By David Bautz, PhD

NASDAQ:NRBO

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Business Update

SAD Part 1 of Phase 1 Trial Data Expected in 3Q24

NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO) is currently conducting a Phase 1 clinical trial of DA-1726 for the treatment of obesity. DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a dual agonist of the GLP-1 receptor (GLP-1R) and the glucagon receptor (GCGR). Part 1 of the trial is a single ascending dose (SAD) study that enrolled 45 obese but otherwise healthy participants randomized into one of five planned cohorts in a 6:3 ratio of DA-1726 or placebo. Part 2 of the trial is a multiple ascending dose (MAD) study that is expected to enroll approximately 36 obese but otherwise healthy participants into four planned cohorts, with each to receive four weekly administrations of DA-1726 or placebo, randomized in a 6:3 ratio. The primary endpoint will assess the safety and tolerability of DA-1726 with secondary endpoints examining the pharmacokinetics (PK) of DA-1726. Exploratory endpoints include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference, and body mass index. Topline results from Part 1 of the study are anticipated in the third quarter of 2024 while topline results from Part 2 are expected in the first quarter of 2025.

Following clearance of the updated IND application with the FDA, we anticipate Part 3 of the Phase 1 trial initiating in the third quarter of 2025 and an interim data readout in mid-2026 and topline results being reported in the second half of 2026. The following slide provides an overview of Part 3 of the trial, which will evaluate early proof of concept and maximum titratable dose of DA-1726.

Joint Research Agreement to Develop Once-Monthly Formulation of DA-1726

On August 6, 2024, NeuroBo announced a joint research agreement, together with Dong-A ST Co. Ltd. and ImmunoForge, to develop a long-acting, once-monthly formulation of DA-1726. ImmunoForge’s elastin-like polypeptide (ELP) platform technology is comprised of individual building blocks derived from a five-amino acid repeat motif found in the human protein elastin. The five-amino acid motif is repeated multiple times to form an ELP biopolymer and this biopolymer can then be covalently attached to a peptide or protein of interest. The ELP fusion proteins undergo a temperature-dependent phase transition, where at lower temperatures the ELP fusion proteins are completely soluble but at warmer temperatures (e.g., body temperature) the ELP fusion proteins are in a gel-like state, resulting in an extended circulating half-life and exposure of active molecules for extended periods of time.