Last10K.com

Gemphire Therapeutics Inc. (GEMP) SEC Filing 10-K Annual report for the fiscal year ending Sunday, December 31, 2017

Gemphire Therapeutics Inc.

CIK: 1638287 Ticker: GEMP

Exhibit 99.1

 

 

Picture 1

Gemphire Therapeutics Reports Fourth Quarter and Fiscal Year 2017 Financial Results

 

Conference Call & Live Webcast Today at 4:30pm Eastern Time

 

 

LIVONIA, Mich., March. 15, 2018 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia, non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), today announced its financial results for the quarter and fiscal year ended December 31, 2017, and provided a corporate update.

 

“2017 was a productive and successful year for Gemphire, with significant progress in our comprehensive Phase 2 program for gemcabene which is designed to show proof of concept in a broad spectrum of cardiometabolic conditions, including hypercholesterolemia, severe hypertriglyceridemia, and NASH,” said Steven Gullans, Ph.D., interim CEO of Gemphire. “Our Phase 2 clinical trials completed in 2017, COBALT-1 and ROYAL-1, both met their primary endpoints, demonstrating that gemcabene is capable of lowering LDL-C, triglycerides and inflammation. In 2018, we expect to make meaningful progress on our remaining Phase 2 trials, including concluding our INDIGO-1 trial in severe hypertriglyceridemia (SHTG) patients in Q2, and enrolling open-label pediatric and adult programs in NAFLD/NASH.  In addition, our goal is to advance gemcabene into Phase 3 in dyslipidemia in the second half of 2018, once agreement with the FDA is reached.” 

 

“We are especially excited to have launched our investigation of gemcabene as a potential treatment for NAFLD/NASH with our recently initiated Phase 2 trials in pediatric NAFLD and in familial partial lipodystrophy (FPL),” added Dr. Gullans.  “Our decision to move forward in NAFLD/NASH is based on the strong rationale for gemcabene to target the underlying pathology of these diseases. We believe that the drug’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.”

 

Fourth Quarter and Recent Corporate Highlights

 

·

Completed patient enrollment in Phase 2b INDIGO-1 trial investigating gemcabene in severe hypertriglyceridemia (SHTG) patients.

o

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

o

Patients are enrolled into one of three arms: gemcabene 300 mg, gemcabene 600 mg or placebo once daily.

o

The primary endpoint is triglyceride (TG) reduction from baseline after 12 weeks.

o

Company remains on track to report top-line results from the study in the second quarter of 2018.

·

Launched a Clinical Program to Develop Gemcabene as a Treatment for NASH/NAFLD.

o

Initiated a Phase 2a proof-of-concept (POC) clinical trial investigating gemcabene as a treatment for pediatric NAFLD.  Pediatric NAFLD/NASH is a large and untreated market and provides an opportunity to advance gemcabene in an underserved area with millions of affected patients.

o

This open label pediatric trial is expected to enroll approximately 40 adolescent children between the ages of 12 and 17 who are diagnosed with NAFLD and abnormal liver function as assessed by liver transaminases.  Top line results are expected in early 2019.


The following information was filed by Gemphire Therapeutics Inc. (GEMP) on Thursday, March 15, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

View differences made from one year to another to evaluate Gemphire Therapeutics Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Gemphire Therapeutics Inc..

Continue

Assess how Gemphire Therapeutics Inc.'s management team is paid from their Annual Proxy

Definitive Proxy Statement (Form DEF 14A)
Screenshot example of actual Proxy Statement

Gemphire Therapeutics Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2018 10-K Annual Report includes:

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors

Continue

Tools

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Balance Sheets
Balance Sheets (parenthetical)
Statements Of Cash Flows
Statements Of Changes In Convertible Preferred Stock And Stockholders??? Equity (deficit)
Statements Of Changes In Convertible Preferred Stock And Stockholders??? Equity (deficit) - Temporary Equity
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)
Commitments And Contingencies - Preferred Stock Dividends (details)
Convertible Series A Preferred Stock
Convertible Series A Preferred Stock (details)
Debt
Debt (tables)
Debt - Convertible Notes (details)
Debt - Intermin Notes (details)
Debt - Term Loan (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 Liabilitie (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 - Convertible Notes (details)
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
Schedule Ii - Valuation And Qualifying Accounts (details)
Share-based Compensation
Share-based Compensation (details)
Share-based Compensation (restricted Stock 10k) (details)
Share-based Compensation (stock Options 10k) (details)
Share-based Compensation (tables)
Share-based Compensation (unrecognized) (details)
Stockholders??? And Members' Deficit
Stockholders??? And Members' Deficit (details)
Stockholders??? And Members' Deficit - Dividend Rights (details)
Stockholders??? And Members' Deficit - Warrants (details)
Subsequent Events
Subsequent Events (details)
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)
The Company And Basis Of Presentation (reverse Stock Split) (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-K Annual Report
Accession Number: 0001558370-18-002275
Submitted to the SEC: Tue Mar 20 2018 5:28:15 PM EST
Accepted by the SEC: Tue Mar 20 2018
Period: Sunday, December 31, 2017
Industry: Pharmaceutical Preparations

External Resources:
Stock Quote
Social Media

Bookmark the Permalink:
https://last10k.com/sec-filings/gemp/0001558370-18-002275.htm