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].
NeuroBo Pharmaceuticals(NRBO) - 2024 Q3 - Quarterly Report