Core Insights - NeuroBo Pharmaceuticals reported positive top-line data from the SAD Part 1 of its Phase 1 clinical trial for DA-1726, indicating favorable safety, tolerability, and dose-linear pharmacokinetics for obesity treatment [2][4] - The company has $21.7 million in cash as of September 30, 2024, which is expected to fund operations into the third quarter of 2025 [15] - Top-line results from the Phase 2a trial of DA-1241 for MASH are anticipated in December 2024, with further data from the MAD Part 2 of the Phase 1 trial of DA-1726 expected in the first quarter of 2025 [6][4] Clinical Developments - The SAD Part 1 trial of DA-1726 involved 45 obese participants, showing no serious adverse events and a favorable safety profile, leading to the addition of cohorts to explore maximum tolerated doses [4][2] - A joint research agreement was signed with Dong-A ST and ImmunoForge to develop a long-acting, once-monthly formulation of DA-1726 [3][5] - The company plans to initiate a multicenter, randomized, double-blind, placebo-controlled Part 3 of the Phase 1 clinical trial for DA-1726 after completing Part 2 [3] Financial Performance - R&D expenses for Q3 2024 were approximately $4.5 million, up from $2.3 million in Q3 2023, primarily due to increased activities for DA-1241 and DA-1726 [7] - For the nine months ended September 30, 2024, R&D expenses totaled approximately $17.5 million, compared to $5.3 million for the same period in 2023, reflecting ramped-up activities following the acquisition of the drug candidates [8] - The net loss for Q3 2024 was approximately $5.7 million, or $0.55 per share, compared to a net loss of $3.8 million, or $0.75 per share, in Q3 2023 [13] Future Milestones - The last patient visit in the MAD study Part 2 is expected in Q4 2024, with top-line data anticipated in Q1 2025 [6] - The planned Phase 1 Part 3 trial for DA-1726 is expected to begin in Q3 2025, with interim data readout around mid-2026 and top-line results in the second half of 2026 [6] - Top-line results from the two-part Phase 2a clinical trial of DA-1241 in MASH are expected in December 2024 [6]

Core Insights - NeuroBo Pharmaceuticals has completed the last patient visit in its two-part Phase 2a clinical trial for DA-1241, a GPR119 agonist targeting metabolic dysfunction-associated steatohepatitis (MASH), with topline data expected in December 2024 [1][2] Company Overview - NeuroBo Pharmaceuticals is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, currently developing DA-1241 for MASH and DA-1726 for obesity [6] Clinical Trial Details - The Phase 2a trial consists of two parts: Part 1 compares DA-1241 to placebo, while Part 2 evaluates DA-1241 in combination with sitagliptin [2] - A total of 109 patients were randomized, with 95 completing the dosing; the trial is designed as a 16-week, multicenter, randomized, double-blind, placebo-controlled study [2][3] Efficacy and Safety Evaluation - The primary endpoint for both parts of the trial is the change in alanine transaminase (ALT) levels at Week 16, with secondary endpoints including cholesterol levels and triglycerides [3] - Safety will be assessed through monitoring adverse events and laboratory abnormalities [3] Mechanism of Action - DA-1241 acts as a GPR119 agonist, promoting the release of gut peptides that influence glucose and lipid metabolism, with preclinical studies showing its potential in reducing liver inflammation and improving glucose control [5][6]

Group 1 - NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases [4] - The company is developing DA-1726 for obesity treatment and DA-1241 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [4] - DA-1726 is a novel oxyntomodulin (OXM) analogue acting as a dual agonist for glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), potentially leading to superior weight loss compared to selective GLP1R agonists [4] - DA-1241 is a G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides and has shown positive effects on liver inflammation, lipid metabolism, and glucose control in preclinical studies [4] Group 2 - Management will participate in the H.C. Wainwright 8th Annual MASH Virtual Conference on October 7, presenting a company overview [1] - One-on-one meetings will be available during the conference for interested investors [2] - The company will also participate in the Maxim Healthcare Virtual Summit from October 15-17, with a virtual fireside chat featuring the CEO and CFO [3]

Financial Performance - Cash position was approximately $27.9 million as of June 30, 2024, expected to fund operations into the second quarter of 2025[11] - Net loss for Q2 2024 was approximately $10.1 million, or $1.85 per share, compared to a net loss of $0.7 million, or $0.15 per share, in Q2 2023[10] - NeuroBo Pharmaceuticals reported total operating expenses of $10,084,000 for the three months ended June 30, 2024, compared to $3,806,000 for the same period in 2023, representing an increase of 164%[19] - The company incurred a net loss of $10,053,000 for the three months ended June 30, 2024, compared to a net loss of $734,000 for the same period in 2023, indicating a significant increase in losses[19] - Research and development expenses for the six months ended June 30, 2024, were $12,978,000, up from $3,001,000 for the same period in 2023, reflecting a 332% increase[19] - The accumulated deficit increased to $(125,032,000) as of June 30, 2024, compared to $(108,265,000) as of December 31, 2023, reflecting a deterioration of 15.5%[18] Research and Development - Research and Development (R&D) expenses for Q2 2024 were approximately $8.1 million, up from $2.4 million in Q2 2023, reflecting increased activities for DA-1241 and DA-1726[6] - DA-1726 demonstrated superiority in weight loss and lipid-lowering effects in pre-clinical models compared to Survodutide and Tirzepatide[1] - The SAD Part 1 of the Phase 1 trial for DA-1726 was fully enrolled with 45 participants, and top-line data is expected in Q3 2024[4] - DA-1241 Phase 2a trial for MASH is underway, with top-line data expected in Q4 2024[5] - A joint research agreement was signed with Dong-A ST and ImmunoForge to develop a long-acting formulation of DA-1726[4] - NeuroBo is developing DA-1726 and DA-1241 for obesity and MASH, respectively, with DA-1726 being a dual agonist that may lead to superior weight loss compared to selective GLP1R agonists[12] - The company is focused on transforming cardiometabolic diseases, with ongoing clinical trials and a commitment to advancing its product candidates[12] Financing and Capital Structure - NeuroBo Pharmaceuticals successfully completed a financing of up to $70 million, with $20 million upfront and an additional $50 million upon the exercise of clinical milestone-based warrants[1] - The company anticipates that Series A Warrants from the June financing could be exercised in the first half of 2025, resulting in gross proceeds of $20 million[11] - As of June 30, 2024, NeuroBo's total current assets were $28,517,000, an increase from $22,512,000 as of December 31, 2023, showing a growth of 27%[17] - The company's cash balance increased to $27,934,000 as of June 30, 2024, compared to $22,435,000 as of December 31, 2023, representing a 24% increase[17] - Total liabilities as of June 30, 2024, were $9,809,000, up from $6,096,000 as of December 31, 2023, indicating a rise of 61%[16] - The weighted average shares of common stock, basic and diluted, were 5,428,906 for the three months ended June 30, 2024, compared to 5,059,003 for the same period in 2023, showing an increase of 7.3%[19]

Successfully Completed a Financing of up to $70 Million, With $20 Million Upfront and an Additional $50 Million of Aggregate Gross Proceeds Upon the Exercise in Full of Clinical Milestone-Based Warrants $27.9 Million in Cash at End of Second Quarter is Expected to Fund the Company Though Multiple ValueCreating Milestones, Into the Second Quarter of 2025. Assuming Positive Results From the DA-1726 Phase 1 MAD Study, the Company Anticipates That the Series A Warrants From the June Financing Could be Exercised ...

No Significant Issues Encountered During the Single Ascending Dose (SAD) Study, Allowing for Previously Reported Accelerated Start to Multiple Ascending Dose (MAD) Part 2 Top Line Data Readout from SAD Part 1 Expected in the Third Quarter of 2024, and from the MAD Part 2 in the First Quarter of 2025 CAMBRIDGE, Mass., Aug. 13, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the completi ...

Collaboration to Leverage ImmunoForge's ELP Platform Technology Which Can Increase the Half-Life of a Drug by up to 200 Times CAMBRIDGE, Mass., Aug. 6, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has signed a joint research agreement, together with Dong-A ST Co. Ltd. and ImmunoForge, to develop a long-acting, once-monthly, formulation of DA-1726, a novel, dual oxyntomodulin ...

CAMBRIDGE, Mass., July 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced the signing of an exclusive license agreement, providing MThera Pharma Co., Ltd. (MTHERA) with the rights to NB-01 for the treatment of painful diabetic neuropathy. The agreement allows MTHERA to conduct research and clinical trials, including, but not limited to, a potential Phase 3 clinical trial in t ...

CAMBRIDGE, Mass., July 11, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that Hyung Heon Kim, President and Chief Executive Officer and Marshall H. Woodworth, Chief Financial Officer, will present a company overview at the Emerging Growth Conference on Thursday, July 18, 2024 at 10:50 am ET. After the presentation, NeuroBo management will open the floor for questions. Please submit y ...

Top-Line Data Readout From the Single Ascending Dose Part 1 Expected in the Third Quarter of 2024, and From the Multiple Ascending Dose Part 2 in the First Quarter of 2025 Recent Financing of up to $70 million Will Fund the Ongoing Clinical Development of DA-1726 "Dosing of the first patient in Part 2 of this trial, late in the second quarter, ahead of schedule, is a further reflection of our strong commitment to swiftly advancing the clinical development of DA-1726, which holds promise as a highly differen ...