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Navidea Q2 2021 Conference Call Transcript

Navidea Biopharmaceuticals, Inc. (NAVB) CEO Jed Latkin on Q2 2021 Results - Earnings Call Transcript

Navidea Biopharmaceuticals, Inc. (NAVB) Q2 2021 Earnings Conference Call August 11, 2021 5:00 PM ET

Company Participants

Jed Latkin - Chief Executive Officer, Chief Financial Officer and Chief Operating Officer

Michael Rosol - Chief Medical Officer

Erika Eves - Vice President of Finance and Administration

William Regan - Chief Compliance Officer

Conference Call Participants

Michael Okunewitch - Maxim Group LLC


Greetings, and welcome to Navidea Biopharmaceuticals 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. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Jed Latkin, Chief Executive Officer. Thank you. You may begin.

Jed Latkin

Thank you, Doug. Just want to remind people 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. Navidea’s Chief Medical Officer, Dr. Mike Rosol and the Company’s Vice President of Finance, Erika Eves, will be joining me on the call today.

During the course of this conference call, we will be making forward-looking statements regarding future events and the future performance of the Company. These events relate to our business plans to develop Navidea’s molecular diagnostics and immunotherapeutics, 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 COVID-19 pandemic on Navidea’s 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 filing and annual filing with the SEC.

I also want to say, if you can hear in the background, there is a bit of a rainstorm here. So if we drop off, that means we lost power and we will get back on as quickly as possible just in case.

The second quarter marked another key milestone in Navidea’s long-running quest to get its 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 receive word that we will have a meeting with them on September 1.

Between now and September 1, 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. The goal is to have a productive meeting with the FDA and be able to quickly move from that meeting into the launch of Phase III.

The clinical team is ready to launch with most of the centers that were involved in 3-31 and 3-35 and we have a whole slew of new sites prepared to launch for 3-33 as well. The goal is to have a broader trial as possible that will accomplish two goals: One, to allow for rapid enrollment of the trial; and two, prepare a ready audience for when the product is approved and ready for commercial launch. The more sites we use, the more of those sites will become customers in the future.

In this past quarter, we also had a successful verdict in the Delaware Court in the case of Macrophage Therapeutics versus Dr. Michael Goldberg. The Court found that Dr. Goldberg breached his fiduciary duty to the company. In this past quarter, we also completed our funding with Keystone, receiving a total of $4.5 million on a $15 million Series B preferred agreement. The company and Keystone mutually agreed to terminate the arrangement despite the previous promised and committed guaranteed funding.

Our discussions with Jubilant continue and have been quite productive on many fronts. We were going to wait for the 3-32 data before we make any final decisions as that data should unlock more value to the company and its final negotiation of a commercial agreement with a potential partner.

As I discussed on the last call, we were pleasantly surprised with our Arm 3 data from 3-31 that gives added importance to our series that should be validated by the biopsy data generated in 3-32. If you recall our presentation, we have two bubbles of potential peak sales for the RA product and the data from 3-32 will get us closer to that larger bubble faster as it will 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 goal of the product to get the patients on to the right treatment faster to mitigate side effects and wasted time on using a drug that is ineffective for individuals on RA. I'm also very impressed with how quickly we enrolled the 3-35 trial and built up a substantial normative database of images that will increase the effectiveness of the digital reads that are currently being worked on by our two imaging partners.

As I have discussed in the past, this database is key because an AI read is only as good as the compendium of historical data that has been fed into it, similar to how a self-driving car works, the more data you have at the outset, the more accurate the algorithmic read is. Another item is the recent approval by the FDA and the neurological space makes one of our dormant in licensed products a bit more valuable, and 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 tireless hours of work in this most difficult environment as the 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 RA, but the turbo charging of the therapeutic efforts going forward.

Now I'd like to turn the call over to Dr. Rosol, who will cover the clinical portion of the call. Mike?

Michael Rosol

Thanks, 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 and upcoming meeting with the FDA. As I announced on the first quarter update call, trial enrollment and imaging events were completed in the first quarter in our Phase IIb study NAV3-31. As you know, this trial and the data from it were critical to moving forward in RA.

As a reminder, this was a three arm trial. In arms 1 and 2, we evaluated the repeatability, reproducibility and stability of our tilmanocept imaging readout in both healthy subjects and in patients with active RA. And in the third arm, we mirrored the upcoming Phase III study to obtain data to help with sample sizing for the Phase III, and to have a first look at the ability of tilmanocept 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 3 data continued as promised. We have data now from the completed trial demonstrating that technetium 99M tilmanocept 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 RA involved inflammation, and that tilmanocept imaging can provide an early prediction of treatment efficacy of anti-TNF alpha therapy.

In short, the analysis from the complete set of Arm 3 patients has continued to demonstrate high accuracy overall and early prediction of treatment effect with a strong predictive value in particular for non-responders to anti-TNF alpha therapy, even from the baseline scan alone in a defined subset of patients.

In these patients, those exhibiting a low level of tilmanocept uptake in their joints on their initial baseline scan, who likely represent the fibroid subtype of RA, we've discussed on previous calls, there was an almost 90% non-response rate to anti-TNF alpha therapy using a clinical gold standard assessment. This results on its own the ability to use a single time point scan to predict that an 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 cost, 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 3 subjects, the data continue to support our hypotheses. The results from the full dataset from this trial will be submitted for presentation at an upcoming International meeting. And of course, we planned 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 RA 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 NAV3-31 along with our proposed plan for the Phase III.

At the end of March, the FDA provided us with feedback on that briefing package. This was an official FDA meeting, but in written response form 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 tilmanocept imaging could help address the large unmet medical need in RA patient treatment. At that time they also requested that we continue with the full analysis of the complete Phase IIb dataset, and when done that we request the standard End-Of-Phase II Type B Meeting with them. This occurs once a Phase II program has done and 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 IIb trials are completed, you analyze the full datasets, 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 is held. Our strategy has been to work very closely with FDA all along the way in our program development 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 beyond. 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 II Meeting, all of which has been done and the meeting will be held on September 1, as Jed said, and as you've seen in our press release.

In some detail, what this means is that we work from the time of feedback from the FDA, the end of March to late 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, write up what is known as the clinical study report for the trial and update the giant briefing package submitted in February with the completed data and in response to the constructive comments from the FDA, all in the span of about three months to when we submitted the meeting request. All told this amounts to more than 2,500 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 nor heard of so much work getting done in such a short amount of time in the industry. I tell you all of this so that you can be assured that the people here are supremely dedicated and work diligently, efficiently and hard. What happens now is we continue to prepare for the conference call discussion with the FDA. They have our data in hand, and we have responded to their comments from March. They will be evaluating the data from the NAV3-31 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 is always been to keep a 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 referenced earlier, which will have significant benefits to the commercial product.

We have nearly completed our healthy control study NAV3-35 to establish what is called the normative database for tilmanocept in RA, an integral part of our ability to discriminate RA inflamed joints from those that don't have inflammation is the knowledge of what a healthy joint looks like quantitatively. We use the healthy control data from Arm 1 of the completed Phase IIb to start to set these parameters, and we will use this study to add to the size of this current normative database.

This should enable us to discriminate RA involved joints from non-RA 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 tilmanocept will play an essential part in both the Phase III data analysis as well as the commercial product.

As of today, we've enrolled just over 115 subjects out of a projected 135 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 these are primarily healthy controls, we are also age and sex matching them to the RA population, and so we have defined numbers in different groups we must fill. The rapid rollout in enrollment is a real credit to our clinical trial operations team. I should also mention that the FDA acknowledged the importance of the study for RA program developments in our recent interaction with them.

Our comparison study of tilmanocept imaging to joint biopsy, NAV3-32 is in active recruitment. In this Phase IIb study, we are comparing tilmanocept imaging to histology from the joints of patients with active RA. We aim to recruit patients with each of the three subtypes of RA to obtain comparative imaging and pathology results in order to establish the correlation between our imaging signal and the number and density of macrophages in RA patients joints.

We have opened up Northwestern University and Bard Health of London already. And as the end of this week, our third site will be open at a Research and Rheumatology Center out in Los Angeles. We are also planning to open up another center in the UK. 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 CD206 as a biomarker for RA, as well as to engage with pharma for its use in trials of new RA therapeutics.

It will also provide rheumatologists with gold standard information related to our imaging readout and the fundamental biology of a patient’s RA. For example, results from this study could directly demonstrate that tilmanocept imaging can be used to determine a patient's subtype of RA without having to do an invasive biopsy. And this would have implications for what class of therapies might or might not work in that particular patient. This could therefore have immediate impact on the management of RA 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 an enrollment and data analysis is ongoing. The data we have seen thus far have been promising in terms of localization of tilmanocept to sites of atherosclerotic plaque and they've been in line with what we reported in our pilot study we co-published with them previously. Preclinical studies of Gallium tilmanocept imaging for our NIH-funded project with the University of Alabama, Birmingham, are also ongoing.

On the therapeutic front, we continue to make strides forward. For indications in oncology, we have performed preclinical studies that demonstrate macrophage phenotype change from an immunosuppressive to a pro-inflammatory state, as well as a synergistic effect on tumour growth reduction in animal models using our doxorubicin containing construct with an approved checkpoint inhibitor therapy. Put much more simply, the tumours 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 tumour 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 Science's Frontiers in Cancer Immunotherapy 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 are also carried out this past quarter as well as evaluations of methods of improving targeted penetration and delivery while reducing off-target uptake and the biodistribution characteristics of our next-generation molecules as well. These latter two studies relating to increasing the delivery of our molecule, whether it’d be labeled as a radiopharmaceutical or with the drug for a therapeutic to areas of interest versus off-target localization could have far reaching positive implications for compounds related to efficacy and safety. As these preclinical studies are completed, we will update you and announce when and where results will be presented.

We are also looking at different therapeutic payloads and we will 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 autoimmunity, inflammation and in diseases of metabolism. As 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 USPTO has issued our patent for the application titled “Compounds and Methods for Diagnosis and Treatment of Viral Infections.” This relates to possible therapies for a variety of viral diseases, including dengue, yellow fever and other diseases caused by the flavivirus. Our provisional patent application titled “Synthesis of Uniformly Defined Molecular Weight Mannosylated Dextrans and Derivatives Thereof” was converted to an A1 application on July 9, and we've received notice of allowance of claims in foreign jurisdictions for an application broadly involving diagnosis and treatment of diseases involving CD206 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 of the last quarter that we wanted to touch on for this update. We remain largely focused on the RA pipeline, specifically preparation for our upcoming discussion with the FDA and for the Phase III as well as enrollment in the currently open biopsy study and normative database study, while we continue in the mean while to support 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.

Jed Latkin

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, they'll make us a lot more efficient, 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 that should make Navidea quite an exciting story over the next several quarters.

With that, I just want to introduce Erika Eves, and get the financial update. Erika?

Erika Eves

Thank you, Jed. Total net revenues for the second quarter of 2021 were $261,000, compared to $271,000 for the same period in 2020. Total net revenues for the first six months of 2021 were $385,000, compared to $427,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, offset by receipt of reimbursement 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 Manocept 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 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. The net increase was primarily due to increased consulting services related to preparing for European distribution of Tc99 tilmanocept, employee compensation including incentive-based awards, insurance cost, director fees related to additional board members, general office expenses, travel costs and European license fees, partially offset by decreased legal and professional services and Investor Relations costs.

Navidea’s net loss attributable to common stockholders for the second quarter of 2021 was $2.7 million, or $0.09 per share, compared to $2.4 million, or $0.11 per share, for the same period in 2020. The net loss attributable to common stockholders for the first six months of 2021 was $5.6 million, or $0.20 per share, compared to $5.1 million, or $0.24 per share for the same period in 2020. And finally, Navidea ended the second quarter of 2021 with $7.1 million in cash and cash equivalents.

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

Jed Latkin

Thank you, Erika. With that, I'd like to open up the floor to the Q&A. Doug, you can open up the Q&A line.

Question-and-Answer Session


Thank you. Ladies and gentlemen, we will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Jason McCarthy with Maxim Group. Please proceed with your question.

Michael Okunewitch

Hey guys. Thanks for taking the question. This is Michael Okunewitch on the line for Jason.

Jed Latkin

Excellent. Thank you, Michael. How are you doing?

Michael Okunewitch

Doing well. So I'd like to see – just first off, if 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?

Jed Latkin

That's a good question. As I 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's not too much the Phase III launch, although, that will be a pretty key milestone for us. What will be important, will be some of the data that we get from 3-32. So as the data rolls in from 3-32, we'll be processing that and then deciding whether or not we move 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 3-32 data as it's just going to unlock that much more value to the product. And I'm willing to wait, get the 3-32 data, which we anticipate is going to be very positive, which just gives us an opportunity to get a much larger upfront than we would if we waited.

I mean, you think about it, you go through the pros and cons. If it isn't, 3-32 isn't good, then any agreement you make with any commercial partner is going to have out clauses anyway. So why sign and secure a deal? Let's say, $17 million, when you can wait, get the 3-32 data and find a 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.

Michael Okunewitch

All right. Thank you. That makes a lot of sense. I actually wanted to touch on 3-32. As you mentioned, Mike, we actually did see some signs that in certain patients, likely the fibroid subtype, you were able to determine at baseline whether or not they would respond. So can this be looked at as somewhat de-risking the readout for 3-32 since you already have some at the very least anecdotal evidence?

Michael Rosol

Yes. That's a good question. This is Mike, and a good conclusion. So indeed – so in Arm 3, we had a number of subjects that had low localization and our hypothesis would be that those are the so-called fibroid, regardless of whether or not there's a fibroid that they have a low level of macrophage involvement, 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-TNFs and almost never do you responded, it's rare. And so that was our hypothesis in our Arm 3 of the 31 trial, those subjects who looked like they had low levels of localization both qualitatively and quantitatively, 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 truthing.

So as you're suggesting, given that, that meets the – what we predicted based on all of these – the other literature and hypothesis that we've created based on that literature, in some sense indeed that suggests that the NAV3-32 data ought to align, right, at least in those cases that have low level of localization. They are likely going to be the ones that don't have a high number of – the high number in density of the macrophages will be classified as the fibroid and [boom] are unlikely to respond. So yes, it's a de-risking for NAV3-32. Sure.

Michael Okunewitch

All right. 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 think about the timelines on the Phase III because you now have a date for that end of Phase II. How quickly following that meeting would you expect a response from the FDA and get that trial up and running?

Jed Latkin

Actually we have 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 here, and so if he wants, he can chime in on the typical timing. Remember, it's hard to judge – I'll say my piece, 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 his thoughts on that. And this is Bill Regan, our Director of – our Chief of Strategy as well as Regulatory.

William Regan

Hi. Bill Regan. Thank you, Jed. Appreciate that. Yes, so we'll have the meeting. The meeting will be based upon responses to the questions that we have posed to FDA. We will have feedback that very day at the 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. So we will have a feel for what direction we need to head in at the day of the meeting, and 30 days later we'll have that confirmed by the FDA meeting minutes.

Michael Rosol

Thanks Bill. This is Mike again. And then just to add on to the end of that, we'll be of course working with what we learned from that meeting. If we feel like and here we need to make some modifications to the protocol that we've – the draft protocol that we've submitted with this package, then we'll 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 has said the number of times, and I have as well, we'll be working to get the sites lined up and ready and all the processes in place to open them up as soon as we can after all of that is done with the protocol.

Jed Latkin


Michael Okunewitch

Yes. Thank you very much for taking my questions.

Michael Rosol

Excellent. Thank you.

Jed Latkin

Doug, what's the next question.


Our next question comes from the line of Mike Rockley, a Private Investor. Please proceed with your question.

Unidentified Analyst

Good day, Jed, Mike, Erika, and everybody. Thanks for taking my questions here. My first question, let me carry around 3-32. It seems [indiscernible] of London, already did some preliminary work in 2020 and issued a research paper where they were talking about the pauci-immune synovial type, which is one of the types. And he appeared to who have use some of your formulations to quantify his results. This was May of 2020. So do you guys are – is that already an early indicator?

Michael Rosol

Yes. So great question, Mike. This is Mike. Yes. So that paper is actually a great paper that supports our hypothesis and many of the things that I've been saying based on what we've learned in prior literature. So what [Karl’s] did in that paper very, very briefly is he did synovial tissue biopsy on a number of subjects who were about to be put on an anti-TNF alpha therapy, then he determined their subtype and he divided them in his kind of the standard paradigm that he's helped develop the fibroid or the pauci-immune. That's actually the same subtype, the ones that have low level of macrophages, then the myeloid and lymphoid myeloid, those have more macrophages. And there's a kind of a gradient there in any event.

What he found was that the fibroid in the pauci-immune, sure enough, when he looked 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 suggests that non-response rate can even be higher than that. So that completely lines up with our hypothesis. 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 going to be able to correlate our imaging readout with the biopsy data. And that will tell a very nice story we think.

Unidentified Analyst

And he seemed to – Michael he has purely implied, he used your formulations to write his tests. Is that correct? Or can you disclose that?

Michael Rosol

No, we didn't do imaging on those subjects, but the methods that he's using to assess the cellularity, the types of cells and the number and density will be the exact same that we're using in this trial in the 32 trial.

Unidentified Analyst

Okay. Now let me go back into the 3-31 IIb responses. In the latest investor presentation of July 26, there was a slide 25 that showed the results – some of the results from the test and it seems to be pretty elegant in the results. I don't know if you recall that or not, but it was the Arm 3 3-31, yes, prediction of the treatment response. That seemed to be pretty elegant. I mean, it was so simple, but it said everything. I mean, what kind of questions would there be after seeing that?

Michael Rosol

Thank you. No, you're right. Yes. 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 it’s Slide 25, I think that number I think is right. But even I know the slide well. It shows it has panels of images taken in RA subjects of their hands and wrists at week zero before they started anti-TNF alpha treatment and then five weeks later. The top row shows a patient who responds according to our imaging readout between baseline and week five in that certain of the joints that have localization, the localization signal goes down by one month or five weeks later. And we would predict that those who are going down are going to be getting better clinically over time and sure enough, they tend to get better. The data are very strong. Our accuracy is very high, and 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 in some of the joints of the subject. And so we would predict that the anti-TNF is not working in that patient. Sure enough, when you follow that patient up later and do clinical assessments, it was not – that person was not getting better and in fact was getting a little bit worse. So as you said, yes, I'm glad you brought that up. And I hope everybody takes a look at that. We think it tells the story quite in a compelling way, I think so. Thanks.

Unidentified Analyst

And this is the story on each patient who was on a trial the FDA would have seen, correct?

Michael Rosol

Yes. So these data of course are included in our package. And this has also been presented as well at an International Meeting of Rheumatology, the ACR meeting.

Unidentified Analyst

And what was – did you get favorable feedback from that?

Michael Rosol

I mean, people really like this. I don't want to reveal who or why, and I don't want to give any clues who this was, but some of these data – I sent a summary table of our data to a key opinion leader in rheumatology. And his first line to me was – I just love this line. It was these data are insane. His next line was, 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 be a high person here, but 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 in the end.

Unidentified Analyst

Okay. Thanks for elaborating on that. It's appreciated. Now how many sites are you currently looking at for the P3? Or are you closer to the 25 or the 50 to start?

Michael Rosol

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 in prepping them to open up. And how many we open, we're probably going to be going for the larger under that scale, but it's going to depend on a variety of factors, including resourcing and enrollment rates. We have a fairly aggressive plan for opening up large numbers of sites quickly. And I know this is the team that can do that. So likely we'll shoot more towards the higher end of that, but it depends, and I'm not going to promise the number right now.

Unidentified Analyst

Thank you. Well, taking that going into the balance sheet, if you look at the $7.1 million in cash, Jed or Erika, and then you look at the funding that was still to come from Jubilant the $2.1 million, you look at your recent cost of R&D and G&A and you project that forward. It looks like with the – under the hypothesis for P3 starts in the fourth quarter, it looks like you can get into the fourth quarter if not to the end of the year all the cash you have. Is that a fair projection or way off?

Jed Latkin

Yes. I mean, 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?

Unidentified Analyst

The last was based upon the cash you have on the balance sheet. The $2.1 million funding still to come from Keystone and looking at your last quarter’s costs and the increased costs going into P3 in the fourth quarter, it looks like you could have enough cash to get well into the fourth quarter of 2021 or the year end 2021. Is that a fair projection?

Jed Latkin

That’s our situation, so the cash number is sufficient to get us into next year. I mean, I think obviously we're always evaluating 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'll bring in some cash between now and the end of the year. I think there's some other things that we have not discussed that should bring in some more money on to the balance sheet in a 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 looking, we're always open to potential. But I think for now we have the cash on the balance sheet, certainly to get things launched, certainly that bring us into next year.

Unidentified Analyst

Okay. I'd like to have just a couple more questions. It seems to be – you mentioned there was a lot of stuff going on that people never hear about. But in reading a lot of the stuff – there's a lot of stuff going on using tilmanocept and using the CD206 concept. There's a meeting at the end of August in Germany, where France is going to present some CD206 data using tilmanocept. And there is a lot of work going on M1, M2 replacement – reprogramming studies in the EU. And of course, you're working with – try to find a new marketing partner over there. Can you elaborate any more on Europe, your efforts on the new partner and all these studies going on in Europe on M1 and M2 and using tilmanocept?

Jed Latkin

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 thankfully with the allowance to being able to travel, we've been over there a few times to meet with the individuals on the companies that might be our partner in the future. I mean, I think that we continue to sell it with Norgine’s help. I mean, they've been doing distribution for us. We do have a distribution set up. We're obviously getting some of the regulatory approvals and a lot of that stuff in order. There are ongoing trials and whatnot within Europe. I mean, I think we intend to expand our RA 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 RA product. LYMPHOSEEK to be honest with you, perfectly brutally honest as I have been on these calls, LYMPHOSEEK is going to be more of a challenge. 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 sort of doing a reset. I mean to quote some of our past politicians, they talk about resetting relations with certain countries. So we're doing a reset there.

And then with that reset 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 there's 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 do get a lot of inbound questions for sales of the product. And so that's certainly something that we're dealing with. We do have a distribution arrangement, as I said. But I would expect movement on the distribution arrangement over the next several quarters as we get all the regulatory stuff in order.

In terms of the trials, I mean there are a bunch of ongoing testing going on with tilmanocept. I mean, we continue to provide it. There are people all over the continent as well as the UK were interested in using the product for different trials and obviously we're doing a lot of work here on the therapeutic side, on the trials as we really spent a lot of time perfecting the chemistry, I mean some of the key things that we really needed to. The 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 our product that is really ready to move into the next phase.

Unidentified Analyst

Okay. Appreciate your follow-up on that. And so it looks like with the advancement in the molecule, you guys have made tremendous strides in that over the last year or two and now it's being used more broadly for studies everywhere. Is that a summation?

Jed Latkin

Yes, it is. I mean, I think, I vowed three years ago to not bring up the past and I'm not going to here. 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've said in the past is you've got to be able to make it reproducible, you 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 reproducible from time one to time two. And we hadn't done that in the past. So we are doing that now. And that is why we've been able to – one, the paper work 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. 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 produce 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 MedChem lab in conjunction with our chemistry team. And I continue to be very excited about the future of that product.

Michael Rosol

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 key role that macrophages broadly speaking play 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 for example, in oncology, as well as its applications in lymph node, lymphatic mapping, sentinel lymph node assessment state. So you're seeing all of these things start to be recognized and we're seeing more and more studies out there. And we're involved in some of these or many of these in different ways, as Jed said, we'll talk about in the future.

Unidentified Analyst

Excellent. And my last question. This is probably the least important. The prior management team formed out 4694, the Alzheimer's amyloid imaging product. And there seems to be a lot in the literature with Navidea getting mentioned quite frequently now in owning that science. Has the team or the company that you form that out to making any progress with the amyloid imaging, or can you talk about that?

Jed Latkin

I hinted at that in my opening remarks. 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 is simple. Everybody has obviously been following the story. I'm not going to mention another – other competitors therapeutics, there's obviously debate over the efficacy of the usefulness of this. The FDA has been put in a 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 there are three different companies working on it. I'm not going to mention them on the call, but you've got everybody listening. Everybody on the call here knows who those companies are. Those products do show hope and there is 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 going to do 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 awhile 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 rights and royalties on that. If those products come to market, we will make money on it.

And certainly on 4694, we've been smart. We haven't spent money on it, but we do have the data. We have kept the brands in the freezer, and we will capitalize on that. And so it's important, it's something that we feel strongly about. Few years ago, we brought in the product because 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 there are three behind it that look pretty good. The company, which has base in Philadelphia has a product that looks like, it's a bit more effective certainly at removing 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's going to be – given the cost of those drugs, we assume and Bill – Bill Regan been with me on some of these calls that we've had and some of the meetings in Washington that there'll be pay – they'll certainly pay for the imaging agent because they're going to want to make sure that the product is working and the patient is 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.

Unidentified Analyst

Okay. Lastly, I'd like to say as a long-term investor, Jed, I appreciate your efforts, Mike's efforts, Bill's efforts, Erika's and your whole team's efforts. So I cannot imagine what must have been like to get through this last 18 months and the progress you've made. I think the whole team deserves a pat on the back. Anyway, that's the end of my call. Thank you.

Jed Latkin

Well, thank you, Mike. I appreciate it. And I think we have – is there another question Doug?


Yes. Our next question comes from the line of [Robert Issler], a Private Investor. Please proceed with your question.

Unidentified Analyst

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

Jed Latkin

Thank you, Robert. And I don't think there is – Doug is there anything else from the queue?


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

Jed Latkin

I wanted to thank everybody for calling in. I also want to thank the whole team here. The room is actually not just Erika, Bill, Mike and myself, there is several other people in here, Bonnie, Jeff and another person, who are all in here. And we are very excited about the team that we're putting together here. And we're really happy with the progress we're making. And I'd like to say that we're excited for the September 1 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, Bonnie has been doing a phenomenal job, traveling 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 with Jubilant or whoever, probably 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 a ready audience for this product, especially when they realize how well it works. The negative predictive value, the positive predictive value, these are all things that will 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 we will speak to you guys soon. We'll be presenting a quite a few conferences over the next couple of months. So I'm excited about that already. Hopefully, they don't get canceled because of the Delta variant. But we have signed up, we will be presenting, and 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 line at this time and have a wonderful day.


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