Q3 2022 Navidea Biopharmaceuticals Inc Earnings Call
Greetings and welcome to the Eaton the video Biopharmaceuticals quarter, three earnings call and business update.
At this time all participants are in a listen only mode. A brief 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 and as a reminder, this conference call is being recorded it is now my pleasure to introduce Dr. Michael Rosell, Chief Medical Officer. Thank you Michael you may begin.
Thank you and welcome to everybody. Thank you for joining us here today on our earnings call.
This call is being webcast live on our website IR dot into video Dot com and a replay will be made available.
There isn't an accompanying.
Following prepared remarks, we will be conducting a live Q&A session.
<unk> share of its board of directors, Mr. Alex Capello, It's Vice chair Mr. Kim Scott its vice President of Finance and administration Erika Eves and me are joining you on the call here 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 than immuno therapeutics, which include clinical and regulatory developments and timing of clinical data readouts along with capital.
<unk> and strategic matters.
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.
C C.
As we begin our update I thought it would be helpful to detail a few of our key areas of focus in our 'twenty 'twenty three planning.
One we'll continue with you or a phase III trial success to full enrollment NDA submission and FDA approval.
Two we will fully fund the phase III trial company management and the board of directors are engaged with multiple potential capital providers in support of our mission to identify this full or a trial funding. Our goal is to be fully funded in 2023.
Three we will attract and retain top biopharmaceutical talent.
As our re development program success grows so does the need to grow our team to help support key milestone achievements support key strategic relationships and initiate new P. R. I our efforts as a way to share our trial in milestone success.
As we look at Q3, specifically the company successfully received an additional $1 million in capacity bridge using the same bridge loan facility currently in place from the company's Vice chair of its board of directors Mr. Scott.
The company also successfully raised $6 2 million in proceeds from its most recent right recent rights offering with the investment banking arm of Maxim group, if exercised additional proceeds of up to 11 6 million maybe received through the exercise of warrants issued in that same rights offering.
We also received an accelerated reimbursement payment of $800000 for certain research and development expenses from our strategic partner.
We have advanced our clinical trials in rheumatoid arthritis, as well as our pipeline and other diagnostic indications and in therapeutics.
We continue to make solid progress on our phase two b trial in rheumatoid arthritis or are a comparing imaging the biopsy and we have just this week presented at an international conference our updated promising preliminary results supporting <unk> ability to distinguish the fibroid path to type from the non fibroid.
In the first 13 participants evaluated by the time of the presentation Finalization more on that in a moment.
These strong early results do support our hypotheses and provide excellent data in support of <unk> imaging as a biomarker of CD <unk> six expression enjoying some patients with all or a.
We also continue to enroll into the phase III and opened up an additional nine sites in August and early September bringing our total opened 12. We also continued to advance our therapeutics and imaging applications through key existing collaborations with well known institutions and investigators across the globe.
As we work to grow and advance the company's intellectual property.
We're very proud of the progress we have made in the planning we are putting in place to benefit our associates and our shareholders here at in the video.
Regarding the CRD and Dr. Goldberg litigation matters of the company is at two rulings that essentially bracket. It's exposure in both the company will continue to minimize exposure.
Now I would like to provide a brief update specific to our clinical results I'll begin with the progress in our rheumatoid arthritis program.
So we continue to enroll into our phase III trial as I, just mentioned and are a as we've recently announced that we have opened up those nine additional sites. The initial indications we're pursuing for FDA approval are one early prediction of treatment response to a new or first time anti TNF alpha therapy and two.
To identify our eh patients with low levels 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 a therapy is working in a patient with already because if a drug is not working the.
Patient's disease is not being treated and this can lead to long term health consequences, along with unnecessary high drug costs for ineffective therapies that bring with them possible side effects.
Our phase III trial will establish the ability of <unk> imaging to serve as an early predictor of treatment response in our eh patients switching to an anti TNF alpha therapy addressing the unmet medical need.
Nab 332, our comparison study of <unk> imaging to joined biopsy remains an active recruitment.
As we've announced and discussed previously the preliminary results of this trial are promising our aim is to recruit patients with each of the three paths of types of already.
To obtain comparative imaging and pathology results and the trial is designed so that we enroll a minimum of four subjects in each of the three subtypes of RA fibroid diffuse myeloid and lymphoid myeloid. So overall trial size has been expected to range between 12 and 24 participants to date.
We have enrolled 14 participants and achieve the minimum of more.
Or more in two out of three of those paths type buckets with patients having at both our imaging and joined biopsies completed.
The primary objective of this study is to assess the relationship between joint specific to Atlanta Sept uptake values and the path of biology of already involve joint tissue.
Knowledge of an individual patient's pathet type may be clinically important because it may predict too which are a therapy a patient is likely to respond.
There's a growing body of literature, suggesting that those patients with the fibroid type of RA are much less responsive to the anti TNF alpha drugs and so a means of determining whether or not a patient has this particular past. The type is seen as extremely important to a number of key opinion leaders and rheumatology.
As of this time, there is no reliable way of assessing a patient's path of the type of our a other than by doing an invasive biopsy and we have a hypothesized that <unk> could provide this information by providing a way to do a virtual biopsy of a patient's are a.
We just finished showing updated preliminary results on the first 13 patients at this week's American college of Rheumatology meeting.
This is the largest rheumatology conference in the World. These results indicated that till man of Sept uptake in our a inflamed joints is able to discretely differentiates patients with the fibroid path of type I E. Those with low macrophage involvement from those having either the diffuse myeloid or lymphoma myeloid path.
The types of our a I E those with higher macrophage involvement.
As of this time today, we've been able to clearly classified patient says either fibroid or non fibroid based on our imaging results taken before biopsy and all 15 participants.
These data also provides support for one of our indications in the phase III trial that 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.
As I mentioned, there is increasing evidence that if a patient has the fibroid type of or a they're less likely to receive significant benefit from anti TNF alphas.
You might recall that our in our previously completed phase <unk> study Nab 331, where we looked at the efficacy of <unk> imaging at early prediction of treatment response, those patients in that trial, who exhibited a low level of <unk> uptake in their joints on their baseline scan alone had an almost 90%.
Non response rates to anti TNF Alpha therapy, using the clinical gold standard assessment.
Importantly, these promising early results have opened up conversations with pharmaceutical companies developing therapeutics for our a with the possibility of <unk> imaging being used as a biomarker in drug development pipelines.
The key differentiator between now and prior discussions we have had is that we have these additional promising data in hand, and as we move forward to trial completion. If these current results hold will be an <unk> and an even better position for discussions with companies with which to work.
We continue to make very good progress in automating the image quantification as well, which will have significant benefit for the commercial product. We have the letter of intent and continue to work a letter of intent and continue to work closely with MIM software on the full agreement for them to be our commercial partner for image.
Vacation of <unk> imaging and our E.
Once again MIM is a leading medical imaging software company with a large footprint in the nuclear medicine space. They completed a pilot study using data from our earlier trials demonstrating that they can develop a fully automated application that can robustly reproduce our quantitative imaging readouts using our proprietary algorithm.
This will be important for rollout of a commercial product the ability to perform quantitative reads of our images rapidly and reproducibility and at large scale through automated means is critical to widespread use and adoption of <unk> for our a keep in mind that all of this the image analysis methodology as well as the date.
Upon which it is built including the normative database you have heard me discuss before is not only critical to deriving the most accurate insensitive read of our R. A images, but it also serves as a significant barrier to entry to possible competitors in this space.
We will continue to work with MIM to finalize terms of our partnership and will make an announcement when completed.
So in other areas of our diagnostics pipeline development in cardiovascular disease. The group at the Massachusetts General Hospital in Boston published the results of the investigator initiated atherosclerotic plaque imaging study that we help to support the.
The data are promising in terms of localization of command us up to sites of atherosclerotic plaque and were in line with what was reported in the pilot study we co published with them previously we press released this publication that the most recent publication and you can find reference to it in that release.
Preclinical studies on gallium 68, <unk> for pet imaging and related next generation manage theft imaging agents have progressed significantly through internal work here at <unk> and through extra miro collaborations with researchers at the University of Alabama at Birmingham or UAV.
We have completed work on our NIH funded preclinical studies for evaluating gallium 68 till may NSF and various new imaging agents similar till to manifest in a mouse model of atherosclerosis.
Work with UAB on another important set of preclinical imaging studies was completed and presented at the society of nuclear Medicine, and molecular imaging meeting last summer a manuscript is currently in the second round of peer review.
This work looked at a method to increase the localization of our imaging agent to target tissues. While additional 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 highly successful showing that we can dramatically increase localization of a neutral manner SAP like imaging agent to tumors, while simultaneously and significantly blocking off target localization to deliver this has important implications for our therapeutics as well.
On the therapeutic asset front, we are advancing our candidates in the oncology and anti inflammatory spaces in preclinical studies with the goal of filing investigational new drug applications or ind's to advance to human studies in 2024.
These filings will be significant inflection points and opportunities for licensing and partnering deals.
Work on new drug delivery construct a new targeted payload has progressed these.
These new construct carry new drug payloads that may be more effective than doxorubicin for beneficially altering the immune status of tumor macrophages for example.
Results in mice have demonstrated that when administered alone or in combination with another cancer drug. These therapeutic construct significantly reduce the rate of tumor growth by an average of 76%.
Some of our results covering new bisphosphonate payload construct were recently presented at the tumor myeloid directed therapy summit meeting.
More recently on November 10th in fact, the whole spectrum of results for both our Paclitaxel and novel Bisphosphonate construct were presented at the annual meeting of the society for immunotherapy of cancer or <unk> held in Boston mass.
This work is about advancing to a lead candidate for macrophage phenotype altering drugs for oncology indications I can tell you. The work presented at Citi was well received and we had a steady stream of attention.
In vitro studies examining the ability of our dexamethasone construct for inflammatory indications have shown positive results as well demonstrating macrophage phenotype change. These constructs will soon be tested in preclinical models.
Preclinical studies are also ongoing and leishmaniasis leishmaniasis as a vector borne chronic disease caused by a protozoan parasite that replicates in CD to a six positive macrophages. It is transmitted to humans through the bite of infected sandflies found in parts of the tropics sub trough tropics.
In southern Europe .
It's rare in the U S, but in more tropical countries, where the sand five vectors are found it as a common serious and potentially life threatening disease.
The FDA has designated leishmaniasis is a neglected tropical disease, making new therapeutics potentially eligible for a priority review voucher.
That in our case, we could sell potentially for more than enough to back cover cost of development as well as accelerate the number of other pipeline candidates.
We have earlier work, we published in 2017, showing that high <unk> expressing macrophages play a role in the dominant form of the disease.
And we recently renewed preclinical studies with one of the world leaders in leishmaniasis at the NIH and we know it promising results from several preclinical studies.
Last of these studies was just recently replicated demonstrating that one of the company's therapeutic construct could dramatically reduce the growth of leishman I'll parasites in a mouse model of the disease.
These exciting results indicate a new mechanism of action for our therapeutic construct and set the stage for further in vivo preclinical studies with these collaborators at NIH.
If these continue to hold we will perform preclinical safety and toxicity studies and advance towards I N D status application as well.
And so our therapeutic pipeline is robust and moving forward.
That brings me to our overall intellectual property front, we received notification of issuance of patent from the U S. PTO as well as the state of Israel for our patent application covering the manifest based therapeutic for leishmaniasis, we continue to submit new provisional applications and work on pending ones.
We have filed a new provisional patent application, describing a novel degradable linker for the therapeutic payloads dexamethasone in paclitaxel containing macro manas up therapeutic construct.
This linker was used in some of the studies I just mentioned a few moments ago.
These constructs are being evaluated pre clinically for effects on macrophages and in animal models of oncology and inflammatory indications.
All told we have filed five new provisional patents since the end of last year.
In partnership with our excellent patent attorneys, we have an active IP protection strategy for the company that will provide needed protections and rights to both our current diagnostic and therapeutic agents as well as to our next generation molecule than disease indications.
Regarding lymphocyte Europe , and the rest of the World. Our strategy has been and remains to find the right partners for marketing and distribution for Lymphoseek and other company pipeline candidates in Europe and beyond the reason for this is we are focusing on our long term strategy of partnering for marketing and distribution.
On that drug manufacturing and supply front for both Lymphoseek and they are a product. We have we have been and continue to work with a new active pharmaceutical ingredient or API supplier as well as our final drug product supplier progress continues and as of this time, we are advancing towards completion of these and readiness.
As for clinical and commercial supply.
This work has implications for Lymphoseek in China, and lymphoma aim in India, as we need to be able to supply a steady and reliable stream of product to our partners in these countries.
You might have seen our press release announcing publication of the manuscript by an Australian investigator using til manifest. This was the first such study coming out of Australia. In this investigator and his colleagues are enthusiastic about using lymphoseek in Australia going forward.
So these are just some of the highlights of the last quarter that I wanted to touch on for this update.
We remain largely focused on the raw pipeline, specifically the phase two imaging to biopsy trial as well as 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 our network of clinical trial sites and academic research collaborators for all of their hard work.
Our strategy remains to advance our pipeline products to key inflection points and seek appropriate partnerships for commercialization and marketing.
With that I'll now turn it over to Erica for financial updates Erika.
Thank you Mike.
Consistent with peers focused on the successful completion of phase III trials, our revenues for Q3 were minimal.
Total revenues for the third quarter of 2022 were approximately $8000 compared to 96000 for the same period in 2021.
Total revenues for the first nine months of 2022 were $65000 compared to $481000 for the same period in 2021.
The decrease was primarily due to the 2021 partial recovery of deaths that were previously written off in 2015 the.
The 2021 receipt of reimbursement from Cardinal health of certain R&D costs.
Decreased grant revenue related to small business innovation research grant from the National Institutes of health supporting <unk> development and decreased license revenue from transitional sales I would tell him out of Sept in Europe .
Research and development expenses for the third quarter of 2022 were $1 2 million compared to 1 million for the same period of 2021 R&D.
R&D expenses for the first nine months of 2022 were $4 1 million compared to $3 8 million for the same period in 2021.
Selling general and administrative expenses for the third quarter of 2022, or $3 6 million compared to $1 5 million for the same period in 2021.
SG&A expenses for the first nine months of 2022 were $6 7 million.
Compared to $5 1 million for the same period in 2021.
Following the ruling by the Texas Court in August 2022, the company recorded $2 $6 million in legal fees pursuant to the C. R. CRT judgment and that was recorded in SG&A.
Because it is net loss attributable to common stockholders for the third quarter of 2022 was $7 7 million or 25 cents per share compared to $2 4 million or <unk> <unk> per share for the same period in 2021.
Our net loss attributed to common stockholders for the first nine months of 2022 was $13 7 million or <unk> 45 per share compared to $8 1 million or 28 cents per share for the same period in 2021.
And finally in Nvidia ended the third quarter of 2022 with $4 6 million in cash and cash equivalents.
Thanks, Mike.
Thank you Erica and now I'll turn the call over to any questions that might be out there we'd be happy to address once again joining me on the call is our chair of the board, Alex and Capello as well as.
Mr. Kim Scott, our Vice chair and Eric <unk>. So I think we should be able to handle any questions that come our way.
Yeah.
Thank you we will now be conducting a question and answer session and if he would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate that your line is in the question queue. You May press star two if he would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
We ask that you please limit yourself to one question and one follow up and if you have more please reenter the queue.
Thank you.
One moment, please when we poll for any questions.
And our first question comes from the line of Michael <unk> with Maxim Group. Please proceed with your question.
Hey, guys. Thank you for taking the question like the rest of the progress this quarter.
Thanks, Mike.
Uh huh.
Yes, I just wanted to first touch on for those nine additional sites for any of those used in prior studies for Tc til and.
How is the above average rate of recruitment held up as you've added these new sites.
Yeah, Great question. So yes, we have we we took advantage of the kind of conglomeration of of research centers and in certain geographic areas as well as the imaging centers that we've worked with before so there are there is an imaging center for example that we've worked with in prior trials that are.
<unk> has is fed into by several different rheumatology practices. So we took advantage of that and so that is happening. So it's an imaging center, we've used before as well we have a couple of rheumatology sites. We've used previously that we've opened up into the study. So we tried to take advantage of of our prior experience.
With sites that have been excellent recruiters to bring them in there are several other sites that are in the queue to come into the phase III that we worked with in prior studies in and they're anxious to come in we just need the accelerant of of AR increased capital into the company. So we can go full bore on that front and.
Yes, right now we're still.
We're above the average recruitment rate for our <unk> trials phase two and phase three in North America. Historically, we continue to maintain that.
And eat where.
Where we're doing that even with the fact that we just opened nine of these sites and as I mentioned end of August early September and very frequently it'll take a month or two or more for sites to really get rolling in some of the sites are in that boat to be Frank other sites just started role enrolling rapidly right away. So.
And there are different reasons for that overall, we're we're we're maintaining are above the average recruitment rates significantly. So so things are looking very good.
Alright, Thank you for that and then just.
One follow up for me I wanted to see if you could give on.
Date on either you know how many are the proportion of.
Responders versus non responders, which have enrolled the study so far since it could impact the overall trial size.
Okay.
Great question, Yeah, we are tracking that and what we're doing is without unblinded. The study we were able to see the clinical response rates are at three and six months and right now we have a good number of patients at the three month.
Milestone in so we can look at their clinical responses and without going into the details without without releasing too much information here, we're trending more towards the lower end of the trial size possibilities, which would be great. So as you know maybe not others on the phone here the phase III trial size could.
Range from about 200 to 672, and we're trending more towards the mid to lower end of that based on the response rate. So things are looking really good there.
Alright, Thank you very much and again, thanks for taking my questions Youre welcome. Thank you.
Thank you and our next question comes from the line of Mike rationale a private Investor. Please proceed with your question.
Okay.
Yes Doctor Rosell appreciate we concise strategic outlook presented at the beginning that was very useful.
My first question is are you able to share how many people who have been enrolled in the face of the $3 33, so far.
Thanks, Mike a good question, yeah, I'm not going to share that today, what we'll do is we're tracking that and when we hit certain milestones, we'll we'll make announcements as appropriate when those are hit so stay tuned is what I'd say, but enrollment is going well.
Okay.
Blow up on 332, you said, you've had 15 patients enrolled now or you're still running at 100% match.
Yeah, we're 100% match.
You can't do better than that right and then Mike I know you already.
Yeah, Yeah, Yeah, that's 14.
14, okay.
Now on the on that at 100% match. That's excellent is how important is it to now differentiate between the yeah.
Fibroid and the Nam five right I know, you're still trying to differentiate between the dikes you said the Liverpool.
Is that really that critical.
Yeah, Great question so the.
What we're hearing from the Rheumatologists out there and I was just at the American College of Rheumatology meeting over the weekend and I met with a number of key opinion leaders in rheumatology and really the really the big players in rheumatology and are in the world not just in the U S. That's not me bragging, that's me, giving them complements.
And the word from those folks that primarily the the they're really excited about the fibroid and non fibroid differentiation because theres, a nice body of literature already suggesting that being able to distinguish between those two types can really give you significant information for helping guy.
<unk> patients to a more appropriate therapy or guide them away from a therapy that.
It is less appropriate for for their type of disease. So that I think is a primary importance distinguishing between the diffuse myeloid and lymphoid myeloid isn't.
It is important as well and it depends on who you ask there are there are certain scenarios, where its importance may rise, particularly for example in the development of therapeutics that may target. One of these specific subtypes or two out of three of the subtypes of <unk>. So you can imagine scenarios where.
Where its importance is elevated and we've heard that.
From key opinion leaders as well as pharmaceutical companies directly.
And there's a growing body of literature, suggesting that some some agents work better on one of those two types than the other as well, but that's more of an evolving field. Currently so really the fibroid. Non fibroid is is as seen kind of across the board is extremely important and very exciting.
Because right now you can't do it any other way other than by doing an invasive biopsy. So our virtual biopsy as a way to do it noninvasively and quickly.
And Ah Theres growing emergence of the idea of looking distinguishing between the other two types. So.
Would you still be considered the gold standard if you could only do that.
Hum.
Fibroid spot versus the non fibroid would you still go yeah, Yeah, I mean that is absolutely tremendous value.
Because again you can't do it any other way than doing the biopsies the biopsies, depending on who does them have a 15% plus or minus 5% or so a margin of error, they're difficult to do Ah patients don't like to do them. That's why these trials are hard to recruit for these biopsy trial. So.
With our scan being able to distinguish fibroid from non fibroid the word I heard on the street.
Is that would be tremendous value to the field of rheumatology.
Excellent well you know your science is so robust I'll go back into the queue and come back then thank you.
Oh actually I think you're back in the queue yeah.
Back to number one Mike.
Get back and economies.
Overall.
Okay Alright.
Yeah.
Thank you there are no further questions at this time I would like to turn the floor back over to Michael for any closing comments.
Oh, that's right, we'll do a Mike Rocky Ali has one more question, we'll let him ask now Oh I'm, sorry, I do see that he just re queue. Thank you.
Mike.
Thanks, very much on the science, who you mentioned that being at these conferences and that you didn't have a lot of feedback, particularly cancer immuno therapies.
The conference can you give us some generalization of the type of questions. They were proving it with.
Sure. So one of the interesting things of our construct is what we're doing is where we're attaching. These these known therapeutics like Paclitaxel <unk> doxorubicin and now Bisphosphonates, which in general are known drugs. Although importantly, we've created a novel Bisphosphonate. So that's also very.
Lighting.
But those drugs have known mechanisms of action when they are attached to our molecule our massive platform and delivered through the CD to a six.
Pathway, they actually have different mechanisms of action than free drugs themselves and what they're doing is they are actually changing the phenotype of the macrophage rather than doing what they do is pure cancer drugs for example, the Paclitaxel <unk> doxorubicin.
They are not achieving their effect in that same way, where they go in and stop cell division or you know cause cell death, they're actually going into the macrophage and changing the phenotype in this case more or in these cases more towards the pro inflammatory type, which rallies and stimulate the body's immune response in our in our animal.
Models against the tumors.
And this is very exciting so we had a number of questions related to that that mechanism of action and that led to a lot of excitement and then the results themselves and I'll post the poster onto our website in the coming days, where we're posting the American college of Rheumatology posters on the website later today.
Tomorrow as well so you can look at the poster, but in our data what we've done is not only are we driving the phenotype more towards the pro inflammatory state, but we're also having other effects like we're reducing the surf alpha signal of which relates to the macrophage Oh I'm sorry, the tumor cell don't eat me signal.
So what we're doing is worth were suppressing surf Alpha which would then work in a roundabout way to.
Get over the hurdle that the tumor cells present, where they stopped the macrophages from eating them basically keeping things simple. So we have a kind of we have a surprising and really cool unexpected additional mechanism of action, that's really on the cutting edge of of of Immunotherapies and can.
Sir.
So not only do we can we drive the phenotype of certain way in so doing we're actually stimulating the phenotype.
And in a way that is the at the leading edge of what's going on in the immuno oncology space. So we had a large number of people who are very excited by that and and the encouraging thing for this small company from Columbus, Ohio, or Dublin, Ohio, specifically is we're at the forefront our data are right. There at the forefront of this kind of <unk>.
Medicine. So you know our need is to get the accelerant as I said earlier to drive these things more rapidly into the clinic, but the technology is there. The science is there and we're doing all we can do advance it as rapidly as possible, but it's really very exciting.
So with that.
That forefront with that kind of like be driving T. D 163, lower as an example.
So there's all sorts of things going on here. So some of the macrophage markers that represent macrophages that are more anti inflammatory or wound healing. So those are those are going down in the cells and with our immuno oncology agents. The ones that are are recognized as the pro.
Inflammatory markers those are going up.
Part of those some markers are going up that interact with T cells to tell the T cells to attack.
The tumor cells and those are going up as well and then these other things that are involved in what's called checkpoint inhibition are going down. So we have this concert of different.
Are things going on when we introduce our construct that all work together to rally the body's immune response to the macrophages in the T cells against the tumors and we're seeing all of that in our studies and and and so yeah and so that's a it's just really exciting.
Thank you there are no further questions at this time and I would like to turn the floor back over to Michael for any closing comments.
Thank you I'd like to thank you all for joining us today and for your support of the company and the people here, we will close the call now and see you I believe that the annual meeting it will be the next a milestone on the calendar.
Thank you very much.
This concludes today's teleconference. You may now disconnect. Your lines at this time. Thank you for your participation and have a great day.
Yeah.
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Yeah.
Yeah.
Yeah.
Okay.