U.S. Markets closed

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

Q4 2018 Navidea Biopharmaceuticals Inc Earnings Call

DUBLIN Mar 13, 2019 (Thomson StreetEvents) -- Edited Transcript of Navidea Biopharmaceuticals Inc earnings conference call or presentation Thursday, March 7, 2019 at 10:00:00pm GMT

TEXT version of Transcript

================================================================================

Corporate Participants

================================================================================

* Erika Gibson

Navidea Biopharmaceuticals, Inc - Director of Finance & Administration

* Jed A. Latkin

Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director

* Michael Stanley Rosol

Navidea Biopharmaceuticals, Inc - Chief Medical Officer

================================================================================

Conference Call Participants

================================================================================

* Caroline H. Palomeque

Maxim Group LLC, Research Division - Senior VP & Senior Biotechnology Analyst

================================================================================

Presentation

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

Greetings, and welcome to Navidea Biopharmaceuticals Fourth Quarter 2018 Earnings Conference Call and Business Update. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Jed Latkin.

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Thank you, Dana. Good afternoon, and welcome everyone to Navidea's Fourth Quarter 2018 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 2018, which ended on December 31, 2018, along with a discussion of goals and milestones for 2019. 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 Director of Finance and Administration, Erika Gibson; and our Chief Medical Officer, Dr. Mike Rosol.

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 the 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 clearance or approvals to distribute and market future products in the clinical IVD market; failure by the marketplace to accept the products and 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 our listing with the NYSE American Stock Exchange; inability to maintain effective internal control of our 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 any obligation to update its forward-looking statements to reflect future events or circumstances.

I want to start by saying that our comments this quarter, once again, will be relatively brief in comparison to previous quarters to allow for more time for Q&A at the end of the call.

Now I would like to turn to a recap of the quarter. Navidea had a productive fourth quarter but not as productive as the company would have liked. We advanced the business and our novel imaging pipeline by preparing to launch our clinical Phase IIb and Phase III trials for our rheumatoid arthritis diagnostic product. We feel confident that the trials that we have designed, should they be successful, could make this a go-to diagnostic in the $15 billion rheumatoid arthritis market. Rheumatoid arthritis is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population. If the product is successfully developed, approved and commercialized, we expect to play a major role in the management of rheumatoid arthritis patients worldwide. As we have said before, 5 of the top 10 selling drugs in the world are biologics used to treat RA and related diseases. These drugs are often not very effective, are extremely costly and have many toxic side effects.

Several companies have reached out to us, and we have had multiple partnership discussions regarding the potential use of tilmanocept in their trials to assist in predicting the effectiveness of available treatments.

This past quarter, we engaged in continuing dialogue with the FDA about the proposed trials. Unfortunately, the government shutdown slowed that process down. We expect to have some guidance from them very soon. We are working with the FDA on the exact trial design in order to maximize the utility of the label that we can achieve upon completion of the trials. It's of the utmost importance that we seek to maximize the value of the data generated in the upcoming trials so that we can get a robust approval that will not only be easily accepted by rheumatologists, but will also gain critical acceptance by insurance companies, so that our diagnostic product is reimbursed.

Furthermore, this data that we generate will help us in our discussions with potential partners and collaborators on the biomarker side. The stability data as well as the pathology data is crucial for us as we have never done these sorts of trials before.

Our accomplishments this quarter reflect the strength of our team and the potential of our pipeline of innovative diagnostics. I want to focus a bit on the previous point, the strength of our team.

This past quarter, the company did 3 key things on that front. We appointed 2 new independent members to the board, Kathy Rouan, a 30-year Glaxo veteran, who has been a very active participant in helping us plan our future trials and making introduction to other industry veterans; and Adam Cutler, an experienced CFO in the industry and an individual that has been working to assist me on the financial planning side. With these 2 members, Navidea has an active and majority independent board for the first time in many, many years. Claudine, Michael, Adam and Kathy have all been key contributors to our planning over the past several months. I am truly grateful for each of their contributions, hard work and dedication to seeing Navidea succeed.

What is also important to note is that we have really listened to what the shareholders had to say. And for 2019, our corporate goals are clear: get at least 1 partnership, 1 research collaboration and get all 3 parts of the RA trial started. I am pleased to announce that we are ready to launch the [3 31] trial as all the sites have been qualified and the imaging center has been engaged and the database is formed and ready to go. Now we just need to hear back from the FDA, so we can launch the trial.

On the management side, we are so pleased that Dr. Michael Rosol decided to join the team from Novartis. He brings a fresh perspective to the company. And as an imaging expert, we now have an individual whose whole career has been focused on imaging, which is something that the company has not had before.

In fact, let me turn the call over to Dr. Rosol now so he can give a brief overview of his experience and his plans for the team. Michael?

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Thanks, Jed. Hello, everyone. I'm happy to participate in today's call. I'm a long-time biomedical imaging scientist with experience in both academia and industry. I received training at the Boston University School of Medicine, MGH, Harvard and Mayo. I then went on to serve as faculty and Research Imaging Center Director at Children's Hospital Los Angeles, USC and the Medical University of South Carolina. Most recently, I was at Novartis, where I was first head of their translational imaging group and ran imaging in both pre-clinical and clinical trials in a variety of disease areas.

I joined Navidea in December of 2018 because I believe in the technology and the people. I do, of course, know about Lymphoseek already, and therefore, had some knowledge of the company's IP. I spent time face-to-face with Jed and on the phone with the board member and senior management and became convinced the company was headed in the right direction and was under the right leadership.

As for the technology, the tilmanocept platform offers great opportunities in both the diagnostic and therapeutic spaces. As you know, evidence continues to mount, demonstrating the critical roles macrophages play in human disease. And our IP and agents give us the ability to address these diseases to help in diagnosis, stratification and therapy, and so I'm excited to be here.

I can also say that I have found the team members here to be dedicated and passionate about the company, their work and the opportunity to help people. As you heard, we are ramping up to begin all 3 of our trials on RA this year, including the definitive Phase III. And we're optimistic that this will lead us to FDA approval. We are also in discussions with possible partners and collaborators in not only the RA space but in other disease areas as well.

Now I would like to turn the call back over to Jed. Jed?

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Okay. Before I hand the call over to Erika, I also want to take a moment to address the current disputes with Dr. Goldberg. As we had previously disclosed, Navidea, Macrophage Therapeutics and Dr. Goldberg entered into an agreement related to Dr. Goldberg's resignation from Navidea, which provided for payments and share issuances to Dr. Goldberg in Navidea and super voting stock in MT. Before definitive agreements were entered into, Dr. Goldberg represented that he had, without board or shareholder approval, created a wholly owned subsidiary of MT, transferred all of the assets of MT into that subsidiary and then issued himself stock in the subsidiary. Based on these actions, the board of Macrophage Therapeutics terminated Dr. Goldberg as CEO. On February 20, Macrophage commenced litigation in Delaware against Dr. Goldberg seeking damages, and a declaration of reported transactions conducted by Dr. Goldberg is void. On March 1, 2019, the Delaware Court indicated at a hearing that would enter a status quo order, which would preserve the status quo, meaning that all operations of MT and the newly created subsidiary would be conducted at the direction of the MT board.

Also on February 19, Navidea commenced an action in the Southern District of New York alleging claims against Dr. Goldberg under the August agreement and seeking a declaration that Navidea's performance under the August agreement is excused and that Navidea is entitled to terminate the August agreement as a result of Goldberg's actions.

Due to the current procedural status of these cases, we will not comment further on the pending litigations with Dr. Goldberg.

I would now like to turn the call over to Erika to go through some of the financial updates. Erika?

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Thank you, Jed. Our consolidated balance sheets and statements of operations have been reclassified as required by current accounting standards for all periods presented to reflect the line of business sold to Cardinal Health as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the period being disclosed.

Total revenues for the fourth quarter of 2018 were $119,000 compared to $395,000 in the same period of 2017. The decrease was primarily due to a reduction in grant revenue related to SBIR grant from the NIH supporting Manocept development. Total revenues for the full year of 2018 were $1.2 million compared to $1.8 million in 2017. The decrease was primarily due to a reduction in grant revenue, offset by increased license revenue related to the sublicense of NAV4694 to Meilleur. Revenue in both years included other revenue from our marketing partners in Europe and China related to development work performed at their request.

Research and development expenses for the fourth quarter of 2018 were $854,000 compared to $1.7 million in the same period of 2017. R&D expenses for the full year of 2018 were $4.2 million compared to $4.5 million in 2017. The decrease in both periods was primarily due to net decreases in Manocept development costs for clinical trials, coupled with decreased compensation costs resulting from headcount reduction.

Selling, general and administrative expenses for the fourth quarter of 2018 were $1.4 million compared to $2.2 million in the same period of 2017. SG&A expenses for the full year of 2018 were $7.7 million compared to $11.2 million during 2017. The net decrease in both periods was primarily due to decreased legal and professional services as well as decreased general office, insurance, depreciation, rent and travel expenses, offset by termination costs associated with the resignation of our former CEO in 2018.

Navidea's net loss attributable to common stockholders for the fourth quarter of 2018 was $3.2 million or $0.02 per share compared to a net loss attributable to common stockholders of $4.1 million or $0.03 per share for the same period in 2017. Navidea's net loss attributable to common stockholders for the full year of 2018 was $16.1 million or $0.09 per share compared to net income attributable to common stockholders of $74.9 million or $0.47 per share in 2017.

Navidea ended the fourth quarter of 2018 with $4.3 million in cash and investments.

With that, I'll turn the call back to Jed.

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Thank you, Erika. I just want to thank everybody for joining us this afternoon. And now I would like to open up the line for questions, please.

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) Our first question comes from the line of Caroline Palomeque with Maxim Group.

--------------------------------------------------------------------------------

Caroline H. Palomeque, Maxim Group LLC, Research Division - Senior VP & Senior Biotechnology Analyst [2]

--------------------------------------------------------------------------------

So I just wondered if you could add any color to the ongoing discussions on partnering your programs. And are you speaking mainly to large pharma or other biotech? And then I have a follow-up after.

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Thank you, Caroline. So we are having discussions with both large pharmas and other companies within our industry, the diagnostic space. And we are also actually having several discussions with universities as well. So there are many different fronts that we're looking at, different companies are potentially looking to our product to use for different things, some in their trial development; other in initial-stage developments to see the effectiveness of a molecule; and then obviously in terms of RA, the potential to partner as we go forward with the trials.

--------------------------------------------------------------------------------

Caroline H. Palomeque, Maxim Group LLC, Research Division - Senior VP & Senior Biotechnology Analyst [4]

--------------------------------------------------------------------------------

Okay. And is that RA Phase III trial still on track to initiate in the first quarter?

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [5]

--------------------------------------------------------------------------------

Also, the idea is that the first part -- so there are going to be 3 parts to the trial. The first part is on track to begin in the first quarter, yes.

--------------------------------------------------------------------------------

Caroline H. Palomeque, Maxim Group LLC, Research Division - Senior VP & Senior Biotechnology Analyst [6]

--------------------------------------------------------------------------------

Okay. Great. And then -- so just my last question. Just can you talk about the data that you're generating in the neurodegenerative CNS space? Are there certain biomarkers that you're looking for?

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [7]

--------------------------------------------------------------------------------

Well, currently, part of the -- what we're looking at on the therapeutic side is actually in individuals that already have a diminished blood-brain barrier. So that's where we're looking at with the project with Krabbe disease, for instance, that was being done at the University of Connecticut. In terms of the diagnostic side, we are waiting to see if we have any transport through the blood-brain barrier, and we're going to get more of that data from the cardiovascular trial that we're running at Mass General Harvard with Dr. Grinspoon.

--------------------------------------------------------------------------------

Operator [8]

--------------------------------------------------------------------------------

Our next question comes from the line of [Jacob Novawitz], a private investor.

--------------------------------------------------------------------------------

Unidentified Participant, [9]

--------------------------------------------------------------------------------

Regarding the New York Stock Exchange continued listing requirement, I was noticing on the report that you just came out. It says March 31 it was extended to. What can you tell me about our plan for that?

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [10]

--------------------------------------------------------------------------------

So we need to, prior to March 31, get the 20-day average trading volume of the stock above $0.20 or we would have to do a reverse split prior to that date.

--------------------------------------------------------------------------------

Unidentified Participant, [11]

--------------------------------------------------------------------------------

Okay. And then my second question relates to the cash burn rate. So if we had $4.3 million as of December 31, and according to the fourth quarter, we spent about $2.2 million. We spent $854,000 on R&D and $1.4 million in SG&A, how are we going to -- how much longer can we survive on the cash that we have left?

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [12]

--------------------------------------------------------------------------------

So we do have -- we still have runway for the next several quarters, I would say. And what we are looking at is other potential financing options and also in discussions with potential partners to be able to bring in upfront payments on that as well. So we are exploring all options with that right now.

--------------------------------------------------------------------------------

Operator [13]

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Unidentified Participant, [14]

--------------------------------------------------------------------------------

Jed, I do appreciate your dedication. I don't think there's anybody who does understand how dedicated you are. So speaking for myself and I hope many, we do appreciate your dedication. I have several questions here. The financial ones were already answered, so I will try to stick with the -- so I'll be focusing on the more technical ones. You mentioned that you had applied for several clinical study fund grants. Have you got any update on that yet?

--------------------------------------------------------------------------------

Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc - Chief Medical Officer [15]

--------------------------------------------------------------------------------

Yes. So this is Mike Rosol. We have a grant currently under review with collaborators and academia in the cardiovascular space. So that's the current one. There will be a couple more that will be submitted in the next couple of quarters, I can say.

--------------------------------------------------------------------------------

Unidentified Participant, [16]

--------------------------------------------------------------------------------

So right now you have 1 grant -- I mean, proposal working, as I understand?

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [17]

--------------------------------------------------------------------------------

Well, we currently have 2 grants in the KS space. And then we've submitted a number of grants, and we are working on some more to submit for the next deadline.

--------------------------------------------------------------------------------

Unidentified Participant, [18]

--------------------------------------------------------------------------------

Okay. On biomarkers, you had 2 separate initiatives going on. One was with the FDA, you had qualified. And the other one was trying to pursue biomarkers with the clinical studies in the commercial environment. You've talked a little bit about RA. Are there any others that are progressing, particularly the FDA qualification?

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Well, we've continued with that FDA program. It got away a little bit because of the shutdown. But we've had those calls, and we are continuing along that path. But that is a regular, I would say, every few weeks to a month, we have that. We continue to move that ball across the goal line, and I would expect that we will have more visibility on that over the next upcoming quarters. In terms of using in other areas, we had several meetings at the end of last quarter and the beginning of this quarter potentially for using this in other indications, other than in RA, mainly imaging the tumor microenvironment is something that people seem to be very interested in. So that is an area that we'd like to focus on.

--------------------------------------------------------------------------------

Unidentified Participant, [20]

--------------------------------------------------------------------------------

Okay. On the Krabbe and the twitcher mouse state, you were expecting some results on the twitcher mouse state. Have you received any of those yet?

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

When -- as soon as we receive that data and we can sort of evaluate it, we'll make that known to The Street. That is still pending. I mean, that's a very intricate -- the mice have to breathe. You have to get ones that live when they're born so it's not that easy. So we are still working on that. We continue to move forward, and we're hoping to get some more data. We've had some good data so far, but we'd like to get more. So we need to have it in a more robust setting, not just a few mice but we'd like to have from quite a few, so that way we could decide whether or not to take the next steps or not. But the early indications are positive.

--------------------------------------------------------------------------------

Unidentified Participant, [22]

--------------------------------------------------------------------------------

Okay. That's great. Can you give a little more update on both KS studies, the imaging clinical study and the preclinical study -- the preclinical therapeutic study?

--------------------------------------------------------------------------------

Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc - Chief Medical Officer [23]

--------------------------------------------------------------------------------

Sure. Yes. So both these studies are still ongoing. The -- in the imaging, we've had some early results that we're evaluating. And we've done a slight modification to the protocol to take advantage of some of the learnings early on, so we're pushing forward with that. Similarly, in the preclinical space, progress is being made on that grant as well.

--------------------------------------------------------------------------------

Unidentified Participant, [24]

--------------------------------------------------------------------------------

Originally, you were targeting end of this year, next year to have the preclinical work done, so you can file an IND. Is that -- I know you have cash burn issues. But are you still progressing towards the target this year or next year on the preclinical Krabbe therapeutic?

--------------------------------------------------------------------------------

Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc - Chief Medical Officer [25]

--------------------------------------------------------------------------------

So that was a -- you threw in the Krabbe at the end there. So I don't know what you're saying.

--------------------------------------------------------------------------------

Unidentified Participant, [26]

--------------------------------------------------------------------------------

I'm sorry, I meant KS. Sorry.

--------------------------------------------------------------------------------

Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc - Chief Medical Officer [27]

--------------------------------------------------------------------------------

Yes, yes. Yes, we're on track with that in the preclinical space. I think that's a reasonable -- it's reasonable still. Absolutely.

--------------------------------------------------------------------------------

Unidentified Participant, [28]

--------------------------------------------------------------------------------

All right. On cardiovascular with Dr. Grinspoon at the Massachusetts General, you have 2 ongoing studies there. Last time, you mentioned they were making some progress. Is there a progress accelerated on those 2 studies or still at the same pace?

--------------------------------------------------------------------------------

Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc - Chief Medical Officer [29]

--------------------------------------------------------------------------------

Yes. So just to clarify, it's one study ongoing now. There was a Phase I study that was completed, and that set up the Phase II study that is currently ongoing. And so there has been progress made even in the last -- in this quarter. And we're actually hoping to speak with him soon to get a further update on what's been happening more recently. But I can say that we have seen progress there as well.

--------------------------------------------------------------------------------

Unidentified Participant, [30]

--------------------------------------------------------------------------------

When is the Phase II study on exactly then? I mean, he had 2 ongoing studies there, one on the application of tilmanocept for imaging macrophage-specific inflammation, and you have one using Manocept for imaging arterial inflammation? Which one is in Phase II?

--------------------------------------------------------------------------------

Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc - Chief Medical Officer [31]

--------------------------------------------------------------------------------

Yes. So right now, it's a -- so originally, the Phase I kind of proof of concept was subcu. And what we're doing now is an IV study, right? So the idea behind why you would do that is the -- we have FDA, EMA approval for Lymphoseek to be subcutaneously injected. So that's our first proof of concept typically. What we've done is we've gotten permission from the FDA to do human studies on a variety of disease indications where we use the IV route of administration. So why would you do that? So you might -- maybe it's transparent to most of you. But if you do an IV route of administration, you can kind of get a bolus effect, right? You could do a fast injection right into the bloodstream and your stuff can go where it needs to go more rapidly with the general idea that you will -- you hope to see a similar distribution. And you would note there's no reason why we'd expect a different one overall, but the localization may be greater because it got this kind of bolus effect. So that's the general principle, and now we're starting -- we're not starting, we are doing these IV studies with -- or he's is doing them, and we're getting updates from him.

--------------------------------------------------------------------------------

Unidentified Participant, [32]

--------------------------------------------------------------------------------

And that's essentially a Phase II, you said?

--------------------------------------------------------------------------------

Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc - Chief Medical Officer [33]

--------------------------------------------------------------------------------

Yes.

--------------------------------------------------------------------------------

Unidentified Participant, [34]

--------------------------------------------------------------------------------

Okay. That was the very original one you started in a couple of years or so go. Is that, that one?

--------------------------------------------------------------------------------

Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc - Chief Medical Officer [35]

--------------------------------------------------------------------------------

It depends on what you mean. So the first one, again, was the subcu, and then there's the IV. And so that one -- the IV one -- yes, I mean, it's ongoing, yes.

--------------------------------------------------------------------------------

Unidentified Participant, [36]

--------------------------------------------------------------------------------

Okay. The other one he was doing was the one that was called the application of tilmanocept for imaging macrophage-specific inflammation. Are they still progressing on that?

--------------------------------------------------------------------------------

Michael Stanley Rosol, Navidea Biopharmaceuticals, Inc - Chief Medical Officer [37]

--------------------------------------------------------------------------------

Yes. Yes, that was the subcu one. Yes. So some of these titles get so kind of lofty that you have to dive into the details to see what they are, yes.

--------------------------------------------------------------------------------

Unidentified Participant, [38]

--------------------------------------------------------------------------------

Okay. So it's fair to say that there is one ongoing now, looking both at that inflammation -- and both are -- or it's rolled into one now that's the IV injection?

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

Yes. It's a natural projection, right? So we started with the SC, subcutaneous injection proof of concept, and that's the Phase I. And now you look at that, you see if there's any promise, you see if anything bad happens and nothing did, and it showed promise so you move into the IV. So that's where we are.

--------------------------------------------------------------------------------

Unidentified Participant, [40]

--------------------------------------------------------------------------------

Okay. And one question. This one may be for you, Jed. In the agreement that you had with Michael Goldberg and the MT were funding several people in MT. And one was a lady named -- I'm going to murder this, I'm sure, Nai Fang Wang. What is she working on -- or he?

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [41]

--------------------------------------------------------------------------------

Nai Fang is a he, and he was working on various tests for RA and other inflammatory conditions on the therapeutic side.

--------------------------------------------------------------------------------

Unidentified Participant, [42]

--------------------------------------------------------------------------------

Okay. So it wasn't oral or anything like that?

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [43]

--------------------------------------------------------------------------------

The oral was part of that. But that is -- that was part of it, but the testing so far has been in other areas, RA and other inflammatory indicators and autoimmune.

--------------------------------------------------------------------------------

Operator [44]

--------------------------------------------------------------------------------

Our next question comes from the line of [Joe Ski], a private investor.

--------------------------------------------------------------------------------

Unidentified Participant, [45]

--------------------------------------------------------------------------------

Jed, I was wondering where are we with CRG.

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [46]

--------------------------------------------------------------------------------

That's a good question. So we have a conference in front of the Ohio judge on March 29. And at that conference, both sides are going to produce documents related to our allegation that they took $4.2 million too much. We've presented to the judge, Judge Engelhart in Texas' decision, which in our opinion clearly shows that they overdrew on the letter of credit by $4.2 million. And so we are seeking at that conference on the 29th to see where the money has gone, so we can further buttress our case against them and get our $4.2 million back.

--------------------------------------------------------------------------------

Unidentified Participant, [47]

--------------------------------------------------------------------------------

Are they trying to mediate with you?

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [48]

--------------------------------------------------------------------------------

They have not responded to repeated attempts for mediation.

--------------------------------------------------------------------------------

Unidentified Participant, [49]

--------------------------------------------------------------------------------

Right, right. Okay. And anything on the Lymphoseek with Cardinal? Any payments?

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [50]

--------------------------------------------------------------------------------

Well, the payments have ceased because we settled with them at -- in the middle of last year to get the advancement of the final bunch of guaranteed payments. And they have not tripped any of the milestones yet, which would get more payments. But none of those milestones have been crossed yet.

--------------------------------------------------------------------------------

Operator [51]

--------------------------------------------------------------------------------

Our next question comes from the line of [Chris Moretti] with [Elite].

--------------------------------------------------------------------------------

Unidentified Participant, [52]

--------------------------------------------------------------------------------

Jed, I wanted to see if you might go into a little bit more detail on what the plan is with regards to the New York Stock Exchange that might be coming up on the 31st, if there's any plan, anything that's going to offset or disrupt this. Or I mean, are we basically heading for a reverse split?

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

[Chris], that's a very good question. I mean, I think given that we have to get the average price above the $0.20 level, we are probably headed towards a reverse split. The board has to meet on that in the next several days to set a potential date for that. But we are also still awaiting to hear if we get earlier news from the FDA, then make that announcement and see what would happen to the stock. But the plan is probably to trend back the reverse split prior to the end of the month, yes.

--------------------------------------------------------------------------------

Unidentified Participant, [54]

--------------------------------------------------------------------------------

And do we know what that number is? Or what the proposal is?

--------------------------------------------------------------------------------

Jed A. Latkin, Navidea Biopharmaceuticals, Inc - CEO, COO, CFO, Secretary, Treasurer & Director [55]

--------------------------------------------------------------------------------

The proposal, as approved last year, was for a minimal of 5:1 and a maximum of 20:1. So it would be somewhere in between those 2.

--------------------------------------------------------------------------------

Operator [56]

--------------------------------------------------------------------------------

Ladies and gentlemen, we have reached the end of the question-and-answer session. And I would like to turn the call back to Jed Latkin for closing remarks.

--------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------

I just wanted to thank everybody for tuning in to the call today. I really am looking forward to the next several quarters. We have a lot of exciting things going on. And hopefully, we will be speaking again very soon. Thanks a lot.

--------------------------------------------------------------------------------

Operator [58]

--------------------------------------------------------------------------------

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.