Biora Therapeutics, Inc.

Welcome to the Biolab Therapeutics first 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 conference, please press star then zero on your telephone keypad. As a reminder, this conference is being recorded. I will now turn the call over to Christy Grabowski. Director of IR Communications with LifeSci Advisors, Biora's investor relations firm. Thank you. Please go ahead.

Thank you, Operator. Good afternoon and welcome to the Biora Therapeutics First Quarter 2023 Corporate Update and Financial Results Conference Call. Joining me on the call are Adi Mohanty, Chief Executive Officer, and Eric Despartes, 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 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 the actual results could differ materially from those projected in any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, as well as risks related to our business, please see the company's periodic reports filed with the SEC. With that, I will now turn the call over to Adi Mohanty, CEO of BioAura Therapeutics. Adi?

Thanks, Christy, and thank you, everyone, for joining us. Since our last call six weeks ago, we have continued executing on development plans for our NaviCAP targeted delivery platform, completing much of the data analysis from this talk study in our BT600 program with results that are encouraging. With our BioJet systemic delivery program, we made excellent progress with device development and began preclinical studies using an autonomous version of our next generation BioJet device. Based on the top line bioavailability results we shared in March that were more than double our target levels, we progressed rapidly to preclinical testing with one of our pharma collaborators. We're also planning to present detailed bioavailability results from our Biojet platform at an upcoming medical conference. Finally, we strengthened our clinical team with the addition of Dr. Ariella Kelman as chief medical officer, which is good timing as we prepare to enter the clinic this year. Moving on to the program updates, first, I'll cover our NaviCAP targeted therapeutics platform with our lead program BT600 in ulcerative colitis. Currently available therapeutics for ulcerative colitis, or UC, work by entering the bloodstream and being circulated systemically throughout the body with a limited amount of drug reaching the site of disease in the colon. Our solution is based on the NaviCAP platform, which uses an orally ingestible device about the size of a fish oil pill that is designed to deliver drug directly to the colon using our GI tract localization technology. Our lead program, BT600, is our proprietary liquid formulation of tofacidinib delivered via the NaviCamp device. A commercially available version of tofacidinib is approved for the treatment of UC. Today, tofacidinib is administered orally. And like other orally delivered drugs, it is taken up systemically with a limited amount reaching the area of disease in the colon. By delivering drug where it is needed at the site of disease, BT600 has the potential to deliver sufficient drug to the tissue of the targeted area to improve efficacy and also reduce systemic exposure which may improve safety. Although global sales for UC drugs are approximately $7 billion per year and growing, We know UC patients are still suffering tremendously with a large unmet need. We believe we can potentially solve one of the primary treatment gaps, which is the inability to achieve high enough drug levels in the diseased tissue without systemic toxicity. That's why we're excited about the results that we're seeing from the toxicology study for BT600. At the time of our last call in March, we had recently completed execution of our toxicology study for BT 600 during which we administered over 600 drug device combinations in canines. Since then, we have received a majority of the data and the results continue to look good. All planned devices were administered and we observed no adverse events or safety signals. Of particular note, There were no safety findings on histopathology of the colon or on blood safety and chemistry tests, including liver function tests, even at the highest 25 milligram dose of tofacitinib. With the NAVICAP platform, our goal is to achieve high drug concentrations in the colon tissue, and we want to see these levels going down between doses and not accumulating. When we look at drug levels in the blood, we want to see some drug in the blood, but at low levels because it is believed that reducing systemic exposure can improve safety. In our previous seven-day canine study, we measured tissue drug levels at six and 12 hours after administration of the last dose and saw tissue concentrations exceeding IC90, which is what we want to see. In this talk study, we measured drug levels in tissue 24 hours after administration of the last dose and saw drug in colon tissues with levels suggesting that the drug does not accumulate over time, which is another favorable sign of safety. Taken in the aggregate, we believe these studies support the ability of BT600 to deliver high concentrations of drug to colon tissue to potentially drive efficacy and then dissipate in a short enough time to support safety. In the recent toxicology study, we continued to see peak drug levels in blood at approximately one quarter of what would be expected with the equivalent dose of commercially available tofacitinib using traditional oral administration. This further supports our desired approach of having lower levels of systemic exposure to potentially reduce toxicity. Final analysis is still ongoing, and we anticipate receiving the audited report in the coming weeks. We're also tracking well on progress with other aspects of the program, and we currently remain on track for our planned IND filing in Q3. We also recently announced that Dr. Ariella Kelman has joined Biura as chief medical officer, bringing valuable experience as an immunologist and strengthening our clinical team. Ariella's medical background and broad experience with dozens of early-stage and late-stage development programs for therapeutics over her 15 plus years at Genentech will be valuable as we prepare to file our IND for BT600 and then progress our program into later stages of development. Moving on to our BioJet systemic therapeutics platform. The BioJet platform aims to facilitate systemic oral delivery of drugs that would otherwise require injection or infusion. The BioJet platform is based on an orally ingestible device that provides liquid jet delivery to the small intestine to maximize systemic uptake. The platform has the potential to deliver a broad range of large molecules such as proteins, peptides, and nucleic acids without complex reformulation. We believe this platform can help improve disease management and associated patient outcomes and reduce intravenous infusion costs across a range of chronic use indications. Most of all, we believe this will improve patient convenience, which has been shown to affect patient compliance. These improvements could also help injectable biotherapeutics, such as monoclonals, become more competitive with alternatives. During Q1, we announced top-line results from preclinical studies with two drugs, adalimumab, a monoclonal antibody, and semaglutide, a peptide and GLP-1 receptor agonist. In the preclinical study with samaglutide, we achieved more than double our target bioavailability using BioJet platform. I'm excited to share that data from this study was accepted as a late-breaking abstract at the American Diabetes Association scientific sessions. We think the acceptance of this abstract as a late-breaker indicates the tremendous interest by the scientific community in oral delivery of GLP-1 agonists and other large molecules. We look forward to sharing detailed results from the study at the upcoming ADA meeting in June. We recently conducted a round of preclinical testing with our collaborator, Ionis Pharmaceuticals, using an endoscopically activated biogid device with an Ionis antisense oligonucleotide molecule. We're awaiting updates on results of that study and will share more as soon as we're able to. In the few short weeks since our last call, we've also conducted preclinical testing with an autonomously triggered Biogen device. We expect testing to continue through the coming weeks, and we remain on track to generate data during Q2 that we believe are necessary to enable our other two pharma collaborators to initiate testing with their own molecules. We look forward to progressing these collaborations and advancing toward our goal of achieving meaningful partnerships for our BioJet platform later this year. We continue to see potential for multiple partnerships over time due to the broad applicability of the BioJet platform to different molecules. As a reminder, one aspect of our comprehensive patent position for the BioJet platform is a key patent granted last year which covers methods for using an ingestible device to treat a condition using jet delivery of a GLP-1 receptor agonist formulation to the small intestine to achieve systemic uptake. This puts BioAura in a very strong competitive position for providing oral delivery of GLP-1s. With the success of drugs like Ozempic and Bonjaro, We're seeing analyst projections for the GLP-1 market being revised upward to 100 billion annually within the next 10 years. To summarize our anticipated milestones for both platforms. For our NaviCap platform, we remain committed to filing an IND for BT600 in Q3, and we anticipate initiating our phase one trial before the end of the year. For our BioJet platform, we're continuing development of our autonomous Bioget device with additional preclinical data generation expected during the second quarter of 2023. We also expect to continue to test and initiate new testing of the Bioget device with the molecules of our pharma collaborators. We also look forward to sharing results for our Bioget preclinical study with semaglutide at the American Diabetes Association scientific sessions on June 23rd. With that, I'll now turn the call over to Eric for a review of our financial results and capital market activities.