Half Year 2023 Biora Therapeutics Inc Earnings Call
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Greetings and welcome to debate Terabits per second quarter 2023 earnings calls at this time.
Alfred Chip on Saturday night listen only mode. A brief question and Mr. Essentially following the formal presentation.
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It's now my pleasure to introduce your host check by dollar managing director, who leads to life Science advisor.
Thank you you might be getting.
Thank you operator, good afternoon, and welcome to the bio Therapeutics second quarter 2023, corporate update and financial results Conference call.
Joining me on the call are audio biology, Chief Executive Officer, and Eric <unk>, Chief Financial Officer.
Before I turn the call over to Mr. Bahati I would like to remind you that today's call will include forward looking statements within the meaning of the federal securities laws, including but not limited to the types of statements identified as forward looking in our quarterly report on Form 10-Q that was filed or will file a little later today.
And our subsequent reports with D. A C C, which are available on our website in the investors section.
These forward looking statements represent our views only as of the date of this call and involve involve substantial risks and uncertainties, including many that are beyond our control.
Please note that the actual results could differ materially from those expressed in the forward looking statements.
For a further description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the forward looking statements as well as risks relating to our business. Please see the company's periodic reports with the SEC.
With that I would.
I'll turn the call over to antibiotics C E O therapeutics.
Thanks Chuck.
And thank you everyone for joining us during the second quarter, we continued to make excellent progress with our navi kept platform advancing toward our planned R&D filing in Q3 and with our bio jet platform, where we continued our progress on device development and testing.
We also further strengthened our intellectual property position for both platforms.
Burst.
An update on our Navi capped targeted therapeutics platform with our lead program <unk> 600, and ulcerative colitis.
Currently available therapeutics for ulcerative colitis, or you see work by entering the bloodstream and circulating systemically throughout the body with a limited amount of drug reaching the colon, which is the site of the disease.
Research suggests there is a minimum amount of drug needed in the tissue at the site of disease to achieve better therapeutic outcomes.
Reaching or exceeding this threshold in the tissue should improve patient outcomes, where you see.
Our <unk> platform uses a device about the size of fish oil pills that one swallowed is designed to deliver drugs directly to the colon using our Gi tract localization technology.
The commercially available version of Tofacitinib is approved in capsule form for the treatment of UC.
Like other drugs deficit and it is taken up systemically with a limited amount, reaching the area of disease in the colon.
By delivering drug where it is needed at the site of disease. We believe our B T 600 program can deliver sufficient drug to the tissue of the targeted area to improve efficacy.
This localized delivery along with our proprietary formulation has shown in animal studies.
The ability to deliver the right amount of drug to the tissue, even with a lower overall dose than the currently approved dose tofacitinib.
So we're extremely focused on getting down to cap into the clinic and everything we're working on right now with this program is intended to enable our planned September I N D filing I'm.
I'm happy to report that we are on track with our plans.
All of the analyses from our talk study, which was conducted earlier this year had been completed.
We continue to believe that these results support our assessment of readiness for phase one.
As we shared previously all planned devices were administered without any adverse events or safety signals, even at the highest 25 milligram dose of deficit in it.
We measure drug levels and Colin tissue 24 hours after administration of the last dose and observed drug levels supporting our ability to reach the appropriate tissue drug concentration.
We observed that the drug did not accumulate over time, which is a favorable side of safety.
We also observed peak drugs drug levels in blood that are approximately one third of what would be expected with the equivalent dose of commercially available tofacitinib.
As we prepare for a phase one trial, we have conducted another device function study, which demonstrated outstanding performance and supports our assessment of device function in humans.
We recently announced preliminary results from this study and.
And we subsequently completed the study as planned after 16 healthy volunteers had been administered the navi cap device.
Our phase one ready device performed as intended in 15 out of 16 subjects.
The <unk> device accurately identified entry into the colon triggered release up its non drug payload and achieved distribution throughout the colon.
The greater than 90% performance is consistent with our previous human studies it exceeds our minimum device function requirements and it gives us confidence as we head toward the clinic.
From the latest study we generated a series of images that show the NASDAQ cap device progressing through the GI track activating upon entry to the colon and dispersion of the payload throughout the colon.
We've included these time lapse images and video in our corporate deck on our website.
Might you to take a look at that.
The study once again showed the robustness to find out a cat platform, which performed as designed across a range of expected defenses in Gi motility between study participants.
Looking ahead to the planned phase one study, we hope to see data that confirm the learnings from our animal studies and confirmed my hypotheses that BT 600 can safely deliver tofacitinib locally to the colon, resulting in sufficient colonic tissue levels and low systemic exposure.
The phase one study design includes a colon tissue biopsy and all subjects at the end of the study.
Tissue biopsy is not typical for a phase one study in healthy volunteers, but we feel this information will be extremely valuable in informing the design of a future studies in patients with UC.
This proposed trial design has been discussed with the F D a and they have been supportive of it so far.
We expect to exit phase one with safety data, but also with critical data on potential exposure in both serum and tissue, which could be much more informative than a typical phase one trial.
In addition to progress towards the R&D. We also had some nice wins on the IP front recently, having been awarded a group of U S and European patents directed to methods of treating ulcerative colitis, using our Napa cap device to deliver well known IBD drugs, such as Janus kinase inhibitors anti <unk>.
Tegra ends in I O 12 twenty-three inhibitors.
Our extensive IP will allow us to organically expand our pipeline to several potential targets.
We believe the Nabokov platform could transform treatment options for many other diseases of the Gi track and that progress would be T 600 will unlock significant new opportunities for by Aura.
Summarize we're on track and remain confident in our progress toward eight September R&D filing for them they have a cap program.
We believe we can potentially address the large unmet need for UC patients by solving one of the primary treatment gaps, which is the inability to achieve high enough drug levels in the diseased tissue without systemic toxicity.
Yeah.
Moving onto our Biogen systemic therapeutics platform.
Our goal with the Biogen platform is to provide needle free oral delivery of large molecules.
It is based on the device the size of a multi vitamin that once swallowed is designed to deliver a drug into the small intestine.
Using liquid jet injection to maximize systemic uptake.
We believe the Baidu platform can transform patient care by improving patient convenience, which has been shown to affect patient compliance.
We see this leading to better disease management and associated patient outcomes across a range of chronic use indications.
During the second quarter, we presented recent data generated with the Biogen platform at the American Diabetes Association scientific sessions, where we assessed the bioavailability of semi Glu tide delivered via our bio jet device in an animal model.
In two studies, we achieved more than double our target average by availability of 15%, which tells us that so far based on the data the biogen platform can deliver existing liquid drug formulations with bioavailability similar to injection.
We base our claims data generated in animals, where we use IV delivery as a control.
Because I V is considered the gold standard, particularly.
When it comes to bioavailability you.
Using the IV standard as a measuring stick our bio availability would be quite impressive compared to other oral delivery methods.
Ever.
Some of our competitors use subcutaneous injection as a comparator arm.
Subcutaneous injection is known to achieve.
About 60% of the bioavailability of IV administration.
If we compare our bio jet platform using the measuring stick of sub Q injection, we see that we're achieving bioavailability similar to injection for the molecules, we have tested which is meaningfully better than what others have achieved.
We will be presenting more biogen generated data at the European Association for the study of diabetes annual meeting, which will be held in October .
As planned during.
During Q2, we have continued development and testing of the autonomous Lee triggered version of our latest Spadger device.
We have successfully adapted our previous autonomous trigger designs to this latest device.
After several rounds of design evolution in testing, we've been able to achieve our device function targets, while continuing to exceed our performance target of 15% by availability.
We're now repeating these tests. So we can have a robust dataset for discussions with our pharma collaborators.
We remain encouraged by interactions with our collaborators and look forward to further progress and subsequently advancing toward our goal of achieving meaningful partnerships for our Biogen platform.
Well many organizations have been working to solve the challenges of oral delivery of large molecules. Our approach stands out because of our liquid delivery method, which is not only able to achieve excellent bioavailability, but is also able to deliver an existing liquid formulation.
We are formulating a drug it's time consuming and expensive so the ability to use existing liquid formulations gives us another potential competitive advantage.
Looking ahead to the future of disease management, we think it will involve more complex molecules such as dual and triple agonist for diabetes management and also a combination therapies, which are all harder to make into pellets. We think our bio jet platform will be well positioned to deliver these more complex therapies.
Now the potential advantage of our technology is the ability to achieve uptake of drugs and hard to reach areas like the liver.
A large number of disease targets resided in the liver and it is a key area for gene expression therapies. For example, RNA therapies that rely on liver targeted delivery of antisense oligonucleotides.
Other oral delivery technologies have not been able to address this challenge.
We are awaiting data from studies, we completed with one of our collaborators that may provide useful information on our ability to deliver these types of therapies and we look forward to sharing more of this in the coming weeks.
We recently announced further progress on the IP front related to the Baidu platform as well.
With additional patents covering key features of our liquid jet injection technology.
With approximately 38 issued patents and pending applications covering our delivery platform and methods, we're using liquid check delivery to treat patients. We are in a strong competitive position to participate in delivery of the 100 billion dollar plus G. O P. One agonist market as well as many other large.
Fuel such as proteins peptides and nucleic acids.
To summarize our anticipated milestones.
For now the Cat platform, we remain on track for filing in R&D for BT 600 in September and we anticipate initiating our phase one trial before the end of the year.
For our Bajaj platform, we're confirming the performance of our autonomous next generation Badger device.
And we expect to continue generating preclinical data during the third quarter of 2023.
We expect to continue testing the budget device with the molecules are pharma collaborators in the coming months.
We look forward to sharing additional biogen preclinical data at the European Association for the study of diabetes annual meeting in October .
With that I'll now turn the call over to Eric for a review of our financial results and capital market activities.
Thanks, Eddie and good afternoon, everyone.
During the second quarter operating expenses, excluding stock based compensation expenses remained stable at $12 $5 million with continued investment in device development and preclinical activities.
Breaking this down G&A expenses in the second quarter were $7 $7 million, excluding stock based compensation expenses, while R&D expenses in the second quarter were $5 $2 million, excluding stock based compensation expenses.
We've been continuing to streamline our G&A expenses, and making great progress in focusing on investments on al.
Our R&D programs.
While more than 30% of our G&A spend in Q2 was still composed of legacy span.
We expect that will gradually Taylor by early next year.
Our core Opex spend remains very much focus towards our R&D programs, which makes sense as we rapidly move towards the clinic.
Yeah.
While spending will continue to fluctuate from month to month as we progress towards the clinic, we maintain our guidance of an average monthly operating cash burn of approximately $4 million.
We successfully raised $8 million in gross equity proceeds during the second quarter.
Which funded the majority of our Q3 operating expenses, leading to only a slight reduction in our cash balance to $26 $5 million as of June 30th 2023.
We also continued to make progress with monetizing remaining legacy assets, which will also add incremental funding.
Finally, we continue to work actively optimizing our capital structure to maintain and enhance our public company profile and we expect to have some updates.
With that I will now turn the call back over to Adam.
Thanks, Eric firewall continues to make strides with both or neither cap targeted oral delivery platform, where we are focused on entering the clinic with our B T 600 program and our Biogen systemic oral delivery platform, where we're focused on confirming the performance of our next gen device and.
Wrestling with pharma collaborations we look forward to providing further updates as we achieve these milestones.
With that operator, we're now ready for questions.
Thank you Susan.
Ill be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
You May press Star two if you would like to remove your question from the Q4 participants using speaker you keep them each is might be necessary to pick up your handset before pressing the star.
One moment, please why do we pool for questions.
Thank you our first question from Joe <unk> from H C Wainwright.
Please go ahead.
Good afternoon, gentlemen, and thank you for taking the question very nice to see the recent Nab.
Now the cap data. So you know I wanted to focus on that for a couple of moments if you don't mind so.
I guess the focus of my question is on business development. So obviously, you're dealing with you see right now and you see associated drugs, you're also getting the level of bile bioavailability that you'd like to see and you're getting the tissue targeting so I guess my two questions are you know.
How do these data impact your overall business development strategy and also what is the potential sort of scientific or clinical impact base.
Based on the type of drug that you use within the Nab of cap system. Thanks, a lot.
Yeah.
Thanks for the question Joe.
So.
It's a slightly complex question when you talk about how does it impact our BD strategy clearly, we're really excited about how it's performing so our navi care platform.
You know our phase one ready devices. We just ran it it is working amazingly well, so our Gi tract localization technology fingers out exactly where we want the drug to be dropped. So the programming is set we can tweak that if we want and do different drugs in different parts of the Gi track.
There's various ways, we could do a lot more with this platform, but we're staying focused on trying to get to this UC trial, where.
For those who May know do you see area you would know that Tofacitinib is a very powerful molecule. It works extremely well problem as it works. So well that you know a huge amount of this becomes toxic to the body and in order to get the right amount of drug in the colon you.
<unk> got a dose up to the point, where it's toxic.
And you get a great response, so solving the problem of not having systemic toxicity by having too much going around in the blood, but getting enough drug to the tissue would make this a substantially different therapeutic option that many physicians would love to have and certainly.
Patients so what we're seeing is.
With.
The way we have delivered it and this is through the animal studies, we get something in the range of a third or a quarter.
The amount of drug that you would normally get in the blood, but we're getting a lot more in the tissue, which makes sense right. We have a formulation that is a liquid formulation that when it's dropped in the colon coach the colon and you get most of that uptake through that colon tissue and getting a lot more in that tissue than any.
The method so.
We want to stay focused on getting a little bit further along we think that we don't need to go much further right. If we can show in our upcoming trial that.
We get there.
The kinds of blood concentrations were getting in animals, the kinds of tissue concentrations were getting in animals that we get confirmation that you can get a large amount of drug in the tissue the amount that is required and.
And you can use a much smaller dose of tofacitinib and get less systemic exposure, but still get some.
All of those things allow us to then have the opportunity to discuss how we keep going forward for now we're planning to then move on to using the drug in patients.
We want to stay focused on UC, because we think that it not only is a great target as you you mentioned right you know right now there's been a couple three really great Bill.
Business transactions in the UC arena with billions of dollars for companies that have had early stage drugs that large companies want.
But it unlocks our entire platform.
I know, there's a long answer but what it says is if we continue just a little bit further and show that the platform works and this particular approach for UC works, we could do something in the UC space, we could do a lot more with the entire platform. We also got some new IP that allows us to do a lot more drugs are various.
Kinds in the Gi track.
Most of these you might be familiar with so we unlock many different perhaps well work and we will remain open to many of those options.
In a short few months.
Great I appreciate the answer.
Our next question.
Jim's from Julian Harrison from B T. I G. Please sure you can go ahead.
Hi, Thank you for taking my questions and congrats on the progress on BT 600, I'm curious how soon you could proceed to dosing in ulcerative colitis patients and then are there any device related considerations or parameter changes when you make that move from healthy volunteers to UC patients.
Yeah.
Yeah. Thanks, Julien for the question that second part I'll take first a which is really interesting right. There's been a lot of questions about hey, when you put this in humans. It doesn't work because you know and yes, we have done it so.
So far we have done more than 80 human subjects and interestingly, we've actually done it with patients. So we've had UC patients and you can find it on our website, we have some data where we've used this device.
With the card programming in UC patients up various different severity. So we've gone from you know less severe you you know the Mayo score going from two to six to eight so we've gone to more severe patients.
Amazingly. It works every single time, so even in the environment, where they've got a you know inflammation bleeding motility issues.
It worked so we know that the device would work.
And we did it without obviously the the drug payload the device would work in UC patients. The device works in healthy patients with over 80 subjects now we know that we're getting a greater than 90%.
Performance functionally and it's doing the right thing at the right time. So we don't think we will need to tweak the device going from our phase one where we will be using a healthy volunteers to the patients themselves. What I think will be more interesting and which we want to get too.
Is.
Is there a accumulation in the tissue as I mentioned right you know in the animals, we saw that there wasn't any but getting to that answer and getting some of the other which we're we're not worried about getting but will be just a good confirmation to get in the phase one is what the systemic exposure is.
Well, what all the other safety PK and PD data, we can gather all of those would be helpful. Input. So that we can quickly propose a.
In patient study and we intend to do that we think that you know in terms of Derisking.
When we get just this phase one data lots of people will be.
Begin to appreciate what we're going to be able to do in patients.
Very helpful. Thank you.
Okay.
One moment, please why do we pull for questions.
Our next question.
John King from my Yankee Mantovani from B Riley Securities Lisa you can go ahead.
Hey, guys Madison on for Matt Thanks for taking the call congrats on the progress.
For the device function study could you talk to any differences to keep in mind as we think about the phase one b T 600, initiation and particularly in regards to the biopsy just wondering how performing the biopsy may impact execution goals.
Enrollment goals.
And then any color on the Fda's kind of perspective would be helpful. For example, if you sense any kind of pushback or hesitation.
And then lastly.
Could you remind us.
Of the timeline that the FDA has to respond once you submit your IMT and September thanks.
Yeah.
Thanks for the question. It is an important one because we are.
Fully kind of baked in is the taking the biopsy, we would love to get the answer on.
What the tissue concentrations are obviously, what we're doing is a single tissue biopsy at the very end.
Oh, the Mad studies, so it's not like we're taking it routinely that would be more difficult in healthy volunteers as opposed to patients. So what we want is a answer on the tissue, we will do that at the end.
That is not.
As onerous and we're working with our very top notch clinical trial, operator, who has absolutely confirm that this is something they can do as.
As far as the FDA interaction.
A few months ago, we actually had a type C interaction with the FDA, where we had detailed all of what we wanted to do we got a very detailed responses from them that is what gives us comfort that they were quite supportive of our approach and what we were planning to do they had somehow.
Full input on some.
Some small areas of the trial design, which we have incorporated or are incorporating and so we feel pretty good that you know our interactions with the agencies have been good the clinical trial. Operator has indicated that this is something that is very doable.
Working very closely with the people who would actually run the trial.
And if you remember a few months ago, we got our new Chief Medical Officer, who is also quite familiar with our what we're trying to execute so well.
We're pretty comfortable we feel good about where we are at.
When we file as you know a typical R&D.
You know after filing it's about a 30 day.
Period of time before you can say, yes, let's go ahead and start executing on the trial itself. So we feel sometime later this year, we will be activating the sites in actually doing some trading of people this year and hopefully getting to data fairly soon.
Alright, great well I appreciate the color.
Okay.
Our next question scheme from Joan vendor amongst them film Zacks, Lisa you can go ahead.
Thank you and good afternoon.
What are some of the primary endpoint do you anticipate that you will look forward and you get to a pivotal trial in UC program.
Are there any precedent for that.
Okay platform or what the FDA might look for when you get to that next stage.
Yes.
Yeah, Joe I think yeah, theres been a lot of UC trials, it's pretty well defined it's very well understood things like you know.
How quickly you get mad.
That initial response, how many weeks. It takes there are extremely well defined you know tons of trials have been done in this play in this space.
You.
So that is really not that big a question.
You know we think we can easily show also comparative data because there's just so much data out there on how different molecules are performed.
Easy to do.
Straightforward, we don't think that's going to be a question when it comes to the specifics of Navvy cap no. There is no other such thing out there.
There is no localization technology that is only available that you can just take a pill every day and it goes to the right spot and drops are the payload.
That there is a part of that that makes it.
A more interesting than almost any other typical drug trial right. You know most of the endpoints will be drug endpoints and so that's pretty common.
I think what it would be more interesting as early on the functionality and safety around just having a device go through every day and come out every day or you know as these patients are taking them.
Which is where there will be some amount of additional.
Data collection around just any impact of the device, which we think will get very early on like I said, we've already got you know over 80 subjects that we have done.
These are the devices with collecting all of that into a database of safety around being able to use the device every day, we've done over 600 of these in the talks trial, we did with our with the dogs, where we saw there was no impact from weather it was a device going through.
When how it operated whether it was stuck in there for you know with two or three of them at the same time, all various kinds of ways that the device might perform we saw and there was no issue. So we'll see some more of that with the phase one we will see so I think we will collect all of that that is the additional data.
We will have to collect as the device aspect of it but when it comes to the phase III outcomes. Typical standard do you see trial outcomes, which are really well established with lots and lots of different data. So we think by the time, we get there.
It'll be quite straightforward.
Thank you I appreciate the detail.
Then moving to bio jet what are the next steps that we anticipate there before and I M. D is ready for that program.
Yeah, so with our bio jet program.
Works that we have taken a slightly different tack instead of getting too quickly.
Indiana clinical trial on our own we want to leverage these conversations we've had and we do have three.
Current collaborators.
Really large companies that we're working with very closely where we want to establish what the baidu platform could do using their molecules. So where we are as you know we had our a research device that worked last year, we evolved that to a next generation clinical.
Ready device this year, we did a.
Instant trigger mechanisms so that everything inside the PIL could be tested with then in the last few months added on the autonomous trigger because last year, we had already used in autonomous trigger. So we've got now data with the autonomous trigger that looks like Yep. It's working we can get the autonomous trigger to work with the device we've.
<unk> had some data.
In a few weeks or less we will have additional data that will now make a robust enough package to talk with our collaborators the existing ones and others and start using their molecule. So one of them has already allowed us to use. So we have an antisense I think this is the the one name was.
A lot of users are illness, and actually allowed to use as the others.
You know we want to work with them in full trust of their requirements, which is we can share their names as we go further.
But we have used them antisense device antisense molecule will use other molecules from those collaborators, we will have that data and in the coming weeks and months.
We think that information will allow us to.
Go into something of a more meaningful partnership with these or other collaborators and we think that as its first step.
Establishing what the Biogen platform can do.
In the next short few weeks and start working with our collaborators molecules are in the next few months.
And then progress to meaningful partnerships with these or other collaborators.
The coming months.
And that's what we have planned we wanted to make sure that we stay focused we say resource efficient until we get to next year, where we can expand both the platforms right. You know by then we will have confirmation of both of our platforms and organically be able to expand our pipeline substantially.
As our resources Grub.
Great.
And then regarding the collaborations the elitist collaborations, but I think from working in certain therapeutic areas.
Perspective partners.
Yeah. That's a that's a good question at this point, we have not allowed ourselves to be tied down that way.
So unless we get to a meaningful partnerships, we will not allow ourselves to be tied down these give us plenty of room to do anything that we need to do at this point and hopefully we will be able to get further down the road, where we can talk about which areas we are.
Adding ourselves from because we've struck a different meaningful partnership.
Great. Thank you I appreciate it.
Yeah.
There are no further questions at this time I would like now to turn the floor back over to Mr. <unk> for closing comments. Please Sir you can go ahead.
Thank you all for joining us today.
We're encouraged by the progress, we're making and we look forward to keeping you updated on our progress.
Have a good evening. Thank you.
This concludes today's teleconference. You might disconnect your lines at this time. Thank you for your participation.
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