Biora Therapeutics, Inc.

Welcome to the BioRF Therapeutics 3rd Quarter 2022 Earnings Call. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then 1 on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and 0. I will now turn the call over to Alexandra Schumann, Associate Director with LifeSci Advisors, Biura's Investor Relations Firm. Thank you, Operator.

Good afternoon and welcome to the Biura Therapeutics Third Quarter 2022 Corporate Update and Financial Results Conference Call. Joining me on the call are Adi Mohanty, Chief Executive Officer, and Eric Desbarbes, 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 will file later today and our subsequent reports filed with the SEC, which will all be available on our website in the Investors section. These forward-looking statements represent our views only as of the day 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 statement. For a further description of the risks and uncertainties that could cause the actual results to differ materially from those expressed in the forward-looking statements, as well as the 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 Wahanti, the CEO of BioR Therapeutics.

Thanks, Alex, and thank you, everyone, for joining us. During the quarter, we continued to focus on execution and made important progress towards our IND filing for PGN 600. We presented at key scientific conferences more detailed data from our device function studies for our targeted therapeutics program. In our systemic therapeutics program, we continue to optimize our device and presented important new data at multiple scientific conferences. While almost all our energy and focus is on our therapeutics pipeline, we remain committed to capturing value from our legacy assets through sale, licensing, or other agreements. We recently completed a transaction with Roche to sell some of our legacy IP. And earlier this year, we completed a spin-out of our liquid biopsy assets to a company now funded by an experienced venture capital firm to further develop the program. As those programs move forward towards key value inflection points, our stake in the assets could eventually result in meaningful financial return to Biora. We continue to pursue opportunities to create further value with our other remaining legacy assets. We also opportunistically raised incremental capital to extend our runway towards key data readouts next year. Eric will cover the details later in the call. We're very happy with the continued support from our largest current investor, Ethereum. Their additional investment in Barora illustrates not only their commitment to the therapeutics programs we're developing, but also their belief, which we share, that our stock is currently undervalued. First, let me cover our targeted therapeutics platform with our lead program in ulcerative colitis. Annual global sales for UC drugs are estimated to be approximately $7 billion, and the inflammatory bowel disease or IBD space overall is about $19 billion globally. Currently available therapeutics work by being taken up systemically throughout the body with a limited amount reaching the disease area or tissue in the colon. Moreover, most therapeutics are given via IV or needle-based administration, which adds to the patient's burden. Our lead program, PGN600, is a proprietary liquid formulation of tifocidinib in an easy-to-administer oral device that can deliver a drug to the colon using our targeted technology. The device is approximately the size of a fish oil pill. A commercially available version of tifocidinib is approved for the treatment of UCs. Tufacitinib is administered orally, and like other drugs that are orally delivered, is mostly absorbed in the stomach or the upper GI tract, whereas UC is a disease of the lower GI tract. By delivering drug topically at the site of disease where it is needed, PGN600 has the potential to improve efficacy and also limit systemic exposure to improve safety. We're extremely pleased with the ongoing development of our targeted drug delivery device. At the recent American College of Gastroenterology annual meeting, we shared the results from our PM602 study. This study assessed the safety and performance of the device in active UC patients. Given the different GI physiology and disease activity in these patients, it is critical that the device performs as intended and can identify entry into the colon, activate, and release a payload in UC patients. In this study, the device was orally ingested by patients with active moderate to severe ulcerative colitis. After identification of colon entry, we showed the device released a saline solution payload that included radioisotopes. Synthographic imaging was used to independently indicate device localization and payload delivery targeted to the lower GI tract. The device was well tolerated, and the study demonstrated that in all patients The device accurately identified entry into the colon, triggered release of a liquid payload, and importantly, achieved distribution across the entire lower colon. The results of this study have been reviewed by world-renowned gastroenterologists, including members of our IBD Clinical Advisory Board, who have provided feedback that these results demonstrate the potential of the targeted therapeutics platform to transform management of ulcerative colitis by improving efficacy through increased drug concentration in the colon, while potentially minimizing the harmful side effects associated with high systemic drug uptake. This successful study in ulcerative colitis patients supports the safety and performance of the device and is a key step in advancing our PGN600 program. We have now completed three successful human studies with our device, which demonstrates the potential of the platform for localized delivery of drugs. We're not aware of any other oral drug delivery technology that can accurately detect colon entry, especially in an environment of inflammation, bleeding, and highly variable motility seen with patients who have UC. As previously shared, we're planning a Phase I single and multiple ascending dose study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of PGN600. We expect that the single ascending dose study will include 24 healthy volunteers and evaluate drug concentration in serum and feces. The multiple ascending dose study is also planned to include 24 healthy volunteers with repeat daily dosing for seven days. And in addition to drug concentrations in serum and feces, we will also measure drug concentrations in colon tissue. Two different doses of PGN600 are planned for both studies. 5, and 10 milligrams of tofacidinib daily. These doses are well below the commercially approved induction dose of tofacidinib of 10 milligrams twice daily. We have included a diagram of our clinical study design in the corporate presentation on our website. We have shown important data on the correlation between tissue concentration of tofacidinib and improved patient outcomes. If the clinical data generated in our Phase I trial confirms that we can safely achieve high tissue concentrations, just as we have seen with PGN600 in preclinical studies, we believe there's a high likelihood of improving remission rates in UC patients compared to current therapies. Because of the well-known therapeutic profile of tilfacitinib in standard oral formulations, we believe our development risks for PGN600 are reduced. Soon after the phase one trial is completed, we plan to move into a disease interventional study where we will evaluate clinical remission after eight weeks treatment with PGN600 in active UC patients. We received constructive feedback from the FDA earlier this year that helped clarify our next steps, and we have been able to incorporate suggestions generally aligned with our development plans. We're continuing active engagement with the agency over the next few months as we prepare to file our IND early next year. We know that a vast majority of UC patients are still suffering with a large unmet need. Our solution can potentially solve one of the main gaps of all the current therapeutic options, which is the inability to get enough drug to the diseased tissue. So we're keen to move this program forward expeditiously while ensuring that we follow the necessary regulatory and clinical steps. Next, I'll cover our systemic therapeutics platform. During the third quarter, we continued development of our systemic delivery device. As mentioned before, we've seen very encouraging data from this platform early in the year. Over the last several months, we've been moving forward with development of the device to evolve from a research-grade device to a clinical-grade device. Our ongoing improvements and evolution of the device will ensure sourcing of parts from suppliers that can meet the stringent regulatory requirements for medical human use. We had expected to complete these improvements in late summer. However, some supplier sourcing challenges affected our timelines by a few weeks. Having worked through these supply issues, we're now moving forward with our studies and hope to complete these in the coming months. If successful, these data could be sufficient to progress our program towards our goal of expanding our pharma collaborations and partnership discussions. As a reminder, our systemic therapeutics platform aims to facilitate oral administration of drugs that would otherwise require injection or infusion. Our solution is an oral device which provides liquid jet delivery of large molecules 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, reduce intravenous infusion costs, help expand the market for drugs across a range of chronic use indications, and help biotherapeutics, such as monoclonals, become more competitive with small molecule substitutes. During the third quarter, we presented data on both our preclinical model development as well as other key data at scientific conferences, including the American College of Gastroenterology Annual Scientific Meeting, Controlled Release Society Annual Meeting, and the Parental Drug Association Universe of Pre-filled Syringes and Injection Devices Conference. As we progress our clinical-grade device, we're conducting animal studies to ensure that we can generate data that is similar to the data generated with our research-grade device. We expect to continue to evolve the device and generate data in the coming months. Our collaborators continue to be very supportive of our work on this platform. We believe that achieving 10% to 15% bioavailability through oral delivery would enable our platform to be commercially viable with a broad range of large molecules. And we believe that data from these studies could be sufficient to progress our collaborations and potential new partnerships into next stages. To summarize some of our anticipated upcoming milestones for both platforms. We plan to initiate a talk study with PGN 600 after we obtain final feedback from the FDA on our study protocols later this year. And based on the results, intend to file an IND in Q1 2023 to support the initiation of our phase one study. We expect to start having interim data around mid next year and to complete the study by Q3 23. We're continuing to optimize our next generation systemic therapeutics device to support additional preclinical data generation by Q1 23. And based on the additional data, we expect to expand our collaborations during the remainder of 2023. Finally, we expect to initiate our phase two trial for PGM 600 after completion of phase one next year. With that, I'll now turn the call over to Eric Desparbes for a discussion of our financial results and capital market activities.