Biora Therapeutics Inc. Q1 2023 Earnings Call
Welcome to the bio therapeutics first quarter 'twenty to 'twenty three financial results call.
At this time all participants are in a listen only mode.
A brief question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press Star then zero on your telephone keypad.
As a reminder, this conference is being recorded.
I will now turn the call over to Kristine Kubacki director of IR communication with lots of advisers by whereas Investor Relations. Thank you. Please go ahead.
Thank you operator, good afternoon, and welcome to the bio or a therapeutics first quarter 2023, corporate update and financial results Conference call.
Joining me on the call are Audi Mohanty, Chief Executive Officer, and Eric <unk>, Chief Financial Officer.
Before I turn the call over to Mr. Mohan T. 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 we filed or will file later today.
And our subsequent reports filed with the SEC, 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 substantial risks and uncertainties, including many that are beyond our control.
Please note that the actual results could differ materially from those projected in any 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 related to our business. Please see the company's periodic reports filed with the SEC.
With that I will now turn the call over to Altimo hunky, CEO , a buy or a therapeutics Audi.
Thanks Christy.
Thank you everyone for joining us.
Since our last call six weeks ago, we have continued executing on development plans for an RV care of targeted delivery platform completing much of the data analysis from this talk study in our <unk> 600 program with results that are encouraging.
With our barge at systemic delivery program, we made excellent progress with device development and began preclinical studies using an autonomous version of our next generation Biogen device.
Based on the topline by availability results, we shared in March that were more than double our target levels. We progressed rapidly to preclinical testing with one of our former collaborators.
We're also planning to present detailed by the availability of results from our barger platform at an upcoming medical conference.
Finally, we strengthened our clinical team with the addition of Dr. Arriola, Calvin as Chief Medical Officer.
Which is good timing as we prepare to enter the clinic this year.
Moving onto the program updates first I'll cover our <unk> targeted therapeutics platform with our lead program <unk> 600, and ulcerative colitis.
Currently available therapeutic salts rate of colitis or you see.
Work by entering the bloodstream and being circulated systemically throughout the body with a limited amount of drug reaching decide of disease in the colon.
Our solution is based on the Medicare platform, which uses an orally ingestible device.
The size of official Io pill that is designed to deliver drug directly to the colon using our G archrock localization technology.
Our lead program <unk> 600 is a proprietary liquid formulation of Tofacitinib delivered via the magic App device.
Our commercially available version of Tofacitinib is approved for the treatment of UC.
Today Tofacitinib is administered orally and like other orally delivered drugs. It is taken up systemically with a limited about reaching the area of disease in the colon.
But delivering drug where it is needed at the side of disease. BT 600 has the potential to deliver sufficient drug to the tissue of the targeted area to improve efficacy and also reduce systemic exposure, which may improve safety.
Although global sales for U C drugs are approximately $7 billion per year and growing.
No UC patients are still suffering tremendously with a large unmet need.
We believe we can potentially solve one of the primary treatment gaps, which is the inability to achieve high enough drug levels in the diseased tissue without systemic toxicity.
That's why we're excited about the results that we're seeing from the toxicology study for <unk> 600.
At the time of our last call in March we have recently completed execution of our toxicology study for <unk> 600, during which we administered over 600 drug device combinations in canines.
Since then we have received a majority of the data and the results continue to look good.
All planned devices were administered and we observed no adverse events or safety signals.
Particular note.
There were no safety findings on histopathology of the colon or a blood safety and chemistry tests, including liver function tests, even at the highest 25 milligram dose of Tofacitinib.
With the navigator platform our goal is to achieve high drug concentrations in the colon tissue.
And we want to see these levels going down between doses and not accumulating when.
When we look at drug levels in the blood, we want to see some drug in the blood, but at low levels. Because it is believed that reducing systemic exposure can improve safety.
In our previous seven day canine study, we measured tissue drug levels at six and 12 hours. After administration of the last dose and soft tissue concentrations exceeding IC 90, which is what we want to see.
In this talk study, we measure drug levels in tissue 24 hours. After administration of the last dose and saw a drug in colon tissues with levels, suggesting that the drug does not accumulate over time, which is another favorable sign of safety.
In the aggregate we believe these studies support the ability of between 600 to deliver high concentrations of drug to colon tissue to potentially drive efficacy and then dissipate in a short enough time to support safety.
In the recent toxicology study, we continued to see peak drug levels in the blood at approximately one quarter of what would be expected with the equivalent dose of commercially available tofacitinib using traditional oral administration.
This further supports our desired approach of having lower levels of systemic exposure to potentially reduce toxicity.
Final analysis is still ongoing and we anticipate receiving the audited report in the coming weeks.
We're also tracking well on progress with other aspects of the program and we currently remain on track for our planned R&D filing in Q3.
We also recently announced that Dr area I'll, let Kelvin has joined <unk> as Chief Medical officer, bringing valuable experience as an immunologist and strengthening our clinical team.
Our ella's medical background and broad experience with dozens of early stage and late stage development programs for therapeutics over 15, plus years at Genentech will be valuable as we prepare to file our R&D for <unk> 600, and then progress our programs into later stages of development.
Moving onto our bio jet systemic therapeutics platform.
The Biogen platform aims to facilitate systemic oral delivery of drugs that would otherwise require injection or infusion.
The Biogen platform is based on an orally ingestible device that provides liquid jet delivery to the small intestine to maximize systemic uptake.
The platform has the potential to deliver a broad range of large molecules such as proteins peptides and nucleic acids without complex re formulation.
We believe this platform can help improve disease management and associated patient outcomes and reduce intravenous infusion costs across a range of chronic use indications.
Most of all we believe this will improve patient convenience, which has been shown to affect patient compliance.
These improvements could also help injectable bio therapeutics, such as <unk> become more competitive with alternatives.
During Q1, we announced topline results from preclinical studies with two drugs.
We map, a monoclonal antibody and summer blue tied a peptide and G O P. One receptor agonist.
And the preclinical study with some with new tide, we achieved more than double our target by availability using budget platform.
I'm excited to share the data from this study was accepted as a late breaking abstract at the American Diabetes Association scientific sessions.
We think the acceptance of this abstract as a late breaker indicates the tremendous interest by the scientific community in oral delivery of <unk> agonists and other large molecules.
We look forward to sharing detailed results from the study at the upcoming Ada meeting in June .
We recently conducted a round of preclinical testing with our collaborator <unk> pharmaceuticals, using an endoscopic Lee activated biogen device with an iodous antisense oligonucleotide molecule.
We're awaiting updates on the results of that study and we'll share more as soon as we're able to.
In the few short weeks since our last call. We have also conducted preclinical testing with an autonomous Lee triggered biogen device.
We expect testing to continue through the coming weeks and we remain on track to generate data. During Q2 that we believe are necessary to enable our other two pharma collaborators to initiate testing with their own molecules.
We look forward to progressing these collaborations and advancing toward our goal of achieving meaningful partnerships for our Biogen platform later this year.
We continue to see potential for multiple partnerships over time due to the broad applicability of the budget platform to different molecules.
As a reminder.
One aspect of a comprehensive patent position for the Biogen platform is a key patent granted last year, which covers methods for using an ingestible device to treat a condition using jet delivery of a G. L. P. One receptor agonist formulation to the small intestine to achieve systemic uptake.
This puts <unk> in a very strong competitive position for providing oral delivery of GOP ones.
With the success of drugs like <unk> and <unk>, we're seeing analysts' projections for the <unk>, one market being revised upward to 100 billion annually within the next 10 years.
To summarize our anticipated milestones for both platforms.
For navigator platform, we remain committed to filing in R&D for <unk> 600 in Q3, and we anticipate initiating a phase one trial before the end of the year.
For our Biogen platform, we're continuing development of our autonomous budget device with additional preclinical data generation expected during the second quarter of 2023.
We also expect to continue to test and initiate new testing of the Biogen device with the molecules are for pharma collaborators.
We also look forward to sharing results for our Biogen preclinical study with some glue tied at the American Diabetes Association scientific sessions on June 23.
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 first quarter operating expenses, excluding stock based compensation expenses were $13 $2 million, an increase of $1 6 million compared to Q4 'twenty two.
Primarily driven by higher investments in device development and preclinical activities.
Breaking this down G&A expenses in the first quarter were $8 4 million, including $1 $5 million in stock based compensation expenses.
R&D expenses in the first quarter were $7 $2 million.
<unk> zero point $9 million in stock based compensation expenses.
While our 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 $12 $9 million in gross proceeds from our ATM program. During the first quarter effectively funding our Q1 operating expenses, leading to a stable cash balance of $30 $5 million as of March 31 2023.
We also continued to make progress with monetizing remaining legacy assets, which might add incremental funding in the near future.
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 before our next call.
With that I will now turn the call back over to Eddie.
Thanks, Eric.
<unk> continues to make strides with both our navi capped targeted oral delivery platform, where we're focused on entering the clinic with our <unk> 600 program and.
Our bio jet systemic oral delivery platform, where we're focused on completing our next gen device and progressing with pharma collaborators, we look forward to providing further updates as we achieve our milestones.
With that operator, we're.
We're now ready for questions.
Thank you we will now be conducting a question and answer session.
I would like to ask a question. Please press Star then one on your telephone keypad.
Confirmation tone will indicate your line is in the question queue.
You May press Star two.
I'd like to remove your question from the queue.
All participants using speaker equipment, it might be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
The first question is from from my Young Martini of B Riley Securities. Please go ahead.
Hi, This is <unk> on.
My congrats on the completion of the Tox study for six hungry program and looking forward to seeing more data update from you guys I have a couple of questions. If I may on the six hunker program, it's great to see the peak trough level always found one culture. All ROE trial can you comment on if the horsefly.
<unk> in block is different from the hour routes as well following on that can you maybe share the rows our clearance following.
This draft clearer rating wise, we are.
The majority of that was a drunk coal.
And then I have a follow up.
Okay, Hi, everyone.
So you asked about the half life.
Interestingly, what we find is pretty consistent with what <unk> seen in the literature that Tofacitinib, which is.
A very typical half life and clearance we impact more is time to reach C. Max and the AUC. So we're going to start getting really technical about these things, but the bottom line is we think we have a.
Better profile.
Where we don't get to that <unk>, which is where people end up with the toxicity issues. So we're at about a quarter of what would happen to the regulatory precedent. However, it behaves the same way added normally as it normally does which is it clears and with a similar half life and clears out within the same amount of time that it was normal.
Clear out.
We don't see accumulation in the blood, we don't see accumulation in the tissue.
Which is all good signs.
That encourage us as we move forward.
Got it thanks for the clarification and regarding the R&D filing in <unk> can you clarify is the 14th <unk>. Tox study is the only experiment you need to file that R&D and for these jokes. He talk study is an HP involved as you know there's a.
And industry wide sharpening our HP at the moment.
Yeah, well, so we don't have a.
Supply issue.
We need as you know for an R&D, primarily its a safety study that we have with this talk study, we're completing but there's several other aspects.
Stability data, there's there's all of the CMC sections, and we've been generating stability data, which continues to look encouraging. So all of those things. We are already in progress, creating all of that data will be receiving final reports on the safety studies over the coming weeks, which is why we keep thinking look.
With what we've seen so far.
It gives us confidence in being able to be in a position to file R&D in Q3.
Got it thanks for taking our questions.
The next question is from Joe.
Thank goodness of H C. Wainwright. Please go ahead.
Hey, everyone, Matt on your for Joe two questions from Us on the GL you Werent biotech program are the first one I was wondering if you could maybe preview the types of data that you might be presenting at the Ada meeting and then second given the popularity of the GOP. One agonists do you have any other additional updates around the potential partners our partner conversations you're having for the program and it's already.
Potential to keep it now thank you very much.
Okay map so.
In the next months as we said we're going to be presenting data that data is all the data that we generated with our next generation device, which is a device that we are currently.
<unk> to test, we're really excited about it as we mentioned we got greater than twice our target and just as a reminder, our target is around 15% bioavailability and we were able to get more than double of that.
The numbers were I think we announced were somewhere in the 37% range, but what we couldnt share with the details.
Various animals and all of the.
Tightness of the CV and so we'll be sharing how consistent and how well it performed with multiple.
Animals in that study, so thats pretty interesting and its.
Youre right Theres a lot of interest in the <unk> ones right now, there's a significant amount of <unk>.
News that has been created.
Yes, we get questions all the time and the fact that we also have this.
Broader G L P. One patent.
Which has to do with.
All kinds of <unk>, one molecules that might want to be administered with a jet system internally like we do with our bio jet program.
We do have options to keep some of that in house and so our conversations with our biotech.
Platform.
40 broad 40 y.
Raging.
In terms of number of types of molecules disease areas, we absolutely think that.
As we get past, having collaborations or partnerships, we can and will have in house programs that we will take forward.
Our goal this year is to stay focused and streamlined our navi cap program into the UC patients get a phase one started get the data generated in the Biogen program to create these <unk>.
Opportunities for collaborations and partnerships and then we do have enough IP as well as data generated to create our own program, where we could take for example, potentially a oral alternative to the injectable GOP ones that is absolutely something we could and wood.
Look at doing.
But the near term.
Clarity in the company and our goal is stay focused over the next few months, we could have some very very interesting.
Data generated and Thats.
That will help us with what we plan to do in the future.
Yep, great totally makes sense, thanks for the update.
At this moment there are no further questions I would now.
Like to turn the floor back over to Monty for closing comments.
Thank you all once again for joining us for our Q1 2023 financial results call.
We're really happy with the progress, we're making and look forward to keeping everyone updated as things progress.
Thank you.
Ladies and gentlemen that concludes this conference. Thank you for joining US you may now disconnect your lines.
Yeah.
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Okay.
Yeah.
Uh huh.
Yeah.
Yeah.
Okay.
[music].
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[music].
Welcome to the bio therapeutics first quarter 'twenty to 'twenty three financial results call.
At this time all participants are in a listen only mode.
A brief question and answer session will follow the formal presentation.
Anyone should require operator assistance during the conference. Please press Star then zero on your telephone keypad.
As a reminder, this conference is being recorded.
I will now turn the call over to Kristy Karbowski director of IR Communications with lots of advisors Biowaste Investor Relations. Thank you. Please go ahead.
Thank you operator, good afternoon, and welcome to the bio Therapeutics first quarter 2023, corporate update and financial results Conference call.
Joining me on the call are Audi Mohan T, Chief Executive Officer, and Eric <unk>, Chief Financial Officer.
Before I turn the call over to Mr. Mohan T. 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 we filed or will file later.
Today and our subsequent reports filed with the SEC, 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 substantial risks and uncertainties, including many that are beyond our control.
Please note that the actual results could differ materially from those projected in any 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 related to our business. Please see the company's periodic reports filed with the SEC.
With that I will now turn the call over to Ali Mohan <unk> CEO of bio or a therapeutics Audi.
Thanks Christy.
Thank you everyone for joining us.
Since our last call six weeks ago, we have continued executing on development plans for our <unk> targeted delivery platform completing much of the data analysis from this talk study in our <unk> 600 program with results that are encouraging.
With our bio jet systemic delivery program, we made excellent progress with device development and began preclinical studies using an autonomous version of our next generation Biogen device.
Based on the topline by availability results, we shared in March that were more than double our target levels. We progressed rapidly to preclinical testing with one of our pharma collaborators.
We're also planning to present detailed bio availability results from our biotech platform at an upcoming medical conference.
Finally, we strengthened our clinical team with the addition of Dr. Arriola, Calvin as Chief Medical Officer.
Which is good timing as we prepare to enter the clinic this year.
Moving onto the program updates first I'll cover our <unk> targeted therapeutics platform with our lead program <unk> 600, and ulcerative colitis.
Currently available therapeutics for ulcerative colitis or UC.
Work by entering the bloodstream and being circulated systemically throughout the body with a limited amount of drug reaching the side of disease in the colon.
Our solution is based on the <unk> platform, which uses an orally ingestible device.
The size of official oilfield that is designed to deliver drug directly to the colon using our Gi tract localization technology.
Our lead program <unk> 600 is a proprietary liquid formulation of Tofacitinib delivered via the magic App device.
Our commercially available version of Tofacitinib is approved for the treatment of UC.
Today Tofacitinib is administered orally and like other orally delivered drugs. It is taken up systemically with a limited about reaching the area of disease in the colon.
But delivering drug where it is needed at the side of disease. BT 600 has the potential to deliver sufficient drug to the tissue of the targeted area.
Improved efficacy and also reduce systemic exposure, which may improve safety.
Although global sales for UC drugs are approximately $7 billion per year and growing.
We know UC patients are still suffering tremendously with a large unmet need.
We believe we can potentially solve one of the primary treatment gaps, which is the inability to achieve high enough drug levels in the diseased tissue without systemic toxicity.
That's why we're excited about the results that we're seeing from the toxicology study for <unk> 600.
At the time of our last call in March we have recently completed execution of our toxicology study for BT 600, during which we administered over 600 drug device combinations in canines.
Since then we have received a majority of the data and the results continue to look good.
All planned devices were administered and we observed no adverse events or safety signals.
Particular note there.
There were no safety findings on histopathology of the colon or on blood safety and chemistry tests, including liver function tests, even at the highest 25 milligram dose of Tofacitinib.
With the navigate platform our goal is to achieve high drug concentrations in the colon tissue.
And we want to see these levels going down between doses and not accumulating.
When we look at drug levels in the blood, we want to see some drug in the blood, but at low levels. Because it is believed that reducing systemic exposure can improve safety.
In our previous seven <unk> canine study, we measured tissue drug levels at six and 12 hours. After administration of the last dose and soft tissue concentrations exceeding IC 90, which is what we want to see.
In this talk study, we measure drug levels in tissue 24 hours. After administration of the last dose and saw a drug in colon tissues with levels, suggesting that the drug does not accumulate over time, which is another favorable sign of safety.
Taken in the aggregate we believe these studies support the ability of between 600 to deliver high concentrations of drug to colon tissue to potentially drive efficacy and then dissipate in a short enough time to support safety.
In the recent toxicology study, we continued to see peak drug levels in blood at approximately one quarter of what would be expected with the equivalent dose of commercially available tofacitinib using traditional oral administration.
This further supports our desired approach of having lower levels of systemic exposure to potentially reduce toxicity.
Final analysis is still ongoing and we anticipate receiving the audited report in the coming weeks.
We're also tracking well on progress with other aspects of the program and we currently remain on track for our planned R&D filing in Q3.
We also recently announced that Dr. <unk> has joined <unk> as Chief Medical officer, bringing valuable experience as an immunologist and strengthening our clinical team.
Our ALLL medical background and broad experience with dozens of early stage and late stage development programs for therapeutics over 15, plus years at Genentech will be valuable as we prepare to file our R&D for <unk> 600, and then progress our programs into later stages of development.
Moving onto our bio jet systemic therapeutics platform.
The Biogen platform aims to facilitate systemic oral delivery of drugs that would otherwise require injection or infusion.
The Biogen platform is based on an orally ingestible device that provides liquid jet delivery to the small intestine to maximize systemic uptake.
The platform has the potential to deliver a broad range of large molecules such as proteins peptides and nucleic acids without complex we formulation.
We believe this platform can help improve disease management and associated patient outcomes and reduce intravenous infusion costs across a range of chronic use indications.
Most of all we believe this will improve patient convenience, which has been shown to affect patient compliance.
These improvements could also help injectable biotherapeutics, such as <unk> become more competitive with alternatives.
During Q1, we announced topline results from preclinical studies with two drugs.
At <unk>, our monoclonal antibody and some are glue tied a peptide and GOP one receptor agonist.
And the preclinical study with some of the low tide, we achieved more than double our target by availability using budget platform.
I am excited to share the data from this study was accepted as a late breaking abstract at the American Diabetes Association scientific sessions.
We think the acceptance of this abstract as a late breaker indicates the tremendous interest by the scientific community in oral delivery of <unk> agonists and other large molecules.
We look forward to sharing detailed results from the study at the upcoming Ada meeting in June .
We recently conducted a round of preclinical testing with our collaborator <unk> pharmaceuticals, using an endoscopic Lee activated biogen device with an <unk> antisense oligonucleotide molecule.
We're awaiting updates on the results of that study and we'll share more as soon as we're able to.
In the few short weeks since our last call. We have also conducted preclinical testing with an autonomous Lee triggered Biogen device, we expect testing to continue through the coming weeks and we remain on track to generate data. During Q2 that we believe are necessary to enable our <unk>.
Other two pharma collaborators to initiate testing with their own molecules.
We look forward to progressing these collaborations and advancing toward our goal of achieving meaningful partnerships for our Biogen platform later this year.
We continue to see potential for multiple partnerships over time due to the broad applicability of the biogen platform to different molecules.
As a reminder.
One aspect of a comprehensive patent position for the Biogen platform is a key patent granted last year, which covers methods for using an ingestible device to treat a condition using jet delivery of a <unk> one receptor agonist formulation to the small intestine to achieve systemic uptake.
This puts <unk> in a very strong competitive position for providing oral delivery of GOP ones.
With the success of drugs like <unk> and <unk>.
We're seeing analysts' projections for the GOP, one market being revised upward to 100 billion annually within the next 10 years.
To summarize our anticipated milestones for both platforms.
For our <unk> platform, we remain committed to filing in R&D for <unk> 600 in Q3, and we anticipate initiating a phase one trial for the end of the year.
For our Biogen platform, we're continuing development of our autonomous budget device with additional preclinical data generation expected during the second quarter of 2023.
We also expect to continue to test and initiate new testing of the Biogen device with the molecules of a pharma collaborators.
We also look forward to sharing results for our Biogen preclinical study with summit Glu tied at the American Diabetes Association scientific sessions on June 23.
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 first quarter operating expenses, excluding stock based compensation expenses were $13 $2 million, an increase of $1 6 million compared to Q4 'twenty two.
Primarily driven by higher investments in device development and preclinical activities.
Breaking this down G&A expenses in the first quarter were $8 $4 million.
Including $1 5 million in stock based compensation expenses, while R&D expenses in the first quarter were $7 $2 million, including $0 9 million and stock based compensation expenses.
While our 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 $12 9 million in gross proceeds from our ATM program. During the first quarter effectively funding our Q1 operating expenses, leading to a stable cash balance of $30 $5 million as of March 31 2023.
We also continue to make progress with monetizing remaining legacy assets, which might add incremental funding in the near future.
Finally.
We continue to work actively on optimizing our capital structure to maintain and enhance our public company profile and we expect to have some updates before our next call.
With that I will now turn the call back over to Eddie.
Thanks, Eric.
<unk> continues to make strides with both our <unk> targeted oral delivery platform, where we're focused on entering the clinic with our <unk> 600 program.
And our Biogen systemic oral delivery platform, where we're focused on completing our next gen device and progressing with pharma collaborators, we look forward to providing further updates as we achieve our milestones.
With that operator.
We're now ready for questions.
Thank you we will now be conducting a question and answer session.
If you would like to ask a question. Please press Star then one on your telephone keypad.
Confirmation tone will indicate your line is in the question queue.
You May pay Star then two.
We'd like to remove your question from the queue.
All participants using speaker equipment, it might be necessary to pick up your handset before pressing the star key one moment. Please while we poll for questions.
The first question is from from my Young Martini of B Riley Securities. Please go ahead.
Hi, this is <unk>.
My congrats on the completion of the Tox study for six hungry program and looking forward to seeing more data update from you guys I have a couple of questions. If I may on the six homegrown program, it's great to see the peak level, it's about one quarter of all ROE drop claim comment if the hotline.
<unk> in block is different from the hour routes as well following on that Tim.
You may be sure that our clearance following.
This drug delivery device we are.
The majority of that was a drag coal.
And then I have a follow up.
Okay, Hi, Johann.
So you asked about the half life into.
Interestingly, what we find is really consistent with what <unk> seen in literature that Tofacitinib, which is.
A very typical half life and clearance what we impact more.
Is time to reach C. Max and the AUC. So we're going to start getting really technical about these things, but the bottom line is we think we have a.
Better profile.
Where we don't get to that <unk>, which is where people end up with the toxicity issues. So we're at about a quarter of what would happen to the regulatory emphasis nib. However, it behaves the same way added normally as it normally does which is it clears and with a similar half life and clears out within the same amount of time that it.
Normally clear out with.
We don't see accumulation in blood, we don't see accumulation in the tissue.
Which is all good signs.
That encourage us as we move forward.
Got it thanks for the clarification and regarding the R&D filing in <unk>.
To clarify is the 14 day <unk> Tox study is the only experiment you need to file that R&D and for this Joe can you talk study is HPE walk as you know there is a an industrywide sharpening our HP at the moment.
Yes, well, so we don't have a.
A supply issue.
We need as you know for an R&D, primarily its a safety study that we have.
With this talk study we are completing but there's several other aspects.
Stability data.
There is all of the CMC sections, and we've been generating stability data, which continues to look encouraging. So all of those things. We are already in progress, creating all of that data will be receiving final reports on the safety studies over the coming weeks, which is why we keep thinking look what we've seen so far.
It gives us confidence in being able to be in a position to file R&D in Q3.
Got it thanks for taking our questions.
The next question is from Joe <unk>.
<unk> of H C. Wainwright. Please go ahead.
Hey, everyone, Matt on your for Joe two questions from Us on the <unk> program.
The first one I was wondering if you can maybe preview the types of data that you might be presenting at the Ada meeting and then second given the popularity of the GOP <unk> agonists do you have any other additional updates around the potential partners our partner conversations you're having for the program and is there any potential to keep it now thank you very much.
Okay, Matt so.
In the next months as we said we're going to be presenting data that data is all the data that we generated with our next generation device, which is the device that we are currently.
<unk> to test, we're really excited about it as we mentioned we got greater than twice our target and just as a reminder, our target is around 15% bioavailability.
We were able to get more than double of that.
The numbers were I think we announced were some somewhere in the 37% range, but what we couldnt share with the details.
Various animals at all.
Tightness of the CV and so we'll be sharing how consistent and how well it performed with multiple.
Animals in that study, so thats pretty interesting and its.
Youre right. There is a lot of interest in the <unk> ones right now, there's a significant amount of <unk>.
News that has been created.
Yes, we get questions all the time and the fact that we also have this.
Broader <unk> patents.
Which has to do with.
All kinds of <unk>, one molecules that might want to be administered with a jet system internally like we do with our bio jet program.
We do have options to keep some of that in house and so our conversations with our budget.
Platform.
Really broad 40 y.
Raging.
In terms of number of types of molecules disease areas, we absolutely think that.
As we get past, having collaborations and partnerships, we can and will have in house programs that we will take forward.
Our goal this year is to stay focused and streamlined our.
Our navi cap program into the UC.
Patients get a phase one started get the data generated in the Biogen program to create these.
Opportunities for collaborations and partnerships and then we do have enough IP as well as data generated to create our own program, where we could take for example, potentially a oral alternative to the injectable <unk> ones that is absolutely something we could end.
Look at doing.
But the near term.
Clarity in the company and our goal is stay focused over the next few months, we could have some very very interesting.
Data generated.
That's something that will help us with what we plan to do in the future.
Yep, Great makes sense, thanks for the update.
At this moment there are no further questions.
I'd like to turn the floor back over to Monty for closing comments.
Thank you all once again for joining us for our Q1 2023 financial results call.
We're really happy with the progress, we're making and look forward to keeping everyone updated as things progress.
Thank you.
Ladies and gentlemen that concludes this conference. Thank you for joining US you may now disconnect your lines.