Biora Therapeutics, Inc.

Greetings and welcome to the BioAura Therapeutics third quarter 2023 earnings 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 zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Chuck Padala, Managing Director with Lifestyle Advisors. Thank you, Chuck. You may begin.

Thank you, Operator. Good afternoon and welcome to the Biola Therapeutics Third Quarter 2023 Corporate Update and Financial Results Conference Call. Joining me on the call are Adi Mahanty, Chief Executive Officer, Eric Vesparvis, 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 in the meaning of the federal securities laws, including but not limited to the types of statements identified as forward-looking in our portal reports, Form 10-Q, that we will file later today, and our subsequent reports filed with the SEC, which are available on our website, the Investor section. These forward-looking statements represent our views only as of the date of this call about substantial risks and uncertainties, including many that are beyond our control. Please note the 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 SEC. With that, I will now turn the call over to Adi Mahanty, CEO of Iora Therapeutics. Adi?

Thanks, Chuck, and thank you, everyone, for joining us. During the third quarter, we continued to make excellent progress with both of our platform technologies. The NaviCAP platform is rapidly advancing towards initiation of a phase one clinical trial by year end, and development of the Biojet platform has accelerated with an increased pace of data generation from several molecules, including those of our pharma collaborators. First, an update on our NaviCAP targeted therapeutics platform with our lead program, BT600, in ulcerative colitis. Research suggests there is a minimum level of drug needed in the tissue at the site of disease to achieve better therapeutic outcomes in ulcerative colitis, or UC. Our technology can potentially increase tissue concentration without systemic toxicity, which could provide improved outcomes for UC patients. We hope to demonstrate this with a phase one clinical trial, which we are on track to initiate by end of this year. Earlier, we filed our IND application with the FDA as planned. The IND for BT600 includes extensive manufacturing for clinical and toxicology data, as well as clinical device function data from our four separate studies in both healthy volunteers and UC patients. So it's a sizable filing that includes over 300 documents, larger than a typical submission, because we have both drug and device information. The FDA often generates questions and requests information as they review these types of filings. Towards the end of the FDA review period, we received some questions that required us to provide additional information, which we had. We discussed the questions of the agency, and as a result of our conversation, it became clear that it was appropriate for us to refile, which we did. This allows the FDA to have additional time to review our application and the additional information. We continue to have a constructive dialogue with the FDA, and it's understandable that the extensiveness of the information supporting our IND would require additional time for review. We hope the review will be satisfactorily completed by the end of this month. If so, we anticipate maintaining our timeline to initiate a phase one trial before the end of this year. We are, to our knowledge, the first company to file an IND for a drug and ingestible device combination. While other companies have pursued clinical studies that's outside the U.S., we believe it's important to engage U.S. regulators as early as possible and to take the most rigorous path to approval. We've successfully completed four human studies in which the NaviCab device performed as designed across a range of expected differences in GI motility in both healthy volunteers and UC patients. The next step is to use the NaviCab device to deliver tofacitinib. We aim to prove our treatment hypotheses by confirming that we can achieve sufficient drug levels in the colon tissue along with low systemic exposure. We anticipate exiting Phase 1 with not only safety data, but also with critical data on potential exposure in both plasma and tissue, which would be much more informative than a typical Phase 1 trial. In addition to progressing towards Phase 1, we continue to expand our intellectual property coverage for the NaviCAP platform. Recently, we received notice of allowance of a new patent that encompasses the novel treatment paradigm of our BT600 program, with its targeted delivery of JAK inhibitors to the GI tract. We will share more details in the coming weeks on the patent issues. Earlier this year, we were awarded another group of US and European patents that expanded our coverage for additional therapeutic targets for UC. We hold one of, if not, the world's most comprehensive IP portfolio for drug delivery using ingestible devices with 30 patent families for the NaviCap platform alone. As we progress our UC program, we gain more data on the overall platform, and the combination of IP and platform development will allow us to expand our pipeline organically with additional programs. Moving on to our BioJet systemic therapeutics platform. Our goal with the BioJet platform is to provide needle-free oral delivery of therapeutic molecules. The BioJet platform is based on a small capsule that, once swallowed, is designed to deliver drug into the wall of the small intestine using liquid jet injection. We believe the BioJet platform can provide an alternative to needle-based delivery of complex molecules and could also enable those molecules to more efficiently reach the liver through delivery into the small intestine. As planned during Q3, we continued development and testing to confirm the performance of our next-gen BioJet 2 device, which allowed us to progress further and begin testing our pharma collaborators' molecules with the device. In October, we presented new data at the European Association for the Study of Diabetes, where we confirmed that our Biogel2 device exceeded its performance targets. Across three studies in a porcine model, 96% of animals showed semaglutide in systemic circulation at clinically relevant levels for up to 10 days following administration. Among the 22 animals dosed with semaglutide, oral bioavailability averaged 20.5%, which exceeds both the device performance and bioavailability targets set by us and our collaborators. Data analysis from animal studies were also completed with one of our collaborators' molecules to demonstrate the potential of the Biojet platform to achieve uptake of large molecules into the liver. Many disease targets reside in the liver, and it's a key area of focus for RNA-based therapeutics, such as antisense oligonucleotides or siRNA-based drugs. Large molecules must typically be delivered via IV or sub-Q injection because they cannot survive the stomach acid and are too large for absorption through the small intestine. The challenge with IV or sub-Q delivery is most of the drug is metabolized before it reaches the liver. Our technology uses liquid injection into the small intestine, which is an optimal delivery pathway to the liver. to the BioJet platform to provide a unique advantage for liver-targeted oral delivery of large molecules. While we aren't clear to share data yet, I can say that the results of the study with our collaborator's molecule were extremely encouraging. We also recently completed another set of animal studies for a second collaborator and are in the process of having the hundreds of samples analyzed. These data, they provide further support for the BioJet platform's ability to deliver large molecules. In addition, we're initiating preclinical studies with a third pharma collaborator. As we continue the progress of the BioJet platform and produce further data, we have seen increasing interest from potential partners, and we're actively negotiating an agreement with a fourth potential pharma collaborator. It is common for research collaborations to have strict confidentiality requirements early on, particularly those involving very large companies and highly competitive drugs. We appreciate the need to share as much information as possible with our stakeholders, but we rely on our collaborators' permission and timing to share information. We'll continue to be as transparent as possible while being good partners and respecting the disclosure rules established with our collaborators. We believe we're well positioned with the Bioget platform's several advantages, its ability to achieve category-leading bioavailability of complex molecules, its ability to deliver existing liquid formulations and large payloads in the multi-milligram range, and its potential to enable liver-targeted delivery of large molecules. We're excited to see the accelerating development of the Biojet platform, and we look forward to sharing more about the progress with our existing and new collaborators and potential partners. To summarize our anticipated milestones, for our Navigap platform, we await the FDA's response for IND application, and we anticipate initiating our Phase I trial before the end of the year. Initial Phase I data is anticipated early next year, and if we begin the trial before the end of this year as planned, we expect to complete the execution of the trial in Q1 with final data coming after that. For our BioJet platform, we expect to continue generating data from animal studies with the molecules of our pharma collaborators during the fourth quarter. With three existing and potentially a fourth new collaboration, all generating data that add to the overall development data set of the platform, we anticipate accelerating interest from others. With that, I will now turn the call over to Eric for review of our financial results and capital market activities.