NRBO NeuroBo Pharmaceuticals Inc.

1.85
-0.04  -2%
Previous Close 1.89
Open 1.87
52 Week Low 1.82
52 Week High 7.6094
Market Cap $49,197,392
Shares 26,593,185
Float 10,710,246
Enterprise Value $41,362,983
Volume 289,643
Av. Daily Volume 578,539
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Drug Pipeline

Drug Stage Notes
ANA-001
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 safety data reviewed by DMC, the committee has recommended the continuation of the trial without modification. Phase 3 initiation and Phase 2 portion of the trial expected to be completed 4Q 2021.
NB-02
Dyslipidemia
Phase 1
Phase 1
Phase 1 trial to be initiated 2H 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.

Latest News

  1. BOSTON, Oct. 13, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced that an independent Data Monitoring Committee (DMC) reviewed safety data from 36 patients treated in the Phase 2/3 clinical trial of NeuroBo's lead drug candidate, ANA001, a proprietary oral niclosamide formulation being developed as a potential treatment for COVID-19. Based on those findings, the DMC recommended the continuation of the trial without modification.

    The two-part Phase 2/3 multi-center, double blind, placebo-controlled study to assess safety, tolerability, and…

    BOSTON, Oct. 13, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced that an independent Data Monitoring Committee (DMC) reviewed safety data from 36 patients treated in the Phase 2/3 clinical trial of NeuroBo's lead drug candidate, ANA001, a proprietary oral niclosamide formulation being developed as a potential treatment for COVID-19. Based on those findings, the DMC recommended the continuation of the trial without modification.

    The two-part Phase 2/3 multi-center, double blind, placebo-controlled study to assess safety, tolerability, and efficacy of ANA001 is being conducted in the U.S. In both phases of the study, hospitalized patients with moderate to severe COVID-19 (patients not requiring ventilators) receive a seven-day course of ANA001 (niclosamide capsules) in addition to standard-of-care treatment. The Phase 2 part of the trial is expected to enroll 60 patients and the primary objective is to assess safety and tolerability. Secondary objectives include measurements of efficacy (median time to hospital discharge) and pharmacokinetics (PK).

    The Phase 3 part of the trial is expected to enroll several hundred patients, with the primary endpoints being median time to hospital discharge, safety and tolerability. Secondary objectives will evaluate clinical improvement and the need and duration for rescue therapy.

    "The DMC's recommendation to continue enrollment of the Phase 2/3 clinical trial, without modification, is an important milestone for our lead drug candidate, ANA001, as a potential treatment for COVID-19," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. "We look forward to continuing the development of this potentially life-saving therapy to address the ongoing need for safe and effective COVID-19 treatments, particularly as this pandemic is evolving into an endemic. We expect to complete the Phase 2 portion of the trial in the fourth quarter of this year and to achieve a number of value-creating milestones with this program in the coming months, including initiation of the Phase 3 of trial."

    For more information on this clinical trial, please visit: www.clinicaltrials.gov, NCT04603924

    About Niclosamide and ANA001

    ANA001 is a proprietary oral niclosamide formulation in development as a treatment for patients with COVID-19. Niclosamide has antiviral and anti-inflammatory properties, and a well-understood safety profile in humans. ANA001 is currently being studied in a 60-subject Phase 2 clinical trial conducted in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. In preclinical research by an independent academic group published in Antimicrobial Agents and Chemotherapy, niclosamide inhibited viral replication in vitro and was more potent than remdesivir in the same assay.

    Additional in vitro studies have shown that niclosamide prevents replication of SARS-CoV-2 at very low concentrations and that the compound appears to exhibit three distinct mechanisms of action: 1) acting as a potent antiviral against a variety of other viruses including influenza; 2) reducing inflammation without suppressing the immune system; and 3) providing bronchodilation, which is a useful pulmonary mechanism for at-risk patients with underlying pulmonary and/or cardiovascular conditions.

    As a result, the company believes ANA001 has the potential to reduce viral load and inflammation associated with cytokine dysregulation, acute respiratory distress syndrome (ARDS), and coagulation abnormalities and thus improve time to clinical improvement defined as hospital discharge recorded using the WHO Ordinal Scale for Clinical Improvement.

    The company believes ANA001 has distinct competitive advantages in this market, including (1) offering an effective treatment for COVID-19; (2) having 3+ year marketing exclusivity in the U.S. upon U.S. Food and Drug Administration (FDA) approval; (3) providing ease of administration via a capsule formulation and potential to dramatically lower overall treatment cost; and (4) possessing a proven safety profile (generic niclosamide has been used safely for 50 years as a treatment for tapeworm infections).

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on developing and commercializing multi-modal disease-modifying therapies for viral, neuropathic, and neurodegenerative diseases, has a current portfolio of four drug candidates. The company's recently acquired ANA001 candidate is a proprietary oral niclosamide formulation in development as a treatment for patients with COVID-19. Niclosamide has antiviral and anti-inflammatory properties, and a well-understood safety profile in humans. ANA001 is currently being studied in a Phase 2/3 clinical trial conducted at up to 20 clinical sites in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. 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 the global COVID-19 crisis, a planned Phase 3 study of NB-01 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 fourth program, Gemcabene, was previously being developed for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease. Gemcabene is currently being assessed as an acute treatment for COVID-19.

    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 failure to obtain all of the benefits or recognize all of the synergies anticipated from the ANA acquisition; the integration of ANA potentially diverting management resources from operational matters and other strategic opportunities; the effect of future milestone payments and royalties specified in the ANA acquisition agreement on the results of operations and financial position of NeuroBo; 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, including with respect to ANA001 and Gemcabene; the timing of the availability of data from NeuroBo's clinical trials, including with respect to ANA001 and Gemcabene;  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, including ANA001 and Gemcabene; 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 Securities and Exchange Commission 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.

    Contact:

    Rx Communications Group

    Michael Miller

    +1-917-633-6086

    mmiller@rxir.com

     

    Cision View original content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-announces-positive-recommendation-from-independent-data-safety-monitoring-committee-of-phase-23-clinical-trial-of-ana001-in-hospitalized-patients-with-moderate-to-severe-covid-19-301399070.html

    SOURCE NeuroBo Pharmaceuticals, Inc.

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  2. BOSTON, Oct. 5, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced the closing of its previously announced registered direct offering of 4,307,693 shares of the Company's common stock, at a purchase price of $3.25 per share. In a concurrent private placement, the Company issued to the investors in the registered direct offering unregistered warrants to purchase up to 4,307,693 shares of the Company's common stock. 

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

    The warrants have an exercise price of $3.75

    BOSTON, Oct. 5, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced the closing of its previously announced registered direct offering of 4,307,693 shares of the Company's common stock, at a purchase price of $3.25 per share. In a concurrent private placement, the Company issued to the investors in the registered direct offering unregistered warrants to purchase up to 4,307,693 shares of the Company's common stock. 

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

    The warrants have an exercise price of $3.75 per share, will be exercisable commencing six months following the date of issuance for a period of three and one-half years from the date of issuance. 

    After deducting the placement agent's fees and other estimated offering expenses to be paid by the Company, the Company received net proceeds of approximately $12.7 million. The Company intends to use the net proceeds from this offering for working capital, capital expenditures and general corporate purposes.

    The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by NeuroBo pursuant to a "shelf" registration statement on Form S-3 (File No. 333-256135) previously filed with the Securities and Exchange Commission (the "SEC") on May 14, 2021 and declared effective by the SEC on May 26, 2021. The offering of the shares of common stock were 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 have been 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 (212) 856-5711 or e-mail at placements@hcwco.com.

    The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the Act), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

    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., a clinical-stage biotechnology company focused on developing and commercializing multi-modal disease-modifying therapies for viral, neuropathic, and neurodegenerative diseases, has a current portfolio of four drug candidates. The company's recently acquired ANA001 candidate is a proprietary oral niclosamide formulation in development as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators). Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. ANA001 is currently being studied in a 60-subject Phase 2/3 clinical trial conducted at up to 20 clinical sites in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. 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 the global COVID-19 crisis, a planned Phase 3 study of NB-01 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 fourth program, Gemcabene, was previously being developed for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease. Gemcabene is currently being assessed as an acute treatment for COVID-19.

    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: the failure to obtain all of the benefits or recognize all of the synergies anticipated from the ANA acquisition; the integration of ANA potentially diverting management resources from operational matters and other strategic opportunities; the effect of future milestone payments and royalties specified in the ANA acquisition agreement on the results of operations and financial position of NeuroBo; 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, including with respect to ANA001 and Gemcabene; the timing of the availability of data from NeuroBo's clinical trials, including with respect to ANA001 and Gemcabene;  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, including ANA001 and Gemcabene; 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 Securities and Exchange Commission 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

    Michael Miller

    +1-917-633-6086

    mmiller@rxir.com

    Cision View original content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-closes-14-million-registered-direct-offering-301393289.html

    SOURCE NeuroBo Pharmaceuticals, Inc.

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  3. BOSTON, Oct. 1, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced that it has entered into a definitive agreement with several institutional investors for the purchase and sale in a registered direct offering of 4,307,693 shares of the Company's common stock, at a purchase price of $3.25 per share. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 4,307,693 shares of the Company's common stock.  The closing of the offering is expected…

    BOSTON, Oct. 1, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced that it has entered into a definitive agreement with several institutional investors for the purchase and sale in a registered direct offering of 4,307,693 shares of the Company's common stock, at a purchase price of $3.25 per share. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 4,307,693 shares of the Company's common stock.  The closing of the offering is expected to occur on or about October 5, 2021, subject to the satisfaction of customary closing conditions.

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

    The warrants have an exercise price of $3.75 per share, will be exercisable commencing six months following the date of issuance for a period of three and one-half years from the date of issuance. 

    The gross proceeds to NeuroBo from this offering are expected to be approximately $14 million, before deducting the placement agent's fees and other offering expenses. The Company intends to use the net proceeds from this offering for working capital, capital expenditures and general corporate purposes.

    The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by NeuroBo pursuant to a "shelf" registration statement on Form S-3 (File No. 333-256135) previously filed with the Securities and Exchange Commission (the "SEC") on May 14, 2021 and declared effective by the SEC on May 26, 2021. The offering of the shares of common stock will be 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 will be filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, 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 (212) 856-5711 or e-mail at placements@hcwco.com.

    The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the Act), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

    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., a clinical-stage biotechnology company focused on developing and commercializing multi-modal disease-modifying therapies for viral, neuropathic, and neurodegenerative diseases, has a current portfolio of four drug candidates. The company's recently acquired ANA001 candidate is a proprietary oral niclosamide formulation in development as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators). Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. ANA001 is currently being studied in a 60-subject Phase 2/3 clinical trial conducted at up to 20 clinical sites in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. 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 the global COVID-19 crisis, a planned Phase 3 study of NB-01 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 fourth program, Gemcabene, was previously being developed for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease. Gemcabene is currently being assessed as an acute treatment for COVID-19.

    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 completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and 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: the failure to obtain all of the benefits or recognize all of the synergies anticipated from the ANA acquisition; the integration of ANA potentially diverting management resources from operational matters and other strategic opportunities; the effect of future milestone payments and royalties specified in the ANA acquisition agreement on the results of operations and financial position of NeuroBo; 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, including with respect to ANA001 and Gemcabene; the timing of the availability of data from NeuroBo's clinical trials, including with respect to ANA001 and Gemcabene;  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, including ANA001 and Gemcabene; 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 Securities and Exchange Commission 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

    Michael Miller

    +1-917-633-6086

    mmiller@rxir.com

    Cision View original content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-announces-14-million-registered-direct-offering-301389668.html

    SOURCE NeuroBo Pharmaceuticals, Inc.

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  4. BOSTON, Aug. 16, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2021.

    Management Commentary

    "During the second quarter, we continued to advance the Phase 2/3 clinical trial of our lead drug candidate, ANA001, a proprietary oral niclosamide formulation, in development as a treatment for patients with moderate to severe COVID-19," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. "While enrollment of the Phase 2 portion of the trial in the U.S. had initially…

    BOSTON, Aug. 16, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2021.

    Management Commentary

    "During the second quarter, we continued to advance the Phase 2/3 clinical trial of our lead drug candidate, ANA001, a proprietary oral niclosamide formulation, in development as a treatment for patients with moderate to severe COVID-19," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. "While enrollment of the Phase 2 portion of the trial in the U.S. had initially progressed at a slow rate due to high vaccination rates and a deceleration of COVID-19 hospitalizations, the spread of the Delta variant has reversed that trend and enrollment has now accelerated. As a result, we expect to complete the Phase 2 portion of the trial in the fourth quarter. We look forward to a number of value-creating milestones with our COVID-19 programs in the coming months."

    Dr. Kang continued, "In July, we were delighted to enhance our Board of Directors with the elections of Hyung Heon Kim and Andrew Koven.  Their collective industry leadership experience and legal expertise is greatly valued as we seek to advance our pipeline of multi-modal disease-modifying therapies for viral, neuropathic, and neurodegenerative diseases."

    Second Quarter 2021 Financial and Operating Results

    • Research and Development (R&D) Expenses were $2.0 million for the three months ended June 30, 2021 as compared to $0.7 million for the three months ended June 30, 2020. The $1.3 million increase in the second quarter of 2021 was primarily attributed to an overall increase in research development activity in 2021 on a net basis when compared to the comparable quarter in the prior year.
    • General and Administrative Expenses were $1.9 million for the three months ended June 30, 2021, compared to $1.7 million for the three months ended June 30, 2020. The increase of $0.2 million in the current period was primarily due to additional insurance premium costs of $0.1 million, payroll costs of $0.1 million and consulting costs of $0.1 million, offset in part by a reduction of facility related costs of $0.1 million when compared to the comparable period in the prior year.
    • Net Loss for the quarter ended June 30, 2021 was $3.9 million, or $0.18 per basic and diluted share, based on 22,200,074 weighted average common shares outstanding, compared with a net loss of $2.4 million, or $0.15 per basic and diluted share, based on 16,303,681 weighted average common shares outstanding for the quarter ended June 30, 2020.
    • Cash and Cash Equivalents were $9.5 million as of June 30, 2021, compared with $10.1 million as of December 31, 2020. Operating at its current level of clinical activity, NeuroBo expects its cash position will be adequate to fund operations into the first quarter of 2022.

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on developing and commercializing multi-modal disease-modifying therapies for viral, neuropathic, and neurodegenerative diseases, has a current portfolio of four drug candidates. The company's recently acquired ANA001 candidate is a proprietary oral niclosamide formulation in development as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators). Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. ANA001 is currently being studied in a 60-subject Phase 2/3 clinical trial conducted at up to 20 clinical sites in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. 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 the global COVID-19 crisis, a planned Phase 3 study of NB-01 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 fourth program, Gemcabene, was previously being developed for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease. Gemcabene is currently being assessed as an acute treatment for COVID-19.

    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 failure to obtain all of the benefits or recognize all of the synergies anticipated from the ANA acquisition; the integration of ANA potentially diverting management resources from operational matters and other strategic opportunities; the effect of future milestone payments and royalties specified in the ANA acquisition agreement on the results of operations and financial position of NeuroBo; 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, including with respect to ANA001 and Gemcabene; the timing of the availability of data from NeuroBo's clinical trials, including with respect to ANA001 and Gemcabene;  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, including ANA001 and Gemcabene; 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 Securities and Exchange Commission 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

    Michael Miller

    +1-917-633-6086

    mmiller@rxir.com

    - Tables to Follow -

     

    NeuroBo Pharmaceuticals, Inc.

    Consolidated Balance Sheets

    (in thousands, except share amounts and par value)





















    June 30, 



    December 31, 







    2021



    2020







    (unaudited)









    Assets















    Current assets:















     Cash



    $

    9,513



    $

    10,089



     Prepaid expenses





    789





    546



     Other assets





    166





    48



    Total current assets





    10,468





    10,683



    Right-of-use assets and other





    117





    130



    Property and equipment, net





    134





    155



    Total assets



    $

    10,719



    $

    10,968



    Liabilities and stockholders' equity















    Current liabilities:















    Accounts payable



    $

    347



    $

    2,575



    Accrued liabilities





    811





    1,096



    Lease liability, short-term





    25





    24



    Total current liabilities





    1,183





    3,695



    Lease liability, long-term





    58





    70



    Total liabilities





    1,241





    3,765



    Commitments and contingencies (Notes 4, 5, 6 and 11)















    Stockholders' equity















    Preferred stock, $0.001 par value; 10,000,000 shares authorized as of June 30, 2021 and December 31, 2020; no shares issued or outstanding as of June 30, 2021 and December 31, 2020.











    Common stock, $0.001 par value per share, 100,000,000 shares authorized as of June 30, 2021 and December 31, 2020; 22,285,492 and 19,671,182 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively.





    22





    20



    Additional paid–in capital





    83,242





    73,713



    Accumulated other comprehensive income





    3





    14



    Accumulated deficit





    (73,789)





    (66,544)



    Total stockholders' equity





    9,478





    7,203



    Total liabilities and stockholders' equity



    $

    10,719



    $

    10,968



     

    NeuroBo Pharmaceuticals, Inc.

    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, 







    2021



    2020



    2021



    2020



    Operating expenses:



























    Research and development



    $

    2,012



    $

    674



    $

    3,155



    $

    2,826



    General and administrative





    1,914





    1,718





    4,101





    4,315



    Total operating expenses





    3,926





    2,392





    7,256





    7,141



    Loss from operations





    (3,926)





    (2,392)





    (7,256)





    (7,141)



    Interest income





    5





    8





    11





    28



    Other expense, net

















    (1)



    Loss before income taxes





    (3,921)





    (2,384)





    (7,245)





    (7,114)



    Provision for income taxes



















    Net loss





    (3,921)





    (2,384)





    (7,245)





    (7,114)



    Other comprehensive (loss) income, net of tax





    (4)





    6





    (11)





    (28)



    Comprehensive loss



    $

    (3,925)



    $

    (2,378)



    $

    (7,256)



    $

    (7,142)



    Loss per share:



























    Net loss per share, basic and diluted



    $

    (0.18)



    $

    (0.15)



    $

    (0.33)



    $

    (0.44)



    Weighted average common shares outstanding:



























    Basic and diluted





    22,200,074





    16,303,681





    21,909,464





    15,987,240



     

    Cision View original content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-reports-second-quarter-2021-financial-results-301355545.html

    SOURCE NeuroBo Pharmaceuticals, Inc.

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  5. BOSTON, July 12, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced the results of the elections conducted at its Annual Meeting of Shareholders, held Friday July 9, 2021, during which  Hyung Heon Kim and Andrew I. Koven were elected to the Company's Board of Directors .

    Neither Akash Bakshi nor Jeong Gyun Oh stood for re-election at the Annual Meeting. The Board would like to thank Mr. Bakshi and Mr. Oh for their service.  The NeuroBo Board now consists of  seven directors, six of whom are considered independent directors.

    "On behalf of…

    BOSTON, July 12, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced the results of the elections conducted at its Annual Meeting of Shareholders, held Friday July 9, 2021, during which  Hyung Heon Kim and Andrew I. Koven were elected to the Company's Board of Directors .

    Neither Akash Bakshi nor Jeong Gyun Oh stood for re-election at the Annual Meeting. The Board would like to thank Mr. Bakshi and Mr. Oh for their service.  The NeuroBo Board now consists of  seven directors, six of whom are considered independent directors.

    "On behalf of the NeuroBo Board, I am delighted to welcome Hyung and Andrew to the Company. Their collective industry leadership experience and legal expertise will be greatly valued as we advance our pipeline of multi-modal disease-modifying therapies for viral, neuropathic, and neurodegenerative diseases," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. 

    "This is an exciting time to join the NeuroBo Board as the Company is making great strides in advancing its lead asset, ANA001, toward late-stage development in viral diseases, starting with COVID-19. I look forward to working with NeuroBo's Board and executive management to support the Company's future growth," commented Mr. Kim.

    "NeuroBo is at an important juncture in its evolution, and I look forward to leveraging my many years of experience leading drug development companies in order to help the Company realize its long-term vision," said Mr. Koven.

    Hyung Heon Kim

    Mr. Kim is the General Counsel and a Vice President of Dong-A ST and Dong-A Socio Group, a Korean-based group of companies mainly engaged in the research, development, production and sale of pharmaceuticals, medical devices and APIs. Mr. Kim has served as General Counsel of Dong-A ST since January 2018 and as a Vice President of Dong-A ST since December 2020. He previously served as Executive Director of Dong-A ST from January 2018 through December 2020. Earlier, Mr. Kim was Head of International Legal Affairs for Dong-A Socio Holdings Co., Ltd., a Korean-based holding company for the Dong-A Socio group of companies, from 2012 to 2018. Prior to joining Dong-A Socio Group, Mr. Kim served as legal counsel to SK Energy Co., Ltd. and SK Innovation Co., Ltd. from 2008 to 2011. Since April 2021, Mr. Kim has served as a director of AnaPath Services GmbH, a private Swiss-based provider of scientific research and development services, and STP America Research Corp, a private New Jersey-based research and development company.

    Mr. Kim received his Bachelor of Law degree from Soongshil University in Korea and his Juris Doctor from Washington University School of Law.

    Andrew I. Koven

    Mr. Koven is the Lead Independent Director of Kala Pharmaceuticals, Inc., a public biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, and has been, since December 2018; and has been a member of the Kala Board of Directors since September 2017. Mr. Koven was, until his retirement in January 2019, the President and Chief Business Officer of Aralez Pharmaceuticals Inc., a public specialty pharmaceutical company, and served in that role with the company's predecessor, Pozen Inc., commencing in June 2015. Prior to joining Pozen, Mr. Koven was Executive Vice President, Chief Administrative Officer and General Counsel of Auxilium Pharmaceuticals Inc., a public specialty biopharmaceutical company, from February 2012 until January 2015, when it was acquired by Endo International plc. Mr. Koven served as President and Chief Administrative Officer and a member of the Board of Directors of Neurologix, Inc., a company focused on the development of multiple innovative gene therapy development programs, from September 2011 to November 2011. Before Neurologix, Mr. Koven held the Executive Vice President and Chief Administrative and Legal Officer position at  Inspire Pharmaceuticals, Inc., a public specialty pharmaceutical company, from July 2010 until May 2011 when it was acquired by Merck & Co., Inc. From March 2007 until February 2010, Mr. Koven was Executive Vice President, General Counsel and Corporate Secretary of Sepracor Inc. (now Sunovion), a public specialty pharmaceutical company, until its acquisition by Dainippon Sumitomo Pharma Co., Ltd. in 2010. Prior to joining Sepracor, Mr. Koven served as Executive Vice President, General Counsel and Corporate Secretary of Kos Pharmaceuticals, Inc., a public specialty pharmaceutical company, from August 2003 until its acquisition by Abbott Laboratories (now AbbVie) in December 2006. Mr. Koven began his career in the pharmaceutical industry first as an Assistant General Counsel and then as Associate General Counsel at Warner-Lambert Company from 1993 to 2000, followed by his role as Senior Vice President and General Counsel at Lavipharm Corporation from 2000 to 2003. From 1986 to 1992 he was a corporate associate at Cahill, Gordon & Reindel in New York. From 1992 to 1993 he served as Counsel, Corporate and Investment Division, at The at The Equitable Life Assurance Society of the U.S.

    Mr. Koven holds a Master of Laws (LL.M.) Degree from Columbia University School of Law and a Bachelor of Laws (LL.B.) Degree and Bachelor of Arts Degree in Political Science from Dalhousie University.

    About NeuroBo Pharmaceuticals

    NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on developing and commercializing multi-modal disease-modifying therapies for viral, neuropathic, and neurodegenerative diseases, has a current portfolio of four drug candidates. The company's recently acquired ANA001 candidate is a proprietary oral niclosamide formulation in development as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators). Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. ANA001 is currently being studied in a 60-subject Phase 2/3 clinical trial conducted at up to 20 clinical sites in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. 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 the global COVID-19 crisis, a planned Phase 3 study of NB-01 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 fourth program, Gemcabene, was previously being developed for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease. Gemcabene is currently being assessed as an acute treatment for COVID-19.

    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 failure to obtain all of the benefits or recognize all of the synergies anticipated from the ANA acquisition; the integration of ANA potentially diverting management resources from operational matters and other strategic opportunities; the effect of future milestone payments and royalties specified in the ANA acquisition agreement on the results of operations and financial position of NeuroBo; 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, including with respect to ANA001 and Gemcabene; the timing of the availability of data from NeuroBo's clinical trials, including with respect to ANA001 and Gemcabene;  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, including ANA001 and Gemcabene; 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 Securities and Exchange Commission 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

    Michael Miller

    +1-917-633-6086

    mmiller@rxir.com

    Cision View original content:https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-shareholders-elect-hyung-heon-kim-and-andrew-i-koven-to-neurobos-board-of-directors-301331168.html

    SOURCE NeuroBo Pharmaceuticals, Inc.

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