Release Date: August 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Successful completion of Phase 1 clinical trial for BT-600 using the NaviCap platform.
- Significant progress with partners on the BioJet platform, including active partnership discussions with large pharma companies.
- Positive pharmacokinetic data showing targeted drug delivery to the colon with reduced systemic exposure.
- Strong support from large shareholders, resulting in a $16 million capital raise.
- Presentation of Phase 1 clinical trial data at the upcoming American College of Gastroenterology Annual Meeting.
Negative Points
- High operating expenses of $14.5 million in Q2, excluding stock-based compensation.
- Continued investment required for device development and clinical activities.
- 40% of G&A costs associated with legacy matters, which are expected to be eliminated by the end of the year.
- Uncertainty around the completion and details of the pharma partnership discussions.
- Potential challenges in scaling up manufacturing capacity for NaviCap devices to meet future demand.
Q & A Highlights
Highlights of Biora Therapeutics Inc (BIOR, Financial) Q2 2024 Earnings Call
Q: Can you provide an update on the partnership negotiations?
A: Discussions are narrowing and focusing on the best way to work with potentially more than one partner. The talks started broadly but are now honing in on specifics. We are close to finalizing and hope to share more details soon. - Aditya Mohanty, CEO
Q: How does the drug uptake differ between the oral product and the NaviCap platform?
A: The oral product gets absorbed in the small intestine and enters systemic circulation, while the NaviCap platform delivers the drug directly to the colon, resulting in higher tissue exposure and lower systemic levels. This approach aims to improve therapeutic outcomes and reduce toxicity. - Aditya Mohanty, CEO
Q: Have you estimated how much of the drug from the NaviCap platform passes through the body without being absorbed?
A: Majority of the drug gets absorbed in the colon, with some passing through. We have collected data on this and will share more information at upcoming conferences. - Aditya Mohanty, CEO
Q: What is your current capacity for device availability and manufacturing for more advanced clinical studies?
A: We have contract manufacturers in place to produce several hundred to a few thousand NaviCap devices. We are also working on further automation to scale up production for future needs. - Aditya Mohanty, CEO
Q: How does the bioavailability of the BioJet platform compare to IV formulations?
A: The BioJet platform achieves around 40% bioavailability, which is close to subcutaneous injections (50-60% of IV). This is significantly higher than other oral delivery methods, which typically achieve single-digit bioavailability. - Aditya Mohanty, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
