NRBO NeuroBo Pharmaceuticals Inc.

5.41
-0.07  -1%
Previous Close 5.48
Open 5.48
52 Week Low 4.82
52 Week High 30
Market Cap $88,871,731
Shares 16,427,307
Float 4,513,732
Enterprise Value $76,783,003
Volume 9,233
Av. Daily Volume 13,693
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Drug Pipeline

Drug Stage Notes
NB-02
Dyslipidemia
Phase 1
Phase 1
Phase 1 trial to be initiated 1H 2021.
Gemcabene
Dyslipidemia
Phase 2
Phase 2
Phase 2 partial clinical hold remains - May 26, 2020.
NB-01
Diabetic neuropathic pain (DNP)
Phase 3
Phase 3
Phase 3 trial has been postponed due to COVID-19.
Gemcabene - COBALT-1
Homozygous Familial Hypercholesterolemia (HoFH)
Phase 2b
Phase 2b
Phase 2b data released June 28, 2017 - primary endpoint met.
Gemcabene - INDIGO-1
Severe Hypertriglyceridemia (SHTG)
Phase 2b
Phase 2b
Phase 2b primary endpoint met - June 28, 2018.
Gemcabene
Familial Partial Lipodystrophy (FPL)
Phase 2a
Phase 2a
Phase 2 top-line released June 26, 2019.
Gemcabene
Familial Partial Lipodystrophy (FPL)
Phase 2
Phase 2
Phase 3 trial planned.

Latest News

  1. BOSTON, Nov. 13, 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 third quarter ended September 30, 2020.

    "Throughout the third quarter and recent weeks, we continued to evaluate a variety of potential options for bringing the NB-01 asset to the market through a different regulatory pathway, including as an orphan drug or a rare disease indication," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo.

    "We had continued work on preparing an Investigational New Drug (IND) application for…

    BOSTON, Nov. 13, 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 third quarter ended September 30, 2020.

    "Throughout the third quarter and recent weeks, we continued to evaluate a variety of potential options for bringing the NB-01 asset to the market through a different regulatory pathway, including as an orphan drug or a rare disease indication," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo.

    "We had continued work on preparing an Investigational New Drug (IND) application for submission to the U.S. Food and Drug Administration (FDA) for NB-02, our multi-component drug compound that, in pre-clinical models, has shown to impact multiple pathways involved in neurodegenerative disease.  Given the global resurgence of COVID-19, we have postponed continued work on the IND and 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 second half of 2021.

    "We are also evaluating a number of potential opportunities that complement our multi-modal drug platforms.  Our development activity is mindful of conserving financial resources.  Toward that end, we believe we have the resources to fund our operations into the third quarter of 2021," concluded Dr. Kang.

    Third 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 September 30, 2020 and the operations of NeuroBo as a private company for the comparable quarter ended September 30, 2019.

    • Research and Development (R&D) Expenses were $1.3 million for the three months ended September 30, 2020, compared to $1.2 million for the three months ended September 30, 2019. The $0.1 million increase in the third quarter of 2020 was primarily attributed to CRO termination costs of $0.6 million, offset in part by the reduction in clinical trial activity of $0.3 million, given the determination in March 2020 to postpone Phase 3 clinical trials of NB-01. R&D expenses during the three months ended September 30, 2020 and 2019 included stock-based compensation of zero and $60,000, respectively.
    • General and Administrative Expenses were $1.8 million for the three months ended September 30, 2020, compared with $2.5 million for the three months ended September 30, 2019. The decrease of $0.7 million was primarily due to the reduction in transaction related costs that occurred during the third quarter of 2019 associated with legal, accounting and other consulting support of $1.6 million, offset by cost increases in the current quarter of $0.9 million related largely to director and officer insurance premiums of $0.4 million, public company related costs of $0.2 million, stock based compensation costs of $0.2 million, and payroll related costs of $0.1 million. Stock-based compensation costs during the three-month periods ended September 30, 2020 and 2019 were $0.2 million and a credit of $(6,000), respectively.
    • Net Loss for the third quarter ended September 30, 2020 was approximately $3.1 million, or $0.19 per basic and diluted share, based on 16,427,307 weighted average common shares outstanding, compared with a net loss of approximately $3.6 million, or $0.70 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 $12.4 million as of September 30, 2020, compared with $13.9 million at December 31, 2019. The Company expects that its cash position will be adequate to fund operations into the third quarter of 2021.

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc. has a current portfolio of three drug candidates. The company's NB-01 candidate has been shown in a Phase 2 study to significantly reduce pain symptoms associated with painful diabetic neuropathy (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 NB-02 drug candidate 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, was developed 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; the economic feasibility of developing NB-01 under an alternative pathway including pursuant to the terms of NeuroBo's exclusive license agreement with Dong-A ST; 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)























    September 30, 



    December 31, 







    2020



    2019







    (unaudited)







    Assets















    Current assets:















     Cash



    $

    12,353



    $

    13,908



     Restricted cash









    15



     Prepaid expenses





    511





    153



     Other assets





    34





    42



    Total current assets





    12,898





    14,118



    Right-of-use assets





    100





    116



    Property and equipment, net





    167





    200



    Other assets





    33





    34



    Total assets



    $

    13,198



    $

    14,468



    Liabilities and stockholders' equity















    Current liabilities:















    Accounts payable



    $

    1,101



    $

    638



    Accrued liabilities





    2,491





    1,422



    Lease liability, short-term





    23





    22



    Total current liabilities





    3,615





    2,082



    Lease and other long-term liabilities





    77





    94



    Total liabilities





    3,692





    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 September 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 September

    30, 2020 and December 31, 2019, respectively.





    17





    16



    Additional paid–in capital





    56,526





    49,130



    Accumulated other comprehensive (loss) income





    (3)





    12



    Accumulated deficit





    (47,034)





    (36,866)



    Total stockholders' equity





    9,506





    12,292



    Total liabilities and stockholders' equity



    $

    13,198



    $

    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 Nine Months Ended







    September 30, 



    September 30, 







    2020



    2019



    2020



    2019



    Operating expenses:



























    Research and development



    $

    1,265



    $

    1,150



    $

    4,091



    $

    3,898



    General and administrative





    1,795





    2,495





    6,110





    4,085



    Total operating expenses





    3,060





    3,645





    10,201





    7,983



    Loss from operations





    (3,060)





    (3,645)





    (10,201)





    (7,983)



    Interest income (expense), net





    6





    24





    34





    (3)



    Other (expense) income, net













    (1)







    Loss before income taxes





    (3,054)





    (3,621)





    (10,168)





    (7,986)



    Provision for income taxes



















    Net loss





    (3,054)





    (3,621)





    (10,168)





    (7,986)



    Other comprehensive income (loss):



























     Foreign currency translation gain (loss), net of

    tax





    13





    (11)





    (15)





    (2)



    Total other comprehensive income (loss)





    13





    (11)





    (15)





    (2)



    Comprehensive loss



    $

    (3,041)



    $

    (3,632)



    $

    (10,183)



    $

    (7,988)



    Loss per share:



























    Net loss per share, basic and diluted



    $

    (0.19)



    $

    (0.70)



    $

    (0.63)



    $

    (1.55)



    Weighted average common shares outstanding:



























    Basic and diluted





    16,427,307





    5,166,812





    16,135,000





    5,166,812



     

    Cision View original content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-third-quarter-2020-financial-results-301172950.html

    SOURCE NeuroBo Pharmaceuticals, Inc.

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  2. 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

     

    Cision View original content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-appoints-douglas-j-swirsky-to-the-board-of-directors-301122677.html

    SOURCE NeuroBo Pharmaceuticals, Inc.

    View Full Article Hide Full Article
  3. 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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  4. 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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  5. 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


     

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