Financial Performance - Total operating expenses for the three months ended September 30, 2024, were $6.3 million, an increase of $2.4 million, or 60.8%, compared to the same period in 2023[89]. - Net loss for the three months ended September 30, 2024, was $5.7 million, or $0.55 per share, compared to a net loss of $3.8 million, or $0.75 per share for the same period in 2023[94]. - Total operating expenses for the nine months ended September 30, 2024, were $23.2 million, an increase of $13.0 million, or 127.3%, compared to the same period in 2023[95]. - Net loss for the nine months ended September 30, 2024, was $22.4 million, or $3.24 per share, compared to a net loss of $7.2 million, or $1.41 per share for the same period in 2023[100]. - Cash balance as of September 30, 2024, was $21.7 million, with an accumulated deficit of $130.7 million[102]. - Net cash used in operating activities was $19.3 million for the nine months ended September 30, 2024, compared to $7.4 million for the same period in 2023[108]. - Net cash provided by financing activities was $18.5 million for the nine months ended September 30, 2024, compared to net cash used of $0.1 million in 2023[110]. Research and Development - Research and development expenses for the three months ended September 30, 2024, were $4.5 million, an increase of $2.2 million, or 97.1%, compared to the same period in 2023[90]. - Research and development expenses for the nine months ended September 30, 2024, were $17.5 million, an increase of $12.2 million compared to the same period in 2023[95]. - R&D expenses increased by $12.2 million, or 230.5%, to $17.5 million for the nine months ended September 30, 2024, primarily due to clinical trial activities for DA-1241 and DA-1726[96]. - DA-1241 is currently in a Phase 2a trial for the treatment of MASH, with 109 patients randomized and top-line results expected in December 2024[77]. - DA-1726 is in a Phase 1 trial for obesity, with 45 subjects randomized in the single ascending dose study, which was found to be safe and well tolerated[80]. - A joint research agreement was signed with ImmunoForge to develop a long-acting formulation of DA-1726 utilizing ELP technology[84]. - An exclusive out-license agreement was signed with MThera for the development and commercialization of NB-01 for painful diabetic neuropathy[85]. Income and Expenses - Total other income for the three months ended September 30, 2024, was $0.6 million, an increase of $0.5 million, or 709.3%, compared to the same period in 2023[92]. - Total other income decreased by $2.3 million, or 73.7%, to $0.8 million for the nine months ended September 30, 2024, primarily due to lower gains from warrant liabilities[99]. - General and administrative expenses rose by $0.8 million, or 16.3%, to $5.7 million for the nine months ended September 30, 2024, mainly due to higher employee compensation[98]. Future Outlook - The company expects to continue incurring net losses and negative cash flows from operating activities for the foreseeable future due to ongoing clinical trials[102]. - The company plans to fund operations through equity offerings, debt financings, or collaborations, but there is no assurance of obtaining financing on acceptable terms[103]. Legal and Compliance - Material weaknesses in internal control over financial reporting have been identified, and remediation efforts are ongoing[119]. - NeuroBo Pharmaceuticals is not currently involved in any claims or legal proceedings that are likely to have a material adverse effect on its business[125]. - The company acknowledges that litigation can have an adverse impact due to defense and settlement costs, as well as diversion of management resources[125]. - Management believes that current legal proceedings will not materially affect the company's financial position[125]. - The company is engaged in ordinary course business activities that may lead to various claims and legal proceedings[125]. - There is an emphasis on the potential adverse impacts of litigation, highlighting risk management considerations[125]. - The company maintains a proactive stance in monitoring legal risks associated with its operations[125]. - No specific financial figures or performance metrics were disclosed in the legal proceedings section[125]. - The company continues to prioritize its core business despite potential legal challenges[125]. - Management resources may be diverted due to litigation, which could impact operational efficiency[125].

Financial Performance - NeuroBo Pharmaceuticals reported a net loss of approximately $5.7 million for Q3 2024, or $0.55 per share, compared to a net loss of approximately $3.8 million, or $0.75 per share, in Q3 2023[13]. - The net loss for the three months ended September 30, 2024, was $5,652 thousand, compared to a net loss of $3,818 thousand for the same period in 2023, reflecting an increase in loss of approximately 48.0%[24]. - The loss per share for the three months ended September 30, 2024, was $(0.55), compared to $(0.75) for the same period in 2023[24]. Research and Development - Research and Development (R&D) expenses for Q3 2024 were approximately $4.5 million, up from approximately $2.3 million in Q3 2023, reflecting increased activities for DA-1241 and DA-1726[7]. - R&D expenses for the nine months ended September 30, 2024, were approximately $17.5 million, compared to $5.3 million for the same period in 2023, reflecting increased clinical trial expenditures[8]. - Research and development expenses for the three months ended September 30, 2024, were $4,517 thousand, up 97.2% from $2,292 thousand for the same period in 2023[24]. - Positive top-line data from the SAD Part 1 of the Phase 1 trial of DA-1726 indicated favorable safety and tolerability, with 45 participants showing no serious adverse events[5]. - Top-line results from the Phase 2a trial of DA-1241 for the treatment of MASH are expected in December 2024[6]. - The last patient visit in the MAD study Part 2 for DA-1726 is expected in Q4 2024, with top-line data anticipated in Q1 2025[6]. - The company plans to initiate Part 3 of the Phase 1 clinical trial for DA-1726 in Q3 2025, following the completion of Part 2[4]. - A joint research agreement was signed with Dong-A ST and ImmunoForge to develop a long-acting, once-monthly formulation of DA-1726[3]. Financial Position - The company had approximately $21.7 million in cash as of September 30, 2024, expected to fund operations into Q3 2025[15]. - Total current assets decreased from $22,512 thousand as of December 31, 2023, to $21,935 thousand as of September 30, 2024, a decline of approximately 2.56%[21]. - Total liabilities increased from $6,096 thousand as of December 31, 2023, to $9,193 thousand as of September 30, 2024, representing an increase of approximately 50.00%[22]. - Total stockholders' equity decreased from $16,685 thousand as of December 31, 2023, to $12,953 thousand as of September 30, 2024, a decline of approximately 22.4%[23]. Other Income and Expenses - Total other income for Q3 2024 was approximately $0.6 million, compared to $0.1 million in Q3 2023, primarily due to a gain related to the change in fair value of warrant liabilities[11]. - Total operating expenses rose to $6,259 thousand for the three months ended September 30, 2024, compared to $3,893 thousand for the same period in 2023, an increase of approximately 60.7%[24]. - The change in fair value of warrant liabilities resulted in an income of $297 thousand for the three months ended September 30, 2024, compared to an expense of $(87) thousand for the same period in 2023[24]. - Interest income increased to $310 thousand for the three months ended September 30, 2024, from $162 thousand for the same period in 2023, an increase of approximately 91.4%[24].

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 ...

Core Insights - NeuroBo Pharmaceuticals has signed an exclusive license agreement with MThera Pharma for NB-01, aimed at treating painful diabetic neuropathy, allowing MThera to conduct research and clinical trials, including a potential Phase 3 trial in the U.S. and South Korea [1][2] - The agreement is a strategic move for NeuroBo to focus on the clinical development of its other assets, DA-1726 and DA-1241, while leveraging MThera's expertise in natural medicines and botanical drugs [2] - MThera plans to utilize its SyMthomics platform technology to identify the mechanism of action and active ingredients of NB-01, aiming to advance it into the next phase of clinical development [2] Company Overview - NeuroBo Pharmaceuticals is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, currently developing DA-1726 for obesity and DA-1241 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) [4] - DA-1726 is a novel oxyntomodulin analogue acting as a dual agonist for GLP1R and GCGR, potentially leading to superior weight loss compared to selective GLP1R agonists [4] - DA-1241 is a GPR119 agonist that has shown positive effects on liver inflammation, lipid metabolism, and glucose control in preclinical studies [4] MThera Pharma Overview - MThera Pharma, based in Seoul, South Korea, develops first-in-class botanical drug products using multi-component therapies for chronic diseases like Parkinson's and inflammatory bowel disease [3] - The company's SyMthomics platform integrates AI-based systems biology and bioinformatics to ensure therapeutic consistency and meet FDA requirements [3]