The combined company expects to submit an application with results of a preclinical mouse safety study to the Food and Drug Administration (FDA) in early 2020 to address a partial clinical hold related to gemcabene’s activation of peroxisome proliferation-activated receptor (PPAR) and, if approved, would be poised to progress into Phase 3 human studies. ET on July 25, 2019 to discuss the proposed merger transaction. Obtenez des informations détaillées sur l'Action Neurobo Pharmaceuticals Inc (NRBO) y compris Prix, Graphiques, Analyses Techniques, Données historiques, Rapports Neurobo Pharmaceuticals et … Posted on 01/10/2020 342 . Gemphire and NeuroBo anticipate that subsequent events and developments will cause their respective views to change. A webcast replay will be available on the investors and media sections of the Gemphire website for all interested parties following the call and will be archived and available for 90 days. Gemphire, and its directors and executive officers, and NeuroBo, and its directors and executive officers, may be deemed to be participants in the solicitation of proxies from the stockholders of Gemphire in connection with the proposed merger. Gemcabene has been studied in more than 1,100 human subjects in a total of 25 Phase 1 and Phase 2 trials with demonstrated efficacy and safety. Gemphire Therapeutics Announces Stockholder Approval of Proposals Required for Merger with NeuroBo Pharmaceuticals PRESS RELEASE GlobeNewswire Dec. 6, 2019, 08:42 AM Phase 3 clinical trials are expected to begin in the fourth quarter of 2019. The company is focused on providing new treatment options for cardiometabolic diseases through its complementary, convenient, cost-effective product candidate, gemcabene, as an add-on to the standard of care, especially with statins that will benefit patients, physicians, and payers. The company’s lead drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN) has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. NeuroBo licensed NB-01 from Korean pharmaceutical company Dong-A ST. NB-01 has successfully completed Korean and U.S. Investors and stockholders are urged to read the proxy statement/prospectus/information statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. NeuroBo Pharmaceuticals has completed its previously announced combination with Gemphire Therapeutics. The merged company will focus on the development of NeuroBo’s clinical-stage drug candidates for the treatment of neurodegenerative diseases. Forward-looking statements are usually identified by the use of words such as “believes,” “anticipates,” “expects,” “intends,” “plans,” “ideal,” “may,” “potential,” “will,” “could” and similar expressions. As part of the merger, Gemphire stockholders received non-transferable contingent value rights (CVRs) entitling the holders to receive in aggregate, after the retention of $500,000 by the combined company and certain other permitted deductions, 80% of the net proceeds, if any, in the event the gemcabene assets are sold or licensed during the 10-year period following the closing of the merger or pursuant to the license agreement with Beijing SL. On July 24 th, we announced the signing of a merger agreement with NeuroBo Pharmaceuticals, Inc. for an all-stock transaction expected to close later this year,” noted Steven Gullans, Ph.D., CEO of Gemphire. In addition, the forward-looking statements included in this press release represent Gemphire’s and NeuroBo’s views as of the date hereof. NeuroBo Pharmaceuticals Inc. is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. Initiation of enrollment in the first Phase 3 study with NB-01 is anticipated in the first half of 2020 and will enroll approximately 460 subjects with PDN across the U.S. NeuroBo’s IND-ready second drug candidate, NB-02, is targeted for the treatment of Alzheimer’s disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. NeuroBo Pharmaceuticals Inc., formerly known as Gemphire Therapeutics Inc., is based in Northville, United States. “Concomitantly, we announced an out-licensing deal with Beijing SL Pharmaceutical Co., Ltd for the rights to gemcabene in mainland China, Hong Kong, Macau and Taiwan. This partnership is expected to provide an upfront gross payment of $2.5 million to Gemphire and back end milestone and royalty payments to the combined company if certain development and commercialization milestones are met. Risks and uncertainties related to NeuroBo that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: NeuroBo’s plans to develop and commercialize its product candidates; the timing of completion of NeuroBo’s planned clinical trials; the timing of the availability of data from NeuroBo’s clinical trials; NeuroBo’s plans to research, develop and commercialize its current and future product candidates; NeuroBo’s ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo’s product candidates; NeuroBo’s commercialization, marketing and manufacturing capabilities and strategy; NeuroBo’s ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to NeuroBo’s competitors and its industry; the impact of government laws and regulations; NeuroBo’s ability to protect its intellectual property position; and NeuroBo’s estimates regarding future revenue, expenses, capital requirements and need for additional financing following the proposed transaction. The transaction has been approved by the board of directors of both companies. The company’s multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. NeuroBo’s IND-ready second drug candidate, NB-02, is focused on the treatment of Alzheimer’s disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. BOSTON–(BUSINESS WIRE)–NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today reported that the previously announced merger between NeuroBo Pharmaceuticals, Inc., (“NeuroBo”) and Gemphire Therapeutics (Nasdaq: GEMP) closed on December 31, 2019. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. In Phase 2 clinical trials, NB-01 has shown efficacy comparable to existing therapies and a superior safety profile. 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. NeuroBo Pharmaceuticals, Inc., formerly Gemphire Therapeutics Inc., is a clinical-stage biotechnology company. 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. In connection with the closing of the transaction, Gemphire will change its name to NeuroBo Pharmaceuticals, Inc. and the Company’s shares are expected to commence trading on The Nasdaq Capital Market under the symbol “NRBO”. The board of directors for the post-merger combined company will be comprised of six directors, one of whom will be Steve Gullans, Ph.D., Gemphire’s current president and chief executive officer and member of the Gemphire board of directors. These forward-looking statements should not be relied upon as representing NeuroBo’s views as of any date subsequent to the date hereof. The merged firm will advance NeuroBo’s clinical-stage drug candidates for neurodegenerative disorders. NeuroBo Pharmaceuticals, Inc, anciennement Gemphire Therapeutics Inc, est une société de biotechnologie au stade clinique. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today reported that the previously announced merger between NeuroBo Pharmaceuticals, Inc., ("NeuroBo") and Gemphire Therapeutics (Nasdaq: GEMP) closed on December 31, 2019. NeuroBo Pharmaceuticals, Inc, anciennement Gemphire Therapeutics Inc, est une société de biotechnologie au stade clinique. NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases. On a pro forma basis and based upon the number of shares of Gemphire common stock to be issued in the merger, the pre-merger Gemphire shareholders will own approximately 4.06% of the post-merger combined company and the pre-merger NeuroBo investors will own approximately 95.94% of the post-merger combined company on a fully-diluted basis. ET on July 25, 2019. View source version on businesswire.com:https://www.businesswire.com/news/home/20200110005495/en/, KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA, INDUSTRY KEYWORD: BIOTECHNOLOGY OTHER HEALTH HEALTH PHARMACEUTICAL CLINICAL TRIALS, PUB: 01/10/2020 05:00 PM/DISC: 01/10/2020 05:00 PM, http://www.businesswire.com/news/home/20200110005495/en. Phase 2 proof-of-concept clinical trials, showing that NB-01 provided significant relief of diabetic neuropathic pain with minimal side effects, compared to placebo. Upon completion of the merger, Gemphire will change its name to NeuroBo Pharmaceuticals, Inc., and plans to change its ticker symbol on the Nasdaq Capital Market to “NRBO.” The merged company will focus on the development of NeuroBo’s clinical-stage drug candidates for the treatment of neurodegenerative diseases. NeuroBo Pharmaceuticals, based in Boston, MA, 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. The combined company will also continue to support the partnership with Beijing SL Pharmaceutical, Co., Ltd. (“Beijing SL”), for gemcabene rights in China. This multi-component drug approach has the potential to address the underlying mechanisms of PDN, reduce neuropathic pain symptoms and slow disease progression. LIVONIA, Mich., Sept. 24, 2018 -- Gemphire Therapeutics Inc. , a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders,... | December 25, 2020 Additionally, the live, listen-only webcast of the conference call can be accessed by visiting the investors and media section of the Gemphire website at www.gemphire.com, or the investors and media section of the NeuroBo website at www.neurobopharma.com. Ashley RobinsonLifeSci Advisors LLC(617) 535-7742, Nicole FranklinRacepoint Global(617) 624-3264nfranklin@racepointglobal.com. In addition, NeuroBo plans to continue the advancement of gemcabene, which has been in development by Gemphire for the treatment of dyslipidemia. NeuroBo is focused on the development of a treatment for diabetic neuropathic pain (DNP), with its lead drug candidate, NB-01, in Phase 3 clinical development as a first-line, disease-modifying therapy. Press release content from Business Wire. Additional information about Gemphire’s directors and executive officers is included in Gemphire’s Annual Report on Form 10-K for the year that ended December 31, 2018, filed with the SEC on March 18, 2019. We evaluated numerous potential merger partners and recognized that NeuroBo has a solid base of investors and the potential to deliver significant value based on its pipeline assets. NeuroBo Pharmaceuticals, Inc. Common Stock (NRBO) Stock Quotes - Nasdaq offers stock quotes & market activity data for US and global markets. In addition, Gemphire stockholders of record as of immediately prior to the effective time of the merger will receive non-transferable contingent value rights (CVRs) entitling the holders to receive in the aggregate, after the retention of $500,000 by the combined company and certain other permitted deductions, 80% of the net proceeds, if any, received during the 15-year period following the merger from transactions entered into during the 10-year period following the merger involving the sale or license of gemcabene. “As we move towards developing both NB-01 and NB-02, we believe that having shares publicly traded on Nasdaq will provide greater opportunity to advance our therapeutic pipeline and corporate strategy.”. In connection with the proposed transaction between Gemphire and NeuroBo, the parties intend to file relevant materials with the SEC, including a registration statement on Form S-4 that will contain a combined proxy statement/prospectus/information statement. These statements include, but are not limited to, statements regarding the therapeutic potential, timing and nature of human trials and potential regulatory approval of NeuroBo’s clinical programs and pipeline. NeuroBo Pharmaceuticals Inc. is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. Gemphire’s Phase 2 clinical program is evaluating the efficacy and safety of gemcabene in hypercholesterolemia, hypertriglyceridemia and fatty liver disease, including Familial Hypercholesterolemia (FH), Severe Hypertriglyceridemia (SHTG), Non-alcoholic Steatohepatitis (NASH)/Non-alcoholic Fatty Liver Disease (NAFLD) and Atherosclerotic Cardiovascular Disease (ASCVD). Gemphire Therapeutics Inc. and Boston-based NeuroBo Pharmaceuticals Inc. have agreed to a deal that will result in Gemphire changing its name to NeuroBo Pharmaceuticals. Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the proxy statement/prospectus/information statement referred to above. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. After the merger, NeuroBo investors will own 95.94% of the new company, while Gemphire shareholders will own around 4.06%. Transaction to Create Nasdaq-listed Biotechnology Company Focused on Advancing NeuroBo’s Clinical-Stage Pipeline, NeuroBo Poised to Advance Lead Drug Candidate into Phase 3 Trials for Neuropathic Pain Indications, NeuroBo Recently Received Aggregate Gross Proceeds of $24.24 Million in Series B Financing, Gemphire Out-Licenses Gemcabene to Beijing SL Pharmaceutical Co. for Chinese Market, Companies to Host Conference Call at 8:30 a.m. NeuroBo will focus on advancing the company’s clinical-stage pipeline for neurodegenerative diseases. The company’s novel lead candidate NB-01 is a drug … NB-01 is a natural product candidate that restores nerve growth factor levels in pre-clinical models of pain. “As we look ahead, we have some important milestones on the horizon. The AP news staff was not involved in its creation. The corporate headquarters of the combined organization is located in Boston, Massachusetts. NeuroBo Pharmaceuticals and Gemphire Therapeutics Complete Merger. Ms. Na Yeon (Irene) Kim, M.S., MBA, was appointed as chairman of the board. In a randomized, placebo-controlled Phase 2 clinical trial, NB-01 significantly improved pain scores from baseline as measured by the NRS, an 11-point numeric rating scale commonly used in pain studies, and showed an excellent safety profile when compared to retrospective safety data on existing therapies. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on … “NeuroBo represents an ideal merger partner for us,” stated Dr. Steve Gullans, president and chief executive officer of Gemphire. NeuroBo’s IND-ready second drug candidate, NB-02, focuses on the treatment of neurodegenerative diseases. NeuroBo Pharmaceuticals, a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today reported that the previously announced merger between NeuroBo Pharmaceuticals and Gemphire Therapeutics closed on December 31, 2019. The combined unit will operate as NeuroBo Pharmaceuticals with NeuroBo shareholders holding a 96.24% stake in the firm. Connect with the definitive source for global and local news, https://www.businesswire.com/news/home/20200110005495/en/. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today reported that the previously announced merger between NeuroBo Pharmaceuticals, Inc., (NeuroBo) and Gemphire Therapeutics (Nasdaq: GEMP) closed on December 31, 2019. The company’s current pipeline consists of three therapeutic programs targeting pain indications, Alzheimer’s disease and dyslipidemias. Honigman LLP is serving as legal counsel to Gemphire. The new combined company, known as NeuroBo Pharmaceuticals … Upon the merger between Gemphire Therapeutics, Inc. and NeuroBo Pharmaceuticals, Inc. at year-end 2019, the formerly private NeuroBo was considered the accounting acquirer. This communication shall not constitute an offer to sell, the solicitation of an offer to sell or an offer to buy or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today reported that the previously announced merger between NeuroBo Pharmaceuticals, Inc., (“NeuroBo”) and Gemphire Therapeutics (Nasdaq: GEMP) closed on December 31, 2019. The company’s novel lead program, NB-01, is an oral drug candidate for painful diabetic neuropathy (PDN). Ladenburg Thalmann & Co. Inc. is acting as financial advisor to Gemphire for the transaction and Consilium Partners Inc. is acting as financial advisor to NeuroBo for the transaction. NeuroBo acquired NB-02 outright from Dong-A ST. “We are excited about the opportunities and resources that will become available to NeuroBo and its therapeutic pipeline as a result of the merger,” explained John L. Brooks III, president and chief executive officer, NeuroBo Pharmaceuticals. Immediately after the closing of the merger, NeuroBo shareholders owned 96.24%, and current Gemphire stockholders owned 3.76% of NeuroBo’s common stock. Today, Gemphire also announced that the company has signed an out-licensing partnership with Beijing SL Pharmaceutical Co. Ltd. to advance its drug candidate, gemcabene, into the Chinese market. is serving as legal counsel to NeuroBo. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker “NRBO” on December 31, 2019. Two Phase 2b trials supporting hypercholesterolemia and one Phase 2b trial in SHTG were recently completed under NCT02722408, NCT02634151 and NCT02944383, respectively. These factors, risks and uncertainties include, but are not limited to: risks relating to the completion of the merger, including the need for stockholder approval and the satisfaction of closing conditions; risks that the conditions to the milestone and royalty payments pursuant to the licensing partnership with Beijing SL Pharmaceutical Co. may not be met; risks related to Gemphire’s ability to correctly estimate and manage its operating expenses and its expenses associated with the proposed merger pending closing; the cash balances of the combined company following the closing of the merger; the ability of Gemphire to remain listed on the Nasdaq Capital Market; the risk that as a result of adjustments to the exchange ratio, Gemphire shareholders or NeuroBo stockholders could own more or less of the combined company than is currently anticipated; the risk that the conditions to payment under the CVRs will not be met and that the CVRs may otherwise never deliver any value to Gemphire stockholders; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed merger; the success and timing of regulatory submissions and pre-clinical and clinical trials; regulatory requirements or developments; changes to clinical trial designs and regulatory pathways; changes in capital resource requirements; and other factors discussed in the "Risk Factors" section of Gemphire’s most recent annual report, subsequent quarterly reports and in other filings Gemphire makes with the SEC from time to time. Important Additional Information Will be Filed with the SEC. Enrollment in the first study in the Phase 3 program for NB-01 in the U.S. is expected to begin in the first half of 2020, with a target enrollment of approximately 460 subjects with PDN. The company’s novel lead candidate NB-01 is a drug candidate for diabetic neuropathic pain. NeuroBo believes that leveraging the therapeutic properties of its natural product-based platform will drive a paradigm shift in the treatment of DNP and other neurodegenerative diseases where drug safety combined with efficacy is a strong unmet need. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today reported that the previously announced merger between NeuroBo Pharmaceuticals, Inc., (“NeuroBo”) and Gemphire Therapeutics (Nasdaq: GEMP) closed on December 31, 2019.The new combined company, known as NeuroBo Pharmaceuticals … NeuroBo Pharmaceuticals is set to secure a Nasdaq listing through a reverse merger with Gemphire Therapeutics. Following the merger, John L. Brooks III will be appointed to serve as the post-merger combined company’s president and chief executive officer. NeuroBo Pharmaceuticals & Gemphire Therapeutics Merger Building a pipeline of treatment candidates for neurodegenerative diseases that affect millions of patients worldwide Novel Treatment Candidates for Neurodegenerative Conditions July 2019. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. In addition, the forward-looking statements included in this press release represent NeuroBo’s views as of the date hereof. LIVONIA, Mich. and BOSTON, July 26, 2019 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (Gemphire) (Nasdaq: GEMP), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of dyslipidemia as well as nonalcoholic fatty liver disease, and NeuroBo Pharmaceuticals, Inc. (NeuroBo), a privately-held clinical-stage biotechnology company focused on novel, disease-modifying therapies for neurodegenerative diseases, today jointly announced that they have entered into a definitive agreement whereby NeuroBo will merge with a wholly-owned subsidiary of Gemphire in an all-stock transaction. Gemphire Therapeutics has agreed to merge with biotechnology company NeuroBo Pharmaceuticals in an all-stock transaction. Get NeuroBo Pharmaceuticals alerts: A … “NeuroBo has a compelling Phase 3 program with NB-01 in diabetic neuropathic pain and a strong team to advance its pipeline. NeuroBo’s second drug candidate, NB-02, is in development for the treatment of neurodegenerative diseases associated with the pathological dysfunction of the amyloid-beta and tau proteins in the human brain, which include Alzheimer’s disease and tauopathies. Investors and shareholders will be able to obtain free copies of the proxy statement/prospectus/information statement and other documents filed by Gemphire with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. 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. 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