Biora Therapeutics, Inc.

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 has been recorded. I will now turn the call over to Chuck Padala Managing Director with LifeSci Advisors, Biura's Investor Relations Firm. Please go ahead.

Thank you, Operator. Good afternoon and welcome to the Biura Therapeutics Second Quarter 2024 Corporate Update and Financial Results Conference Call. Joining me on the call are Adi Mahadi, Chief Executive Officer, and Eric Desparves, Chief Financial Officer. Before I turn the call over to Mr. Mahanty, 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 in 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 actual results could differ materially from those expressed in the forward-looking statement. 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. With that, I will now turn the call over to Adi Bhatti, CEO of Biura Therapeutics. Adi?

Thanks, Chuck, and thank you, everyone, for joining us. It's been a very productive and busy quarter for Biura with the announcement of our successful Phase I clinical trial for the BT600 program using our NaviCAP platform and significant work in progress with partners on the BioJet platform. I'll begin with our NaviCAP 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. 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. 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. Although several attempts have been made, there has not been a reliable way to achieve colon tissue targeted delivery of therapeutics. With our approach, we aim to achieve higher drug exposure and activity in colon tissue by delivering drug 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. 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 tofacitinib. 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 I results did indeed confirm this, with tofacitinib detected across all three biopsy sites in the distal colon. 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 5 mg and 10 mg in this trial, which are a quarter to half of the approved doses for conventional tofacitinib. 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 release in 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. 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. 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. 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 risks. Our Phase I data demonstrate a proof of mechanism for this. 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 therapies. In the near term, our Phase I 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. Everything we have 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 I clinical trial to the medical community. Moving on to our biogid 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. 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 in 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. 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. In June, we shared an update at an industry meeting, the NextGen Peptide Formulation and Delivery Summit, where our head of research, Dr. Shart 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. 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. 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 Navigap platform, we continue to share results from our successful Phase I 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 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. With that, I'll now turn the call over to Eric for a review of our financial results and capital market activities.