Okay. Good morning, everybody. Welcome to our H.C. Wainwright at Home Fireside Chat with Biora, which, from a disclosure standpoint, we do cover with a buy rating. My name is Joseph Pantginis. I'm the head of research and managing director at H.C. Wainwright, and very happy to do this talk with Chief Executive Officer, Adi Mohanty, Chief Financial Officer, Eric d'Esparbes, and Chief Medical Officer, Dr. Ariella Kelman. Guys, thank you so much for being with us today, and, you know, for the sake of time and being thorough, I just want to dive right in. So thanks for being here. So I know, Adi, you might want to start with some high-level comments, but in 2023, Biora was very busy behind the scenes.
Of course, we always say, you know, things that you don't get credit for from the street, but, you know, still very, very busy and accomplished a lot with regard to preclinical studies, collaborative work, which we'll hear a lot more detail later on, and prepping for your first clinical study, now ongoing with BT-600 under the NaviCap platform. Before we dive into all these details a little later, I was hoping to get a more high-level view of your technology at Biora with all the important questions of, you know, why? Why are you doing it?
Specifically, you know, you have two delivery technologies, NaviCap and BioJet, and, you know, after your intro comments, I'm hoping to get a little bit of describing how each of these work and what they look to provide to the clinic and for patients, and how they differ from each other. So I know that's a long-winded question, but I think it encompasses really what you're doing at the high level.
Yeah. Well, first, I want to thank H.C. Wainwright for hosting us today, and thank you, Joe, for your continued diligent analysis and reports. We're happy to be here and happy to speak with you, with the investors online this morning. Just a quick note, we'll be making some forward-looking statements today, and we invite investors to read all our risk factors included in our SEC filings. You're right, we have been very busy behind the scenes. We've done some really heavy lifting to transform the company. We spent the better part of the year laying a foundation as we pivoted and focused on our therapeutic platforms. This included skills and talent evolution. We also evolved both our platforms to their next generation versions.
We reduced our spend, we made tremendous progress in our capital structure, which was a huge achievement, especially given the capital market environment of the last year or so. That also shows the confidence our investors have in our programs. We, we also put a majority of our legacy issues behind us, and those that remain are trending favorably, so that we expect that they'll also be resolved with minimal impact on us going forward. We've had a lot of wins. We've really honed our ability to execute on the product development objectives with both our platforms, and let me then tell you about these two platforms. Both work as ingestible devices. They are ingestible drug device combinations, but their goals and mechanisms are quite different. First is our NaviCap platform.
The NaviCap platform is designed to deliver drugs directly to the site of disease in the GI tract, and our first application is to use it to deliver drug to the colon. We do this using an ingestible smart pill equipped with proprietary localization technology. That is, we have a way to detect the different anatomical or physiological changes of the GI tract. This allows for many applications, but, in our first program, we have it set up to detect when it enters the colon and then release a payload. We believe that targeting drug directly to the colon would improve outcomes in severe GI diseases. We're initially targeting treatment of ulcerative colitis using a proprietary formulation of tofacitinib. Different formulation is commercially available as Xeljanz, and we're currently in Phase I trials with healthy volunteers on this program.
We'll talk about this more later, as you mentioned. On our BioJet platform, our goal is to provide oral delivery of drugs that would otherwise require injection or infusion, essentially needles. We do this using a small capsule the size of a multivitamin that uses liquid jet injection technology to deliver a liquid drug into the small intestine, where it can then enter systemic circulation. We think this platform can deliver a broad range of large molecules, including proteins, peptides, nucleic acids. We've already tested this with GLP-1, like semaglutide, monoclonal antibodies, like Humira, antisense oligonucleotides, and we continue to work on developing data with other molecules. So we believe both of these are true platform technologies and that the current programs will prove the two platforms and demonstrate the broad possibilities of all the other things that we can do with them.
For example, there are at least 100 molecules that are currently delivered using needles that could be potential candidates for the BioJet platform.
Fantastic! Now, I really appreciate that introduction. So before we get into the details, I think one of the things that might not be recognized by the street as you look at the company, I want to add a little layer before the details of the programs. Part of your efforts at Biora have been to put up a significant intellectual property foundation... you know, platform thesis, what have you, surrounding your technology. Can you summarize the protections that are in place and pending? It seems like you really have some broad-reaching protections.
Yeah. It would really be a summary because we hold pretty comprehensive IP portfolio in ingestible devices. Our team has spent years building up a portfolio that includes over 100 granted patents and over another 100 pending applications across our two platforms. For example, with the BioJet platform, we own internal liquid jet delivery. Lots of companies are working on oral delivery methods that haven't panned out, and we think our delivery technology is superior. And if somebody wants to try and do liquid jet delivery, well, we were there first. We own it. We have it very well covered. Similarly, with NaviCap, we have comprehensive IP for the technology, as well as various therapeutic targets for the treatment of GI disorders using our technology.
Our autonomous localization technology, pretty ingenious, doesn't have the problems that other technologies do, like variable pH or intestinal motility. So yes, homegrown, fully owned, awesome IP coverage, great technology.
Fantastic. I appreciate that. So, let's dive in a little bit with the NaviCap. And I guess I'll take a two-pronged approach here. You know, ulcerative colitis, as you've described, you're in a SAD MAD study at the moment, which we'll talk about later again, is your first indication that you are targeting. Of course, no pun intended there. Why do we need NaviCap? Aren't current blockbuster drugs like Xeljanz doing the job? You know, where is the clinical need here?
Yeah, we'll let Ariella go.
Okay, well, thanks very much for asking that really important question, Joe. Despite progress over the past 2 decades in ulcerative colitis and IBD overall, the medical need remains quite high. Patients with ulcerative colitis continue to suffer from pain, from severe diarrhea, bloody stools, and high rates of disability. Patients with ulcerative colitis routinely say, even with all the new treatments, that ulcerative colitis controls their life. The goals of treatment include resolution of symptoms, what you would call just feeling overall better, and healing of colon tissue on endoscopy. So what we can see when we look at the tissue, and in clinical trials, that's called endoscopic improvement. It's a specific endpoint, and even with new treatments, about 60% of patients don't achieve remission with induction, and less than half, less than half show endoscopic improvement.
They've got ongoing disease, which leads to damage and ultimately disability. There's still a fairly high rate of colectomy and surgery, so today's medications aren't doing enough, and we believe that we can do better. Research shows that part of the inability to achieve remission and relief for many patients is due to the inability to achieve high levels of drug in the colon tissue at the site of disease with current systemic treatments. Because you have to go from the systemic circulation into the colon tissue. BT-600 is a combination product of NaviCap with tofacitinib, and it's designed to deliver drug directly to the site of disease in the colon, with the potential to improve efficacy and to reduce systemic toxicity. So we think that we can achieve high tissue and low systemic or blood drug concentrations.
We've seen this in animals, and this is very different than any other medication that is currently in development or currently approved. It's different from current injectables and oral treatments. Those deliver drugs systemically through the bloodstream or into systemic circulation via the small intestine, not directly into the colon, and the colon is the site of disease in UC specifically. Our current Phase I clinical trial seeks to show this type of pharmacokinetic profile in healthy volunteers, and PK data in healthy volunteers is relevant to patients with UC. So we think this Phase I study is really quite important in translating to the clinic and to patients. And our KOLs, our clinical advisors who really are the world's leading experts in IBD, they believe in this hypothesis.
We just met with them last week and discussed future clinical trials. And we are planning future trials in patients with UC.
Got it. I really appreciate-
Joe.
that background. Very important. Go ahead, Adi.
Let me just add, you know, you got the clinicians or the doctors' version of the real need. Look at what's happening recently. There is another way you can measure the real need. Look at the transactions that have happened in this space. The companies, big companies, have spent lots of money, right? Pfizer spent $606.7 billion to buy an asset in the last year. Merck spent $10 point some billion dollars to buy an asset just a few months ago. Genentech spent $7 billion. All of these companies spending money to get assets in this space is another way to say, yes, there is a need. And even though all of these newer assets are slight improvements to the past, that still leaves more than half the patients without real solutions. And so that, that's, it's, it's both ways.
The investment going in should also be able to tell you there's a big gap.
Got it. I appreciate that perspective. So, I guess, Ariella, I mean, as part of the evolution of you describing the SAD MAD study and what might be coming up in the clinic, you know, I want to get a sense first of, you know, what got you there, and that's some of the preclinical data around NaviCap, you know, including what we consider to be compelling animal data. You alluded to that, you know, showing the device perform as planned or even better. Hopefully, you could give a bit of a summary of what you've seen.
Sure, sure. So, we have administered over 600 doses of BT-600, so the combination product in animal studies. And, we've done a couple of different kinds of animal studies. We've done a GLP toxicology study, which is required by health authorities, before dosing patients. And we've also done other types of head-to-head animal safety studies, where we have directly in a randomized way looked at conventional oral tofacitinib versus BT-600. And what we have seen is increased colon tissue drug levels compared to standard oral tablets, and lower levels in plasma, significantly lower, even at doses that were quite a bit lower than approved doses, so half or more lower.
This is the type of drug and drug profile that we're hoping to achieve in patients, because we believe that higher concentrations in tissue will improve efficacy, while lower doses and systemic absorption could improve safety and reduce adverse effects. We have also seen a really excellent safety profile in our animal studies as well, which looked quite a bit different than animal studies in the past with conventional JAK inhibitors.
Can you remind us what animals you've been looking at and why that's important for this indication?
Oh, sure. So, our key animal model is the beagle dog. And so, you know, these studies are typically done in canines because of their ability to swallow the capsule and because of the anatomy of their digestive tracts, which makes it translatable to humans.
Got it. No, thank you for that. So I guess, you know, and now moving more towards the clinic, a good glance at the data thus far in humans, earlier than the SAD MAD, appears to be showing nice translation from the animal models. And of course, that's always a key question in moving from preclinical to the clinic. Can you go over the path thus far before the SAD MAD, including what we consider to be the powerful imaging data of proper payload distribution, which studies have been done at this point?
Yeah. Thanks, Joe, for asking that. So even before our first in-human study of BT-600, so NaviCap plus the drug, we have actually done quite a number of human studies. So, we have performed 4 human trials of NaviCap without drug. And in these studies, over 80 NaviCap devices, over 80, were swallowed by about 50 study participants. And those include both healthy volunteers as well as patients with ulcerative colitis. And, that's really, really important, because we've been able to assess the NaviCap in people who have a variety of GI tract motility, gastrointestinal transit time, things like this that are very important in ulcerative colitis patients. We've also been able to assess the function of NaviCap in patients who have visible blood in stool.
So, that's important, because we use this autolocation technology, which relies on changes in light reflection. And so that wasn't affected by the presence of blood in stool that we'd expect in patients. We've also been able to study the NaviCap as part of these trials in fasted and fed states. So we didn't see any kind of food effect, which is obviously really important in the real world. You don't want to have to force people to fast unnecessarily. You know, we live in a society where we're eating all the time. So that's clinically important, right? And we haven't seen any safety concerns in these studies, that's critical.
So that's in addition to the over 600 doses of the drug device combination that we've tested in animals. Most of these human studies use scintigraphy imaging. So that's a method to view the images of the NaviCap as it moves through the GI tract, locates the colon, and delivers its payload. We are able to visualize all of that, and the studies showed that the NaviCap functioned as designed. In 93% of cases, it located and targeted the colon directly, and it coated the entire colon with its payload. And that was true in healthy volunteers and in patients with ulcerative colitis.
We've got some really compelling video images on our website, and I would invite you and others to go ahead and have a look, because a picture is really worth a thousand words. And we were thrilled to see it. The last study was done just past the summer, and I was at the site, and I saw it myself, and it's really terrific, and gives us a lot of confidence in our Phase I study. So, you know, I think that, you know, I'm just looking forward to Phase I study and seeing that data.
No, absolutely. Well, I can certainly attest that the dispersion images in the as it transits the colon are quite exciting. So hopefully looking it to translate to further UC patients. So I guess at this point, you know, let's dive more into the clinic. You know, you started to discuss the Phase I SAD MAD. So you recently started the study after, you know, and I guess you can talk to really the size of the IND because you really have both technical issues regarding the device itself, plus the payload and what have you. So I have to think it was a pretty extensive IND. I don't know if you wanted to comment on that, but you know, then really look at the Phase I SAD MAD in healthy volunteers with BT-600.
Can you describe the endpoint that you're looking at and the key expectations that the street can look for?
Yeah. So thanks, Joe, and thanks for commenting on our IND. So as far as we know, this is actually the first IND that has been cleared for an ingestible drug-device combination. So it wasn't just, you know, new for Biora, it was also new for the FDA, and there were really a lot of learnings. It was a large IND, over 300 documents, including information on both drug and device. So, you know, really highly technical and yeah, we worked really constructively with the FDA on that submission, and we're very happy to have it cleared and to be able to dose in our Phase I study. I'm happy to report that the trial is going well.
I visited the study center myself recently, where the device has been easy to handle. Twelve study participants have taken BT-600 without safety concerns as of today. We expect that the next twelve subjects will be dosed by the end of this week. The Phase I study is a U.S.-based, so it's being conducted here in the United States, randomized, double-blind, placebo-controlled study. It has two parts, as you said, the SAD, single ascending dose, and the MAD, multiple ascending dose, and it will enroll a total of 48 people. The study is testing single doses of NaviCap that are filled with either 5 milligrams or 10 milligrams, as well as placebo, followed by daily doses for a week of either 5 milligrams or 10 milligrams.
The doses are lower than approved tofacitinib doses because those are taken twice daily, and this is once daily dose. And we chose this lower dose based on our ability to achieve high levels of colon tissue concentration, without safety concerns in preclinical studies. As is typical for a Phase I, the primary endpoint is safety. But in this study, we are doing extensive PK/PD, a bit more than is typical in a Phase I healthy volunteer study. And specifically, what I mean is we're not only assessing plasma drug levels, we're also assessing colon tissue drug levels, to better understand the PK/PD effects of BT-600. We expect to see drug released directly into the colon. That's what we've seen preclinically, and that's what we've seen in the clinical studies, the device function studies of the NaviCap.
We expect to see that here. We expect to see lower drug levels in plasma than expected with conventional oral tofa. The study includes sigmoidoscopies with colon tissue biopsy for the 24 subjects in the MAD portion of the study. That's gonna be done at the very end in 24 people. And those are being done to assess the exploratory endpoint of colon tissue concentrations. Keep in mind that because these are healthy participants and not people with UC, it's being done at a single time point in a healthy population. So what do we expect to see?
We expect to be able to detect colon tissue drug concentrations, but the precise levels that are measurable at a single time point, with this type of procedure, as opposed to a full colonoscopy that you'd do in UC patients, are still unknown. But, I'm quite optimistic, and we remain optimistic that we'll see good levels and that it will be translatable to UC patients. And we expect to have data from the SAD portion of the study in about two months, and, that'll be followed by final study data in the following months. So pretty soon this year, we expect to see data from this study.
That's fantastic, and definitely a lot more type of data than a typical SAD MAD, as you alluded to. I guess when you do the sigmoidoscopies and the tissue biopsies, how many doses would those patients have gotten in the MAD?
Yeah. So they will have gotten a week's worth of daily dosing.
Got it. Got it.
Mm-hmm.
Perfect. So obviously, great data to look forward to here. I guess once you deliver the MAD data, you know, when can we expect to get into actual UC patients directly, of course it could change tomorrow, but what would a glance at the study design look like?
... Yeah. So, we're planning a small mechanistic study to begin this year, so the second half of 2024. And that's really to confirm plasma and tissue pharmacokinetics, so drug levels, and pharmacodynamics in patients with ulcerative colitis. Those results, we think, could inform a future Phase II proof-of-concept clinical trial. And a typical Phase II study, you know, would have anywhere from 40-90 patients with UC, so that would be a much larger experience. But we think that we could see data in UC patients even earlier than it would take to conduct a Phase II. Our KOLs have confirmed that healthy volunteer data on blood and tissue are fairly representative to that in patients.
And so, you know, we actually do want to proceed to a Phase II study as quickly as we can, and we think that a small study ahead of time, in UC subjects, might be sufficient to get us there.
Got it. Got it. And, so, like, looking forward, too, with regard to that study, I know we've been talking about Xeljanz, but tofacitinib, you're using a special, you know, formulation for that. You're not using Xeljanz, Xeljanz, per se. Excuse me. So with that in mind, for BT-600, does third-line therapy represent your first go-to-market strategy? I think, you know, people would like to see how we could, model that for the future.
Let me try that one. So it's a little bit early to start talking about what line, but it is interesting, right? From my perspective, the fact that people who have failed many other drugs end up on Xeljanz, and so this is my non-clinical opinion, tells me how well that works and how great that product could be. But there's, you know, some thoughts about what is happening with JAK inhibitors that's in the market that may or may not be all completely true. We're going to solve the biggest issue with that, which is instead of giving 20 or 30 mg a day, we might be giving five or 10 and achieving higher colon tissue concentration.
If the data we plan to generate turns out the way we expect it to go, the potential to use BT-600 sooner and with more patients rises dramatically. And so it's a little early for us to predict that, but we expect that we can be much more useful for a lot more patients than what Xeljanz has been.
Right.
It has another aspect. So many of those, you know, Ariella mentioned we met with the KOLs, which, by the way, are also on our website. If you go look them up, they are the world's top GI physicians. Working with a small company tells you how much they believe in our technology. These are really, really top physicians in the world. The people are starting to try combination therapies because there's such a big need, and, you know, you're starting to see some trials. And there's a big constraint when you're trying to do a trial with a combination of drugs, each of them individually having toxicology or tox limits. We could solve that if we can reduce that burden with BT-600 of those tox issues, then we become a perfect candidate for combination therapies, potentially.
So there's a lot that can happen with BT-600.
Right. No, very, very fair. Really appreciate a fantastic framework for NaviCap and BT-600 there. Looking forward to the SAD/MAD data. So, with that said, I'm going to switch gears a little bit over to BioJet. You know, earlier you gave its description, and now I'm looking for a little bit more of a summary of where it's been, where is it going? You know, first, for example, you had some device optimization previously last year and a little bit more. Is that all settled now? Where, where does the sort of the program stand?
Yeah, I think I'll refer to my opening comment of last year. Lots of heavy lifting, transformation. Device development in general would be expected to continue for a long time, and we want to keep making it better. However, the heavy lift was done last year. We evolved to our BioJet 2 device that had several improvements, including clinical grade materials, etc. We developed the process of development, the methods to build this, to test rapidly and get really good at execution. That heavy lift showed if you look at the last few months and the news that we've shared, where we started to then, with BioJet 2, generate data. We generated data with our molecules, and then we quickly moved on to generate data with multiple collaborators' molecules. You know, we've generated data with 3 of our collaborators, soon to be 4.
And with all of them, we are meeting or exceeding our performance targets for the platform. So, I'll tell you more about what the targets look like. But yes, the heavy lift BioJet 2 happened. We're going to continue to evolve it and make it even better, but we're using a device that looks really, really good.
No, that's great. And I guess, with that said, with all the heavy lifting you've done and some of the background stuff, can you summarize some of your preclinical takeaways, including your work, which obviously is an extremely hot topic right now with Semaglutide? You know, where do you see overall differentiation there, you know, if it were to progress? And, you know, what other molecules are you potentially working on, and what do you think would move into the clinic? I know that's a lot of forward-looking statements right there, but I think what I'm trying to get at here is that you seem to really have a lot of optionality with the program.
... You're correct. You know, a lot of optionality, broad applicability. So let me, let me, go back to what at the core, when we started out, we thought. We did a lot of work internally and with our collaborators to come up with what might be the right sort of criteria to say you might have a really great, oral delivery option. And we, what we concurred and came up with was that around 15% bioavailability compared to IV is something that looks commercially viable for most molecules, along with some sort of variability constraint. Now, I'll tell you, variability means each dose, how much do you really get? As an example, Rybelsus is 1% bioavailable and ±100%. It's on that label. I'm not making this up.
So we thought something better than that would be a great option, and our collaborators and us, we came up with a number, and so far, we are doing at least double or better than that, right? So we've shown data with Semaglutide that shows greater than 30% bioavailability with a pretty tight consistency. Consistency from dose to dose, ranging in the range of around subcutaneous injections. So even injections are variable. They go, right, ±40, 50% is what you get for bioavailability in injections. So we're showing something that is similar in ways to a subcu injection in terms of bioavailability and variability, which is fantastic, right? And compared to other potential oral delivery options, way, way better. There's another interesting part.
You know, there are some kinds of medications that need specific targeting, like liver targeting, in the case of RNA-based therapeutics, like antisense oligonucleotides, siRNA, those kinds of things, and most oral options fail them because they don't get to the liver. We have announced data that showed we saw great liver targeting with our technology. Part of that had to do with the fact that, you know, our liquid jet injection in the small intestine ends up with a really short path to the hepatic portal system, and so that means that we could do that uniquely compared to any other technology. So we're continuing to do more work. We've already done two different animal studies with different molecules that show this liver targeting.
I know I get, you know, maybe a little bit excited, but let me just try to summarize here. So compared to most oral technologies, most of which seem to have some, you know, limitations in terms of reaching bioavailability in the single-digit % range, typically, we have the ability to reach bioavailability comparable to subcu injection, sort of with the bioavailability, also the consistency, potential to target liver, potential to use so many different molecules, because one of the bigger things in our technology is we can use essentially the same formulation with minor tweaks to what's currently being used in an injection, where most other technologies need quite a, you know, fair amount of reformulation work, and that leads to extra hurdles.
It's a pretty elegant, sort of simple mechanical technology and can deliver a pretty large payload in the multi-milligram dose. All of these are distinguishing features compared to all the other technologies, and so we think the opportunity is big, the, you know, applicability is large, but we want to still try and get through some, one or two of them, and then be able to expand some more.
I appreciate that. So, like, based on all that optionality for the future, you know, let's just pick one. Like I mentioned, Semaglutide. You know, what, what have you shown, you know, thus far with that molecule, again, since it's been such a hot topic?
Yeah, it is. So, we have some presentations if you wanna look up, and, you know, we've got them on our website, links to them. We've got papers, or conferences where we've been, and we've shown the data, multiple times that we can do Semaglutide at, like I said, over 30%, bioavailability. We have our own molecule. We have ways to move that development forward fairly quickly. We also have collaborators, and so at this point, given our limitations of what we can say and cannot say, we think there are pathways to move some of these things fairly quickly over the next short period of time, as we generate some final data with some of our collaborators, that will allow us to determine pathways forward.
Okay, absolutely fair. So again, shifting gears a little bit, you know, we've talked really about the key investment case points for your technology, the clinical paths forward, and really a lot of good data to support those paths forward. But however, a major part of the thesis that we've been focusing on is the business development potential of your platforms, 'cause obviously, you have so much going on, you're not gonna do all of it yourself. You know, for example, BioJet already has pharma collaborations, including what you recently disclosed. One of those collaborators is AstraZeneca. You already had Ionis and beyond, so a couple of unnamed.... To the extent that you can disclose, you know, what kind of work are you being tasked with from these collaborators?
You know, what are the general deliverables, and what represents the critical triggers, if you will, to move the collaboration to an actual official partnership? You know, to that, to that end, do you think we can expect anything this year, forward-looking?
Yeah, no, it's a fair question. And, and Joe, you know, I, I totally get it. We get that a lot, and I totally understand the frustration when, you know, it's like: "Well, why can't you tell me more?" We are in this unique position. I, I've been in smaller companies where it's really hard to get the attention of large companies early on. We're in this unique position where lots of large companies are really interested in what we're doing. But then a lot of these large companies, they have competitive reasons and other reasons to not expose what they're working on too soon, and so they put a lot of limitations on us. We want to be good partners, we want to work with them.
We think, you know, there's lots of future potential, but then we want to stay within some of those restrictions. Now, you mentioned AZ. One of the reasons we were able to share their name was we made enough progress in the relationship with them so that they allowed us to say, "Sure, you can now go ahead and tell them that." And what are the kinds of things we worked on, right? Initially, they liked the concept of BioJet, and then, we worked together to say, what are sort of... I mentioned, right? What are the parameters that they would make this interesting, like the 15%, at least minimum bioavailability, the variability or consistency from dose to dose, data with their molecule, not just ours, 'cause, you know, we've generated data with multiple molecules.
So we work with them to show them that we could do this consistently with a certain level of bioavailability with our molecules. Then, we have to use their molecules, and we started doing that. And so there are just a couple of other smaller steps as we move forward in each of these relationships. We expect some, not all, to then be able to progress pretty quickly. You mentioned this year, that is our expectation that, if not this, then something else should be able to progress to the next stage of a different kind of instead of a collaboration, I call it more of a partnership. In the collaboration stage, we're working together, which is great, right? We learn a lot as a small company, what those endpoints are, what those criteria are, what are they looking for.
We learn a lot, and it seems fairly consistent. So anything we do with each of these partners helps build the platform overall. So we're learning from each of these, we're generating the data, we're getting closer to where there's enough data for them to take the next step, and it allows us also, in the meantime, to open other conversations. Like I said, we get a lot of incoming, and every time we've shared more data, we've got a lot more incoming interest. But for all of them, there are a couple of these small steps that we have to still take, right? Generate data with their molecule and a couple other smaller things. I truly, I'm not trying to hold back.
I would share everything we could, but it makes sense for us to have these significant partners who we expect to be long-term partners with in a big way, to follow their rules. So we're gonna do it the right way. We've made tremendous progress, and I really believe this year, if not one of these, something else, we absolutely can do something more than what a collaboration is, so more like a partnership, and there's various forms that could take. I think we want to stay focused and, you know, we want to stay resource-efficient. We will focus, and we are focused entirely on making this partnership move, and once we get that, we will come back and refocus on our own molecules and our own clinical trials with the platform.
Mentioned before, 100 or so different molecules, so possibilities are broad. Getting one or two of these on board is absolutely our near-term goal this year.
No, that, that's great. I understand that, and I'm not gonna challenge your relationship with pharma's legal teams here. But, look, I, I guess you really can't genericize the deliverables because every relationship with your collaborators is different. You don't basically say, "Hey, you know, we'll do these experiments, and, you know, where's the partnership?" So I think you really have a lot going on there. But I, I guess I'll ask this, and I don't know if, Eric, you want to chime in on this as well, but you know, what kind of, say, financial assistance, if any, do you get from your collaborators to be able to help with these programs?
Yeah. You know, so they share spend. So this, so when we do programs with them, they share our spend, like, you know, for animal studies, for formulation for molecules, they provide molecules. So it helps us quite a lot 'cause then, you know, the, it's not exactly a 50/50 split, but they share maybe more than that. So we don't want to put numbers around it, but so we do get good spend sharing when we work with them, 'cause they're really keen on it, right, Eric? It's not... They want to know, too. So that's kind of how it goes, and... it will become something different as we go forward, because you've seen a lot of the kinds of things that can happen after.
What I'm hearing, and I don't want to put words in your mouth, is sort of a cash-efficient strategy that could deliver the answers the collaborators want?
Yes.
Okay. All right. So with that said, I have to say I really appreciate all of your answers. Ariella, this was great, getting all the clinical and, you know, clinical needs and the, you know, really the views of the programs here. Lots to look forward to this year, and of course, we can't put any timing on partnerships, but I guess based on what you've been doing and the progress you've made to be able to disclose that AstraZeneca is one of those programs, you know, hopefully will deliver something meaningful to the street as well as you guys. So with that said, thank you very much, and I don't know, Adi, if you wanted to have any sort of sum-up commentary with regard to how we should view Biora going into the rest of the year.
Oh, well, again, thanks for having us. You know, we really appreciate it. If you heard from Ariella or from Eric or from any of us, we are really excited about what we're working on. Two really unique platforms, huge need in IBD, but even beyond that, and nobody else can do this, right? There's no localization technology that can do what we're doing. There is no oral technology that can consistently deliver product in the colon. So huge need, making great progress. Within a few months, we have some critical data that could be transformational. To me, it completely changes the way the de-risking of the program is viewed, once we have that early data, because we know Xeljanz works. Now, we know our device works in humans. The combination, we'll get that data in the short few months.
So huge thing that will keep us moving, and then we can look for a future expansion of NaviCap BioJet. We really wish we could get this, you know, quicker to the whole world because transformational technology, where it really supports our vision, where we are reimagining the way any drug can be delivered without needles. And so to be able to get away from needles and be able to have a technology that can come close to a SubQ in terms of the way it shows bioavailability and consistency, will allow for so many different things. So we think this is the year. We did a lot of work, laid the foundation, got good at execution. This is the year where we deliver on these data that show the world what we internally love about the two technologies. Thank you for having us.
Excellent. Biora team, thank you very, very much. As a reminder, I want to tell everyone, make sure you go check out that drug dispersion data on the company's website. Very nice pictures, and everyone, have a fantastic week. Thanks a lot.
Thanks, Joe.