1. BOSTON, Sept. 2, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced that Douglas J. Swirsky, President and Chief Executive Officer of publicly traded Rexahn Pharmaceuticals, Inc., has been appointed to the Company's Board of Directors, effective September 1, 2020. In addition to his position as an independent director, Mr. Swirsky will also serve as a member of the Audit Committee. He replaces Steven Gullans, Ph.D., who resigned from the Board of Directors effective August 31, 2020.

    "Doug brings to Neurobo more than two decades of relevant experience…

    BOSTON, Sept. 2, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced that Douglas J. Swirsky, President and Chief Executive Officer of publicly traded Rexahn Pharmaceuticals, Inc., has been appointed to the Company's Board of Directors, effective September 1, 2020. In addition to his position as an independent director, Mr. Swirsky will also serve as a member of the Audit Committee. He replaces Steven Gullans, Ph.D., who resigned from the Board of Directors effective August 31, 2020.

    "Doug brings to Neurobo more than two decades of relevant experience in the biopharmaceutical and healthcare sectors, having served as a director of, or in senior management positions at, a number of publicly held companies over the last 14 years and having provided counsel to corporate clients as a healthcare investment banker," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. "Doug's vast industry expertise and proven leadership capabilities make him a valuable asset, and we look forward to working together on our clinical and preclinical pipeline activities. As we welcome Doug to the NeuroBo team, I want to also extend our sincere gratitude to Dr. Gullans for his service on the Board and his contributions to our merger with Gemphire."

    In addition to his roles at Rexahn, Mr. Swirsky is currently Chairman of the Board of Cellectar Biosciences, Inc., a publicly traded, clinical stage biopharmaceutical company. Prior to joining Rexahn in January 2018, from 2013 through its sale to Precigen, Inc. (formerly known as Intrexon Corporation) in 2017, Mr. Swirsky was President and Chief Executive Officer of publicly traded biotechnology company, GenVec, Inc., which he joined in 2006 as Chief Financial Officer. Prior to joining GenVec, Mr. Swirsky worked at Stifel Nicolaus, where he served as a managing director and the head of Life Sciences Investment Banking. Previously, Mr. Swirsky held investment banking positions at UBS, PaineWebber, Morgan Stanley, and Legg Mason.  

    Mr. Swirsky is a certified public accountant and a CFA® charterholder. He received his B.S. in Business Administration from Boston University and his M.B.A. from the Kellogg School of Management at Northwestern University.

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative and cardiometabolic diseases affecting millions of patients worldwide. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company's drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN), has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. Due to global COVID-19 crisis, a planned Phase 3 study was postponed. In the interim, NeuroBo is exploring a potential orphan drug indication targeting chronic pain for NB-01. NeuroBo's drug candidate, NB-02, is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. The company's third program, Gemcabene, is focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease.

    NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. In December 2019, NeuroBo merged with Gemphire Therapeutics and through such merger, became listed on the Nasdaq Stock Market and added the Gemcabene family of related assets to its portfolio. For more information visit: https://www.neurobopharma.com.

    Contacts:

    Rx Communications Group

    Michael Miller

    +1-917-633-6086

     

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  2. BOSTON, Aug. 11, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced financial results for the second quarter ended June 30, 2020.

    "As planned, throughout the second quarter, our Board, management and scientific team evaluated a number of potential options for advancing the NB-01 clinical asset through different regulatory pathways," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. "Development of NB-01 as an orphan drug is key among the alternatives we are considering, and we may conduct feasibility studies to…

    BOSTON, Aug. 11, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced financial results for the second quarter ended June 30, 2020.

    "As planned, throughout the second quarter, our Board, management and scientific team evaluated a number of potential options for advancing the NB-01 clinical asset through different regulatory pathways," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. "Development of NB-01 as an orphan drug is key among the alternatives we are considering, and we may conduct feasibility studies to identify a specific rare disease relevant to this product candidate. While we had considered marketing NB-01 as a nutraceutical product, we have now determined not to pursue this pathway at this time."

    Dr. Kang continued, "We are preparing an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for NB-02. We intend to postpone the first human clinical trials for NB-02 until global health and macroeconomic conditions improve, with a view toward commencing clinical trial activity in the first half of 2021, subject to improvement of the constraints imposed by the COVID-19 pandemic. We are also considering engaging with a strategic partner to assist with clinical trials for NB-02."

    The Company previously announced, in May 2020, that it received written communication from the FDA stating that the clinical development program for Gemcabene remains on a partial clinical hold. The Company is reviewing its options regarding Gemcabene.

    Second Quarter Financial and Operating Results Highlights

    Upon the merger between Gemphire Therapeutics, Inc. and NeuroBo Pharmaceuticals, Inc. at year-end 2019, the formerly private NeuroBo was considered the accounting acquirer. In accordance with generally accepted accounting principles, the historical financial statements of private company, NeuroBo, are considered the financial statements of the combined company, with the merger accounted for as an acquisition of the Gemcabene family of related assets on December 30, 2019. The following highlights, therefore, represent the combined operations of both companies for the quarter ended June 30, 2020 and the operations of NeuroBo as a private company for the comparable quarter ended June 30, 2019.

    • Research and Development (R&D) Expenses were approximately $0.7 million for the three months ended June 30, 2020 compared with approximately $0.9 million for the three months ended June 30, 2019. The approximately $0.3 million decrease in the second quarter of 2020 was primarily due to the overall reduction of clinical trial activity given the March 2020 decision to postpone Phase 3 clinical trials of NB-01. R&D expenses during the three months ended June 30, 2020 and 2019 included stock-based compensation of $4,000 and $16,000, respectively. 
    • General and Administrative Expenses were $1.7 million for the three months ended June 30, 2020, compared with $0.9 million for the three months ended June 30, 2019. The increase of $0.8 million was primarily due to the ramp up costs associated with operating and reporting as a public company and to post-Merger support costs in the second quarter of 2020. Stock-based compensation costs during the three-month periods ended June 30, 2020 and 2019 were $0.2 million and $63,000, respectively.
    • Net Loss for the second quarter ended June 30, 2020 was approximately $2.4 million, or $0.15 per basic and diluted share, based on 16,303,681 weighted average common shares outstanding, compared with a net loss of approximately $1.9 million, or $0.37 per basic and diluted share, based on 5,166,812 weighted average common shares outstanding for the same period in 2019.
    • Cash and Cash Equivalents were $14.3 million as of June 30, 2020, compared with $13.9 million at December 31, 2019. The Company expects that its cash position, which includes the net proceeds from the April 2020 registered direct common stock offering, will be adequate to fund operations into the second quarter of 2021.

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative and cardiometabolic diseases affecting millions of patients worldwide. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company's drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN), has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. Due to global COVID-19 crisis, a planned Phase 3 study was postponed. In the interim, NeuroBo is exploring a potential orphan drug indication targeting chronic pain for NB-01. NeuroBo's drug candidate, NB-02, is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. The company's third program, Gemcabene, is focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease.

    NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. In December 2019, NeuroBo merged with Gemphire Therapeutics and through such merger, became listed on the Nasdaq Stock Market and added the Gemcabene family of related assets to its portfolio. For more information visit: https://www.neurobopharma.com.

    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. These factors, risks and uncertainties include, but are not limited to: the occurrence of health epidemics or contagious diseases, such as COVID-19, and potential effects on NeuroBo's business, clinical trial sites, supply chain and manufacturing facilities; NeuroBo's ability to continue as a going concern; the timing of completion of NeuroBo's planned clinical trials; the timing of the availability of data from NeuroBo's clinical trials; NeuroBo's plans to research, develop and commercialize its current and future product candidates, including the potential alternative pathways for NB-01; NeuroBo's ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo's product candidates; the impact of government laws and regulations; NeuroBo's ability to protect its intellectual property position; and NeuroBo's need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K and in our other filings with the Securities and Exchange Commission. 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:

    Rx Communications Group

    Melody Carey

    +1-917-322-2571

    - Tables to Follow -

     

    NeuroBo Pharmaceuticals, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands, except share amounts and par value)























    June 30, 



    December 31, 







    2020



    2019







    (unaudited)







    Assets















    Current assets:















     Cash



    $

    14,298



    $

    13,908



     Restricted cash









    15



     Prepaid expenses





    908





    153



     Other assets





    37





    42



    Total current assets





    15,243





    14,118



    Right-of-use assets





    105





    116



    Property and equipment, net





    172





    200



    Other assets





    32





    34



    Total assets



    $

    15,552



    $

    14,468



    Liabilities and stockholders' equity















    Current liabilities:















    Accounts payable



    $

    1,683



    $

    638



    Accrued liabilities





    1,426





    1,422



    Lease liability, short-term





    23





    22



    Total current liabilities





    3,132





    2,082



    Lease and other long-term liabilities





    82





    94



    Total liabilities





    3,214





    2,176



    Commitments and contingencies















    Stockholders' equity:















    Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares

    issued or outstanding as of June 30, 2020 and December 31, 2019.











    Common stock, $0.001 par value per share, 100,000,000 shares authorized;

    16,427,307 and 15,592,718 shares issued and outstanding as of June 30, 2

    020 and December 31, 2019, respectively.





    17





    16



    Additional paid–in capital





    56,317





    49,130



    Accumulated other comprehensive (loss) income





    (16)





    12



    Accumulated deficit





    (43,980)





    (36,866)



    Total stockholders' equity





    12,338





    12,292



    Total liabilities and stockholders' equity



    $

    15,552



    $

    14,468



     

    NeuroBo Pharmaceuticals, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)

    (unaudited)

































    For the Three Months Ended



    For the Six Months Ended







    June 30, 



    June 30, 







    2020



    2019



    2020



    2019



    Operating expenses:



























    Research and development



    $

    674



    $

    948



    $

    2,826



    $

    2,748



    General and administrative





    1,718





    939





    4,315





    1,590



    Total operating expenses





    2,392





    1,887





    7,141





    4,338



    Loss from operations





    (2,392)





    (1,887)





    (7,141)





    (4,338)



    Interest income (expense), net





    8





    (14)





    28





    (27)



    Other expense, net













    (1)







    Loss before income taxes





    (2,384)





    (1,901)





    (7,114)





    (4,365)



    Provision for income taxes



















    Net loss





    (2,384)





    (1,901)





    (7,114)





    (4,365)



    Other comprehensive loss:



























     Foreign currency translation loss, net of tax





    6





    11





    (28)





    9



    Total other comprehensive loss





    6





    11





    (28)





    9



    Comprehensive loss



    $

    (2,378)



    $

    (1,890)



    $

    (7,142)



    $

    (4,356)



    Loss per share:



























    Net loss per share, basic and diluted



    $

    (0.15)



    $

    (0.37)



    $

    (0.44)



    $

    (0.84)



    Weighted average common shares outstanding:



























    Basic and diluted





    16,303,681





    5,166,812





    15,987,240





    5,166,812



     

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  3. BOSTON, May 26, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced that it received written communication from the U.S. Food and Drug Administration (FDA) that the clinical development program for Gemcabene, a peroxisome proliferation-activated receptor (PPARα) agonist, under development as a once-daily, oral therapy for the treatment of dyslipidemia, remains on partial clinical hold. In January 2016, the Gemcabene Phase 2 clinical study was placed on partial clinical hold as the FDA requested 2-year rat and mouse carcinogenicity studies to…

    BOSTON, May 26, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced that it received written communication from the U.S. Food and Drug Administration (FDA) that the clinical development program for Gemcabene, a peroxisome proliferation-activated receptor (PPARα) agonist, under development as a once-daily, oral therapy for the treatment of dyslipidemia, remains on partial clinical hold. In January 2016, the Gemcabene Phase 2 clinical study was placed on partial clinical hold as the FDA requested 2-year rat and mouse carcinogenicity studies to be completed and submitted.  

    In May 2018, the company submitted the requested data to the FDA, which the Agency determined was insufficient to lift the partial clinical hold at that time. On April 20, 2020, the company filed an amendment to the FDA's partial clinical hold letter received in June 2018.

    "While we are disappointed that the partial clinical hold was not lifted at this time, we plan to request additional clarification regarding the resolution options the FDA suggest in their  response letter, in order to better evaluate a path forward for Gemcabene as a treatment for dyslipidemia," said Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo.

    About NeuroBo Pharmaceuticals
    NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative and cardiometabolic diseases affecting millions of patients worldwide. The company's multimodal approach has the potential to address multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company's drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN), has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. Due to the global COVID-19 crisis, a planned Phase 3 study is currently postponed. In the interim, NeuroBo is exploring a potential orphan drug indication and/or a nutraceutical pathway targeting chronic pain for NB-01. NeuroBo's drug candidate, NB-02, is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. The company is also exploring an orphan drug pathway for NB-02. The company's third program, Gemcabene, is focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease.

    NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. In December 2019, NeuroBo merged with Gemphire Therapeutics and through such merger, became listed on the Nasdaq Stock Market and added the Gemcabene family of related assets to its portfolio. For more information visit: https://www.neurobopharma.com.

    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. These factors, risks and uncertainties include, but are not limited to the factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K and in our other filings with the Securities and Exchange Commission. 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:

    Rx Communications Group
    Michael Miller
    +1-917-633-6086

     

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  4. BOSTON, May 20, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced financial results for the first quarter ended March 31, 2020.

    "The first quarter and subsequent  months have been another productive period for the company, marked by the successful completion, in a very challenging capital market, of a registered direct common stock offering in April that bolstered our cash position by $7.5 million, significantly strengthening the balance sheet and providing a cash runway through the first quarter of 2021. Additionally, we were issued a key…

    BOSTON, May 20, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced financial results for the first quarter ended March 31, 2020.

    "The first quarter and subsequent  months have been another productive period for the company, marked by the successful completion, in a very challenging capital market, of a registered direct common stock offering in April that bolstered our cash position by $7.5 million, significantly strengthening the balance sheet and providing a cash runway through the first quarter of 2021. Additionally, we were issued a key U.S. composition patent covering NB-02 which, given its demonstrated multimodal therapeutic advantages, may represent an important new alternative for the prevention and treatment of Alzheimer's and other neurodegenerative disorders," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. "Subject to improvement of global health and macroeconomic conditions, we plan to submit an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for NB-02 and to initiate a Phase 1 trial in the first quarter of next year."

    Dr. Kang continued, "We have continued to devote scientific resources to evaluating the potential to bring the NB-01 asset to the market through a different regulatory pathway. The avenues of exploration include development of NB-01 as an orphan drug and/or a nutraceutical (non-pharmaceutical) product. Additionally, we submitted the complete response letter to the FDA and continue to expect a reply in the second  quarter regarding removal of the partial clinical hold for Gemcabene, our novel, once-daily, oral therapy designed to target known lipid metabolic pathways to lower levels of LDL-C, hsCRP and triglycerides. If we receive a favorable decision, we will be able to evaluate further options for this key clinical asset."

    First Quarter Financial and Operating Results Highlights

    Upon the merger between Gemphire Therapeutics, Inc. and NeuroBo Pharmaceuticals, Inc. at year-end 2019, the formerly private NeuroBo was considered the accounting acquirer. In accordance with generally accepted accounting principles, the historical financial statements of private company, NeuroBo, are considered the financial statements of the combined company, with the merger accounted for as an acquisition of the Gemcabene family of related assets on December 30, 2019.  The following highlights, therefore, represent the combined operations of both companies for the quarter ended March 31, 2020 and the operations of NeuroBo as a private company for the comparable quarter ended March 31, 2019.

    • Research and Development (R&D) Expenses were $2.2 million for the three months ended March 31, 2020 compared with $1.8 million for the three months ended March 31, 2019. The $0.4 million increase in 2020 was primarily attributed to the CRO termination costs associated with the Phase 3 clinical trials of NB-01 in the amount of $0.7 million, and to the further development of Gemcabene under the Contingent Value Rights Agreement in the amount of $0.4 million, offset in part by the overall reduction of clinical trial activity in the current quarter when compared to the comparable period in the prior year. R&D expenses during the three months ended March 31, 2020 and 2019 included stock-based compensation of $14,000 and $39,000, respectively.
       
    • General and Administrative Expenses were $2.6 million for the first quarter ended March 31, 2020, compared with $0.7 million for the three months ended March 31, 2019. The increase of $1.9 million was primarily due to the ramp up costs associated with operating and reporting as a public company and to post-Merger support costs in the first quarter of 2020.
       
    • Net Loss for the first quarter ended March 31, 2020 was approximately $4.8 million, or $0.30 per basic and diluted share, based on 15,670,800 weighted average common shares outstanding, compared with a net loss of approximately $2.5 million, or $0.48 per basic and diluted share, based on 5,166,812 weighted average common shares outstanding for the same period in 2019.
       
    • Cash and Cash Equivalents were $9.8 million as of March 31, 2020, compared with $13.9 million at December 31, 2019. The company expects that its cash position, including the net proceeds from the April 2020 registered direct common stock offering, will be adequate to fund operations through the first quarter of 2021.

    About NeuroBo Pharmaceuticals
    NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative and cardiometabolic diseases affecting millions of patients worldwide. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company's drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN), has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. Due to global COVID-19 crisis, a planned Phase 3 study is currently postponed. In the interim, NeuroBo is exploring a potential orphan drug indication and/or a nutraceutical pathway targeting chronic pain for NB-01. NeuroBo's drug candidate, NB-02, is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. The company is also exploring an orphan drug pathway for NB-02. The company's third program, Gemcabene, is focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease.

    NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. In December 2019, NeuroBo merged with Gemcabene and through such merger, became listed on the Nasdaq Stock Market and added the Gemcabene family of related assets to its portfolio. For more information visit: https://www.neurobopharma.com.

    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. These factors, risks and uncertainties include, but are not limited to: the occurrence of health epidemics or contagious diseases, such as COVID-19, and potential effects on NeuroBo's business, clinical trial sites, supply chain and manufacturing facilities; NeuroBo's ability to continue as a going concern; the timing of completion of NeuroBo's planned clinical trials; the timing of the availability of data from NeuroBo's clinical trials; NeuroBo's plans to research, develop and commercialize its current and future product candidates, including the potential alternative pathways for NB-01; NeuroBo's ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo's product candidates; the impact of government laws and regulations; NeuroBo's ability to protect its intellectual property position; and NeuroBo's need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K and in our other filings with the Securities and Exchange Commission . 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:

    Rx Communications Group
    Melody Carey
    +1-917-322-2571

    - Tables to Follow -

     

    NeuroBo Pharmaceuticals, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands, except share amounts and par value)












    March 31,


    December 31,




    2020


    2019




    (unaudited)





    Assets








    Current assets:








     Cash


    $

    9,799


    $

    13,908


     Restricted cash



    15



    15


     Prepaid expenses



    1,332



    153


     Other assets



    65



    42


    Total current assets



    11,211



    14,118


    Right-of-use assets and other



    143



    150


    Property and equipment, net



    181



    200


    Total assets


    $

    11,535


    $

    14,468


    Liabilities and stockholders' equity








    Current liabilities:








    Accounts payable


    $

    1,273


    $

    638


    Accrued liabilities



    2,411



    1,422


    Lease liability, short-term



    22



    22


    Total current liabilities



    3,706



    2,082


    Lease and other long-term liabilities



    89



    94


    Total liabilities



    3,795



    2,176


    Commitments and contingencies








    Stockholders' equity:








    Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding as of March 31, 2020 and December 31, 2019.






    Common stock, $0.001 par value per share, 100,000,000 shares authorized; 15,677,307 and 15,592,718 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively.



    16



    16


    Additional paid–in capital



    49,342



    49,130


    Accumulated other comprehensive income



    (22)



    12


    Accumulated deficit



    (41,596)



    (36,866)


    Total stockholders' equity



    7,740



    12,292


    Total liabilities and stockholders' equity


    $

    11,535


    $

    14,468


     

     

    NeuroBo Pharmaceuticals, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)

    (unaudited)








    For the Three Months Ended




    March 31,




    2020


    2019


    Operating expenses:








    Research and development


    $

    2,152


    $

    1,800


    General and administrative



    2,597



    651


    Total operating expenses



    4,749



    2,451


    Loss from operations



    (4,749)



    (2,451)


    Interest (expense) income, net



    20



    (13)


    Other income (expense), net



    (1)




    Loss before income taxes



    (4,730)



    (2,464)


    Provision for income taxes






    Net loss



    (4,730)



    (2,464)


    Other comprehensive loss:








    Foreign currency translation loss, net of tax



    (34)



    (2)


    Total other comprehensive loss



    (34)



    (2)


    Comprehensive loss


    $

    (4,764)


    $

    (2,466)


    Loss per share:








    Net loss per share, basic and diluted


    $

    (0.30)


    $

    (0.48)


    Weighted average common shares outstanding:








    Basic and diluted



    15,670,800



    5,166,812


     

    Cision View original content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-first-quarter-2020-financial-results-301063091.html

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  5. BOSTON, April 21, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced that on March 17, 2020 the United States Patent and Trademark Office issued Patent No. 10,588,927 B2, entitled, "Composition Containing Mixed Extract of Mulberry and Poria Cocos Peel."

    The patent covers the extract of a mixture containing mulberry and Poria cocos peel, which are the active ingredients contained in the composition, at a certain ratio or a method of treating a degenerative neurological disease using the extract. The extract has memory improving activity through…

    BOSTON, April 21, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced that on March 17, 2020 the United States Patent and Trademark Office issued Patent No. 10,588,927 B2, entitled, "Composition Containing Mixed Extract of Mulberry and Poria Cocos Peel."

    The patent covers the extract of a mixture containing mulberry and Poria cocos peel, which are the active ingredients contained in the composition, at a certain ratio or a method of treating a degenerative neurological disease using the extract. The extract has memory improving activity through the inhibition of acetylcholine esterase, and neuroprotective effects and neuron protection by inhibiting the formation of beta amyloid and tau phosphorylation and promoting NGF production. 

    "The issuance of this U.S. patent further strengthens NeuroBo Pharmaceuticals' intellectual property position and, notably, comes closely on the heels of the similar patent issued to us by the European Patent Office in February of this year," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of the company. "As important, this additional composition patent validates our position that NB-02, in development for Alzheimer's disease and other dementias, may be useful as a pharmaceutical for preventing or treating degenerative neurological diseases."

    Dr. Kang continued, "Our recently announced $7.5 million financing, when combined with current cash on hand, will allow us to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for NB-02 and to initiate a Phase 1 trial when global health and macroeconomic conditions improve. We look forward to moving ahead with this program in order to further explore its considerable promise as a neuroprotective agent, which has been demonstrated in extensive preclinical studies. If successful, we believe that NB-02 could drive a paradigm shift in the treatment of Alzheimer's disease and other neurodegenerative disorders."

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative and cardiometabolic diseases affecting millions of patients worldwide. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company's lead drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN), has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. Due to global COVID-19 crisis, a planned Phase 3 study is currently postponed. In the interim, NeuroBo is exploring a nutraceutical pathway targeting chronic pain. NeuroBo's IND-ready second drug candidate, NB-02, is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. The company is also exploring an orphan drug pathway for NB-02. The company's third program, gemcabene, is focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease.

    NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. For more information, visit: https://www.neurobopharma.com/.

    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. These factors, risks and uncertainties include, but are not limited to: the occurrence of health epidemics or contagious diseases, such as COVID-19, and potential effects on NeuroBo's business, clinical trial sites, supply chain and manufacturing facilities; NeuroBo's ability to continue as a going concern; the timing of completion of NeuroBo's planned clinical trials; the timing of the availability of data from NeuroBo's clinical trials; NeuroBo's plans to research, develop and commercialize its current and future product candidates, including the potential alternative pathways for NB-01; NeuroBo's ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo's product candidates; the impact of government laws and regulations; NeuroBo's ability to protect its intellectual property position; and NeuroBo's need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K filed with the SEC on or about the date hereof. 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:

    Rx Communications Group
    Melody Carey
    +1-917-322-2571

    Cision View original content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-announces-issuance-of-us-patent-providing-broad-coverage-of-nb-02-for-neurodegenerative-disorders-301044131.html

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  6. BOSTON, April 16, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced that it has closed its previously announced registered direct offering of 750,000 shares of its common stock at a price of $10.00 per share, for aggregate gross proceeds of approximately $7.5 million. The Company intends to use the net proceeds from this offering for working capital, capital expenditures and general corporate purposes.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The shares of common stock were offered by NeuroBo pursuant…

    BOSTON, April 16, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced that it has closed its previously announced registered direct offering of 750,000 shares of its common stock at a price of $10.00 per share, for aggregate gross proceeds of approximately $7.5 million. The Company intends to use the net proceeds from this offering for working capital, capital expenditures and general corporate purposes.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The shares of common stock were offered by NeuroBo pursuant to a "shelf" registration statement on Form S-3 (File No. 333-220315) previously filed with the Securities and Exchange Commission (the "SEC") on September 1, 2017 and declared effective by the SEC on September 12, 2017. The offering of the securities was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered was filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company's lead drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN), has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. NeuroBo's second drug candidate, NB-02, is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain.

    NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. For more information, visit: https://www.neurobopharma.com/.

    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 intended use of net proceeds from the registered direct offering as well as 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. These factors, risks and uncertainties include, but are not limited to: market and other conditions, the occurrence of health epidemics or contagious diseases, such as COVID-19, and potential effects on NeuroBo's business, clinical trial sites, supply chain and manufacturing facilities; NeuroBo's ability to continue as a going concern; the timing of completion of NeuroBo's planned clinical trials; the timing of the availability of data from NeuroBo's clinical trials; NeuroBo's plans to research, develop and commercialize its current and future product candidates, including the potential alternative pathways for NB-01; NeuroBo's ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo's product candidates; the impact of government laws and regulations; NeuroBo's ability to protect its intellectual property position; and NeuroBo's need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K filed with the SEC on or about the date hereof. 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, except as required by law. These forward-looking statements should not be relied upon as representing NeuroBo's views as of any date subsequent to the date hereof.

    Contact:
    Rx Communications Group
    Melody Carey
    +1-917-322-2571

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  7. BOSTON, March 30, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced financial results for the year ended December 31, 2019 and provided a corporate strategic update.

    "The closing of the merger between Gemphire Therapeutics, Inc. and NeuroBo Pharmaceuticals, Inc. at year end 2019 was a pivotal moment for NeuroBo, as it provided increased visibility with a Nasdaq listing and afforded the company a platform to pursue its long-term goals," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of the combined company. "With the current…

    BOSTON, March 30, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, today announced financial results for the year ended December 31, 2019 and provided a corporate strategic update.

    "The closing of the merger between Gemphire Therapeutics, Inc. and NeuroBo Pharmaceuticals, Inc. at year end 2019 was a pivotal moment for NeuroBo, as it provided increased visibility with a Nasdaq listing and afforded the company a platform to pursue its long-term goals," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of the combined company. "With the current macroeconomic environment, however, including the global health emergency caused by the COVID-19 pandemic, we have recently taken a number of prudent strategic steps to ensure that the company is positioned to weather this unprecedented situation. Specifically, to conserve financial resources, we have decided to postpone the initiation of Phase 3 clinical trials for NB-01, which would be very challenging in the short- or medium-term. Consequently, in the first quarter of 2020, we ceased work on Phase 3 trials for NB-01 and gave notice of termination of all related contract arrangements with our contract research organizations. We are currently re-evaluating alternatives to bring the NB-01 asset to the market through a different regulatory pathway. Development of NB-01 as an orphan drug is among the alternatives we are considering, and we may conduct feasibility studies to identify a rare disease relevant to NB-01. Additionally, we are considering marketing the NB-01 product line as nutraceutical products.

    "We remain optimistic about the considerable promise of our second program, NB-02, which, in preclinical studies, has shown potential as a neuroprotective agent, and we believe that the multimodal therapeutic advantages of NB-02 could potentially represent a paradigm shift in the treatment of Alzheimer's disease and other neurodegenerative diseases," continued Dr. Kang. "Although NB-02 is almost ready for the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), we intend to postpone our first-in-human clinical trials until market conditions improve. In the interim, we remain very excited about this particular program and, based on the strength of the data generated to date, we are assessing whether to pursue further development of NB-02 as an orphan drug."

    Dr. Kang also noted that the company expects a response from the FDA in the second quarter of this year regarding removal of the partial clinical hold for Gemcabene.

    With the above-described pause in clinical activity, management noted that the $13.9 million in cash on hand as of December 31, 2019, should be sufficient to fund operations at current levels through December 2020. "We look forward to reinstating the clinical activities of our robust platform of disease-modifying therapies for neurodegenerative and cardiometabolic diseases and we are actively pursuing various financing opportunities in the interim," concluded Dr. Kang.

    Overview of Current Clinical Pipeline

    • NB-01 – addresses a range of mechanisms that contribute to neuropathic pain and nerve degeneration in diabetic and other peripheral neuropathies. These include a decrease in key inflammatory markers, restoration of nerve growth factor (NGF) to normal levels, and reduction of advanced glycation end products (AGEs). NB-01 also reduces levels of TNF-α and IL-6, both of which are markers of inflammation, which are implicated in diabetes-related complications. NB-01 also restores the neurotrophin NGF, which is involved in nerve growth, maintenance and repair.
                                   
      NB-01 was developed primarily as a treatment for painful diabetic neuropathy (PDN), but NB-01 can also treat other neuropathic pain conditions, including chemotherapy-induced peripheral neuropathy and post-traumatic peripheral neuropathy. The global neuropathic pain market is currently estimated to be greater than $5 billion and is projected to grow to more than $10 billion by 2026. In the United States, there are currently only three FDA-approved treatments for PDN.
                                   
      The company believes that NB-01 has the potential to offer pain alleviation with minimal side effects and to be potentially the first disease-modifying therapy impacting the underlying disease mechanisms. NB-01 has successfully completed two Phase 2 proof-of-concept clinical trials for PDN.
                                       
      In addition to the pharmaceutical market to treat pain, there is a very large and growing market for nutraceuticals in this arena. Since NB-01 is derived from natural products, the company is considering marketing NB-01 as a nutraceutical (non-pharmaceutical) product.
                                    
    • NB-02 - has the potential to treat the symptoms of cognitive impairment and modify the progression of neurodegenerative diseases associated with the malfunction of a protein called tau, and with amyloid beta plaque deposition. NB-02 has shown considerable promise as a neuroprotective agent in preclinical studies, demonstrating a multimodal mechanism of action including inhibition of tau phosphorylation, acetylcholinesterase (AChE) inhibition, inhibition of toxicity and amyloid plaque formation, and anti-inflammatory effects. The company intends to further leverage the benefits of tau modulation by NB-02 in conjunction with the other pathway effects to explore treatment of certain dementias such as the tauopathies.
                                     
      The company believes that leveraging the therapeutic advantages of NB-02 will drive a paradigm shift in the treatment of Alzheimer's disease and other neurodegenerative diseases. The company also is assessing whether to pursue further development of NB-02 as an orphan drug.
                                           
    • Gemcabene – is a novel, once-daily, oral therapy designed to target known lipid metabolic pathways to lower levels of LDL-C, hsCRP and triglycerides, that originally was licensed from Pfizer. It is in development for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease, focused on orphan indications such as homozygous familial hypercholesterolemia (HoFH), as well as severe hypertriglyceridemia (SHTG). Gemcabene has been tested as a monotherapy and in combination with statins and other drugs in more than 1,100 subjects across 25 Phase 1 and Phase 2 clinical trials and has demonstrated promising evidence of efficacy, safety and tolerability.
                                         
      In August 2018, Gemphire announced that the FDA, following submission of its two-year rodent carcinogenicity study, had requested additional preclinical studies, including a 13-week PPARα knockout mouse study. The in vitro PPAR transactivation studies and subchronic study of Gemcabene in PPARα knock-out mice are completed, and the company is expecting to receive a response from the FDA in the second quarter of 2020 regarding removal of the partial clinical hold.

    NeuroBo Financial and Operating Results Highlights

    Although public company Gemphire was considered the legal acquirer in the merger and issued shares of its common stock to effect the merger, the formerly private NeuroBo was considered the accounting acquirer. In accordance with generally accepted accounting principles, the historical financial statements of private company NeuroBo are considered the financial statements of the combined company, with the merger accounted for as an acquisition of the Gemcabene family of related assets on December 30, 2019.  The following highlights therefore represent the operations of NeuroBo as a private company except for the effects of the merger on December 30, 2019 and the combined operations of both companies for the post-merger balance of December 2019.

    • Research and Development (R&D) Expenses were approximately $5.3 million for the year ended December 31, 2019, as compared to approximately $5.1 million for the year ended December 31, 2018. The increase of approximately $0.3 million was largely due to payroll costs in connection with newly hired personnel and costs attributed to the newly constituted Scientific Advisory Board, offset in part by a reduction in clinical trial activity due to timing of underlying studies.
    • Acquired In-process Research and Development Expenses were approximately $12.2 million for the year ended December 31, 2019, as compared to approximately $8.8 million for the year ended December 31, 2018. The increase of approximately $3.3 million was attributable to research and development projects of Gemphire which were in-process at the merger date and expensed on the merger date.
    • General and Administrative Expenses were approximately $2.7 million for the year ended December 31, 2019, as compared to approximately $1.6 million for the year ended December 31, 2018. The approximate increase of $1.1 million was primarily due to an increase in personnel-related costs, legal expenses, and operational consulting fees, among others.
    • Net Loss for year ended December 31, 2019 was approximately $21.3 million, or $4.08 per basic and diluted share, based on 5,224,178 weighted average common shares outstanding, compared to a net loss of approximately $15.5 million, or $3.65 per basic and diluted share, based on 4,251,330 weighted average common shares outstanding for the year ended December 31, 2018.
    • Cash and Cash Equivalents as of December 31, 2019 of $13.9 million should be sufficient to fund the company's operations at the planned level of scientific activity through December 2020.

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company's lead drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN), has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. NeuroBo's IND-ready second drug candidate, NB-02, is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain.

    NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. For more information, visit: https://www.neurobopharma.com/.

    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. These factors, risks and uncertainties include, but are not limited to: the occurrence of health epidemics or contagious diseases, such as COVID-19, and potential effects on NeuroBo's business, clinical trial sites, supply chain and manufacturing facilities; NeuroBo's ability to continue as a going concern; the timing of completion of NeuroBo's planned clinical trials; the timing of the availability of data from NeuroBo's clinical trials; NeuroBo's plans to research, develop and commercialize its current and future product candidates, including the potential alternative pathways for NB-01; NeuroBo's ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo's product candidates; the impact of government laws and regulations; NeuroBo's ability to protect its intellectual property position; and NeuroBo's need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K filed with the SEC on or about the date hereof. 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:

    Rx Communications Group
    Melody Carey
    +1-917-322-2571

    Financials

     

    NeuroBo Pharmaceuticals, Inc.

    Consolidated Balance Sheets

    (in thousands)





    At December 31,




    2019


    2018

    Assets





    Current assets:






    Cash

    $

    13,908

    $

    2,845


    Restricted Cash


    15


    -


    Prepaid expenses


    153


    929


    Other assets


    42


    34

    Total current assets


    14,118


    3,808


    Right-of-use assets and other


    150


    9


    Property and equipment, net


    200


    3

    Total assets

    $

    14,468

    $

    3,820







    Liabilities, redeemable convertible preferred
    stock and stockholders' equity (deficit)





    Current liabilities






    Accounts payable

    $

    638

    $

    170


    Accrued liabilities


    1,422


    49


    Lease liability, short-term


    22


    -

    Total current liabilities


    2,082


    219


    Convertible notes-related party


    -


    118


    Lease and other long-term liabilities


    94


    23

    Total liabilities


    2,176


    360

    Commitments and contingencies





    Redeemable convertible preferred stock


    -


    16,746

    Stockholders' equity (deficit)






    Preferred stock


    -


    -


    Common stock


    16


    -


    Additional paid-in capital


    49,130


    2,266


    Accumulated other comprehensive income


    12


    2


    Accumulated deficit


    (36,866)


    (15,554)

    Total stockholders' equity (deficit)

    $

    12,292


    (13,286)

    Total liabilities, redeemable convertible
    preferred stock stockholders' equity (deficit)

    $

    14,468

    $

    3,820

     

    NeuroBo Pharmaceuticals, Inc.

    Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)






     For the Year Ended

    December 31,





    2019


    2018

    Operating expenses:






    Research and development

    $

    5,324

    $

    5,066


    Acquired in-process research and development


    12,151


    8,815


    General and administrative


    2,701


    1,605



    Total operating expenses


    20,176


    15,486

    Loss from operations


    (20,176)


    (15,486)


    Loss on extinguishment


    (1,114)


    -


    Interest (expense) income, net


    (22)


    (40)


    Other income (expense), net


    -


    (3)

    Loss before income taxes


    (21,312)


    (15,529)

    Provision for income taxes


    -


    -

    Net loss



    (21,312)


    (15,529)

    Other comprehensive loss, net of tax


    10


    2

    Comprehensive loss

    $

    (21,302)

    $

    (15,527)

    Loss per share






    Net loss  per share, basic and diluted

    $

    (4.08)

    $

    (3.65)

    Weighted average common shares outstanding






    Basic and diluted


    5,224,178


    4,251,330

     

    Cision View original content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-year-end-2019-financial-results-and-provides-corporate-strategic-update-301031959.html

    SOURCE NeuroBo Pharmaceuticals, Inc.

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  8. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today announced that it will present at Biotech Showcase 2020, to be held January 13-15, 2020 at the Hilton San Francisco Union Square.

    Presentation Details

    Presenter: Richard J. Kang, Ph.D., president and chief executive officer

    Date: Wednesday, January 15, 2020

    Time: 9 a.m. (PST)

    Track: Franciscan D (Ballroom Level)

    Venue: Hilton San Francisco Union Square Hotel, 333 O'Farrell Street, San Francisco, CA

    A link to the live audio webcast of the presentation will be available in the Investors & Media section of the company's website: https://www.neurobopharma.com/news. An archived version of…

    NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today announced that it will present at Biotech Showcase 2020, to be held January 13-15, 2020 at the Hilton San Francisco Union Square.

    Presentation Details

    Presenter: Richard J. Kang, Ph.D., president and chief executive officer

    Date: Wednesday, January 15, 2020

    Time: 9 a.m. (PST)

    Track: Franciscan D (Ballroom Level)

    Venue: Hilton San Francisco Union Square Hotel, 333 O'Farrell Street, San Francisco, CA

    A link to the live audio webcast of the presentation will be available in the Investors & Media section of the company's website: https://www.neurobopharma.com/news. An archived version of the webcast will be available following the presentation.

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc., is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company's lead drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN) has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. Enrollment in the first study in the Phase 3 program for NB-01 in the U.S. is expected to begin in the first half of 2020, with a target enrollment of approximately 460 subjects with PDN. NeuroBo's IND-ready second drug candidate, NB-02, is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain.

    NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. For more information, visit: https://www.neurobopharma.com/.

    About Biotech Showcase

    Biotech Showcase™ is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry's largest annual health care investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this bellwether week, which sets the tone for the coming year. Now in its eleventh year, this rapidly growing conference features multiple tracks of presenting companies, plenary sessions, workshops, networking and an opportunity to schedule one-to-one meetings. Biotech Showcase is produced by Demy-Colton and EBD Group. Both organizations have a long history of producing high quality programs that support the biotechnology and broader life sciences industry.

    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 therapeutic potential, timing and nature of human 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. These factors, risks and uncertainties include, but are not limited to: NeuroBo's plans to develop and commercialize its product candidates; the timing of completion of NeuroBo's planned clinical trials; the timing of the availability of data from NeuroBo's clinical trials; NeuroBo's plans to research, develop and commercialize its current and future product candidates; NeuroBo's ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo's product candidates; NeuroBo's commercialization, marketing and manufacturing capabilities and strategy; the impact of government laws and regulations; NeuroBo's ability to protect its intellectual property position; and NeuroBo's need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of SEC filings the combined company makes with the SEC from time to time. 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.

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  9. - Shares of the Combined Company, NeuroBo Pharmaceuticals, Began Trading on the Nasdaq Exchange Under the Symbol NRBO on December 31, 2019

    - NeuroBo Pharmaceuticals to Focus on Advancing Clinical Stage Pipeline for Neurodegenerative Diseases

    NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today reported that the previously announced merger between NeuroBo Pharmaceuticals, Inc., ("NeuroBo") and Gemphire Therapeutics (NASDAQ:GEMP) closed on December 31, 2019. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker "NRBO" on December 31, 2019. NeuroBo will focus on advancing the company's…

    - Shares of the Combined Company, NeuroBo Pharmaceuticals, Began Trading on the Nasdaq Exchange Under the Symbol NRBO on December 31, 2019

    - NeuroBo Pharmaceuticals to Focus on Advancing Clinical Stage Pipeline for Neurodegenerative Diseases

    NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today reported that the previously announced merger between NeuroBo Pharmaceuticals, Inc., ("NeuroBo") and Gemphire Therapeutics (NASDAQ:GEMP) closed on December 31, 2019. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker "NRBO" on December 31, 2019. NeuroBo will focus on advancing the company's clinical-stage pipeline for neurodegenerative diseases.

    "We believe that the closing of the merger signifies a transformative event that will provide NeuroBo with the opportunity to achieve its next level of corporate growth as we continue to advance our promising pipeline for neurodegenerative diseases," said Richard J. Kang, Ph.D., president and chief executive officer of the combined company. "As we look ahead, we have some important milestones on the horizon. The first study in our Phase 3 program for our lead drug candidate, NB-01, for painful diabetic neuropathy (PDN), will begin screening patients soon in the U.S. and we are designing a first-in-human trial for NB-02, targeted at Alzheimer's disease and diseases associated with the pathological dysfunction of tau proteins in the brain."

    The company's novel lead program, NB-01, is an oral drug candidate for painful diabetic neuropathy (PDN). In a randomized, placebo-controlled Phase 2 clinical trial, NB-01 significantly improved pain scores from baseline as measured by the NRS, an 11-point numeric rating scale commonly used in pain studies, and showed an excellent safety profile when compared to retrospective safety data on existing therapies. In pre-clinical studies in animal models of diabetes, NB-01 reduced general inflammation and neuro-inflammation as measured by IL-6 and TNF-α, reduced advanced glycation end products (AGEs), which are implicated in diabetic neuropathy, and elevated levels of nerve growth factor (NGF) to normal physiological levels, which has been shown to promote nerve growth, survival and repair. This multi-component drug approach has the potential to address the underlying mechanisms of PDN, reduce neuropathic pain symptoms and slow disease progression. Initiation of enrollment in the first Phase 3 study with NB-01 is anticipated in the first half of 2020 and will enroll approximately 460 subjects with PDN across the U.S.

    NeuroBo's IND-ready second drug candidate, NB-02, is targeted for the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. Preclinical animal disease model studies of NB-02 have provided evidence of efficacy and safety in neurodegeneration.

    In addition, NeuroBo plans to continue the advancement of gemcabene, which has been in development by Gemphire for the treatment of dyslipidemia. Gemcabene has been studied in more than 1,100 human subjects in a total of 25 Phase 1 and Phase 2 trials with demonstrated efficacy and safety. The combined company expects to submit an application with results of a preclinical mouse safety study to the Food and Drug Administration (FDA) in early 2020 to address a partial clinical hold related to gemcabene's activation of peroxisome proliferation-activated receptor (PPAR) and, if approved, would be poised to progress into Phase 3 human studies. The combined company will also continue to support the partnership with Beijing SL Pharmaceutical, Co., Ltd. ("Beijing SL"), for gemcabene rights in China.

    Immediately after the closing of the merger, NeuroBo shareholders owned 96.24%, and current Gemphire stockholders owned 3.76% of NeuroBo's common stock. As part of the merger, Gemphire stockholders received non-transferable contingent value rights (CVRs) entitling the holders to receive in aggregate, after the retention of $500,000 by the combined company and certain other permitted deductions, 80% of the net proceeds, if any, in the event the gemcabene assets are sold or licensed during the 10-year period following the closing of the merger or pursuant to the license agreement with Beijing SL.

    The combined organization will operate under the leadership of NeuroBo's new President and Chief Executive Officer, Richard J. Kang, Ph.D., and Chief Medical Officer, Mark Versavel, M.D., Ph.D., MBA. The board of directors of the combined organization is comprised of seven directors: two directors from the former NeuroBo board, one director from the former Gemphire board and four newly appointed members designated by NeuroBo prior to the merger. Ms. Na Yeon (Irene) Kim, M.S., MBA, was appointed as chairman of the board. The corporate headquarters of the combined organization is located in Boston, Massachusetts.

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc., is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company's lead drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN) has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. Enrollment in the first study in the Phase 3 program for NB-01 in the U.S. is expected to begin in the first half of 2020, with a target enrollment of approximately 460 subjects with PDN. NeuroBo's IND-ready second drug candidate, NB-02, is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain.

    NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. For more information, visit: https://www.neurobopharma.com/.

    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 therapeutic potential, timing and nature of human 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. These factors, risks and uncertainties include, but are not limited to: NeuroBo's plans to develop and commercialize its product candidates; the timing of completion of NeuroBo's planned clinical trials; the timing of the availability of data from NeuroBo's clinical trials; NeuroBo's plans to research, develop and commercialize its current and future product candidates; NeuroBo's ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo's product candidates; NeuroBo's commercialization, marketing and manufacturing capabilities and strategy; the impact of government laws and regulations; NeuroBo's ability to protect its intellectual property position; and NeuroBo's need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of SEC filings the combined company makes with the SEC from time to time. 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.

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