nimacimab (RYI-018) / Skye Biosci - LARVOL DELTA

Skye Bioscience Demonstrates Over 30% Weight Loss with Nimacimab and Tirzepatide Combination in Preclinical Model (GlobeNewswire) - "Skye Bioscience, Inc...announced new preclinical data for its novel CB1 antibody, nimacimab. In a murine diet-induced obesity (DIO) model, after 25 days of treatment, results demonstrated: Greater than 30% weight loss when nimacimab was combined with the dual GLP-1/GIP agonist, tirzepatide; Nimacimab alone demonstrated 23.5% weight loss, comparable to monlunabant and tirzepatide alone."

Preclinical • Obesity

Nimacimab, a Peripherally Restricted CB1 Inhibitor, Promotes Metabolic Homeostasis in a Diet-Induced Obesity (DIO) Mouse Model as Demonstrated by Weight Loss, Restored Hormonal Regulation, and Reduced Inflammatory Biomarkers (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Preclinical • Metabolic Disorders • Obesity

Skye Bioscience Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Enrollment completed in Phase 2a CBeyond trial of CB1 inhibitor, nimacimab, in obesity and overweight. Faster-than-expected enrollment enables full top-line Phase 2a data in late Q3/early Q4 2025, ahead of schedule; interim analysis removed. Phase 2a dosing extended to 52 weeks to enhance long-term safety, tolerability, and efficacy data....Two independent data safety monitoring board reviews have been successfully completed. 16 US Clinical Sites: Welcomed a leading academic center of excellence in obesity as a clinical trial site during Q1 2025....Upcoming Milestones: Q2 2025: Nimacimab preclinical data being presented at scientific/medical conferences."

DSMB • P2a data • Preclinical • Trial status • Obesity

CBeyond: Study to Evaluate the Effect on Obesity of Once Weekly Nimacimab Injection and Once Weekly Nimacimab Injection Co-administered With Semaglutide Injection Versus Placebo (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Skye Bioscience, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

CBeyond: Study to Evaluate the Effect on Obesity of Once Weekly Nimacimab Injection and Once Weekly Nimacimab Injection Co-administered With Semaglutide Injection Versus Placebo (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Skye Bioscience, Inc.

New P2 trial • Genetic Disorders • Obesity

Bird Rock Bio files IND application for phase 2 study of nimacimab for treatment of renal diseases (PRNewswire) - "Bird Rock Bio, Inc....announced today that the Company has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a phase 2 clinical study of nimacimab, also known as RYI-018, in patients with one of the following renal diseases: diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), or immunoglobulin A (IgA) nephropathy."

IND • Focal Segmental Glomerulosclerosis

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis (clinicaltrials.gov) - P2; N=6; Active, not recruiting; Sponsor: Bird Rock Bio, Inc.; Recruiting ➔ Active, not recruiting; N=14 ➔ 6; Trial completion date: Dec 2019 ➔ Apr 2020

Clinical • Enrollment change • Enrollment closed • Trial completion date

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis (clinicaltrials.gov) - P2; N=14; Recruiting; Sponsor: Bird Rock Bio, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: May 2019 ➔ Aug 2019

Clinical • Enrollment open • Trial initiation date

Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD) (clinicaltrials.gov) - P1; N=84; Completed; Sponsor: Bird Rock Bio, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion