Biora Therapeutics(BIOR) - 2023 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Operating expenses excluding stock-based compensation remained stable at $12.5 million, with G&A expenses at $7.7 million and R&D expenses at $5.2 million for Q2 2023 [28][56] - The company raised $8 million in gross equity proceeds during Q2, leading to a slight reduction in cash balance to $26.5 million as of June 30, 2023 [56] Business Line Data and Key Metrics Changes - The NaviCap platform is on track for an IND filing in September, with a focus on the BT-600 program for ulcerative colitis [51][54] - The BioJet platform aims to provide needle-free, oral delivery of large molecules, with ongoing development and testing of the next-generation device [9][10] Market Data and Key Metrics Changes - The BioJet platform is positioned to participate in the $100 billion plus GLP-1 agonist market, with approximately 38 issued patents and pending applications [11] - The company is focused on addressing the unmet needs in ulcerative colitis, which has seen significant business transactions worth billions in recent years [35] Company Strategy and Development Direction - The company aims to transform treatment options for various GI diseases through the NaviCap platform, while the BioJet platform is expected to enhance patient compliance and outcomes [8][9] - The strategy includes leveraging collaborations with large companies to establish the BioJet platform's capabilities [46][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress towards the IND filing for the NaviCap program and the potential to address significant unmet needs for UC patients [51][62] - The company anticipates initiating the Phase 1 trial for the NaviCap platform before the end of the year, with a focus on confirming device performance and safety [54][56] Other Important Information - The NaviCap device demonstrated over 90% performance in identifying entry into the colon and triggering the release of its payload [6][19] - The company has strengthened its intellectual property position with new patents related to the NaviCap device and its applications in treating ulcerative colitis [23][8] Q&A Session Summary Question: How soon could dosing in ulcerative colitis patients proceed? - Management indicated that they have already conducted studies with UC patients and are confident in the device's performance, expecting to propose a patient study soon after Phase 1 data is gathered [37][38] Question: What are the differences to consider for the Phase 1 BT-600 initiation? - Management confirmed that the biopsy at the end of the study is manageable and will not significantly impact execution goals, with FDA interactions being supportive [41][42] Question: What primary endpoints does the FDA anticipate for the pivotal trial? - Management noted that typical UC trial outcomes are well established, and they expect to demonstrate comparative data easily due to the extensive existing data [45][70]