NASDAQ:NRBO
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Business Update
First Patient Dosed in Phase 1 Trial of DA-1726
On April 18, 2024, NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO) announced the first patient was dosed in the 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 is expected to enroll approximately 45 obese but otherwise healthy participants randomized into one of five planned cohorts. Each cohort will be randomized 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.
Enrollment Complete in Part 1 of Phase 2a Trial of DA-1241
On April 1, 2024, NeuroBo announced the completion of enrollment of Part 1 of the two-part, Phase 2a clinical trial of DA-1241 for the treatment of metabolic dysfunction-associated steatohepatitis (MASH; formerly NASH). This follows the news in March 2024, in which NeuroBo announced that the Safety Review Committee (SRC) recommended that the two-part Phase 2a trial of DA-1241 continue without modification following a blinded safety review of the first six months of study conduct. We anticipate topline data from the trial in the second half of 2024.
The Phase 2a trial of DA-1241 is designed to be a 16-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of the compound in subjects with presumed MASH. Part 1 is exploring the efficacy of DA-1241 compared to placebo and enrolled approximately 49 subjects, who were randomized in a 1:2:1 ratio into three cohorts: DA-1241 50 mg, DA-1241 100 mg, or placebo. Part 2 will explore the efficacy of DA-1241 in combination with sitagliptin compared to placebo. Approximately 37 subjects will be randomized in a 2:1 ratio into two treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo.
DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist. GPR119 activation in the liver inhibits lipid synthesis and activation of immune cells and hepatic stellate cells, which are involved in MASH pathogenesis. Additionally, GPR119 agonism in the pancreas and gut results in insulin secretion and the release of key metabolic peptides GLP-1, GIP, and PYY, which are involved in glucose and lipid metabolism.
Financial Update
On March 28, 2024, NeuroBo announced financial results for fiscal year 2023. As expected, the company did not report any revenues in the year ending December 31, 2023. R&D expenses in 2023 were approximately $9.2 million compared to approximately $2.8 million in 2022. The increase was primarily attributed to increased drug manufacturing costs, non-clinical and pre-clinical services, clinical trials, and consulting. G&A expenses in 2023 were approximately $6.7 million compared to approximately $8.6 million in 2022. The decrease was primarily attributable to lower insurance costs, stock-based compensation, legal and professional fees, and employee compensation and benefits.
As of December 31, 2023, NeuroBo had approximately $22.4 million in cash and cash equivalents. We estimate that this is sufficient to fund operations into the fourth quarter of 2024. As of March 25, 2024, NeuroBo had approximately 4.9 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 5.1 million.
Conclusion
We’re glad to see that the first patient has been dosed in the Phase 1 trial of DA-1726 and that the company has moved up the timelines significantly for the topline data readouts. Where previously we had anticipated topline data from Part 1 of the study in the first half of 2025, we now anticipate data from Part 1 of the trial in the third quarter of 2024. Similarly, we had previously anticipated topline data from Part 2 of the trial in the second half of 2025 and we now anticipate topline data from Part 2 of the trial in the first quarter of 2025. In addition, we are looking forward to topline data from the Phase 2a trial of DA-1241 in the second half of 2024. With no changes to our model our valuation remains at $25 per share.
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