Biora Therapeutics (BIOR) H.C. Wainwright 26th Annual Global Investment Conference summary

Program overviews and innovation focus

• Two main programs: NaviCap for targeted GI drug delivery and BioJet for oral delivery of biologics.

• NaviCap aims to treat ulcerative colitis by delivering drugs directly to the colon, reducing systemic exposure and toxicity.

• BioJet targets needle-free delivery of large molecules, addressing compliance issues in chronic diseases like diabetes.

• Both platforms are designed as drug-device combinations with broad applicability for various therapies.

Clinical trial results and platform validation

• NaviCap phase I trial in healthy volunteers showed successful targeted delivery, with drug detected in blood only after 6+ hours.

• Achieved 2-4x lower systemic drug exposure compared to commercial alternatives, with pancolonic coverage confirmed by biopsies.

• Tissue concentrations exceeded IC50 and projected to remain above IC90 for at least 16 hours post-dose, correlating with clinical response.

• Platform demonstrated safety, tolerability, and potential for use with multiple drug classes beyond JAK inhibitors.

Strategic direction and partnering

• Next steps for NaviCap include designing a clinical study in UC patients to generate early efficacy data.

• BioJet has shown high bioavailability and consistent delivery with various molecules, including semaglutide and adalimumab.

• Active partnering discussions underway with multiple pharma collaborators for BioJet, aiming for non-dilutive funding and broad adoption.

• Both programs are positioned as category-leading solutions in their respective fields, with upcoming catalysts anticipated.