Biora Therapeutics(BIOR) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Operating expenses for Q3 2023 were $23.3 million, up from $14.9 million in Q2 2023, primarily due to a one-time stock-based compensation charge of approximately $9 million [32][45] - The net loss for the quarter was $73.5 million, which included non-cash charges of $9 million for stock-based compensation and $53.2 million related to the convertible note exchange [45][32] - The effective operating cash burn for the quarter was $12.7 million, with an average monthly operating cash burn maintained at approximately $4 million [45][32] Business Line Data and Key Metrics Changes - The NaviCap platform is on track to initiate a Phase 1 clinical trial by the end of 2023, with initial data expected early next year [15][60] - The BioJet platform has shown promising results in animal studies, with 96% of animals demonstrating systemic circulation of semaglutide at clinically relevant levels [11][12] - The company is actively negotiating with a fourth pharma collaborator for the BioJet platform, indicating increasing interest from potential partners [13][66] Market Data and Key Metrics Changes - The company has successfully raised nearly $6 million in gross proceeds through various sources since the last call, including monetizing legacy assets [36] - The company continues to target non-dilutive funding sources and is engaged with the investor community to secure necessary capital for program development [36] Company Strategy and Development Direction - The company aims to expand its intellectual property coverage for the NaviCap platform, having received a notice of allowance for a new patent related to the BT-600 program [8][25] - The BioJet platform is positioned to provide needle-free oral delivery of therapeutic molecules, with ongoing development and testing of the next-gen BioJet 2 device [10][26] - The company is focused on progressing its collaborations with pharma partners to generate data that could lead to meaningful partnerships in the future [55][66] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA's review process for the BT-600 IND application, anticipating clearance in November and trial initiation in December [51][60] - The company is preparing for the Phase 1 trial by ensuring all necessary materials and protocols are in place, indicating readiness to proceed upon FDA clearance [70][63] - Management noted that the collaborations with pharma partners are yielding positive results, which could accelerate interest and lead to more partnerships [66][55] Other Important Information - The company has a comprehensive IP portfolio for drug delivery using ingestible devices, with 30 patent families for the NaviCap platform alone [25] - The company is actively working to reduce its convertible note balance, having already reduced it by $50 million through a note exchange agreement [31] Q&A Session Summary Question: Update on BT-600 IND and study initiation - Management clarified that the IND resubmission was tactical, providing additional information to the FDA, and they expect a standard 30-day review process [60][81] Question: Readiness for Phase 1 program - Management confirmed that all necessary preparations for the Phase 1 trial are on track, including site readiness and material supply [70][63] Question: Timeline for BioJet partnerships - Management indicated that data generation from ongoing studies will facilitate discussions for potential partnerships, with a focus on translating research collaborations into meaningful partnerships [55][66]