Gemcabene Calcium

Dosing of First Patient in Phase 2a Clinical Trial of DA-1241 Expected September 2023 Cash and Cash Equivalents of $28.7 Million, Expected to Fund the Company into 2024, Through Multiple Clinical Milestones BOSTON, Aug. 9, 2023 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced financial results for the second quarter ended June 30, 2023 and provided a corporate strategic update. "During the second quarter and thereafter, we have made significant progress advancing the development of our two promising cardiometabolic assets, which address the underserved nonalcoholic steatohepatitis (NASH) market and the significant obesity and type 2 diabetes (T2D) markets," stated Joe Hooker, Interim President and Chief Executive Officer of NeuroBo. "Notably, in May, we received U.S. Food and Drug Administration (FDA) approval of our Investigational New Drug (IND) application for DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, for the treatment of NASH. This was followed, just recently, with receipt of first site Institutional Review Board (IRB) approval for the Phase 2a clinical trial of DA-1241. We look forward to working closely with our contract research organization (CRO) partner and our site investigators, with the goal to dose the first patient next month. We believe that the mechanism of action of DA-1241 will translate into a new and effective treatment for NASH. In preclinical studies, DA-1241 demonstrated a beneficial effect on liver inflammation and fibrosis, lipid metabolism and glucose metabolism, and was shown to be safe and well tolerated in Phase 1a/1b studies in healthy volunteers and patients with T2D. As previously announced, the two-part design will provide optionality for an interim analysis in the first half of 2024, and we anticipate a full data readout in the second half of 2024. "Additionally, in June, positive preclinical data was presented at the American Diabetes Association's 83rd Scientific Sessions, demonstrating that our second asset, DA-1726, a novel oxyntomodulin (OXM) analogue which acts as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist, elicits superior weight loss efficacy compared to Semaglutide (SEMA) and Tirzepatide (TIR) and effective glycemic control in mice models. We intend to advance DA-1726 through the IND process during the second half of this year. If accepted by the FDA, we plan to initiate a Phase 1a safety study in the first half of 2024, with a data readout expected in the second half of 2024. Based on the preclinical evidence demonstrating superior body weight loss compared with other selective GLP1R agonists, we are optimistic about the potential of DA-1726 to address the significant obesity market." Mr. Hooker added, "We have also made progress toward our goal of evaluating potential out-licensing and acquisition opportunities for our four legacy therapeutic programs and recently announced signing of a term sheet with MThera Pharma Co., Ltd. (MTHERA) to out-license the worldwide rights, outside of Korea, for NB-01 for the treatment of painful diabetic neuropathy. With MTHERA's deep knowledge of manufacturing, evaluating the quality of, and researching natural medicines and botanical drugs, we consider it the optimal partner to progress the clinical development of NB-01. Meanwhile, we continue to evaluate potential opportunities for our three remaining legacy therapeutic programs, ANA001, NB-02 and Gemcabene. With a cash cushion of $28.7 million at quarter end to fund operations through multiple, near-term value creating milestones, we are enthusiastic about the potential of our cardiometabolic assets and look forward to continued execution to drive shareholder value." Second Quarter 2023 and Subsequent Highlights August 2023: Received the first site IRB approval for Zeid Kayali, M.D., Medical Director at Inland Empire Liver Foundation, in Rialto, CA, to proceed with the Phase 2a clinical trial of DA-1241, a novel GPR119 agonist, for the treatment of NASH. The dosing of the first patient in part one of the two-part, Phase 2a clinical trial is expected to occur in September of 2023. August 2023: Signed a term sheet with MTHERA to out-license the worldwide rights, excluding Korea, for NB-01, for the treatment of painful diabetic neuropathy, and allowing MTHERA to conduct research in order to seek new patents for NB-01 and conduct clinical trials, including, but not limited to, a potential Phase 3 clinical trial in the United States for the future commercialization of NB-01. June 2023: Presented preclinical data on DA-1726, a novel OXM analogue functioning as a GLP1R and GCGR dual agonist, showing an ability to elicit superior weight loss efficacy compared to SEMA and TIR. Additionally, DA-1276 has shown effective glycemic control. The data was presented in one ePoster theater discussion and two general poster presentations at the American Diabetes Association's 83rd Scientific Sessions. May 2023: Appointed Mark A. Glickman, a highly accomplished pharmaceutical industry executive with more than 30 years of industry experience, to the Board of Directors. May 2023: Received FDA clearance for the Company's IND application for a two-part, Phase 2a clinical trial of DA-1241 for the treatment of NASH. Second Quarter 2023 Financial and Operating Results Research and Development (R&D) Expenses were approximately $2.4 million for the three months ended June 30, 2023 as compared to approximately $1.0 million for the three months ended June 30, 2022. The approximate $1.4 million increase was primarily related to costs as the Company prepared for the clinical trial of DA-1241, set to begin in the third quarter of 2023, including increases in drug manufacturing and toxicology studies of $0.7 million and $0.6 million, respectively. The increase is also partially attributable to related clinical study and overhead costs in the aggregate of $0.1 million. For the six months ended June 30, 2023, R&D expenses were approximately $3.0 million, as compared to approximately $1.9 million for the six months ended June 30, 2022. The approximate $1.1 million increase was primarily related to costs as the Company prepared for the clinical trial of DA-1241 set to begin in the third quarter of 2023, including increases in toxicology studies and related to drug manufacturing of $0.9 million and $0.6 million, respectively. The increase is partially offset by a decrease in clinical trial costs of $0.4 million, as the Company was finishing the ANA 001 study during the six months ended June 30, 2022, and a decrease in drug manufacturing for the Company's legacy assets of $0.1 million. General and Administrative Expenses were approximately $1.4 million for the three months ended June 30, 2023, as compared to approximately $2.2 million for the three months ended June 30, 2022. The decrease of approximately $0.8 million in the current period was primarily due to a decrease in professional fees of $0.5 million related to the exploration of business opportunities during the three months ended June 30, 2022, as well as a decrease in insurance costs of approximately $0.2 million, and a decrease in stock-based compensation of $0.2 million, offset primarily by increases in employee payroll and executive consultants in the aggregate of $0.1 million. For the six months ended June 30, 2023, G&A expenses were approximately $3.3 million, as compared to approximately $4.2 million for the six months ended June 30, 2022. The decrease of approximately $0.9 million in the current period was primarily due to a decrease in professional fees of $0.3 million related to the exploration of business opportunities during the six months ended June 30, 2022, as well as a decrease in insurance costs of approximately $0.4 million, and a decrease in stock-based compensation of $0.5 million, offset primarily by increases in employee payroll and executive consultants in the aggregate of $0.3 million. Net Loss for the three months ended June 30, 2023 was $0.7 million, or $0.02 per basic and diluted share, based on 40,472,026 weighted average shares of common stock outstanding, compared with a net loss of $3.3 million, or $3.72 per basic and diluted share, based on 888,693 weighted average shares of common stock outstanding for the three months ended June 30, 2022. Net Loss for the six months ended June 30, 2023 was $3.3 million, or $0.08 per basic and diluted share, based on 40,472,026 weighted average shares of common stock outstanding, compared with a net loss of $6.2 million, or $6.95 per basic and diluted share, based on 888,693 weighted average shares of common stock outstanding for the six months ended June 30, 2022. Cash and Cash Equivalents were $28.7 million as of June 30, 2023, compared with $33.4 million as of December 31, 2022. The company expects its cash position will be adequate to fund operations into 2024. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Non-Alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM), and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, which promotes the release of key gut peptides GLP-1, GIP, and PYY. In preclinical studies, DA-1241 demonstrated 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. DA-1726 is a novel oxyntomodulin (OXM) analogue that acts 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. For more information, please visit . Forward Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements about the closing of the offering of securities. 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 release, including, without limitation, those risks associated with our ability to execute on our commercial strategy, the timeline for regulatory submissions, regulatory steps and potential regulatory approval of our 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 ability to integrate the new product candidates into NeuroBo's business in a timely and cost-efficient manner; the cooperation of our contract manufacturers, clinical study partners and others involved in the development of our current and future product candidates; our ability to initiate and complete clinical trials on a timely basis; our ability to recruit sites and subjects for our clinical trials; costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; our ability to out-license or sell assets related to our legacy programs; changes in applicable laws or regulations; 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 our filings with the SEC. 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. Contact: Rx Communications Group Michael Miller +1-917-633-6086 [email protected] - Tables to Follow - SOURCE NeuroBo Pharmaceuticals, Inc.

BOSTON, Aug. 2, 2023 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced that it has entered into a term sheet with MThera Pharma Co., Ltd. (MTHERA) which provides for the terms under which NeuroBo will out-license the worldwide rights, outside of Korea, for NB-01 for the treatment of painful diabetic neuropathy to MTHERA. The term sheet allows MTHERA to conduct research in order to seek new patents for NB-01 and conduct clinical trials, including, but not limited to, a potential Phase 3 clinical trial in the United States for the future commercialization of NB-01. The financial terms of the term sheet, which are binding, were not disclosed. "We believe that MTHERA's extensive experience in manufacturing, quality control and clinical development of natural medicines and botanical drugs makes it the perfect partner to continue the development of NB-01, "stated Joseph Hooker, Interim President and Chief Executive Officer of NeuroBo. "Since acquiring the cardiometabolic assets DA-1241 and DA-1726, we have focused diligently to evaluate potential out-licensing and acquisition opportunities for our four legacy therapeutic programs, ANA001, NB-01, NB-02 and Gemcabene, and this term sheet with MTHERA is a testament to those efforts. We look forward to working with MTHERA to assist them in manufacturing NB-01 for potential clinical trials and to facilitate discussions with contract manufacturing companies including our partner, Dong-A ST, Co. Ltd." "We are grateful to NeuroBo and Dong-A ST for the opportunity to participate in the research and development of NB-01," stated Dr. Mi Won Sohn, Chief Executive Officer of MTHERA. "NB-01, as a drug candidate for diabetic neuropathy, has obtained excellent efficacy results in a phase 2 trial in the U.S., and we anticipate developing it as a potential treatment for peripheral diabetes. Utilizing MTHERA's platform technology, SyMthomics, the mechanism of action and active ingredients of NB-01 will be thoroughly identified to help predict clinical efficacy as an innovative treatment with the intent of advancing NB-01 into the next phase of clinical development." About MThera Pharma MThera Pharma Co., Ltd., headquartered in Seoul, South Korea, is a biopharmaceutical company developing first-in-class botanical drug products using novel, multi-component/multi-target-driven disease-modifying therapies to address diverse etiology and treat chronic incurable diseases such as Parkinson's disease, dementia and inflammatory bowel disease. MThera's platform technology, SyMthomics, consists of its MThera-CODA system (AI based in silico system), a cutting-edge multi-omics integration technology, as well as systems biology and bioinformatics. MThera's standardization technology and advanced CMC technology for raw materials, drug substances and drug products are designed to meet the U.S. Food and Drug Administration requirements for therapeutic consistency. For more information, please visit . About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Non-Alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM), and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, which promotes the release of key gut peptides GLP-1, GIP, and PYY. In preclinical studies, DA-1241 demonstrated 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. DA-1726 is a novel oxyntomodulin (OXM) analogue that acts 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. For more information, please visit . Forward Looking Statements Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, statements regarding the development of NeuroBo's product candidates and the therapeutic potential, timing and nature of clinical trials and potential regulatory approval of NeuroBo's clinical programs and pipeline. Forward-looking statements are usually identified by the use of words, such as "believes," "anticipates," "expects," "intends," "plans," "may," "potential," "will," "could" and similar expressions. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy the advancement of NeuroBo's drug development pipeline, in particular through clinical development, NeuroBo's ability to follow the timeline for regulatory submissions and obtain regulatory approvals with respect to the development and commercialization of NeuroBo's current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A, including the impact on future financial and operating results of NeuroBo; the ability to integrate the new product candidates into NeuroBo's business in a timely and cost-efficient manner; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; changes in applicable laws or regulations; effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; the ability of NeuroBo to successfully out-license or sell the assets associated with its legacy therapeutic programs; the ability of NeuroBo to benefit from any such out-license or sale of such assets; and other risks and uncertainties described in NeuroBo's filings with the SEC; and other factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 30, 2023. In addition, the forward-looking statements included in this press release represent NeuroBo's views as of the date hereof. NeuroBo anticipates that subsequent events and developments will cause its views to change. However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing NeuroBo's views as of any date subsequent to the date hereof. Contacts Investors & Media: Rx Communications Group Michael Miller +1-917-633-6086 [email protected] SOURCE NeuroBo Pharmaceuticals, Inc.