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Gemphire Therapeutics Inc. (GEMP) SEC Filing 10-Q Quarterly report for the period ending Friday, March 31, 2017

Gemphire Therapeutics Inc.

CIK: 1638287 Ticker: GEMP

Exhibit 99.1

Picture 1

 

Gemphire Announces First Quarter 2017 Financial Results and

Provides Corporate Update

 

LIVONIA, Michigan, May 9, 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 first quarter ended March 31, 2017, and provided a corporate update.

 

“The first quarter was a very productive start to 2017 for Gemphire, highlighted by continued progress in developing gemcabene, our first-in-class, once-daily, oral drug candidate for the treatment of dyslipidemia and NALFD/NASH,” said Mina Sooch, President and CEO of Gemphire.  “We are currently conducting three late stage clinical trials for gemcabene: our COBALT-1 trial for HoFH patients; our ROYAL-1 trial for hypercholesterolemia, including HeFH and ASCVD patients on maximally tolerated statins; and, our INDIGO-1 trial for SHTG patients.  During the quarter, we completed enrollment of both our COBALT-1 and ROYAL-1 trials, on or ahead of schedule, and enrolled our first patients in our INDIGO-1 trial.  We expect to report top line data from our COBALT-1 and ROYAL-1 studies in June and third quarter 2017, respectively.  The third trial, INDIGO-1, is currently enrolling and we expect top line data in early 2018.  Based on gemcabene’s lipid-lowering and anti-inflammatory mechanism of action, and on the strength of positive preclinical data we announced during the first quarter, we also have plans to launch a Phase 2 clinical development program in NASH this year.”

 

First Quarter & Recent Corporate Highlights

·

In January, we announced positive preclinical proof of concept data on gemcabene in the treatment of nonalcoholic steatohepatitis (NASH) and plans to launch a clinical development program in NASH.

·

In January, we announced positive interim data on the LDL-C primary endpoint from the ongoing open label COBALT-1 trial investigating gemcabene in homozygous familial hypercholesterolemia  (HoFH) patients.  No serious adverse events (SAEs) have been reported and the safety profile remains consistent with previous studies.

·

In March, we presented results of a double-blind, randomized, placebo controlled, Phase 2 trial that investigated the insulin sensitization and LDL-C lowering of gemcabene in non-diabetic, obese patients at the American College of Cardiology 66th Annual Scientific Session in Washington, D.C.  Gemcabene was associated with a doubling of mean increase in glucose disposal rate to 13% compared to a 6.8% increase for placebo, and it lowered LDL-C by 40%, consistent with past results in hypercholesterolemia subjects.

·

In March, we closed a $12.5 million private placement that extends the Company’s projected cash runway to late 2018.  The net proceeds provide funding for the planned clinical development program for gemcabene in NASH patients, manufacturing and related process development activities, and general corporate purposes.  

·

In May, we presented a poster on gemcabene’s mechanism of action at the Arteriosclerosis, Thrombosis and Vascular Biology | Peripheral Vascular Disease (ATVB|PVD) 2017 Scientific Sessions, which took place in Minneapolis, MN.


The following information was filed by Gemphire Therapeutics Inc. (GEMP) on Tuesday, May 9, 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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Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Balance Sheets
Condensed Balance Sheets (parenthetical)
Condensed Statements Of Cash Flows
Condensed Statements Of Changes In Convertible Preferred Stock And Stockholders' Deficit - Temporary Equity
Condensed Statements Of Changes In Convertible Preferred Stock And Stockholders??? Equity (deficit)
Condensed Statements Of Comprehensive Loss
Accrued Liabilities
Accrued Liabilities (details)
Accrued Liabilities (tables)
Commitments And Contigencies - Other Agreements (details)
Commitments And Contigencies - Pfizer License Agreement (details)
Commitments And Contigencies - Preferred Stock Dividends (details)
Commitments And Contingencies
Convertible Series A Preferred Stock
Convertible Series A Preferred Stock (details)
Debt
Debt (details)
Fair Value Measurements
Fair Value Measurements (tables)
Fair Value Measurements - Narrative (details)
Fair Value Measurements - Roll-forward Of Premium Conversion Derivative Liabilities (details)
Income Taxes
Income Taxes (details)
License Agreement
License Agreement (details)
Net Loss Per Common Share
Net Loss Per Common Share (details)
Net Loss Per Common Share (tables)
Net Loss Per Common Share - Antidilutive Securities (details)
Net Loss Per Common Share - Earning Per Share (details)
Related Party Transactions
Related Party Transactions - Convertible Notes (details)
Related Party Transactions - Interim Notes (details)
Related Party Transactions - Ipo And Private Placement (details)
Related Party Transactions - Rental Agreement (details)
Share-based Compensation
Share-based Compensation (details)
Share-based Compensation (restricted Stock) (details)
Share-based Compensation (stock Options) (details)
Share-based Compensation (tables)
Share-based Compensation (unrecognized) (details)
Stockholders??? Equity (deficit)
Stockholders??? Equity (deficit) (details)
Subsequent Events
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (details)
Summary Of Significant Accounting Policies (policies)
The Company And Basis Of Presentation
The Company And Basis Of Presentation (ipo And Capital Requirements) (details)
The Company And Basis Of Presentation (private Placement Offering) (details)

Material Contracts, Statements, Certifications & more

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

Ticker: GEMP
CIK: 1638287
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-17-004134
Submitted to the SEC: Wed May 10 2017 4:31:38 PM EST
Accepted by the SEC: Wed May 10 2017
Period: Friday, March 31, 2017
Industry: Pharmaceutical Preparations

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