Gemphire Announces First Quarter 2017 Financial Results and Provides Corporate Update
“The first quarter was a very productive start to 2017 for Gemphire, highlighted by continued progress in developing gemcabene, our first-in-class, once-daily, oral drug candidate for the treatment of dyslipidemia and NALFD/NASH,” said
First Quarter & Recent Corporate Highlights
- In January, we announced positive preclinical proof of concept data on gemcabene in the treatment of nonalcoholic steatohepatitis (NASH) and plans to launch a clinical development program in NASH.
- In January, we announced positive interim data on the LDL-C primary endpoint from the ongoing open label COBALT-1 trial investigating gemcabene in homozygous familial hypercholesterolemia (HoFH) patients. No serious adverse events (SAEs) have been reported and the safety profile remains consistent with previous studies.
- In March, we presented results of a double-blind, randomized, placebo controlled, Phase 2 trial that investigated the insulin sensitization and LDL-C lowering of gemcabene in non-diabetic, obese patients at the
American College of Cardiology 66th Annual Scientific Session inWashington , D.C. Gemcabene was associated with a doubling of mean increase in glucose disposal rate to 13% compared to a 6.8% increase for placebo, and it lowered LDL-C by 40%, consistent with past results in hypercholesterolemia subjects. - In March, we closed a
$12.5 million private placement that extends the Company’s projected cash runway to late 2018. The net proceeds provide funding for the planned clinical development program for gemcabene in NASH patients, manufacturing and related process development activities, and general corporate purposes. - In May, we presented a poster on gemcabene’s mechanism of action at the Arteriosclerosis, Thrombosis and Vascular Biology | Peripheral Vascular Disease (ATVB|PVD) 2017 Scientific Sessions, which took place in Minneapolis, MN.
Upcoming 2017 and 2018 Clinical Milestones
- Top-line results from COBALT-1 Phase 2b trial are expected in late
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 targeted for the first quarter of 2018 based on current pace of enrollment.
- Plan to initiate Phase 2 clinical development program (AZURE-1) in NASH in the second half of 2017 with top-line results targeted for second half of 2018.
First Quarter 2017 Financial Update
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
Net loss attributable to common stockholders for the three months ended
Cash and cash equivalents at
As we previously guided, management expects full year 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. Accordingly, we expect second quarter 2017 operating expenses and cash used in operations to continue to be substantially above comparable prior period levels, and to be above first quarter 2017 levels. In addition, management expects quarterly non-cash, share-based compensation levels to trend at or above first quarter levels through 2017. Based on the Company’s current operating plans, management believes existing cash, including the net proceeds from the private placement, is sufficient to fund operations through completion of all three of the ongoing dyslipidemia trials, as well as the new NASH Phase 2 trial expected to be complete in the second half of 2018.
Corporate Update
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In March, the Company announced the results of a Phase 2 trial that investigated insulin sensitization and LDL-C lowering by gemcabene in non-diabetic, obese patients. The results were featured in a poster presentation at the
In May, the Company presented a Poster at the Arteriosclerosis, Thrombosis and Vascular Biology | Peripheral Vascular Disease (ATVB|PVD) 2017 Scientific Sessions confirming the pleiotropic effects with multiple mechanisms of action for gemcabene in in vitro models. Across the various models, gemcabene was shown to lower hepatic gene biomarkers for lipid regulation (ACC1, APOC-III, Sulfatase 2,ADH4, and HMG-CoA Synthase 2) and inflammation (CRP, TNF-α, MCP-1, CCR2, CCR5, NF-Kβ, MIP-1β) as well as plasma biomarkers (LDL-C, TG, hsCRP).
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 inhibition of 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 and improve insulin sensitization. Gemcabene is liver-directed and reduces apoC-III mRNA and plasma levels. Gemcabene also reduces acetyl-CoA carboxylase (ACC1) 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 STAM™ 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 fourth planned trial in NASH to initiate in second half of 2017. 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 Annual Report on Form 10-K for the year ended
Gemphire Therapeutics Inc. Balance Sheet Data (in thousands) |
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March 31, | December 31, | |||||||
2017 | 2016 | |||||||
(unaudited) |
||||||||
Cash and cash equivalents | $ | 29,282 | $ | 24,033 | ||||
Total assets | 29,842 | 24,754 | ||||||
Accounts payable and accrued liabilities | 4,543 | 4,121 | ||||||
Total liabilities | 4,545 | 4,122 | ||||||
Common stock | 18 | 17 | ||||||
Additional paid–in capital | 59,834 | 47,674 | ||||||
Accumulated deficit | (34,555 | ) | (27,059 | ) | ||||
Total stockholders’ equity | 25,297 | 20,632 |
Condensed Statements of Comprehensive Loss (in thousands, except per share amounts) |
||||||||
For the Three Months Ended | ||||||||
March 31, | ||||||||
2017 | 2016 | |||||||
(unaudited) | ||||||||
Operating expenses: | ||||||||
General and administrative | $ | 2,223 | $ | 1,050 | ||||
Research and development | 5,280 | 1,176 | ||||||
Total operating expenses | 7,503 | 2,226 | ||||||
Loss from operations | (7,503 | ) | (2,226 | ) | ||||
Interest and other income (expense), net | 7 | 123 | ||||||
Net loss | $ | (7,496 | ) | $ | (2,103 | ) | ||
Adjustment to redemption value on Series A convertible preferred stock | — | (149 | ) | |||||
Net loss attributable to common stockholders | $ | (7,496 | ) | $ | (2,252 | ) | ||
Net loss per share: | ||||||||
Basic and diluted | $ | (0.79 | ) | $ | (0.65 | ) | ||
Number of shares used in per share calculations: | ||||||||
Basic and diluted | 9,521 | 3,469 |
Contact:Andrew McDonald , Ph.D.LifeSci Advisors, LLC (646) 597-6987Jeff Mathiesen , CFOGemphire Therapeutics Inc. (734)-245-1700