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

Gemphire Therapeutics Inc.

CIK: 1638287 Ticker: GEMP

Exhibit 99.1

 

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

 

 

LIVONIA, Mich., November 8, 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 nine months ended September 30, 2018, and provided a corporate update.

 

“During the third quarter we had several accomplishments that are important to the continued development of gemcabene,” said Steven Gullans, Ph.D., CEO of Gemphire. “We negotiated our license agreement with Pfizer to extend the timeline to commercialization of gemcabene and we renegotiated the terms of our debt facility with Silicon Valley Bank (SVB) to provide additional flexibility. We also made significant adjustments to our headcount and cash burn to extend our cash runway into at least the fourth quarter of 2019.”

 

“Our immediate priority is to work closely with the FDA to release the partial clinical hold on gemcabene, with the goal of proceeding to an End of Phase 2 meeting in 2019 and reaching agreement on the design of a Phase 3 clinical program. We continue to believe that gemcabene is a differentiated, late stage candidate for cardiometabolic disease, and has successfully shown clinical benefits in both orphan and broader dyslipidemia indications,” concluded Dr. Gullans.  

 

Third quarter 2018 Corporate Highlights

·

Gemcabene is on partial clinical hold with respect to clinical trials of longer than six months in duration. The Company plans to conduct a sub-chronic (13-week) toxicology study that has been requested by the FDA and expects to submit the additional results in the second quarter of 2019.  The Company continues to be free to conduct clinical trials with gemcabene that are six months or less in duration.

·

In the ongoing 24 week open-label Phase 2a trial investigating gemcabene in adult patients with familial partial lipodystrophy (FPL), an interim safety review by the Data Safety and Monitoring Board (DSMB) of the first three patients, on a dose of 300 mg/dL,  did not uncover safety or tolerability concerns nor was there a change in biomarkers that would indicate concerns about liver function.  The principal investigator in the trial intends to closely monitor these patients while including MRI-PDFF scans to be reviewed at interim time points. Following the DSMB interim review, additional patients have been enrolled and top-line data, including MRI-PDFF, is expected in Q2 2019. 

·

The investigator-led open label Phase 2a proof-of-concept trial evaluating gemcabene in pediatric patients with non-alcoholic fatty liver disease (NAFLD) was terminated due to lack of efficacy and liver signals observed in the patients that underwent 12-week MRI-PDFF imaging scans. In cooperation with the principal investigator, the Company is continuing to gather information to determine whether the unanticipated problems could be related to variables such as diet, age, compliance, or other factors.  

·

The Company amended the license agreement with Pfizer to extend the period of first commercial sale of gemcabene to April 2024.

·

The Company amended the debt facility agreement with SVB to provide additional flexibility.


The following information was filed by Gemphire Therapeutics Inc. (GEMP) on Thursday, November 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
Condensed Balance Sheets
Condensed Balance Sheets (Parenthetical)
Condensed Statements Of Changes In Stockholders??? Equity (Deficit)
Condensed Statements Of Comprehensive Loss
Statements Of Cash Flows
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
Share-Based Compensation (Details)
Share-Based Compensation (Tables)
Share-Based Compensation - 2016 Employee Stock Purchase Plan (Details)
Share-Based Compensation - Executives (Details)
Share-Based Compensation - Restricted Stock (Details)
Share-Based Compensation - Stock Options (Details)
Stockholders??? Equity
Stockholders??? Equity (Details)
Stockholders??? Equity - Dividend Rights (Details)
Stockholders??? Equity - Warrants (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 (Follow-On Offering) (Details)
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: 0001558370-18-009021
Submitted to the SEC: Thu Nov 08 2018 4:19:28 PM EST
Accepted by the SEC: Thu Nov 08 2018
Period: Sunday, September 30, 2018
Industry: Pharmaceutical Preparations

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