Q2 2024 Biora Therapeutics Inc Earnings Call

Speaker Change: i

Operator: Therapeutics, Second Quarter, 2024, 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 and 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 Lifestyle Advisors, Biora's Investor Relations

Operator: Therapeutics, Second Quarter, 2024, Financial Results Call. At this time, all participants are in a listen-only mode.

Speaker Change: Welcome to the Biola Therapeutics Second Quarter 2024 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.

Speaker Change: If anyone should require operator assistance during the conference, please press star and zero on your telephone keypad.

Speaker Change: As a reminder, this conference has been recorded.

Operator: A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and 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.

Chuck Padala: I will now turn the call over to Chuck Padala, Managing Director with Lifesci Advisors, Bioras Investor Relations Firm. Please go ahead.

Chuck Padala: Thank you, operator. Good afternoon and welcome to the Biora Therapeutics second quarter 2024 Corporate Update and Financial Results. Joining me on the call are Aditya Mohanty, Chief Executive Officer, and Eric Desparvis, Chief Financial, 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 our subsequent reports filed with the SEC, which are available on our website in the Investor section.

Charles Padala: Good afternoon, and welcome to the Biora Therapeutics second quarter 2024 corporate update and financial results conference call. Joining me on the call are Aditya Mohanty, Chief Executive Officer, and Eric Gaspardus, Chief Financial Officer. 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 our subsequent reports filed with the SEC, which are available.

Chuck Padala: These four liquid 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 actual results could differ materially from those expressed in this forward-looking statement.

Speaker Change: Thank you, Operator. Good afternoon, and welcome to the Biora Therapeutics Second Quarter 2024 Corporate Update and Financial Results Conference Call.

Speaker Change: Joining me on the call are Arie Mohanty, Chief Executive Officer, and Eric Gaspardus, Chief Financial Officer.

Charles Padala: 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. Please note that actual results could differ materially from those expressed in the forward-looking statements. For a 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: Before I turn the call over to Mr. Mohanty, I would like to remind you that today's call will include forward-looking statements.

Speaker Change: 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 investor section.

Speaker Change: These four liquid 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: Please note that actual results could differ materially from those expressed in the forward-looking statement.

Speaker Change: For 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.

Chuck Padala: If you prefer a description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the Forward Look to Savings, 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 Adi Mohanty, CEO of Biora Therapeutics. Thank you, Chuck.

Charles Padala: With that, I will now turn the call over to Adi Mohanty, CEO of Biora Therapeutics. Thank you, Chuck.

Speaker Change: With that, I will now turn the call over to Aditya Mohanty, CEO of Bayora Therapeutics. Aditya?

Aditya Mohanty: And thank you everyone for joining us. It's been a very productive and busy quarter for Biora with the announcement of our successful phase one clinical trial for the BT600 program using our NaviCAP platform and significant work and progress with partners on the BioJet platform. I'll begin with our NaviCat platform. We were pleased to see the large number of people who joined a recent KOL event, which was co-hosted by Dr. Bruce Sands of Mount Sinai and Dr. Brian Fagan of the University of Western Ontario.

Aditya Mohanty: And thank you everyone for joining us. It's been a very productive and busy quarter for Biora with the announcement of our successful phase one clinical trial for the BT600 program using our NaviCAP platform and significant work and progress with partners on the BioJet platform. I'll begin with our NaviCAD platform. We were pleased to see the large number of people who joined a recent KOL event, which was co-hosted by Dr. Bruce Sands of Mount Sinai and Dr. Brian Fagan of the University of Western Ontario.

Aditya Mohanty: Thanks, Chuck, and thank you, everyone, for joining us.

Aditya Mohanty: It's been a very productive and busy quarter for BioAura with the announcement of our successful Phase I clinical trial for the BT600 program using our NaviCAP platform and significant work and progress with partners on the BioJet platform.

Aditya Mohanty: I'll begin with our NaviCAD platform.

Aditya Mohanty: We were pleased to see the large number of people who joined our recent KOL event, which was co-hosted by Dr. Bruce Sands of Mount Sinai and Dr. Brian Fagan of the University of Western Ontario.

Aditya Mohanty: These two physicians are legends in the treatment of IVD, and if you look at many of the major clinical trials in UC therapies, you'll see both these names appear over and over, including as principal investigators. It was great to have them help us present and contextualize our clinical trial results for BT600. BT600 is being developed for the treatment of ulcerative colitis, which is an inflammatory disease that affects the mucosal and submucosal layers of the colon. It's largely a local disease of the colon tissue.

Aditya Mohanty: These two physicians are legends in the treatment of IBD, and if you look at many of the major clinical trials in UC therapies, you'll see both these names appear over and over, including as principal investigators. It was great to have them help us present and contextualize our clinical trial results for BT600. BT600 is being developed for the treatment of ulcerative colitis, which is an inflammatory disease that affects the mucosal and submucosal layers of the colon. It's largely a local disease of the colon tissue.

Speaker Change: These two physicians are legends in the treatment of IBD. And if you look at many of the major clinical trials in UC therapies, you'll see both these names appear over and over, including as principal investigators.

Speaker Change: It was great to have them help us present and contextualize our clinical trial results for BT600.

Speaker Change: BT600 is being developed for the treatment of ulcerative colitis, which is an inflammatory disease that affects the mucosal and submucosal layers of the colon.

Speaker Change: It's largely a local disease of the colon tissue.

Aditya Mohanty: Despite knowing for over 30 years that UC is a disease of the colon tissue, even now, patients are treated by receiving powerful drugs systemically in an attempt to reach therapeutic levels in the colon. Research shows that UC patients with higher drug exposure in the colon tissue have significantly better responses to therapy. However, although several attempts have been made, there has not been a reliable way to achieve targeted delivery of therapeutics to the colon.

Aditya Mohanty: Despite knowing for over 30 years that UC is a disease of the colon tissue, even now, patients are treated by receiving powerful drugs systemically in an attempt to reach therapeutic levels in the colon. Research shows that UC patients with higher drug exposure in the colon tissue have significantly better responses to therapy. However, although several attempts have been made, there has not been a reliable way to achieve targeted delivery of therapeutics to the colon.

Speaker Change: Despite knowing for over 30 years that UC is a disease of the colon tissue, even now patients are treated by receiving powerful drugs systemically in an attempt to reach therapeutic levels in the colon.

Speaker Change: Research shows that UC patients with higher drug exposure in the colon tissue have significantly better responses to therapy.

Speaker Change: Although several attempts have been made, there has not been a reliable way to achieve colon tissue targeted delivery of therapeutics.

Aditya Mohanty: With our approach, we aim to achieve higher drug exposure and activity in colon tissue by delivering drugs directly to the site of disease. Our phase one clinical trial was a very big step forward in demonstrating the NaviCalc platform's ability to achieve this direct topical delivery to the colon, and we're incredibly pleased to have met all our objectives with this study. Looking at the pharmacokinetic data, we achieved a PK profile consistent with drug delivery in the colon. The timing of when tofacitinib shows up in the blood at about six hours compared to 30 minutes for conventional oral therapy is an indicator of the drug entering systemic circulation via the colon.

Aditya Mohanty: With our approach, we aim to achieve higher drug exposure and activity in colon tissue by delivering drugs directly to the site of disease. Our phase one clinical trial was a very big step forward in demonstrating the NaviCAP platform's ability to achieve this direct topical delivery to the colon, and we're incredibly pleased to have met all our objectives with this study. Looking at the pharmacokinetic data, we achieved a PK profile consistent with drug delivery in the colon. The timing of when tofacitinib shows up in the blood at about six hours compared to 30 minutes for conventional oral therapy is an indicator of the drug entering systemic circulation via the colon.

Speaker Change: With our approach, we aim to achieve higher drug exposure and activity in colon tissue by delivering drug directly to the site of disease.

Speaker Change: Our Phase I clinical trial was a very big step forward in demonstrating the NaviCalc platform's ability to achieve this direct topical delivery to the colon, and we're incredibly pleased to have met all our objectives with this study.

Speaker Change: Looking at the pharmacokinetic data, we achieved a PK profile consistent with drug delivery in the colon.

Speaker Change: The timing of when tofacitinib shows up in the blood at about six hours compared to 30 minutes for conventional oral therapy is an indicator of the drug entering systemic circulation via the colon.

Aditya Mohanty: With this delivery approach, we wanted to see lower levels in systemic circulation, and we did. Systemic levels were three to four times lower than with conventional or delivery. We believe this could help reduce toxicity risks, which are a known issue with many UC drugs, including JAK inhibitors. We also wanted to get some data on colon tissue exposure to tofacit. As you may recall, NAVICAP has been programmed to deliver medicine at the entry into the colon.

Aditya Mohanty: With this delivery approach, we wanted to see lower levels in systemic circulation, and we did. Systemic levels were three to four times lower than with conventional delivery. We believe this could help reduce toxicity risks, which are a known issue with many UC drugs, including JAK inhibitors. We also wanted to get some data on colon tissue exposure to tofacit.

Speaker Change: With this delivery approach, we wanted to see lower levels in systemic circulation, and we did.

Speaker Change: The stomach levels were three to four times lower than with conventional or delivery.

Speaker Change: We believe this could help reduce toxicity risks, which are a known issue with many UC drugs, including JAK inhibitors.

Speaker Change: We also wanted to get some data on colon tissue exposure to tofacitinib.

Aditya Mohanty: As you may recall, NAVICAP has been programmed to deliver at the entry to the colon. We wanted to confirm that the drug travels from the proximal colon to the distal or far side of the colon, as we saw with payload delivery in several previous device function studies. Our Phase I results did indeed confirm this, with topacidinib detected across all three biopsy sites in the distal colon. However, we anticipated that tissue levels at these biopsy sites could be quite low because of a trial design that required performing those biopsies at 24 hours or four to five half-lives after the final dose, along with extensive colon preparation before the procedure.

Speaker Change: As you may recall, NATICAP has been programmed to deliver at the entry to the colon.

Aditya Mohanty: We wanted to confirm that drug travels from the proximal colon to the distal or far side of the colon, as we saw with payload delivery in several previous device function studies. Our Phase I results did indeed confirm this, with tofacitinib detected across all three biopsy sites in the distal colon. We anticipated that tissue levels at these biopsy sites could be quite low because of a trial design that required performing those biopsies at 24 hours or 4 to 5 half-lives after the final dose, along with extensive colon preparation before the procedure.

Speaker Change: We wanted to confirm that drug travels from the proximal colon to the distal or far side of the colon, as we saw with payload delivery in several previous device function studies.

Speaker Change: Our Phase I results did indeed confirm this, with tofacidinib detected across all three biopsy sites in the distal colon.

Speaker Change: We anticipated that tissue levels of these biopsy sites could be quite low.

Speaker Change: because of a trial design that required performing those biopsies at 24 hours or 4 to 5 half-lives after the final dose, along with extensive colon prep before the procedure.

Aditya Mohanty: Despite the late timing of the biopsy, we observed drug tissue concentrations above the IC50 level in all three locations. This is especially notable since we studied daily doses of 5 MIGs and 10 MIGs in this trial, which are a quarter to half of the approved doses for conventional typhosid. The data also showed a strong correlation between plasma and tissue levels, and because of this correlation, we were able to model tissue concentrations at earlier time points, which predicts that tissue levels should exceed IC90 for at least 16 hours after dosing. Across both study arms, we saw greater than 95% accuracy of release of the colon with no early release before colon entry, which is excellent performance. We also saw excellent safety data in the trial.

Aditya Mohanty: Despite the late timing of the biopsy, we observed drug tissue concentrations above the IC50 level in all three locations. This is especially notable since we studied daily doses of 5 mg and 10 mg in this trial, which are a quarter to half of the approved doses for conventional typhosidinase. The data also showed a strong correlation between plasma and tissue levels, and because of this correlation, we were able to model tissue concentrations at earlier time points, which predicts that tissue levels should exceed IC90 for at least 16 hours after dosing.

Speaker Change: Despite the late timing of the biopsy, we observed drug tissue concentrations above the IC50 level for all three locations.

Speaker Change: This is especially notable since we studied daily doses of 5 MIGs and 10 MIGs in this trial, which are a quarter to half of the approved doses for conventional typhus admit.

Speaker Change: The data also showed a strong correlation between plasma and tissue levels, and because of this correlation, we were able to model tissue concentrations at earlier time points, which predicts that tissue levels should exceed IC90 through at least 16 hours after dosing.

Aditya Mohanty: Across both study arms, we saw greater than 95% accuracy of release of the colon with no early release before colon entry, which is excellent performance. We also saw excellent safety data in the trial. A lot of the details were included in our KOL presentation.

Speaker Change: Across both study arms, we saw greater than 95% accuracy of release of the colon, with no early release before colon entry, which is excellent performance.

Speaker Change: We also saw excellent safety data in the trial.

Aditya Mohanty: A lot of the details were included in our KOL presentation. If you haven't viewed that event yet, I invite you to watch the replay where our Chief Medical Officer, Dr. Ariella Kelman, who did an amazing job leading this clinical trial, presents the data. Patients with UC continue to experience tremendous difficulties in achieving and sustaining remission.

Speaker Change: A lot of the details were included in our KOL presentation. If you haven't viewed that event yet, I invite you to watch the replay where our Chief Medical Officer, Dr. Ariella Kelman, who did an amazing job leading this clinical trial, presents the data.

Aditya Mohanty: If you haven't viewed that event yet, I invite you to watch the replay where our Chief Medical Officer, Dr. Ariella Kelman, who did an amazing job leading this clinical trial, presents the data. Patients with UC continue to experience tremendous difficulties in achieving and sustaining remission, and we remain focused on the serious unmet need.

Speaker Change: Patients with UC continue to experience tremendous difficulties in achieving and sustaining remission.

Aditya Mohanty: And we remain focused on the serious unmet need. Despite the many approved advanced therapies, a therapeutic ceiling exists at about 30% above placebo. A delta of 15 to 30% induction efficacy simply isn't good enough for a condition that causes tremendous suffering for so many.

Aditya Mohanty: Despite the many approved advanced therapies, a therapeutic ceiling exists at about 30% above placebo. A delta of 15-30% induction efficacy simply isn't good enough for a condition that causes tremendous suffering for so many. We believe the NaviCAP platform is important because it has the potential to break this therapeutic ceiling through several approaches. First, we think this platform can optimize JAK inhibitor therapy by achieving better therapeutic outcomes while reducing safety risk. Our phase one data demonstrate a proof of mechanism for this. Second,

Speaker Change: And we remain focused on the serious unmet need.

Speaker Change: Despite the many approved advanced therapies, a therapeutic ceiling exists at about 30% above placebo.

Speaker Change: A delta of 15-30% induction efficacy simply isn't good enough for a condition that causes tremendous suffering for so many.

Aditya Mohanty: We believe the NaviCAP platform is important because it has the potential to break this therapeutic ceiling through several approaches. First, we think this platform can optimize JAK inhibitor therapy by achieving better therapeutic outcomes while reducing safety risk. Our phase one data demonstrate a proof of mechanism for this.

Speaker Change: We believe the NaviCAP platform is important because it has the potential to break this therapeutic ceiling through several approaches.

Speaker Change: First, we think this platform can optimize JAK inhibitor therapy by achieving better therapeutic outcomes while reducing safety risks.

Speaker Change: Our Phase I data demonstrate a proof of mechanism for this.

Aditya Mohanty: Research shows that colon-targeted delivery could also improve outcomes for other drug classes, such as TNF inhibitors and integrin inhibitors. We believe the NAVICAP platform could deliver those molecules, and we ultimately envision a portfolio of optimized UC therapy. Third, leading physicians talk about the importance of enabling combination therapy for UC in order to target multiple inflammatory pathways. We believe the NAVICAP platform would be very well positioned to facilitate combination therapy. In the near term, our phase one results clearly support a clinical development plan that moves us into a clinical study in UC patients. Our objective with that study is to confirm the PK profile in UC patients and to inform dose selection for a subsequent induction efficacy trial.

Aditya Mohanty: Research shows that colon-targeted delivery could also improve outcomes for other drug classes, such as TNF inhibitors and integrin inhibitors. We believe the NAVICAP platform could deliver those molecules, and we ultimately envision a portfolio of optimized UC therapies. Third, leading physicians talk about the importance of enabling combination therapy for UC in order to target multiple inflammatory pathways. We believe the NAVICAP platform would be very well positioned to facilitate combination therapy. In the near term, our phase one results clearly support a clinical development plan that moves us into a clinical study in UC patients.

Speaker Change: Second, research shows that colon-targeted delivery could also improve outcomes for other drug classes such as TNF inhibitors and integrin inhibitors.

Speaker Change: We believe the NAVICAP platform could deliver those molecules, and we ultimately envision a portfolio of optimized UC therapies.

Speaker Change: Third, leading physicians talk about the importance of enabling combination therapy for UC in order to target multiple inflammatory pathways.

Speaker Change: We believe the NAVICAP platform would be very well positioned to facilitate combination therapies.

Speaker Change: In the near term, our phase one results clearly support a clinical development plan that moves us into a clinical study in UC patients.

Aditya Mohanty: Our objective with that study is to confirm the PK profile in UC patients and to inform dose selection for a subsequent induction efficacy trial. Everything we've seen indicates that our approach should lead to improved response and reduced toxicity for UC patients, and we're eager to continue with clinical development to prove that out. We're also looking forward to the American College of Gastroenterology's annual meeting in October, where we will be presenting data from our phase one clinical trial to the medical community.

Speaker Change: Our objective with that study is to confirm the PK profile in UC patients and to inform dose selection for a subsequent induction efficacy trial.

Aditya Mohanty: Everything we've seen indicates that our approach should lead to improved response and reduced toxicity for UC patients, and we're eager to continue with clinical development to prove that out. We're also looking forward to the American College of Gastroenterology's annual meeting in October, where we will be presenting data from our Phase 1 clinical trial to the medical community. Moving on to our BioJIT systemic therapeutics platform, the BioJet platform continues to exceed its performance targets and shows outstanding promise to solve the challenge of oral delivery of large molecules, which has been called the holy grail of drug delivery. Our goal with Biojet is to provide an alternative to needle-based delivery of complex molecules.

Speaker Change: Everything we have seen indicates that our approach should lead to improved response and reduce toxicity for UC patients and we're eager to continue with clinical development to prove that out.

Speaker Change: We're also looking forward to the American College of Gastroenterology's annual meeting in October, where we will be presenting data from our Phase I clinical trial to the medical community.

Aditya Mohanty: Moving on to our BioJIT systemic therapeutics platform, the BioJet platform continues to exceed its performance targets and shows outstanding promise to solve the challenge of oral delivery of large molecules, which has been called the holy grail of drug delivery. Our goal with Biojet is to provide an alternative to needle-based delivery of complex molecules. The platform could also enable those molecules to more efficiently reach the liver, which is difficult with other oral delivery methods.

Speaker Change: Moving on to our BioJet systemic therapeutics platform. The BioJet platform continues to exceed its performance targets and shows outstanding promise to solve the challenge of oral delivery of large molecules which has been called the holy grail of drug delivery.

Speaker Change: Our goal with Biojet is to provide an alternative to needle-based delivery of complex molecules.

Speaker Change: The platform could also enable those molecules to more efficiently reach the liver, which is difficult with other oral delivery methods.

Aditya Mohanty: As I shared with you last quarter, we established a defined partnering process with interested pharma parties, and during the past quarter, we've made significant steps forward with that. Our goal was to achieve a critical mass of data and to have partner stated interest confirmed by mid-year. We met that goal.

Aditya Mohanty: The platform could also enable those molecules to more efficiently reach the liver, which is difficult with other oral delivery methods. As I shared with you last quarter, we established a defined partnering process with interested pharmaceutical parties. And during the past quarter, we've made significant steps forward with that. Our goal was to achieve a critical mass of data and to have partner stated interest confirmed by mid-year. We left that, and we're currently in active partnership discussions with more than one large pharma. We anticipate bringing at least one of these through to completion in the near term. I'm unable to provide details until we conclude, but I can say that we remain on track to achieve our partnership goal for 2024.

Speaker Change: As I shared with you last quarter, we established a defined partnering process with interested pharma parties, and during the past quarter, we've made significant steps forward with that.

Speaker Change: Our goal was to achieve a critical mass of data and to have partner-stated interest confirmed by mid-year. We met that goal.

Aditya Mohanty: And we're currently in active partnership discussions with more than one large pharmaceutical company, and we anticipate bringing at least one of these through to completion in the near term. I'm unable to provide details until we conclude, but I can say that we remain on track to achieve our partnership goal for 2024. This progress has also been recognized by several of our large shareholders, who are stepping up to support our operations while we conclude our partnership process. Eric will speak a little more about that shortly.

Speaker Change: And we're currently in active partnership discussions with more than one large pharma company.

Speaker Change: We anticipate bringing at least one of these through to completion in the near term.

Speaker Change: I'm unable to provide details until we conclude, but I can say that we remain on track to achieve our partnership goal for 2024.

Aditya Mohanty: This progress has also been recognized by several of our large shareholders who are stepping up to support our operations while we conclude our partnership process. Eric will speak a little more about that shortly. In June, we shared an update at an industry meeting, the Next Gen Peptide Formulation and Delivery Summit, where our Head of Research, Dr. Sharath Singh, presented on a panel discussion alongside his peers from Lilly, Merck, and Novo Nordisk, who are all pursuing oral delivery of peptides such as GLP-1 receptor agonists.

Speaker Change: This progress has also been recognized by several of our large shareholders who are stepping up to support our operations while we conclude our partnership process.

Aditya Mohanty: In June, we shared an update at an industry meeting, the Next Gen Peptide Formulation and Delivery Summit, where our Head of Research, Dr. Sharath Singh, presented on a panel discussion alongside his peers from Lilly, Merck, and Novo Nordisk, who are all pursuing oral delivery of peptides such as GLP-1 receptor agonists. Dr. Singh also presented a session focused solely on the BioJet platform, where he shared our continued progress in demonstrating category-leading bioavailability across multiple complex molecules, including antibodies, peptides, and antisense oligonucleotides.

Speaker Change: Eric will speak a little more about that shortly.

Eric Gaspardus: In June, we shared an update at an industry meeting, the Next Gen Peptide Formulation and Delivery Summit.

Speaker Change: where our Head of Research, Dr. Sharath Singh, presented on a panel discussion alongside his peers from Lilly, Merck, and Novo Nordisk, who are all pursuing oral delivery of peptides such as GLP-1 receptor agonists.

Aditya Mohanty: Dr. Singh also presented a session focused solely on the Biojet platform, where he shared our continued progress in demonstrating category-leading bioavailability across multiple complex molecules, including antibodies, peptides, and antisense oligonucleotides. We remain encouraged by the interest in the BioJet Platform's ability to deliver multi-milligram payloads using existing liquid formulations and its potential to enable liver-targeted delivery of large molecules. With all of these competitive advantages,

Speaker Change: Dr. Singh also presented a session focused solely on the BioJet platform, where he shared our continued progress in demonstrating category-leading bioavailability across multiple complex molecules including antibodies, peptides, and antisense oligonucleotides.

Aditya Mohanty: We remain encouraged by the interest in the BioJet Platform's ability to deliver multi-milligram payloads using existing liquid formulations and its potential to enable liver-targeted delivery of large molecules, with all of these competitive advantages. We're in an excellent position with the BioJet platform, and we look forward to evolving our plans as we bring on pharma partners. To summarize our anticipated milestones, for our NaviCAP platform, we continue to share results from a successful Phase 1 clinical trial for BT600.

Speaker Change: We remain encouraged by the interest in BioJet Platform's ability to deliver multi-milligram payloads using existing liquid formulations and its potential to enable liver-targeted delivery of large molecules.

Aditya Mohanty: We're in an excellent position with the BioJet platform, and we look forward to evolving our plans as we bring on pharma partners. To summarize our anticipated milestones, For our NaviCAP platform, we continue to share results from a successful phase one clinical trial for BT600. We will next be presenting trial data at the American College of Gastroenterology annual meeting in October. We anticipate initiating a clinical study with BT600 in UC patients towards the end of the year.

Speaker Change: With all of these competitive advantages, we're in an excellent position with the BioJet platform and we look forward to evolving our plans as we bring on pharma partners.

Speaker Change: to summarize our anticipated milestones.

Speaker Change: For our NaviCAP platform, we continue to share results from a successful phase 1 clinical trial for BT600. We will next be presenting trial data at the American College of Gastroenterology annual meeting in October.

Aditya Mohanty: We will next be presenting trial data at the American College of Gastroenterology annual meeting in October. We anticipate initiating a clinical study with BT600 in UC patients towards the end of the year. For our BioJet platform, we're in active partnership discussions with more than one large pharma company as part of our defined process. We remain on track toward our goal of partnership for the BioJIT 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 with BT600 in UC patients towards the end of the year.

Aditya Mohanty: For our BioJet platform, we're in active partnership discussions with more than one large pharma company as part of our defined process. We remain on track toward our goal of partnership for the BioJIT 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. Thanks, Eddie, and good afternoon, everyone.

Speaker Change: For our BioJet platform, we're in active partnership discussions with more than one large pharma company as part of our defined process. We remain on track toward our goal of partnership for the BioJet platform in 2024.

Speaker Change: With that, I'll now turn the call over to Eric for a review of our financial results and capital market activities.

Eric Gaspardus: Thanks, Eddie, and good afternoon, everyone. Earlier today, we announced a capital raise that provides crucial funding for the company. We're happy to see the continued support from investors as we progress towards important milestones for Biora. I'll first cover our financial results and then provide more background on our transactions. Operating expenses during the second quarter, excluding stock-based compensation expenses, were $14.5 million, with continued investment in device development, preclinical, and clinical activities. To break this down further, G&A expenses in the second quarter, excluding stock-based compensation expenses, were $7.5 million, of which approximately 60% was core activities, leaving nearly 40% of G&A costs associated with legacy matters, which we are working to eliminate by the end of the year. R&D expenses, excluding stock-based compensation expenses, were $7 million.

Eric Desparvis: Earlier today, we announced a capital raise that provides crucial funding for the company. We're happy to see the continued support from investors as we progress towards important milestones for Biora. I'll first cover our financial results and then provide more background on our transactions. Operating expenses during the second quarter, excluding stock-based compensation expenses, were $14.5 million, with continued investment in device development, preclinical, and clinical activities. To break this down further, G&A expenses in the second quarter, excluding stock-based compensation expenses, were $7.5 million, of which approximately 60% was core activities spent, leaving nearly 40% of G&A costs associated with legacy matters, which we are working to eliminate by the end of the year. R&D expenses, excluding stock-based compensation expenses, were $7 million.

Eric Gaspardus: Thanks, Eddie, and good afternoon, everyone.

Eric Gaspardus: Earlier today, we announced a capital raise that provides crucial funding for the company. We're happy to see the continued support from investors as we progress towards important milestones for Bayera. I'll first cover our financial results and then provide more background on our transaction.

Eric Gaspardus: As a result, Biora's core OpEx spend was $11.7 million in Q2, with the majority of the spend allocated to our R&D programs, including the execution of our clinical development with NaviCap and BT600 and preclinical work with BioJet with our pharma collaborator. 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 on our actual operating cash balance. We also have other non-cash items in our income statement, including changes in derivative and warrant liability.

Eric Desparvis: As a result, Biora's core OpEx spend was $11.7 million in Q2, with the majority of the spend allocated to our R&D programs, including the execution of our clinical development with NaviCAP and BT600 and preclinical work with BioJet with our pharma collaborator. 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 on our actual operating cash. We also have other non-cash items in our income statement, including changes in derivative and warrant liability.

Eric Gaspardus: Operating expenses during the second quarter, excluding stock-based compensation expenses, were $14.5 million with continued investment in device development, preclinical, and clinical activities.

Eric Gaspardus: To break this down further,

Eric Gaspardus: G&A expenses in the second quarter, excluding stock-based compensation expenses, were $7.5 million, of which approximately 60% was core activities spent.

Eric Gaspardus: leaving nearly 40% of GNA costs associated with legacy matters which we are working to eliminate by the end of the year.

Eric Gaspardus: R&D expenses, excluding stock-based compensation expenses, were $7 million.

Speaker Change: As a result, Bayura's core OPEX spend was $11.7 million in Q2.

Speaker Change: with the majority of the spend allocated to our R&D programs, including the execution of our clinical development with NaviCAP and BT600, and preclinical work with our pharma collaborators.

Speaker Change: 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 on our actual operating cash burn.

Speaker Change: We also have other non-cash items in our income statement, including changes in derivative and warrant liabilities.

Eric Gaspardus: As a result, we are posting a $6.5 million net income position for the second quarter of 2024. Moving on to our capital raise announced this afternoon. We made a series of transactions last year and in early 2024 where we substantially reduced our outstanding notes balance, but more importantly, we brought in $19.8 million in new investments from a core group of large institutions. We are happy to see these same institutions adding an additional $60 million to their capital commitment to Biora.

Eric Desparvis: As a result, we are posting a $6.5 million net income position for the second quarter of 2024. Moving on to our capital raise and answer set. We made a series of transactions last year and in early 2024 where we substantially reduced our outstanding notes balance, but more importantly, we brought in $19.8 million in new investment from a core group of large institutions. We are happy to see these same institutions adding an additional $60 million to their capital commitment to BIORA.

Speaker Change: As a result, we are posting a $6.5 million net income position for the second quarter of 2024.

Speaker Change: Moving on to our capital raise announced this afternoon.

Speaker Change: We made a series of transactions last year and in early 2024 where we substantially reduced our outstanding notes balance, but more importantly, we brought in $19.8 million in new investments from a core group of large institutions.

Speaker Change: We are happy to see these same institutions adding an additional $60 million to their capital commitment to BioA.

Eric Gaspardus: The transaction is structured as an additional $16 million contribution from our note holders to the existing facility to be provided in tranches of $4 million increments as needed by the company. This allows us to raise complementary capital from other sources, if available, and preserve this funding as required. In addition, there is a large equity component to this capital raise from convertible features and warrants allocation, highlighting a strong focus on the future value of our stock.

Eric Desparvis: The transaction is structured as an additional $16 million contribution from our note holders to the existing facility to be provided in tranches of $4 million increments as needed by the company. This allows us to raise complementary capital from other sources, if available, and preserve this funding as required. In addition, there is a large equity component to this capital raise from convertible features and warrants allocation, highlighting a strong focus on the future value of our stock.

Speaker Change: The transaction is structured as an additional $16 million contribution from our note holders to the existing facility to be provided in tranches of $4 million increments as needed by the company.

Speaker Change: This allows us to raise complimentary capital from other sources, if available, and preserve this funding as required.

Speaker Change: In addition, there's a large equity component to this capital raise from convertible features and warrants allocation, highlighting a strong focus on the future value of our stock.

Eric Gaspardus: We and our investors view and structure this transaction as a bridge to an anticipated pharma partnership, and we're excited by what lies ahead for Biora. With that, I will now turn the call back over to Adi.

Eric Desparvis: We and our investors view and structure this transaction as a bridge to an anticipated pharma partnership, and we're excited by what lies ahead for Biora. With that, I will now turn the call back over to Adi. Thanks, Eric.

Speaker Change: We, and our investors, view and structure this transaction as a bridge to an anticipated pharma partnership, and we're excited by what lies ahead for Bayera.

Speaker Change: With that, I will now turn the call back over to Adi.

Aditya Mohanty: We're actively working towards completing our first pharma partnership for the BioJet platform, and we look forward to sharing more. And for BT600 and the NaviCAP platform, we're preparing for the next stage of clinical development as we work to break the therapeutic ceiling in UC. Operator, we're now ready for questions.

Aditya Mohanty: We're actively working towards completing our first pharma partnership for the BioJet platform, and we look forward to sharing more. And for BT600 and the NaviCAP platform, we're preparing for the next stage of clinical development as we work to break the therapeutic ceiling in UC. Operator, we're now ready for questions. Thank you. Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star and one on the telephone keypad. A confirmation tone will indicate your line is in the queue. You may press star and two if you would like to remove your question from the queue.

Adi: Thanks, Eric.

Adi: We're actively working towards completing our first pharma partnership for the BioJet platform, and we look forward to sharing more. And for BT600 and the NaviCAP platform, we're preparing for the next stage of clinical development as we work to break the therapeutic ceiling in UC.

Speaker Change: Operator, we're now ready for questions.

Operator: Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star and one on the telephone keypad. A confirmation tone will indicate your line is in the queue. You may press star and two 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. Ladies and gentlemen, we will wait for a moment while we poll you for questions. The first question is from John Vandermosten with Zach. Please go ahead.

Speaker Change: Thank you.

Speaker Change: Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star and 1 on your telephone keypad. A confirmation tone will indicate your line is in the queue.

Speaker Change: You may press star and 2 if you would like to remove your question from the queue.

Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Ladies and gentlemen, we will wait for a moment while we poll for questions. The first question is from John Vandermosten with Zach, please go ahead, and good afternoon, Aditya, and Eric. Start out with a question on just the topics of negotiation.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker Change: Ladies and gentlemen, we will wait for a moment while we poll for questions.

Speaker Change: The first question is from John Vandermosten with Zax. Please go ahead.

John Vandermosten: And good afternoon, Adi and Eric. I'll start out with a question on just the topics of negotiation with your partnership. You know, I know you can't say too much about it, but is it revolving around market assumptions, pricing, penetration, technical execution, or you know, I'm just wondering kind of how the talks are going and what are the main areas of focus.

John Vandermosten: And good afternoon, Aditya and Eric. I'll start out with a question on just the topics of negotiation with your partnership.

John Vandermosten: And I know you can't say too much about it, but is it revolving around marketing? Pricing, Penetration, Technical Execution. I'm just wondering how the talks are going and what the main areas of focus are. Hi, John.

John Vandermosten: I know you can't say too much about it, but is it revolving around market assumptions, pricing, penetration, technical execution, or?

Speaker Change: I'm just wondering how the talks are going and what are the main areas of focus.

Aditya Mohanty: Yeah, the discussions are narrowing. So they did start very broad with all the things you're talking about, but they are starting to narrow, and we're trying to figure out the best way to work with potentially more than one partner and how that would work. So we're getting there. We'd love to tell you more, but it's kind of difficult. We're really close to the end of it, and so hopefully, we'll be able to share it fairly soon.

Aditya Mohanty: John Vandermosten, Joseph Pantginis, Julian Harrison, Ariella Kelman, Rei Tan, and Biora Therapeut We're really close to the end of it, and so hopefully, we'll be able to share it fairly soon.

Speaker Change: Hi, John. Yeah, the discussions are...

Speaker Change: are narrowing, so they did start very broad with all the things you're talking about.

Speaker Change: But they are starting to narrow, and we're trying to figure out the best way to work with potentially more than one partner and how that would work. So we're getting there. We'd love to tell you more, but it's kind of difficult.

Speaker Change: We're really close to the end of it and so hopefully we'll be able to share fairly soon.

John Vandermosten: Great. Exciting times for that!

John Vandermosten: Great It was exciting. And then I had a couple of technical questions about the results from the... When we look at the uptake of the drug and, from, you know, the oral route. Ariella Kelman, Rei Tan, Biora Therapeut, Mayank Mamtani, Ariella Kelman, Rei Tan, Biora You know, in one way, it's getting to the tissue through the vasculature, and the other way... Direct contact with the tissue, and I'm wondering if there's any you know if you looked at that at all and have anything to say about the difference in the way it kind of gets, interesting question because for us, that is the core of why we believe we can do what they have not been able to do, which is get a lot more tissue where I mean drug where it matters so, Zeljanz or oral tofacitinib It goes into the entire blood system, and certainly, blood circulates everywhere, including the colon.

Speaker Change: Great, exciting times for that. And then I had a couple of technical questions about the results from the VT600 trial. When we look at the uptake of the drug and...

John Vandermosten: And then I have a couple of technical questions about the results of the VT600 trial. When we look at the uptake of the drug and from, you know, the oral route. Ariella Kelman, Mayank Mamtani, Ariella Kelman, Rei Tan, Biora Therapeut, You know, in one way, it's getting to the tissue through the vasculature, and the other way, it's through direct contact with the tissue. And I'm wondering if there's any, you know, if you looked at that at all and had anything to say about, you know, the difference in the way it kind of gets to where it needs to go.

Speaker Change: from, you know, the oral,

Speaker Change: oral versus when it's given through the pill.

Speaker Change: You know in one way, it's getting to the tissue through the vasculature and the other way It's through direct contact with the tissue And I'm wondering if there's any you know if you looked at that at all and have anything to say about you know the difference In the way it kind of gets to where it needs to go

Aditya Mohanty: Interesting question because for us, that is the core of why we believe we can do what they have not been able to do, which is get a lot more tissue where I mean drug where it matters. So Zeljanz, or oral tofacitinib, basically gets absorbed just after the stomach in that small GI tract, which is where a lot of these oral medications get absorbed. Lots of vasculature; it goes into the entire blood system, and certainly, blood circulates everywhere, including the colon.

Speaker Change: Interesting question, because for us, that is the core of why we believe we can do what they have not been able to do, which is get a lot more tissue, I mean drug, where it matters.

Speaker Change: or oral tofacitinib, basically gets absorbed just after the stomach in that small GI tract, which is where a lot of these oral medications get absorbed.

Speaker Change: Lots of vasculature, it goes into the entire blood system and certainly the blood circulates everywhere including the colon. So it comes in through the blood into the colon and you get to a certain quantity.

Aditya Mohanty: So it comes in through the blood into the colon, and you get to a certain quantity. And all the published data shows what quantities they get to. So we are able to compare because there are enough publications that show, hey, if you had a 10 mg dose and if you had it twice a day, how much do you get in the tissue? and the difficulty there is. If you want to increase that, how do you do that? And they've tried.

Aditya Mohanty: So it comes in through the blood into the colon, and you get to a certain quantity. And all the published data shows what quantities they get to. So we are able to compare because there are enough publications that show, hey, if you had a 10 mg dose and if you had it twice a day, how much do you get in the tissue? and the difficulty there is. If you want to increase that, how do you do that? And they've tried.

Speaker Change: And all the published data shows what quantities they get to. So we are able to compare because there's enough publications that show, hey, if you had a 10 mg dose and if you had it twice a day, how much do you get in the tissue? And the difficulty there is...

Aditya Mohanty: So at our KOL events, I think it was Dr. Fagan who also mentioned that, look, people who did these drug trials also tried 30 mg and got better. Outcomes response, however, you know, with the toxicity, the adverse events were worse, and so the approved label is 10 twice a day, so 20 megs and not 30. All of these are telling you, look, through the blood, you get to the colon, but in order to get enough, you just cannot dose high enough.

Aditya Mohanty: So at our KOL events, I think it was Dr. Fagan who also mentioned that, look, people who did these drug trials also tried 30 mg and got better. Outcomes response, however, you know, with the toxicity, the adverse events were worse. And so the approved label is 10 twice a day, so 20 megs and not 30.

Speaker Change: If you want to increase that, how do you do that? And they've tried. So, on our KOL events, I think it was Dr. Fagan who also mentioned that, look, people who did these drug trials also tried 30 mg and got better results.

Speaker Change: Outcomes response, however, you know with the toxicity the adverse events were worse and so the approved label is 10 twice a day so 20 megs and not 30. All of these telling you look through the blood you get to the colon but in order to get enough you just cannot dose high enough.

Aditya Mohanty: All of this telling you, look, through the blood, you get to the colon, but in order to get enough, you just cannot dose high enough. We get past the small intestine into the colon, and when we drop the drug along the colon, one of the concerns was, would you actually have uptake in the tissue? So when it goes through the tissue, again, in that KOL event, there's actually some really nice, how it works, presentation done by Dr. Sands, as well as some pictures.

Aditya Mohanty: We get past the small intestine into the colon, and when we drop the drug along the colon, one of the concerns was, would you actually have uptake in the tissue? So when it goes through the tissue, again, at that KOL event, there's actually some really nice how it works presentations done by Dr. Sands, as well as some pictures. So if you look it up, it goes through the tissue and comes out, some of it into the blood.

Speaker Change: We

Speaker Change: Get past the small intestine into the colon and when we drop the drug along the colon

Speaker Change: One of the concerns was...

Speaker Change: Would you actually have

Dr. Sands: uptake in the tissue. So, when it goes through the tissue, again, in that KOL event, there's actually some really nice how it works presentation done by Dr. Sands, as well as there's some pictures. So, if you look it up, it goes through the tissue.

Aditya Mohanty: So if you look it up, it goes through the tissue and comes out some of it into the blood. And so when we notice the first time is about six hours into the dose that you start seeing the drug in the blood, and then it peaks around eight to ten hours. So it's getting more and more absorbed into the tissue and coming out of the blood. Being in the blood systemically is not great.

Dr. Sands: and comes out, some of it, into the blood. And so...

Aditya Mohanty: And so when we notice the first time is about six hours into the dose that you start seeing the drug in the blood, and then it peaks around eight to ten hours, so it's over time getting more and more absorbed into the tissue and coming out of the blood. Being in the blood systemically is not great; you need just a really small amount, not a high amount, so we can get large quantities into that tissue that we need to reach without having And that was the beauty of it.

Speaker Change: when we notice first time is about six hours into the dose that you start seeing drug in the blood and then it peaks around eight to 10 hours. So it's over time getting more and more absorbed in the tissue and coming out of the blood.

Speaker Change: Being in the blood systemically is not great. You need just a really small amount, not the high amounts. So we can get large quantities into that tissue that we need to reach without having to get a lot into the blood.

Aditya Mohanty: You need just a really small amount, not large amounts. So we can get large quantities into that tissue that we need to reach without having to get a lot into the blood. And that was the beauty of it.

Aditya Mohanty: So if you look at it, there is some information in clinical trials already that says, you know, more would give you better outcomes. And you can compare it with other JAK inhibitors also, where they keep dosing it higher and higher. Response is great; it's the adverse reactions they have to stop. So the fact that we can get extremely high tissue exposure with very small systemic exposure is a big deal. And we did walk through how we got that information. Partly in the KOL, partly in the DAX.

Aditya Mohanty: So if you look at it, there is some information in clinical trials already that says, you know, more would give you better outcomes. And you can compare it with other JAK inhibitors also, where they keep dosing it higher and higher. Response is great, but it's the adverse reactions they have to stop. So the fact that we can get extremely high tissue exposure with very small systemic exposure is a big deal, and we did walk through how we got that information, partly in the KOL, partly in the DAC. I encourage people to look it up; it's really exciting; we were thrilled with what we saw, exactly what we hoped it would be.

Speaker Change: And that was the beauty of it. So if you look at it, it's...

Speaker Change: There is some information in clinical trials already that says more would give you better outcomes. And you can compare with other JAK inhibitors also where they keep dosing higher and higher. Response is great, it's the adverse reactions they have to stop.

Speaker Change: The fact that we can get extremely high tissue exposure with very small systemic exposure is a big deal, and we did walk through how we got that information, partly in the KOL, partly in the DEX.

Aditya Mohanty: I encourage people to look it up; it's really exciting; we were thrilled with what we saw; exactly what we hoped for. Great. And that was a good technical description there. And then, you know, kind of on the same line when, you know, when you take the oral product, it's already approved. The entire amount of drug is processed through the body, but when you're using the mechanical pill... Not all of it is really processed.

Speaker Change: So I encourage people to look it up. It's really exciting. We were thrilled with what we saw, exactly what we hoped for.

John Vandermosten: Great. And that was a good technical description there. And then, you know, kind of on the same line when when you take the oral product, it's already approved, the entire amount of drug is processed through the body. But when you're using the mechanical pill, not all of it is really processed. Some of it passes through. Have you done any work to estimate how much of the drug kind of passes through and not or doesn't touch the body at all? Or is that something that's very difficult?

Speaker Change: Great. And that was a good technical description there. And then, you know, kind of along the same lines, when, you know, when you take the oral, the oral product, it's already approved.

Speaker Change: The entire amount of drug is processed through the body, but when you're using the mechanical pill, not all of it is really processed. Some of it passes through. Have you done any work to estimate how much of the drug kind of passes through and doesn't touch upon the body at all? Or is that something that's very difficult to measure?

John Vandermosten: Some of it passes through. Have you done any work to estimate how much of the drug kind of passes through and doesn't touch the body at all? Or is that something that's very low?

Operator: the Biora Therapeutics, Second Quarter, 2024, 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.

Aditya Mohanty: Interesting question. So, we do have some of that information. We collected all these different things, and we'll be sharing more information. The majority of it does get absorbed in the colon. Some of it sometimes does come out the other end without getting absorbed, but we did collect that information. We know because we dropped the load at the beginning entry to the colon. And over time, it crosses the entire colon.

Aditya Mohanty: Interesting question. So what do we, we do have some of that information. So we collected all these different things, and we'll be sharing more information. The majority of it does get absorbed in the colon. Some of it sometimes does come out the other end without getting absorbed, but we did collect that information. We know because we dropped the load at the beginning entry to the colon. And over time, it crosses the entire colon, and remember, we took biopsies, so we know it went all the way to the end of the colon.

Speaker Change: Interesting question.

Speaker Change: We do have some of that information.

Speaker Change: So we collected all these different things and we'll be sharing more information.

Operator: If anyone should require or operate our assistance during the conference, please press star and zero on a telephone keypad. As a reminder, this conference has been recorded.

Speaker Change: majority of it does get absorbed in the colon some of it in sometimes does come out the other end without getting absorbed but we did collect that information we know because we dropped the load at the beginning entry to the colon

Chuck Padala: I will now turn the call over to Chuck Padala, managing director with lifestyle advisors, Biora's investor relations firm, please go ahead. Thank you, operator. Good afternoon and welcome to the Biora Therapeutics, Second Quarter, 2024, Corporate Update, and Financial Results Scarfers Call. Joining me on the call are Aditya Mohanty, Chief Executive Officer, Eric Disparvis, Chief Financial Officer. 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 10Q that we filed or will file later today in our subsequent reports filed with the SEC, which are available on our website in the investor section.

Aditya Mohanty: And remember, we took biopsies. So we know it went all the way to the end of the colon. The majority of it does get absorbed, and the small quantities that come out, and we'll share some more of that data at the coming conference, as we mentioned.

Speaker Change: And over time, it crosses the entire colon. And remember, we took biopsies, so we know it went all the way to the end of the colon. The majority, if it does get absorbed...

Aditya Mohanty: The majority of it does get absorbed, and the small quantities that come out, and we'll share some more of that data at the coming conference, as we mentioned. So we do have that, and we'll continue to collect more of that information to see how much of this drug goes into the tissue and what, if any, comes out the other way.

Speaker Change: and the small quantities that come out, and we'll share some more of that data in the coming conference, as we mentioned. So we do have that, and we'll continue to collect more of that information to see how much of this drug goes in the tissue and what, if any, comes out the other end.

John Vandermosten: So we do have that, and we'll continue to collect more of that information to see how much of this drug goes into the tissue and what, if any, comes out the other end. Great. All right. We're looking forward to it.

John Vandermosten: Great. All right. We're looking forward to it. Thank you, Eddie.

Chuck Padala: These forward-looking statements represent our views only as of the date of this call and involve substantial risk and uncertainties, including many that are beyond our control. Please note that actual results could differ materially from those expressed in the forward-looking statement. Prefer the 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: Great, all right, we're looking forward to it and thank you Eddie.

Joseph Pantginis: Thank you. The next question is from Joe Pantginis with HC Wainwright. Please go ahead.

Operator: Thank you, Aditya. Thank you, thank you. The next question is from Joe Pantginis with HC Wainwright. Please go ahead.

Eddie: Thank you.

Eddie: Thank you. The next question is from Joe Pantginis with HC Wainwright. Please go ahead.

Joseph Pantginis: Hey everybody, good afternoon, and thanks for taking the question. So, on the logistics front, in anticipation of more advanced clinical studies, whether in your hands or in a partner's hands, I was hoping you could discuss your relative current capacity and intermediate needs for the device, you know, availability, and manufacturing.

Joseph Pantginis: Good afternoon, everybody. Good afternoon. Good afternoon, everybody.

Operator: So, two questions. On the logistics front, in anticipation of, you know, more advanced clinical studies, whether in your hands or in a partner's, Relative Current Capacity. Yeah, so you're talking about NaviCAP.

Joe Pantginis: Hey, everybody. Good afternoon, and thanks for taking the question. So, two questions. First is a logistics question, and second is a perspective question. So, on the logistics front, in anticipation of, you know, more advanced clinical studies, whether in your hands or in a partner's hands, I was hoping you could discuss your relative current capacity and intermediate needs for device, you know, availability and manufacturing.

Aditya Mohanty: Yeah, so you're talking about NaviCAP. Yeah. Yeah.

Joe Pantginis: Yeah, so you were talking about NaviCAP. Yes.

Aditya Mohanty: Yeah. So NaviCap, which is being used in our BT600 for the UC trial, we have some contract manufacturers already that we work with. We have our internal team that has the expertise to build a handful of these, but we even already work with some contract manufacturers that we could make several hundred, and we've planned to be able to make several thousand. We're ready to do that in a short period of time.

Aditya Mohanty: So NaviCAP, which is being used in our BT600 for the UC trial. We have some contract manufacturers already that we work with. We have our internal team that has the expertise to build a handful of these, but we already work with some contract manufacturers that we could make several hundred, and we've planned to be able to make several thousand. We're ready to do that in a short period of time, but in the meantime, we're working on further automation so that when we need them, we'll be able to make plenty of these.

Joe Pantginis: Yeah.

Speaker Change: So NaviCap, which is being used in our BT600 for the UC trial, we have some contract manufacturers already that we work with. We have our internal team that has the expertise to build like a handful of these, but we even already work with some contract manufacturers that we could make.

Aditya Mohanty: With that, I will now turn the call over to Aditya Mohanty, CEO of Biora Therapeutics. Adity? Thanks, Chuck, and thank you, everyone, for joining us. It's been a very productive and busy quarter for Biora, with the announcement of our successful Phase 1 clinical trial for the BT600 program, using our NaviCat platform, and significant work and progress with partners on the bioget platform. I'll begin with our NaviCat platform. We were pleased to see the large number of people who joined a recent KOL event, which was co-hosted by Dr. Bruce Sands of Mount Sinai and Dr. Brian Fagan of the University of Western Ontario.

Speaker Change: several hundred and we plan to be able to make several thousand.

Aditya Mohanty: But in the meantime, we're working on further automation so that when we need them, we'll be able to make plenty of them. So all of that is in motion for the next short period of time, which would be 12 to 18 months. The ability to make a few thousand of these pills exists, and we have those vendors and contract manufacturers set up to go. So we don't see that as a huge thing.

Speaker Change: We're ready to do that in the short period of time, but in the meantime, we're working on further automation so that

Speaker Change: When we need them, we'll be able to make plenty of these.

Aditya Mohanty: So all of that is in motion for the next short period of time, which would be 12 to 18 months. The ability to make a few thousand of these pills exists, and we have those vendors and contract manufacturers set up to go, so we don't see that as a huge thing. Down the road, though, we do need to do a little more work as we have started building the automation required to be able to make the hundreds of thousands that we would need down the road.

Speaker Change: So, all of that is in motion for the next short period of time, which would be 12 to 18 months. The ability to make a few thousand...

Aditya Mohanty: These two physicians are legends in the treatment of IBD. And if you look at many of the major clinical trials in UC therapies, you'll see both these names appear over and over, including as principal investigators. It was great to have them help us present and contextualize our clinical trial results for BT600. BT600 is being developed for the treatment of ulcerative colitis, which is an inflammatory disease that affects the mucosa and sub-mucosa layers of the colon.

Speaker Change: of these PILs exists, and we have those vendors and contract manufacturers set up to go. So we don't see that as a huge thing. Down the road, though, we do need to do a little more work as we have started building.

Joseph Pantginis: Down the road, though, we do need to do a little more work as we have started building the automation required to build to be able to make the hundreds of thousands that we would need down the road. That's very helpful. Thanks for that. And my perspective question is, I was hoping you could provide... and because, obviously, with bio- Bioavailability.

Speaker Change: the automation required to build, to be able to make the hundreds of thousands that we would need to down the road.

Joseph Pantginis: That's very helpful. Thanks for that.

Speaker Change: That's very helpful. Thanks for that. And then the perspective question is, I was hoping you can provide some information, because obviously with BioJet, you know, the bioavailability is one of the key attributes of the asset.

Aditya Mohanty: It's largely a local disease of the colon tissue. Despite knowing for over 30 years that you see the disease of the colon tissue, even now patients are treated by receiving powerful drugs, aesthetically, in an attempt to reach therapeutic levels in the colon. Research shows that UC patients with higher drug exposure in the colon tissue have significantly better responses to therapy. Although several attempts have been made, there has not been a reliable way to achieve colon tissue-targeted delivery of therapeutics.

Joseph Pantginis: And then the perspective question is, I was hoping you could provide some information because, obviously, with BioJet, you know, the bioavailability is one of the key attributes of the asset. Now, some of the data or a lot of the data that you put out there and you talk about in your press release also as a reminder, you're seeing in the range of 40% bioavailability. So I was hoping you could offer up some perspective as to, you know, how that really compares to IV formulations of drugs.

Aditya Mohanty: Now, some of the data or a lot of the data that you put out there and you talk about in your press release, also as a reminder, you're seeing in the range of 40% bioavailability. So I was hoping you could offer up some perspective as to that, how that really compares to IVF. Oh, wow. Yeah, it's really interesting. So I can just look back to when our head of research, Sharath, was presenting.

Speaker Change: Now, some of the data or a lot of the data that you put out there and you talk about in your press release also as a reminder, you know, you're seeing in the range of 40% bioavailability. So, I was hoping you could offer up some perspective as to, you know, how that really compares to IV formulations of drugs.

Aditya Mohanty: Oh, wow. Yeah, it's really interesting. So, I can just look back to when our head of research, Sharath, was presenting. There were others on that panel.

Speaker Change: Oh, wow. Yeah.

Speaker Change: It's really interesting. So I can just look back to this when our head of research, Sharaf, was presenting. There were others on that panel. They were, you know, from a lot of large pharma companies. They were all talking about the most commonly used methods of trying to make these.

Aditya Mohanty: They were, you know, from a lot of large pharma companies. They were all talking about the most commonly used methods of trying to make these available, you know, through permeability enhancers, through entire coating, all of those. They end up being sort of single digits or mid-single digits, and it's really hard to get that beyond. There are some technologies that have claimed to have higher numbers, but there's nothing that has consistently shown the ability to reach even double digits.

Aditya Mohanty: There were others on that panel. They were, you know, from a lot of large pharmaceutical companies. They were all talking about the most commonly used methods of trying to make these available, you know, through permeability enhancers, through enteric coating, all of those. But they end up being sort of single digits or mid-single digits, and it's really hard to get that beyond. There are some technologies that have claimed to have higher numbers, but there's nothing that has consistently shown the ability to reach even double digits.

Aditya Mohanty: With our approach, we aim to achieve higher drug exposure and activity in colon tissue by delivering drug directly to the side of disease. Our phase one clinical trial was a very big step forward in demonstrating the NaviCAP platform's ability to achieve this direct, optical delivery to the colon, and we're incredibly pleased to have met all our objectives with this study. Looking at the pharmacokinetic data, we achieved a PK profile consistent with drug delivery in the colon.

Speaker Change: available, you know, through permeability enhancers, through entire coating, all of those, they end up being sort of single digits or mid-single digits and it's really hard to get that beyond. There are some technologies that have

Speaker Change: claimed to have higher numbers, but there's nothing that has consistently shown the ability to reach even double digits. So...

Aditya Mohanty: So, it's basically comparing to under 10% for things that potentially could be done reliably, and for us to be able to have a technology, which is what BioJet is, the platform where we can essentially take your formulation that you currently use in your needle-based delivery system and get close to 40%. So when you compare to IV, IV being the gold standard, sub-Q injection ranges in, you know, sort of 50% to 60% of IV. And so getting to 40% of IV, it's almost as good as a sub-Q injection.

Aditya Mohanty: So it's basically comparing to under 10% for things that potentially could be done reliably. And for us to be able to have a technology, which is what Biojet is, the platform where we can essentially take your formulation that you currently use in your needle-based delivery system and get close to 40%. So when you compare to IV, IV being the gold standard, a sub-Q injection ranges in, you know, sort of 50% to 60% of IV. And so getting to 40% of IV, it's almost as good as a sub-Q injection.

Aditya Mohanty: The timing of when typhosidinib shows up in the blood at about six hours, compared to 30 minutes for conventional oral therapy, is an indicator of the drug entering systemic circulation via the colon. With this delivery approach, we wanted to see lower levels in systemic circulation, and we did. Systemic levels were three to four times lower than with conventional or delivery. We believe this could help reduce toxicity risks, which are a known issue with many UC drugs, including Jack inhibitors.

Speaker Change: It's basically comparing to under 10% for things that potentially could be done reliably.

Speaker Change: and for us to be able to have a technology, which is what BioJet is, the platform, where we can essentially take your formulation that you currently use in your needle-based delivery system.

Speaker Change: and get close to 40%. So when you compare to IV, IV being the gold standard, sub-2 injection ranges in, you know, sort of 50 to 60%.

Aditya Mohanty: We also wanted to get some data on colon tissue exposure to typhosidin. As you may recall, NaviCAP has been programmed to deliver at the entry to the colon. We wanted to confirm that drug travels from the proximal colon to the distal or far side of the colon, as we saw with payload delivery in several previous device function studies. Our phase one results did indeed confirm this, with typhosidinib detected across all three biopsy sites in the distal colon.

Aditya Mohanty: We think that's phenomenal, and so do our collaborators. And the fact that we can do this with such minimal manipulation of whatever formulation you have is another big advantage. Over time, we see this as being applicable to so many places. We just have to get to step one and step two, which is coming up really in the near term. So thanks for that question. Perspective-wise, we're thrilled. We keep looking at all these different places for others to show a broadly applicable platform that could do double digits, and it's hard to see.

Speaker Change: of IV. And so getting to 40% of IV, it's almost as good as a sub-Q injection.

Joseph Pantginis: We think that's phenomenal, and so do our collaborators. And the fact that we can do this with such minimal manipulation of whatever formulation you have is another big advantage. Over time, we see this as being applicable to so many places. We just have to get to step one and step two, which is coming up really in the near term. So thanks for that question. Perspective wise, we're thrilled. We keep looking at all these different places for others to show a broadly applicable platform that could do double digits, and it's hard to see. We don't see them. Thanks for the added details.

Joseph Pantginis: Great, thanks for the added details.

Speaker Change: We think that's phenomenal and so do our collaborators and the fact that we can do this

Speaker Change: with such minimal manipulation of whatever formulation you have is another big advantage.

Speaker Change: Over time, we see this as being applicable to so many places.

Speaker Change: We've just got to get to that step one and step two, which is coming up really in the near term. So, thanks for that question. Perspective-wise...

Aditya Mohanty: We anticipated that tissue levels of these biopsy sites could be quite low because of a trial design that required performing those biopsies at 24 hours or four to five half lives after the final dose, along with extensive colon prep before the procedure. Despite the late timing of the biopsy, we observed drug tissue concentrations above the IC50 level for all three locations. This is especially notable since we studied daily doses of five migs and ten migs in this trial, which are a quarter to half of the approved doses for conventional typhosidinib.

Speaker Change: We're thrilled. We keep looking at all these different places for others to show a broadly applicable platform that could do even double digits, and it's hard to see. We don't see them.

Speaker Change: Great. Thanks for the added details.

Aditya Mohanty: As there are no further questions, I would now like to hand the conference over to Aditya for closing comments.

Joseph Pantginis: We don't see them. Great, thanks for the added detail. Thank you. As there are no further questions, I would now like to hand the conference over to Adi for closing comments. Well, I want to thank everyone for joining us. We look forward to keeping you updated as we continue to advance our program. Good afternoon. Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Pantginis, Ariella Kelman, Ariella Kelman, Ariella Kelman, This is a poem by Gautam Sachdeva published on October 6, 1991.

Speaker Change: Thank you.

Speaker Change: As there are no further questions, I would now like to hand the conference over to Adi for closing comments.

Aditya Mohanty: Well, I want to thank everyone for joining us. We look forward to keeping you updated as we continue to advance our program. Good afternoon.

Speaker Change: Well, I want to thank everyone for joining us. We look forward to keeping you updated as we continue to advance our programs.

Operator: Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Adi: Good afternoon.

Speaker Change: Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Aditya Mohanty: The data also showed a strong correlation between plasma and tissue levels, and because of this correlation, we were able to model tissue concentrations at earlier time points, which predicts that tissue levels should exceed IC90 through at least 16 hours after dosing. Across both study arms, we saw greater than 95% accuracy of releasing the colon, with no early release before colon entry, which is excellent performance. We also saw excellent safety data in the trial.

Speaker Change: [music]

Aditya Mohanty: A lot of the details were included in our KOL presentation. If you haven't viewed that event yet, I invite you to watch the replay where a chief medical officer, Dr. Ariela Kellman, who did an amazing job leading this clinical trial, presents the data. Patients with UC continued experience tremendous difficulties in achieving and sustaining remission. And we remain focused on the serious unmet need. Despite the many approved advanced therapies, a therapeutic ceiling exists at about 30% above placebo.

unknown: Satsang with Mooji Copyright 2019 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent. Joseph Pantginis, John Vandermosten, Ariella Kelman

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Aditya Mohanty: A Delta of 15 to 30% induction efficacy simply isn't good enough for a condition that causes tremendous suffering for so many. We believe the NaviCAP platform is important because it has the potential to break this therapeutic ceiling through several approaches. First, we think this platform can optimize Jack inhibitotherapy by achieving better therapeutic outcomes while reducing safety risks. Our phase one data demonstrate a proof of mechanism for this. Second, research shows that colon targets are very important.

Aditya Mohanty: Integrated delivery could also improve outcomes for other drug classes such as TNF inhibitors and integrant inhibitors. We believe the NaviCAP platform could deliver those molecules and we ultimately envision a portfolio of optimized UC therapies. Third, leading physicians talk about the importance of enabling combination therapy for UC in order to target multiple inflammatory pathways. We believe the NaviCAP platform would be very well positioned to facilitate combination therapies. In the near term, a phase one results clearly support a clinical development plan that moves us into a clinical study in UC patients.

Aditya Mohanty: Our objective with that study is to confirm the PK profile in UC patients and to inform dose selection for a subsequent induction efficacy trial. Everything we've seen indicates that our approach should lead to improve response and reduce toxicity for UC patients and we're eager to continue with clinical development to prove that out.

Aditya Mohanty: We're also looking forward to the American College of Gastroenterologies Annual Meeting in October, where we will be presenting data from our phase one clinical trial to the medical community.

Aditya Mohanty: Moving on to our budget systemic therapeutics platform. The budget platform continues to exceed its performance targets and shows outstanding promise to solve the challenge of oral delivery of large molecules, which has been called the Holy Grail of Drug Delivery. Our goal with budget is to provide an alternative to needle-based delivery of complex molecules. The platform could also enable those molecules to more efficiently reach the liver, which is difficult with other oral delivery methods.

Aditya Mohanty: As I shared with you last quarter, we established a defined partnering process with interested pharma parties and during the past quarter, we've made significant steps forward with that. Our goal was to achieve a critical mass of data and to have partner-stated interest confirmed by mid-year. We met that goal and we're currently an active partnership discussions with more than one large pharma company. We anticipate bringing at least one of these through to completion in the near term.

Aditya Mohanty: I'm unable to provide details until we conclude, but I can say that we remain on fact to achieve our partnership goal for 2024. This progress has also been recognized by several of our large shareholders who are stepping up to support our operations while we conclude our partnership process. Eric will speak a little more about that shortly. In June, we shared an update at an industry meeting, the next-gen peptide formulation and delivery summit, where our head of research, Dr. Schardt, saying, presented on a panel discussion alongside his peers from Lily, Mark, and Nova Nordisk, who are all pursuing oral delivery of peptides, such as GLP-1 receptor agonists.

Aditya Mohanty: Dr. Singh also presented a session focused solely on the budget platform, where he shared our continued progress in demonstrating category leading bioavailability across multiple complex molecules, including antibodies, peptides, and anti-sense oligonucleotides. We remain encouraged by the interest in biogen platforms ability to deliver multi-milligram payloads using existing liquid formulations, and its potential to enable liver targeted delivery of large molecules. With all of these competitive advantages, we're in an excellent position with the budget platform, and we look forward to evolving our plans as we bring on farmer partners.

Aditya Mohanty: The summarized are anticipated milestones. For an advocate platform, we continue to share results from a successful phase one clinical trial for BT600. We will next be presenting trial data at the American College of Gastroenterology Annual Meeting in October. We anticipate initiating a clinical study with BT600 in UC patients towards the end of the year. For our bioget platform, we're an active partnership discussions with more than one large farmer company as part of our defined process. We remain on track toward our goal of partnership for the bioget platform in 2024.

Eric Disparvis: 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.

Eric Disparvis: Earlier today, we announced a capital raise that provides crucial funding for the company. We're happy to see the continued support from investors as we progress towards important milestones for Biura. I'll first cover our financial results and then provide more background on a transaction. Operating expenses during the second quarter, excluding stock-based compensation expenses, were $14.5 million with continued investment in devised development, pre-canicle, and clinical activities. To break this down further, GN expenses in the second quarter, excluding stock-based compensation expenses, were $7.5 million, of which approximately 60% was core activities spanned, leaving nearly 40% of G&A costs associated with legacy matters which we are working to eliminate by the end of the year.

Eric Disparvis: R&D expenses, excluding stock-based compensation expenses, were $7 million As a result, Biora's core up expand was $11.7 million in Q2, with the majority of the span allocated to our R&D programs, including the execution of our clinical development with NaviCap and BT600, and preclinical work with our farm out collaborators. 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 on our actual operating cash burn. We also have other non-cash items in our income statement, including changes in derivative and warrant liabilities.

Eric Disparvis: As a result, we are posting a $6.5 million net income position for the second quarter of 2024. Moving on to our capital raise and answer afternoon. We made a series of transactions last year and in early 2024, where we substantially reduce our outstanding notes balance, but more importantly, we brought in $19.8 million in new investments from a core group of large institutions. We are happy to see these same institutions adding an additional $16 million to their capital commitment to Biora.

Eric Disparvis: The transaction is structured as an additional $16 million contribution from our note holders to the existing facility to be provided in tranches of $4 million increments as needed by the company. This allows us to raise complementary capital from other sources if available and preserve this funding as required. In addition, there's a large equity component to this capital raise from convertible features and warrant allocation, highlighting a strong focus on the future value of our stock.

Eric Disparvis: We and our investors view and structure this transaction as a bridge to an anticipated form of partnership, and we're excited by what lies ahead for Biora.

Aditya Mohanty: With that, I will now turn the call back over to Addy. Thanks, Eric.

Aditya Mohanty: We're actively working towards completing our first form of partnership for the bi-adjeb platform, and we look forward to sharing more. And for BT600 and the NaviCat platform, we're preparing for the next stage of clinical development as we work to break the therapeutic ceiling in UC.

Operator: Operator, we're now ready for questions. Thank you.

Operator: Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star and one on your telephone keypad. A confirmation tone will indicate your line is in the queue. You may press star and two 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. Ladies and gentlemen, we would wait for a moment while we poll for questions.

John Vandermosten: The first question is from John Van der Mosten. With Zach, please go ahead. And good afternoon, Addy and Eric.

Aditya Mohanty: I'll start out with a question on just the topics of negotiation, with your partnership. You know, I know you can't say too much about it, but is it revolving around market assumptions, pricing, penetration, technical execution, or, you know, I just want to kind of how the talks are going in one of the main areas of focus. Hi, John. Yeah, the discussions are narrowing, so they did start very broad with all the things you're talking about, but they are starting to narrow and we're trying to figure out the best way to work with potentially more than one partner and how that would work. So we're getting there, we'd love to tell you more, but it's kind of difficult. We're really close to the end of it, and so hopefully we'll be able to share fairly soon.

John Vandermosten: Great, exciting times for that.

John Vandermosten: And then I have a couple of technical questions about the results from the VT-600 trial. When we look at the outtake of the drill hug from, you know, the oral versus when it's given through the pill, you know, in one way it's trying, it's getting to the tissue through the vascular, which are in the other way, it's through direct contact with the tissue. And I'm wondering if there's any, you know, if you look at that at all and have anything to say about, you know, the difference in the way it kind of gets to where it needs to go.

Aditya Mohanty: Interesting question, because for us, that is the core of why we believe we can do what they have not been able to do, which is get a lot more tissue where, I mean, drug where it matters. So Zelljans or oral tophysidmin basically gets absorbed just after the stomach in that small GI track, which is where a lot of these oral medications get absorbed. Lots of vasculature, it goes in to the entire blood system, and certainly the blood circulates everywhere, including the colon.

Aditya Mohanty: So it comes in through the blood into the colon and you get to a certain quantity. And all the published data shows what quantities they get to. So we are able to compare because there's enough publications that show, hey, if you had a 10-meg dose and if you had a twice a day, how much do you get in the tissue? And the difficulty there is, if you want to increase that, how do you do that?

Aditya Mohanty: And they've tried. So on archaeol events, I think it was Dr. Fagan who also mentioned that, look, people who did these drug trials also tried 30 megs and got better outcomes response. However, you know, with the toxicity, the adverse events were worse. And so the approved label is 10 twice a day. So 20 megs and not 30. All of these telling you, look through the blood you get to the colon, but in order to get enough, you just cannot dose enough.

Aditya Mohanty: We get past the small intestine into the colon. And when we drop the drug along the colon, one of the concerns was, would you actually have uptake in the tissue? So when it goes through the tissue, again, in the archaeol event, there's actually some really nice how it works. Presentation done by Dr. Sands as well as there's some pictures. So if you look it up, it goes through the tissue, and comes out some of it into the blood.

Aditya Mohanty: And so when we notice first time is about six hours into the dose that you start seeing, drug in the blood, and then it peaks around eight to ten hours. So it's over time getting more and more absorbed in the tissue and coming out of the blood. Being in the blood systemically is not weight. You need just a really small amount, not the high amounts. So we can get large quantities into that tissue that we need to reach without having to get a lot into the blood.

Aditya Mohanty: And that was the beauty of it. So if you look at it, it's, you know, there is some information in clinical trials already that says, you know, more would give you better outcomes. And you can compare with other jack inhibitors also where they keep dosing higher and higher. Responses great is the adverse reactions. They have to stop. So the fact that we can get extremely high tissue exposure with very small systemic exposure is a big deal.

Aditya Mohanty: And we did walk through how we got that information in partly in the carol, partly in the decks, you know, and encourage people to look it up. It's really exciting. We were thrilled with what we saw exactly what we hope for. Great.

John Vandermosten: And that was a good technical description there.

John Vandermosten: And then, you know, kind of all in the same line, when we take the oral, the oral product, it's already approved. The entire amount of drug is processed through the body. But when you're using the mechanical pill, not all of it is really processed. Some of that passes through. Have you done any work to estimate how much of the drug kind of passes through it and doesn't touch upon the body at all?

John Vandermosten: Or is that something that's very difficult to measure? Interesting question. So we do have some of that information. So we collected all these different things and we'll be sharing more information. Majority if it does get absorbed in the colon, some of it in sometimes does come out the other end without getting absorbed. But we did collect that information. We know because we dropped the load at the beginning entry to the colon.

John Vandermosten: And over time, it crosses the entire colon and remember we took biopsies. So we know it went all the way to the end of the colon. The majority if it does get absorbed and the small quantities that come out. And we'll share some more of that data in the coming conferences we mentioned. So we do have that and we'll continue to collect more of that information to see how much of this drug goes into tissue and what if any comes out the other end. Great. All right. We're looking forward to it. Thank you, Eddie. Thank you.

Joseph Pantginis: The next question is from Joe Pankinus. With HC WinRite, please go ahead. Hey everybody. Good afternoon and thanks for taking the question. So two questions. First is a logistics question. And second is a perspective question.

Aditya Mohanty: So on the logistics front, an anticipation of more advanced clinical studies, whether in your hands or in a partner's hands, I was hoping you could discuss your relative current capacity and intermediate needs for device but availability and manufacturing. Yeah. So you were talking about NaviCAP. Yes. So now the cap which is being used in our BT600 for the UC trial, we have some contract manufacturers already that we work with. We have our internal team that has the expertise to build like a handful of these, but we even already work with some contract manufacturers that we could make several hundred and we plan to be able to make several thousand.

Aditya Mohanty: We're ready to do that in the short period of time, but in the meantime we're working on further automation so that when we need them, we'll be able to make plenty of these. So all of that isn't motion for the next short period of time which would be 12 to 18 months. The ability to make a few thousand of these pills exists and we have those vendors and contract manufacturers set up to go.

Aditya Mohanty: So we don't see that as a as a huge thing down the road though. We do need to do a little more work as we have started building the automation required to build to be able to make the hundreds of thousands that we would need to down the road. That's very helpful. Thanks for that.

Aditya Mohanty: And then the perspective question is I was hoping you can provide some information because obviously with biojet, the bioavailability is one of the key attributes of the asset. Now some of the data or a lot of the data that you put out there and you talk about in your press release also as a reminder, you're seeing in the range of 40% bioavailability so I was hoping you could offer up some perspective as to how that really compares to IV formulations of drugs.

Aditya Mohanty: Oh, wow. Yeah. It is it's it's really interesting. So I can I can just look back to this when our head of research sharp was presenting. There were others on that panel. They were, you know, from all lot of large pharma companies. They were all talking about the most commonly used methods of trying to make these available, you know, through permeability and answers through through entire coding, all of those. They end up being sort of single digits of mid single digits.

Aditya Mohanty: And are it's really hard to get that beyond. There are some technologies that have claimed to have higher numbers. But there's nothing that has consistently shown the ability to reach even double digits. So it's it's basically comparing to under 10% for things that potentially could be done reliably. And for us to be able to have a technology, which is what bioget is the platform where we can essentially take your formulation that you currently use in your needle based delivery system and get close to 40%.

Aditya Mohanty: So when you compare to IV, IV being the gold standard sub two injection ranges in, you know, sort of 50 to 60% of IV. And so getting to 40% of IV, it's almost as good as a sub queue injection. We think that's phenomenal and so do our collaborators and the fact that we can do this with such minimal manipulation of whatever formulation you have is another big advantage. Over time, we see this as being applicable to so many places.

Aditya Mohanty: We just got to get get to that that step one and step two, which is coming up really in the near term. So thanks for that question, perspective wise, we're thrilled we keep looking at all these different places for others to show a broadly applicable platform that could do even double digits and it's hard to see. We don't see them. Great. Thanks for the added details. Thank you.

Aditya Mohanty: As there are no further questions, I would now like to hand the conference over to Adif, closing comments.

Aditya Mohanty: Well, I want to thank everyone for joining us. We look forward to keeping you updated as we continue to advance our programs. Good afternoon. Thank you.

Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.