Q2 2021 Navidea Biopharmaceuticals Inc Earnings Call

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Okay.

Greetings and welcome to the video Bio Pharmaceuticals second quarter 2021 earnings conference call and business update 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.

As a reminder, this conference is being recorded it is now my pleasure to introduce your host Jed Larkin Chief Executive Officer. Thank you you may begin.

Thank you Doug I, just want to remind people. This call is being webcast live on our website IR data video dot com and a replay will be made available. Following prepared remarks, we will be conducting a question and answer segment. The videos Chief Medical Officer, Dr. Mike Russell and the company's Vice President of Finance, Eric <unk> 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 the videos 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.

The impact of 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, including the company's most recent quarterly filing an annual filing with the SEC.

I also want to thank you couldn't hear in the background, there's a bit of a rainstorm here. So.

We drop off that means we lost power and we will get back on as quickly as possible.

Just in case, a second second quarter marked another key milestone in the videos long running quest to get a second product approved in market. We completed a statistical analysis of the full data set from $3.31, and successfully submitted the full package to the FDA and received word that we will have a meeting with them on September 1st between now and September 1st we will have a continuing.

Back and forth with the FDA as we submit answers to the questions that they have and seek to optimize our meeting with them.

<unk> had a productive meeting with the FDA and be able to quickly move from that meeting into the launch of phase III clinical.

Our clinical team is ready to launch with most of the centers that were involved in 331 and 335, we have a whole slew of new sites prepared to watch for 333 as well. The goal is to have as broad a trial as possible that will accomplish two goals one to allow for rapid enrollment of the trial and to prepare a ready audience for when the product is approved and ready for.

Our commercial launch the more sites, we use the more of those sites will become customers in the future.

And this past quarter. We also had a successful verdict in the Delaware Court in the case of macrophage Therapeutics first Dr. Michael Goldberg. The court found that Dr. Goldberg breached their fiduciary duty to the company.

And this past quarter. We also completed our funding with Keystone, receiving a total of $4.5 million a $15 million series D preferred agreement the company and Keystone mutually agreed to terminate the arrangement. Despite the previous promised and committed guaranteed funding.

Our discussions would you want to continue and have been quite productive on many fronts, but we're going to wait for the 332 data before we make any final decisions and that data should unlock more value to the company and its final negotiation of a commercial agreement with a potential partner.

I discussed on our last call we were pleasantly surprised with our arm three data from 331. They gave added importance to our theories that should be validated by the biopsy data generated in 332.

If you recall our presentation, we have two bubbles up potential peak sales for the product and the data from 332 will get us closer to that larger bubble faster as well give the doctors the ability to prescribe something other than the standard anti TNF, 35% to 40% of the time on day zero.

This goes a long way towards achieving the goals of the product to get the patients onto the right treatment faster to mitigate side effects and wasted time on using a drug that is it effective for individuals on all right.

I'm also very impressed with how quickly we enroll the 335 trial and built up a substantial normative database of images that will increase the effectiveness of the digital arena that are currently being worked on by our two imaging partners.

Just in the past this database is key because in a I read is only as good as the compendium of historical data that had been fed into it.

Our self driving car works the more data you out at the outset, the more the more accurate the algorithmic readers.

And other items the reason approval by the FDA and the neurological space makes one of our Dorminey licensed products. It would be more valuable we can expect to have an announcement on that product in the near future.

Before I turn things over to Dr. Rosol I want to once again, thank my entire team for all the pilots hours of work in this most difficult of environments as a team expands we will discuss that more in the near future. We are getting more and more prepared for the long Road ahead, not just with the approval of our a well the turbocharging of the therapeutic efforts going forward now I would like to turn the call over to Dr. Russell who will cover.

The clinical portion of the call.

Well, thank you Jess Thanks, Chad.

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 rheumatoid arthritis program, an upcoming meeting with the FDA as I announced on our first quarter update call trial enrollment in imaging events were completed in the first quarter and our phase <unk> study now of $3.31.

As you know this trial and the data from that were critical to moving forward in a way as a reminder, this one is a three arm trial in arms, one and two we evaluated the repeatability reproducibility and stability of our <unk> imaging readout in both healthy subjects and in patients with active alright, and then the third arm, we mirrored the upcoming.

<unk> three study to obtain data to help with sample sizing for the phase III and to have a first look at the ability of tomato theft imaging to serve as an early predictor of treatment efficacy as we have discussed and presented in the past the interim results from all three arms were very positive and the full arm three data continued this promise.

We have data now from the completed trial, demonstrating that technetium 99 am till <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 already involved inflammation and that tremendous up imaging can provide.

Early prediction of treatment efficacy of anti TNF Alpha Alpha therapy in short the analysis from the complete set of arm three patients has continued to demonstrate high accuracy overall at early prediction of treatment effect with a strong predictive value in particular for non responders to anti TNF Alpha there.

Even from the baseline scan alone in a defined subset of patients.

These patients those exhibiting a low level of telematics app uptake in their joints on their initial baseline scan who likely represent the fibroid subtype of already we've discussed on previous calls there was an almost 90% non response rates to anti TNF Alpha therapy, using a clinical gold standard assessment.

This result, an adult the ability to use a single time point scan to predict that and anti TNF Alpha therapy 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 in combination with the predictive capacity, we see in the rest of the arm three subjects. The data continue to support our hypothesis. The results from the full data set from this trial will be submitted for presentation at an upcoming international meeting and of course, we plan to write these up as soon as possible.

For publication in a medical journal.

So back in February we submitted the detailed briefing package of our entire army program to the FDA as planned with what is called a written response only meeting request. This submission included all of our interim results from Nab $3.31, along with our proposed plan for the phase III at the end of March the FDA provide.

With us with feedback on that briefing package. This was an official FDA meeting, but in written response for them only.

This feedback was positive and constructive they understood. What we are doing why we are doing it and how we are doing it and we remained and remain in alignment.

They agree that a predictive tool like we are proposing with tremendous up imaging could help address the large unmet medical need and are a patient treatment at that time. They also requested that we continue with the full analysis of the complete phase <unk> dataset and when done that we request the standard end of phase II type B meet.

And with them.

This occurs once the phase II program is done in prior to beginning of phase III.

I should emphasize that that is the typical way of proceeding in drug development. Once the phase II phase III trials are completed you analyze the full datasets and then you have what is called an end of phase II type B meeting with the FDA, where discussion of moving on to the phase III has helped our strategy has been to work very closely with FDA all along the way in our program.

Relevant to help give us the best chance of success. So we first submitted our interim results last quarter and requested their feedback then about proceeding.

We think this has served us well to be sure. We are in alignment and setting ourselves up for the best chance of success as we move to phase III and hopefully be off.

Since receiving that feedback we have worked diligently to complete the trial analysis and submit the updated briefing package to the FDA along with the request for the end of Phase two meeting all of which has been done and the meeting will be held on September 1st as Jed said and as you've seen in our press release and some detail. What this means is that we work.

From the time, a feedback from the FDA. The end of March to later June early July to qualitatively and quantitatively analyze the images from the completed study analyze and interpret the results from these images and the clinical assessments in concert with our statistics group wide up what is known as the clinical <unk>.

Study report for the trial and update the giant briefing package submitted in February with the completed data in response to the constructive comments from the FDA all in a span of about three months when we submitted the meeting request.

All told this amounts to more than 2500 pages and many late nights of seven day work weeks with all credit to individuals and the team here and our contractors I personally have not seen or heard.

So much work getting done in such a short amount of time in the industry. I told you all of this so that you can be assured that the people here are supremely dedicated and work diligently to efficiently and heart what.

What happens now as we continue to prepare for the conference call discussion with the FDA. The EVAR data in hand, and we have responded to their comments from March.

There will be evaluating the data from the <unk> 31 trial and considering our full draft protocol and statistical analysis plan for the phase III.

Following this meeting we should have a good sense of where things stand for opening up the phase III. Our goal again has always been to keep in close communication with the FDA as we move along to ensure that everything is in place for possible approval when the phase III is complete.

As I mentioned before we have several key sites that we should be able to open up quickly once given a finalized protocol for approval.

I want to also mention that we continue to make very good progress in automating the image quantification as well as Jed referred referenced earlier, which will have significant benefit to the commercial product we.

Nearly completed our healthy control study Nab 335 to establish what is called a normative database towards Atlanta Sept in L. A and integral part of our ability to discriminate already inflamed joints from those that don't have inflammation is the knowledge of what healthy joints look like quantitatively we.

We use the healthy control data from arm one of the completed phase two b to start to set these parameters and we'll use this study to add to the size of the current normative database.

This should enable us to discriminate or an RNA involve joins from not already inflamed joints with improved accuracy and should have a positive impact on our ability to predict treatment response. This normative database, establishing the parameters of what a normal joint looks like with tremendous up will play an essential part in both the phase III data analysis.

As well as the commercial product.

As of today, we have enrolled just over 115 subjects out of a projected $1.35 total and are on track to complete enrollment in the coming weeks.

I should note that the recruitment into this trial was remarkably fast we opened up the first four sites in May and while there. These are primarily healthy controls were also age and sex matching them to the RA population and so we have defined numbers and different groups, we must fill.

The rapid rollout and enrollment is a real credit to our clinical trial operations team.

You also mentioned that the FDA acknowledged the importance of this study Ferrara program developments and our recent interaction with them.

Our comparison study of <unk> imaging to joint biopsy now of $3.32 is in active recruitment in this phase <unk> study, we are comparing <unk> imaging to histology from the joints of patients with active RA, we aimed to recruit patients with each of the three subtypes of already to obtain comparative imaging in pathology.

<unk> results in order to establish the correlation between our imaging signal and the number and density of macrophages in all eight patients joints. We have opened up northwestern University and Barts health of London already and as of the end of this week. Our third site site will be opened at a research in rheumatology sun or out in Los Angeles.

We are also planning to open up another center in the U K.

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 its use in trials of <unk> Therapeutics, who will also provide rheumatologists with goldstar.

<unk> information related to our imaging readout and the fundamental biology of a patient's all right. For example results from this study could directly demonstrate that tremendous up imaging can be used to determine a patient subtype of alright without having to do an invasive biopsy 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 eh patients.

On the cardiovascular disease front work is continuing on the investigator initiated atherosclerotic plaque imaging study at mass General Hospital in Boston.

They recently completed enrollment and data analysis is ongoing and the data we've seen thus far been promising in terms of localization of Humana to sites of atherosclerotic plaque and had been in line with what we reported in our pilot study, we co published with them previously pre.

Preclinical studies of gallium to Atlanta Sept imaging for NIH funded project with the University of Alabama, Birmingham are also ongoing.

On the therapeutic front, we continue to make strides forward four indications in oncology. We have performed preclinical studies that demonstrate macrophage phenotype changed from an immuno suppressive to a pro inflammatory state as well as a synergistic effect on tumor growth reduction in animal models, using our doxorubicin containing cost.

Struck with an approved checkpoint inhibitor therapy.

But much more simply the tumors grow at a significantly reduced 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 in combination 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 the results. Thus far we presented these results at the New York Academy of Sciences Frontiers in cancer Immunotherapy therapy Symposium in May and are completing work on the first of several related manuscripts.

Further preclinical studies, including a dose schedule study looking at different starting points for therapy were also carried out this past quarter as.

As well as the valuations of methods of improving targeted penetration and delivery, while reducing off target uptake in the bio distribution characteristics of our next generation molecules as well. These latter two studies relating to increasing the delivery of our molecule whether it would be labeled as a radiopharmaceutical or what.

The drug for a therapeutic areas of interest versus off target localization could have far reaching positive implications for our compounds related to efficacy and safety.

As these preclinical studies are completed we will update you and announce when and where our results will be presented we're also looking at different therapeutic payloads and we'll be performing in vitro studies using these in the coming weeks and months and in the inflammatory disease indication space. We have made significant progress in optimizing our molecule that.

Contains dexamethasone as its targeted payload this molecule could have broad reaching applications in auto immunity inflammation and in diseases of metabolism.

Is this construct is characterized in vitro we already have begun planning animal studies and so our therapeutic pipeline is robust and moving forward.

On the intellectual property front the U S. PTO has issued a patent for the application titled compounds and methods for diagnosis and treatment of viral infections. This relates to possible therapies for a variety of virus viral diseases, including dengue yellow fever, and other diseases caused by flavor viruses.

Our provisional patent application titled synthesis of uniformly defined molecular weight monopoly the deck strands and derivatives thereof was converted to an <unk> application on July nine.

And we've received notice of allowance of claims in foreign jurisdictions for an application broadly involving diagnosis and treatment of diseases involving C. D to our six expressing cells.

So I hope you can see 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.

Those are just some of the highlights over the last quarter that we wanted to touch on for this update we remain largely focused on the <unk> pipeline, specifically preparation for our upcoming discussion with the FDA and for the phase III as well as enrollment and the currently open biopsy study enormous database study, while we continue in the Meanwhile to sue.

Port and push for progress on our other diagnostic and therapeutic indications.

As always I want to thank the team here for their tireless efforts to keep things moving forward and our network of clinical trial sites and academic research collaborators for all of their hard work.

Thank you now I would like to turn the call back over to Jed.

Thank you Mike as you can see we've really been pushing forward here, there's been a lot of work going on behind the scenes stuff that we don't talk about on a daily basis things that make this company run that will make us a lot more efficient and.

And that we do hope to talk about in the future. There are really quite a few items going on both here and in Europe and in other places around the globe are that should make the video quite an exciting story over the next several quarters with that I, just want to introduce Erika Eves and get the financial updates Erika.

Thank you Chad.

Our total net revenues for the second quarter of 2021 were $261000 compared to $271000 for the same period in 2020.

Total net revenues for the first six months of 2021 were $385000 compared to $427000 for the same period 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 offset by receipt of <unk>.

<unk> from Cardinal health of certain research and development costs and the partial recovery of debts previously written off in 2015.

R&D expenses for the second quarter of 2021 were $1.5 million compared to $1.3 million in the same period in 2020 R&D expenses for the first six months of 2021 were $2.7 million compared to $2.3 million in the same period in 2020.

The increase was primarily due to net increases in drug project expenses, including increased manifest diagnostic and therapeutic development costs.

The net increase in research and development expenses.

Also included increased regulatory consulting expenses offset by decreased employee compensation.

Selling general and administration administrative expenses for the second quarter of 2021 were $1.4 million compared to $1.3 million in the same period in 2020.

SG&A expenses for the first six months of 2021 were $3.7 million compared to $3.2 million in the same period in 2020.

And that increase was primarily due to increased consulting services related to preparing for European distribution of TC 99 mm Telemundo steps employee compensation, including incentive based awards insurance costs director fees related to additional board members General office expenses travel.

Cost and European license fees, partially offset by decreased legal and professional services and Investor relations costs.

<unk> net loss attributable to common stockholders for the second quarter of 2021.

It was $2.7 million or nine cents per share compared to $2.4 million or 11 cents per share for the same period in 2020.

The net loss attributable to common stockholders for the first six months of 2020, one was $5.6 million or <unk> 20 per share compared to $5.1 million or <unk> 24 cents per share for the same period in 2020.

Finally, the video ended the second quarter of 2021 was $7.1 million in cash and cash equivalents.

I'll now turn the call back over to Jeff for closing remarks.

Erica.

With that I would like to open up the floor to the Q&A dog you can open up the Q&A line.

Thank you, ladies and gentlemen, we will now be conducting a question and answer session. If you'd like to ask a question you May press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the Q4 participants using speaker equipment. It may be necessary to pick up your handset before.

Pressing the star kit or.

Our first question comes from the line of Jason Mccarthy with Maxim Group. Please proceed with your question.

Hey, guys. Thanks for taking the question. This is Michael with Juno, which on the line for Jason.

Excellent Michael How're you doing.

Doing well.

So I'd like to see just first off you could give us a bit of an update on where things are with jubilant are they kind of waiting for the.

FDA meeting up ahead, and then we'll get an update where are we on that.

That's a good question as I've said, a few times, we are in discussions with jubilant actually on a number of fronts, which I really can't go into but more importantly.

It is not so much the phase III launched although that will be a pretty key milestone for us what will be important will be the will be some of the data that we get from <unk> 32, so as the data rolls in from $3.32, a we'll be processing that and then deciding whether or not.

We moved forward or don't move forward I think from our perspective, given how these typical contracts work I think it's important that we get the 332 data as it is just going to unlock that much more value to the product and I'm willing to wait get to $3.32 data, which we anticipate can be very positive.

Which just gives us an opportunity to get a much larger upfront than we would if we waited I mean do you think about it you go through the pros and cons. If it isn't really 32 isn't good then any agreement you can make with any commercial partner isn't alcohols as anyway, So why sign and secure a deal, let's say 17 million when you can.

Do you get to 332 data and final deal I don't know $25 million to $30 million. It just makes sense to do it and so that's a given the funding we have on the books and the cash we have in the bank. It just made sense to do that since we have the runway to launch the trial get the trial going and really get things up and running.

Alright, Thank you that makes a lot of sense.

Oh, it's actually wanted to touch on $3.32.

You mentioned, Mike we actually did see some signs that in certain patients you know likely the fibroid subtype.

You were able to determine at least at baseline whether or not they would respond.

No.

This would be looked at as somewhat derisking. The readout for 332 since you already have some you know at the very least anecdotal evidence.

Yeah. That's a good question. This is Mike so and a good conclusion. So indeed, so in arm three we had a number of subjects that had a that had low localization and our hypothesis would be that those are the so called fibroid, regardless of whether or not theres, a fibroid that they have a low level of macrophages.

<unk>, which is one of the main characteristics of the fibroid and in those subjects. We know from other literature that if you don't have a lot of macrophages you tend to not respond to the anti TNF and almost almost never do you responders are it's rare and so that that was our hypothesis.

In our arm three of the 31 trial those subjects, who looked like they had low levels of localization, both qualitatively and quantitatively did.

Did not receive a clinical or achieve a clinical response at 12 and 24 weeks about 90% of the time as I said and so that all lines up with these hypotheses and 31 is going to be the ground truth thing so as you're suggesting given that that meets the you know what we predicted based on all of these are the other literature.

Sure and the hypotheses that we've created based on that literature.

In some sense indeed.

You know that suggest that the NAV 332 data ought to align right at it.

At least in those cases that have low level of local localization. They are likely going to be the ones that don't have a high number of and the high number and density of the macrophages be classified as the fibroid and boom are unlikely to respond so yeah. It's a derisking.

For now 332 sure.

Alright. Thank you and then just one more for me and then I'll hop back in the queue I wanted to ask just how we should how we should think about the timelines on the phase three because you now have a date for that end of phase two.

How quickly following that meeting would you expect a response from the FDA and get that trial up and running.

Actually we have a another person here on the call Bill Regan is in the room as we've been spending a lot of time doing my regulatory discussions.

Discussions here and.

And so if he wants he can chime in on the typical timing remember it's hard to judge all say might be so it's hard to judge exactly what the FDA is going to say, but if somebody who's been doing this a lot longer than I have I'll, let him chime in on on his thoughts on that and just give us a building.

Bill Regan our director.

Director of our chief of strategy as well as the regulatory.

Hi, Rick and thank you John I appreciate that Oh.

So we will have the meeting the meeting will be based upon responses to the questions that we oppose the FDA.

We'll have feedback that very day after meeting as to the acceptability of our package and any modifications we may have to make.

Typically the official minutes come out 30 days after the meeting.

We will have a feel for what direction, we need to in.

They are leaving and 30 days later, we'll have that confirmed by the FDA meeting minutes.

Thanks, Bill This is Mike again, and then just to add onto the end of that will be of course working with.

With what we learned from that meeting if we need to if we feel like and here we need to make some modifications to the protocol that we've got the draft protocol that we've submitted with this package then we will be working on that as well.

As much as we can in the while we're waiting for the official.

Minutes from the FDA and then our clinical trial team of course, as Jed said, the number of times and I hope as well, we'll be working to get the sites lined up and ready.

All the processes in place to open them up as soon as we can after after all of that is done with the protocol good.

Yeah. Thank you very much for taking my questions.

Excellent. Thank you.

Doug What's the next question.

Our next question comes from the line of Mike Robert Lee with <unk>.

Private Investor. Please proceed with your question.

I mean, they did Mike.

Eric and everybody. Thanks for taking my questions here.

My first question that'd be carrying around 332.

It seems that puts all of this out of London already did some preliminary work in 2020 and issued a research paper, where they were talking about Uh huh.

Pouchy immune Snow Hill type, which is one of the types.

He appeared to use some of your formulation.

Quantify as a result this was may of 2020. So do you guys or is that already an early indicator.

Yeah. So great question, Mike This is Mike.

Yeah, so that that paper is actually a great paper that supports our hypotheses and many of the things that I've been saying.

Based on what our what we've learned in prior literature. So so what caused in that paper very very briefly is he.

Did synovia tissue biopsy on a number of subjects, who were about to be put on an anti TNF alpha therapy.

Then he determined there subtype and he divided them in is and it's kind of the standard paradigm that he's helped develop of the fibroid or the policy immune that's actually the same subtype the ones that have low level of macrophages in the myeloid and lymphoid myeloid those have more macrophages and there's a kind of a gradient there and any of that.

He found was that the fibroid in the policy immune sure enough. When you look back at them three and six months later clinically.

Something like 80% of those did not achieve a significant clinical response to their anti TNF Alpha therapy, and there's other data that suggest that that non response rate can even be higher than that so that completely lined up with our hypotheses and now what we're doing in 32 of course is we're going to tie it all together right. So we're going to have the imaging.

And the biopsy and the same people and we're gonna be able to correlate our imaging readout with the biopsy data and that will tell a very nice story, we think.

So and he think he seemed to Michael here.

Quiet.

But he is your formulations.

His tests.

Can you disclose that.

Oh, no we didnt do imaging on those subjects, but the message that he's using to assess the cellular <unk> the types of cells and the number and density will be the exact same that we're using in this trial and the 32 trial.

Okay.

And go back into the 331.

To be responses in the latest investor presentation on July 26.

There was a slide 25 showed the.

<unk> results when some of the results from the test and it seems to be a pretty elegant.

And the results I don't recall that or not but it was RMB 331, yeah prediction of treatment response that seem to be pretty elegant.

It was so simple, but it said everything I mean, what kind of questions would be after seeing that.

Thank you.

No no youre right, yes, so I yeah.

I know that slide very well so what it is and I encourage anybody on this call to look it up it's on our investor deck and its slide 25, I think that that number I think is right, but in any event I know the slide well. It shows it has panels of images taken NRA subjects of their hands and risks at week zero before they started to anti TNF Alpha treatment and then five weeks.

Later, the top row shows the Ah.

Ah patients who responds.

According to our imaging readout between baseline and week, five and that certain of the joints that of localization. The localization that signal goes down by one month or five weeks later, and we would predict that those who are going down or going to be getting better clinically overtime and sure enough. They tend to get better. The data are very strong our accuracy is very high.

This is one example, the bottom row shows a patient where the localization of our imaging readout does not go down it actually goes up and some of the joints of the subject and so we would predict that the anti TNF is not working and that patient sure enough. When you follow that patient up later and do clinical assessments. It was not that person was not getting better.

In fact was getting a little bit worse. So as you said, yes, I'm glad you brought.

Brought that up and I hope everybody takes a look at that we think it's it tells the story.

Quite in a compelling way I think so and.

And this is and this is the story on each patient.

Yeah, Yeah, you would've seen correct.

Yeah. So these data of course are included in our package.

This has also been presented as well at an international meeting of Rheumatology ACR meeting.

And what was there.

Favorable feedback from that.

I mean people really like this I I don't want to reveal who or why and I don't want to give.

Give any clue to this was but some of these data I sent a summary table of our data to a to a key opinion leader in rheumatology and as first line to me was I just love. This line. It was these data are insane [laughter].

Next line was it I can't believe how great. This is anyway and his email went on to say that so that's the kind of response, we're getting not to not to be a hype person here, but it's really it's really exciting to be able to show. These data to our key opinion leaders and to hear such responses because they know what it might mean for their patients.

And that's what this is all about and yet so.

Yes, okay. Thanks for elaborating on that its appreciate it now how many sites are you currently looking at for the P. Three are you closer to the 25 or 50 to start.

Well, we've got we have over 50 that we've identified in the United States alone.

And probably a good 20 of those were intimately involved with currently at.

Different levels and prepping them to open up and how many we open we're probably going to be going for the larger a larger end of that scale, but it's going to depend on a variety of factors, including you know resourcing and enrollment rates, we have a fairly aggressive.

Our plan for for opening up a large numbers of sites quickly and I know this is a team that can do that.

So likely will will shoot more towards the higher end of that but it depends and.

I'm not going to promise the number right now so.

We're taking that going into the balance sheet, you look at the $7.1 million in cash generator.

When you look at the funding that was still to come from Google with the $2.1 million you look at your recent Pos of R&D and G&A and you project that forward it looks like with the you know.

So.

You know under a hypothesis that piece really starts in the fourth quarter. It looks like you can get into the fourth quarter, if not through the end of the year.

All the cash you have is that a fair projection are way off.

I mean.

[laughter].

Yeah, I mean I.

I think that I mean, I think we're.

I think we're in a I think we're in a fine situation I mean, I sort of you cut out a little bit. So I missed part of your question can you just repeat that last part.

The last was based upon the cash you have on the balance sheet with $2.1 million funding still will come from Keystone and looking at your last quarter's constantly increased costs from going into a P. Three in the fourth quarter looks like you could have enough cash to get well into the fourth quarter of 2021 or to year end 'twenty.

'twenty one is that fair.

No.

Our situation so the the cash number.

Is sufficient to get us into next year I mean, I think obviously, we're always evaluating you know our different options I wouldn't say, we're not we do have a few other things as I alluded to in my remarks that we will bring in some cash between now and the end of the year I think there are some other things that we have not discussed that should bring in some more money onto the balance sheet and.

Non dilutive manner between now and the end of the year, which will add to our cash on balance sheet. So I'm comfortable with where we are in a cash balance, but as with any company. We're always we're always looking we're always.

Open to potential but I think for now are we are we have the cash on the balance sheet certainly to get things launched certainly that bring us into into next year.

Okay I'd like to I would just a couple more questions.

That seems to be you mentioned there was a lot of stuff going on that you know people never hear about but I'm reading a lot of the stuff that you. There's a lot of stuff going on using Hillman as Sip and using C. D. Two or six concept. There's a meeting at the end of August in Germany.

France is going to present.

C D. Two O six data using to manage that and there's a lot of work going on M. One M tube replacement reprogramming studies in Europe and.

Of course, you're working with the with profit and find a new marketing partner over there can you elaborate anymore on Europe.

Your efforts on the new partner in all these studies going on in Europe, when you want them to and used them to balance it.

In terms of the partner for Lymphoseek those discussions remain ongoing I mean, we've made some great part we've made some great strides.

Nothing that I'm going to disclose at this juncture, but you know we've thankfully with the allowance of being able to travel we've been over there a few times to meet with the the individuals' on that cause the company's at.

B our partner in the future.

That you know we continue to sell it with nor jeans help I mean, they're they've been doing distribution for us we do have a distribution setup. We're obviously getting some of the regulatory approvals and a lot of that stuff in order, they're our ongoing trials and whatnot within Europe, I mean, I think we intend to expand.

Our array trials into Europe, so that we can hit the ground running there as well I mean, obviously there is a lot of interest in the raw product lymphoseek to be honest with you I perfectly brutally honest as I have been on these calls are you know when it's going to be more of a challenge.

You know, it's the rollout in Europe.

Was not handled as well as we would like the pricing obviously was way out of whack with any sort of reality and we really are bar are sort of doing a reset I mean to to quote some of our past politicians they talked about resetting relations with certain countries. So we're going to we're doing a reset there and then with that reset.

At a lower price bar, but something that'll be attractive for the hospitals to get them to prescribe it because of.

The efficacy of the product, obviously theres a higher bar in Europe than there is in the U S. Because the competing product doesn't have as many drawbacks as FSC does in the U S. But what I'm, saying is that there is interest we have we do get a lot of inbound questions for sales of the product and so that certainly.

Nothing that we're dealing with we do have a distribution arrangement as I said, but I would expect movement on the.

The distribution arrangement over the next several quarters.

As we get all the regulatory stuff in in order in terms of the trials I mean, there are a bunch of ongoing testing going on with to manage that I mean, we continue to provide it.

There are people all over the continent as well as the U K, we're interested in using the product for different trials are and obviously, we're doing a lot of work here on the therapeutic side on the trials as we've really spent a lot of time.

You know perfecting the chemistry, I mean, some of the key things that we really needed to step one and two as I've said in the past that weren't done have now been done and those have all been done in the last year or two and so that's something that has made a product that is really ready to move into the next phase.

Okay. I appreciate your follow up on that and so it looks like with the advancement of the molecule you guys have made tremendous strides in that or the last a year or two and now its being used more broadly for studies everywhere than summation.

Yeah. It is I mean, I think you know.

I vowed three years ago to not bring up the past and I'm not going to hear but thanks to our chemistry team out in Massachusetts, and hopefully soon to be here in Ohio.

We've made the steps that we've needed to do to make the product reproducible I mean, I think the key to any tests as we said in the past is you got to be able to make a reproducible you've got to be able to run a trial with correct controls.

That you can have results that you can show people and show that is.

Reputable from time wanted to time too and we hadn't done that in the past, but we are doing that now and that is why we've been able to won at the paperwork that we presented in May is something that we never could have done in the past and some of the trials that we have ongoing that we don't discuss but will in the future.

You know we have the ability to do that now that we didn't in the past there was some preliminary work that said listen your molecule is great, but you need to make it consistently and it needs to be the same molecule every time, you reduce it which we hadn't been doing but now we are and so I'm really proud of the work that has been done over at the Nat Cat in lab and <unk>.

Conjunction with our our our chemistry team and I continue to be very excited about the future of that product.

And Mike. This is Mike just want to add to that as you pointed out there's a growing.

Body of literature and awareness of the <unk>.

The key role that macrophages are broadly speaking play and in a wide variety of diseases and so I think you're seeing that reflected in the literature and in this growing number of studies as well as you know for example in oncology as well as its applications in the lymph node lymphatic mapping Sentinel lymph node assessments state.

So you're seeing all of these things start to be recognized in <unk> and and we're seeing more and more studies are out there and we're involved in some of these are many of these in different ways as Jed said, we'll talk about in the future. So.

Excellent and my last question. This is probably the least important but.

The prior management team formed out 46.94, the Alzheimer's amyloid.

Imaging.

Got it.

And.

There seems to be a lot in the literature with the video getting mentioned quite frequently now in owning that science Hill.

Has your team that the.

Companies to farm that out to making any progress with the amyloid imaging or can you talk about that.

And I I I.

Hinted at that in my opening remarks if.

If you if you go back to the transcript I'm not going to talk about it any further but I mean, we allowed ourselves the option to negotiate a deal on that and I mean, the issue was simple everybody has obviously been following the story I'm not going to mentioned in other you know other competitors therapeutics, there's obviously debate over.

The efficacy of the usefulness of this you know the FDA has been put in that situation, where they want to be seen as acting and doing something for what is a huge unmet need.

Certainly in the U S. I mean, obviously Europe has its own versions of how they want to treat Alzheimer's or not treat Alzheimer's, but in the U S. It's a hot button issue, it's something that I mean, certainly a lot of people were surprised when that drug got approved but there are three more compounds behind it. So are there are three different companies work.

On it you know I'm not going to mention them on the call, but you've got everybody listening oh, everybody on that on the call here knows who those companies are those products do show hope.

And there is gonna be theres going to be need for a best in class beta amyloid imaging agent that one shows the presence or lack thereof of beta amyloid on day zero and then can also show progress over time.

And that is something that we have we still have the rights to it.

And we have the option to make a deal on it and that's something that.

We are going to do and that's something that we're gonna do you know hopefully sooner rather than later I'm not going to be making any imminent statements or anything like that but these are discussions that have been ongoing for quite a while.

Similar to what happened with 5001, which.

As you've seen from our filings we've received money for because now it looks like that might actually also come to market. So we've retained right.

We've retained rights and royalties on that.

If those products come to market, we will make money on it and certainly on 4694, a we've been smart we havent spend money on it but we do have the data we have kept the brains and freezing in the freezer and we will capitalize on that and so it's a it's important you know it's a it's something that we feel strongly about.

Many Ceos ago, we brought in the product because there there was a feeling that there is a need for this product. Unfortunately, so many drugs failed.

Obviously this latest one got approved whether or not it works.

That's not for me to debate, but they're three behind it.

It looked pretty good the company you know which has.

In Philadelphia has a product that looks like it's a bit more effective certainly at removing a beta amyloid and when that product comes to market. We have an imaging agent that's going to work for it and provided that there is gonna be giving the cost of those drugs we assume.

And Bill's got Bill Regan has been with me on some of these calls that we've had in some of the meetings in Washington that there'll be there'll be pay they'll certainly pay for the imaging agent because theyre going to want to make sure that the product is working and the patients based on the high price that these companies are going to charge for it. So there is value to that product and we will get value for that product.

Okay, and lastly, I like to say as long term investors.

Your efforts Mikes efforts Bill's efforts, Eric because in your whole team's efforts. So I cannot imagine what missed it must have been like to get through this last 18 months and the progress you've made.

Thank the whole team deserves a pat on the back anyway. That's the end of my call. Thank you.

Thank you Mike I appreciate it.

And I think we have a is there another question Doug.

Yeah. So our next question comes from the line of Robert a private Investor. Please proceed with your question.

No actually my question has been answered, but thank you anyway.

Thank you Robert and I don't think there's anything else in the queue.

There are no other questions in the queue I'd like to hand, it back over to Jay lacking for closing remarks.

I wanted to thank everybody for calling in I also want to thank the whole team here in the room is actually not just Erica Bill Mike and myself there are several other people in here.

Bonnie Jeff and another person.

Who are all in here and.

And we are very excited about the team that we're putting together here.

And we're really I'm happy with the progress, we're making and I'd like to say that we're excited for the September 1st meeting hopefully, we'll get a positive readout from that hopefully we'll be able to launch shortly thereafter, because we're ready to go I mean bond he's been doing a phenomenal job traveling all over the all over the country.

Opening up sites getting sites ready targeting new sites and as I said in my remarks, which I can't stress enough. The more sites, we open and target the more people get excited about the product and we are establishing I mean, you have to think commercially whether it's a jubilant or whoever.

Probably a jubilant, but we have to think commercially about this and the more people that are using it the more people get exposed to it the more they will be ready audience for this product, especially.

When they realize how well it works the negative predictive value of the positive predictive value of these are all things that'll be flushed out in the phase III and we're just very excited about it so I want to thank everybody for calling in and Oh, We will speak to you guys. Soon we will be presenting at quite a few conferences over the next couple of months. So I'm excited about that already hopefully they don't get canceled.

Cause of the Delta variant, but we have signed up we will be presenting and we look forward I look forward to seeing everybody on the road.

Thank you and have a great night everybody.

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