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Gemphire Therapeutics Inc. (GEMP) SEC Filing 10-Q Quarterly report for the period ending Saturday, June 30, 2018

Gemphire Therapeutics Inc.

CIK: 1638287 Ticker: GEMP

Exhibit 99.1

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

 

LIVONIA, Mich., August 13, 2018

 -- Gemphire Therapeutics Inc. (NASDAQ: GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and nonalcoholic steatohepatitis (NASH), today announced financial results for the quarter and six months ended June 30, 2018, and provided a corporate update.

 

“We capped off our second quarter by announcing that our INDIGO-1 trial investigating gemcabene in severe hypertriglyceridemia (SHTG) patients achieved its primary endpoint,” said Steven Gullans, Ph.D., CEO of Gemphire. “We were pleased to successfully complete our third Phase 2b trial in dyslipidemia and look forward to finalizing our Phase 3 program once we are able to provide the FDA with the additional information they recently requested.”

 

“While last week’s decision by the Data and Safety Monitoring Board of our primary investigator to terminate the Phase 2a pediatric NAFLD trial will cause us to put our plans to develop gemcabene in this particular population on hold, we remain confident that gemcabene has the potential to be an effective therapy for a host of cardiometabolic patients and we intend to continue to develop gemcabene to address multiple indications.”

 

Second Quarter 2018 Corporate Highlights

·

Announced gemcabene achieved its primary endpoint in the Phase 2 INDIGO-1 study of severe hypertriglyceridemia (SHTG) patients (> 500 mg/dL)

o

Primary endpoint met with median triglycerides (TG) significantly decreased by 47% in gemcabene 600 mg group compared to 27% for placebo (P=0.0063; ranked ANCOVA).

o

The clinical target for SHTG patients is to reach a serum TG level of less than 500 mg/dL. The 600 mg gemcabene group attained a significantly lower median level of serum TGs of 333 mg/dL compared to placebo of 538 mg/dL (P=0.0137) at the end of the study. 

o

Multiple secondary endpoints achieved with 600 mg gemcabene, including placebo-corrected median decreases in LDL-C, non-HDL-C, VLDL-C, apoB, apoE, apoCIII and SAA.

o

Adverse events (AEs) were generally mild to moderate, occurring less frequently with gemcabene than placebo. No severe adverse events (SAEs) were observed with gemcabene.

·

Appointed Steven Gullans, Ph.D., as President and Chief Executive Officer. Dr. Gullans served as Interim President and Chief Executive Officer of Gemphire from May 2017 to May 2018.

 

Recent Corporate Developments

 

·

U.S. Food and Drug Administration (FDA) requested that the Company produce data from a sub-chronic toxicology study to support lifting the partial clinical hold on gemcabene with respect to clinical trials of longer than six months in duration.

o

The Company is working with the FDA to release the partial hold, with the goal of proceeding to an End of Phase 2 meeting and reaching an agreement on the design of a Phase 3 clinical program in dyslipidemia.  It plans to conduct the studies required by the FDA and expects to submit the additional results in the second quarter of 2019.

o

The Company continues to be free to conduct clinical trials with gemcabene that do not extend beyond six months in duration.

·

The investigator-led open label Phase 2a proof-of-concept trial evaluating gemcabene in pediatric NAFLD was terminated due to unexpected liver problems observed in the patients that underwent 12-week MRI-PDFF imaging scans. 


The following information was filed by Gemphire Therapeutics Inc. (GEMP) on Monday, August 13, 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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Gemphire Therapeutics Inc. provided additional information to their SEC Filing as exhibits

Ticker: GEMP
CIK: 1638287
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-18-007065
Submitted to the SEC: Tue Aug 14 2018 12:37:56 PM EST
Accepted by the SEC: Tue Aug 14 2018
Period: Saturday, June 30, 2018
Industry: Pharmaceutical Preparations

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