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Edited Transcript of NAVB earnings conference call or presentation 7-Nov-19 10:00pm GMT

Q3 2019 Navidea Biopharmaceuticals Inc Earnings Call

DUBLIN Nov 16, 2019 (Thomson StreetEvents) -- Edited Transcript of Navidea Biopharmaceuticals Inc earnings conference call or presentation Thursday, November 7, 2019 at 10:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Erika Gibson

Navidea Biopharmaceuticals, Inc. - Director of Finance & Administration

* Jed A. Latkin

Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director

* Michael Stanley Rosol

Navidea Biopharmaceuticals, Inc. - Chief Medical Officer

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Conference Call Participants

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* Jason Wesly McCarthy

Maxim Group LLC, Research Division - Senior MD

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Presentation

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Operator [1]

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Greetings, and welcome to the Navidea's Biopharmaceuticals Third Quarter 2019 Earnings Call. (Operator Instructions) I will now turn the conference over to your host, Jed Latkin, you may begin, Mr. Latkin.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [2]

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Thank you, Jerry. Good afternoon, and welcome, everyone, to Navidea's Third Quarter 2019 Earnings Call. I am Jed Latkin, Chief Executive Officer of Navidea Biopharmaceuticals. This call will cover Navidea's financial operating results for the third quarter of 2019, which ended on September 30, 2019, along with a discussion of goals and milestones for the remainder of 2019 and into 2020. Following our prepared remarks, we will open up the conference call to a question-and-answer session.

With me on our call today is our Chief Medical Officer, Dr. Mike Rosol; and our Director of Finance and Administration, Erika [Gibson]. But before we begin our formal remarks, I would like to remind everyone that some of the statements on this conference call may be considered forward-looking statements within the meaning of Section 27A and Securities Act of 1933 as amended and Section 21E of the Securities and Exchange Act of 1934 as amended. That concerns matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in forward-looking statements. Words such as expects, anticipates, intends, plans, aims, targets, beliefs, seeks, estimates, optimistic, potential, goal, suggests and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of the company's bodily fluid-based diagnostic tests as well as the company's ability to develop and successfully commercialize such test platforms for early detection of cancer and the diagnosis and monitoring of rheumatoid arthritis. The company's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if we fail to develop a commercialized diagnostic product, we may be unable to execute our plan of operations.

Other risks and uncertainties include the company's failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IBD market, a failure by the marketplace to accept the products in the company's development pipeline or any other diagnostic products the company might develop. The company will face fierce competition and the company's intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; inability to maintain our listing with the NYSE American; inability to maintain effective internal control over financial reporting; the outcome of any pending litigation; and other risks identified in the company's most recent annual report on Form 10-K and quarterly reports on Form 10-Q as well as other documents that the company files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about the company's business, based in part on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict.

Forward-looking statements are made as of the date of this conference call and except as required by law, the company does not undertake the obligation to update its forward-looking statements to reflect future events or circumstances.

I want to start by saying that our comments this quarter will be primarily focused on our ongoing preclinical and clinical research efforts, including the newly informed research collaboration with IMV announced earlier today. I am very pleased with the progress of the company as we're making on many fronts. Dr. Rosol is going to update you on several key milestones that we've hit over the past several months, and I anticipate other positive announcements over the upcoming months.

This past quarter marked a significant step forward in the transformation of Navidea from a development stage company to a commercial stage company. As detailed on last week's call, the first interim look was quite successful and encouraging. While many might not appreciate the significance of the results, the clinicians running the trial understand that the repeatability and stability represented in these images was key as it's something that this company has never shown before. It's also important to note for some that might not know this, but the results of the interim work was shared with investors and potential partners, all at the same time. What this means is we are taking this data and finally having the opportunity to sit down and discuss their significance with individuals that may be interested in partnering, either in the distribution, imaging or full commercialization of the product. I know that many are frustrated out there with how long the process is taking, but as I've stressed repeatedly in the past, we are looking for the right deal, with the right partner and not just something quick that we can make an announcement and issue a press release. It's important that we do not repeat the past mistakes of this company and give away the rights to our products long before they are approved and on the market. We feel confident that the people that we are currently in negotiations with are the right potential partners for Navidea. While these negotiations are ongoing, management and the Board will do everything to make sure that the company is adequately funded, so that we don't have to be forced to do a deal just to keep the trials on track.

I really want to commend my team here for all the work that they're doing. While we don't go into the minute details with all of you, there's a tremendous amount of moving pieces that goes into this trial and the work surrounding it. When I came to this company close to 4 years ago, I was amazed at how disorganized we were. But now I can say that we are really focused on completing the task at hand. I know that I am often very tough on the crew, but I want to take a moment to thank all of them for their tireless work on the trials.

With that, I'd like to turn the call over to Dr. Rosol for more details on our development front. Mike?

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [3]

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Thank you, Jed, and hello, everyone. As always, I'm happy to participate in today's call and provide you with updates from the clinical side. We recently described in detail the progress on the Phase IIb trial in RA and the positive results of the interim analysis. And I encourage you to listen to the recording or read the transcript of the call from October 29, if you haven't had the chance to do so already. At this time, we have enrolled over half of the planned 105 subjects over 7 total sites in this study. Remember that through the first 2 arms of this 3-arm study, we are evaluating 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 are mirroring our upcoming Phase III study in order to enable us to obtain data to help validate our target calculations for the Phase III.

The interim results on the first 2 arms were very positive, demonstrating low variability of imaging, both within day and over time. Those data demonstrated that technetium 99m tilmanocept can provide robust quantitative imaging in healthy controls and in patients with active RA and that this imaging is stable, reproducible and can define joints with and without RA involved inflammation. This is fundamentally important to advancing our technology into a successful product in RA. And so as you can imagine, we are delighted with the results, and we've been discussing these data with potential partners as Jed mentioned, and as you would expect, the data have been well received. We will continue to enroll into this trial and are planning for the start of the Phase IIb comparative study of our imaging readout through histopathology from the joints of patients with RA as well as the Phase III. We are well positioned for the Phase III, since most of the sites that are currently recruiting into the ongoing Phase II -- IIb will be rolled right into that trial, and so the logistics and strategies for our recruitment will have already been established.

You might have seen the press release from this morning, announcing our research collaboration agreement with IMV Inc. As IMV self-described, they are a clinical stage immuno-oncology company. Meaning, in this case, that they have run and are running clinical trials evaluating the efficacy of their immunotherapy against different types of cancer. The purpose of this collaboration between our 2 companies is to conduct preclinical studies to evaluate the combinatory effect of our proprietary activated macrophage targeting compounds, along with IMV's T cell-activating platform. I'd encourage you to visit their website and look at their publications for more detail.

But briefly, IMV has the therapeutic that helps to activate and enhance the body's T cells that can then target tumors. And our therapeutic, of course, actively targets macrophages that are known to surround tumors and form part of a tumor resistance system to the body's own immune system, including those aforementioned T cells, which would otherwise attack the tumor cells. By combination of the activation of the body's own T cells through IMV's agent and the removal of a portion of the tumor's self-defense network through our agent, we believe we should see a significant antitumor effect. We hypothesized that this combination of IMV's T-cell activation therapy with our CD206 targeted therapeutic could lead to a powerful new approach to treating a variety of cancers. And we hope that these first studies will provide evidence to advance us towards this goal. From our end, this collaboration builds upon work we have done, demonstrating increased efficacy of other therapeutics when used in combination with our Manocept constructs containing a chemotherapeutic, including work we just recently performed at an external contract research organization, funded by our NIH Therapeutics Award. We have been accruing data over the last 2 to 3 years that are strongly supportive of the idea that our targeted therapeutic construct can improve the efficacy of several types. And indeed, we think many or possibly most types of therapies directed against cancers.

And so with IMV's compelling data regarding their technology, it seemed a natural fit to discuss a possible collaboration with them. And after some rounds of conversations and data sharing under confidentiality agreement with IMV's senior leadership, it was agreed that there could be great potential here for an additive or synergistic effect of our combined technologies for cancer treatment. This is a nonexclusive arrangement, meaning that we are also free to pursue other collaborations. And while I cannot get into terms of the agreement at this time, I can say that we are not spending money on our therapeutics initiatives beyond the grant funding allocated towards those initiatives. We believe that this agreement paves the way for additional collaborations in the therapeutics space.

I'm pleased to tell you that we have now completed patient enrollment and imaging of all subjects in our NIH-funded Phase II study in Kaposi Sarcoma. As outlined in the study's title in this trial, we have done an evaluation of the safety of escalating doses of Tc99m tilmanocept by intravenous injection and a comparison to subcutaneous injection in HIV patients diagnosed with KS. You might recall that KS cells express the CD206 receptor that our technology targets. And so from both the diagnostic imaging perspective as well as a therapeutics perspective, it makes sense to pursue it as an indication as well as the continued impact it has on HIV-infected people, both in the U.S. and in particular, throughout Africa. Qualitatively, what we're seeing is excellent localization of KS lesions and visualization of the lymphatics in these patients. With completion of subject enrollment, now some in vitro work remains as well as detailed evaluation of the images and following full analysis and wrap up, we hope we can open up discussion with the FDA about a path to an sNDA in KS before too long.

We also have the ongoing atherosclerotic plaque imaging study at MGH in Boston. Dr. Grinspoon there is continuing to run this investigator-initiated study that we provided supportive funds for to look at the ability of technetium tilmanocept to detect atherosclerotic plaques enriched with activated macrophages. This is building upon the work we published with them that provided evidence supportive of this in HIV-infected patients and Framingham Risk Score matched healthy controls.

We have regular update discussions with him and his team, and they are on track with completion of an internal milestone in the study expected in the coming days to weeks. And at that time, we will have a detailed discussion of next steps. The data we have seen thus far are in line with the earlier published work and supportive of the hypothesis that tilmanocept can provide an excellent signal to background read of, so-called, soft plaque in the orders of patients. As part of the next steps, we'll be discussing plans to speak with FDA about indications in cardiovascular disease. This work also aligns, of course, with our recently received Phase I small business technology transfer grant from the NIH, our National Heart, Lung and Blood Institute to support a collaboration with the University of Alabama, Birmingham, looking at Gallium-68 tilmanocept for PET imaging of atherosclerotic plaques. Work making the Gallium tilmanocept agent has already begun and preclinical studies with that will begin shortly.

As we outlined in our press release about this, this project fits in with our existing atherosclerosis pipeline and will enable us to test tilmanocept as a PET imaging agent and compare it to F18 FDG PET imaging, a widely studied method of looking at macrophages and plaque, but one which we believe has significant deficiencies in comparison to tilmanocept. We're also continuing to expand our IP portfolio. We have filed 2 new provisional patent applications just in this last quarter. The first of these relates to the therapeutics side and the second could be fundamentally important to advance both our diagnostic and therapeutics pipeline. This makes for a total of 4 provisional patents filed since January, and we likely will file another before year's end.

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 and moving that towards submission to the FDA, while we continue the support and push for progress on our other diagnostic and therapeutic indications. As always, I want to thank the team here for their absolutely tireless efforts to keep things moving 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?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [4]

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Thank you, Mike, and thanks for the summary. Keep moving the ball forward. Now I'd like to turn the call over for the financial updates to Erika. Erika?

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Erika Gibson, Navidea Biopharmaceuticals, Inc. - Director of Finance & Administration [5]

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Thank you, Jed. Our consolidated balance sheets, statements of operations and statements of stockholders' equity have been restated as required, all periods presented to reflect the April 2019 reverse stock split as if it had occurred on January 1, 2018. Our consolidated statements of cash flows were not impacted by the reverse stock split.

Total revenues for the third quarter of 2019 were $237,000 compared to $231,000 in the same period of 2018. Total revenues for the first 9 months of 2019 were $539,000 compared to $1.1 million in the same period of 2018. The year-to-date decrease was primarily due to a decrease in license revenue related to the sublicense of our NAV4694 technology, which included a nonrefundable upfront payment in 2018, coupled with a reduction in grant revenue related to small business innovation research grants from the National Institutes of Health supporting Manocept development. Research and development expenses for the third quarter of 2019 were $1.8 million compared to $1.2 million in the same period of 2018. R&D expenses for the first 9 months of 2019 were $3.6 million compared to $3.4 million in the same period of 2018. The year-to-date increase was primarily due to net increases in drug project expenses, including Manocept diagnostic and Tc99m tilmanocept development costs, offset by decreased Manocept therapeutic and NAV4694 development costs. The net increase in R&D expenses also included decreased compensation costs resulting from net decreased salaries and headcount.

Selling, general and administrative expenses for the third quarter of 2019 were $1.5 million compared to $2.7 million in the same period of 2018. SG&A expenses for the first 9 months of 2019 were $5.1 million compared to $6.2 million in the same period in 2018. Decreased compensation primarily related to the resignation of our former CEO in 2018, coupled with net decreased related support costs such as director compensation, general office expenses and taxes, but were offset by increased legal and professional services, primarily related to the Goldberg litigation.

Navidea's net loss attributable to common stockholders for the third quarter of 2019 was $3.1 million or $0.17 per share compared to a net loss attributable to common stockholders of $3.8 million or $0.46 per share for the same period in 2018. Navidea's net loss attributable to common stockholders for the first 9 months of 2019 was $8.2 million or $0.62 per share compared to a net loss attributable to common stockholders of $13 million or $1.58 per share for the same period in 2018.

And finally, Navidea ended the third quarter of 2019 with $2.8 million in cash and investments. And with that, I will turn the call back over to Jed.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [6]

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Thank you, Erika. Prior to turning to the Q&A, I just wanted to mention 2 more things. First of all, I wanted to thank my business and development team for helping get the IMV deal done and to continue to work on the other deals that we're working on together. Joel and Jeff have been working constantly, chasing up every lead, sending out myriad invites to meetings and calls and being available 24 hours a day to help move things forward. I sincerely want to thank both of them, and I hope that we continue the good work, and hopefully, we'll have some very exciting announcements over the next several months. Secondly, I wanted to assure all of our investors that the best is yet to come. We have major milestones on the horizon, and we will do everything in our power to make sure we achieve our goals in a timely manner. We will not let anything slow us down.

Now I'd like to turn the call back to Jerry to open up the line for Q&A.

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Questions and Answers

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Operator [1]

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(Operator Instructions) We have a question from Jason McCarthy, Maxim Group.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [2]

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I'd like to see if you could give us a bit more granularity on when we could see some more imaging data from the Phase IIb? And then how that plays into the P3? Are we going to need to wait for the arm 1 and 2 final data to get that off the ground? Or is it more just a matter of how the FDA meeting plan -- pans out?

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [3]

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Jason, good questions. This is Mike Rosol. So the data from the interim analysis likely will be presented at the EULAR meeting, that's the big rheumatology meeting -- congress that's held annually in Europe, with about 14,000 participants then in June. So those -- at that time, we'll have the data in more detail that we presented the -- at the press release and in the last phone call as well as data that we have accumulated in the interim time period as well. So that'll be one point where information will get out there more widely to the public. Then the other look would be at the interim analysis for the arm 3 of the Phase III -- Phase IIb that's running now. And so that, as I mentioned on the October 29 call, would be probably in the next couple of months, we should have enough data accumulated in that arm so that we can then do our interim look there and then talk about what we're seeing there, right? And of course, those -- that's an important point. But the pivotal -- what we presented last week was worth that -- gave us the evidence we needed and confidence to keep going forward. So that was great stuff. Now the -- let's see, what was your other question? Did I get to it all?

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [4]

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Just about the, I guess, the timing of the FDA meetings?

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [5]

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Yes. Yes. So the start of the Phase III is not contingent. One of your -- I think, one of the things that led you up to that, what you're asking is the -- if you weren't, then I apologize, but just for clarity sake, the start of the Phase III doesn't have to be when the Phase IIb is over. So we're still expecting to stagger these. I think we're speaking internally about the strategy. So right now, we're continuing to evaluate the Phase IIb results and enrollments, and we're going to make the final decision on the Phase III start likely next month, and we're planning for that meeting request with the FDA very shortly.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [6]

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All right. And then I was actually wanting to see if you could provide a bit of a refresher on, specifically, the NAV3-32 study, because you're still planning to initiate that here. I'd like to see if you could just kind of refresh us on what that study is going to demonstrate, if it's successful? And then how that would enable you guys to expand the label to the broader RA market from the original anti-TNF therapy market?

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [7]

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Yes. So that study is a study comparing the imaging readout in subjects with active RA to the histopathology read obtained after doing synovial tissue biopsy from the same subjects. So we would do an imaging procedure with tilmanocept in these folks and then do a biopsy and look for a correlation between the number and density of activated macrophages, and those will be identified by expression of CD206 in those tissue samples and compare that to the imaging read. So the kinds of information we think we'll get from that, of course, is a direct correlation with the imaging signal intensity to the number and density of the macrophages. And we think there will be a good correlation there.

And if you recall, there are thought to be 3 different subtypes of rheumatoid arthritis, or there's a classification scheme that exists, that subdivides RA into 3 different subtypes, maybe to better put this. Those subtypes, the -- 2 out of 3 of those have heavy macrophage involvement, the third subtype is, so-called, fibroid subtype, has much lower macrophage involvement. And we would predict that our imaging readout would reflect all of those, right? So the one -- the RA subtype that has low activated macrophage involvement, we would predict that our imaging read would not show a lot of localization in the joints. And I can tell you, stepping back a little bit to the interim analysis data, qualitatively and quantitatively, we do see several cases in the active RA arm that indeed look like that, they don't have great localization. And it's about the same percentage as you would expect from the literature on the population of these different subtypes, the population distribution. So roughly speaking, about 25% to 1/3 of folks out there with RA are thought to have this hybrid subtype and then about an equal number amongst the rest of the subjects divided between the other 2 subtypes. And that kind of distribution looks to be what we're seeing in our imaging readout in the currently running Phase IIb at the IA. But we don't have the final correlation with -- the proof point from the pathology that we'll be able to get to NAV3-32.

So that will be able to give us that, kind of, final bit of evidence that shows that our imaging readout really does map to the macrophages, and we've got a whole boatload of evidence that suggests that in other indications is what -- in the preclinical space as well as clinical and including in some samples from patients with RA, but this would really, wrap that up and put a bow on it, that we could map to the macrophage number and density and provide information that relates potentially to the subtype. And so -- then if you can start to get information showing that you can predict the subtype -- and maybe it's only that we could predict the fibroid subtype versus the other 2, right? So maybe it's kind of binary. That would still be a significant benefit to the rheumatologists of the world and their patients because then you can start to say, well, maybe we need to -- we can then provide information that could be critical to selecting the right therapy or the best therapy for that type of patient.

So you might recall that I've mentioned before that the patients with the, so-called fibroid subtype don't respond as well to the anti-TNF [license]. If we can predict from the baseline scan and if NAV3-32 will give us that fundamental mapping to the macrophage themselves then to the subtyping, we can predict it from the baseline scan, and we can say, "Hey, you should go on a different type of therapy altogether." And that would be of great benefit to many folks. And then with NAV 332, being able to -- with our -- with the data in hand, where we can tie our readout to the subtype, we then could speak to as we have been to pharma companies who are developing different types of therapies that may, for example, target the macrophages directly. And we could say, "Hey, our readout maps directly and here's the fundamental data that shows that it does map directly to the number and density of macrophages in humans." And so we think that would expand the ability to -- or the interest from pharma to work with us in development of their drugs. And there are all sorts of possibilities that might come from that.

Now interestingly -- and I've mentioned this before, and I want to reiterate, we've spoken to the FDA, as you know. The FDA has said that, that NAV3-32 trial, the correlation of the imaging readout with histopathology, is not on the critical path for registration in indications in RA, the indications that we're going for initially. But we think it's important information to move things forward and to provide this -- that subtyping information with the fundamental underpinning of data that we've actually acquired in humans. So we think there are benefits to getting it additionally. You also may recall that we are pursuing biomarker qualification with the FDA for CD206 as a biomarker of activated macrophages in rheumatoid arthritis. To get that qualification, we really need to map our imaging readout to the fundamental histopathology, the number and density of the macrophages. So that study will also be important for getting the FDA qualification as a registration, it's not really registration, it's qualification as a biomarker for CD206 in its -- in RA-induced inflammation. So with all that said, these are the goals of the NAV3-32, to tie the imaging to the fundamental biology. And that could provide a number of opportunities that we think would be important and beneficial to the world and to the company. Hopefully, I answered your question.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [8]

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Very comprehensive, very helpful, too. There's just one more real quick one. I don't want to take up any more of your time, but I wanted to see if you could just give us an update on the time lines for the cardiovascular and Kaposi Sarcoma study, especially now that you've completed enrollment in the latter?

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [9]

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Yes. So the -- in the KS study, that in vitro work and the quantitation of the imaging readout should happen over the next several weeks to a month or 2, right? So that should be fairly rapidly that we close out the -- at least first pass evaluation of all of the data. And so with that in hand, we'll meet internally as well as with our collaborators at UCSF and discuss what are -- setting up a meeting with the FDA in the coming months to then decide what we would need to do, to do a study, a Phase III study to get approval for indications like KS. So a month or so for the data, kind of, close out and wrap up. At some point, of course, since the data looked fairly compelling or very compelling, actually, qualitatively, we'll write this up and present this somewhere in the not-too-distant future. But I would imagine we'll be thinking of meeting with the FDA in the first quarter of 2020. I don't promise that, but that would be my expectation.

And then in the atherosclerosis pipeline, so the work with Greenspoon at Mass General is going well. Like I said, we expect to have -- he's hit an internal milestone. I don't think I'm at liberty to reveal what it is because this is an IAS study, so it's really their study that we provided funds for and we dialogue with them regularly, but it is their study. So what we will discuss with him in the coming -- probably in the next several weeks, where we are. The data that I've seen so far, I think it's okay to say, as I mentioned in my opening remarks here, that the data are very strong. They're in line with what we've seen previously in the publication that we did back in 2017. So I think, there's a lot of promise there. So we'll see after discussions with him, likely we'll then be doing the same thing we're doing with KS and decide what it would look like to do a trial for indications in RA -- I'm sorry, in atherosclerosis and think about a meeting with the FDA, likely in the first or second quarter of 2020. So.

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Operator [10]

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We have a question from Mike [Rachi], who is a private investor.

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Unidentified Participant, [11]

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I'd like to continue with the -- flying on some of the trials. You're running a -- the university -- Washington University has filed for a clinical trial in mapping the draining of the lymph nodes in CS malignancy. This is quite a unique way to go because it's only been recently in the last couple of years that they determined that lymph nodes are drained in this area of the body. Can you give us a little more on that? It seems quite exciting to me.

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [12]

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Yes, I saw that. I think it's exciting as well. To be honest with you, that is not in our -- we have had nothing to do with that. That is a study that likely falls more into the Lymphoseek side of things. But as you've noticed, and you may have made the connection here, I mentioned that in Kaposi Sarcoma. So one of the comorbidities, one of the issues that arises in subjects who have KS very frequently as lymphedema. So they get an accumulation of edema typically in their lower extremities. And this is a very negative side effect of KS and the -- what we've seen in our results of -- so far with UCSF, the results that I've looked at without doing the full quantitation of these images is that we can show this and map this very well with our -- with tilmanocept, and this could have important implications into the monitoring of those folks, the assessment of the severity of their disease, the status of their disease, the progression of their disease and all sorts of things. And I think, in a general sense that this follows in the same line of what you just said. So indeed, it's exciting.

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Unidentified Participant, [13]

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Okay. Do you have any updates on the -- is there a trial being done in South Africa or someplace also?

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [14]

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Yes. So we've got the -- there's an investigator-initiated study in South Africa looking at Gallium tilmanocept. So it's a PET agent, Gallium-68 is a PET probe, technetium 99m is a SPECT probe, right? So they're just -- they admit different types of radiation. So there's Gallium tilmanocept -- a Gallium tilmanocept study going on in South Africa in patients with TB, who are HIV-infected and those who have TB but are not HIV-infected. And so currently, the update there is the PI on that study has done a pilot study. I think he needs -- he's almost completed it, of patients with TB with and without HIV as well, and we will be discussing the results of that pilot in the coming weeks. But indeed, that is something that is ongoing.

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Unidentified Participant, [15]

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The third one is Dr. Vera in University of California has been working on some Ga-68 in renal imaging. And last time, it was kind of discussed at several conference calls that he would like to start a clinical trial on that. Has there been any advancements made in that, that you can share?

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [16]

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Yes. We're in, obviously, close contact with David Vera on these studies and in other areas as well. And I don't know what he would want me to say here, but he is advancing towards beginning their clinical studies in that area. So those -- keep watching, those should happen relatively soon.

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Unidentified Participant, [17]

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Okay. Two more questions. Are there any upcoming presentations that you folks are planning? Or right now, is it pretty much just go as you go with no industry presentations?

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [18]

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Well, it depends on what you mean. So in terms of scientific ones, we are -- we'll be planning for, likely, as I mentioned, EULAR. We may send some of these other data, the KS data as well as the atherosclerotic plaque data, we will probably be on the lookout for meetings in the spring, summer and fall. So be on the lookout for those. I myself will be attending the American College of Rheumatology meeting next week. We're not presenting there, but we'll be doing -- we'll be holding meetings with our -- the PIs of the different clinical trial sites that we have for the Phase IIb as well as those, for the next Phase IIb and the Phase III. So we'll be having discussions with those. In terms of investor presentations, if it's not a part of your question...

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [19]

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We've been very...

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [20]

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Go for it, Jed.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [21]

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Yes, we've been very active. We've been very active on the investor side doing both 1-day road shows in different cities and those will continue. And we have also have couple of -- a bunch of conferences that we are planning on attending, including 1 this week, and then we're going to be attending conferences over the next several months. So we have quite a few conferences set up that we will be participating at. And we'll make announcements on those. And if we do a presentation, we will get those webcast, so that everybody can listen in on them.

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Unidentified Participant, [22]

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Okay. Two questions on -- that leads into 2 questions on the business side. As we're approaching February and probably because you won't have any more major conference calls on the business side before then. The New York, NYSE American had some targets, I believe, for February next year. Is there anything new you can share with us on those? Or is it just as we're moving along now?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [23]

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So we continue to be -- to give them their quarterly updates. We're actually on the phone with the New York Stock Exchange quite regularly to make sure that they know what our business plan is. And so we continue to update them. I actually do intend to do an interim call. The Q&A that we had done previously, I do plan on holding one of those either at the end of December or beginning of January, perhaps prior to the JPMorgan week or maybe right after that. So there will be another update prior to the year-end call, which we'll have in March.

What I would say is we are continuing to work with them. There are minimum requirements that we have to hit. And I can assure you that we're going to do whatever it takes to make sure that we remain in compliance with the New York Stock Exchange.

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Unidentified Participant, [24]

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And the last question is you mentioned that there was $2.84 million in cash at the end of the third quarter, and it looked like -- because there wasn't a cash flow statement there, but there was an income statement, that you may have spent $3 million last quarter. Do you think -- obviously, you have other funding ideas or opportunities coming, but right now, is the cash sufficient to keep going for a couple of months?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [25]

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We do have sufficient cash to last us into the end of the year, and we're exploring all options, including the potential partnership opportunities as well as other discussions we're having with various partners and existing partners and potentially new ones. So we do keep all the options on the table.

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Operator [26]

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(Operator Instructions) We have a question from Mr. Rick Drew, a private investor.

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Unidentified Participant, [27]

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This is to Jed and Mike. I appreciate the call and all the efforts being put forward. I didn't hear any mention as to the voucher that was discussed in past CCs. Are we still pursuing a voucher, I think, for [Crabs] disease? And if so, is there a time line you could share as to when a possible submission may take place?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [28]

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Rick, that's a very good question. We're continuing to work on that program, so that program is moving along. It is -- as you know, we funded it in advance. And so we're continuing to gather data, and we will continue to gather data. I don't have a time line that we can discuss for the voucher. I think that's something that we are going to pursue because if we continue to do the research that we've been doing up to date, it would fall under that program. But that is something for down the road, but it's something that we're not abandoning it. We are continuing to work with it. We continue to speak with the investigator who's doing the trial, and we will continue to aggregate data, and hopefully, push that forward so that we can have something to discuss more on that in the middle of next year.

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Operator [29]

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There are no questions at this time. I'd like to turn the conference back over to Mr. Jed Latkin for closing remarks. Please go ahead, sir.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [30]

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Thank you, Jerry. I just want to thank everybody once again for tuning in. As you know, we continue to work tirelessly towards achieving the goals. We are very, very focused on rheumatoid arthritis as you know. We are continuing to make sure that we enroll the trial in a timely manner. We move towards the second interim look, which is coming up. And more importantly, as we've shown from this quarter's remarks, we have not dropped the ball in any other programs. The other programs that have been funded are moving forward, where we have grants for, continues to move forward. And I just want to say one more time that I really want to thank my team, we're small, but we continue to work hard. The office is populated 7 days a week because we are really pushing forward to hit those time lines and to make sure that we get this very, very big project completed and to market. I just want to thank you, again, and hopefully, we'll be speaking again in the December and January timeframe.

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Operator [31]

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This concludes today's conference. You may disconnect your telephones at this time. Thank you for your participation, and have a good evening.