Biora Therapeutics(BIOR) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Operating expenses for Q1 2023 were $13.2 million, an increase of $1.6 million compared to Q4 2022, primarily due to higher investment in device development and preclinical activities [34] - The company reported a stable cash balance of $30.5 million as of March 31, 2023, after raising $12.9 million in gross proceeds from its ATM program during Q1 [35] Business Line Data and Key Metrics Changes - The NaviCap-targeted delivery platform's lead program, BT-600, aims to deliver drug directly to the colon, with encouraging results from toxicology studies showing peak drug levels in blood at approximately one-quarter of what would be expected with traditional oral administration [12][21] - The BioJet platform achieved more than double the target bioavailability in preclinical studies with semaglutide, indicating strong potential for systemic oral delivery of drugs [15][30] Market Data and Key Metrics Changes - Global sales for ulcerative colitis drugs are approximately $7 billion per year and growing, highlighting a significant unmet need in the market [11] - The GLP-1 market is projected to reach $100 billion annually within the next 10 years, driven by the success of drugs like Ozempic and Mounjaro [18] Company Strategy and Development Direction - The company is focused on entering the clinic with the BT-600 program and progressing the BioJet platform, with plans to file an IND for BT-600 in Q3 2023 and initiate a Phase I trial by the end of the year [22][23] - The company aims to create partnerships for the BioJet platform while also considering in-house development of oral alternatives to injectable GLP-1s [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety profile of BT-600, noting no accumulation of drug in blood or tissue, which is a positive sign as they move forward [27][21] - The company is optimistic about generating meaningful data in the coming months that will aid in collaboration opportunities and partnerships [31] Other Important Information - The company has strengthened its clinical team with the addition of Dr. Ariella Kelman as Chief Medical Officer, which is timely as they prepare to enter clinical trials [13] - The company is actively working on optimizing its capital structure to enhance its public company profile [35] Q&A Session Summary Question: Can you comment on the half-life in blood for the BT-600 program? - Management indicated that the half-life is consistent with literature on tofacitinib, with a better profile that avoids peak drug levels associated with toxicity [27] Question: Is the 14-day GLP-tox study the only requirement for the IND filing? - Management clarified that while the tox study is crucial, additional data such as stability data and CMC sections are also necessary for the IND filing [29] Question: What data will be presented at the ADA meeting regarding the GLP-1 BioJet program? - Management confirmed that they will present data showing more than double the target bioavailability achieved with the next-generation device, with specific details to be shared at the meeting [30] Question: Are there any updates on potential partnerships for the BioJet program? - Management stated that conversations regarding partnerships are broad and ongoing, with the potential to keep some programs in-house as well [41]