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Gemphire Therapeutics Inc. (GEMP) SEC Filing 10-K Annual report for the fiscal year ending Saturday, December 31, 2016

Gemphire Therapeutics Inc.

CIK: 1638287 Ticker: GEMP

Exhibit 99.1

 

 

Gemphire Announces Fiscal Year 2016 Financial Results and Provides Corporate Update

 

Announces Date for 2017 Annual Meeting of Stockholders

 

Conference Call and Live Webcast, Today at 4:30 Eastern Time

 

LIVONIA, Michigan, March 15, 2017 — Gemphire Therapeutics Inc. (NASDAQ: GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and NASH, today announced

financial results for the fourth quarter and full fiscal year ended December 31, 2016 and provided a corporate update.

 

“Since our IPO in 2016, we continue to advance our clinical programs to validate the therapeutic potential of gemcabene as a first-in-class, once-daily, oral drug candidate for the treatment of dyslipidemia and NASH,” said Mina Sooch, President and CEO of Gemphire.  “Our experienced team that has been involved in the development of Lipitor® and other cardiometabolic drugs has successfully launched a comprehensive clinical program evaluating gemcabene in the broad dyslipidemia indications of HeFH/ASCVD and SHTG, as well as in the orphan HoFH population.  With the close of the recent financing, we are expanding our Phase 2 clinical program with a fourth planned trial evaluating gemcabene in NASH.”

 

“Our target market opportunity is over 20 million cardiovascular and NASH patients in the US that need additional cost-effective, complementary new therapies to reduce the risk of cardiovascular and liver diseases,” continued Ms. Sooch.  “It is an exciting time to develop a late stage asset in the cardiovascular and NASH space given the recent positive industry developments with Amgen’s positive PCSK9 inhibitor outcomes study further strengthening the LDL-C hypothesis relevant for our ROYAL program and Intercept’s encouraging FDA guidance on acceptable surrogate endpoints for Phase 3 trials, providing a more efficient development path for the NASH indication with no approved therapies.  We look forward to a transformational year in 2017 with data readouts expected from all three of our Phase 2b trials in dyslipidemia patients.”

 

Fourth Quarter and Recent Corporate Highlights

 

·                  In October 2016, Gemphire appointed Lee Golden, M.D., an interventional cardiologist with extensive biotech and large-cap pharma experience, as our Chief Medical Officer.

 

·                  In November 2016, a key US provisional application was converted to a PCT application directed to the use of gemcabene for treating patients with mixed dyslipidemia or NASH.  Any patents issued from this application, absent extension, would expire in 2036.  Further, in October 2016, a European patent was granted and validated in 21 European countries including the UK, Germany, France, and the Netherlands for the use of gemcabene for decreasing the risk for developing pancreatitis for SHTG patients with triglycerides 500 mg/dL or greater.  These patents will expire in 2031 absent any extension.

 

·                  In November 2016, we initiated enrollment for the ROYAL-1 study, a randomized, placebo-controlled, double-blind Phase 2b trial designed to evaluate gemcabene in the treatment of patients with hypercholesterolemia, including those with HeFH and ASCVD, not adequately controlled for

 

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The following information was filed by Gemphire Therapeutics Inc. (GEMP) on Wednesday, March 15, 2017 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
Balance Sheets
Balance Sheets (parenthetical)
Statements Of Cash Flows
Statements Of Changes In Convertible Preferred Stock And Stockholders' Deficit
Statements Of Changes In Convertible Preferred Stock And Stockholders' Deficit - Temporary Equity
Statements Of Comprehensive Loss
Accrued Liabilities
Accrued Liabilities (details)
Accrued Liabilities (tables)
Commitments And Contigencies - Other Agreements (details)
Commitments And Contigencies - Pfizer License Agreement (details)
Commitments And Contigencies - Preferred Stock Dividends (details)
Commitments And Contingencies
Commitments And Contingencies (tables)
Convertible Series A Preferred Stock
Convertible Series A Preferred Stock (details)
Debt
Debt (details)
Fair Value Measurements
Fair Value Measurements (tables)
Fair Value Measurements - Financial Instruments Measured On Recurring Basis (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
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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 - Convertible Notes (details)
Related Party Transactions - Interim Notes (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) (details)
Share-based Compensation (stock Options) (details)
Share-based Compensation (tables)
Share-based Compensation (unrecognized) (details)
Stockholders??? And Members??? Equity (deficit)
Stockholders??? And Members??? Equity (deficit) (details)
Subsequent Events
Subsequent Events (details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (details)
Summary Of Significant Accounting Policies (policies)
Supplementary Data ??? Quarterly Financial Data (unaudited)
Supplementary Data ??? Quarterly Financial Data (unaudited) (details)
Supplementary Data ??? Quarterly Financial Data (unaudited) (tables)
The Company And Basis Of Presentation
The Company And Basis Of Presentation (basis Of Presentation) (details)
The Company And Basis Of Presentation (ipo And Capital Requirements) (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: 0001558370-17-001962
Submitted to the SEC: Mon Mar 20 2017 9:49:55 PM EST
Accepted by the SEC: Tue Mar 21 2017
Period: Saturday, December 31, 2016
Industry: Pharmaceutical Preparations

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