Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Line Data Readout Expected in the Third Quarter of 2024 Anticipate First Patient to be Dosed in the Multiple Ascending Dose Part 2 of the Phase 1 Clinical Trial of DA-1726 in the Third Quarter of 2024 Part 2 of the Phase 2a Trial of DA-1241 for the Treatment of MASH Underway After Enrollment of Part 1 Completed, With Data Expected in the Fourth Quarter of 2024 Cash of $16.0 Million, Expected to Fund the Company Into the Fourth Quarter of 2024 CAMBRIDGE, Mass., May 9, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update. "During the first quarter and subsequently, we continued to diligently advance the clinical development of our two, next generation cardiometabolic assets, with promising therapeutic potential in the obesity and metabolic dysfunction-associated steatohepatitis (MASH) markets," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "This past month, we began dosing patients in our first-in-human, Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), in obesity. Based on pre-clinical evidence generated to date, we strongly believe that DA-1726 may offer a superior tolerability profile compared to currently available GLP-1 agonists, due to its unique ratio of GLP1R and glucagon receptors, reducing food intake while increasing energy expenditure, leading to improved patient outcomes. Looking ahead for DA-1726, we eagerly anticipate presenting new, compelling pre-clinical data at the American Diabetes Association 84th Scientific Sessions in June of this year. We anticipate reporting top-line data from the single ascending dose (SAD) Part 1 in the third quarter of this year and also expect to dose the first patient in the multiple ascending dose (MAD) Part 2 in the third quarter of this year, with the expectation for the top-line data from the MAD Part 2 in the first quarter of 2025." Mr. Kim continued, "Additionally, just after quarter end, we fully enrolled Part 1 of the Phase 2a clinical trial for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist for treating MASH. This milestone followed closely on the heels of the Safety Review Committee (SRC) approval, allowing the study to continue without modification, an early indication of the safety of DA-1241. Part 2 of this trial, in combination with sitagliptin, a DPP4 inhibitor, continues to enroll patients. Pre-clinical safety data, reported in January, showed promising results for DA-1241 for this combination therapy. Notably, two poster presentations, with new pre-clinical evidence on DA-1241 in combination with semaglutide (Segovia®), will be presented at the EASL Congress 2024, in June. Based on both pre-clinical and clinical evidence generated to date, we continue to believe that DA-1241 has the potential to be a safe and effective treatment for MASH and anticipate reporting top-line results in the fourth quarter of this year." First Quarter 2024 and Subsequent Highlights April 2024: Dosed the first patient in the SAD Part 1 of its two-part Phase 1 clinical trial of DA-1726 for the treatment of obesity. April 2024: Completed enrollment of Part 1 of its two-part Phase 2a trial evaluating the efficacy and safety of DA-1241 in MASH. Approximately 49 patients with presumed MASH were randomized into Part 1 with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo. March 2024: Received SRC approval to continue the two-part Phase 2a trial of DA-1241 for the treatment of MASH without modification following a blinded safety review of the first six months of study conduct. March 2024: Announced the appointment of Marshall Woodworth as Chief Financial Officer, following his tenure as Acting Chief Financial Officer. February 2024: Received first site Institutional Review Board (IRB) approval for Alexander Prezioso, M.D., Investigator, Clinical Pharmacology of Miami, in Hialeah, FL, to proceed with the Phase 1 clinical trial of DA-1726 for the treatment of obesity. February 2024: Announced that the FDA has cleared its Investigational New Drug (IND) application for the Phase 1 clinical trial of DA-1726 in obesity. January 2024: Reported positive pre-clinical safety data of DA-1241 in combination with sitagliptin, a DPP4 inhibitor. The pre-clinical results demonstrated that once daily oral administration in rats, of sitagliptin alone (180 mg/kg/day), DA-1241 alone (100 mg/kg/day), or sitagliptin in combination with DA-1241 (up to 180/100 mg/kg/day sitagliptin+DA-1241) for 13 weeks, was well tolerated with no adverse effects. Additionally, opened enrollment for Part 2 of its Phase 2a clinical trial of DA-1241 when co-administered with sitagliptin for the treatment of MASH. Anticipated Clinical Milestones DA-1726 in Obesity: Top-line data from the single ascending dose (SAD) Part 1 is expected in the third quarter of 2024. Initiation of the multiple ascending dose (MAD) study Part 2 is expected in the third quarter of 2024 and the top-line data expected in the first quarter of 2025. DA-1241 in MASH: Full enrollment of the two-part Phase 2a clinical trial of DA-1241 in MASH is expected in the third quarter of 2024. Top-line results are expected to be available in the fourth quarter of 2024. First Quarter Financial and Operating Results Research and Development (R&D) Expenses were approximately $4.9 million for the three months ended March 31, 2024, as compared to approximately $0.6 million for the three months ended March 31, 2023. The increase of approximately $4.3 million was primarily attributable to increased development activities for DA-1241 and DA-1726. Specifically, the $4.3 million increase in R&D expenses was primarily attributable to (i) $3.9 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii) $0.4 million in higher employee compensation and benefits. General and Administrative Expenses were approximately $2.0 million for the three months ended March 31, 2024, compared to approximately $1.9 million for the three months ended March 31, 2023. The increase of approximately $0.1 million was primarily attributable to $0.2 million in higher non-cash stock-based compensation, partially offset by $0.1 million in lower legal and professional fees. Other Income (Expense) was approximately $0.2 million for the three months ended March 31, 2024, compared to approximately ($0.1 million) for the three months ended March 31, 2023. The change was primarily attributable to $0.2 million of interest income earned on our cash balance for the three months ended March 31, 2024, of which there was none for the three months ended March 31, 2023. Net Loss for the three months ended March 31, 2024, was approximately $6.7 million, or $1.32 per basic and diluted share, based on 5,089,408 weighted average shares of common stock, basic and diluted, compared with a net loss of approximately $2.6 million, or $0.51 per basic and diluted share, based on 5,059,003 weighted average shares of common stock, basic and diluted, for the three months ended March 31, 2023. Cash was approximately $16.0 million as of March 31, 2024, compared to approximately $22.4 million as of December 31, 2023. The company expects its cash position will be adequate to fund operations into the fourth quarter of 2024 ...