DA-1241

Data Revealed Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics (PK) Top-Line Data Readout from the MAD Part 2 Expected in the First Quarter of 2025 Planned Phase 1 Part 3 Will Evaluate Early Proof of Concept CAMBRIDGE, Mass., Sept. 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive top-line safety, tolerability, and dose-linear pharmacokinetics (PK) data from the single ascending dose (SAD) Part 1 of its 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), for the treatment of obesity. In the SAD Part 1 of the Phase 1 clinical trial, a total of 45 obese, otherwise healthy participants were randomized in a double-blind, 6:3 ratio of DA-1726 or placebo. Single ascending doses were found to be safe and well tolerated, with no serious adverse events. Only 5 subjects in the DA-1726 treatment group reported adverse events (AEs) compared with 3 subjects in the placebo group. A dose-linear PK profile was observed across the investigated dose range. Additional cohorts are being added to the SAD Part 1 to explore the maximum tolerated dose. "The safety, tolerability and dose-linear PK data generated from the Part 1 SAD trial are highly encouraging and allowed for the accelerated initiation of our multiple ascending dose (MAD) study," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "In light of the strong safety profile from the SAD Part 1 of the study, we are in the process of adding one or more cohorts to further explore the maximum tolerated dose, which will allow us to realize the full potential of DA-1726. Based on the preclinical data generated to date, as well as DA-1726's balanced activation of GLP1R and glucagon receptors, which increases energy expenditure, we continue to believe that DA-1726 may become a best-in-class obesity drug with a better tolerability profile than currently marketed GLP-1 agonists, and those now in late-stage clinical trials. We eagerly anticipate reporting top-line data from the MAD Part 2 in the first quarter of 2025, which will give us an early read on clinical efficacy. Additionally, we continue to plan Part 3 of the trial that will explore early proof of concept." The MAD Part 2 of the Phase 1 trial is a randomized, placebo-controlled, double-blind study to investigate the safety, tolerability, PK, and PD of multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 2 is expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into 4 planned cohorts, each to receive 4 weekly administrations of DA-1726 or placebo. The first patient in the MAD study was dosed ahead of schedule, in late June, as previously reported. The primary endpoint of the Phase 1 trial is to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints will include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others. For more information on this clinical trial, please visit: NCT06252220. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®) and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. For more information, please visit . Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: NeuroBo Pharmaceuticals Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE NeuroBo Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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 Value-Creating 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 in the First Half of 2025, Resulting in Gross Proceeds of $20 Million In Pre-Clinical Models, DA-1726 Demonstrated Superiority in Weight Loss, Retention of Lean Body Mass and Lipid-Lowering Effects, Plus Superior Glucose Lowering Effects Compared to Survodutide; Lipid-Lowering Effect Also Shown to be Superior Compared to Tirzepatide Fully Enrolled the SAD Part 1 of the Phase 1 Trial of DA-1726, With Top-Line Data Readout Expected in the Third Quarter of 2024, and From the MAD Part 2 in the First Quarter of 2025 Planned Phase 1 Part 3 Trial of DA-1726 in Obesity Will Assess Total Weight Loss at 24 Weeks, Exploring Maximum Titratable Dose and Dietary Changes; Interim Data Readout Expected Mid-2026 with Top-Line Data in the Second Half of 2026 Entered into a Joint Research Agreement, Together With Dong-A ST and ImmunoForge to Develop a Long-Acting Once-Monthly Formulation of DA-1726 Part 2 of the Phase 2a Trial of DA-1241 for the Treatment of MASH Underway With Top-Line Data Expected in the Fourth Quarter of 2024 CAMBRIDGE, Mass., Aug. 14, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the second quarter ended June 30, 2024 and provided a corporate update. "During the second quarter and subsequently, we made remarkable progress advancing the clinical development of our two, next generation cardiometabolic assets and are now well capitalized to execute on our upcoming DA-1726 milestones following our recent, successful financing of up to $70 million in aggregate gross proceeds, with $20 million upfront and $50 million of clinical milestone-based warrants," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "We expect this financing will enable us to fully fund an early proof-of-concept multicenter, randomized, double-blind, placebo-controlled Part 3 of the 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), for the treatment of obesity. Part 3, which will begin upon completion of Part 2, will explore changes in baseline, at 24 weeks, for total weight loss, weight loss through fat or lean muscle mass reduction, dietary changes, maximum-tolerated individualized dose and other exploratory endpoints. Additionally, 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 differentiated therapy for the treatment of obesity. It is also worth noting that, just last week, we signed a joint research agreement, together with our collaboration partner, Dong-A ST and ImmunoForge, as a first step toward potentially developing a long-acting formulation of DA-1726 which would both enhance patient compliance and ease of administration. "During the American Diabetes Association (ADA) 84th Scientific Sessions in June, we shared pre-clinical data that highlighted the unique characteristics of DA-1726 compared to other obesity drugs in the same class. The data suggests that DA-1726's unique GLP-1 and glucagon receptor activity ratio may be responsible for its differentiated profile. In obese mouse models, DA-1726 demonstrated significant reductions in cholesterol levels and superior weight loss, compared to survodutide, a drug with the same mechanism of action, while also exhibiting superior glucose lowering and retention of relative lean body mass preservation. Previous pre-clinical research also indicated that DA-1726 led to weight reduction while consuming more food than tirzepatide. Additional data presented at the ADA, from a hypercholesterolemia rat model, confirmed that DA-1726 is also more effective than tirzepatide in lowering cholesterol levels potentially due to its glucagon action and GLP-1 effect, while also preventing weight gain. These pre-clinical findings suggest that DA-1726 could emerge as a best-in-class obesity drug with improved tolerability compared to current GLP-1 agonists and those in late-stage clinical trials, given its balanced activation of GLP1R and glucagon receptors, while increasing energy expenditure. Yesterday, we announced the full enrollment of the single ascending dose (SAD) Part 1, for which we anticipate reporting top-line data in the third quarter of this year and top-line data from the MAD Part 2 in the first quarter of 2025. Upon clearance of an updated Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), we expect to dose the first patient in Part 3 during the third quarter of 2025, providing an interim data readout in or around mid-2026 and issuing top-line results in the second half of 2026." Mr. Kim concluded, "Additionally, early in the quarter, 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, exploring the efficacy of DA-1241 in combination with sitagliptin, a DPP-4 inhibitor, which we believe will show synergistic effects compared to DA-1241, alone. New pre-clinical evidence on DA-1241 in combination with semaglutide (Wegovy®), was 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 August 2024: Completed enrollment in the SAD Part 1 of the Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity. A total of 45 participants were enrolled and randomized into one of 5 cohorts, with each cohort having been randomized in a 6:3 ratio of DA-1726 to placebo. August 2024: Signed a joint research agreement, along with Dong-A ST and ImmunoForge, to develop a long-acting, once-monthly, formulation of DA-1726 utilizing ImmunoForge's long-lasting half-life extension Elastin-Like Polypeptide (ELP) platform technology. July 2024: Signed an exclusive out-license agreement, providing MThera Pharma Co., Ltd. (MTHERA) with the rights to develop and commercialize NB-01, one of four legacy assets, for the treatment of painful diabetic neuropathy, allowing MTHERA to conduct research and clinical trials, including, but not limited to, a potential Phase 3 clinical trial in the United States and South Korea, for the future commercialization of NB-01. July 2024: Engaged veteran biotech and pharmaceutical professional, Chris Fang, MD, as Advisor/Consulting Chief Medical Officer, effective July, 2, 2024. June 2024: Completed enrollment of Part 2 of the Phase 2a trial evaluating the efficacy and safety of DA-1241 in MASH. Approximately 37 patients with presumed MASH were randomized with a 2:1 ratio into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo. June 2024: Dosed the first patient in the MAD Part 2 of its two-part 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), for the treatment of obesity. June 2024: Closed a concurrent placement and registered direct offering priced at-the-market under Nasdaq rules, with $20 million up front with up to an additional $50 million of aggregate gross proceeds upon the exercise in full of clinical milestone-based warrants. June 2024: Presented pre-clinical data at the American Diabetes Association (ADA) 84th Scientific Sessions, suggesting that DA-1726 demonstrated superiority in weight loss, retention of lean body mass, and lipid-lowering effects compared to survodutide. June 2024: Presented new pre-clinical data, at the EASL Congress, that suggests DA-1241, in combination with semaglutide (Wegovy®), a GLP1R agonist, improves liver fibrosis and demonstrates additive hepatoprotective effects in pre-clinical metabolic dysfunction-associated steatohepatitis (MASH) models compared to either treatment alone. April 2024: Dosed the first patient in the SAD Part 1 of its 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 with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo. 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. The last patient visit in the multiple ascending dose (MAD) study Part 2 is expected in the fourth quarter of 2024 and the top-line data is expected in the first quarter of 2025. Upon clearance of an updated IND application with the FDA, the first patient in Part 3 is expected to be enrolled during the third quarter of 2025, with an interim data readout in or around mid-2026 and top-line results are expected in the second half of 2026. DA-1241 in MASH: Top-line results from the two-part Phase 2a clinical trial of DA-1241 in MASH are expected to be available in the fourth quarter of 2024. Second Quarter Financial and Operating Results Research and Development (R&D) Expenses were approximately $8.1 million for the three months ended June 30, 2024, as compared to approximately $2.4 million for the three months ended June 30, 2023. The increase of approximately $5.7 million was primarily related to increased R&D activities for DA-1241 and DA-1726 for the three months ended June 30, 2024 following commencement of the Phase 2a clinical trial for DA-1241 and Phase 1 trial for DA-1726, compared to the three months ended June 30, 2023 when R&D activities were starting to ramp up following the acquisition of DA-1241 and DA-1726 in the fourth quarter of 2022. Specifically, the $5.7 million increase in R&D expenses was primarily attributable to (i) $5.4 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii) $0.3 million in higher employee compensation and benefits. R&D expenses were approximately $13.0 million for the six months ended June 30, 2024, as compared to approximately $3.0 million for the six months ended June 30, 2023. The approximately $10.0 million increase was primarily related to increased R&D activities for DA-1241 and DA-1726. Specifically, the $10.0 million increase in R&D expenses was primarily attributable to (i) $9.3 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii) $0.7 million in higher employee compensation and benefits. General and Administrative (G&A) Expenses were approximately $2.0 million for the three months ended June 30, 2024, compared to approximately $1.4 million for the three months ended June 30, 2023. The increase of approximately $0.6 million was primarily attributable to $0.4 million in higher employee compensation and benefits and $0.1 million in higher non-cash stock-based compensation. G&A expenses were approximately $4.0 million for the six months ended June 30, 2024, as compared to approximately $3.3 million for the six months ended June 30, 2023. The approximately $0.7 million increase was primarily attributable to $0.4 million in higher employee compensation and benefits and $0.2 million in higher non-cash stock-based compensation. Other Income was approximately $31 thousand for the three months ended June 30, 2024, as compared to approximately $3.1 million for the three months ended June 30, 2023. The approximately $3.0 million decrease was primarily attributable to a loss of $0.1 million related to the change in fair value of warrant liabilities for the three months ended June 30, 2024, compared to a gain of $3.1 million for the three months ended June 30, 2023, partially offset by $0.2 million of interest income earned on the cash balance for the three months ended June 30, 2024, of which there was none for the three months ended June 30, 2023. Other income was approximately $0.2 million for the six months ended June 30, 2024, as compared to approximately $3.0 million for the six months ended June 30, 2023. The approximately $2.8 million decrease was primarily attributable to the recording of a loss of $0.2 million related to the change in fair value of warrant liabilities for the six months ended June 30, 2024 compared to a gain of $3.0 million for three months ended June 30, 2023, partially offset by $0.4 million of interest income earned on the cash balance for the six months ended June 30, 2024, of which there was none for the six months ended June 30, 2023. Net Loss for the three months ended June 30, 2024, was approximately $10.1 million, or $1.85 per basic and diluted share, based on 5,428,906 weighted average shares of common stock, basic and diluted, compared with a net loss of approximately $0.7 million, or $0.15 per basic and diluted share, based on 5,059,003 weighted average shares of common stock, basic and diluted, for the three months ended June 30, 2023. Net loss for the six months ended June 30, 2024, was approximately $16.8 million, or $3.19 per basic and diluted share, based on 5,259,939 weighted average shares of common stock, basic and diluted, compared with a net loss of approximately $3.3 million, or $0.66 per basic and diluted share, based on 5,059,003 weighted average shares of common stock, basic and diluted, for the six months ended June 30, 2023. Cash was approximately $27.9 million as of June 30, 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 second quarter of 2025. The Company anticipates that the Series A Warrants from the June financing could be exercised in the first half of 2025, resulting in gross proceeds of $20 million. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. For more information, please visit . Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects," "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K.. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: NeuroBo Pharmaceuticals, Inc. Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] - Tables to Follow - SOURCE NeuroBo Pharmaceuticals, Inc.