Q1 2021 Navidea Biopharmaceuticals Inc Earnings Call
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Greetings and welcome to the videos first quarter 2021 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being reported I would now like to turn the conference over to your host jet lagged and CEO.
Yes.
Thank you this call is being webcast live on our website and a replay will be made available. Following prepared remarks, we will be conducting a question and answer segment and the videos Chief Medical officer, Dr for Microsoft and the company's Vice President Finance, Eric and needs will be joining me on the call today.
And of 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 the golf and the videos molecular diagnostics and immuno therapeutics, 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 and.
On the video business operation.
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 for or update forward looking statements, whether as a result of new information future events or otherwise and investors.
Should read carefully the risks and uncertainties described and within the Safe Harbor section of our website as well as the risk factors included and the company's most recent quarterly and annual filings with the SEC.
The first quarter and the beginning of the second quarter has been quite eventful. So far are for.
I'll get the squarely on processing all of the data for 331 and presented the complete package to the FDA and for the yen.
And the phase to be meeting the process of quite laborious and we're spending a vast majority of our time focused on the reads and the data. Meanwhile, as we're completing the data compilation. We are also fully prepared for launch phase III, we have targeted all of the new sites and getting them ready in conjunction with our current sites for the phase two that will all be participating on the phase III.
332 was launched in Illinois, and the ease of been completed and the U K. We are actively looking for patients and this important trial.
The data and we hope to glean from this trial will help expand the label of the or a product right off the bat and we think it's sort of really help us hit the ground running one of the product launches after its approval by the FDA.
Our discussions in Europe are continuing but in the meantime, we have set up a distribution network with an existing distributor in Europe and are now just awaiting some of the final inspection and in order to get the go ahead and you start selling the product on our own we.
We have targeted several potential long term partners and I've got quite a few meetings, which have gone very well and.
And the items are completed we will share our progress on the market on several key fronts and manufacturing and distribution.
And this past quarter, we completed the $5 million placement with the largest shareholder Mr. Scott and continue towards the inflows from Keystone and they work towards completing the $15 million commitment under the series D preferred which is expected to wrap up and the first week of June.
Our discussions with your Bill and continue and we have turned our focus towards the data that we will generate over the next several quarters and the 332 trial.
The biopsy data that we hope to generate and we start to enroll patients will be invaluable towards increasing the value of the raw product. We feel strongly that positive correlation of results and that trial will enhance the label of the product right from the get go with northwestern and the U K up and running we expect to have patients getting biopsy zone.
We expect the next quarter to be very busy as we continue the dialogue with the FDA and get ready for the launch of the phase III for all right. It's important that we do things the right way and and the right time, taking shortcuts and not an option as we get one chance to put our best foot forward with the FDA.
The last several weeks, we have also partially reconstituted the board Michael Rice, the chairman and Adam Cutler have both retired from the board and I want to thank them for their years of service and Kathy ruin and has stepped up and has been appointed the chairperson of the board. She has over 30 years' experience and pharmaceuticals and is perfectly suited to lead and the videos board going forward to replace.
Adam and Michael Amit Bhalla, the CFO and of Infinity Biologics is the name of that many of the field now and he was the senior analyst for almost 10 years at Citigroup covering life science tools diagnostics and Med Tech.
Amit covered most of our peer group and brings and unprecedented body of knowledge to the two are to the board as it pertains to our industry.
We are very fortunate that he agreed to join the board has experienced the city as well all of his time as VP of global strategy and development of Becton, Dickinson and will be and assets and the video and she will step right in and help us with our strategy and planning going forward.
I am also sad and to announce the Joel Kaufman had agreed to accept the role at some of for and has moved on from the video I want to thank him for his years of service and wish him luck and his new role.
Before I turn things over and Dr. Rosol I want to once again, thank my entire team for their tireless hours of work and it's most difficult of environments and I also want to thank my Chief compliance officer of Mr. Regan for Brady and the trip across the pond with me a few weeks ago. Despite all the hurdles we had to go through to get clearance for our trip and I would like to turn the call over the Doctor Rosell, who will cover the clinical portion of the call.
Thank you Jed and Hello, everyone as always I'm happy to participate and today's call and provide you with updates from the clinical side.
So I'll begin with the progress on our phase two of the trial now of 331 and our E S.
As I announced on the call two months ago, all patients and all visits have occurred in the study and we are in the midst of the analysis of the full data set and trial closeout.
This trial and the data we have analyzed for them. It thus far were critical to moving us forward and already as a reminder of this phase two b as of three arm trial and arms, one and two we are evaluating the repeatability reproducibility and stability of our telemetry the imaging readout in both healthy subjects and in patients with active RA and in the third.
Third arm, we are mirroring the upcoming phase III study to obtain data to help with sample sizing for the phase III and to have a first look at the ability of coming out of Sept imaging the serve as an early predictor of treatment efficacy.
As we have discussed and presented in the past the interim results from all three arms were very positive we have data demonstrating the technetium 99 of them to let us up and can provide robust quantitative imaging and the healthy controls and and patients with active already that the imaging is reproducible and can define joints with and without our a and b.
All of the inflammation and the tremendous up the imaging can provide and early prediction of treatment efficacy of anti TNF Alpha therapy at the.
This time the ongoing analysis from the complete set of patients continues to demonstrate high accuracy overall and the strong predictive value in particular for non responders to anti TNF alpha therapies, even from the baseline scan alone and the defined subset of patients and these patients those exhibiting a low level.
All of the tremendous uptake and their choice on the initial baseline scan who likely represents the fibroid subtype of all right. There was about a 92% non response rates the anti TNF alpha of therapy, using a clinical gold standard assessment.
And this resolved on its own of the ability to use the single time point scan to predict non response to anti TNF Alpha therapy and of particular group of patients would be a powerful tool for rheumatologists to be able to rule out an entire class of therapies from the get go avoiding the high costs possible side effects and possible worsening of the busy.
And that could otherwise be the case and combination with the predictive capacity, we are seeing and the rest of the arm three subjects and the data continued to look very good during this last quarter, we submitted our briefing package containing the interim results from the three arms of the study as well as the proposed phase III design and analysis plan too.
The S D E and the.
The FDA has provided us with constructive feedback and we continue the communication overall of the feedback that we received we received was positive and they understand what we're doing why we're doing it and how we are doing it and we remain and alignment.
They agree that of predictive tool like we are proposing with to manage the imaging could help address the large unmet medical need and all of a patient treatment.
They have requested that we continue with the full analysis of the complete phase II dataset and have the typical end of phase II type B meeting that occurs once that is done prior to the getting the phase III.
Given that the overall sample size and the interim look at arm three of was relatively small it is not unexpected that they would like to see the full dataset before we start the phase III and so we will ask for that and the phase two meeting when we finished the analysis and write off.
You should know that this is the usual process with the FDA, having this kind of meeting prior to the initiation of the phase III and we're working hard to complete the analysis and report and get it back to the.
Our goal has always been to keep in close communication with the FDA as we move a lot of this program to ensure that everything is in place for possible approval when the phase III is complete.
Want to also mentioned that we are making good progress and automating the imaging readout as well and this will have significant benefit to the commercial product. We have now opened up the healthy control study now of 335 to establish what is called the normative database. The first of all manifest and already and integral part of our ability to discriminate already and flames.
Joyce for those that do not have inflammation is the knowledge of what the healthy joint looks like quantitatively, we use the healthy control data from on one of the current phase two b trial to start to set these parameters and we will use this study to add to the size of this current normative database and this should enable us to discriminate already involved.
And it's from non already inflamed joints with improved accuracy and sort of a positive impact on our ability to predict treatment response. This normative database of establishing the parameters of what the normal July it looks like with the Medisoft will play an essential role in both of the phase III data analysis as well as the commercial product as I.
And on the last call and additional objective of this trial will be to evaluate the spec C T and the number of healthy subjects and already involved patients in order to establish the feasibility and possible utility of spect imaging for these purposes.
For some potential advantages to using spec C. T for this type of imaging and this pilot arm should put us on a good position looking forward to the application of the specs the key for tomato soup, the imaging and all the way we've opened up the first of eight sites now and the trial will run in parallel with the phase three as well as with the biopsy study. This first site on.
Already has a good number of healthy volunteers lined up and fact, oh and ever growing the number and several of the others wouldn't affect the open up the short.
So speaking of the biopsy study now of $3 32, we'd now open both the northwestern University and Barts health of London, as Jud mentioned into the Phase II study, where we're comparing to manifest the imaging the histopathology from the joints of patients with all of it.
We aim to recruit patients with each of the three subtypes of already to obtain comparator of imaging and pathology results from biopsies over there already inflamed joints and there were a couple of rounds of COVID-19 related delays and opening up the U K site, but as of this moment. The site is open and they are actively screening for patients and the reason we have selected the <unk>.
The K side is that our lead principal investigator for the trial is located there and he is the world's leading position enjoyed biopsies of patients with all day and he maintains the labs specializing in the examination of the pathological tissues from these biopsies and remember this trial is not required for FDA approval and the initial indications and all the way that we're going.
And for but we believe it is critical in order to achieve qualification of CD to all six of the biomarker for already is willing to engage with pharma for its possible use and trials of new way of alright therapeutics and it will.
I'll also provide rheumatologists with gold standard information related to our imaging readout and the fundamental biology of the patients already for example results for this study for directly demonstrate the tremendous up the imaging can be used to determine of patient subtype of all our a and this would have implications for what class of therapies might or might not.
Work on that particular patient this could therefore have immediate impact on the management of our eight patients.
On the cardiovascular disease front work continues on the investigator initiated atherosclerotic plaque imaging study at MGH and Boston and they are very close to achieving full enrollment and in fact, they just made a couple of more volunteers. The data we have seen thus far and continue to be promising in terms of localization of tomorrow on the shelf telematics up to site.
The plaque and they had been in line with what we reported and the pilot study and we co published with the previously preclinical studies of gallium 68 till Medisoft imaging for NIH funded project with the University of Alabama, Birmingham or also on growth.
On the therapeutic front, we continue to make strides forward for indications in oncology remember that we have performed preclinical studies that demonstrate macrophage phenotype changed from an immunosuppressive two of pro inflammatory state as well as the synergistic effect on tumor growth reduction and animal models using our doxorubicin.
And containing construct with and approved checkpoint inhibitor therapy.
Put more simply the tumors grow at a significantly reduced rate with our molecule combined with an approved drug compared to the approved drug alone. We've now seen this and different tumor models and combined with different therapies and these are important mechanism of action and proof of concept studies that need to be done in order to move forward and we are of.
So I didn't by the results thus far we will be presenting these results at the New York Academy of Sciences, Frontiers and cancer Immunotherapy Symposium on May 14th at 136 P. M and you can find more details on our earlier press release on our website.
Further preclinical studies, including the dosing schedule study looking at different starting points for therapy are set to begin this quarter. We're also looking at different therapeutic payloads and we'll be performing in vitro studies using these in the coming weeks and months and so our therapeutic pipeline is robust and moving forward. We also.
So continue to collect preclinical results related to increasing the delivery of our molecule whether it be labeled as the radiopharmaceutical or with the drug for a therapeutic to areas of interest versus off target localization. This could have far reaching positive implications for our compounds related the efficacy and safety we continue to.
Make significant strides towards producing the next generation of our molecule that we think will improve performance and both diagnostic as well as therapeutic applications as well.
And you might've seen our press release earlier today and.
Now, saying that investigators at the University of California, and San Diego have received and NIH grant to perform of Phase. One study looking at Hillman of Sept as of kidney imaging agent. We think this application holds tremendous promise and wanted to highlight that for everyone and you should also know that there are a number of investigator initiated studies we are.
Supporting and one way or another and other applications of telematics after Olympus C and as the results from these become available we will highlight those as appropriate.
On the IP front, we have received the notice of allowance from the U S. P. P O for the patent application titled compounds and methods for diagnosis and treatment of viral infections.
And this relates to possible therapies for a variety of the viral diseases, including dengue yellow fever, and other diseases caused by the flavor of virus.
The family, we have also filed and other invention disclosure related to prediction of treatment response, and our a and are putting the finishing touches on another involving new methods of chemical synthesis.
As I mentioned previously and we have and 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 nextgen molecules and disease indications.
Those are the 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 completion of the analysis of the phase two be full dataset preparation for the phase III and enrollment into the currently open and biopsy enormity of database studies, while we continue to support.
And push for progress on our other diagnostic and therapeutic indications and as always and 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.
Now I would like to turn the call back over the jet Jed.
And Mike as you can see we have a lot going on and all of the different areas of the company. So now let's move on to the financial updates with the Iraqi and Erica.
Ken.
Total net revenues for the first quarter of 2021 for 124000 compared to 156000 and for the same period in 2020 the.
Decrease was primarily due to decreased grant revenue related to small business innovation and research grants from the National Institutes of health and supporting me and a self development.
And that decrease was offset by a partial recovery and the first quarter of 2021 of debt that were previously written off in 2015.
Research and development expenses for the first quarter of 2021 for 1.2 million compared to 999000 and the same period in 2020.
The increase was primarily due to the net increases in drug project expenses, including increased manifest diagnostic and therapeutic development costs and increased TC 99, and tomato SAP development costs and.
And Ross the offset by decreased employee compensation.
Okay.
Selling general and administrative expenses for the first quarter of 2021 were $2 $2 million compared the $1 8 million and the same period and 2020 and.
The increase was primarily due to increased legal and professional services insurance Investor Relations services and employee compensation offset by decreased franchise taxes.
And finally net.
Net loss attributable to common stockholders for the first quarter of 2021 was $3 million or <unk> 11 per share compared to $2 $7 million or <unk> 13 per share for the same period and 2020.
And the video ended the first quarter of 2021, with $7 5 million and cash and cash equivalents.
I will now turn the call back over to John for closing remarks.
And you Erica and you can see things are really progressing very well. We finally have a substantial amount of cash on the balance sheet that will help us as we move forward into the phase III and the $3 32 trial and we remain very excited about what's to come over the next couple of quarters with that a J.
And like you to open up the line for Q&A.
Great. Thank you.
If you would like.
We will now be conducting a question and answer session. If you would like to ask the question. Please press star one on your telephone keypad and of confirmation tone will indicate that your line is and the Q.
You May press Star two if you would like to remove your question from the Q4 participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Okay.
Our first question is from Jason Mccarthy with Maxim Group. Please proceed.
Hey, guys and the Muslim casino, which on the line for Jason Thanks for taking the question.
Thanks, Michael.
So I'd like to see if you could give just a little bit more granularity on what kind of timeline, we should be looking at for some of the upcoming events like the phase to be meeting the full data from the phase two b and then the the.
And atherosclerosis.
Sure. So this is Mike rosol, thanks for the question the.
The analysis of the full face to be as ongoing without what we're projecting is that we should have those fully analyzed and in parallel we're working on the clinical study and report that will submit to the FDA over the next though.
The.
Maybe end of June or early July is what we're hoping for to get this done and get it done well on.
And I think that's a reasonable then what we'll do at some point and that interval and he doesn't make the meeting request with the FDA and then of course, there's a process there for when they get back to you and set up the meeting and.
So we'll be a little bit at the mercy of the F D. A as well as the guidance says and they've been very good about following their guidance is even as you know the country and they're just in the COVID-19 stuff. So I would anticipate that that would happen.
And you know ideally that'll happen in the summer sometime in the formal summer. So and you know we're gonna have been working on these things day and night as we are and we'll try to push these you know these timelines and shorten them as much as possible, but that's part of those are probably reasonable there's quite a bit of data and actually we're learning and.
And a very good way some some things and doing some further analysis of the full dataset now from the phase two b.
And there's lots of encouraging stuff coming out of it so and and for the FDA briefing book that we submitted before that work of course is very important to getting us to this point and much of that work that we've done we would have had to do at the end of the road anyway. So preparing the giant 800 and plus page document.
It's something that debt.
It's nice that the bulk of that is behind us and that we can just slaughtered and the final data on our analysis and and discussions from the full dataset. So I think we're in a good place. The FDA feedback was very positive overall I was really pleased to see that they understood.
All of the nuances of what we're doing and we seem to be and good alignment with them and.
And so that's the RNA side of things in terms of the atherosclerosis.
To be fair I don't know if they're on the phone the they're probably not but the MGH votes are probably getting tired of me bugging them, but theyre doing a great job.
They've had one or two subjects not to get too much into the weeds here, but they've had one or two subjects and they've needed to recruit and they've just had a number of the circumstances happen and that those folks hadn't been able to make their scheduled appointment so really there at the at the the very end of the road in terms of acquiring the full set of health ease as well as.
Eight patients for the trial, but I anticipate that almost any day now and then you know what the what they've been doing in parallel of analyzing the data as they collect it.
On both for the the spec C T side of things as well as the <unk> component to look at the comparisons of the C. T with the uptake of until the antiseptic and what we've seen so far and it has been very promising but that should happen. Soon you know I don't want of promise for them and we're not running net study, where it's an investigator initiated once I can't hold them to tap.
But they're they're interested and infinite, finishing this up and moving to the next thing as soon as possible as well as we are so it should happen pretty soon and we'll let you know.
Good alright, Thank you, Mike Yeah, Yeah, and and I have another one that you might actually be particularly qualified to answer here.
And I wanted to ask you a bit about the news you put out of this morning, how does the unmet need and diabetic nephropathy compared of something like alright, and what's the target market for something like this there are similar but you know of typing and treat and response angle and you have with our eight or is it just more traditional disease monitoring.
Well in terms of the the population I think the you know the number of folks with diabetes. Unfortunately is large and an ever growing so I think of.
The there's a there's a wide large market for kidney monitoring and paid patients with diabetes as well as.
You saw if you read the quotes and you probably did from the UCSD investigators and their potential applications and in the renal cancers as well and so I think the the market is opportunity is large the medical need is large and theres nothing really out there. These days to monitor all of these patients and particularly the diabetics and and early stage.
Debt this potentially could do in terms of the the the mechanism I mean, we are I'm not sure you actually asked that but I'll just say it anyway.
And it turns out that and important group of cells and the kidneys actually express CD two of six the so called the MS. Angela sells and so tremendous upped our it turns out is taken up by the cells and we have seen it's.
It's taken up at quite a good level and and some of the preliminary work to get to the space. There's been some promising already and patients who have kidney disease that there's a differential uptake and normals versus patients with kidney disease. So we think it shows a lot of promise and I think it's a very large market and I'm not sure I answered you.
Last question if you on it if I didn't ask it again and I'll see if I can answer.
And I just wanted to know if that theres. The if there's like a phenotype typing and treatment response angle as you have with the Ora O or for monitoring.
Yeah, I mean I.
That's a great question I think the applications will evolve.
Initially the first pass is just to be kind of and look to see if the image and read off can be a predictor of the of kidney disease. Oh does the of disease status set of given time point that then with Bayou potentially the ability to to look early on to see when somebody is crossing over into two of tight.
The disease that you're monitoring right, so chronic kidney disease and this case, so it would be a maybe and initial kind of surveillance tool for screening and then monitoring and these folks over time as they evolve and then potentially for treatment response. Indeed, so if there's if there are therapies out there for either the chronic kidney disease or even and renal cancers.
Hum.
Alleviate some of these these disease processes and then in theory, we should be able to monitor the the treatment response as well, but that's further down the road.
Yeah.
Alright, Thank you very much of it and just one more follow up on the financial side. If you guys don't mind, what did you see and give US an update on the talks with the the investors the ones that committed at $5 way back in August 2020, if you of any and any new news on that.
We do not have any new news on that of the commitment remains outstanding that is a ongoing discussion and the focus has been on the 5 million that Mr. Scott committed as well as the continued funding by Keystone and so that is where we're focused for now those dollars alone and get us to where we need to be on the completion of.
Of the phase III.
But I assure you we will be taking actions as it pertains to the $5 million at $5 of share at some point and time in the near future.
Alright, Thank you guys for taking my questions.
Thank you our next question Jeff.
Yeah.
Yes. Our next question is from Mike Rusch, Julie and private Investor. Please proceed.
Yes, good day jet and Michael and Eric Thanks for taking my call the for.
First question.
The first question pertains more to the $3 31, and and what the F and with your meeting with the FDA.
Give us any more on.
And you said the F D a understood it.
Yeah, Hey, Mike This is Mike Yeah, Yeah. So they are are they understood. The the the process of quantitation and that we're doing the predictive capacity of the imaging and how we're looking at that as.
And as well as our our clinical assessment targets and very nicely I might've mentioned and as previously because.
And because of the feel of our a and so or a clinical assessment and so nebulous and noisy as folks embedded in the field likes to say the FDA has allowed and and I think even expanded and the allowance and and very positively on the.
The clinical milestone of the clinical targets that we're lapping two what the heck of lot of saying so what I mean is there are many different ways to assess.
And if a patient is getting better or not and all of our a rights over time, they've essentially said to us that you know you can use the full.
Armamentarium of those different kind of composite clinical assessments just map. The one that standard of used are accepted by the by the folks out there and and go with that and if you can predict that early then that's a win and what's what we're learning and resume fully analyze the phase II data.
Is that actually where we're and and this may not be the end of the story, but it's the current status right now we're actually mapping to what is known as the ACR 50 of responds very well and that ACR 50 of response of the American College of Rheumatology 50 is a response criteria that rheumatologists think as is.
On a very significant one because what it means is that a patient is.
And it's getting better by 50% or more and a bunch of these individual assessments that are performed by the by the rheumatologist and so if a patient is getting better and a handful of these assessments by 50% and more that's considered a significant response clinically and the patient is and a much better place and we're lapping to that very.
Very well and fact that looks to be our best map and so that's really good and so the nice thing about the FDA responses, we've collected a whole series of composite scores and our phase two b trial of the Nab 331, and they said Hey, that's great and you might even add a couple and the phase three so I think that's the.
A very good thing overall.
Overall like I said, the you know when we look through the response.
The there was nothing that debt raised any major flags are I think they they understood our milestones and what we're projecting to Ah. They just want us to come back and you know with the full data set so that we can be.
Be sure that the story remains the same and right now it's a it's looking pretty good for that so.
And so what's your summarizing is maybe didn't show any hesitancy as to the quality of the data and the the results you were saying it was more give us the rest.
Yeah, Yeah, exactly I think that's a fair statement yeah.
Okay. My next question.
Is on the three dashed 32 a day.
Has any patients biopsy he'd been done yet either at north West and you said not in the U K up is has there been any biopsies done the northwestern yet.
No unfortunately, not yet there.
Actively looking.
And you know, it's not unsurprising for two reasons, it's not it's not awesome.
But one thing it often takes sites a while to get things rolling we see this all the time and clinical trials, it's really not uncommon at all this is the first one we've done with northwestern and so theyre getting things rolling they are screening one to two patients per week. The other part that makes it somewhat unsurprising as.
There are you know I think especially with the COVID-19 scenario of situation, there and maybe people who are less willing to commit to a trial that as of this invasive component and come in and do that but I think that's probably alleviating they're doing a good job of identifying patients and the I think it's only a matter of time before the you know the the floodgates start to hope.
And or at least I hope so.
I think for all the things lighten up.
Mike It's it's and this is Jed here I think it's interesting to note that as a the individuals' sitting in the room here with me are most importantly, Bonnie and Mike No debt. When we were doing on three every week I was quite disappointed and in the slow uptake at the beginning but then you sort of had the hockey stick I mean, we got you know one to pay.
And so it's very very slow.
But to reiterate I think once they get their feet under it and they really get the knack of the you know going through the patients and and and going through and screening correctly I do think that the enrollment will pick up quite quite nicely, but more importantly, also are with the U K, just having gotten going that's really.
Where we expect to get the lion's share of our patients because it's something that they've they've done and it's something that it is.
And you know it's more are they are more used to out there. So that's but yeah, but just to reiterate what Mike also don't underestimate. The fact that he is an invasive procedure, it's small but it is invasive but we do keep on top of the sites and we're going to continue to open up a few more and I really focus on I'm trying to get the patients in.
And quickly as we possibly can.
And the Union.
Really the sorry to interrupt you like this is like again the use of the U K just to follow up on what Chad said.
Cost of the tell us that the U K is the world leader and this and he is probably the best at recruiting. So you know it's a very good that he's been able to open up so it's all of them like back to you.
Oh, no sorry, I didn't mean to interrupt can you elaborate further on what the differences and screening versus the biopsy in other words will the screen and number of people and bring them back in for the biopsy or those that have been screened are not going to be considered what that mean.
Oh, there's a little bit of both I mean, so to meet the criteria. There there's an extensive criteria for exclusion or inclusion into the trial right like any trial and and this was the the identified patients of the Rheumatologist and say I think you know this person who's coming in as a possible candidate they have to meet the inclusion exclusion.
The list and then additionally, they.
And they need to have for example specific for this trial, but not others.
Need to have a whats known as the synovitis score of a certain value and that's basically there you know at least one of the joints has to be and flame due of certain degree otherwise, they're not going to be able to participate and the trial and theres, a long and long and boring story behind that but it's the necessary component for all of these biopsy trials. So once they pass the kind of.
You know clinical assessment and general. They also then have to do a if they make it past all of those hurdles they run into and ultrasound to make sure they've got enough the inflammation going on and they are joined at least one of the joints. So that we can then biopsy. It. So some folks don't even get to that stage, maybe the majority of them and then there then there are those who have to make it past that stage.
Screening is a it takes more than one visit if the person goes all the way through to maybe a couple of visits for this trial.
The screen the one to two of week is a pretty good rate and then yeah. It's actually really good at is yeah. Remember also these idiots the patients have to do it for the benefit of science and you can't just you know offer that and thousands and thousands of dollars. It's it's if there's a nominal fee they get but its really theyre doing it for the good of.
The overall community and obviously once we start getting those patients and things get rolling and they get used to it are as I said, we do expect that the enrollment is picking up and we want and you know we've been working with these investigators and preparation. So none of this is a is the surprise. So we have plans as Jeff alluded to we've always had plans to open up multiple sites both.
And the U K. We're also looking at a couple of other sites and the United States as well. So we're going to do what it takes two of you know get enrollment happening and rolling as fast as possible and and as Jed mentioned and the and the law of 331 trial. There was a time when we weren't getting patients hit them on all of a sudden the the the <unk>.
<unk> opened up and people people got it down Pat and then we as you might recall, we started actually recruiting at a higher rate debt is out than is typical for a pharma company in the in North America, and rheumatoid arthritis and all that.
And we're gonna be and the same place again because the.
The team not me and the team is including you know loved by body here is really good at this stuff.
When you do anticipate and sometime in the future of having an interim assessment of the 332 that you will be able to share of youre not that far along yet.
Well, we're going to.
And we built it and it's an adaptive design and the sense that we're looking at a minimum of four subjects and each of the three subtypes of all the way. So once we've recruited those we'll then look at the data and see how that correlation of the imaging readout to the number and density of the macrophages from the biopsy looks and.
And based on that look we will then decide if we're going to enroll more patients or if we have a good and the all complete enough story to tell but because we can't select so you know we don't know until we've recruited them. We you know we don't know when it will hit the for four and four of it might have to where we might get lucky and just worked through 12 and all of those grade and the day to look.
Awesome, well, we might have to recruit you know more than 12 and older to get that for four for through the door pardon the path of the wrong [laughter] of button.
Of the we will have that interim look.
And which might be the final look so.
Okay.
One more last question on the $3 32 from a layman's from a layman's terminology what it looks like the Mi is the biopsy will give you of physical validation the <unk>.
Rheumatoid arthritis.
Excuse me the Rheumatologist will then be able to know from the when they use the readings.
And see the quantification day theres been a physical testing.
So will that give them greater encouragement, but what they're seeing on the readings and the images and the quantification has been validated and that kind of the guts of this the gives them some of some certainty.
Yeah.
This is Mike and we'll have validated through the study if all goes according to our hypotheses will have validated that the imaging readout directly relates to the macrophage of which relates to the subtype of already so we'll have that linkage from the the imaging to the subtype of already so optum optimally not only will we ever kind of of grounding. So.
All of the ground truth, just as you're saying that the image represents the pathology.
The optimally, we'll be giving them the ability to have a virtual of biopsy, where they don't necessarily need to do that biopsy, but the image of the readout alone can be predictive of the subtype and from that there's a growing body of literature that suggests from numerous trials that are that have happened and our ongoing debt.
The different subtypes of raw respond differently to different classes of drugs. So the end goal is to be able to say from a scan. This is the subtype you're likely to have these are the classes of drugs that have shown some benefits. These are the classes that don't show benefit so avoid dose because of the rheumatologists at the end of the day.
They would like some tools that tell them that help guide them for what kind of therapy. The patients should be on because right now, it's literally trial and error as.
And as amazing as that sounds because of these biopsies are not done routinely they're never going to be done and part of as part of clinical practice routinely and theyre not done at very many many centers. So right now theres no other way to get this information. So if we can get it to them from our scans that would be great for them and for their patients as well as of course the inch.
Tours would like that because you know they don't want to pay for drugs that are not going to be having an effect and I can tell you what I've been hinting at if not outright saying is that the data from that 331 are in line with our hypothesis that one of those subtypes of <unk>. The so called fibroid tight.
It's known that there aren't many macrophages involved and those and that sub type of its also known that those folks don't respond to anti TNF Alpha is very well, maybe maybe 80% of them, 75% to 80% don't receive or achieve a clinical response.
What we're seeing in our study matches with our hypothesis that those some of those patients will not have much localization of clematis up and their joints and then therefore, we predict their fibroid and that they won't respond without knowing for sure of the ground truth, because we don't have the the biopsy yet the ones, who looked like normals or much of.
Like healthy without a lot of localization and naphtha and 31, they're not responding 92% of those are not responding to the anti TNF alphas that completely matches up with all the hypothesis and it's very exciting when we told our kols or key opinion leaders about this and that's what they're jazzed about the ability to be able to tell early on.
On the subtype, which then gives them information to guide them and what treatment to choose or not to choose so.
But translating this into the next two steps that this when should help also give comfort to minimize any pushback from the therapy providers of anti TNF of houses and they had a correct statement or not that is the correct statement and that's and that's what's important because remember this is gonna be and the end of the day provided.
And that this bears out and then they get the data. This is gonna be the key for the insurance companies and the hook to get them to make sure. The doctors use this on day zero because to be able to eliminate a full class which is the tier one clients. It's very important to have this data and that is something that.
The kols across the board, including those and we've just got the different areas have said that if this is what it is based on what we've seen and the arm. Three then that is.
You know the real hook that they're looking for because something that on day zero eliminates a tier one drug is very important and if we can do that to the tune of the 92% range that.
And that is going to be very very compelling and that's why we feel that 32 will be very helpful. In guiding on how we proceed are once.
And once we get the approval.
We would also translate into giving a higher level of <unk>.
Comfort to your marker and we will be optimistic and say that's jubilant Ah to move forward with the aggressive marketing plan, because you've mentioned yet and it's gonna be a very expensive campaign to get up on the marketing. So it should give them comfort two and give them. The rheumatologist is gonna be receptive to this.
Not to put too fine a point on it the since this is that this is the.
It kind of it comes down to the US which is why we've pivoted our discussions for that very reason.
Given what we saw and on three and given the nature of how the data was coming in and we would be foolish to go forward prior to getting this data because of the data is something very very valuable remember the original label the idea was anti TNF.
Monitor you know being able to predict but if you have that first step where you can knock out 35% to 40% of those with this type of phenotype right off the bat and we could get that on the labor right away well, that's a very very compelling reason to use it and.
Especially since as we all know and as I said I've. Given this example of millions of hot and somebody who's in the anti TNF user I know how these things work. So I I do enjoy discussing these people with other people because.
If you aren't in the system and if you're not a product of these biological drugs you don't understand the hurdles that it takes and I do and so that's something that's very important and that's why the half something that can tell you 35% to 40% of the time on average that its just not going to work and those.
And in the subset that is a very very big deal one of the Kols, we spoke to say and right off the bat well they weren't a big fan of the whole anti TNF because of the market is definitely changing the fact is the anti TNF, though for the first line. They are you know there are biosimilars out there, which are cheaper or the other the.
Other treatments are more expensive and if we can eliminate that and allow the insurance companies to have comfort to move on to the next here because there's just not going to work that saves the system money that gets people treated better faster and it also alleviates the other issues because remember when you see.
Start taking and anti TNF you put yourself on a on the time clock believe me I know because I have to get my infusion every eight weeks, if you Miss with and a few days your body becomes immune to it and then you're sort of screwed not to put too fine a point on it and you don't want to do that just like you don't want to start on the anti TNF.
It's not of work because then that creates other issues and your body when your body starts producing more TNF too.
And to sort of compensate for the changes that the biologic are having on you and so this is something that is very very important and in our discussions with our potential partner. This is something that we are focused on and this is something we remain focused on and that is why this data will unlock what we feel will be a better.
And we'll be a better overall agreements and that is why we are willing to wait.
And we have the financing in place and two it's going to unlock a better more robust financial package for and video.
Yeah.
Excellent. Okay. So any are any other questions Joe.
Yes. Our next question will be from Alan Stone with Wall Street Research. Please proceed.
Yeah, Hi, Chad and.
And Michael very nice presentation.
And and Erica.
The true just wanted to I was asked by some people are just a couple of days ago to take a look at your company and did.
And there's a little bit of reading about it over the weekend and yesterday and.
Suezmax and be able to listen to your conference calls a day.
I was wondering.
And it seems to me and my you know based on.
Just the size of the market unmet medical needs that you have that your your share value appears to be you know.
Probably lower than it should be.
And I was wondering if there are other companies.
Companies and the U S Big pharma companies and the U S or Europe that might be doing anything at all similar to the type of.
Discovery.
But you're looking to.
Create here and.
And the competitive nature of this.
Yeah. Thanks. This is Mike rosol, so Jeff can handle the money side, but I think youre right the.
The the share price doesn't reflect the possible of value share the that we're bringing to the table I think possibly the.
There are competitive molecules right that are taught that can target the macrophage.
But without being too biased here there are few things a few points to that one theres, none that I know of that are really being rallied by with the large impetus or large couple of them behind them.
The ones that are being migrated forward in terms of research and again to bias. The side I think this is a it's one of the reasons I'm here because I did my own due diligence they have their own deficiencies compared to the tone out of Sip molecule. The that we have so I think we have some of some biological advantages that those.
The overall of those other molecules that are out there that might be used for assessing.
The assessing disease status, whether it be to the macrophage or some of the other cells that are involved and all of our a.
So we have that the advantage. We also are way ahead of those folks even the ones that are being bought up by maybe smaller research groups or with smaller efforts then and the video has brought to the table. So I don't see.
And maybe some maybe you'll surprise me of somebody else, where it was something that I haven't said I've missed and I don't see a large competitor emerging and a short time period. So I think we're gonna we're gonna be good for quite some time in terms of what we're doing and in terms of other methodologies for assessing this and the imaging domain, where we're the leader.
There are those who are looking at different bloodborne, biomarkers and using machine learning algorithms to predict the treatment response.
Either from baseline of overtime.
And I think from the data that we've seen we also have the advantages over those folks and I could go into that and some further one on one discussion whatever the you know whatever I'm allowed to say, but in any event. There are folks who are looking into it because of the market is large, but we have advantages over the imaging modalities, the kind of molecules as well as I.
Think over these kind of algorithmic based approaches.
Debt, but make us really put us at the forefront of this.
Oh for Jaguar and.
Just just a follow up on net a little bit.
How many potential.
So are there for you out there and let's say and.
And the phase III clinical trials and for.
The licensing types of the deals that you could be making out there.
How many are there are there.
Maybe you could just give us some indication of that.
That's the that's an excellent question I think that on the <unk> side and I think as you know we signed an Mou with one partner, who we feel could be a very good long term partner on the raw side, we're very excited.
Excited by the prospect of especially given the marketing muscle that they could put behind the molecule, but you actually hit on a great point off for the overarching theme of what and the video hopes to become over you know over the next several years and I think it gets back to where the stock price is.
It is not right to discuss that and a call. So we won't but what I will say is that there have been many years of potential and it is a you know similar to what they used to joke. The Walter Mondale was the potential for the you know the.
Hope for the future of the Democratic Party and he always will be.
But with this there were certain key steps that needed to be taken on certain sides of the business that have now been taken b. The formulation basic chemistry basic testing things that were never done in the past, but now have been done that will allow us to partner first of 332.
We will give us the biomarker support that we need that will allow us to potentially partner in trials with all of the companies that are out there developing new or a treatment and if you look on trials dot Gov.
Who's who of every single major pharmaceutical is looking at new methods of action, a new molecules be the non injectables oral and.
Biologics different pathways of raw egg that is very important but more importantly, the molecule as it is.
It will be done in the future as we have made certain key changes that we have not discussed nor will we at this juncture, we will make it more compatible to get us to what the original idea was for and the video which is to be able to take other products take other therapeutics and make them better by making them more.
Targeted and delivering them and a better way.
The idea of the targeted payload delivery only works when you have the right chemistry. The molecule that is what it says it is and we are finally at a point, where we have that molecule.
And this is stuff we have not discussed nor will we discuss but theres a lot of things going on behind the scenes and we've made a lot of changes and a lot of improvements that will bear out we feel over the next several years that will make this a very compelling and very interesting company, which is why we think.
We are so fundamentally undervalued because for many years there was promise, but there was no delivery for many years there were discussions.
About certain parts, but but no poster presentations as we've discussed we will have one this week and it is something that we are very very excited about because we finally have taken the key steps to really get us in the right place things.
And things that hadn't been done and the past. So we do feel that on that side of the business. There are very many potential partnerships, but that will come and time and I am not going to tell you today I'd be lying if I did that you can expect something tomorrow or even in the next several quarters, but we are taking the right steps we are fine.
Going step by step as we're supposed to and as you are supposed to develop a product and now that we've done that without discussing it with the stuff we've done over the last several years.
And we are really really excited to start putting that into action over the next several quarters and years to come.
Yes, Thank you and I look forward to following up with you.
Excellent Allen. Thank you so much for your question Joe do we have one we have done and probably for one more question.
Yes, we have another question for Mike Rusch yearly.
Private Investor. Please proceed.
Yeah, sorry, I had one last question can you highlight anything and we will see as investors.
In the frontier symposium the abstract will.
That will be a very encouraging or do we have to wait and see the abstract.
Oh.
Yeah. This is Mike Rosol, I think I touched on it and my and my little preamble to the abstract today. So I think it's I think it's OK I think of what.
What youll see is that we have accumulated evidence of our mechanism of action, which I think is obviously very important for therapeutic and we've shown that we can change the phenotype of macrophages with our construct and drive them from one type of the kind of.
The so called for steel type debt as protective and the cases of cancers. For example, two of more pro inflammatory type debt actually rallied the body's immune system against the cancer right. So that's something you'll see some fundamental data on and you'll also see data from one of the tumor models that we've run in.
And in rodents, where we've shown that our drug actually and are in a type of tumor that is moderately responsive to and approved therapy, So and already approved checkpoint inhibitor therapy. It's generally as its class of humans, we actually show that we can make that therapy better at least.
From the data showing that the tumor growth.
Option has increased what our drug is used in concert with that approved drug but one of them.
The size of that and that's why I'm emphasizing it and that is.
It's the already approved drugs that we actually appear to make performed better right in terms of its tumor response, and a number of animal models, and you're going to see that and it and one of those and what we're doing now as I also mentioned on the call is worth we're engaging with the contract research organization and the one where we ran some of these studies.
And in rodents to look at different dosing.
Both of the amounts of our construct as well as delivery time points related to that other approved drug and enel.
Other cancer types, just so that we can hone in on this and and perhaps you know maximize the efficacy of the synergistic response so.
And a nutshell youre going to see some fundamental mechanism of action as well as some proof of concept and a relevant rodent model all of which is critical to moving forward and do a possible first in human.
What is the improvement and the rodent model Sydney and.
And your you yeah, Yeah, I wouldn't mention it if it wasn't statistically significant.
So it is indeed, the statistically significant so and again.
I want to emphasize that that model was chosen specifically because even the approved therapy is not super duper responsive we wanted to give ourselves some dynamic range to show that we're actually having a synergistic effect and we indeed saw that so it's very encouraging.
Alright, Thanks for taking my last call appreciate it thank you gentlemen, and ladies and for the day. Thank you.
Excellent I think that's all we have time for so I just want to thank everybody for dialing in today, we look forward to hopefully at some news over the next couple of months of certain key items for the company come to fruition. We are we are expecting over the next several months and I look forward to speaking to all of the guys soon and the new.
The future.
Uh huh.
Ladies and gentlemen.
On today's conference you may disconnect. Your lines at this time. Thank you very much for your participation and have a great day.