NASDAQ:NRBO
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Business Update
DA-1726 Exhibits Superiority to Survodutide in Pre-Clinical Models
On June 22, 2024, NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO) announced that pre-clinical data for DA-1726, the company’s dual oxyntomodulin (OXM) analog agonist of glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), demonstrated superiority in weight loss, retention of lean body mass, and lipid-lowering effects compared to survodutide. The data was presented in a poster at the American Diabetes Association (ADA) 84th Scientific Sessions. A copy of the poster can be found here.
The following image shows the different pre-clinical models utilized in the current study. Diet-induced obese (DIO) mice were used to evaluate the effect of DA-1726 and survodutide on body weight loss and fat mass loss while hyperlipidemic rats were utilized to analyze the effect on DA-1726 and tirzepatide on plasma lipids.
Comparison with Survodutide on body weight loss
In this study, DIO mice were treated with 200 nmol/kg DA-1726 or 70 nmol/kg survodutide twice a week for three weeks. The following images show the change in body weight and food intake over the course of the three-week study. Both the survodutide- and DA-1726-treated animals showed a statistically significant decrease in body weight and food intake compared to the control mice. In addition, DA-1726 showed superior weight loss efficacy compared to survodutde in spite of the fact that DA-1726-treated mice consumed more food.
DA-1726 also effectively lowered major plasma parameters (total cholesterol – T-CHO; triglycerides – TG; glucose – GLU) while significantly increasing the expression of energy expenditure related genes in brown adipose tissue (BAT).
Comparison with Survodutide on fat mass loss
In this study, DIO mice were treated with 60 nmol/kg DA-1726 or 30 nmol/kg survodutide daily for three weeks. Similar to the previous study, the following graphs show higher weight loss in the DA-1726-treated animals compared to the survodutide-treated animals with similar dietary intake. Histological analysis of fat mass also revealed an increase in beige or brown adipose-like cells in white adipose tissue, which supports the proposed mechanism of increased energy expenditure.
Looking specifically at fat mass, the following graphs show that DA-1726 treatment resulted in a greater reduction in fat mass and a higher percentage of lean mass preservation compared to survodutide treatment after two weeks of daily dosing.
Comparison with Tirzepatide on lipid-lowering
In this study, hyperlipidemic rats were treated with 500 nmol/kg DA-1726 or 50 nmol/kg tirzepatide twice a week for three weeks. The following graphs show that DA-1726 was more effective than tirzepatide in regulating lipid metabolism and suppressing weight gain despite having similar food intake.
Overall, these results point to DA-1726 being a potential best-in-class asset, potentially through the unique GLP-1 to glucagon receptor activity ratio. The fact that the compound is potentially superior to survodutide and has similar weight loss reduction as tirzepatide is very encouraging as the company looks to carve out a niche in the obesity market.
Phase 1 Part 3 Study Details
NeuroBo is currently conducting a Phase 1 trial of DA-1726. Part 1 and 2 of the trial are a single ascending dose (SAD – Part 1) and multiple ascending dose (MAD – Part 2) study in obese but otherwise healthy individuals. We anticipate topline results from Part 1 in the third quarter of 2024 and topline results from Part 2 in the first quarter of 2025. We anticipate Part 3 of the Phase 1 trial initiating in the third quarter of 2025 and topline results from Part 3 being reported in the second half of 2026. The following slide provides an overview of Part 3, which will evaluate the efficacy and maximum titratable dose of DA-1726.
Financial Update
On June 24, 2024, NeuroBo announced a private placement of 4,325,701 shares of common stock at a purchase price of $3.93. In addition, the company conducted a direct offering of 763,359 shares at the same purchase price. In addition, NeuroBo issued 5,089,060 Series A warrants and 7,633,591 Series B warrants with an exercise price of $3.93. The warrants will become exercisable following shareholder approval of the issuance of shares upon exercise of the warrants. The Series A warrants will expire on the earlier of 12 months following shareholder approval or 60 days following the public announcement of positive Phase 1 MAD data for DA-1726. The Series B warrants will expire on the earlier of five years following shareholder approval or six months following the public announcement of positive Phase 1 Part 3 data for DA-1726.
Conclusion
The pre-clinical data presented by NeuroBo at ADA are very encouraging and demonstrates the potential best-in-class properties for DA-1726. We look forward to topline results from Part 1 of the Phase 1 clinical trial of DA-1726 in the third quarter of 2024 followed by topline results of Part 2 of the Phase 1 trial in the first quarter of 2025. Following the recent financing, the company is now sufficiently capitalized through the topline data readout of Part 3 of the Phase 1 trial. We have incorporated the recent financing into our model, which has resulted in a slight decrease in our valuation, however this does not diminish our enthusiasm for the stock or the potential for DA-1726. Our valuation is now $22 per share.
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