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Gemphire Therapeutics Inc. (GEMP) SEC Filing 10-Q Quarterly report for the period ending Saturday, March 31, 2018

Gemphire Therapeutics Inc.

CIK: 1638287 Ticker: GEMP

Exhibit 99.1

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Gemphire Therapeutics Reports First Quarter 2018 Financial Results and Provides Corporate Update

 

 

LIVONIA, Mich., May 08, 2018

 -- Gemphire Therapeutics Inc. (NASDAQ: GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including non-alcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and dyslipidemia, today announced financial results for the first quarter ended March 31, 2018, and provided a corporate update.

 

“Gemphire had a strong start to 2018 with continued progress advancing gemcabene in the clinic,” said Steven Gullans, Ph.D., CEO of Gemphire. “We launched a clinical program in NAFLD and NASH with an initial focus on pediatric NAFLD and familial partial lipodystrophy in adults. Our goal is that the two ongoing trials will generate proof-of-concept data and prepare the way for confirmatory trials in broader NASH adult and pediatric populations. We believe that gemcabene’s novel mechanism of action, which includes both cardio- and liver-protective properties, together with its favorable safety profile, will provide it with a distinct competitive advantage in these diseases, if approved.”

 

“We completed enrollment in the INDIGO-1 trial investigating gemcabene in severe hypertriglyceridemia (SHTG) patients and we look forward to announcing top line results in the near future,” continued Dr. Gullans.  “We believe that gemcabene has the potential to become part of the standard of care for SHTG. With approximately 3.5 million SHTG patients in the United States alone that are at risk for developing acute pancreatitis and organ failure, it represents one of the more prevalent indications we are exploring. In these patients there is an urgent need for fast and effective lowering of triglyceride levels in order to prevent this progression to acute pancreatitis.”

 

First Quarter 2018 and Recent Corporate Highlights

 

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Completed patient enrollment in INDIGO-1 clinical trial in severe hypertriglyceridemia (SHTG) patients.

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Phase 2b INDIGO-1 is a 12 week, multicenter, double-blind, placebo-controlled, randomized trial investigating gemcabene in patients with SHTG (TG ≥ 500mg/dL) with or without background statin therapy.

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The primary endpoint is triglyceride (TG) reduction from baseline after 12 weeks. The Company plans to report top-line results in second quarter 2018.

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Initiated clinical program in pediatric nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) patients.

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GEM-IIT-601 Phase 2a trial is an open label, investigator initiated, proof-of-concept (POC) trial with the expectation to enroll approximately 40 adolescents (ages of 12 to 17)


The following information was filed by Gemphire Therapeutics Inc. (GEMP) on Tuesday, May 8, 2018 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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Inside this 10-Q Quarterly Report

Document And Entity Information
Balance Sheets
Balance Sheets (parenthetical)
Condensed Statements Of Changes In Stockholders’ Equity (deficit)
Statements Of Cash Flows
Statements Of Comprehensive Loss
Accrued Liabilities
Accrued Liabilities (details)
Accrued Liabilities (tables)
Commitments And Contingencies
Commitments And Contingencies (tables)
Commitments And Contingencies - Other Agreements (details)
Commitments And Contingencies - Pfizer License Agreement (details)
Debt
Debt (tables)
Debt - Term Loan (details)
Defined Contribution Plan
Defined Contribution Plan (details)
Fair Value Measurements
Fair Value Measurements - Narrative (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 (details)
Share-based Compensation
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Share-based Compensation (restricted Stock) (details)
Share-based Compensation (stock Options) (details)
Share-based Compensation (tables)
Stockholders’ Equity
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Stockholders’ Equity - Dividend Rights (details)
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Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (policies)
The Company And Basis Of Presentation
The Company And Basis Of Presentation (follow-on Offering) (details)
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Gemphire Therapeutics Inc. provided additional information to their SEC Filing as exhibits

Ticker: GEMP
CIK: 1638287
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-18-004320
Submitted to the SEC: Tue May 08 2018 4:31:08 PM EST
Accepted by the SEC: Tue May 08 2018
Period: Saturday, March 31, 2018
Industry: Pharmaceutical Preparations

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