Q1 2022 Navidea Biopharmaceuticals Inc Earnings Call
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Thank you for holding your call will begin shortly.
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Uh huh.
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Welcome given the video bio for me keep it simple its first quarter 2022 earnings call and business update I will now turn the call over to the Chief Medical Officer from Millennium, Michael Russell You may begin.
Thank you and thank you all for joining us for today's earning call.
This call is being webcast live on our website IR dot and the video Dot com and a replay will be made available. Following prepared remarks, we will be conducting a live Q&A session new videos, Vice President of Finance and administration Erika 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 new videos molecular diagnostics in immuno therapeutics, which include clinical and regulatory developments and timing of clinical data readouts along with capital resources.
Strategic matters as well as the impact of the COVID-19 pandemic on the video 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 lets 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 that 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 <unk>.
Word of directors, Mr. Kim Scott as well as a small milestone payment due in another potential payment upcoming there's 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 two b 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 Pathet type from the non fibroid in our first 11 evaluated patients.
These strong early results support our hypotheses and provide great data in support of <unk> imaging as a biomarker of CD to a six expression enjoyed for patients with RA. We also continue to enroll into DRA phase III and have recently opened up another site. Additionally, we are advancing our therapeutics in imaging apt.
Locations 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.
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 will begin with progress in our rheumatoid arthritis or RA program.
So we continue to enroll into the phase III trial in <unk>, we've reached double digits now and 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 <unk> trial, and we're happy to see that they've hit the ground running.
The indications, we're going forward all array or one early prediction of treatment response to our new our 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 reliable early predictor of whether or not a therapy is working in a patient with <unk> because of the 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 <unk> imaging to serve as an early predictor of treatment response in 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 now.
<unk> 332, our comparison study of <unk> imaging to joined biopsy remains an 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 paths the types of or a two obtained comparative imaging and pathology results and the trial is designed so that we enroll a minimum of four subjects in each of the three paths types of aura.
The fibroid, the diffuse myeloid and lymphoid myeloid. 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 lymphoma Alloyed importantly, there is currently no way in advance to know what path. The type of RA 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 <unk> uptake values and the pathway biology of already involved joined.
Knowledge of an individual patient's pathet type may be clinically important because it may predict two which are a therapy a patient is likely to respond.
There is a growing body of literature, suggesting that those patients with the fibroid subtype of <unk> 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 pathet type is seen as extremely important to a number of key opinion leaders in rheumatology.
<unk> as.
As I just mentioned as of this time there is no reliable way of assessing the path. The type of patients are a other than by doing a biopsy.
And we have hypothesized that till manifest imaging could provide this information.
So preliminary results on those first 11 patients indicate that <unk> uptake NRA inflamed joints is able to discretely differentiate patients with the fibroid path to type those who have low macrophage involvement from those having either the diffuse myeloid or lymphoma myeloid pass the types of Ara those with.
Higher macrophage involvement.
So seven of the subjects had relatively low levels of <unk> uptake all seven of those subjects were found to have the fibroid pass the type seven out of seven.
Out of the remaining four subjects three of the diffused myeloid and one had the lymphoma myeloid pathet types.
Those subjects with either the fewest myeloid or lymphoma myeloid passive types had on average more than three times the <unk> uptake as the average subject with the fibroid Pathet type so all of those subjects had higher uptake.
Then the fibroid patients.
To date, we have been able to clearly classify patients then is either fibroid or non fibroid based on our imaging results taken before the biopsy in all 11 cases.
These data also provides support for one of our indications in the phase III 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 an increasing there is increasing evidence that if a patient has the fibroid paths of the type of RA there.
Less likely to receive significant clinical benefit from anti TNF Alpha therapy.
You might recall that in our previously completed phase <unk> study that contained a pilot arm looking at the efficacy of <unk> imaging at early prediction of treatment response, those patients who exhibited a low level of <unk> uptake in their joints on their baseline scan had an almost 90% non response rate to <unk>.
It is 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've 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 will 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 <unk> imaging in RA.
Once again NIM 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.
Terry algorithm.
This will be important for rollout of a commercial product the ability to perform the quantitative reads rapidly and reproducibility and at large scale through automated means is critical to large scale use of <unk> Ferrari keep in.
And that all of this the image analysis methodology as well as the data upon which it is built including the normative database you have heard us discuss before is not only critical to deriving the most accurate insensitive objective read of our images, but it also serves as a significant barrier to entry to possible competitors in this.
Space.
We will continue to work with NIM to finalize terms of the partnership and we will 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 U S market and secondary European market research valuation for the raw 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 pre.
<unk> and <unk> and include input from leading rheumatologists across the United States.
The jubilant Mou an exclusivity period are still in effect as we have mentioned in the past the completion of the Nab $3 32 biopsy study is an important milestone for both us and jubilant.
I have been and continue to be in communication with their leadership and had been involved in these discussions since the beginning we are keeping them up to date on the study progress and NAV $3 32 results.
As we advance 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 were completed on the investigator initiated atherosclerotic plaque imaging study at mass General Hospital in Boston the.
The data are promising in terms of localization of <unk> 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.
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 pre.
Preclinical studies on gallium 68, <unk> for pet imaging and related next generation <unk> imaging agents have progressed significantly through internal work Aetna video and through extramural collaborations with researchers at the University of Alabama, Birmingham or UAV.
We have completed work on our NIH funded preclinical studies for evaluating gallium <unk> and various new imaging agents similar to <unk> in a mouse model of atherosclerosis work on another important set of preclinical clinical imaging studies was completed in an abstract has been accepted at an international meeting and in managed care.
<unk> has been submitted as well.
This work looked at our new technology designed to increase the localization of our imaging agent to target tissues, while our second technology was designed to block off target imaging agent localization to the liver, which is a major site of localization when <unk> is administered by intravenous injection.
These studies were very successful showing that we can dramatically increase localization of our new <unk> like imaging agent to tumors, while simultaneously and significantly blocking off target localization to deliver.
Additional work on new drug delivery construct and new targeted payloads has also progressed these.
These new construct carrying 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 construct 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 re release details we will.
We also announced recently that we have received a notice of allowance from the U S. PTO for our patent application covering our managed asset base therapeutic for leishmaniasis lease.
<unk> is a vector borne chronic disease caused by a protozoan parasite that replicates and CD <unk> positive macrophages.
It is transmitted to humans through the bite of infected sandflies found in parts of the tropics subtropics in southern Europe .
It's rare in the U S, but in more tropical countries, where the sand fly vectors are found leishmaniasis, 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 range from as low as 67, two 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 CD to a six 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.
Follow on preclinical study is currently underway.
As these studies progress we will keep you updated to further research supports the efficacy of our therapeutic construct for treating leishmaniasis. The awarding of a priority review voucher could have significant economic value for new video.
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 one we have conceived and submitted several new provisionals too in the last quarter up till now and have another two in the works that should go out in the coming days and weeks.
First of those recently filed is related to new methods of attaching chemotherapeutic to the <unk> platform and the second relates to maximizing target tissue uptake and off target competitive blocking these.
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 are in 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.
<unk> molecules and disease indications.
We also recently press release, the regulatory approval of Lymphoseek as lymphoma aim in India as.
As mentioned in that release, our partner in India, <unk> Therapeutics will lead the commercialization efforts. There. We're delighted that <unk> 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 would 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 <unk> imaging to biopsy trial and the phase III, 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.
And now let's move on to the financial updates and with that I'll introduce Eric aid Erica.
Thanks, Mike.
The total net revenues for the first quarter of 2022 were zero compared to $124000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of 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 about 2022, and 2021 were approximately $1 2 million.
Decreases in manifest diagnostic and Tom intercept development costs and decreased regulatory consulting expenses were offset by increased manifest 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.
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.
<unk> net loss attributable to common stockholders for the first quarter of 2022 was $3 million or <unk> 10 per share compared to $3 million or <unk> 11 per share for the same period in 2021.
And finally in the video 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 call for questions.
Yeah.
Okay.
Question.
One on your telephone keypad.
Good question.
One on your telephone keypad.
Thanks, Kevin.
Yeah.
Okay Alan for your question.
Hello.
Michael.
Okay.
Michael Your line is open.
Hi, there. Thank you for taking my question and congrats on the progress.
Thanks, Bob.
I guess my first question I'd like to ask regarding the 32 study.
Is there a chance that just it.
Probability don't work out and you're unable to enroll enough patients.
Given.
Pat with tight since you can't test this before they actually enroll.
Is there a possibility of meeting two weeks band enrollment capturing.
Patients to actually get a meaningful result.
Thanks.
What do you mean by expand enrollment do you mean sites or just yeah just.
Adding additional patients, but let's say you don't get enough lymphoma myeloid this time, yes.
Yes, yes, the 12 to 24. Thanks. Thanks, Michael This is Mike Rosol so.
The expectation originally was 12 months to 24, but indeed, we could increase that what we can also do as you know and we are monitoring this closely of course is.
If we feel we have enough data to tell a compelling story and we can also stop the trial.
Based on our fibroids versus non fibroid differentiation I would like and we would like to give it a.
A little bit of a greater shake here to see if we could accumulate some patients in those other two paths type specifically, but lymphoma myeloid. So we can get a better idea of whether or not we can 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.
We will take what we have because of these data are important already so we can we can do a number of things yes.
Alright, thank you.
And then I'd also like to just touch on the.
Kind of on the marketing side of the product.
These are complex sales, where you need buy in from both the nuclear medicine and Rheumatologists. So.
Sure.
The primary group.
Something like this would be marketed from marketing to you or would you expect that payers could also help drive adoption given the efficacy issues with CNS in the fibroid phenotype.
Absolutely Great question. So we think the rheumatologists are going to be the primary.
People, we need to market too because they will drive the.
The nuc met folks as well im not leaving them out there very excited about having another.
Possible radiopharmaceutical and they're in their I'll raw material that they can then use to have their machines being busy and their doctors reading so theyre very interested as well, but I think it's really the rheumatologists, who are going to be driving this and indeed, the payers should have a great interest in it.
In addition, we have not met with payers, yet, but it's in our on our on our upcoming roadmap to meet with payers and start these kinds of discussions.
Alright. Thank you very much and then just one more from 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 additional studies to demonstrate the effectiveness.
MIM software solution and if so could you use your existing imaging results to run it as a retrospective.
Yes, great question. So indeed, what we're doing our conversations with memo that our expectation is we will be running the we'll be validating their software readout on the phase III 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.
500 10-K approval.
The automated readout in parallel with.
The phase III and the end of the phase III and I've been involved in those kinds of submissions before that had been successful with other companies.
And remember of course does this for a living so we.
They've started training.
<unk>, they're automated algorithm on our earlier obtain data from the phase II studies, and we're going to be using the phase III data as well as the normative database data to really.
Holiday this and we will be comparing it to the the plan is currently is to compare it to the to the nuclear med dock imaging reads that'll be part of the phase III.
Alright. Thank you very much I really appreciate you taking my questions Youre welcome.
Our next question is going to come.
Shelly.
Mike Your line is open.
Yes, thanks for taking my questions.
Erica.
Keystone converted any of their common share rights. They held at the end of December .
No they have not.
Okay. Thank you.
Can we assume then that you balloons because the contracts.
Due diligence is still in place.
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 Okay. That's fair. Thank you Dr.
Dr Rosol couple of questions.
I appreciate the update and the emphasis on the $3 32.
100% image matching.
But you did on particularly on the fibroid.
I don't think the market understands how critical or important that was thats pretty significant.
Yeah, I think youre, absolutely right I mean that was a.
I've been around for a while and maybe I started when I was super young like Erica did here and any of that.
Often say, 100% resolved now again this isn't the end of the study.
Preliminary report preliminary progress, but so far we're batting 1000, 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.
Pathology.
So indeed.
I guess the market doesn't recognize that yet I can tell you. There are there are players in this field who have recognized it so we've had.
Group's 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 will need to get these results out there and so the plan will be to submit these results to the upcoming.
Large rheumatology conferences as well as imaging conferences as well, but and following on with the previous question from Michael from Maxim.
Really getting the getting this news out there to the rheumatologist is important starting making a splash in that domain.
I'll help and then of course, we do need to get word out to the wider market as well.
Okay can you elaborate for us what the importance is a differentiated differentiating between those two non fibroid.
Pack types, how critical is that to differentiate.
Or is it just two quick ones.
It might depend on who you ask but as it as there is a growing body of research, suggesting are demonstrating that the fibroid versus non fibroid broadly speaking have difference response rates to the biologics and other drugs.
That holds true as well for the diffuse myeloid versus the lymphoid Pathet types. There are there are data out there that suggest.
One of those paths of types 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 direct to give the physician a rheumatologist or information that could really help them Taylor.
A fine tuned fashion the the treatment that they then prescribed for their patient, but already it is a significant win if you could say this whole class of drugs is the most commonly used class of anti TNF alphas have a very reduced chance of working on your patient you should look elsewhere that already in.
<unk> itself is a big win and already there is information that.
No.
Looking at those other two classes the non fibroid other drugs broadly speaking biologics.
We will have a chance on those as well as the anti TNF and the fibroids are much less likely to respond to the anti TNF. 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 TNF is a big one.
And the Rheumatologists are very excited about that but again due to reiterate being able to tease out the one versus the other of those two other pathet types will be good additive information that can help them really narrow in on the kind of.
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 at the forefront of rheumatology in and.
Are a mess.
Medicine, which is a good place to be.
It would seem to me that some of the big drug.
Farmers.
In this area would be very very interested in those.
Have you have you reached out to them or are they.
<unk> reached out to you can you share that.
Yes on both counts so it's been a two way street. So there yes.
So indeed, yes, there are drug companies who are they.
They may or may not already have a <unk>.
Certain class of therapy for RA already in the market.
But realizing that any one of those has a.
Depending.
Depending on the milestones you use the clinical assessments less than a 50 50 chance of working in any patient they realize that there is opportunity and need in other and developing other drugs in these other classes and so many of these drug companies are working on these these new therapies.
And it can be very beneficial to them to be able to determine in advance what path. The type of array of particular patient has.
Not just for the responsiveness or non responsiveness to their drug, but maybe even to enter the trial. So they could they could use this to enrich their trials for example, or also as a as a biomarker of efficacy right. So there are a number of uses that this.
We believe and we're starting to demonstrate that <unk> could provide that would be beneficial for them as they develop new drugs. So getting back to the first part yes, we've we've been in touch and Ah and it's been through us and through them contacting us.
What one question because this 332 tie so closely to the Google deal.
Under the <unk> deal can you share are you allowed to visit with other potential.
And because we are talking here about other people reaching out to you are you allowed to talk to other people about potentially doing something with the ari or reach taking under the <unk> brand.
Yes, so often exclusively thanks, Michael it's an exclusive agreement for the the rights in certain domains for the <unk>.
Possible product in the indications that I gave that so that does not cover some of these other possibilities in terror territories does that make sense.
So right now you'd be restricted in what I'll call, the North America, or U S territory, but not in others.
Great.
Okay.
On the I know others are probably in the queue. So I'll make this the last question and I'll go back in.
Yes. This this IP that video has remained.
Has a significantly higher fair market value on the balance sheet no doubt about that.
Scott your costs on the balance sheet, Eric I think would verify that and you've created such a higher fair market value.
Many have any strategy how to go out.
How to.
Tell the world.
About <unk> <unk>.
Around this fast developing mannose receptor.
Receptor science.
You guys entering into any kind of strategy on how to tell the world about.
Yes, 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 end.
In the one on ones.
With all of the above we certainly bring this up as a something of great value and I think it's been universally recognized those that are broadly at least.
And in terms of the the greater world in general.
When we do any academic presentations are cross releases.
There are about how we're advancing the science.
I mean this is embedded within that right. So we do make announcements about our about our IP and patents being allowed claims being allowed in patents being granted.
I don't know that during our our presentations, we specifically called 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 are 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 its are assumed and the progress we're making in your science and maybe we can do a better job of getting the message out there to the broader.
I appreciate that I'll go I'll go back into queue, but I think on your presentation you ought to highlight it because I don't think people are selling growth in their own world and they're all a little.
<unk> I don't think they understand as I, just don't think youre capturing of the EV tools.
I really appreciate it so I'll go back in the queue.
Got it.
Yes.
Okay.
And as a reminder to join the queue. Please press star one.
From Keybanc. Please press star one on your telephone keypad.
Our next question is going to come from.
Yes.
Sir your.
Your line is open.
Hello, Dr. Roseville. This is Eddie English thanks for taking my call.
I would like to first ask.
When do you expect the Royal Free Hospital in London to began recruiting for the $3 32.
Thanks, Eddie So we've we've been trying to schedule the what's called the site initiation visit with them.
And last I heard this morning, it's either next week or the week. After so once you add the full site initiation visit which follows upon all sorts of contracts <unk> staff and our site qualification visit then they're officially opened 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.
Hoping that that might help us get to the full four objectives.
Talking about you and me both yes, okay.
Next question has the request for a drug import license have been filed in India for <unk>.
Would you agree that the estimated time for processing, Chris there is approximately three months.
Yes, so that's the that's about the right timeline, we spoke to the Sayer.
<unk> recently in terms of once they filed it it can be a little bit longer and as Dave 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 of new drug product manufacturer and so that needs to happen in 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 <unk> folks will be applying for the import license as well and we'll keep you up to date on that but so there is there is some added time on top of that before that three months. So that will take a bit of time, but we're in a good place with those folks and we're trying to.
To streamline things so they get what they need as soon as as soon as we can provided and they are ready to go to the regulatory authorities.
Okay.
Speaking of Sayer.
Noticed their website website is still.
Indicating the lymphoma aim is awaiting <unk> approval and I haven't seen a press release from them on the approval in India for lymphoma.
So with that why do you think the results they will achieve in India will be different from north <unk> results in the EU.
Yes, so on the first part.
That's interesting I have 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 asked us to send them the link.
So I don't know why they havent 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 leadership and they were going to go back to their board of directors.
With a plan.
I wasn't around for the nor gene experience I think these folks have a good understanding of the market and how to 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 theyre going to make the same kind of mistake.
And hopefully no new ones.
That <unk> made in the past in terms of over pricing and maybe not getting the word out as well as they should have in Europe .
I don't think theyre going to be doing that.
And remember that was nor Jeanne's first and only a radiopharmaceutical.
And so <unk> has a little more experience in this domain.
Okay. Thank you.
Last question is something that we've.
We've talked about for years now and that's <unk>.
Theres a seemingly open ended due diligence agreement with them and it's frustrating for many shareholders and some blades, maybe it's even the prolonged analysis is having a significant negative impact on the stock price can.
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 a milestone bound.
Do you have some other exploration criteria and what information they need to complete their assessment because two years is a long time.
Yes. It is it is I appreciate the question. So what I can say is the they remain interested we've I discuss with their leadership are regularly 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 <unk>.
<unk>.
And I can tell you it is milestone based.
And we Havent come right out and said it but you've you've understood at this point that our.
A significant milestone there is the Nab $33 32 trial. So I think that much I can say its not open ended its not a forever and it has been amended over time.
For various reasons and so again they remain interested in.
And we are in good discussion with them.
And we do have milestones that are out there.
Good.
Alright. Thank you very much that's all I have.
Alright.
Gentlemen.
Thanks, a lot.
Okay.
And our next question coming from Michael.
Yeah.
Your line is open.
Yes, Thanks for taking my question I'll try and finish up with these two.
Erica.
Zero revenue.
License sales in the first quarter as you noted.
Dr. Rosenberg, Erica they've been able to get any more product to the EU to start reselling love. If they were out of stock or was that just coincidental or how is that working that restocking.
Yes. So thanks, Mike This is Mike so it has never been out of stock there was a.
There was a logistics transitioned from stock supply from <unk> to our distributor and so that that caused some some lag youll see those those sales pick up.
Coming quarters, now that Thats been kind of worked through and so we're we've done all that we can do to make sure that there is a continuing supply.
Of Lymphoseek in Europe .
And without going too far on a ledge here, we've seen some some interest in utilizing this.
In Europe , but I think there is.
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.
It was founded by those results were about $3, 32% to 100% match.
I think if I remember I'll be by our drug as a room broke or something.
The wrangler developing or trials this would seem to be very very important to somebody like remind.
Or am I misunderstanding that trial.
No youre right, so that's abbvie, and Thats, where invoke and Youre right and <unk> is a is a JAK inhibitor. So it's a different kind of nextgen or second line therapy for rheumatoid arthritis, and and and you may have seen back by the way and in September the FDA put a put out a notice.
With kind of with a with a warning that.
Because of side effects from using ringbark, they reiterated the FDA that.
As that the anti TNF Alpha therapy should be utilized first before patients are put on on Ringbark and so abbvie.
Abbvie and others I think our natural possible partners here in various ways one as I mentioned is maybe.
For us to be using to manage that for them to be using <unk> as a biomarker.
Predictive of efficacy of their drugs potentially enriching their trials or stratify.
Looking at the fibroid versus the non fibroid and seeing if the drugs work on one or both classes of those.
And so I think we're a natural partner for for many of these for any of these pharmaceutical companies, making these these next generation rheumatoid arthritis drugs and I'm not promising anything but as I said, we've as we've kind of as we've progressed and those results were released the preliminary results we've seen some some interest.
Related to everything that I, just said based on those <unk> hundred 32 results. So you are right to keep looking at those Mike and we hope that as that trial continues in.
These great results, we will also continue.
And we'll keep you posted on these discussions we're having are.
Related to that whenever something significant happens.
So I hope I'm cat, we're all counting on those potential lenders to be listening in to these phone calls listening to these excellent feedback we're hearing because whoever funds.
Got it.
That's something for human time, not just for the shareholders. So I hope people really appreciate that so thanks for taking my call.
Yeah Youre welcome.
Our next question is coming from Edward <unk>.
Thank you Sir.
Your line is open.
This is Andy again I did have a.
Question about the financing for Eric if I could.
And the last one of the last calls Erica the chairman.
<unk> 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.
Is it still.
The preference and likelihood that this financing deal would be a multi year thing that would provide the video for long term funding as opposed to short range.
Yeah, 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 too many different potential opportunities and we're evaluating many different possibilities.
Not all of which may be that that one large now.
And he mentioned that.
The deal could.
Involved.
I'll leave you 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.
One potential framework, yes.
But as I said, we are we are looking.
Looking at and evaluating a number of different possible scenarios.
Okay.
Thank you very much.
Youre welcome.
Okay.
It is all over the time that we've had for your questions.
Now I'll turn it back to Mike Doyle for closing statements.
Thank you and thanks, everyone for your attention today for dialing in.
And for our remaining interested in and our progress, we'll we'll keep our noses to the grindstone and we will speak to you again next time, we have some news to announce.
And to that thank you.
Okay.
Okay.
That's your call.
You may now disconnect.
No.