Gemphire Therapeutics Inc. (GEMP) 10-Q Quarterly Report Mon Aug 14 2017

Gemphire Therapeutics Inc. (NASDAQ: GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and NASH, today announced financial results for the three and six month periods ended June 30, 2017, and provided a corporate update.

“Gemphire successfully met its two major Phase 2 clinical milestones in the last six months demonstrating safety and LDL-C lowering efficacy of gemcabene in patients with HoFH in the COBALT-1 trial and in patients with hypercholesterolemia in the ROYAL-1 trial,” said Steven Gullans, Ph.D., interim CEO of Gemphire. “These data continue to support gemcabene’s development for LDL-C reduction when used in combination with approved therapies, including atorvastatin, rosuvastatin and simvastatin at the highest intensity, as well as PCSK9 inhibitors and ezetimibe. We believe these and our historical data uniquely position gemcabene as the only oral add on therapy in late stage development with the potential to safely combine on top of any currently-approved therapy at any dose to further enhance LDL-C lowering.”

“Our strategy is to develop gemcabene in patients who are at high risk for life threatening conditions due to their dyslipidemias despite current therapies. We believe the results of the COBALT-1 and ROYAL-1 trials, combined with the 18 Phase 1 and 2 trials previously completed will provide us with sufficient data to support an end of Phase 2 meeting in 2018 to discuss the company’s gemcabene Phase 3 programs in patients with hypercholesterolemia (ASCVD and HeFH), and HoFH. We are also pursuing the utility of gemcabene in NASH and plan to initiate a Phase 2 clinical trial later in 2017,” concluded Dr. Gullans.

Second Quarter & Recent Corporate and Financial Highlights

In June, we announced that gemcabene achieved the primary endpoint for LDL cholesterol in our Phase 2b COBALT-1 trial. COBALT-1 evaluated gemcabene in homozygous familial hypercholesterolemia (HoFH) patients who are on stable maximally tolerated lipid-lowering therapies.

In May, we presented a poster on gemcabene’s mechanism of action based on preclinical findings at the Arteriosclerosis, Thrombosis and Vascular Biology | Peripheral Vascular Disease (ATVB|PVD) 2017 Scientific Sessions. Across the various animal models, gemcabene was shown to lower hepatic gene biomarkers for lipid regulation (ACC1, APOC-III, Sulfatase 2,ADH4, and HMG-CoA Synthase 2) and inflammation (CRP, TNF-α, MCP-1, CCR2, CCR5, NF-Kβ, MIP-1β) as well as plasma biomarkers (LDL-C, TG, hsCRP).

In May, we hosted a key opinion leader meeting for investors in New York featuring David E. Cohen, M.D., Ph.D., of Weill Cornell Medical Institute who discussed the clinical landscape for the treatment of nonalcoholic steatohepatitis (NASH).

The following information was filed by Gemphire Therapeutics Inc. (GEMP) on Monday, August 14, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Gemphire Therapeutics Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2017 10-K Annual Report includes:

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Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

Gemphire Therapeutics Inc. provided additional information to their SEC Filing as exhibits

Exhibit 10.1: Material Contract

Exhibit 10.2: Material Contract

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: GEMP
CIK: 1638287
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-17-006610
Submitted to the SEC: Mon Aug 14 2017 9:15:04 AM EST
Accepted by the SEC: Mon Aug 14 2017
Period: Friday, June 30, 2017
Industry: Pharmaceutical Preparations

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Gemphire Therapeutics Inc. (GEMP) SEC Filing 10-Q Quarterly report for the period ending Friday, June 30, 2017

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