Q1 2022 Biora Therapeutics Inc Earnings Call
programs. We will continue to look for ways to maximize...
We'll continue to look for ways to maximize our legacy assets.
We recently announced the appointment of Paul Shabram as SVP technical operations.
We recently announced the appointment of Paul Chamberlain as SVP technical operations.
Paul brings over 30 years of biotech experience, leading successful development programs and commercial products, while implementing novel manufacturing processes. I'm very happy to have Paul join our team, where his focus will be on growing our device and therapeutics capabilities to optimize performance and manufacturing in support of our clinical program.
Paul brings over 30 years of biotech experience, leading successful development programs and commercial products, while implementing novel manufacturing processes.
I'm very happy to have join our team where his focus will be on growing our device and therapeutics capabilities to optimize performance in manufacturing in support of our clinical programs.
We continue to build the skills and capabilities required to be a successful biotherapeutics company.
We continue to build the skills and capabilities required to be a successful biotherapeutics company.
We also recently expanded our internal engineering and manufacturing capabilities with the addition of the new technical operations phase.
We also recently expanded our internal engineering and manufacturing capabilities with the addition of a new technical operation space.
Moving on to our programs, first, with our targeted therapeutics plan.
Moving onto our programs first with our targeted therapeutics platform.
As a reminder, our first program with this platform is an ulcerative colitis or use.
As a reminder, our first program with this platform as an ulcerative colitis or UC.
Annual global sales for UC drugs are estimated to be $10 billion globally, and the inflammatory bowel disease or IBD space overall is $19 billion globally. Our lead program, DGN-600, is a proprietary liquid formulation of tococitinib delivered in the colon using our targeted delivery technology, which is a capsule approximately the size of a fish oil.
Annual global sales for UC drugs are estimated to be $7 billion globally, and the inflammatory bowel disease or IBD space overall is $19 billion globally.
Lead program PGM 600.
As a proprietary liquid formulation of Tofacitinib delivered in the colon using our targeted delivery technology, which is a capsule approximately the size of our fish oil pills.
A commercially available version of tofacitinib is approved for the treatment of eucine.
Our commercially available version of Tofacitinib is approved for the treatment of UC.
So for certain, it currently is administered orally and like other drugs that are orally delivered is mostly absorbed in the stomach or the upper GI tract or as you see is a disease of the lower GI tract.
Tofacitinib currently is administered orally and like other drugs that are orally delivered is mostly absorbed in the stomach or the upper Gi track.
Whereas you see is a disease of the lower Gi tract.
In conjunction with our scientific collaborators, we will present at Digestive Disease Week, BDW, in San Diego later this month, data that builds upon presentations at the European Crohn's and Colitis Organization and the Belgian Week of Gastroenterology Conferences earlier this year.
In conjunction with our scientific collaborators, we will present at digestive disease week Btw in San Diego later this month.
Data that builds upon presentations at the European Crohns, and colitis organization and the Belgian week of Gastroenterology conferences earlier this year.
The data presented at these conferences was from moderate to severe UC patients taking to the system.
The data presented at these conferences was from moderate to severe UC patients taking tofacitinib.
GI tissue biopsies were obtained from these patients, and a clear correlation was identified between higher concentrations of drug in the tissue and improved endoscopic output.
GI tissue biopsies obtained from these patients and a clear correlation was identified between higher concentrations of drug in the tissue and improve endoscopic outcomes.
We believe our proprietary platform can achieve the goals of significantly increasing drug levels in diseased tissue while reducing systemic exposure.
We believe our proprietary platform can achieve the goals of significantly increasing drug levels and disease tissue, while reducing systemic exposure.
Our preclinical results show that successful targeted delivery with PGN600 enables about 25 times higher concentration in colon tissue compared to the equivalent standard oral dose while showing significantly less systemic exposure.
Our preclinical results show that successful targeted delivery with PGM 600 enables about 25 costs higher concentration in colon tissue compared to the equivalent standard oral dose, while showing significantly less systemic exposure.
This demonstrates the potential for PGN 600 to safely increase drug levels at the site of disease, which could dramatically improve disease management for UC patients.
This demonstrates the potential for PGM 600 to safely increase drug levels at the site of disease, which can dramatically improve disease management for UC patients.
During the first quarter, we completed a discussion with our clinical advisory board, which includes Dr. William Sandborg, Dr. Gert Hans, Dr. Bruce Sands, and Dr. Sabreen Vermeer, who are all leading experts in GI diseases and used their inputs to refine our clinical development program.
During the first quarter, we completed a discussion with our clinical Advisory Board, which includes Dr. William Sandbar, Dr. Gert Hans Dr. Bruce Sands adopt serene earlier.
We're all leading experts in Gi diseases and use their inputs to refine our clinical development programs.
We recently submitted our Type C meeting request to the FDA with our proposed clinical development plan.
We recently submitted our type C meeting request to the FDA with our proposed clinical development plans.
We hope to have FDA agreement in response by the end of this quarter.
We hope to have FDA agreement in response by the end of this quarter.
Following that response, we will be submitting an IND later this year for a phase one study with PGN 600, which should keep up on track for our plan phase two study next year.
Following that response, we will be submitting an IND later this year for a phase one study with PGM 600, which should keep us on track for our planned phase II study next year.
It's important to note that our plan phase one clinical trial with PGN600 will also evaluate both blood and colonic tissue levels of tofacitin.
It's important to note that our planned phase one clinical trial with <unk> 600 <unk>.
Also evaluate both blood and colonic tissue levels of Tofacitinib.
Given the data we've already generated and presented on the correlation between tissue concentration of pifecidinib and improved patient outcomes, if the clinical data generated in our phase 1 trial confirmed...
Given the data we've already generated and presented on the correlation between tissue concentration of possessiveness and improved patient outcomes.
If the clinical data generated in our phase one trial confirms.
that we can safely achieve high-tissue concentrations just as we have seen with PGF600 and pre-quinical studies, we believe the likelihood of improving remission rates in subsequent studies in UC patients is high.
That we can safely achieve high tissue concentrations just as we have seen with PGM 600 in preclinical studies.
We believe the likelihood of improving remission rates and subsequent studies and UC patients is high.
Because of the well-known therapeutic profile of Tofocinib in standard oral formulations and the ability to utilize or reference these existing data, we believe our development risks for PGN600 are reduced.
Because of the well known therapeutic profile of Tofacitinib and standard oral formulations and the ability to utilize our referenced these existing data we believe our development risks for PGM 600 are reduced.
Soon after the phase one trial is completed, we plan to initiate a disease interventional study where we may learn more definitively about the benefits a solution can bring to UCM.
Soon after the phase one phase one trial was completed with.
We plan to initiate a disease interventional study, where we may learn more definitively about the benefits of solution could bring to UC patients.
While we prepare for these critical drug-device combination clinical studies, we also continue to progress with clinical studies demonstrating the function of the device.
While we prepare for these critical drug device combination clinical studies. We also continue to progress with clinical studies, demonstrating the function of the device.
We have successfully completed a device function study in healthy volunteers and are currently actively enrolling two more clinical studies.
We have successfully completed a device function study in healthy volunteers and are currently actively enrolling two more clinical studies.
The first is a study to evaluate the effects of food on the function of the device. The second aims to confirm device
The first is a study to evaluate the effects of food on the function of the device the.
Second aims to confirm device function in UC patients.
Patient enrollment is ongoing and expected to be completed in the second quarter.
Patient enrollment is ongoing and expected to be completed in the second quarter.
Positive results from these studies should further confirm the robustness of our platform and demonstrate its utility for delivering a wide range of therapeutics to the fight of disease in use situations and other GI diseases.
Positive results from these studies should further confirm the robustness of our platform and demonstrate its utility for delivering a wide range of therapeutics to the site of disease and UC patients and other Gi diseases.
Our overall clinical development path may have some advantages because we're using molecules that have well-known safety and efficacy profiles.
Our overall clinical development path may have some advantages because we are using molecules that have well known safety and efficacy profile.
If we're able to demonstrate that the device functions as desired, the next step to demonstrate that the combination
If we're able to demonstrate that the device functions as desired the next step to demonstrate that the combination.
works should have a higher likelihood of success compared to many other therapeutics and early development.
Works should have a higher likelihood of success compared to many other therapeutics in redevelopment.
Each development stage that we successfully achieve will increase the value of the current program and really the entire platform, thus strengthening our position to discuss partnership opportunities and future commercialization.
Each development stage that we successfully achieved will increase the value of the current program and really the entire platform, thus strengthening our position to assess and discuss partnership opportunities and future commercialization.
Achievement of development milestones will also inform our plans for future product expansion of our targeted therapeutics platform. Next.
Achievement of development milestones will also inform our plans for future product expansion of our targeted therapeutics platform.
Next I'll cover our systemic bio therapeutics platform.
The goal of this platform is to facilitate oral administration of drugs that would otherwise require injection or infusion.
The goal of this platform is to facilitate oral administration of drug that would otherwise require injection or infusion.
Our systemic therapeutics delivery solution is an old capsule which provides liquid jet delivery of large molecules.
Our systemic therapeutics delivery solution is an oral capsule, which provides liquid.
Delivery of large molecules.
In order to maximize systemic uptake.
We believe this platform can help improve disease management and associated patient outcomes, reduce intravenous infusion costs, help expand the market for drugs across a range of chronic use indications, and help bottom therapeutics such as monoclonals become more competitive with small molecules.
We believe this platform can help improve disease management and associated patient outcomes with you.
Intravenous infusion costs also.
Help expand the market for drugs across a range of chronic use indications and how biotherapeutics such as monoclonal become more competitive with small molecule substitutes.
Our platform, with the protective capsule and jet, means this system has the capability to deliver a range of approved large molecules such as proteins, peptides, and nucleic acid without complex reformulation.
Our platform with the protective capsule and jet means this system has the capability to deliver a range of approved large molecules such as proteins peptides and nucleic acid without complex re formulation.
As a reminder, we already have multiple R&D collaborators for this technology.
As a reminder, we already have multiple R&D collaborators for this technology.
Since our last call, we've continued to make progress with the device.
Since our last call we've continued to make progress with device.
design and manufacturing, and making improvements that will increase device performance, reliability, and manufacturability.
Assigned in manufacturing and making improvements that will increase device performance reliability and manufacturer ability.
Although we have data with several molecules on this platform, such as the monocle, antibody, adelumamab.
Although we have data with several molecules on those platform such as the monoclonal antibody <unk>.
Our initial focus is on a high concentration formulation of the peptide lyroglutide, a GLP1 receptor agonist.
Our initial focus is on a high concentration formulation of the peptide liraglutide a GOP one receptor agonist.
We believe that achieving 10% to 15% bioavailability through oral delivery would enable our platform to be commercially viable with a broad range of large molecules, and we have already demonstrated the animal models that we can achieve up to 67% bioavailability for monocle antibodies.
We believe that achieving 10% to 15% bioavailability through oral delivery with enable our platform to be commercially viable with a broad range of large molecules and we have already demonstrated the animal models that we can achieve up to 67% bioavailability for multiple antibody.
We will be presenting pre-clinical data on the performance of this platform at the controlled release society annual meeting, which will take place in July , and we expect to share existing and future results at other upcoming conferences.
We will be presenting preclinical data on the performance of this platform at the controlled release Society annual meeting, which will take place in July and we expect the share existing and future results at other upcoming conferences.
As with our other platform, here too, we're initially using drugs with established safety and efficacy profiles, which should result in several advantages in the regulatory pathways and development plans for this platform.
As with our other platform here too were initially using drugs with established safety and efficacy profiles, which should result in several advantages in the regulatory pathways and development plans for this platform.
We expect to run additional preclinical studies in the coming months.
We expect the run additional preclinical studies in the coming months.
These additional data could be sufficient to progress our collaborations into next stages and allow us to be ready for human clinical trials demonstrating effective delivery of therapeutics next year.
These additional data could be sufficient to progress our collaborations into next stages and allow us to be ready for human clinical trials, demonstrating effective delivery of therapeutics next year.
For now, we plan to take one systemic therapeutic program forward to these later stages, which we expect will show the broad applicability of the platform for use with many other existing and in-development therapeutics.
Now we plan to take one systemic therapeutic program forward. These latest stages, which we expect will show the broad applicability of the platform, we use with many other existing and in development therapeutics.
Although our targeted and systemic therapeutic platforms are the primary focus of the company in the near term, we continue to incubate our other platform technologies for the future.
Although our targeted and systemic therapeutic platforms are the primary focus of the company in the near term.
We continue to incubate our other platform technologies for the future.
At digestive disease week in May.
We will share proof of concept results from a clinical study demonstrating the ability of our recoverable sampling system, our third platform technology, which uses an oral capsule to non-invasively collect and preserve a microbiome sample.
We will share proof of concept results from our clinical study demonstrating the ability of our recoverable sampling system, our third platform technology, which uses an oral capsule to noninvasively collect and preserve our microbiome samples.
We believe the ability to collect, preserve, recover, and analyze analytes from specific regions of the intestine has numerous potential applications for diagnostics and for drug discovery and development.
We believe the ability to collect preserve recover and analyzed analytes from specific regions of the intestine as numerous potential applications for diagnostics and for drug discovery and development.
To summarize some of our upcoming milestones.
We expect to complete our targeted therapeutics device function study in fed state and in UC patients in Q3.
We expect to complete our targeted therapeutics device function study in fed state at in UC patients in Q3.
We will review our clinical plan for PGM succumbed with the FDA in the coming months ahead of launching our phase one study during the fourth quarter.
We will review our clinical plans for PGM 600, with the FDA in the coming months ahead of launching our phase one study during the fourth quarter.
We expect to generate and share upcoming conferences by availability data from our systemic therapeutics program, which will enable our first clinical studies to begin next year.
We expect to generate and share at upcoming conferences bioavailability data from our systemic therapeutics program, which will enable our first clinical studies to begin next year.
With that, I'll now turn the call over to Eric for a discussion of our financial results and capital market activities. Thanks.
With that I'll now turn the call over to Eric for a discussion of our financial results and capital market activities.
Thanks, Eddie and good afternoon, everyone.
As Addy mentioned earlier, we've now completed our company transformation into a therapeutics company with the goal of leading the oral delivery of biotherapeutics.
As Eddie mentioned earlier, we've now completed our company transformation into a therapeutics company with the goal of leading the oral delivery of borrower therapeutics.
We're now a more focused organization with a much reduced cash burn profile.
We're now a more focused organization with a much reduced cash burn profile.
with a spin out of our single molecule detection platform with created the opportunity to generate a return on our past investment while eliminating the associated cash flow.
With the spin out of our single molecule detection platform with created the opportunity to generate a return on our past investments, while eliminating the associated cash burn.
Our near-term focus remains optimizing capital allocation to our pipeline with the goal of generating value through the achievement of key development milestones and clinical data generation.
Our near term focus remains optimizing capital allocation to our pipeline with the goal of generating value through the achievement of key development milestones and clinical data generation.
Operating expenses, excluding spec-based compensation expenses, were $18 million in the first quarter of 2021, in line with our previous guidance, as we've now completed the transfer of our molecular testing ask.
Operating expenses, excluding stock based compensation expenses were $18 million in the first quarter of 2021 in line with our previous guidance as we have now completed the transfer of our Medicare testing assets.
More specifically, GNA expenses in the first quarter were $13.5 million, including $1.7 million in stack-based compensation expense, while R&D expenses in the first quarter were $6.6 million, including $0.3 million in stack-based compensation expense.
More specifically G&A expenses in the first quarter were $13 5 million, including $1 7 million in stock based compensation expense.
While R&D expenses in the first quarter were $6 $6 million.
Including zero point $3 million in stock based compensation expenses as we mentioned in our previous call. We expect G&A expenses to gradually reduce by Q4. This year, while our R&D expenses will mainly track of clinical activities workflow and expect to end the year with our monthly operating cash burn of less than 4 million.
As we mentioned in our previous call, we expect GNA expenses to gradually reduce by Q4 this year, while our R&D expenses will mainly track our clinical activities workflow and expect to end the year with a monthly operating cash burn of less than four million dollars.
We had a cash balance of $67.2 million as of March 31, 2021, giving us runway well into 2023, thanks to our reduced cash burn.
We had a cash balance of $67 $2 million as of March 31, 2021, giving us runway well into 2023, thanks to our reduced cash burn.
With the relaunch of the company of viral therapeutics, we have a very active IR plan ahead of us to engage with investors.
With the relaunch of the company is <unk> therapeutics, we have a very active IR plan ahead of us to engage with investors.
tell our story, and make sure our important programs have adequate visibility with the investor community.
Tell our story and make sure our important programs have adequate visibility with the investor community.
We are seeing an increasing following from biotech analysts and invite investors to contact us if you have any interest in our programs and development strategy. With that, I will now turn the call back to over.
We are seeing an increasing following from biotech analyst and invite investors to contact us if you have an interest in our programs and development strategy.
With that I will now turn the call back to over to Eddie.
Thanks, Eric.
So we're making good progress with our pipeline and are excited about the launch of Bioretherapeutics. I'd like to invite you to learn more about Bioreh by visiting our new website at bioretherapeutics.com, where you can also view our updated corporate presentation under the investor section.
So we're making good progress with our pipeline and are excited about the launch of <unk> Therapeutics I would like to invite you to learn more about by Ora are visiting our new website at biotherapeutics Dot Com, where you can also view our updated corporate presentation under the investors section.
You'll also find links on our website to the new BioRx Therapeutics social media accounts where we invite you to follow along with us on our mission to reimagine therapeutics. With that, operator, we're now ready for
You'll also find links on our website to the new borrower therapeutics, social media accounts, where.
Where we invite you to follow along with US on our mission to re imagine therapeutics with <unk>.
Operator, we're now ready for questions.
Thank you. To register a question, you may press the 1 followed by the 4 on your telephone. You will hear a 3-tone prompt to acknowledge your request. If your question has been answered and you would like to withdraw your registration, please press the 1 followed by the 3.
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And Ali to your request. If your question has been answered and you would like to withdraw your registration. Please press the one followed by the three.
And our first question is from the line of Julian Harrison with BTIG. Please go ahead.
And our first question is from the line of truly Julian Harrison with BP.
Please go ahead.
Hi, thank you for taking my questions and congrats in all of the recent progress. First on PGN 600. I understand the initial patient population you want to focus on in the clinic or our biologic experience. You see patients, but just wondering at this point, if biologic, naive patients might be of interest in the future and by extension, the potential for, excuse me, potential for first line positioning.
Hi, Thank you for taking my questions and congrats on all the recent progress first on PJM 600, I understand the initial patient population do you want to focus on in the clinic, our biologic experience you see patients, but just wondering at this point, if biologic naive patients might be of interest in the future and by <unk>.
The potential boat show excuse me potential for first line positioning.
Hi, Julien.
Certainly, that question might be more appropriate in a few months because you're right. We are starting with experienced folks, but given the preclinical data and our.
Certainly that that question Mike.
It might be more appropriate in a few months because you're right. We are starting with experienced folks.
But given the preclinical data and our.
potential outcomes, we think absolutely there is an opportunity to move up the use of these kinds of drugs, the first line, and so naive might be something absolutely that we could do. But it's a bit early to talk about that.
Potential outcomes, we think absolutely there is a opportunity to move up the use of these.
These kinds of drugs to first line is so naive might be something absolutely that we could do.
But it's a bit early to talk about that.
We believe in the potential of doing that, but we'll get to that soon.
We believe in the potential of doing that but we'll get to that suit.
Okay, got it. And then regarding ongoing preclinical work for your systemic delivery platform, I'm wondering if you could talk a little more about what you want to further characterize or optimize before filing your first ID here before you're on to
Okay got it and then regarding ongoing preclinical work for your systemic delivery platform I'm wondering if you could talk a little more about what you want to further characterize their optimized before filing your first 90 here before year end.
So on the systemic program, I think actually there's a couple other really exciting interesting data points that might be coming out this month. So we're doing a few more animal studies.
So on the systemic program I think actually there is a couple of other really exciting interesting data points that might be coming out. This month. So we're doing a few more animal studies.
I think in our talk earlier, we mentioned that
I think in our <unk>.
Talk earlier, we mentioned that we.
We've gotten indication that a 10% to 15% bi-availability would be interesting, and that this is not just from purely our analysis, it's also because we have these collaborators which is great, we're able to work with these companies that could be potential users of this technology who are saying, look, that 10% to 15% is the interesting range in terms of being commercially viable.
We've got an indication that a 10% to 15% by availability.
Interesting and then this is not just from purely our analysis. It's also because we have these collaborators which is great. We're able to work with these.
Company is that that could be potential users of this technology, who are saying look that 10% to 15% is the interesting range in terms of being commercially viable so for us to be able to do a few more animal studies, which is why we would see a lot of this data have that available in the next few months with me.
So for us to be able to do a few more animal studies, which is where we would see a lot of this data, have that available in the next few months, would mean a lot in terms of how we proceed. One, our own program, how do we take that conversation to the FDA? But two, equally important is what our collaborators have to say and how we progress those relationships with the data in hand.
A lot in terms of how we proceed one our own program, how do we take that conversation with the FDA, but two equally important is what our collaborators have to say on how we progress with those relationships with the data in hand.
Okay, great. Thanks very much.
Yeah.
And as a reminder, you can press 1-4 to register any questions. And our next question comes from the line of Mayank Memtani with B. Riley Securities. Please go ahead.
As a reminder, you can press one for to register any questions and our next question comes from the line of Mank, Montana with B Riley Securities. Please go ahead.
Hi, good afternoon team. This is Saul Hills has me asking questions for my uncle. Congrats on all the progress throughout the quarter.
Hi, Good afternoon team Mr. Thornhill has me asking a question for Mike Congrats on all the progress throughout the quarter.
Maybe just at a high level, could you provide a bit more qualitative color on really the clinical development and regulatory path forward for you see, and, you know, to the extent you're able to disclose what that disease intervention study might look like and then also in that same context. What are the requirements in terms of the device? And if you could touch on the manufacturing improvements as well in scalability as you get to late stage development, that'd be great. Thank you.
Just at a high level could you provide a bit more qualitative color on really the clinical development and regulatory path forward for U C.
To the extent, you're able to disclose what that disease intervention study might look like and then also in that same context, what are the FDA requirements in terms of the device.
If you could touch on the manufacturing improvements as well and scalability as you get to late stage development that would be great. Thank you.
Well, that was probably four or five or six questions outside of cover of them.
Well I don't know it was probably four or five or six questions outside to cover them.
I think we've talked about, we recently filed a type C meeting, so in that type C
Sure.
I think we've talked about.
Recently filed a type C meeting so in that type C.
not sorry meeting a type C filing to the FDA. We have made our proposal for what we think a good development plan would be. We are being
Sorry meeting a type C filing to the FDA.
Have made our proposal for what we think a good development plan would be we are being a little bit conservative and being very careful and thoughtful about how we go.
a little bit conservative and being very careful and thoughtful about how we go.
and take this program forward, so we're proposing to do a fairly typical phase one study.
And take this program forward. So we're proposing to do a fairly typical phase one study.
And we think that, you know, this is good as the first program in this platform that would be helpful for us to get some data that would be like a normal Phase 1 data.
And we think that this is good as the first program in this platform that would be helpful for us to get some data.
That would be like a normal phase one data, but given that there is such a great co relation between concentration of drug in the tissue.
Given that there's such a great correlation between concentration of drug in the tissue and potential disease outcomes, we can learn that in phase one. We can learn how much we get. We can have a lot of really good information, not just on the tissue, but also on the systemic levels of the drug. So,
And potential disease outcomes, we can learn that in phase one we can learn how much we get we can.
Have a lot of really good information not just on the tissue, but also on the systemic levels of the drug. So we think this phase one is probably more useful than just learning purely about safety. We believe there should be a lot less safety. So we haven't yet talked about the exact.
We think this phase one is probably more useful than just learning purely about safety. We believe there should be a lot less safety.
We haven't yet talked about the exact plan, we want to take a little more time to have some response from the FDA to be able to share it, but it is a pretty typical phase one.
Plan, we want to take a little more time to have some response from the FDA to be able to share it but it is a pretty typical phase one.
you know, what we normally expect with a single dose, with a multiple ascending dose, you know, but the potential doses are absolutely going to be lower than what is currently commercially on commercial label because we know we can get more drug. So a smaller dose, typical phase one study, quickly moving to that disease intervention study, we're proposing that we think we can do a,
What we would normally expect expect with.
A single dose with a multiple ascending dose.
But.
Actual doses are absolutely going to be lower than what is currently.
Commercially commercial label, because we know we can get more drug so smaller dose typical phase one study quickly moving to that disease intervention study.
We are proposing that we think we can do a <unk>.
pretty robust, serious phase 2 study that would be potentially placebo-controlled with, you know,
Pretty robust serious phase II study that would be potentially.
Placebo controlled with.
<unk>.
the disease state and moderate severe disease. And then as we get initial data, we might be able to have.
The disease state and moderate severe disease, and then as we get initial data we might be able to.
Have.
And so I don't wanna say exactly what the design would be, but we might be able to have data that helps us evolve that trial. That's a little more than we have shared, but hopefully very soon we will have all the details be able to give you the entire study proposal.
And so I don't want to say exactly what the design would be but we might be able to have data that helps us evolve that trial.
That's a little more than.
We have shared but hopefully very soon we will have all the details to be able to give you the entire.
Study proposal.
That's really helpful. Thank you.
And we have no other questions on the phone line at this time, I will now turn it back over for closing remarks.
And we have no other questions on the phone line at this time I will now turn it back over for closing remarks.
Okay, well, thank you all for joining our first biotherapeutics learning call. We look forward to keeping you updated on our progress. Have a good evening.
Okay.
Well. Thank you all for joining our first biotherapeutics, earning call. We look forward to keeping you updated on our progress have a good evening.
That does conclude your conference call for today. We thank you for your participation, and athlete, please disconnect your lines.
That does conclude your conference call for today, we thank you for your participation and ask Lee. Please disconnect your lines.
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