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Edited Transcript of NAVB earnings conference call or presentation 11-Mar-20 9:00pm GMT

Q4 2019 Navidea Biopharmaceuticals Inc Earnings Call

DUBLIN Mar 24, 2020 (Thomson StreetEvents) -- Edited Transcript of Navidea Biopharmaceuticals Inc earnings conference call or presentation Wednesday, March 11, 2020 at 9:00:00pm 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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* Michael Okunewitch

Maxim Group LLC, Research Division - Equity Research Associate

* Vernon Tolentino Bernardino

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

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Presentation

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Operator [1]

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Greetings. Welcome to Navidea Biopharmaceuticals Q4 2019 Earnings and Business Update Conference Call. (Operator Instructions) Please note, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Jed Latkin, CEO. Thank you. You may begin.

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

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Thank you. Good afternoon, and welcome, everyone, to Navidea's Fourth Quarter 2019 Earnings Call. I am Jed Latkin, Chief Executive Officer of Navidea Biopharmaceuticals. This call will cover Navidea's financial and operating results for the fourth quarter of 2019, which ended on December 31, 2019, along with a discussion of goals and milestones for 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 Eves.

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 of the Securities Act of 1933 as amended and Section 21E of Securities 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 the forward-looking statements. Words such as expects, anticipates, intends, plans, aims, targets, believes, 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 and commercialize diagnostic products, 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 diagnostic market and its rapid technological change; 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 an 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 once again be primarily focused on our ongoing preclinical and clinical research efforts. While we have a lot of things going on at the moment, I want to keep the discussion focused on what we are focused on, which is bringing the RA product to market. I am very pleased with the progress that the company has been 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 major positive announcements over the next month or 2.

I've always guided The Street and our owners, you, the loyal shareholders, that we would seek out the right partner at the right time and not let funding be the main deciding point. We have really accomplished a lot on the clinical side and on the funding side as well. We creatively limited the dilution and regained compliance with NYSE by raising approximately $7.6 million about 4 weeks ago. This deal would have been considered a good deal in any market, but given what is going on around us, it was truly remarkable win for the company and its shareholders. We now have runway and time to complete the 31 trial and complete our partnership discussions. I can honestly say that I am more enthusiastic today than I've ever been in the 4 years that I've been with Navidea. As we narrowed down our list of potential partners, I assure you that we are getting closer and closer to the finish line.

We have also been moving ahead on a number of different fronts in various areas of the business to bring more of our products front and center. The best news is that all the deal-making in the radiopharmaceutical sector, it seems that the current market ructions are having virtually no impact on the company's -- on company's appetite for transactions. I also, once again, want to commend my finance team, my regulatory team and, certainly, last but not least, the clinical team for all the hard work they've been doing. We closed our arms 1 and 2 faster than I'd ever expected and I have seen an incredible pickup in enrollments in arm 3 as well. We are now moving forward with the independent reads to confirm everything, and we'll be speaking with all of you again very, very soon.

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.

So I'll begin with the progress on our currently running Phase IIb trial in RA. I'm pleased to announce that we have completed enrollment in both arms 1 and 2 of this trial and are more than halfway through recruitment in arm 3. Current projections are that this trial will complete this year as scheduled. In arms 1 and 2, you might recall, 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 power calculations for the Phase III. As announced previously, 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 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. We have written an abstract on the results of the first interim analysis and submitted it for presentation at the international conference.

The next milestone is the interim look at the arm 3 data. Our plan has been to wait until about half of the arm 3 subjects had their second imaging event at 5 weeks post initiation of anti-TNF therapy. We are well on our way to this milestone and expect those next image sets to be acquired in the coming weeks. We will then complete analysis of these data and have an idea of the magnitude of change we might expect to see from baseline scan to 5 weeks post therapy start in RA subjects.

I want to make sure we give credit to our clinical trial team, who worked diligently, literally day and night in order to keep things moving as efficiently and rapidly as possible while maintaining quality and integrity of data and provide evidence to you to let you know that the team here is performing at a high level. One good example of that is in our recruitment rate. Evidence suggests that typical recruitment rates in North America and Western Europe for Phase II and III trials in RA are about 0.4 subjects per month per principal investigator. This means it typically takes about 2.5 months for a specific site to recruit 1 subject in these trials.

Our recruitment rate in our current trial is 1.2 subjects per site per month. And our arm 3 rate has increased significantly in the last several months, as Jed alluded to. So much so that we are optimistic that we can complete enrollment into that arm before too long. With that rate of 1.2 per month, per site, we are enrolling at about 3x the typical rate across RA trials and across pharma companies, both large and small, and all of that with a relatively lean, but obviously, efficient team and a protocol in arm 3 that is actually a difficult one to recruit into compared to many other RA trial designs.

We will continue to enroll into arm 3 of this trial and are planning for the start of the Phase IIb comparative study of our imaging readout to 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 IIb will be rolled right into that trial, and so the logistics and strategies for recruitment will be established. Our current plan is to initiate that comparative imaging to histopath Phase IIb study in the upcoming quarter. This study will primarily enroll subjects in the U.K., where our principal investigator, the world's leading physician in synovial tissue biopsy of patients with RA, is located and where there is a network of academic centers that also have specialists in this domain. We'll have at least 1 site in the U.S. as well. We've spent many months preparing to initiate this trial and are well on our way to having all needed approvals and contracts in place to begin. We had pushed out the start of this trial, while we made sure that we'd have the financial resources to run it adequately while also finishing up the current Phase IIb and beginning the Phase III. Recall that this Phase IIb trial isn't 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 possible pharma partners for its use in trials of their new RA therapeutics.

Our plan at this time for the Phase III is to be ready to begin following meeting with the FDA with our interim analysis 1 and 2 results in hand, so we can be sure we are fully aligned on the Phase III objectives and targets, and that first patient first visit should happen later this year.

We have also been working to further refine our quantitative method for determining the amount of localization of tilmanocept in the joints of both healthy subjects and patients with RA. As you know, this is our key readout and the foundation upon which all of our indications in RA rests. At the time of our first interim analysis, we had evaluated both the method originally proposed following our prior Phase II study as well as a modified method we developed as we looked at old and new data rolling in. It was the modified method that provided the best results. We believe we have made significant improvements in the analysis method and will continue to refine it with data from the currently running trial in preparation for the Phase III.

Directly related to this, we recently converted the so-called tilmanocept uptake value provisional patent application to an A1 application. As part of this conversion, we made significant revisions to the original claims with our newly discovered improvements in quantitative methodology. The goal, of course, is to optimize the imaging read method to provide the lowest variability, most robust quantitation possible.

In other indications, we've now completed patient enrollment and imaging of all subjects in our NIH-funded study in Kaposi's Sarcoma. As outlined in the study's title, in this trial, we sought to evaluate the safety of escalating doses of tilmanocept by IV injection and pro forma 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 a 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. We have had our site closeout and database lock in this trial and are waiting the final biopsy results. No safety signal was detected, and we completed a comparison of subcu injection to IV injection in these patients as planned. Final read of clinical assessment to imaging will take place shortly.

Qualitatively, what we have seen is excellent localization of KS lesions and visualization of the lymphatics. Following full analysis and wrap-up, we hope to open up discussion with the FDA about the path to an sNDA in KS before too long.

We also have the 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 tilmanocept to detect plaques enriched with activated macrophages. This is building upon the work we've published with them already that provided evidence supportive of this in HIV-infected patients and Framingham Risk Score matched healthy controls. We've had regular update discussions with him and his team, and they have completed an internal milestone in this study looking at imaging results via different routes of administration. The data we have seen 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 aortas of these patients.

We are having internal discussions on what specific indications in cardiovascular disease to go for and what the next trial might look like. And we have engaged with external possible partners as well to help support these studies. Once our trial plan outline is finalized, we will request a meeting with the FDA to discuss.

This work also aligns, of course, with the Phase I grant we have with the NHLBI that we have in support of our collaboration with the University of Alabama at Birmingham, looking at Gallium-68 tilmanocept for PET imaging of plaques. Preclinical studies are ongoing, and we recently received the first data set. As we outlined in our press release about this, this project fits in with our existing pipeline of atherosclerosis and will enable us to test tilmanocept as a PET imaging agent and compare it to F18 FDG PET imaging, which is a widely studied method of looking at macrophages and plaque, but one which we believe has significant deficiencies in comparison to tilmanocept.

On the therapeutic side, we have preclinical study plans in place and have had our kickoff meeting for the research collaboration with IMV, the clinical stage immuno-oncology company that we recently announced a research agreement with. Remember, 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 their T-cell activating platform.

Based on our discussions with IMV, I'd expect the first study to begin shortly.

Along those lines, we are having good discussions with other players in the therapeutic space about possible collaborative efforts. Using funding from our NIH Therapeutics grant, we have made significant steps towards synthesizing a robust, reproducible and scalable therapeutic construct that can then be tested in human studies. We have also made significant strides into making a next generation of our molecule that we think will provide for improvement in certain diagnostic and therapeutic applications. We also have received positive results from our mechanism of action studies of our doxorubicin-containing construct in cell culture and in preclinical models, and we aim to hold a pre-IND meeting with the FDA this year. We expect to submit manuscripts for publication this year covering these mechanism of action studies as well as the synthesis market.

This month, we will be converting another provisional patent application, in this case, the therapeutic patent to an A1 application. We expect to file at least 1 new provisional patent application this year on improvements in chemical synthesis. Finally, we have also initiated work on new therapeutic constructs with payloads other than dexamethasone and doxorubicin. So those are just some of the highlights of the last quarter that we wanted to touch on through this update. We remain largely focused on the RA pipeline and moving that towards submission to the FDA, while we continue 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, our CEO, Jed, for allowing us the space and opportunity to achieve these goals, 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.

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

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Thanks, Mike. Now let's move over to the financial updates with Erika.

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

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Thank you, Jed. As a reminder, our consolidated balance sheets, statements of operations and statement of stockholders' equity have been restated as required for 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 fourth quarters of both 2018 and 2019 were $119,000. Total revenues in 2019 were $658,000 compared to $1.2 million in 2018. The year-to-year decrease was primarily due to a decrease in license revenue related to the sublicense of the company's NAV4694 technology, which included a nonrefundable upfront payment in 2018, coupled with a reduction in grant revenue related to Small Business Innovation Research grant from the National Institutes of Health supporting Manocept development.

Research and development expenses for the fourth quarter of 2019 were $1.7 million compared to $854,000 in the same period of 2018. R&D expenses in 2019 were $5.3 million compared to $4.2 million in 2018. The increase was primarily due to net increases in drug project development expenses, which include Manocept diagnostic and tilmanocept development costs, offset by decreased Manocept therapeutic and NAV4694 development costs.

SG&A expenses for the fourth quarter of 2019 were $1.2 million compared to $1.4 million in the same period of 2018. SG&A expenses for 2019 were $6.3 million compared to $7.7 million in 2018. The decrease was primarily related to the resignation of the company's former CEO in 2018, coupled with net decreases in salaries and bonuses, investor relations, general office expenses and taxes, and offset by increased legal and professional services, primarily related to the litigation with the company's former CEO.

Navidea's net loss attributable to common stockholders for the fourth quarter of 2019 was $2.8 million, or $0.15 per share, compared to $3.2 million, or $0.33 per share, for the same period in 2018. Our net loss attributable to common stockholders for the full year 2019 was $10.9 million, or $0.76 per share, compared to $16.1 million, or $1.89 per share, for 2018.

And finally, Navidea ended the fourth quarter of 2019 with $1 million in cash and investments. As disclosed in Navidea's recent filings with the SEC, the company executed funding transactions totaling $7.6 million in proceeds during the first quarter of 2020.

And with that, I'll 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. Once again, I just wanted to thank everybody for calling in. I want to thank the team for all their hard work. And more importantly, I just want people to know how hard everybody is working here, how diligent our clinicians have been working on enrolling more and more patients into the study, and really just how excited everybody is here to get the other trials up and running and really move this product forward into the approval stage.

With that, I'd like to turn it over to the operator to open up the Q&A.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Our first question comes from the line of Jason McCarthy with Maxim Group.

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Michael Okunewitch, Maxim Group LLC, Research Division - Equity Research Associate [2]

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Jed, this is Michael Okunewitch on for Jason. So the first question -- I have a couple here. I'd like to see if you could kind of help break down the Tc-Til pathway forward, particularly surrounding the 32 Phase IIb study because that one looks pretty interesting. I'd like to see what the market for Tc-Til looks like in the minimum case. So like just the 31 and 33 studies versus if you can actually demonstrate that correlation to immunohistochemistry with the 32 study?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [3]

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Well, I'm going to take part of it and then let Dr. Rosol take the other part. In our estimates, so we've been going over market sizes, and that's something that's in our presentation. We have those 2 bubbles. We do think that conservatively in North America alone, 31/33 gets us in 0.5 billion range and then opening up the phenotyping and everything else probably gets us somewhere into the 1 billion to 1.5 billion range in North America alone. Just remember, you're looking at a base of $50 billion in revenues for the RA therapeutics, a market that really doesn't have any diagnostic that is really objective. And more importantly, the way that we've already been working in terms of the pricing and how aggressive we're going to really market it, we do think that we're going to be able to capture that share. So we think the 31 really opens it up, especially since the anti-TNFs are the de facto, the main go to. But 32, especially with some of the stuff that Dr. Rosol is going to talk about in a minute, really, really widens it because there are so many different options out there. And I think what our investors really need to understand, I think, it's still lost on the stock, I guess, because of the history and all the other stuff, is the fact that this is an area that has lots and lots of treatment options, probably the most treatment options of anything out there. And yet, there's no real diagnostic. All the treatment options are expensive. All of them have side effects. And more importantly, all of them have different mechanisms of action. And without a proper diagnostic and monitoring tool, you're flying blind. And so it's give everybody an anti-TNF to start or let's start with something else, let's do something else.

But -- so where the insurance companies push the anti-TNFs because of their tiering, our diagnostic is going to change all that and it will change it for the better. So a lot of the pushback is well, will the Humira people possibly be angry. That's not -- that's actually the exact opposite of what our diagnostic is going to do because our diagnostic is going to say simply those who are getting better, stay on their current treatment. Those who aren't, get them off of it as soon as possible, so they're not exposed.

Remember, the fears going on right now with coronavirus is mainly for individuals like myself and other people on biologics because you have a compromised immune system. And so if your immune system is compromised and your medicine is not working, I mean, why you want the drug in the first place? Our diagnostic is going to be able to eliminate that. And that's why we're so excited, and that's why the addressable market is so large.

Now Dr. Rosol could shed a little bit more light on the sort of the differences and how the market changes with those 2 sets of trials.

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [4]

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Yes. So Jed did a very good job there. So at 31, the currently running Phase IIb as well as the Phase III, we're looking at a change from baseline to 5-week scan and whether or not that is predictive on outcome. What the comparative study to the pathobiology will give us is the pathotyping or subtyping the mapping to those different subtypes, based on just 1 scan, potentially the baseline scan. And so that looks like it's gaining in importance. And why is that? It turns out that from this plethora of different biologics and different therapies that are out there, they're growing the publication -- number of publications out there suggesting that different pathotypes or subtypes respond differently to different biologics. And if we can tell a physician, a rheumatologist, at the time that the patient comes and gets the first scan, what subtype of disease there -- this particular patient might have, then they might be able to rule out, for example, an entire class of drugs. The insurers would love that. The patients would love that because they wouldn't have been put on one of these biologics that potentially has very severe side effects. And, of course, the physician would like it as well because you get the person on the right drug sooner rather than later. So -- and this is all throughout those different pathotypes. So it turns out that the more we can give the physician information about the subtype of disease, the better that physician can then prescribe a medication for that person, along with the fact that we can then monitor if the patient is receiving a benefit from the particular drug that is then prescribed. So as Jed said, that really opens up and expands the market quite a bit. So...

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Michael Okunewitch, Maxim Group LLC, Research Division - Equity Research Associate [5]

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All right. Yes. And then actually, I'd like to tie that end to the enrollment speed that you guys are seeing because it's pretty impressive. I'd like to see if you could comment maybe on some of the reasons why it could be going so much faster than the average, especially considering that there are other typical difficulties with cross disciplinary therapeutic diagnostics, could this be indicative of the unmet need in the market out there for reliable imaging agents that can help inform treatment decisions in RA?

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

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So I'm going to let Michael handle that. But before I start, I thank you for that question, and I'm glad that you as an outside person has recognized the enrollment speed. Because I myself don't. Because I always -- I'm always getting on the clinical team constantly. And having been shown the numbers and looked at the averages, I am very impressed with the job they've done. But that doesn't mean I'm happy with them. I still continue to yell at them every single day and make sure that if we don't have patients enrolled every day, it's not a fun day at the office. But I'll let Dr. Rosol handle the rest of that.

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

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Yes, this is Mike. We don't rest on our laurels here because they're gone the next day. No, I appreciate it. So yes, so that's a great question. So I think you've hit upon something there. So there are 2 sides to this answer. One is we have an experienced clinical trial team, who not only have done work with Navidea and in our first RA trials, but in the field in general. And so there's a lot of experience here and expertise in how to engage with sites, how to choose the right sites to engage with and how to continue the engagement process because you really need to -- there's kind of a fine line of being -- talking to the sites, communicating with them from the PIs, down to the coordinators, down to the staff who maybe do the actual exams themselves, the imaging exams, for example, and bothering them too much. So I think this group is really good, has been really good at figuring out that happy middle, that place where we keep the PIs engaged. We let them know that we're thinking of them. It's important to us as well as the staff kind of downstream from them.

And the second half of this is exactly as you said. What we're seeing is a recognition, both from the nuc med side, the imaging side as well as from the rheumatologists that there's a need and an opportunity here. The rheumatologists see the great need for their patients and in their practices. And every time we speak to them and we speak to them all at least monthly, the PIs themselves that is, we hear this from them and how they're excited about this, and they ask us how is the recruitment going, what can they do to help increase it. What -- we learn from them and they learn from us and from other sites that we bring that -- we bring that information from other sites to them. And then on the nuc med side, they're interested in having another tool in their toolkit, right, to apply and to use as nuclear med physicians. And so they want to play a role in this as well, and so they're excited about that.

So indeed, we've got a really good team here who know what they're doing and who engage the right sites and engage them appropriately. And then we've got an excited group of PIs, both on the rheumatology side as well as the nuc med side. And yes, I have some bias here, of course, but this team is really -- I've been around the field for a while, and I've seen teams in large and small companies. And this is kind of an A team here, I think, that's doing a really bang-up job. And so we want to make sure we give them appropriate credit. So...

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Michael Okunewitch, Maxim Group LLC, Research Division - Equity Research Associate [8]

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All right. I just got one more, kind of, more of a housekeeping question. I just like to confirm on some of the time lines. So for arm 3, you guys said that you met that 50% enrollment mark, and you should have the raw data coming in the next few weeks. So should we expect to see that actual data around mid-2020 or so? And then when are you anticipating the full data from 3-31?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [9]

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Yes. So the -- indeed, we're just over half of the subjects enrolled in the -- in arm 3, and we're waiting on just a handful -- a small handful of those to have their 5-week scans. Several of them have had their 24 -- their 12 and 24-week scans, which will only be helpful for us in terms of looking at these data. So the plan is once those roll in, in the coming weeks, and we're actually going to be working on it before then. But of course, once all the data are in, then we'll crunch those numbers, give them to our statisticians and that will take, all of that, the final number crunching, the statistician analysis will take some weeks. I don't want to promise on time lines there, but we'll do our best. We're setting up things so that we can achieve our goals as rapidly as possible. We do -- we try to do things smartly and efficiently here, so the statisticians are ready and waiting. They know what they're going to receive. They've already got the programs written. So we've got all these pieces in place already. So they'll be ready once they receive the data to do things rapidly.

So yes, it will take some weeks or a matter of couple of months or so. But give or take, plus or minus there, some number of weeks. So that will be in -- it looks like if we get the -- at the rate we're going in terms of recruitment and enrollment into the arm 3, we optimistically think maybe we can get all of the subjects enrolled maybe by the end of April, right? Again, don't hold me to it, but that's the way things are looking as of this moment on this phone call that, that is achievable. So then, if you remember the protocol design, we've got maximally a 6-month follow-up scan in those patients. If they don't drop out of the study earlier because they've gone off their anti-TNF-alpha, and they might. About half the subjects we expect will go off earlier. So if they follow up that way, then we'd be -- we'd have 6 months plus April, right? So we imagine all those data are going to be in by the end of this year. And then we'll do our analyses of the full data set of arms 1, 2 and 3, and then we'll write up our clinical study report and you'll be one of the first to know about it. You, the royal you.

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Operator [10]

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Our next question comes from the line of Vernon Bernardino with H.C. Wainwright.

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Vernon Tolentino Bernardino, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [11]

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Congrats on the progress. It looks like you've got a lot of things coming up as far as the Phase IIb and RA and definitely looking forward to the mid-2020 readout. So my questions are also related to the enrollment rate and the 3x typical rates. So congrats on that to the team. It sounds like the experience pays as usual. And I guess, related to the question that the prior analysts asked, if you could expand a little further, the unmet medical need there. It seems like it could translate into market opportunity. Have you had additional thoughts as to what that may translate into? Or is that already built into your expectations as far as the market opportunity is concerned?

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

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I think it's built in. We -- and Jed can comment on this further. We do -- we've known for quite some time that there's a great medical need and our KOLs that we've contacted over the last several years in the rheumatology space have told us about that. And so I think in our models, we built in a fairly rapid growth rate that actually is conservative based on our discussions with these rheumatologists that now are experienced in this kind of trial. So indeed, there's a great medical need. I mean, just to revisit this and maybe you already understand this well. Right now, the -- in the treatment of RA, it's a trial and error approach, right? Some of it is dictated by cost. So very often, for example, in the U.K., you must put a patient on a methotrexate, even though there's a decent chance that, that won't do a bit of good. But because it's super cheap to put a patient on methotrexate, you got to start them on that. And then you have to wait a few months to determine if that is even working. And then you can seek approval to go to a biologic. That has basically been the model in the U.S., although some health insurance companies are starting to recognize that maybe going through these cheaper nonbiologics isn't always the best case scenario, even for them and their own costs -- their cost burden. So we're hearing more from rheumatologists that there's some flexibility there. But really, they're kind of blind here. They're going on kind of sense of smell. So it's a trial and error of different drugs and you have to wait to see if it's working.

About half the time, these drugs -- any particular drug won't work on any particular patient. And then you won't know that for maybe 3 to 6 months, and bad things are happening in that time period potentially to the patient. And so -- and things might be getting worse. And then you have to repeat this again with another trial and error. You've learned something from the first time so maybe you go to something else, but they're really shooting in the dark. And so rheumatologists are very excited about this. And I think we are seeing this in part of -- we're seeing this played out in our clinical trial enrollment rate.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [13]

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Yes. And it's a good point because I think that as a lot of our shareholders, and I can see the list on the call, everybody who's dialed in and has been involved in the company for a long time, this is something that has really progressed over time to just looking at diagnosis, just looking at that to realizing, working with the KOLs, the thing that we stressed when we talk with everybody is that, when we got Lymphoseek approved, I wasn't here, but it was sort of a different pathway. It's a great drug, remains a great drug. It's growing nicely in the U.S. We're looking forward to having some growth in Europe in the very near future as well. But more importantly, it was not necessarily done the right way, as in we didn't get the right KOLs when we were doing the trial.

As we've grown with these trials, it's all because of what we got as the feedback from our KOLs, what would they prescribe, what do they want, and that's how we've taken this drug down the path that it's going down. It's very different than what we were talking about just a few years ago, which is why the Phase II was structured differently than it probably should have been. But the way we're looking at it now, it's something that is creating a lifetime value of a customer that -- what the KOL wants. And also, we're taking the next step by making it all-digital, as you know. And so this allows for patient portability, but it also allows for really to be able to build on using all the great digital stuff that's out there, using all the innovation and being able to have this data bank that will serve the patients well and serve the product well as it grows and more and more data comes in. So this is seriously something that is going to grow over time. We do not actually factor in the value of the data into our estimates, so that's one thing that we are keeping a very conservative look at by not actually considering the value of it, at this juncture. But we understand that the monitoring aspect of things is really what all the KOLs want, and that's why the trials are structured the way they are.

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

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Yes, this is Mike. That's exactly the right point that Jed made. We -- the trial design itself as well as the Phase III, we incorporated the feedback from the KOLs, and this is the kind of trial that they all have focused on and said this is what we need, down to the imaging assessment time points. There's virtual -- unanimous agreement on the design of this trial. In fact, I think, it is unanimous, which is amazing. And they're all very excited to see the results. So there you go.

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Vernon Tolentino Bernardino, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [15]

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So I guess, the 3x typical rate is driven by tilmanocept and this can likely be translated into real-life upon approval?

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

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Yes. My expectation would be the fact that they're so excited and enthused about this and working so hard to recruit should translate into the -- what they want to implement in their clinical practice. Absolutely.

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Vernon Tolentino Bernardino, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [17]

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Terrific. That's very exciting. And then my other question is, you had mentioned the conversion of the tilmanocept uptake value quantitative image analysis provisional patent to an A1 patent application. Is there perhaps an idea how that could translate into like a market opportunity, if anything?

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

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Yes. So that quantitative method is actually the nuts and bolts of what we'll be offering. So that is the means -- that will be the -- that forms the foundation of the algorithm that we will be employing through our central reading laboratory to read these images. So it plays an integral role in the product itself in RA. And as a little bit of a tease, it's written broadly enough and the fundamentals of it are broad enough that it actually might be -- have significant value in other domains related to imaging quantitation, and I'll just leave that at that.

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Vernon Tolentino Bernardino, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [19]

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Terrific. Very exciting. I'm looking forward to the data in the next several weeks and, yes, the exciting progress of tilmanocept Phase IIb and into Phase III. Congratulations.

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

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Thank you.

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

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Thank you, Vernon.

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Operator [22]

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Our next question comes from the line of [Michael Lou], private investor.

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Unidentified Participant, [23]

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So I have 2 different questions. I guess the first question is pretty short. I'd like to know whether Mr. Scott or any entity or person affiliated with him was the purchaser of the Ohio judgment that the company disclosed last month.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [24]

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He was not nor was it any entity affiliated with him.

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Unidentified Participant, [25]

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Okay. The second question is a question management is probably tired of getting, and I understand that management has said on several times that they will not make a deal with respect to RA with any partner that doesn't recognize the full value of the potential product. But I guess from sitting here as a shareholder, who's been in the stock for a significant period of time, I guess, what I'm trying to understand is why it seems like deadlines keep getting pushed out. In the Q2 call, back in August of last year, I think management said that securing a partnership with the right partner under the right terms is a primary goal for the company still in 2019. Then in October, when the company announced the interim results, I think, things were said such as we received quite a lot of inquiries. It's assisted in moving the ball forward. This should lead to other positive things in a very quick manner. On the Q3 call then in November, a couple of weeks later, "I want to assure all our investors the best is yet to come. We have major milestones on the horizon. We'll do everything in our power to make sure we achieve our goals in a timely manner. We're not going to let anything slow us down." And I mean, I could go on and on. But I'm just trying to understand why it seems like these deadlines keep getting pushed out.

And I guess one other related question possibly for Mike, is also on the Q3 call, I believe you said that the start of the Phase III does not have to be when the Phase IIb is over and the company was expecting to stagger those 2 results. And if I understood comments earlier today, that has now possibly changed, that the company would like to finalize the take -- the Phase IIb trials before initiating Phase III or really finalizing any partnership discussions. So I'm just trying to understand why these deadlines seem to keep getting pushed out.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [26]

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Michael, thank you for the question. And so I'll take the first part, and I'll let Dr. Rosol handle the second part. I would say that the -- you are correct. This is something that we've been talking about. We have had discussions. I did -- for full disclosure, I thought about 1.5 years ago, we were going to have a deal. In the end, the terms I thought were not appropriate for what we wanted. We had another offer, which was pretty good with a very large company. But once again, I think the issues with what we've gotten offered so far, and this was a year ago and not now with what's on the table today, were more of the -- you're running out of money. You can't finish this trial, and there's no way you're going to be able to issue any equity. There's no way you're going to be able to raise any money. You're screwed. Let's make a deal.

And that's just not the case. I mean, we've been able to find investors, get more investors, bring more money into the company by thinking creatively. And now I can tell you that the term sheets that are on the table right now are for bigger numbers. We are -- we have multiple companies doing third-party paid research now on the company, so third-party valuations of the product to confirm that. One of those companies has actually confirmed what our numbers are. Unfortunately, they paid for it, so we don't get access to that report. But they have confirmed it, and we are further along than we've ever been and the numbers have all been discussed. And we said, this is what we want. This is the terms of the milestones that we want, and this is what's going to take to do that, and we're not going to waver off of that. I'm not -- I really, really strenuously want to say that we are not going to make a deal just to make a deal. We've had that opportunity. We've said, no, thank you to a few parties already. And we are in discussions right now with the ones who are the most interested. And those terms, I think, are quite favorable for us and for the partner as well because we do believe there's a lot of value in this product and the partners that we are talking to understand that. And we are really getting very close to that announcement.

I mean I think that, unfortunately, the one thing is, being a little company versus a big company, we are somewhat at the whim of Board votes, internal meetings and these independent third-party valuations. But with all of those coming to an end, I do expect that we're going to have something to discuss with the market in a short order. Now I don't want to be like the experts with Alan Greenspan's financial statements and everybody analyzing every single word and saying, well, if you say that, it means 2 weeks or whatever. I do expect to have something within the near term. And that's why I said in my opening remarks, within the next 2 or so months.

And I will let Dr. Rosol handle the other side of the question, unless you wanted to have a -- unless you had a response.

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Unidentified Participant, [27]

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No, no, I appreciate the candor and the response.

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [28]

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Yes. So thanks, Michael. This is Michael. Nice to speak with you. So the -- good question. The Phase IIb, we're still planning to stagger this, right? So it is not the case that we're -- that -- and I apologize if I was not clear. We're not waiting until the Phase IIb that's currently running is completely finished or all the data are in before we start the Phase III. Rather what we're doing is we're waiting for the interim and -- both of the interim looks to be fully in. So the first one that we announced in October as well as in this -- the one that relates to the arm 3 that we should be having coming up fairly soon. Then once we've looked at those data, what you have to do, you request a meeting with the FDA. The kind of meeting, this is, there's a minimum of 60 days between the time you request it and the time they give it to you. It doesn't have to be at 60 days, but that's the minimum. And so we don't want to ask for that meeting until we have the data in hand and know what the heck we're going to be talking about really and finally and fully, we want to do this smartly. So what I'm doing is projecting out. So the idea is we'll start the Phase III. We will still be recruiting into the currently running Phase IIb -- or not recruiting into, but by that point, we'll just be following up those subjects who are already enrolled in arm 3 of the trial, but there will be a stagger there.

And so in terms of the time line of that, I think, we've evolved a little bit in our -- the plan here in terms of what we would want to bring data-wise to the FDA. And so maybe that has pushed things out a little bit as well as even though our overall recruitment rate is super stellar. To be frank with you, there was a period of a couple of months late maybe in Q3, Q4 last year where the arm 3 enrollment had lagged, right? And so the sites we're recruiting greatly into the arm 2 and the reason for that is most likely, it's an easier arm to recruit into. And so I think folks, maybe even the coordinators on the ground were pushing more for recruitment in that arm than the others. We said, "Hey, folks, we met with the PIs and continue to speak with them and said, make sure you don't neglect that other arm." And then, everybody woke -- kind of reawaken and that enrollment now is going great guns. So there was that as well. But we're not waiting until the end of the Phase IIb before we start the Phase III. Does that answer your question?

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Unidentified Participant, [29]

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It does.

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Operator [30]

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(Operator Instructions) Our next question comes from the line of [Mike Rickelle], private investor.

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Unidentified Participant, [31]

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Yes, this is Mike, again. The questions so far have been excellent and appreciate those people who have asked them. First, I'd like to say, Jed, congratulations on that really low discount rate you got on that accounts receivable, so that was very impressive.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [32]

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Thank you, Mike.

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Unidentified Participant, [33]

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Now we talked in generalities and Mr. Mike Rosol in the press release, you said we have our eye on the next interim results on the timing outlook. What -- you talked -- are you thinking that the next interim results will be in the next couple of months or is it longer than that?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [34]

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Yes. I mean, that's what we're shooting for. So we've got the number of subjects that we'd like enrolled, and we need to follow up the -- we need to have those 5-week scans in from the last few who haven't. And then like I said, we'll be beginning to analyze those data in a rolling fashion. And we need the analysis done and then the statisticians, and we're trying to position it so that we can do this most expeditiously, right, because we're excited to see these results. And, of course, you folks are as well. We're excited to get them in so that we can then prepare our questions and discussions with the FDA. But I would say that you're correct on the time line. So we'd like those within the next couple of months.

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Unidentified Participant, [35]

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Okay. Now earlier in the prepared remarks, you said going to the FDA on the P3 for RA later in the year, is that -- are you implying late in the year or maybe after the midyear?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [36]

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No, no. So the idea is, it might be -- it'll probably be right around the midyear, right? So if we get those data in within a couple of months, like I said, we've got the 60-day period from the time you request the meeting with the FDA until they give it to you. So that might put us into the summer. Then once we've got all the go-ahead, the blessing that we believe we're going to get from the FDA because remember, we've met with them all along the way. They've been in line with our thinking. What we -- we want to show them the data from the pilot arm of the currently running trial that mirrors the Phase III as well as the repeatability, reproducibility and stability data because we're using those to set our benchmarks for what the objectives and endpoints will be in the Phase III in exact line with what they've recommended we do. But we need some numbers for that, right? So we're going to bring those to the table to the FDA. We're preparing -- even as we speak, we're setting up sites for the Phase III. So once we get that response from the FDA and all systems are go, then we'll start to engage the machinery at full operation to get that Phase III going.

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Unidentified Participant, [37]

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Okay. Now in the press release, it said that the funds that you've received from the recent financings and the accounts receivables would launch you into the next critical trials. How far do those funds launch you into the start of the RA P3? Do they get you into the start of the RA P3?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [38]

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Oh, yes. Yes, for sure. I mean I think that these funds -- and remember, things are going to change when the interim results come as well. So we'll adjust for that. But these funds, if everything else remains equal and the same, definitely get us into the Phase III and also probably get us the launch of the 32 as well. We're just working on the logistics on the 32. So that's something that we are going to push forward as well. I think that it gives us a very nice runway to get those things going without having to rely on anything else in the near term.

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [39]

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Yes. These trials -- this is Mike Rosol. These trials -- by the way, that's how you say my last name, Rosol. I'd like to ask how to say your last name, you call in all the time, and I appreciate it. And I don't know how to say your last name, but 1 second. We -- these trials may be less expensive than you think they are. We've mapped these out. And with everything else aside, I'm not going to give you the exact numbers, but they're significantly less than your typical clinical trial. And that's one of the beauties of kind of an imaging-based trial rather than a large-scale therapeutic trial. Anyway, how do you say your last name exactly, please?

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Unidentified Participant, [40]

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[Rickelle, Mike Rickelle].

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [41]

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Wow, that was not what I was doing. So thank you for that. All right. Mike, do you have another one?

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Unidentified Participant, [42]

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I try to fool people, so I can't ever be tracked down. Yes, I have just a couple more. I appreciate what you're sharing. You shared a little bit on the KS imaging trial being complete and your next steps. But one of the interest also is the KS therapeutic trial and the IND timing. That's been in the reports for quite a while. Are you still planning this year to go to the FDA for an IND on KS therapeutics or not? Or can you share that?

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [43]

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Yes, pre-IND meeting anyway. So the -- those data are actually very strong data. So we've continued those studies from the funding of that grant with UCSF. And as I mentioned in my notes here that, my scripted comments, we plan to be writing those up. We may actually be presenting those at an international meeting before too long. They're actually very exciting and so we think we're going to be in a good position to meet with the FDA. And yes, there's a lot going on with a small team, but I would like to go to the FDA before the end of the year with that, yes.

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Unidentified Participant, [44]

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Okay. I have 3 more questions, if you don't mind.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [45]

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Keep adding questions.

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Unidentified Participant, [46]

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Okay. But they kind of get into today's world a little bit. Has there been any further subjects injected in the Pretoria Ga-68 trial -- TB trial?

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [47]

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Yes. So the update there is, Mike Sathekge, and I'm really butchering his name. But anyway, that's how I'm going to say it. I'm sticking to it. He's a nuc med physician there who's running that investigator-initiated trial. He's done a handful of subjects. I think at last count, he had injected 7 subjects. And what he'd -- what his rolling conclusion was, based on those pilot data is that he wanted to increase the mass dose and potentially the radiolabel amount of Gallium-68 on these. And then, go forward and do more subjects. So that it could increase the signal. He'd also been working towards optimizing and we kibitzed with them. We didn't direct it because it's an IIS, but we gave him our thoughts as well, and he can do with them as he thinks. We gave him some ideas about maybe an optimal imaging window as well based on what he had shared with us. And so as far as I know, what he's been doing currently is he's writing up a revised protocol to change the mass dose, the radiolabel dose and maybe the imaging time to get an optimal imaging window and imaging material. And then, he'll go forward more with the pilot study. But that study is indeed progressing.

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Unidentified Participant, [48]

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Okay. The next to the last question evolves around viruses. And you've done a lot of work on the preclinical trials on Zika and Dengue. And you had some really good results on MT1002 and MT2002 in preclinical trials, which you were getting data together. Do you think with all of the concern with the coronavirus that there will be any grant funding available to help you push these forward? Or is that not in the offering?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [49]

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No, absolutely. There could be grant funding to push these forward and those preliminary data are very compelling in the leishmaniasis domain as well as in Dengue. But to be frank, we are prioritizing what we're putting our efforts forward on. And we don't want to -- I think maybe I wasn't here, but I think maybe there was a little bit of shiny object syndrome in the past, and we don't want to replicate that kind of history of the company. Since we are a small, lean and mean machine, we want to focus on the biggest targets where we think we can bring the biggest impact most rapidly, right? And then as we grow, we can expand out into these other areas. But indeed, there are compelling data in those domains. And it is something that we're monitoring not to use the -- there's a pun there somewhere with people being monitored for coronavirus. But we're, of course, aware of these things and the possible grant funding in these domains, so disease areas.

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Unidentified Participant, [50]

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Do you expect peaking in? I mean I know you're trying to be focused and I understand all that, but with grant funding, you obviously, you have to be able to obtain some third-party services to help. Do you anticipate any funding coming through on that? Or have you even applied for any?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [51]

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We have to talk about that in terms of applications because you're right. Once you get the money, you can involve third parties who might do a great majority of the actual physical work. But of course, it takes some intellectual input to get the grant, to get them funded. So we're trying to focus on the things we're focusing on for the reasons that I said. But again, it's not that it's thrown aside because there is some promise there, so we're going to keep looking at that.

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Unidentified Participant, [52]

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Okay. And the last question is a big tent -- the umbrella type question. And I think you get it all the times, Jed, when you go to these various conferences. Is there any pending competition to the Manocept platform that you know that is out there or that is pending?

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [53]

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Not that we've seen. And believe me, we have some very diligent shareholders and individuals on our team, I'm talking about you, who have been very aware of looking at that. I mean we look at everything out there. We're constantly really going through to find out if there's anything out there, and there really isn't anything out there. And so we're going to continue to push this product forward, obviously, so we are in the market. But as of now, there's really nothing else out there that can do what we do or is in testing. I think that what's always been interesting to me is, obviously, you see the different multiples. Although now, the way the market has been going, all the multiples are compressing. But you see the different multiples between diagnostic and therapeutic, but you also see another thing. You see a very, very large focus in the news today about diagnostic testing and how important it is and how important it is to stay ahead of that. I think that this really brings a focus back to companies like ours. And I'm not saying we have a coronavirus test because we don't. We're really focused on RA, not that we couldn't pick up the virus if we wanted to with our technology, but that's [slithering under] there. But there is a focus on diagnostic testing, especially in an area where things like pandemic outbreak cause massive stress to the health care system and anything that can possibly lower the cost burden to the system will be something that more and more will be not only embraced, but insisted upon.

And that's why we're really excited about the technology. That's why we're really pushing it. Would that invite other competitors into the market? Potentially. But there's nobody thankfully right now who has what we have. And that's why we are moving forward to really getting this to market. We keep on pushing the IP. Our team here, Dr. Ralph is constantly filing new IP to make sure that we protect all of our patents and enhance all of our patents, and that's something that we're going to continue to do. And so we are very excited about it. I mean, unfortunately, with what's been going on in the market and in the world, we hope and pray for everybody's safety. But it has once again brought a focus back on to the diagnostic space, which serves a very, very critical role in our health care system.

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [54]

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Yes. And Mike, this is Mike Rosol. I just wanted to -- go on, Mike. You go.

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Unidentified Participant, [55]

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No, I was just going to say, this big umbrella, this big tent focus on no pending competition mitigates, in my view, the fact that it may take a little longer to get all of your RA subjects tested. It may take longer to get a partner with a win-win. That is a real mitigating factor. So yes, everybody would like to partner faster. Everybody would like a win-win. Everybody likes the trial faster. We're all human and that's what we would like. But this is a real mitigating factor. And I think it's something that adds great value that's not recognized.

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Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc. - Chief Medical Officer [56]

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No, I think -- this is Mike Rosol. You're absolutely right, Mike. And what I was going to say is not only do Dave Ralph and I and Jed and others, like yourself, spend our nights scanning the literature in the world, looking for what else is going on in this domain. I can say, maybe you'll be interested in this, as part of these partnership discussions, particularly in the RA domain, we've had very high level people at very high level places and very smart people do a lot of their own due diligence. And they've asked us our thoughts on the competitive landscape and we've told them what we think. And none of them have come -- they've all said, again, unanimously, you're right. There's nothing on the horizon that does what your stuff does and not going to happen in any near term, if ever. So that's really encouraging. And we've heard that from these independent folks who have a reason to be critical, right? And they come back and say, there's nothing out there. So it inspires some confidence in us, but we're not -- we still won't sleep well anyway.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [57]

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Are there any other questions?

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Operator [58]

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There are no further questions at this time. And I would like to turn the floor back over to management for any closing remarks.

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Jed A. Latkin, Navidea Biopharmaceuticals, Inc. - CEO, COO, CFO & Director [59]

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Okay. Well, we just want to thank everybody for calling in. As always, if anybody has any other questions, they can always e-mail me or call at any time. And I just want to -- I look forward to speaking to you guys again in the very near future. Okay. Have a great day.

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Operator [60]

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This concludes today's teleconference. You may now disconnect your lines at this time. Thank you for your participation, and have a wonderful day.