Biora Therapeutics (BIOR) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Platform overview and pipeline

• Two proprietary platforms: NaviCap for targeted GI drug delivery and BioJet for systemic, needle-free oral delivery of complex molecules.

• NaviCap is being used in a UC trial, delivering drugs directly to the colon for improved efficacy.

• BioJet enables oral delivery of peptides, antibodies, and oligonucleotides, using existing injectable formulations.

• Focus on partnerships for BioJet and advancing NaviCap further in clinical trials before broader partnering.

• Several collaborations with major pharma companies for BioJet, aiming to convert these into formal partnerships.

Recent clinical data and implications

• Phase I trial with NaviCap and tofacitinib showed >95% accuracy in colon targeting and payload delivery.

• Biopsies confirmed drug presence in colon tissue 24 hours post-dose, even after colon prep.

• Achieved IC50 levels in colon with 3-4x lower plasma concentration than standard oral tofacitinib, reducing systemic toxicity.

• Delayed Tmax (8-10 hours vs. 30 minutes) indicates targeted delivery and prolonged tissue exposure.

• Data supports potential for higher efficacy and safety, aiming to break the therapeutic response ceiling in UC.

Strategic focus and next steps

• Next clinical steps include finalizing reports and planning a larger UC trial (phase Ib/2a) with patients, targeting trial start by year-end.

• Exploring a shorter regulatory path to approval, possibly requiring only induction trials.

• Adalimumab program is in preclinical stage; future development will leverage regulatory learnings from tofacitinib.

• NaviCap partnering discussions to begin now that phase I data addresses key questions.

• BioJet partnerships expected to be announced in the coming weeks.