Q1 2024 Biora Therapeutics Inc Earnings Call
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Operator: Greetings and welcome to Biora Therapeutics' First Quarter 2024 Financial Results Call. At this time, all participants are in listen-only mode. A 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 Chuck Padala, Managing Director with Lifesci Advisors, Biora's Investor Relations firm. Please go ahead.
Greetings and welcome to buyer of Therapeutics first quarter 'twenty 'twenty full financial results call.
At this time, all participants are in listen only mode.
Speaker Change: A 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.
Speaker Change: As a reminder, this conference is being recorded.
Charles Padala: I will now turn the call over to Chuck Modelo, <unk> director with lifestyle advisors by Yours Investor Relations from <unk>.
Please go ahead.
Charles Padala: Thank you operator.
Charles Padala: Good afternoon, and welcome to the Biora Therapeutics First Quarter 2024 Corporate Update and Financial Results Conference Call. Joining me on the call are Aditya Mohanty, Chief Executive Officer, and Eric DeSparbas, Chief Financial Officer.
Speaker Change: Good afternoon, and welcome to the Byword Therapeutics first quarter 'twenty 'twenty, four corporate update and financial results Conference call.
Speaker Change: Joining me on the call our Rd, Mohanty, Chief Executive Officer, and Eric <unk>, Chief Financial Officer.
Charles Padala: Before I turn the call over to Mr. Mohanty, I would like to remind you that today's call will include forward-looking statements within the meaning of the federal securities law, 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 investor 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.
Speaker Change: Before I turn the call over to Mr. Mohanty 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 Europe.
Speaker Change: Subsequent to our reports filed with the SEC, which are available on our website in the investors section.
Aditya P. Mohanty: 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.
Charles Padala: Please note that 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 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 Aditya Mohanty, CEO of Biora Therapeutics.
Aditya P. Mohanty: Please note that the actual results could differ materially from those expressed in the forward looking statements.
Aditya P. Mohanty: 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.
Speaker Change: With that I'll now turn the call over to Alibaba I D C. They arent actually already.
Speaker Change: Thanks Chuck.
Aditya P. Mohanty: And thank you, everyone, for joining us. In the short few weeks since our last corporate update, we have made excellent progress in the execution of our clinical development plans for the MAVICAP platform, successfully completing dosing of our clinical study of BT600. For the BioJet platform, we have continued to advance our goals for both platform development and business development with pharma. Here is an update on our NaviCAP targeted therapeutics platform with our lead program, BT600, and ulcerative colitis. The basis of our clinical approach to ulcerative colitis, or UC, is the importance of achieving higher drug exposure and activity in colon tissue. The battle against UC is fought in the tissue, in the colonic mucosa.
Speaker Change: And thank you everyone for joining us.
Speaker Change: In the short few weeks since our last corporate update we had excellent progress in the execution of our clinical development plans for the Navy kept platform.
Alibaba IDC: Access can be completing dosing of a clinical study of P. T six.
Speaker Change: Well the Biogen platform, we have continued to advance our goals for both platform development and business development that farm.
Speaker Change: First.
Speaker Change: And I think on our novel targeted therapeutics platform with our lead program <unk> 600, and ulcerative colitis.
Speaker Change: The basis of phone clinical approach to ulcerative colitis or do you see it.
Speaker Change: It is the importance of achieving higher drug exposure and activity in colon tissue.
Speaker Change: The battle and Youll see it pop into tissue and the colonic mucosa.
Aditya P. Mohanty: Research shows that higher drug exposure and activity in the colonic tissue is associated with a higher likelihood of better clinical outcomes across drug classes, including JAK inhibitors and anti-TNF. However, achieving increased drug levels in the colon tissue is not as simple as increasing the dose since many of the advanced therapeutics for UC are dose limited due to systemic toxicity risk. That's why our NaviCAP platform has been designed to provide anatomically targeted delivery of therapeutics directly to the site of disease in the colon.
Speaker Change: Research shows that higher drug exposure and activity in the colonic tissue is associated with a higher likelihood of better clinical outcomes across drug classes, including JAK inhibitors and anti TNF.
Speaker Change: Achieving increased drug level in colon teacher is not as simple as increasing the dose since many of the advanced Therapeutics, where you see adult smoker I didn't do the systemic toxicity risks.
Speaker Change: That's why our Navi cap platform has been designed to provide anatomically targeted delivery of therapeutics directly to the side of diseases Nicole it.
Aditya P. Mohanty: Studies with NAVICAP have shown that payload is delivered along the entire length of the colon, achieving complete colonic coverage. In fact, we will be sharing more of that data at the Digestive Disease Week conference in Washington, D.C. later this month. We will present clinical data on the function of the MAVICAP device across four different studies in humans, including healthy participants and active UC patients.
Speaker Change: That is not a Catholic shown that payload is delivered along the entire length of the colon achieving complete colonic coverage.
Speaker Change: In fact, we will be sharing more of that data at the digestive disease week conference in Washington D. C. Later this month.
Speaker Change: We will present clinical data on the function of the Magicjack device across four different studies in humans, including healthy participants and active UC patients.
Aditya P. Mohanty: These data show successful performance of the device, as well as full colonic coverage achieved by the NaviCAD platform. During our last update, we shared positive interim results from the single dose portion of our BT600 clinical trial. To recap, we found that all NaviCAP devices performed as intended and were well tolerated. No safety signals were observed.
Speaker Change: Actually I was successful performance of the device as well as a full colonic coverage achieved by the <unk> platform.
Speaker Change: During our last update we shared positive interim results from the single dose portion of our between 600 clinical trial.
Speaker Change: To recap we found that.
Speaker Change: All the other cab devices performed as intended and were well tolerated.
Speaker Change: No safety signals were observed.
Aditya P. Mohanty: Measurable topacidinib in the blood was first observed at approximately six hours, with maximal concentrations at approximately eight hours post-ingestion, which is consistent with drug delivery and absorption in the colon. That is what is intended in MaviCap, and it is in contrast to what is seen with conventional oral trophocytinib, where maximum blood concentrations occur at 30 minutes to an hour after injection, consistent with absorption in the upper GI Colonic delivery of BT600 was associated with three to four times lower systemic levels of turposidness.
Speaker Change: Measurable Tofacitinib and blood was first observed at approximately six hours with maximal concentration at approximately eight hours post injection, which is consistent with drug delivery and absorption in the colon.
Speaker Change: That is what is intended to allow the cap and it is in contrast to what is seen with conventional tofacitinib, where maximum blood concentrations occur at 30 minutes to an hour after injection consistent with absorption in the Gi tract.
Speaker Change: Colonic delivery L. P. T 600 was associated with three to four times lower systemic levels of Tofacitinib.
Aditya P. Mohanty: These data suggest drug delivery and absorption in the colon as opposed to the upper GI tract, and they indicate the potential to achieve greater concentrations of drug in the colon tissue compared with conventional methods. Everything we've seen so far indicates that our approach could lead to improved efficacy and reduced toxicity for UC patients. We're keen to see and share the data from the remainder of the trial, and to that end, we recently announced the completion of the remaining portion of the trial, in which a cohort of 24 healthy participants received BP-600 at 5mg or 10mg doses of pifacidinib or placebo, with once-daily dosing for 7 days, in addition to blood samples.
Speaker Change: These data suggest drug delivery and absorption in the colon.
Speaker Change: As opposed to the upper Gi tract.
Speaker Change: And they indicate the potential to achieve greater concentration of drug in the colon tissue compared with conventional methods.
Speaker Change: Everything we've seen so far indicate that all approach could lead to improve efficacy and reduce toxicity for UC patients.
Speaker Change: We're keen to see and share the data from the remainder of the trial and to that end, we recently announced completion of the remaining portion of the trial.
Speaker Change: In which a cohort of 24 in healthy participants received 5600 at five milligrams or 10 milligram doses of <unk> or placebo with once daily dosing for seven days.
Speaker Change: In addition, the blood samples.
Aditya P. Mohanty: We also obtained colon tissue biopsies in this part of the study. We're now awaiting the analysis of those results, and we anticipate sharing full study data in late June. These data will also be discussed with GI experts and key opinion leaders, including those on our Clinical Advisory Board. In addition to the conclusion of our clinical trial of healthy volunteers, we continue to plan for a study in UC patients to begin later this year.
Speaker Change: We also obtained colon tissue biopsies in this part of the study.
Speaker Change: We're now awaiting the analysis of those results and we anticipate sharing full study data in late June.
Speaker Change: These data will also be discussing the G I experts and key opinion leaders, including those on a clinical advisory board.
Speaker Change: In addition to the conclusion of preclinical trials healthy volunteers, we continue to plan for a study in UC patients to begin later this year.
Aditya P. Mohanty: Getting data and patients would add to our learnings from phase one and help us prepare for future trials with an eye towards maintaining our accelerated clinical development cadence for the NaviCAP platform. We're gratified to see the excellent results so far, and we're excited to share the remaining data from our clinical trial later this quarter. Despite all the advanced therapies for UC, patients continue to experience tremendous difficulties in achieving and sustaining remission, and we remain focused on the serious unmet need in patients with UC.
Speaker Change: Getting data in patients would add to our learnings from phase one and help us prepare for future trials with an eye towards maintaining our accelerated clinical development cadence for the navi capped platform.
Speaker Change: We're gratified to see the excellent results so far and we're excited to share the remaining data from a clinical trial later this quarter.
Speaker Change: Fight all the advanced therapies for you see patients continue to experience tremendous difficulties in achieving and sustaining remission.
Speaker Change: Main focus on the serious unmet need in patients with UC.
Aditya P. Mohanty: We believe we can optimize compensatory therapy in UC by achieving higher, potentially more efficacious drug exposure in tissue without the need for high systemic exposure. Beyond VT600, we believe the NaviCAP platform has the potential to create a portfolio of optimized UC therapies. Moving on to our Biojet systemic therapeutics platform, the BioJet platform continues to exceed its performance targets and shows outstanding promise to solve the challenges of oil delivery of large molecules, which has been called the holy grail of drug delivery.
Speaker Change: We believe we can optimize temperature the therapy and you see by achieving fire potentially more efficacious drug exposure in tissue.
Speaker Change: The need for high systemic exposure.
Speaker Change: Beyond <unk> 600, we believe the <unk> platform has the potential to create a portfolio of optimized UC therapies.
Speaker Change: Moving onto our Biogen systemic therapeutics platform.
Speaker Change: The Biogen platform continues to exceed its performance targets.
Speaker Change: <unk> outstanding promise to solve the challenges of own delivery of large molecules, which has been called the Holy Grail of drug delivery.
Aditya P. Mohanty: Liquid Jet Delivery is the foundation of the BioJet platform. It uses a small capsule that, once swallowed, delivers drug through a liquid jet into the lumen of the small intestine, where it is absorbed into systemic circulation. We believe the BioJet platform can provide an alternative to needle-based delivery of complex molecules. It also enables those molecules to more efficiently reach the liver, which is difficult with other oral delivery methods.
Speaker Change: Liquid jet delivery is the foundation of the Baidu platform.
Speaker Change: It was a small capsule that once swallowed delivers drugs through language and took a little bit of the small intestine.
Speaker Change: Where it is absorbed into systemic circulation.
Speaker Change: We believe the bio jet platform can provide.
Speaker Change: Oregon to needle based delivery of complex molecules.
Speaker Change: It also enables those molecules to more efficiently reach the liver, which is difficult to other all delivery methods.
Aditya P. Mohanty: We've completed further animal studies over the past few months that demonstrate advances in consistency and bioavailability for our peptide candidates from the blue type and for Adlimumab, our antibody candidate, in addition to collaborator molecules. As a reminder, the performance target that is considered commercially viable by us and our pharma collaborators is 15% compared to IV. We now have preclinical data demonstrating the BioJet platform's ability to achieve category-leading bioavailability of complex molecules, to deliver existing formulations without complex reformulation, to deliver large payloads in the multi-milligram range, and its potential to enable liver-targeted delivery of large molecules. With all of these competitive advantages, we believe we're in an excellent position with the project platform.
Speaker Change: We've completed further animal studies over the past few months that demonstrate advances and consistency and by then the ability for our peptide candidates under blue tide and.
Speaker Change: So at Lima Mad are antibody candidate in addition to collaborate of molecules.
Speaker Change: As a reminder, the performance targets that is considered commercially viable by us and our pharma collaborators is 15% compared to IV.
Speaker Change: We now have.
Speaker Change: Preclinical data demonstrating the biogen platform's ability to Ah.
Speaker Change: Achieved category, leading bioavailability of complex molecules to.
Speaker Change: To deliver existing formulations without complex formulation.
Speaker Change: Large payloads in the bumpy milligram range.
Speaker Change: And its potential to enable liver targeted delivery of large molecules.
Speaker Change: With all of these competitive advantages we believe we're in an excellent position with the Baidu platform.
Aditya P. Mohanty: Our work with collaborators is progressing well, and we look forward to sharing an update on our preclinical data at an upcoming conference in June. Our initial focus with BioJet was on creating an in vivo proof of concept that liquid jet injection technology could successfully inject and deliver large molecules into the small intestine. We used our first generation device to assess performance with somaglutide and an adenovimab variant, as well as with molecules from our collaborators. The Blue Dome Experiment.
Speaker Change: Our work with collaborators is progressing well and we look forward to sharing an update on our preclinical data at an upcoming conference in June.
Speaker Change: Our initial focus with Biogen was on creating an in vivo proof of concept that liquid jet injection technology successfully inject and deliver a large molecules into the small intestine.
Speaker Change: We used our first generation device.
Speaker Change: <unk> performance with some blue tide and in Abilene him out there and as well as with molecules from our collaborators.
Speaker Change: Do those experiments.
Aditya P. Mohanty: We were able to achieve an average bioavailability of over 20% for animals with a detectable drug in blood. We have continued to make improvements to the biojet assembly and manufacturing process, which are required for later stages of development for this platform. We successfully evolved our NaviCAP device from proof of concept to the clinical stage under an IMD. We're able to leverage that expertise with our BioJet platform. This will serve us well as we prepare for further development, including future clinical studies with biogen.
We were able to achieve an average buyer the ability of over 20% so animals with detectable in blood.
Speaker Change: We have continued to make improvements to the Biogen Assembly and manufacturing process, which are required for later stages of development for this platform.
Speaker Change: We successfully evolved our navi cap device from proof of concept clinical stage.
Andy: Hi, Andy.
Speaker Change: We're able to leverage that expertise with a biogen platform.
Speaker Change: This will serve us well as we prepare for further development, including future clinical studies with Biogen.
Aditya P. Mohanty: We are currently running a partnership process for interested parties and are flexible on the way we may work together. We're encouraged by the engagement shown by some of our current collaborators in this process, and we're also seeing strong interest from new companies. The goal is to have a critical mass of data and interested parties to have partner-stated interest confirmed by mid-year. We're evaluating like-minded partners who see the potential for the BioJet platform and are eager to bring this technology to the clinic.
Speaker Change: We are currently running a partnering process for interested parties and are flexible on the way when they work together.
Speaker Change: We're encouraged by the engagement shown with this process by some of our current collaborators and we're also seeing strong interest from new companies.
Speaker Change: The goal is to have a critical mass of data and interested parties to have partner stated interest confirmed by midyear.
Speaker Change: We're evaluating Likeminded partners.
Speaker Change: See the potential for the Biogen platform and are eager to bring this technology to the clinic.
Aditya P. Mohanty: Now to summarize our anticipated milestones. For our NaviTAP platform, we have completed the execution of the MAD portion of our clinical trial for BT600. We plan to share data from the completed SAD and MAD study toward the end of the second quarter. Additionally, we will present clinical data on the function of the MAVICAP device across four different studies in healthy human participants and active UC patients at the Digestive Disease Week conference in Washington, D.C. later this month.
Speaker Change: Now to summarize our anticipated milestones.
Speaker Change: For our navigator platform we.
Speaker Change: We have completed execution of the Mad portion of a clinical trial for <unk> 600, <unk>, we plan to share data from the.
Speaker Change: <unk> completed sad and Mad study towards the end of the second quarter.
Speaker Change: We will present clinical data on the function of the Magicjack device across four different studies in healthy human participants and active UC patients at the digestive disease week conference in Washington D. C. Later this month.
Aditya P. Mohanty: We anticipate initiating a clinical study with BT600 inpatients with UC during the second half of 2024. For our BioJet platform, an update on data from recent animal studies will be shared at the NextGen Peptide Formulation and Delivery Summit in June. We continue to progress toward our goal of an enhanced partnership for the BioJet platform in 2024. With that, I'll now turn the call over to Eric for a review of our financial results and capital market activity.
Speaker Change: We anticipate initiating a clinical study would be two 600 in patients with UC during the second half of 'twenty 'twenty four.
Speaker Change: For our Biogen platform and update on data from recent animal studies will be shared at the Nextgen peptide formulation and delivery summit in June.
Speaker Change: We continue to progress toward our goal of an enhanced partnership for the Biogen platform in 2024.
Eric: With that I'll now turn the call who go to Eric for a review of our financial results and capital market activities.
Eric Desparbes: Thanks, Eddie, and good afternoon, everyone. We remain very active in capital market activities during the first quarter. I'll first cover our financial results and then provide more background on the continued positive evolution of our balance sheet. Operating expenses during the first quarter, excluding spec-based compensation expenses, were $40.5 million, with continued investment in device development, preclinical, and clinical activities. To break this down further, G&A expenses in the first quarter, excluding stock-based compensation expenses, were $8.1 million, of which 60% was core activity spend, leaving almost 40% of G&A costs associated with legacy matters, which we are actively working to eliminate by the end of the year.
Eric: Thanks, Eddie and good afternoon, everyone.
Eric: We remain very active with capital market activities during the first quarter.
Eric: I'll first cover our financial results and then provide more background on the continued positive evolution of our balance sheet.
Eric: Operating expenses during the first quarter, excluding stock based compensation expenses were $45 million with continued investment in device development and preclinical and clinical activities.
Eric: To break this down further G&A expenses in the first quarter, excluding stock based compensation expenses were $8 $1 million.
Eric: 60%, what's core activities span, leaving almost 40% of G&A costs associated with legacy matters, which we are actively working to eliminate by the end of the year.
Eric Desparbes: All in all, the expenses, excluding stock-based compensation expenses, were $6.4 million. The result... Biora's core OPEX span was $11.5 million in Q1, with the majority of the span allocated to our R&D programs, including execution of our clinical development with Medi-Cap and preclinical work on Biojet with our Pharma Collaborator. The net loss was $4.2 million for the three months ended March 31, 2024, which included non-cash stock-based compensation expense and gain for change in warrants liability.
Eric: R&D expenses, excluding stock based compensation expenses $6 $4 million the result.
Speaker Change: Core Opex that was $11 $5 million in Q1 with the majority of the standard located.
Speaker Change: Located to our R&D programs.
Speaker Change: Execution of our clinical development with that recap and preclinical work in biotech pharma collaborators.
Speaker Change: Net loss was $4 $2 million for the three months ended March 31st 2024.
Speaker Change: This included noncash stock based compensation expense and game changing warrants liabilities.
Eric Desparbes: I'd like to remind investors that our financial results include many non-cash items, which is why we also refer to operating expenses, excluding those elements, for better guidance around our actual operating cash grant, which was $11.5 million for a quarter, as I just noted. Moving on to our capital structure. As a reminder, we reduced outstanding notes by more than $80 million in 2023, a 75% reduction in the company's net debt in 2023 alone.
Speaker Change: I'd like to remind investors that our financial results in too many noncash items, which is why we also referred to operating expenses, excluding those elements better guidance around the actual cash burn, which was $11 $5 million for the quarter.
No.
Speaker Change: Moving onto our capital structure.
Speaker Change: As a reminder, we reduced outstanding notes by more than $80 million in 2023, 75% reduction in the company's net.
Speaker Change: In 2023 alone.
Eric Desparbes: We made further progress during the first quarter by completing a third node exchange combined with new capital investment, bringing total new institutional investment into Biora through these exchanges to $19.8 million in the last two quarters. As a result, we materially reduced our convertible note balance to approximately $52 million by the end of the first quarter.
Speaker Change: We made further progress during the first quarter by completing a third note exchange.
Speaker Change: And with new capital investment, bringing total new investment institutional and investment and to buy a lot through these exchanges.
Speaker Change: $19 $8 million in the last two quarters.
Speaker Change: As a result, we materially reduced our kind of a convertible note balance to approximately $62 million, but are you out of the first quarter.
Eric Desparbes: We truly appreciate this commitment from our institutional investors, as their agreement to trade debt-for-equity demonstrates continued confidence in the potential value of our stock. During the quarter, we complemented this funding from equity holders by securing $3 million from the monetization of legacy assets. Equity proceeds of $2.9 million and a $6 million raise through a registered direct placement, which closed in early April. This brings our total capital raise over the last four months to more than $31 million, demonstrating strong access to capital markets.
Speaker Change: We truly appreciate his commitment from our institutional investors as their agreement to trade that's for equity demonstrates continued confidence in the potential value of our stock.
Speaker Change: During the quarter, we complemented this funding some noteholders by securing $3 million from the monetization of legacy assets equally people receive up to one $5 million.
Speaker Change: $6 million raised through a registered direct placement, which closed in early April.
Speaker Change: This brings our total capital raised over the last four months more than $31 million demonstrating strong access to capital markets.
Eric Desparbes: We are making good progress with our efforts to further optimize our capital structure, and we expect to have additional updates soon. We believe this series of transactions set up the company for success, ahead of our important clinical data readout later this quarter and the eventual development of partnerships with Pharma. With that, I will now turn the call back over to Aditya.
We are making good progress with our efforts to further optimize our capital structure and we expect to have additional updates.
Speaker Change: We believe this series of transactions to set up the company for success ahead of our important clinical data Readouts later, this quarter and the eventual development partnerships with pharma.
Eddie: With that I will now turn the call back over to Eddie.
Eddie: Thanks, Eric.
Aditya P. Mohanty: We're excited to present data from our BT600 clinical trial for the NaviCAP platform in the coming weeks. For the BioJet platform, we're focused on progressing towards partnerships this year. We look forward to providing further updates as we continue to achieve our milestones. Operator, we're now ready for questions.
Eddie: We're excited to present data from a Btu 600 clinical trial for the navigator platform in the coming weeks.
Speaker Change: The Biogen platform well focused on progressing towards partnerships. This year, we look forward to providing further updates as we continue to achieve our milestones.
Speaker Change: Operator.
Speaker Change: We're now ready for questions.
Operator: Thank you, sir. Ladies and gentlemen, at this time, we will be conducting a question and answer session. If you would like to ask a question, please press star then 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press the star key and then 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Again, if you would like to ask a question, please press star and then 1 now. The first question that we have comes from Joe Pantginis of HCU Wainwright. Please go ahead.
Speaker Change: Thank you Sir.
Speaker Change: Ladies and gentlemen at this time, we will be conducting a question and answer session.
Speaker Change: If you would like to ask a question. Please press Star then one on your telephone keypad.
Speaker Change: A confirmation tone will indicate your line is in the question queue.
Speaker Change: You May press time into if you would like to move your question from the queue.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: If you would like to ask a question. Please press star and then one no.
Speaker Change: The first question that we have comes from Joe Pat finish of H C. Wainwright. Please go ahead.
Joseph Pantginis: Hey guys, good afternoon. Thanks for taking the questions. So first, I'm just curious if you could give a little perspective. With the NAVICAP program, with tofacitinib, obviously, it appears encouraging that your plasma levels that you're seeing are three to four times lower than you talk about. So I'm just wondering if you could give a little perspective about physicians' views on that, and is that within the target range you were looking for? Would you like to see even lower levels? Or sort of, where does it play on the physician expectation continuum?
Joseph Pantginis: Hey, guys. Good afternoon. Thanks for taking the questions. So first I'm just curious if you could give a little perspective with.
Aditya P. Mohanty: Thanks.
Joseph Pantginis: With it now the cap program with Tofacitinib. It's obviously it appears encouraging that your plasma levels that you're seeing are three to four times lower as you talk about so I'm. Just wondering if you could give a little perspective about you know physicians views towards that end you know what is that within that target range you were looking for.
Joseph Pantginis: Or would you like to see even lower levels or you know sort of where does it play on the you know physician expectation continuum.
Aditya P. Mohanty: Yeah, Joe. So you're right, we are seeing three to four times lower. What I can say is, from conversations with physicians, No is better. Three to four times matters a lot.
Joe: Yeah, Joe So you're right. We are seeing three to four times lower what I can say is we know from conversations with physicians.
Speaker Change: No it's better three to four times matters a lot that is.
Speaker Change: Probably slightly higher than physicians expectation well you have to combine that with what we're also doing which is.
Aditya P. Mohanty: That is probably slightly higher than physicians' expectations. But you have to combine that with what we're also doing, which is a much lower dose because on the other side, which is the tissue side, so the plasma side was three to four times less; on the tissue side, it was multiples higher. So the goal is to get much more in the tissue, which we believe we can do, at a lower dose than the current label dose for Telfer-Cygnet and for Zelgen.
Speaker Change: A much lower dose because on the other side, which is the tissue side. So the plasma side with three to four times, a little less on the tissue side, where multiples higher so the goal being to get much more in the tissue, which we believe we can do we can lower dose than the current label dose a Ford.
Speaker Change: A sudden it plays out Dan.
Aditya P. Mohanty: And there are actually publications that talk about how a 10-meg dose behaves with a single ascending dose like we have, and so we can look at whether we get more in the Tissue, likely because we see the six-hour delay, and yes, initial conversations with a couple of our Clinical Advisory Board members were, well, quite encouraging. They seemed quite interested in the data, and this is good. So far, so good, really what we want.
Dan: And they're actually publications that talk about how we can make those behaves.
Dan: With a single ascending dose like we had until we get look that we get more.
Dan: And the tissue likely because we see the six hour delay and yes.
Dan: Initial conversations with a couple of our clinical advisory board members, where well quite encouraging they they seem quite interested way if the data and this is good so far so good really what we wanted.
Joseph Pantginis: That's helpful, thanks. And then, looking forward a little bit to the second half, can you give some more, maybe, you know, broad strokes with regard to the design of the UC study?
Speaker Change: No. That's helpful. Thanks, and then I guess looking forward a little bit to the second half can you give some more maybe.
Speaker Change: Brush strokes with regard to the design of the UC study.
Aditya P. Mohanty: So we'll get to the UC study in a few weeks. But what we're really excited about is, well, hardly in a few weeks, right?
Speaker Change: So we'll get to the UC study are in a in a few weeks what we're really excited about it.
Speaker Change: Well in like hardly even in a few weeks right, we said and in the later part of June So in a few weeks, we're going to have the mad data.
Aditya P. Mohanty: We said in the latter part of June, so in a few weeks, we're going to have the MADD data, and the data is starting to roll in. We're getting ready to share it with everybody. Having some information on what that MADD data looks like will help us, as we've already started work on that UC patient study. We've got protocols, we've got things, but we'll make some final determinations after we look at the MADD data, after we get the actions from GI experts, from key opinion leaders, and we'll have some time. And so we'll be able to share a lot more. Let's get past the MADD in the coming weeks.
Speaker Change: And the data is starting to roll in we're getting ready to share it with everybody having some information on what that Mad data looks like will help us.
Speaker Change: As we've already started work on that you see patient study, we've got protocols without things, but we will make some final determination. After we look at the Mad data. After we get reactions from G. I experts from key opinion leaders and we will have some time and so we'll be able to share a lot more.
Speaker Change: Let's let's get past the mad in the coming weeks.
Joseph Pantginis: And then my last question, if you don't mind, and I guess this is a little more, even more forward-looking statement, if you will. When you talk about potential partnerships in 2024, what would be, what would we essentially be looking for? These sort of early collaborations to do some, you know, maybe models or maybe clinical partnerships or, you know, what, what sort of continuum are we looking at?
Speaker Change: Absolutely Fair and then my last question, if you don't mind and again this is a little more even more forward looking statement. If you will when you talk about potential partnerships in 2020 for you know what would be what would we are essentially looking for the sort of like early collaborations to do some you know maybe model.
Speaker Change: <unk> or maybe clinical partnerships or you know what what sort of a continuum are we looking at.
Speaker Change: Yeah.
Aditya P. Mohanty: Fair question, Joe. So I will tell you, we are pretty excited about the fact that, you know, when we talked about in our prepared remarks, we actually are running a process. We're running a process trying to get to a conclusive answer very soon, and we'll have a lot more specifics in a short few months that we can share with everybody. Clearly, we're past the feasibility collaboration kind of stage, and we will be happy to do more for others who might want to do it, but that's really not our focus.
Joe: Great question, Joe So.
Joe: I will tell you we are pretty excited with the fact that hey, you know.
Speaker Change: When we talked about in our prepared remarks that we actually are running a process. We're running a process trying to get to a conclusive answer very soon and we'll have a lot more specifics in a short few months that we can share with everybody clearly we're past the feasibility collaboration.
Speaker Change: Kind of a stage.
Speaker Change: He will be happy to do more for others, who might want to do it but that's really not our focus what we want to get too it's somebody who's willing to say, we're getting we want to take this into the clinic and then we can work on the specifics of their molecule their disease indication combine it with what we have and prepare to take.
Aditya P. Mohanty: What we want to get to is somebody who's willing to say we're getting, we want to take this into the clinic, and then we can work on the specifics of their molecule, their disease indication, combine it with what we have, and prepare to take this into the clinic. So that kind of collaboration doesn't mean we would say no to a commercial collaboration. That's not the kind of anything that makes sense right now.
This into the clinic, so it would be.
Speaker Change: That kind of collaboration doesn't mean, we would say no to a commercial collaboration that that's not kind of anything that makes sense right now ideally, though we are looking for somebody and we've seen that interest and so we're looking for somebody who wants to take something into the clinic that we can work together on and clearly beyond.
Aditya P. Mohanty: Ideally, though, we are looking for somebody, and we've seen that interest, and so we're looking for somebody who wants to take something into the clinic that we can work together on and, clearly, beyond a collaboration but a serious partnership. Great. Thank you, Adi.
Speaker Change: It collaboration but a serious serious partnership.
Joseph Pantginis: Great. Thank you, Adi.
Eddie: Great. Thank you Eddie.
Operator: Thank you. The next question we have comes from Julian Harrison of BTIG. Please go ahead.
Eddie: Thank you.
Speaker Change: The next question we have comes from Julian Harrison of P. T. I G. Pease go ahead.
Julian Reed Harrison: Good afternoon, this is Rayyan for Julian. Thank you for taking our questions and congratulations on all the progress. Just a follow-up on a previous question, how are you framing expectations for the VP600 top-line data that is expected within the next few weeks? Are you guiding to a certain bar for success? And then we have a follow-up.
Speaker Change: Good afternoon. This is Matt on for Julien. Thank you for taking our questions and congrats on all the progress.
Speaker Change: Just a follow up on a previous question are you.
Speaker Change: How are you framing expectations.
Speaker Change: 600 topline data that is expected within the next few weeks are you guiding to a certain.
Speaker Change: Certain bar for success and then we have a follow up.
Aditya P. Mohanty: Yeah, so, to us, a confirmation of SAD data would be a success because we clearly saw that that six-hour delay in the uptake and all the data kind of supported colonic uptake, supported more in the colon, supported, you know, even if you look at the data that we shared that showed how it washed out through the body over time. And so to have multiple doses over several days and have no issues with all these multiple devices being in the body potentially at the same time, that would be something that we would want to confirm.
Speaker Change: Yeah, so to us it.
Speaker Change: Confirmation sad data would be success, because we clearly saw that that six hour delay and the uptake and all the data kind of supported colonic uptake supported more in the colon supported you know even if you look at the data that we shared that showed how it washed out.
Speaker Change: The body over time.
Speaker Change: And so to have multiple dosing over several days and had no issues with all these multiple devices being in the body potentially at the same time that would be something that we would want to confirm and getting similar data to sad would be awesome, we will have some tissue data.
Aditya P. Mohanty: And getting similar data to SAD would be awesome. We will have some tissue data to support it, but we kind of already know, right, with the plasma data that we're getting colonic uptake, and that needs to be confirmed over multiple doses over multiple days. That, to us, would be success because that's what we're looking for.
Speaker Change: Supported but when you kind of already know right with the plasma data that we're getting colonic uptake and that needs to be confirmed over a multiple doses over multiple days.
Speaker Change: That to us would be success, because that's what we're looking for.
Aditya P. Mohanty: Great, thank you. Looking forward to the data. And then, turning to your Adalimumab biosimilar program, what are some factors that might influence a go-no-go decision there?
Speaker Change: Great. Thank you looking forward to the data and then turning to your other new map Biosimilar program. What are some factors that might influence that go or no go decision there.
Aditya P. Mohanty: It's a little early to be making a go, no-go decisions, but I think we're extremely encouraged by what's happening with the TOFA. We have some early data with ADA. We want to take this TOFA a little further, maybe beyond that, get some patient data, and that would guide us in our ADA. We think, potentially, that it could be a shorter development program for the ADA. Because if you remember what we keep saying with, [inaudible] We're actually expecting to have a much better initial remission rate than what is currently approved and what is currently available with the various molecules.
Speaker Change: Hum.
Speaker Change: So it's a little early to be making a go no go I think we're so we're extremely encouraged about what's happening with the profile. We have some early data with Ara. We wanted to take this profile a little further maybe beyond that get some patient data and that will guide us in our arrow, we think Patel.
Speaker Change: It's really that it could be a shorter development program for the add on.
Speaker Change: Cause if you if you remember what we keep saying with.
Speaker Change: Tofacitinib.
Speaker Change: We're actually expecting to have.
Speaker Change: Eventually a much better initial remission rate than what is currently approved and what is currently available with the various molecules that significant gap off you know almost all even the latest of drugs that are approved or in that 15% to 30% remission rate are in the beginning we think we can do better than.
Aditya P. Mohanty: That significant gap of, you know, almost all, even the latest drugs that are approved are in that 15 to 30 percent remission rate in the beginning. We think we can do better than that. So taking our BT600 program to a point where we can show better outcomes is important. However, with the ADA, we could take the learnings from the BT600 a little bit and also look for a slightly different outcome that could be a much shorter and faster development plan.
Speaker Change: And that so taking our Beacon 600 program to a point, where we can show better outcome is important however would be outta, we could take the learnings from the BT 600, a little bit but also look for a slightly different outcome that could be a lot shorter and faster development plan.
Julian Reed Harrison: Great, thank you. Very helpful. And I guess, looking a little more forward, how are you thinking about the obesity opportunity with your pipeline? Are there certain payloads that you're more interested in than others? I understand it's early days.
Speaker Change: Great. Thank you very helpful and I guess I'm looking.
Speaker Change: Alright more forward how are you thinking about that obesity opportunity with your pipeline are there certain payloads that you are more interested in than others.
Speaker Change: I understand it's early days.
Speaker Change: Yeah. So.
Aditya P. Mohanty: Yeah, so we have done a fair amount of work, as you know, with somaglutide, but that's not necessarily a molecule we're right now talking about taking to the clinic. We decided that, in the short run, we want to get this partnership that would allow us to take something into the clinic, potentially with a partner's molecule in the partner's preferred indication. That would allow us to, with the current resources, progress this platform really much faster and more efficiently, even for the investors. And so we'll get back to a clinical program for Biojet that would be our own sometime past that, maybe next year.
Speaker Change: We have done a fair amount of work as you know with some of the new time, but that's not necessarily a molecule where right now are talking about taking the clinic, we decided that in the short run we.
Speaker Change: We want to get this partnership that would allow us to take something into the clinic potentially with a partner is a molecule and are in the partners preferred indication.
That would allow us to with the current resources progressed this platform really.
Speaker Change: Much faster.
Speaker Change: And more efficiently even for the investors and so we'll get back to a clinical program for bio jet that would be our own sometimes pass that maybe next year.
Julian Reed Harrison: Great. Thank you. Congratulations again on all the progress. I'm looking forward to the BC 600 data.
Speaker Change: Great. Thank you congrats again on all the progress and looking forward to the V. T 600 data.
Speaker Change: Thank you.
Speaker Change: Okay.
Operator: Thank you. Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then 1 now. The next question we have comes from John Vandermosten from Zax. Please go ahead.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen, just a reminder, if you would like to ask a question. Please press star and then one now.
Speaker Change: The next question we have comes from John Santa Marston from Zacks. Please go ahead.
John D. Vandermosten: Great, thank you, and good afternoon, Adi and Eric. Let me start out with a question on the BT600 Phase 1 trial. I know you're looking at safety and PK. What else might you share at the June conference from the trial?
Speaker Change: Great. Thank you and good afternoon Adient Eric.
Speaker Change: Let me start out with a question on the <unk> 600 phase one trial and I know youre looking at safety and Teekay.
Speaker Change: What else might you share at the June conference from the trial.
Speaker Change: Hum.
Aditya P. Mohanty: So clearly, what we want to confirm is what we have been talking about from the beginning, that we can deliver more drug to the tissue, less to the plasma, at a lower dose than what is currently being used. We got that first indication in animals, then we got that next indication with our single dose, which said, yep, it goes to the colon and over time comes out. We want to make sure we can do that in a sustained way over multiple doses. Getting those data is truly the confirmation of our approach.
Speaker Change: So clearly.
Speaker Change: What we want to confirm is what we have been talking about from the beginning that we can deliver.
Speaker Change: More drug in the tissue last in plasma.
Speaker Change: Out of a lower dose than what is currently being used.
Speaker Change: Got that first indication in animals, when we got back for next indications with our single dose, which said yep. It goes through the colon and overtime comes out we want to make sure. We can do that in a sustained way over multiple doses.
Speaker Change: Getting those data truly.
Speaker Change: Is the confirmation of our approach.
Aditya P. Mohanty: As tokacidmin has already been proven, right, you know, everybody kind of knows that tokacidmin works. The issue there has been, in order to make it work, doctors keep having to prescribe even higher doses than what's on the label. So that's really toxic, to be able to get the tissue concentration with a low plasma concentration really is a home run. So that's kind of what we're looking to get.
Speaker Change: And Tofacitinib has already been proven right.
Speaker Change: We kind of know the temperatures of it works.
Issue there has been in order to make it work doctors keep having to prescribe even a higher dose than what's on the label. So.
Speaker Change: That's really toxic.
Speaker Change: To be able to get the the tissue concentration with low plasma concentration really is a homerun. So that's kind of what we're looking to get.
Speaker Change: Okay.
John D. Vandermosten: And looking at Biojet, based on your commentary in the press release and on the call, it seems like there may have been some new inquiries since the last earnings release. And I'm wondering what the conversations are revolving around. Is it more the financial aspects of moving forward, or is it related to device design or something else?
Speaker Change: And looking at bio jet based on your on your commentary in the press release and on the call. It seems like there may have been some new inquiries since the S. Since our last earnings release and I'm you know I'm wondering what the conversations are revolving around is it more of the financial aspects of moving forward or is it related to device design or or something else.
Aditya P. Mohanty: Yeah, John, so yes, we got more interest. You are correct in picking that up.
John: Yeah, John So yes, we got more interest you are correct in picking that up.
Aditya P. Mohanty: Part of that has also been us driving this process and making people aware that look, we are running a process. Of course, we'd love to continue collaborating, learning more along with you.
John: Part of that is also been a us driving to this process and making people aware that look we are running a process.
John: Of course, we'd love to continue collaborating learning more along with you, but we need to make some choices on who we work with going forward getting into the clinic and so when when we drove this process that drove some of the timeline in some way, which is great I think for us for them for investors.
Aditya P. Mohanty: We need to make some choices on who we work with going forward, getting into the clinic. And so when we drove this process, that drove some of the timeline in some ways, which is great, I think, for us, for them, for investors that we're getting to have a decision fairly soon. We're still fairly open with the conversations at this point around entities that we're talking to. Some have a clear idea of a molecule they want to take forward and want to talk through that.
John: That's where we're getting to are going to have a decision fairly soon.
John: We're still fairly open with the conversations at this point are around them.
John: B.
John: Yes.
Aditya P. Mohanty: Some have a broader number of molecules they might want to take forward, agreeing on, yes, the idea here is to take it to the clinic. Now when we go to the clinic, if we need to optimize certain things for that specific indication, that specific molecule, we have that ability with our platform, and we'll do that, but that's all going to be based on agreeing to something that gets us to the clinic. That's really the conversation, and then because there are multiple conversations, you know, we just got to get people approximately within a certain timeline to a point where we can make decisions.
John:
John: Entities that we're talking to some have a clear idea of the molecule. They want to take forward and wanted to talk through that.
John: I have a broader number of molecules they might want to take forward and agreeing on yes. The idea here is to take in the clinic now in going through the clinic.
John: We need to optimize certain things for that specific indication that specific molecule.
John: We have that ability with our platform and we'll do that but that's all going to be based on lean to something that gets us to clinic, that's really the conversation and then because there's multiple conversations you know we just got to get people approximately within a certain timeline to a point, where we can make our decisions.
John D. Vandermosten: Okay and you know another thought that came to mind is you know how you negotiate with multiple parties when you have you know probably the the big pharma they want to get as broad a license from you as they can to perhaps block others but you'll want to keep it as narrow as possible I guess you know how do we look at that are you negotiating on Specific Biologics, or is it... You know, or is there some other kind of way that you you narrow down what they will be able to license?
Speaker Change: Okay, and you know another thought that came to mind as you know how you negotiate with multiple parties. When you have you know probably the big pharma they want to get as broad a license from us they can to perhaps block others, but you want to keep it as narrow as possible I guess you know how how do we look at that are you negotiating on.
Speaker Change: Specific specific biologics or is it are you now or is there. Some other kind of way that you you narrow down what they won't be able to license.
Aditya P. Mohanty: So I appreciate we have to get the specifics. The good news is we're getting very close to being able to share the specifics in a short few months. The breadth of your questions means it could take a long time to get through them all. But we'll have answers very soon. We're absolutely, but we are focused on trying to maximize the value and maintain optionality. So we're trying not to give away a bunch of our optionality. That is clearly a priority for us.
Speaker Change: Yeah.
Vivek: So I appreciate we have to get the specifics. The good news is we're getting very close to being able to share specifics in a short few months. Okay. [laughter]. The the breadth of your question Vivek, we could take a long time to get through.
Vivek: Look I have answers very field, we're absolutely, but we all focused on trying to maximize the value and maintain optionality. So we're trying not to give away a bunch of our optionality that is clearly a priority for us.
John D. Vandermosten: Right, you've got to walk that narrow path, I guess, between the two. And then, last question on what is next for capital structure. There's been a lot of movement over the last several months, and we've seen the capital structure improve dramatically. What do we see next in terms of...
Speaker Change: Right, you've got to walk that narrow path I guess between the two yeah and then the last question on on what is next for capital structure I know, there's been a lot of movement over the last several months and you know we've seen the capital structure improve dramatically what what do we see next in terms of that.
Eric Desparbes: Yeah, so thanks, John. This is Eric here.
Erez: Yeah. So thanks, John So this is erez here.
Erez: So we've talked here about having a lot of milestones coming up very important catalysts I think those will be pretty much. It. She just stablish, we take the capital structure at Max I think we can expect to have a further.
Eric Desparbes: So, we've talked here about having a lot of milestones coming up, very important catalysts. I think those will be pretty much the key to establishing how we take the capital structure, and I think we can expect to have further simplification of the note structures and, If we achieve our milestones and the expected results, we could potentially see an improvement in the market capitalization of the company. So the way I would answer is, let's wait and see how we generate that. I think it will answer a lot of those questions.
Erez: Verification of the email structures and.
Erez: If we yes achieve our milestones and our expected results, we could potentially see an improvement in the market capitalization of the company. So.
Erez: The way I would answer is let's wait and see and we generally thought that I think it will answered a lot of those questions.
John D. Vandermosten: Okay, great. Thank you, Eric. Thank you, Adi. Thank you.
John D. Vandermosten: Okay, great. Thank you, Eric. Thank you.
Speaker Change: Okay, great. Thank you Erik Thank you Ronnie.
Speaker Change: Thank you.
Speaker Change: Thank you.
Operator: Ladies and gentlemen, just a final reminder, if you would like to ask a question, please press star and then 1 now. We'll pause for a moment to see if we have any further questions. At this stage, there are no further questions. Ladies and gentlemen, we have reached the end of our question and answer session, and I would like to turn the call back to Aditya Mohanty for closing remarks. Please go ahead
Speaker Change: Ladies and gentlemen, just a final reminder, if you would like to ask a question. Please press star and then one now.
Speaker Change: Well pause a moment to see if we have any further questions.
Speaker Change: So at this stage there are no further questions ladies.
Speaker Change: Ladies and gentlemen, we have reached the end of our question and answer session and I would like to turn the call back to Aarti Mohanty for closing remarks. Please go ahead Sir.
Aditya P. Mohanty: I want to thank everyone for joining us today. I really appreciate your time. We are eager and looking forward to coming back and sharing updates very soon. Thank you.
Aditya P. Mohanty: I want to thank everyone for joining us today I really appreciate your time, we are eager and looking forward to coming back and sharing updates very soon thank you.
Operator: Thank you. Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect your lines.
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Aditya P. Mohanty: Yeah.
Speaker Change: Thank you ladies and gentlemen that then concludes today's conference. Thank you for joining US you may now disconnect your lines.
Speaker Change: Yeah.
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Speaker Change: [music].
Speaker Change: Hum.
Speaker Change: Yeah.
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