Biora Therapeutics (BIOR) PT Lowered to $15 at H.C. Wainwright

H.C. Wainwright analyst Joseph Pantginis lowered the price target on Biora Therapeutics (NASDAQ: BIOR) to $15.00 (from $50.00) while maintaining a Buy rating.

The analyst comments "Initial SAD data reaffirm NaviCap's MoA and fruther de-risk upcoming clinical readouts. During 2023, Biora made significant headway advancing its two leading drug delivery devices: Biojet and NaviCap. The BioJet made considerable progress in preclinical evaluations; data readouts using BioJet is anticipated throughout 2024. Moreover, NaviCap recently entered the clinic in a SAD/MAD Phase 1 healthy volunteer (HV) study. Recall, BT-600 combines an orally administered NaviCap device with a liquid formulation of tofacitinib to treat moderate to severe UC. The Phase 1 is a randomized, double-blind, placebo-controlled, SAD/MAD clinical trial designed to evaluate the safety, PK, and PD of orally administered BT-600. As part of the 2023 results, Biora disclosed initial results from the SAD portion of the Phase 1. Key outcomes and takeaways from the SAD cohort include: 1) BT-600 was safe and well tolerated; 2) All participants receiving devices, containing active drug, exhibited systemic drug absorption. Measurable tofacitinib in blood was observed at six hours; mean time to Tmax was 8–10 hours following administration (vs. 0.5-1.0 hours for conventional oral tofacitinib). Results are indicative of absorption occurring in the colon, as expected; 3) Plasma tofacitinib levels were approximately 3-4x lower than conventional oral tofacitinib at the same doses. Max plasma concentration (Cmax) of 26 ng/mL for BT-600 at the 10 mg dose of tofacitinib, vs. 88 ng/mL for conventionally administered oral tofacitinib at a 10 mg dose. These data suggest localized delivery enables higher colon tissue drug concentrations, while sparing high systemic drug levels; 4) Dose-proportional pharmacokinetics were also observed, with consistently lower plasma drug concentrations with the 5 mg dose than the 10 mg dose; and 5) Biora anticipates reporting final SAD/MAD data, including colon tissue biopsy results, during 2Q24 and plans to present topline data shortly after. Reiterate Buy rating while lowering PT to $15 from $50."

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