Q4 2022 Navidea Biopharmaceuticals Inc Earnings Call
Greetings and welcome to the New video Biopharmaceuticals fourth quarter 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. As a reminder, this conference is being recorded it is now my pleasure to introduce to you Dr. Michael Dr. Michael Rosell, Chief Medical Officer.
Thank you Mike you may begin.
Thank you and thank you all for joining US here today for the earnings call and business update.
This call is being webcast live on our website IR dot and the video Dot com and a replay will be made available. Following prepared remarks, we will be conducting a live Q&A session as you've just heard the videos chair of its board of directors, Mr. Alex Capello, The Vice chair of its board of directors, Mr. Kim Scott It twice.
President of Finance and administration, Ms Erika Eves and its controller Mr. Joe Meyer are all joining me on the call today. During the course of this conference call, we will be making forward looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop new videos molecular.
Sticks out immuno therapeutics, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources 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 SEC.
As we begin our update and look back at events from Q4 to date. So I thought it would be helpful to reiterate a few of our key areas of focus in our 'twenty to 'twenty three planning.
One we will continue our a rheumatoid arthritis phase III trial success to full enrollment NDA submission and the FDA approval.
Two we will fully fund the phase III trial and the board of directors is actively engaged in discussions with capital providers in support of our mission to identify this full already trial funding. Our goal is to be fully funded this year.
Three will attract and retain the industry's top biopharmaceutical talent as our re development program success grows so does the need to grow our team to help support key milestone achievements identify and support key strategic relationships and initiate new P. R. I our efforts as a way to share our trial in milestone success.
As I mentioned, a moment ago on the financing front. The board of directors is actively engaged in our financing effort and we hope to have news to announce there shortly.
In the last quarter, 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, comparing imaging to biopsy and during Q4, we presented at an international conference our updated promising.
Preliminary results supporting <unk> ability to distinguish the fibroid pamphletize from the lawn fibroid in the first 13 participants are evaluated by the time of the presentation.
These strong early results support our hypotheses and provide excellent data and supportive to manifest imaging as a biomarker of city tour six expression enjoins the patients with already.
We also continue to enroll into the phase III and are actively enrolling and 12 sites. We continue 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 the company's intellectual property.
We are proud of the progress we have made in our planning, we're putting in place to benefit our associates and our shareholders here at in the video.
Regarding the <unk> and Dr. Goldberg litigation matters. The company has had rulings that essentially bracket it's exposure in both we.
We will continue to minimize exposure now.
Now I'd like to provide a brief update specific to our clinical results. So I'll begin with the progress in our rheumatoid arthritis program.
The Nab 333 of the phase three we continue to have good enrollment into this phase III trial and are a the initial indications we are pursuing for FDA approval are one early prediction of treatment response to our new our first time anti TNF alpha therapy and to identify our eh patients with low level.
Of localization of <unk>, 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 of the drug is not working the patient's disease is not being treated and this can lead to long term health consequences, along with the unnecessary high drug costs for ineffective therapies that alt.
So 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 all RA patients switching to an anti TNF alpha therapy.
By saying that unmet medical need.
And Nab 332, our comparison study of <unk> imaging to join biopsy.
We remain in active recruitment as we've announced and discussed previously the preliminary results of this trial had been promising our aim is to recruit patients with each of the three paso types of array 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.
To date, we have achieved our enrollment targets in two out of those three of those paths type buckets with patients having had both our imaging and joined biopsies completed.
The primary objective of this study is to assess the relationship between joint specific Tom Anisette uptake values and the powerful biology of the already involved joints knowledge of an individual or a patients pass type maybe 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 already are much less responsive to the anti TNF alpha drugs and so a means of determining whether or not a patient has this particular path of type is seen as extremely important to a number of key opinion leaders in rheumatology.
As of this time, there is no reliable way of assessing a patient's paso type of raw other than by doing a biopsy and we have hypothesized that <unk> could provide this information.
So we presented updated preliminary results on the first 13 patients back at November as American College of Rheumatology meeting, that's the largest rheumatology conference in the World. These results presented their indicated that till medisoft uptake in the already inflamed joints is able to discretely differentiate patients with the.
Fibroid path to type that is patients with low macrophage involvement from those having either the diffuse myeloid or lymphoma myeloid types of RA.
That is patients with higher macrophage involvement.
So these data also provides support for one of our indications in the phase III trial.
The ability to predict from the baseline scan alone whether a patient is likely to receive a meaningful clinical benefit from an anti TNF alpha therapy since as I mentioned, there is increasing evidence that if a patient has the fibroid type of or a they are less likely to receive significant clinical benefit from anti TNF Alpha therapy.
You might recall that in our previously completed phase <unk> study now $3 31 that contained a pilot arm looking at the efficacy of <unk> imaging at early prediction of treatment response, those patients who exhibited a low level of tomato uptake into joints under baseline scan before they started therapy had at all.
Most 90% non response rates anti TNF alpha therapy, using a clinical gold standard assessment.
Importantly, these promising early results have opened up conversations with pharmaceutical companies, who are developing therapeutics Ferrara with the possibility of tomato sept imaging being used as a biomarker in their drug development pipelines.
The key differentiator between now and prior discussions we've had with these kind of companies is that we have this additional promising data in hand, and as we move forward.
And gather more data towards trial completion. If these current results hold we will be in an even better position for discussions with companies with which to work.
We continue to make very good progress in automating the imaging quantification as well, which will have significant benefit for the commercial product we have.
We're working closely with MIM software N I M on a definitive agreement for them to be our commercial partner for image quantification of tomato stopped imaging and our E C.
So once again NIM is a leading medical imaging software company based in Cleveland with our large footprint in the nuclear medicine space. We are currently integrating their existing image analysis workflow into our phase III trial and their software should be used for the image analysis for this trial as well as our normative database trial data.
Their workflow for these trials is extremely well designed and by integrating them into our trials at this stage. This should be helpful for development and integration of a fully automated workflow that they are developing.
Already they have completed a pilot study using data from our earlier trials demonstrating that they can develop this fully automated application that should be able to robustly, we produce our quantitative imaging reads using our proprietary algorithm.
This is important for rollout of a commercial product the ability to perform the quantitative imaging reads rapidly and reproducibility without having to have a bunch of people in the room actually drawing the reference regions in the regions of interest will help US go with large scale through this automated method and that will be critical.
To large scale adoption of tomato Ferrara.
Keep in mind that all of this the image analysis methodology as well as the data upon which it is built including the normal database you've heard us discuss before is not only critical to driving the most accurate insensitive objective read of our images, but it also serves as a significant barrier to entry to possible competitors in this.
Space.
You might have also seen the conversion of a provisional patent application to in a one patent application earlier. This month. This application involves using clinical and serological markers in combination with our imaging readout to possibly improve our predictive capacity for treatment outcome over using our imaging alone.
So we will have IP protection on combinatorial approaches as well if they work and if granted we have data from the NAV 331 phase <unk> trial that I just referenced that was completed a while ago that suggest this indeed might work.
And the diagnostics pipeline development, we've completed preclinical studies on gallium 68, <unk> for pet imaging and related next generation manage theft imaging agents.
We work on this in collaboration with researchers at the University of Alabama at Birmingham or UAB. We've also completed work on our NIH funded preclinical studies for evaluating gallium 68 till nanosecond and various new imaging agents similar to come at us up in a mouse model of basketball sclerosis.
Work on another important set of preclinical studies was completed with our collaborators at UAB. This work explored varying the molecular weights of til nano satellite construct and evaluating their biodefense following intravenous injection with and without competitive blocking results showed that by varying the molecular weights.
Of these compounds and introducing competitive blocking agents it was possible to significantly increase localization of <unk> imaging and therapeutic constructs to target tissues like tumors, while concurrently reducing localization to off target organs, such as the liver.
These results show a path to improving our diagnostic imaging and two greater and more effective targeted delivery of our therapeutic construct to tumors and other sites of macrophage involved pathology.
We presented these results at the society of nuclear Medicine, and molecular imaging meeting last summer.
And these were electronically published on March 7th of this year in the journal molecular imaging in biology, and you can access that online.
On the therapeutic assets front, we are advancing our candidates in the oncology and anti inflammatory spaces in preclinical studies with the goal of filing an investigational new drug applications to advance to human trials in 2024.
These filings will be significant inflection points and opportunities for licensing and partnering deals for the company.
Work on new drug delivery construct a new targeted payloads has also progressed. 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 mouse models have demonstrated that when administered alone or in combination with another cancer drug. These therapeutic construct significantly reduced the rate of tumor growth by an average of 76%.
Some of our results covering new bisphosphonate payload constructs were presented at the tumor myeloid directed therapy summit meeting.
More recently on November 10th the full spectrum of results for the Paclitaxel a novel Bisphosphonate constructs were presented at the annual meeting of the society for immunotherapy of cancer held in Boston.
In addition, we completed whats called a maximum tolerated dose study in mice for our best Bisphosphonate carrying construct the results of this study will facilitate design of studies intended to evaluate anti cancer efficacy of this construct in the future.
All of our preclinical work with potential cancer immunotherapy constructs are intended to enable them to video to choose a lead candidate for macro type phenotype altering drugs for oncology indications.
Preclinical studies are also ongoing and leishmaniasis leishmaniasis as a vector borne chronic disease caused by a protozoan parasite that replicates and CD two or six positive macrophages. It is transmitted to humans through the bite of infected sand flies found in parts of the tropics subtropics in southern Europe .
It's rare in the United States, but in more tropical countries, where the sand side vectors are found it as a common serious and potentially life threatening disease.
The U S. FDA has designated leishmaniasis as a neglected tropical disease, making new therapeutics of this disease potentially eligible for what's called a priority review voucher that into video could sell potentially for more than enough to back cover the cost of development as well as accelerated a number of other pipeline.
Candidates.
Previously in the video scientists and our collaborators at the NIH published research results demonstrating that high C. C. C. D 206, expressing macrophages play a role in the dominant form of the disease. This project has advanced significantly in the last year with results from three separate experiments showing that our novel.
Construct created by Nvidia has significant therapeutic potential to control leishman aisle infer.
Infections in mice.
Concurrent with reduced numbers of these parasites alterations in the immune status of the lesions that are caused by leishmaniasis were observed with potential implications for the mechanism of action of our novel therapeutic construct additional experiments are ongoing or are planned to follow up on these very <unk>.
Thomas thing initial results.
That brings me to our overall intellectual property front.
<unk> received notification of issuance of a patent from the United States patent and trademark office for the company's application titled compositions and methods for altering macrophage phenotype.
This patent covers the ability of our construct to stimulate an immune response against tumors through targeted delivery of payloads that change the nature of macrophages to make them more pro inflammatory.
Efficacy of these constructs has been demonstrated in preclinical studies, including the ones I just spoke about.
We have also received notifications of issuance of patent application in of patents in Israel and in Canada. Please refer to the earnings call press release from earlier today for more detail.
So we continue to submit new provisional applications and work on our pending ones. We have filed a new provisional patent application describing a new chemistry for addition of Manto sugars to a monopoly dextran based imaging and therapeutic construct this new chemistry results in a different linkage holding the manto.
Onto our construct one that is more stable than the linkage currently used and is designed to facilitate commercial scale up and production of our next generation imaging and therapeutic constructs.
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 through our next generation molecules and disease indications.
On the Lymphoseek front 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 in other company pipeline candidates in Europe and beyond.
The reason for this is we are focusing on the long term strategy of partnering for marketing and distribution Ananda.
The drug manufacturing and supply front for both Lymphoseek and the <unk> product, we have been and continue to work with a new active pharmaceutical ingredients 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 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.
So these are just some of the highlights of the last quarter that we wanted to touch on for this update we remain largely focused on the RA pipeline specifically the phase two be imaging to biopsy trial and the phase III, while we continue to support and push for progress on our other diagnostic and therapeutic indications.
Always I want to thank the team here for their tireless efforts to keep things moving and our network of clinical trial sites and academic research collaborators for all of their hard work.
Our business strategy remains to advance our pipeline products to key inflection points and seek appropriate partnerships for commercialization and marketing.
So with that I'll close the update summary update I want to thank you and I'm going to turn it over to Eric and all for the financials Erica.
Thank you bank.
Just last week I will be leaving the video at the end of the month.
Current controller, Joe Meyer will be taking over many of my responsibilities.
Like to introduce all of you to Joe who will now read the financial results for the fourth quarter and full year of 2022.
Thanks, Erica and for the first time Hello, everyone total.
Total revenues for the three months period ended December 31, 2022 were approximately $1000 compared to 50000 for the same period in 2021.
Total revenues for the year ended December 31, 2022 were 66000 compared to 532000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of debts previously written off in 2015.
The 2021 receipt of reimbursement from Cardinal health.
Certain research and development costs.
Decrease grant revenue relative relative to small business innovation research grant from the NIH supporting management development and decreased license revenue from transactional sales up tremendous up in Europe .
Research and development expenses for Q4 were $1 9 million compared to $1 4 million for the same period in 2021.
R&D expenses for the full year 2022 were six zero million compared to $5 1 million for the full year 2021.
That year over year increase was primarily due to increased drug project expenses and increase employee compensation, including incentive based awards offset by decreased regulatory consulting expenses.
Selling general and administrative expenses or SG&A for Q4 were $1 3 million compared to $2 3 million for the same period in 2021.
SG&A expenses for the full year 2022 were $8 million compared to $7 5 million for the full year 2021.
Following the ruling by the Texas Court in August 2022, the company recorded $2 6 million of legal fees and SG&A pursuant to the CRD judgment the.
The year over year increase was also due to increases in insurance and depreciation and amortization, partially offset by decreases in employee compensation, including fringe benefits and incentive based awards expenses related to European operations travel legal and professional services Investor relations and shareholder.
Services General office expenses facilities costs losses on the abandonment of certain intellectual property and franchise taxes.
The video net loss attributable to common stockholders for Q4 was $3 5 million or <unk> 11 per share compared to $3 7 million or <unk> 12 per share for the same period in 2021.
Net loss attributable to common stockholders for the full year 2022 was $17 2 million or 0.5 dollars $6 8-K, 56 cents per share compared to $11 7 million or <unk> 40 per share for the full year 2021.
The video ended the fourth quarter of 2022 with approximately $2 million in cash and cash equivalents.
And with that I'll throw it back to you Mike.
Thank you, Joe and Eric Thanks for everything Erika that you've done over the years not just my years here, but before and now I'd like to open up the call to questions I'll, let the moderator do that more professionally but I just did a joining me for the Q&A session of course will be the folks here in this room and myself Eric Zhou.
And then indeed, we have valves capello, the chair of our board as well as Mr. Kim stopped the Vice chair.
And thank you Sir we will now be conducting the question and answer session. If you'd 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 you 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 then jump back into the queue. If you have any additional questions. Thank you.
One moment, please when we pull for questions.
And our first question comes from the line of Edward English a private Investor. Please proceed with your question.
Good afternoon, Mike This is Eddie English and thanks for taking my calls or questions before I ask my first question, though I would like to extend a shout out to Eric before the 30 plus years of service and support not only the video, but our shareholders and to wish her.
Barry very best in her new endeavors.
With that like the elephant in the room based on the report that came out this afternoon and in my mind is the current cash position with only 2 million at the end of the fourth quarter and our historical cash burn rate of 800000 to a million a month.
Can you shed some light on how far in the future.
All can operate with your existing cash reserves.
Hey, Thanks for the question and I appreciate the shout out I'm sure Erika Duster banking.
Yeah.
In any event. So a great question really it's no secret that the company has been on our resource limited environment, but we are optimistic that we'll have something to announce around capital infusion soon as I mentioned the board members of the board are working diligently on this and that's really all that we can say about it at the current time I appreciate the question though.
So that's the that's really what we can say right now.
Okay, one follow up and I'll abide by the rules and then go back into queue, because I have a few more but my next question is around your plans to become NYSE compliance by July 28 are you all are on schedule to meet that deadline or what can you tell us.
About that.
I'm going to let Erica use her great financial wisdom to have one she should have something to say on this last year and I go for this one final word for me yeah. So obviously one of the biggest issues facing us is.
The NYSE cure a that is required and I think the financing that the board is currently working on should go a long way towards.
Towards satisfying.
The requirements and so I would say at this time expectations are that we will.
Deed become regained compliance with NYSE at the end of the cure period.
Great. Thank you I'll go back into queue and abide by the rules here. Thanks.
Thanks, Ed.
And our next question comes from the line of Robert Carlson with another private.
Please proceed with your question.
Yes, Thank you for taking my call.
I appreciate you touching on Lymphoseek, a few minutes ago.
When you hope hopefully you can expand a little bit on that.
I know that.
It's been eight years.
Since we've.
Retaining the international rights to throw in.
Lymphoseek.
And in all that time.
We've not been able to generate any significant revenue.
And I wanted if.
If you could put it your.
Your honesty I Miss is there something more specific that we could do to make this happen or is lymphoseek a lost cause at this point.
Yeah, Great question, I'm I'm happy to answer and give you as much transparency as possible. So.
That's all that's the summer long story that I'll try to stick to a shorter version of so as you as you and others know on this call. We the video had licensed the European rights.
Lymphoseek to a company called <unk>.
And there are fine company their strategy.
Might say it was probably not an optimal strategy for penetrating the market of Sentinel lymph node biopsy assessments are lymphoscintigraphy in Europe .
And it's not all just on their strategy.
In Europe , there is a a viable competitor for lymphocytic. It's a version of a it's a colloidal compound there are different names, but one of the common names as nano called and it's a pretty good agent right for its relatively inexpensive in fact, it's actually very inexpensive and it's pretty good.
We and others and there's a growing body of late of research that supports this suspect or or believe that there are advantages to lymphoseek over this product that has really dominated the market in Europe for years. So launching didn't do you know maybe the optimal strategy for penetrating a market that already has.
Buyable product, we do think there are advantages to it and to be fair to Nord gene. It's been years in the making that researchers have.
Produce publications that support what I, just said is our beliefs that lymphoseek has advantages.
One thing we think lodging did.
Maybe that wasn't what we would do is they'd priced lymphoseek out of premium without having enough of these data in hand to make the case in the very highly regulated European market to adopt lymphoseek over a good product does that makes sense. So yeah. What we have done is we've brought back the rights is as <unk>.
You probably know of Lymphoseek Europe , two new video and we've spent a significant amount of time getting our API and drug product development processes.
Here, so that we could potentially supply the European market as well as the rest of the rest of the world with Lymphoseek and or the raw product.
So.
With all of that said we are actively in discussions.
With possible partners for Lymphoseek in Europe , because it is not just us and some kols, who believe there are advantages.
Lymphoseek to nano coal or these nano coal and related products.
But there are other possible partners, who believe it as well having said that it's you know there is a viable product out there and so the case must be made strongly in a very highly regulated environment in Europe . So there are a lot of it's not quite as smooth sailing as it as it is in the United States, that's maybe too much.
Flavor of detail for you, but it is a product that we think has advantages over the existing product that dominates and where we are in discussions and I hope I didn't say that in this call I think I did we've said it before and so we'll we'll continue to have those in and see you know what what the market will bear.
But we're optimistic that that's about as honest as I can be.
Thank thank you very much.
Good luck.
And the next question comes from the line of Mike rationale private Investor. Please proceed with your question.
Yes Doctor Roses, Thanks for taking my call and Erika like everyone. We wish you well in the future and things for your 31 years, Joe Welcome on Board.
My question initial question is observation first I think.
There was a great under appreciation for this patent.
But you received on the M. One M two reprogramming.
Tammy I, just don't think the market's appreciated yet and I don't know if maybe investors have appreciated to me it seems quite outstanding but taking that as an observation. There's also been a lot of science developed Doctor rose over the last little while the M. One and M. Two reprogramming.
Weather in reverse or inverse also it may be applicable in many other diseases in inflammation can you expand on that a little bit and do you believe that you'll be we'll be seeing patent applications on that in the future.
Yes, Thanks, Mike.
Right on all counts and good questions.
So some background for folks who aren't so in in depth into the field.
Broadly speaking there are macrophages can be pro inflammatory.
Stimulate an immune response, that's the so-called M. One macrophages that you just heard Mike referred to and then the M. Two macrophages that are more.
They have the opposite kind of affects their wound healing they quiet down the immune response.
Some people would say in tumors paradoxical either their pro tumor actually so there are these kind of extremes of the macrophage in the macrophage world and looking at changing the phenotypes of the macrophage driving them from one of those the one for example to the M two or vice versa is.
It's a very hot topic across the world.
Because macrophages are very powerful and prevalent cell type in the body and they're involved in almost all diseases.
And so the opportunities there to help people to treat diseases is enormous.
Macro phages play a key role in cancer.
Growth in metastases.
And in cancers.
The macrophages that dominate in and around the cancers are the kind of wound healing. So called pro tumor types of macrophages, but actually act as it kind of force field around the tumors could prevent the body's natural immune response from attacking the tumors and so what we and many other.
<unk> are doing across the globe related specific cancer as we're looking at therapies that are treatments that might change the phenotype of the nature of the macrophage and drive them from the the wound healing them twos to the pro inflammatory M. Once and if you can do that in people who have cancer and in those.
In those tumors themselves you can then rallied the body's immune response to attack the cancer.
[laughter].
As of as of May of 2021 to give you an idea of how large these efforts are globally to do just what I've told you.
There were 606 clinical trials that we're running or had been completed just to do what I just said.
Related to cancers, it's a huge field and you know what's cool about it is really we're at the forefront of that not necessarily in the progression of our therapeutic construct into humans.
But in the technology and what our drugs have been show what we have been able to show they can do in the in vitro or preclinical phases.
So we're right there at the leading edge of this incredibly large opportunity field or space to help patients and to treat a large number of diseases from cancers to others.
I can get into that in a moment and that patent that that Mike referenced was.
It was about was giving us our intellectual property around using our construct to change the phenotype of the nature of macrophages as I just described.
And yes, they're going to be a whole series of patents that follow suit or applications around that the fact that we can target macrophages of all types, the ones and twos and everything in between with our construct means that we can deliver all sorts of cool things payloads were called loosely.
Two the macrophages and we can perturb them and drive them in different directions, and we have a very flexible adaptable molecule that has all sorts of really great advantages over what almost every other group out there is using and I'm not just saying that because I work here, it's true and so we have this great opportunity to be able to.
Really shake up the world in these therapeutic domains and one of the major thing holding us back as a small company of course has been resources financial resources. So we're very good at making a lot happened with a little.
And so our goal of course of this year and you've heard it before but I believe significantly that thing you know things are different now than they used to be our goal is to be fully funded so that we can help drive those things towards first in human trials, which is where we can those kinds of inflection points or opportunities for large.
It's whether they be partnering or license deals or whatever or whatever we might decide to do so we're trying to drive them towards that so I might've gone astray from what you originally asked but that patent is very important there will be others coming along the way that are related there are some already you just don't know about it yet because they're not published.
And this is a very hot and exciting area in not just cancer research, but in other diseases. So you know I've mentioned and cancers, you want to drive the M. Two or wound healing pro tumor type macrophages to M. One pro inflammatory injury and many other diseases, including <unk>.
Most all inflammatory and infectious diseases, you wanted to do the opposite.
Want to take the inflamed pro inflammatory macrophages that are doing a lot of stuff to try to attack whatever the infectious agent is.
The body has a hard time controlling those things precisely so what do you want to do is you want to drive those towards the the more wound healing type and we have data, suggesting that we can do that with our dexamethasone construct so we can perturb the macrophages and drive them in one direction or the other and with that the world is.
Of our oyster and almost every disease is touched by the macrophage macrophage plays a central or critical role.
So that's my my Spiel hopefully I addressed your question Mike You did it you did an excellent answer thanks, Dr. Rosol. So my follow up on that is it.
Observation that I can make and maybe you can't opine on it but it's I think it's opening up the I N D. We're really open this up to the world.
And on that do you have any other guidelines you can give us into 2024 on your target range for bad I M D.
Yeah.
Okay.
Sorry, Thanks, I think that's still that's still our goal and our objective obviously it'll be really helped us to we'll have significant help propelling us forward with with full funding.
But that is still an achievable goal because we've advanced some of these are significantly in the preclinical space and what you want to do to get towards that I and the other kind of two domino's that need to fall roughly speaking or at a high level are you need to establish that in preclinical models that youre construct or your therapy is safe.
And tolerated and there were some specific studies you have to do for that but they're very well known and established in and we can box those out and we've already accounted for those in our timeline and then the other thing you have to do is show that you can actually make the drug in a scalable fashion and its reliable and safe to be injected and so those are the the rest.
The other two dominoes that need to fall, it's fairly reasonable for us we think to get to those in the timelines you've seen you know with the caveat always we need to be resource properly.
Excellent I'll come back into the queue. Thank you so much.
Yeah.
And the next question is a follow up from Edward English a private investor. Please proceed.
Hello, again Doctor Rosell, I'm curious, though I've noticed and what's available to us.
And the public in the Securities and exchange filings that there haven't been any stock granted to the board of directors since right.
In late November I haven't seen any form fours has something changed with the compensation for the board or are they now receiving cash or can you elaborate on what's changed and if so why.
Go on please.
Yeah. So in 'twenty late 2021 the directors adopted a compensation plan for the next 12 months.
Hmm.
Due to our.
Funding situation many of the directors have chosen to defer compensation.
Until we achieve full funding and so.
Can't really speak for the board. So I believe that that May have had something to do with their decision to not award themselves. An additional package. This year I think that they are probably waiting until until we feel like they don't have to defer any longer.
Absolutely several months ago all of us.
All of us.
We're pretty much suspended.
We've all been working several months without compensation.
Alright, well, thank you and some for the whole year.
Okay.
Thank you.
Next question by phone them up and that'll be.
My question for the day, you still have the third party assessment for the use of the two men have stepped in and they are a program.
Out on the site and it has revenue projections that are quite appealing.
And I'm just curious if you all still stand by those projections.
I think there some 41 million in revenue you projected for the year 2024.
If those projections are slipped or changed in anyway.
Yeah. This is Mike so the numbers I think are solid numbers in terms of the the market potential and the growth curves. Even you know those are always based on modeling in terms of the the timelines I mean, the where we're doing our best to meet the timelines that are on the investor deck that is.
Out there right now, but you know to be honest. Some of these projections were based on opening up a full suite of sites or a larger number of sites at a certain stage and then going forward from that period and we've been frankly in our resource limited environment for a while now so some of these things are just naturally going to be pushed forward unless and this is where it gets.
Very complicated so I'm not giving you double talk I'm I'm, giving you real talk unless the we could open up more sites than we built.
Built into the original model enrolment is always something that you know we have some control over but not full and then.
There are several other factors that are including the trial size, which is variable based on the response rate to the anti TNF Alpha therapies. So you put all of that into the Hopper the resource limited environment, where we have not been able to open up all the sites, we wanted to yet and some of these other variables and they can kind of counteract each other so you end up with the same.
You know our resolution of everything at the same time or might get driven forward or even happen earlier, so more likely than not it gets pushed forward a little bit if you have to run a long time without a full complement of clinical trial sites open and that's kind of where we are now so so I hope that doesn't sound handwavy, but like you know those.
The the first jet revenue generated maybe pushed off a bit but the numbers themselves and the trajectory once it happens we still standby and believe because we have a good idea of the competitive landscape and and the data that we're bringing to the table. So far are significantly better than anything I've seen out there.
That makes sense, yes.
Yes.
If I could summarize I think you're telling me the potential is still there and it's very robust, but the timing could go either way.
You got it yeah, okay, well I'll end it there and just say thank you for taking my questions and certainly looking forward to some new news soon on your bunnies.
Thank you very much thank you.
And the next question is a follow up from Mike Ross, Yeah private Investor. Please proceed.
Yes, Dr. Rosenberg, a two follow up questions.
You mentioned briefly that as you advance the science engagement of future funding partners improve.
Are those still active talks ongoing on the or a P. P partner potential is that still in the works and still progressing.
Yeah. Thanks, Mike Yeah, that's it and Theres a complicated answer behind that the answer is yes, we're still in and I've said. This I can say it now where we're in discussions are related to the implementation of the use of tomato theft in partnership with other drug development companies and those are.
There's a lot of interest in the NAFTA 32 phase II B study for that in terms of the overall business partner for Ferrari.
I think there are opportunities to discuss as we as we roll with other possible with possible business partners as we roll into the through the trials, but really and again to be honest, what I think my mic rosell.
The place where you are in the best position to get the most Bang for your Buck is when you've completed the trials and have strong data in hand from that point on to all the way to an into or through FDA approval that puts you in the strongest position I believe because then you have a proved out to one degree or another.
Diagnostic so again, if you want me to be completely honest here doing deals earlier, you usually you you'll give up something because theres more risk right. It's all about the our NPV right right. So the longer we can go with it can be fully funded and drive this towards completion of a trial good data F D. A.
NDA submission believe me then we're in the strongest position to do a deal. So I think that's the strategy that you should pursue at least if you can and what we're trying to do that strategy. It doesn't mean, if something happens in the intervening months or so we're.
We're not turning it away, we're listening, but what we want to make the best that we can of what we've got here and are really that that's the store so well.
Well I think we're taking that approach of extracting the best value with the with the most.
Informed and progressed results is the would be the desired way to go and I think I'll finish with the comment that you made in the rheumatoid arthritis treatment patent application that should encourage people to this and in two of the embodiment and 106 or more than 11. It was stated.
That's.
Exciting perfect prediction.
Marketable test responses.
Were generated in that testing.
Testing for the treatment can you expand on any of that because that you know that just exemplifies and amplifies the potential of this are aided the results you were seeing in the treatment.
Alright of the or a patent application can you Uh huh.
Sure. So thanks for that that patent is is primarily about the youth.
Using a combinatorial approach for achieving a better prediction capacity for our imaging agent for predicting treatment response in our a and so.
We know that are that in the data so far clematis up imaging is a is a very good predictor and the data so far of clinical outcome at three and six months.
And what we're what we started to look at it after the phase <unk> study was.
Could.
Is it an independent and additive predictor to other clinical serological, biomarkers, which for the most part or entire part have really kind of failed to be adequate on their own or even in combinations. Although there's a lot of people looking at different combinations. So we looked at our our imaging prediction in.
Nation with all sorts of different clinical and blood based that's what I mean by serological Biomarkers that are no normally obtained in all eight patients.
We looked at these and all sorts of different cool ways and what we found was that.
It looks like and we only have limited data to date, but it might be that are if we take a very powerful imaging readout and combine it with some.
Readily available and already validated clinical biomarkers we.
We might be able to improve our prediction capacity in some circumstances upwards towards the U S.
Sensitivity of 100 right are perfect for what we're gonna be perfect across the world across everybody across all time, but it's really about taking a prominent oriel approach of our imaging readout with other biomarkers that are available.
And it looks like there might be value there and by filing a patent then of course, we will we have the intellectual property protection and in so far as it relates to the therapeutics that should be therapeutic.
Agnostic, although to date, we've only looked at the anti TNF alphas.
The exciting thing there is what we've what we've learned to date is.
Our imaging readout is an objective independent predictor of whether or not a patient is getting better or not.
From a treatment of an anti TNF alpha or with an anti TNF Alpha it's independent of all of the other clinical and serological or blood based Biomarkers. That's one and it's really strong if you add some of those and we're looking to see which is the best combination then you might improve your prediction you know it's much closer or.
Not much closer because there's not even a lot of sealing left but even closer to the ceiling of getting it right. All the time or most of the time or the vast majority of the time. So that's really cool and promising so we're really trying to get to what is the you know the optimal predictive capacity for any patient days their drug going to work.
Or not or is it working or not early now related to the therapeutics.
It's it's less specific and that it's not really specifically outlined in that patent however.
The fact that we can deliver and we've demonstrated that we can deliver in an imaging pro two already inflamed joints and.
And we can do this reliably repeated repeatedly and stably it should not escaped your attention that then we could easily swap that out for therapeutic. So we believe that we also have a potential powerful therapeutic in our hands pardon the pun of hands, but and that remains to be explored.
More fully when the company is funding, but indeed, we have the potential for a powerful therapeutic and what we're doing and that patent application is showing that on the diagnostic side.
We really we really have all the basis covered if that makes sense, yes. So on the on a therapeutic it did you guys do and then any preclinical just.
It's a small test to see if that therapeutic validated that concept you just talked about that's not in the patent maybe tried anything or I imagine you're here.
Yeah. There are preclinical studies that had been done in the past and there was some promise to those so.
Let me leave it at that but really and we have a plan for how we can go forward and really fleshed that out but in the limited data that I've seen to date in and most of this predates my time here there was already parmesan and we know a lot more than we knew them. So I think it's only a rolling in a better position.
Excellent. Thank you so much for taking all my questions.
Thank you.
There are no further questions at this time I would like to turn the floor back over to Dr. Mike Russell for any closing comments.
Alright, I think you've heard enough from me today I want to thank you for joining us today for your engagement and all of your questions. Once again I want to thank Erica for all her hard work here over the years and welcome Joe here to the Fray at least the public facing freight I'm sure he's going to be great and have a fun time and hopefully we'll be talking to you folks before.
Too long so thank you and have a great evening.
This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation and have a great day.
Yeah.
Okay.
Yeah.
Yeah.
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