Release Date: May 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Biora Therapeutics Inc (BIOR, Financial) successfully completed dosing in their clinical study of BT. 600, showing progress in their clinical development plans.
- The Navigator platform demonstrated effective and targeted drug delivery, potentially leading to improved efficacy and reduced toxicity for ulcerative colitis patients.
- Biora Therapeutics Inc (BIOR) reported positive interim results from the single dose portion of the BT. 600 clinical trial, with all navigation devices performing as intended and well tolerated.
- The company's Biologic platform continues to exceed performance targets, showing promise in the delivery of large molecules and potentially providing an alternative to needle-based delivery.
- Biora Therapeutics Inc (BIOR) has made significant advancements in their budget and systemic therapeutics platforms, with preclinical data demonstrating leading bioavailability of complex molecules.
Negative Points
- The company faces substantial risks and uncertainties that could materially affect the actual results, as mentioned in the forward-looking statements.
- Operating expenses for the first quarter were high, totaling $14.5 million, driven by continued investment in device development and clinical activities.
- Biora Therapeutics Inc (BIOR) reported a net loss of $4.2 million for the three months ended March 31, 2024, indicating financial challenges.
- Despite advancements, the company still needs to manage and eliminate 40% of G&A costs associated with legacy matters by the end of the year.
- The company is in the process of optimizing its capital structure, which remains complex and requires further simplification.
Q & A Highlights
Q: Can you provide some perspective on the Nadcap program with tofacitinib, particularly regarding the plasma levels being three to four times lower?
A: Adi Mohanty, CEO of Biora Therapeutics, explained that the lower plasma levels are significant and slightly higher than physicians' expectations. The focus is on achieving much higher drug concentrations in the tissue at a lower dose, which is considered beneficial and aligns with their clinical goals.
Q: What are the expectations for the upcoming top-line data for VP. 600?
A: CEO Adi Mohanty stated that confirming the previous data, which indicated colonic uptake and reduced plasma levels, would be considered a success. The upcoming data should support the sustained delivery and effectiveness of their approach.
Q: Could you discuss the design of the upcoming study in UC patients in the second half of the year?
A: Adi Mohanty mentioned that the study's final design would be influenced by the upcoming MAD data and feedback from clinical experts. Details will be finalized and shared after reviewing the comprehensive data set and consulting with key opinion leaders.
Q: What are you looking for in potential partnerships for 2024, particularly regarding early collaborations?
A: The CEO highlighted that they are seeking partners ready to advance candidates into clinical trials, moving beyond feasibility studies. The focus is on partners who are committed to clinical development rather than just exploratory collaborations.
Q: How are you framing expectations for the BT. 600 Phase one trial data to be shared at the June conference?
A: Adi Mohanty emphasized the goal to confirm sustained drug delivery with lower plasma concentration and higher tissue concentration, which would validate their drug delivery technology's effectiveness.
Q: Can you provide insights into the discussions around new inquiries for the biojet platform?
A: The CEO mentioned increased interest due to their proactive approach in seeking partners for clinical development. Discussions vary, with some potential partners having specific molecules in mind, while others are considering broader applications.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
