that fair, yes, I believe so down the road I mean, there are some other things that are.
That we potentially have I mean, obviously.
You might have noticed in the press release that we made and announced that there was something about 46 94 expenses interesting to note there.
The reason why we said in the press release that the expenses increased they actually did increase in 2019, they actually were negative because we were able to realize some realized some gains against it and they were zero for 2020, so on accounting basis from a negative to zero is actually an increase but given that there are two treatments out there.
<unk> that do target the beta amyloid, whether or not they work or not there is always that possibility.
That we will have a $1 million milestone coming from Miller at some point in time I think that adds those treatments get more play in the news I am not going to comment on what I think about the biogen versus the new Lily the path forward, but there is always that potential that without spur.
Any money, we could see a $1 million payment from them and they were actually also a couple of other opportunities to get some milestones on 5001.
Which we've actually taken in a little bit of money on that that is something that we still hold the database on that product has actually.
Been moving forward.
With a undisclosed partner and if that does get approved and we think that it might get approved as an imaging agent we could see a million dollar approval milestone from them that is something that we actually signed a contract on to to have so thats something that that could happen in the future I don't know the timing of it.
Depends on this company getting the approval and then after that if it actually makes the market we could receive up to an additional $2 million in sales sales.
Loans over the next several years once the products start selling.
In addition to that on the press release, you mentioned the new Grant can you give us more details on that.
No I mean, we do on the gallium grant.
Yeah, Yeah, yeah on the gallon growth that we've been that we've been working on I mean, we do think that there is value there.
And we hope to we hope to really get some very good data from that which we can then use I mean I think as you know we've been there are a lot of things. We're working on that we haven't discussed I mean, I think it's important that we continue to move the ball forward in many in many different areas and we will discuss those areas when we.
Feel there is something really to talk about I really do want to stress that I'm not going to be talking about things that are really not fully baked I mean, I think that's a mistake that had happened in the past I don't want to revisit those mistakes. It if that had happened in the past when other when other individuals' spoke about potential things, but I assure you we.
We're moving forward in a lot of different areas and as soon as we have something tangible that we can actually really talk about we will be talking about that.
Why we waited so long to talk about it with you I mean, the OSU negotiations were going on for two years to finalize those patents and we didn't really discuss it or even mentioned it until it actually happened because I just I want to try to avoid setting any of sending any unrealistic expectations, but I am I am excited like I said 5000.
One is something we sort of kept on our back pocket, we did taken $200000 on revenues on that.
And I do expect with the backing of this big partner in conjunction with the new partner that has it. They do think they can get it across the finish line and if they do get it approved then that will be $1 million that we have never counted on I'm still not counting that in the budget, but if it does get approved that'll be something nice to have.
Okay.
On an on jubilant Ah a couple more questions on queue go on deal get done.
Diligence.
Been a lot of discussion on that.
On a given what's gone on with Covid and the fact that we have just not been able to meet face to face and all of our discussions have been.
To resume and we've had many and we continue to have many.
We've agreed on both sides to continue the dialogue I think that in exchange for that agreement.
Very much pushing.
For a rework of what we think will be the upfronts and it's a rework in a positive manner because there's more data is generated the product <unk>.
Generally it's more value so in order to increase and continue the due diligence time, we had to make sure that any any increase negotiations due to the COVID-19 delays would net potentially more money for the company and so that has something that we have agreement on both sides and as we continue these negotiations on the dude.
Diligence.
And coupled with the data we hope to generate with 332, we feel that if we decide to go forward and sign the final agreement.
We think that the shareholders hopefully will be happier with what would be an increased upfront versus what we had announced in August.
Well, that's an excellent piece of information did you go on.
And they do deal with that's where did they find some excitement in the molecule itself.
Sure.
I mean, it's hard for me to comment on what you blend you know on what they thought or didn't think I think that.
You know on I choose my words carefully I think that they were very excited about the predictive power of the <unk> of the molecule and the arm three based on one of our theories and our theory, which is really on lynchpin as I discussed earlier for what we're working on for a part of the year.
Illness of the molecule will be backed up by $3 32, and when that happens not if but when that happens we.
We feel that that is going to unlock an increased amount of value, but the key is as we've always talked about in the past even when we were discussing the Nash stop biopsy is the best way to look at things, but biopsy is just something you are never going to do and so looking at the biopsies that were going to do on $3 32, which are completely <unk>.
Dave and I want to thank in advance the patients that sign up for it.
I know that we're looking at and we're actively recruiting so I want to thank those patients in advance on a step up to do that because it will really give us a amount of data that we think is going to establish.
A baseline for whether or not a patient is going to get an anti TNF right off the bat and for antibody and unless and I come from this from experience as I've.
I've never made any secret about I suffer from Crohn's I've gone through a lot of different medicines over a lot of different times thankfully as of Crohn's patients have the ability to get a colonoscopy, it's not the most pleasant thing in the world, but certainly for anybody over 50 out there I do encourage you to get those colonoscopy, but for me the only way I can get my insurance to pay from my <unk>.
And as might go for a yearly colonoscopy.
And the insurance company is very very strength, it's actually funny prior to this call. The insurance company actually just call me two to get the colonoscopy results that I that I, just add a month ago, because they had not seen it or else. They wont approve the medicine, but within our a patient you don't have that benefit.
And the insurance companies say treatment number one is anti TNF and anti TNF doesn't work a lot of times on Weibo.
Way back when when we started this whole process Doctor Cup. Dr. Goldberg, We all said the exact same thing it is the largest product in the world and it doesn't work 50% of the time, we actually now have a molecule that we feel that with a certain phenotype. We can spot that early Ah and the $3 32 will.
[noise] firm that and that will create a lot of value. Because we can then go to the insurance company and say listen we've done a full phase III trial, we know that 35% to 40% of the time patients with this phenotype will not respond 80% or greater on the time to an anti TNF why bother putting them on it when there's so many other choices and we think that will be compelling.
And that is really what we're hoping to do with the 332 trial as well as the full phase III trial and also don't you know.
Not minimize the effect of the 335 trial that we're going to launch where we're going to get more and more of the normal so that when we do launch the product we really can hit the ground running with a very fulsome database that will allow the AI really to take over.
Not going to cut out the people reading it we want people to look at it but we're going to make sure that the artificial intelligence. The AI portion and the algorithm portion really works and is really honed for when we're ready to launch and we're in active discussions with several different groups working on that working through the data and this 335 trial will give us a larger database of images that will.
Really help make that AI work faster and faster similar to the example that I gave years ago when talking about Alexa when Alexa Amazon's Alexa first started it really wasn't very good because it just didn't have a big body of questions being asked to it but now it's fantastic and everybody has one in every house and everybody uses it every day, we want our <unk>.
<unk> to be used a lot right away and so by doing $3 35, we will be increasing that database and we'll have more and more images that we can use as reference points to really make sure that we can.
Get the doctors to diagnose it and get the doctors to prescribe it use it to diagnose and really move through the process that flow diagram that we put together that it's on our website, we really want that to be as as quick as possible.
How many sites have been contracted.
D R. A T. Three you've said you'll take some place between 25 sites on you.
Actually firmly contracted side and if so how many.
No. We're on the process of doing that this is Mike It will be 25 to up to 50 as you said they were on the works actually right [laughter] Jed just gesture right next to US here in the boardroom the conference room as our giant on a whiteboard as the list of the sites. So we're in the process with all of those to get them.
Ready to go and as you've heard me mentioned several times some of the key sites from our currently running trial that.
Net of recruited especially into arm three are anxious to these sites for the phase III and so likely those are they are they have a running start on likely those will be the first ones that we open up so we're preparing to open up as quickly as possible. We don't have a contract specifically signed for that yet it's part of the reason for that.
Because that's the way it's done right. So we need to finalize protocol IRB approval all sorts of things before you then move to that stage and all of that is happening behind the scenes and once the FDA gives us their feedback we'll hit go as soon as possible.
Well, how many sites.
Tentatively agreed are you over the 25 or.
So we have 50, who are interested yes.
Okay.
Court now.
With what you're talking to the FDA about on your preliminary package are you still looking at a 12 month trial.
On that.
Got it.
Yeah, we've mapped out a number of different scenarios, depending on how many sites, we can open and looking at our average recruitment rate from our currently you know the trial that just completed.
As you've heard me mentioned before in that trial, we actually.
Enrolled at a more rapid rate than the typical phase II or phase III study in North America for rheumatoid arthritis, which I think as you know.
A great Testament to the hard workers are in the clinical team as well as me aside as well as in the the sites themselves. So.
You know there is a six month follow up for these patients in this study right because as you know the standard of care is to put a patient on an anti TNF Alpha and then bring them back three to six months later to do clinical assessments.
So for our predictive capacity, we really need to target the six month time point as well as the three month and that's again an agreement with the FDA and so there is that tail right. So our goal will be to recruit as many subjects as rapidly as possible in order to you know to meet to make the trial run.
As efficiently, but also as short as possible right. So I don't want to promise a year.
Depends on how many sites we can open in what the recruitment rate is but we're going to do our level best to to make it.
Short as possible and we have a track record showing that we do a really good job of that so.
On my last question is more on the scientific side. It's on your true last patent application, who the one on Uh huh.
Method for altering the math on screen product and then the other one was the more recent one in February on the abolition of the M. Two macrofossil. We're there in those two patent applications. It was indicated that three human blood samples were taken to run some of the cash can you share any more on what those three human.
Samples were and what actually transpired on what was oncology tests.
Yeah. I know these are these are samples that are available from on.
And working with our contract research organization collaborators or companies.
Companies that we contract with who are expert at these some of these in vitro assays. What you can do is you can get the samples and take out the macrophages and then grow them up and culture.
The way.
So that you can then perform tests on those macrophages derived directly from human subjects now we haven't done those just from the work we've done with contract research organizations.
To elaborate on a little a little bit. We also do this work in collaboration with UCSF on separate samples. So now we've actually taken data from.
More than three at least six on actually at this point I think it's nine different human subjects taken their macrophages out from the peripheral blood growing them up and culture and shown that we can flip the phenotype of drive the phenotype to different types of macrophages, depending on what kind of.
Construct that we've generated we pour on top of them right. So the two patents you've mentioned or we refer to them internally flipped the tam or flip the tumor associated macrophages to us and by that I mean, the phenotype flipping and then kill the Tam on that as to ablate them and we've shown.
In vitro as well as in vivo in tumor models in rodents that we can change the phenotype to a more pro inflammatory state to enable the body's own immune system to attack tumors as well as therapeutics that we approved therapeutics that we introduce.
And we can also kill those as well if we want to but the main.
We think the main benefit is from the flipping them driving their phenotype to a pro inflammatory state, but basically the short version of my answer is that these are these are samples from humans not specific with on to oncology cases, we've taken their blood you can isolate their macrophages grow them up in in vitro and then do things to them to <unk>.
See if you can moderate them in different ways.
In parallel we've done these tumor models in different rodents different tumors and shown that those in vitro results can be replicated in vivo and that they also have an impact on the tumor growth. So low is that the myeloid derived suppressor cell and pack.
Yeah, Yeah. So we saw that and that's a that's a really cool finding so it turns out that in order for cancers too many cancers to grow and metastasize.
There are a group of cells that called the myeloid derived suppressor cells that seem to play an important role in that and I won't get into the literature, there too much but it turns out that those myeloid derived suppressor cells are one very important subtype express CD two O six and we actually can impact those and we've been shown to reduce them by about.
A half and we think that will have.
Implications for reducing the possibility of certain cancers to metastasize. So that was kind of an added bonus if you will of our of our therapeutic construct and we've shown that in vivo. Indeed, we reduced the numbers of those myeloid derived suppressor cells by about a half.
Long term, we think that's going to be very important well.
Well from a language from a layman's observation, that's kind of a bite targeting isn't it.
We're targeting the tumor microenvironment, where the Tam the Tam on your your.
Changing those and then also at the same time, you're seeing an impact from the cancer cell itself.
I'd call that a bite targeting I guess, but what how would you phrase that yeah, well well to be clear, we're not we're not targeting the cancer cells directly although there might be indirect effects from the from the whatever payload, we're bringing but the primary action of our construct is on the Tam as you mentioned the tumor associated <unk>.
Macro phages getting rid of that so called force field that my.
My predecessor here had referred to it as in others as well in the field. So we kind of eliminate that force field and actually ramp up the body's immune system to enable it to attack the tumor as well as increase the efficacy of other therapeutics that had been prevented from reaching the target by that so called force field the myeloid.
Suppressor cells themselves aren't the cancer cells, but they support the cancer growth as well as metastases and we do target those and that is a direct targeting and we are a bleeding those or at least reducing their numbers.
I I say that because there may be different reasons, that's happening, but what we're reducing those numbers in that sense. If you were referring to those as you know cancer yourself, there really cancer support cells, we R&D targeting those and having a direct activity.
The last comment that I have.
Or is it to ski University study.
N C I N and M. Katz also participate.
In middle of 2020, and they clearly identified.
On to macrophage.
Probably the true.
The entry point.
Into the body.
M. A C D E and reported the body from the original bacteria and viruses. So however, we really you got there we got to this point that seems like an exciting observation.
Part of a tool to educate people.
On the potential here, particularly as these preclinical he law, but is that a fair or not.
Yeah, No. That's fair that's fair I actually saw that that article that you referenced and indeed I mean this is an ancient system that evolved in order to for the body to fight off the.
Invasion of different.
Different attacking agents and it's been co opted in used by the body's immune system for many different purposes, and the fact that we targeted and it plays such a crucial role in so many different disease processes is.
It is a great advantage of our molecule.
And it gives us the ability.
On to possibly impact of a really great variety of diseases, both from a diagnostic perspective as well as therapeutic so so absolutely yeah that was a better defined.
Uh huh.
But you have a point on that is.
Two O six jamar has evolved over the last 10 years it looks like an opportunistic net target the market hasn't recognized yet I think that's a fair statement the market just hasn't been on credit.
Yes, Youre right. This this molecule was ahead of its time in many ways in and now the world is waking up to it.
And the scientific literature is growing that that marker in these macrophages play a role in and so many diseases in a fundamental way that again this.
This is an exciting time for the technology and the company you know all else aside for the reasons that you were mentioning so I agree.
I'd like to finish by thanking the board on.
Again, everybody on that for getting the financial position of this company back it's been a long time many years, that's the balance sheet had cash on it on this.
Finishing them out so thank you for strengthening the balance sheet and keeping the company.
And lastly, I'd like to thank you for all the fight you did her to get back empty to the shareholders.
So that science, that's a big success that I don't think much credits given force. So thank you for getting back that therapy therapeutic trial. It was a good win.
That's all I have thank.
Thank you Michael I appreciate that so I.
I've got to move on to any other questions.
Yes. Our next question is from Michael low.
Please state your question.
Yes, Hi, I appreciate that I have an overarching comment and then a couple of quick questions all of which derived from that comment.
On the comment seems to comment is that in my opinion. It seems like for whatever reason, which I cant frankly figure out your seems to be a strong reluctance on the part of the company to make disclosures.
Net are positive and that might do things to increase the stock price of the company.
You know and in no particular order for example, I noticed in the press release and Joe reiterated. This on his comments that since December 31, 2020. The company has received seven $9 million of cash. So I saw the press release that Mr. Scott invested 5 million could you guys. Please explain to us where the.
Incremental $2 nine came from in the price per share.
Et cetera, and the timing of that investment.
That's the continuing funding from Keystone on the series D preferred.
And then why was it I've got to believe that $2 9 million to a company of new videos current financial status is a material amount why was that not disclosed or did I just miss that press release.
We disclosed that in August when they signed the agreement that they would be funding $15 million on an average price of $2 and 91 five to 905 per.
Per share on weather.
Wasn't there a floor of what is there a floor of five when they were a floor of $5. Now. It was it was like this is a Keystone series D preferred that was disclosed.
In August I believe was when we signed the agreement and the funding is for a nine month $15 million guaranteed funding with a floor price of 2915.
So what we.
We've had some offline Congress stations about you know the one of the press releases back then about the 5 million I'm, sorry, the $5 per share floor on the $5 75 or whatever cap.
What what was that in relation to.
That was the master funding.
On our Keystone and asked if not affiliates.
They have signed a document that theyre not affiliated massive is run by an individual named Dan Weinstein and Keystone. The portfolio manager is so many and Fred Zaino.
Okay, so they're they're not affiliated entities in anyway.
They are they have signed agreements.
You're disclosing that they are not affiliates.
Okay.
A couple of minutes ago on response to one of the questions. You made a comment that you know the jubilant due diligence on going and it's been slow down a little bit by Covid.
The Mou was signed in August of 2020.
So we we're smack in the middle of Covid there. The jubilant press release says they made a $1 million equity investment in exchange for a quote unquote limited exclusivity period, Obviously limited is and you know on the minds of the Beholder, but you know we're now going on seven months here.
And to my knowledge the company does not disclose what that exclusivity period is to the extent that results keep coming in and are positive I would just I mean, it seems to me, they're getting basically a free look.
Right Theyre not theyre not getting a free work so as more data is generated the cost of them goes up.
Okay.
So if we decided to commence if we decided to sign an agreement a final agreement on it are the <unk>.
Cost would increase based on the amount of data that is generated by the company.
The Mou has been described as binding is that binding from start to finish there are only certain provisions of that Mou binding.
Like you know cash expenses and exclusivity in certain yeah, there are certain true.
<unk> that are binding and certain that are not yes.
Okay.
With respect to the IP and I think it's terrific to.
To hear about some of the progress that the company has made and I think we might have also had a yeah offline discussion about this but I think in one of your fireside chats previously.
And one of the you know prerecorded videos there was mention of some press releases relating to patents and I understand obviously I understand the reluctance of the company to discuss these prior two filings with the U S PTO et cetera, but it seems to me that once filings have been made and are granted.
Did the company is protected y y or disclosures not made regarding these.
Uh huh.
We are we made a we actually did do a press release on I'll ask Hugh to discuss the IP and the filings of that.
So that was that was press released and its been discussed on multiple presentation. Since then.
I've I've asked you and Joel and emails for copies of those annoying and you said there were no press releases you can point me to any but okay.
And I guess my last question is last I think it was last week, possibly two weeks ago. Mr. Scott filed another amendment I don't know 345 years 13D about our scheduled conference call isn't that conference call happened if not one is it scheduled for and if it has happened can you. Please disclose what if anything was discussed there to the extent that.
And then M N P I.
We had a conference call with Mr. Scott and were just discussing.
He is a.
He's made some suggestions and we've had some open dialogue.
But that conference call has taken place I would say that nothing material was discussed on the call.
When you say suggestions are you are you free to discuss what those suggestions were.
No.
[laughter] okay.
I tried.
Uh huh.
Okay. Thank you next question.
Our final question comes from Edward English. Please state your question.
Hello, Jade this is Eddie English. Thank you for taking my questions I have about three or four if you would indulge me.
I think you probably have some insights into what these are my first question is around the marketing.
Of the alright product if we assume next year, we'll have an approved product I'm interested to know now.
Now you will be marketing the two the Rheumatologists are two they are a patience.
Using a planning to use T. The advertising like other pharmaceutical companies do to sell there are a drugs and lastly, informing the insurance companies have the benefits of this product from their perspective can you.
She had some color or details around those strategies.
That's actually an excellent question and that's something that I think that people have like.
Have missed.
Repeatedly unfortunately with this company that we when we signed an agreement years ago, and I really I don't like to dwell on the past on I'm not going to on a say briefly we signed an agreement with a great partner in Cardinal on but we signed an agreement that didnt really require.
Any of that and you really hit the nail on the head. This is a product that we feel strongly will do very well, but it will need to be marketed and it will need to be pushed and that's why you know in our discussions that's one of the things that we really worked on with jubilant. There is a minimum spend involved in terms of our marketing budget, which will be which which one.
The agreement is finally signed when we decided to proceed with that will be extensive will include a lot of a lot of marketing dollars I can't guarantee television advertising that will be their discussion, but we are going to be guaranteed minimum spend per year on a rollout and that's something that is really really key for the product.
I'm doing a deal for a diagnostic like this isn't just okay, how much money you're going to give us upfront. There's so many different parts of it theres. So many different things to it and marketing is a very big part of it and that was a part of our discussions that continues to be part of our discussions and thats something that yes, there will be.
In conjunction with a partner very heavy marketing spend and we looked at some of the other products in the market for diagnostics. Since this will be the first of its kind, we didn't really have direct comps, but we looked at spending level and it's going to be tens of millions of dollars that will be spent by our partner on the marketing and we need.
To make sure that it's money that's spent that they spend at that it's part and parcel of the agreement.
That's something that we didn't have in the past.
With Lymphoseek in either Europe, or the U S and those are things that we are making sure that are included in any agreement.
Than we do now and Thats actually also part of the diligence because as youre going through the discussions with Rheumatologists. The Kols panels, you have to set a bar and figure out what needs to be spent how much would be spent and how it should be spent and so your question was really fantastic and there will be a significant spend.
But that will be targeted and.
And we will be included in any agreement that we make.
That will be spent by our partner that we bring into the fold.
Okay. Thanks, Thanks for that and second question is around our revenue projections.
I'm wondering if you plan to start giving us any.
More detail in advance around your revenue projections.
Considering that we have a new emphasis on humana.
In Europe revenue for 2021 and then.
Any details you can give us your estimates you can give us on a breakeven.
So during the.
Possible revenue from they are a product in 2022.
Well, we would expect revenue from the <unk> product in 2023, probably are and so I would I would say as we get further along into the phase III and we get a very good sense of when we can expect.
The last patient last visit we can start really start going through the revenue projections and once again that would also be something that would be done in conjunction with our partner, we will get to that point, but I still think we're at least a year away from that before we can start talking about those projections, but we have looked at some third party.
There have been third party consultants hired by our potential partner that had gone through some of the revenue projections.
They seem consistent with what we projected which is we feel as an initial label up to a half a billion dollar product and with an expanded label over $1 billion a year on revenue, but once again those are things that will take time, so I would expect that the ramp up will be.
Similar to what you see with other diagnostic products, so youre not going to it's not going to be I said originally a few years ago I try to compare it to what do you see with a therapeutic where you had sovaldi and <unk>, which was a product to cure hepatitis went from zero to $8 billion in one year, you don't see that with the diagnostic I think with with us.
Youll see a nice increase a nice ramp up over time. The good thing about our product is we feel that its utility is going to create lifetime value patients. So unlike lymphoseek, where we want to only see the patient wants we want to hope that we find the Sentinel lymph nodes. They do the biopsy their cancer is cured.
And hopefully they will have long healthy lives and we never have to see them again with aura. Unfortunately since there is no cure each patient we bring in as a patient we're going to have for life similar to that's why Humira is a $20 billion product because it doesn't cure or anything it just it just hopefully puts patients in remission and our diagnostic agent will monitor.
These patients to make sure that they are on the right care. So as the sort of as it builds you've got one patient and then you have ample I've been too so on and so forth. So the revenues build upon themselves.
But that's something that will we will really start fine tuning and start disclosing more and more of.
As we get further along into the phase III.
But I would not expect any any revenues until 2021 added comment. This is Mike rosol. So of course on the clinical side, what we'll be doing along the way is as we will be publishing and are getting a word out to meetings.
At meetings, where a rheumatologist congregate, so there'll be a growing awareness and that onus is on us of course to disseminate. These are the results that we've achieved so far as well as the ones that we predict we will achieve going forward. So there'll be won't be play a role in the educational process, the rheumatologists as well as the new <unk>.
<unk> by the way. We're also excited in general do you have another tool that they can use in their toolkit. So we'll be doing that as well so back to you Jeff.
Okay. Thank you you said you're on another question Edward excellent Yeah, actually I have two more on out and I'll try to wrap this up pretty quick.
No problem.
Hi, I'm interested in maybe Dr. Rosenberg on them.
Comment on this but I'm interested on any more detail you can give us on the work you were doing with I M. B. You know there was a collaboration announced some time ago with them and I'm wondering what can you share with us about that.
Yeah, Great question. So we on they actually essentially shut down all research activities due to Covid for a very long time, and then when they opened up they opened up and focused solely it seems on COVID-19 and so we have been.
This isn't a.
Disparaging them in any way I'm, giving the fact, so we've been checking in with them every couple of months, saying you know whats the time, what's the horizon look like and just recently, we did this yet again and we.
We should be preceding knock on wood.
With our first preclinical studies with them, where we will be evaluating our construct in concert with their so called cancer vaccine, although I think actually they themselves don't like that terminology anymore. Although they were using it. So anyway, we should start studies in the next several months with them preclinical finally, but really we've been wet it ready and waiting in the wings.
And anxious to get going with them, but we of course, we haven't been sitting on our hands and so we've been doing our own studies with different therapeutics as I mentioned looking at tumor models ourself to show that our drug can work synergistically with already approved compounds.
To reduce tumor burden so.
Yeah.
Excellent. Thank you.
My last question is with the World care clinical agreement regarding the imaging workflow for our a I was curious.
Is that agreement been finalized and are you using world here with the existing already studies and well that'd be a part of the upcoming phase III studies, and so there'll be prepared to hit the ground running.
When the product is approved.
So we're working with the world care on.
On our <unk> 332 trial as well as on the normative database trial, they will be working with us as well as on the phase III and we're preparing with them behind.
Behind the scenes to to have them be ready for all of those.
And to be ready for the longer term play.
And when we finalize that for the commercial product in that.
We're evaluating still internally because there were a number of options we might pursue but we're working with them on on the upcoming trials and we're very excited about it and they have great expertise.
In imaging in general as well as in nuclear Medicine research and I think it's a it's a good relationship.
Excellent.
That's all on and I'll just close to say thank you did to the entire team have.
On a lot of good work in the last year or so thank you very much. Thank you Edward I really appreciate it.
I apologize, we've gone a little bit over time, but we're always available for questions as Michael pointed out I mean, you are always welcome to call or email and and we'll be there to answer any questions that you might have so I just wanted to close the call say, thank you everybody for being shareholders.
Look forward to hopefully some announcements in the near future on the FTA and and some of the trials and some other stuff in the future.
Thank you so much.
This concludes today's conference and you may disconnect your lines at this time.
Dissipation.
Okay.