Navidea Biopharmaceuticals Inc. (NYSEMKT:NAVB) Q3 2018 Earnings Conference Call November 7, 2018 4:30 PM ET
Jed Latkin – Chief Executive Officer, Chief Financial Officer and Chief Operating Officer
Erika Gibson – Director of Finance and Administration
Michael Diana – Maxim Group
Rufus Carlson – Private Investor
Joe Pelican – Private Investor
Mike Rigali – Private Investor
Rob Bookbinder – National Securities
Jacob Notowitz – Private Investor
This call will cover Navidea’s Financial and Operating Results for the Third Quarter 2018, which ended on September 30, 2018, along with the discussion on the goals and milestones for the rest of 2018 and into 2019. Following our prepared remarks, we will open up the conference call to question-and-answer session.
With me today is also our Director of Finance and Administration, Erika Gibson. Before we begin the formal remarks, I just want 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 concern 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, optimizing, 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, rheumatoid arthritis and other diseases.
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 IVD market; a failure by the marketplace to accept the products in the Company’s development pipeline or any other diagnostic products the Company might develop; the Company will face fierce competition and the Company’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; 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 be relatively brief in comparison to previous quarters to allow for more time for Q&A at the end of the call.
Now, let’s just do a quick recap of the quarter and a bit of an update going forward. Navidea had a productive third quarter as we advance the business on our novel imaging pipeline. Importantly, we gained recognition from the scientific and medical communities. First, we gain acceptance into the National Institute of Health Commercialization Accelerator Program, CAP. CAP is highly selective program and designed to facilitate and accelerate the commercial success of SBIR funded commercialization projects.
Navidea will participate in CAP for nine months, beginning in October of 2018, during which the program will provide tactical support for Navidea’s rheumatoid arthritis imaging related commercialization initiative. We anticipate that this program will facilitate the establishment of contacts between Navidea and potential corporate collaborators and partners as well as between Navidea and potential investors.
In fact, we have already had the first of these meetings and it was quite productive. We have been setup with our program coordinator and we’re in the process of refining our pitch with her in order to reach the widest set of potential partners. Each time we meet with her, we will further drill down on our golden objectives for the future.
In addition, we presented encouraging data on technetium 99 tilmanocept, the first product developed and commercialized by the company based on the Manocept platform at the American College of Rheumatology Annual Meeting. The results presented were from two completed trials. The data support the need for further studies to examine the correlation of tilmanocept uptake with CD206 positive synovial macrophages over time, which may provide valuable clinically significant insight into the ability to quantitatively monitor treatment response.
RA 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, we expect to play a major role in the management of worldwide RA patients. As we’ve said before, five 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 or extremely costly and many have toxic side effects.
This past quarter, we met with the FDA to discuss the rheumatoid arthritis and activated macrophage data as well as next steps for the program. 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 is properly labeled and reimbursed.
I want to stress that going forward as I’m CEO of the Company, we will not dwell upon past discussions or past items. Will I will say is that going forward, we are going to examine every single step to make sure that everything is done correctly on this launch. We want to assure that we have the right partners lined up, the right reimbursement setup and also as wider distribution as possible to an order to really capitalize on what we feel is a very critical unmet need in the market.
Our accomplishments this quarter reflect the strength of our team and the potential of our pipeline of innovative diagnostics. Further, the acceptance into the NIH’s program in addition to a $3 million private placement by a long-term investor provides us with assistance to advance our RA program and product portfolio. I am pleased with our progress and look forward to a strong finish to the year.
Before I hand the call over to Erika, I want to briefly discuss Fred Cope’s exit from Navidea. Approximately, three and a half weeks ago, Dr. Cope was put on administrative lead by the company. Dr. Cope and resigned from his position after the company identified certain issues relating to his conduct and his performance.
These issues are still being discussed and the lawyers who advise us that we are not able to discuss particulars that disjuncture. His departure will not have a material impact on our business development, because Macrophage will be pursuing the therapeutic indications under their new management at MT. and the diagnostic applications will continue to be developed under the current clinical and regulatory team. We have just recently started discussions with several promising individuals, who can assist the team in that area as well, and I would expect some announcements on that front over the next several months.
I would now like to turn the call over to Erika GIbson to discuss the financials for the third quarter of 2018. Erika?
Thank you, Jed. Our consolidated balance sheet 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 periods being disclosed.
Total revenues for the third quarter of 2018 were $231,000 compared to $224,000 in the third quarter of 2017. The increase was primarily due royalty revenue related to our license agreement with SpePharm in Europe, coupled with license revenue for activities related to the sublicense of NAV4694 to Meilleur Technologies and the sublicense of Tc99m tilmanocept to Sinotau. No royalty revenue or license revenue was recognized during the third quarter of 2017.
Total revenues for the first nine months of 2018 were $1.1 million compared to $1.4 million for the same period in 2017. Revenue for the nine months included the royalty and license revenue mentioned earlier, as well as grant revenue, primarily related to SBIR grants from the NIH supporting Manocept development. Other revenue for the first nine months of 2018 was from our marketing partners in Europe and China related to development work performed at their request.
Research and development expenses for the third quarter of 2018 were $1.2 compared to $875,000 in the third quarter of 2017. R&D expenses for the first nine months of 2018 were $3.4 million compared to $2.8 million during the same period in 2017. The increase in both periods was primarily due to net increases in drug project expenses related to increased therapeutics development costs from research consulting, regulatory consulting, and preclinical testing.
Selling, general and administrative expenses for the third quarter of 2018 were $2.7 million, compared to $1.7 million in the third quarter of 2017. The net increase was primarily due to increased compensation including incentive-based awards as well as termination costs associated with the resignation of our former CEO. SG&A expenses for the first nine months of 2018 were $6.3 million, compared to $9 million during the same period in 2017. The net decrease was primarily due to decreased legal and professional services, as well as decreased general office, insurance, rent, and travel expenses.
Navidea’s net loss attributable to common stockholders for the quarter ended September 30, 2018 was $3.8 million, or $0.02 per share, compared to a net loss attributable to common stockholders of $1.4 million, or $0.01 per share, for the same period in 2017. Navidea’s net loss attributable to common stockholders for the nine-month period ended September 30, 2018 was $13 million, or $0.08 per share, compared to net income attributable to common stockholders of $79 million, or $0.49 per share, for the same period in 2017. Navidea ended the third quarter of 2018 with $6.5 million in cash and investments.
With that, I’ll turn the call back to Jed.
Thank you, Erika. So now I just want to thank everybody for joining us on the call. And I wanted to open it up for questions. Doug, you can start getting the queue ready.
Thank you. Ladies and gentlemen, we will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Jason McCarthy with Maxim Group. Please proceed with your question.
Hi, Michael Diana on for Jason. Thanks for taking my question. So, Lymphoseek, which was based on the same technology as your pipeline and RA and NASH was purchased by Cardinal Health for around $80 million. I was wondering if you could talk about the difference in market sizes between sentinel node biopsy and your current pipeline indications like RA and NASH.
That’s a great question. So we feel that, I mean, let’s take them individually. NASH is something that’s going to be a little bit harder to quantify. We think that the potential market could be very big. However, for NASH, you really going to need a some sort of change, a therapeutic out there that has changed similar to the market for an Alzheimer’s traits are, as you know, the NAV4694 product, which we’ve outlicensed. It’s a great bit amyloid tracer, but there’s unfortunately no therapeutic that treats that area.
So for the NASH diagnostic to be something very big potentially in the future, we would really need a therapeutic out there to get approved and then we would seek to potentially look to partner that imaging agent, for something that they might be able to use as a companion diagnostic to what any NASH product.
On the RA side, that’s really a much clearer path forward. We’ve estimated that the overall market for RA diagnostic is probably approximately $5 billion. Given that the other the therapeutics in there and you have the DMARDs, just the anti-inflammatories and then you move on to the biologics, the anti-TNFs, and then all the other methods of actions, the ILs, the PDs, et cetera. That is a massive multibillion – multi-hundred billion dollar market.
And we think that in our discussions with rheumatologists, especially at the ACR a few weeks ago, there is an unmet need where just using the DA score, which is squeezing a knuckle and seeing on a pain scale of 1 to 10, how it feels. Our imaging agent could be a potential paradigm shift. Where you would image of patient on the way in, you would be assessed a score that would be read by a proprietary algorithm. And then going forward, we would monitor your treatment depending on how severe the patient is, 3 months, 6 months, 12 months, and then that would go back to the central imaging lab and there will be a processing of the score.
So you’d be able to see is there a real change from timeframe to timeframe based on the treatment. And if there’s no change or if it’s getting worse, then you would possibly consider another treatment. And these are all the discussions that we’re currently having with the FDA to work on getting that as part of the label when we get this product approved. So we do feel that unlike sentinel lymph node mapping, which in a best case scenario was going to be a maybe $100 million or $200 million market, a one and done market also. This is something that will be a, you get them on the way in and it’s a continual monitoring agent.
So this is the kind of thing that you really want to have, because it’s going to establish a baseline and then you will continually get treatments over time. There will be those similar to a blood test, you would be imaged, whenever you went to see a rheumatologist, you would get an image and that’d be – something that’d be a continuing source of revenue for the company. So we’re looking at this potentially not necessarily for the product, but we feel that the overall market for the RA diagnostics is around 5 billion globally for the year – per year.
Okay. Yes, thank you. And then just one more going over to the technology side, like if you go into a little more detail on how macrophage targeting enables Tc99m tilmanocept to be such a potentially versatile diagnostic tool. I know you talked a little bit about NASH, but particularly in NASH as we see that space evolve and move towards therapeutics in there.
Well, I think its once again, that is a good question. As we’ve said in our presentations, our ability to target the CD206 with a binding affinity, multiples greater than any other product out there. I mean, you’re looking at binding affinities 10 to the minus 9 as great as 10 to the minus 11 or 10 to the minus 13. We feel that we can use this in many different areas. As our Phase 1 in cardiovascular showed and now we’re doing a Phase 2 in cardiovascular. We can detect the earliest forms of plat formation using our subcu administration.
So we feel that in cardio, for instance, we’ll be able to spot inflammation in the heart and be able to give it a score before you can even see the earliest forms of soft plaque impinging upon the vessel wall. Similar with rheumatoid arthritis, if you look at our presentation, which is on the web, you can see how we can target the knuckle, the joint, the toe, the ankle. You can see areas where there is inflammation and is an inflammation and so it really opens us up to limitless possibilities.
That being said, I need to stress for everybody on the phone call that we are laser focused on getting the RA product to market. There are many uses of our molecule. We’re very excited about it in the long-term, but we are going to focus on getting RA to market and then everything else will come after that. It is important that we follow the steps as we’re outlining with the FDA. Start the trial, do the different arms of the trial and get to commercialization, before we really start to do everything else, because we need to show people that we’re going to succeed with RA and then move to a different indication thereafter.
Okay. Thank you very much, very helpful.
Thank you. Okay, next question.
Our next question comes from the line of Rufus Carlson, a Private Investor. Please proceed with your question.
Yes. Yes, good afternoon. We don’t usually get into many details regarding our international Lymphoseek sales, but where the results are good news or bad news, could you specify as to the results to-date and the forecasts?
Rufus, that’s a very good question. I was actually just meeting with our European partner yesterday, actually two days ago. And the project is coming along there. I think that the best market so far has been staying. There’s been quite a few doses given there. I think that it is starting to gain traction. I would not expect the European market to be a source of any really big revenues in the near-term. I do think that they are starting to see traction.
Unfortunately Norgine doesn’t publish their projections. I see their projections, but we’re not at liberty to disclose them. I do think there’ll be significantly greater than the $9,000 we’ve seen so far. So I do expect a multiple of that for next year based on their projection, a nice multiple of that.
But I can’t give a projection on that. I will say this. One of the good things to report is we are moving rapidly with both India and China on the approval process there. So I do expect to one get milestones from India within the next 6 months to 12 months. And I would expect within the next 12 months to start seeing some milestones from China. And hopefully within two years, we’re going to start seeing the sales in India. And then depending on the CFDA, we could see sales in China within 2.5 years to 3 years.
And our Chinese partners is – has robust projections for China. But I’m going to take a wait and see approach on that. We are currently having discussions with other countries. And we’ll continue to make announcements as we reach deals. I mean I actively, we had sales in the Middle East for instance, but that’s the sales there are so small, that I just didn’t see the upside in selling a few doses versus the risk of if something went wrong, something administered it. So we’re really only going to look to partner in areas where we could see significant dosages. And that’s in the order of 2,000, 3,000, and more per year.
Okay. Well, thank you very much.
I appreciate that, Rufus.
Our next question comes from the line of Joe Pelican from a Private Investor. Please proceed with your question.
Hey, how are you there, Jed?
Good, very good.
Quick question for you. Just want to know how as if you can give us all like an elevator pitch of what Navidea’s investor presentation, investor strategy is and if it’s changed from what it was in the last administration?
Well, that’s a good question, Joe. So since I took over a fulltime as CEO in August, we’ve had over 50 one on one meetings with both investors and partners. We are currently in partnership actually with our Chairman of the Board, Michael Rice working on a whole new IR rollout, which will be put together over the next several weeks. And that will include a more aggressive approach to presenting to retail investors, family offices, first, and then eventually moving to institutional investors.
I think that for the size that we’re at right now, the retail and family office or our main focuses. We’ve actually had several meetings with family offices that did start buying the stock. I mean I think you saw a few weeks ago there was increased volume in the stock. And we feel pretty strongly that that was from some of the meetings that we had just about a month and a half ago when we were doing a road show in a couple of cities on the East Coast.
We’re going to continue to push that will be at the – we’ll be presenting at a couple conferences before the end of the year. And then we’re really going to hopefully, if we have what I think will have in terms of the sign off on the program for the RA, really get aggressive from January as we seek to do a partnership on the RA program and in conjunction with that, look to really get aggressive with our investor meetings.
Okay. And on a follow-up to that, I mean MT obviously needs a venture capital partner in order to fund going forward, has there been any progress on that or is there anything you can talk about on the MT front?
I’d actually say that we’ve had a tremendous amount of meetings on the MT side over the last several weeks, which has been very, very positive. We’ve had actually more meetings over the last month or so than we’ve had in quite a while. And there is really a lot of interest in the product and that’s from the – let’s say from the pharmaceutical side.
On the investor side, we’ve had quite a few investor meetings as well. As we said before, these do take time. I think that obviously Dr. Goldberg and Joel Kaufman could really comment on it better, but we are waiting for some key results on the front that what we had discussed before on some of the stuff with our 2000 product and perhaps disease. So once we have those results, I do think that we’ll be able to start really marketing harder and bringing in a venture partner.
Okay. And lastly, if I may just on the CV, I know that the focus is on RA. Can you like build out what we’re looking at on a timeline for CV to get it through the Phase 2 and into the Phase 3? And what kind of a feedback have you been getting from Dr. Grinspoon and other investigators that are involved with it?
It’s an excellent question, Joe. And so, as you know, the CV study that we’re currently viewing, so the Phase 2, we’ll call it study is fully funded and the way we did it is we fully funded it giving a grant to the university. So that gives then we weigh and how long they take and how they recruit patients. They have recruited a few patients. We’ve had had some initial scans. I think we haven’t really had extensive discussions with them yet. I would anticipate that the timeline that we have on the web where we’ll have some tangible results within the next quarter or two should still be applicable. And what I would like to say is that in the discussions that we’ve had with pharmaceutical companies, I do know that there are waiting to see the full results from that trial.
So that way, they can know what we have and whether or not it’s something that they can partner on either use the biomarker or potentially partner on a Phase 3 trial. But I’m going to reserve what I say on that until we have more patients imaged and a real more thorough discussion with Dr. Grinspoon to know what’s going on with that. But the good thing about the CV is that it’s fully funded.
So when I said we’re going to really focus on RA, we are really focusing on RA. Dr. Grinspoon who has the funding, he’s going to focus on CV and we’ll complete that trial. But the main focus of our clinical team is to get the RA program to completion. I don’t want people to think that we’re taking our eye off the ball that we’re trying to do too much. I think that one of the things that is really going to be the mantra here is we are about to launch a very extensive, a very in-depth trial. And I don’t want it to be messed up. I want to make sure that we really hit the ball out of the park on this trial.
Thank you, Joe.
Our next question comes from the line of [indiscernible] with Navidea Biopharmaceuticals. Please proceed with your question.
Yeah. Hi Jed, thanks for your presentation today. And I was wondering if you had an idea of how far off establishment of a partnership or joint venture was for Navidea – talk a little bit in the past.
It’s a good question. I know this is something that’s been on top of everybody’s mind. I would say in the last month, we’ve had just multiple discussions with quite a few potential partners. We’re at, I would say a decently advanced stage with several, but unfortunately and I’m not saying unfortunately, in a bad way, I’m saying unfortunately its now in the hands of the company. We’ve made our presentation. We’re actually working hand in hand with one company right now, on a presentation to some fairly high up individuals.
I’m hoping that we’ll get a better sense from that company by the end of the year of where we are with them. We’ve had several second meetings with several other companies. I think that one of the catalysts will be, once we have a good sense from the FDA, what the actual trial design is going to be in the sign off. That will give us something tangible to go back to do some of the second and third meetings with some of the other companies out there. With this other particular company, this discussion has been very fruitful and hopefully, something will happen. I can’t guarantee that something will happen, but we’ve had very good discussions with this company.
Okay. And related to that is a which trial are you referring to when you’re talking about the interest by outside…
So the rheumatoid arthritis trial, so I think that getting the sign off from the FDA, which we are back and forth and back and forth. And it’s – we’re – I can’t talk more about it, because we’re still going back and forth with them, but getting the sign off will be a very big, very significant milestone in our history, because it’s going to give us our marching orders. We’re going to know exactly what we need to do. We’re in constant contact with the people we’re going to be running the trials and all the different sites. My ACR was not just filled with partnering meetings, but with meeting with the doctors and the individuals that are going to be running these sites.
And so we’re fully geared up and ready to go. We just have to get the final design lock down. As soon as that happens, we will make an announcement to the street that has happened. And then we’ll go full steam ahead.
Okay, great. Thanks very much.
Excellent. Thank you, Joseph.
Our next question comes from the line of Mike Rigali, a Private Investor. Please proceed with your question.
Yes, Jed. Thanks for taking the call. My question evolves around the second Grinspoon study, where he’s looking at CD206 and macrophages in a more general way in HIV patients. Earlier you talked about CV, do you have any comments on that second in Massachusetts Hospital study?
It’s a good question and it’s something that we are all anxiously anticipating. I don’t yet, because we haven’t gotten enough images. We have some preliminary image data. We need to see more before we can have a substantive discussion with Dr. Grinspoon. So we’re lining up the patients now, they’re doing the administration and when we get a significant number – a significant enough number of patients will have a more substantive discussions with Dr. Grinspoon and then we’ll be able to possibly present some of that data. But I couldn’t – I can’t say something for sure now until we have the data. And I don’t want to – Mike, I don’t want to promise something before it’s ready. I’m not going to – I can’t say that we’re going to have it, if we don’t have it yet. So as soon as we get it, I will be sure to share it with the street.
Right. If you read the research in the industry, it appears that the CD206 research is blossoming in many, many diseases. So it looks like the downstream from here is quite opportunistic. One question on the where we put your mouse data, is there anything else you can share on that?
So we’re still waiting for the next set of data from that. I can’t really discuss any more than that. I mean, we’re waiting on the next set of data. We’re in the process of delivering more of the molecule to the group in the University of Connecticut. We are continuing to fund that. That is continuing to move forward. But there’s no further update on that at this juncture. But we are moving in forward. It is very much on top. That is the number one priority for MT at this juncture.
Okay. And my last question, I appreciate you taking these. Is on grants funding – is there anything on the near term horizon in any more NIH funding?
So we – so the past deadline in August, we submitted for three grants, I believe, and we have a deadline – for the next set of grants and we are going to be submitting, I believe either two or three more. So we’ve submitted – there are a bunch that we’ve submitted one in conjunction with UCSD, and then we submitted one on the therapeutic side and we submitted another one on the diagnostic side.
So we have – I have to check when we’re going to hear back from that, but we have been fairly active with that. So we did, I will say in credit to my staff here in Dublin, while most people were taking the summers off, we were really putting in, burning the midnight oil to one get the grant submissions together and two get a 900 page FDA package together and out to the FDA in the middle of the summer, something which you just don’t see, we have a really small staff here. They’ve really spent a lot of hard work getting everything together and – so we’re going to – we’re hoping to get some positive news on the grants and we are going to be submitting some more in January, but we’re really, we’re really pushing it here. We really are.
All right, thanks. So that’s great information. Appreciate it.
Thank you, Mike.
Our next question comes from the line of Rob Bookbinder with National Securities. Please proceed with your question.
Yes. Hi, Jed, thanks for taking my call. Just on the RA, sounds like that’s what the focus is. What the back and forth with the FDA. Can you maybe draw a timeline for us, like a best case scenario, when you may envision you guys being able to go to trial, maybe the length of the trip, potential trial or anything, any, any sort of a bullet points for us to kind of drawn?
I mean, I appreciate the question. I think that whenever you’re dealing with the FDA, government organization, it’s hard to pinpoint a timeframe. Our ideal scenario is we’d like to have our marching orders and our – are really go ahead plan by the end of the year. I think that is achievable. I hope that’s achievable. I think obviously once the holidays start getting involved it gets a little bit hard, but we are going to be submitting over the next week or so, a full synopsis and our plan. And then it’s in their court, as to how quickly they get back to us.
So we’re doing everything we can on our side to get this done by the end of the year. I don’t want to make a promise that I can’t keep because similar to our court cases, you know, we’re hopeful on Ohio, but within the court’s hands. It’s timing of the same thing, with the FDA will get the synopsis into them, we’re going to get all the documents and the backup that they need. And then it’ll be up to them how quickly they can turn around and give us the sign off or come back with questions and then we can answer those questions. I am hoping for the end of the year.
So we’re going to make every possible effort to get this done by the end of the year, but in the end of the day, we do have to have the FDA cooperated. And so far they’ve been great. I mean, we’ve really – we had the meeting, they made great suggestions in the meeting. I think that, it couldn’t have gone any better in my opinion. And, I’m really excited about the potential. And hopefully, they’ll continue to be as cooperative and it’s helpful if they’ve been to this date.
So it goes, I’ve been really happy with how they treated the process so far. And they’re very excited about the product, because you look at it, one of the major cost to the healthcare system of these biologics. I mean, Humira is doing $20 billion a year, and it just doesn’t work most of the time. It’s somebody who was on Humira, I mean, it just doesn’t work all the time. I’m not on it anymore, because it just doesn’t work. They need an objective not a subjective, if they need an objective test out there, more accurate than Prometheus that, that will show whether or not the macrophage levels are going down. It is the inflammation going down. Is it time to switch treatments or stay on the same treatment, because it’s working.
We are on the verge of offering that to the market, we just have to show the value proposition, which we feel the FDA is very much in line with us on. And then they just have to sign off on it. But I couldn’t say, when they would do it or not, because once again, it’s up to them. I don’t control that timeline. But we are going to do our best on our side to get everything in as soon as they asked for it, if they ask us a question, we’re going to answer it right away.
Great, thank you.
Thank you. Rob.
Our next question comes from the line of Jacob Notowitz, a Private Investor. Please proceed with your question.
Yes. My question relates to the cash flow of Navidea. So once we do get approval of the trial for the RA. Does Navidea have enough funds on hand to cover the cost of the RA trial or is it going to be required to have a partnership to have that trial?
Jacob, that’s a great question. So we have enough funds to get the trial up and running. And then we would actively be seeking a partnership to bring in the funds to the completion. So we have what it takes to get it going, which is what we need. And then we’re going to seek funds to from a partnership to really bring it to its completion, because there are a few things that we’re going to need to do. I think they’re – once again I said I’m not going to dwell on the past. So I’m just going to look to the future. I think that we’re going to put in place some of the steps that we didn’t do with Lymphoseek with the RA trial and that will require money down the road, but we have enough to get the trial up and running and then we would seek partnership.
Do you have any idea, I mean, you must have an idea, but what the expenses are expected to be like the total cost of the trial over its lifetime.
I have a very extensive model down to the penny, but unfortunately it’s not something that we disclosed. There are very few companies out there ever disclosed what they spend on their trials. You’ll see it in R&D, that’ll be reflected in the income statement on R&D, but very few companies disclose what the trials cost. I will say this, we have several NDAs out there with companies, who have seen the budget as well. But it’s not something I’m going to disclose publicly. It’s a trade secret. My companies don’t willingly disclose what they’re spending per trial. We’ve really optimized it. We’ve gone back and forth and I can tell you had a lot of heated discussions over the model, but this is a massive file that is exceedingly detailed down to the patient test and everything. And so, we are really, really very focused on the cost on this. We’re not going to spend a dollar more than we need to. I do think that overall the trial is projected to be significantly less than what we spent on Lymphoseek, the approval for that. But, it’s not something I’m going to disclose to this juncture.
No problem. Thank you very much.
Thank you, Jacob.
Our next question comes from the line of [indiscernible] a Private Investor. Please proceed with your question.
Good afternoon. Thanks for taking my call. A couple of questions, so the first one, I guess kind of isn’t maybe an extension on the first call. If there isn’t any additional financing or outside investment. How long would you expect the company to be able to operate based upon his current asset?
So it’s a good question. I would anticipate that we have enough runway to go into the middle of next year, if nothing else changes. So if we don’t get any money from Ohio, which I’m not budgeting, if we don’t have a partnership, if we don’t get any other grants. So we have enough money to last us until the middle of next year. I think that we have a lot of options out there for bringing in financing that would be minimally dilutive, if we don’t get a partnership, but there – we do have the resources available to bring in to not have to do something massively dilutive, if we don’t want to. I think that, if there’s an opportunity to do a partnership, that is our first choice, that is something that we’re going to explore exhaustedly before we seek to do any other type of funding.
Okay, thank you. Second question is, so you’ve touched a lot upon different things that are going on within the organization and different things you’re working on. If you had to narrow down and say – narrow down into maybe two or three milestones. What would those be the type 2 or 3 milestones that you’re expecting to hit over the next three months?
Okay. So the sign off from the FDA is our top milestone. It’s not a foregone conclusion and never is until it’s done. And so I would say that’s a significant milestone, because it gives – we will have to present and this is what we’re doing a very expansive value proposition to the FDA. The FDA has seen that, we’re back and forth with them. So they’re – let’s say a quasi agreement on our trial design. So the – sort of the okay to our trial design would be a significant milestone. I think that launching off of that, a potential partnership or research agreement with a company would be a nice positive and that’s – I think that would be a big positive. I mean obviously that’d be a major positive. I mean if we can land a partnership based moving off of the FDA approval of the trial design, then that would be a real, a real nice positive for us. And then hopefully, some positive data on the cardiovascular side, so we’ll be having some more trials. I don’t think – I don’t know if that’ll be within three months, just because we’re entering the holiday season, so that might be a little bit into the first quarter or middle of first quarter of 2019. But the two major things I would look for or hopefully the FDA approval on the trial design, sort of their sign off on our go forward plan and then potentially a partnership or research agreement with a significant company.
Great. Thank you.
I also just wanted to interject as we had a question on the line that two things, one on the Tel Aviv Stock Exchange delisting and then also the New York Stock Exchange issues. So the Tel Aviv Stock Exchange, we decided as a board and accompany to delist from the exchange voluntarily. There’s significant cost to remaining listed on the Tel Aviv Stock Exchange and our volume there is de minimus at best. And it just the pros and cons of keeping a listing open and spending, tens of thousands of dollars a year and up, just weren’t in our view and the board’s view just not worth it. If our market cap grows, then the saying was if the market cap grows and maybe we’d get included in some indices in the Tel Aviv Stock Exchange. The investors that we’ve met with in Israel are just as willing to buy the stocks in the U.S. as they are on the Tel Aviv Exchange.
So I just didn’t see – we didn’t see the upside to keeping that open, especially given the exposure of being listed on another exchange, having to make sure your disclosures are launched the same time as the knife as they are on the Tel Aviv Exchange. It was just a lot of added expense for a very small company wasn’t needed. And also, I mean there is a history there in the Tel Aviv listing that sort of caps a little bit of a cloud on the company as well. It just wasn’t worth it for the upside. And the New York Stock Exchange, we have discussions with them on a constant basis, as we said, they accepted our plan. We are hoping that if we can consistently get our market cap above $50 million for two consecutive quarters, that will take care of all of our issues.
And that is really our aim. We have presented them an extensive plan, considering potential partnerships, other stuff, and we have to keep them updated on a quarterly basis. We do have calls with them quite frequently. But for now we are doing everything we can to stay in compliance with them. So we are – so far we’re on good footing on that. So I would say that, so for there we are well. I mean, we responded, we gave them a very, very detailed presentation, in fact, when we did the call, they were very thankful. They said that they have been from a small company, seen such a detailed plan before. So that was a nice positive. And then, Doug, are there any other questions in the queue?
There are no other questions in the queue. I’d like to hand it back to you for closing comments.
Okay, once again I want to thank everybody for calling in. As you know, we’re always available for further discussion. I really think that the next two quarters are going to be very exciting for both the Navidea and for Macrophage Therapeutics. And we’re really excited about the future and I just want to thank everybody for being shareholders and hopefully we will talk to you soon if not at the next conference, perhaps in the next investor Q&A that we’ll probably be doing in the next month or so. Thanks a lot everybody and have a great day.