Gemphire Therapeutics Inc. (GEMP) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

Gemphire Therapeutics Inc.

CIK: 1638287 Ticker: GEMP

Exhibit 99.1


Gemphire Therapeutics Reports Fourth Quarter and Fiscal Year 2018 Financial Results


LIVONIA, Mich., March 15, 2019 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease, focused on orphan indications, as well as nonalcoholic fatty liver disease (NAFLD/NASH), today announced its financial results for the quarter and fiscal year ended December 31, 2018, and provided a corporate update.


“2018 was a year of progress for Gemphire with our Phase 2 INDIGO-1 trial investigating gemcabene in severe hypertriglyceridemia (SHTG) successfully meeting its primary endpoint,” said Steven Gullans,  Ph.D, CEO of Gemphire. “In addition, patient enrollment was completed in an investigator-initiated Phase 2 study in familial partial lipodystrophy (FPL).  On the other hand, the FDA requested that we provide additional information regarding preclinical toxicology before it will consider lifting our clinical hold and scheduling an End of Phase 2 (EOP2) meeting. We are moving propitiously to achieve this milestone and move into Phase 3.”


“In August, we received unexpected news when the pediatric non-alcoholic fatty liver disease (NAFLD) study was halted early by the Data Safety Monitoring Board (DSMB) due to unanticipated problems,” added Gullans. “While there were no serious adverse events (SAEs), the first three patients experienced increased circulating liver enzyme levels and increased liver fat content. Unlike prior studies of gemcabene in adults, the pediatric patients gained weight and did not experience a decrease in serum triglycerides (TGs).  Moreover patients were poorly compliant in taking the drug as assessed by tablet counts and blood drug levels. Being cautious with regard to the patients, we fully supported the decision to discontinue the trial, and we look forward to seeing how and whether, we can further resolve these findings.”


Fourth Quarter and Recent Corporate Highlights



Completed patient enrollment in a proof-of-concept (POC) Phase 2 trial investigating gemcabene in FPL


This investigator initiated trial (GEM-IIT-602) is an unblinded, 24 week study being conducted at the University of Michigan.


All patients receive 300 mg/day dose for the first 12 weeks, and then are randomized to either the same dose or a higher dose of 600 mg/day for the subsequent 12 weeks.


The primary endpoint is TG reduction from baseline after 12 weeks. Secondary endpoints include measurement of liver fat fraction by MRI-PDFF.


The trial is on track to report top-line results in the second quarter of 2019.


FPL is considered an orphan indication and represents an unmet clinical need.



The POC Phase 2 trial in pediatric non-alcoholic fatty liver disease (NAFLD) was halted early


An open-label, 12 week, investigator initiated trial (GEM-IIT-601) was undertaken to assess gemcabene (300 mg/d) in pediatric patients (12-17 years old) with NAFLD.


The study enrolled 6 patients and in August 2018, the DSMB halted the trial early due to “unanticipated problems” in the first three patients.


The primary efficacy endpoint of alanine amino transferase (ALT) increased beyond baseline levels in two of these three patients. In addition, all three patients had an increase in the

The following information was filed by Gemphire Therapeutics Inc. (GEMP) on Friday, March 15, 2019 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-K Annual 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-K Annual 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
Statements Of Changes In Convertible Preferred Stock And Stockholders??? Equity (Deficit) - Temporary Equity
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)
Commitments And Contingencies - Preferred Stock Dividends (Details)
Convertible Series A Preferred Stock
Convertible Series A Preferred Stock (Details)
Debt (Tables)
Debt - Interim Notes (Details)
Debt - Term Loan (Details)
Debt - Term Loan Minimum Aggregate Future Payments (Details)
Defined Contribution Plan
Defined Contribution Plan (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)
Income Taxes (Tables)
Income Taxes - Additional Information (Details)
Income Taxes - Reconciliation Of Income Tax (Details)
Income Taxes -Significant Components Of Deferred Tax Assets And Liabilities (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)
Quarterly Data
Quarterly Data (Details)
Quarterly Data (Tables)
Related Party Transactions
Related Party Transactions - Interim Notes (Details)
Related Party Transactions - Ipo And Private Placement (Details)
Related Party Transactions - Rental Agreement (Details)
Schedule Ii - Valuation And Qualifying Accounts (Details)
Share-Based Compensation
Share-Based Compensation (Details)
Share-Based Compensation (Tables)
Share-Based Compensation - 2016 Employee Stock Purchase Plan (Details)
Share-Based Compensation - Assumptions (Details)
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Share-Based Compensation - Stock Options (Details)
Stockholders??? Equity (Deficit)
Stockholders??? Equity (Deficit) (Details)
Stockholders??? Equity (Deficit) - Dividend Rights (Details)
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Subsequent Events
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Summary Of Significant Accounting Policies
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The Company And Basis Of Presentation
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The Company And Basis Of Presentation (Reverse Stock Split) (Details)

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

Ticker: GEMP
CIK: 1638287
Form Type: 10-K Annual Report
Accession Number: 0001558370-19-002192
Submitted to the SEC: Fri Mar 15 2019 8:33:08 PM EST
Accepted by the SEC: Mon Mar 18 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations

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