Navidea Biopharmaceuticals, Inc.

Thank you, and thank you all for joining us for today's earning call. This call is being webcast live on our website, ir.nvidia.com, and a replay will be made available. Following prepared remarks, we will be conducting a live Q&A session. NVIDIA's Vice President of Finance and Administration, Erica Eves, will be joining me on the call today. During the course of this conference call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop NVIDIA's molecular diagnostics and immunotherapeutics, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters, as well as the impact of the COVID-19 pandemic on NVIDIA's business operations. All of these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions, risks, and uncertainties, and could cause actual results to differ materially. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events, or otherwise. Investors should read carefully the risks and uncertainties described within the Safe Harbor section of our website, as well as the risk factors included in the company's most recent quarterly and annual filing with the SEC. And now let's begin with our update. During the first quarter of 2022 and since, we have continued to work on financing for the company. We continue our engagement with multiple investment banks and options are being pursued. In terms of capital, Erica will cover the financials in detail, but we have the bridge loan funds we have received from the company's largest shareholder and vice chair of the board of directors, Mr. Kim Scott, as well as a small milestone payment due and another potential payment upcoming. This is all I can say at the current time, but be assured that we are working on this continually. We will provide you with updates as we are able to do so. Overall, we've made good progress on our Phase IIb trial in rheumatoid arthritis, comparing imaging to biopsy, and I hope you saw our press release several weeks ago highlighting the promising preliminary results and our ability to distinguish the fibroid pathotype from the non-fibroid in our first 11 evaluated patients. These strong early results support our hypotheses and provide great data in support of telmanisept imaging as a biomarker of CD206 expression in joints of patients with RA. We also continue to enroll into the RA Phase III and have recently opened up another site. Additionally, we are advancing our therapeutics and imaging applications through collaborative relationships with various well-known institutions and investigators across the globe, and we are growing and diligently maintaining the company's intellectual property. The team here works extremely hard and efficiently, and I'm very proud to be associated with this outstanding group of individuals. Senior management continues to work closely with the board of directors, and we are united in moving the company forward. As we've said in the recent past, there are many things we are working on behind the scenes, and we will provide you with updates as soon as we are able and as appropriate. Now I would like to provide more detail around the clinical updates. I'll begin with progress in our rheumatoid arthritis or RA program. So we continue to enroll into the Phase III trial in RA. We've reached double digits now in patient enrollment and have just recently opened up a third site. We've selected the first sites carefully based on our experience with them in our previous Phase IIb trial and we're happy to see that they've hit the ground running. The indications we're going for in RA are one, early prediction of treatment response to a new or first-time anti-TNF alpha therapy, and two, to identify patients with low level of localization who are less likely to respond to anti-TNF alpha therapy. As we have discussed previously, there is a large unmet need for a reliable early predictor of whether or not a therapy is working in a patient with RA. Because if a drug is not working, the patient's disease is not being treated, and this can lead to long-term health consequences along with unnecessary high drug costs for ineffective therapies that bring with them possible side effects. Our Phase III trial will establish the ability of telmanicept imaging to serve as an early predictor of treatment response in RA patients switching to an anti-TNF-alpha therapy, addressing that unmet medical need. Once we have funding in place, we can really hit the gas and open up many more sites that we have been lining up. In preparation for that, we have been and are negotiating site contracts with a large number of sites, and we have conducted literally dozens of site qualification visits to prepare the sites for opening. NAV 332, our comparison study of telmanisept imaging to joint biopsy, remains in active recruitment. As we've announced and discussed recently, The preliminary results of this trial were promising. Our aim is to recruit patients with each of the three pathotypes of RA to obtain comparative imaging and pathology results. And the trial is designed so that we enroll a minimum of four subjects in each of the three pathotypes of RA, the fibroid, the diffuse myeloid, and lymphomyeloid. So overall trial size has been expected to range between 12 and 24. To date, we have 11 patients who have had both their imaging and joint biopsies completed, another patient scheduled for imaging next week, and others in the queue. Out of the completed 11, we have seven fibroid, three diffuse myeloid, and one lymphomyeloid. Importantly, there is currently no way in advance to know what pathotype of RA a patient has other than via biopsy. So our enrollment is based on those who are willing and eligible to enroll. The primary objective of this study is to assess the relationship between joint-specific telmanicept uptake values and the pathobiology of RA-involved joints. Knowledge of an individual RA patient's pathotype may be clinically important because it may predict to which RA therapy a patient is likely to respond. There is a growing body of literature suggesting that those patients with the fibroid subtype of RA are much less responsive to the anti-TNF-alpha drugs than the other subtypes. And so a means of determining whether or not a patient has this particular pathotype is seen as extremely important to a number of key opinion leaders in rheumatology. As I just mentioned, as of this time, there is no reliable way of assessing the pathotype of a patient's RA other than by doing a biopsy. And we have hypothesized that telmanicept imaging could provide this information. So preliminary results on those first 11 patients indicate that telmanicept uptake in RA inflamed joints is able to discreetly differentiate patients with the fibroid pathotype, those who have low macrophage involvement, from those having either the diffuse myeloid or lymphomyeloid pathotypes of RA, those with higher macrophage involvement. So seven of the subjects had relatively low levels of telmanicept uptake. All seven of those subjects were found to have the fibroid pathotype, seven out of seven. Out of the remaining four subjects, three had the diffuse myeloid and one had the lymphomyeloid pathotypes. Those subjects with either the diffuse myeloid or lymphomyeloid pathotypes had, on average, more than three times the telmanicept uptake as the average subject with the fibroid pathotype. So all of those subjects had higher uptake than the fibroid patients. To date, we have been able to clearly classify patients then as either fibroid or non-fibroid based on our imaging results taken before the biopsy in all 11 cases. These data also provide support for one of our indications in the phase three trial, namely the ability to predict from a baseline scan alone whether a patient is likely to receive a meaningful clinical benefit from an anti-TNF-alpha therapy. Since, as I mentioned, there is increasing evidence that if a patient has the fibroid pathotype of RA, they are less likely to receive significant clinical benefit from anti-TNF-alpha therapy. You might recall that in our previously completed Phase IIb study that contained a pilot arm looking at the efficacy of telmanisept imaging at early prediction of treatment response, those patients who exhibited a low level of telmanisept uptake in their joints on their baseline scan had an almost 90% non-response rate to anti-TNF alpha therapy using the clinical gold standard assessments. Finally, these biopsy trials are notoriously slow recruiting, but in fact, our recruitment rate over our number of sites is several times faster than what our lead principal investigator indicated he would have expected. As usual, the clinical operations team here has done a great job at exceeding expectations. We have another patient scheduled, as I mentioned, for imaging next week, several more in screening or in discussions about screening over the next several weeks. We'll keep you posted on the progress. We continue to make very good progress on automating the image quantification as well, which will have significant benefit for the commercial product. We have the letter of intent and are working closely with MIM software on the full agreement for them to be our commercial partner for imaging quantification of telmanicept imaging in RA. Once again, MIM is a leading medical imaging software company based in Cleveland with a large footprint in the nuclear medicine space. They completed a pilot study using data from our trials demonstrating that they can develop a fully automated application that can robustly reproduce our quantitative imaging reads using our proprietary algorithm. This will be important for rollout of a commercial product. The ability to perform the quantitative reads rapidly and reproducibly and at large scale through automated means is critical to large-scale use of Tolmanisept for RA. Keep in mind that all of this, the image analysis methodology as well as the data upon which it is built, including the normative database you've heard us discuss before, is not only critical to deriving the most accurate and sensitive objective read of our RA images, but it also serves as a significant barrier to entry to possible competitors in this space. We'll continue to work with MIM to finalize terms of the partnership, and we'll make an announcement when we're done. There are many factors to consider as we work through the agreement, but our goal is to have it completed within the next couple of months. We also recently released the updated primary US market and secondary European market research valuation for the RA product if it is approved. That report is available on our website. The results of this analysis validate our assumptions regarding the great need for and potential value of our potential product in RA and include input from leading rheumatologists across the United States. The Jubilant MOU and exclusivity period are still in effect. As we have mentioned in the past, the completion of the NAV332 biopsy study is an important milestone for both us and Jubilant. I have been and continue to be in communication with their leadership and have been involved in these discussions since the beginning. We are keeping them up to date on the study progress and NAV 332 results. As we advance in our clinical program and as long as our data remains supportive of our hypotheses, not only are we de-risking the program and asset, but also increasing our value position. On the cardiovascular disease front, Work completed on the investigator-initiated atherosclerotic plaque imaging study at Mass General Hospital in Boston. The data are promising in terms of localization of telmanicept to sites of plaque and have been in line with what was reported in the pilot study we co-published with them several years ago. The group at MGH presented an abstract at an international conference in February and have submitted a manuscript based on the full study results. When that manuscript is accepted, we will let you know. On the preclinical therapeutic assets front, we are advancing our candidates in the oncology and anti-inflammatory spaces. Preclinical studies on Gallium-68 tilmanisept for PET imaging and related next-generation manisept imaging agents have progressed significantly through internal work at NVIDIA and through extramural collaborations with researchers at the University of Alabama, Birmingham, or UAB. We have completed work on our NIH-funded preclinical studies for evaluating gallium, tilmanisept, and various new imaging agents similar to tilmanisept in a mouse model of atherosclerosis. Work on another important set of preclinical imaging studies was completed, and an abstract has been accepted at an international meeting, and a manuscript has been submitted as well. This work looked at a new technology designed to increase the localization of our imaging agent to target tissues. while a second technology was designed to block off-target imaging agent localization to the liver, which is a major site of localization when telmanisept is administered by intravenous injection. These studies were very successful, showing that we can dramatically increase localization of a new telmanisept-like imaging agent to tumors while simultaneously and significantly blocking off-target localization to the liver. Additional work on new drug delivery constructs and new targeted payloads has also progressed. These new constructs carry new drug payloads that may be more effective than doxorubicin for beneficially altering the immune status of tumor macrophages, for example. Results in mouse models have demonstrated that when administered alone or in combination with another cancer drug, these therapeutic constructs significantly reduce the rate of tumor growth. Some of these results should soon be presented at a cancer therapeutics meeting as well. When we are allowed to release details, we will. We also announced recently that we have received a notice of allowance from the USPTO for our patent application covering a mannosep-based therapeutic for leishmaniasis. Leishmaniasis is a vector-borne chronic disease caused by a protozoan parasite that replicates in CD206-positive macrophages. It is transmitted to humans through the bite of infected sandflies found in parts of the tropics, subtropics, and southern Europe. It's rare in the U.S., but in more tropical countries where the sandfly vectors are found, leishmaniasis is a common, serious, and potentially life-threatening disease. Because of this situation, it's classified as a neglected tropical disease and is on the FDA's list of tropical diseases eligible to receive a priority review voucher. These are vouchers issued by the FDA that allow the recipient to expedite review of a new drug product. These vouchers can be sold to other companies and dollar figures have ranged from as low as $67 million to hundreds of millions of dollars. The goal is to spur the development of new treatments for diseases that would otherwise not be developed. So back to Leishmaniasis, we have earlier work published in 2017 demonstrating that high CD206 expressing macrophages play a role in the dominant form of the disease. And more recently, we have renewed preclinical studies with one of the world leaders in this area and have promising early results. A follow-on preclinical study is currently underway. As these studies progress, we will keep you updated. If further research supports the efficacy of our therapeutic constructs for treating leishmaniasis, The awarding of a priority review voucher could have significant economic value for NVIDIA. This is extremely important and reveals more of the potential of our platform technology as well as our strategy. And so our therapeutic pipeline is robust and moving forward. That brings me to our overall intellectual property front. We continue to submit new provisional applications and work on our pending applications. In the last six months, since November 1st, We have conceived and submitted several new provisionals, two in the last quarter up till now, and have another two in the works that should go out in the coming days and weeks. The first of those recently filed is related to new methods of attaching chemotherapeutics to the MANICEP platform, and the second relates to maximizing target tissue uptake and off-target competitive blocking. These have important implications for pipeline indications. As you can see on today's earnings call update press release, we have also had claims allowed on different patent applications in various countries. We have an active IP protection strategy that we believe will provide needed protections and rights to both our current diagnostic and therapeutic agents as well as to our next generation molecules and disease indications. We also recently press released the regulatory approval of Lymphaseq as LymphoAIM in India. As mentioned in that release, our partner in India, Sayer Therapeutics, will lead the commercialization efforts there. We're delighted that LymphoAIM has received regulatory approval in India and will be available to patients in need. There is a small milestone payment due for completion of the regulatory application inquiry process, as well as another due upon receipt of the import license. We'd expect that first payment by the end of this quarter. So these are just some of the highlights of the last quarter that we wanted to touch on for this update. We remain largely focused on the RA pipeline, specifically the phase 2B imaging to biopsy trial and the phase 3, 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 and our network of clinical trial sites and academic research collaborators for all of their hard work. Thank you, and now let's move on to the financial updates, and with that I'll introduce Erika Ease. Erika?

Thanks, Mike. So total net revenues for the first quarter of 2022 were zero, compared to $124,000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of debts previously written off in 2015. coupled with recognition of license revenue related to transitional sales in Europe in 2021. Research and development expenses for the first quarters of both 2022 and 2021 were approximately $1.2 million. Decreases in MANICEP diagnostic and to MANICEP development costs and decreased regulatory consulting expenses were offset by increased MANICEP therapeutic development costs employee compensation, including fringe benefits and incentive-based awards, and recruiting expenses. Selling general and administrative expenses for the first quarter of 2022 were $1.8 million, compared to $2.2 million in the same period in 2021. Decreases in employee compensation, including fringe benefits and incentive-based awards, legal and professional services, general office expenses, travel, franchise taxes, and investor relations costs were offset by increased director fees, some losses on the abandonment of certain intellectual property, and increased insurance costs. NVIDIA's net loss attributable to common stockholders for the first quarter of 2022 was $3 million or 10 cents per share, compared to $3 million or 11 cents per share for the same period in 2021. And finally, NVIDIA ended the first quarter of 2022 with $1.2 million in cash and cash equivalents. With the receipt of the $1.5 million bridge loan from Mr. Scott, we believe we currently have enough cash on hand to continue operations at least through the end of the second quarter. And turn it back over to Mike.

Thank you. And now let's open up the questions.

Okay, if you would like to ask a question, press star 1 on your telephone keypad. Again, to ask a question, press star 1 on your telephone keypad. And I'll just give it a few moments for the queue to build. Okay, our first question is going to come from Michael Kunowich with Maxon Group. Michael, your line is open.

Hey there, thank you for taking my question and congrats on the progress. Thanks. So I guess my first question I'd like to ask regarding the 32 study, is there a chance that just if, you know, the probabilities don't work out and you're unable to enroll enough patients of a given pathotype since you can't test this before they actually enroll, Is there a possibility of needing to expand enrollment to capture enough patients to actually get a meaningful result?

What do you mean by expand enrollment? Do you mean sites or just, yeah?

No, just add in additional patients. Let's say you don't get enough lymphomyeloid patients.

Yeah, yeah, yeah. Yeah, the 12 to 24, thanks, Michael. This is Mike Rosel. So the expectation originally was 12 to 24, but indeed we could increase that. What we could also do is, you know, and we're monitoring this closely, of course, is, you know, if we feel we have enough data to tell a compelling story, we can also stop the trial, you know, based on our fibroid versus non-fibroid differentiation. I would like and we would like to give it, you know, a little bit of a greater shake here to see if we could you know, accumulate some patients in those other two pathotypes, specifically the lymphomyeloid, so we can get a better idea of whether or not we could distinguish between those two. So, yeah, if we keep hitting mostly fibroids, we could increase it beyond the 24, or we could look at the data and say we've learned enough for now and, you know, we'll take what we have because these data are important already. So we can do a number of things, yeah.

All right, thank you. And then I'd also like to just touch on the marketing side of the product since these are complex sales where you need buy-in from both the nuclear medicine and rheumatologists. So who's the primary group that something like this would be marketed to? Or would you expect that payers could also help drive adoption given the the efficacy issues with TNS and the fibroid phenotype?

Absolutely. Great question. So we think the rheumatologists are going to be the primary people we need to market to because they'll drive this. The new med folks as well, I'm not leaving them out. They're very excited about having another possible radiopharmaceutical in their armamentarium that they can then use to have their machines being busy and their doctors reading. So they're very interested as well, but I think it's really the rheumatologists who are gonna be driving this. And indeed, the payers should have a great interest in addition. We have not met with payers yet, but it's on our upcoming roadmap to meet with payers and start these kinds of discussions.

All right, thank you very much. And just one more for me and I'll hop back in the queue. But I wanted to ask regarding the automation of result interpretation. Is this something that you would need to run an additional study to demonstrate the effectiveness of a MIM software solution? And if so, could you use your existing imaging results to run it as a retrospective?

Yeah, great question. So, indeed. What we're doing, our conversations with MIM are that our expectation is we will be running the, we'll be validating their software readout on the phase three data, as well as the normative database data. So the plan is, and we're working through the details of this, but the plan is likely to go for 510 approval of the automated readout in parallel with the phase three and the end of the phase three. And I've been involved in those kinds of submissions before that have been successful with other companies. And MIM, of course, does this for a living. So they've started training their automated algorithm on our earlier obtained data from the Phase 2 studies. And we're going to be using the Phase 3 data as well as the normative database data to really validate this. And we'll be comparing it to the – the plan is currently is to compare it to the nuclear med doc imaging reads that will be part of the phase three.

All right. Thank you very much. I really appreciate you taking my questions.

You're welcome.

Our next question is going to come from Mike Grischelli, a private investor. Mike, your line is open.

Yes. Thanks for taking my questions. Erica, has Keystone converted any of their common share rights that they held at the end of December?

No, they have not.

Okay. And can we assume then that Jubilant is, because the contract is still, or the due diligence is still in place, that Jubilant is still holding their shares? Can we assume that also?

Well, I suppose we might make an assumption, but it would be just that. We really only get reports on the ultimate shareholders, especially for those that hold in street name, generally only once a year in preparation for the annual meeting. So I can tell you as of July of 2021, yes, Jubilant still was holding those shares. But I haven't seen an update since then, so I can't tell you for sure right now.

OK, that's fair. Thank you. Dr. Rozal, a couple of questions. Appreciate the update and the emphasis on the 332. That 100% image matching that you did, particularly on the fibroid, I don't think the market understands how critical or important that was. That's pretty significant, isn't it?

Yeah, I think you're absolutely right. I mean, that was, you know, you don't, I've been around for a while, and maybe I started when I was super young like Erica did here. In any event, you don't often see 100% results. Now, again, this isn't the end of the study. It's a preliminary report, preliminary progress. But so far, we're batting 1,000, as they say, and we've been able to bucket patients into the fibroid or non-fibroid completely accurately, at least with the gold standard of the pathology. So indeed, I guess the market hasn't recognized that yet. I can tell you there are players in this field who have recognized it. So we've had groups reach out to us that are involved in this field who are pretty excited about those, at least to the level of wanting to learn more. And some of this is on us as well, right? So we'll need to get these results out there. And so the plan will be to submit these results to the upcoming you know, large rheumatology conferences, as well as imaging conferences as well. But in following on with the previous question from Michael from Maxim, really getting this news out there to the rheumatologist is important. Starting making a splash in that domain will help. And then, of course, we do need to get word out to the wider market as well.

Can you elaborate for us what the importance is of differentiating between those two non-fibroid pathotypes? How critical is that to differentiate between those, or is it just a preference?

It might depend on who you ask, but as there is a growing body of research suggesting or demonstrating that the fibroid versus non-fibroid, broadly speaking, have different response rates to the biologics and other drugs, That holds true as well for the diffuse myeloid versus the lymphoid pathotypes. There are data out there that suggest one of those pathotypes may be more or less responsive to one or other biologic. So kind of a long-term goal would really be able to do imaging and give the physician, the rheumatologist, information that could really help them tailor in a fine-tuned fashion the the treatment that they then prescribe for their patient. But already it is a significant win. If you could say this whole class of drugs, the most commonly used class, anti-TNF alphas, have a very reduced chance of working on your patient, you should look elsewhere. That already, in and of itself, is a big win. And already there's information that, you know, looking at those other two classes, the non-fibroids, other drugs, broadly speaking, biologics, will have a chance on those as well as the anti-TNFs, and the fibroids are much less likely to respond to the anti-TNFs. So moving a large group of patients, maybe a third of patients around the globe, being able to tell from a baseline scan that they're unlikely to receive a benefit from the anti-TNFs is a big win, and the rheumatologists are very excited about that. But again, to reiterate, being able to tease out the, you know, one versus the other of those two other pathotypes will be good additive information that can help them really narrow in on the kind of, you know, the drug class for those patients that has a better chance of working. So it's important, but really the, indeed the kind of most important thing, I think, is the fibroid versus non-fibroid. And all of this is, is evolving in the literature and in the understanding of rheumatologists. So we're really at the forefront of rheumatology and RA medicine, which is a good place to be.

It would seem to me that some of the big drug farms in this area would be very, very interested in this. Have you reached out to them, or have they reached out to you, or can you share that?

Yes on both counts. So it's been a two-way street. So there, yes. So indeed, yeah, there are drug companies who are, you know, they may or may not already have a certain class of therapy for RA already in the market. But realizing that any one of those has, you know, depending on the milestones you use the clinical assessments, less than a 50-50 chance of working in any patient. they realize that there's opportunity and need in developing other drugs in these other classes. And so many of these drug companies are working on these new therapies. And it could be very beneficial to them to be able to determine in advance what pathotype of RA a particular patient has. not just for the responsiveness or non-responsiveness to their drug, but maybe even to enter the trial. So they could use this to enrich their trials, for example, or also as a biomarker of efficacy, right? So there are a number of uses that this, that we believe and we're starting to demonstrate that Tilmanisept could provide that would be beneficial for them as they develop new drugs. So getting back to the first part, yes, we've been in touch and And it's been through us and through them contacting us.

One question, because this 332 ties so closely to the Jubilant deal. Under the Jubilant deal, can you share, are you allowed to visit with other potential, because we're talking here about other people reaching out to you, are you allowed to to talk to other people about potentially doing something with the RA or are we sticking under the jubilant? Thanks, Michael.

It's an exclusive agreement for the rights in certain domains for the RA possible product in the indications that I gave. So that does not cover some of these other possibilities and territories. Does that make sense?

Okay, so right now you'd be restricted in what I'll call the North America or U.S. territory, but not in others. Is that correct? Okay. I know others are probably in the queue, so I'll make this the last question and go back in. This IP that NVIDIA has re-installed has a significantly higher fair market value than it's on the balance sheet. No doubt about that, because you just got your costs on the balance sheet. Eric, I think, would verify that. And you created such a higher fair market value. Does the company have any strategy how to go out, how to tell the world about this ring fence that you've done around this fast-developing MANO CD206 receptor science? Are you guys entering into any kind of strategy on how to tell the world about this?

Yeah, good question, Mike. We do... In all of our discussions with possible investors and partners, these are critical points that we bring up in those discussions. So in the one-on-ones with all of the above, we certainly bring this up as something of great value, and I think it's been universally recognized as that, or broadly at least. And in terms of the greater world in general, of course, when we do any academic work, presentations or press releases, you know, they're about how we're advancing the science. I mean, this is embedded within that, right? So we do make announcements about our IP and patents being allowed, claims being allowed, and patents being granted. You know, I don't know that during our presentations we specifically call that out. Maybe it's implied. Most companies don't. But in general, we are... And in specific, when we speak with any possible investors or partners, these are key points of those discussions. So the message is always getting there to the players that we're speaking to or trying to speak to, whether we've reached out to them in the hopes of having something happen or whether discussions are actually happening. And then more broadly, again, if you do presentations and press releases, you can mention it or it's assumed in the progress you're making in your science. And maybe we can do a better job of getting the message out there to the broader world.

I appreciate that. I'll go back in the queue. But I think on your presentations you ought to highlight it because I don't think people are so engrossed in their own world and their own little cubicle. I don't think they understand this. I just don't think your capturing of this CD206 science is really appreciated. So I'll go back in the queue.

Got it. Thanks.

And as a reminder to join the queue, please press star 1 on your telephone keypad. Please press star 1 on your telephone keypad. And our next question is going to come from Edward English, a private investor. Edward, your line is open.

Hello, Dr. Rosal. This is Eddie English. Thanks for taking my call. I would like first to ask, when do you expect the Royal Free Hospital

in london to begin recruiting for the 332. thanks heidi so we've uh we've been trying to schedule the what's called the site initiation visit with them um and and last i heard uh this morning it's either next week or the week after so once you've had the full site initiation visit which follows upon all sorts of contractual stuff and a site qualification visit then they're officially open to enroll. So that should happen in the next one or two weeks unless somebody cancels. But that's my understanding from speaking to the clinical team. So it's coming up.

Okay. I'm hoping that that might help us get to the 444 objective that we talked about. You and me both. Okay. Next question. Has the request for a drug import license been filed in India to Manicep and Would you agree that the estimated time for processing the request there is approximately three months?

Yeah, so that's about the right timeline. We spoke to the SARE folks recently in terms of once they filed it, it can be a little bit longer. And as they've said, your miles may vary depending on what's happening. But in this case, what we're also doing, remember, is we are developing, we're bringing up to speed a new drug product manufacturer. And so that needs to happen, and all of the paperwork for that also needs to be sent over to the Indian regulatory authorities. So that will take some lead time to do that, and then the sayer folks will be applying for the import license as well. And we'll keep you up to date on that. But so there's, there's some added time, uh, on top of that before that three months. So that will take a bit of time, but, um, we're in a good place with those folks and we're trying to, uh, streamline things. So they get what they need as soon as, as soon as we can provide it and they are ready to go to the regulatory authorities.

Okay. Uh, speaking of Sayer, uh, I've noticed their website website is still. indicating that LymphoAIM is awaiting DCGI approval. And I haven't seen a press release from them on the approval in India for LymphoAIM. So with that, why do you think the results they will achieve in India will be different from Norgen's results in the EU?

Yeah, so on the first part, you know, that's interesting. I've seen that as well. They were involved in our press release, and they were very responsive and excited about getting the press release out, and they asked us to send them the link. So I don't know why they haven't updated their website. I have a feeling their website hasn't been updated a lot recently in general. But the folks we spoke to were very enthused of leadership, and they were going to go back to their board of directors with a plan. I think, you know, I wasn't around for the Norgene experience. I think these folks have a good understanding of the market and what kind of price point they need to set. They have an understanding of the competitive landscape in India. I can say this because I've spoken to them. So I don't think they're going to make the same kind of mistakes and hopefully no new ones that Norgine made in the past in terms of overpricing and maybe not getting the word out as well as they should have in Europe. I don't think they're going to be doing that. And remember, that was Norgene's first and only radiopharmaceutical. And so, Sayre has a little more experience in this domain, so.

Okay, thank you. My last question is something I know we've talked about for years now and that's jubilant. There's a seemingly open-ended due diligence agreement with them, and it's frustrating for many shareholders, and some believe maybe it's even the prolonged analysis is having a significant negative impact on the stock price. Can you explain why you can't divulge more detail about the due diligence process for them? Specifically, is the due diligence interval time-bound? Is it milestone bound or do you have some other exploration criteria and what information they need to complete their assessment? Because two years is a long time.

Yeah, it is. It is. I appreciate the question. So what I can say is the, um, they remain interested. We've, I discussed, uh, with their leadership, uh, regularly, um, or I'm in discussions with them. I've known them for the entire time I've been involved in those discussions. The MOU has had revisions over time, and I can tell you it is milestone-based. And we haven't come right out and said it, but you've understood at this point that a significant milestone there is the NAV3332 trial. So I think that much I can say. It's not open-ended. It's not forever. And it has been amended over time for various reasons. And so, again, they remain interested, and we are in good discussion with them, and we do have milestones that are out there.

All good?

All right.

Thank you very much. That's all I have. You're welcome.

Thanks a lot.

Okay.

And our next question is coming from Mike or Shelly once again. Mike, your line is open.

Yes, thanks for taking my question. I'll try to finish up with these two. Erica, we had zero revenue on licensed sales in the first quarter, as you noted. Have Dr. Rozal or Erica, have they been able to get any more product to the EU to start reselling that if they were out of stock? Or was that just coincidental? Or how is that working, restocking the EU?

Yeah, so thanks, Mike. This is Mike. So it has never been out of stock. There was a logistics transition from stock supply from Norgene to our distributor. And so that caused some lag. You'll see those sales pick up in the coming quarters now that that's been kind of worked through. And so we've done all that we can do to make sure that there's a continuing supply of lymphocytic in Europe. And And without going too far out on a ledge here, we've seen some interest in utilizing this in Europe. And I think there's very good potential for the product in Europe, despite where it's been before.

Well, that's a good piece of news. And let me try to finish up, because I'm just so astounded by those results in that 332, that 100% match. And I think if I remember right, Abivai and their drug, is it RIMVOC or something? The way they're developing their trials, this would seem to be very, very important to somebody like them. Or am I misunderstanding their trials?

No, you're right. So that's AbbVie and that's RIMVOC. And you're right. And RIMVOC is a JAK inhibitor. So it's a different kind of next-gen or second-line therapy for rheumatoid arthritis therapy. And you may have seen, back, by the way, in September, the FDA put out a notice with a warning that because of side effects from using RINVOC, they reiterated the FDA that the anti-TNF-alpha therapies should be utilized first before patients are put on RINVOC. And so, AbbVie and others, I think, are natural possible treatments. partners here in various ways. One, as I mentioned, is maybe for us to be using Tilmanisept or them to be using Tilmanisept as a biomarker, predictive of efficacy of their drugs, potentially enriching their trials or stratifying, you know, looking at the fibroid versus the non-fibroid and seeing if their drugs work on one or both classes of those. I think we're a natural partner for any of these pharmaceutical companies making these next-generation rheumatoid arthritis drugs. I'm not promising anything, but as I said, as we've progressed and those results were released, the preliminary results, we've seen some interest related to everything that I just said based on those NAV332 results. So you're right to keep looking at those, Mike, and we hope that as that trial continues and that these great results will also continue and we'll keep you posted on these discussions we're having related to that whenever something significant happens.

Well, I hope. We're all counting on those potential funders to be listening in to these phone calls and listening to these excellent feedback we're hearing because whoever funds this is really going to fund it. something for humankind, not just for the shareholders. So I hope people really appreciate that. So thanks for taking my call today.

Yeah, you're welcome. Okay. Next question is coming from Edward English, a private investor.

Edward, your line is open.

This is Eddie again. I did have a question about the financing for Erica, if I could, uh, in the last one of the last calls erica the chairman elaborated on his preference to have a larger financing deal that would be multi-year i'm assuming you're involved in what's going on with the larger financing plans and activities uh is it still uh the preference and likelihood that this financing deal would be a multi-year thing that would provide NVIDIA for long-term funding as opposed to short-range?

Yes, I would say that that would still be the preferred route, would be to kind of do one large funding and then not have to worry about it for a couple more years. However, that being said, we are open to many different potential opportunities, and we're evaluating many different possibilities, not all of which may be that one large sum.

And he mentioned that the deal could involve, you know, I believe he used the word day one money, followed by milestones that... provide additional funding and so forth. Is that still the framework that's being actively pursued?

Yeah, I mean, that is one potential framework, yes. But as I said, we are looking at and evaluating a number of different possible scenarios.

Thank you very much. You're welcome.

Okay, unfortunately, that is all of the time that we've had for questions.

So we'll now turn it back to Mike Rosso for closing statements.

Thank you, and thanks, everyone, for your attention today, for dialing in, and for remaining interested in our progress. We'll keep our noses to the grindstone, and we will speak to you again next time we have some news to announce. And see you then. Thank you.