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
“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
“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
Fourth Quarter and Recent Corporate Highlights
- In
October 2016 , Gemphire appointedLee 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, inOctober 2016 , a European patent was granted and validated in 21 European countries including theUK ,Germany ,France , andthe 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 LDL-C on high-intensity or moderate-intensity stable statin therapy. Enrollment has completed ahead of schedule. This indication, consistent with the PCKS9 inhibitor labels for Repatha® and Praluent®, represents 11 million addressable patients in the US. - In
December 2016 , we initiated screening for the INDIGO-1 study, a randomized, placebo-controlled, double-blind Phase2b trial evaluating gemcabene to lower triglycerides in SHTG patients. This indication represents 3 million addressable patients in the US. - In
January 2017 , we announced positive preclinical proof of concept data on gemcabene in the treatment of NASH and plans to launch a clinical development program in NASH in 2017. This indication represents 6 million addressable patients in the US. - In
January 2017 , we announced positive interim data on the LDL-C primary endpoint from the ongoing open label COBALT-1 trial investigating gemcabene in HoFH patients. No SAEs have been reported and the safety profile remains consistent with previous studies. Gemcabene hasFDA orphan designation for HoFH in the US. - In
March 2017 , we closed on a$12.5 million private placement that provides funding for the AZURE-1 Phase 2 trial investigating gemcabene in NASH patients, manufacturing activities, and general corporate purposes. This extends the Company’s cash runway until at least late 2018.
Upcoming 2017 Clinical Milestones
- Poster presentation at
American College of Cardiology (ACC) AnnualScientific Session inMarch 2017 on gemcabene lipid-lowering effects and insulin sensitization in obese patients. - Top-line results from COBALT-1 Phase 2b trial are expected in
June 2017 . - Top-line results from ROYAL-1 Phase 2b trial are expected in the third quarter of 2017.
- Top-line results from INDIGO-1 Phase 2b trial are expected in the fourth quarter of 2017.
- Plan to initiate AZURE-1 Phase 2 trial in NASH in the second half of 2017.
Year End 2016 Financial Update
General and administrative expense for the three months and full year ended
Research and development expense for the three months and full year ended
Net loss attributable to common stockholders for the three months and full year ended
Cash and cash equivalents at
On
For 2017, management expects operating expenses and cash used in operating activities to be approximately double 2016 levels, primarily in research and development as we fund our ongoing clinical trials, and to be more heavily weighted in the first two quarters of 2017, aligned with the activity levels of ongoing trials. In addition, non-cash compensation expenses are currently approximately
Corporate Update
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Conference Call Details
Management will host an investment community conference call today,
Annual Meeting of Stockholders
Gemphire today announced that it will host its Annual Meeting of Stockholders on Tuesday, May 23, 2017 at
Because the date of the Annual Meeting is more than 30 days before the anniversary date of last year’s Annual Meeting (which took place by written consent in lieu of such Annual Meeting prior to the Company’s initial public offering), pursuant to applicable
About Gemcabene
Gemphire’s product candidate, gemcabene (CI-1027), is a first-in-class, once-daily, oral therapy that may be suitable for patients who are unable to achieve normal levels of LDL-C or triglycerides with currently approved therapies, primarily statins. Gemcabene's mechanism of action is designed to enhance the clearance of very low-density lipoproteins (VLDLs) in the plasma and inhibit the production of cholesterol and triglycerides in the liver. The combined effect for these mechanisms has been clinically observed to result in a reduction of plasma VLDL-C, LDL-C, and triglycerides. In addition, gemcabene has been shown to markedly lower C-reactive protein. Gemcabene is liver-directed and reduces apoC-III mRNA and plasma levels. Gemcabene also reduces acetyl-CoA carboxylase (ACC) and CCR2/CCR5 receptor mRNA levels, which may have applications in non-alcoholic steatohepatitis (NASH)/non-alcoholic fatty liver disease (NAFLD). Gemcabene has demonstrated proof of concept efficacy in the STAMTM model for NASH developed at
About Gemphire
Gemphire is a clinical-stage biopharmaceutical company that is committed to helping patients with cardiometabolic disorders, including dyslipidemia and NASH. We are focused on providing new treatment options for cardiometabolic diseases through our complementary, convenient, cost-effective product candidate gemcabene as add-on to the standard of care especially statins that will benefit patients, physicians, and payors. Gemphire has initiated 3 clinical trials for homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH)/atherosclerotic cardiovascular disease (ASCVD), and severe hypertriglyceridemia (SHTG) under NCT02722408, NCT02634151, and NCT02944383, respectively with a 4th planned trial in NASH. Please visit www.gemphire.com for more information.
Forward Looking Statements
Any statements in this press release about Gemphire’s future expectations, plans and prospects, including statements about Gemphire’s financial prospects, future operations and sufficiency of funds for future operations, clinical development of Gemphire’s product candidate, expectations regarding future clinical trials and future expectations and plans and prospects for Gemphire, expectations regarding operating expenses and cash used in operations, and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," “scheduled” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the success and timing of Gemphire’s regulatory submissions and pre-clinical and clinical trials; regulatory requirements or developments; changes to Gemphire’s clinical trial designs and regulatory pathways; changes in Gemphire’s capital resource requirements; Gemphire’s ability to obtain additional financing; Gemphire’s ability to successfully market and distribute its product candidate, if approved; Gemphire’s ability to obtain and maintain its intellectual property protection; and other factors discussed in the "Risk Factors" section of Gemphire’s Quarterly Report on Form 10-Q for the quarterly period ended
Gemphire Therapeutics Inc. | |||||||||||
Balance Sheet Data | |||||||||||
(in thousands) | |||||||||||
December 31, | December 31, | ||||||||||
2016 | 2015 | ||||||||||
(unaudited) |
|||||||||||
Cash and cash equivalents | $ | 24,033 | $ | 3,620 | |||||||
Total assets | 24,754 | 4,490 | |||||||||
Accounts payable and accrued liabilities | 4,121 | 2,148 | |||||||||
Convertible notes | — | 6,769 | |||||||||
Total liabilities | 4,122 | 8,917 | |||||||||
Series A convertible preferred stock | — | 7,953 | |||||||||
Common stock | 17 | 12 | |||||||||
Additional paid–in capital | 47,674 | — | |||||||||
Accumulated deficit | (27,059 | ) | (12,392 | ) | |||||||
Total stockholders’ equity (deficit) | 20,632 | (12,380 | ) | ||||||||
Condensed Statements of Comprehensive Loss | ||||||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||
For the Three Months Ended | For the Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Operating expenses: | ||||||||||||||||
General and administrative | $ | 2,389 | $ | 1,047 | $ | 5,956 | $ | 3,177 | ||||||||
Research and development | 4,839 | 1,464 | 8,740 | 3,991 | ||||||||||||
Acquired in–process research and development | — | — | — | 908 | ||||||||||||
Total operating expenses | 7,228 | 2,511 | 14,696 | 8,076 | ||||||||||||
Loss from operations | (7,228 | ) | (2,511 | ) | (14,696 | ) | (8,076 | ) | ||||||||
Interest and other income (expense) | 14 | (59 | ) | 110 | (953 | ) | ||||||||||
Net loss | $ | (7,214 | ) | $ | (2,570 | ) | $ | (14,586 | ) | $ | (9,029 | ) | ||||
Adjustment to redemption value on Series A convertible preferred stock | — | (150 | ) | (366 | ) | (2,968 | ) | |||||||||
Premium upon substantial modification of convertible notes with certain stockholders | — | (1,047 | ) | — | (1,047 | ) | ||||||||||
Net loss attributable to common stockholders | $ | (7,214 | ) | $ | (3,767 | ) | $ | (14,952 | ) | $ | (13,044 | ) | ||||
Net loss per share: | ||||||||||||||||
Basic and diluted | $ | (0.78 | ) | $ | (1.14 | ) | $ | (2.57 | ) | $ | (4.54 | ) | ||||
Number of shares used in per share calculations: | ||||||||||||||||
Basic and diluted | 9,264 | 3,297 | 5,809 | 2,875 | ||||||||||||
Contact:Andrew McDonald , Ph.D.LifeSci Advisors, LLC (646) 597-6987Jeff Mathiesen , CFOGemphire Therapeutics Inc. (734)-245-1700