Biora Therapeutics, Inc.

Welcome to the Biola Therapeutics first quarter 2022 earnings call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question and answer session. At that time, if you have a question, please press the 1 followed by the 4 on your telephone keypad. If at any time during the conference you need to reach an operator, please press star 0. As a reminder, today's conference is being recorded. I will now turn the call over to Chuck Padala, Managing Director with Life Science Advisors. Biore Therapeutics Investor Relations Firm.

Thank you, Operator. Good afternoon and welcome to the Biore Therapeutics First Quarter 2022 Corporate Update and Financial Results Conference Call. Joining me on the call are Adi Mohanty, Chief Executive Officer, and Eric Desparves, 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 law, 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 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 statement. 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 Iora Therapeutics.

Hello everyone and thank you for joining us. First I'll review our recent corporate highlights and then I will recap where we are with each program. We took a big step forward in our transformation as we launched Biura Therapeutics today. The name Biura was chosen to reflect our focus on oral biotherapeutics. Biura's mission is to reimagine therapeutics and we envision a a world where patients have access to life-improving therapies without needles. Biora's purpose is to develop therapies that improve patients' health and quality of life by developing innovative, smart pills. We're initially focused on two platforms. One is our novel approach of targeted therapeutics for the treatment of serious GI diseases. We believe we can help patients by delivering a therapeutic formulation directly to the site of disease in the GI tract. Our first program with this platform delivers drug by coating the large intestine with a formulation that's optimized for topical application. Our targeted approach has been shown to reduce systemic uptake, which has been implicated in toxic or adverse impacts to patients. Second is our technology that allows for oral delivery of therapeutics, most of which Today, it can only be administered using needles. With this platform, we're aiming to maximize systemic uptake of large molecules by using liquid jet delivery to the small intestine via an easy-to-use oral capsule. In the few weeks since our last call, we've made significant progress on our transformation. We announced last week that we completed a transaction for our single molecule detection technologies, which were designed to enable rapid, low-cost assessment of biomolecules via liquid biopsy. We've contributed all assets related to these technologies to newly formed Enumera Molecular, which intends to develop and commercialize the platform and will be funded with an initial 12.5 million Series A financing round led by Arboretum Ventures, a sophisticated healthcare investor. We're pleased to enable Enumera and Arboretum Ventures to develop this opportunity for which we have a minority ownership stake with potential financial upside and without committing any funds or resources from the company. This is an example of our commitment to maximizing value from our legacy diagnostic assets while maintaining focus on our core future therapeutics programs. We will continue to look for ways to maximize our legacy assets. We recently announced the appointment of Paul Chabram as SVP Technical Operations. Paul brings over 30 years of biotech experience leading successful development programs and commercial products while implementing novel manufacturing processes. I'm very happy to have Paul join our team, where his focus will be on growing our device and therapeutics capabilities to optimize performance and manufacturing in support of our clinical programs. We continue to build the skills and capabilities required to be a successful biotherapeutics company. We also recently expanded our internal engineering and manufacturing capabilities with the addition of a new technical operation space. Moving on to our programs, first with our targeted therapeutics platform. As a reminder, our first program with this platform is in ulcerative colitis, or UC. Annual global sales for UC drugs are estimated to be $7 billion globally, and the inflammatory bowel disease, or IBD space overall, is $19 billion globally. Our lead program, PGN600, is a proprietary liquid formulation of tocacitinib delivered in the colon using our targeted delivery technology, which is a capsule approximately the size of a fish oil pill. A commercially available version of tofacitinib is approved for the treatment of UC. Tofacitinib currently 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. In conjunction with our scientific collaborators, we will present at Digestive Disease Week, DDW, in San Diego later this month, Data that builds upon presentations at the European Crohn's and Colitis Organization at the Belgian Week of Gastroenterology conferences earlier this year. The data presented at these conferences was from moderate to severe UC patients taking to the fitness. GI tissue biopsies were obtained from these patients, and a clear correlation was identified between higher concentrations of drug in the tissue and improved endoscopic outcomes. We believe our proprietary platform can achieve the goals of significantly increasing drug levels in diseased tissue while reducing systemic exposure. Our preclinical results show that successful targeted delivery with PGN600 enables about 25 times higher concentration in colon tissue compared to the equivalent standard oral dose while showing significantly less systemic exposure. This demonstrates the potential for PGM-600 to safely increase drug levels at the site of disease, which could dramatically improve disease management for UC patients. During the first quarter, we completed a discussion with our clinical advisory board, which includes Dr. William Sanborn, Dr. Gert Hans, Dr. Bruce Sands, and Dr. Severine Vermeer, who are all leading experts in GI diseases and used their inputs to refine our clinical development programs. We recently submitted our Type C meeting request to the FDA with our proposed clinical development plans. We hope to have FDA agreement and response by the end of this quarter. Following that response, we will be submitting an IND later this year for a Phase I study with PGM-600, which should keep us on track for our planned Phase II study next year. It's important to note that our planned Phase I clinical trial with PGN600 will also evaluate both blood and colonic tissue levels of tufacitinib. Given the data we've already generated and presented on the correlation between tissue concentration of tufacitinib 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 the likelihood of improving remission rates in subsequent studies in UC patients is high. Because of the well-known therapeutic profile of tofacitinib in standard oral formulations and the ability to utilize or reference these existing data, we believe our development risks for PGN600 are reduced. Soon after the phase one trial is completed, we plan to initiate a disease interventional study where we may learn more definitively about the benefits a solution can bring to UC patients. While we prepare for these critical drug-device combination clinical studies, we also continue to progress with clinical studies demonstrating the function of the device. We have successfully completed a device function study in healthy volunteers and are currently actively enrolling two more clinical studies. The first is a study to evaluate the effects of food on the function of the device. The second aims to confirm device function in UC patients. Patient enrollment is ongoing and expected to be completed in the second quarter. Positive results from these studies should further confirm the robustness of our platform and demonstrate its utility for delivering a wide range of therapeutics to the site of disease in UC patients and other GI diseases. Our overall clinical development path may have some advantages because we're using molecules that have well-known safety and efficacy profiles. If we're able to demonstrate that the device functions as desired, the next step to demonstrate that the combination works should have a higher likelihood of success compared to many other therapeutics in early development. Each development stage that we successfully achieve will increase the value of the current program and really the entire platform, thus strengthening our position to assess and discuss partnership opportunities and future commercialization. Achievement and development milestones will also inform our plans for future product expansion of our targeted therapeutics platform. Next, I'll cover our systemic biotherapeutics platform. The goal of this platform is to facilitate oral administration of drugs that would otherwise require injection or infusion. Our systemic therapeutics delivery solution is an oral capsule which provides liquid jet delivery of large molecules in order to maximize systemic uptake. 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. Our platform with the protective capsule and JET means this system has the capability to deliver a range of approved large molecules such as proteins, peptides, and nucleic acids without complex reformulations. As a reminder, we already have multiple R&D collaborators for this technology. Since our last call, we've continued to make progress with device design and manufacturing, and making improvements that will increase device performance, reliability, and manufacturability. Although we have data with several molecules on this platform, such as the monocle antibody adalumamab, our initial focus is on a high concentration formulation of the peptide liraglutide, a GLP-1 receptor agonist. 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 have already demonstrated the animal models that we can achieve up to 67% bioavailability for a monoclonal antibody. We will be presenting preclinical data on the performance of this platform at the Controlled Release Society Annual Meeting, which will take place in July, and we expect to share existing and future results at other upcoming conferences. As with our other platform, here too, we're initially using drugs with established safety and efficacy profiles, which should result in several advantages in the regulatory pathways and development plans for this platform. We expect to run additional preclinical studies in the coming months. These additional data could be sufficient to progress our collaborations into next stages and allow us to be ready for human clinical trials demonstrating effective delivery of therapeutics next year. For now, we plan to take one systemic therapeutic program forward to these later stages, which we expect will show the broad applicability of the platform for use with many other existing and in-development therapeutics. Although our targeted and systemic therapeutic platforms are the primary focus of the company in the near term, we continue to incubate our other platform technologies for the future. At Digestive Disease Week in May, we will share proof of concept results from a clinical study demonstrating the ability of our recoverable sampling system, our third platform technology, which uses an oral capsule to non-invasively collect and preserve a microbiome sample. We believe the ability to collect, preserve, recover, and analyze analytes from specific regions of the intestine has numerous potential applications for diagnostics and for drug discovery and development. To summarize some of our upcoming milestones, we expect to complete our targeted therapeutics device function study in fed state and in UC patients in Q3. We will review our clinical plan for PGM-600 with the FDA in the coming months, ahead of launching our phase one study during the fourth quarter. We expect to generate and share upcoming conferences via availability data from our systemic therapeutics program, which will enable our first clinical studies to begin next year. With that, I'll now turn the call over to Eric for a discussion of our financial results and capital market activities.