Pipeline

GLP‑1 receptor agonists (GLP‑1RAs) show transdiagnostic activity across substance‑use and compulsive disorders, enabling a multi‑indication development strategy.

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Program
Stage
Alcohol Use Disorder (AUD)
Phase 3 start: Q1 2026
Cocaine & Methamphetamine Use Disorders (CUD/MUD)
Phase 2/3 start: Q3 2026
Opioid Use Disorder (OUD)
Clinical strategy in planning
Additional Indications
TBD
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Lead Indication

BT‑001 for Alcohol Use Disorder (AUD)

Phase 3 pathway aligned with FDA

Best‑in‑class, once‑weekly GLP‑1RA candidate for AUD.

Clinical & Commercial Rationale

  • •≈29M with AUD; ~3% currently treated.
  • •Potential for superior efficacy vs SOC (naltrexone, extended‑release naltrexone).
  • •Once‑weekly dosing designed to improve adherence vs SOC.
  • •Positioned for first‑to‑market or co‑launch relative to key competitors (e.g., Lilly/brenipatide).
  • •Favorable reimbursement dynamics anticipated in AUD.
  • •High patient/provider appeal; class‑demonstrated benefits for metabolic comorbidities (glycemic control and weight loss).
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Second Indication

BT‑001 for Stimulant Use Disorders (CUD/MUD)

Phase 2/3 protocol development underway

Addressing stimulant‑use disorders with no FDA‑approved pharmacotherapies.

Clinical & Commercial Rationale

  • •≈1.2M with CUD; no FDA‑approved pharmacotherapies.
  • •≈1.6M with MUD; no FDA‑approved pharmacotherapies.
  • •Favorable reimbursement dynamics with strong payor mandates.
  • •Potential to reduce polysubstance craving/use in stimulant ± opioid comorbidity.
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Additional Indication

BT‑001 for Opioid Use Disorder (OUD)

Opportunity to address the opioid crisis with a non‑opioid mechanism of action.

Clinical & Commercial Rationale

  • •≈4.8M with OUD; ~17% receive medications for OUD (MOUD).
  • •Compatible with existing MOUD; potential additive efficacy.
  • •May appeal to patients declining opioid‑based SOC therapies.
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Additional Indications

BT‑001: Additional Indications

Expanding the platform across compulsive and behavioral disorders.

Clinical & Commercial Rationale

  • •Emerging class evidence across additional indications (e.g., smoking cessation, cannabis use disorder, select behavioral disorders).
  • •Program expansion will be evidence‑driven as the class data evolve.