Q4 2023 Biora Therapeutics Inc Earnings Call

Operator: Welcome to the Biora Therapeutics fourth quarter 2023 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 call, please press star zero on your telephone key.

Welcome to the two P. R therapeutics fourth quarter 2023 financial results call.

This time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.

That anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

Chuck Padala: As a reminder, this conference is being recorded. I will now turn the call over to Chuck Padala, Managing Director with Lifesciences. Biora's investor, Thank you, operator. Good afternoon and welcome to the Biora Therapeutics fourth quarter 2023 Corporate Update and Financial Results Conference. Joining me on the call are Aditya Mohanty, Chief Executive Officer, Ariella Kelman, Chief Medical Officer, and Eric Desbarbes, Chief Financial, Before I turn the call over to Mr. Mohanty, I'd like to remind you that today's call will include forward-looking statements within the meaning of the federal securities law, including, but not limited to, the types of statements identified as forward-looking in our quarterly report on Form 10-K that we plan to file in the next few days, and our subsequent reports filed with the SEC, which are available on our website in the Investors, 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.

As a reminder, this conference is being recorded I would now turn the call over to Chuck put all the managing director with lifestyle advisors Yours investor relationship.

Chuck: Thank you operator.

Chuck: Good afternoon, and welcome to the bio Rad Therapeutics fourth quarter 2023, corporate update and financial results Conference call.

Chuck: Joining me on the call our Rd, Bahati, Chief Executive officer, or Yellow Kelvin Chief Medical Officer, and Erik just Barb as Chief Financial Officer.

Chuck: Before I turn the call over to Mr. Mohanty I'd like to remind you that today's call will include forward looking statements within the meaning of the federal Securities law, including but not limited to the types of statements identified as forward looking in our quarterly report on Form 10-K that we plan to file in the next few days and our subsequent reports filed.

Aditya P. Mohanty: With the SEC, which are available on our website in the investors section.

Aditya P. Mohanty: These forward looking statements represent our views only as of the date of this call and involve substantial risks and uncertainties, including many that are beyond our control.

Chuck Padala: Please note that actual results could differ materially from those expressed in the forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, as well as risks related to our business, please see the company's periodic reports filed with the SBA. With that, I will now turn the call over to Aditya Mohanty, CEO of Biora Therapeutics. Thank you, Aditya.

Aditya P. Mohanty: Please note that the actual results could differ materially from those expressed in the forward looking statement.

Aditya P. Mohanty: 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.

Speaker Change: With that I'll now turn the call over to Alibaba D. C E. L F I R therapeutics.

Aditya P. Mohanty: Thanks, Chuck, and thank you, everyone, for joining us. The fourth quarter capped a transformational year for Biora. We made excellent progress with both our platform technologies as we continued our strong execution. The NaviCAP platform continues to hit its milestones. As forecasted, we achieved clearance of our IMD by the FDA, and we initiated our BT600 clinical trial, which we believe to be the first clinical trial in the US for an ingestible drug-device combination. I'm also pleased to see the progress with our Viaget platform. We'll talk more about Viaget a bit later, of course. I'm joined today by our Chief Medical Officer, Ariella, who will share an update on our BT600 clinical trial. Are you out loud?

Speaker Change: Thanks, Jeff and thank you everyone for joining us.

Speaker Change: The fourth quarter capped a transformational year for bio <unk>.

Speaker Change: Made excellent progress in both our platform technologies, and we continued our strong execution.

Speaker Change: Now the Capp platform continues to hit its five stones.

Speaker Change: As forecasted we achieved clearance by the FDA.

Speaker Change: <unk> initiated our P. T 600 clinical trial, which we believe to be the first clinical trial in the U S for an ingestible drug device combination.

Speaker Change: I'm also pleased to see the progress with our larger platform.

Speaker Change: We'll talk more about <unk> a bit later.

Speaker Change: First I'm joined today by our Chief Medical Officer are yellow, who will share an update on our P. T 600 clinical trial.

Yellow: Our yellow.

Ariella Kelman: Thank you, Adi. I'm happy to be here and to speak with you all. Patients with ulcerative colitis, or UC, continue to have significant unmet needs, and research shows that the inability to achieve high enough levels of drug in colon tissue with current treatments is a barrier to better efficacy. Our goals are to improve efficacy by precisely delivering drugs to the colon with our NABICAP device, thereby achieving increased drug concentrations in colon tissue with potentially less systemic toxicity due to lower drug levels in the bloodstream. As you know, we have previously conducted four separate device function studies in humans, confirming that NaviCAP is able to bypass the upper gastrointestinal tract, detect the colon, and precisely deliver payload into the colon. Our ongoing phase one study is the first clinical trial of our NaviCAP device platform in combination with active drugs. We initiated our BT600 clinical trial in January. It is a randomized, double-blind, placebo-controlled, single and multiple ascending dose clinical study. Its objectives are to evaluate the safety and pharmacokinetics and pharmacodynamics, including effects on colon tissue, of BT600 when administered orally to healthy adult volunteers. The study consists of two parts.

Thank you already I'm happy to be here and to speak with you all.

Speaker Change: It sounds like ulcerative colitis or you see.

Yellow: New to have significant unmet needs and research shows that the inability to achieve high enough levels of drug and calling tissue with current treatment is a barrier to better efficacy our goals are to improve efficacy by precisely delivering drug to the column with our magicjack device.

Yellow: Thereby achieving increased drug concentration and colin tissue with potentially less systemic toxicity due to lower drug levels and what street.

Yellow: As you know we previously conducted four separate device function studies.

Yellow: Hum.

Yellow: Confirming that it's able to bypass the upper gastrointestinal track detect colon and precisely deliver payload into the colon.

Yellow: Our ongoing phase one study is the first clinical trial of our <unk> device platform in combination with active drug.

Yellow: We initiated our Beachy 600 clinical trial in January it is a randomized double blind placebo controlled single and multiple ascending dose clinical study.

Yellow: Its objectives are to evaluate the safety and pharmacokinetics and pharmacodynamics include.

Yellow: Including effect phone call in tissue.

Yellow: B G 600, when administered orally in healthy adult volunteers.

Yellow: The study consists of two parts.

Ariella Kelman: The first is a single ascending dose, or SAD, comprised of 24 participants receiving BT600, which is Navicap in combination with a proprietary liquid formulation of tofacitinib at 5mg or 10mg doses or placebo. This portion of the trial has now been completed, and I'm happy to share those results with you today. We intend to present the full data in future publications and scientific forums.

Yellow: The first is a single ascending dose or sad comprised of 24 participants receiving E. G 600, which is now be capped in combination with our proprietary liquid formulation of tofacitinib.

Yellow: Five milligram or 10 milligram doses or placebo.

This portion of the trial has now been completed and I'm happy to share those results with you today.

Yellow: Intend to present, the full data in future publication and scientific forums.

Yellow: Yeah.

Unknown Speaker: We're excited about the single-dose data, and it's consistent with what we expected in terms of pharmacokinetics and safety. BG 600 was well tolerated.

Yellow: We're excited about the single dose data.

Yellow: It's consistent with what we expected in terms of pharmacokinetics and safety.

Yellow: D. G 600 was well tolerated the.

Unknown Speaker: The pharmacokinetic data show that BT600 functioned as intended and designed. Specifically, the devices opened in the colon and released the drug at times that we predicted in human device function and animal studies. All administered devices containing active drug showed corresponding systemic absorption. This indicates that every NaviCAP device released and delivered drugs to every study participant. There is evidence of anatomically targeted delivery in the colon. Measurable tofacitinib in the blood was first observed at approximately six hours, with a maximal concentration at approximately eight hours post ingestion. This is what's intended with NABICAP, and it's different than what is seen with conventional oral topacitinib, where maximal blood concentrations occur at 30 minutes to an hour after an, This suggests that drug delivery and absorption occur in the colon as opposed to the upper gastrointestinal tract. Further, dose-proportional pharmacokinetics were observed, with consistently lower plasma drug concentrations with the 5 mg dose than the 10 mg dose. Tofacitinib plasma levels were approximately three to four times lower than those seen with conventional oral tofacitinib at the same dose.

Yellow: The pharmacokinetic data show that V. G 600 functioned as intended and designed.

Yellow: Physically devices opened in the colon and release drug at times that we predicted and human device function in animal studies.

Yellow: All administered devices containing active drug showed corresponding systemic absorption.

Yellow: It indicates that every natty cap device released and deliberate drug every study participants.

Yellow: There is evidence of anatomically targeted delivery in the colon.

Measurable net in blood was first observed at approximately six hours with maximal concentration at approximately eight hours post ingestion.

Yellow: This is what's intended with natty cap and it's different than what is seen with conventional oral tofacitinib.

Yellow: We're maximum blood concentration occur at 30 minutes to an hour after ingestion.

This suggests that drug delivery and absorption occurred in the colon as opposed to the upper gastrointestinal tract.

Yellow: Further dose proportional pharmacokinetics were observed with consistently lower plasma drug concentration with the five milligram dose than the 10 milligram dose.

Yellow: So as I sit in a plasma levels were approximately three to four times lower than are seen with conventional oral tofacitinib at the same doses confirming results from previous animal studies with B T 600.

Ariella Kelman: Confirming Results from Previous Animal Studies with BTC. The pattern of plasma levels over time suggests passage of the drug through the colonic tissue into systemic circulation, indicating that we might expect to see elevated colon tissue levels. These data are what we hope, with more drugs being delivered to the colon and a reduced amount in the blood. We are also pleased with the performance of the device, with what appears to be all devices functioning as expected and adding to the growing body of data on NaviCAP device performance. This is single-dose data, and we look forward to confirming and expanding on these findings with the multiple-dose portion of the study. The Multiple Ascending Dose, or MADD, cohort is comprised of 24 participants receiving BT600 at 5mg and 10mg doses of topacitinib or placebo, with once daily dosing for 7 days. This is half of the daily dose for conventional topacitinib, which is normally dosed twice daily.

Yellow: The pattern of plasma levels overtime suggest passage of drugs through the colonic tissue into systemic circulation, indicating that we might expect to see elevated colon tissue level.

Yellow: These data are what we hope to see with more drugs being deliberate in the colon and a reduced amount in the blood.

Yellow: We are also pleased with the performance of the device with what appears to be all devices functioning as expected and adding to the growing body of data on navvy cap device performance.

Yellow: It's a single dose data and we look forward to confirming and expanding on these findings with the multiple dose portion of the study and.

Yellow: The multiple ascending dose or Mad cohort is comprised of 24 participants receiving between 605 milligram and 10 milligram doses of Tofacitinib or placebo with once daily dosing for seven days. This is part of the daily dose for conventional type.

Yellow: I sit in it which is normally dosed twice daily.

Ariella Kelman: In addition to regular blood samples, we will also be obtaining colon tissue biopsies at the end of the study. Dosing for the MAD portion of the study is currently underway, and I can confirm things are progressing well, and we're pleased with the execution of the study so far. We anticipate having final study data, which includes both the SAD and MAD portions, including data on effects in colon tissue toward the end of the second quarter. Audi At this time, I'll turn it back over to you.

Yellow: In addition to regular blood samples, we will also be obtaining colon tissue biopsies at the end of the study.

Yellow: The thing for the Mad portion of the study is currently underway and I can confirm things are progressing well and we're pleased with the execution of the study so far.

Yellow: We anticipate having final study data, which includes both the sad and mad portion, including data on effects in colon tissue toward the end of the second quarter.

Yellow: Audi at this time I'll turn it back over to you.

Aditya P. Mohanty: Thanks, Ariella. The data we're seeing so far is truly outstanding, which isn't a surprise to us but is very gratifying as we work to prove the NaviCAP platform's potential to create a new treatment paradigm for IBD. As Ariella mentioned, our NaviCAP technology can potentially increase tissue concentration while reducing systemic exposure, which is what we're aiming to demonstrate at the conclusion of the current trial. We believe this will lead to better outcomes for patients suffering from ulcerative colitis. So far, our clinical trial has demonstrated that the NaviCAP device has functioned as intended by delivering drug precisely into the colon, illustrating the potential for our platform beyond the current Tocosidnip payload delivery. The data suggest the potential to achieve greater concentrations of drug in the colon tissue compared with conventional methods. We believe this will lead to improved patient outcomes. We also saw that the blood concentration of tocacidinib absorbed through the colon was substantially lower than with conventional treatment.

Audi: Thanks, our yellow.

Audi: The data we're seeing so far are truly outstanding which isn't a surprise to us, but it's very gratifying as we work to prove the navigator platforms potential to create a new treatment paradigm for IBD.

Audi: As already mentioned, our navigate technology can potentially increase tissue concentration, while reducing systemic exposure, which is what we're aiming to demonstrate at the conclusion of the current trial.

Audi: We believe this will lead to better outcomes for patients suffering from ulcerative colitis.

Audi: So far all.

Audi: All clinical trials has demonstrated that the navi cab devices functioned as intended by delivering drug precisely in the colon.

Audi: Illustrating the potential for our platform beyond the current tofacitinib payload delivery.

Audi: The data suggest the potential to achieve greater concentration of drug in the colon tissue compared with conventional methods.

Audi: We believe this will lead to improved patient outcomes.

Audi: You saw that blood concentration of tofacitinib absorbed through the colon, but substantially lower than the conventional treatment.

Aditya P. Mohanty: This could reduce toxicity for patients and open the door to combination therapy in use. In addition to the anticipated conclusion of our clinical trial, we're also looking ahead and actively planning a study in UC patients during the second half of 2024. The purpose of this study is to confirm plasma and tissue pharmacokinetics and pharmacodynamics in UC patients and to inform our plans for future trials.

Audi: This could reduce toxicity for patients and open the door to combination therapy in UC.

Audi: In addition to the anticipated conclusion of our clinical trial. We're also looking ahead and actively planning a study in UC patients during the second half of 2024.

Audi: The purpose of this study is to confirm plasma and tissue pharmacokinetics and pharmacodynamics in UC patients.

Audi: And to inform our plans for future trials.

Aditya P. Mohanty: Although KOLs have confirmed that healthy volunteer data on blood and tissue are fairly representative of that in UC patients, we want to proceed to trials in UC patients quickly and maintain an accelerated pace of development. Meanwhile, while we're focused on clinical execution for NaviCAP and the BT600 program, our team also continues to increase the strength of our intellectual property portfolio for both our platforms. We believe we hold the most comprehensive IP portfolio for drug delivery using ingestible devices, with over 100 granted patents and over 100 pending applications across our two platforms. Recent wins include a patent addressing anatomically targeted delivery of JAK inhibitors to the GI tract. This patent directly supports our BT600 program, which involves delivery of a proprietary formulation of tofacitinib, a JAK inhibitor. We also received notice of an important new patent for a Biojet platform, which broadly covers key jet parameters for liquid jet delivery of a drug to the GI tract.

Audi: Although kols have confirmed that healthy volunteer data on blood and tissue are fairly representative to that and you see patients. We want to proceed to trial, then UC patients quickly and maintain an accelerated pace of development.

Speaker Change: Well, we're focused on clinical execution for Navy cap and the B T 600 program.

Speaker Change: I'm also continues to increase the strength of our intellectual property portfolio for both of our platforms.

Speaker Change: We believe we hold the most comprehensive IP portfolio for drug delivery using ingestible devices.

Speaker Change: With over hundred granted patents and over hundred pending applications across our two platforms.

Recent wins included a patent addressing anatomically targeted delivery of JAK inhibitors to the Gi tract.

Speaker Change: This is probably directly supports our BT 600 program, which involves delivery of a proprietary formulation of Tofacitinib a JAK inhibitor.

Speaker Change: We also received notice of an important new patent for our bio jet platform, which broadly covers key jet parameters for liquid jet delivery of a drug to the Gi tract.

Aditya P. Mohanty: Between this and our existing IP portfolio for the BioJet platform, I think we can say that we invented and we own liquid jet delivery to the GI tract. We continue to make excellent progress with the BioJet platform. Liquid jet delivery is the foundation of this platform. It's designed to achieve oral delivery of large molecules using a small capsule that, once swallowed, delivers a stream of liquid drug into the wall of the small intestine, where it can be absorbed into systemic circulation. We believe the BioJet platform can provide an alternative to needle-based delivery of complex molecules. It could also enable those molecules to more efficiently reach the liver, which is difficult with other oral delivery methods.

Speaker Change: Between this and our existing IP portfolio for the Baidu platform.

Speaker Change: We can say that we.

Speaker Change: We invented and we own liquid jet delivery to the Gi tract.

Speaker Change: We continue to make excellent progress with the Biogen platform liquid jet deliveries the foundation of this platform.

Speaker Change: It's designed to achieve all of them agree with large molecules using a small capsule that one swallowed. The look is a stream of liquid drug into the wall of the small at this time, what can be absorbed into systemic circulation.

We believe the Biogen platform can provide an alternative to needle based delivery of complex molecules.

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

Unknown Speaker: Over the past few quarters, we've made strong progress in assessing both our own as well as collaborative molecules with the Biogen device. We have optimized benchtop systems that enable rapid iteration with our animal studies, enabling faster assessment of molecules and formulations, which has made us more efficient in our development. We successfully performed animal studies with peptides, antibodies, and oligonucleotides and achieved bioavailability in excess of 20% compared to IV infusion with our first generation device.

Speaker Change: Over the past few quarters, we've made strong progress in assessing both our own as well as collaborating molecules with the Biogen device.

Speaker Change: We have optimized bench top systems that enable rapid iteration without animal studies, enabling faster assessment of molecules and formulations, which has made us more efficient in our development.

Speaker Change: We successfully performed animal studies with peptides antibodies and oligonucleotides and achieved by availability in excess of 20% compared to IV infusion with a first generation device.

Unknown Speaker: As a reminder, the performance target that is considered commercially viable by us and our pharma collaborators is around 15% compared to IV. In December, we announced a new research collaboration with a large pharmaceutical company. We recently completed animal studies with their molecule, and we expect to receive the data from that study in the coming weeks.

Speaker Change: As a reminder, the performance target that is considered commercially viable by us and our pharma collaborators is around 15% compared to I D.

Speaker Change: In December we announced a new research collaboration with a large pharmaceutical company. We recently completed animal studies with that molecule and we expect to receive the data from that study in the coming weeks.

Unknown Speaker: While we execute on collaborative molecules, we also continue to enhance our core biojet platform. We have completed further animal studies over the past few months that demonstrate even better bioavailability in the 30 to 40% range for a peptide candidate semaglutide, as well as with adenlymumab or antibody candidates. We will be sharing more details of the data at an upcoming conference in June. We believe we're in an excellent position with the badge of technology, which has a number of competitive advantages, such as its ability to achieve category-leading bioavailability of complex molecules.

Speaker Change: While we execute on collaborative molecules. We also continue to enhance our core budget platform.

Speaker Change: We have completed further animal studies over the past few months that demonstrate even better bioavailability in the 30% to 40% range for our peptide candidates I'm, a gluten hard as well as with I believe me mab or antibody candidates.

Speaker Change: We'll be sharing more details of the data at an upcoming conference in June.

Speaker Change: We believe we're in excellent position with the budget technology, which has a number of competitive advantages.

Speaker Change: Its ability to achieve category, leading bio availability of complex molecules.

Aditya P. Mohanty: Its ability to deliver existing liquid formulations without complex reformulation. Its ability to deliver large payloads in the multi milligram range, and its potential to enable liver-targeted delivery of large molecules. With the broad applicability of this technology, we continue to see interest from potential pharma partners. Our goal in the near term remains to get a more enhanced partnership this year with either our current collaborators or others. We're making good progress on that front and continue to see even more interest from potential partner companies. To summarize our anticipated progress, for our NAVICAP platform, we await the conclusion of our VT600 clinical trial in the US, and we expect the execution of the MAD portion to be completed during Q2. We anticipate receiving final SADMAD data during Q2, and we plan to share top-line data from the study as quickly as possible.

Speaker Change: Its ability to deliver existing liquid formulation without complex formulation.

Speaker Change: Its ability to deliver large payloads in the multi milligram range.

Speaker Change: And its potential to enable liver targeted delivery of large molecules.

Speaker Change: But the broad applicability of this technology, we continue to see interest from potential pharma partners.

Speaker Change: Our goal in the near term remains to get a more enhanced partnership this year with either our current collaborators or others.

Speaker Change: We're making good progress on that front and continue to see even more interest from potential partner companies.

Speaker Change: To summarize our anticipated milestones.

Speaker Change: For our Medicare platform, we await the conclusion of our BT 600 clinical trials in the U S and we expect the execution of the Mad portion to be completed during Q2.

Speaker Change: We anticipate receiving final sad Mad data during Q2, and we plan to share top line data from this study as quickly as possible.

Speaker Change: Yeah.

Eric Desbarbes: We also plan to initiate a clinical study in UC patients during the second half of 2024. For our BioJet platform, we anticipate data from the recent animal study with our large Pharma III collaborator during Q2, and we expect to share an update on some of our recent animal studies at an upcoming conference. We continue to progress toward our goal of an enhanced partnership 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: We also plan to initiate a clinical study in UC patients during the second half of 'twenty 'twenty four.

Speaker Change: For our budget platform, we anticipate data from the recent animal study with our large pharma three collaborator during Q2, and we expect to share an update on some of our recent animal studies at an upcoming conference.

Speaker Change: We continue to progress toward our goal of an enhanced partnership in 2024.

Speaker Change: With that I'll now turn the call over to Eric.

Eric: Review of our financial results and capital market activities.

Eric: Thanks, Eddie and good afternoon, everyone.

Eric Desbarbes: We have had a number of important capital market activities since our last call. I'll first cover our financial results and then provide more background on the positive evolution of our balance. Operating expenses during the fourth quarter were $13.3 million, which was more aligned with our normal expected run rate compared to the prior quarter when we had a one-time stock-based compensation non-cash charge related to the vesting of employees' restricted stock units. Excluding stock-based compensation expenses, operating expenses were $11.8 million during the fourth quarter, with continued investment in device development, preclinical, and clinical activities. To break this down further, G&A expenses in the fourth quarter were $6.3 million, excluding stock-based compensation expenses, while R&D expenses in the fourth quarter were $5.5 million, also excluding stock-based compensation expenses. Our core OPEX spend remains focused on our R&D programs, execution of our clinical development with NaviCAP, and preclinical work on BioJet with our PharmacoloBrain. Our net loss was $15.4 million for the three months ended December 31, 2023.

Eric: We had a number of important capital market activities since our last call.

Eric: I'll first cover our financial results and then provide a more background on the positive evolution of our balance sheet.

Eric: Operating expenses during the fourth quarter was $13 $3 million, which was more aligned with our normal expected run rate compared to the prior quarter. When we had a onetime stock based compensation noncash charge related to vesting of employee restricted stock units.

Eric: Excluding stock based compensation expenses operating expenses were $11 $8 million during the fourth quarter with continued investment in device development preclinical and clinical activities.

Eric: To break this down further G&A.

G&A expenses in the fourth quarter were $6 $3 million, excluding stock based compensation expenses, while R&D expenses in the fourth quarter were $5 $5 million also excluding stock based compensation expenses.

Eric: Our core Opex spend remains focused on our R&D programs execution of our clinical development with Navy cap and preclinical work on bio jet with our pharma collaborators.

Eric: Net loss was $15 4 million for the three months ended December 31, 2023 also more in line with our expected run rate compared to the third quarter, which included noncash charges for stock based compensation expense and large noncash charges attributable to the convertible note exchange we implemented in September 'twenty two.

Eric Desbarbes: Also, more in line with our expected runway compared to the third quarter, which included non-cash charges for stock-based compensation expense and large non-cash charges attributable to the convertible note exchange we implemented in September 2023. We also made substantial progress during the fourth quarter in our ongoing efforts to eliminate activities and spend associated with legacy matters, which still represented more than 30% of our G&A cash spent in Q4. Those efforts culminated recently with the monetization of our investment in Enumero Molecular, generating $3 million in non-dilutive capital. We also reached an agreement in principle to resolve one of the company's legacy securities litigation matters, and we are confident about the potential of any remaining legacy issues having a minimal impact on Biora going forward.

Eric: Three.

Eric: We also made substantial progress during the fourth quarter and our ongoing efforts to eliminate activities and spend associated with legacy matters, which still represented more than 30% of our G&A cash spend in Q4.

Eric: Those efforts culminated recently with the monetization of our investment in in Humira molecule are generating $3 million in non dilutive capital.

Eric: We also reached an agreement in principle to resolve one of the company's legacy Securities litigation matters, and we are confident about the potential of any remaining legacy issues I think minimal impact on buyer going forward.

Eric Desbarbes: Moving on to the capital structure. As a reminder, we took a substantial step forward during the third quarter by reducing the unconvertible note balance by $50 million through a note exchange agreement. I provided guidance during our last call that we were making progress in further reducing our remaining notes balance. We executed well on this front, and we're very happy to announce in December a convertible note exchange which also brought $17 million in new capital to Biora. In total, we reduced outstanding notes by more than $80 million in 2023, a 75% reduction of the company's net debt in 2023 alone. In accordance with GAAP, we will be reflecting in our balance sheet other items beyond the actual outstanding balance of the notes, including derivative and warrant liabilities, and future interest payables.

Eric: Moving onto our capital structure.

Eric: As a reminder, we had made substantial a substantial step forward during the third quarter by reducing on convertible note balance by $50 million through note exchange Arena.

Eric: <unk> provided guidance during our last call that we were making progress in further reducing all remaining notes balance we executed well on this front and we're very happy to announce in December the convertible note exchange, which also brought $17 million in new capital to Barbara.

Eric: In total we reduced outstanding notes by more than $80 million in 2020, 3% to 75% reduction of the company's net debt in 2023 alone.

Eric: In accordance with GAAP, we will be reflecting in our balance sheet other items beyond the actual outstanding balance of the notes, including derivative and warrant liabilities and future interest payables. So we invite investors to read notes six and seven so our financials when we file our 10-K to highlight the actual reduced notes principal back.

Eric Desbarbes: So we invite investors to read notes 6 and 7 to our financials when we file our 10-K to highlight the actual reduced notes principal balance at the end of 2023, which went down from $132 million to approximately $51 million during that period. The substantial reduction in notes outstanding and new capital investment from large institutional investors demonstrates continued support for our program. In fact, we announced earlier in March a third node exchange combined with new capital investment, bringing total new institutional investment in Tuvara through these exchanges to $19.8 million over the last four months.

Eric: And so at the end of 2020, three which went down from $132 million to approximately 51 million during that period.

Eric: The substantial reduction in notes outstanding and new capital investment from large institutional investors demonstrates continued support for our programs.

In fact, we announced earlier in March a third note exchange combined with new capital investment.

Eric: Bringing total new institutional investment in tomorrow through these exchanges to $19 $8 million over the last four months.

Aditya P. Mohanty: We truly appreciate this commitment from our investors, and we want to highlight the significant equity component of these transactions, which shows their acute focus on the potential value of our stock. We believe this series of transactions sets us up nicely for success ahead of important clinical data and the development of future potential partnerships with pharma. With that, I will now turn the call back over to Adi. Thanks, Eric.

Eric: We truly appreciate this commitment from our investors and we want to highlight the significant equity component of these transactions, which chose their acute focus on the potential value of our stock.

Eric: We believe this series of transactions sets us up nicely for success ahead of important clinical data and the development of future potential partnerships with pharma.

Eric: With that I will now turn the call back over to Eddie.

Eddie: Thanks, Eric.

Aditya P. Mohanty: We're excited to start the year with great early data from our BT600 trial and are focused on continuing strong clinical execution to complete this trial. The BioJet platform will focus on progressing towards partnerships this year. We look forward to providing further updates as we continue to achieve our goals. Operator, we're now ready for.

Eddie: We're excited to start the year with a great early data from our <unk> 600 trial and are focused on continuing our strong clinical execution to complete this trial.

Eddie: From the Biogen platform will focus on progressing towards partnerships this year.

Eddie: We look forward to providing further updates as we continue to achieve our milestones.

Eddie: Operator.

Speaker Change: We're now ready for questions.

Speaker Change: Okay.

Operator: Thank you. Now, we can open any questions and answers. If you'd like to ask a question, please press star one on your telephone keypad. The confirmation time will indicate your line is in the question queue.

Speaker Change: Thank you well now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question Kim.

John D. Vandermosten: You may you may press star two if you would like to remove your question. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we poll for questions. Thank you. Our first question is from John Vandermosten with SACS. Please proceed with your question. Great. Thank you, and good afternoon, everyone. I wanted to first say congratulations on the huge reduction in debt. That's a great change.

Speaker Change: You May press Star 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 Q1 moment. Please while we poll for questions.

Speaker Change: Thank you. Our first question is from John Zandra, Boston with <unk>. Please proceed with your question.

John Zandra: Great. Thank you and good afternoon, everyone wanted to first say congratulations for the huge reduction in debt. That's that's a great change and wanted to pose the first question about just the next steps for the for <unk> 600.

Unknown Speaker: And I wanted to pose the first question about just the next steps for BT600. Now that you've shown good PK and PD numbers and understanding that the underlying drug tofacitinib is already approved, what do you expect to see to get this in front of the FDA for approval following the second half study in the UC patients? Thanks for the question, John. Before we get to what we want to put in front of the FDA, what we should say is we're really excited about what's coming up in the very, very near future that we talked about in this coming second quarter. So I'll let Ariella talk to you a little bit about the math portion of our data, and then we'll come back to what's next. Go ahead, Arianna.

John Zandra: Now that you've shown good PK and in a P D a.

John Zandra: Numbers and you know understanding the theater lying drug Tofacitinib has already approved what kind of what do you expect to see you know to get this in front of the FDA for approval.

John Zandra: Following the following that the second half a study and in the U C patients.

John Zandra: Yes.

Speaker Change: Well thanks for the question John.

Speaker Change: Before we get to what we want to put in front of the FDA. What we should say is we're really excited about what's coming up.

Speaker Change: Very very near future that we talked about in this coming second quarter. So I'll. Let are you allowed to talk to you a little bit about that.

Speaker Change: <unk> portion of our data and then we'll come back to what's next go.

Speaker Change: Go ahead, okay. Thanks, very much already and so we're looking forward to the results from the <unk> portion of the Phase one study and we expect to have those by the early summer. So end of Q2 and what we expect to see there is again pharmacokinetic data, but this time.

Ariella Kelman: Okay, thanks very much, Adi. So we're looking forward to the results from the MAD portion of the Phase I study, and we expect to have those by the early summer, so end of Q2. And what we expect to see there is, again, pharmacokinetic data, but this time over a multi-dose course, so daily dosing for one week. And we hope to confirm a same or similar pharmacokinetic profile, which confirms that NaviCAP is functioning as designed and delivering the medicine to the colon. And we also are expecting to receive data on colon tissue, including colon tissue concentration from biopsies, as well as histology data for safety and pharmacodynamic data from the colon tissue. So we're looking forward to that. Thanks, Ariel.

Speaker Change: On over a multi dose course, so daily dosing for one week and we hope to kind of.

Speaker Change: On a same or similar pharmacokinetic profile, which confirms that the now the cap is functioning as designed and delivering in the colon.

Speaker Change: And we also are expecting to receive data on colon tissue, including a colon tissue concentration from biopsies as well as histology data for safety and Pharmacodynamic data from the Collins. This year. So what we're looking forward.

Speaker Change: Tibet.

Aditya P. Mohanty: So John, I think, you know, once we get this, we will know a lot more. Of course, we're keen to move this as fast as possible. But it's really great to get the data we do have now, right? I mean, this is what we've been looking for. Can you get more drug in the colon and less in the blood?

Tibet: Thanks, John.

Speaker Change: John I think you know once we get this we will know a lot more of course, we are keen to move this as fast as possible, but it's really great to get the data. We do have now right. I mean this is what we've been looking at.

Speaker Change: Can you get.

Speaker Change: More drug into the colon and lessen the blood. So it's fantastic we're getting that people know Coca said that you know it's been used so many patients. It works. So yes, we have approaches where you got to look at but let's look at this data that's coming up now.

Unknown Speaker: So it's fantastic. We're getting that people know tofacitinib, you know, it's been used by so many patients at work. So yes, we have approaches we're going to look at. But let's look at this data that's coming up now. I also wanted to look at the larger environment of getting biologics or larger molecule drugs delivered orally.

Speaker Change: It sounds good and.

You know I just wanted to to to look at just the the larger environment of getting biologics or large molecule drugs delivered orally you know we've done some research on our side, it's showing about 300 or $400 billion in revenues from biologics and then of course, there's the 100 billion number that I think Goldman put out there about the potential for G. O P. One agonist, so theres a lot.

Unknown Speaker: We've done some research on our side showing about $300-400 billion in revenues from biologics, and then, of course, there's the $100 billion number that I think Goldman put out there about the potential for GLP-1 agonists. So there are a lot of products that could potentially be used this way, and there are a lot of benefits to that, which we all know about. What is keeping sponsors back from really jumping on board with this and moving it forward as fast as possible? What do they want to see before executing, I guess, something that has money behind it?

There's a lot of our products that could potentially be used this way and you know.

Speaker Change: There's a lot of benefits of that which we all know about.

Speaker Change: What is keeping sponsors back from you know really jumping on board with this and moving it forward as fast as possible what do they want to see before executing I guess, you know something that has money behind it.

Unknown Speaker: Unknown Speaker. So you're talking about our BioJet platform, which is absolutely designed to be able to deliver these biologics. So I wouldn't say. Our difficulty has been that we are already engaged with several large pharma companies. I can't tell you a lot of details. I've talked about this in the past because they want to stay quiet until they get to a certain point where they're willing to share what the discussions end up resulting in.

Speaker Change: So you were talking about our bio jet platforms, which absolutely is designed to be able to deliver these biologics so I wouldn't say.

Speaker Change: It's it's the our difficulty has been we are already engaged with several large pharma companies.

Speaker Change: I'll tell you a lot of details Ive talked about this in the past because they wanted to stay quiet.

Until they get to a certain.

Speaker Change: What they are willing to share what our discussions are end up resulting in so we are absolutely fully engaged in several conversations.

Unknown Speaker: So we are absolutely fully engaged in several conversations. Partnerships are hard to predict in terms of timing, but we feel pretty good about the way these engagements and conversations have gone, so we could likely do something this year. So we keep saying, yeah, this year we're gonna get into a partnership with somebody. And I know that that's kind of hard to say, because we don't publish the relationship and what they're looking for, and we're not allowed to, but what we can say is the engagement is great, we're fully involved, we're doing a lot of work, it's progressing, and hopefully we'll be able to share more fairly soon.

Speaker Change: Thank you.

Speaker Change: Yeah.

Speaker Change: Partnerships are hard to predict in terms of timing.

But we feel pretty good about the way these engagements and conversations have gone that we could likely do something this year. So we keep saying yeah. This year, we're going to get to a partnership with somebody.

Speaker Change: And I know that that's kind of hard to say.

Speaker Change: Because we don't publish.

Speaker Change: The relationship and what Theyre looking for and we're not allowed to but what we can say is the engagements grade fully involved we're doing a lot of work it's progressing.

Speaker Change: And hopefully we'll be able to share more fairly soon.

Unknown Speaker: Great. Great. All right. Thank you, Aditya. I appreciate it.

Speaker Change: Great Great Alright, Thank you Andy I appreciate it.

Operator: As a reminder, if you'd like to ask a question, please press star 1 on your telephone. Our next question is from Julian Harrison with BTIG. Please proceed with your question. Good afternoon, this is Rayyan speaking for Julian. Congratulations on the progress in data so far, and thank you for taking our questions. We had a couple on BP-600. The first question is, if adequate PK is confirmed in this final FADMAD data, expect it in two, would you be open to studying or developing any other payloads for IBD where optimized TK in the gut could lead to more efficacy? A fantastic question.

Speaker Change: Although reminder, if you'd like to ask a question. Please press star one on your telephone keypad.

Speaker Change: Our next question is from Julian Harrison with <unk>. Please proceed with your question.

Speaker Change: Good afternoon. This is ray on for Julien Congrats on the progress on the data so far and thank you for taking our questions. We had a couple on <unk> 600 <unk>.

Ray: If adequate PK as confirmed in this final sad Mad data export it into Q&A would you be open to studying or developing any other payloads for IBD, where optimized PK and the guy could lead to more efficacy.

Speaker Change: Fantastic question. So you do know or maybe you don't that we keep talking about.

Unknown Speaker: So you do know, or maybe you don't, that we keep talking about; we have our own version of Adlimumab, and we've done some work with it. Certainly, we know that there are certain other molecules we could use this approach with, and we could quickly turn to that. Now, we don't want to jump ahead. We do have internal know-how, the availability of the molecule, and the ability to expand fairly quickly, but we're not going to jump.

Speaker Change: We have our own version of a lemur, Matt we've done some work with it.

Speaker Change: Certainly we know that there are certain other molecules, we could use this approach with.

Speaker Change: And we could quickly turned to that now we don't want to jump ahead, we do have internal knowhow availability of molecule and <unk>.

Speaker Change: Ability to expand fairly quickly, but we're not going to jump, where you're going to get this data and have the ability to do all those things either by ourselves or with somebody so yes opportunities will start to really grow very quickly.

Unknown Speaker: We're going to get this data and have the ability to do all those things, either by ourselves or with somebody. So yes, opportunities will start to really grow very quickly in the next few months as we get this data. Great, thanks.

Speaker Change: In the next few months as we get this data.

Speaker Change: Great. Thanks, we had another one on potential use I know you touched on potential using combination therapies earlier, but could you elaborate on potential potential positioning in the current UC landscape, Kevin BT 600, preliminary safety profile and how this might influence the target population.

Unknown Speaker: We had another one on potential use. I know you touched on potential use in combination therapies earlier, but could you elaborate on potential positioning in the current UC landscape given... Okay, so it's a little tougher to talk about the... Unknown Speaker.

Kevin: For enrollment in a future phase one P.

Speaker Change: Okay. So it's a little tougher to talk about the.

Unknown Speaker: .. Combination Therapy Landscape. There are, as you know, some trials already happening where people are starting to try multiple molecules in this patient population because Here's the core issue, right? You know, like, almost all of these drugs end up working for 20 or 25% of the population, and the remainder, like two-thirds, don't have anything.

Speaker Change: <unk> combination therapy landscape. There are as you know some trials are already happening where people are starting to try.

Speaker Change: Multiple molecules in these in this patient population because.

Speaker Change: Here's the core issue right you know like almost all of these drugs they end up.

Speaker Change:

Speaker Change: Working for 20 or 25% of the population and the remainder like two thirds don't have anything.

Unknown Speaker: And so people are trying these combinations. The biggest issue often holding people back is toxicity, and toxicity with each individual drug. And then when you compound it with multiple drugs, so clearly having a potentially lower toxic or toxicity or low level provides the opportunity to try multiple things along with BT600. So we have had some preliminary conversations, but it's a bit early to start telling you exactly what kind of combinations we could use. We do see the potential for BT600 to move much sooner than where tofacitinib is currently in terms of where it's used in second, third line therapy.

Speaker Change: And so people are trying these combinations.

Speaker Change: The biggest issue often holding people back is toxicity and toxicity with each individual drug and then when you compound it with multiple drugs, so clearly having a potentially door toxic.

Speaker Change: Our toxicity or low level <unk>.

Speaker Change: Provides the opportunity to try multiple things along with BT 600, So we have had some preliminary.

Speaker Change: Conversations, but its a bit early to start telling you exactly what kind of combinations. We can use we.

Speaker Change: We do see the potential for <unk> 600 to move.

Speaker Change: Much sooner than we're currently Tofacitinib is in terms of where it is used in second third line therapy.

Unknown Speaker: And so the opportunity is going to be much larger as we go forward. We will know more. It's a little early to tell you that.

Speaker Change: And so the opportunity is going to be much larger as we go forward. We will know more it's a little early to tell you that in terms of being acting the selection of the patients I'll, let our L. I'll tell you a little bit about our current thinking of potentially what kind of patients we're thinking about with phase one b.

Ariella Kelman: In terms of affecting the selection of the patients, I'll let Ariella tell you a little bit about our current thinking about potentially what kind of patients we're thinking about with Phase 1B, but that'll evolve as we learn more from our MAD. Okay, thanks. Yeah, thanks very much, Adi. So we are planning a study in UC patients during the second half of 2024. And we should be able to provide more details in the coming months. But, you know, considering our goals for BT600, which are higher colon tissue concentrations, which we know from data across multiple treatments can lead to greater inhibition of the JAK-STAT pathway at the site of disease and are associated with better efficacy in patients with UC, we think that the first population that should be studied are patients with moderate to severe ulcerative colitis.

Speaker Change: But that will evolve as we learn more from our mad.

Got it okay. Thanks, Matt Yeah, Thanks, very much I D.

Speaker Change: We're planning a study in UC patients during the second half of 2024, and we should be able to provide more details in the coming months, but.

Considering our goals for <unk>, 600, which are higher calling tissue concentrations, which we know from data across multiple treatments can lead to greater inhibition of the JAK stat pathway at the site of disease and are associated with better efficacy in patients with UC.

Speaker Change: I think that the first population that should be studied our patients with moderate to severe ulcerative colitis and that's what we're targeting for for Chile.

Unknown Speaker: And that's what we're targeting for a UC trial. Got it. Thank you. Very helpful. Thank you. There are no further questions at this time. I'd like to hand the call back over to Aditya Mohanty for any closing comments.

Speaker Change: Got it thank you very helpful.

Speaker Change: Thank you there are no further questions at this time I'd like to hand, the call back over to Ari Mohan <unk> for any closing comments.

Aditya P. Mohanty: Thank you all for joining us. We're really excited about our progress and look forward to coming back and keeping everybody updated. Thank you. Thank you all once again for joining us for the fourth quarter 2023 financial results. We are excited about the progress. Have a good evening, everyone. This completes our.

Aditya P. Mohanty: Thank you all for joining us.

Aditya P. Mohanty: Really excited with our progress and look forward to coming back and keeping everybody updated thank you.

Aditya P. Mohanty: Thank you all once again for joining us for the fourth quarter 2023 financial results call. We are excited about the progress.

Have a good evening everyone. This complete careful.